HHS Acquisition Regulation: Regulatory Review, 80634-80714 [2024-17095]

Download as PDF 80634 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules DEPARTMENT OF HEALTH AND HUMAN SERVICES 48 CFR Parts 301, 302, 303, 304, 305, 306, 308, 309, 311, 312, 313, 314, 315, 316, 318, 319, 322, 323, 324, 325, 326, 327, 330, 331, 332, 333, 334, 335, 336, 337, 341, 342, 343, 344, 345, 347, 352, and 370 RIN 0991–AC36 HHS Acquisition Regulation: Regulatory Review Department of Health and Human Services. ACTION: Proposed rule. AGENCY: The Department of Health and Human Services (HHS) is proposing to amend and update its Health and Human Services Acquisition Regulation (HHSAR) to update and streamline the HHSAR. Under this initiative, all parts of the regulation were reviewed to streamline the regulation, to revise or remove policy superseded by changes in the Federal Acquisition Regulation (FAR), to remove any procedural guidance that is internal to HHS into a new HHS Acquisition Manual (HHSAM) as internal policies, guidance, and instructions. The rule would add new coverage to implement agency unique requirements. The HHSAR would also be updated to reflect organizational changes in the Department, incorporate recent statutory changes and government mandates, and to accomplish editorial revisions for clarification. DATES: Comments must be received on or before December 2, 2024, to be considered in the formulation of the final rule. ADDRESSES: Submit written comments in response to HHSAR Case 2023–002 through the Federal eRulemaking Portal at: https://www.regulations.gov by searching for ‘‘HHSAR Case 2023–002’’. Select the link ‘‘Comment Now’’ and follow the ‘‘Submit a comment’’ instructions. Please include your name, company name (if any), and indicate they are submitted in response to ‘‘RIN 0991–AC36—HHS Acquisition Regulation: Regulatory Review (HHSAR Case 2023–002).’’ Warning: Do not include any personally identifiable information (such as name, address, or other contact information) or confidential business information that you do not want publicly disclosed. All comments may be posted on the internet and can be retrieved by most internet search engines. No deletions, modifications, or redactions will be made to comments received. ddrumheller on DSK120RN23PROD with PROPOSALS2 SUMMARY: VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 Inspection of Public Comments: All comments received before the close of the comment period will be available for viewing by the public, including personally identifiable or confidential business information that is included in a comment. You may wish to consider limiting the amount of personal information that you provide in any voluntary public comment submission you make. HHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of https://www.regulations.gov. Follow the search instructions on that website to view the public comments. FOR FURTHER INFORMATION CONTACT: Mr. Jarreau Vieira, Chief, Acquisition RuleMaking Branch, U.S. Department of Health and Human Services, Office of the Assistant Secretary for Financial Resources, Office of Acquisition Policy, 200 Independence Avenue SW, Washington, DC 20201. Email: acquisition_policy@hhs.gov, Telephone: (202) 731–4625. This is not a toll-free telephone number. SUPPLEMENTARY INFORMATION: I. Background This rulemaking is being taken under the authority of the Office of Federal Procurement Policy (OFPP) Act which provides the authority for an agency head to authorize the issuance of agency acquisition regulations that implement or supplement the FAR. The OFPP Act, as codified in 41 U.S.C. 1702, provides the authority for the FAR and for the issuance of agency acquisition regulations consistent with the FAR. This authority ensures that Government procurements are handled fairly and consistently, that the Government receives overall best value, and that the Government and contractors both operate under a known set of rules. The statute at 41 U.S.C. 1121(b) provides authority for the FAR, while 41 U.S.C. 1121(e), 1702(b)(3)(e), and 1702(c)(2), when read together, provide authority for the issuance of agency acquisition regulations consistent with the FAR. HHS issues the HHSAR under these authorities. HHS has determined that changes to the HHSAR are necessary to align it to the FAR. As a result, the HHS Acquisition Policy Division Integrated Project Team (IPT) under the direction of the Senior Procurement Executive and composed of representatives from HHS’s operating divisions (OPDIVs) and staff divisions (STAFFDIVs) and other PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 agency stakeholders, have participated in reviews of the regulation, resulting in a complete revision of the HHSAR. HHS conducted a comprehensive review of the HHSAR with the goal of updating obsolete coverage, streamlining policies and procedures where applicable consistent with current guidance, and moving internal policies applicable to the HHS acquisition workforce to a new HHS Acquisition Manual (HHSAM). The HHSAM will incorporate portions of the internal procedural guidance removed from the HHSAR, as well as other internal agency acquisition policy. This proposed rule reflects changes that need to be made to the HHSAR to implement and/or supplement the FAR. HHS is proposing to substantially revise and streamline the HHSAR to update or remove references to superseded or obsolete policies, procedures, and organizations and to incorporate electronic links to FAR provisions and other matters referenced in the HHSAR. Other revisions include incorporating additional policies, solicitation provisions, and/or contract clauses into the HHSAR to implement and supplement the FAR and satisfy HHS unique mission needs and responsibilities. This includes incorporating changes in dollar and approval thresholds, definitions, and HHS position titles and offices. The reissued HHSAR proposed in this notice would correct inconsistencies, remove redundant and duplicate material already covered by the FAR, delete outdated material or information, and appropriately renumber HHSAR text, clauses, and provisions where required to comport with FAR format, numbering, and arrangement. All amendments, revisions, and removals have been reviewed and concurred with by a HHSAR revision team from each of the OPDIVs/STAFFDIVs and key agency stakeholders. This effort will create a 2024 edition of the HHSAR. Currently, HHS is tracking a number of new FAR case proposed and final rules, as well as Executive orders (E.O.s) and directives that the Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (the Councils) are reviewing for potential impact to the FAR system. The Executive orders include E.O. 13985, ‘‘Advancing Racial Equity and Support for Underserved Communities Through the Federal Government’’ (86 FR 7009; Jan. 25, 2021), E.O. 14005, ‘‘Ensuring the Future is Made in All of America by All of America’s Workers’’ (86 FR 7475; Jan. 28, 2021), and E.O. 14008, ‘‘Tackling the Climate Crisis at Home and Abroad’’ (86 FR 7619; Feb. 1, 2021). If and when FAR cases and proposed E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules rules are drafted and FAR final rules are published, HHS intends to examine each of these for impact to the HHSAR and any updates that may be required to maintain the HHSAR. HHS is institutionalizing an ongoing, sustained HHSAR refreshment process, so that as FAR proposed and final rules, E.O.s, and other directives are issued, HHS will initiate new HHSAR cases to bring the regulation in alignment and to avoid duplication, as necessary. HHS will examine any FAR final rules that become effective and will take into consideration such FAR changes, as appropriate, in subsequent rulemakings. When needed, HHS will also consider use of an advanced notice of proposed rulemaking (ANPRM) to obtain public input as the agency implements rulemaking to address new and emerging issues that may be identified by the Councils or by HHS as a result of E.O.s and other directives. HHS will use this public input to inform how HHS implements such guidance in the HHSAR. The HHSAR uses the regulatory structure and arrangement of the FAR, and headings and subject areas are broken up consistent with the FAR content. The HHSAR is divided into subchapters, parts (each of which covers a separate aspect of acquisition), subparts, sections, and subsections. When Federal agencies acquire supplies and services using appropriated funds, the purchase is governed by the FAR, set forth at title 48 Code of Federal Regulations (CFR), chapter 1, parts 1 through 53, and the agency regulations that implement and supplement the FAR. The HHSAR is set forth at 48 CFR, chapter 3, parts 301 through 370. HHS is proposing to revise the HHSAR to add new policy or regulatory requirements and to remove any guidance that is applicable only to HHS’s internal operating processes or procedures. Codified acquisition regulations may be amended and revised only through rulemaking. ddrumheller on DSK120RN23PROD with PROPOSALS2 Discussion and Analysis HHS proposes to make the following changes to the HHSAR as a part of its updating and streamlining initiative. For procedural guidance cited below that is proposed to be deleted from the HHSAR, each section cited for removal has been considered for inclusion in HHS’s internal agency operating procedures in accordance with FAR 1.301(a)(2). Similarly, delegations of authorities that are removed from the HHSAR will be included in the HHSAM as internal agency guidance. VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 We propose to revise the following parts of the HHSAR, 48 CFR chapter 3: Parts 301, 302, 303, 304, 305, 306, 308, 309, 311, 312, 313, 314, 315, 316, 319, 322, 323, 324, 326, 327, 330, 331, 332, 333, 334, 335, 336, 337, 342, 352, and 370. We propose to add seven (7) parts to the HHSAR: Parts 318 (Emergency Acquisitions); 325 (Foreign Acquisition); 341 (Acquisition of Utility Services); 343 (Contract Modifications); 344 (Subcontracting Policies and Procedures); 345 (Government Property); and 347 (Transportation). And, to streamline the HHSAR and improve its use and benefit to the public, small businesses, and the HHS acquisition workforce, we propose to remove the following three (3) parts from the HHSAR: Parts 307 (Acquisition Planning); 310 (Market Research); and 317 (Special Contracting Methods). This would also move internal procedural guidance still applicable from these parts to the HHSAM, and/or remove outdated and unnecessary text or policy redundant to the FAR. We propose to revise the authority citations cited in each HHSAR part to reflect as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. Where additional authorities for a specific part are applicable, we identify them under that discussion of each HHSAR part later in this preamble. We propose to retain the authority of 5 U.S.C. 301. This authority provides that the head of an Executive department or military department may prescribe regulations for the government of his department, the conduct of its employees, the distribution and performance of its business, and the custody, use, and preservation of its records, papers, and property. We propose to retain the authority of 40 U.S.C. 121(c) and slightly revise the reference. This authorizes the head of each executive agency to issue orders and directives that the agency head considers necessary to carry out the FAR. We propose to include a reference to 41 U.S.C. 1121(c)(3). This provision states that the authority of an executive agency under another law to prescribe policies, regulations, procedures, and forms for procurement is subject to the authority conferred in section 1121, as well as other sections of title 41. We propose to add an authority citation for 41 U.S.C. 1702 which addresses the acquisition planning and management responsibilities of HHS’ Senior Procurement Executive. And we propose to add the citation of ‘‘48 CFR 1.301 through 1.304’’ to reflect PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 80635 the authority and responsibility set forth in the FAR and delegated to Federal agencies to issue agency regulations that supplement and implement the FAR. Any other proposed changes to authorities are shown under the individual parts below. Throughout the proposed rule (including in the discussion of each proposed revised or new HHSAR part), whenever HHS indicates that it proposes to revise and update the citation(s) to the FAR and HHSAR, it is for the purpose of comporting with FAR Drafting Guidelines convention and style, and in accordance with FAR 1.105–2, Arrangement of regulations, that specifies how the FAR and by extension the HHSAR is to be referenced within the body of the regulation. References to revising and updating citations are to either correct the current citations, correct any FAR or HHSAR references to a more suitable citation, or add appropriate FAR or HHSAR citations where necessary. HHSAR Subchapter Headings Under the authority of 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702, and 48 CFR 1.301 through 1.304 we propose to update the following HHSAR subchapter heading to align with the Federal Acquisition Regulation, title 48, chapter 1: • SUBCHAPTER B—COMPETITION AND ACQUISITION PLANNING is revised to read: SUBCHAPTER B— ACQUISITION PLANNING We propose to update the following HHSAR subchapter numbering and heading to provide a similar numbering and heading construct as other agency supplemental regulations: • SUBCHAPTER M—HHS SUPPLEMENTATIONS is revised to read: SUBCHAPTER I—DEPARTMENT SUPPLEMENTARY REGULATIONS HHSAR Part 301—HHS Acquisition Regulation System We propose to revise the authority citations for part 301, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(b), (c)(3); 41 U.S.C. 1303(a)(2); 41 U.S.C. 1702, 1707; and 48 CFR 1.301 through 1.304. In addition to the authorities described in the Discussion and Analysis above, we propose to add the authority of the statute at 41 U.S.C. 1121(b) which provides authority for the FAR, while 41 U.S.C. 1121(e), 41 U.S.C. 1702(b)(3)(e), and 41 U.S.C. 1702(c)(2), when read together, provide authority for the issuance of agency acquisition regulations consistent with the FAR. E:\FR\FM\03OCP2.SGM 03OCP2 ddrumheller on DSK120RN23PROD with PROPOSALS2 80636 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules We also propose to add the authority of 41 U.S.C. 1303(a)(2) to HHSAR part 301. This authority provides that other regulations relating to procurement issued by an executive agency shall be limited to regulation essential to implement Government-wide policies and procedures within the agency, and additional policies and procedures required to satisfy the specific and unique needs of the agency. HHS follows these limitations on the policy and procedures promulgated in the HHSAR. We also propose to add the authority of 41 U.S.C. 1707 to HHSAR part 301. This authority prescribes the required publication of proposed rules that HHS follows to ensure transparency and the ability of the public to comment on the unique policies and procedures HHS has identified to implement specific agency requirements to fulfill its mission and issue and administer contracts and acquisitions in accordance with the FAR. We propose to add section 301.000, Scope of part, to prescribe general Department of Health and Human Services Acquisition Regulation (HHSAR) policies, including information regarding the maintenance and administration of the HHSAR, acquisition policies, and procedures for deviation from the HHSAR and the Federal Acquisition Regulation (FAR). In subpart 301.1, Purpose, Authority, Issuance, we propose to revise section 301.101, Purpose, to remove scope of part language now covered in section 301.000, as well as moving the remaining language to the more appropriately placed new subpart 301.3, Agency Acquisition Regulations, section 301.301, Policy. We propose to add language that the subpart establishes uniform acquisition policies and procedures to implement and supplement the FAR, and the authorities under which the HHSAR is issued. We propose to revise section 301.103, Authority, to prescribe the delegated authority by the Secretary of HHS to the Senior Procurement Executive (SPE) for clarity and explain the authority under which the HHSAR is issued, move the 48 CFR chapter 3 reference to new section 301.501–1, as well as other administrative edits. We propose to add section 301.104, Applicability, to prescribe that the FAR and the HHSAR apply to all HHS acquisitions, except where expressly excluded. We propose to add sections 301.105, Issuance, and 301.105–1, Publication and code arrangement, to identify the HHSAR issuance as 48 CFR chapter 3, VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 which was moved from section 301.103. We propose to add section 301.105–2 Arrangement of regulations, to prescribe the HHSAR arrangement, numbering system, and references and citations, to conform with FAR 1.105–2. We propose to add section 301.105–3, Copies, regarding access to and HHSAR availability. We propose to revise section 301.106, OMB Approval under the Paperwork Reduction Act, to revise the title to comport with FAR 1.106, and to identify that the list of the information collection and recordkeeping requirements contained in the HHSAR, approved by the Office of Management and Budget (OMB), are revised to reflect current approved information collections. This list would be otherwise publicly available on reginfo.gov after a final rule pertaining to this proposed rule is published and effective. We propose to add section 301.107, Certifications, to prescribe when a new requirement for a certification by a contractor or offeror may be included in the HHSAR, per 41 U.S.C. 1304(a)(b)(3). We propose to remove the reserved subpart 301.2, as unnecessarily needed. We propose to add subpart 301.3, Agency Acquisition Regulations, and section 301.301, Policy, where we propose to move the language from section 301.101 to be more appropriately placed here to describe that the HHSAR contains HHS policies governing implementation and supplementation of the FAR, including minor administrative edits. We propose to add section 301.301– 70, Amendment of the HHSAR, as an HHS supplemental section to the FAR prescribing the processes for requesting a change to the HHSAR and maintenance of HHSAR and HHSAM content and publication. We propose to add section 301.303– 70, Publication and codification— HHSAR, to prescribe that the HHSAR and HHSAM shall parallel the FAR in format, arrangement, and numbering systems. The section also establishes that HHSAR titles and numbering sequencing shall conform with the FAR to the maximum extent practicable, describes the policy, guidance and/or procedures regarding HHSAR numbering sequence when supplementing the FAR, and provides unique HHS Operating Division guidance on supplementary material numbering sequencing. We propose to add section 301.304, Agency control and compliance procedures, which provides that the SPE is responsible for amending the HHSAR for compliance with FAR 1.304. PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 In subpart 301.470, Deviations from the FAR and HHSAR, we propose to remove section 301.401, Deviations, and revise the section number and title to section 301.402, Policy, and propose additional references to new sections 301.403 and 301.404, as well as administrative edits for clarification. We propose to add section 301.403, Individual deviations, to prescribe the delegated authority to the SPE. We propose to add section 301.404, Class deviations, to prescribe the delegated authority to the SPE. In subpart 301.6, Career Development, Contracting Authority, and Responsibilities, we propose to add section 301.601, General, to prescribe the delegated authority to the Chief Acquisition Officer and the SPE, to manage the HHS contracting functions. We propose to add the authorities delegated to the SPE in paragraph (a), and the authorities the SPE may further delegate to other HHS officials, such as the heads of the contracting activities (HCAs), and that HCA’s may authorize the use of ordering officers, in paragraph (b). We propose to revise section 301.602– 3, Ratification of unauthorized commitments, in paragraph (a) with administrative edits and to move agency procedural language to be appropriately placed in the HHSAM. We propose to remove paragraph (b)(2) as repetitive to the FAR and moving paragraph (c)(5) to the HHSAM as procedural language. We propose to revise section 301.603, Selection, appointment, and termination of appointment of contracting officers, and 301.603–1, General, to establish SPE and re-delegable authority. We propose to add section 301.603– 3, Appointment, to prescribe agency policy regarding contracting officer appointments and delegations of authority, and that HCAs may delegate micro-purchase authority to HHS employees under the HHS Governmentwide Purchase Card Program. We propose to add section 301.604, Contracting Officer’s Representative (COR), and 301.604–70, Contract clause, which provides the prescription for contracting officers to insert the new clause at 352.201–70, Contracting Officer’s Representative, in solicitations and contracts, when the contracting officer intends to designate a COR. We propose to add section 301.707, Signatory authority, to state that the signature authorities for determinations and findings, when delegable in the FAR, are prescribed in the applicable HHSAR parts or corresponding HHSAM part. E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS2 HHSAR Part 302—Definitions of Words and Terms We propose to revise the authority citations for part 302, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. In subpart 302.1, Definitions, and section 302.101, Definitions, we propose to add one new definition, remove one definition, and revise two existing definitions. We propose to add the definition for ordering officer, and to remove the definition for Contracting Officer’s Representative as it is duplicative of the FAR. We also propose to revise the definition for agency head or head of the agency to add delegation designation clarifications, and to revise the definition for head of the contracting activity (HCA) to make minor edits and to add the HHSAR citation for HCA delegated authorities. HHSAR Part 303—Improper Business Practices and Personal Conflicts of Interest We propose to revise the authority citations for part 303, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. In subpart 303.1, Safeguards, we propose to revise the text at 303.101–3, Agency regulations, to specify employee applicability of the HHS Standards of Conduct, as found in 45 CFR part 73. We propose to remove 303.104–7, Violations or possible violations of the Procurement Integrity Act, to appropriately move the content to the HHSAM as agency procedures. In subpart 303.2, Contractor Gratuities to Government Personnel, we propose no revisions to section 303.203, Reporting suspected violations of the Gratuities clause. We propose to add section 303.204, Treatment of violations, to provide guidance required by FAR 3.203, and to provide notice and hearing information required by FAR 3.204. The section identifies the Suspending and Debarring Official (SDO) as the official designated to make the determination whether a violation of the Gratuities clause at FAR 52.203–3 has occurred and what action will be taken under FAR 3.204(c). We also propose adding the cross reference to 309.406–3, Procedures, when the SDO determines that a violation has occurred, and that debarment is being considered. In subpart 303.6, Contracts with Government Employees or VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 Organizations Owned or Controlled by Them, we propose to revise section 303.603, Exceptions, with minor administrative edits for clarification. In subpart 303.7, Voiding and Rescinding Contracts, we propose to revise section 303.704, Policy, with a minor administrative edit. We propose to remove subpart 303.10, Contractor Code of Business Ethics and Conduct, and section 303.1003, Requirements, to appropriately move the content to the HHSAM as agency procedures. HHSAR Part 304—Administrative and Information Matters We propose to revise the authority citations for part 304, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to revise the title of part 304 to ‘‘Administrative and Information Matters,’’ to comport with FAR part 4. We propose to remove subpart 304.6, Contract Reporting, and section 304.6, General, and propose the content be moved to the HHSAM as agency procedures. We propose to remove subpart 304.16, Unique Procurement Instrument Identifiers, and section 304.1600, Scope of subpart, and we propose the content be moved to the HHSAM as agency procedures. In subpart 304.71, Review and Approval of Proposed Contract Actions, we propose to remove the underlying sections, and reserve the subpart. We propose to remove section 304.7100, Policy, and propose the content be moved to the HHSAM as agency procedures. In subpart 304.72, Affordable Care Act Prevention and Public Health Fund— Reporting Requirements, section 304.7200, Scope of subpart, we propose to move some of the language to the retitled section 304.7201, Policy, due to the nature of the implementing language. We propose to retitle section 304.7201 as ‘‘Policy,’’ and move paragraphs (a) through (c) to the HHSAM as agency procedures. We propose minor administrative edits to the remaining content and restructuring the section to accommodate the relocated from section 304.7200. We propose to revise section 304.7202, Contract clause, to add the applicable solicitations and contract actions value of $25,000 or more threshold, and to provide minor administrative edits. PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 80637 HHSAR Part 305—Publicizing Contract Actions We propose to revise the authority citations for part 305, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to remove subpart 305.3, Synopses of Contract Awards, and section 305.303, Announcement of contract awards, and propose the content be moved to the HHSAM as agency procedures. We propose to add subpart 305.4, Release of Information, and section 305.402, General public, to state that requests from the public for specific records pertaining to contract actions shall be processed according to the Freedom of Information Act. We propose to add sections 305.470, Contractor award announcements, advertisements, and releases, and 305.470–1, Policy, to provide policy that restricts contractors from referring to its HHS contract(s) in commercial advertising in a manner that states or implies the Government approves or endorses the contractor’s products or services, or considers them superior to other products and services. This section also states that HHS contractors share responsibility for protecting sensitive and classified information, and approval requirements by the contracting officer prior to the release of any contract award information by the contractor. We propose to add section 305.470– 2, Contract clause, which would also prescribe clause 352.205–70, Advertisements, Publicizing Awards, and Releases, in solicitations and contracts that exceed the simplified acquisition threshold and includes an Alternate I for contracts involving sensitive or classified information. We propose removing subpart 305.5, Paid Advertisements, and section 305.502, Authority, and propose to move the content to the HHSAM as agency procedures. In subpart 305.70, Publicizing Requirements Funded From the Affordable Care Act Prevention and Public Health Fund, we propose minor administrative edits for clarification to sections 305.7003, Publicizing preaward, and 305.7004, Publicizing postaward. HHSAR Part 306—Competition Requirements We propose to revise the authority citations for part 306, for the reasons set forth in the discussion and analysis E:\FR\FM\03OCP2.SGM 03OCP2 80638 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS2 section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. In subpart 306.2, Full and Open Competition After Exclusion of Sources, we propose to revise section 306.202, Establishing or maintaining alternative sources, by redesignating paragraph (a) as paragraph (b)(1) to comport with FAR and HHSAR numbering policy, move the existing content at paragraph (b)(1) to the HHSAM as agency procedures, and provide administrative edits for clarification. In subpart 306.3, Other Than Full and Open Competition, in section 306.302– 1, Only one responsible source and no other supplies or services will satisfy agency requirements, we propose to remove the reference to FAR 6.302–1 in the title, assign paragraph designation (a)(2) to the first paragraph to comport with FAR and HHSAR numbering policy, and to add descriptive implementing language. We propose to add section 306.302–2, Unusual and compelling urgency, to prescribe delegated authority to the SPE regarding making the determination that exceptional circumstances apply when seeking a total period of performance exceeding one year, including all options, for a contract awarded or modified using the authority at FAR 6.302–2(d)(1)(ii). In subpart 306.5, Competition Advocates, we propose to revise the title to ‘‘Advocates for Competition,’’ to comport with the FAR subpart title. We propose to revise section 306.501, Requirement, to prescribe the designation of the Advocate for Competition as the Director, Acquisition Policy Division, Office of Acquisitions (ASFR/APD). We also propose to add that the Director, ASFR/APD may further delegate this authority to appoint an alternate agency advocate for competition, and that the HHS Advocate for Competition shall designate procuring activity advocates for competition in accordance with FAR 6.501. We also propose to add the uniform resource locator for the location of the list of HHS procuring activity advocates for competition. HHSAR Part 307—Acquisition Planning We propose to remove and reserve HHSAR part 307 in its entirety including underlying section 307.105, Contents of written acquisition plans, as the language is duplicative of the FAR, and to move other content to the HHSAM as needed as agency internal procedures. VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 HHSAR Part 308—Required Sources of Supplies and Services We propose to revise the authority citations for part 308, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to remove subpart 308.4, Federal Supply Schedules, and section 308.405–6, Limited source justification and approval, as duplicative to the FAR, and to move some content to the HHSAM as agency procedures. In subpart 308.8, Acquisition of Printing and Related Supplies, we recommend removing sections 308.800, Scope of subpart, and 308.801, Definitions, as the sections contain content duplicative of the FAR, and procedural in nature. We propose to move the applicable content to the HHSAM as agency procedures. In section 308.802, Policy, we propose to revise the existing content to explicitly state that unless specifically authorized in HHS contracts, no printing by a contractor or subcontractor is authorized under an HHS contract. And we propose to add language that permits contracting officers to authorize limited printing pursuant to the clause prescribed at section 308.870. We also propose to remove the information about HHS’ designated central printing authority to the HHSAM as internal agency guidance. We propose to revise section 308.803 by renumbering and retitling it to 308.870, Contract clause, which prescribes clause 352.208–70, Printing and Duplication, to be inserted in all solicitations, contracts, and orders for supplies or services over the simplified acquisition threshold, unless printing or increased duplication is authorized by statute. HHSAR Part 309—Contractor Qualifications We propose to revise the authority citations for part 309, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to add subpart 309.1, Responsible Prospective Contracts, and sections 309.104, Standards, and 309.104–1, General standards, to establish that for cost-reimbursement or incentive type contracts, or contracts with progress payments, the prospective contractor’s accounting system must provide reasonable stated assurances. In subpart 309.4, Debarment, Suspension, and Ineligibility, we PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 propose adding section 309.400, Scope of subpart, to establish that the subpart implements FAR subpart 9.4 and prescribes HHS procedures and related actions for the suspension and debarment of contractors. We propose to revise section 309.403, Definitions, by adding the definition for the Suspension and Debarment (S&D) Committee introduced in revised section 309.406–3. We also propose revising the existing definition to the Suspending and Debarring Official (SDO) to comport with the FAR 9.403, as well as revising the title of the appointed HHS SDO to Deputy Assistant Secretary for Acquisitions, to reflect the current title. We propose to remove section 309.404, System for Award Management (SAM) exclusions, as much of the content is duplicative of the FAR, and the remaining content be moved to the HHSAM as agency procedures. We propose to revise section 309.405, Effect of listing, by removing from the section title ‘‘(compelling reason determinations),’’ to comport with the title at FAR 9.405, and to move the existing content in paragraph (a) to the HHSAM as agency procedures and replace the content with language to prescribe the delegation of authority to the SDO and permit further redelegation to the HCA. We propose to add section 309.405– 1, Continuation of current contracts, which authorizes the continuation of contracts for contractors debarred (or proposed to be debarred) or suspended. It also requires a written determination before the award of orders or options on existing contracts with these contractors (see FAR 9.405–1(a)(2)) and delegates authority to the SDO with further redelegation to the HCA. We also propose to add section 309.405–2, Restrictions on subcontracting, which prescribes the delegated authority to the SDO, who further redelegates the authority to the HCA to consent to a contractor’s use of a subcontractor who is suspended, proposed for debarment, or is debarred. We propose to add section 309.406– 1, General, to provide additional SDO debarment consideration and determination factors and examples. We propose to revise section 309.406– 3, Procedures, to include minor administrative edits to the existing content, and to introduce a formal Suspending and Debarring Committee (S&D Committee) to assist the SDO in the final determination for debarment. This section also provides additional public-facing debarment referral procedures and S&D Committee procedures for transparency. E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules We propose to add sections 309.407, Suspension, and 309.407–1, General, to prescribe the delegated authority to the SDO to determine whether to continue business dealings with a suspended contractor, and to establish the SDO as the suspending official under the Federal Management Regulation at 41 CFR 102–117.295. We propose to revise section 309.407– 3, Procedures, to include minor administrative edits to the existing content, and to introduce a formal Suspending and Debarring Committee (S&D Committee) to assist the SDO in the final determination for suspension. This section also provides additional public-facing suspension referral procedures and S&D Committee procedures for transparency. We propose to revise section 309.470– 1, Situations where reports are required, to make administrative edits in stating that the contracting officer shall report to the HCA and SDO regarding the situations listed thereafter. We propose to add section 309.471, Fact-finding procedures, to establish procedures to resolve genuine disputes of material fact involving debarment or suspension determinations. The section provides details to include the Office of General Council, witnesses, and other factors needed to assist the SDO in a final suspension or debarment determination. We propose to add subpart 309.5, Organizational and Consultant Conflicts of Interest, and section 309.503, Waiver, to provide that the SPE is the designee at FAR 9.403 to waive general rules or procedures of the subpart. We also propose to add section 309.507–1, Solicitation provision, which prescribes the new provision at 352.209–70, Organizational Conflicts of Interest, to be included in any solicitation for the services addressed at FAR 9.502. HHSAR Part 310—Market Research We propose to remove HHSAR part 310, Market Research, and reserve the part as we propose to remove the coverage currently contained at section 310.001 as duplicative of the FAR. ddrumheller on DSK120RN23PROD with PROPOSALS2 HHSAR Part 311—Describing Agency Needs We propose to revise the authority citations for part 311, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to add subpart 311.1, Selecting and Developing Requirement Documents, and section 311.103, Market VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 acceptance, to prescribe that the authority is delegated to the HCA. We propose to add subpart 311.5, Liquidated Damages, and section 311.501, Policy, to establish that the HCA may reduce or waive the amount of liquidated damages assessed under a contracts, if the Commissioner, Financial Management Service, or designee, approves. We propose to add subpart 311.6, Priorities and Allocations, to provide information on the HHS Health Resources Priorities and Allocation System (HRPAS) that is part of the Federal Priorities and Allocations System. This subpart references guidance and procedures for use of the Defense Production Act (DPA) priorities and allocations authority with respect to health resources necessary or appropriate to promote the national defense as delegated to the Secretary of HHS. We propose to add section 311.600, Scope of subpart, to establish that the subpart details information on the HHS HRPAS that is part of the Federal Priorities and Allocations System. This subpart references guidance and procedures for use of the DPA priorities and allocations authority with respect to health resources necessary or appropriate to promote the national defense as delegated to the Secretary. We propose to add section 311.601, Definitions, to establish two definitions, national defense and rated order, as the definitions differ slightly from the FAR and are derived from 45 CFR part 101. We propose to add section 311.602– 70, The Health Resources Priorities and Allocation System, to reference Executive Order (E.O.) 13603, National Defense Resources Preparedness, dated March 16, 2012. This E.O. provides the Secretary the authority to require acceptance and priority performance of contracts or orders (other than contracts of employment) to promote the national defense over performance of any other contracts or orders, and to allocate materials, services, and facilities as deemed necessary or appropriate to promote the national defense, with respect to health resources is delegated to the Secretary. We propose to add section 311.603, Procedures, and section 311.603–70, Agency program, to reference specific HHS agency procedures as set forth in the HRPAS regulations at 45 CFR part 101, which provides guidance and procedures for use of the DPA priorities and allocations authority with respect to health resources, including the use of priority rated orders, necessary or appropriate to promote the national defense. PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 80639 In subpart 311.70, Section 508 Accessibility Standards, we propose to reserve the subpart, as we propose to move the content at section 311.7000, Defining electronic information technology requirements, to the HHSAM as agency procedures. In subpart 311.71, Public Accommodations and Commercial Facilities, we propose to revise section 311.7102, Contract clause, which prescribes clause 352.211–1, Public Accommodations and Commercial Facilities, be inserted in solicitations, contracts, and orders requiring the contractor to conduct events in accordance with 311.7100(b). We propose to revise clause number to 352.211–70, to comport with FAR numbering convention of supplemental clauses. In subpart 311.72, Conference Funding and Sponsorship, we propose minor administrative edits to section 311.7201, Funding and sponsorship. We also propose to revise section 311.7202, Contract clause, which prescribes clause 352.211–2, Conference Sponsorship Request and Conference Materials Disclaimer, be inserted in solicitations, contracts, and orders providing funding which partially or fully supports a conference. We propose to revise clause number to 352.211–71, to comport with FAR numbering convention of supplemental clauses. In subpart 311.73, Contractor Collection of Information, we propose minor administrative edits to section 311.7300, Policy. We also propose to revise section 311.7301, Contract clause, which prescribes clause 352.211–3, Paperwork Reduction Act, be inserted in solicitations, contracts, and orders that require a contractor to collect the same information from 10 or more persons. We propose to revise the clause number to 352.211–72, to comport with FAR numbering convention of supplemental clauses. HHSAR Part 312—Acquisition of Commercial Products and Commercial Services We propose to revise the authority citations for part 312, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to revise the title of part 312 to ‘‘Acquisition of Commercial Products and Commercial Services,’’ to comport with the FAR part 12 title. We propose to remove subpart 312.1, Acquisition of Commercial Items— General, and section 312.101, Policy, E:\FR\FM\03OCP2.SGM 03OCP2 80640 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS2 moving the content to the HHSAM as agency procedures. We propose to remove subpart 312.2, Special Requirements for the Acquisition of Commercial Items, and section 312.202, Market research and description of agency need, as the content is duplicative to the FAR. We propose adding subpart 312.3, Solicitation Provisions and Contract Clauses for the Acquisition of Commercial Products and Commercial Services, consisting of section 312.301, which prescribes clause 352.212–70, Gray Market and Counterfeit Items, which requires the contracting officer to insert in solicitations and contracts for new medical supplies, new medical equipment, new information technology equipment, and maintenance of medical or information technology equipment that includes replacement parts, if used, refurbished, or remanufactured parts are unacceptable, when the associated solicitation includes FAR provisions 52.212–1, Instructions to Offerors— Commercial Products and Commercial Services, and 52.212–2, Evaluation— Commercial Products and Commercial Services. HHSAR Part 313—Simplified Acquisition Procedures We propose to revise the authority citations for part 313, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to revise part 313, Simplified Acquisition Procedures, to remove one section and substantively revise subpart 313.3 to enact legislative requirements. We propose to remove section 313.003, Policy, which provides section 508 of the Rehabilitation Act of 1973 guidance for Information and Communication Technology acquisition. This guidance is also found at 339.203(a) and will be addressed in the HHSAM in part 339. We also propose to revise subpart 313.3, Simplified Acquisition Methods, and section 313.301, Governmentwide commercial purchase card. The existing content at 313.301 is removed and placed in the HHSAM as it is more appropriate for internal agency operating procedures. We propose to redesignate the section as 313.301–70, revise the heading to read ‘‘Governmentwide commercial purchase card—purchases of PPE’’, and state that the Infrastructure Investment and Jobs Act (IIJA), Public Law 117–58, Subtitle C, Make Personal Protective Equipment (PPE) in America (MPPEIA), applies to all purchases of PPE including those VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 transactions made using the Governmentwide commercial purchase card under the micro-purchase threshold. We are including a cross reference to subpart 325.71 for definitions, restrictions, and exceptions, when procuring PPE. HHSAR Part 314—Sealed Bidding We propose to revise the authority citations for part 314, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to remove subpart 314.1, Use of Sealed Bidding, and section 314.103, Policy, which states that electronic and information technology supplies and service shall comply with section 508 of the Rehabilitation Act of 1973, as the content is appropriately covered in part 339, Acquisition of Information Technology. We propose to retain subpart 314.4, Opening of Bids and Award of Contract, and section 314.404–1, Cancellation of invitations after opening, with no change to the content. We propose to revise section 314.407–3, Other mistakes disclosed before award, to add delegation, without redelegation, language to the HCA’s authority. We also propose to revise section 314.407– 4, Mistakes after award, to add delegation, without redelegation, language to the HCA’s authority. We propose to add sections 314.408, Award, and 314.408–70, Award when only one bid is received, to provide when only one bid is received in response to an invitation for bids, such bid may be considered and accepted if the contracting officer makes a written determination, approved one level above the contracting officer, documenting the stated issues in the section, and that the determination shall be placed in the contract file. HHSAR Part 315—Contracting by Negotiation We propose to revise the authority citations for part 315, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. In subpart 315.2, Solicitation and Receipt of Proposals and Information, we propose to remove section 315.204– 5, Part IV—Representations and instructions, as the content is repetitive to the FAR, and moving some content to the HHSAM as agency procedure. We recommend retaining section 315.208, Submission, modification, PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 revision, and withdrawal of proposals, as a title with no content, and moving the current content to new section 315.208–70, Submission, modification, revision, and withdrawal of proposals— R&D acquisitions, to clarify that the content applies in the case of biomedical or behavioral research and development acquisitions only. We also propose to restructure the content into redesignated paragraph numbers. Paragraph (a) contains the original 315.208(b) text, revised for clarity. Paragraph (b) is a new proposed paragraph that sets forth the policy permitting the contracting officer to consider a proposal received concerning biomedical or behavioral research and development (R&D) acquisitions after the date specified for receipt, under certain conditions. It is based on the existing provision at 352.215–70, Late Proposals and Revisions, that pertains only to biomedical or behavioral R&D solicitations using competitive proposals. While the provision itself was previously codified, there was no corresponding policy in the HHSAR, which is now provided. Paragraph (c) contains the original 315.208(b)(2) content. We propose redesignating the paragraph as paragraph (c), removing the acronym ‘‘HCA’’, and substituting it with ‘‘contracting officer’’ to reflect that the contracting officer will exercise this authority rather than the HCA. We propose to add section 315.209– 70, Solicitation provision, which prescribes the provision 352.215–70, Late Proposals and Revisions—R&D Solicitations, in biomedical or behavioral R&D competitive acquisition solicitations subject to the requirements of 315.208–70(a) and the authorization of the HCA. In subpart 315.3, Source Selection, we propose to revise section 315.303–70 by incorporating administrative edits and formatting revisions to the section for clarification. We propose to revise section 315.304, Evaluation factors and significant subfactors, by removing the term ‘‘electronic and information technology (EIT)’’ and replacing it with ‘‘information and communication technology (ICT)’’ to comport with FAR subpart 315.3 terminology. We propose to revise the section to provide clarity that the requirement is that contracting officers shall include a separate technical evaluation factor pertaining to compliance with section 508 requirements, rather than the language as now shown that appears to just require contracting officers to comply with the general tenets of section 508. We also propose to add a reference to 339.203. E:\FR\FM\03OCP2.SGM 03OCP2 ddrumheller on DSK120RN23PROD with PROPOSALS2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules We propose to revise section 315.305, Proposal evaluation, by removing the content and leaving the header with no text. We propose adding section 315.305–70, Proposal evaluation—use of non-Federal evaluators, and revising and updating the content now at 315.305(c)(1) through (2) and move it to 315.305–70. Accordingly, we propose to reformat and redesignate the text in section 315.305 from paragraphs (c)(1) and (2) to paragraphs (a) and (b) to comport with FAR numbering requirements, and to include paragraphs (b)(1) through (4), and to add a new paragraph (c) to outline HHS’s policy with respect to use of non-Federal evaluators. We also propose administrative edits in the section for clarification. In paragraph (a), we propose to add language that add the requirement that the Source Selection Authority or the contracting officer, as applicable, make the decision to disclose proposals to non-Federal evaluators and to add a reference to FAR 15.305(c) at the end of the paragraph. In paragraph (b), redesignated from paragraph (c)(1), we propose to add content that when an offeror’s or contractor’s proposal will be disclosed outside the Government, the provision prescribed at 315.305–71 requires that the contractor and its employees, as well as any subcontractors and their employees, agree that when performing work as an evaluator under a Government contract that they will use the data (trade secrets, business data, and technical data) contained in the proposal for evaluation purposes only. Proposed paragraphs (b)(1) through (4) provides other conditions and restrictions on use of non-Federal evaluators. In paragraph (c), it requires that the agreement shall be signed by the contractor and the assigned contractor employee, subcontractor, or consultant (i.e., the non-Federal evaluator) and filed in the contract file of an offeror’s proposal. We propose to add section 315.305– 71, Solicitation provision, to prescribe the provision at 352.215–71, Use of Non-Federal Evaluators—Conditions for Evaluating Proposals, in solicitations when the Government may use nonFederal evaluators to evaluate an offeror’s or contractor’s proposals and offers. In subpart 315.4, Contract Pricing, at section 314.404–2, Data to support proposal analysis, we propose to revise the section title to comport with the FAR section title, provide administrative edits within the section for clarification, and move some of the VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 content to the HHSAM as agency procedures. In subpart 315.6, Unsolicited Proposals, we propose to add section 315.604, Agency points of contact, to establish minimum information that HHS operating divisions/staff divisions must make available to potential offerors of unsolicited proposals in accordance with FAR 15.604(a) and assigning this responsibility to the HCAs. Additionally, we propose adding a uniform resource locator to the HHS internet web page to provide the HHS point of contact information. We propose to revise section 315.605– 70, Content of unsolicited proposals— warranty by offeror, by revising the title and number of the section to redesignate it as a supplement to the FAR, and to add ‘‘—warranty by offeror,’’ to reflect the focus of the content, distinguishable from the FAR. We also propose minor administrative edits to comport with FAR formatting requirements. We propose to retain section 315.606, Agency procedures, with no changes. We propose to revise section 315.606– 1, Receipt and initial review, to redesignate the paragraph number to comport with the appropriate FAR paragraph being implemented. HHSAR Part 316—Types of Contracts We propose to revise the authority citations for part 316, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. In subpart 316.3, Cost-Reimbursement Contracts, section 316.307, Contract clauses, we propose to revise paragraph (a)(1), which prescribes clause 352.216– 70, Allowable Cost and Payment for Hospitals, and requires contracting officer to insert the clause in solicitations and contracts when a costreimbursement contract with a hospital (profit or non-profit) is contemplated and when the clause 52.216–7 is inserted in the contract. We propose to revise the content with administrative edits for clarification. We also propose to revise the clause content with administrative edits to remove the reference to 45 CFR part 75. We also propose to remove paragraph (a)(2), which prescribes clause 352.216–70, Additional Cost Principles for Hospitals (Profit and Non-Profit), and requires contracting officer to insert the clause when a cost-reimbursement contract with a hospital (profit or non-profit) is contemplated. We propose to appropriately move this clause to part 331, Contract Cost Principles and Procedures. PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 80641 In subpart 316.5, Indefinite-Delivery Contracts, section 316.505, Ordering, we propose to revise paragraph (b)(8) to update the title of the HHS Advocate for Competition to comport with FAR usage and to designate the HHS Advocate for Competition as the task-order and delivery-order ombudsman. The section is also updated to require each HHS HCA to designate, in writing, a taskorder and delivery-order ombudsman and to provide the website on the HHS internet where this is listed. We propose to remove subpart 316.6, Time-and-Materials, Labor-Hour, and Letter Contracts, and sections 316.603, Letter contracts, and 316.303–3, Limitations, as internal operational procedures or delegations that will be moved to the HHS Acquisition Manual (HHSAM). HHSAR Part 317—Special Contracting Methods We propose to remove part 317, Special Contracting Methods, and reserve the part as we propose to remove the current part content. We propose to remove subpart 317.1, Multi-Year Contracting, and section 317.104, General, moving the content to the HHSAM as agency procedure. We propose to remove sections 317.105, Policy, and 317.105–1, Uses, moving the content to the HHSAM as agency procedure. We propose to remove section 317.107, Options, moving the content to the HHSAM as agency procedure. We propose to remove section 317.108, Congressional notification, moving the content to the HHSAM as agency procedures. We propose to remove subpart 317.2, Options, and section 317.204, Contracts, removing most of the content as duplicative to the FAR, and moving the remaining content to the HHSAM as agency procedures. HHSAR Part 318—Emergency Acquisitions We propose to add the authority citations for part 318, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to add section 318.000 to identify that part 318 will set forth additional emergency acquisition flexibilities. We also propose to add section 318.001, Definition, and section 318.001–71, Agency delegation of determination, to prescribe the delegated authority to the HCA to utilize emergency acquisition flexibilities and make the agency head determinations as E:\FR\FM\03OCP2.SGM 03OCP2 80642 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS2 set forth in FAR part 18 and as defined in subpart 318.2. We propose to add subpart 318.1, Available Acquisition Flexibilities, section 318.109, Priorities and allocations, and section 318.109–70, The Health Resources Priorities and Allocation System, to provide description and reference to subpart 311.6 to comport with FAR formatting. We propose to add subpart 318.2, Emergency Acquisition Flexibilities, and section 318.202–70, Specific HHS flexibilities, to provide four specific definitions to reflect the delegated emergency authorities for: the Micropurchase threshold; the Simplified acquisition threshold; Commercial product or commercial service treatment; and Simplified procedures for certain commercial products and commercial services. We propose to add 318.270, Head of the agency delegations, to prescribe the delegated authority to the HCA to make the determinations in the listed FAR references, which include FAR 2.101, definitions of ‘‘Simplified acquisition threshold’’ and ‘‘Micro-purchase threshold, 12.102(f), 13.201(g), and 13.500(c)(1). HHSAR Part 319—Small Business Programs We propose to revise the authority citations for part 319, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 15 U.S.C. 631, et seq.; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to add the authority of 15 U.S.C. 631, et seq. (the Small Business Act), as an authority pertaining to small business programs. We propose to clarify subpart 319.2, Policies, by making minor administrative updates in citations, references, and titles of individuals. We propose redesignating paragraph (d) of 319.201as paragraph (c) to align with FAR 19.201, as the topical coverage more appropriately falls under paragraph (c). We also add ‘‘Executive’’ to the title for the OSDBU Director. We propose redesignating paragraph (e) of 319.201 as paragraph (d) to align with FAR 19.201, as the topical coverage more appropriately falls under paragraph (d). We are removing the language that dealt with SBS review of all acquisitions that are not set-aside. The matter is more appropriately addressed in internal procedural policy in the HHS Acquisition Manual (HHSAM). In subpart 319.2, we are adding section 319.202 to provide the requirement that contracting officers VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 document set-aside actions and recommendation on HHS Form 653, Small Business Program Review. We propose to remove the coverage concerning unique mentor-protégé clauses as the HHS Mentor Protégé (MP) program is no longer in effect. Therefore, references to the program and related clauses have been deleted from the HHSAR. HHS follows the SBA Federal-wide guidance. We propose adding subpart 319.8, Contracting With the Small Business Administration (the 8(a) Program), to provide coverage for the SBA partnership agreement. Under this subpart we are adding coverage at sections 319.800, General, 319.811, Preparing the contracts, and 319.811– 370, SBA Partnership Agreement and contract clauses. This subpart prescribes two new clauses to be used when an 8(a) acquisition is processed pursuant to the Partnership Agreement: 352.219–72, HHS Notification of Competition Limited to Eligible 8(a) Participants, and for noncompetitive solicitations and awards, we propose adding the clause at 352.219–73, Notification of Section 8(a) Direct Awards, instead of the prescribed FAR clauses at 52.219–11, Special 8(a) Contract Conditions; 52.219–12, Special 8(a) Subcontract Conditions; and 52.219–17, Section 8(a) Award, as it governs HHS unique agency requirements. HHSAR Part 322—Application of Labor Laws to Government Acquisitions We propose to revise the authority citations for part 322, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to revise HHSAR part 322 by adding a new subpart 322.1 and revising the existing subpart 322.8. We propose to add subpart 322.1, Basic Labor Policies, to provide the procedures for the admittance of union representatives to HHS facilities. Under this subpart we propose to add section 322.101, Labor relations, as a header with no underlying text. We propose to add section 322.101–70, Admittance of union representatives to HHS facilities, to provide necessary admittance policy and procedures, and reporting requirements if entry is denied. In paragraph (a) it states that it is HHS policy to admit labor union representatives of contractor employees to HHS facilities to visit work sites and transact labor union business with contractors, their employees, or union stewards pursuant to existing union collective bargaining agreements. Their PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 presence shall not interfere with the contractor’s work progress under an HHS contract nor violate the safety or security regulations that may be applicable to persons visiting the facility. The union representatives will not be permitted to conduct meetings, collect union dues, or make speeches concerning union matters while visiting a work site. Paragraph (b) would require that whenever a union representative is denied entry to a facility or work site, the person denying entry shall make a written report to the HHS labor coordinator, the Office of the General Counsel (OGC), or corresponding labor advisor, with a copy to the cognizant contracting officer within two working days after the request for entry is denied. The report shall include the reason(s) for the denial, the name of the representative denied entry, the union affiliation and number, and the name and title of the person that denied the entry. We propose to revise subpart 322.8, Equal Employment Opportunity, to include a new section 322.808, Complaints. The new section would require that contractors shall, in good faith, cooperate with HHS in investigations of Equal Employment Opportunity (EEO) complaints processed pursuant to 29 CFR part 1614 and in accordance with clause 352.222– 70 as prescribed in this subpart. We propose to revise section 322.810, Solicitation provisions and contract clauses, to redesignate the paragraph from (h) to (e) to properly align with the FAR, and to add ‘‘and Anti-Harassment’’ to the title of the clause, 352.222–70, so the title of the clause would read ‘‘Contractor Cooperation in Equal Employment Opportunity and AntiHarassment Investigations.’’ The clause is prescribed to be included in solicitations, contracts, and order that include the clause at FAR 52.222–26, Equal Opportunity. HHSAR Part 323—Environment, Sustainable Acquisition, and Material Safety We propose to revise the authority citations for part 323, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to revise HHSAR part 323 by updating the header of the part to ‘‘Environment, Sustainable Acquisition, and Material Safety,’’ to align with the title for FAR part 23 recently updated effective May 22, 2024, via FAR Case 2022–006 (RIN 2900–AO43) final rule (89 FR 30212). Additionally, we propose E:\FR\FM\03OCP2.SGM 03OCP2 ddrumheller on DSK120RN23PROD with PROPOSALS2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules moving text from existing sections to a new subpart 323.3 to properly align with the FAR, and to redesignate existing subpart 323.71 to 323.1 as described below. We propose to remove sections 323.7000, 323.7001, and 323.7002 and move the coverage under a new subpart 323.3 where it will align with the FAR coverage concerning hazardous material identification. We propose to revise subpart 323.71, Sustainable Acquisition Requirements, by renumbering and retitling the header for the subpart as 323.1, Sustainable Products and Services. This aligns with the updated FAR subpart title and numbering. We propose to remove sections 323.7101 and 323.7102 as internal agency procedures that will be updated and moved to the HHSAM. The remaining sections, 323.7100 and 323.7103, would be renumbered as 323.103–70 and 323.109–70, respectively to appropriately align with the FAR. In proposed section 323.103–70, Policy—Sustainable Acquisition Plan, the existing text is removed as unnecessary and redundant to the FAR. A new paragraph (a) is added to provide that contracting officers may, for new contracts and orders above the micropurchase threshold, insert an evaluation factor on the offeror’s Sustainable Action Plan in the solicitation. And a new paragraph (b) is added to require that offerors, when the solicitation includes the provision prescribed at 323.109–70 (i.e., the newly numbered 352.223–70, Instructions to Offerors— Sustainable Acquisition Plan), offerors shall include a Sustainable Acquisition Plan in their technical proposal addressing sustainable products for services for delivery under any resulting contract, and that the contracting officer shall incorporate the final Sustainable Acquisition Plan into the contract. In proposed section 323.109–70, Solicitation provision, the prescribed provision number is updated to reflect 352.223–70, and the title is updated to reflect ‘‘Instructions to Offerors— Sustainable Acquisition Plan.’’ We propose to add subpart 323.3, Hazardous Material Identification, Material Safety Data, and Notice of Radioactive Materials, to reflect the revised FAR header at FAR subpart 23.3, and we propose to add underlying sections 323.300 and 323.304–70. The new subpart aligns with the FAR and adds updated language moved from sections 323.7000, 323.7001, and 323.7002. Section 323.300, Scope of subpart, identifies this subpart provides procedures for administering safety and health requirements. In section VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 323.304–70, Contract clause, clause 352.223–71, Safety and Health, is prescribed to be inserted in solicitations and contracts that involve hazardous materials or hazardous operations and details for which types of requirements. HHSAR Part 324—Protection of Privacy and Freedom of Information We propose to revise the authority citations for part 324, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to make only limited revisions at this time to HHSAR part 324 as this part will be updated through future rulemaking. To align with FAR numbering conventions in FAR subpart 24.1, we propose to renumber 324.103 to 324.103–70 and renumber 324.104 to 324.103–71. We propose to amend section 324.105, Contract clauses, by renumbering it to 324.104 to align with the FAR and revising paragraph (b) to add at the end of the sentence for the prescription of HHSAR clause 352.224– 71, Confidential Information, the phrase ‘‘. . . and in solicitations, contracts, and orders that include the clause at 352.227–71, Rights in Data— Supplement—Exceptional Circumstances.’’ We also propose in this sentence to remove the word ‘‘to’’ in front of ‘‘third party information’’ so it would read ‘‘to Government or third party confidential information.’’ HHSAR Part 325—Foreign Acquisition We propose to revise the authority citations for part 325, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to add HHSAR part 325 to provide agency policies and procedures and the restrictions on Make Personal Protective Equipment (PPE) in America. This rule would add subpart 325.71, Make PPE in America Act Restrictions on Foreign Acquisition of Personal Protective Equipment, and underlying sections 325.7100 through 325.7103 as described below. In section 325.7100, Scope of subpart, it indicates that the subpart contains restrictions on the acquisition of certain personal protective equipment as required by the Make PPE in America Act (Pub. L. 117–58) for solicitations and contracts issued by HHS (among other agencies not included under the purview of this regulation). This subpart would codify the class deviation to the HHSAR issued by the HHS Senior PO 00000 Frm 00011 Fmt 4701 Sfmt 4702 80643 Procurement Executive on February 9, 2023, that implemented the Make PPE in America Act, Division G, Title IX, Subtitle C, secs. 70951–70953 of the Infrastructure Investment and Jobs Act (Pub. L. 117–58), dated November 15, 2021. On November 15, 2021, the President signed, the Infrastructure Investment and Jobs Act (IIJA). As part of the IIJA, Congress enacted the Make PPE in America Act (the Act). In promulgating the Act, Congress found, among other things, that the COVID–19 pandemic exposed the vulnerability of the United States’ supply chains with respect to PPE and the lack of domestic production of PPE, including the components and materials thereof. To meet the needs for a long-term investment strategy for the domestic production of PPE items critical to the U.S. national response to a public health emergency, including, but not limited to, the COVID–19 pandemic, the Act requires action by HHS, the Department of Homeland Security, and the Department of Veterans Affairs (the covered agencies). To incentivize domestic manufacturing of PPE, the Act imposes certain requirements for contracts awarded by the covered agencies for the procurement of PPE. The class deviation issued by the Senior Procurement Executive implemented the tenets of the Act applicable to HHS in advance of rulemaking. This rule seeks public comment on the proposed language to be added to the HHSAR that HHS has been following and in effect at the agency since February 9, 2023. In section 325.7101, Definitions, we propose six definitions to ensure common understanding and meaning as used in this part—component, domestic personal protective equipment, foreignmade domestic personal protective equipment, foreign personal protective equipment, personal protective equipment, and United States. We propose to add section 325.7102, Restrictions on certain personal protective equipment, as a header with no text. In section 325.7102–1, Restrictions, certain restrictions are identified that implement section 70952 of the Make PPE in America Act, and they apply to all contracts and orders for the purchase of personal protective equipment. These restrictions include the requirement for contracting officers to purchase domestic personal protective equipment (PPE), except as provided in section 325.7102–2, Exceptions. And the text provides that any contract for PPE shall have a base period of performance of at least two years, plus any option periods, as required by law. E:\FR\FM\03OCP2.SGM 03OCP2 80644 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS2 In section 325.7102–2, Exceptions, paragraph (a) provides that acquisitions of PPE in certain categories are not subject to the restrictions in section 325.7102–1, to include PPE where the HHS Secretary has maximized sources for foreign-made domestic PPE, and where the HHS Secretary certifies every 120 days that it is necessary to procure PPE under alternative procedures to respond to the immediate needs of a public health emergency. Other exceptions set forth in paragraph (b) include an item of PPE or component thereof, including those described in paragraph (a), that is, or includes, a material listed in FAR 25.104 as one for which a nonavailability determination has been made; or to which the HHS Secretary— • Determines that a sufficient quantity of a satisfactory quality that is grown, reprocessed, reused, or produced in the United States cannot be procured as, and when, needed at United States market prices; and • Certifies every 120 days that it is necessary to procure PPE to respond to the immediate needs of a public health emergency. Under paragraph (c), the HHS Secretary is authorized to make the certification in paragraphs (a) and (b) or the nonavailability or unreasonable cost determination; supporting documentation requirements and approval levels are further outlined for the public. In section 325.7103, Solicitation provisions and contract clauses, paragraph (a), clause 352.225–70, Made in America—Personal Protective Equipment, is prescribed to be inserted in solicitations and contracts, regardless of dollar value, when procuring any item covered under 325.7102–1(a). And in paragraph (b), provision 352.225–71, Made in America Certificate—Personal Protective Equipment, would be required to be inserted in solicitations containing the clause at 352.225–70. HHSAR Part 326—Other Socioeconomic Programs We propose to revise the authority citations for part 326, for the reasons set forth in the discussion and analysis section and as described below, to read as follows: 5 U.S.C. 301; 25 U.S.C. 47; 25 U.S.C. 1633; 25 U.S.C. 5301 et seq.; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; 42 U.S.C. 2003 and 48 CFR 1.301 through 1.304. We propose to retain the existing authorities of 5 U.S.C. 301; 25 U.S.C. 47; 25 U.S.C. 1633; and 42 U.S.C. 2003 as applicable to the subject matter and requirements set forth in the part. We removed the authority citation for 41 U.S.C. 253(c)(5) VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 as it no longer exists. Additionally, we propose to add the authority citations for 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304 as set forth in the discussion and analysis section above, to align part 326 with the other parts set forth in 48 U.S.C. chapter 3. We propose to add one additional authority under which Public Law 93–638 was recodified: 25 U.S.C. 5301 et seq., as it sets forth requirements that impact acquisitions under 25 U.S.C. chapter 46, Indian Self-Determination and Education Assistance. We propose to make minor administrative and non-substantive technical changes to the part to update numbering conventions to FAR drafting standards, to spell out words, correct capitalization, and update references, including revising the table of contents and numbering of current subparts to properly align with the FAR and conform to FAR drafting conventions as follows: • Revise the current subpart numbering for subpart 326.5, Indian Preference in Employment, Training, and Subcontracting Opportunities, to subpart 326.70. The underlying sections and subsections would be renumbered accordingly. Other numbering and minor administrative edits are made to comport with FAR drafting guidelines. • Revise the current subpart numbering for subpart 326.6, Acquisitions Under the Buy Indian Act, to subpart 326.71. The underlying sections and subsections would be renumbered accordingly. Other numbering and minor administrative edits are made to comport with FAR drafting guidelines. • Revise the current subpart numbering for subpart 326.7, Acquisitions Requiring the Native American Graves Protection and Repatriation Act, to subpart 326.72. The underlying sections and subsections would be renumbered accordingly. We also propose to make certain limited revisions to update the part: • In section 326.501 (proposed to be renumbered to 326.7001, we updated to the current citations. • In section 326.502 (proposed to be renumbered and retitled to 326.7002, Additional Definitions), we propose the following changes: (1) delete section 326.502(c) and (d) as duplicative of FAR 26.101; (2) add definitions to reflect those at 25 U.S.C. 3504; (3) revised paragraph (b); (4) redesignate paragraphs (a), (b), (e), and (f), and; (4) revise this section by renumbering 326.502 as shown to comport with the FAR drafting guidelines. We propose to add the following definitions: PO 00000 Frm 00012 Fmt 4701 Sfmt 4702 construction contract, construction programs, contract funding, direct program costs, indirect costs, indirect cost rate, mature contract, Secretary, self-determination contract, state education agency, Tribal organization or as relevant to the part and the usage from the cited authorities. • In 326.505 (proposed to be renumbered to 326.7005), we propose to revise the header title to read ‘‘Contract clauses’’ in lieu of ‘‘Applicability’’ as the section prescribes two clauses: 352.226–70, Indian Preference, and 352.226–71, Indian Preference Program, and the naming convention for the header comports with the FAR. • In subpart 326.6, Acquisitions Under the Buy Indian Act, we have made minimal revisions. Note: An update to subpart 326.6, Acquisitions Under the Buy Indian Act, took place recently. The update was published in the Federal Register on 1/13/2022, with an effective date of March 14, 2022. The rule is intended to establish Buy Indian Act acquisition policies and procedures for HHS that are consistent with rules proposed and/or adopted by the Department of the Interior (DOI). Due to the recent HHSAR changes and the tremendous collaborative effort to implement time sensitive legislative mandates, we are not proposing any substantive changes to this subpart. However, there are minor technical changes that are necessary to integrate this collaborative effort into the HHSAR update project to be FAR compliant. These changes include the following: Æ We propose to revise this subpart by renumbering 326.6 as shown to comport with the FAR drafting guidelines. Specifically, we recommend this subpart be referenced as 326.71 since it is unique to HHS and has no correlation to the programs under the FAR part. Headings and references within the subpart have been updated to reflect the new numbering scheme. The underlying sections and subsections would be renumbered accordingly. Other numbering and minor administrative edits are made to comport with FAR drafting guidelines. Æ In section 326.602 (proposed to be renumbered to 326.7102), we propose to revise the header title to ‘‘Applicability’’ and to add the text that will be moved from 326.602–1. Æ We propose to remove 326.602–1, Scope of part. The placement and text for this material more properly falls under the proposed section 326.7102, Applicability. Æ In section 326.604–2, Procedures for Acquisitions under the Buy Indian Act (proposed to be renumbered to 326.7104–2), we propose to remove E:\FR\FM\03OCP2.SGM 03OCP2 ddrumheller on DSK120RN23PROD with PROPOSALS2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules paragraph (e) in its entirety and move the prescriptions for clauses under a new proposed section 326.7104–5, Solicitation provisions and contract clauses, to comport with FAR drafting convention and style. Æ We propose to add section 326.7104–4, Performance and payment bonds. This text is moved from a section proposed to be removed, 326.605–2, Performance and payment bonds, to reflect the requirements of 25 U.S.C. 47a and to permit contracting officers to accept alternative forms of security in lieu of performance and payment bonds if a determination is made that such forms of security provide the Government with adequate security for performance and payment. Æ We propose to renumber and retitle section 326.605, Contract Requirements, to 326.7105, Solicitation provisions and contract clauses, and move the prescriptions for the existing provisions and clauses in 326.604–2(c) to this section and renumber the provisions and clauses accordingly: 352.226–73, Notice of Indian Small Business Economic Enterprise Set-Aside; 352.226–74, Notice of Indian Economic Enterprise Set-Aside; 352.226–75, Indian Economic Enterprise Subcontracting Limitations; and 352.226–76, Indian Economic Enterprise Representation; and 352.226–75, Indian Economic Enterprise Subcontracting Limitations. Æ We propose to remove section 326.605–2, Performance and payment bonds. Updated text concerning the requirements under this paragraph is proposed to move to section 326.7104– 4, Performance and payment bonds, as the placement earlier in the subpart is more appropriate with the last section of the subpart reflecting any prescribed provisions or clauses to comport with FAR drafting conventions. Æ In section 326.606–2, Representation provision, we propose to renumber it to 326.7106–2 based on the renumbering of all sections within the subpart, and adding one requirement in paragraph (c) for the contracting officer to include the documentation in the file, when the head of the contracting activity is informed in writing of all suspected Indian Economic Enterprise (IEE) misrepresentations by an offeror or failure to provide written notification of a change in IEE eligibility. • In subpart 326.7, Acquisitions Requiring the Native American Graves Protection and Repatriation Act, we propose to revise this subpart by renumbering it as subpart 326.72 to comport with the FAR drafting guidelines and reflect as a unique HHS supplement. The underlying sections VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 and subsections would be renumbered accordingly. Other numbering and minor administrative edits are made to comport with FAR drafting guidelines. HHSAR Part 327—Patents, Data, and Copyrights We propose to revise the authority citations for part 327, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. In subpart 327.3, Patent Rights Under Government Contracts, we propose to revise section 327.303 by renumbering it to 327.303–70 and changing the header to read ‘‘Contract clause’’ in lieu of ‘‘Solicitation provision and contract clause’’ since it prescribes only one clause. We also propose to update the text to reflect the revised numbering and title of clause 352.227–11, Patent Rights—Exceptional Circumstances, to now read, ‘‘352.227–70, Patent Rights— Supplement—Exceptional Circumstances,’’ and to prescribe its use in solicitations, contracts, and orders that include the FAR clause at 52.227– 11, Patent Rights—Ownership by the Contractor. Instructions to the contracting officer that are internal operating procedures are removed and will be revised and moved to the HHSAM. In subpart 327.4, Rights in Data and Copyrights, we propose to remove section 327.404–70, Solicitation provision and contract clause, as the prescription is being moved to section 327.409 where all the subpart’s prescriptions will be located. We propose to revise section 327.409, Solicitation provision and contract clauses, by renumbering it to 327.409– 70 and revising the header title to ‘‘Contract clauses’’ to reflect that only contract clauses are prescribed in the subpart. In paragraph (a) we propose to update the citation to the prescribed clause 352.227–14 and renumber it to ‘‘352.227–71’’ to comport with FAR drafting guidelines, and to retitle the clause to ‘‘Rights in Data— Supplement—Exceptional Circumstances.’’ We also propose to prescribe its use in solicitations, contracts, and others that include the FAR clause at 52.227–14, Rights in Data—General, and have updated the grammar and structure of the sentence to provide clarity. We propose to add paragraph (b) to set forth the prescription for the clause moved from the removed section 327.404–70, and renumber the clause from ‘‘352.227–70, Publications and PO 00000 Frm 00013 Fmt 4701 Sfmt 4702 80645 Publicity’’ to ‘‘352.227–72, Publications and Publicity.’’ HHSAR Part 330—Cost Accounting Standards We propose to revise the authority citations for part 330, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. In subpart 330.2, CAS Program Requirements, in section 330.201–5, Waiver, we propose to revise his section to restructure and clarify the sentence that states the Senior Procurement Executive is authorized to exercise the waiver authority under FAR 30.201– 5(a)(1) when the conditions at FAR 30.201–5(a)(1) are met. We propose to remove the coverage concerning the Operating and Staff Divisions and forwarding the waiver requests to the Senior Procurement Executive as it is internal operating procedures more appropriate to the HHS Acquisition Manual (HHSAM). HHSAR Part 331—Contract Cost Principles and Procedures We propose to revise the authority citations for part 331, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. In subpart 331.1, Applicability, we propose to revise section 331.101–70, Salary rate limitation, to renumber it to section 331.170, to align with FAR drafting convention numbering as there is no existing FAR section to intelligibly implement the required HHS policy and numbering as ‘‘331.170’’ places it appropriately as a supplement to subpart 331. We also propose to remove the paragraph (a) designation as there is no paragraph (b), and to remove the reference to a fiscal year as not necessary to the policy requirement. We also propose to revise the paragraph to update and provide the name of the Rates of Basic Pay for the Executive Schedule (EX) Level II, that is found on the Office of Personnel Management website. We also propose to remove the designation of paragraph (b) as the text will be contained in a new proposed section. We propose to add section 331.101–70, Contract clause, to contain the prescription for clause 352.231–70, Salary Rate Limitation, that was previously contained in paragraph (b) under the prior existing section 331.101–70, and to fix sentence E:\FR\FM\03OCP2.SGM 03OCP2 80646 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS2 construction and punctuation to provide clarity. HHSAR Part 332—Contract Funding We propose to revise the authority citations for part 332, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to revise HHSAR part 332, Contract Financing, by adding introductory sections 332.006, 332.006– 1, and 332.006–4 to align with the FAR. We propose to add section 332.006, Reduction or suspension of contract payments upon finding of fraud, as a section header with no text to align with the FAR. We propose to add section 332.006– 1, General, paragraph (b), to provide that the Senior Procurement Executive (SPE) is authorized to make the determination there is substantial evidence that a contractor’s request for advance, partial, or progress payments is based on fraud, and may direct further payments to the contractor be reduced or suspended, in accordance with FAR 32.006 and that the authority may not be redelegated. And we propose to also add section 332.006–4, Procedures, paragraph (b), to align with the FAR and to designate the Remedy Coordination Official (RCO) for HHS as the SPE, who shall carry out the responsibilities in FAR 32.006–4(b). We add paragraph (e) under this section to implement the FAR and stipulate that the RCO is authorized to carry out the responsibilities of the agency head in FAR 32.006–4(e) to notify the contractor of the reasons for the recommended action and of its right to submit information within a reasonable period of time in response to the proposed action under FAR 32.006. In paragraph (e)(1), HHS sets forth the procedures to be followed for the notice of proposed action and the requirement to send it to the last known address of the contractor, the contractor’s counsel, or agent for service of process, by certified mail, return receipt requested, or any other method that provides signed evidence of receipt. In the case of a business, the notice of proposed action may be sent to any partner, principal, officer, director, owner or co-owner, or joint venture. We also propose to set forth the due process rights for contractors to be afforded an opportunity to appear before the RCO to present information or argument in person or through a representative and to supplement the oral presentation with written information and argument. In paragraph (e)(2), additional processes and procedures for due process rights are VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 established including that the proceedings will be conducted in an informal manner without the requirement for a transcript. It also would state that if the RCO does not receive a reply from the contractor within 30 calendar days, the RCO will base his or her recommendations on the information available. The RCO is required to make a determination whether or not substantial evidence of fraud exists. And, in paragraph (g) under section 332.006–4, we propose to require that the SPE shall provide a copy of each final determination and the supporting documentation to the contractor, the RCO, the contracting officer, and the HHS Office of the Inspector General (OIG). We propose to add subpart 332.2, Commercial Product and Commercial Service Purchase Financing, and the underlying section 332.202, General, to provide that the SPE is authorized to approve actions for commercial item purchase financing pursuant to FAR 32.202. In subpart 332.4, we propose to revise the subpart header title from ‘‘Advance Payments for Non-Commercial Items’’ to ‘‘Advance Payments for Other Than Commercial Acquisitions’’ to align with the updated title in the FAR. In section 332.402, General, we propose to revise the sentence for clarity that the head of the contracting activity (HCA) is authorized to make determinations related to advance payments and that the authority may not be redelegated. We propose to remove section 332.407, Interest, as this delegation by the agency head to the HCA to make the determination required by FAR 32.407(d) is being moved to the HHSAM. In subpart 332.5, Progress Payments Based on Costs, we propose to correct the header title listed in the HHSAR to match the FAR by adding an ‘‘s’’ to the existing word ‘‘Cost.’’ In section 332.501–2, Unusual progress payments, we propose to revise the sentence to comport with FAR drafting guidelines and style, and rephrased the same delegation that authorizes the HCA to approve unusual progress payments and to stipulate that the authority may not be relegated. In subpart 332.7, Contract Funding, we propose to remove section 332.702, Policy, and move it to the HHSAM as internal operational policy. We propose to retain the underlying sections 332.703–1, General, and 332.703–71, Incrementally funded costreimbursement contracts, as important policy and procedures contracting officers shall follow when administering PO 00000 Frm 00014 Fmt 4701 Sfmt 4702 incremental funding under an HHS contract and the considerations contracting officers must examine when approving the use of incrementally funded cost-reimbursement contracts. We also propose to redesignate 332.703– 71 to 332.703–70. We propose to revise the numbering of section 332.703–72, Incremental Funding Table, to ‘‘332.703–71’’ based on the redesignation of 332.703–71 to 332.703–70. We propose to revise the header title of section 332.706, Solicitation provision and contract clauses, to ‘‘Contract clauses’’ to align with the FAR. In subpart 332.70, Electronic Submission and Processing of Payment Requests, and the underlying sections 332.7001, 332.7002, and 332.7003, we make minor editorial formatting and capitalization corrections. In section 332.7003, Contract clause, we add language that states the clause at 352.232–71, Electronic Submission of Payment Requests, is to be used in all solicitations and contracts, unless an exception at HHSAR 332.7002(a) or (b) applies. HHSAR Part 333—Protests, Disputes, and Appeals We propose to revise the authority citations for part 333, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to revise HHSAR part 333 to revise text and add sections as described below. In subpart 333.1, Protests, we propose to revise section 333.102, General, to make minor typographical and editorial updates and remove the paragraph designation of (g)(1). In section 333.103, Protests to the agency, we propose to substantially revise the content to provide clarity by identifying that the contracting officer prepares the determination pursuant to FAR 33.103(f)(1) and to state that the contracting activity’s designated protest official control officer, in consultation with the cognizant HHS legal office, may approve the determination subject to the procedures in 333.103–70. We propose to add section 333.103– 70, Procedures—protests to HHS, paragraphs (a) through (d), to provide agency procedures on how HHS will handle protests submitted to the agency. This includes providing information on protests to the contracting officer, and a higher-level independent review or appeal of a contracting officer decision for protests files directly with the E:\FR\FM\03OCP2.SGM 03OCP2 ddrumheller on DSK120RN23PROD with PROPOSALS2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules agency. We also propose to add language at paragraph (d) that if protests are pending with the contracting officer and have not been decided yet, an independent review of a protest filed pursuant to paragraph (a)(2) will not be considered. We propose to add section 333.103– 71, Agency actions on specific protests, to provide that the following types of protests may be dismissed without consideration of the merits or may be forwarded to another agency for appropriate action: • Contract administration. Disputes between a contractor and HHS are resolved under the disputes clause (see the Dispute statute, 41 U.S.C. chapter 71). • Small business size standards and standard industrial classification. These are handled by the Small Business Administration. • Small business certificate of competency program. A protest made under section 8(b)(7) of the Small Business Act, or in regard to any issuance of a certificate of competency or refusal to issue a certificate under that section, is not reviewed in accordance with bid protest procedures unless there is a showing of possible fraud or bad faith on the part of Government officials. • Decision not to set-aside under section 8(a) of the Small Business Act. The decision to place or not to place a procurement under the 8(a) program is not subject to review unless there is a showing of possible fraud or bad faith on the part of Government officials or that regulations may have been violated (see 15 U.S.C. 637(a)). • Affirmative determination of responsibility by the contracting officer. An affirmative determination of responsibility will not be reviewed unless there is a showing that such determination was made fraudulently or in bad faith or that definitive responsibility criteria in the solicitation were not met. • Contracts subject to FAR subpart 22.6—Contracts for Materials, Supplies, Articles, and Equipment. Challenges concerning the legal status of a firm as a regular dealer or manufacturer within the meaning of 41 U.S.C. chapter 65 are determined solely by the procuring agency, the SBA (if a small business is involved), and the Secretary of Labor (see FAR subpart 22.6). • Subcontractor protests. The contracting agency will not consider subcontractor protests except where HHS determines it is in the interest of the Government. • Judicial proceedings. The contracting agency will not consider VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 protests where the matter involved is the subject of litigation before a court of competent jurisdiction. • Alternative dispute resolution. Bidders/offerors and HHS contracting officers are encouraged to use alternative dispute resolution (ADR) procedures to resolve protests at any stage in the protest process. If ADR is used, HHS will not furnish any documentation in an ADR proceeding beyond what is required by FAR 33.103. In subpart 333.2, Disputes and Appeals, we propose to add section 333.201, Definitions, to provide the definition for Agency board of contract appeals for HHS means the Civilian Board of Contract Appeals (CBCA). We propose to revise section 333.203, Applicability, to make minor editorial corrections, to use the acronym CBCA, and to provide an updated address for each method of filing—e-file, U.S. Postal Service, or Overnight or Courier Delivery. In section 333.209, Suspected fraudulent claims, we propose to add to the end of the existing sentence that the contracting officer may submit any instance of a contractor’s suspected fraudulent claim for potential referral to the Department of Justice through the head of the contracting activity (HCA). We propose to add section 333.214, Alternative dispute resolution (ADR), to state that contracting officers and contractors are encouraged to use alternative dispute resolution (ADR) procedures, and that guidance on ADR may be obtained at the U.S. Civilian Board of Contract Appeals website at https://www.cbca.gsa.gov. And in section 333.215–70, Contract clauses, we propose to revise paragraph (b) to revise the phrase, ‘‘commercial item’’ to ‘‘commercial product or commercial service’’ to comport with the updated usage of the terms in the FAR. HHSAR Part 334—Major System Acquisition We propose to revise the authority citations for part 334, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to revise HHSAR part 334 to make minor editorial changes to provide clarity to the sentence structure and to add needed references. In section 334.201, Policy, introductory sentence, we are adding the acronym ‘‘(EVMS)’’ after earned value management system to permit usage of the acronym later in the section. In paragraph (b), we remove the PO 00000 Frm 00015 Fmt 4701 Sfmt 4702 80647 fully spelled out term and use the EVMS acronym. In section 334.202, Integrated Baseline Reviews (IBRs), we remove the acronym usage in the header. In paragraph (a), we reconstructed the sentence for clarity by adding the term ‘‘Integrated Baseline Review (IBR)’’ and a reference to FAR 34.201(a), and we remove the phrase ‘‘normally should read’’ and replace it with ‘‘is usually’’. HHSAR Part 335—Research and Development Contracting We propose to revise the authority citations for part 335, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to revise HHSAR part 335 to make minor editorial changes to provide clarity, to remove material more appropriate to internal agency procedures in the HHSAM, to add needed FAR references, and to remove two sections that are unnecessary. In section 335.070–1, Policy, paragraph (a), we propose to remove the last sentence as it contains a general statement concerning the Government’s interest that is unnecessary and vague. We propose to remove paragraph (c) as more appropriate to internal agency procedures that may be revised and moved to the HHSAM. In section 335.070–2, Amount of costsharing, paragraph (a), we propose to add the phrase ‘‘appropriate (see FAR 16.303 and FAR 42.707)’’ to provide key FAR references. We propose to remove sections 335.071, which is reserved, and 335.072, Key personnel. Section 335.071 was reserved during a previous rulemaking and is no longer required to be reserved. Section 335.072, Key personnel, is removed as internal agency guidance more appropriate to be revised and moved to the HHSAM. HHSAR Part 336—Construction and Architect-Engineer Contracts We propose to revise the authority citations for part 336, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to revise HHSAR part 336 to remove one subpart and add a new subpart and make other necessary editorial changes. We propose to remove subpart 336.1, General, and the underlying section 336.104, Policy, as the information repeats the FAR and also contains a E:\FR\FM\03OCP2.SGM 03OCP2 ddrumheller on DSK120RN23PROD with PROPOSALS2 80648 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules general reference to internal agency Facilities Management guidance that is vague and more appropriate to place in the HHSAM as internal operational procedures. We propose to add subpart 336.2, Special Aspects of Contracting for Construction, and sections 336.203 and 336.204, to provide policy on the use of Government estimates of construction costs and other policy and procedures on the disclosure of the magnitude of construction projects. In section 336.203, Government estimate of construction costs, paragraph (a), we propose to require that the Government estimate must be designated ‘‘CUI Controlled by: HHS, [OPDIV/STAFFDIV designation’’ unless the nature of the information therein requires a security classification or other classification, in which event it shall be handled in accordance with applicable security regulations. The designation would only be removed when the estimate is made public in accordance with the procedures outlined in the section. In paragraph (b), if the acquisition is by sealed bidding, a sealed copy of the detailed Government estimate must be filed with the bids until bid opening. After the bids are read and recorded, the ‘‘CUI’’ designation, or other classification, must be removed and the estimate read and recorded in the same detail as the bids. In paragraph (c), we propose procedures governing the use of the marking if the acquisition is by negotiation. In section 336.204, Disclosure of the magnitude of construction projects, we propose policy that requires the contracting officer to utilize the estimated price ranges defined in FAR 36.204(a) through (e) as further supplemented in paragraphs (f) through (h) in this section when identifying the magnitude of an HHS project in advance notices and solicitations. In paragraph (f), we propose that for estimated price ranges between $1,000,000 and $5,000,000, the contracting officer shall identify the magnitude of an HHS project in advance notices and solicitations in terms of the following price ranges: • Between $1,000,000 and $2,000,000. • Between $2,000,000 and $5,000,000. In paragraph (g), the estimated price ranges are between $5,000,000 and $10,000,000. And in paragraph (h), for estimated price ranges greater than $10,000,000, the contracting officer shall identify the magnitude of an HHS project in advance notices and solicitations in terms of one of the following price ranges: VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 • Between $10,000,000 and $20,000,000. • Between $20,000,000 and $50,000,000. • Between $50,000,000 and $100,000,000. • Between $100,000,000 and $150,000,000. • Between $150,000,000 and $200,000,000. • Between $200,000,000 and $250,000,000. • More than $250,000,000. In subpart 336.5, Contract Clause, we propose to make minor editorial revisions and to revise the header title of the subpart to ‘‘Contract Clauses’’ to align with the FAR. In section 336.570, Contract clause, paragraph (a), we remove the word ‘‘all’’ before ‘‘design-build requirements’’ as it is unnecessary. In paragraph (b), we make minor capitalization corrections. We propose to remove paragraph (c) in its entirety as internal agency guidance that will be considered for the HHSAM and is unnecessary in the HHSAR. HHSAR Part 337—Service Contracting We propose to revise the authority citations for part 337, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to revise HHSAR part 337 to provide updated agency policy and procedures to implement specific requirements concerning performance on HHS service contracts, and to add a new subpart 337.70 that provides the policy for the clauses prescribed by this part. We propose to revise the header title of HHSAR part 337 from ‘‘Service Contracting—General’’ to ‘‘Service Contracting’’ to align with the FAR title. We propose to remove subpart 337.1, Service Contracting—General, which currently contains prescriptions of key clauses required to be inserted into certain HHS solicitations and contracts. This coverage is proposed to be revised and moved to another new section specifically pertaining to prescriptions for contract clauses, 337.3306, as described below, to comport with FAR drafting standards and guidance. We propose to add subpart 337.70, Services—Special Contract Requirements, to provide the policy and procedures applicable to the clauses prescribed under this part. We propose to add sections 337.7000, 337.7001, 337.7002, 337.7003, 337.7004, 337.7005, and 337.7006 as discussed below. We propose to add section 337.7000, Prohibition on smoking in facilities PO 00000 Frm 00016 Fmt 4701 Sfmt 4702 during delivery of services to children, to detail the policy prohibition on smoking in certain facilities where certain federally funded children’s services are provided pursuant to 20 U.S.C. 7181 (Pub. L. 107–110, the ProChildren Act of 2001 (the Act)). Contractors are required to represent to the contracting officer and agree that by submission of its bid or offer and if awarded a contract for this requirement, the contractor agrees to comply with the requirements of the Act and the prohibition of smoking in facilities as specified in paragraph (a). The contractor shall enforce the provisions of the clause prescribed in 337.7006(a), and ensure that each of its employees, subcontractors, and any subcontractor staff, is made aware of, understands, and complies with the provisions of the Act. This section also outlines the penalties for failure to comply with the Act. We propose to add section 337.7001, Reporting of child abuse by covered professionals and key definitions, to implement the requirements of Public Law 101–647, known as the Crime Control Act of 1990 (the Act) (34 U.S.C. 20341), which imposes responsibilities on certain individuals who, while engaged in a professional capacity or activity as a covered professional, as defined in the Act, on Federal land or in a federally-operated (or contracted) facility, learn of facts that give the individual reason to suspect that a child has suffered an incident of child abuse. Paragraph (c) details the reporting requirements, and paragraph (d) contains the requirement that the offeror shall represent that it understands that by submission of its bid or offer and if awarded a contract for a requirement, the Contractor agrees to comply with the requirements of the Act. Contracting officers shall ensure the requirements of clause 352.237–71 are flowed down to subcontractors at any tier. We propose to add section 337.7002, Requirement for background checks— childcare services, to set forth the agency policy and requirement for background checks pursuant to Public Law 101–647, known as the Crime Control Act of 1990 (the Act) (34 U.S.C. 20351), requires that all individuals involved with the provision of childcare services to children under the age of 18 undergo a criminal background check. Any conviction for a sex crime, an offense involving a child victim, or a drug felony, may be grounds for denying employment or for dismissal of an employee providing any childcare services. This would require the contracting officer to provide the necessary information to the contractor E:\FR\FM\03OCP2.SGM 03OCP2 ddrumheller on DSK120RN23PROD with PROPOSALS2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules regarding the process for obtaining the background check. And it contains the representation requirement that the offeror shall represent that it understands that by submission of its bid or offer and if awarded a contract for a requirement, the contractor agrees to comply with the requirements of the Act. Contracting officers shall ensure the requirements of clause 352.237–72 are flowed down to subcontractors at any tier. We propose to add section 337.7003, Indian Child Protection and Family Violence Act-background investigations, to ensure protection of Indian children, and to implement requirements of the Indian Child Protection and Family Violence Act, Public Law 101–630 (25 U.S.C. 3201, et seq.), which prohibits employment, including personal service contracts, with anyone who has been convicted of any crime of violence when performance under a contract may require duties and responsibilities of a contractor, its employees, subcontractors, or third parties providing service under the contract that involve regular contact with or control over Indian children. The Act requires that a contractor and its employees and subcontractors, at any tier, be subject to a character and background investigation. This investigation is conducted by the Indian Health Service, Office of Human Resources. This section would require that as a prerequisite to providing services under a contract involving access to Indian children, contractors shall— • Complete and sign a declaration concerning the background of employees or subcontractors providing such services as required by the terms and conditions of the contract; • Provide information as required by the contracting officer to ascertain such information about its employees, subcontractors, and third parties providing services under the contract; • Report convictions of any crime of violence immediately to the contracting officer that involve such employees, subcontractors, or third parties, who may be employed or are currently employed under the contract; and • Flow down clause the clause prescribed at 337.7006(d), 352.337–73, Indian Child Protection and Family Violence Act—Background Investigations, into all subcontracts, at any tier. We propose to add section 337.7004, Non-discrimination in service delivery, to implement HHS policy that no person otherwise eligible will be excluded from participation in, denied the benefits of, or subjected to discrimination in the VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 administration of HHS programs and services based on non-merit factors such as race, color, national origin, religion, sex, gender identity, sexual orientation, or disability (physical or mental). It would include a representation requirement that the offeror shall represent that it understands that by submission of its bid or offer and if awarded a contract for a requirement, the contractor agrees to comply with the requirements of the policy. Contracting officers shall ensure the requirements of clause 352.237–74 are flowed down to subcontractors at any tier. We propose to add section 337.7005, Key personnel, to implement HHS policy on identification and use of key personnel when considered essential to work performance under an HHS contract. We propose to require contractors to provide notice if they divert proposed personnel deemed key personnel. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals in a contract to other programs or contracts, the contractor shall notify the contracting officer and submit a justification for the diversion or replacement, and request to replace the individual. It would also outline notification, justification, and replacement requirements. We propose to add section 337.7006, Contract clauses, to provide the prescription for the use of the following clauses in both solicitations and contracts as required by each prescription: • 352.237–70, Nonsmoking Policy— Delivery of Services to Children • 352.237–71, Reporting of Child Abuse • 352.237–72, Requirement for Background Checks • 352.237–73, Indian Child Protection and Family Violence Act— Background Investigations • 352.237–74, Non-Discrimination in Service Delivery • 352.237–75, Key Personnel HHSAR Part 341—Acquisition of Utility Services We propose to add authority citations for part 341, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to add HHSAR part 341, Acquisition of Utility Services, and subparts 341.1, General, and 341.5, Solicitation Provision and Contract Clauses, to provide policy on purchases of utility services from nonregulated and regulated utility suppliers, and the acquisition of energy when purchased as a commodity in accordance with FAR part 41. PO 00000 Frm 00017 Fmt 4701 Sfmt 4702 80649 We propose to add subpart 341.1, General, and section 341.102, Applicability, paragraph (a), to implement FAR 41.102(a) and to state that this part applies to purchases of utility services from nonregulated and regulated utility suppliers when a delegation of authority from GSA for those services is requested and obtained. In paragraph (b)(4), we provide the explanation that the acquisition of energy, such as electricity, and natural or manufactured gas, when purchased as a commodity is considered to be acquisitions of supplies rather than utility services as described in FAR part 41. We propose to add subpart 341.5, Solicitation Provision and Contract Clauses, and sections 341.501 and 341.501–70. In section 341.501, Solicitation provision and contract clauses, we propose to add the section header with no text for alignment with the FAR where HHS supplements coverage in an underlying section. In section 341.501–70, Disputes—utility contracts, we propose to require contracting officers to insert the clause at 352.241–70, Disputes—Utility Contracts, in solicitations and contracts for utility services subject to the jurisdiction and regulation of a utility rate commission, to provide the notice to the contractor on specific disputes requirements concerning utilities. In the clause, it provides that the requirements of the Disputes clause at FAR 52.233– 1 are supplemented to provide that matters involving the interpretation of tariffed retail rates, tariff rate schedules, and tariffed terms provided under this contract are subject to any determinations by the independent regulatory body having jurisdiction (i.e., the Federal Energy Regulatory Commission, a state-wide agency, or an agency with less than state-wide jurisdiction when operating pursuant to state authority. The body has the power to fix, establish, or control the rates and services of utility suppliers.). HHSAR Part 342—Contract Administration and Audit Services We propose to revise the authority citations for part 342, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to revise HHSAR part 342 to update its header title, and to add subpart 342.2. We propose to revise and update the header title of part 342 from ‘‘Contract Administration’’ to ‘‘Contract E:\FR\FM\03OCP2.SGM 03OCP2 ddrumheller on DSK120RN23PROD with PROPOSALS2 80650 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules Administration and Audit Service’’ to align with the FAR part title. We propose to add subpart 342.2, Contract Administration, and sections 342.270, 342.271, and 342.272, to set forth policy and procedures with respect to the use of Contracting Officer’s Representatives (CORs) in contract administration, the Administrative Contracting Officer’s (ACO) role in contract administration and delegated functions, and prescribed agency contract clauses. We propose to add section 342.270, Contracting Officer’s Representatives role in contract administration, to establish that a contracting officer may designate a qualified person to be the Contracting Officer’s Representative (COR) for the purpose of performing certain technical functions in administering a contract. Paragraph (b) would provide that the COR may act solely as a technical representative of the contracting officer and is not authorized to perform any function that results in a change in the scope, price, terms, or conditions of the contract, and that the designation must be in writing and a copy of the designation must be furnished to the contractor and the ACO. We propose to add section 342.271, Administrative Contracting Officer’s role in contract administration and delegated functions, to provide the department’s use of an Administrative Contracting Officer Letter of Delegation, which means a delegation of functions as set forth in FAR 42.202 and 42.302 and this section, that is issued by a contracting officer to delegate certain contract administration or specialized support services. This section would limit the ACO’s authority to the actions detailed in the delegation, state that they shall be set forth in a written ACO Letter of Delegation issued by the contracting officer to the accepting contract administration office and designated administrative contracting officer. This section would require that the ACO Letter of Delegation shall contain the information required in FAR 42.202(a) through (c) and identify the responsibilities and limitations of the ACO. A copy of the delegation will be furnished to the contractor and the ACO. And we propose to add section 342.272, Contract clauses, to prescribe two clauses to be used: The clause at 352.242–70, Administrative Contracting Officer, to be inserted in solicitations and contracts expected to exceed the micro-purchase threshold, when contract administration is delegated, and the clause at 352.242–71, Government Construction Contract VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 Administration, to be inserted in solicitations and contracts for construction expected to exceed the micro-purchase threshold, when contract administration is delegated HHSAR Part 343—Contract Modifications We propose to add authority citations for part 343, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to add HHSAR part 343, Contract Modifications, and subpart 343.2, Change Orders, to provide agency policy on the definitization of unpriced change orders with an estimated value exceeding $5 million. We propose to add subpart 342.2, Change Orders, and sections 343.204, Administration; 343.204–70, Definitization; and 343.205, Contract clauses. We propose to add section 343.204, Administration, as a section header with no text, and the underlying section 343.204–70, Definitization, to establish policy with respect to the definitization of unpriced change orders with an estimated value exceeding $5 million. This section would require that unpriced change orders, when authorized by the contracting officer, shall contain a not-to-exceed price and requires a definitization schedules that provide for definitization by— • The date after issuance of the change order may not exceed 180 days after the contractor submits a qualifying proposal); or • The date on which the amount of funds paid to the contractor under the contract action is equal to more than 50 percent of the not-to-exceed price. This section would also provide that if the contractor does not submit a timely qualifying proposal, the contracting officer may suspend or reduce progress payments under FAR 32.503–6 or take other appropriate action. The section would also provide a limitations on obligations in paragraph (b) that the Government shall not obligate more than 50 percent of the notto-exceed price before definitization. However, if a contractor submits a qualifying proposal before 50 percent of the not-to-exceed price has been obligated by the Government, the limitation on obligations before definitization may be increased to no more than 75 percent. Exceptions are provided as authorized by the head of the contracting activity (HCA). The HCA may waive the limitations for unpriced change orders if the HCA determines PO 00000 Frm 00018 Fmt 4701 Sfmt 4702 that the waiver is necessary to support an emergency acquisition operation. We propose to add section 343.205, Contract clauses, to provide agency policy that as authorized in the introductory text of clauses FAR 52.243–1, Changes—Fixed-Price; 52.243–2, Changes—CostReimbursement; and 52.243–4, Changes, and in the prescription at FAR 43.205(c) for FAR 52.243–3, Changes—Time-andMaterials or Labor-Hours, the contracting officer may vary the period within which a contractor must assert its right to an equitable adjustment, but the extended period shall not exceed 60 calendar days, unless approval is one level above the contracting officer. HHSAR Part 344—Subcontracting Policies and Procedures We propose to add authority citations for part 344, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to add HHSAR part 344, Subcontracting Policies and Procedures, and underlying subparts 344.2, Consent to Subcontracts, and 344.3, Contractors’ Purchasing Systems Reviews. We propose to add subpart 344.2, Consent to Subcontracts, and section 344.202–2, Considerations, paragraph (a), to require, in addition to the considerations outlined in FAR 44.202– 2(a), that the contracting officer responsible for consent must review the request and supporting data submitted by the contractor and document whether the contractor adequately substantiated the selection as being fair, reasonable, and representing the best value to the Government where other than the lowest price is the basis for subcontractor selection. We propose to add subpart 344.3, Contractors’ Purchasing Systems Reviews, and section 344.303–70, Additional contractors’ purchasing systems reviews, to identify that special attention shall also be paid to reviewing documentation of commercial products and commercial services determinations. Additionally, the section states that if the contractor has an approved purchasing system as defined in FAR 44.101, the contracting officer shall not withhold consent to subcontract without written coordination of the program manager or comparable requiring activity official. This ensures that a decision to withhold consent is made in concert with the full awareness of program officials who have overall programmatic, budget and schedule responsibilities for E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules acquisitions that may be impacted by a decision to withhold consent. ddrumheller on DSK120RN23PROD with PROPOSALS2 HHSAR Part 345—Government Property We propose to add authority citations for part 345, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to add HHSAR part 345, Government Property, and subpart 345.1, General, to provide agency policy and procedures on contractors’ property management system compliance. In subpart 345.1, General, we propose to add sections 345.105–70 and 345.107, Contract clauses. We propose to add section 345.105–70, Contractors’ property management system compliance—policy and procedures, to provide definitions for acceptable property management system, property management system, and significant deficiency when complying with agency policies and procedures. In paragraph (a), policy is provided that the cognizant contracting officer, in consultation with the property administrator, shall determine the acceptability of the system and approve or disapprove the system, and pursue correction of any deficiencies. Paragraph (c) would provide that in evaluating the acceptability of a contractor’s property management system, the contracting officer, in consultation with the property administrator, shall determine whether the contractor’s property management system complies with the system criteria for an acceptable property management system as prescribed in the clause at 352.245–70, Contractor Property Management System Administration. The section also outlines in paragraph (d) the procedures for disposition of findings, including notification to the contractor, in writing, whether the contractor’s property management system is acceptable and approved. If the contracting officer finds that there are one or more significant deficiencies (as defined in the clause at 352.245–70, Contractor Property Management System Administration) due to the contractor’s failure to meet one or more of the property management system criteria in the clause at 352.245–70, the contracting officer shall— • Promptly make an initial written determination on any significant deficiencies and notify the contractor, in writing, providing a description of each significant deficiency in sufficient detail to allow the contractor to understand the deficiency; VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 • Request the contractor to respond, in writing, to the initial determination within 30 days and; • Evaluate the contractor’s response to the initial determination, in consultation with the property administrator, and make a final determination. Paragraph (d)(3) of this section also provides the procedures for final determination and notification to the contractor in writing whether acceptable and approved, whether significant deficiencies remain and the requested corrective actions, disapproval, and monitoring of the system. Paragraphs (e) and (f) provide policy and procedures on system approval, and other contracting officer notifications. We propose to add section 345.107, Contract clauses, to prescribe the HHSAR clause at 352.245–70, Contractor Property Management System Administration, be inserted in solicitations and contracts containing the clause at FAR 52.245–1, Government Property. HHSAR Part 347—Transportation We propose to add authority citations for part 347, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to add part 347, Transportation, to provide unique HHS delivery information and marking requirements. Proposed underlying sections 347.303–6, F.o.b. destination; 347.303–670, Place of delivery, prescribe clause 352.247–70, Delivery Location, or a clause substantially the same as the clause at 352.247–70 in supply contracts when it is necessary to specify delivery locations. Section 347.305, Solicitation provisions, contract clauses, and transportation factors, and its underlying section 347.305–10, Packing, marking, and consignment instructions, prescribes two clauses: • Paragraph (a) prescribes the clause 352.247–71, Marking Deliverables, or a clause substantially the same as 352.247–71 in solicitations and contracts if special marking on deliverables is required. • Paragraph (b) prescribes the clause at 352.247–72, Packing for Domestic Shipment, in contracts when item(s) will be delivered for immediate use to a destination in the continental United States; when the material specification or purchase description does not provide preservation, packaging, packing, and/or marking requirements; and/or when the requiring activity has PO 00000 Frm 00019 Fmt 4701 Sfmt 4702 80651 not cited a specific specification for packaging. HHSAR Part 352—Solicitation Provisions and Contract Clauses We propose to revise the authority citations for part 352, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to revise subpart 352.1, Instructions for Using Provisions and Clauses, to update the underlying sections 352.100, Scope of subpart, and 351.101–70, Application of provisions and clauses, as follows: We propose to revise 352.100, Scope of subpart, to make a minor grammatical revision by adding the word ‘‘supplemental’’ before the words ‘‘provisions and clauses’’ in the text to provide clarity. We propose to add a section header with no text, 352.102, Incorporating provisions and clauses, to align the supplemental HHSAR section that follows it. And we propose to renumber section 352.101–70 to 352.102–70 as the topical coverage in the text more appropriately aligns under FAR 52.102. We propose to add the phrase ‘‘unless fill-ins are required’’ at the end of paragraph (a) to add a caveat to the policy that it is not necessary to also include clauses in a task order or delivery order if it is included in the overarching master instrument. We propose to add clause 352.201–70, Contracting Officer’s Representative, as prescribed in section 301.602–70, to provide that if the contracting officer designates a COR, the contractor will receive a copy of the written designation. It will specify the extent of the COR’s authority to act on behalf of the contracting officer. The COR is not authorized to make any commitments or changes that will affect price, quality, quantity, delivery, or any other term or condition of the contract. We propose to revise clause 352.203– 70, Anti-Lobbying, as prescribed in section 303.808–70, to make minor administrative and grammatical updates, including to the prescription. This clause provides that the contractor shall not use any HHS contract funds for: • Publicity or propaganda purposes; • The preparation, distribution, or use of any kit, pamphlet, booklet, publication, electronic communication, radio, television, or video presentation designed to support or defeat the enactment of legislation before the Congress or any State or local legislature E:\FR\FM\03OCP2.SGM 03OCP2 ddrumheller on DSK120RN23PROD with PROPOSALS2 80652 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules or legislative body, except in presentation to the Congress or any state or local legislature itself; or designed to support or defeat any proposed or pending regulation, administrative action, or order issued by the executive branch of any state or local government, except in presentation to the executive branch of any state or local government itself; • Payment of salary or expenses of the Contractor, or any agent acting for the Contractor, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or Executive order proposed or pending before the Congress or any state government, state legislature or local legislature or legislative body, other than for normal and recognized executive-legislative relationships or participation by an agency or officer of a State, local, or Tribal government in policymaking and administrative processes within the executive branch of that government. We propose to revise clause 352.204– 70, Prevention and Public Health Fund—Reporting Requirements, to update the prescription, and make minor administrative updates. In paragraph (a), we provide an updated citation to Public Law 112–74, section 220(b)(5). In paragraph (c), we correct grammar to move the word ‘‘electronic’’ after the words ‘‘508 compliant.’’ And in paragraphs (c)(2) and (5), we are removing the words ‘‘funds’’ and ‘‘funding’’ respectively for clarity since the acronym ‘‘PPHF’’ contains the word ‘‘fund’’ in its name. We propose to add clause 352.205–70, Advertisements, Publicizing Awards, and Releases, to state that for HHS contracts and orders, the contractor shall not refer to the contract in commercial advertising or similar promotions in such a manner as to state or imply that the product or service provided is endorsed or preferred by the Federal Government or is considered by the Government to be superior to other products or services. An Alternate I version of the clause is proposed for use when a contract involves sensitive or classified information. We propose to revise clause 352.208– 70, Printing and Duplication, to update the prescription to a FAR compliant format, to move all definitions under paragraph (a), to provide context to the clause, to add headers to each paragraph to comport with FAR style and convention, to rephrase paragraphs (b) through (d) for clarity, and to add paragraph (e) to require the clause is flowed down in subcontracts. We propose to add provision 352.209–70, Organizational Conflicts of VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 Interest, to include the requirement that offerors shall provide a statement with its offer which describes, in a concise manner, all relevant facts concerning any past, present, or currently planned interest (financial, contractual, organizational, or otherwise) or actual or potential organizational conflicts of interest relating to the services to be provided under this solicitation. We propose to revise clause 352.211– 1, Public Accommodations and Commercial Facilities, to renumber it to 352.211–70 to comport with FAR drafting standards, and to revise the prescription to comport with FAR style conventions. We propose to revise clause 352.211– 2, Conference Sponsorship Requests and Conference Materials Disclaimer, to renumber it to 352.211–71 to comport with FAR drafting standards, to update the prescription to comport with FAR style conventions, and to make minor grammatical updates to paragraphs (a) and (b) for clarity. We propose to revise clause 352.211– 3, Paperwork Reduction Act, to renumber it to 352.211–72, update the title so it would read: ‘‘Paperwork Reduction Act Requirements,’’ and update the prescription to comport with FAR style conventions. We propose to add clause 352.212–70, Gray Market and Counterfeit Items, to provide important protection for supplies or equipment offered to the Government to prevent unauthorized items from entering the HHS supply chain. HHS’ critical mission is to enhance the health and well-being of all Americans, by providing for effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services. It is imperative that HHS have a high degree of fidelity in the supplies and equipment delivered to support the critical programs under its purview. This clause would importantly require that no used, refurbished, or remanufactured supplies or equipment/ parts shall be provided, and that the procurement is for new Original Equipment Manufacturer (OEM) items only. As stated in paragraph (a), this clause would prohibit gray market items under the contract which are OEM goods intentionally or unintentionally sold outside an authorized sales territory or sold by non-authorized dealers in an authorized sales territory. Paragraph (b) provides that no counterfeit supplies or equipment/parts shall be provided. Counterfeit items include unlawful or unauthorized reproductions, substitutions, or alterations that have been mismarked, PO 00000 Frm 00020 Fmt 4701 Sfmt 4702 misidentified, or otherwise misrepresented to be an authentic, unmodified item from the original manufacturer, or a source with the express written authority of the original manufacturer or current design activity, including an authorized aftermarket manufacturer. Unlawful or unauthorized substitutions include used items represented as new, or the false identification of grade, serial number, lot number, date code, or performance characteristics. The clause would also state in paragraph (c) that the vendor is required to be an OEM, authorized dealer, authorized distributor, or authorized reseller for the proposed equipment, verified by an authorization letter or other documents from the OEM. All software licensing, warranty and service associated with the equipment shall be in accordance with the OEM terms and conditions. We propose to revise provision 352.215–70, Late Proposals and Revisions, by updating the title to add ‘‘- R&D Solicitations’’ to make clear the types of solicitations this clause involves. And we propose to update the prescription to comport with FAR style conventions, and to substantively revise the provision for clarity and standard FAR clause and provision construction that uses lists for ease of reading. This would include revising the introductory text so that it clarifies that notwithstanding the procedures contained in the provision at FAR 52.215–1, Instructions to Offerors— Competitive Acquisition, paragraph (c)(3), the contracting officer may consider a proposal received for biomedical or behavioral research and development (R&D) solicitations after the date specified for receipt if the three conditions set forth in the clause are met. We propose to add provision 352.215–71, Use of Non-Federal Evaluators—Conditions for Evaluating Proposals, as prescribed in 315.305–71, to provide terms and conditions pertaining to the use of non-Federal evaluators when evaluating proposals and offers. We propose to require that to participate in such role as a non-Federal evaluator, the Contractor shall agree that it and its employees, as well as any subcontractors and their employees as non-Federal evaluators will use the data (trade secrets, business data, and technical data) contained in any proposals under review for evaluation purposes only. Further, the Contractor, its employees, and subcontractors and their employees may not release, in whole or in part, any material received from the Government to evaluate and must protect and secure the data against E:\FR\FM\03OCP2.SGM 03OCP2 ddrumheller on DSK120RN23PROD with PROPOSALS2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules unauthorized disclosure. The provision requires each non-Federal evaluator to insert their name, title, company, signature, and date and provide to the HHS office providing the material and the contracting officer. We propose to remove clause 352.216–70, Additional Cost Principles for Hospitals (Profit and Non-Profit), as the requirement is being removed as a clause and placed in another part of the HHSAR—part 331. The clause number will be repurposed for a HHSAR part 316 related clause. We propose to add clause 352.216–70, Allowable Cost and Payment for Hospitals (Profit and Non-Profit), to stipulate that payment amounts requested by the Contractor and included in invoices submitted for payment in accordance with FAR clause 52.216–7, paragraph (a)(1), must be determined allowable by the Contracting Officer in accordance with the FAR clause at 52.216–7, 45 CFR part 75, appendix IX, and FAR subpart 31.2. We propose to remove two outdated clauses as they are no longer relevant to the HHS small business programs: 352.219–70, Mentor-Protégé Program, and 352.219–71, Mentor-Protégé Program Reporting Requirements. HHS does not currently have a mentor protégé program and the clauses are obsolete. We propose to add two clauses related to the 8(a) partnership program under HHSAR part 319: the clause at 352.219– 70, Notification of Competition Limited to Eligible 8(a) Participants, and the clause at 352.219–71, Notification of Section 8(a) Direct Award. We propose to add clause 352.219–70, Notification of Competition Limited to Eligible 8(a) Participants, as prescribed in 319.811–370. This clause provides that when FAR 52.219–18, Notification of Competition Limited to Eligible 8(a) Participants, is utilized in conjunction with the FAR clause at 52.219–18, any award resulting from a solicitation will be made directly by the contracting officer to the successful 8(a) offeror. The contractor shall comply with the limitations on subcontracting requirements as provided in 13 CFR 125.6 and all other 8(a) program requirements, as set forth in 13 CFR part 124. We propose to add clause 352.219–71, Notification of Section 8(a) Direct Award, as prescribed in 319.811–370. The clause alerts 8(a) firms of the direct contract authority and provides that by submission of its offer, the Offeror represents that it is in good standing and that it meets all the criteria for participation in the program in accordance with 13 CFR part 124, VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 including compliance with the limitations on subcontracting, and the other 8(a) program principles and administrative requirement that are still under the SBA purview. We propose to revise clause 352.222– 70, Contractor Cooperation in Equal Employment Opportunity Investigations, by revising the title to read ‘‘Contractor Cooperation in Equal Employment and Anti-Harassment Opportunity Investigations’’ to convey the additional important new content added to the clause. We propose to update the prescription to comport with FAR style conventions, and to substantively revise the provision for clarity and standard FAR clause and provision construction. We propose to substantively revise the flow and content of the paragraphs to provide clarity and add headers to each paragraph. We propose to retain the three definitions from the existing paragraph (a), include the header ‘‘Definitions,’’ and revise the definitions to comport with standard FAR drafting style and convention. We propose to redesignate the existing paragraph (a) as paragraph (b) and add the header ‘‘Cooperation with investigations.’’ In paragraph (b), we also add the requirement for contractors to cooperate in HHS internal Anti-Harassment investigations. We also propose to redesignate paragraph (b) as paragraph (d) and add a header of ‘‘Subcontract flowdown.’’ We propose to update paragraph (c) and add the header ‘‘Compliance.’’ We propose to revise clause 352.223– 71, Instructions to Offerors—Sustainable Acquisition, to renumber it as 352.223– 70 to comport with FAR and agency supplement numbering conventions. We propose to revise the title to read: ‘‘Instructions to Offerors—Sustainable Acquisition Plan,’’ to identify the content of the provision more clearly. We propose to make minor updates to revise the prescription, correct a FAR citations, and make minor grammatical revisions. We propose to revise clause 352.223– 70, Safety and Health, to renumber it as 352.223–71 to comport with FAR and agency supplement numbering conventions and to make other minor updates in the prescription. We propose to add clause 352.225–70, Made in America—Personal Protective Equipment, that provides new legislative requirements from the Make PPE in America Act (Pub. L. 117–58, sec. 70951, dated November 15, 2021). This codifies a class deviation issued by HHS, Department of Health and Human Services (HHS) Class Deviation from the Health and Human Services Acquisition PO 00000 Frm 00021 Fmt 4701 Sfmt 4702 80653 Regulation (HHSAR)—Implementation of the Make Personal Protective Equipment (PPE) in America Act Requirements, issued on February 9. 2023. The clause requires contractors to deliver only domestic personal protective equipment, unless the solicitation specifies delivery of foreignmade domestic personal protective equipment in the provision of the solicitation entitled ‘‘Made in America Certificate—Personal Protective Equipment.’’ The clause is to be inserted in solicitations and contracts for PPE as prescribed in 325.7103(a), above the micro-purchase threshold, when the clause at FAR 52.212–5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders— Commercial Products and Commercial Services, is included in a solicitation or contract for PPE. Contracting officers shall include the full text of the clause at 352.225–70. We propose to add provision 352.225–71, Made in America Certificate—Personal Protective Equipment, in solicitations containing the clause at 352.225–70. The provision requires the offeror to certify that each item of personal protective equipment, except those listed in paragraph (b) of this provision, is domestic personal protective equipment. The clause also requires the offeror to list offered foreign-made domestic personal protective equipment items in paragraph (b). The provision is to be inserted in solicitations as prescribed in 325.7103(b), above the micro-purchase threshold, when the provision at FAR 52.212–3, Offeror Representations and Certifications—Commercial Products and Commercial Services is included in a solicitation for PPE. Contracting officers shall include the full text of the provision at 352.225–71. We propose to revise clause 352.226– 1, Indian Preference, to renumber the clause to 352.226–70 to comport with FAR drafting standards and to make minor updates to the clause prescription and citation. We propose to revise clause 352.226– 2, Indian Preference Program, to renumber the clause to 352.226–71 to comport with FAR drafting standards and to make minor updates to the clause prescription and citation. We propose to revise clause 352.226– 3, Native American Graves Protection and Repatriation Act, to renumber the clause to 352.226–72 to comport with FAR drafting standards and to make minor updates to the clause prescription and citation. We propose to revise clause 352.226– 4, Notice of Indian Small Business Economic Enterprise set-aside, to E:\FR\FM\03OCP2.SGM 03OCP2 ddrumheller on DSK120RN23PROD with PROPOSALS2 80654 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules renumber the clause to 352.226–73, and to capitalize ‘‘Set-Aside’’ in the title to comport with FAR drafting standards and to make minor updates to the clause prescription and citation. We also propose to update an HHSAR citation in the second sentence. We propose to revise clause 352.226– 5, Notice of Indian Economic Enterprise set-aside, to renumber the clause to 352.226–74, and to capitalize ‘‘SetAside’’ in the title to comport with FAR drafting standards and to make minor updates to the clause prescription and citation. We also propose to align the Public Law citation in paragraph (a), in the definition for ‘‘Alaska Native Claims Settlement Act (ANCSA)’’ to reflect the ‘‘Pub. L.’’ abbreviation and to update the HHSAR reference from the ‘‘subpart’’ to the ‘‘section’’ to standardize with FAR drafting standards. We also propose to spell out ‘‘contracting officer’’ in lieu of ‘‘CO’’ throughout the clause, as well as update any HHSAR section citations as these have been renumbered to comport with FAR standard numbering conventions. We propose to revise clause 352.226– 6, Indian Economic Enterprise Subcontracting Limitations, to renumber the clause to 352.226–75, to comport with FAR drafting standards and to make minor updates to the clause prescription and citation. We also propose to spell out ‘‘contracting officer’’ in lieu of ‘‘CO’’ throughout the clause and other minor administrative abbreviation update. We propose to revise clause 352.226– 7, Indian Economic Enterprise Representation, to renumber the clause to 352.226–76, to comport with FAR drafting standards and to make minor updates to the clause prescription and citation. We propose to revise clause 352.227– 11, Patent Rights—Exceptional Circumstances, to renumber the clause to 352.227–70, and to add the word ‘‘Supplement’’ in the title so it now reads: ‘‘Patent Rights—Supplement— Exceptional Circumstances,’’ to comport with FAR drafting standards and to make minor updates to the clause prescription and citation. We propose to remove the first introductory sentence in the clause and move it to a new paragraph (b). We propose to update the definition of ‘‘Agency’’ in paragraph (a) to make reference to HHS operating division or agency, and provide examples (i.e., Centers for Disease Control and Prevention, Food and Drug Administration, etc.). We propose to renumber the existing paragraph (b) to (c) and update the FAR clause 52.227– 11 title in paragraph (c)(2)(ii) to read ‘‘Patent Rights-Ownership by the VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 Contractor’’ to reflect the correct FAR title. We also propose to make minor grammatical and FAR citation reference updates in paragraphs (c)(2)(ii) and (c)(3), and add paragraphs (c)(3)(i) and (ii) to the existing text to appropriately break up the text for ease of reading and reference. And we propose to make other minor citation reference numbering updates in the clause to reflect the correct paragraph numbers and to correct the FAR clause referenced in paragraph (e)(2) to read ‘‘FAR 52.227–11’’ versus ‘‘52.227–13.’’ And we propose to make other minor nonsubstantive administrative updates, and to update HHSAR clause reference cited in the prescription for Alternate I of the clause. We propose to revise clause 352.227– 14, Rights in Data—Exceptional Circumstances, to renumber the clause to 352.227–71, and to add the word ‘‘Supplement’’ in the title so it now reads: ‘‘Rights in Data—Supplement— Exceptional Circumstances,’’ to comport with FAR drafting standards and to make minor updates to the clause prescription and citation. We propose to revise clause 352.227–14, Rights in Data—Exceptional Circumstances, as a supplemental HHSAR clause to FAR clause at 52.227–14, Rights in Data. The current clause, 352.227–14, duplicates the FAR clause at 52.227–14 except for paragraphs (d)(4) through (6). These paragraphs were added to provide HHSspecific direction when a Decision of Exceptional Circumstances was issued (paragraphs (d)(4) and (5)), and to provide additional policy at paragraph (d)(6) regarding confidential information. We propose to remove paragraphs (a) through (d)(3) as redundant to the FAR clause and unnecessary in the proposed revision to the HHS supplemental clause. We propose to retain the existing paragraphs (d)(4) and (5), with minor administrative updates to citations referenced in the text. Additionally, we propose to remove paragraphs (d)(6), (e), (f), (g), (h), and (i) and the Alternate I through V paragraphs of the existing clause. We propose to revise clause 352.227– 70, Publications and Publicity, to renumber the clause to 352.227–72, to comport with FAR drafting standards and to make minor updates to the clause prescription and citation. We propose to revise paragraph (a) to reformat the paragraph to use a list of items the contractor shall send to the contracting officer’s representative. And we propose to make minor administrative and editorial revisions in paragraphs (b) through (d) for clarity. PO 00000 Frm 00022 Fmt 4701 Sfmt 4702 We propose to revise clause 352.231– 70, Salary Rate Limitation, to comport with FAR drafting standards and to make minor updates to the clause prescription and citation and to include a subcontract flowdown requirements in a new paragraph (f). We propose to revise provision 352.232–70, Incremental Funding, to comport with FAR drafting standards and to make minor updates to the provision prescription and citation. We propose to revise clause 352.232– 71, Electronic submission of payment requests, to capitalize the major words in the title and make minor updates to the clause prescription and citation to comport with FAR drafting standards. We propose to revise clause 352.233– 70, Choice of Law (Overseas), to make minor updates to the clause prescription and citation to comport with FAR drafting standards. We propose to revise clause 352.233– 71, Litigation and Claims, to make minor updates to the clause prescription and citation to comport with FAR drafting standards. We propose to revise clause 352.236– 70, Design-Build Contracts, to make minor updates to the clause prescription and citation to comport with FAR drafting standards. We propose to revise clause 352.237– 70, Pro-Children Act, to revise the title of the clause to read: Nonsmoking Policy—Delivery of Services to Children, to make substantive updates to add needed content and bring reference citations up to date, and to make minor updates to the clause prescription and citation to comport with FAR drafting standards. We propose to revise each paragraph in the clause to add headers. In paragraph (a), the paragraph is revised to make clear that smoking is prohibited in facilities where certain federally funded children’s services are provided pursuant to the Pro-Children Act, 20 U.S.C. 7181, Public Law 107–100, sec. 4301 (the Act). Other edits for grammatical clarity are made. In paragraph (b), the text is updated to make clear that the offeror represents and understands that by submission of its bid or offer and if awarded a contract for this requirement the contractor agrees to comply with the requirements of the Act and the prohibition of smoking in facilities as specified in paragraph (a) of the clause. Paragraph (c) is updated to provide information concerning penalties for each violation. And a subcontractor flowdown clause is added as paragraph (d). We propose to revise 352.237–71, Crime Control Act—Reporting of Child Abuse, to revise the title of the clause E:\FR\FM\03OCP2.SGM 03OCP2 ddrumheller on DSK120RN23PROD with PROPOSALS2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules to read: Reporting of Child Abuse, to make substantive updates to add needed content and bring reference citations up to date, and to make minor updates to the clause prescription and citation to comport with FAR drafting standards. We propose to redesignate the existing paragraph (a) as paragraph (b) and move two existing definitions for ‘‘child abuse’’ and ‘‘covered professionals’’ from paragraph (b) into a new paragraph (a), and to add a header titled ‘‘Definitions.’’ We propose to add a header to the redesignated paragraph (b), Responsibility to report child abuse, and to update the statute citation. We propose to remove the existing paragraph (b) in its entirety as the definitions previously in this paragraph have been moved to paragraph (a), Definitions, to align such definition placement at the beginning of the clause to comport with FAR drafting conventions. We propose to add headers to paragraphs (c) and (d), and we propose to add a new paragraph (e) to provide subcontract flow down requirements. We propose to revise clause 352.237– 72, Crime Control Act—Requirement for Background Checks, to revise the title of the clause to read: Requirement for Background Checks, to make substantive updates to add needed content and bring reference citations up to date, and to make minor updates to the clause prescription and citation to comport with FAR drafting standards. We propose to redesignate the existing paragraph (a) as paragraph (b) and move an existing definition for ‘‘child care’’ from paragraph (b) into a new paragraph (a), and to add a header titled ‘‘Definition.’’ We propose to add a header to the redesignated paragraph (b), Requirement for background checks, and to update the statute citation. We propose to add headers to redesignated paragraphs (c) and (d), and we propose to add a new paragraph (e) to provide subcontract flow down requirements. We propose to revise clause 352.237– 73, Indian Child Protection and Family Violence Act, to revise the title of the clause to read: Indian Child Protection and Family Violence Act—Background Investigation, to make substantive updates to add needed content and bring reference citations up to date, and to make minor updates to the clause prescription and citation to comport with FAR drafting standards. We propose to redesignate the paragraphs by adding a designation for paragraph (b) to break up the existing paragraph (a), and to redesignate paragraph (b) as paragraph (c), and add a paragraph (d) to provide subcontract flow down requirements. VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 We propose to revise clause 352.237– 74, Non-Discrimination in Service Delivery, to make substantive updates to add needed content and bring reference citations up to date, and to make minor updates to the clause prescription and citation to comport with FAR drafting standards. We propose to add paragraph designations and headers to the clause, which will now contain paragraphs (a) through (c). We propose paragraph (a), Policy, to provide the policy of HHS that no person otherwise eligible will be excluded from participation in, denied the benefits of, or subjected to discrimination in the administration of HHS programs and services based on non-merit factors such as race, color, national origin, religion, sex, gender identity, sexual orientation, or disability (physical or mental). We propose to add paragraphs (b) and (c) to provide that the offeror represents and understands that by submission of its bid or offer and if awarded a contract for this requirement the contractor agrees to comply with this policy in supporting the program and in performing the services called for under this contract in a non-discriminatory manner. And in paragraph (c) we propose to add a subcontract flow down requirement. We propose to revise clause 352.237– 75, Key Personnel, to make minor administrative and grammatical updates, and to update the clause prescription and citation to comport with FAR drafting standards. We propose to add clause 352.241–70, Disputes—Utility Contracts, to provide that the requirements of the Disputes clause at FAR 52.233–1 are supplemented to provide that matters involving the interpretation of tariffed retail rates, tariff rate schedules, and tariffed terms provided under this contract are subject to any determinations by the independent regulatory body having jurisdiction. We propose to add clause 352.242–70, Administrative Contracting Officer, to stipulate that the contracting officer reserves the right to designate an Administrative Contracting Officer (ACO) for the purpose of performing certain tasks/duties in the administration of the contract. It also states that such designation will be in writing through an ACO Letter of Delegation and will identify the responsibilities and limitations of the ACO, with a copy to be furnished to the contractor. We propose to add clause 352.242–71, Government Construction Contract Administration, to detail certain delegated contract administration functions, for construction contracts, set forth in FAR 42.302 that are delegated, PO 00000 Frm 00023 Fmt 4701 Sfmt 4702 80655 if any, and to stipulate express functions that are not delegated. We propose to add clause 352.245–70, Contractor Property Management System Administration, that would be inserted in solicitations and contracts containing the clause at FAR 52.245–1, Government Property, to require the contractor to establish and maintain an acceptable property management system and that failure to maintain an acceptable property management system, as defined in this clause, may result in disapproval of the system by the contracting officer and/or withholding of payments. The clause provides three definitions, and details what criteria will be utilized by the Government in its review of the contractor’s property management system how system deficiencies will be handled, and how the contracting officer will evaluate the contractor’s response, and the contracting officer’s notification on resolution or disapproval. The clause provides for a contracting officer’s final determination and requires the contractor to, within 45 days of receipt of final determination, either correct the significant deficiencies or submit an acceptable corrective action plan showing milestones and actions to eliminate the significant deficiencies. We propose to add clause 352.247–70, Delivery Location, to be used in supply contracts when it is necessary to specify delivery locations and provides an insert in the clause for the address and identifying data for shipment of deliverable items other than reports. We propose to add clause 352.247–71, Marking Deliverables, as prescribed at 347.305–10(a), Packing, marking, and consignment instructions, or a clause substantially the same as the proposed clause at 352.247–71, in solicitations and contracts if special marking on deliverables is required. We propose to add clause 352.247–72, Packing for Domestic Shipment, as prescribed at 347.205–10(b), in contracts when item(s) will be delivered for immediate use to a destination in the continental United States; when the material specification or purchase description does not provide preservation, packaging, packing, and/or marking requirements; and/or when the requiring activity has not cited a specific specification for packaging. This clause requires that material shall be packed for shipment in such a manner that will ensure acceptance by common carriers and safe delivery at destination. Containers and closures shall comply with regulations of carriers as applicable to the mode of transportation. E:\FR\FM\03OCP2.SGM 03OCP2 80656 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules We propose to revise the provisions and clauses related to HHSAR part 370, as follows, in the order currently reflected in the Code of Federal Regulations: We propose to revise provision 352.270–4a, Notice to Offerors, Protection of Human Subjects, to make minor administrative corrections to renumber the provision to 352.270–70, revise the HHSAR citation referencing the prescription, provide the current electronic Code of Federal Regulations website address for 45 CFR part 46, update other 45 CFR part 46 citations where included in the provision, and add paragraph (h) to provide the registration processes. We propose to revise clause 352.270– 4b, Protection of Human Subjects, to make minor administrative corrections to renumber to 352.270–72 and to revise the HHSAR citation referencing the prescription. We propose to revise 352.270–5a, Notice to Offerors of Requirement for Compliance with Public Health Service Policy on Humane Care and the Use of Laboratory Animals, to make administrative corrections. This includes revising the provision to a clause, renumbering the clause to 352.270–77, revising the title to ‘‘Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals,’’ and revising the HHSAR citation referencing the prescription. These revisions would add paragraph (a), Definitions, and three definitions, as well as additional content to paragraph (b) that the contract will not be awarded without the approval of the Office of Laboratory ddrumheller on DSK120RN23PROD with PROPOSALS2 Existing subpart prescription (in order of sequence) Existing No. Animal Welfare, National Institutes of Health upon receipt of the contractor’s assurance. We propose to revise paragraphs (b) and (c) to combine the current content into paragraph (b), and revise paragraph (c) to permit the contracting officer to immediately suspend, in whole or in part, work performance and further payments if the contractor is not in compliance with any of the requirements and standards in the clause. We propose to revise clause 352.270– 5b, Care of Live Vertebrate Animals, to make minor administrative corrections to renumber the clause to 352.270–78, revise the HHSAR citation referencing the prescription, remove duplicative content in paragraph (c), change the ‘‘Note’’ to new paragraph (e), and other minor edits for clarification. We propose to revise clause 352.270– 6, Restriction on Use of Human Subjects, to make minor administrative corrections to renumber the clause to 352.270–73, revise the HHSAR citation referencing the prescription, and other minor edits for clarification. We propose to remove the ‘‘352.270– 7—352.270–8 [Reserved]’’ annotation as it is no longer needed with the revision, renumbering, and retitling of the clauses and provisions under this part. We propose to revise provision 352.270–9, Non-Discrimination for Conscience, to make minor administrative corrections to renumber the clause to 352.270–79, revise the HHSAR citation referencing the prescription, and to add ‘‘The PEPFAR Stewardship Act of 2013, and The PEPFAR Extension Act of 2018,’’ to paragraph (a). 352.270–4a 352.270–10 352.270–70 352.270–71 370.304(b) ................. 370.304(a) ................. 370.304(c) ................. 352.270–6 352.270–4b 352.270–11 352.270–73 352.270–72 352.270–74 370.304(d) ................. 370.304(e) ................. 352.270–12 352.270–13 352.270–75 352.270–76 370.403(a) ................. 352.270–5a 352.270–77 370.404 ..................... 370.701 ..................... 352.270–5b 352.270–9 352.270–78 352.270–79 We propose to add subpart 352.3, Provision and Clause Matrix, and section 352.301, Solicitation provisions and contract clauses (Matrix). Section VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 Proposed revised prescription for each solicitation provision and contract clause Note: (P)=Provision, (C)=Clause Proposed No. 370.303(a) ................. 370.303(d) ................. 370.304(a): 352.270–70, Notice to Offerors, Protection of Human Subjects (P). 370.304(b): 352.270–71, Notice to Offerors—Protection of Human Subjects, Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required (P). 370.304(d): 352.270–73, Restriction on Use of Human Subjects (C). 370.304(c): 352.270–72, Protection of Human Subjects (C). 370.304(e): 352.270–74, Protection of Human Subjects—Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required (C). 370.304(f): 352.270–75, Needle Exchange (C). 370.304(g): 352.270–76, Continued Ban on Funding Abortion and Continued Ban on Funding of Human Embryo Research (C). 370.403(a): 352.270–77, Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (C). 370.403(b): 352.270–78, Care of Live Vertebrate Animals (C). 370.701: 352.270–79, Non-Discrimination for Conscience (P). 352.301 identifies that the HHSAR matrix is not published in the Code of Federal Regulations and will be PO 00000 We propose to revise provision 352.270–10, Notice to Offerors— Protection of Human Subjects, Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required, to make minor administrative corrections to renumber the clause to 352.270–71, slightly revise the title and the HHSAR citation referencing the prescription, update the citation of the HHSAR provision number in paragraph (a), and other minor punctuation edits. We propose to revise clause 352.270– 11, Protection of Human Subjects— Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required, to make minor administrative corrections to renumber the clause to 352.270–74, revise the HHSAR citation referencing the prescription, update the citation of the HHSAR provision number in paragraph (a), and other minor punctuation edits. We propose to revise clause 352.270– 12, Needle Exchange, to make minor administrative corrections to renumber the clause to 352.270–75 and revise the HHSAR citation referencing the prescription. We propose to revise clause 352.270– 13, Continued Ban on Funding Abortion and Continued Ban on Funding of Human Embryo Research, to make minor administrative corrections to renumber the clause to 352.270–76 and revise the HHSAR citation referencing the prescription. This table reflects the above proposed revisions and renumbering of the HHSAR part 370 prescribed clauses and provisions: Frm 00024 Fmt 4701 Sfmt 4702 available on the Acquisition.gov website. E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules Subchapter M—HHS Supplementations We propose to redesignate and retitle subchapter M, HHS Supplementations, title 48, chapter 3, to subchapter I, Department Supplementary Regulations, to better align with other FAR system regulatory subchapter placements under similar agency supplements to title 48. ddrumheller on DSK120RN23PROD with PROPOSALS2 HHSAR Part 370—Special Programs Affecting Acquisition We propose to revise the authority citations for part 370, for the reasons set forth in the discussion and analysis section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. We propose to revise the title of part 370 to ‘‘Special Programs Affecting Acquisitions,’’ to comport with the plural usage of ‘‘Acquisitions’’ in the subpart titles. In subpart 370.3, Acquisitions Involving Human Subjects, we propose in section 370.300, Scope of subpart, to add a reference to 45 CFR part 46 policy scope and update the references to the 2018 Requirements revisions. Specifically, we are adding a reference to 45 CFR 46.102, which defines the applicability of the HHS policy in general. We are also removing the reference to the old § 46.102(d) and (f), which defined ‘‘Human Subject’’ and ‘‘Research’’ respectively and replacing them with the new 2018 paragraphs (e) and (l). In section 370.301, Policy, we propose to add a reference to the 2018 exemption for certain research as set forth in 45 CFR 46.104. We also propose administrative edits in the second sentence for further clarification. We propose in section 370.302, Federal-wide Assurance (FWA), to revise the title to ‘‘Federal-wide assurance’’ and make other minor edits for clarification. In section 370.303, Notice to offerors/ Provisions, we propose to revise the section title to ‘‘Notice to offerors,’’ moving the two provisions prescribed in paragraphs (a) and (d) to revised section 370.304, Solicitation provisions and contract clause, paragraphs (a) and (b). We also propose in section 370.303 to add a statement at paragraph (a) to reinforce the 2018 Requirements that unless exempt, no contract can start without the required certifications. We propose in section 370.304, Contract clauses, to revise the title to ‘‘Solicitation provisions and contract clause.’’ The following revisions to the text under this section are proposed: • Move provision 352.270–4a, Notice to Offerors—Protection of Human Subjects, from section 370.303, VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 paragraph (a), to be renumbered as 352.270–70, to comport with FAR numbering conventions. The provision is prescribed to be inserted in solicitations that involve human subjects. • Move propose provision 352.270– 10, Notice to Offerors—Protection of Human Subjects, Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required, from section 370.303, paragraph (d), to be renumbered as 352.270–71, to comport with FAR numbering conventions. The provision is prescribed to be inserted in solicitations that involve human subjects when the research is subject to RIHSC review and approval. • Redesignate the existing paragraph (a) to paragraph (c), and renumber the clause 352.270–4b, Protection of Human Subjects, to 352.270–72, to comport with FAR numbering conventions. The clause is prescribed to be inserted in solicitations, contracts, and orders involving human subjects. • Redesignate the existing paragraph (b) to paragraph (d), and renumber the clause 352.270–6, Restriction of Use of Human Subjects, to 352.270–73, to comport with FAR numbering conventions. The clause is prescribed to be inserted in solicitations, contracts, and orders involving human subjects. In contracts and orders if the contractor has an approved FWA of compliance in place but cannot certify prior to award that an IRB registered with OHRP reviewed and approved the research, because definite plans for involvement of human subjects are not set forth in the proposal (e.g., projects in which human subjects’ involvement will depend upon completion of instruments, prior animal studies, or purification of compounds). Under these conditions, the contracting officer may make the award without the requisite certification, as long as the contracting officer includes appropriate conditions in the contract or order. • Redesignate the existing paragraph (c) to paragraph (e), and renumber the clause 352.270–11, Protection of Human Subjects—Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required, to 352.270–74, to comport with FAR numbering conventions. The clause is prescribed to be inserted in solicitations, contracts, and orders that involve human subjects when the research is subject to RIHSC review and approval. • Redesignate the existing paragraph (e) to paragraph (f), and renumber the clause 352.270–12, Needle Exchange, to 352.270–75, to comport with FAR PO 00000 Frm 00025 Fmt 4701 Sfmt 4702 80657 numbering conventions. The clause is prescribed to be inserted in solicitations, contracts, and orders that involve human subjects. • Redesignate the existing paragraph (e) to paragraph (e), and renumber the clause 352.270–13, Continued Ban on Funding Abortion and Continued Ban on Funding of Human Embryo Research, to 352.270–76, to comport with FAR numbering conventions. The clause is prescribed to be inserted in solicitations, contracts, and orders that involve human subjects. In subpart 370.4, Acquisitions Involving the Use of Laboratory Animals, we propose minor edits for clarification, and to move the citation regarding the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy) to new section 370.402, Policy. We propose in new section 370.401, Definitions, to define three definitions used in this subpart, ‘‘Animal,’’ ‘‘Animal Welfare Assurance or assurance,’’ and ‘‘Institutional Animal Care and Use Committee.’’ We propose to redesignate section 370.401 as section 370.402 to comport with FAR conventions and have made conforming revisions in the section to comport with the revised Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, which implements Public Law 99–158. We also propose to redesignate paragraph (b) to paragraph (c), and remove content to the HHSAM as internal procedures, as well as submission requirements that have more appropriately been moved to clause 352.270.77, Compliance with the Public Health Policy on Humane Care and Use of Laboratory Animals, which is prescribed at section 370.403(a). We propose to remove section 370.402 and move the details of the assurance and approval requirements to clause 352.270.77, Compliance with the Public Health Policy on Humane Care and Use of Laboratory Animals, which is prescribed at section 370.403(a). We propose to rename section 370.403 as ‘‘Contract clauses,’’ to reflect that only clauses are prescribed in the section. The following revisions are proposed: • In paragraph (a), change the prescription to renumbered clause 352.270–77, Compliance with the Public Health Policy on Humane Care and Use of Laboratory Animals, which comports with FAR numbering convention. The clause is prescribed to be inserted in solicitations, contracts, and orders that involve live vertebrate animals. • Move the prescription currently at section 370.304 for clause 352.270–5b, Care of Live Vertebrate Animals, to E:\FR\FM\03OCP2.SGM 03OCP2 80658 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules paragraph (b) of section 370.403, Contract clauses, and renumber the clause to 352.270–76, which comports with FAR numbering convention. The clause is prescribed to be inserted in solicitations and contracts that involve live vertebrate animals. • Remove the remaining content in section 370.403 as the language is duplicative of the prescribed clauses. We propose to remove section 370.404, Contract clause, as the content has been moved to section 370.403. In subpart 370.7, Acquisitions Under the Leadership Act, we propose to revise the title of the subpart to ‘‘Acquisitions Under the President’s Emergency Plan for AIDS Relief,’’ as this is the more commonly used title of Public Law 108–25, in addition to the fact the short title, ‘‘Leadership Act,’’ is no longer widely used. In section 370.700, Scope of subpart, we propose to add the ‘‘PEPFAR’’ (‘‘President’s Emergency Plan for AIDS Relief’’) acronym and update the amended public law references to include Public Law 115–305, the PEPFAR Extension Act. In section 370.701, Solicitation provision, we propose to number provision 352.270–9, NonDiscrimination for Conscience, to 352.270–79, to comport with FAR numbering convention. We also propose to revise the prescription language at paragraphs (a) to update with the enacted PEPFAR Stewardship and Oversight Act of 2013 (Pub. L. 113–56) in lieu of the PEPFAR Extension Act of 2018 (Pub. L. 115–305). We also propose to move the content of paragraph (b) to the HHSAM as agency procedures. Regulatory Reviews ddrumheller on DSK120RN23PROD with PROPOSALS2 Executive Order 12866 and 13563 Executive Orders (E.O.) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. The Office of Information and Regulatory Affairs has examined the economic, interagency, budgetary, legal, and policy implications of this regulatory action, and has determined VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 that this rule is not a significant regulatory action under E.O. 12866. HHS’s impact analysis can be found as a supporting document at https:// www.regulations.gov, usually within 48 hours after the rulemaking document is published. Paperwork Reduction Act This proposed rule includes provisions constituting collections of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3521) that require approval by the Office of Management and Budget (OMB). Accordingly, under 44 U.S.C. 3507(d), HHS has submitted a copy of this rulemaking action to OMB for its review. OMB assigns control numbers to collections of information it approves. HHS may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. HHS is revising 12 currently approved collections of information proposed in this rule under the HHSAR, 48 CFR part 352, Solicitation Provisions and Contract Clauses, that are prescribed under and related to the following HHSAR parts: • 48 CFR part 370, Special Programs Affecting Acquisition; • 48 CFR part 327, Patents, Data, and Copyrights; • 48 CFR part 337, Service Contracting—General; and • 48 CFR part 311, Describing Agency Needs. The 12 existing approved information collections followed by their currently designated numbers and titles are reflected below. (Note: The following existing section (clause or provision) numbers may be updated by number or title as reflected later in this section via a table describing the updated burden information.) • 48 CFR 352.270–4a, Notice to Offerors, Protection of Human Subjects. • 48 CFR 352.270–10, Notice to Offerors—Protection of Human Subjects, Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required. • 48 CFR 352.270–4b, Protection of Human Subjects. • 48 CFR 352.270–11, Protection of Human Subjects—Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required. • 48 CFR 352.237–73, Indian Child Protection and Family Violence Act. • 48 CFR 352.270–5a, Notice to Offerors of Requirement for Compliance with Public Health Service Policy on PO 00000 Frm 00026 Fmt 4701 Sfmt 4702 Humane Care and the Use of Laboratory Animals. • 48 CFR 352.270–5b, Care of Live Vertebrate Animals. • 48 CFR 352.211–1, Public Accommodations and Commercial Facilities. • 48 CFR 352.211–2, Conference Sponsorship Request and Conference Materials Disclaimer. • 48 CFR 352.227–11, Patent Rights— Exceptional Circumstances. • 48 CFR 52.227–14, Rights in Data— Exceptional Circumstances. • 48 CFR 352.237–72, Crime Control Act—Requirement for Background Checks. Additionally, HHS is proposing to add six (6) new collections of information in this proposed rule under the HHSAR, 48 CFR part 352, Solicitation Provisions and Contract Clauses, that are prescribed under and related to the following HHSAR parts: • 48 CFR part 304, Administrative Matters (proposed to be revised to a new header to comport with the FAR: Administrative and Information Matters); • 48 CFR part 308, Required Sources of Supplies and Services; • 48 CFR part 309, Contractor Qualifications; • 48 CFR part 323, Environment, Energy and Water Efficiency, Renewable Energy Technologies, Occupational Safety, and Drug–Free Workplace (proposed to be revised to a new header to comport with the FAR: Environment, Sustainable Acquisition, and Material Safety); • 48 CFR part 333, Protests, Disputes, and Appeals; and • 48 CFR part 345, Government Property. The six new proposed approved information collections are as follows (Note: Based on the number of respondents for two of the associated information collections falling under 10 that do not require OMB approval due to exception, HHS is requesting four (4) new approved OMB control numbers for items 1 through 4 as follows out of the six new identified collections of information.): 1. 48 CFR 352.204–70, Prevention and Public Health Fund—Reporting Requirements. 2. 48 CFR 352.209–70, Organizational Conflicts of Interest. 3. 48 CFR 352.208–70, Printing and Duplication. 4. 48 CFR 352.245–70, Contractor Property Management System Administration. 5. 48 CFR 352.223–70, Instructions to Offerors—Sustainable Acquisition Plan. (OMB approval not required at this time.) E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules 6. 48 CFR 352.233–71, Litigation and Claims. (OMB approval not required at this time.) If OMB does not approve the collections of information as requested, HHS will immediately remove the provisions containing a collection of information or take such other action as is directed by OMB. Comments on the collections of information contained in this proposed rule should be submitted to the Office of Management and Budget, Attention: Desk Officer for the Department of Health and Human Services, Office of Information and Regulatory Affairs, Washington, DC 20503, with copies sent by mail or hand delivery to the U.S. Department of Health and Human Services, Office of the Chief Information Officer, Attn: Sherrette Funn, 200 Independence Ave. SW, Room 336E, Washington, DC 20201; or email to sherrette.funn@hhs.gov; and email to https://www.regulations.gov. Comments should indicate that they are submitted in response to ‘‘RIN 0991–AC36—HHS ddrumheller on DSK120RN23PROD with PROPOSALS2 Existing clause/provision number and header title Acquisition Regulation: Regulatory Review (HHSAR Case 2023–002).’’ OMB is required to make a decision concerning the collections of information contained in this proposed rule between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment to OMB is best assured of having its full effect if OMB receives it within 30 days of publication. This does not affect the deadline for the public to comment on the proposed rule. The Department considers comments by the public on proposed collections of information in— • Evaluating whether the proposed collections of information are necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; • Evaluating the accuracy of the Department’s estimate of the burden of the proposed collections of information, including the validity of the methodology and assumptions used; Approved OMB control number • Enhancing the quality, usefulness, and clarity of the information to be collected; and • Minimizing the burden of the collections of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The collection of information on currently approved OMB control numbers can be accessed on reginfo.gov. The following table provides a summary of the proposed revisions of the 12 currently approved collections of information. The proposed revisions do not change information collection requirements and the estimated burden hours. But the proposed revision made changes in the Information Collection Instruments/Instructions. HHS has submitted them to OMB for review and approval. Proposed clause/provision number and header title Proposed other changes Revise the HHSAR citation referencing the prescription. N/A ................................... 450 Revise the HHSAR citation referencing the prescription. Revise the HHSAR citation referencing the prescription. 450 352.270–4a, Notice to Offerors, Protection of Human Subjects. 0990–0431 352.270–70, Notice to Offerors—Protection of Human Subjects. 352.270–10 Notice to Offerors—Protection of Human Subjects, Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required. 352.270–4b, Protection of Human Subjects. 0990–0431 352.270–71, Notice to Offerors—Protection of Human Subjects, Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required. 352.270–72, Protection of Human Subjects. 352.270–11 Protection of Human Subjects—Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required. 352.237–72, Crime Control Act—Requirement for Background Checks. 352.270–5a, Notice to Offerors of Requirement for Compliance with Public Health Service Policy on Humane Care and the Use of Laboratory Animals. 352.270–5b, Care of Live Vertebrate Animals. 0990–0431 0990–0431 0990–0430 0990–0432 0990–0432 352.211–1, Public Accommodations and Commercial Facilities. 0990–0434 352.211–2, Conference Sponsorship Request and Conference Materials Disclaimer. 352.227–11, Patent Rights—Exceptional Circumstances. 0990–0434 352.227–14, Rights in Data—Exceptional Circumstances. VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 0990–0419 0990–0419 PO 00000 80659 352.270–74 Protection of Human Subjects—Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required. 352.237–72, Requirement for Back- Update the prescription ground Checks. and the title. 352.270–77, Compliance with the Pub- Revise the title and lic Health Service Policy on Humane HHSAR citation refCare and Use of Laboratory Animals. erencing the prescription. Adding new content. 352.270–78, Care of Live Vertebrate Revise the HHSAR citaAnimals. tion referencing the prescription and remove duplicative content. 352.211–70, Public Accommodations Revise the prescription to and Commercial Facilities. comport with FAR style conventions. 352.211–71, Conference Sponsorship Update the prescription to Requests and Conference Materials comport with FAR style Disclaimer. conventions. 352.227–70, Patent Rights—Supple- Make minor updates to ment—Exceptional Circumstances. the clause prescription and citation. 352.227–71, Rights in Data—Supple- Make minor updates to ment—Exceptional Circumstances. the clause prescription and citation and remove duplicate content. Frm 00027 Fmt 4701 Sfmt 4702 E:\FR\FM\03OCP2.SGM 03OCP2 Burden hours 450 450 160 54 54 533.5 533.5 5,449.5 5,449.5 80660 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules Approved OMB control number Existing clause/provision number and header title 352.237–73, Indian Child Protection and Family Violence Act. 0990–0433 HHSAR parts 308, 309, 304, 323, 333, and 345 related new collections of information: Individual summaries of collection of information, description of need for information and proposed use Proposed clause/provision number and header title Proposed other changes 352.237–73, Indian Child Protection and Family Violence Act—Background Investigations. Revise title of the clause. Add needed content and bring reference citations up to date. Updates to the clause prescription and citation. of information, along with supporting estimated data are described below. The following table summarizes HHS request for four (4) new OMB control numbers for the four proposed clauses/ HHSAR clause provision OMB control # requesting 1 ....................................................................................................................... 1 ....................................................................................................................... N/A * ................................................................................................................. N/A * ................................................................................................................. 1 ....................................................................................................................... 1 ....................................................................................................................... Burden hours 67 provisions containing collections of information with burdens on the public. Estimated hour 352.208–70 352.209–70 352.233–71 352.223–70 352.204–70 352.245–70 500 150 N/A N/A 260 66 BLS hourly wage rate $42.89 42.89 42.89 42.89 42.89 42.89 Estimated cost to the public $21,445 6,434 N/A N/A 11,151 2,831 * No OMB Control Number is requested because currently, the estimated number of respondents falls below 10. While HHS will collect information it does not meet the threshold for submitting to OMB for approval. As HHS captures more information in the future when the rule is published as final, HHS will continue to examine how much the proposed new collections of information are utilized in HHS procurements. The Bureau of Labor Statistics (BLS) gathers information on full-time wage and salary workers. The BLS hourly wage rate is using the latest (May 2023) available BLS data, the mean hourly wage is $31.48 on BLS wage code—‘‘00– 0000 All Occupations’’ plus 36.25% fringe benefits per OMB Memo M–08– 13 dated March 11, 2008. The 6 new clauses/provisions containing collections of information are described below: • The first new OMB Control number request is for 352.208–70, Printing and Duplication. The collection of information contained in section 308.870, Contract clauses, and part 352 at proposed clause 352.208–70, is described immediately following this paragraph. Summary of collection of information: We propose the use of 352.208–70, Printing and Duplication, as prescribed at 308.870, Contract clauses. The proposed HHSAR clause 352.208–70, Printing and Duplication, is required in all solicitations and contracts for supplies or services over the simplified acquisition threshold, unless printing or increased duplication is authorized by statute. It is intended to prohibit contractors and subcontractors from performing printing, to acquire related supplies, or to provide other printing-related services without prior authorization from the contracting officer. When printing supplies or services are required, and specified under the contract, the Contractor shall submit camera-ready copies of such deliverables to the Contracting Officer’s Representative for printing. The information collection requirement is necessary to ensure deliverables are not duplicated and/or printed without prior approval from the contracting officer. Description of need for information and proposed use of information: Public Law 90–620, (44 U.S.C. 101), Public Printing and Document, was passed to centralize in the United States Government Publishing Office the printing, binding, and distribution of U.S. Government documents. To comply with Public Law 90–620, and to establish parameters on allowable printing under HHS contracts, HHS developed clause 352.208–70, Printing and Duplication. The clause contains the following information collection requirements: the contractor shall submit camera-ready copies of such deliverables to the Contracting Officer’s Representative for printing. ddrumheller on DSK120RN23PROD with PROPOSALS2 BURDEN HOUR CALCULATION Number of respondents × Number of responses per respondent × Number of minutes ÷ by 60 min/ hour Number of burden hours 5,000 ................................................................................................................ 1 10 ........................ 500 • The second new OMB control number request is for 352.209–70, Organizational Conflicts of Interest. The collection of information contained in section 309.507–1, Solicitation provision, and part 352 at proposed provision 352.209–70, is VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 described immediately following this paragraph. Summary of collection of information: We propose to add 352.209–70, Organizational Conflicts of Interest, as prescribed at 309.507–1, Solicitation provision. PO 00000 Frm 00028 Fmt 4701 Sfmt 4702 The proposed rule HHSAR provision 352.209–70, Organizational Conflicts of Interest, is required in all solicitations for the services addressed at FAR 9.502 and is intended to avoid situations which might create an organizational conflict of interest or where the offeror’s E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules performance of work under the contract may provide the contractor with an unfair competitive advantage. HHS would use the information collection requirements to assess whether an organizational conflict of interest exists with the contractor. The information collection requirement is necessary to ensure that the offeror’s performance of work under the contract may not provide the contractor with an unfair competitive advantage. Description of need for information and proposed use of information: Under Public Law 117–324, Preventing Organizational Conflicts of Interest in Federal Acquisition Act, each agency of the Federal Government must prevent organizational conflicts of interest in Federal acquisitions. To comply, HHS developed provision 352.209–70, Organizational Conflicts of Interest. The provision contains the following information collection requirements: The offeror shall provide (1) a statement with its offer which describes all relevant facts concerning any past, present, or currently planned interest 80661 (financial, contractual, organizational, or otherwise) or actual or potential organizational conflicts of interest relating to the services to be provided under this solicitation; (2) same information as (1) for any consultants and subcontractors identified in its proposal and which will provide services under the solicitation; (3) relevant facts that show how its organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest. BURDEN HOUR CALCULATION Number of respondents × Number of responses per respondent × Number of minutes ÷ by 60 min/ hour Number of Burden Hours 150 ................................................................................................................... 1 60 ........................ 150 • The third information collection added in the rule is for 352.233–71, Litigation and Claims. Due to the estimated projected respondents falling under 10, a new OMB control number will not be requested at this time. The information on the collection of information that falls within the exception is provided here for the public’s information and use. HHS will continue to examine in the future after publication of a final rule whether or not the use of the clause increases over 10 in a given fiscal year and proceed with requesting OMB approval if needed at that time. The collection of information contained in section 333.215–70, Contract clauses, and part 352 at proposed clause 352.233–71, is described immediately following this paragraph. Summary of collection of information: We propose to add 352.233–71, Litigation and Claims, as prescribed at 333.215–70, Contract clauses. The proposed rule HHSAR clause 352.233–71, Litigation and Claims, is required in solicitations and contracts when a cost-reimbursement, time-andmaterials, or labor-hour contract is contemplated and is intended to require contractors to notify the Department of Health and Human Services (HHS) immediately for any litigation or claims that may be filed against the contractor arising out of the performance of the contract. The information collection requirement is necessary to determine the need of assigning representatives of HHS to settle or defend any such action or claim. Description of need for information and proposed use of information: To ensure HHS is not liable for the expense of defending any action or for any costs resulting from the loss thereof to the extent that the contractor would have been compensated by insurance due to the contractor failing to secure, through its own fault or negligence, appropriate insurance coverage, HHS developed clause 352.233–71, Litigation and Claims. The clause contains the following information collection requirements: (1) The contractor shall provide written notification immediately to the contracting officer of any action, including any proceeding before an administrative agency, filed against the contractor arising out of the performance of this contract; (2) the contractor shall furnish immediately to the contracting officer copies of all pertinent documents received by the contractor with respect to such action or claim. BURDEN HOUR CALCULATION Number of respondents × Number of responses per respondent × Number of minutes ÷ by 60 min/ hour Number of burden hours 2 (N/A) * ........................................................................................................... 2 (N/A) 60 ........................ 2 (N/A) ddrumheller on DSK120RN23PROD with PROPOSALS2 * Note: Due to the estimated low number of projected respondents, no formal OMB information collection approval is required at this time. HHS will continue monitoring the use of the clause after publication of the final rule. • The fourth information collection added in the rule is for 352.223–70, Instructions to Offerors—Sustainable Acquisition Plan. The collection of information contained in section 323.109–70, Solicitation provision, and part 352 at proposed provision 352.223–70, is described immediately following this paragraph. VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 Summary of collection of information: We propose to add 352.223–70, Instructions to Offerors—Sustainable Acquisition Plan, as prescribed at 323.109–70, Solicitation provision. The proposed rule would add HHSAR provision 352.223–70, Instructions to Offerors—Sustainable Acquisition Plan. It is required in solicitations above the micro-purchase threshold when acquiring a product or service that PO 00000 Frm 00029 Fmt 4701 Sfmt 4702 include sustainable acquisition attributes and is intended to apply FAR subpart 23.1, Sustainable Products and Services. The information collection requirement is necessary to comply with the requirements of Executive Order 13423. Description of need for information and proposed use of information: Executive Order (E.O.) 13423 requires in agency acquisitions of goods and E:\FR\FM\03OCP2.SGM 03OCP2 80662 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules services (i) the use of sustainable environmental practices, including acquisition of biobased, environmentally preferable, energyefficient, water-efficient, and recycledcontent products, and (ii) the use of paper of at least 30 percent postconsumer fiber content. To comply with E.O. 13423, HHS developed provision 352.223–70, Instructions to Offerors— Sustainable Acquisition Plan. The provision contains the following information collection requirements: Offerors shall include a Sustainable Acquisition Plan in their technical proposals. BURDEN HOUR CALCULATION Number of respondents × Number of responses per respondent × Number of minutes ÷ by 60 min/ hour Number of burden hours 6 (N/A) * ........................................................................................................... 1 (N/A) 120 ........................ 12 (N/A) * Note: Due to the estimated low number of projected respondents, no formal OMB information collection approval is required at this time. HHS will continue monitoring the use of the clause after publication of the final rule. • The fifth new information collection, and third request for an OMB control number is for 352.204–70, Prevention and Public Health Fund— Reporting Requirements. The collection of information contained in section 304.7202, Contract clause, and part 352 at proposed clause 352.204–70, is described immediately following this paragraph. Summary of collection of information: We propose to add of 352.204–70, Prevention and Public Health Fund— Reporting Requirements, as prescribed at 304.7202, Contract clause. Proposed rule added HHSAR clause 352.204–70, Prevention and Public Health Fund—Reporting Requirements, is required in all solicitations and contract actions with a value of $25,000 or more funded in whole or in part with Prevention and Public Health Funds (PPHFs), except classified solicitations and contracts and is intended to implement section 220 of Public Law 112–74, FY 2012 Labor, HHS and Education Appropriations Act. The information collection requirement is necessary to comply with the requirements of semi-annual reporting on the use of funds from the Prevention and Public Health Fund (PPHF), Public Law 111–148, sec. 4002. Description of need for information and proposed use of information: Under Public Law 112–74, Consolidated Appropriations Act, 2012, section 220(b)(5), requires each contractor to report on its use of Prevention and Public Health Fund under the contract. To comply with the public law, HHS developed clause 352.204–70, Prevention and Public Health Fund— Reporting Requirements. The clause contains the following information collection requirements: Semi-annual reports from the contractor for all work funded, in whole or in part, by the PPHF, are due no later than 20 days following the end of each 6-month period. ddrumheller on DSK120RN23PROD with PROPOSALS2 BURDEN HOUR CALCULATION Number of respondents × Number of responses per respondent × Number of minutes ÷ by 60 min/ hour Number of burden hours 260 ................................................................................................................... 2 30 ........................ 260 • The sixth new information collection requirement is for 352.245– 70, Contractor Property Management System Administration. The collection of information contained in section 345.107, Contract clauses, and part 352 at proposed clause 352.245–70, Contractor Property Management System Administration, is described immediately following this paragraph. Summary of collection of information: We propose to add 352.245–70, Contractor Property Management System Administration, as prescribed at 345.107, Contract clauses. Proposed rule added HHSAR clause 352.245–70, Contractor Property Management System Administration, is VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 required in solicitations and contracts containing the clause at FAR 52.245–1, Government Property, and is intended to protect HHS’s property. The information collection requirement is necessary to ensure the Contractor’s system or systems for managing and controlling Government property is acceptable by HHS. Description of need for information and proposed use of information: To ensure the contractor is establishing and maintaining an acceptable property management system, HHS developed clause 352.245–70, Contractor Property Management System Administration. The clause contains the following information collection requirements: The contractor shall respond within 30 PO 00000 Frm 00030 Fmt 4701 Sfmt 4702 days to a written initial determination from the contracting officer that identifies significant deficiencies in the contractor’s property management system. HHS estimates that of the 26,128 total contract actions over the Simplified Acquisition Threshold during FY 2018–FY 2022, that no more than 5% (1,306) would require the required contractor property management system administration, and no more than 10% of that subset (131) would be submitting information in any one fiscal year during performance under the contract. We have entered the data below and as HHS obtains more data for future renewals, we will update the estimated burden. E:\FR\FM\03OCP2.SGM 03OCP2 80663 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules BURDEN HOUR CALCULATION Number of respondents × Number of responses per respondent × Number of minutes ÷ by 60 min/ hour Number of Burden Hours 131 ................................................................................................................... 1 30 ........................ 66 Regulatory Flexibility Act The Secretary hereby certifies that this proposed rule would not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601–612). Therefore, pursuant to 5 U.S.C. 605(b), the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604 do not apply. HHS expects that the overall impact of the proposed rule would benefit small businesses because HHS proposes to update the HHSAR to, among other things, revise outdated information, remove extraneous procedural information that applies only to HHS’s internal operating procedures, and remove policy or procedures duplicative of FAR requirements. Any additional costs associated with the rule, such as costs to implement the substantive new and revised requirements concerning Made in America Act, can be factored into the contract price. On this basis, the Secretary hereby certifies that this proposed rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601–612. Therefore, pursuant to 5 U.S.C. 605(b), the initial and final regulatory flexibility analysis requirements of sections 603 and 604 do not apply. While based on the foregoing, HHS has determined that the agency is not required to prepare an Initial Regulatory Flexibility Analysis (IRFA), HHS has prepared an IRFA that is summarized here. Comments are solicited from small businesses and other interested parties and will be considered in the development of the final rule. Initial Regulatory Flexibility Analysis This Initial Regulatory Flexibility Analysis has been prepared consistent with 5 U.S.C. 603. 1. Description of the Reasons why the Action is Being Taken This proposed rule would amend the Health and Human Services Acquisition Regulation (HHSAR) to implement updates to the HHSAR, remove extraneous procedural information that applies only to HHS’s internal operating procedures, and remove policy or procedures duplicative of FAR requirements. The proposed rule also includes substantive new and revised requirements concerning due process rights on debarments and suspensions. Based on a review of the potential impact on small business entities, HHS has determined that the requirements specified in the proposed rule are inherent to successful performance on any Federal contract and are required for both large and small businesses. 2. Succinct Statement of the Objectives of, and Legal Basis for, the Proposed Rule In addition to updating the HHSAR to remove outdated information, remove extraneous procedural information that applies only to HHS’s internal operating procedures, and to remove policy or procedures duplicative of FAR requirements, the proposed rule implements important agency policies and procedures to implement Executive orders and specific requirements of the FAR specified for agency implementation. This must be implemented in the HHSAR in accordance with 41 U.S.C. 1707 and FAR subpart 1.5, which require publication of a proposed rule for public comment. 3. Description of and, Where Feasible, Estimate of the Number of Small Entities to Which the Proposed Rule Will Apply This proposed rule will impact small businesses that provide supplies, services, and construction to HHS as prime contractors or subcontractors, as well as those small business entities that would like to support HHS and who submit quotations, offers and proposals to compete for future opportunities. To estimate the number of small businesses that could potentially be impacted by the proposed rule, HHS focused on those contract award actions over the Simplified Acquisition Threshold (SAT) (in most instances the SAT was $150,000 before June 1, 2018, and $250,000 after June 1, 2018, when the SAT was increased). This is because it is likely that the most impact to small business entities as a result of this important HHSAR update would be at the SAT or above, as the FAR already provides agencies more streamlined policies and procedures under the SAT to ease the burden, both on the public as well as the acquisition workforce, for actions that fall under the SAT. Across the thirteen main Operating Divisions and Staff Divisions we examined the Federal Procurement Data System for HHS contract award actions over the SAT for Fiscal Years (FY) 2018–2022. This data reflects the following HHS contract awards to small business entities as shown in the table below: HHS CONTRACT ACTION AWARDS TO SMALL BUSINESS ENTITIES OVER THE SAT: FY 2018–FY 2022 FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Total Average 2536 2405 2502 2426 2551 12,420 2484 ddrumheller on DSK120RN23PROD with PROPOSALS2 Total ...................... VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 PO 00000 Frm 00031 Fmt 4701 Sfmt 4702 E:\FR\FM\03OCP2.SGM 03OCP2 80664 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules As shown, HHS awarded over 12,420 contracts to small business entities over the SAT during the period FY 2018 through FY 2022. Using this figure to project the potential impact to small business entities that may be affected by the proposed rule, the Department estimates that on average each fiscal year, 2,484 small business entities or more may perform under HHS contracts and be impacted by the acquisition regulations contained in this rulemaking. 4. Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements of the Proposed Rule, Including an Estimate of the Classes of Small Entities Which Will be Subject to the Requirement and the Type of Professional Skills Necessary for Preparation of the Report Or Record The proposed rule includes reporting or recordkeeping requirements. The revised record keeping and reporting requirements and estimated impacts are described in the Paperwork Reduction Act section of the rulemaking. 5. Identification, to the Extent Practicable, of all Relevant Federal Rules Which May Duplicate, Overlap, or Conflict With the Proposed Rule The proposed rule does not duplicate, overlap, or conflict with any other Federal rules. ddrumheller on DSK120RN23PROD with PROPOSALS2 6. Description of any Significant Alternatives to the Proposed Rule Which Accomplish the Stated Objectives of Applicable Statutes and Which Minimize Any Significant Economic Impact of the Rule on Small Entities HHS considered whether any other alternatives would reduce the impact on small businesses but concluded that the proposed rule was necessary for consistency with the FAR, for compliance with new statutes such as Made in America, and to ensure the protection of children entrusted under the care of HHS through unique agency acquisition requirements with respect to important issues such as compliance with reporting of child abuse, nonsmoking, and required background checks. Comments on the Economic Impacts of the Proposed Rule HHS has submitted a copy of the IRFA to the Chief Counsel for Advocacy of the Small Business Administration. HHS will consider comments from small entities concerning the affected HHSAR parts that pertain to this proposed rule. Interested parties should cite 5 U.S.C 601, et seq. and reference VerDate Sep<11>2014 21:18 Oct 02, 2024 Jkt 265001 ‘‘RIN 0991–AC36—HHS Acquisition Regulation: Regulatory Review (HHSAR Case 2023–002),’’ in comments on the certification or the IRFA presented in this proposed rule. Unfunded Mandates The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. HHS has determined that this proposed rule would have no such effect on State, local, and Tribal governments or on the private sector. Therefore, the analytical requirements of UMRA do not apply. List of Subjects 48 CFR Parts 301, 302, 303, 304, 305, 306, 308, 309, 311, 312, 313, 314, 315, 316, 318, 319, 322, 323, 324, 327, 330, 331, 332, 333, 334, 335, 336, 337, 343, 345, 352, and 370 Government procurement. 48 CFR Part 325 Customs duties and inspection, Foreign currencies, Foreign trade, Government procurement. 48 CFR Part 326 Government procurement, Indians, Indians-business and finance, Reporting and recordkeeping requirements. 48 CFR Part 341 Government procurement, Reporting and recordkeeping requirements, Utilities. 48 CFR Parts 342 and 344 Government procurement, Reporting and recordkeeping requirements. PART 303 IMPROPER BUSINESS PRACTICES AND PERSONAL CONFLICTS OF INTEREST * * * * * PART 301—HHS ACQUISITION REGULATION SYSTEM Sec. 301.000 Scope of part. Subpart 301.1—Purpose, Authority, Issuance 301.101 Purpose. 301.103 Authority. 301.104 Applicability. 301.105 Issuance. 301.105–1 Publication and code arrangement. 301.105–2 Arrangement of regulations. 301.105–3 Copies. 301.106 OMB approval under the Paperwork Reduction Act. 301.107 Certifications. Subpart 301.3—Agency Acquisition Regulations 301.301 Policy. 301.301–70 Amendment of the HHSAR. 301.303–70 Publication and codification— HHSAR. 301.304 Agency control and compliance procedures. Subpart 301.470—Deviations from the FAR and HHSAR 301.402 Policy. 301.403 Individual deviations. 301.404 Class deviations. Subpart 301.6—Career Development, Contracting Authority, and Responsibilities 301.601 General. 301.602 Contracting officers. 301.602–3 Ratification of unauthorized commitments. 301.603 Selection, appointment, and termination of appointment of contracting officers. 301.603–1 General. 301.603–3 Appointment. 301.604 Contracting Officer’s Representative (COR). 301.604–70 Contract clause. 48 CFR Part 347 Subpart 301.7—Determination and Findings 301.707 Signatory authority. Freight, Government procurement, Reporting and recordkeeping requirements, Transportation. Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(b), (c)(3); 41 U.S.C. 1303(a)(2); 41 U.S.C. 1702, 1707; and 48 CFR 1.301 through 1.304. Xavier Becerra, Secretary, Department of Health and Human Services. 301.000 For the reasons set out in the preamble, HHS proposes to amend 48 CFR chapter 3 as follows: ■ 1. Revise parts 301 through 303 to read as follows: * * * * * PART 301 HHS ACQUISITION REGULATION SYSTEM PART 302 DEFINITIONS OF WORDS AND TERMS PO 00000 Frm 00032 Fmt 4701 Sfmt 4702 Scope of part. This part sets out general Department of Health and Human Services Acquisition Regulation (HHSAR) policies, including information regarding the purpose, authority, issuance, arrangement, applicability, numbering, implementation, supplementation, and maintenance and administration of the HHSAR. The HHSAR is an integral part of the Federal Acquisition Regulations System. It also includes Health and Human Services E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules (HHS) acquisition policies and procedures for deviation from the HHSAR and the Federal Acquisition Regulation (FAR). Subpart 301.1—Purpose, Authority, Issuance 301.101 Purpose. The HHSAR establishes uniform acquisition policies and procedures, which implement and supplement the Federal Acquisition Regulation (FAR). This subpart also provides the explanation of the authorities under which the HHSAR is issued. 301.103 Authority. (b) The Senior Procurement Executive (SPE), as delegated by the Secretary of HHS, prescribes the HHSAR under the authority of 41 U.S.C. 1707, 5 U.S.C. 301, section 205(c) of the Federal Property and Administrative Services Act of 1949, 40 U.S.C. 121(c)(2), FAR 1.301 through 1.304, and other authorities as cited. 301.104 Applicability. The FAR and the HHSAR apply to all HHS acquisitions as defined in FAR 2.101. 301.105 Issuance. 301.105–1 Publication and code arrangement. (b) The HHSAR is issued as chapter 3 of title 48 in the Code of Federal Regulations (CFR) and referenced as 48 CFR chapter 3. ddrumheller on DSK120RN23PROD with PROPOSALS2 301.105–2 Arrangement of regulations. (a) General. The HHSAR conforms with the arrangement and numbering system prescribed by FAR 1.105–2. (b) Numbering. (1) The numbering illustrations at FAR 1.105–2(b) apply to the HHSAR. Coverage in the HHSAR is identified by the prefix ‘‘3’’ followed by the complete HHSAR citation. For example, 301.105–2(b). (2) Subdivisions below the section or subsection level follow the FAR in this sequence: (a)(1)(i)(A)(1)(i). (c) References and citations. (1) Cross reference to the FAR in the HHSAR will be cited by ‘‘FAR’’ followed by the FAR numbered citation. References to specific citations with the HHSAR will be referenced by the numbered citation only, e.g., 301.105–2. (2) This chapter may be referred to as the Health and Human Services Acquisition Regulation or the HHSAR. (3) Using the HHSAR coverage at 301.105–2(b) as a typical illustration, reference to the— (i) Part would be ‘‘HHSAR part 301’’ outside the HHSAR and ‘‘part 301’’ within the HHSAR. VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 (ii) Subpart would be ‘‘HHSAR subpart 301.1’’ outside the HHSAR and ‘‘subpart 301.1’’ within the HHSAR. (iii) Section would be ‘‘HHSAR 301.105’’ outside the HHSAR and ‘‘301.105’’ within the HHSAR. (iv) Subsection would be ‘‘HHSAR 301.105–1’’ outside the HHSAR and ‘‘301.105–1’’ within the HHSAR. (v) Paragraph would be ‘‘HHSAR 301.105–1(b)’’ outside the HHSAR and ‘‘301.105–1(b)’’ within the HHSAR. 301.105–3 Copies. The HHSAR is available on the internet at https://www.ecfr.gov/current/ title-48/chapter-3 or https:// acquisition.gov. OMB Control No. HHSAR segment 304.7202 ............................... 308.870 ................................. 309.507–1 ............................. 311.7102 ............................... 311.7202 ............................... 327.303–70 ........................... 327.407–70 ........................... 337.7006 ............................... 345.107 ................................. 370.304 ................................. 370.403 ................................. 352.204–70 ........................... 352.208–70 ........................... 352.209–70 ........................... 352.211–70 ........................... 352.211–71 ........................... 352.227–70 ........................... 352.227–71 ........................... 352.237–72 ........................... 352.237–73 ........................... 352.245–70 ........................... 352.270–70 ........................... 352.270–71 ........................... 352.270–72 ........................... 352.270–74 ........................... 352.270–77 ........................... 352.270–78 ........................... 0990–XXXX 0990–XXXX 0990–XXXX 0990–0434 0990–0434 0990–0419 0990–0419 0990–0430, 0990–0433 0990–XXXX 0990–0431 0990–0432 0990–XXXX 0990–XXXX 0990–XXXX 0990–0434 0990–0434 0990–0419 0990–0419 0990–0430 0990–0433 0990–XXXX 0990–0431 0990–0431 0990–0431 0990–0431 0990–0432 0990–0432 301.106 OMB approval under the Paperwork Reduction Act. In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3521), the Office of Management and Budget (OMB) has approved the reporting or recordkeeping provisions that are included in the HHSAR and has given HHS the following approval numbers: 301.107 Certifications. In accordance with 41 U.S.C. 1304, a new requirement for a certification by a contractor or offeror may not be included in the HHSAR unless— (a) The certification is specifically imposed by statute; or (b) Written justification for the certification requirement is provided to the Secretary of HHS by the SPE, and PO 00000 Frm 00033 Fmt 4701 Sfmt 4702 80665 the Secretary of HHS approves, in writing, the inclusion of such certification requirement. Subpart 301.3—Agency Acquisition Regulations 301.301 Policy. (a)(1) HHS implementation and supplementation of the FAR is issued in the HHSAR under authorization and subject to the authority, direction, and control of the HHS Secretary. The HHSAR contains HHS policies that govern the acquisition process or otherwise control acquisition relationships between HHS’ contracting activities and contractors. The HHSAR contains— (i) Requirements of law; (ii) HHS-wide policies; (iii) Deviations from FAR requirements; and (iv) Policies that have a significant effect beyond the internal procedures of HHS or a significant cost or administrative impact on contractors or offerors. (2) Relevant internal policy, procedures, guidance, and instructions not meeting the criteria in paragraph (a)(1) of this section are issued by HHS in the HHSAM. The HHSAM contains internal operating procedures providing supplementary guidance and instructions for carrying out FAR and HHSAR requirements and contains references to other agency policy and guidance issuances. 301.301–70 Amendment of the HHSAR. (a) Changes to the HHSAR may be the result of recommendations from HHS personnel, other Government agencies, or the public. Proposed changes shall be submitted in the following format to the Assistant Secretary for Financial Resources, Office of Acquisitions, Acquisition Policy Division, U.S. Department of Health and Human Services, 200 Independence Ave. SW, Washington, DC 20201: (1) Problem. Succinctly state the problems created by current HHSAR language and describe the factual or legal reasons necessitating regulatory change. (2) Recommendation. Identify the recommended change by using the current language (if applicable) and striking through the proposed deleted words with a horizontal line. Insert proposed language in bold and brackets. If the change is extensive, reflect proposed deleted language in strikethrough and proposed new or revised language with complete paragraphs in bold and brackets. (3) Discussion. Explain why the change is necessary and how it will E:\FR\FM\03OCP2.SGM 03OCP2 80666 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules solve the problem. Address any cost or administrative impact on Government activities, offerors, and contractors, to include potential impact to small businesses. Provide any other information and documents, such as statutes, legal decisions, regulations, and reports, that may be helpful. (4) Point of contact. Provide a point of contact who can answer questions regarding the recommendation, including an email and telephone number. (b) The HHSAR is maintained by the SPE through the HHSAR and HHSAM change process. This process consists of input from various HHS staff and operating divisions specifically designated to formulate Departmental acquisition policies and procedures. (c) HHSAR Acquisition Circulars will be used to publish updates to the HHSAR throughout HHS. ddrumheller on DSK120RN23PROD with PROPOSALS2 301.303–70 HHSAR. Publication and codification— (a) Codification. The HHSAR is codified under chapter 3 in title 48, Code of Federal Regulations. The HHSAR shall parallel the FAR in format, arrangement, and numbering system in accordance with FAR 1.303(a). The HHSAM is non-codified but will also parallel the FAR and the HHSAR in format, arrangement, and numbering system. (b) Implementing the FAR. This paragraph (b) describes language and coverage in the HHSAR that relates to coverage in a FAR part, subpart, section, or subsection. The HHSAR titles and numbering shall conform with the FAR to the maximum extent practicable. Coverage in the HHSAR that implements the FAR uses the identical number sequence and caption of the FAR subpart, section, or subsection being implemented, which may be to the paragraph level. Paragraph numbers and letters are not always shown sequentially but may be shown by the specific FAR paragraph implemented. For example, HHSAR 301.105–1 contains only paragraph (b) because only this paragraph, correlated with the FAR, is implemented in the HHSAR. (c) Supplementing the FAR. This paragraph (c) describes policy, guidance, and/or procedures that are placed in the HHSAR for which there is no direct counterpart in the FAR (potentially no corresponding specific part, subpart, section, or subsection of the FAR and associated titles). Coverage in the HHSAR that supplements the FAR will use part, subpart, section, and subsection numbers ending in ‘‘70’’ or higher, sequentially. A series of numbers beginning with ‘‘70’’ is used VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 for provisions and clauses. For example, HHSAR text supplementing FAR 1.301 would be numbered 301.301–70. See table 1 to this section. (2) Develop, implement, update, and distribute the HHSAR and other acquisition policies, procedures, and guidance. (3) Serve as Department’s functional manager for acquisition, including TABLE 1 TO 301.303–70—HHSAR acquisition guidance, internal controls, NUMBERING systems, training and certification, major investments, reviews, audits, and Is Is FAR implemented supplemented interagency acquisitions issued under as as the authority of FAR subpart 17.5 or 19 .............. 319 319.70 17.7. (4) Approve the selection of heads of 19.5 ........... 319.5 319.570 19.501 ....... 319.501 319.501–70 the contracting activities (HCAs) and 19.501–1 ... 319.501–1 319.501–170 issue contracting officer warrants to HCAs. (5) Revoke HCA acquisition authority. 301.304 Agency control and compliance (6) Manage HHS Acquisition procedures. Workforce Development Program and The SPE is responsible for amending implement the Office of Federal the HHSAR for compliance with FAR Procurement Policy (OFPP) Act and 1.304. Federal Acquisition Institute training Subpart 301.470—Deviations From the and certification programs. (7) Redirect Operating and Staff FAR and HHSAR Division acquisition staff to support the 301.402 Policy. preparation for, or response to, potential Contracting officers shall not deviate or actual emergencies, e.g., terrorist from the FAR or HHSAR without strike, natural disaster, epidemic. (8) The SPE may further delegate obtaining written approval in authority to execute, award, and accordance with 301.403 and 301.404. administer contracts, purchase orders, With full acknowledgement of FAR and other agreements to other HHS 1.102(d) regarding innovative approaches, any deviation from the FAR officials, such as HCAs and contracting officers. At HHS, delegation of certain or the HHSAR requires SPE approval. contract functions and management of 301.403 Individual deviations. the contracting activities of the agency Authority to authorize individual within their approved delegations is deviations from the FAR and HHSAR is made to designated HCAs. A list of delegated to the SPE. HCAs is available at https:// www.hhs.gov/grants/grants-business301.404 Class deviations. contacts/hca-and-key-managers/ (a) Authority to authorize class index.html. deviations from the FAR and HHSAR is (9) HCAs may authorize the use of delegated to the SPE. The SPE may ordering officers to order supplies and authorize class deviations from the FAR services in accordance with the ordering and HHSAR when a class deviation is limits identified in the contract or in the best interest of the Government. agreement or the specific ordering The SPE must comply with the guide. provisions of FAR 1.404. 301.602 Subpart 301.6—Career Development, Contracting Authority, and Responsibilities 301.601 General. (a) The Secretary has delegated to the Chief Acquisition Officer and the SPE (see definitions at 302.101) broad authority to manage HHS’ contracting functions. Except as otherwise provided by statute, HHS regulations, the FAR or the HHSAR, or other specific delegations that may be issued by the Secretary, the authority vested in the Secretary to do the following is delegated to the SPE: (1) Ensure compliance with the FAR and Office of Management and Budget guidance. PO 00000 Frm 00034 Fmt 4701 Sfmt 4702 Contracting officers. 301.602–3 Ratification of unauthorized commitments. (b) Policy. (1) The Government is not bound by agreements with, or contractual commitments made to, prospective contractors by individuals who do not have delegated contracting authority. Unauthorized commitments do not follow the appropriate process for the expenditure of Government funds. Consequently, the Government may not be able to ratify certain actions, putting a contractor at risk for taking direction from a Federal official other than the contracting officer (see FAR 1.602–1). Government employees responsible for unauthorized commitments are subject to disciplinary E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules action. Contractors perform at their own risk when accepting direction from unauthorized officials. Acquisitions can only be made by a contracting officer having authority to enter into such acquisitions. Acquisitions made by other than authorized personnel are contrary to departmental policy and may be considered matters of serious misconduct on the part of an employee making an unauthorized commitment and may result in disciplinary action being taken against an employee who makes an unauthorized commitment. (2) The HCA is the official authorized to ratify an unauthorized commitment. No other re-delegations are authorized. 301.603 Selection, appointment, and termination of appointment of contracting officers. 301.603–1 General. The agency head has delegated broad authority to the Chief Acquisition Officer, who in turn has further delegated this authority to the SPE. The SPE has redelegated specific acquisition authority to the Operating and Staff Division heads and the HCAs to select, appoint, and terminate the appointment of contracting officers. This authority is non-delegable. 301.603–3 Appointment. (a) All contracting officer appointments and delegations of authority will be made in writing. To ensure proper control of redelegated acquisition authorities, HCAs shall maintain a file containing successive delegations of HCA authority through the contracting officer level. (b) HCAs may delegate micropurchase authority to HHS employees under the HHS Governmentwide Purchase Card Program in accordance with agency procedures. 301.604 Contracting Officer’s Representative (COR). 301.604–70 Contract clause. ddrumheller on DSK120RN23PROD with PROPOSALS2 When the contracting officer intends to designate a representative under this section for a solicitation or contract, the contracting officer must include the clause at 352.201–70, Contracting Officer’s Representative, in the solicitation and contract. Subpart 301.7—Determinations and Findings 301.707 Signatory authority. Signature authority for determination and findings, when delegable in the FAR, are prescribed in applicable HHSAR parts or the corresponding HHSAM part. VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 PART 302—DEFINITIONS OF WORDS AND TERMS Sec. 302.000 303.101 Standards of conduct. 303.101–3 Agency regulations. Subpart 303.2—Contractor Gratuities to Government Personnel 303.203 Reporting suspected violations of the Gratuities clause. 303.204 Treatment of violations. Scope of part. Subpart 302.1—Definitions 302.101 Definitions. Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. 302.000 80667 Scope of part. Subpart 303.6—Contracts With Government Employees or Organizations Owned or Controlled by Them 303.602 Exceptions. (a) This part— (1) Defines words and terms that are frequently used in the HHSAR; (2) Provides cross-references to other definitions in the HHSAR of the same word or term; and (3) Provides for the incorporation of these definitions in solicitations and contracts by reference. (b) Other parts, subparts, and sections of this chapter may define other words or terms and those definitions only apply to the part, subpart, or section where the word or term is defined. Subpart 303.7—Voiding and Rescinding Contracts 303.704 Policy. Subpart 302.1—Definitions 303.101–3 302.101 (a) The HHS Standards of Conduct are prescribed in 45 CFR part 73, which apply to all employees of the Department and to special Government employees to the extent described therein. Definitions. As used in this chapter— Agency head or head of the agency, unless otherwise stated, means the Secretary of Health and Human Services or specified designee. When delegated by the Secretary, the specific designee will be reflected in the specific part, subpart, or section where a specified designee other than the Secretary has been designated. Chief Acquisition Officer (CAO) means the Assistant Secretary for Financial Resources. Head of the contracting activity (HCA) means an official having overall responsibility for managing a contracting activity, i.e., the organization within an Operating Division (OPDIV) or Staff Division (STAFFDIV) or other HHS organization which has been delegated broad authority regarding the conduct of acquisition functions (see 301.603–1). Ordering officer means the HHS official authorized to order supplies and services against a FAR-based contract or agreement in accordance with 301.601(a)(10) and agency procedures. Senior Procurement Officer (SPE) means the Deputy Assistant Secretary for Acquisitions. The SPE is responsible for the management and oversight of the acquisition function for the Department. PART 303—IMPROPER BUSINESS PRACTICES AND PERSONAL CONFLICTS OF INTEREST Subpart 303.1—Safeguards Sec. PO 00000 Frm 00035 Fmt 4701 Sfmt 4702 Subpart 303.8—Limitation on the Payment of Funds to Influence Federal Transactions 303.808–70 Solicitation provision and contract clause. Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. Subpart 303.1—Safeguards 303.101 Standards of conduct. Agency regulations. Subpart 303.2—Contractor Gratuities to Government Personnel 303.203 Reporting suspected violations of the Gratuities clause. HHS personnel shall report suspected violations of the clause at FAR 52.203– 3, Gratuities, to the contracting officer, who will in turn report the matter to the Office of General Counsel (OGC), Ethics Division for disposition. 303.204 Treatment of violations. (a) The Suspending and Debarring Official (SDO) shall determine whether or not a violation of the Gratuities clause, FAR 52.203–3, has occurred and what action will be taken under FAR 3.204(c). (c) When the SDO determines that a violation has occurred and that debarment is being considered, the SDO shall follow procedures at 309.406–3. Subpart 303.6—Contracts With Government Employees or Organizations Owned or Controlled by Them 303.602 Exceptions. The head of contracting activity (HCA) is the official authorized to approve an exception to the policy stated in FAR 3.601. This authority is non-delegable. E:\FR\FM\03OCP2.SGM 03OCP2 80668 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules Subpart 303.7—Voiding and Rescinding Contracts 303.704 Policy. (a) The Senior Procurement Executive is delegated the authority to declare void and rescind contracts in accordance with FAR 3.704. This authority is further delegated to the HCA. Subpart 303.8—Limitation on the Payment of Funds To Influence Federal Transactions 303.808–70 Solicitation provision and contract clause. The contracting officer shall insert the clause at 352.203–70, Anti-Lobbying, in solicitations and contracts that exceed the simplified acquisition threshold. PART 304—ADMINISTRATIVE AND INFORMATION MATTERS 2. The authority citation for part 304 is revised to read as follows: ■ Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. 3. Revise the heading for part 304 to read as set forth above. ■ Subparts 304.6 and 304.16 [Removed] ■ 4. Remove subparts 304.6 and 304.16. Subpart 304.71 [Removed and Reserved] 5. Remove and reserve subpart 304.71. 6. Revise subpart 304.72 to read as follows: ■ ■ Subpart 304.72—Affordable Care Act Prevention and Public Health Fund— Reporting Requirements Sec. 304.7200 Scope of subpart. 304.7201 Policy. 304.7202 Contract clause. ddrumheller on DSK120RN23PROD with PROPOSALS2 Scope of subpart. This subpart implements section 220 of Pub. L. 112–74, FY 2012 Labor, HHS and Education Appropriations Act, which requires, semi-annual reporting on the use of funds from the Prevention and Public Health Fund (PPHF), Pub. L. 111–148, sec. 4002. 304.7201 Policy. Contractors that receive awards (or modifications to existing awards) with a value of $25,000 or more funded, in whole or in part, from the PPHF, shall report information specified in the clause at 352.204–70, Prevention and VerDate Sep<11>2014 21:17 Oct 02, 2024 Jkt 265001 304.7202 Contract clause. Insert the clause at 352.204–70, Prevention and Public Health Fund— Reporting Requirements, in all solicitations and contract actions with a value of $25,000 or more funded in whole or in part with Prevention and Public Health Funds (PPHFs), except classified solicitations and contracts. This includes, but is not limited to, awarding, or modifying orders against existing or new contracts issued under FAR subparts 8.4 and 16.5 that will be funded with PPHFs. Contracting officers shall include this clause in any existing contract or order that will be funded with PPHFs. This clause is not required for any contract or order which contains a prior version of the clause at 352.204– 70. ■ 7. Revise subchapters B and C to read as follows: SUBCHAPTER B—ACQUISITION PLANNING Subpart 304.72—Affordable Care Act Prevention and Public Health Fund— Reporting Requirements 304.7200 Public Health Fund—Reporting Requirements, including, but not limited to— (a) The dollar amount of contractor invoices; (b) The supplies delivered and services performed; and (c) Specific information on subcontracts with a value of $25,000 or more. (d) The contracting officer shall make the contractor’s failure to comply with the reporting requirements in this section a part of the contractor’s performance information under FAR subpart 42.15. PART 305 PUBLICIZING CONTRACT ACTIONS PART 306 COMPETITION REQUIREMENTS PART 307 [RESERVED] PART 308 REQUIRED SOURCES OF SUPPLIES AND SERVICES PART 309 CONTRACTOR QUALIFICATIONS PART 310 [RESERVED] PART 311 DESCRIBING AGENCY NEEDS PART 312 ACQUISITION OF COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES SUBCHAPTER C—CONTRACTING METHODS AND CONTRACT TYPES PART 313 SIMPLIFIED ACQUISITION PROCEDURES PART 314 SEALED BIDDING PART 315 CONTRACTING BY NEGOTIATION PART 316 TYPES OF CONTRACTS PART 317 [RESERVED] PART 318 EMERGENCY ACQUISITIONS PO 00000 Frm 00036 Fmt 4701 Sfmt 4702 SUBCHAPTER B—ACQUISITION PLANNING PART 305—PUBLICIZING CONTRACT ACTIONS Subpart 305.4—Release of Information Sec. 305.402 General public. 305.470 Contractor award announcements, advertisements, and releases. 305.470–1 Policy. 305.470–2 Contract clause. Subpart 305.70—Publicizing Requirements Funded From the Affordable Care Act Prevention and Public Health Fund 305.7001 Scope. 305.7002 Applicability. 305.7003 Publicizing preaward. 305.7004 Publicizing postaward. Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. Subpart 305.4—Release of Information 305.402 General public. Requests from the public for specific records pertaining to contract actions shall be processed according to the Freedom of Information Act (FOIA), 5 U.S.C. 552. 305.470 Contractor award announcements, advertisements, and releases. 305.470–1 Policy. (a) Contracting officers should restrict contractors from referring to its HHS contract(s) in its commercial advertising in a manner that states or implies the Government approves or endorses the contractor’s products or services or considers them superior to other products or services. The intent of this policy is to prevent the appearance of Government bias toward any product or service. (b) The Department’s contractors share the responsibility for protecting sensitive and classified information related to efforts under their contracts. For any contract that involves sensitive or classified information, prior to the release of any contract award announcement, advertisement, or other information pertaining to the contract, the contractor must obtain the approval of the responsible contracting officer. 305.470–2 Contract clause. (a) Insert the clause at 352.205–70, Advertisements, Publicizing Awards, and Releases, in all solicitations and contracts that exceed the simplified acquisition threshold. (b) If the contract involves sensitive or classified information, use the clause at 352.205–70 with its Alternate I. E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules Subpart 305.70—Publicizing Requirements Funded From the Affordable Care Act Prevention and Public Health Fund 305.7001 Subpart 306.2—Full and Open Competition After Exclusion of Sources 306.202 Establishing or maintaining alternative sources. Scope. Pursuant to appropriations acts, this subpart prescribes requirements for posting presolicitation and award notices for actions funded in whole or in part from the Prevention and Public Health Fund (PPHF). The requirements of this subpart enhance transparency to the public. 305.7002 Applicability. Subpart 306.3—Other Than Full and Open Competition 306.302 Circumstances permitting other than full and open competition. This subpart applies to all actions funded in whole or in part by the PPHF. 306.302–1 Only one responsible source and no other supplies or services will satisfy agency requirements. 305.7003 (a)(2) For acquisitions covered by 42 U.S.C. 247d–6a(b)(2)(A) concerning conducting and supporting countermeasure research and development activities, ‘‘available from only one responsible source’’ shall be deemed to mean ‘‘available from only one responsible source or only from a limited number of responsible sources’’. Publicizing preaward. Notices of all proposed contract actions, funded in whole or in part by the PPHF, shall be identified on HHS’ Prevention and Public Health Fund website at https://www.hhs.gov/open/ prevention/ no later than one business day after issuance of the solicitation or other request for proposal or quotation document. When applicable, the notice shall provide a link to the full text; for example, a link to the Contract Opportunities notice required by FAR 5.201. 305.7004 Publicizing postaward. Notices of contract actions valued at or above $25,000, funded in whole or in part by the PPHF, shall be identified on HHS’ PPHF website at https:// www.hhs.gov/open/prevention/ index.html no later than five business days after the contract action occurs. PART 306—COMPETITION REQUIREMENTS Subpart 306.2—Full and Open Competition After Exclusion of Sources ddrumheller on DSK120RN23PROD with PROPOSALS2 (b)(1) The Senior Procurement Executive (SPE) is designated to make the required determination and sign the determination and findings (D&F) pursuant to FAR 6.202(b). 306.302–2 urgency. Unusual and compelling (d)(1)(ii) The period of performance shall be limited to the minimum period necessary to meet the urgent and compelling requirements of the work to be performed and to enter into another contract for the required goods or services through the use of competitive procedures, but in no event shall the period of performance exceed one year, including all options pursuant to FAR 6.302–2(d)(1)(ii), unless the Secretary determines that exceptional circumstances apply, approving the determination and the written justifications and approvals described in FAR 6.303 and 6.304 (see FAR 6.303– 2(c)) and HHS internal procedures. Sec. 306.202 Establishing or maintaining alternative sources. Subpart 306.5—Advocates for Competition Subpart 306.3—Other Than Full and Open Competition The Executive Director, Acquisition Policy, Legislation, Oversight & Workforce, Assistant Secretary for Financial Resources (ASFR), Office of Acquisitions is designated as the HHS Advocate for Competition. The Executive Director may further delegate this authority and appoint an alternate agency advocate for competition. The Executive Director shall designate procuring activity advocates for competition in accordance with FAR 6.501. A complete list of HHS procuring activity advocates for competition can be found at: https://www.hhs.gov/ 306.501 306.302 Circumstances permitting other than full and open competition. 306.302–1 Only one responsible source and no other supplies or services will satisfy agency requirements. 306.302–2 Unusual and compelling urgency. Subpart 306.5—Advocates for Competition 306.501 Requirement. Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 PO 00000 Requirement. Frm 00037 Fmt 4701 Sfmt 4702 80669 grants/grants-business-contacts/ competition-advocates/. PART 307 [RESERVED] PART 308—REQUIRED SOURCES OF SUPPLIES AND SERVICES Subpart 308.8—Acquisition of Printing and Related Supplies Sec. 308.802 308.870 Policy. Contract clause. Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. Subpart 308.8—Acquisition of Printing and Related Supplies 308.802 Policy. Government printing must be done by or through the Government Publishing Office (GPO) in accordance with FAR 8.802. Unless specifically authorized in HHS contracts, no printing by the Contractor or any subcontractor is authorized under HHS contracts, whether to support Government printing, to acquire related supplies, or to provide other printing-related services. Contracting officers may authorize limited printing under HHS contracts pursuant to the clause prescribed at 308.870 within the stated limits in the clause. 308.870 Contract clause. The contracting officer shall insert the clause at 352.208–70, Printing and Duplication, in all solicitations, contracts, and orders for supplies or services over the simplified acquisition threshold, unless printing or increased duplication is authorized by statute. PART 309—CONTRACTOR QUALIFICATIONS Subpart 309.1—Responsible Prospective Contracts Sec. 309.104 Standards. 309.104–1 General standards. Subpart 309.4—Debarment, Suspension, and Ineligibility 309.400 Scope of subpart. 309.403 Definitions. 309.405 Effect of listing. 309.405–1 Continuation of current contracts. 309.405–2 Restrictions on subcontracting. 309.406 Debarment. 309.406–1 General. 309.406–3 Procedures. 309.407 Suspension. 309.407–1 General. 309.407–3 Procedures. 309.470 Reporting of suspected causes for debarment or suspension or the taking of evasive actions. E:\FR\FM\03OCP2.SGM 03OCP2 80670 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules 309.470–1 Situations where reports are required. 309.471 Fact-finding procedures. 309.405–1 Continuation of current contracts. Subpart 309.5—Organizational and Consultant Conflicts of Interest 309.503 Waiver. 309.507 Solicitation provisions and contract clause. 309.507–1 Solicitation provisions. Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. Subpart 309.1—Responsible Prospective Contracts 309.104 Standards. 309.104–1 General standards. (e) For cost-reimbursement or incentive type contracts, or contracts which provide for progress payments based on costs or on a percentage or stage of completion, the prospective contractor’s accounting system and related internal controls must provide reasonable assurance that— (1) Applicable laws and regulations are complied with; (2) The accounting system and cost data are reliable; (3) Risk of misallocations and mischarges are minimized; and (4) Contract allocations and charges are consistent with invoice procedures. Subpart 309.4—Debarment, Suspension, and Ineligibility 309.400 Scope of subpart. This subpart implements FAR subpart 9.4 and prescribes HHS procedures and related actions for the suspension and debarment of contractors. 309.403 Definitions. ddrumheller on DSK120RN23PROD with PROPOSALS2 As used in this subpart: Suspending and Debarring Official (SDO) means the individual responsible for final decisions regarding suspension and debarment, as appointed by the agency. The HHS SDO is the Deputy Assistant Secretary for Acquisitions, and Senior Procurement Executive. Suspension & Debarment (S&D) Committee means a committee authorized by the SDO to assist the SDO with suspension and debarment related matters. 309.405 Effect of listing. (a) The authority under FAR 9.405(a) and (e)(2) and (3) to determine where to solicit from, evaluate bids or proposals from, or award contracts to contractors with active exclusions in the System for Award Management (SAM) is delegated to the SDO. This authority is further delegated to the HCA. VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 (a) Notwithstanding the suspensions, proposed debarment, or debarment of a contractor, HHS may continue contracts or subcontracts in existence at the time the contractor was suspended, proposed for debarment, or debarred, unless the cognizant HCA directs otherwise. (b) Authority to make the determinations under FAR 9.405–1(a)(2) is delegated to the SDO and is further delegated to the HCA. The HCA must make a written determination of the compelling reasons in accordance with FAR 9.405–1(a)(2). Compelling reasons for the purposes of FAR 9.405–1(a)(2) include, but are not limited to, urgency of the need for new or continued work and/or, lengthy period to acquire the new work from other sources. 309.405–2 Restrictions on subcontracting. Authority to make the written determination required under FAR 9.405–2 consenting to a contractor’s use of a subcontractor who is suspended, proposed for debarment, or debarred is delegated to the SDO. This authority is further delegated to the HCA. 309.406 Debarment. 309.406–1 General. (a) In addition to the factors listed in FAR 9.406–1, the SDO may consider the following additional factors before arriving at a debarment decision: (1) Whether the contractor had a mechanism, such as a hotline, by which employees could have reported suspected instances of improper conduct, and instructions in place that encouraged employees to make such reports; or (2) Whether the contractor conducted periodic reviews of company business practices, procedures, policies, and internal controls for compliance with standards of conduct and the special requirements of Government contracting. (c) As provided in FAR 9.406–1(c), authority to determine whether to continue business dealings between HHS and a contractor suspended, proposed for debarment, or debarred is delegated to the SDO. 309.406–3 Procedures. (a) HHS procedures are set forth in the HHS Discretionary Suspension and Debarment Handbook for Contracts and Grants (S&D Handbook) at (Link To Be Determined (TBD)). The procedures in this subpart supplement HHS’ internal operational procedures. Any individual may submit a referral to debar an individual or contractor to the SDO or to the S&D Committee. The S&D PO 00000 Frm 00038 Fmt 4701 Sfmt 4702 Committee is an advisory committee to the SDO who retains the final approval authority to debar. (1) The referral for debarment shall be supported with evidence of a cause for debarment listed in FAR 9.406–2. (2) The SDO shall forward referrals for debarment to the S&D Committee. If the referring individual is an HHS employee and the referral for debarment is based on possible criminal or fraudulent activities, the HHS employee shall also refer the matter to the HHS Office of Inspector General. (b) When the S&D Committee finds preponderance of the evidence for a cause for debarment, as listed in FAR 9.406–2, it shall prepare a recommendation and draft notice of proposed debarment for the SDO’s consideration. (c) The notice of proposal to debar shall be issued by the SDO to the contractor and any specifically named affiliates. A notice of proposed debarment shall be issued by the SDO in accordance with FAR 9.406–3(c), by certified mail, return receipt requested, unless one of the flexible procedures set forth in this paragraph (c) is necessary to meet emergency or exigent circumstances which shall be documented in the file. In such cases as approved by the SDO— (1) The written notice shall be sent— (i) By mail, to the last known street address; (ii) To the last known facsimile number; or (iii) To the last known email address. (2) The notice shall be sent— (i) To the contractor, the contractor’s identified counsel for purposes of the administrative proceedings, or the contractor’s agent for service of protest. If sent by email, it shall be sent to the last known email address for all three, if known; and (ii) For each specifically named affiliate, to the affiliate itself, the affiliate’s identified counsel for purposes of the administrative proceedings, or the affiliate’s agent for service of process. If sent by email, it shall be sent to the last known email addresses for all three, if known. (3) The notice shall include the requirements set forth in FAR 9.406– 3(c)(1) through (7). Additionally, in the case of a contractor, HHS may send the notice of proposed debarment to any partner, principal, officer, director, owner or co-owner, or joint venture. The S&D Committee shall concurrently list the appropriate parties as excluded in the SAM in accordance with FAR 9.404. (d) If HHS does not receive a reply from the contractor within 30 days after sending the notice of proposed E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules debarment, the S&D Committee shall prepare a recommendation and refer the case to the SDO for a decision on whether or not to debar based on the information available. (e) If HHS receives a reply from the contractor within 30 days after sending the notice of proposed debarment, the S&D Committee shall consider the information in the reply before the S&D Committee makes its recommendation to the SDO. (f) The S&D Committee, upon the request of the contractor proposed for debarment, shall, as soon as practicable, allow the contractor an opportunity to appear before the S&D Committee to present information or argument personally or through a representative. The contractor may supplement the oral presentation with written information and argument. HHS shall conduct the proceedings in an informal manner and without requirement for a transcript. (g) The S&D Committee will review the contractor’s or individual’s submission in opposition to the proposed debarment to determine whether it raises a genuine dispute over facts material to the proposed debarment and the debarment action is not based on a conviction or civil judgment. The S&D Committee will submit its analyses to the SDO for review. If the SDO finds there is a genuine dispute of material facts, the SDO shall refer the dispute to a designee for a resolution pursuant to 309.470. The SDO shall provide the contractor or individual with the disputed material fact(s). 309.407 Suspension. 309.407–1 General. ddrumheller on DSK120RN23PROD with PROPOSALS2 (a) As provided in FAR 9.407–1(d), authority to determine whether to continue business dealings between HHS and a suspended contractor is delegated to the SDO. Compelling reasons include, but are not limited to, urgency of the need for new or continued work, lengthy time period to acquire the new work from other sources and meeting estimated quantities for requirements contracts. (b) For the purposes of FAR 9.407–1, the SDO is the suspending official. 309.407–3 Procedures. (a) HHS procedures are set forth in the HHS Discretionary Suspension and Debarment Handbook for Contracts and Grants (S&D Handbook) at (Link TBD). The procedures in this subpart supplement HHS’ internal operational procedures. Any individual may submit a referral to suspend an individual or contractor to the SDO or to the S&D VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 Committee. The S&D Committee is an advisory committee to the SDO who retains the final approval authority to issue suspensions. Referrals shall include supporting evidence of a cause for suspension listed in FAR 9.407–2. The SDO will forward the referral to the S&D Committee for analysis. If the referring individual is an HHS employee and the referral for suspension is based on possible criminal or fraudulent activities, the HHS employee shall also refer the matter to the HHS Office of Inspector General. (b) The S&D Committee will forward its analyses to the SDO. When the SDO finds adequate evidence of a cause for suspension, as listed in FAR 9.407–2, the S&D Committee will prepare a recommendation and draft notice of suspension for the SDO’s consideration and approval. (c) In accordance with FAR 9.407–3(c) regarding the notice of suspension, when a contractor or any specifically named affiliates are suspended, they shall be immediately advised by means of delivery set forth in FAR 9.406–3(c) and 309.406–3(c). In the case of a contractor, HHS may send a notice of suspension to any partner, principal, officer, director, owner or co-owner, or joint venture. The S&D Committee concurrently shall list the appropriate parties as excluded in SAM in accordance with FAR 9.404. (d) If HHS receives a reply from the contractor within 30 days after receipt of the notice of suspension, the S&D Committee shall consider the information in the reply before the Committee makes further recommendations to the SDO. The S&D Committee, upon the request of a suspended contractor, shall, as soon as practicable, allow the contractor an opportunity to appear before the S&D Committee to present information or argument personally or through a representative. The contractor may supplement the oral presentation with written information and argument. The proceedings will be conducted in an informal manner and without requirement for a transcript. (e) For the purposes of FAR 9.407– 3(b)(2), in actions not based on an indictment, if the SDO finds that the contractor’s submission in opposition to the suspension raises a genuine dispute over facts material to the suspension, the S&D Committee will submit to the SDO the information received establishing the dispute of material facts. However, the SDO may first coordinate any further proceeding regarding the material facts in dispute with the Department of Justice or with a State prosecuting authority in a case PO 00000 Frm 00039 Fmt 4701 Sfmt 4702 80671 involving a State jurisdiction. HHS shall take no further action to determine disputed material facts pursuant to this section or 309.470 if the Department of Justice or a State prosecuting authority advises HHS in writing that additional proceedings to make such a determination would prejudice Federal or State legal proceedings. (f) If the SDO finds that there is a genuine dispute of material facts, the SDO shall refer the dispute to the designee for resolution pursuant to 309.470. 309.470 Reporting of suspected causes for debarment or suspension or the taking of evasive actions. 309.470–1 required. Situations where reports are The contracting officer shall report to the HCA and the SDO whenever the contracting officer— (a) Knows or suspects that a contractor is committing or has committed any of the acts described in FAR 9.406–2 or 9.407–2; or (b) Suspects a contractor is attempting to evade the prohibitions of debarment or suspension imposed under FAR 9.405, or any other comparable regulation, by changes of address, multiple addresses, formation of new companies, or by other devices. 309.471 Fact-finding procedures. The provisions of this section constitute the procedures to be used to resolve genuine disputes of material fact pursuant to 309.406–3 and 309.407–3. The SDO shall appoint a designee to conduct the fact-finding. The proceedings before the fact-finder will be limited to a finding of the facts in dispute, as determined by the SDO. The fact-finder shall establish the date for the fact-finding hearing, normally to be held within 30 days after the S&D Committee notifies the contractor or individual that the SDO has established a genuine dispute of material fact(s) exists. (a) The Government’s representative and the contractor will have an opportunity to present evidence relevant to the material fact(s) identified by the SDO. The contractor or individual may appear in person or through a representative at the factfinding hearing. The contractor or individual may submit documentary evidence, present witnesses, and confront any person the agency presents. (b) Witnesses may testify in person. Witnesses will be reminded of the official nature of the proceedings and that any false testimony given is subject to criminal prosecution. Witnesses are E:\FR\FM\03OCP2.SGM 03OCP2 80672 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules subject to cross-examination. Hearsay evidence may be presented and will be given appropriate weight by the factfinder. (c) The proceedings shall be transcribed, and a copy of the transcript shall be made available at cost to the contractor upon request, unless the contractor and the fact-finder, by mutual agreement, waive the requirement for a transcript. (d) The fact-finder shall determine the disputed fact(s) by a preponderance of the evidence for proposed debarments, and by adequate evidence for suspensions. Written findings of fact shall be prepared by the fact-finder. A copy of the findings of fact shall be provided to the SDO, the Government’s representative, and the contractor or individual. The SDO will consider the written findings of fact in the decision regarding the suspension or proposed debarment. Waiver. The Senior Procurement Executive is the designee under FAR 9.503. 309.507 Solicitation provisions and contract clause. 309.507–1 Solicitation provisions. ddrumheller on DSK120RN23PROD with PROPOSALS2 PART 310 [RESERVED] PART 311—DESCRIBING AGENCY NEEDS Subpart 311.1—Selecting and Developing Requirements Documents Sec. 311.103 Market acceptance. VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 Subpart 311.71—Public Accommodations and Commercial Facilities 311.7100 Policy. 311.7101 Responsibilities. 311.7102 Contract clause. Subpart 311.72—Conference Funding and Sponsorship 311.7200 Policy. 311.7201 Funding and sponsorship. 311.7202 Contract clause. Subpart 311.73—Contractor Collection of Information 311.7300 311.7301 Policy. Contract clause. Subpart 311.1—Selecting and Developing Requirement Documents 311.103 Market acceptance. (a) The head of the contracting activity (HCA) is delegated this authority. (a) While conflicts of interest may not presently exist, award of certain types of contracts may create potential future organizational conflicts of interest (see FAR 9.508 for examples). If a solicitation may create a potential future organizational conflict of interest, the contracting officer shall insert a provision in the solicitation imposing an appropriate restraint on the contractor’s eligibility for award of contracts in the future. Under FAR 9.507–1, the restraint must be appropriate to the nature of the conflict and may exclude the contractor from award of one or more contracts in the future. (b) The provision at 352.209–70, Organizational Conflicts of Interest, must be included in any solicitation for the services addressed in FAR 9.502. Subpart 311.5—Liquidated Damages 311.501 Policy. Subpart 311.70—[Reserved] Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. Subpart 309.5—Organizational and Consultant Conflicts of Interest 309.503 Subpart 311.6—Priorities and Allocations 311.600 Scope of subpart. 311.601 Definitions. 311.602 General. 311.602–70 The Health Resources Priorities and Allocation System. 311.603 Procedures. 311.603–70 Agency program. Subpart 311.5—Liquidated Damages 311.501 Policy. (d) The HCA may reduce or waive the amount of liquidated damages assessed under a contract, if the Commissioner, Financial Management Service, or designee approves. Subpart 311.6—Priorities and Allocations 311.600 Scope of subpart. This subpart details information on the Health and Human Services (HHS’) Health Resources Priorities and Allocation System (HRPAS) that is part of the Federal Priorities and Allocations System. This subpart references guidance and procedures for use of the Defense Production Act (DPA) priorities and allocations authority with respect to health resources necessary or appropriate to promote the national defense as delegated to the Secretary of HHS. 311.601 Definitions. As used in this subpart— National defense means programs for military and health resources production or construction, military or critical infrastructure assistance to any foreign nation, homeland security, PO 00000 Frm 00040 Fmt 4701 Sfmt 4702 stockpiling, space, and any directly related activity. Such term includes emergency preparedness activities conducted pursuant to title VI of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5195, et seq.) and critical infrastructure protection and restoration. The term national defense is defined broadly and can include critical infrastructure protection and restoration, emergency preparedness and response, and recovery from natural and man-made disasters. Rated order means a prime contract, a subcontract, or a purchase order in support of an approved program issued in accordance with the provisions of this part. 311.602 General. 311.602–70 The Health Resources Priorities and Allocation System. As set forth in Executive Order 13603, National Defense Resources Preparedness, March 16, 2012, the authority to require acceptance and priority performance of contracts or orders (other than contracts of employment) to promote the national defense over performance of any other contracts or orders, and to allocate materials, services, and facilities as deemed necessary or appropriate to promote the national defense, with respect to health resources is delegated to the Secretary of HHS. 311.603 Procedures. 311.603–70 Agency program. Agency procedures are set forth in the HRPAS regulations at 45 CFR part 101. The regulation provides guidance and procedures for use of the DPA priorities and allocations authority with respect to health resources, including the use of priority rated orders, necessary or appropriate to promote the national defense. Subpart 311.70—[Reserved] Subpart 311.71—Public Accommodations and Commercial Facilities 311.7100 Policy. (a) It is HHS policy that all contractors comply with current and any future changes to 28 CFR part 36. For the purpose of this subpart, accessibility is defined as both physical access to public accommodations and commercial facilities, and access to aids and services enabling individuals with sensory disabilities to fully participate in events in public accommodations and commercial facilities. E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules (b) This subpart applies to all contracts requiring contractors to conduct events in public accommodations and commercial facilities open to the public or involving HHS personnel, but not ad hoc meetings necessary or incidental to contract performance. Conference Sponsorship Request and Conference Materials Disclaimer, in solicitations, contracts, and orders providing funding which partially or fully supports a conference. 311.7101 311.7300 Responsibilities. The contractor shall submit a plan assuring that any event held will meet or exceed the minimum accessibility standards set forth in 28 CFR part 36. A consolidated or master plan for contracts requiring numerous events in public accommodations and commercial facilities is acceptable. 311.7102 Contract clause. The contracting officer shall insert the clause at 352.211–70, Public Accommodations and Commercial Facilities, in solicitations, contracts, and orders requiring the contractor to conduct events in accordance with 311.7100(b). Subpart 311.72—Conference Funding and Sponsorship ddrumheller on DSK120RN23PROD with PROPOSALS2 311.7200 Policy. Subpart 311.73—Contractor Collection of Information Policy. In accordance with the Paperwork Reduction Act, contractors shall not proceed with collecting information from surveys, questionnaires, or interviews until the contracting officer’s representative obtains an Office of Management and Budget (OMB) clearance and the contracting officer issues written approval to proceed. For any contract involving a requirement to collect or record information calling either for answers to identical questions from 10 or more persons other than Federal employees, or information from Federal employees which is outside the scope of their employment, for use by the Federal Government or disclosure to third parties, the contracting officer must comply with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). HHS policy requires that all conferences the agency funds or sponsors shall be consistent with HHS missions, objectives, and policies; represent an efficient and effective use of taxpayer funds; and withstand public scrutiny. 311.7301 311.7201 PART 312—ACQUISITION OF COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES Funding and sponsorship. A conference funded through an HHS contract does not automatically imply HHS sponsorship, unless the conference is funded entirely by the agency. Also, HHS staff attendance or participation at a conference does not imply HHS conference sponsorship. Accordingly, for non-conference contracts funded entirely by HHS prior to a contractor claiming HHS sponsorship, the contractor must provide the contracting officer a written request for permission to designate HHS the conference sponsor. The operating division or staff division head, or designee, shall approve such requests. The determination on what constitutes a ‘‘conference contract’’ or a ‘‘nonconference contract’’ shall be made by the contracting officer. 311.7202 Contract clause. To ensure that a contractor: (a) Properly requests approval to designate HHS the conference sponsor, where HHS is not the sole provider of conference funding; and (b) The contracting officer shall include the clause at 352.211–71, VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 Contract clause. The contracting officer shall insert the clause at 352.211–72, Paperwork Reduction Act Requirements, in solicitations, contracts, and orders that require a contractor to collect the same information from 10 or more persons. Subpart 312.3—Solicitation Provisions and Contract Clauses for the Acquisition of Commercial Products and Commercial Services Sec. 312.301 Solicitation provisions and contract clauses for the acquisition of commercial products and commercial services. Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. Subpart 312.3—Solicitation Provisions and Contract Clauses for the Acquisition of Commercial Products and Commercial Services 312.301 Solicitation provisions and contract clauses for the acquisition of commercial products and commercial services. (f) Contracting officers shall insert the clause 352.212–70, Gray Market and Counterfeit Items, in solicitations and contracts for new medical supplies, new medical equipment, new information PO 00000 Frm 00041 Fmt 4701 Sfmt 4702 80673 technology equipment, and maintenance of medical or information technology equipment that includes replacement parts, if used, refurbished, or remanufactured parts are unacceptable, when the associated solicitation includes the provisions at FAR 52.212–1, Instructions to Offerors—Commercial Products and Commercial Services, and 52.212–2, Evaluation—Commercial Products and Commercial Services. SUBCHAPTER C—CONTRACTING METHODS AND CONTRACT TYPES PART 313—SIMPLIFIED ACQUISITION PROCEDURES Subpart 313.3—Simplified Acquisition Methods Sec. 313.301–70 Governmentwide commercial purchase card—purchases of PPE. Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. Subpart 313.3—Simplified Acquisition Methods 313.301–70 Governmentwide commercial purchase card—purchases of PPE. The Infrastructure Investment and Jobs Act (IIJA), Pub. L. 117–58, Subtitle C, Make Personal Protective Equipment (PPE) in America (MPPEIA), applies to all purchases of PPE including those transactions made using the Governmentwide commercial purchase card (GPC) under the micro-purchase threshold. See subpart 325.71 for definitions, restrictions, and exceptions when procuring PPE. PART 314—SEALED BIDDING Subpart 314.4—Opening of Bids and Award of Contract Sec. 314.404 Rejection of bids. 314.404–1 Cancellation of invitations after opening. 314.407 Mistakes in bids. 314.407–3 Other mistakes disclosed before award. 314.407–4 Mistakes after award. 314.408 Award. 314.408–70 Award when only one bid is received. Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. Subpart 314.4—Opening of Bids and Award of Contract 314.404 Rejection of bids. 314.404–1 opening. Cancellation of invitations after (c) The head of the contracting activity (HCA) shall make the E:\FR\FM\03OCP2.SGM 03OCP2 80674 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules 315.606–1 determinations specified in FAR 14.404–1(c). 314.407 Mistakes in bids. 314.407–3 Other mistakes disclosed before award. (e) The HCA is delegated, without redelegation, the authority to make determinations under FAR 14.407–3(a) through (d). 314.407–4 Mistakes after award. (c) The HCA is delegated, without redelegation, the authority to make administrative determinations in connection with alleged post-award mistakes. 314.408 Award. 314.408–70 received. Award when only one bid is When only one bid is received in response to an invitation for bids, such bid may be considered and accepted if the contracting officer makes a written determination, approved one level above the contracting officer, and documents the contract file that— (a) The specifications were clear and not unduly restrictive; (b) Adequate competition was solicited, and it could have been reasonably assumed that more than one bid would have been submitted; (c) The price is fair and reasonable; and (d) The bid is otherwise in accordance with the invitation for bids. Such a determination shall be placed in the file. PART 315—CONTRACTING BY NEGOTIATION Subpart 315.2—Solicitation and Receipt of Proposals and Information Sec. 315.208 Submission, modification, revision, and withdrawal of proposals. 315.208–70 Submission, modification, revision, and withdrawal of proposals— R&D acquisitions. 315.209–70 Solicitation provision. ddrumheller on DSK120RN23PROD with PROPOSALS2 Subpart 315.3—Source Selection 315.303–70 Policy. 315.304 Evaluation factors and significant subfactors. 315.305 Proposal evaluation. 315.305–70 Proposal evaluation—use of non-Federal evaluators. 315.305–71 Solicitation provision. Subpart 315.4—Contract Pricing 315.404 Proposal analysis. 315.404–2 Data to support proposal analysis. Subpart 315.6—Unsolicited Proposals 315.604 Agency points of contact. 315.605–70 Content of unsolicited proposals—warranty by offeror. 315.606 Agency procedures. VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 Receipt and initial review. Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. Subpart 315.2—Solicitation and Receipt of Proposals and Information 315.208 Submission, modification, revision, and withdrawal of proposals. 315.208–70 Submission, modification, revision, and withdrawal of proposals— R&D acquisitions. (a) The provision prescribed at 315.209–70 may be used in competitive solicitations when— (1) The head of contracting activity (HCA) determines that biomedical or behavioral research and development acquisitions may be subject to conditions that could impact timely submission and receipt of proposals other than those specified in FAR 52.215–1(c)(3); (2) Use of the provision is authorized by the HCA; and (3) The provision at FAR 52.215–1, Instructions to Offerors—Competitive Acquisition, is included in the solicitation. (b) When the provision at 315.209–70 is inserted in the solicitation, notwithstanding the procedures contained in the provision at FAR 52.215–1(c)(3), Instructions to Offerors—Competitive Acquisition, the contracting officer may consider a proposal received concerning biomedical or behavioral research and development (R&D) acquisitions after the date specified for receipt if— (1) It appears to offer significant cost or technical advantage to the Government; and (2) It was received before proposals were distributed for evaluation; or (3) It was received within five calendar days after the exact time specified for receipt, whichever is earlier. (c) When the provision at 352.215–70 is included in the solicitation and if the contracting officer intends to consider a proposal or proposals received after the exact time specified for receipt, the contracting officer, with the assistance of cost or technical personnel as appropriate, shall determine in writing that the proposal(s) meets the requirements of the provision at 352.215–70. 315.209–70 Solicitation provision. The contracting officer shall insert the provision at 352.215–70, Late Proposals and Revisions—R&D Solicitations, in biomedical or behavioral R&D competitive acquisition solicitations PO 00000 Frm 00042 Fmt 4701 Sfmt 4702 subject to the requirements of 315.208– 70(a) and the authorization of the HCA. Subpart 315.3—Source Selection 315.303–70 Policy. (a) When an operating division (OPDIV) of the Department of Health and Human Services (HHS) is required by statute to use peer review for technical review of proposals, the requirements of those statutes, any implementing regulatory requirements, and the Federal Advisory Committee Act (5 U.S.C. chapter 10), takes precedence over the otherwise applicable requirements of this subpart. (b) The applicable OPDIV peer review and implementing regulations include— (1) National Institutes of Health—42 U.S.C. 289a and 42 CFR part 52h; (2) Substance Abuse and Mental Health Services Administration—42 U.S.C. 290aa-3; and (3) Agency for Healthcare Research and Quality—42 U.S.C. 299c-1. 315.304 Evaluation factors and significant subfactors. When acquiring information and communication technology (ICT) supplies and services using negotiated procedures, contracting officers shall include a separate technical evaluation factor, or subfactor, concerning compliance with section 508 of the Rehabilitation Act of 1973, as amended (see 339.203). 315.305 Proposal evaluation. 315.305–70 Proposal evaluation—use of non-Federal evaluators. (a) Except when peer review is required by statute as provided in 315.303–70, decisions to disclose proposals to non-Federal evaluators shall be made by the Source Selection Authority or the contracting officer, as applicable, responsible for appointing Source Selection Evaluation Team members in accordance with agency procedures. The avoidance of organizational and personal conflicts of interest must be taken into consideration when making the decision to use non-Federal evaluators (see FAR 15.305(c)). (b) When an offeror’s or contractor’s proposal will be disclosed outside the Government to a contractor or a contractor employee for evaluation purposes, the provision prescribed at 315.305–71 requires that the contractor and its employees, as well as any subcontractors and their employees, to agree that when performing work as an evaluator under a Government contract that they will use the data (trade secrets, business data, and technical data) E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules contained in the proposal for evaluation purposes only. (1) This paragraph (b) does not apply to data obtained from another source without restriction. (2) Upon completion of the evaluation, the non-Federal evaluator shall return to the Government the furnished copy of the proposal or abstract, and all copies thereof, to the HHS office which initially furnished the proposal for evaluation. (3) All electronic records of proposals or proposal-related material shall be provided to the Government and immediately be destroyed and/or deleted from all electronic media. (4) Evaluators shall not contact the offeror concerning any aspects of a proposal’s contents. (c) The agreement shall be signed by the contractor and the assigned contractor employee, subcontractor, or consultant (i.e., the non-Federal evaluator) and filed in the contract file prior to disclosure of an offeror’s proposal. 315.305–71 Solicitation provision. Insert the provision at 352.215–71, Use of Non-Federal Evaluators— Conditions for Evaluating Proposals, in solicitations when the Government may use non-Federal evaluators to evaluate an offeror’s or contractor’s proposals and offers. Subpart 315.4—Contract Pricing 315.404 Proposal analysis. 315.404–2 analysis. Data to support proposal (a)(2) When some or all information sufficient to determine the reasonableness of the proposed cost or price is already available or can be obtained from the cognizant audit agency, or by other means including data obtained through market research (see FAR part 10) the contracting officer may request partial field pricing support as outlined in FAR 15.404–2(a)(2). Subpart 315.6—Unsolicited Proposals 315.604 Agency points of contact. ddrumheller on DSK120RN23PROD with PROPOSALS2 (a) Each HCA is responsible for disseminating the information required at FAR 15.604(a). 315.605–70 Content of unsolicited proposals—warranty by offeror. (a) To ensure against contacts between HHS personnel and prospective offerors that would exceed the limits of advance guidance set forth in FAR 15.604 and potentially result in an unfair advantage to an offeror, the prospective offeror of an unsolicited proposal must include a VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 supporting document in the form of a warranty statement in accordance with paragraph (c) of this section with any unsolicited proposal. (b) Unsolicited proposals submitted without the warranty statement will not be processed by the Government. Contracting officers receiving an unsolicited proposal without this warranty shall not process the proposal until the offeror is notified of the missing language and given an opportunity to submit the supporting documentation. If no warranty statement is provided in a reasonable time, the contracting officer shall reject the unsolicited proposal, notify the offeror of the rejection, and document the actions in the file. (c) Prospective offerors shall submit a supporting document with any submitted unsolicited proposal in the form of a warranty statement as follows: UNSOLICITED PROPOSAL— WARRANTY BY OFFEROR This is to warrant that— (a) This proposal has not been prepared under Government supervision; (b) The methods and approaches stated in the proposal were developed by this offeror; (c) Any contact with HHS personnel has been within the limits of appropriate advance guidance set forth in FAR 15.604; (d) No prior commitments were received from HHS personnel regarding acceptance of this proposal; and (e) This proposal was not previously submitted for an HHS grant award consideration that was rejected for lack of scientific merit. Date: llllllllllllllll Organization: llllllllllll Name: lllllllllllllll Title: lllllllllllllll [This warranty shall be signed by a responsible management official of the proposing organization who is a person authorized to contractually obligate the organization.] 315.606 Agency procedures. (a) The HCA is responsible for establishing procedures to comply with FAR 15.606(a). (b) The HCA or designee shall be the point of contact for coordinating the receipt and processing of unsolicited proposals. 315.606–1 Receipt and initial review. (a)(2) Operating Divisions (OPDIVs) may consider an unsolicited proposal for award of a contract even though an organization initially submitted it as a grant application. However, contracting PO 00000 Frm 00043 Fmt 4701 Sfmt 4702 80675 officers shall not award contracts based on unsolicited proposals that have been rejected for grant awards due to lack of scientific merit. PART 316—TYPES OF CONTRACTS Subpart 316.3—Cost-Reimbursement Contracts Sec. 316.307 Contract clauses. Subpart 316.5—Indefinite-Delivery Contracts 316.505 Ordering. Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. Subpart 316.3—Cost-Reimbursement Contracts 316.307 Contract clauses. (a)(1) The contracting officer shall insert the clause at 352.216–70, Allowable Cost and Payment for Hospitals (Profit and Non-Profit), in solicitations and contracts, when a costreimbursement contract with a hospital (profit or non-profit) is contemplated and when the clause at FAR 52.216–7 is inserted in the contract. Subpart 316.5—Indefinite-Delivery Contracts 316.505 Ordering. (b)(8) The Department of Health and Human Services Advocate for Competition is designated as the taskorder and delivery-order ombudsman. Each HHS HCA shall designate, in writing, a task-order and delivery-order ombudsman. The list of HHS Task-order and Delivery-order ombudsmen is at https://www.hhs.gov/grants/grantsbusiness-contacts/competitionadvocates/. PART 317—[RESERVED] PART 318—EMERGENCY ACQUISITIONS Sec. 318.000 Scope of part. 318.001 Definition. 318.001–70 Agency delegation of determination. Subpart 318.1—Available Acquisition Flexibilities 318.109 Priorities and allocations. 318.109–70 The Health Resources Priorities and Allocation System. Subpart 318.2—Emergency Acquisition Flexibilities 318.202 Defense or recovery from certain events. 318.202–70 Specific HHS flexibilities. 318.270 Head of the agency delegations. E:\FR\FM\03OCP2.SGM 03OCP2 80676 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. 318.000 Scope of part. This part sets forth additional emergency acquisition flexibilities found in FAR part 18. 318.001 Definition. 318.001–70 Agency delegation of determination. The Secretary delegates to the head of the contracting activity (HCA) the authority to utilize emergency acquisition flexibilities and make the agency head determinations as set forth in FAR part 18 and as defined in subpart 318.2. Subpart 318.1—Available Acquisition Flexibilities 318.109 Priorities and allocations. 318.109–70 The Health Resources Priorities and Allocation System. The HHS Health Resources Priorities and Allocation System was established to require acceptance and priority performance of contracts or orders (other than contracts of employment) to promote the national defense over performance of any other contracts or orders, and to allocate materials, services, and facilities as deemed necessary or appropriate to promote the national defense, with respect to health resources. (See subpart 311.6.) Subpart 318.2—Emergency Acquisition Flexibilities 318.202 events. Defense or recovery from certain ddrumheller on DSK120RN23PROD with PROPOSALS2 318.202–70 Specific HHS flexibilities. 20:17 Oct 02, 2024 Jkt 265001 318.270 Head of the agency delegations. The Secretary delegates to the SPE the authority to make the determinations identified in the following FAR references: (a) FAR 2.101, definitions of ‘‘Simplified acquisition threshold’’ and ‘‘Micro-purchase threshold’’; (b) FAR 12.102(f); (c) FAR 13.201(g); and (d) FAR 13.500(c)(1). ■ 8. Revise parts 319 through 323 to read as follows: * * * * * PART 319 SMALL BUSINESS PROGRAMS PARTS 320–321 [RESERVED] PART 322 APPLICATION OF LABOR LAWS TO GOVERNMENT ACQUISITIONS PART 323 ENVIRONMENT, SUSTAINABLE ACQUISITION, AND MATERIAL SAFETY * (a) Micro-purchase threshold. The threshold increases when the SPE determines the supplies or services are to be used to facilitate defense against or recovery from cyber, nuclear, biological, chemical, or radiological attack; to facilitate provision of international disaster assistance; or to support response to an emergency or major disaster. (See FAR 2.101.) (b) Simplified acquisition threshold. The threshold increases when the SPE determines the supplies or services are to be used to facilitate defense against or recovery from cyber, nuclear, biological, chemical, or radiological attack; to facilitate provision of international disaster assistance; or to support response to an emergency or major disaster. (See FAR 2.101.) (c) Commercial product or commercial service treatment. Contracting officers may treat any acquisition of supplies or services as an VerDate Sep<11>2014 acquisition of commercial products or commercial services if the SPE determines the acquisition is to be used to facilitate the defense against or recovery from cyber, nuclear, biological, chemical, or radiological attack. (See FAR 12.102(f)(1) and 13.500(c)(2).) (d) Simplified procedures for certain commercial products and commercial services. The threshold limits authorized for use of this authority may be increased when it is determined by the SPE the acquisition is to facilitate defense against or recovery from cyber, nuclear, biological, chemical, or radiological attack; to facilitate provision of international disaster assistance; or to support response to an emergency or major disaster. (See FAR 13.500(c).) * * * * Subpart 319.2—Policies 319.201 General policy. (c) The functional management responsibilities for the Department of Health and Human Services’ (HHS) small business program are delegated to the Office of Small and Disadvantaged Business Utilization (OSDBU) Executive Director. (d)(1) The HHS OSDBU Executive Director shall exercise full management authority over the small business program and appoints small business specialists (SBS). The SBS shall review and make set-aside recommendations in accordance with Federal Acquisition Regulation (FAR) 19.502, and OSDBU guidance and agency procedures. The review must take place prior to issuing the solicitation. (2) Within the Indian Health Service (IHS), the primary SBS is responsible for IHS’ overall implementation of the HHS small business program; however, each IHS contracting office will assign a small business technical advisor (SBTA) to perform those functions and responsibilities necessary to implement the small business program. The primary IHS SBS shall assist and provide guidance to respective SBTAs. 319.202 Specific policies. Contracting officers shall use HHS Form 653, Small Business Program Review, to document set-aside decisions in accordance with agency procedures. Subpart 319.7—The Small Business Subcontracting Program 319.705 Responsibilities of the contracting officer under the subcontracting assistance program. PART 319—SMALL BUSINESS PROGRAMS 319.705–6 Postaward responsibilities of the contracting officer. Subpart 319.2—Policies Sec. 319.201 General policy. 319.202 Specific policies. (h) The contracting officer shall coordinate with the small business specialist assigned to the contracting activity (and the SBA procurement center representative (PCR), if one is assigned) on all potential determinations to assess liquidated damages pursuant to FAR 19.705–7(a) and (b). OSDBU should also be alerted prior to a final determination. Subpart 319.7—The Small Business Subcontracting Program 319.705 Responsibilities of the contracting officer under the subcontracting assistance program. 319.705–6 Postaward responsibilities of the contracting officer. Subpart 319.8—Contracting With the Small Business Administration (the 8(a) Program) 319.800 General. 319.811 Preparing the contracts. 319.811–370 SBA Partnership Agreement and contract clauses. Authority: 5 U.S.C. 301; 15 U.S.C. 631, et seq.; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. PO 00000 Frm 00044 Fmt 4701 Sfmt 4702 Subpart 319.8—Contracting With the Small Business Administration (the 8(a) Program) 319.800 General. (e) The Small Business Administration (SBA) and HHS have entered into a Partnership Agreement delegating SBA’s contract execution and administrative functions to HHS. Contracting officers shall follow the E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules alternate procedures in the Partnership Agreement and this subpart, as applicable, to award an 8(a) contract. In the event the Partnership Agreement ceases to be in effect, contracting officers shall follow the procedures in FAR subpart 19.8. 319.811 Preparing the contracts. 319.811–370 SBA Partnership Agreement and contract clauses. When an 8(a) acquisition is processed pursuant to the Partnership Agreement, the contracting officer shall: (a) For competitive solicitations and awards, use the clause at FAR 52.219– 18, Notification of Competition Limited to Eligible 8(a) Participants, and clause 352.219–70, Notification of Competition Limited to Eligible 8(a) Participants, substituting paragraph (c) of FAR 52.219–18 with paragraph (c) contained in 352.219–70. (b) For noncompetitive solicitations and awards insert the clause at 352.219– 71, Notification of Section 8(a) Direct Awards, instead of the prescribed clauses at FAR 52.219–11, Special 8(a) Contract Conditions; 52.219–12, Special 8(a) Subcontract Conditions; and 52.219–17, Section 8(a) Award. (c) In all instances, include the clause at FAR 52.219–14, Limitations on Subcontracting, or if applicable 52.219– 33, Nonmanufacturer Rule. PARTS 320–321 [RESERVED] PART 322—APPLICATION OF LABOR LAWS TO GOVERNMENT ACQUISITIONS Subpart 322.1—Basic Labor Policies Sec. 322.101 Labor relations. 322.101–70 Admittance of union representatives to HHS facilities. ddrumheller on DSK120RN23PROD with PROPOSALS2 322.101–70 Admittance of union representatives to HHS facilities. (a) Admittance policy and procedures. It is HHS policy to admit labor union representatives of contractor employees to HHS facilities to visit work sites and transact labor union business with contractors, their employees, or union stewards pursuant to existing union collective bargaining agreements. Their Jkt 265001 The contracting officer shall insert the provision at 352.223–70, Instructions to Offerors—Sustainable Acquisition Plan, in solicitations above the micropurchase threshold when acquiring a product or service that include sustainable acquisition attributes. 322.808 Complaints. Contractors shall, in good faith, cooperate with the Department of Health and Human Services (HHS) in investigations of Equal Employment Opportunity (EEO) complaints processed pursuant to 29 CFR part 1614 and in accordance with clause 352.222– 70 as prescribed in this subpart. 322.810 Solicitation provisions and contract clauses. Sec. 323.103–70 Policy—Sustainable Acquisition Plan. 323.109–70 Solicitation provision. Labor relations. 20:17 Oct 02, 2024 Subpart 322.8—Equal Employment Opportunity Subpart 323.1—Sustainable Products and Services Subpart 322.1—Basic Labor Policies VerDate Sep<11>2014 Subpart 323.1—Sustainable Products and Services PART 323—ENVIRONMENT, SUSTAINABLE ACQUISITION, AND MATERIAL SAFETY Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. 322.101 presence shall not interfere with the contractor’s work progress under an HHS contract, nor violate the safety or security regulations that may be applicable to persons visiting the facility. The union representatives will not be permitted to conduct meetings, collect union dues, or make speeches concerning union matters while visiting a work site. (b) Denied entry reporting. Whenever a union representative is denied entry to a facility or work site, the person denying entry shall make a written report to the HHS labor coordinator, the Office of the General Counsel (OGC), or corresponding labor advisor, with a copy to the cognizant contracting officer within two working days after the request for entry is denied. The report shall include the reason(s) for the denial, the name of the representative denied entry, the union affiliation and number, and the name and title of the person that denied the entry. (e) The contracting officer shall insert the clause at 352.222–70, Contractor Cooperation in Equal Employment Opportunity and Anti-Harassment Investigations, in solicitations, contracts, and orders that include the clause at FAR 52.222–26, Equal Opportunity. Subpart 322.8—Equal Employment Opportunity 322.808 Complaints. 322.810 Solicitation provisions and contract clauses. 80677 323.103–70 Policy—Sustainable Acquisition Plan. (a) For new contracts and orders above the micro-purchase threshold, contracting officers shall insert an evaluation factor on the offeror’s Sustainable Action Plan in the solicitation, when a Sustainable Action Plan is required. (b) When a solicitation includes the provision at 352.223–70, Instructions to Offerors—Sustainable Acquisition Plan, offerors shall include a Sustainable Acquisition Plan in their technical proposal addressing sustainable products for services for delivery under any resulting contract. (c) The contracting officer shall incorporate the final Sustainable Acquisition Plan into the contract. 323.109–70 Solicitation provision. Subpart 323.3—Hazardous Material Identification, Material Safety Data, and Notice of Radioactive Materials 323.300 Scope of subpart. This subpart provides procedures for administering safety and health requirements. 323.304–70 Contract clause. Insert the clause at 352.223–71, Safety and Health, in solicitations and contracts that involve hazardous materials or hazardous operations for the following types of requirements: (a) Services or products. (b) Research, development, or test projects. (c) Transportation of hazardous materials. (d) Construction, including construction of facilities on the contractor’s premises. Subpart 323.3—Hazardous Material Identification, Material Safety Data, and Notice of Radioactive Materials PART 324—PROTECTION OF PRIVACY AND FREEDOM OF INFORMATION 323.300 Scope of subpart. 323.304–70 Contract clause. ■ Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. PO 00000 Frm 00045 Fmt 4701 Sfmt 4702 9. The authority citation for part 324 is revised to read as follows: E:\FR\FM\03OCP2.SGM 03OCP2 80678 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules Subpart 324.1—Protection of Individual Privacy 324.103, 324.104, and 324.105 [Redesignated as 324.103–70, 324.103–71, and 324.104] 10. Redesignate sections 324.103, 324.104, and 324.105 as sections 324.103–70, 324.103–71, and 324.104. ■ 11. Amend newly redesignated section 324.104 by revising paragraph (b) to read as follows: ■ 324.104 Contract clauses. * * * * * (b) The contracting officer shall insert the clause at 352.224–71, Confidential Information, in solicitations, contracts, and orders that require access to Government or third party confidential information, and in solicitations, contracts, and orders that include the clause at 352.227–71, Rights in Data— Supplement—Exceptional Circumstances. ■ 12. Add part 325 to read as follows: PART 325—FOREIGN ACQUISITION Subpart 325.71—Make PPE in America Act Restrictions on Foreign Acquisition of Personal Protective Equipment Sec. 325.7100 Scope of subpart. 325.7101 Definitions. 325.7102 Restrictions on certain personal protective equipment. 325.7102–1 Restrictions. 325.7102–2 Exceptions. 325.7103 Solicitation provisions and contract clauses. Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. Subpart 325.71—Make PPE in America Act Restrictions on Foreign Acquisition of Personal Protective Equipment 325.7100 Scope of subpart. This subpart contains restrictions on the acquisition of certain personal protective equipment (PPE) as required by the Make PPE in America Act (Pub. L. 117–58) for applicable solicitations and contracts issued by HHS. ddrumheller on DSK120RN23PROD with PROPOSALS2 325.7101 Definitions. As used in this subpart— Component, as applied to an item described in 325.7102–1, means an article, material, or supply incorporated directly into an item of personal protective equipment. Domestic personal protective equipment, as applied to an item described in 325.7102–1, means personal protective equipment, including the materials and components thereof, that is grown, reprocessed, VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 reused, or produced in the United States. Foreign-made domestic personal protective equipment, as applied to an item described in 325.7102–2, means personal protective equipment that is assembled outside the United States containing only materials and components that are grown, reprocessed, reused, or produced in the United States. Foreign personal protective equipment means personal protective equipment other than domestic personal protective equipment or foreign-made domestic personal protective equipment. Personal protective equipment, as applied to an item described in 325.7102–1, means surgical masks, respirator masks and powered air purifying respirators and required filters, face shields and protective eyewear, gloves, disposable and reusable surgical and isolation gowns, head and foot coverings, and other gear or clothing used to protect an individual from the transmission of disease. United States, as applied to an item described in 325.7102–1, means the 50 States, the District of Columbia, and the possessions of the United States. 325.7102 Restrictions on certain personal protective equipment. 325.7102–1 Restrictions. The following restrictions implement section 70953 of the Make PPE in America Act, and they apply to all contracts and orders for the purchase of PPE. (a) Except as provided in subsection 325.7102–2, contracting officers shall purchase domestic PPE. (b) Any contract for PPE shall have a base period of performance of at least two years, plus any option periods. 325.7102–2 Exceptions. Acquisitions of PPE in the following categories are not subject to the restrictions in 325.7102–1: (a) Acquisitions of an item of PPE, or component thereof, otherwise covered by 325.7102–1 when the HHS Secretary: (1) Maximizes sources for foreignmade domestic PPE; and (2) Certifies every 120 days that it is necessary to procure PPE under alternative procedures to respond to the immediate needs of a public health emergency. (b) Acquisitions of an item of PPE, or component thereof, including those described in paragraph (a) of this section— (1) That is, or that includes, a material listed in FAR 25.104 as one for which PO 00000 Frm 00046 Fmt 4701 Sfmt 4702 a nonavailability determination has been made; or (2) As to which the HHS Secretary— (i) Determines that a sufficient quantity of a satisfactory quality that is grown, reprocessed, reused, or produced in the United States cannot be procured as, and when, needed at United States market prices; and (ii) Certifies every 120 days that it is necessary to procure PPE to respond to the immediate needs of a public health emergency. (c) When either of the exceptions in paragraph (a) or (b) of this section are used: (1) Only the HHS Secretary is authorized to make the certification in paragraphs (a)(2) and (b)(2)(ii) or the nonavailability or unreasonable cost determination in paragraph (b) of this section. (2) The supporting documentation for the Senior Procurement Executive shall be prepared by the HHS Operating or Staff Division and— (i) For the certification in paragraphs (a)(2) and (b)(2)(ii) of this section, the contracting officer shall— (A) Include a written justification documenting the immediate public health emergency requiring use of alternative procedures; and (B) Obtain written approval of the justification from the head of the contracting activity (HCA) before submission to the Senior Procurement Executive. (ii) For the nonavailability or unreasonable cost determination in paragraph (b) of this section, the contracting officer shall— (A) Include a written justification documenting why a nonavailability or unreasonable cost exception is required; and (B) Obtain written approval of the justification from the HCA before submission to the Senior Procurement Executive. 325.7103 Solicitation provisions and contract clauses. (a) Insert the clause at 352.225–70, Made in America—Personal Protective Equipment, in solicitations and contracts, above the micro-purchase threshold, when procuring any item covered under 325.7102–1(a). When the clause at FAR 52.212–5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders— Commercial Products and Commercial Services, is included in a solicitation or contract for PPE, contracting officers shall include the full text of the clause at 352.225–70. (b) Insert the provision at 352.225–71, Made in America Certificate—Personal E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules Protective Equipment, in solicitations containing the clause at 352.225–70. When the provision at FAR 52.212–3, Offeror Representations and Certifications—Commercial Products and Commercial Services, is included in a solicitation for PPE, contracting officers shall include the full text of the provision at 352.225–71. ■ 13. Revise part 326 to read as follows: PART 326—OTHER SOCIOECONOMIC PROGRAMS Subpart 326.70—Indian Preference in Employment, Training, and Subcontracting Opportunities Sec. 326.7001 326.7002 326.7003 326.7004 326.7005 Statutory requirements. Additional definitions. Compliance enforcement. Tribal preference requirements. Contract clauses. Subpart 326.71—Acquisitions Under the Buy Indian Act ddrumheller on DSK120RN23PROD with PROPOSALS2 326.7100 General. 326.7100–1 Scope of subpart. 326.7100–2 Buy Indian Act acquisition regulations. 326.7101 Definitions. 326.7102 Applicability. 326.7102–1 Restrictions on the use of the Buy Indian Act. 326.7103 Policy. 326.7103–1 Requirement to give preference to Indian Economic Enterprises. 326.7103–2 Delegations and responsibility. 326.7103–3 Deviations. 326.7104 Procedures. 326.7104–1 General. 326.7104–2 Procedures for acquisitions under the Buy Indian Act. 326.7104–3 Debarment and suspension. 326.7104–4 Performance and payment bonds. 326.7105 Solicitation provisions and contract clauses. 326.7106 Representation by an Indian Economic Enterprise offeror. 326.7106–1 General. 326.7106–2 Representation provision. 326.7106–3 Representation process. 326.7107 Challenges to representation. 326.7107–1 Procedure. 326.7107–2 Receipt of challenge. 326.7107–3 Award in the face of challenge. 326.7107–4 Challenge not timely. Subpart 326.72—Acquisitions Requiring the Native American Graves Protection and Repatriation Act 326.7200 326.7201 Scope of subpart. Contract clauses. Authority: 5 U.S.C. 301, 25 U.S.C. 47, 25 U.S.C. 1633, 25 U.S.C. 5301 et seq.; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; 42 U.S.C. 2003; and 48 CFR 1.301 through 1.304. VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 Subpart 326.70—Indian Preference in Employment, Training, and Subcontracting Opportunities 326.7001 Statutory requirements. Any contract or subcontract pursuant to 25 U.S.C. chapter 46, the Act of April 16, 1934 (48 Stat. 596), as amended (25 U.S.C. 5301, et seq.), or any other Act authorizing Federal contracts with or grants to Indian organizations or for the benefit of Indians, shall, to the greatest extent feasible, comply with section 7(b) of the Indian Self-Determination and Education Assistance Act, Public Law 93–638, 88 Stat. 2205 (25 U.S.C. 5307(b)), which provides preferences and opportunities for training and employment in connection with the administration of such contracts, and preference in the award of subcontracts in connection with the administration of such contracts to Indian organizations and to Indian-owned economic enterprises as defined in 25 U.S.C. 1452. 326.7002 Additional definitions. As used in this subpart— (a) Construction contract means a fixed-price or cost-reimbursement selfdetermination contract for a construction project, except that such term does not include any contract— (1) That is limited to providing planning services and construction management services (or a combination of such services); (2) For the Housing Improvement Program or roads maintenance program of the Bureau of Indian Affairs administered by the Secretary of the Interior; or (3) For the health facility maintenance and improvement program administered by the Secretary of Health and Human Services. (Pub. L. 116–180, title II, sec. 201(a), 134 Stat. 878.) (b) Contract funding base means the base level from which contract funding needs are determined, including all contract costs. (c) Indian means a person who is a member of an Indian Tribe. If the contractor has reason to doubt that a person seeking employment preference is an Indian, the contractor shall grant the preference but shall require the individual provide evidence within 30 days from the Tribe concerned that the person is a member of the Tribe. (d) Indian reservation includes Indian reservations, public domain Indian allotments, former Indian reservations in Oklahoma, and land held by incorporated Native groups, regional corporations, and village corporations under the provisions of the Alaska Native Claims Settlement Act (85 Stat. 688; 43 U.S.C. 1601 et seq.). PO 00000 Frm 00047 Fmt 4701 Sfmt 4702 80679 (e) Indian Tribe means any Indian Tribe, band, nation, or other organized group or community, including any Alaska Native village or regional or village corporation as defined in or established pursuant to the Alaska Native Claims Settlement Act (85 Stat. 688; 43 U.S.C. 1601 et seq.), which is recognized as eligible for special programs and services provided by the United States to Indians because of their status as Indians. (f) Indirect costs means costs incurred for a common or joint purpose benefiting more than one contract objective, or which are not readily assignable to the contract objectives specifically benefited without effort disproportionate to the results achieved. (g) On or near an Indian reservation means on a reservation or reservations or within that area surrounding an Indian reservation(s) where a person seeking employment could reasonably commute to and from in the course of a work day. (h) Secretary, unless otherwise designated, means either the Secretary of Health and Human Services or the Secretary of the Interior or both. (i) Self-determination contract means a contract entered into under 25 U.S.C. subchapter I (or a grant or cooperative agreement used under 25 U.S.C. 5308) between a Tribal organization and the appropriate Secretary for the planning, conduct, and administration of programs or services that are otherwise provided to Indian Tribes and members of Indian Tribes pursuant to Federal law, subject to the condition that, except as provided in 25 U.S.C. 5324(a)(3), no contract entered into under 25 U.S.C. subchapter I (or grant or cooperative agreement used under 25 U.S.C. 5308) shall be— (1) Considered to be a procurement contract; or (2) Except as provided in 25 U.S.C. 5328(a)(1), subject to any Federal procurement law (including regulations). (j) Tribal organization means the recognized governing body of any Indian Tribe; any legally established organization of Indians which is controlled, sanctioned, or chartered by such governing body or which is democratically elected by the adult members of the Indian community to be served by such organization and which includes the maximum participation of Indians in all phases of its activities: Provided, that in any case where a contract is let or grant made to an organization to perform services benefiting more than one Indian Tribe, the approval of each such Indian Tribe E:\FR\FM\03OCP2.SGM 03OCP2 80680 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules shall be a prerequisite to the letting or making of such contract or grant. 326.7003 Compliance enforcement. The contracting officer shall promptly investigate and resolve written complaints of noncompliance with the requirements of the clauses at 352.226– 70, Indian Preference, and 352.226–71, Indian Preference Program, filed with the contracting activity. 326.7004 Tribal preference requirements. (a) When the contractor will perform work under a contract on an Indian reservation, the contracting officer may supplement the clause at 352.226–71, Indian Preference Program, by adding specific Indian preference requirements of the Tribe on whose reservation the contractor will work. The contracting activity and the Tribe shall jointly develop supplemental requirements for the contract. Supplemental preference requirements shall represent a further implementation of the requirements of section 7(b) of Public Law 93–638 and require the approval of the affected program director and the appropriate legal office, or a regional attorney, before the contracting officer adds them to a solicitation and resultant contract. Any supplemental preference requirements the contracting officer adds to the clause at 352.226–71, Indian Preference Program shall also clearly identify in the solicitation the additional requirements. (b) Nothing in this subpart shall preclude Tribes from independently developing and enforcing their own Tribal preference requirements. Such independently-developed Tribal preference requirements shall not, except as provided in paragraph (a) of this section, become a requirement in contracts covered under this subpart, and shall not conflict with any Federal statutory or regulatory requirement concerning the award and administration of contracts. ddrumheller on DSK120RN23PROD with PROPOSALS2 326.7005 Contract clauses. The contracting officer shall insert the clause at 352.226–70, Indian Preference, and the clause at 352.226–71, Indian Preference Program, in solicitations and contracts to implement section 7(b) of Public Law 93–638 for all Department of Health and Human Services (HHS) offices. Contracting officers shall use the clauses as follows, except for those exempted solicitations and contracts issued and or awarded pursuant to title I of Public Law 93–638 (25 U.S.C. 450 et seq.): (a) The contracting officer shall insert the clause at 352.226–70, Indian VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 Preference, in solicitations, contracts, and orders when— (1) The award is (or will be) pursuant to an act specifically authorizing such awards with Indian organizations; or (2) The work is specifically for the benefit of Indians and is in addition to any incidental benefits which might otherwise accrue to the general public. (b) The contracting officer shall insert the clause at 352.226–71, Indian Preference Program, in solicitations, contracts, and orders when— (1) The dollar amount of the acquisition is expected to equal or exceed $750,000 for non-construction work or $1.5 million for construction work; (2) The solicitation, contract, or order includes the clause at 352.226–70; and (3) The contracting officer makes the determination, prior to solicitation, that performance will take place in whole or in substantial part on or near an Indian reservation(s). In addition, the contracting officer may insert the clause at 352.226–71 in solicitations, contracts, and orders below the $750,000 threshold or $1.5 million threshold level for non-construction or construction contracts, respectively, but which meet the requirements of paragraphs (b)(2) and (3) of this section, and in the opinion of the contracting officer, offer substantial opportunities for Indian employment, training, and subcontracting. Subpart 326.71—Acquisitions Under the Buy Indian Act 326.7100 General. 326.7100–1 Scope of subpart. This subpart implements policies and procedures for the procurement of supplies, general services, architectengineer (A–E) services, or construction while giving preference to Indian Economic Enterprises under authority of the Buy Indian Act (25 U.S.C. 47). 326.7100–2 Buy Indian Act acquisition regulations. (a) This subpart supplements Federal Acquisition Regulation (FAR) and Health and Human Services Acquisition Regulation (HHSAR) requirements to meet the needs of the Department of Health and Human Services (HHS), Indian Health Service (IHS) in implementing the Buy Indian Act. (b) This subpart is under the direct oversight and control of the head of contracting activity (HCA), within the Office of Management Services (OMS)— IHS, HHS. The HCA, in consultation with the Assistant Secretary for Financial Resources (ASFR) and the Senior Procurement Executive (SPE), is PO 00000 Frm 00048 Fmt 4701 Sfmt 4702 responsible for promulgating this subpart, and following its enactment, will be primarily responsible for implementing its terms. (c) Acquisitions conducted under this subpart are subject to all applicable requirements of the FAR and HHSAR, as well as internal policies, procedures, or instructions issued by IHS. After the FAR, this subpart would take precedence over any inconsistent IHS policies, procedures, or instructions. 326.7101 Definitions. As used in this subpart— Alaska Native Claims Settlement Act (ANCSA) means Public Law 92–203, 85 Stat. 688, codified at 43 U.S.C. 1601– 1629h. Alaska Native Corporation means any Regional Corporation, any Village Corporation, any Urban Corporation, and any Group Corporation as those terms are defined by ANCSA. Buy Indian Act means section 23 of the Act of June 25, 1910, codified at 25 U.S.C. 47. Chief Contracting Officer (CCO) means a person with authority to enter into, administer, or terminate contracts and make related determinations and findings on behalf of the U.S. Government for the respective IHS Areas. Construction means the planning, design, construction and renovation, including associated architecture and engineering services, of IHS facilities pursuant to 25 U.S.C. 1631 and in the construction of safe water and sanitary waste disposal facilities pursuant to 25 U.S.C. 1632. Deviation means an exception to the requirement to use the Buy Indian Act in fulfilling an acquisition requirement subject to the Buy Indian Act. Fair market price means a price based on reasonable costs under normal competitive conditions and not on lowest possible cost, as determined in accordance with FAR 19.202–6(a). Indian means a person who is an enrolled member of an Indian Tribe or ‘‘Native’’ as defined in the Alaska Native Claims Settlement Act. Indian Economic Enterprise (IEE) means any business activity owned by one or more Indians or Indian Tribes that is established for the purpose of profit provided that: The combined Indian or Indian Tribe ownership must constitute not less than 51 percent of the enterprise; the Indians or Indian Tribes must, together, receive at least a majority of the earnings from the contract; and the management and daily business operations of an enterprise must be controlled by one or more individuals who are Indians. To ensure E:\FR\FM\03OCP2.SGM 03OCP2 ddrumheller on DSK120RN23PROD with PROPOSALS2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules actual control over the enterprise, the individuals must possess requisite management or technical capabilities directly related to the primary industry in which the enterprise conducts business. The enterprise must meet these requirements throughout the following time periods: (1) At the time an offer is made in response to a written solicitation; (2) At the time of the contract award; and (3) During the full term of the contract. Indian Health Service (IHS) means operations at all administrative levels of IHS, including Headquarters, Area Offices, and Service Units (inclusive of clinics). Indian Small Business Economic Enterprise (ISBEE) means an IEE that is also a small business concern established in accordance with the criteria and size standards of 13 CFR part 121. Indian Tribe means an Indian Tribe, band, nation, or other recognized group or community that is recognized as eligible for the special programs and services provided by the United States to Indians because of their status as Indians, including any Alaska Native village or regional or village corporation under the Alaska Native Claims Settlement Act (Pub. L. 92–203, 85 Stat. 688; 43 U.S.C. 1601). Interested party means an IEE that is an actual or prospective offeror whose direct economic interest would be affected by the proposed or actual award of a particular contract set-aside pursuant the Buy Indian Act. List of Federally Recognized Tribes means the list published annually in the Federal Register identifying Indian entities that are recognized by and eligible to receive services from the United States Department of the Interior (DOI), Bureau of Indian Affairs (BIA). Transfer Act of 1954 means the authority of transferred responsibility and other health care ‘‘functions, responsibilities, authorities and duties of the Department of the Interior’’ (including the Snyder Act) to Health, Education and Welfare, the predecessor of the HHS (see Pub. L. 83–568, 68 Stat. 674 (1954) (codified at 42 U.S.C. 2001 et seq.)). The Transfer Act authorizes IHS to use the Buy Indian Act (25 U.S.C. 47) to carry out its health care responsibilities. 326.7102 Applicability. Except as provided in 326.7102–1, this subpart applies to all acquisitions above the micro-purchase threshold, including simplified acquisitions, made by IHS, and any HHS operating or staff VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 divisions or agency outside of HHS conducting acquisitions on behalf of IHS. 326.7102–1 Restrictions on the use of the Buy Indian Act. (a) IHS may not use the authority of the Buy Indian Act and the procedures contained in this subpart to award intergovernmental contracts to Tribal organizations to plan, operate, or administer authorized IHS programs (or parts thereof) that are within the scope and intent of the Indian SelfDetermination and Education Assistance Act (ISDEAA) (Pub. L. 93– 638). IHS must use the Buy Indian Act solely to award procurement contracts to IEEs. Contracts subject to ISDEAA are not covered under the FAR and are codified separately under 25 CFR part 900 and 42 CFR part 137. (b) Contract health services (referred to administratively as Purchased/ Referred Care services) are defined at 25 U.S.C. 1603 as excluding services provided by Buy Indian Act contractors. Accordingly, the Buy Indian Act may not be used to obtain services through the Purchased/Referred Care program (previously Contract Health Services). Purchase orders for care authorized pursuant to 42 CFR part 136, subpart C, may be issued without regard to the provisions of this subpart. 326.7103 Policy. 326.7103–1 Requirement to give preference to Indian Economic Enterprises. (a) Except as provided by 25 U.S.C. 1633, IHS must use the negotiation authority of the Buy Indian Act to give preference to IEEs whenever the use of that authority is practicable. Thus, IHS may use the Buy Indian Act to give preference to IEEs through set-asides when acquiring supplies, general services, architect-engineer (A–E) services, or construction to meet IHS needs and requirements. The Buy Indian Act does not apply when mandatory government sources are available, as required by FAR 8.002. (b) Contract awards under the authority of the Buy Indian Act can be pursued via the acquisition procedures prescribed in this subpart in conjunction with the procedures from FAR parts 12, 13, 14, 15 and/or 16. (c) The contracting officer will give priority to ISBEEs for all purchases, regardless of dollar value, by utilizing ISBEE set-aside to the maximum extent possible. Contracting officers when prioritizing ISBEEs may consider either— (1) A set-aside for ISBEEs; or (2) A sole source award to an ISBEE, as authorized under the FAR. PO 00000 Frm 00049 Fmt 4701 Sfmt 4702 80681 (d) If the contracting officer determines after market research that there is no reasonable expectation of obtaining offers from two or more ISBEEs that will be competitive in terms of market price, product quality, and delivery capability, the contracting officer may consider either— (1) A set-aside for IEEs; or (2) A sole source award to an IEE, as authorized under the FAR. (e) If the contracting officer determines after market research that there is no reasonable expectation of obtaining two or more offers that will be competitive in terms of market price, product quality, and delivery capability, from ISBEEs and/or IEEs, then the contracting officer shall follow the Deviation process under 326.7103–3. (f) Price analysis technique(s) provided in FAR 15.404–1(b) shall be used in determination of price fair and reasonableness when only one offer is received from a responsible ISBEE or IEE in response to an acquisition setaside under paragraph (c)(1) or (d)(1) of this section: (1) If the offer meets the technical capability requirements and is not at a reasonable and fair market price, then the contracting officer may negotiate with that enterprise for a reasonable and fair market price, as authorized under the FAR. (2) If the offer meets the technical capability requirements and is at a reasonable and fair market price, then the contracting officer must— (i) Make an award to that enterprise; (ii) Document the reason only one offer was considered; and (iii) Initiate action to increase competition in future solicitations. (g) If the offers received in response to an acquisition set-aside under paragraph (c) or (d) of this section are determined to be unreasonable or otherwise unacceptable upon price and/ or technical evaluations, then the contracting officer must follow the Deviation process under 326.7103–3. The contracting officer must document in the deviation determination the reasons why the IEE offeror(s) were not reasonable or otherwise unacceptable. (1) If a deviation determination is approved, the contracting officer must cancel the current ISBEE or IEE setaside solicitation and inform all offerors in writing. (2) If a deviation determination is approved, the contracting officer must identify, based on current available market research, an alternate set-aside or procurement method. (3) When the solicitation of the same requirement is posted, the contracting E:\FR\FM\03OCP2.SGM 03OCP2 80682 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules officer must inform all previous offerors in writing of the solicitation number. (h) With respect to construction, the provisions of 25 U.S.C. 1633 shall apply. Under 25 U.S.C. 1633, IHS may give a preference to an IEE unless the agency finds, after considering the evaluation criteria listed in 25 U.S.C. 1633, that the project to be contracted for will not be satisfactory or cannot be properly completed or maintained under the proposed contract. 326.7103–2 Delegations and responsibility. (a) The Director, IHS—exercises the authority of the Buy Indian Act pursuant to the Transfer Act of 1954, as delegated pursuant to 25 U.S.C. 1661. Under 25 U.S.C. 1661, the Director is authorized to enter into contracts for the procurement of goods and services to carry out the functions of the IHS. IHS exercises this authority in support of its mission and program activities and as a means of fostering Indian employment and economic development. (b) The IHS HCA is responsible for ensuring that all IHS acquisitions under the Buy Indian Act comply with the requirements of this subpart. 326.7103–3 Deviations. (a) There are certain instances where the application of the Buy Indian Act to an acquisition may not be appropriate. In these instances, the contracting officer must detail the reasons in writing or via email and make a deviation determination. (b) Some acquisitions by their very nature would make such a written determination unnecessary. For example, any order or call placed against an indefinite delivery vehicle that already has an approved deviation from the requirements of the Buy Indian Act. (c) Deviation determinations shall be required for all other acquisitions where the Buy Indian Act is applicable and must be approved as follows: TABLE 1 TO 326.7103–3(c) ddrumheller on DSK120RN23PROD with PROPOSALS2 For a proposed contract action The following official may authorize a deviation Exceeding the Contracting Officer. micro-purchase threshold and up to $25,000. Exceeding Chief Contracting Officer $25,000 but (CCO) (or the IHS Division not exceedof Acquisition Policy (DAP) ing $750,000. Director, absent a CCO). VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 TABLE 1 TO 326.7103–3(c)— Continued For a proposed contract action The following official may authorize a deviation Exceeding $750,000 but not exceeding $15 million. Exceeding $15 million but not exceeding $75 million. Exceeding $75 million. IHS Advocate for Competition. Head of Contracting Activity. HHS Office of Small & Disadvantaged Business Utilization (OSDBU), Office of the General Counsel (OGC), HHS Department Advocate for Competition and the HHS Senior Procurement Executive. (d) Deviations may be authorized prior to issuing the solicitation when the contracting officer makes the following determinations and takes the following actions: (1) The contracting officer determines after market research that there is no reasonable expectation of obtaining offers that will be competitive in terms of market price, quality, and delivery from two or more responsible ISBEEs or IEEs. (2) The deviation determination is authorized by the official listed at paragraph (c) of this section for the applicable contract action. (e) If a deviation determination has been approved, the contracting officer must follow the FAR and HHSAR unless specified otherwise. (f) Acquisitions made under an authorized deviation from the requirements of the Buy Indian Act must be made in conformance with the order of precedence required by FAR 8.002. 326.7104 Procedures. 326.7104–1 General. All acquisitions under the authority of the Buy Indian Act, must conform to all applicable requirements of the FAR and HHSAR. 326.7104–2 Procedures for acquisitions under the Buy Indian Act. (a) Each acquisition of commercial products, commercial services and construction that is subject to FAR part 12 or 13 must be set-aside exclusively for ISBEEs, except as otherwise set forth in this subpart. IHS will use ISBEE commercial products and commercial services, or simplified acquisition setasides to accomplish this preference action. PO 00000 Frm 00050 Fmt 4701 Sfmt 4702 (b) Commercial products and commercial services, or simplified acquisitions under this section must conform to the competition and price reasonableness documentation requirements of FAR 12.209 for commercial products and commercial services acquisitions and FAR 13.106 for simplified acquisitions. (c) When acquiring construction and architect-engineer (A–E) services, solicit proposals and evaluate potential contractors in accordance with FAR part 36. (d) This paragraph (d) applies to solicitations that are not restricted to participation of IEEs. (1) If an interested IEE is identified after a solicitation has been issued, but before the date established for receipt of offers, the contracting office must provide a copy of the solicitation to this enterprise. In this case, the contracting officer: (i) Will not give preference under the Buy Indian Act to the IEE; and (ii) May extend the date for receipt of offers when practical. (2) If more than one IEE is identified after issuing a solicitation, but prior to the date established for receipt of offers, the contracting officer may cancel the solicitation and re-compete it as an IEE set-aside. 326.7104–3 Debarment and suspension. A misrepresentation by an offeror of its status as an IEE, failure to notify the contracting officer of any change in IEE status that would make the contractor ineligible as an IEE, or any violation of the regulations in this subpart by an offeror or an awardee may lead to debarment or suspension in accordance with FAR 9.406 and 9.407 and 309.406 and 309.407. 326.7104–4 bonds. Performance and payment Solicitations requiring performance and payment bonds must conform to FAR part 28 and authorize use of any of the types of security acceptable in accordance with FAR subpart 28.2 or section 11 of Public Law 98–449, the Indian Financing Act Amendments of 1984 (25 U.S.C. 47a). In accordance with FAR 28.102 and 25 U.S.C. 47a, the contracting officer may accept alternative forms of security in lieu of performance and payment bonds if a determination is made that such forms of security provide the Government with adequate security for performance and payment. 326.7105 Solicitation provisions and contract clauses. (a) The contracting officer shall insert the provision at 352.226–73, Notice of E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules Indian Small Business Economic Enterprise Set-Aside, in solicitations for acquisitions that are set-aside to ISBEE concerns under 326.7103–1(c). (b) The contracting officer shall insert the provision at 352.226–74, Notice of Indian Economic Enterprise Set-Aside, in solicitations for acquisitions that are set-aside to IEE concerns in accordance with 326.7103–1(d). (c) The contracting officer shall insert the clause at 352.226–75, Indian Economic Enterprise Subcontracting Limitations, in all solicitations and contracts when the contract award is to be made under the authority of the Buy Indian Act. (d) The contracting officer shall insert the provision at 352.226–76, Indian Economic Enterprise Representation, in all solicitations when the contract award is to be made under the authority of the Buy Indian Act. (e) The contracting officer shall insert the clause at FAR 52.219–14, Limitations on Subcontracting, as prescribed at FAR 19.507(e), in solicitations and contracts for supplies, services, and construction, if any portion of the requirement is to be setaside for ISBEEs and IEEs. (f) The contracting officer must also insert the clause 352.226–76, Indian Economic Enterprise Subcontracting Limitations, in all awards to ISBEEs and IEEs pursuant to this subpart. 326.7106 Representation by an Indian Economic Enterprise offeror. ddrumheller on DSK120RN23PROD with PROPOSALS2 326.7106–1 General. (a) The contracting officer must insert the provision at 352.226–76, Indian Economic Enterprise Representation, in all solicitations regardless of dollar value solicited under 326.7103–1(c) or (d) and in accordance with this subpart. (b) To be considered for an award under 326.7103–1(c) or (d), an offeror must— (1) Certify that it meets the definition of Indian Economic Enterprise in response to a specific solicitation setaside in accordance with the Buy Indian Act and this subpart; and (2) Identify the Indian Tribe(s) upon which the offeror relies for its IEE status. (c) The enterprise must meet the definition of Indian Economic Enterprise throughout the following time periods— (1) At the time an offer is made in response to a solicitation; (2) At the time of contract award; and (3) During the full term of the contract. (d) If, after award, a contractor no longer meets the eligibility requirements VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 as it has certified and as set forth in this section, then the contractor must provide the contracting officer with written notification within 3 calendar days of its failure to comply with the eligibility requirements. The notification must include— (1) Full disclosure of circumstances causing the contractor to lose eligibility status; and (2) A description of actions, if any, that must be taken to regain eligibility. (e) Failure to maintain eligibility under the Buy Indian Act or to provide written notification required by paragraph (d) of this section means that— (1) The contractor may be declared ineligible for future contract awards under this subpart; (2) The contracting officer may consider termination for default of the ongoing contract; and (3) The contracting officer may pursue debarment or suspension of the contractor. (f) The contracting officer will review the offeror’s representation that it is an IEE in a specific bid or proposal and verify that the Indian Tribe(s) that the offeror identified in the representation is either on the List of Federally Recognized Tribes or is an Alaska Native Corporation. A contracting officer will also investigate the representation if an interested party challenges the IEE representation or if the contracting officer has any other reason to question the representation. The contracting officer may ask the offeror for more information to substantiate the representation. Challenges of and questions concerning a specific representation must be referred to the contracting officer or CCO in accordance with 326.7107. (g) Participation in the Mentor-Protégé Program established under section 831 of the National Defense Authorization Act for Fiscal Year 1991 (25 U.S.C. 47 note) does not render an IEE ineligible for contracts awarded under the Buy Indian Act. 326.7106–2 Representation provision. (a) Contracting offices must provide copies of the awardees’ IEE representation to any interested parties upon written request. IHS will make awardees’ IEE representations available via IHS public sites and/or other means. (b) Any false or misleading information submitted by an enterprise when submitting an offer in consideration for an award set-aside under the Buy Indian Act may be a violation of the law punishable under 18 U.S.C. 1001. False claims submitted as part of contract performance may be PO 00000 Frm 00051 Fmt 4701 Sfmt 4702 80683 subject to the penalties enumerated in 31 U.S.C. 3729 to 3731 and 18 U.S.C. 287. (c) The contracting officer shall inform the head of the contracting activity, in writing, within 10 business days, of all suspected IEE misrepresentation by an offeror or failure to provide written notification of a change in IEE eligibility. This shall be included in the contract file. 326.7106–3 Representation process. (a) Only IEEs may participate in acquisitions set-aside in accordance with the Buy Indian Act and this subpart. The procedures in this subpart are intended to support responsible IEEs and prevent circumvention or abuse of the Buy Indian Act. (b) The contracting officer shall review the ownership information furnished under 352.226–76(b) and verify that the Indian Tribe(s) identified is either on the List of Federally Recognized Tribes or is an Alaska Native Corporation. (c) If the contracting officer cannot verify from the offeror submission that the Indian Tribe(s) identified is either on the List of Federally Recognized Tribes or is an Alaska Native Corporation, the contracting officer must allow the offeror to correct information submitted under 352.226– 76(b). The contracting officer should make every effort to allow the offeror to correct the information. If the requirement is time sensitive the contracting officer must specify to the offeror the time and date by which a response is required. (1) If the contracting officer determines the offeror is not responsive, the contracting officer must document the circumstances and inform the offeror of the determination. (2) The contracting officer may ask the appropriate regional Office of the General Counsel to review the IEE representation. (3) The IEE representation does not relieve the contracting officer of the obligation for determining contractor responsibility, as required by FAR subpart 9.1. 326.7107 Challenges to representation. 326.7107–1 Procedure. (a) The contracting officer can accept an offeror’s written representation of being an ISBEE or IEE (as defined in 326.7101) only when it is submitted in response to a Sources Sought Notice, Request for Information (RFI) or with an offer in response to a solicitation under the Buy Indian Act. Another interested party may challenge the representation E:\FR\FM\03OCP2.SGM 03OCP2 80684 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules of an offeror or awardee by filing a written challenge. (b) Upon receipt of the challenge, the contracting officer shall re-verify the representation of the offeror or awardee in accordance with the requirements of this subpart, including the provisions of 326.7106. ddrumheller on DSK120RN23PROD with PROPOSALS2 326.7107–2 Receipt of challenge. (a) An interested party must file any challenges against an offeror’s representation with the cognizant contracting officer. (b) The challenge must be in writing and must contain the basis for the challenge with accurate, complete, specific, and detailed evidence. The evidence must support the allegation that the offeror fails to meet the definition of Indian Economic Enterprise or Indian Small Business Economic Enterprise as defined in 326.7101 or is otherwise ineligible. The contracting officer will dismiss any challenge that is deemed frivolous or that does not meet the conditions in this section. (c) To be considered timely, a challenge must be received by the contracting officer no later than 10 calendar days after the basis of challenge is known or should have been known, whichever is earlier. (1) A challenge may be made orally if it is confirmed in writing within the 10day period after the basis of challenge is known or should have been known, whichever is earlier. (2) A written challenge may be delivered by hand, email, or letter postmarked within the 10-day period after the basis of challenge is known or should have been known, whichever is earlier. (3) A contracting officer’s challenge to a certification is always considered timely, whether filed before or after award. (d) Upon receiving a timely challenge, the contracting officer must: (1) Notify the challenger of the date it was received, and that the representation of the enterprise being challenged is under consideration; and (2) Furnish to the offeror (whose representation is being challenged) a request to provide detailed information on its eligibility by certified mail, return receipt requested or email. (e) Within 3 calendar days after receiving a copy of the challenge and the contracting officer’s request for detailed information, the challenged offeror must file, as specified at paragraph (d)(2) of this section, with the contracting officer a complete statement answering the allegations in the challenge and furnish evidence to VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 support its position on representation. If the offeror does not submit the required material within the 3 calendar days, or another period of time granted by the contracting officer, the contracting officer may assume that the offeror does not intend to dispute the challenge and must not award to the challenged offeror. (f) Within 10 calendar days after receiving a challenge, the challenged offeror’s response, and any other pertinent information, the contracting officer must determine the representation status of the challenged offeror and notify the challenger and the challenged offeror of the decision by certified mail, return receipt requested or email, and make known to all parties the option to appeal the determination to IHS DAP. (g) If the representation accompanying an offer is challenged and subsequently upheld by DAP, the written notification of this action must state the reason(s). 326.7107–3 Award in the face of challenge. (a) Award of a contract in the face of challenge only may be made on the basis of the contracting officer’s written determination that the challenged offeror’s representation is valid. (1) This determination is final unless it is appealed to DAP, and the contracting officer is notified of the appeal before award. (2) If an award was made before the contracting officer received notice of appeal, the contract is presumed to be valid. (b) After receiving a challenge involving an offeror being considered for award, the contracting officer must not award the contract until the contracting officer has determined the validity of the representation. Award may be made in the face of a timely challenge when the contracting officer determines in writing that an award must be made to protect the public interest, is urgently required, or a prompt award will otherwise be advantageous to the Government. (c) If a timely challenge on representation is filed with the contracting officer and received before award in response to a specific offer and solicitation, the contracting officer must notify eligible offerors within one day that the award will be withheld. The contracting officer also may ask eligible offerors to extend the period for acceptance of their proposals. (d) If a challenge on representation is filed with the contracting officer and received after award in response to a specific offer and solicitation, the contracting officer need not suspend contract performance or terminate the PO 00000 Frm 00052 Fmt 4701 Sfmt 4702 awarded contract unless the contracting officer believes that an award may be invalidated, and a delay would prejudice the Government’s interest. However, if contract performance is to be suspended, the contracting officer would follow those guidelines as outlined in FAR part 49. 326.7107–4 Challenge not timely. If a contracting officer receives an untimely filed challenge of a representation, the contracting officer must notify the challenger that the challenge cannot be considered on the instant acquisition but will be considered in any future actions. However, the contracting officer may question at any time, before or after award, the representation of an IEE. Subpart 326.72—Acquisitions Requiring the Native American Graves Protection and Repatriation Act 326.7200 Scope of subpart. Public Law 101–601, dated November 16, 1990, also known as the Native American Graves Protection and Repatriation Act, imposes certain responsibilities on individuals and organizations when they discover Native American cultural items (including human remains) on Federal or Tribal lands. 326.7201 Contract clauses. The contracting officer shall insert the clause at 352.226–72, Native American Graves Protection and Repatriation Act, in solicitations, contracts, and orders requiring performance on Tribal lands or those for construction projects on Federal or Tribal lands. ■ 14. Revise subchapter E to read as follows: SUBCHAPTER E—GENERAL CONTRACTING REQUIREMENTS PART 327 PATENTS, DATA, AND COPYRIGHTS PARTS 328–329 [RESERVED] PART 330 COST ACCOUNTING STANDARDS ADMINISTRATION PART 331 CONTRACT COST PRINCIPLES AND PROCEDURES PART 332 CONTRACT FINANCING PART 333 PROTESTS, DISPUTES, AND APPEALS PART 327—PATENTS, DATA, AND COPYRIGHTS Subpart 327.3—Patent Rights Under Government Contracts Sec. 327.303–70 Contract clause. Subpart 327.4—Rights in Data and Copyrights 327.409–70 Contract clauses. E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. PART 331—CONTRACT COST PRINCIPLES AND PROCEDURES Subpart 327.3—Patent Rights Under Government Contracts Subpart 331.1—Applicability Sec. 331.170 Salary rate limitation. 331.171 Contract clause. 327.303–70 Contract clause. The contracting officer shall insert the clause at 352.227–70, Patent Rights— Supplement—Exceptional Circumstances, in solicitations, contracts, and orders that include the clause at FAR 52.227–11, Patent Rights—Ownership by the Contractor, and a Determination of Exceptional Circumstances (DEC) involving the provision of materials has been executed and Agency policies and procedures prescribe its use. Subpart 327.4—Rights in Data and Copyrights 327.409–70 Contract clauses. (a) The contracting officer shall insert the clause at 352.227–71, Rights in Data—Supplement—Exceptional Circumstances, in solicitations, contracts, and orders that include the clause at FAR 52.227–14, Rights in DataGeneral, a Determination of Exceptional Circumstances (DEC) has been executed and agency policies and procedures prescribe its use. (b) The contracting officer shall insert the clause at 352.227–72, Publications and Publicity, in solicitations, contracts, and orders involving requirements which could lead to the contractor publishing the results of its work under the contract. PARTS 328–329 [RESERVED] PART 330—COST ACCOUNTING STANDARDS Subpart 330.2—CAS Program Requirements Sec. 330.201 Contract requirements. 330.201–5 Waiver. Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. ddrumheller on DSK120RN23PROD with PROPOSALS2 Subpart 330.2—CAS Program Requirements 330.201 Contract requirements. 330.201–5 Waiver. The Senior Procurement Executive is authorized to exercise the waiver authority under FAR 30.201–5(a)(1) when the conditions at FAR 30.201– 5(a)(1) are met. This authority cannot be redelegated. VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 332.006–1 Subpart 331.1—Applicability Salary rate limitation. Congress has stipulated in the Department of Health and Human Services appropriations acts and continuing resolutions that, under certain contracts (and subcontracts thereunder), appropriated funds cannot be used to pay the direct salary of an individual above the Rates of Basic Pay for the Executive Schedule (EX), Level II, contained on the Office of Personnel Management website. The applicable rates for each year are identified in the EX Salary Table found at www.opm.gov. 331.171 Contract clause. The contracting officer shall insert the clause at 352.231–70, Salary Rate Limitation, in solicitations and contracts when a cost-reimbursement, fixed-price level-of-effort, time-and-materials, or labor-hour contract is contemplated. PART 332—CONTRACT FINANCING Sec. 332.006 Reduction or suspension of contract payments upon finding of fraud. 332.006–1 General. 332.006–4 Procedures. Subpart 332.2—Commercial Product and Commercial Service Purchase Financing 332.202 General. Subpart 332.4—Advance Payments for Other Than Commercial Acquisitions 332.402 General. Subpart 332.5—Progress Payments Based on Costs 332.501 General. 332.501–2 Unusual progress payments. Subpart 332.7—Contract Funding 332.703 Contract funding requirements. 332.703–1 General. 332.703–70 Incrementally funded costreimbursement contracts. 332.703–71 Incremental funding table. 332.706 Contract clauses. 332.706–2 Clauses for limitation of cost or funds. Subpart 332.70—Electronic Submission and Processing of Payment Requests 332.7000 Scope of subpart. 332.7001 Definition. 332.7002 Policy. 332.7003 Contract clause. PO 00000 Frm 00053 Fmt 4701 Sfmt 4702 Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. 332.006 Reduction or suspension of contract payments upon finding of fraud. Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. 331.170 80685 General. (b) The Senior Procurement Executive (SPE) is authorized to make the determination there is substantial evidence that a contractor’s request for advance, partial, or progress payments is based on fraud, and may direct further payments to the contractor be reduced or suspended, in accordance with FAR 32.006. This authority may not be redelegated. 332.006–4 Procedures. (b) The Remedy Coordination Official (RCO) for HHS is the SPE, who shall carry out the responsibilities in FAR 32.006–4(b). (e) The RCO shall carry out the responsibilities of the agency head in FAR 32.006–4(e) to notify the contractor of the reasons for the recommended action and of its right to submit information within a reasonable period of time in response to the proposed action under FAR 32.006. (1) The notice of proposed action will be sent to the last known address of the contractor, the contractor’s counsel, or agent for service of process, by certified mail, return receipt requested, or any other method that provides signed evidence of receipt. In the case of a business, the notice of proposed action may be sent to any partner, principal, officer, director, owner or co-owner, or joint venture. The contractor will be afforded an opportunity to appear before the RCO to present information or argument in person or through a representative and may supplement the oral presentation with written information and argument. (2) The proceedings will be conducted in an informal manner and without the requirement for a transcript. If the RCO does not receive a reply from the contractor within 30 calendar days, the RCO will base his or her recommendations on the information available. Any recommendation of the RCO under FAR 31.006–4(a) and paragraph (b) of this section, must address the results of this notification and the information, if any, provided by the contractor. After reviewing all the information, the RCO shall make a determination whether or not substantial evidence of fraud exists. (g) In addition to following the procedures in FAR 32.006–4, the SPE shall provide a copy of each final determination and the supporting documentation to the contractor, the E:\FR\FM\03OCP2.SGM 03OCP2 80686 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules RCO, the contracting officer, and the HHS Office of the Inspector General (OIG). The contracting officer will place a copy of the determination and the supporting documentation in the contract file. Subpart 332.2—Commercial Product and Commercial Service Purchase Financing 332.202 General. The SPE is authorized to approve actions for commercial item purchase financing pursuant to FAR 32.202. Subpart 332.4—Advance Payments for Other Than Commercial Acquisitions 332.402 General. (e) The head of the contracting activity (HCA) is authorized to make determinations related to advanced payments and shall ensure compliance with FAR 32.402. This authority may not be redelegated. Subpart 332.5—Progress Payments Based on Costs 332.501 General. 332.501–2 Unusual progress payments. (a)(3) The HCA is authorized to approve unusual progress payments. This authority may not be redelegated. Subpart 332.7—Contract Funding 332.703 Contract funding requirements. 332.703–1 General. ddrumheller on DSK120RN23PROD with PROPOSALS2 (b) The following requirements govern all solicitations and contracts using incremental funding, as appropriate: (1) The contracting officer shall consider the estimated total cost of the contract, including all planned increments of performance when determining the requirements that must be met before contract execution (e.g., Justification and Approvals, clearances, and approvals). (2) The solicitation and resultant contract shall include a statement of work or performance work statement that describes the total project, covers all proposed increments of performance, and contains a schedule of planned increments of performance. No funding increment may exceed 1 year, and the services rendered during each increment of performance must provide a specific material benefit that can stand alone if the remaining effort is not funded. The resultant contract shall also include the corresponding amount of funds planned for obligation for each increment of performance. (3) The contracting officer shall request that offerors respond to the solicitation with technical and cost proposals for the entire project, and shall require distinct technical and cost break-outs of the planned increments of performance. (4) Proposals shall be evaluated, and any discussions and negotiations shall be conducted based upon the total project, including all planned increments of performance. 332.703–70 Incrementally funded costreimbursement contracts. Incremental funding may be used in cost-reimbursement contracts for severable services only when all of the following circumstances are present: (a) Funding of increments after the initial increment of performance is provided from the appropriation account available for obligation at that time; (b) The project represents a bona fide need of the fiscal year in which the contract is awarded and initially funded (i.e., the initial increment of performance) and is also a bona fide CLIN, task number, or description Start date of increment of performance End date of increment of performance .............................................................................. ........................ ........................ * To be inserted after negotiation (c) Total funds currently obligated and available for payment under this contract are $__[insert amount funded to date]. (d) The contracting officer may issue unilateral modifications to obligate additional funds to the contract and make related changes to paragraphs (b) and/or (c) above. (e) Until this contract is fully funded, the requirements of the clause at FAR 52.232–22, Limitation of Funds, shall VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 Incremental funding table. (a) The contracting officer shall insert substantially the language in figure 1 to this section in ‘‘Section B: Supplies or Services and Prices or Costs,’’ ‘‘Table 1,’’ in all cost-reimbursement contracts for severable services using incremental funding. The language requires the contracting officer to: (1) Insert the initial funding obligated by the award; (2) Identify the increment of performance covered by the funding provided; and (3) Specify the start and end dates for each increment of performance, as required by the ‘‘Limitation of Funds’’ clause at FAR 52.232–22. (b) Modification of the language is permitted to fit specific circumstances of the contract, including but not limited to language necessary to reflect the specific type of cost reimbursement contract awarded, but the language may not be omitted completely. Figure 1 to 332.703–71—Incremental Funding Table Table 1–B. Estimated Cost— Incrementally Funded Contract (a) The total estimated cost to the Government for full performance of this contract, including all allowable direct and indirect costs, is $__[insert full amount]. (b) The following represents the schedule* by which the Government expects to allot funds to this contract: Fee ($) (as appropriate) [Total] Contract clauses. 332.706–2 funds. 332.703–71 Estimated cost ($) govern. Once the contract is fully funded, the requirements of the clause at FAR 52.232–20, Limitation of Cost, govern. 332.706 need of each subsequent fiscal year whose appropriation will be used; and (c) The project’s significance provides reasonable assurance that subsequent year appropriations will be made available to fund the project’s continuation and completion. Clauses for limitation of cost or [Total] Frm 00054 Fmt 4701 Sfmt 4702 [Total] Funding, in all solicitations when a cost-reimbursement contract for severable services using incremental funding is contemplated. The provision requires the contracting officer to insert a specific increment of performance that the initial funding is expected to cover. (b) In addition to the clause at FAR 52.232–22, Limitation of Funds, the contracting officer shall insert the provision at 352.232–70, Incremental PO 00000 Estimated cost plus fee ($) (as appropriate) E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules Subpart 332.70—Electronic Submission and Processing of Payment Requests Submission of Payment Requests, in all solicitations and contracts, unless an exception at 332.7002(a) or (b) applies. 332.7000 PART 333—PROTESTS, DISPUTES, AND APPEALS Scope of subpart. This subpart prescribes policies and procedures for electronic submission and processing of payment requests. 332.7001 Definition. As used in this subpart, payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b) and the applicable Payment clause included in the contract. ddrumheller on DSK120RN23PROD with PROPOSALS2 332.7002 Policy. (a) Contracts shall require the electronic submission of payment requests, except for— (1) Purchases paid for with a Governmentwide commercial purchase card; and (2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise classified information or national security. (b) Where a contract otherwise requires the electronic submission of invoices, the contracting officer may authorize alternate procedures only if the contracting officer makes a written determination that— (1) The Department of Health and Human Services (HHS) is unable to receive electronic payment requests or provide acceptance electronically; (2) The contractor has demonstrated that electronic submission would be unduly burdensome; or (3) The contractor is in the process of transitioning to electronic submission of payment requests but needs additional time to complete such transition. Authorizations granted on the basis of this paragraph (b)(3) must specify a date by which the contractor will transition to electronic submission. (c) Except as provided in paragraphs (a) and (b) of this section, HHS officials shall process electronic payment submissions through the Department of the Treasury Invoice Processing Platform or successor system. (d) If the requirement for electronic submission of payment requests is waived under paragraph (a)(2) or (b) of this section, the contract or alternate payment authorization, as applicable, shall specify the form and method of payment request submission. 332.7003 Contract clause. Except as provided in 332.7002(a), use the clause at 352.232–71, Electronic VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 Subpart 333.1—Protests Sec. 333.102 General. 333.103 Protests to the agency. 333.103–70 Procedures—protests to HHS. 333.103–71 Agency action on specific protests. Subpart 333.2—Disputes and Appeals 333.201 Definitions. 333.203 Applicability. 333.209 Suspected fraudulent claims. 333.214 Alternative dispute resolution (ADR). 333.215–70 Contract clauses. Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. Subpart 333.1—Protests 333.102 General. The Office of General CounselGeneral Law Division serves as the liaison for protests lodged with the Government Accountability Office (GAO), is designated as the office responsible for all protests within the Department of Health and Human Services and serves as the notification point with GAO for all protests. 333.103 Protests to the agency. (f)(1) The contracting officer prepares the determination pursuant to FAR 33.103(f)(1), to award a contract notwithstanding the protest. The contracting activity’s designated protest official, in consultation with the cognizant HHS legal office, may approve the determination subject to the procedures in 333.103–70. 333.103–70 Procedures—protests to HHS. (a) Agency protests. Pursuant to FAR 33.103(d)(4), an interested party may protest to the contracting officer or, as an alternative, may request an independent review at a level above the contracting officer as provided in this section. An interested party may also appeal to HHS a contracting officer’s decision on a protest. (1) Protests to the contracting officer. Protests to the contracting officer shall be in writing and shall be addressed where the offer/bid is to be submitted or as indicated in the solicitation. (2) Independent review or appeal of a contracting officer decision—protest filed directly with the agency. Protests requesting an independent review one level above the contracting officer and appeals within HHS to a designated PO 00000 Frm 00055 Fmt 4701 Sfmt 4702 80687 official above the level of the contracting officer, shall be addressed to the applicable designated official specified, and as instructed, in the solicitation. (b) Pending protests filed with contracting officer not considered. An independent review of a protest filed pursuant to paragraph (a)(2) of this section will not be considered if the interested party has a protest on the same or similar issues pending with the contracting officer. 333.103–71 protests. Agency actions on specific (a) Agency actions on specific types of protests. The following types of protests may be dismissed without consideration of the merits or may be forwarded to another agency for appropriate action: (1) Contract administration. Disputes between a contractor and HHS are resolved under the disputes clause (see the Dispute statute, 41 U.S.C. chapter 71). (2) Small business size standards and standard industrial classification. Challenges of established size standards, ownership and control, or the size status of particular firm, and challenges of the selected standard industrial classification are for review solely by the Small Business Administration (SBA) (see 15 U.S.C. 637(b)(6); 13 CFR 121.1002). (3) Small business certificate of competency program. A protest made under section 8(b)(7) of the Small Business Act, or in regard to any issuance of a certificate of competency or refusal to issue a certificate under that section, is not reviewed in accordance with bid protest procedures unless there is a showing of possible fraud or bad faith on the part of Government officials. (4) Decision not to set-aside under section 8(a) of the Small Business Act. The decision to place or not to place a procurement under the 8(a) program is not subject to review unless there is a showing of possible fraud or bad faith on the part of Government officials or that regulations may have been violated (see 15 U.S.C. 637(a)). (5) Affirmative determination of responsibility by the contracting officer. An affirmative determination of responsibility will not be reviewed unless there is a showing that such determination was made fraudulently or in bad faith or that definitive responsibility criteria in the solicitation were not met. (6) Contracts subject to FAR subpart 22.6. Challenges concerning the legal status of a firm as a regular dealer or manufacturer within the meaning of 41 E:\FR\FM\03OCP2.SGM 03OCP2 80688 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules U.S.C. chapter 65 are determined solely by the procuring agency, the SBA (if a small business is involved), and the Secretary of Labor (see FAR subpart 22.6). (7) Subcontractor protests. The contracting agency will not consider subcontractor protests except where HHS determines it is in the interest of the Government. (8) Judicial proceedings. The contracting agency will not consider protests where the matter involved is the subject of litigation before a court of competent jurisdiction. (b) Alternative dispute resolution. Bidders/offerors and HHS contracting officers are encouraged to use alternative dispute resolution (ADR) procedures to resolve protests at any stage in the protest process. If ADR is used, HHS will not furnish any documentation in an ADR proceeding beyond what is required by FAR 33.103. Subpart 333.2—Disputes and Appeals 333.201 Definitions. Agency board of contract appeals for HHS means the Civilian Board of Contract Appeals (CBCA) (see https:// cbca.gov). ddrumheller on DSK120RN23PROD with PROPOSALS2 333.203 Applicability. (c) The CBCA is the authorized board to hear and determine disputes for the Department. All filings must be submitted to the Clerk of the Board. Filings may be made in the following ways and the board’s address for each method of filing is as follows (the public should verify current operating procedures and delivery instructions with the CBCA, found at https:// cbca.gov/howto/filing.html#where): (1) In person or by courier: These filings should be made in the Clerk’s office, located in room 6006, 6th Floor, of 1800 M Street NW, Washington, DC 20036. Check with the Clerk of the Board for any impacts due to national emergencies or other exigent circumstances to confirm whether inperson deliveries are accepted. (2) By United States Postal Service mail: 1800 F Street NW, Washington, DC 20405. (3) By facsimile transmission: These filings should be sent to the Clerk at (202) 606–0019. (4) By electronic mail (e-file): cbca.efile@cbca.gov. Specific e-file instructions and prohibitions can be found at https://cbca.gov/howto/ efiling.html. 333.209 Suspected fraudulent claims. The contracting officer shall submit any instance of a contractor’s suspected VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 fraudulent claim to the Office of Inspector General for investigation and potential referral to the Department of Justice through the head of the contracting activity (HCA). 333.214 (ADR). Alternative dispute resolution Contracting officers and contractors are encouraged to use alternative dispute resolution (ADR) procedures. Guidance on ADR may be obtained at the U.S. Civilian Board of Contract Appeals website at https:// www.cbca.gsa.gov. 333.215–70 Contract clauses. (a) The contracting officer shall insert the clause at 352.233–70, Choice of Law (Overseas), in solicitations and contracts when performance will be outside the United States, its possessions, and Puerto Rico, except as otherwise provided in a government-togovernment agreement. (b) The contracting officer shall insert the clause at 352.233–71, Litigation and Claims, in solicitations and contracts when a cost-reimbursement, time-andmaterials, or labor-hour contract is contemplated (other than a contract for a commercial product or commercial service). ■ 15. Revise parts 334 through 337 to read as follows: * * * * * PART 334 MAJOR SYSTEM ACQUISITION PART 335 RESEARCH AND DEVELOPMENT CONTRACTING PART 336 CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS PART 337 SERVICE CONTRACTING * * * * * PART 334—MAJOR SYSTEM ACQUISITION Subpart 334.2—Earned Value Management System Sec. 334.201 334.202 Policy. Integrated Baseline Reviews. Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. Subpart 334.2—Earned Value Management System 334.201 334.202 Integrated Baseline Reviews. (a) An Integrated Baseline Review (IBR) is usually conducted as a postaward activity when an EVMS is required in accordance with FAR 34.201(a). A pre-award IBR may be conducted only if— (1) The acquisition plan contains documentation that demonstrates the need and rationale for a pre-award IBR, including an assessment of the impact on the source selection schedule and the expected benefits; (2) The use of a pre-award IBR is approved in writing by the head of the contracting activity prior to the issuance of the solicitation; (3) The source selection plan and solicitation specifically address how the results of a pre-award IBR will be used during source selection, including any weight to be given to it in source evaluation; and (4) Specific arrangements are made, and budget authority is provided, to compensate all offerors who prepare for or participate in a pre-award IBR; and the solicitation informs prospective offerors of the means for and conditions of such compensation. Policy. The Department of Health and Human Services applies the earned value management system (EVMS) requirement as follows: (a) For cost or incentive contracts and subcontracts valued at $20 million or more, the contractor’s earned value PO 00000 management system shall comply with the guidelines in the American National Standards Institute/Electronic Industries Alliance Standard 748, Earned Value Management Systems (ANSI/EIA–748). (b) For cost or incentive contracts and subcontracts valued at $50 million or more, the contractor shall have an EVMS that has been determined by the cognizant Federal agency to be in compliance with the guidelines in ANSI/EIA–748. (c) For cost or incentive contracts and subcontracts valued at less than $20 million— (1) The application of earned value management is optional at the discretion of the program/project manager and is a risk-based decision that must be supported by a cost/benefit analysis; and (2) A decision to apply earned value management shall be documented in the contract file. (d) For firm-fixed-price contracts and subcontracts of any dollar value the application of earned value management is discouraged. Frm 00056 Fmt 4701 Sfmt 4702 PART 335—RESEARCH AND DEVELOPMENT CONTRACTING Sec. 335.070 Cost-sharing. 335.070–1 Policy. 335.070–2 Amount of cost-sharing. 335.070–3 Method of cost-sharing. E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. 335.070 Cost-sharing. 335.070–1 Policy. (a) Contracting activities should encourage contractors to contribute to the cost of performing research and development (R&D), through the use of cost-sharing contracts, where there is a probability that the contractor will receive present or future benefits from participation as described in Federal Acquisition Regulation (FAR) 16.303. Examples include increased technical know-how, training for employees, acquisition of goods or services, development of a commercially viable product that can be sold in the commercial market and use of background knowledge in future contracts. Cost-sharing is intended to serve the mutual interests of the Government and its contractors by helping to ensure efficient utilization of the resources available for the conduct of R&D projects and by promoting sound planning and prudent fiscal policies of the contractor. (b) The contracting officer should use a cost-sharing contract for R&D contracts unless the contracting officer determines that a request for costsharing would not be appropriate. ddrumheller on DSK120RN23PROD with PROPOSALS2 335.070–2 Amount of cost-sharing. When cost-sharing is appropriate, the contracting officer shall use the following guidelines to determine the amount of cost participation by the contractor: (a) The amount of cost participation depends on the extent to which the R&D effort or results are likely to enhance the contractor’s capability, expertise, or competitive position, and the value of this enhancement to the contractor. Therefore, contractor cost participation could reasonably range from as little as one percent or less of the total project cost to more than 50 percent of the total project cost. Ultimately, cost-sharing is a negotiable item. As such, the amount of cost-sharing shall be proportional to the anticipated value of the contractor’s gain. (b) If the contractor will not acquire title to, or the right to use, inventions, patents, or technical information resulting from the R&D project, it is normally appropriate to obtain less costsharing than in cases in which the contractor acquires these rights. (c) If the R&D is expected to be of only minor value to the contractor, and if a statute does not require cost-sharing, it may be appropriate for the contractor to make a contribution in the form of a VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 reduced fee or profit rather than sharing costs of the project. Alternatively, a limitation on indirect cost rates might be appropriate (see FAR 16.303 and 42.707). (d) The contractor’s participation may be considered over the total term of the project, so that a relatively high contribution in one year may be offset by a relatively low contribution in another. Care must be exercised that the intent to cost-share in future years does not become illusory. Redetermination of the cost sharing arrangement might be appropriate depending on future circumstances. (e) A relatively low degree of costsharing may be appropriate if an area of R&D requires special stimulus in the national interest. 335.070–3 Method of cost-sharing. Cost-sharing on individual contracts may be accomplished either by a contribution of part or all of one or more elements of allowable cost of the work being performed or by a fixed amount or stated percentage of the total allowable costs of the project. Contractors shall not charge costs contributed to the Government under any other instrument (e.g., grant or contract), including allocations to other instruments as part of any independent R&D program. PART 336—CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS Subpart 336.2—Special Aspects of Contracting for Construction Sec. 336.203 Government estimate of construction costs. 336.204 Disclosure of the magnitude of construction projects. Subpart 336.5—Contract Clauses 336.570 Contract clause. Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. Subpart 336.2—Special Aspects of Contracting for Construction 336.203 Government estimate of construction costs. (a) The Government estimate must be designated ‘‘CUI Controlled by: HHS, [OPDIV/STAFFDIV]’’ unless the nature of the information therein requires a security classification or other classification, in which event it shall be handled in accordance with applicable security regulations. The ‘‘CUI Controlled by: HHS, [OPDIV/ STAFFDIV]’’ designation, or other classification, must be removed only when the estimate is made public in PO 00000 Frm 00057 Fmt 4701 Sfmt 4702 80689 accordance with the instructions in paragraphs (b) and (c) of this section. (b) If the acquisition is by sealed bidding, a sealed copy of the detailed Government estimate must be filed with the bids until bid opening. After the bids are read and recorded, the ‘‘CUI Controlled by: HHS, [OPDIV/ STAFFDIV]’’ designation, or other classification, must be removed and the estimate read and recorded in the same detail as the bids. (c) If the acquisition is by negotiation, the following procedures apply: (1) The overall amount of the Government estimate must not be disclosed prior to award; (2) At the time of award, the ‘‘CUI Controlled by: HHS, [OPDIV/ STAFFDIV]’’ designation, or other classification, on the Government estimate must be removed; and (3) After award, the Government estimate may be revealed, upon request, at the discretion of the contracting officer. 336.204 Disclosure of the magnitude of construction projects. The contracting officer shall utilize the estimated price ranges defined in FAR 36.204(a) through (e) as further supplemented by paragraphs (f) through (h) of this section when identifying the magnitude of an HHS project in advance notices and solicitations: (f) For estimated price ranges between $1,000,000 and $5,000,000, the contracting officer shall identify the magnitude of an HHS project in advance notices and solicitations in terms of the following price ranges: (1) Between $1,000,000 and $2,000,000. (2) Between $2,000,000 and $5,000,000. (g) Between $5,000,000 and $10,000,000. (h) For estimated price ranges greater than $10,000,000, the contracting officer shall identify the magnitude of an HHS project in advance notices and solicitations in terms of one of the following price ranges: (1) Between $10,000,000 and $20,000,000. (2) Between $20,000,000 and $50,000,000. (3) Between $50,000,000 and $100,000,000. (4) Between $100,000,000 and $150,000,000. (5) Between $150,000,000 and $200,000,000. (6) Between $200,000,000 and $250,000,000. (7) More than $250,000,000. E:\FR\FM\03OCP2.SGM 03OCP2 80690 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules Subpart 336.5—Contract Clauses 336.570 Contract clause. (a) The contracting officer shall insert the clause at 352.236–70, Design-Build Contracts, in all solicitations and contracts for design-build requirements. (b) The contracting officer shall use Alternate I to the clause at 352.236–70, Design-Build Contracts, in all solicitations and contracts for construction when fast-track procedures are being used. PART 337—SERVICE CONTRACTING Subpart 337.70—Services—Special Contract Requirements Sec. 337.7000 Prohibition on smoking in facilities during delivery of services to children. 337.7001 Reporting of child abuse by covered professionals. 337.7002 Requirement for background checks—childcare services. 337.7003 Indian Child Protection and Family Violence Act—background investigations. 337.7004 Non-discrimination in service delivery. 337.7005 Key personnel. 337.7006 Contract clauses. Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. Subpart 337.70—Services—Special Contract Requirements ddrumheller on DSK120RN23PROD with PROPOSALS2 337.7000 Prohibition on smoking in facilities during delivery of services to children. (a) Policy-prohibition on smoking in certain facilities where certain federally funded children’s services are provided. When performing services under contracts awarded by the U.S. Department of Health and Human Services (HHS) where children’s services are provided, contractors including employees, subcontractors, and third-parties performing services on behalf of a contractor are prohibited from smoking in facilities where certain federally funded children’s services are provided pursuant to 20 U.S.C. 7181 (Pub. L. 107–110, the Pro-Children Act of 2001 (the Act)). Smoking is prohibited within any indoor facility (or portion thereof), whether owned, leased, or contracted for, or involving indoor facilities that are constructed, operated, or maintained with Federal funds, that is used for the routine or regular provision of— (1) Kindergarten, elementary, or secondary education or library services; or VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 (2) Health or day care services that are provided to children under the age of 18. (b) Representation and agreement. Contractors are required to represent to the contracting officer and agree that by submission of its bid or offer and if awarded a contract, the contractor agrees to comply with the requirements of the Act and the prohibition of smoking in facilities as specified in paragraph (a) of this section. The contractor shall enforce the provisions of the clause prescribed in 337.7006(a), and ensure that each of its employees, subcontractors, and any subcontractor staff, is made aware of, understands, and complies with the provisions of the Act. (c) Penalties. Failure to comply with the Act may result in the imposition of a civil monetary penalty in an amount not to exceed $1,000 for each violation and/or the imposition of an administrative compliance order on the responsible entity after proper notice in accordance with agency procedures. 337.7001 Reporting of child abuse by covered professionals. (a) Definitions. As used in this subpart— Child abuse means the physical or mental injury, sexual abuse or exploitation, or negligent treatment of a child. Covered professionals means those persons engaged in professions and activities in eight different categories including, but not limited to, teachers, social workers, physicians, dentists, medical residents or interns, hospital personnel and administrators, nurses, health care practitioners, chiropractors, osteopaths, pharmacists, optometrists, podiatrists, emergency medical technicians, ambulance drivers, alcohol or drug treatment personnel, psychologists, psychiatrists, mental health professionals, childcare workers and administrators, and commercial film and photo processors. (b) Responsibility to report child abuse. Public Law 101–647, known as the Crime Control Act of 1990 (the Act) (34 U.S.C. 20341), imposes responsibilities on certain individuals who, while engaged in a professional capacity or activity as a covered professional, as defined in the Act, on Federal land or in a federally-operated (or contracted) facility, learn of facts that give the individual reason to suspect that a child has suffered an incident of child abuse. (c) Reporting requirements. Accordingly, any person engaged in a covered profession or activity under an HHS contract or subcontract (i.e., a PO 00000 Frm 00058 Fmt 4701 Sfmt 4702 covered professional), regardless of the purpose of the contract or subcontract, shall immediately report a suspected child abuse incident in accordance with the provisions of the Act. If a child is suspected of being harmed, the appropriate State Child Abuse Hotline, local child protective services (CPS), or law enforcement agency shall be contacted. For more information about where and how to file a report, Contractors may contact the Childhelp USA, National Child Abuse Hotline (1– 800–4–A–CHILD). Any covered professional failing to make a timely report of such incident shall be guilty of a Class B misdemeanor. (d) Representation. The offeror shall represent that it understands that by submission of its bid or offer and if awarded a contract for a requirement, the Contractor agrees to comply with the requirements of the Act. Contracting officers shall ensure the requirements of clause 352.237–71 are flowed down to subcontractors at any tier. 337.7002 Requirement for background checks—childcare services. (a) Definition. As used in this subpart, childcare services means and include, but are not limited to, social services, health and mental health care, child (day) care, education (whether or not directly involved in teaching), and rehabilitative programs. (b) Requirement for background checks. Public Law 101–647, known as the Crime Control Act of 1990 (the Act) (34 U.S.C. 20351), requires that all individuals involved with the provision of childcare services to children under the age of 18 undergo a criminal background check. Any conviction for a sex crime, an offense involving a child victim, or a drug felony, may be grounds for denying employment or for dismissal of an employee providing any childcare services. (c) Background check protocols. The contracting officer will provide the necessary information to the contractor regarding the process for obtaining the background check. The contractor may hire a staff person provisionally prior to the completion of a background check, if at all times prior to the receipt of the background check during which children are in the care of the newlyhired person, the person is within the sight and under the supervision of a previously investigated staff person. (d) Representation. The offeror shall represent that it understands that by submission of its bid or offer and if awarded a contract for a requirement, the contractor agrees to comply with the requirements of the Act. Contracting officers shall ensure the requirements of E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules clause 352.237–72 are flowed down to subcontractors at any tier. ddrumheller on DSK120RN23PROD with PROPOSALS2 337.7003 Indian Child Protection and Family Violence Act—background investigations. (a) To ensure protection of Indian children, the Indian Child Protection and Family Violence Act, Public Law 101–630 (25 U.S.C. 3201, et seq.), prohibits employment, including personal service contracts, with anyone who has been convicted of any crime of violence when performance under a contract may require duties and responsibilities of a contractor, its employees, subcontractors, or third parties providing service under the contract that involve regular contact with or control over Indian children. The Act requires that a contractor and its employees and subcontractors, at any tier, be subject to a character and background investigation. This investigation is conducted by the Indian Health Service, Office of Human Resources. (b) Until such time as the contractor or its employees and subcontractors have been notified of completion of the investigation, the contractor and its employees and subcontractors shall have no unsupervised contact with Indian children. In order to initiate this background investigation, the contractor and its employees and subcontractors must provide information as required in the contract or as directed by the contracting officer. (c) As a prerequisite to providing services under a contract involving access to Indian children, contractors shall— (1) Complete and sign a declaration concerning the background of employees or subcontractors providing such services as required by the terms and conditions of the contract; (2) Provide information as required by the contracting officer to ascertain such information about its employees, subcontractors, and third parties providing services under the contract; (3) Report convictions of any crime of violence immediately to the contracting officer that involve such employees, subcontractors, or third parties, who may be employed or are currently employed under the contract; and (4) Flow down clause the clause prescribed at 337.7006(d), 352.337–73, Indian Child Protection and Family Violence Act—Background Investigations, into all subcontracts, at any tier. 337.7004 delivery. Non-discrimination in service (a) Policy. It is the policy of the HHS that no person otherwise eligible will be VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 excluded from participation in, denied the benefits of, or subjected to discrimination in the administration of HHS programs and services based on non-merit factors such as race, color, national origin, religion, sex, gender identity, sexual orientation, or disability (physical or mental). (b) Representation. The offeror shall represent that it understands that by submission of its bid or offer and if awarded a contract for a requirement, the contractor agrees to comply with the requirements of the policy. Contracting officers shall ensure the requirements of clause 352.237–74 are flowed down to subcontractors at any tier. 337.7005 Key personnel. (a) To ensure successful performance under an HHS contract, it may be necessary for the contracting officer to require contractors to identify certain positions as key personnel when considered to be essential to work performance. (b) Contractors must provide notice if they divert proposed personnel deemed key personnel. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals in a contract to other programs or contracts, the contractor shall notify the contracting officer and submit a justification for the diversion or replacement, and request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement’s skills, experience, and credentials meet or exceed the requirements of the contract. The contract should be modified to add or delete key personnel as necessary to reflect the agreement of the parties. (c) If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than 30 days’ notice, the contractor must provide the maximum notice practicable under the circumstances. The contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the contracting officer. 337.7006 Contract clauses. (a) The contracting officer shall insert the clause at 352.237–70, Nonsmoking Policy—Delivery of Services to Children, in solicitations, contracts, and orders that involve health or daycare services that are provided to children under the age of 18 on a routine or regular basis pursuant to the ProChildren Act of 2001 as set forth in 337.7000. (b) The contracting officer shall insert the clause at 352.237–71, Reporting of Child Abuse, in solicitations, contracts, PO 00000 Frm 00059 Fmt 4701 Sfmt 4702 80691 and orders that require performance on Federal land or in a federally operated (or contracted) facility and involve ‘‘covered professionals’’ performed by persons specified in the Crime Control Act of 1990 (34 U.S.C. 20341) engaged in a covered profession or activity under an HHS contract or subcontract, regardless of the purpose of the contract or subcontract, including, but not limited to those performed by— (1) Teachers; (2) Social workers; (3) Physicians, nurses, dentists, health care practitioners, optometrists, psychologists, emergency medical technicians, alcohol or drug treatment personnel; and (4) Childcare workers and administrators, emergency medical technicians and ambulance drivers. (c) The contracting officer shall insert the clause at 352.237–72, Requirement for Background Checks, in solicitations, contracts, and orders that involve providing childcare services to children under the age of 18, including social services, health and mental health care, child-(day) care, education (whether or not directly involved in teaching), and rehabilitative programs covered under the Crime Control Act of 1990 (34 U.S.C. 20351). (d) The contracting officer shall insert the clause at 352.237–73, Indian Child Protection and Family Violence Act— Background Investigations, in all solicitations, contracts, and orders when performance of the contract may involve regular contact with or control over Indian children. The required declaration shall also be included in section J of the solicitation and contract. This clause shall be included by all contracting officers supporting the Indian Health Service, whether issued by IHS or through or by use of an interagency agreement. (e) The contracting officer shall insert the clause at 352.237–74, NonDiscrimination in Service Delivery, in solicitations, contracts, and orders involving delivery of services under HHS’ programs directly to the public. (f) The contracting officer shall insert the clause at 352.237–75, Key Personnel, in solicitations, contracts, and orders when the contracting officer will require the contractor to designate contractor key personnel. PART 338 [ADDED AND RESERVED] 16. Add reserved part 338 to subchapter F. ■ PART 340 [ADDED AND RESERVED] 17. Add reserved part 340 to subchapter F. ■ E:\FR\FM\03OCP2.SGM 03OCP2 80692 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules 18. Add part 341 to subchapter F to read as follows: ■ PART 341—ACQUISITION OF UTILITY SERVICES Subpart 341.1—General Sec. 341.102 Applicability. Subpart 342.7—Indirect Cost Rates 342.705 Final indirect cost rates. Subpart 341.5—Solicitation Provision and Contract Clauses 341.501 Solicitation provision and contract clauses. 341.501–70 Disputes—utility contracts. Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. Subpart 341.1—General 341.102 Applicability. (a) This part applies to purchases of utility services from nonregulated and regulated utility suppliers when a delegation of authority from the General Services Administration (GSA) for those services is requested and obtained. (b)(4) The acquisition of energy, such as electricity, and natural or manufactured gas, when purchased as a commodity is considered to be acquisitions of supplies rather than utility services as described in FAR part 41. Subpart 341.5—Solicitation Provision and Contract Clauses 341.501 Solicitation provision and contract clauses. 341.501–70 Disputes—utility contracts. ddrumheller on DSK120RN23PROD with PROPOSALS2 SUBCHAPTER G—CONTRACT MANAGEMENT PART 342 CONTRACT ADMINISTRATION AND AUDIT SERVICES PART 343 CONTRACT MODIFICATIONS PART 344 SUBCONTRACTING POLICIES AND PROCEDURES PART 345 GOVERNMENT PROPERTY PART 346 [RESERVED] PART 347 TRANSPORTATION PARTS 348–351 [RESERVED] SUBCHAPTER G—CONTRACT MANAGEMENT PART 342—CONTRACT ADMINISTRATION AND AUDIT SERVICES Subpart 342.2—Contract Administration Sec. 20:17 Oct 02, 2024 Jkt 265001 Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. Subpart 342.2—Contract Administration 342.270 Contracting Officer’s Representatives role in contract administration. (a) A contracting officer may designate a qualified person to be the Contracting Officer’s Representative (COR) for the purpose of performing certain technical functions in administering a contract. (b) The COR acts solely as a technical representative of the contracting officer and is not authorized to perform any function that results in a change in the scope, price, terms, or conditions of the contract. (c) A COR designation must be made in writing by the contracting officer. The designation shall identify the responsibilities and limitations of the COR. A copy of the designation must be furnished to the contractor and the Administrative Contracting Officer (ACO), when applicable. 342.271 Administrative Contracting Officer’s role in contract administration and delegated functions. The contracting officer shall insert the clause at 352.241–70, Disputes—Utility Contracts, in solicitations and contracts for utility services subject to the jurisdiction and regulation of a utility rate commission. ■ 19. Revise subchapter G to read as follows: VerDate Sep<11>2014 342.270 Contracting Officer’s Representatives role in contract administration. 342.271 Administrative Contracting Officer’s role in contract administration and delegated functions. 342.272 Contract clauses. (a) As used in this subpart, Administrative Contracting Officer (ACO) Letter of Delegation means a delegation of functions as set forth in FAR 42.202 and 42.302 and this section that is issued by a contracting officer to delegate certain contract administration or specialized support services. (b) Contracting officers are authorized to delegate certain contract administration or specialized support services in accordance with FAR 42.202 and 42.302 to ACOs. (c) The ACO’s authority is limited to the actions detailed in the delegation. (d) The delegations of authority shall be set forth in a written ACO Letter of Delegation issued by the contracting officer to the accepting contract administration office and designated administrative contracting officer. The ACO Letter of Delegation shall contain the information required in FAR 42.202(a) through (c) and identify the responsibilities and limitations of the ACO. A copy of the delegation will be furnished to the contractor and the ACO. PO 00000 Frm 00060 Fmt 4701 Sfmt 4702 342.272 Contract clauses. (a) The contracting officer shall insert the clause at 352.242–70, Administrative Contracting Officer, in solicitations and contracts expected to exceed the micro-purchase threshold, when contract administration is delegated. (b) The contracting officer shall insert the clause at 352.242–71, Government Construction Contract Administration, in solicitations and contracts for construction expected to exceed the micro-purchase threshold, when contract administration is delegated. Subpart 342.7—Indirect Cost Rates 342.705 Final indirect cost rates. Contract actions for which the Department of Health and Human Services is the cognizant Federal agency: (a) The Financial Management Services, Division of Cost Allocation, Program Support Center, shall establish facilities and administration costs, also known as indirect cost rates, research patient care rates, and, as necessary, fringe benefits, computer, and other special costing rates for use in contracts awarded to State and local governments, colleges and universities, hospitals, and other nonprofit organizations. (b) The National Institute of Health, Division of Financial Advisory Services, shall establish indirect cost rates and similar rates for use in contracts awarded to for profit organizations. PART 343—CONTRACT MODIFICATIONS Subpart 343.2—Change Orders Sec. 343.204 Administration. 343.204–70 Definitization. 343.205 Contract clauses. Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. Subpart 343.2—Change Orders 343.204 Administration. 343.204–70 Definitization. (a) Applicability. This section applies to unpriced change orders with an estimated value exceeding $5 million. (b) Price ceiling. Unpriced change orders shall include a not-to-exceed price. (c) Definitization schedule. (1) Unpriced change orders shall contain definitization schedules that provide for definitization by— (i) The date after issuance of the change order may not exceed 180 days after the contractor submits a qualifying proposal); or E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules (ii) The date on which the amount of funds paid to the contractor under the contract action is equal to more than 50 percent of the not-to-exceed price. (2) Submission of a qualifying proposal in accordance with the definitization schedule is a material element of the contract. If the contractor does not submit a timely qualifying proposal, the contracting officer may suspend or reduce progress payments under FAR 32.503–6 or take other appropriate action. (d) Limitations on obligations. (1) The Government shall not obligate more than 50 percent of the not-to-exceed price before definitization. However, if a contractor submits a qualifying proposal before 50 percent of the not-toexceed price has been obligated by the Government, the limitation on obligations before definitization may be increased to no more than 75 percent. (2) Obligations should be consistent with the contractor’s requirements for the undefinitized period. (e) Exception. The head of the contracting activity (HCA) may waive the limitations in paragraph (c) of this section for unpriced change orders if the HCA determines that the waiver is necessary to support an emergency acquisition operation. 343.205 Subpart 345.1—General 344.201 Consent and advance notification requirements. 344.201–1 Consent requirements. (a) In accordance with section 824 of the National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115–232), notwithstanding the requirements in FAR 44.201–1(a), the contracting officer shall not withhold consent to subcontract without the written approval of the contracting officer’s representative, if the contractor has an approved purchasing system, as defined in FAR 44.101. 344.202 Contracting officer’s evaluation. 344.202–2 Considerations. (a) In addition to the considerations outlined in FAR 44.202–2(a), the contracting officer responsible for consent must review the request and supporting data and document in writing whether the contractor adequately substantiated the selection as being fair, reasonable, and representing the best value to the Government where other than the lowest price is the basis for subcontractor selection. Subpart 344.3—Contractors’ Purchasing Systems Reviews Contract clauses. As authorized in the introductory text of clauses at FAR 52.243–1, Changes— Fixed-Price; 52.243–2, Changes—CostReimbursement; and 52.243–4, Changes, and in the prescription at FAR 43.205(c) for FAR 52.243–3, Changes—Time-andMaterials or Labor-Hours, the contracting officer may vary the period within which a contractor must assert its right to an equitable adjustment, but the extended period shall not exceed 60 calendar days, unless approval is one level above the contracting officer. PART 344—SUBCONTRACTING POLICIES AND PROCEDURES Subpart 344.2—Consent to Subcontracts ddrumheller on DSK120RN23PROD with PROPOSALS2 Subpart 344.2—Consent to Subcontracts Sec. 344.201 Consent and advance notification requirements. 344.201–1 Consent requirements. 344.202 Contracting officer’s evaluation. 344.202–2 Considerations. Subpart 344.3—Contractors’ Purchasing Systems Reviews 344.303–70 Additional contractors’ purchasing system review considerations. (a) During contractor purchasing systems reviews (CPSRs), special attention shall also be paid to reviewing documentation of commercial products and commercial services determinations to ensure compliance with the definition of commercial products and commercial services in FAR 2.101. (b) The contracting officer shall not withhold consent to subcontract without the written coordination of the program manager, or comparable requiring activity official exercising program management responsibilities, if the contractor has an approved purchasing system as defined in FAR 44.101. PART 345—GOVERNMENT PROPERTY Subpart 345.1—General 344.303–70 Additional contractors’ purchasing system review considerations. Sec. 345.105–70 Contractors’ property management system compliance—policy and procedures. 345.107 Contract clauses. Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 PO 00000 Frm 00061 Fmt 4701 Sfmt 4702 80693 345.105–70 Contractors’ property management system compliance—policy and procedures. (a) Definitions. As used in this part— Acceptable property management system means a property system that complies with the system criteria in accordance with paragraph (f) of the clause at FAR 52.245–1. Property management system means the contractor’s system or systems for managing and controlling Government property. Significant deficiency means a shortcoming in the system that materially affects the ability of officials of the Department of Health and Human Services to rely upon information produced by the system that is needed for management purposes. (b) Policy. The cognizant contracting officer, in consultation with the property administrator, shall— (1) Determine the acceptability of the system and approve or disapprove the system; and (2) Pursue correction of any deficiencies. (c) Acceptable property management system. In evaluating the acceptability of a contractor’s property management system, the contracting officer, in consultation with the property administrator, shall determine whether the contractor’s property management system complies with the system criteria for an acceptable property management system as prescribed in the clause at 352.245–70, Contractor Property Management System Administration. (d) Disposition of findings—(1) Reporting of findings. The property administrator shall document findings and recommendations in a report to the contracting officer. If the property administrator identifies any significant property system deficiencies, the report shall describe the deficiencies in sufficient detail to allow the contracting officer to understand the deficiencies. (2) Initial determination. (i) The contracting officer shall review findings and recommendations and, if there are no significant deficiencies, shall promptly notify the contractor, in writing, that the contractor’s property management system is acceptable and approved; or (ii) If the contracting officer finds that there are one or more significant deficiencies (as defined in the clause at 352.245–70, Contractor Property Management System Administration) due to the contractor’s failure to meet one or more of the property management system criteria in the E:\FR\FM\03OCP2.SGM 03OCP2 ddrumheller on DSK120RN23PROD with PROPOSALS2 80694 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules clause at 352.245–70, the contracting officer shall— (A) Promptly make an initial written determination on any significant deficiencies and notify the contractor, in writing, providing a description of each significant deficiency in sufficient detail to allow the contractor to understand the deficiency; (B) Request the contractor to respond, in writing, to the initial determination within 30 days; and (C) Evaluate the contractor’s response to the initial determination, in consultation with the property administrator, and make a final determination. (3) Final determination. (i) The contracting officer shall make a final determination and notify the contractor, in writing, that— (A) The contractor’s property management system is acceptable and approved, and no significant deficiencies remain; or (B) Significant deficiencies remain. The notice shall identify any remaining significant deficiencies, and indicate the adequacy of any proposed or completed corrective action. The contracting officer shall— (1) Request that the contractor, within 45 days of receipt of the final determination, either correct the deficiencies or submit an acceptable corrective action plan showing milestones and actions to eliminate the deficiencies; (2) Disapprove the system in accordance with the clause at 352.245– 70, Contractor Property Management System Administration; and (3) Take other remedies such as withholding payments as appropriate in accordance with the terms and conditions of the contract. (ii) Monitor a contractor’s corrective action and the correction of significant deficiencies. (e) System approval. The contracting officer shall promptly approve a previously disapproved property management system and notify the contractor when the contracting officer determines, in consultation with the property administrator, that there are no remaining significant deficiencies. (f) Contracting officer notifications. The cognizant contracting officer shall promptly distribute copies of a determination to approve a system, disapprove a system and withhold payments, or approve a previously disapproved system and release withheld payments to the auditor; payment office; affected contracting officers at the buying activities; and cognizant contracting officers in VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 contract administration activities, as appropriate. 347.306 Transportation factors in the evaluation of offers. 345.107 347.306–70 Contract clauses. Records of claims. The contracting officer shall insert the clause at 352.245–70, Contractor Property Management System Administration, in solicitations and contracts containing the clause at FAR 52.245–1, Government Property. When contracting for transportation, and consistent with FAR 15.304, contracting officers should consider using offerors’ record of claims involving loss or damage as an evaluation factor or subfactor. PART 346 [RESERVED] PARTS 348–351 [RESERVED] PART 347—TRANSPORTATION PART 352—SOLICITATION PROVISIONS AND CONTRACT CLAUSES Subpart 347.3—Transportation in Supply Contracts Sec. 347.303–6 F.o.b. destination. 347.303–670 Place of delivery. 347.305 Solicitation provisions, contract clauses, and transportation factors. 347.305–10 Packing, marking, and consignment instructions. 347.306 Transportation factors in the evaluation of offers. 347.306–70 Records of claims. Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. Subpart 347.3—Transportation in Supply Contracts 347.303–6 Place of delivery. The contracting officer shall insert clause 352.247–70, Delivery Location, or a clause substantially the same as the clause at 352.247–70, in supply contracts when it is necessary to specify delivery locations. If necessary, the clause may reference an attachment which lists various delivery locations and other delivery details (e.g., quantities to be delivered to each location, etc.). 347.305 Solicitation provisions, contract clauses, and transportation factors. 347.305–10 Packing, marking, and consignment instructions. (a) The contracting officer shall insert clause 352.247–71, Marking Deliverables, or a clause substantially the same as 352.247–71, in solicitations and contracts if special marking on deliverables is required. (b) The contracting officer shall insert the clause at 352.247–72, Packing for Domestic Shipment, in contracts when item(s) will be delivered for immediate use to a destination in the continental United States; when the material specification or purchase description does not provide preservation, packaging, packing, and/or marking requirements; and/or when the requiring activity has not cited a specific specification for packaging. PO 00000 Frm 00062 Fmt 4701 Sfmt 4702 Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. 21. Revise subpart 352.1 to read as follows: ■ Subpart 352.1—Instructions for Using Provisions and Clauses Sec. 352.100 Scope of subpart. 352.102 Incorporating provisions and clauses. 352.102–70 Application of provisions and clauses. Subpart 352.1—Instructions for Using Provisions and Clauses F.o.b. destination. 347.303–670 20. The authority citation for part 352 is revised to read as follows: ■ 352.100 Scope of subpart. This subpart provides guidance for applying the Department of Health and Human Services supplemental provisions and clauses in solicitations, contracts, and orders. 352.102 Incorporating provisions and clauses. 352.102–70 clauses. Application of provisions and (a) If a clause is included in the master instrument (e.g., in an indefinitedelivery, indefinite-quantity contract, or a blanket purchase agreement), it is not necessary to also include the clause in a task order or delivery order thereunder, unless fill-ins are required. (b) When a dollar amount or dollar threshold is specified (e.g., $25 million or simplified acquisition threshold), the dollar amount of the award (contract or order) includes any options thereunder. Subpart 352.2—Text of Provisions and Clauses 22. Add section 352.201–70 to read as follows: ■ 352.201–70 Contracting Officer’s Representative. As prescribed in 301.604–70, insert the following clause: Contracting Officer’s Representative (DATE) E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules (a) Definition. Contracting officer’s representative (COR) means an individual designated in accordance with FAR 1.602– 2(d) and authorized in writing by the Contracting Officer to perform specific technical or administrative functions. (b) If the Contracting Officer designates a COR, the Contractor will receive a copy of the written designation. It will specify the extent of the COR’s authority to act on behalf of the Contracting Officer. The COR is not authorized to make any commitments or changes that will affect price, quality, quantity, delivery, or any other term or condition of the contract. (End of clause) ■ 23. Revise sections 352.203–70 and 352.204–70 to read as follows: 352.203–70 Anti-Lobbying. ddrumheller on DSK120RN23PROD with PROPOSALS2 As prescribed in 303.808–70, insert the following clause: Anti-Lobbying (DATE) Pursuant to the HHS annual appropriations acts, except for normal and recognized executive-legislative relationships, the Contractor shall not use any HHS contract funds for— (a) Publicity or propaganda purposes; (b) The preparation, distribution, or use of any kit, pamphlet, booklet, publication, electronic communication, radio, television, or video presentation designed to support or defeat the enactment of legislation before the Congress or any State or local legislature or legislative body, except in presentation to the Congress or any state or local legislature itself; or designed to support or defeat any proposed or pending regulation, administrative action, or order issued by the executive branch of any state or local government, except in presentation to the executive branch of any state or local government itself; or (c) Payment of salary or expenses of the Contractor, or any agent acting for the Contractor, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or Executive order proposed or pending before the Congress or any state government, state legislature or local legislature or legislative body, other than for normal and recognized executive-legislative relationships or participation by an agency or officer of a state, local, or tribal government in policymaking and administrative processes within the executive branch of that government. (d) The prohibitions in paragraphs (a), (b), and (c) shall include any activity to advocate or promote any proposed, pending, or future federal, state, or local tax increase, or any proposed, pending, or future requirement for, or restriction on, any legal consumer product, including its sale or marketing, including, but not limited to, the advocacy or promotion of gun control. (End of clause) 352.204–70 Prevention and Public Health Fund—Reporting Requirements. As prescribed in 304.7202, insert the following clause: VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 Prevention and Public Health Fund— Reporting Requirements (DATE) (a) Pursuant to public law this contract requires the contractor to provide products or services or both that are funded from the Prevention and Public Health Fund (PPHF), Public Law 111–148, sec. 4002. Public Law 112–74, section 220(b)(5), requires each contractor to report on its use of these funds under this contract. These reports will be made available to the public. (b) Semi-annual reports from the Contractor for all work funded, in whole or in part, by the PPHF, are due no later than 20 days following the end of each 6-month period. The 6-month reporting periods are January through June and July through December. The first report is due no later than 20 days after the end of the 6-month period following contract award. Subsequent reports are due no later than 20 days after the end of each reporting period. If applicable, the Contractor shall submit its final report for the remainder of the contract period no later than 20 days after the end of the reporting period in which the contract ended. (c) The Contractor shall provide the following information in a Section 508 compliant electronic format to the Contracting Officer. (1) The Government contract and order number, as applicable. (2) The amount of PPHFs invoiced by the contractor for the reporting period and the cumulative amount invoiced for the contract or order. (3) A list of all significant services performed, or supplies delivered, including construction, for which the contractor invoiced in the reporting period. (4) Program or project title, if any. (5) The Contractor shall report any subcontract funded in whole or in part with PPHFs valued at $25,000 or more. The Contractor shall advise the subcontractor that the information will be made available to the public. The Contractor shall report: (i) Name and address of the subcontractor. (ii) Amount of the subcontract award. (iii) Date of the subcontract award. (iv) A description of the products or services (including construction) being provided under the subcontract. (End of clause) ■ 24. Add section 352.205–70 to read as follows: 352.205–70 Advertisements, Publicizing Awards, and Releases. As prescribed in 305.470–2, insert the following clause: Advertisements, Publicizing Awards, and Releases (DATE) The Contractor shall not refer to this contract in commercial advertising or similar promotions in such a manner as to state or imply that the product or service provided is endorsed or preferred by the Federal Government or is considered by the Government to be superior to other products or services. (End of clause) Alternate I (DATE). If a contract involves sensitive or classified PO 00000 Frm 00063 Fmt 4701 Sfmt 4702 80695 information, designate the paragraph in the base clause as (a) and add the following paragraph (b) to the clause: (b) All advertisements, releases, announcements, or other publication regarding this contract or the agency programs and projects covered under it, or the results or conclusions made pursuant to performance, must be approved by the Contracting Officer. Under no circumstances shall the Contractor, or anyone acting on behalf of the Contractor, refer to the supplies, services, or equipment furnished pursuant to the provisions of this contract in any publicity, release, or commercial advertising without first obtaining explicit written consent to do so from the Contracting Officer. ■ 25. Revise section 352.208–70 to read as follows: 352.208–70 Printing and Duplication. As prescribed in 308.870, insert the following clause: Printing and Duplication (DATE) (a) Definitions. As used in this clause— Duplicating/copying means the term as defined in the Government Printing and Binding Regulations published by the Joint Committee on Printing, U.S. Congress, Title I: Definitions. Government printing means printing, binding, and blank book work for the use of an executive department, independent agency, or establishment of the Government (see Government Printing and Binding Regulations published by the Joint Committee on Printing, U.S. Congress, Title I: Definitions). Printing means the term as defined in the Government Printing and Binding Regulations published by the Joint Committee on Printing, U.S. Congress, Title I: Definitions. Related supplies means supplies that are used and equipment that is usable in printing and binding operations. Other printing-related services means composition, platemaking, presswork, binding, and micrographics when used as a substitute for printing. (b) Prohibitions. Unless otherwise specified, no printing by the Contractor or any subcontractor is authorized for performance under the contract, whether to support Government printing, to acquire related supplies, or to provide other printingrelated services. When printing supplies or services are required, and specified under the contract, the Contractor shall submit cameraready copies of such deliverables to the Contracting Officer’s Representative for printing through, or by the Government Printing Office, except as authorized by the Contracting Officer. (c) Limited printing authorized. If necessary for performance of the contract, the Contractor may duplicate or copy less than 5,000 production units of any one page, or less than 25,000 production units in the aggregate of multiple pages for the use of a department or agency. A production unit is E:\FR\FM\03OCP2.SGM 03OCP2 80696 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules defined as one sheet, size 8.5 x 11 inches, one side only, and one color. The pages may not exceed a maximum image size of 10 3⁄4 by 14 1⁄4 inches. This page limit applies to each printing requirement and not for all printing requirements under the entire contract. (d) Approval procedures for printing, duplication, and other printing-related services. Contractors must obtain approval from the Contracting Officer for all printing, as well as duplicating/copying in excess of the limited printing authorized stated limits in paragraph (c). The cost of any unauthorized printing or duplicating/copying under this contract is unallowable and the Contractor will not be reimbursed. (e) Subcontracts. The Contractor shall include the substance of this clause, including this paragraph (e), in subcontracts under this contract (including subcontracts for the acquisition of commercial products and commercial services). (End of clause) ■ 26. Add section 352.209–70 to read as follows: 352.209–70 Interest. Organizational Conflicts of ddrumheller on DSK120RN23PROD with PROPOSALS2 As prescribed in 309.507–1(b), insert the following provision: Organizational Conflicts of Interest (DATE) (a) It is in the best interest of the Government to avoid situations which might create an organizational conflict of interest or where the Offeror’s performance of work under the contract may provide the Contractor with an unfair competitive advantage. The term ‘‘organizational conflict of interest’’ means that because of other activities or relationships with other persons, a person is unable to render impartial assistance or advice to the Government, or the person’s objectivity in performing the contract work is or might be otherwise impaired, or the person has an unfair competitive advantage. (b) The Offeror shall provide a statement with its offer which describes, in a concise manner, all relevant facts concerning any past, present, or currently planned interest (financial, contractual, organizational, or otherwise) or actual or potential organizational conflicts of interest relating to the services to be provided under this solicitation. The Offeror shall also provide statements with its offer containing the same information for any consultants and subcontractors identified in its proposal and which will provide services under the solicitation. The Offeror may also provide relevant facts that show how its organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest. (c) Based on this information and any other information solicited or obtained by the Contracting Officer, the Contracting Officer may determine that an organizational conflict of interest exists which would warrant disqualifying the Contractor for award of the contract unless the organizational conflict of interest can be mitigated to the Contracting Officer’s satisfaction by negotiating terms and VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 conditions of the contract to that effect. If the conflict of interest cannot be mitigated and if the Contracting Officer finds that it is in the best interest of the United States to award the contract, the Contracting Officer shall request a waiver in accordance with FAR 9.503. (d) Nondisclosure or misrepresentation of actual or potential organizational conflicts of interest at the time of the offer or arising as a result of a modification to the contract, may result in the termination of the contract at no expense to the Government. (End of provision) 352.211–1 through 352.211–3 [Redesignated as 352.211–70 through 352.211–72] 27. Redesignate sections 352.211–1 through 352.211–3 as sections 352.211– 70 through 352.211–72. ■ 28. Revise newly redesignated sections 352.211–70 through 352.211– 72 to read as follows: ■ 352.211–70 Public Accommodations and Commercial Facilities. As prescribed in 311.7102, insert the following clause: Public Accommodations and Commercial Facilities (DATE) The Contractor agrees as follows: (a) Except for ad hoc meetings necessary or incidental to contract performance, the Contractor shall develop a plan to assure that any event held pursuant to this contract will meet or exceed the minimum accessibility standards set forth in 28 CFR part 36— Nondiscrimination on the Basis of Disability by Public Accommodations and in Commercial Facilities. The Contractor shall submit the plan to the Contracting Officer and must receive approval prior to the event. The Contractor may submit a consolidated or master plan for contracts requiring numerous events in lieu of separate plans. (b) The Contractor shall manage the contract in accordance with the standards set forth in 28 CFR part 36. (End of clause) 352.211–71 Conference Sponsorship Requests and Conference Materials Disclaimer. As prescribed in 311.7202, insert the following clause: Conference Sponsorship Request and Conference Materials Disclaimer (DATE) (a) If HHS is not the sole provider of funding under this contract, then the Contractor shall submit a written request (including rationale) to the Contracting Officer for permission to claim such HHS sponsorship, prior to the Contractor claiming HHS conference sponsorship. (b) The Contractor shall include the following statement on conference materials, including promotional materials, agendas, and websites, whether or not HHS is the conference sponsor: ‘‘This conference was funded, in whole or in part, through a contract (insert contract number) with the Department of Health and PO 00000 Frm 00064 Fmt 4701 Sfmt 4702 Human Services (HHS) (insert name of OPDIV or STAFFDIV). The views expressed in written conference materials and by speakers and moderators at this conference, do not necessarily reflect the official policies of HHS, nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.’’ (c) Unless authorized in writing by the Contracting Officer, the Contractor shall not display the HHS logo on any conference materials. (End of clause) 352.211–72 Paperwork Reduction Act Requirements. As prescribed in 311.7301, insert the following clause: Paperwork Reduction Act Requirements (DATE) (a) This contract involves a requirement to collect or record information calling either for answers to identical questions from 10 or more persons other than Federal employees, or information from Federal employees which is outside the scope of their employment, for use by the Federal government or disclosure to third parties; therefore, the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) shall apply to this contract. No plan, questionnaire, interview guide or other similar device for collecting information (whether repetitive or single time) may be used without the Office of Management and Budget (OMB) first providing clearance. Contractors and the Contracting Officer’s Representative shall be guided by the provisions of 5 CFR part 1320, Controlling Paperwork Burdens on the Public, and seek the advice of the HHS operating division or Office of the Secretary Reports Clearance Officer to determine the procedures for acquiring OMB clearance. (b) The Contractor shall not expend any funds or begin any data collection until the Contracting Officer provides the Contractor with written notification authorizing the expenditure of funds and the collection of data. The Contractor shall allow at least 120 days for OMB clearance. The Contracting Officer will consider excessive delays caused by the Government which arise out of causes beyond the control and without the fault or negligence of the Contractor in accordance with the Excusable Delays or Default clause of this contract. (End of clause) ■ 29. Add section 352.212–70 to read as follows: 352.212–70 Items. Gray Market and Counterfeit As prescribed in 312.301(f), insert the following clause: Gray Market and Counterfeit Items (DATE) (a) No used, refurbished, or remanufactured supplies or equipment/parts shall be provided. This procurement is for new Original Equipment Manufacturer (OEM) items only. No gray market items shall be provided. Gray market items are OEM goods intentionally or unintentionally sold outside an authorized sales territory or sold E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules by non-authorized dealers in an authorized sales territory. (b) No counterfeit supplies or equipment/ parts shall be provided. Counterfeit items include unlawful or unauthorized reproductions, substitutions, or alterations that have been mismarked, misidentified, or otherwise misrepresented to be an authentic, unmodified item from the original manufacturer, or a source with the express written authority of the original manufacturer or current design activity, including an authorized aftermarket manufacturer. Unlawful or unauthorized substitutions include used items represented as new, or the false identification of grade, serial number, lot number, date code, or performance characteristics. (c) The vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system, verified by an authorization letter or other documents from the OEM. All software licensing, warranty and service associated with the equipment/ system shall be in accordance with the OEM terms and conditions. (End of clause) ■ 30. Revise section 352.215–70 to read as follows: 352.215–70 Late Proposals and Revisions—R&D Solicitations. As prescribed in 315.209–70, insert the following provision: Late Proposals and Revisions—R&D Solicitations (DATE) Notwithstanding the procedures contained in the provision at FAR 52.215–1, Instructions to Offerors-Competitive Acquisition, paragraph (c)(3), the Contracting Officer may consider a proposal received for biomedical or behavioral research and development (R&D) solicitations after the date specified for receipt if— (a) It appears to offer significant cost or technical advantage to the Government; and (b) It was received before proposals were distributed for evaluation; or (c) It was received within five calendar days after the exact time specified for receipt, whichever is earlier. (End of provision) ■ 31. Add section 352.215–71 to read as follows: 352.215–71 Use of Non-Federal Evaluators—Conditions for Evaluating Proposals. ddrumheller on DSK120RN23PROD with PROPOSALS2 As prescribed in 315.305–71, insert the following provision: Non-Federal Evaluators—Conditions for Evaluating Proposals (DATE) (a) Prohibition on the use and release of proposal data. The contractor agrees that it and its employees, as well as any subcontractors and their employees as nonFederal evaluators will use the data (trade secrets, business data, and technical data) contained in any proposals under review for evaluation purposes only. Further, the contractor, its employees, and subcontractors and their employees may not release, in VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 whole or in part, any material received from the Government to evaluate and must protect and secure the data against unauthorized disclosure. This does not apply to data obtained from another source without restriction. (b) Notices, legends, and return of materials. Any notice or legend placed on the proposal by either HHS, or the offeror shall be applied to any reproduction or abstract provided to the evaluator or made by the evaluator. Upon completion of the evaluation, the evaluator shall return the furnished copy of the proposal or abstract furnished by the Government, and all copies thereof, to the HHS office which initially furnished the proposal for evaluation. (c) Electronic records. All electronic records of proposals or proposal-related material shall be provided to the Government and immediately be destroyed and/or deleted from all electronic media. (d) Non-contact with offerors of proposals under evaluation. The evaluator shall not contact the offeror concerning any aspects of a proposal’s contents. (e) Requirement to sign agreement. Each non-Federal evaluator shall complete, sign, and provide to the HHS office furnishing the proposal for review and the Contracting Officer, a signed acknowledgement of this agreement and insert the name, title, company, signature, and date set forth in paragraph (f) of this clause. (f) Agreement. By signing the agreement as shown in this paragraph, the non-Federal evaluator agrees, in order to participate under an HHS contract providing services to HHS as a non-Federal evaluator, to adhere to the terms and conditions set forth in paragraphs (a)–(e) of this provision. The agreement will be retained by the HHS office providing the proposal data and the Contracting Officer. Name: lllllllllllllllll Title: llllllllllllllllll Company: llllllllllllllll Signature: llllllllllllllll Date: llllllllllllllllll (End of provision) ■ 32. Revise section 352.216–70 to read as follows: 352.216–70 Allowable Cost and Payment for Hospitals (Profit and Non-Profit). As prescribed in 316.307(a)(1), insert the following clause: Allowable Cost and Payment for Hospitals (Profit and Non-Profit) (DATE) Payment amounts requested by the Contractor and included in invoices submitted for payment in accordance with Federal Acquisition Regulation (FAR) clause 52.216–7, paragraph (a)(1), must be determined allowable by the Contracting Officer in accordance with the FAR clause at 52.216–7, 45 CFR part 75, appendix IX, and FAR subpart 31.2, in effect on the date of this contract and in accordance with the terms of this contract. (End of clause) ■ 33. Revise sections 352.219–70 and 352.219–71 to read as follows: PO 00000 Frm 00065 Fmt 4701 Sfmt 4702 80697 352.219–70 Notification of Competition Limited to Eligible 8(a) Participants. As prescribed in 319.811–370(a), insert the following clause and use in conjunction with the clause at FAR 52.219–18: Notification of Competition Limited to Eligible 8(a) Participants (DATE) Substitute paragraph (c) in FAR Clause 52.219–18 as follows: (c) Any award resulting from this solicitation will be made directly by the Contracting Officer to the successful 8(a) offeror. Although SBA is not identified as such in the award form, SBA is still the Prime Contractor. Contractor shall comply with the limitations on subcontracting as provided in 13 CFR 125.6 and all other 8(a) program requirements, as set forth in 13 CFR part 124. (End of clause) 352.219–71 Notification of Section 8(a) Direct Award. As prescribed in 319.811–70(b), insert the following clause: Notification of Section 8(a) Direct Award (DATE) (a) Offers are solicited only from small business concerns expressly certified by the Small Business Administration (SBA) for participation in the SBA’s 8(a) Program. By submission of its offer, the Offeror represents that it is in good standing and that it meets all of the criteria for participation in the program in accordance with 13 CFR part 124. (b) Any award resulting from this solicitation will be made directly by the Contracting Officer to the successful 8(a) offeror. Although SBA is not identified as such in the award form, SBA is still the Prime Contractor. (c) This contract is issued as a direct award between the contracting activity and the 8(a) Contractor pursuant to the Partnership Agreement (PA) between the Small Business Administration (SBA) and the Department of Health and Human Services. (d) SBA retains responsibility for 8(a) certification, 8(a) eligibility determinations and related issues, and providing counseling and assistance to the 8(a) Contractor under the 8(a) program. The cognizant SBA district office is: ________[To be completed by the Contracting Officer at the time of award]. (e) The contracting activity is responsible for administering the contract and taking any action on behalf of the Government under the terms and conditions of the contract. However, the contracting activity shall give advance notice to the SBA before it issues a final notice terminating performance, either in whole or in part, under the contract. The contracting activity shall obtain SBA’s approval prior to processing any novation agreement(s). The contracting activity may assign contract administration functions to a contract administration office. (f) The Contractor agrees: (1) To notify the Contracting Officer, simultaneous with its notification to SBA (as required by SBA’s 8(a) regulations), when the owner or owners upon whom 8(a) eligibility E:\FR\FM\03OCP2.SGM 03OCP2 80698 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules is based plan to relinquish ownership or control of the concern. (2) Consistent with 15 U.S.C. 637(a)(21), transfer of ownership or control shall result in termination of the contract for convenience, unless SBA waives the requirement for termination prior to the actual relinquishing of ownership and control. (3) It will adhere to the requirements of FAR 52.219–14, Limitations of Subcontracting, and other requirements in 13 CFR part 124 and 13 CFR 125.6, as applicable (g) Any proposed joint venture involving an 8(a) Participant must be approved by SBA before contracts are awarded. (End of clause) ■ 34. Revise section 352.222–70 to read as follows: 352.222–70 Contractor Cooperation in Equal Employment Opportunity and AntiHarassment Investigations. ddrumheller on DSK120RN23PROD with PROPOSALS2 As prescribed in 322.810(e), insert the following clause: Contractor Cooperation in Equal Employment Opportunity and Anti-Harassment Investigations (DATE) (a) Definitions. As used in this clause— Complaint means a formal or informal complaint that has been filed with Health and Human Services (HHS), HHS agency Equal Employment Opportunity (EEO) officials, the Equal Employment Opportunity Commission (EEOC), the Office of Federal Contract Compliance Programs (OFCCP) or a court of competent jurisdiction. Contractor employee means all current Contractor employees who work or worked under this contract. The term also includes current employees of subcontractors who work or worked under this contract. In the case of Contractor and subcontractor employees who worked under this contract, but who are no longer employed by the Contractor or subcontractor, or who have been assigned to another entity within the Contractor’s or subcontractor’s organization, the Contractor shall provide HHS with that employee’s last known mailing address, email address, and telephone number, if that employee has been identified as a witness in an EEO or Anti-Harassment complaint or investigation. Good faith cooperation means, but is not limited to, making Contractor employees available, with the presence or assistance of counsel as deemed appropriate by the Contractor, for— (1) Formal and informal interviews by EEO counselors, the OFCCP, or other Agency officials processing EEO or Anti-Harassment complaints; (2) Formal or informal interviews by EEO investigators charged with investigating complaints of unlawful discrimination filed by Federal employees; (3) Reviewing and signing appropriate affidavits or declarations summarizing statements provided by such Contractor employees during EEO or Anti-Harassment investigations; (4) Producing documents requested by EEO counselors, EEO investigators, OFCCP investigators, Agency employees, or the VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 EEOC in connection with a pending EEO or Anti-Harassment complaint; and (5) Preparing for and providing testimony in depositions or in hearings before the Merit Systems Protection Board, EEOC, OFCCP, and U.S. District Court. (b) Cooperation with investigations. In addition to complying with the clause at FAR 52.222–26, Equal Opportunity, the Contractor shall, in good faith, cooperate with the Department of Health and Human Services (HHS) in investigations of Equal Employment Opportunity (EEO) complaints processed pursuant to 29 CFR part 1614 and internal Anti-Harassment investigations. (c) Compliance. Failure on the part of the Contractor or its subcontractors to comply with the terms of this clause may be grounds for the Contracting Officer to terminate this contract for default (or for cause when using FAR part 12 procedures) in accordance with the termination clause contained in the contract. (d) Subcontract flowdown. The Contractor shall include the terms and conditions of this clause in its entirety in all subcontract solicitations and subcontracts awarded, at any tier, under this contract. (End of clause) ■ 35. Revise sections 352.223–70 and 352.223–71 to read as follows: 352.223–70 Instructions to Offerors— Sustainable Acquisition Plan. As prescribed in 323.109–70, insert the following provision: Instructions to Offerors—Sustainable Acquisition Plan (DATE) Offerors shall include a Sustainable Acquisition Plan in their technical proposals. The Plan must describe their approach and the quality assurance mechanisms in place for applying FAR subpart 23.1, Sustainable Products and Services, and other Federal laws, regulations and Executive Orders governing sustainable acquisition. The Plan shall clearly identify those products and services included in Federal sustainable acquisition preference programs by categorizing them along with their respective price/cost in the following eight groups: Recycled Content, Energy Efficient, Biobased, Environmentally Preferable, Electronic Product Environment Assessment Tool, Water-Efficient, Non-Ozone Depleting Substances, and Alternative Fuel Vehicle and Alternative Fuels. (End of provision) 352.223–71 Safety and Health. As prescribed in 323.304–70, insert the following clause: Safety and Health (DATE) (a) To help ensure the protection of the life and health of all persons, and to help prevent damage to property, the Contractor shall comply with all Federal, State, and local laws and regulations applicable to the work being performed under this contract. These laws are implemented or enforced by the Environmental Protection Agency, Occupational Safety and Health Administration (OSHA) and other regulatory/ PO 00000 Frm 00066 Fmt 4701 Sfmt 4702 enforcement agencies at the Federal, State, and local levels. (1) In addition, the Contractor shall comply with the following regulations when developing and implementing health and safety operating procedures and practices for both personnel and facilities involving the use or handling of hazardous materials and the conduct of research, development, or test projects: (i) 29 CFR 1910.1030, Bloodborne pathogens; 29 CFR 1910.1450, Occupational exposure to hazardous chemicals in laboratories; and other applicable occupational health and safety standards issued by OSHA and included in 29 CFR part 1910. These regulations are available at https://www.osha.gov/. (ii) Nuclear Regulatory Commission Standards and Regulations, pursuant to the Energy Reorganization Act of 1974 (42 U.S.C. 5801 et seq.). The Contractor may obtain copies from the U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001. (2) The following Government guidelines are recommended for developing and implementing health and safety operating procedures and practices for both personnel and facilities: (i) Biosafety in Microbiological and Biomedical Laboratories, CDC. This publication is available at https:// www.cdc.gov/biosafety/publications/ index.htm. (ii) Prudent Practices for Safety in Laboratories (1995), National Research Council, National Academy Press, 500 Fifth Street NW, Lockbox 285, Washington, DC 20055 (ISBN 0–309–05229–7). This publication is available at https:// www.nap.edu/catalog/4911/prudentpractices-in-the-laboratory-han. (b) Further, the Contractor shall take or cause to be taken additional safety measures as the Contracting Officer, in conjunction with the Contracting Officer’s Representative or other appropriate officials, determines to be reasonably necessary. If compliance with these additional safety measures results in an increase or decrease in the cost or time required for performance of any part of work under this contract, the Contracting Officer will make an equitable adjustment in accordance with the applicable ‘‘Changes’’ clause set forth in this contract. (c) The Contractor shall maintain an accurate record of, and promptly report to the Contracting Officer, all accidents or incidents resulting in the exposure of persons to toxic substances, hazardous materials or hazardous operations; the injury or death of any person; or damage to property incidental to work performed under the contract resulting from toxic or hazardous materials and resulting in any or all violations for which the Contractor has been cited by any Federal, State or local regulatory/enforcement agency. The report citing all accidents or incidents resulting in the exposure of persons to toxic substances, hazardous materials or hazardous operations; the injury or death of any person; or damage to property incidental to work performed under the contract resulting from toxic or hazardous materials and resulting in any or all violations for which the Contractor has been cited shall include a copy of the notice E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules of violation and the findings of any inquiry or inspection, and an analysis addressing the impact these violations may have on the work remaining to be performed. The report shall also state the required action(s), if any, to be taken to correct any violation(s) noted by the Federal, State, or local regulatory/ enforcement agency and the time frame allowed by the agency to accomplish the necessary corrective action. (d) If the Contractor fails or refuses to comply with the Federal, State or local regulatory/enforcement agency’s directive(s) regarding any violation(s) and prescribed corrective action(s), the Contracting Officer may issue an order stopping all or part of the work until satisfactory corrective action (as approved by the Federal, State, or local regulatory/enforcement agencies) has been taken and documented to the Contracting Officer. No part of the time lost due to any such stop work order shall form the basis for a request for extension or costs or damages by the Contractor. (e) The Contractor shall insert the substance of this clause in each subcontract involving toxic substances, hazardous materials, or hazardous operations. The Contractor is responsible for the compliance of its subcontractors with the provisions of this clause. (End of clause) ■ 36. Add sections 352.225–70 and 352.225–71 to read as follows: 352.225–70 Made in America—Personal Protective Equipment. ddrumheller on DSK120RN23PROD with PROPOSALS2 As prescribed in 325.7103(a), insert the following clause: Made in America—Personal Protective Equipment (DATE) (a) Definitions. As used in this clause— Component, as applied to an item described in subsection (b) of this clause, means an article, material, or supply incorporated directly into personal protective equipment. Domestic personal protective equipment, as applied to an item described in subsection (b) of this clause, means personal protective equipment, including the materials and components thereof, that is grown, reprocessed, reused, or produced in the United States. Foreign-made domestic personal protective equipment, as applied to an item described in subsection (b) of this clause, means personal protective equipment that is assembled outside the United States containing only materials and components that are grown, reprocessed, reused, or produced in the United States. Foreign personal protective equipment means personal protective equipment other than domestic personal protective equipment or foreign-made domestic personal protective equipment. Personal protective equipment, as applied to an item described in subsection (b) of this clause, means surgical masks, respirator masks and powered air purifying respirators and required filters, face shields and protective eyewear, gloves, disposable and reusable surgical and isolation gowns, head and foot coverings, and other gear or clothing VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 used to protect an individual from the transmission of disease. United States, as applied to an item described in subsection (b) of this clause, means the 50 States, the District of Columbia, and the possessions of the United States. (b) Requirement. The Contractor shall deliver only domestic personal protective equipment, unless it specified delivery of foreign-made domestic personal protective equipment in the provision of the solicitation entitled ‘‘Made in America Certificate— Personal Protective Equipment.’’ (End of clause) 352.225–71 Made in America Certificate— Personal Protective Equipment. As prescribed in 325.7103(b), insert the following provision: Made In America Certificate—Personal Protective Equipment (DATE) (a)(1) The Offeror certifies that each item of personal protective equipment, except those listed in paragraph (b) of this provision, is domestic personal protective equipment. (2) The Offeror shall list offered foreignmade domestic personal protective equipment items in paragraph (b). (3) The terms ‘‘domestic personal protective equipment,’’ ‘‘foreign-made domestic personal protective equipment,’’ foreign personal protective equipment,’’ and ‘‘personal protective equipment,’’ are defined in the clause of this solicitation entitled ‘‘Made in America—Personal Protective Equipment.’’ (b) Foreign-made Domestic Personal Protective Equipment: Line-Item No. Country of origin [List as necessary] (End of provision) 352.226–1 through 352.226–7 [Redesignated as 352.226–70 through 352.226–76] 37. Redesignate sections 352.226–1 through 352.226–7 as sections 352.226– 70 through 352.226–76. ■ 38. Revise newly redesignated sections 352.226–70 through 352.226– 76 to read as follows: ■ Sec. * * * * * 352.226–70 Indian Preference. 352.226–71 Indian Preference Program. 352.226–72 Native American Graves Protection and Repatriation Act. 352.226–73 Notice of Indian Small Business Economic Enterprise Set-Aside. 352.226–74 Notice of Indian Economic Enterprise Set-Aside. 352.226–75 Indian Economic Enterprise Subcontracting Limitations. 352.226–76 Indian Economic Enterprise Representation. * PO 00000 * * Frm 00067 * Fmt 4701 * Sfmt 4702 352.226–70 80699 Indian Preference. As prescribed in 326.7005(a), insert the following clause: Indian Preference (DATE) (a) The Contractor agrees to give preference in employment opportunities under this contract to Indians who can perform required work, regardless of age (subject to existing laws and regulations), sex, religion, or tribal affiliation. To the extent feasible and consistent with the efficient performance of this contract, the Contractor further agrees to give preference in employment and training opportunities under this contract to Indians who are not fully qualified to perform regardless of age (subject to existing laws and regulations), sex, religion, or tribal affiliation. The Contractor also agrees to give preference to Indian organizations and Indian-owned economic enterprises in the awarding of any subcontracts to the extent feasible and consistent with the efficient performance of this contract. The Contractor shall maintain the necessary statistical records to demonstrate compliance with this paragraph. (b) In connection with the Indian employment preference requirements of this clause, the Contractor shall provide reasonable opportunities for training, incident to such employment. Such training shall include on-the-job, classroom, or apprenticeship training designed to increase the vocational effectiveness of an Indian employee. (c) If the Contractor is unable to fill its employment and training opportunities after giving full consideration to Indians as required by this clause, the Contractor may satisfy those needs by selecting non-Indian persons in accordance with the clause of this contract entitled ‘‘Equal Opportunity.’’ (d) If no Indian organizations or Indianowned economic enterprises are available under reasonable terms and conditions, including price, for awarding of subcontracts in connection with the work performed under this contract, the Contractor agrees to comply with the provisions of this contract involving utilization of small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; women-owned small businesses; or small disadvantaged businesses. (e) As used in this clause, (1) Indian means a person who is a member of an Indian tribe. If the Contractor has reason to doubt that a person seeking employment preference is an Indian, the Contractor shall grant the preference but shall require the individual provide evidence within 30 days from the tribe concerned that the person is a member of the tribe. (2) Indian tribe means an Indian tribe, pueblo, band, nation, or other organized group or community, including Alaska Native village or regional or village corporation as defined in or established pursuant to the Alaska Native Claims Settlement Act (85 Stat. 688; 43 U.S.C. 1601) which the United States recognizes as eligible for the special programs and services provided to Indians because of its status as Indians. (3) Indian organization means the governing body of any Indian Tribe or entity E:\FR\FM\03OCP2.SGM 03OCP2 80700 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules established or recognized by such governing body in accordance with the Indian Financing Act of 1974 (88 Stat. 77; 25 U.S.C. 1451). (4) Indian-owned economic enterprise means any Indian-owned commercial, industrial, or business activity established or organized for the purpose of profit, provided that such Indian ownership shall constitute not less than 51 percent of the enterprise, and that ownership shall encompass active operation and control of the enterprise. (f) The Contractor agrees to include the provisions of this clause, including this paragraph (f), in each subcontract awarded at any tier under this contract. (g) In the event of noncompliance with this clause, the Contracting Officer may terminate the contract in whole or in part or may pursue any other remedies authorized by law or by other provisions of the contract. (End of clause) 352.226–71 Indian Preference Program. ddrumheller on DSK120RN23PROD with PROPOSALS2 As prescribed in 326.7005(b), insert the following clause: Indian Preference Program (DATE) (a) In addition to the requirements of the clause of this contract entitled ‘‘Indian Preference,’’ the Contractor agrees to establish and conduct an Indian preference program which will expand opportunities for Indians to receive preference for employment and training in connection with the work performed under this contract, and which will expand the opportunities for Indian organizations and Indian-owned economic enterprises to receive a preference in the awarding of subcontracts. In this connection, the Contractor shall perform the following: (1) Designate a liaison officer who will maintain liaison with the Government and the Tribe(s) on Indian preference matters; supervise compliance with the provisions of this clause; and administer the Contractor’s Indian preference program. (2) Advise its recruitment sources in writing and include a statement in all employment advertisements that Indian applicants receive preference in employment and training incident to such employment. (3) Not more than 20 calendar days after award of the contract, post a written notice setting forth the Contractor’s employment needs and related training opportunities in the tribal office of any reservations on or near the contract work location. The notice shall include the approximate numbers and types of employees needed; the approximate dates of employment; any experience or special skills required for employment; training opportunities available; and other pertinent information necessary to advise prospective employees of any other employment requirements. The Contractor shall also request the tribe(s) on or near whose reservation(s) the Contractor will perform contract work to provide assistance filling its employment needs and training opportunities. The Contracting Officer will advise the Contractor of the name, location, and phone number of the Tribal officials to contact regarding the posting of notices and requests for Tribal assistance. (4) Establish and conduct a subcontracting program which gives preference to Indian VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 organizations and Indian-owned economic enterprises as subcontractors (including suppliers) under this contract. The Contractor shall give public notice of existing subcontracting opportunities and, to the extent feasible and consistent with the efficient performance of this contract, shall solicit bids or proposals from Indian organizations or Indian-owned economic enterprises only. The Contractor shall request assistance and information on Indian firms qualified as subcontractors (including suppliers) from the Tribe(s) on or near whose reservation(s) the Contractor will perform contract work. The Contracting Officer will advise the Contractor of the name, location, and phone number of the Tribal officials to contact regarding the request for assistance and information. Public notices and solicitations for existing subcontracting opportunities shall provide an equitable opportunity for Indian firms to submit bids or proposals by including— (i) A clear description of the supplies or services required, including quantities, specifications, and delivery schedules that facilitate the participation of Indian firms; (ii) A statement indicating that Indian organizations and Indian-owned economic enterprises will receive preference in accordance with section 7(b) of Public Law 93–638; 88 Stat. 2205; 25 U.S.C. 450e(b); (iii) Definitions for the terms ‘‘Indian organization’’ and ‘‘Indian-owned economic enterprise’’ prescribed under the ‘‘Indian Preference’’ clause of this contract; (iv) A statement that the bidder or offeror shall complete certifying that it is an Indian organization or Indian-owned economic enterprise; and (v) A closing date for receipt of bids or proposals which provides sufficient time for preparation and submission of a bid or proposal. If, after soliciting bids or proposals from Indian organizations and Indian-owned economic enterprises, the Contractor receives no responsive bid or acceptable proposal, the Contractor shall comply with the requirements of paragraph (d) of the ‘‘Indian Preference’’ clause of this contract. If the Contractor receives one or more responsive bids or conforming proposals, the Contractor shall award the contract to the low, responsive, responsible bidder or conforming offer from a responsible offeror if the price is reasonable. If the Contractor determines the low responsive bid or conforming proposal’s price is unreasonable, the Contractor shall attempt to negotiate a reasonable price and award a subcontract. If parties cannot agree on a reasonable price, the Contractor shall comply with the requirements of paragraph (d) of the ‘‘Indian Preference’’ clause of this contract. (5) Maintain written records under this contract which demonstrate— (i) The numbers of Indians seeking employment for each employment position available under this contract; (ii) The number and types of positions filled by Indians and non-Indians; (iii) The total number of Indians employed under this contract; (iv) For those positions having both Indian and non-Indian applicants, and a non-Indian is selected for employment, the reason(s) PO 00000 Frm 00068 Fmt 4701 Sfmt 4702 why the Contractor did not select the Indian applicant; (v) Actions taken to give preference to Indian organizations and Indian-owned economic enterprises for subcontracting opportunities which exist under this contract; (vi) Reasons why Indian subcontractors and or suppliers did not receive preference for each requirement where the Contractor determined that such preference was inconsistent with efficient contract performance; and (vii) The number of Indian organizations and Indian-owned economic enterprises contacted, and the number receiving subcontract awards under this contract. (6) Submit to the Contracting Officer for approval a quarterly report summarizing the Contractor’s Indian preference program and indicating the number and types of available positions filled by Indians and non-Indians, and the dollar amounts of all subcontracts awarded to Indian organizations and Indianowned economic enterprises, and to all other firms. (7) Maintain records pursuant to this clause and keep them available for review by the Government for one year after final payment under this contract, or for such longer period in accordance with requirements of any other clause of this contract or by applicable law or regulation. (b) For purposes of this clause, the following definitions of terms shall apply: (1) The terms Indian, Indian tribe, Indian organization, and Indian-owned economic enterprise are defined in the clause of this contract entitled Indian Preference. (2) Indian reservation includes Indian reservations, public domain Indian allotments, former Indian reservations in Oklahoma, and land held by incorporated Native groups, regional corporations, and village corporations under the provisions of the Alaska Native Claims Settlement Act (85 Stat. 688; 43 U.S.C. 1601 et seq.) (3) On or near an Indian reservation means on a reservation or reservations or within that area surrounding an Indian reservation(s) where a person seeking employment could reasonably expect to commute to and from in the course of a work day. (c) Nothing in the requirements of this clause shall preclude Indian tribes from independently developing and enforcing their own Indian preference requirements. Such requirements must not conflict with any Federal statutory or regulatory requirement dealing with the award and administration of contracts. (d) The Contractor agrees to include the provisions of this clause, including this paragraph (d), in each subcontract awarded at any tier under this contract and to notify the Contracting Officer of such subcontracts. (e) In the event of noncompliance with this clause, the Contracting Officer may terminate the contract in whole or in part or may pursue any other remedies authorized by law or by other provisions of the contract. (End of clause) E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules 352.226–72 Native American Graves Protection and Repatriation Act. 352.226–74 Notice of Indian Economic Enterprise Set-Aside. As prescribed in 326.7201, insert the following clause: As prescribed in 326.7105(b), insert the following clause: Native American Graves Protection and Repatriation Act (DATE) (a) Public Law 101–601, dated November 16, 1990, also known as the Native American Graves Protection and Repatriation Act, imposes certain responsibilities on individuals and organizations when they discover Native American cultural items (including human remains) on Federal or tribal lands. (b) In the event the Contractor discovers Native American cultural items (including human remains, associated funerary objects, unassociated funerary objects, sacred objects and cultural patrimony), as defined in the Act during contract performance, the Contractor shall— (1) Immediately cease activity in the area of the discovery; (2) Notify the Contracting Officer of the discovery; and (3) Make a reasonable effort to protect the items discovered before resuming such activity. Upon receipt of the Contractor’s discovery notice, the Contracting Officer will notify the appropriate authorities as required by the Act. (c) Unless otherwise specified by the Contracting Officer, the Contractor may resume activity in the area on the 31st calendar day following the date that the appropriate authorities certify receipt of the discovery notice. The Contracting Officer shall provide to the Contractor the date that the appropriate authorities certify receipt of the discovery notice and the date on which the Contractor may resume activities. (End of clause) 352.226–73 Notice of Indian Small Business Economic Enterprise Set-Aside. ddrumheller on DSK120RN23PROD with PROPOSALS2 As prescribed in 326.7105(a), and in lieu of the requirements of 48 CFR 19.508, insert the following provision: Notice of Indian Small Business Economic Enterprise Set-Aside (DATE) Under the Buy Indian Act, 25 U.S.C. 47, offers are solicited only from Indian Economic Enterprises (see 326.7106) that are also small business concerns. Any acquisition resulting from this solicitation will be from such a concern. As required by 352.226–76(b), offerors shall include a completed Indian Economic Enterprise Representation form in response to Sources Sought Notices, Request for Information (RFI) and as part of the proposal submission. The Indian Economic Enterprise Representation form, available on the IHS DAP public website (www.IHS.gov/DAP), shall be included in synopses, presolicitation notices, and solicitations for the acquisitions under the Buy Indian Act. Offers received from enterprises that are not both Indian Economic Enterprises and small business concerns will not be considered and will be rejected. (End of clause) VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 Notice of Indian Economic Enterprise SetAside (DATE) (a) Definitions. As used in this clause: Alaska Native Claims Settlement Act (ANCSA) means Pub. L. 92–203 (December 18, 1971), 85 Stat. 688, codified at 43 U.S.C. 1601–1629h. Indian means a person who is an enrolled member of an Indian Tribe or ‘‘Native’’ as defined in the Alaska Native Claims Settlement Act. Indian Economic Enterprise means any business activity owned by one or more Indians or Indian Tribes that is established for the purpose of profit provided that: The combined Indian or Indian Tribe ownership must constitute not less than 51 percent of the enterprise; the Indians or Indian Tribes must, together, receive at least a majority of the earnings from the contract; and the management and daily business operations of an enterprise must be controlled by one or more individuals who are Indians. To ensure actual control over the enterprise, the individuals must possess requisite management or technical capabilities directly related to the primary industry in which the enterprise conducts business. The enterprise must meet these requirements throughout the following time periods— (1) At the time an offer is made in response to a written solicitation; (2) At the time of the contract award; and (3) During the full term of the contract. Indian Tribe means an Indian Tribe, band, nation, or other recognized group or community that is recognized as eligible for the special programs and services provided by the United States to Indians because of their status as Indians, including any Alaska Native village or regional or village corporation under the Alaska Native Claims Settlement Act (Pub. L. 92–203, 85 Stat. 688; 43 U.S.C. 1601). Representation means the positive statement by an enterprise of its eligibility for preferential consideration and participation for acquisitions conducted under the Buy Indian Act, 25 U.S.C. 47, in accordance with the procedures in section 326.7106. (b) General. (1) Under the Buy Indian Act, offers are solicited only from Indian Economic Enterprises. (2) The Contracting Officer will reject all offers received from ineligible enterprises. (3) Any award resulting from this solicitation will be made to an Indian Economic Enterprise, as defined in paragraph (a) of this clause. (c) Required submissions. In response to this solicitation, an offeror must also provide the following: (1) A description of the required percentage of the work/costs to be provided by the offeror over the contract term as required by the clause at 352.226–75, Subcontracting Limitations; and (2) Qualifications of the key personnel (if any) that will be assigned to the contract. (d) Required assurance. The offeror must provide written assurance to the Contracting PO 00000 Frm 00069 Fmt 4701 Sfmt 4702 80701 Officer that the offeror is and will remain in compliance with the requirements of this clause. It must do this before the Contracting Officer awards the Buy Indian Act contract and upon successful and timely completion of the contract, but before the Contracting Officer accepts the work or product. (e) Non-responsiveness. Failure to provide the information required by paragraphs (c) and (d) of this clause may cause the Contracting Officer to find an offer nonresponsive and reject it. (f) Eligibility. (1) Participation in the Mentor-Protégé Program established under section 831 of the National Defense Authorization Act for Fiscal Year 1991 (25 U.S.C. 47 note) does not render an Indian Economic Enterprise ineligible for contracts awarded under the Buy Indian Act. (2) If a contractor no longer meets the definition of an Indian Economic Enterprise after award, the contractor must notify the Contracting Officer immediately and in writing. The notification must include full disclosure of circumstances causing the contractor to lose eligibility status and a description of any actions that the contractor will take to regain eligibility. Failure to give the Contracting Officer immediate written notification means that: (i) The economic enterprise may be declared ineligible for future contract awards under this part; and (ii) The Contracting Officer may consider termination for default if it is in the best interest of the government. (g) Representation. Under the Buy Indian Act, 25 U.S.C. 47, offers are solicited only from Indian Economic Enterprises (see 326.7106). As required by 352.226–76(b), offerors shall include a completed Indian Economic Enterprise Representation form in response to Sources Sought Notices, Request for Information (RFI) and as part of the proposal submission. The Indian Economic Enterprise Representation form, available on the IHS DAP public website (www.IHS.gov/ DAP), shall be included in synopses, presolicitation notices, and solicitations for the acquisitions under the Buy Indian Act. Offers received from enterprises that are not Indian Economic Enterprises shall not be considered. (End of clause) 352.226–75 Indian Economic Enterprise Subcontracting Limitations. As prescribed in 326.7105(c), insert the following clause: Indian Economic Enterprise Subcontracting Limitations (DATE) (a) Definitions. As used in this clause— (1) Indian Economic Enterprise means any business activity owned by one or more Indians or Indian Tribes that is established for the purpose of profit provided that: The combined Indian or Indian Tribe ownership must constitute not less than 51 percent of the enterprise; the Indians or Indian Tribes must, together, receive at least a majority of the earnings from the contract; and the management and daily business operations of an enterprise must be controlled by one or more individuals who are Indians. To ensure actual control over the enterprise, the E:\FR\FM\03OCP2.SGM 03OCP2 80702 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules individuals must possess requisite management or technical capabilities directly related to the primary industry in which the enterprise conducts business. The enterprise must meet these requirements throughout the following time periods: (i) At the time an offer is made in response to a written solicitation; (ii) At the time of the contract award; and (iii) During the full term of the contract. (2) Subcontract means any contract, as defined in FAR subpart 2.1, entered into by a subcontractor to furnish supplies or services for performance of the prime contractor or subcontractor. It includes, but is not limited to, purchase orders, and changes and modifications to purchase orders. (3) Subcontractor means any supplier, distributor, vendor, or firm that furnishes supplies or services to or for a prime contractor or another subcontractor. (b) Required percentages of work by the concern. The contractor must comply with FAR 52.219–14, Limitations on Subcontracting, clause in allocating what percentage of work to subcontract. The contractor shall not subcontract work exceeding the subcontract limitations in FAR 52.219–14 to a concern other than a responsible Indian Economic Enterprise. (c) Work performed by non-IEE subcontractor employees. Any work that an IEE subcontractor does not perform with its own employee shall be considered subcontracted work for the purpose of calculating percentages of subcontract work in accordance with FAR 52.219–14, Limitations on Subcontracting. (d) Cooperation. The Contractor must— (1) Carry out the requirements of this clause to the fullest extent; and (2) Cooperate in any study or survey that the Contracting Officer, Indian Health Service or its agents may conduct to verify the contractor’s compliance with this clause. (e) Incorporation in subcontracts. The contractor must incorporate the substance of this clause, including this paragraph (e), in all subcontracts for general services, architect-engineer (A–E) services and construction awarded under this contract. (End of clause) 352.226–76 Indian Economic Enterprise Representation. ddrumheller on DSK120RN23PROD with PROPOSALS2 As prescribed in 326.7105(d), insert the following provision: Indian Economic Enterprise Representation (DATE) (a) The offeror must represent as part of its offer that it does meet the definition of Indian Economic Enterprise (IEE) as defined in 326.7101 and that it intends to meet the definition of an IEE throughout the performance of the contract. The offeror must notify the contracting officer immediately, via email, if there is any ownership change affecting compliance with this representation. (b) The representation must be made on the designated IHS Indian Economic Enterprise Representation form or any successor forms through which the offeror will certify that the ownership requirements defined by 326.7101 are met. VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 (c) Any false or misleading information submitted by an enterprise when submitting an offer in consideration for an award setaside under the Buy Indian Act is a violation of the law punishable under 18 U.S.C. 1001. False claims submitted as part of contract performance are subject to the penalties enumerated in 31 U.S.C. 3729 to 3731 and 18 U.S.C. 287. (End of provision) 352.227–11, 352.227–14, and 352.227–70 [Redesignated as 352.227–70, 352.227–71, and 352.227–72] 39. Redesignate sections 352.227–11, 352.227–14, and 352.227–70 as sections 352.227–70, 352.227–71, and 352.227– 72. ■ 40. Revise newly redesignated sections 352.227–70 through 352.227– 72 to read as follows: ■ 352.227–70 Patent Rights—Supplement— Exceptional Circumstances. As prescribed in 327.303–70, insert the following clause: Patent Rights—Supplement—Exceptional Circumstances (DATE) (a) Definitions. As used in this clause— Agency means the U.S. Department of Health and Human Services operating division or agency (i.e., Centers for Disease Control and Prevention, Food and Drug Administration, etc.) that is entering into this contract. Class 1 Subject Invention means a Subject Invention described and defined in the Determination of Exceptional Circumstances (DEC) that will be assigned to a third party assignee, or assigned as directed by the Agency. Class 2 Subject Invention means a Subject Invention described and defined in the DEC. Class 3 Subject Invention means a Subject Invention that does not fall into Class 1 or Class 2 as defined in this clause. DEC means the Determination of Exceptional Circumstances signed by ______[insert approving official] on ____ [insert date] and titled ‘‘______[insert description].’’ Invention means any invention or discovery, which is or may be patentable or otherwise protectable under Title 35 of United States Code, or any novel variety of plant that is or may be protectable under the Plant Variety Protection Act (7 U.S.C. 2321, et seq.) Made means, when used in relation to any invention other than a plant variety, the conception or first actual reduction to practice of such invention; or when used in relation to a plant variety, that the Contractor has at least tentatively determined that the variety has been reproduced with recognized characteristics. Material means any proprietary material, method, product, composition, compound, or device, whether patented or unpatented, which is provided to the Contractor under this contract. Nonprofit organization means a university or other institution of higher education or an organization of the type described in section PO 00000 Frm 00070 Fmt 4701 Sfmt 4702 501(c)(3) of the Internal Revenue Code of 1954 (26 U.S.C. 501(c)) and exempt from taxation under section 501(a) of the Internal Revenue Code (26 U.S.C. 501(a)) or any nonprofit scientific or educational organization qualified under a state nonprofit organization statute. Practical application means to manufacture, in the case of a composition or product; to practice, in the case of a process or method, or to operate, in the case of a machine or system; and, in each case, under such conditions as to establish that the invention is being utilized and that its benefits are, to the extent permitted by law or Government regulations, available to the public on reasonable terms. Small business firm means a small business concern as defined at section 2 of Public Law 85–536, 15 U.S.C. 632 et seq., and FAR 19.102. For the purpose of this clause, the size standards for small business concerns involved in Government procurement and subcontracting at 13 CFR 121.401 through 413, will be used. Subject invention means any invention of the Contractor made in the performance of work under this contract. Third party assignee means any entity or organization that may, as described in the DEC, be assigned Class 1 inventions. (b) General. This clause applies to all Contractor and subcontractor (at all tiers) Subject Inventions. (c) Allocation of principal rights. (1) Retention of pre-existing rights. Third party assignees shall retain all preexisting rights to Material in which the third party assignee has a proprietary interest. (2) Allocation of Subject Invention rights. (i) Disposition of Class 1 Subject Inventions. (A) Assignment to the third party assignee or as directed by the Agency. The Contractor shall assign to the third party assignee designated by the Agency the entire right, title, and interest throughout the world to each Subject Invention, or otherwise dispose of or transfer those rights as directed by the Agency, except to the extent that rights are retained by the Contractor under paragraph (c)(3) of this clause. Any such assignment or other disposition or transfer of rights will be subject to a nonexclusive, nontransferable, irrevocable, paid-up license to the U.S. Government to practice or have practiced the Subject Invention for or on behalf of the U.S. throughout the world. Any assignment shall additionally be subject to the ‘‘March-in rights’’ of 35 U.S.C. 203. If the Contractor is a U.S. nonprofit organization it may retain a royalty free, nonexclusive, nontransferable license to practice the invention for all nonprofit research including for educational purposes, and to permit other U.S. nonprofit organizations to do so. (B) [Reserved] (ii) Disposition of Class 2 and 3 Subject Inventions. Class 2 Subject Inventions shall be governed by FAR clause 52.227–11, Patent Rights-Ownership by the Contractor. However, the Contractor shall grant a license in the Class 2 Subject Inventions to the provider of the Material or other party designated by the Agency as set forth in Alternate I of this clause, if incorporated. E:\FR\FM\03OCP2.SGM 03OCP2 ddrumheller on DSK120RN23PROD with PROPOSALS2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules (iii) Class 3 Subject Inventions shall be governed by FAR clause 52.227–11, Patent Rights—Ownership by the Contractor. (3) Greater rights determinations. The Contractor, or an employee-inventor after consultation by the Agency with the Contractor, may request greater rights than are provided in paragraph (c)(1) of this clause in accordance with the procedures of FAR 27.304–1(c). In addition to the considerations set forth in FAR 27.304–1(c), the Agency may consider whether granting the requested greater rights will interfere with rights of the Government or any third party assignee or otherwise impede the ability of the Government or the third party assignee to, for example, develop and commercialize new compounds, dosage forms, therapies, preventative measures, technologies, or other approaches with potential for the diagnosis, prognosis, prevention, and treatment of human diseases. (i) A request for a determination of whether the Contractor or the employee-inventor is entitled to retain such greater rights must be submitted to the Agency Contracting Officer at the time of the first disclosure of the invention pursuant to paragraph (d)(1) of this clause, and in accordance with the procedures of FAR 27.304–1(c) or not later than 8 months thereafter, unless a longer period is requested in writing by the Contractor and authorized in writing by the Contracting Officer for good cause. Each determination of greater rights under this contract shall be subject to FAR clause 52.227–13, paragraph (c) and to any reservations and conditions deemed to be appropriate by the Agency such as the requirement to assign or exclusively license the rights to Subject Inventions to the third party assignee. (ii) A determination by the Agency denying a request by the Contractor for greater rights in a Subject Invention may be appealed within 30 days of the date the Contractor is notified of the determination to an Agency official at a level above the individual who made the determination. If greater rights are granted, the Contractor must file a patent application on the invention. Upon request, the Contractor shall provide the filing date, serial number and title, a copy of the patent application (including an English-language version if filed in a language other than English), and patent number and issue date for any Subject Invention in any country for which the Contractor has retained title. Upon request, the Contractor shall furnish the Government an irrevocable power to inspect and make copies of the patent application file. (d) Invention disclosure by Contractor. The Contractor shall disclose in writing each Subject Invention to the Contracting Officer and to the Director, Division of Extramural Inventions and Technology Resources (DEITR), if directed by the Contracting Officer, as provided in paragraph (j) of this clause within 2 months after the inventor discloses it in writing to Contractor personnel responsible for patent matters. (1) The disclosure to the Contracting Officer shall be in the form of a written report and shall identify the contract under which the invention was made and all inventors. It VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 shall be sufficiently complete in technical detail to convey a clear understanding to the extent known at the time of the disclosure, of the nature, purpose, operation, and the physical, chemical, biological, or electrical characteristics of the invention. The disclosure shall also identify any publication, on sale (offer for sale), or public use of the invention and whether a manuscript describing the invention has been submitted for publication, and if so, whether it has been accepted for publication at the time of disclosure. (2) In addition, after disclosure to the Agency, the Contractor will promptly notify the Contracting Officer and DEITR of the acceptance of any manuscript describing the invention for publication or of any on sale or public use planned by the Contractor. If the Contractor assigns a Subject Invention to the third party assignee, then the Contractor and its employee inventors shall assist the third party assignee in securing patent protection. All costs of securing the patent, including the cost of the Contractor’s assistance, are at the third party’s expense. Any assistance provided by the Contractor and its employee inventors to the third party assignee or other costs incurred in securing patent protection shall be solely at the third party’s expense and not billable to the contract. (e) Contractor action to protect the third party assignee’s and the Government’s interest. (1) The Contractor agrees to execute or to have executed and promptly deliver to the Agency all instruments necessary to: Establish or confirm the rights the Government has throughout the world in Subject Inventions pursuant to paragraph (c) of this clause; convey title to a third party assignee in accordance with paragraph (b) of this clause; and enable the third party assignee to obtain patent protection throughout the world in that Subject Invention. (2) The Contractor agrees to require, by written agreement, its employees, other than clerical and nontechnical employees, to disclose promptly in writing to personnel identified as responsible for the administration of patent matters and in a format suggested by the Contractor, each Subject Invention ‘‘made’’ under contract in order that the Contractor can comply with the disclosure provisions of paragraph (c) of this clause, and to execute all papers necessary to file patent applications on Subject Inventions and to establish the Government’s rights or a third party assignee’s rights in the Subject Inventions. This disclosure format should require, as a minimum, the information required by subparagraph (c)(1) of this clause. The Contractor shall instruct such employees, through employee agreements or other suitable educational programs, on the importance of reporting inventions in sufficient time to permit the filing of patent applications prior to U.S. or foreign statutory bars. (3) If the Contractor is granted greater rights, the Contractor agrees to include, within the specification of any United States non-provisional patent application it files, and any patent issuing thereon, covering a Subject Invention the following statement: PO 00000 Frm 00071 Fmt 4701 Sfmt 4702 80703 ‘‘This invention was made with Government support under (identify the Contract) awarded by (identify the specific Agency). The Government has certain rights in the invention.’’ (4) The Contractor agrees to provide a final invention statement and certification prior to the closeout of the contract listing all Subject Inventions or stating that there were none. (f) Subcontracts. (1) The Contractor shall include this clause in all subcontracts, regardless of tier, for experimental, developmental, or research work. At all tiers, the clause must be modified to identify the parties with the statement: ‘‘References to the Government are not changed, and the subcontractor has all rights and obligations of the Contractor in the clause.’’ The Contractor will not, as part of the consideration for awarding the contract, obtain rights in the subcontractor’s Subject Inventions. (2) In subcontracts, at any tier, the Agency, the subcontractor, and the Contractor agree that the mutual obligations of the parties created by this clause constitute a contract between the subcontractor and the Agency with respect to the matters covered by the clause; provided, however, that nothing in this paragraph is intended to confer any jurisdiction under the Contract Disputes Act in connection with proceedings under paragraph (k)(1)(4) of FAR clause 52.227–11. (g) Reporting on utilization of Subject Inventions in the event greater rights are granted to the Contractor. The Contractor agrees to submit, on request, periodic reports no more frequently than annually on the utilization of a Subject Invention or on efforts at obtaining such utilization that are being made by the Contractor or its licensees or assignees when a request under paragraph (c)(3). has been granted by the Agency. Such reports shall include information regarding the status of development, date of first commercial sale or use, gross royalties received by the Contractor, and such other data and information as the Agency may reasonably specify. The Contractor also agrees to provide additional reports as may be requested by the Agency in connection with any march-in proceeding undertaken by the Agency in accordance with paragraph (h) of this clause. As required by 35 U.S.C. 202(c)(5), the Agency agrees it will not disclose such information to persons outside the Government without permission of the Contractor. (h) Preference for United States industry in the event greater rights are granted to the Contractor. Notwithstanding any other provision of this clause, the Contractor agrees that neither it nor any assignee will grant to any person the exclusive right to use or sell any Subject Invention in the United States unless such person agrees that any product embodying the Subject Invention or produced through the use of the Subject Invention will be manufactured substantially in the United States. However, in individual cases, the requirement for such an agreement may be waived by the Agency upon a showing by the Contractor or its assignee that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United E:\FR\FM\03OCP2.SGM 03OCP2 ddrumheller on DSK120RN23PROD with PROPOSALS2 80704 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules States or that under the circumstances domestic manufacture is not commercially feasible. (i) March-in rights in the event greater rights are granted to the Contractor. The Contractor acknowledges that, with respect to any Subject Invention in which it has acquired ownership through the exercise of the rights specified in paragraph (c)(3) of this clause, the Agency has the right to require licensing pursuant to 35 U.S.C. 203 and 210(c), and in accordance with the procedures in 37 CFR 401.6 and any supplemental regulations of Agency in effect on the date of contract award. (j) Special provisions for contracts with nonprofit organizations in the event greater rights are granted to the Contractor. If the Contractor is a nonprofit organization, it shall— (1) Not assign rights to a Subject Invention in the United States without the written approval of the Agency, except where an assignment is made to an organization that has as one of its primary functions the management of inventions, provided that the assignee shall be subject to the same provisions as the Contractor; (2) Share royalties collected on a Subject Invention with the inventor, including Federal employee co-inventors (but through their Agency if the Agency deems it appropriate) when the Subject Invention is assigned in accordance with 35 U.S.C. 202(e) and 37 CFR 401.10; (3) Use the balance of any royalties or income earned by the Contractor with respect to Subject Inventions, after payment of expenses (including payments to inventors) incidental to the administration of Subject Inventions for the support of scientific research or education; (4) Make efforts that are reasonable under the circumstances to attract licensees of Subject Inventions that are small business concerns, and give a preference to a small business concern when licensing a Subject Invention if the Contractor determines that the small business concern has a plan or proposal for marketing the invention which, if executed, is equally as likely to bring the invention to practical application as any plans or proposals from applicants that are not small business concerns; provided, that the Contractor is also satisfied that the small business concern has the capability and resources to carry out its plan or proposal. The decision whether to give a preference in any specific case will be at the discretion of the Contractor; and (5) Allow the Secretary of Commerce to review the Contractor’s licensing program and decisions regarding small business applicants, and negotiate changes to its licensing policies, procedures, or practices with the Secretary of Commerce when the Secretary’s review discloses that the Contractor could take reasonable steps to more effectively implement the requirements of paragraph (i)(4) of this clause. (k) Communications. All invention disclosures and requests for greater rights shall be sent to the Agency Contracting Officer, as directed by the Contracting Officer. Additionally, a copy of all disclosures, confirmatory licenses to the VerDate Sep<11>2014 20:56 Oct 02, 2024 Jkt 265001 Government, face page of the patent applications, waivers and other routine communications under this funding agreement at all tiers must be sent to: [llllll Insert Agency Address] Agency Invention Reporting website: https:// public.era.nih.gov/iedison. (End of clause) Alternate I (DATE). As prescribed in 327.303–70, the license to Class 2 inventions recited in 352.227– 70(c)(2)(ii) is as follows: [llllll Insert description of license to Class 2 inventions] 352.227–71 Rights in Data—Supplement— Exceptional Circumstances. As prescribed in 327.409–70(a), insert the following clause: Rights in Data—Supplement—Exceptional Circumstances (DATE) (a) In addition to any other provisions, set forth in this contract, the Contractor shall ensure that information concerning possible inventions made under this contract is not prematurely published thereby adversely affecting the ability to obtain patent protection on such inventions. Accordingly, the Contractor will provide the Contracting Officer a copy of any publication or other public disclosure relating to the work performed under this contract at least 30 days in advance of the disclosure. Upon the Contracting Officer’s request, the Contractor agrees to delay the public disclosure of such data or publication of a specified paper for a reasonable time specified by the Contracting Officer, not to exceed 6 months, to allow for the filing of domestic and international patent applications in accordance with HHSAR clause at 352.227– 70, Patent Rights—Supplement—Exceptional Circumstances. (See FAR clause at 52.227– 14, Rights in Data-General.) (b) The Contractor agrees that in accordance with FAR clause 52.214–14, paragraph (d)(2), proprietary data on material(s) provided to the Contractor under or through this contract shall be used only for the purpose for which they were provided, including screening, evaluation or optimization and for no other purpose. (End of clause) 352.227–72 Publications and Publicity. As prescribed in 327.409–70(b), insert the following clause: Publications and Publicity (DATE) (a) Unless otherwise specified in this contract, the Contractor may publish the results of its work under this contract. The Contractor shall promptly send to the Contracting Officer’s Representative— (1) A copy of each article submitted for publication; (2) Information of when the article or other publication is published; and, (3) A copy of the published article. (b) Unless authorized in writing by the Contracting Officer, the Contractor shall not display the HHS logo or the official HHS seal, including HHS Operating Division or Staff Division logos, on any publications. PO 00000 Frm 00072 Fmt 4701 Sfmt 4702 (c) The Contractor shall not reference the product(s) or service(s) awarded under this contract in advertising, as defined in FAR 31.205–1, in any manner which states or implies HHS approval or endorsement of the product(s) or service(s) provided. (d) The contractor shall include this clause in all subcontracts where the subcontractor may propose publishing the results of its work under a subcontract. (End of clause) ■ 41. Revise sections 352.231–70 through 352.237–75 to read as follows: * * * * * Sec. 352.231–70 Salary Rate Limitation. 352.232–70 Incremental Funding. 352.232–71 Electronic Submission of Payment Requests. 352.233–70 Choice of Law (Overseas). 352.233–71 Litigation and Claims. 352.236–70 Design-Build Contracts. 352.237–70 Nonsmoking Policy—Delivery of Services to Children. 352.237–71 Reporting of Child Abuse. 352.237–72 Requirement for Background Checks. 352.237–73 Indian Child Protection and Family Violence Act—Background Investigations. 352.237–74 Non-Discrimination in Service Delivery. 352.237–75 Key Personnel. * * 352.231–70 * * * Salary Rate Limitation. As prescribed in 331.171, insert the following clause: Salary Rate Limitation (DATE) (a) The Contractor shall not use contract funds to pay the direct salary of an individual at a rate in excess of the Federal Executive Schedule Level II in effect on the date the contract was awarded. (b) For purposes of the salary rate limitation, the terms ‘‘direct salary,’’ ‘‘salary,’’ and ‘‘institutional base salary,’’ have the same meaning and are collectively referred to as ‘‘direct salary,’’ in this clause. An individual’s direct salary is the annual compensation that the Contractor pays for an individual’s direct effort (costs) under the contract. Direct salary excludes any income that an individual may be permitted to earn outside of duties to the Contractor. Direct salary also excludes fringe benefits, overhead, and general and administrative expenses (also referred to as indirect costs or facilities and administrative costs). The salary rate limitation does not restrict the salary that an organization may pay an individual working under a Department of Health and Human Services contract or order; it merely limits the portion of that salary that may be paid with contract funds. (c) The salary rate limitation also applies to individuals under subcontracts. (d) If this is a multiple-year contract or order, it may be subject to unilateral modification by the Contracting Officer to ensure that an individual is not paid at a rate that exceeds the salary rate limitation provision established in the HHS appropriations act used to fund this contract. E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules (e) See the salaries and wages pay tables on the Office of Personnel Management website for Federal Executive Schedule salary levels. (f) Contractors shall flow down this clause into any resulting subcontract(s). (End of clause) 352.232–70 Incremental Funding. As prescribed in 332.706–2(b), insert the following provision: Incremental Funding (DATE) The Government intends to negotiate and award a cost-reimbursement contract using incremental funding as described in the clause at FAR 52.232–22, ‘‘Limitation of Funds’’. The initial obligation of funds under the contract is expected to cover llllll[insert the appropriate increment of performance]. The Government intends to obligate additional funds up to and including the full estimated cost of the contract for the remaining periods of performance by unilateral contract modification. However, the Government is not required to reimburse the Contractor for costs incurred in excess of the total amount obligated, nor is the Contractor required to perform beyond the level supported by the total amount obligated. (End of provision) 352.232–71 Electronic Submission of Payment Requests. ddrumheller on DSK120RN23PROD with PROPOSALS2 As prescribed in 332.7003, insert the following clause: Electronic Submission of Payment Requests (DATE) (a) Definitions. As used in this clause— Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), ‘‘Content of Invoices’’, and the applicable Payment clause included in this contract. (b) Submission instructions. Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site. (c) Alternate submission procedures. The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures. (d) Submission of alternate payment procedures authorization. If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer’s written authorization with each payment request. (End of clause) 352.233–70 Choice of Law (Overseas). As prescribed in 333.215–70(a), insert the following clause: Choice of Law (Overseas) (DATE) VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 This contract shall be construed in accordance with the substantive laws of the United States of America. By the execution of this contract, the Contractor expressly agrees to waive any rights to invoke the jurisdiction of local national courts where this contract is performed and agrees to accept the exclusive jurisdiction of the United States Civilian Board of Contract Appeals or the United States Court of Federal Claims for hearing and determination of any and all disputes that may arise under the Disputes clause of this contract. (End of clause) 352.233–71 Litigation and Claims. As prescribed in 333.215–70(b), insert the following clause: Litigation and Claims (DATE) (a) The Contractor shall provide written notification immediately to the Contracting Officer of any action, including any proceeding before an administrative agency, filed against the Contractor arising out of the performance of this contract, including, but not limited to the performance of any subcontract hereunder; and any claim against the Contractor the cost and expense of which is allowable under the clause entitled ‘‘Allowable Cost and Payment.’’ (b) Except as otherwise directed by the Contracting Officer, the Contractor shall furnish immediately to the Contracting Officer copies of all pertinent documents received by the Contractor with respect to such action or claim. To the extent not in conflict with any applicable policy of insurance, the Contractor may, with the Contracting Officer’s approval, settle any such action or claim. If required by the Contracting Officer, the Contractor shall effect an assignment and subrogation in favor of the Government of all the Contractor’s rights and claims (except those against the Government) arising out of any such action or claim against the Contractor; and authorize representatives of the Government to settle or defend any such action or claim and to represent the Contractor in, or to take charge of, any action. (c) If the Government undertakes a settlement or defense of an action or claim, the Contractor shall furnish all reasonable assistance in effecting a settlement or asserting a defense. Where an action against the Contractor is not covered by a policy of insurance, the Contractor shall, with the approval of the Contracting Officer, proceed with the defense of the action in good faith. The Government shall not be liable for the expense of defending any action or for any costs resulting from the loss thereof to the extent that the Contractor would have been compensated by insurance which was required by other terms or conditions of this contract, by law or regulation, or by written direction of the Contracting Officer, but which the Contractor failed to secure through its own fault or negligence. In any event, unless otherwise expressly provided in this contract, the Government shall not reimburse or indemnify the Contractor for any liability loss, cost, or expense, which the Contractor may incur or be subject to by reason of any loss, injury or damage, to the person or to PO 00000 Frm 00073 Fmt 4701 Sfmt 4702 80705 real or personal property of any third parties as may accrue during, or arise from, the performance of this contract. (End of clause) 352.236–70 Design-Build Contracts. As prescribed in 336.570(a), insert the following clause: Design-Build Contracts (DATE) (a) General. (1) The contract constitutes and defines the entire agreement between the Contractor and the Government. This contract includes the standard or special contract clauses and schedules included at the time of award. This contract incorporates by reference: (i) The solicitation in its entirety (with the exception of instructions to offerors and evaluation criteria which do not become part of the award document); (ii) The specifications and statement of work; (iii) All drawings, cuts and illustrations, included in the solicitation and any amendments during all proposal phases leading up to award; (iv) Exhibits and other attachments; and (v) The successful Offeror’s accepted proposal. (2) In the event of conflict or inconsistency between any of the requirements of the various portions of this contract, precedence shall be given in the following order: (i) Betterments: Any portions of the Offeror’s proposal which exceed the requirements of the solicitation and which go beyond repair and improve the value of the property. (ii) The contract clauses and schedules included during the solicitation or at the time of award. (iii) All requirements (other than betterments) of the accepted proposal. (iv) Any design products, including but not limited to plans, specifications, engineering studies and analyses, shop drawings, equipment installation drawings, etc. These are ‘‘deliverables’’ under the contract and are not part of the contract itself. (3) Design products must conform to all requirements of the contract, in the order of precedence stated here. (b) Responsibility of the contractor for design. (1) The Contractor shall be responsible for the professional quality, technical accuracy, and the coordination of all designs, drawings, specifications, and other non-construction services furnished by the Contractor under this contract. The Contractor shall, without additional compensation, correct or revise any errors or deficiency in its designs, drawings, specifications, and other non-construction services and perform any necessary rework or modifications, including any damage to real or personal property, resulting from the design error or omission. (2) Neither the Government’s review, approval or acceptance of, nor payment for, the services required under this contract shall be construed to operate as a waiver of any rights under this contract or of any cause of action arising out of the performance of this contract. The Contractor shall be and remain liable to the Government in E:\FR\FM\03OCP2.SGM 03OCP2 ddrumheller on DSK120RN23PROD with PROPOSALS2 80706 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules accordance with applicable law for all damages to the Government caused by the Contractor’s negligent performance of any of these services furnished under this contract. (3) The rights and remedies of the Government provided for under this contract are in addition to any other rights and remedies provided by law. (4) If the Contractor is comprised of more than one legal entity each such entity shall be jointly and severally liable with respect to all rights and remedies of the Government. (c) Sequence of design—construction. (1) After receipt of the Contract Award, the Contractor shall initiate design, comply with all design submission requirements, and obtain Government review of each submission. No construction may be started until the Government reviews the Final Design submission and determines it satisfactory for purposes of beginning construction. The Contracting Officer will notify the Contractor when the design is cleared for construction. The Government will not grant any time extension for any design resubmittal required when, in the opinion of the Contracting Officer, the initial submission failed to meet the minimum quality requirements as set forth in the Contract. (2) If the Government allows the Contractor to proceed with limited construction based on pending minor revisions to the reviewed Final Design submission, no payment will be made for any completed or in-progress construction related to the pending revisions until they are completed, resubmitted, and are satisfactory to the Government. (3) No payment will be made for any completed or in-progress construction until all required submittals have been made, reviewed, and are satisfactory to the Government. (d) Constructor’s role during design. The Contractor’s construction management key personnel shall be actively involved during the design process to effectively integrate the design and construction requirements of this contract. In addition to the typical required construction activities, the constructor’s involvement includes, but is not limited to actions such as: integrating the design schedule into the Master Schedule to maximize the effectiveness of fast-tracking design and construction (within the limits, if any, allowed in the contract), ensuring constructability and economy of the design, integrating the shop drawing and installation drawing process into the design, executing the material and equipment acquisition programs to meet critical schedules, effectively interfacing the construction Quality Control (QC) program with the design QC program, and maintaining and providing the design team with accurate, upto-date redline and as-built documentation. The Contractor shall require and manage the active involvement of key trade subcontractors in the above activities. (e) Preconstruction conference. (1) A preconstruction conference will be arranged by the Contracting Officer after award of contract and before commencement of work. The Contracting Officer or designated representative will notify the Contractor of the time, date, and location for the meeting. VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 At this conference, the Contractor shall be oriented with respect to Government procedures and line of authority, contractual, administrative, and construction matters. (2) The Contractor shall bring to this conference, in completed form, a Certificate of Insurance, plus the following items in either completed or draft form— (i) Accident Prevention Plan; (ii) Quality Control Plan; (iii) Letter Appointing Superintendent; (iv) Transmittal Register; (v) Power of Attorney and Certified Copy of Resolution; (vi) Network Analysis System, (when identified in the contract schedule as applicable); (vii) List of Subcontractors; (viii) SF 1413; (ix) Performance and Payment Bonds; and (x) Schedule of Values. (3) A letter of record will be written documenting all items discussed at the conference, and a copy will be furnished by the Contracting Officer to all in attendance. (f) Payment for design under fixed-price design-build contracts. (1) The Contracting Officer may approve progress payments for work performed during the project design phase up to the maximum amount of ll [Contracting Officer to insert percent figure up to 6%.] If none stated, the amount is four (4) percent of the contract price. (2) Contractor invoices for payment must be accompanied by satisfactory documentation supporting the amounts for which payments are requested. Progress payments approved by the Contracting Officer during the project design phase in no way constitute an acceptance of functional and aesthetic design elements nor acceptance of a final settlement amount in the event of a buy-out nor a waiver of any contractual requirements. (g) Unscheduled jobsite shutdowns. Due to security reasons during the life of this contract the Government may on an unscheduled basis require the contractor to shut down its jobsite for two days per year at no additional cost. This shall not constitute a suspension of work under FAR 52.242–14, Suspension of Work. (End of clause) Alternate I (DATE). When fast track procedures are being used, replace paragraph (c) of the basic clause with the following: (c) Sequence of design build. (1) After receipt of the Contract Award the Contractor shall initiate design, comply with all design submissions requirements and obtain Government review of each submission. The contractor may begin construction on portions of the work for which the Government has reviewed the final design submission and has determined satisfactory for purposes of beginning construction. The Contracting Officer will notify the Contractor when the design is cleared for construction. The Government will not grant any time extension for any design resubmittal PO 00000 Frm 00074 Fmt 4701 Sfmt 4702 required when, in the opinion of the Contracting Officer, the initial submission failed to meet the minimum quality requirements as set forth in the Contract. (2) If the Government allows the Contractor to proceed with the construction based on pending minor revisions to the reviewed Final Design submission, no payment will be made for any in-place construction related to the pending revisions until they are completed, resubmitted, and are satisfactory to the Government. (3) No payment will be made for any in-place construction until all required submittals have been made, reviewed, and are satisfactory to the Government. 352.237–70 Nonsmoking Policy—Delivery of Services to Children. As prescribed in 337.7006(a), insert the following clause: Nonsmoking Policy—Delivery of Services to Children (DATE) (a) Prohibition. Smoking is prohibited in facilities where certain federally funded children’s services are provided pursuant to the Pro-Children Act of 2001 (20 U.S.C. 7181, Public Law 107–110, sec. 4301 (the Act)). Accordingly, smoking is prohibited within any indoor facility (or portion thereof), whether owned, leased, or contracted for, or involving indoor facilities that are constructed, operated, or maintained with Federal funds, that is used for the routine or regular provision of— (1) Kindergarten, elementary, or secondary education or library services, or (2) Health or day care services that are provided to children under the age of 18. (b) Agreement. The offeror represents and understands that by submission of its bid or offer and if awarded a contract for this requirement, the Contractor agrees to comply with the requirements of the Act and the prohibition of smoking in facilities as specified in paragraph (a) of this clause. The Contractor shall enforce the provisions of this clause and ensure that each of its employees, subcontractors and any subcontractor staff, is made aware of, understands, and complies with the provisions of the Act. (c) Penalties. Failure to comply with the Act may result in the imposition of a civil monetary penalty in an amount not to exceed $1,000 for each violation and/or the imposition of an administrative compliance order on the responsible party. Each day a violation continues constitutes a separate violation. In the case of any civil penalty assessed, the total amount shall not exceed 50 percent of the amount of Federal funds received by the Contractor for the fiscal year in which the continuing violation occurred. Penalties will be imposed only after appropriate written notice, or an administrative compliance order may be issued by the designated HHS official only after an opportunity for a hearing in accordance with 5 U.S.C. 554. Before making such assessment or issuing such order, or both, the Secretary of HHS or designee shall E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules give written notice of the assessment or order to the Contractor by certified mail with return receipt and provide information in the notice of an opportunity to request in writing, not later than 30 days after the date of receipt of such notice, such hearing. Notwithstanding any specific civil penalties and compliance orders referenced herein, the Contracting Officer may take other remedies under the contract for failure to comply with the terms and conditions of the contract. (d) Subcontract flow down. The Contractor shall insert the text of this clause, including this paragraph (d), in subcontracts at any tier. The Contractor shall be responsible for compliance by any subcontractor or lowertier subcontractor with the provisions set forth in paragraphs (a) through (c) of this clause. requirement, the Contractor agrees to comply with the requirements of the Act. The Act also applies to all applicable subcontracts awarded under this contract. Accordingly, the Contractor shall ensure that each of its employees, and any subcontractor staff, is made aware of, understands, and complies with the provisions of the Act. (e) Subcontract flow down. The Contractor shall insert the text of this clause, including this paragraph (d), in subcontracts at any tier. The Contractor shall be responsible for compliance by any subcontractor or lowertier subcontractor with the provisions set forth in paragraphs (a) through (d) of this clause. (End of clause) 352.237–72 Checks. 352.237–71 As prescribed in 337.7006(c), insert the following clause: Reporting of Child Abuse. ddrumheller on DSK120RN23PROD with PROPOSALS2 As prescribed in 337.7006(b), insert the following clause: Reporting of Child Abuse (DATE) (a) Definitions. As used in this clause— Child abuse means the physical or mental injury, sexual abuse or exploitation, or negligent treatment of a child. Covered professionals means those persons engaged in professions and activities in eight different categories including, but not limited to, teachers, social workers, physicians, dentists, medical residents or interns, hospital personnel and administrators, nurses, health care practitioners, chiropractors, osteopaths, pharmacists, optometrists, podiatrists, emergency medical technicians, ambulance drivers, alcohol or drug treatment personnel, psychologists, psychiatrists, mental health professionals, child care workers and administrators, and commercial film and photo processors. (b) Responsibility to report child abuse. Public Law 101–647, known as the Crime Control Act of 1990 (the Act) (34 U.S.C. 20341), imposes responsibilities on certain individuals (i.e., covered professionals) to report child abuse who, while engaged in a professional capacity or activity, as defined in the Act, on Federal land or in a federallyoperated (or contracted) facility, learn of facts that give the individual reason to suspect that a child has suffered an incident of child abuse. (c) Reporting protocols. Accordingly, any person engaged in a covered profession or activity under an HHS contract or subcontract, regardless of the purpose of the contract or subcontract, shall immediately report a suspected child abuse incident in accordance with the provisions of the Act. If a child is suspected of being harmed, the appropriate State Child Abuse Hotline, local child protective services (CPS), or law enforcement agency shall be contacted. For more information about where and how to file a report, contact the Childhelp USA, National Child Abuse Hotline (1–800–4–A– CHILD). Any covered professional failing to make a timely report of such incident shall be guilty of a Class B misdemeanor. (d) Agreement. The offeror represents and understands that by submission of its bid or offer and if awarded a contract for this VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 (End of clause) Requirement for Background Requirement for Background Checks (DATE) (a) Definition. As used in this clause— Child care services means and include, but are not limited to, social services, health and mental health care, child (day) care, education (whether or not directly involved in teaching), and rehabilitative programs. (b) Requirement for background checks. Public Law 101–647, known as the Crime Control Act of 1990 (the Act) (34 U.S.C. 20351), requires that all individuals involved with the provision of child care services to children under the age of 18 undergo a criminal background check. Any conviction for a sex crime, an offense involving a child victim, or a drug felony, may be grounds for denying employment or for dismissal of an employee providing any child care services. (c) Background check protocols. The Contracting Officer will provide the necessary information to the Contractor regarding the process for obtaining the background check. The Contractor may hire a staff person provisionally prior to the completion of a background check, if at all times prior to the receipt of the background check during which children are in the care of the newly-hired person, the person is within the sight and under the supervision of a previously investigated staff person. (d) Agreement. The offeror represents and understands that by submission of its bid or offer and if awarded a contract for this requirement, the Contractor agrees to comply with the requirements of the Act. The Act also applies to all applicable subcontracts awarded under this contract. Accordingly, the Contractor shall ensure that each of its employees, and any subcontractor staff, is made aware of, understands, and complies with the provisions of the Act. (e) Subcontract flow down. The Contractor shall insert the text of this clause, including this paragraph (d), in subcontracts at any tier. The Contractor shall be responsible for compliance by any subcontractor or lowertier subcontractor with the provisions set forth in paragraphs (a) through (d) of this clause. (End of clause) PO 00000 Frm 00075 Fmt 4701 Sfmt 4702 80707 352.237–73 Indian Child Protection and Family Violence Act—Background Investigations. As prescribed in 337.7006(d), insert the following clause: Indian Child Protection and Family Violence Act—Background Investigations (DATE) (a) Requirement for background checks. This contract is subject to the Indian Child Protection and Family Violence Act, Public Law 101–630 (25 U.S.C. 3201, et seq.). The duties and responsibilities required by this contract may involve regular contact with or control over Indian children. Public Law 101–630 prohibits employment, including Personal Service Contracts, with anyone who has been convicted of any crime of violence. Any such conviction should immediately be brought to the attention of the Contracting Officer. Performance under this contract requires a Contractor and its employees and subcontractors to be subject to a background investigation. (b) Background check protocols. The Contractor and its employees and subcontractors, at any tier, will be subject to a character and background investigation, conducted by the Indian Health Service, Office of Human Resources. Until such time as the Contractor or its employees and subcontractors have been notified of completion of the investigation, the Contractor and its employees and subcontractors shall have no unsupervised contact with Indian children. In order to initiate this background investigation, the Contractor and its employees and subcontractors must provide information as required in this contract or as directed by the Contracting Officer. (c) Signed declaration prerequisite. As a prerequisite to providing services under this contract, the Contractor is required to complete and sign the declaration found in Section J of this contract. (d) Subcontract flow down. The Contractor shall insert the text of this clause, including this paragraph (d), in subcontracts at any tier. The Contractor shall be responsible for compliance by any subcontractor or lowertier subcontractor with the provisions set forth in paragraphs (a) through (c) of this clause. (End of clause) 352.237–74 Delivery. Non-Discrimination in Service As prescribed in 337.7006(e), insert the following clause: Non-Discrimination In Service Delivery (DATE) (a) Policy. It is the policy of the Department of Health and Human Services (HHS) that no person otherwise eligible will be excluded from participation in, denied the benefits of, or subjected to discrimination in the administration of HHS programs and services based on non-merit factors such as race, color, national origin, religion, sex, gender identity, sexual orientation, or disability (physical or mental). This includes the requirement for non-discrimination in contracts involving delivery of services under HHS’ programs directly to the public. E:\FR\FM\03OCP2.SGM 03OCP2 80708 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules (b) Agreement. The offeror represents and understands that by submission of its bid or offer and if awarded a contract for this requirement, the Contractor agrees to comply with this policy in supporting the program and in performing the services called for under this contract in a non-discriminatory manner. The contractor shall ensure that each of its employees, and any subcontractor staff, is made aware of, understands, and complies with this policy. (c) Subcontract flow down. The Contractor shall insert the text of this clause, including this paragraph (c), in subcontracts at any tier, in subcontracts that support or perform the specified program and services. The Contractor shall be responsible for compliance by any subcontractor or lowertier subcontractor with the provisions set forth in paragraphs (a) through (c) of this clause. (End of clause) ddrumheller on DSK120RN23PROD with PROPOSALS2 (End of clause) ■ 42. Add sections 352.241–70, 352.242–70, 352.242–71, 352.245–70, 352.247–70, 352.247–71, and 352.247– 72 to read as follows: * * * * * Sec. 352.241–70 Disputes—Utility Contracts. 352.242–70 Administrative Contracting Officer. 352.242–71 Government Construction Contract Administration. 352.245–70 Contractor Property Management System Administration. 352.247–70 Delivery Location. 352.247–71 Marking Deliverables. 352.247–72 Packing for Domestic Shipment. * * VerDate Sep<11>2014 Disputes—Utility Contracts. As prescribed in 341.501–70, insert the following clause: Disputes—Utility Contracts (DATE) (a) Definition. As used in this clause, Independent regulatory body means the Federal Energy Regulatory Commission, a state-wide agency, or an agency with less than state-wide jurisdiction when operating pursuant to state authority. The body has the power to fix, establish, or control the rates and services of utility suppliers. (b) Independent Regulatory Body determinations. The requirements of the Disputes clause at FAR 52.233–1 are supplemented to provide that matters involving the interpretation of tariffed retail rates, tariff rate schedules, and tariffed terms provided under this contract are subject to any determinations by the independent regulatory body having jurisdiction. (End of clause) 352.237–75 Key Personnel. As prescribed in 337.7006(f), insert the following clause: Key Personnel (DATE) The key personnel specified in this contract are essential to work performance under the contract. At least 30 days prior to the Contractor voluntarily diverting any of the specified individuals to other programs or contracts, the Contractor shall notify the Contracting Officer and submit a justification for the diversion or replacement and request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement’s skills, experience, and credentials meet or exceed the requirements of the contract. If the employee of the contractor is terminated for cause or separates from the Contractor voluntarily with less than 30 days’ notice, the Contractor must provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract should be modified to add or delete key personnel as necessary to reflect the agreement of the parties. * 352.241–70 * * 20:17 Oct 02, 2024 Jkt 265001 352.242–70 Officer. Administrative Contracting As prescribed in 342.272(a), insert the following clause: Administrative Contracting Officer (DATE) The Contracting Officer reserves the right to designate an Administrative Contracting Officer (ACO) for the purpose of performing certain tasks/duties in the administration of the contract. Such designation will be in writing through an ACO Letter of Delegation and will identify the responsibilities and limitations of the ACO. A copy of the ACO Letter of Delegation will be furnished to the Contractor. (End of clause) 352.242–71 Government Construction Contract Administration. As prescribed in 342.272(b), insert the following clause. This is a fill-in clause. Government Construction Contract Administration (DATE) (a) Contract administration functions set forth in FAR 42.302 are hereby delegated to: ________[Insert name and office address of Administrative Contracting Officer (ACO)] (b) The following functions will be retained by the Contracting Officer and are not redelegable: ________[Contracting Officer to list all functions set forth in FAR 42.302 that are not redelegable to the ACO, revise the following or enter ‘‘None,’’ when applicable] (1) Award of contract modifications either through supplemental agreements or change orders that exceed the ACO’s appointed warrant limitations. (2) Issuance of default letters. (3) Issuance of Cure or Show-Cause Notices. (4) Suspension of work letters and/or modifications. (5) Issuance of Contracting Officer final determination letters. (6) Issuance of termination notices. (7) Authorization of final payment. (c) The work will be under the direction Contracting Officer or delegated PO 00000 Frm 00076 Fmt 4701 Sfmt 4702 Administrative Contracting Officer as identified in paragraph (a), who may further delegate support services responsibilities to a Contracting Officer’s Representative (COR), as identified below. A copy of the COR Appointment Letter shall be furnished to the Contractor: ________[Contracting Officer or ACO to insert name and office address of COR and list the COR’s delegated authority.] (End of clause) 352.245–70 Contractor Property Management System Administration. As prescribed in 345.107, insert the following clause: Contractor Property Management System Administration (DATE) (a) Definitions. As used in this clause— Acceptable property management system means a property system that complies with the system criteria in paragraph (c) of this clause. Property management system means the Contractor’s system or systems for managing and controlling Government property. Significant deficiency means a shortcoming in the system that materially affects the ability of officials of the Department of Health and Human Services to rely upon information produced by the system that is needed for management purposes. (b) General. The Contractor shall establish and maintain an acceptable property management system. Failure to maintain an acceptable property management system, as defined in this clause, may result in disapproval of the system by the Contracting Officer and/or withholding of payments. (c) System criteria. The Contractor’s property management system shall be in accordance with paragraph (f) of the contract clause at Federal Acquisition Regulation 52.245–1. (d) Significant deficiencies. (1) The Contracting Officer will provide an initial determination to the Contractor, in writing, of any significant deficiencies. The initial determination will describe the deficiency in sufficient detail to allow the Contractor to understand the deficiency. (2) The Contractor shall respond within 30 days to a written initial determination from the Contracting Officer that identifies significant deficiencies in the Contractor’s property management system. If the Contractor disagrees with the initial determination, the Contractor shall state, in writing, its rationale for disagreeing. (3) The Contracting Officer will evaluate the Contractor’s response and notify the Contractor, in writing, of the Contracting Officer’s final determination concerning— (i) Remaining significant deficiencies; (ii) The adequacy of any proposed or completed corrective action; and (iii) System disapproval, if the Contracting Officer determines that one or more significant deficiencies remain. (e) Contracting Officer’s final determination. If the Contractor receives the Contracting Officer’s final determination of significant deficiencies, the Contractor shall, within 45 days of receipt of the final determination, either correct the significant E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules deficiencies or submit an acceptable corrective action plan showing milestones and actions to eliminate the significant deficiencies. Old section 352.270–13 ........................... (End of clause) 352.247–70 352.270–7 and 352.270–8 Delivery Location. Delivery Location (DATE) Shipment of deliverable items, other than reports, shall be to: ______[Contracting Officer shall insert appropriate identifying data]. (End of clause) Marking Deliverables. As prescribed in 347.305–10(a) insert a clause substantially the same as the following: Marking Deliverables (DATE) (a) The contract number shall be placed on or adjacent to all exterior mailing or shipping labels of deliverable items called for by the contract. (b) Mark deliverables, except reports, for: ________[Contracting Officer shall insert appropriate identifying data]. (End of clause) 352.247–72 Shipment. Packing for Domestic As prescribed in 347.305–10(b), insert a clause substantially the same as the following: Packing for Domestic Shipment (DATE) Material shall be packed for shipment in such a manner that will ensure acceptance by common carriers and safe delivery at destination. Containers and closures shall comply with regulations of carriers as applicable to the mode of transportation. (End of clause) 352.270–1 through 352.270–3 [Removed] 43. Remove reserved sections 352.270–1 through 352.270–3. ■ 352.270–4a, 352.270–4b, 352.270–5a, 352.270–5b, 352.270–6, 352.270–9, 352.270– 10, 352.270–11, 352.270–12, and 352.270–13 [Redesignated] 44. Redesignate sections 352.270–4a, 352.270–4b, 352.270–5a, 352.270–5b, 352.270–6, 352.270–9, 352.270–10, 352.270–11, 352.270–12, and 352.270– 13 as follows: ddrumheller on DSK120RN23PROD with PROPOSALS2 ■ Old section 352.270–4a ........................... 352.270–4b ........................... 352.270–5a ........................... 352.270–5b ........................... 352.270–6 ............................. 352.270–9 ............................. 352.270–10 ........................... 352.270–11 ........................... 352.270–12 ........................... VerDate Sep<11>2014 20:17 Oct 02, 2024 352.270–76 [Removed] 45. Remove reserved sections 352.270–7 and 352.270–8. ■ 46. Revise newly redesignated sections 352.270–70 through 352.270– 79 to read as follows: * * * * * ■ As prescribed in 347.303–670, insert a clause substantially the same as the following: 352.247–71 New section New section 352.270–70 352.270–72 352.270–77 352.270–78 352.270–73 352.270–79 352.270–71 352.270–74 352.270–75 Jkt 265001 Sec. 352.270–70 Notice to Offerors—Protection of Human Subjects. 352.270–71 Notice to Offerors—Protection of Human Subjects, Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required. 352.270–72 Protection of Human Subjects. 352.270–73 Restriction on Use of Human Subjects. 352.270–74 Protection of Human Subjects— Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required. 352.270–75 Needle Exchange. 352.270–76 Continued Ban on Funding Abortion and Continued Ban on Funding of Human Embryo Research. 352.270–77 Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals. 352.270–78 Care of Live Vertebrate Animals. 352.270–79 Non-Discrimination for Conscience. * * * * * 352.270–70 Notice to Offerors—Protection of Human Subjects. As prescribed in 370.304(a), insert the following provision: Notice to Offerors—Protection of Human Subjects (DATE) (a) The Department of Health and Human Services (HHS) regulations for the protection of human subjects, 45 CFR part 46, are available on the Office for Human Research Protections (OHRP) website at: https:// www.hhs.gov/ohrp/. These regulations provide a systematic means, based on established ethical principles, to safeguard the rights and welfare of human subjects participating in research activities supported or conducted by HHS. The regulation is also available at https:// www.ecfr.gov/current/title-45/subtitle-A/ subchapter-A/part-46. (b) The regulations at 45 CFR 46.102, among other things, define a human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. In most cases, the regulations extend to the use of human organs, tissue, and body fluids from individually identifiable human PO 00000 Frm 00077 Fmt 4701 Sfmt 4702 80709 subjects as well as to graphic, written, or recorded information derived from individually identifiable human subjects. 45 CFR part 46 does not directly regulate the use of autopsy materials; instead, applicable state and local laws govern their use. (c) Activities which involve human subjects in one or more of the categories set forth in 45 CFR 46.104, Exempt research, are exempt from complying with 45 CFR part 46. See https://www.hhs.gov/ohrp/ humansubjects/guidance/45cfr46.html. (d) Inappropriate designations of the noninvolvement of human subjects or of exempt categories of research in a project may result in delays in the review of a proposal. (e) In accordance with 45 CFR part 46, offerors considered for award shall file an acceptable Federal-wide Assurance (FWA) of compliance with OHRP specifying review procedures and assigning responsibilities for the protection of human subjects. The FWA is the only type of assurance that OHRP accepts or approves. The initial and continuing review of a research project by an institutional review board shall ensure that: The risks to subjects are minimized; risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result; selection of subjects is equitable; and informed consent will be obtained and documented by methods that are adequate and appropriate. Depending on the nature of the research, additional requirements may apply; see 45 CFR 46.111 at https://www.hhs.gov/ohrp/ regulations-and-policy/regulations/45-cfr-46/ revised-common-rule-regulatory-text/ index.html#46.111 for additional requirements regarding initial and continuing review. HHS regulations for the protection of human subjects (45 CFR part 46), information regarding OHRP registration and assurance requirements/processes, and OHRP contact information is available at the OHRP website (at https://www.hhs.gov/ohrp/assurances/ index.html). (f) Offerors may consult with OHRP only for general advice or guidance concerning either regulatory requirements or ethical issues pertaining to research involving human subjects. Only the contracting officer may offer information concerning a solicitation. (g) The offeror shall document in its proposal the approved FWA from OHRP, related to the designated Institutional Review Board (IRB) reviewing and overseeing the research. If the offeror does not have an approved FWA from OHRP, the offeror must obtain an FWA before the deadline for proposal submission. When possible, the offeror shall also certify the IRB’s review and approval of the research. If the offeror cannot obtain this certification by the time of proposal submission they must include an explanation in their proposal. Never conduct research covered by 45 CFR part 46 prior to receiving certification of the research’s review and approval by the IRB. (h) Registering an IRB and obtaining an FWA are related but separate processes. The web page for electronic submission of new IRB registrations and FWAs, or update/ E:\FR\FM\03OCP2.SGM 03OCP2 80710 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules renewal of existing IORGs/IRBs and FWAs is at https://ohrp.cit.nih.gov/efile/Default.aspx. (End of provision) Alternate I (DATE). As prescribed in 370.304(a), the Contracting Officer shall substitute the following paragraph (g) for paragraph (g) of the basic provision. (g) The offeror’s proposal shall document that it has an approved or active FWA from OHRP, related to the designated IRB reviewing and overseeing the research. (1) When possible, the offeror shall also certify the IRB has reviewed and approved the research. If the offeror cannot make this certification at the time of proposal submission, its proposal must include an explanation. Never conduct research covered by 45 CFR part 46 prior to receiving certification of the research’s review and approval by the IRB. (2) If the offeror does not have an active FWA from OHRP, the offeror shall take all necessary steps to obtain an FWA prior to the deadline for proposal submission. If the offeror cannot obtain an FWA before the proposal submission date, the proposal shall indicate the steps/actions the offeror will take to obtain OHRP approval within [Contracting Officer must insert a time period in which the FWA must be obtained]. Upon obtaining FWA approval, submit the approval notice to the Contracting Officer. 352.270–71 Notice to Offerors—Protection of Human Subjects, Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required. ddrumheller on DSK120RN23PROD with PROPOSALS2 As prescribed in 370.304(b), insert the following provision: Notice to Offerors—Protection of Human Subjects, Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required (DATE) (a) All Offerors proposing research expected to involve human subjects shall comply with the regulations set forth in 45 CFR part 46, and with the provision at HHSAR 352.270–70. (b) The Offeror shall have an acceptable Assurance of Compliance on file with the Office for Human Research Protections (OHRP), whenever it submits a proposal to the FDA for research expected to involve human subjects. Direct questions regarding Federal-wide Assurance to OHRP. The Offeror’s proposal shall include a copy of the acceptable Assurance of Compliance. (c) After the contract has been awarded, the Contractor shall take the following actions: (1) The Institutional Review Board (IRB) specified in the Offeror’s Assurance of Compliance, hereafter referred to as ‘‘the local IRB,’’ shall review the proposed research protocol. A letter from the local IRB stating that the proposed research protocol has been reviewed and approved, and thus adequately protects the rights and welfare of VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 human subjects involved, or a letter stating that the proposed research is exempt under 45 CFR 46.101(b) shall be submitted to the Contracting Officer. (2) Upon award, the successful Offeror, hereafter ‘‘the Contractor,’’ shall submit its proposed research protocol to the FDA’s Research Involving Human Subjects Committee (RIHSC). The RIHSC or its designee will review and approve the research protocol to assure it adequately protects the rights and welfare of human subjects involved. The RIHSC or designee will also determine whether the proposed research is exempt under 45 CFR 46.101(b). The Contractor shall submit, to the Contracting Officer of record, a copy of the RIHSC’s or its designee’s letter stating that it reviewed and approved the proposed research protocol. (d) The Contractor shall not advertise for, recruit, or enroll human subjects, or otherwise commence any research involving human subjects until RIHSC or its designee reviews and approves its research. The Contractor may begin other limited aspects of contract performance prior to receiving RIHSC’s or designee’s approval of the proposed research protocol. Research involving human subjects may commence immediately upon the Contractor’s receipt of RIHSC’s or designee’s approval; however, the Contractor shall submit a copy of RIHSC’s or its designee’s approval to the Contracting Officer within three business days of its receipt. (e) A Contractor’s failure to obtain RIHSC’s or its designee’s approval of its proposed research may result in termination of its contract. However, failure to obtain RIHSC’s or its designee’s approval during initial review will not automatically result in termination of the contract. Instead, the Contractor may correct any deficiencies identified during the initial RIHSC or designee review and resubmit the proposed research protocol to RIHSC or its designee for a second review. The Contractor is encouraged to solicit the RIHSC’s or its designee’s input during the resubmission process. (f) The Contractor shall seek RIHSC’s or its designee’s and local IRB review and approval whenever making modifications, amendments, or other changes to the research protocol. Such modifications, amendments and changes include, but are not limited to changes in investigators, informed consent forms, and recruitment advertisements. The Contractor may institute changes immediately after receiving both the local IRB and RIHSC or its designee approval (except when necessary to eliminate apparent immediate hazards to the subject); however, the Contractor shall submit a copy of the letter evidencing RIHSC’s or its designee’s approval of the proposed changes to the Contracting Officer within three business days of its receipt. (a) The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR part 46 and with the Contractor’s current Federalwide Assurance (FWA) on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services. The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR part 46 and the Assurance of Compliance. (b) The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract and shall ensure that work is conducted in a proper manner and as safely as is feasible. The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract. Nothing in this contract shall create an agency or employee relationship between the Government and the Contractor, or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent Contractor without creating liability on the part of the Government for the acts of the Contractor or its employees. (c) Contractors involving other agencies or institutions in activities considered to be engaged in research involving human subjects must ensure that such other agencies or institutions obtain their own FWA if they are routinely engaged in research involving human subjects or ensure that such agencies or institutions are covered by the Contractors’ FWA via designation as agents of the institution or via individual investigator agreements (see OHRP website at: https:// www.hhs.gov/ohrp/register-irbs-and-obtainfwas/). (d) If at any time during the performance of this contract the Contractor is not in compliance with any of the requirements and or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. The Contracting Officer may communicate the notice of suspension by telephone with confirmation in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer’s written notice of suspension, the Contracting Officer may, after consultation with OHRP, terminate this contract in whole or in part. (End of provision) 352.270–73 Subjects. 352.270–72 As prescribed in 370.304(d), insert the following clause: Protection of Human Subjects. As prescribed in 370.304(c), insert the following clause: Protection of Human Subjects (DATE) PO 00000 Frm 00078 Fmt 4701 Sfmt 4702 (End of clause) Restriction on Use of Human Restriction on Use of Human Subjects (DATE) E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules Pursuant to 45 CFR part 46, Protection of Human Research Subjects, the Contractor shall not expend funds under this award for research involving human subjects or engage in any human subjects research activity prior to the Contracting Officer’s receipt of a certification that the research has been reviewed and approved by the Institutional Review Board registered with the Office for Human Research Protections (OHRP). This restriction applies to all collaborating sites, whether domestic or foreign, and subcontractors. The Contractor must ensure compliance by collaborators and subcontractors. (End of clause) 352.270–74 Protection of Human Subjects—Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required. (End of clause) ddrumheller on DSK120RN23PROD with PROPOSALS2 As prescribed in 370.304(e), insert the following clause: Protection of Human Subjects—Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required (DATE) (a) The Contractor agrees to protect the rights and welfare of human subjects involved in research under this contract by complying with 45 CFR part 46 and the clause at HHSAR 352.270–72. (b) Initial proof of compliance with 45 CFR part 46 shall consist of (1) A copy of a current Federal-wide Assurance on file with OHRP. The copy of a current Federal-wide Assurance shall be included with the Contractor’s proposal; (2) A letter from the Contractor’s local IRB (the Institutional Review Board (IRB) specified in the Offeror’s Assurance of Compliance) stating that it has reviewed and approved the proposed research protocol. The letter from the local IRB shall be submitted to the Contracting Office; and (3) A copy of a letter from the RIHSC stating that it or its designee has reviewed and approved the proposed research protocol. This shall be submitted to the Contracting Officer within three business days of its issuance. The Contractor shall not advertise for, recruit, or enroll human subjects, or otherwise commence any research involving human subjects under this contract, until RIHSC has reviewed and approved its research. The Contractor may commence other limited aspects of contract performance prior to receiving RIHSC or its designee approval of its proposed research protocol. Research involving human subjects may commence immediately upon the Contractor’s receipt of RIHSC or its designee approval; however, the Contractor shall submit a copy of RIHSC’s or its designee’s letter of approval to the Contracting Officer within three business days of its receipt. Failure to obtain RIHSC or its designee approval of proposed research protocols may result in the termination of this contract. (c) The Contractor further agrees that: (1) The Contractor will provide a letter from RIHSC, at least annually, stating that RIHSC or its designee has reviewed and approved the research protocols for research performed under this contract. This shall be VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 submitted to the Contracting Officer for inclusion in the contract file. (2) The Contractor will submit all proposed modifications and amendments to research protocols for research performed under this contract to RIHSC for review and approval. Modifications and amendments include, but are not limited, to changes to consent forms and advertising materials, and the addition or deletion of investigators. Changes may be instituted immediately after the Contractor has received both the local IRB and RIHSC or its designee approval (except when necessary to eliminate apparent immediate hazards to the subject); however, the Contractor shall submit a copy of the letter evidencing RIHSC’s or its designee’s approval of the proposed changes to the Contracting Officer within three business days of its receipt. 352.270–75 Needle Exchange. As prescribed in 370.304(f), insert the following clause: Needle Exchange (DATE) The Contractor shall not use any funds obligated under this contract to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug. (End of clause) 352.270–76 Continued Ban on Funding Abortion and Continued Ban on Funding of Human Embryo Research. As prescribed in 370.304(g), insert the following clause: Continued Ban on Funding Abortion and Continued Ban on Funding of Human Embryo Research (DATE) (a) The Contractor shall not use any funds obligated under this contract for any abortion. (b) The Contractor shall not use any funds obligated under this contract for the following— (1) The creation of a human embryo or embryos for research purposes; or (2) Research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury of death greater than that allowed for research on fetuses in utero under 45 CFR part 46 and Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). (c) The term ‘‘human embryo or embryos’’ includes any organism, not protected as a human subject under 45 CFR part 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes of human diploid cells. (d) The Contractor shall not use any Federal funds for the cloning of human beings. (End of clause) 352.270–77 Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals. As prescribed in 370.403(a), insert the following clause: PO 00000 Frm 00079 Fmt 4701 Sfmt 4702 80711 Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (DATE) (a) Definitions. Animal means any live, vertebrate animal used or intended for use in research, research training, experimentation, or biological testing for related purposes. Animal Welfare Assurance or Assurance means the documentation from an institution assuring institutional compliance with the Public Health Service Policy on Human Care and Use of Laboratory Animals available at https://olaw.nih.gov/policies-laws/phspolicy.htm. Institutional Animal Care and Use Committee (IACUC) means an intended generic term for a committee whose function is to ensure that the care and use of animals in PHS-conducted or supported activities are appropriate and humane in accordance with this Policy. However, each institution may identify the committee by whatever name it chooses. An appropriate IACUC performs the functions described in the Public Health Service Policy on Human Care and Use of Laboratory Animals, section IV, paragraph B. (b) Requirement for Written Animal Welfare Assurance and IACUC approval. This contract includes research, research training, biological testing, housing and maintenance, and other activities involving live vertebrate animals and is subject to the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy). The PHS Policy establishes a number of requirements for research activities involving animals. The contract will not be awarded without the approval of the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH) on the successful offeror’s written Animal Welfare Assurance and verification of the proposed institution(s) IACUC approval. (1) Offerors shall include in their proposal a written Animal Welfare Assurance (assurance), committing the proposed institution(s) to comply with the provisions of the PHS Policy, the Animal Welfare Act, and the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC). (2) Pursuant to the PHS Policy, section IV.A.3., offerors shall establish an IACUC, qualified through the experience and expertise of its members, to oversee the institution’s animal program, facilities, and procedures. Offerors shall provide verification of IACUC approval in their proposals. Offerors shall review and comply with the PHS Policy details regarding assurance and IACUC requirements. (3) The contract will not be awarded without OLAW approval of the successful offeror’s written Animal Welfare Assurance. (c) If at any time during performance of this contract, the Contracting Officer determines, in consultation with the OLAW, NIH, that the Contractor is not in compliance with any of the requirements and standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work performance and further payments under this contract until the noncompliance is corrected. Notice of the suspension may be E:\FR\FM\03OCP2.SGM 03OCP2 80712 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules communicated by telephone and confirmed in writing. If the Contractor fails to come into compliance within the period of time designated by the Contracting Officer, the Contracting Officer may, in consultation with OLAW, NIH, terminate the contract in whole or in part, and the Contractor’s name may be removed from the list of those contractors with Animal Welfare Assurances. (End of clause) 352.270–78 Animals. Care of Live Vertebrate ddrumheller on DSK120RN23PROD with PROPOSALS2 As prescribed in 370.403(b), insert the following clause: Care of Live Vertebrate Animals (DATE) (a) Before performance of any contract involving animal-related activities where the species is regulated by the United Sates Department of Agriculture (USDA), the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer. (b) The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR 2.1 through 2.11, or from a source that is exempt from licensing under those sections. (c) The Contractor shall comply with USDA pertinent laws and regulations of the USDA (see 7 U.S.C. 2131 et seq. and 9 CFR chapter I, subchapter A, parts 1 through 4). Where a conflict exists within the standards, the more stringent standard shall govern. (d) If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare, National Institutes of Health, that the Contractor is not in compliance with any of the requirements and standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work performance and further payments under this contract until the noncompliance is corrected. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to come into compliance within the period of time designated by the Contracting Officer, the Contracting Officer may, in consultation with OLAW, NIH, terminate the contract in whole or in part. (e) The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737 (email: ace@ aphis.usda.gov; website: https:// www.aphis.usda.gov/wps/portal/aphis/ ourfocus/animalwelfare). (End of clause) VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 352.270–79 Non-Discrimination for Conscience. PART 353—[REMOVED AND RESERVED] As prescribed in 370.701, insert the following provision: ■ Non-Discrimination for Conscience (DATE) (a) Section 301(d) of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act, as amended, provides that an organization, including a faith-based organization, that is otherwise eligible to receive assistance under section 104A of the Foreign Assistance Act of 1961, under the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003, under the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, The PEPFAR Stewardship Act of 2013, and The PEPFAR Extension Act of 2018, or under any amendment to the foregoing Acts for HIV/AIDS prevention, treatment, or care— (1) Shall not be required, as a condition of receiving such assistance, to— (i) Endorse or utilize a multisectoral or comprehensive approach to combating HIV/ AIDS; or (ii) Endorse, utilize, make a referral to, become integrated with, or otherwise participate in any program or activity to which the organization has a religious or moral objection. (2) Shall not be discriminated against under the provisions of law in paragraph (a) for refusing to meet any requirement described in paragraph (a)(1) in this solicitation. (b) Accordingly, an offeror who believes this solicitation contains work requirements requiring it endorse or utilize a multisectoral or comprehensive approach to combating HIV/AIDS, or endorse, utilize, make referral to, become integrated with, or otherwise participate in a program or activity to which it has a religious or moral objection, shall identify those work requirements it excluded in its technical proposal. (c) The Government acknowledges that an offeror has specific rights, as cited in paragraph (b), to exclude certain work requirements in this solicitation from its proposal. However, the Government reserves the right to not make an award to an offeror whose proposal does not comply with the salient work requirements of the solicitation. Any exercise of that Government right will be made by the Head of the Contracting Activity. (End of provision) ■ 47. Add subpart 352.3 to read as follows: Subpart 352.3—Provision and Clause Matrix 352.301 Solicitation provisions and contract clauses (Matrix). The HHSAR matrix is not published in the CFR. It is available on the Acquisition.gov website at https:// www.acquisition.gov/hhsar. PO 00000 Frm 00080 Fmt 4701 Sfmt 4702 48. Remove and reserve part 353. PARTS 354 through 369 [ADDED AND RESERVED] 49. Add reserved parts 354 through 369 to subchapter H. ■ Subchapter M [Redesignated as Subchapter I] 50. Redesignate subchapter M as subchapter I. ■ 51. Revise newly redesignated subchapter I to read as follows: ■ SUBCHAPTER I—DEPARTMENT SUPPLEMENTARY REGULATIONS PART 370 SPECIAL PROGRAMS AFFECTING ACQUISITIONS PARTS 371–399 [RESERVED] PART 370—SPECIAL PROGRAMS AFFECTING ACQUISITIONS Subparts 370.1–370.2 [Reserved] Subpart 370.3—Acquisitions Involving Human Subjects Sec. 370.300 Scope of subpart. 370.301 Policy. 370.302 Federal-wide assurance. 370.303 Notice to offerors. 370.304 Solicitation provisions and contract clauses. Subpart 370.4—Acquisitions Involving the Use of Laboratory Animals 370.400 370.401 370.402 370.403 Scope of subpart. Definitions. Policy. Contract clauses. Subparts 370.5–370.6 [Reserved] Subpart 370.7—Acquisitions Under the President’s Emergency Plan for AIDS Relief 370.700 370.701 Scope of subpart. Solicitation provision. Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. Subparts 370.1–370.2 [Reserved] Subpart 370.3—Acquisitions Involving Human Subjects 370.300 Scope of subpart. This subpart implements the Basic HHS Policy for Protection of Human Research Subjects under 45 CFR part 46 and applies to all research activities conducted under contracts involving human subjects. See 45 CFR 46.101 (for scope of the policy) and 46.102(e) and (l) (for pertinent definitions). E:\FR\FM\03OCP2.SGM 03OCP2 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules 370.301 Policy. It is the Department of Health and Human Services (HHS) policy that the contracting officer shall not award a contract involving human subjects until the prospective contractor provides assurance that the activity will undergo initial and continuing review by an appropriate Institutional Review Board (IRB) in accordance with HHS regulations at 45 CFR 46.103. Except for research eligible for exemption under 45 CFR 46.104, the contracting officer shall require a Federal-wide assurance (FWA) of each, approved by the HHS Office for Human Research Protections (OHRP), of each contractor, subcontractor, or institution engaged in human subjects research in performance of a contract. OHRP administers the assurance covering all HHS-supported or HHSconducted activities involving human subjects. 370.302 Federal-wide assurance. (a) OHRP-Approved FWAs are found at the following website: https:// ohrp.cit.nih.gov/search/search .aspx?styp=bsc. (b) Normally a contractor, subcontractor, or institution must provide approval of a FWA before a contract is awarded. If a contractor, subcontractor, or institution does not currently hold an approved FWA, it shall submit an explanation with its proposal and an FWA application prior to submitting a proposal. The contracting officer, on a case-by-case basis, may make award without an approved assurance in consultation with OHRP. (c) A contractor, subcontractor, or institution must submit all FWAs, including new FWAs, using the electronic submission system available through the OHRP website at https:// ohrp.cit.nih.gov/efile/, unless an institution lacks the ability to do so electronically. If an institution believes it lacks the ability to submit its FWA electronically, it must contact OHRP by telephone or email (see https:// www.hhs.gov/ohrp/assurances/ index.html) and explain why it is unable to submit its FWA electronically. ddrumheller on DSK120RN23PROD with PROPOSALS2 370.303 Notice to offerors. (a) The contracting officer shall notify offerors of the HHS Basic Policy for Protection of Human Subjects and required certifications. Unless otherwise exempted by 45 CFR part 46, no contract involving human subjects may start without these certifications. See 370.304 for applicable provisions and clauses. (b) Institutions having an OHRPapproved FWA shall certify IRB VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 approval of submitted proposals in the manner required by instructions for completion of the contract proposal; by completion of an OMB Form No. 0990– 0263, Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption (Common Rule); or by letter indicating the institution’s OHRP-assigned FWA number, the date of IRB review and approval, and the type of review (convened or expedited). The date of IRB approval must not be more than 12 months prior to the deadline for proposal submission. (c) The contracting officer generally will not request FWAs for contractors, subcontractors, or institutions prior to selecting a contract proposal for negotiation. When a contractor submits an FWA, it provides certification for the initial contract period; no additional documentation is required. If the contract provides for additional years to complete the project, the contractor shall certify annually in the manner described in paragraph (a) of this section. 370.304 Solicitation provisions and contract clauses. (a) The contracting officer shall insert the provision at 352.270–70, Notice to Offerors—Protection of Human Subjects, in solicitations that involve human subjects. The contracting officer shall use the clause with its Alternate I when the agency is prescribing a date later than the proposal submission by which the offeror must have an approved FWA. (b) For the Food and Drug Administration (FDA), the contracting officer shall insert the provision at 352.270–71, Notice to Offerors— Protection of Human Subjects, Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required, in solicitations that involve human subjects when the research is subject to RIHSC review and approval. (c) The contracting officer shall insert the clause at 352.270–72, Protection of Human Subjects, in solicitations, contracts and orders involving human subjects. (d) The contracting officer shall insert the clause at 352.270–73, Restriction on Use of Human Subjects, in contracts and orders if the contractor has an approved FWA of compliance in place, but cannot certify prior to award that an IRB registered with OHRP reviewed and approved the research, because definite plans for involvement of human subjects are not set forth in the proposal (e.g., projects in which human subjects’ involvement will depend upon completion of instruments, prior animal PO 00000 Frm 00081 Fmt 4701 Sfmt 4702 80713 studies, or purification of compounds). Under these conditions, the contracting officer may make the award without the requisite certification, as long as the contracting officer includes appropriate conditions in the contract or order. (e) For FDA, the contracting officer shall insert the clause at 352.270–74, Protection of Human Subjects— Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required, in contracts and orders that involve human subjects when the research is subject to RIHSC review and approval. (f) The contracting officer shall insert the clause at 352.270–75, Needle Exchange, in solicitations, contracts, and orders involving human subjects. (g) The contracting officer shall insert the clause at 352.270–76, Continued Ban on Funding Abortion and Continued Ban on Funding of Human Embryo Research, in solicitations, contracts, and orders involving human subjects. Subpart 370.4—Acquisitions Involving the Use of Laboratory Animals 370.400 Scope of subpart. This subpart applies to HHS contracts that include research, research training, biological testing, housing and maintenance, and other activities involving live vertebrate animals. 370.401 Definitions. As used in this subpart— Animal means any live, vertebrate animal used or intended for use in research, research training, experimentation, or biological testing for related purposes. Animal Welfare Assurance or assurance means the documentation from an institution assuring institutional compliance with the Public Health Service Policy on Human Care and Use of Laboratory Animals at https://grants.nih.gov/grants/olaw/ references/PHSPolicyLabAnimals.pdf. Institutional Animal Care and Use Committee (IACUC) means an intended generic term for a committee whose function is to ensure that the care and use of animals in PHS-conducted or supported activities are appropriate and humane in accordance with the policy in 370.402. However, each institution may identify the committee by whatever name it chooses. An appropriate IACUC performs the functions described in the Public Health Service Policy on Human Care and Use of Laboratory Animals, section IV, paragraph B. 370.402 Policy. (a) Proposals submitted in response to solicitations involving research on E:\FR\FM\03OCP2.SGM 03OCP2 80714 Federal Register / Vol. 89, No. 192 / Thursday, October 3, 2024 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS2 animals administered by the National Institutes of Health (NIH) or any national research institute shall include satisfactory assurances from the offeror or submitter to the Government, pursuant to the Health Research Extension Act of 1975 (Pub. L. 99–158, sec. 495(c)), that the contract work will be subject to initial and continuing review by an appropriate IACUC. See the Public Health Service Policy on Human Care and Use of Laboratory Animals at https://grants.nih.gov/ grants/olaw/references/ PHSPolicyLabAnimals.pdf implements (Pub. L. 99–158) for additional information. (b) The contracting officer shall ensure that offerors and contractors comply with the assurance and review requirements of the Public Health Service Policy on Human Care and Use of Laboratory Animals on all actions involving research on animals. (c) The contracting officer shall not award a contract involving research on animals without an applicable Animal Welfare Assurance approved by the VerDate Sep<11>2014 20:17 Oct 02, 2024 Jkt 265001 Office of Laboratory Animal Welfare (OLAW), NIH, for any institution proposed involved in research on animals to be performed under the contract. 370.403 Contract clauses. (a) The contracting officer shall insert the clause at 352.270–77, Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, in solicitations and contracts involving live vertebrate animals. (b) The contracting officer shall insert the clause at 352.270–78, Care of Live Vertebrate Animals, in solicitations and contracts that involve live vertebrate animals. Subparts 370.5–370.6 [Reserved] Subpart 370.7—Acquisitions Under the President’s Emergency Plan for AIDS Relief 370.700 Scope of subpart. This subpart applies to contracts involving Human Immunodeficiency PO 00000 Frm 00082 Fmt 4701 Sfmt 9990 Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) programs under the President’s Emergency Plan for AIDS Relief (PEPFAR) as established by the United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003, as amended (Pub. L. 108– 25, Pub. L. 110–293, Pub. L. 113–56, and Pub. L. 115–305). 370.701 Solicitation provision. The contracting officer shall insert the provision at 352.270–79, NonDiscrimination for Conscience, in solicitations valued at more than the micro-purchase threshold, which include work associated with the implementation of HIV/AIDS programs under PEPFAR. PARTS 371–399 [RESERVED] Subchapters J through L [Removed] 52. Remove reserved subchapters J through L. ■ [FR Doc. 2024–17095 Filed 10–2–24; 8:45 am] BILLING CODE 4151–19–P E:\FR\FM\03OCP2.SGM 03OCP2

Agencies

[Federal Register Volume 89, Number 192 (Thursday, October 3, 2024)]
[Proposed Rules]
[Pages 80634-80714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17095]



[[Page 80633]]

Vol. 89

Thursday,

No. 192

October 3, 2024

Part II





Department of Health and Human Services





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48 CFR Parts 301, 302, 303, et al.





HHS Acquisition Regulation: Regulatory Review; Proposed Rule

Federal Register / Vol. 89 , No. 192 / Thursday, October 3, 2024 / 
Proposed Rules

[[Page 80634]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

48 CFR Parts 301, 302, 303, 304, 305, 306, 308, 309, 311, 312, 313, 
314, 315, 316, 318, 319, 322, 323, 324, 325, 326, 327, 330, 331, 
332, 333, 334, 335, 336, 337, 341, 342, 343, 344, 345, 347, 352, 
and 370

RIN 0991-AC36


HHS Acquisition Regulation: Regulatory Review

AGENCY: Department of Health and Human Services.

ACTION: Proposed rule.

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SUMMARY: The Department of Health and Human Services (HHS) is proposing 
to amend and update its Health and Human Services Acquisition 
Regulation (HHSAR) to update and streamline the HHSAR. Under this 
initiative, all parts of the regulation were reviewed to streamline the 
regulation, to revise or remove policy superseded by changes in the 
Federal Acquisition Regulation (FAR), to remove any procedural guidance 
that is internal to HHS into a new HHS Acquisition Manual (HHSAM) as 
internal policies, guidance, and instructions. The rule would add new 
coverage to implement agency unique requirements. The HHSAR would also 
be updated to reflect organizational changes in the Department, 
incorporate recent statutory changes and government mandates, and to 
accomplish editorial revisions for clarification.

DATES: Comments must be received on or before December 2, 2024, to be 
considered in the formulation of the final rule.

ADDRESSES: Submit written comments in response to HHSAR Case 2023-002 
through the Federal eRulemaking Portal at: https://www.regulations.gov 
by searching for ``HHSAR Case 2023-002''. Select the link ``Comment 
Now'' and follow the ``Submit a comment'' instructions. Please include 
your name, company name (if any), and indicate they are submitted in 
response to ``RIN 0991-AC36--HHS Acquisition Regulation: Regulatory 
Review (HHSAR Case 2023-002).''
    Warning: Do not include any personally identifiable information 
(such as name, address, or other contact information) or confidential 
business information that you do not want publicly disclosed. All 
comments may be posted on the internet and can be retrieved by most 
internet search engines. No deletions, modifications, or redactions 
will be made to comments received.
    Inspection of Public Comments: All comments received before the 
close of the comment period will be available for viewing by the 
public, including personally identifiable or confidential business 
information that is included in a comment. You may wish to consider 
limiting the amount of personal information that you provide in any 
voluntary public comment submission you make. HHS may withhold 
information provided in comments from public viewing that it determines 
may impact the privacy of an individual or is offensive. For additional 
information, please read the Privacy Act notice that is available via 
the link in the footer of https://www.regulations.gov. Follow the 
search instructions on that website to view the public comments.

FOR FURTHER INFORMATION CONTACT: Mr. Jarreau Vieira, Chief, Acquisition 
Rule-Making Branch, U.S. Department of Health and Human Services, 
Office of the Assistant Secretary for Financial Resources, Office of 
Acquisition Policy, 200 Independence Avenue SW, Washington, DC 20201. 
Email: [email protected], Telephone: (202) 731-4625. This is 
not a toll-free telephone number.

SUPPLEMENTARY INFORMATION: 

I. Background

    This rulemaking is being taken under the authority of the Office of 
Federal Procurement Policy (OFPP) Act which provides the authority for 
an agency head to authorize the issuance of agency acquisition 
regulations that implement or supplement the FAR. The OFPP Act, as 
codified in 41 U.S.C. 1702, provides the authority for the FAR and for 
the issuance of agency acquisition regulations consistent with the FAR. 
This authority ensures that Government procurements are handled fairly 
and consistently, that the Government receives overall best value, and 
that the Government and contractors both operate under a known set of 
rules. The statute at 41 U.S.C. 1121(b) provides authority for the FAR, 
while 41 U.S.C. 1121(e), 1702(b)(3)(e), and 1702(c)(2), when read 
together, provide authority for the issuance of agency acquisition 
regulations consistent with the FAR. HHS issues the HHSAR under these 
authorities.
    HHS has determined that changes to the HHSAR are necessary to align 
it to the FAR. As a result, the HHS Acquisition Policy Division 
Integrated Project Team (IPT) under the direction of the Senior 
Procurement Executive and composed of representatives from HHS's 
operating divisions (OPDIVs) and staff divisions (STAFFDIVs) and other 
agency stakeholders, have participated in reviews of the regulation, 
resulting in a complete revision of the HHSAR. HHS conducted a 
comprehensive review of the HHSAR with the goal of updating obsolete 
coverage, streamlining policies and procedures where applicable 
consistent with current guidance, and moving internal policies 
applicable to the HHS acquisition workforce to a new HHS Acquisition 
Manual (HHSAM). The HHSAM will incorporate portions of the internal 
procedural guidance removed from the HHSAR, as well as other internal 
agency acquisition policy.
    This proposed rule reflects changes that need to be made to the 
HHSAR to implement and/or supplement the FAR. HHS is proposing to 
substantially revise and streamline the HHSAR to update or remove 
references to superseded or obsolete policies, procedures, and 
organizations and to incorporate electronic links to FAR provisions and 
other matters referenced in the HHSAR. Other revisions include 
incorporating additional policies, solicitation provisions, and/or 
contract clauses into the HHSAR to implement and supplement the FAR and 
satisfy HHS unique mission needs and responsibilities. This includes 
incorporating changes in dollar and approval thresholds, definitions, 
and HHS position titles and offices. The reissued HHSAR proposed in 
this notice would correct inconsistencies, remove redundant and 
duplicate material already covered by the FAR, delete outdated material 
or information, and appropriately renumber HHSAR text, clauses, and 
provisions where required to comport with FAR format, numbering, and 
arrangement. All amendments, revisions, and removals have been reviewed 
and concurred with by a HHSAR revision team from each of the OPDIVs/
STAFFDIVs and key agency stakeholders. This effort will create a 2024 
edition of the HHSAR.
    Currently, HHS is tracking a number of new FAR case proposed and 
final rules, as well as Executive orders (E.O.s) and directives that 
the Civilian Agency Acquisition Council and the Defense Acquisition 
Regulations Council (the Councils) are reviewing for potential impact 
to the FAR system. The Executive orders include E.O. 13985, ``Advancing 
Racial Equity and Support for Underserved Communities Through the 
Federal Government'' (86 FR 7009; Jan. 25, 2021), E.O. 14005, 
``Ensuring the Future is Made in All of America by All of America's 
Workers'' (86 FR 7475; Jan. 28, 2021), and E.O. 14008, ``Tackling the 
Climate Crisis at Home and Abroad'' (86 FR 7619; Feb. 1, 2021). If and 
when FAR cases and proposed

[[Page 80635]]

rules are drafted and FAR final rules are published, HHS intends to 
examine each of these for impact to the HHSAR and any updates that may 
be required to maintain the HHSAR. HHS is institutionalizing an 
ongoing, sustained HHSAR refreshment process, so that as FAR proposed 
and final rules, E.O.s, and other directives are issued, HHS will 
initiate new HHSAR cases to bring the regulation in alignment and to 
avoid duplication, as necessary. HHS will examine any FAR final rules 
that become effective and will take into consideration such FAR 
changes, as appropriate, in subsequent rulemakings. When needed, HHS 
will also consider use of an advanced notice of proposed rulemaking 
(ANPRM) to obtain public input as the agency implements rulemaking to 
address new and emerging issues that may be identified by the Councils 
or by HHS as a result of E.O.s and other directives. HHS will use this 
public input to inform how HHS implements such guidance in the HHSAR.
    The HHSAR uses the regulatory structure and arrangement of the FAR, 
and headings and subject areas are broken up consistent with the FAR 
content. The HHSAR is divided into subchapters, parts (each of which 
covers a separate aspect of acquisition), subparts, sections, and 
subsections.
    When Federal agencies acquire supplies and services using 
appropriated funds, the purchase is governed by the FAR, set forth at 
title 48 Code of Federal Regulations (CFR), chapter 1, parts 1 through 
53, and the agency regulations that implement and supplement the FAR. 
The HHSAR is set forth at 48 CFR, chapter 3, parts 301 through 370.
    HHS is proposing to revise the HHSAR to add new policy or 
regulatory requirements and to remove any guidance that is applicable 
only to HHS's internal operating processes or procedures. Codified 
acquisition regulations may be amended and revised only through 
rulemaking.

Discussion and Analysis

    HHS proposes to make the following changes to the HHSAR as a part 
of its updating and streamlining initiative. For procedural guidance 
cited below that is proposed to be deleted from the HHSAR, each section 
cited for removal has been considered for inclusion in HHS's internal 
agency operating procedures in accordance with FAR 1.301(a)(2). 
Similarly, delegations of authorities that are removed from the HHSAR 
will be included in the HHSAM as internal agency guidance.
    We propose to revise the following parts of the HHSAR, 48 CFR 
chapter 3: Parts 301, 302, 303, 304, 305, 306, 308, 309, 311, 312, 313, 
314, 315, 316, 319, 322, 323, 324, 326, 327, 330, 331, 332, 333, 334, 
335, 336, 337, 342, 352, and 370.
    We propose to add seven (7) parts to the HHSAR: Parts 318 
(Emergency Acquisitions); 325 (Foreign Acquisition); 341 (Acquisition 
of Utility Services); 343 (Contract Modifications); 344 (Subcontracting 
Policies and Procedures); 345 (Government Property); and 347 
(Transportation).
    And, to streamline the HHSAR and improve its use and benefit to the 
public, small businesses, and the HHS acquisition workforce, we propose 
to remove the following three (3) parts from the HHSAR: Parts 307 
(Acquisition Planning); 310 (Market Research); and 317 (Special 
Contracting Methods). This would also move internal procedural guidance 
still applicable from these parts to the HHSAM, and/or remove outdated 
and unnecessary text or policy redundant to the FAR.
    We propose to revise the authority citations cited in each HHSAR 
part to reflect as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 
1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. Where 
additional authorities for a specific part are applicable, we identify 
them under that discussion of each HHSAR part later in this preamble.
    We propose to retain the authority of 5 U.S.C. 301. This authority 
provides that the head of an Executive department or military 
department may prescribe regulations for the government of his 
department, the conduct of its employees, the distribution and 
performance of its business, and the custody, use, and preservation of 
its records, papers, and property.
    We propose to retain the authority of 40 U.S.C. 121(c) and slightly 
revise the reference. This authorizes the head of each executive agency 
to issue orders and directives that the agency head considers necessary 
to carry out the FAR.
    We propose to include a reference to 41 U.S.C. 1121(c)(3). This 
provision states that the authority of an executive agency under 
another law to prescribe policies, regulations, procedures, and forms 
for procurement is subject to the authority conferred in section 1121, 
as well as other sections of title 41.
    We propose to add an authority citation for 41 U.S.C. 1702 which 
addresses the acquisition planning and management responsibilities of 
HHS' Senior Procurement Executive.
    And we propose to add the citation of ``48 CFR 1.301 through 
1.304'' to reflect the authority and responsibility set forth in the 
FAR and delegated to Federal agencies to issue agency regulations that 
supplement and implement the FAR.
    Any other proposed changes to authorities are shown under the 
individual parts below.
    Throughout the proposed rule (including in the discussion of each 
proposed revised or new HHSAR part), whenever HHS indicates that it 
proposes to revise and update the citation(s) to the FAR and HHSAR, it 
is for the purpose of comporting with FAR Drafting Guidelines 
convention and style, and in accordance with FAR 1.105-2, Arrangement 
of regulations, that specifies how the FAR and by extension the HHSAR 
is to be referenced within the body of the regulation. References to 
revising and updating citations are to either correct the current 
citations, correct any FAR or HHSAR references to a more suitable 
citation, or add appropriate FAR or HHSAR citations where necessary.

HHSAR Subchapter Headings

    Under the authority of 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 
1121(c)(3); 41 U.S.C. 1702, and 48 CFR 1.301 through 1.304 we propose 
to update the following HHSAR subchapter heading to align with the 
Federal Acquisition Regulation, title 48, chapter 1:
     SUBCHAPTER B--COMPETITION AND ACQUISITION PLANNING is 
revised to read: SUBCHAPTER B--ACQUISITION PLANNING
    We propose to update the following HHSAR subchapter numbering and 
heading to provide a similar numbering and heading construct as other 
agency supplemental regulations:
     SUBCHAPTER M--HHS SUPPLEMENTATIONS is revised to read: 
SUBCHAPTER I--DEPARTMENT SUPPLEMENTARY REGULATIONS

HHSAR Part 301--HHS Acquisition Regulation System

    We propose to revise the authority citations for part 301, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(b), (c)(3); 41 
U.S.C. 1303(a)(2); 41 U.S.C. 1702, 1707; and 48 CFR 1.301 through 
1.304.
    In addition to the authorities described in the Discussion and 
Analysis above, we propose to add the authority of the statute at 41 
U.S.C. 1121(b) which provides authority for the FAR, while 41 U.S.C. 
1121(e), 41 U.S.C. 1702(b)(3)(e), and 41 U.S.C. 1702(c)(2), when read 
together, provide authority for the issuance of agency acquisition 
regulations consistent with the FAR.

[[Page 80636]]

    We also propose to add the authority of 41 U.S.C. 1303(a)(2) to 
HHSAR part 301. This authority provides that other regulations relating 
to procurement issued by an executive agency shall be limited to 
regulation essential to implement Government-wide policies and 
procedures within the agency, and additional policies and procedures 
required to satisfy the specific and unique needs of the agency. HHS 
follows these limitations on the policy and procedures promulgated in 
the HHSAR.
    We also propose to add the authority of 41 U.S.C. 1707 to HHSAR 
part 301. This authority prescribes the required publication of 
proposed rules that HHS follows to ensure transparency and the ability 
of the public to comment on the unique policies and procedures HHS has 
identified to implement specific agency requirements to fulfill its 
mission and issue and administer contracts and acquisitions in 
accordance with the FAR.
    We propose to add section 301.000, Scope of part, to prescribe 
general Department of Health and Human Services Acquisition Regulation 
(HHSAR) policies, including information regarding the maintenance and 
administration of the HHSAR, acquisition policies, and procedures for 
deviation from the HHSAR and the Federal Acquisition Regulation (FAR).
    In subpart 301.1, Purpose, Authority, Issuance, we propose to 
revise section 301.101, Purpose, to remove scope of part language now 
covered in section 301.000, as well as moving the remaining language to 
the more appropriately placed new subpart 301.3, Agency Acquisition 
Regulations, section 301.301, Policy. We propose to add language that 
the subpart establishes uniform acquisition policies and procedures to 
implement and supplement the FAR, and the authorities under which the 
HHSAR is issued.
    We propose to revise section 301.103, Authority, to prescribe the 
delegated authority by the Secretary of HHS to the Senior Procurement 
Executive (SPE) for clarity and explain the authority under which the 
HHSAR is issued, move the 48 CFR chapter 3 reference to new section 
301.501-1, as well as other administrative edits.
    We propose to add section 301.104, Applicability, to prescribe that 
the FAR and the HHSAR apply to all HHS acquisitions, except where 
expressly excluded.
    We propose to add sections 301.105, Issuance, and 301.105-1, 
Publication and code arrangement, to identify the HHSAR issuance as 48 
CFR chapter 3, which was moved from section 301.103. We propose to add 
section 301.105-2 Arrangement of regulations, to prescribe the HHSAR 
arrangement, numbering system, and references and citations, to conform 
with FAR 1.105-2. We propose to add section 301.105-3, Copies, 
regarding access to and HHSAR availability.
    We propose to revise section 301.106, OMB Approval under the 
Paperwork Reduction Act, to revise the title to comport with FAR 1.106, 
and to identify that the list of the information collection and 
recordkeeping requirements contained in the HHSAR, approved by the 
Office of Management and Budget (OMB), are revised to reflect current 
approved information collections. This list would be otherwise publicly 
available on reginfo.gov after a final rule pertaining to this proposed 
rule is published and effective.
    We propose to add section 301.107, Certifications, to prescribe 
when a new requirement for a certification by a contractor or offeror 
may be included in the HHSAR, per 41 U.S.C. 1304(a)(b)(3).
    We propose to remove the reserved subpart 301.2, as unnecessarily 
needed.
    We propose to add subpart 301.3, Agency Acquisition Regulations, 
and section 301.301, Policy, where we propose to move the language from 
section 301.101 to be more appropriately placed here to describe that 
the HHSAR contains HHS policies governing implementation and 
supplementation of the FAR, including minor administrative edits.
    We propose to add section 301.301-70, Amendment of the HHSAR, as an 
HHS supplemental section to the FAR prescribing the processes for 
requesting a change to the HHSAR and maintenance of HHSAR and HHSAM 
content and publication.
    We propose to add section 301.303-70, Publication and 
codification--HHSAR, to prescribe that the HHSAR and HHSAM shall 
parallel the FAR in format, arrangement, and numbering systems. The 
section also establishes that HHSAR titles and numbering sequencing 
shall conform with the FAR to the maximum extent practicable, describes 
the policy, guidance and/or procedures regarding HHSAR numbering 
sequence when supplementing the FAR, and provides unique HHS Operating 
Division guidance on supplementary material numbering sequencing.
    We propose to add section 301.304, Agency control and compliance 
procedures, which provides that the SPE is responsible for amending the 
HHSAR for compliance with FAR 1.304.
    In subpart 301.470, Deviations from the FAR and HHSAR, we propose 
to remove section 301.401, Deviations, and revise the section number 
and title to section 301.402, Policy, and propose additional references 
to new sections 301.403 and 301.404, as well as administrative edits 
for clarification. We propose to add section 301.403, Individual 
deviations, to prescribe the delegated authority to the SPE. We propose 
to add section 301.404, Class deviations, to prescribe the delegated 
authority to the SPE.
    In subpart 301.6, Career Development, Contracting Authority, and 
Responsibilities, we propose to add section 301.601, General, to 
prescribe the delegated authority to the Chief Acquisition Officer and 
the SPE, to manage the HHS contracting functions. We propose to add the 
authorities delegated to the SPE in paragraph (a), and the authorities 
the SPE may further delegate to other HHS officials, such as the heads 
of the contracting activities (HCAs), and that HCA's may authorize the 
use of ordering officers, in paragraph (b).
    We propose to revise section 301.602-3, Ratification of 
unauthorized commitments, in paragraph (a) with administrative edits 
and to move agency procedural language to be appropriately placed in 
the HHSAM. We propose to remove paragraph (b)(2) as repetitive to the 
FAR and moving paragraph (c)(5) to the HHSAM as procedural language.
    We propose to revise section 301.603, Selection, appointment, and 
termination of appointment of contracting officers, and 301.603-1, 
General, to establish SPE and re-delegable authority.
    We propose to add section 301.603-3, Appointment, to prescribe 
agency policy regarding contracting officer appointments and 
delegations of authority, and that HCAs may delegate micro-purchase 
authority to HHS employees under the HHS Governmentwide Purchase Card 
Program.
    We propose to add section 301.604, Contracting Officer's 
Representative (COR), and 301.604-70, Contract clause, which provides 
the prescription for contracting officers to insert the new clause at 
352.201-70, Contracting Officer's Representative, in solicitations and 
contracts, when the contracting officer intends to designate a COR.
    We propose to add section 301.707, Signatory authority, to state 
that the signature authorities for determinations and findings, when 
delegable in the FAR, are prescribed in the applicable HHSAR parts or 
corresponding HHSAM part.

[[Page 80637]]

HHSAR Part 302--Definitions of Words and Terms

    We propose to revise the authority citations for part 302, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    In subpart 302.1, Definitions, and section 302.101, Definitions, we 
propose to add one new definition, remove one definition, and revise 
two existing definitions. We propose to add the definition for ordering 
officer, and to remove the definition for Contracting Officer's 
Representative as it is duplicative of the FAR. We also propose to 
revise the definition for agency head or head of the agency to add 
delegation designation clarifications, and to revise the definition for 
head of the contracting activity (HCA) to make minor edits and to add 
the HHSAR citation for HCA delegated authorities.

HHSAR Part 303--Improper Business Practices and Personal Conflicts of 
Interest

    We propose to revise the authority citations for part 303, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    In subpart 303.1, Safeguards, we propose to revise the text at 
303.101-3, Agency regulations, to specify employee applicability of the 
HHS Standards of Conduct, as found in 45 CFR part 73. We propose to 
remove 303.104-7, Violations or possible violations of the Procurement 
Integrity Act, to appropriately move the content to the HHSAM as agency 
procedures.
    In subpart 303.2, Contractor Gratuities to Government Personnel, we 
propose no revisions to section 303.203, Reporting suspected violations 
of the Gratuities clause. We propose to add section 303.204, Treatment 
of violations, to provide guidance required by FAR 3.203, and to 
provide notice and hearing information required by FAR 3.204. The 
section identifies the Suspending and Debarring Official (SDO) as the 
official designated to make the determination whether a violation of 
the Gratuities clause at FAR 52.203-3 has occurred and what action will 
be taken under FAR 3.204(c). We also propose adding the cross reference 
to 309.406-3, Procedures, when the SDO determines that a violation has 
occurred, and that debarment is being considered.
    In subpart 303.6, Contracts with Government Employees or 
Organizations Owned or Controlled by Them, we propose to revise section 
303.603, Exceptions, with minor administrative edits for clarification.
    In subpart 303.7, Voiding and Rescinding Contracts, we propose to 
revise section 303.704, Policy, with a minor administrative edit.
    We propose to remove subpart 303.10, Contractor Code of Business 
Ethics and Conduct, and section 303.1003, Requirements, to 
appropriately move the content to the HHSAM as agency procedures.

HHSAR Part 304--Administrative and Information Matters

    We propose to revise the authority citations for part 304, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    We propose to revise the title of part 304 to ``Administrative and 
Information Matters,'' to comport with FAR part 4.
    We propose to remove subpart 304.6, Contract Reporting, and section 
304.6, General, and propose the content be moved to the HHSAM as agency 
procedures.
    We propose to remove subpart 304.16, Unique Procurement Instrument 
Identifiers, and section 304.1600, Scope of subpart, and we propose the 
content be moved to the HHSAM as agency procedures.
    In subpart 304.71, Review and Approval of Proposed Contract 
Actions, we propose to remove the underlying sections, and reserve the 
subpart. We propose to remove section 304.7100, Policy, and propose the 
content be moved to the HHSAM as agency procedures.
    In subpart 304.72, Affordable Care Act Prevention and Public Health 
Fund--Reporting Requirements, section 304.7200, Scope of subpart, we 
propose to move some of the language to the retitled section 304.7201, 
Policy, due to the nature of the implementing language.
    We propose to retitle section 304.7201 as ``Policy,'' and move 
paragraphs (a) through (c) to the HHSAM as agency procedures. We 
propose minor administrative edits to the remaining content and 
restructuring the section to accommodate the relocated from section 
304.7200.
    We propose to revise section 304.7202, Contract clause, to add the 
applicable solicitations and contract actions value of $25,000 or more 
threshold, and to provide minor administrative edits.

HHSAR Part 305--Publicizing Contract Actions

    We propose to revise the authority citations for part 305, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    We propose to remove subpart 305.3, Synopses of Contract Awards, 
and section 305.303, Announcement of contract awards, and propose the 
content be moved to the HHSAM as agency procedures.
    We propose to add subpart 305.4, Release of Information, and 
section 305.402, General public, to state that requests from the public 
for specific records pertaining to contract actions shall be processed 
according to the Freedom of Information Act. We propose to add sections 
305.470, Contractor award announcements, advertisements, and releases, 
and 305.470-1, Policy, to provide policy that restricts contractors 
from referring to its HHS contract(s) in commercial advertising in a 
manner that states or implies the Government approves or endorses the 
contractor's products or services, or considers them superior to other 
products and services. This section also states that HHS contractors 
share responsibility for protecting sensitive and classified 
information, and approval requirements by the contracting officer prior 
to the release of any contract award information by the contractor.
    We propose to add section 305.470-2, Contract clause, which would 
also prescribe clause 352.205-70, Advertisements, Publicizing Awards, 
and Releases, in solicitations and contracts that exceed the simplified 
acquisition threshold and includes an Alternate I for contracts 
involving sensitive or classified information.
    We propose removing subpart 305.5, Paid Advertisements, and section 
305.502, Authority, and propose to move the content to the HHSAM as 
agency procedures.
    In subpart 305.70, Publicizing Requirements Funded From the 
Affordable Care Act Prevention and Public Health Fund, we propose minor 
administrative edits for clarification to sections 305.7003, 
Publicizing preaward, and 305.7004, Publicizing postaward.

HHSAR Part 306--Competition Requirements

    We propose to revise the authority citations for part 306, for the 
reasons set forth in the discussion and analysis

[[Page 80638]]

section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 
1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    In subpart 306.2, Full and Open Competition After Exclusion of 
Sources, we propose to revise section 306.202, Establishing or 
maintaining alternative sources, by redesignating paragraph (a) as 
paragraph (b)(1) to comport with FAR and HHSAR numbering policy, move 
the existing content at paragraph (b)(1) to the HHSAM as agency 
procedures, and provide administrative edits for clarification.
    In subpart 306.3, Other Than Full and Open Competition, in section 
306.302-1, Only one responsible source and no other supplies or 
services will satisfy agency requirements, we propose to remove the 
reference to FAR 6.302-1 in the title, assign paragraph designation 
(a)(2) to the first paragraph to comport with FAR and HHSAR numbering 
policy, and to add descriptive implementing language. We propose to add 
section 306.302-2, Unusual and compelling urgency, to prescribe 
delegated authority to the SPE regarding making the determination that 
exceptional circumstances apply when seeking a total period of 
performance exceeding one year, including all options, for a contract 
awarded or modified using the authority at FAR 6.302-2(d)(1)(ii).
    In subpart 306.5, Competition Advocates, we propose to revise the 
title to ``Advocates for Competition,'' to comport with the FAR subpart 
title. We propose to revise section 306.501, Requirement, to prescribe 
the designation of the Advocate for Competition as the Director, 
Acquisition Policy Division, Office of Acquisitions (ASFR/APD). We also 
propose to add that the Director, ASFR/APD may further delegate this 
authority to appoint an alternate agency advocate for competition, and 
that the HHS Advocate for Competition shall designate procuring 
activity advocates for competition in accordance with FAR 6.501. We 
also propose to add the uniform resource locator for the location of 
the list of HHS procuring activity advocates for competition.

HHSAR Part 307--Acquisition Planning

    We propose to remove and reserve HHSAR part 307 in its entirety 
including underlying section 307.105, Contents of written acquisition 
plans, as the language is duplicative of the FAR, and to move other 
content to the HHSAM as needed as agency internal procedures.

HHSAR Part 308--Required Sources of Supplies and Services

    We propose to revise the authority citations for part 308, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    We propose to remove subpart 308.4, Federal Supply Schedules, and 
section 308.405-6, Limited source justification and approval, as 
duplicative to the FAR, and to move some content to the HHSAM as agency 
procedures.
    In subpart 308.8, Acquisition of Printing and Related Supplies, we 
recommend removing sections 308.800, Scope of subpart, and 308.801, 
Definitions, as the sections contain content duplicative of the FAR, 
and procedural in nature. We propose to move the applicable content to 
the HHSAM as agency procedures. In section 308.802, Policy, we propose 
to revise the existing content to explicitly state that unless 
specifically authorized in HHS contracts, no printing by a contractor 
or subcontractor is authorized under an HHS contract. And we propose to 
add language that permits contracting officers to authorize limited 
printing pursuant to the clause prescribed at section 308.870. We also 
propose to remove the information about HHS' designated central 
printing authority to the HHSAM as internal agency guidance.
    We propose to revise section 308.803 by renumbering and retitling 
it to 308.870, Contract clause, which prescribes clause 352.208-70, 
Printing and Duplication, to be inserted in all solicitations, 
contracts, and orders for supplies or services over the simplified 
acquisition threshold, unless printing or increased duplication is 
authorized by statute.

HHSAR Part 309--Contractor Qualifications

    We propose to revise the authority citations for part 309, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    We propose to add subpart 309.1, Responsible Prospective Contracts, 
and sections 309.104, Standards, and 309.104-1, General standards, to 
establish that for cost-reimbursement or incentive type contracts, or 
contracts with progress payments, the prospective contractor's 
accounting system must provide reasonable stated assurances.
    In subpart 309.4, Debarment, Suspension, and Ineligibility, we 
propose adding section 309.400, Scope of subpart, to establish that the 
subpart implements FAR subpart 9.4 and prescribes HHS procedures and 
related actions for the suspension and debarment of contractors.
    We propose to revise section 309.403, Definitions, by adding the 
definition for the Suspension and Debarment (S&D) Committee introduced 
in revised section 309.406-3. We also propose revising the existing 
definition to the Suspending and Debarring Official (SDO) to comport 
with the FAR 9.403, as well as revising the title of the appointed HHS 
SDO to Deputy Assistant Secretary for Acquisitions, to reflect the 
current title.
    We propose to remove section 309.404, System for Award Management 
(SAM) exclusions, as much of the content is duplicative of the FAR, and 
the remaining content be moved to the HHSAM as agency procedures.
    We propose to revise section 309.405, Effect of listing, by 
removing from the section title ``(compelling reason determinations),'' 
to comport with the title at FAR 9.405, and to move the existing 
content in paragraph (a) to the HHSAM as agency procedures and replace 
the content with language to prescribe the delegation of authority to 
the SDO and permit further redelegation to the HCA.
    We propose to add section 309.405-1, Continuation of current 
contracts, which authorizes the continuation of contracts for 
contractors debarred (or proposed to be debarred) or suspended. It also 
requires a written determination before the award of orders or options 
on existing contracts with these contractors (see FAR 9.405-1(a)(2)) 
and delegates authority to the SDO with further redelegation to the 
HCA. We also propose to add section 309.405-2, Restrictions on 
subcontracting, which prescribes the delegated authority to the SDO, 
who further redelegates the authority to the HCA to consent to a 
contractor's use of a subcontractor who is suspended, proposed for 
debarment, or is debarred.
    We propose to add section 309.406-1, General, to provide additional 
SDO debarment consideration and determination factors and examples.
    We propose to revise section 309.406-3, Procedures, to include 
minor administrative edits to the existing content, and to introduce a 
formal Suspending and Debarring Committee (S&D Committee) to assist the 
SDO in the final determination for debarment. This section also 
provides additional public-facing debarment referral procedures and S&D 
Committee procedures for transparency.

[[Page 80639]]

    We propose to add sections 309.407, Suspension, and 309.407-1, 
General, to prescribe the delegated authority to the SDO to determine 
whether to continue business dealings with a suspended contractor, and 
to establish the SDO as the suspending official under the Federal 
Management Regulation at 41 CFR 102-117.295.
    We propose to revise section 309.407-3, Procedures, to include 
minor administrative edits to the existing content, and to introduce a 
formal Suspending and Debarring Committee (S&D Committee) to assist the 
SDO in the final determination for suspension. This section also 
provides additional public-facing suspension referral procedures and 
S&D Committee procedures for transparency.
    We propose to revise section 309.470-1, Situations where reports 
are required, to make administrative edits in stating that the 
contracting officer shall report to the HCA and SDO regarding the 
situations listed thereafter.
    We propose to add section 309.471, Fact-finding procedures, to 
establish procedures to resolve genuine disputes of material fact 
involving debarment or suspension determinations. The section provides 
details to include the Office of General Council, witnesses, and other 
factors needed to assist the SDO in a final suspension or debarment 
determination.
    We propose to add subpart 309.5, Organizational and Consultant 
Conflicts of Interest, and section 309.503, Waiver, to provide that the 
SPE is the designee at FAR 9.403 to waive general rules or procedures 
of the subpart. We also propose to add section 309.507-1, Solicitation 
provision, which prescribes the new provision at 352.209-70, 
Organizational Conflicts of Interest, to be included in any 
solicitation for the services addressed at FAR 9.502.

HHSAR Part 310--Market Research

    We propose to remove HHSAR part 310, Market Research, and reserve 
the part as we propose to remove the coverage currently contained at 
section 310.001 as duplicative of the FAR.

HHSAR Part 311--Describing Agency Needs

    We propose to revise the authority citations for part 311, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    We propose to add subpart 311.1, Selecting and Developing 
Requirement Documents, and section 311.103, Market acceptance, to 
prescribe that the authority is delegated to the HCA.
    We propose to add subpart 311.5, Liquidated Damages, and section 
311.501, Policy, to establish that the HCA may reduce or waive the 
amount of liquidated damages assessed under a contracts, if the 
Commissioner, Financial Management Service, or designee, approves.
    We propose to add subpart 311.6, Priorities and Allocations, to 
provide information on the HHS Health Resources Priorities and 
Allocation System (HRPAS) that is part of the Federal Priorities and 
Allocations System. This subpart references guidance and procedures for 
use of the Defense Production Act (DPA) priorities and allocations 
authority with respect to health resources necessary or appropriate to 
promote the national defense as delegated to the Secretary of HHS.
    We propose to add section 311.600, Scope of subpart, to establish 
that the subpart details information on the HHS HRPAS that is part of 
the Federal Priorities and Allocations System. This subpart references 
guidance and procedures for use of the DPA priorities and allocations 
authority with respect to health resources necessary or appropriate to 
promote the national defense as delegated to the Secretary.
    We propose to add section 311.601, Definitions, to establish two 
definitions, national defense and rated order, as the definitions 
differ slightly from the FAR and are derived from 45 CFR part 101.
    We propose to add section 311.602-70, The Health Resources 
Priorities and Allocation System, to reference Executive Order (E.O.) 
13603, National Defense Resources Preparedness, dated March 16, 2012. 
This E.O. provides the Secretary the authority to require acceptance 
and priority performance of contracts or orders (other than contracts 
of employment) to promote the national defense over performance of any 
other contracts or orders, and to allocate materials, services, and 
facilities as deemed necessary or appropriate to promote the national 
defense, with respect to health resources is delegated to the 
Secretary.
    We propose to add section 311.603, Procedures, and section 311.603-
70, Agency program, to reference specific HHS agency procedures as set 
forth in the HRPAS regulations at 45 CFR part 101, which provides 
guidance and procedures for use of the DPA priorities and allocations 
authority with respect to health resources, including the use of 
priority rated orders, necessary or appropriate to promote the national 
defense.
    In subpart 311.70, Section 508 Accessibility Standards, we propose 
to reserve the subpart, as we propose to move the content at section 
311.7000, Defining electronic information technology requirements, to 
the HHSAM as agency procedures.
    In subpart 311.71, Public Accommodations and Commercial Facilities, 
we propose to revise section 311.7102, Contract clause, which 
prescribes clause 352.211-1, Public Accommodations and Commercial 
Facilities, be inserted in solicitations, contracts, and orders 
requiring the contractor to conduct events in accordance with 
311.7100(b). We propose to revise clause number to 352.211-70, to 
comport with FAR numbering convention of supplemental clauses.
    In subpart 311.72, Conference Funding and Sponsorship, we propose 
minor administrative edits to section 311.7201, Funding and 
sponsorship. We also propose to revise section 311.7202, Contract 
clause, which prescribes clause 352.211-2, Conference Sponsorship 
Request and Conference Materials Disclaimer, be inserted in 
solicitations, contracts, and orders providing funding which partially 
or fully supports a conference. We propose to revise clause number to 
352.211-71, to comport with FAR numbering convention of supplemental 
clauses.
    In subpart 311.73, Contractor Collection of Information, we propose 
minor administrative edits to section 311.7300, Policy. We also propose 
to revise section 311.7301, Contract clause, which prescribes clause 
352.211-3, Paperwork Reduction Act, be inserted in solicitations, 
contracts, and orders that require a contractor to collect the same 
information from 10 or more persons. We propose to revise the clause 
number to 352.211-72, to comport with FAR numbering convention of 
supplemental clauses.

HHSAR Part 312--Acquisition of Commercial Products and Commercial 
Services

    We propose to revise the authority citations for part 312, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    We propose to revise the title of part 312 to ``Acquisition of 
Commercial Products and Commercial Services,'' to comport with the FAR 
part 12 title.
    We propose to remove subpart 312.1, Acquisition of Commercial 
Items--General, and section 312.101, Policy,

[[Page 80640]]

moving the content to the HHSAM as agency procedures.
    We propose to remove subpart 312.2, Special Requirements for the 
Acquisition of Commercial Items, and section 312.202, Market research 
and description of agency need, as the content is duplicative to the 
FAR.
    We propose adding subpart 312.3, Solicitation Provisions and 
Contract Clauses for the Acquisition of Commercial Products and 
Commercial Services, consisting of section 312.301, which prescribes 
clause 352.212-70, Gray Market and Counterfeit Items, which requires 
the contracting officer to insert in solicitations and contracts for 
new medical supplies, new medical equipment, new information technology 
equipment, and maintenance of medical or information technology 
equipment that includes replacement parts, if used, refurbished, or 
remanufactured parts are unacceptable, when the associated solicitation 
includes FAR provisions 52.212-1, Instructions to Offerors--Commercial 
Products and Commercial Services, and 52.212-2, Evaluation--Commercial 
Products and Commercial Services.

HHSAR Part 313--Simplified Acquisition Procedures

    We propose to revise the authority citations for part 313, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    We propose to revise part 313, Simplified Acquisition Procedures, 
to remove one section and substantively revise subpart 313.3 to enact 
legislative requirements. We propose to remove section 313.003, Policy, 
which provides section 508 of the Rehabilitation Act of 1973 guidance 
for Information and Communication Technology acquisition. This guidance 
is also found at 339.203(a) and will be addressed in the HHSAM in part 
339.
    We also propose to revise subpart 313.3, Simplified Acquisition 
Methods, and section 313.301, Governmentwide commercial purchase card. 
The existing content at 313.301 is removed and placed in the HHSAM as 
it is more appropriate for internal agency operating procedures. We 
propose to redesignate the section as 313.301-70, revise the heading to 
read ``Governmentwide commercial purchase card--purchases of PPE'', and 
state that the Infrastructure Investment and Jobs Act (IIJA), Public 
Law 117-58, Subtitle C, Make Personal Protective Equipment (PPE) in 
America (MPPEIA), applies to all purchases of PPE including those 
transactions made using the Governmentwide commercial purchase card 
under the micro-purchase threshold. We are including a cross reference 
to subpart 325.71 for definitions, restrictions, and exceptions, when 
procuring PPE.

HHSAR Part 314--Sealed Bidding

    We propose to revise the authority citations for part 314, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    We propose to remove subpart 314.1, Use of Sealed Bidding, and 
section 314.103, Policy, which states that electronic and information 
technology supplies and service shall comply with section 508 of the 
Rehabilitation Act of 1973, as the content is appropriately covered in 
part 339, Acquisition of Information Technology.
    We propose to retain subpart 314.4, Opening of Bids and Award of 
Contract, and section 314.404-1, Cancellation of invitations after 
opening, with no change to the content. We propose to revise section 
314.407-3, Other mistakes disclosed before award, to add delegation, 
without redelegation, language to the HCA's authority. We also propose 
to revise section 314.407-4, Mistakes after award, to add delegation, 
without redelegation, language to the HCA's authority.
    We propose to add sections 314.408, Award, and 314.408-70, Award 
when only one bid is received, to provide when only one bid is received 
in response to an invitation for bids, such bid may be considered and 
accepted if the contracting officer makes a written determination, 
approved one level above the contracting officer, documenting the 
stated issues in the section, and that the determination shall be 
placed in the contract file.

HHSAR Part 315--Contracting by Negotiation

    We propose to revise the authority citations for part 315, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    In subpart 315.2, Solicitation and Receipt of Proposals and 
Information, we propose to remove section 315.204-5, Part IV--
Representations and instructions, as the content is repetitive to the 
FAR, and moving some content to the HHSAM as agency procedure.
    We recommend retaining section 315.208, Submission, modification, 
revision, and withdrawal of proposals, as a title with no content, and 
moving the current content to new section 315.208-70, Submission, 
modification, revision, and withdrawal of proposals--R&D acquisitions, 
to clarify that the content applies in the case of biomedical or 
behavioral research and development acquisitions only. We also propose 
to restructure the content into redesignated paragraph numbers. 
Paragraph (a) contains the original 315.208(b) text, revised for 
clarity. Paragraph (b) is a new proposed paragraph that sets forth the 
policy permitting the contracting officer to consider a proposal 
received concerning biomedical or behavioral research and development 
(R&D) acquisitions after the date specified for receipt, under certain 
conditions. It is based on the existing provision at 352.215-70, Late 
Proposals and Revisions, that pertains only to biomedical or behavioral 
R&D solicitations using competitive proposals. While the provision 
itself was previously codified, there was no corresponding policy in 
the HHSAR, which is now provided. Paragraph (c) contains the original 
315.208(b)(2) content. We propose redesignating the paragraph as 
paragraph (c), removing the acronym ``HCA'', and substituting it with 
``contracting officer'' to reflect that the contracting officer will 
exercise this authority rather than the HCA.
    We propose to add section 315.209-70, Solicitation provision, which 
prescribes the provision 352.215-70, Late Proposals and Revisions--R&D 
Solicitations, in biomedical or behavioral R&D competitive acquisition 
solicitations subject to the requirements of 315.208-70(a) and the 
authorization of the HCA.
    In subpart 315.3, Source Selection, we propose to revise section 
315.303-70 by incorporating administrative edits and formatting 
revisions to the section for clarification.
    We propose to revise section 315.304, Evaluation factors and 
significant subfactors, by removing the term ``electronic and 
information technology (EIT)'' and replacing it with ``information and 
communication technology (ICT)'' to comport with FAR subpart 315.3 
terminology. We propose to revise the section to provide clarity that 
the requirement is that contracting officers shall include a separate 
technical evaluation factor pertaining to compliance with section 508 
requirements, rather than the language as now shown that appears to 
just require contracting officers to comply with the general tenets of 
section 508. We also propose to add a reference to 339.203.

[[Page 80641]]

    We propose to revise section 315.305, Proposal evaluation, by 
removing the content and leaving the header with no text. We propose 
adding section 315.305-70, Proposal evaluation--use of non-Federal 
evaluators, and revising and updating the content now at 315.305(c)(1) 
through (2) and move it to 315.305-70. Accordingly, we propose to 
reformat and redesignate the text in section 315.305 from paragraphs 
(c)(1) and (2) to paragraphs (a) and (b) to comport with FAR numbering 
requirements, and to include paragraphs (b)(1) through (4), and to add 
a new paragraph (c) to outline HHS's policy with respect to use of non-
Federal evaluators. We also propose administrative edits in the section 
for clarification.
    In paragraph (a), we propose to add language that add the 
requirement that the Source Selection Authority or the contracting 
officer, as applicable, make the decision to disclose proposals to non-
Federal evaluators and to add a reference to FAR 15.305(c) at the end 
of the paragraph.
    In paragraph (b), redesignated from paragraph (c)(1), we propose to 
add content that when an offeror's or contractor's proposal will be 
disclosed outside the Government, the provision prescribed at 315.305-
71 requires that the contractor and its employees, as well as any 
subcontractors and their employees, agree that when performing work as 
an evaluator under a Government contract that they will use the data 
(trade secrets, business data, and technical data) contained in the 
proposal for evaluation purposes only. Proposed paragraphs (b)(1) 
through (4) provides other conditions and restrictions on use of non-
Federal evaluators. In paragraph (c), it requires that the agreement 
shall be signed by the contractor and the assigned contractor employee, 
subcontractor, or consultant (i.e., the non-Federal evaluator) and 
filed in the contract file of an offeror's proposal.
    We propose to add section 315.305-71, Solicitation provision, to 
prescribe the provision at 352.215-71, Use of Non-Federal Evaluators--
Conditions for Evaluating Proposals, in solicitations when the 
Government may use non-Federal evaluators to evaluate an offeror's or 
contractor's proposals and offers.
    In subpart 315.4, Contract Pricing, at section 314.404-2, Data to 
support proposal analysis, we propose to revise the section title to 
comport with the FAR section title, provide administrative edits within 
the section for clarification, and move some of the content to the 
HHSAM as agency procedures.
    In subpart 315.6, Unsolicited Proposals, we propose to add section 
315.604, Agency points of contact, to establish minimum information 
that HHS operating divisions/staff divisions must make available to 
potential offerors of unsolicited proposals in accordance with FAR 
15.604(a) and assigning this responsibility to the HCAs. Additionally, 
we propose adding a uniform resource locator to the HHS internet web 
page to provide the HHS point of contact information.
    We propose to revise section 315.605-70, Content of unsolicited 
proposals--warranty by offeror, by revising the title and number of the 
section to redesignate it as a supplement to the FAR, and to add ``--
warranty by offeror,'' to reflect the focus of the content, 
distinguishable from the FAR. We also propose minor administrative 
edits to comport with FAR formatting requirements.
    We propose to retain section 315.606, Agency procedures, with no 
changes.
    We propose to revise section 315.606-1, Receipt and initial review, 
to redesignate the paragraph number to comport with the appropriate FAR 
paragraph being implemented.

HHSAR Part 316--Types of Contracts

    We propose to revise the authority citations for part 316, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    In subpart 316.3, Cost-Reimbursement Contracts, section 316.307, 
Contract clauses, we propose to revise paragraph (a)(1), which 
prescribes clause 352.216-70, Allowable Cost and Payment for Hospitals, 
and requires contracting officer to insert the clause in solicitations 
and contracts when a cost-reimbursement contract with a hospital 
(profit or non-profit) is contemplated and when the clause 52.216-7 is 
inserted in the contract. We propose to revise the content with 
administrative edits for clarification. We also propose to revise the 
clause content with administrative edits to remove the reference to 45 
CFR part 75. We also propose to remove paragraph (a)(2), which 
prescribes clause 352.216-70, Additional Cost Principles for Hospitals 
(Profit and Non-Profit), and requires contracting officer to insert the 
clause when a cost-reimbursement contract with a hospital (profit or 
non-profit) is contemplated. We propose to appropriately move this 
clause to part 331, Contract Cost Principles and Procedures.
    In subpart 316.5, Indefinite-Delivery Contracts, section 316.505, 
Ordering, we propose to revise paragraph (b)(8) to update the title of 
the HHS Advocate for Competition to comport with FAR usage and to 
designate the HHS Advocate for Competition as the task-order and 
delivery-order ombudsman. The section is also updated to require each 
HHS HCA to designate, in writing, a task-order and delivery-order 
ombudsman and to provide the website on the HHS internet where this is 
listed.
    We propose to remove subpart 316.6, Time-and-Materials, Labor-Hour, 
and Letter Contracts, and sections 316.603, Letter contracts, and 
316.303-3, Limitations, as internal operational procedures or 
delegations that will be moved to the HHS Acquisition Manual (HHSAM).

HHSAR Part 317--Special Contracting Methods

    We propose to remove part 317, Special Contracting Methods, and 
reserve the part as we propose to remove the current part content.
    We propose to remove subpart 317.1, Multi-Year Contracting, and 
section 317.104, General, moving the content to the HHSAM as agency 
procedure.
    We propose to remove sections 317.105, Policy, and 317.105-1, Uses, 
moving the content to the HHSAM as agency procedure.
    We propose to remove section 317.107, Options, moving the content 
to the HHSAM as agency procedure.
    We propose to remove section 317.108, Congressional notification, 
moving the content to the HHSAM as agency procedures.
    We propose to remove subpart 317.2, Options, and section 317.204, 
Contracts, removing most of the content as duplicative to the FAR, and 
moving the remaining content to the HHSAM as agency procedures.

HHSAR Part 318--Emergency Acquisitions

    We propose to add the authority citations for part 318, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    We propose to add section 318.000 to identify that part 318 will 
set forth additional emergency acquisition flexibilities. We also 
propose to add section 318.001, Definition, and section 318.001-71, 
Agency delegation of determination, to prescribe the delegated 
authority to the HCA to utilize emergency acquisition flexibilities and 
make the agency head determinations as

[[Page 80642]]

set forth in FAR part 18 and as defined in subpart 318.2.
    We propose to add subpart 318.1, Available Acquisition 
Flexibilities, section 318.109, Priorities and allocations, and section 
318.109-70, The Health Resources Priorities and Allocation System, to 
provide description and reference to subpart 311.6 to comport with FAR 
formatting.
    We propose to add subpart 318.2, Emergency Acquisition 
Flexibilities, and section 318.202-70, Specific HHS flexibilities, to 
provide four specific definitions to reflect the delegated emergency 
authorities for: the Micro-purchase threshold; the Simplified 
acquisition threshold; Commercial product or commercial service 
treatment; and Simplified procedures for certain commercial products 
and commercial services.
    We propose to add 318.270, Head of the agency delegations, to 
prescribe the delegated authority to the HCA to make the determinations 
in the listed FAR references, which include FAR 2.101, definitions of 
``Simplified acquisition threshold'' and ``Micro-purchase threshold, 
12.102(f), 13.201(g), and 13.500(c)(1).

HHSAR Part 319--Small Business Programs

    We propose to revise the authority citations for part 319, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 15 U.S.C. 631, et seq.; 40 U.S.C. 121(c); 41 
U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    We propose to add the authority of 15 U.S.C. 631, et seq. (the 
Small Business Act), as an authority pertaining to small business 
programs.
    We propose to clarify subpart 319.2, Policies, by making minor 
administrative updates in citations, references, and titles of 
individuals.
    We propose redesignating paragraph (d) of 319.201as paragraph (c) 
to align with FAR 19.201, as the topical coverage more appropriately 
falls under paragraph (c). We also add ``Executive'' to the title for 
the OSDBU Director.
    We propose redesignating paragraph (e) of 319.201 as paragraph (d) 
to align with FAR 19.201, as the topical coverage more appropriately 
falls under paragraph (d). We are removing the language that dealt with 
SBS review of all acquisitions that are not set-aside. The matter is 
more appropriately addressed in internal procedural policy in the HHS 
Acquisition Manual (HHSAM).
    In subpart 319.2, we are adding section 319.202 to provide the 
requirement that contracting officers document set-aside actions and 
recommendation on HHS Form 653, Small Business Program Review.
    We propose to remove the coverage concerning unique mentor-
prot[eacute]g[eacute] clauses as the HHS Mentor Prot[eacute]g[eacute] 
(MP) program is no longer in effect. Therefore, references to the 
program and related clauses have been deleted from the HHSAR. HHS 
follows the SBA Federal-wide guidance.
    We propose adding subpart 319.8, Contracting With the Small 
Business Administration (the 8(a) Program), to provide coverage for the 
SBA partnership agreement. Under this subpart we are adding coverage at 
sections 319.800, General, 319.811, Preparing the contracts, and 
319.811-370, SBA Partnership Agreement and contract clauses. This 
subpart prescribes two new clauses to be used when an 8(a) acquisition 
is processed pursuant to the Partnership Agreement: 352.219-72, HHS 
Notification of Competition Limited to Eligible 8(a) Participants, and 
for noncompetitive solicitations and awards, we propose adding the 
clause at 352.219-73, Notification of Section 8(a) Direct Awards, 
instead of the prescribed FAR clauses at 52.219-11, Special 8(a) 
Contract Conditions; 52.219-12, Special 8(a) Subcontract Conditions; 
and 52.219-17, Section 8(a) Award, as it governs HHS unique agency 
requirements.

HHSAR Part 322--Application of Labor Laws to Government Acquisitions

    We propose to revise the authority citations for part 322, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    We propose to revise HHSAR part 322 by adding a new subpart 322.1 
and revising the existing subpart 322.8.
    We propose to add subpart 322.1, Basic Labor Policies, to provide 
the procedures for the admittance of union representatives to HHS 
facilities. Under this subpart we propose to add section 322.101, Labor 
relations, as a header with no underlying text. We propose to add 
section 322.101-70, Admittance of union representatives to HHS 
facilities, to provide necessary admittance policy and procedures, and 
reporting requirements if entry is denied. In paragraph (a) it states 
that it is HHS policy to admit labor union representatives of 
contractor employees to HHS facilities to visit work sites and transact 
labor union business with contractors, their employees, or union 
stewards pursuant to existing union collective bargaining agreements. 
Their presence shall not interfere with the contractor's work progress 
under an HHS contract nor violate the safety or security regulations 
that may be applicable to persons visiting the facility. The union 
representatives will not be permitted to conduct meetings, collect 
union dues, or make speeches concerning union matters while visiting a 
work site. Paragraph (b) would require that whenever a union 
representative is denied entry to a facility or work site, the person 
denying entry shall make a written report to the HHS labor coordinator, 
the Office of the General Counsel (OGC), or corresponding labor 
advisor, with a copy to the cognizant contracting officer within two 
working days after the request for entry is denied. The report shall 
include the reason(s) for the denial, the name of the representative 
denied entry, the union affiliation and number, and the name and title 
of the person that denied the entry.
    We propose to revise subpart 322.8, Equal Employment Opportunity, 
to include a new section 322.808, Complaints. The new section would 
require that contractors shall, in good faith, cooperate with HHS in 
investigations of Equal Employment Opportunity (EEO) complaints 
processed pursuant to 29 CFR part 1614 and in accordance with clause 
352.222-70 as prescribed in this subpart.
    We propose to revise section 322.810, Solicitation provisions and 
contract clauses, to redesignate the paragraph from (h) to (e) to 
properly align with the FAR, and to add ``and Anti-Harassment'' to the 
title of the clause, 352.222-70, so the title of the clause would read 
``Contractor Cooperation in Equal Employment Opportunity and Anti-
Harassment Investigations.'' The clause is prescribed to be included in 
solicitations, contracts, and order that include the clause at FAR 
52.222-26, Equal Opportunity.

HHSAR Part 323--Environment, Sustainable Acquisition, and Material 
Safety

    We propose to revise the authority citations for part 323, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    We propose to revise HHSAR part 323 by updating the header of the 
part to ``Environment, Sustainable Acquisition, and Material Safety,'' 
to align with the title for FAR part 23 recently updated effective May 
22, 2024, via FAR Case 2022-006 (RIN 2900-AO43) final rule (89 FR 
30212). Additionally, we propose

[[Page 80643]]

moving text from existing sections to a new subpart 323.3 to properly 
align with the FAR, and to redesignate existing subpart 323.71 to 323.1 
as described below.
    We propose to remove sections 323.7000, 323.7001, and 323.7002 and 
move the coverage under a new subpart 323.3 where it will align with 
the FAR coverage concerning hazardous material identification.
    We propose to revise subpart 323.71, Sustainable Acquisition 
Requirements, by renumbering and retitling the header for the subpart 
as 323.1, Sustainable Products and Services. This aligns with the 
updated FAR subpart title and numbering. We propose to remove sections 
323.7101 and 323.7102 as internal agency procedures that will be 
updated and moved to the HHSAM. The remaining sections, 323.7100 and 
323.7103, would be renumbered as 323.103-70 and 323.109-70, 
respectively to appropriately align with the FAR.
    In proposed section 323.103-70, Policy--Sustainable Acquisition 
Plan, the existing text is removed as unnecessary and redundant to the 
FAR. A new paragraph (a) is added to provide that contracting officers 
may, for new contracts and orders above the micro-purchase threshold, 
insert an evaluation factor on the offeror's Sustainable Action Plan in 
the solicitation. And a new paragraph (b) is added to require that 
offerors, when the solicitation includes the provision prescribed at 
323.109-70 (i.e., the newly numbered 352.223-70, Instructions to 
Offerors--Sustainable Acquisition Plan), offerors shall include a 
Sustainable Acquisition Plan in their technical proposal addressing 
sustainable products for services for delivery under any resulting 
contract, and that the contracting officer shall incorporate the final 
Sustainable Acquisition Plan into the contract.
    In proposed section 323.109-70, Solicitation provision, the 
prescribed provision number is updated to reflect 352.223-70, and the 
title is updated to reflect ``Instructions to Offerors--Sustainable 
Acquisition Plan.''
    We propose to add subpart 323.3, Hazardous Material Identification, 
Material Safety Data, and Notice of Radioactive Materials, to reflect 
the revised FAR header at FAR subpart 23.3, and we propose to add 
underlying sections 323.300 and 323.304-70. The new subpart aligns with 
the FAR and adds updated language moved from sections 323.7000, 
323.7001, and 323.7002. Section 323.300, Scope of subpart, identifies 
this subpart provides procedures for administering safety and health 
requirements. In section 323.304-70, Contract clause, clause 352.223-
71, Safety and Health, is prescribed to be inserted in solicitations 
and contracts that involve hazardous materials or hazardous operations 
and details for which types of requirements.

HHSAR Part 324--Protection of Privacy and Freedom of Information

    We propose to revise the authority citations for part 324, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    We propose to make only limited revisions at this time to HHSAR 
part 324 as this part will be updated through future rulemaking. To 
align with FAR numbering conventions in FAR subpart 24.1, we propose to 
renumber 324.103 to 324.103-70 and renumber 324.104 to 324.103-71. We 
propose to amend section 324.105, Contract clauses, by renumbering it 
to 324.104 to align with the FAR and revising paragraph (b) to add at 
the end of the sentence for the prescription of HHSAR clause 352.224-
71, Confidential Information, the phrase ``. . . and in solicitations, 
contracts, and orders that include the clause at 352.227-71, Rights in 
Data--Supplement--Exceptional Circumstances.'' We also propose in this 
sentence to remove the word ``to'' in front of ``third party 
information'' so it would read ``to Government or third party 
confidential information.''

HHSAR Part 325--Foreign Acquisition

    We propose to revise the authority citations for part 325, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    We propose to add HHSAR part 325 to provide agency policies and 
procedures and the restrictions on Make Personal Protective Equipment 
(PPE) in America. This rule would add subpart 325.71, Make PPE in 
America Act Restrictions on Foreign Acquisition of Personal Protective 
Equipment, and underlying sections 325.7100 through 325.7103 as 
described below.
    In section 325.7100, Scope of subpart, it indicates that the 
subpart contains restrictions on the acquisition of certain personal 
protective equipment as required by the Make PPE in America Act (Pub. 
L. 117-58) for solicitations and contracts issued by HHS (among other 
agencies not included under the purview of this regulation). This 
subpart would codify the class deviation to the HHSAR issued by the HHS 
Senior Procurement Executive on February 9, 2023, that implemented the 
Make PPE in America Act, Division G, Title IX, Subtitle C, secs. 70951-
70953 of the Infrastructure Investment and Jobs Act (Pub. L. 117-58), 
dated November 15, 2021. On November 15, 2021, the President signed, 
the Infrastructure Investment and Jobs Act (IIJA). As part of the IIJA, 
Congress enacted the Make PPE in America Act (the Act). In promulgating 
the Act, Congress found, among other things, that the COVID-19 pandemic 
exposed the vulnerability of the United States' supply chains with 
respect to PPE and the lack of domestic production of PPE, including 
the components and materials thereof. To meet the needs for a long-term 
investment strategy for the domestic production of PPE items critical 
to the U.S. national response to a public health emergency, including, 
but not limited to, the COVID-19 pandemic, the Act requires action by 
HHS, the Department of Homeland Security, and the Department of 
Veterans Affairs (the covered agencies). To incentivize domestic 
manufacturing of PPE, the Act imposes certain requirements for 
contracts awarded by the covered agencies for the procurement of PPE.
    The class deviation issued by the Senior Procurement Executive 
implemented the tenets of the Act applicable to HHS in advance of 
rulemaking. This rule seeks public comment on the proposed language to 
be added to the HHSAR that HHS has been following and in effect at the 
agency since February 9, 2023.
    In section 325.7101, Definitions, we propose six definitions to 
ensure common understanding and meaning as used in this part--
component, domestic personal protective equipment, foreign-made 
domestic personal protective equipment, foreign personal protective 
equipment, personal protective equipment, and United States.
    We propose to add section 325.7102, Restrictions on certain 
personal protective equipment, as a header with no text.
    In section 325.7102-1, Restrictions, certain restrictions are 
identified that implement section 70952 of the Make PPE in America Act, 
and they apply to all contracts and orders for the purchase of personal 
protective equipment. These restrictions include the requirement for 
contracting officers to purchase domestic personal protective equipment 
(PPE), except as provided in section 325.7102-2, Exceptions. And the 
text provides that any contract for PPE shall have a base period of 
performance of at least two years, plus any option periods, as required 
by law.

[[Page 80644]]

    In section 325.7102-2, Exceptions, paragraph (a) provides that 
acquisitions of PPE in certain categories are not subject to the 
restrictions in section 325.7102-1, to include PPE where the HHS 
Secretary has maximized sources for foreign-made domestic PPE, and 
where the HHS Secretary certifies every 120 days that it is necessary 
to procure PPE under alternative procedures to respond to the immediate 
needs of a public health emergency. Other exceptions set forth in 
paragraph (b) include an item of PPE or component thereof, including 
those described in paragraph (a), that is, or includes, a material 
listed in FAR 25.104 as one for which a nonavailability determination 
has been made; or to which the HHS Secretary--
     Determines that a sufficient quantity of a satisfactory 
quality that is grown, reprocessed, reused, or produced in the United 
States cannot be procured as, and when, needed at United States market 
prices; and
     Certifies every 120 days that it is necessary to procure 
PPE to respond to the immediate needs of a public health emergency.

Under paragraph (c), the HHS Secretary is authorized to make the 
certification in paragraphs (a) and (b) or the nonavailability or 
unreasonable cost determination; supporting documentation requirements 
and approval levels are further outlined for the public.
    In section 325.7103, Solicitation provisions and contract clauses, 
paragraph (a), clause 352.225-70, Made in America--Personal Protective 
Equipment, is prescribed to be inserted in solicitations and contracts, 
regardless of dollar value, when procuring any item covered under 
325.7102-1(a). And in paragraph (b), provision 352.225-71, Made in 
America Certificate--Personal Protective Equipment, would be required 
to be inserted in solicitations containing the clause at 352.225-70.

HHSAR Part 326--Other Socioeconomic Programs

    We propose to revise the authority citations for part 326, for the 
reasons set forth in the discussion and analysis section and as 
described below, to read as follows: 5 U.S.C. 301; 25 U.S.C. 47; 25 
U.S.C. 1633; 25 U.S.C. 5301 et seq.; 40 U.S.C. 121(c); 41 U.S.C. 
1121(c)(3); 41 U.S.C. 1702; 42 U.S.C. 2003 and 48 CFR 1.301 through 
1.304. We propose to retain the existing authorities of 5 U.S.C. 301; 
25 U.S.C. 47; 25 U.S.C. 1633; and 42 U.S.C. 2003 as applicable to the 
subject matter and requirements set forth in the part. We removed the 
authority citation for 41 U.S.C. 253(c)(5) as it no longer exists. 
Additionally, we propose to add the authority citations for 40 U.S.C. 
121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 
1.304 as set forth in the discussion and analysis section above, to 
align part 326 with the other parts set forth in 48 U.S.C. chapter 3. 
We propose to add one additional authority under which Public Law 93-
638 was recodified: 25 U.S.C. 5301 et seq., as it sets forth 
requirements that impact acquisitions under 25 U.S.C. chapter 46, 
Indian Self-Determination and Education Assistance.
    We propose to make minor administrative and non-substantive 
technical changes to the part to update numbering conventions to FAR 
drafting standards, to spell out words, correct capitalization, and 
update references, including revising the table of contents and 
numbering of current subparts to properly align with the FAR and 
conform to FAR drafting conventions as follows:
     Revise the current subpart numbering for subpart 326.5, 
Indian Preference in Employment, Training, and Subcontracting 
Opportunities, to subpart 326.70. The underlying sections and 
subsections would be renumbered accordingly. Other numbering and minor 
administrative edits are made to comport with FAR drafting guidelines.
     Revise the current subpart numbering for subpart 326.6, 
Acquisitions Under the Buy Indian Act, to subpart 326.71. The 
underlying sections and subsections would be renumbered accordingly. 
Other numbering and minor administrative edits are made to comport with 
FAR drafting guidelines.
     Revise the current subpart numbering for subpart 326.7, 
Acquisitions Requiring the Native American Graves Protection and 
Repatriation Act, to subpart 326.72. The underlying sections and 
subsections would be renumbered accordingly.
    We also propose to make certain limited revisions to update the 
part:
     In section 326.501 (proposed to be renumbered to 326.7001, 
we updated to the current citations.
     In section 326.502 (proposed to be renumbered and retitled 
to 326.7002, Additional Definitions), we propose the following changes: 
(1) delete section 326.502(c) and (d) as duplicative of FAR 26.101; (2) 
add definitions to reflect those at 25 U.S.C. 3504; (3) revised 
paragraph (b); (4) redesignate paragraphs (a), (b), (e), and (f), and; 
(4) revise this section by renumbering 326.502 as shown to comport with 
the FAR drafting guidelines. We propose to add the following 
definitions: construction contract, construction programs, contract 
funding, direct program costs, indirect costs, indirect cost rate, 
mature contract, Secretary, self-determination contract, state 
education agency, Tribal organization or as relevant to the part and 
the usage from the cited authorities.
     In 326.505 (proposed to be renumbered to 326.7005), we 
propose to revise the header title to read ``Contract clauses'' in lieu 
of ``Applicability'' as the section prescribes two clauses: 352.226-70, 
Indian Preference, and 352.226-71, Indian Preference Program, and the 
naming convention for the header comports with the FAR.
     In subpart 326.6, Acquisitions Under the Buy Indian Act, 
we have made minimal revisions. Note: An update to subpart 326.6, 
Acquisitions Under the Buy Indian Act, took place recently. The update 
was published in the Federal Register on 1/13/2022, with an effective 
date of March 14, 2022. The rule is intended to establish Buy Indian 
Act acquisition policies and procedures for HHS that are consistent 
with rules proposed and/or adopted by the Department of the Interior 
(DOI). Due to the recent HHSAR changes and the tremendous collaborative 
effort to implement time sensitive legislative mandates, we are not 
proposing any substantive changes to this subpart. However, there are 
minor technical changes that are necessary to integrate this 
collaborative effort into the HHSAR update project to be FAR compliant. 
These changes include the following:
    [cir] We propose to revise this subpart by renumbering 326.6 as 
shown to comport with the FAR drafting guidelines. Specifically, we 
recommend this subpart be referenced as 326.71 since it is unique to 
HHS and has no correlation to the programs under the FAR part. Headings 
and references within the subpart have been updated to reflect the new 
numbering scheme. The underlying sections and subsections would be 
renumbered accordingly. Other numbering and minor administrative edits 
are made to comport with FAR drafting guidelines.
    [cir] In section 326.602 (proposed to be renumbered to 326.7102), 
we propose to revise the header title to ``Applicability'' and to add 
the text that will be moved from 326.602-1.
    [cir] We propose to remove 326.602-1, Scope of part. The placement 
and text for this material more properly falls under the proposed 
section 326.7102, Applicability.
    [cir] In section 326.604-2, Procedures for Acquisitions under the 
Buy Indian Act (proposed to be renumbered to 326.7104-2), we propose to 
remove

[[Page 80645]]

paragraph (e) in its entirety and move the prescriptions for clauses 
under a new proposed section 326.7104-5, Solicitation provisions and 
contract clauses, to comport with FAR drafting convention and style.
    [cir] We propose to add section 326.7104-4, Performance and payment 
bonds. This text is moved from a section proposed to be removed, 
326.605-2, Performance and payment bonds, to reflect the requirements 
of 25 U.S.C. 47a and to permit contracting officers to accept 
alternative forms of security in lieu of performance and payment bonds 
if a determination is made that such forms of security provide the 
Government with adequate security for performance and payment.
    [cir] We propose to renumber and retitle section 326.605, Contract 
Requirements, to 326.7105, Solicitation provisions and contract 
clauses, and move the prescriptions for the existing provisions and 
clauses in 326.604-2(c) to this section and renumber the provisions and 
clauses accordingly: 352.226-73, Notice of Indian Small Business 
Economic Enterprise Set-Aside; 352.226-74, Notice of Indian Economic 
Enterprise Set-Aside; 352.226-75, Indian Economic Enterprise 
Subcontracting Limitations; and 352.226-76, Indian Economic Enterprise 
Representation; and 352.226-75, Indian Economic Enterprise 
Subcontracting Limitations.
    [cir] We propose to remove section 326.605-2, Performance and 
payment bonds. Updated text concerning the requirements under this 
paragraph is proposed to move to section 326.7104-4, Performance and 
payment bonds, as the placement earlier in the subpart is more 
appropriate with the last section of the subpart reflecting any 
prescribed provisions or clauses to comport with FAR drafting 
conventions.
    [cir] In section 326.606-2, Representation provision, we propose to 
renumber it to 326.7106-2 based on the renumbering of all sections 
within the subpart, and adding one requirement in paragraph (c) for the 
contracting officer to include the documentation in the file, when the 
head of the contracting activity is informed in writing of all 
suspected Indian Economic Enterprise (IEE) misrepresentations by an 
offeror or failure to provide written notification of a change in IEE 
eligibility.
     In subpart 326.7, Acquisitions Requiring the Native 
American Graves Protection and Repatriation Act, we propose to revise 
this subpart by renumbering it as subpart 326.72 to comport with the 
FAR drafting guidelines and reflect as a unique HHS supplement. The 
underlying sections and subsections would be renumbered accordingly. 
Other numbering and minor administrative edits are made to comport with 
FAR drafting guidelines.

HHSAR Part 327--Patents, Data, and Copyrights

    We propose to revise the authority citations for part 327, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    In subpart 327.3, Patent Rights Under Government Contracts, we 
propose to revise section 327.303 by renumbering it to 327.303-70 and 
changing the header to read ``Contract clause'' in lieu of 
``Solicitation provision and contract clause'' since it prescribes only 
one clause. We also propose to update the text to reflect the revised 
numbering and title of clause 352.227-11, Patent Rights--Exceptional 
Circumstances, to now read, ``352.227-70, Patent Rights--Supplement--
Exceptional Circumstances,'' and to prescribe its use in solicitations, 
contracts, and orders that include the FAR clause at 52.227-11, Patent 
Rights--Ownership by the Contractor. Instructions to the contracting 
officer that are internal operating procedures are removed and will be 
revised and moved to the HHSAM.
    In subpart 327.4, Rights in Data and Copyrights, we propose to 
remove section 327.404-70, Solicitation provision and contract clause, 
as the prescription is being moved to section 327.409 where all the 
subpart's prescriptions will be located.
    We propose to revise section 327.409, Solicitation provision and 
contract clauses, by renumbering it to 327.409-70 and revising the 
header title to ``Contract clauses'' to reflect that only contract 
clauses are prescribed in the subpart. In paragraph (a) we propose to 
update the citation to the prescribed clause 352.227-14 and renumber it 
to ``352.227-71'' to comport with FAR drafting guidelines, and to 
retitle the clause to ``Rights in Data--Supplement--Exceptional 
Circumstances.'' We also propose to prescribe its use in solicitations, 
contracts, and others that include the FAR clause at 52.227-14, Rights 
in Data--General, and have updated the grammar and structure of the 
sentence to provide clarity.
    We propose to add paragraph (b) to set forth the prescription for 
the clause moved from the removed section 327.404-70, and renumber the 
clause from ``352.227-70, Publications and Publicity'' to ``352.227-72, 
Publications and Publicity.''

HHSAR Part 330--Cost Accounting Standards

    We propose to revise the authority citations for part 330, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    In subpart 330.2, CAS Program Requirements, in section 330.201-5, 
Waiver, we propose to revise his section to restructure and clarify the 
sentence that states the Senior Procurement Executive is authorized to 
exercise the waiver authority under FAR 30.201-5(a)(1) when the 
conditions at FAR 30.201-5(a)(1) are met. We propose to remove the 
coverage concerning the Operating and Staff Divisions and forwarding 
the waiver requests to the Senior Procurement Executive as it is 
internal operating procedures more appropriate to the HHS Acquisition 
Manual (HHSAM).

HHSAR Part 331--Contract Cost Principles and Procedures

    We propose to revise the authority citations for part 331, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    In subpart 331.1, Applicability, we propose to revise section 
331.101-70, Salary rate limitation, to renumber it to section 331.170, 
to align with FAR drafting convention numbering as there is no existing 
FAR section to intelligibly implement the required HHS policy and 
numbering as ``331.170'' places it appropriately as a supplement to 
subpart 331. We also propose to remove the paragraph (a) designation as 
there is no paragraph (b), and to remove the reference to a fiscal year 
as not necessary to the policy requirement. We also propose to revise 
the paragraph to update and provide the name of the Rates of Basic Pay 
for the Executive Schedule (EX) Level II, that is found on the Office 
of Personnel Management website.
    We also propose to remove the designation of paragraph (b) as the 
text will be contained in a new proposed section. We propose to add 
section 331.101-70, Contract clause, to contain the prescription for 
clause 352.231-70, Salary Rate Limitation, that was previously 
contained in paragraph (b) under the prior existing section 331.101-70, 
and to fix sentence

[[Page 80646]]

construction and punctuation to provide clarity.

HHSAR Part 332--Contract Funding

    We propose to revise the authority citations for part 332, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    We propose to revise HHSAR part 332, Contract Financing, by adding 
introductory sections 332.006, 332.006-1, and 332.006-4 to align with 
the FAR.
    We propose to add section 332.006, Reduction or suspension of 
contract payments upon finding of fraud, as a section header with no 
text to align with the FAR.
    We propose to add section 332.006-1, General, paragraph (b), to 
provide that the Senior Procurement Executive (SPE) is authorized to 
make the determination there is substantial evidence that a 
contractor's request for advance, partial, or progress payments is 
based on fraud, and may direct further payments to the contractor be 
reduced or suspended, in accordance with FAR 32.006 and that the 
authority may not be redelegated.
    And we propose to also add section 332.006-4, Procedures, paragraph 
(b), to align with the FAR and to designate the Remedy Coordination 
Official (RCO) for HHS as the SPE, who shall carry out the 
responsibilities in FAR 32.006-4(b). We add paragraph (e) under this 
section to implement the FAR and stipulate that the RCO is authorized 
to carry out the responsibilities of the agency head in FAR 32.006-4(e) 
to notify the contractor of the reasons for the recommended action and 
of its right to submit information within a reasonable period of time 
in response to the proposed action under FAR 32.006. In paragraph 
(e)(1), HHS sets forth the procedures to be followed for the notice of 
proposed action and the requirement to send it to the last known 
address of the contractor, the contractor's counsel, or agent for 
service of process, by certified mail, return receipt requested, or any 
other method that provides signed evidence of receipt. In the case of a 
business, the notice of proposed action may be sent to any partner, 
principal, officer, director, owner or co-owner, or joint venture. We 
also propose to set forth the due process rights for contractors to be 
afforded an opportunity to appear before the RCO to present information 
or argument in person or through a representative and to supplement the 
oral presentation with written information and argument. In paragraph 
(e)(2), additional processes and procedures for due process rights are 
established including that the proceedings will be conducted in an 
informal manner without the requirement for a transcript. It also would 
state that if the RCO does not receive a reply from the contractor 
within 30 calendar days, the RCO will base his or her recommendations 
on the information available. The RCO is required to make a 
determination whether or not substantial evidence of fraud exists.
    And, in paragraph (g) under section 332.006-4, we propose to 
require that the SPE shall provide a copy of each final determination 
and the supporting documentation to the contractor, the RCO, the 
contracting officer, and the HHS Office of the Inspector General (OIG).
    We propose to add subpart 332.2, Commercial Product and Commercial 
Service Purchase Financing, and the underlying section 332.202, 
General, to provide that the SPE is authorized to approve actions for 
commercial item purchase financing pursuant to FAR 32.202.
    In subpart 332.4, we propose to revise the subpart header title 
from ``Advance Payments for Non-Commercial Items'' to ``Advance 
Payments for Other Than Commercial Acquisitions'' to align with the 
updated title in the FAR. In section 332.402, General, we propose to 
revise the sentence for clarity that the head of the contracting 
activity (HCA) is authorized to make determinations related to advance 
payments and that the authority may not be redelegated. We propose to 
remove section 332.407, Interest, as this delegation by the agency head 
to the HCA to make the determination required by FAR 32.407(d) is being 
moved to the HHSAM.
    In subpart 332.5, Progress Payments Based on Costs, we propose to 
correct the header title listed in the HHSAR to match the FAR by adding 
an ``s'' to the existing word ``Cost.'' In section 332.501-2, Unusual 
progress payments, we propose to revise the sentence to comport with 
FAR drafting guidelines and style, and rephrased the same delegation 
that authorizes the HCA to approve unusual progress payments and to 
stipulate that the authority may not be relegated.
    In subpart 332.7, Contract Funding, we propose to remove section 
332.702, Policy, and move it to the HHSAM as internal operational 
policy.
    We propose to retain the underlying sections 332.703-1, General, 
and 332.703-71, Incrementally funded cost-reimbursement contracts, as 
important policy and procedures contracting officers shall follow when 
administering incremental funding under an HHS contract and the 
considerations contracting officers must examine when approving the use 
of incrementally funded cost-reimbursement contracts. We also propose 
to redesignate 332.703-71 to 332.703-70.
    We propose to revise the numbering of section 332.703-72, 
Incremental Funding Table, to ``332.703-71'' based on the redesignation 
of 332.703-71 to 332.703-70.
    We propose to revise the header title of section 332.706, 
Solicitation provision and contract clauses, to ``Contract clauses'' to 
align with the FAR.
    In subpart 332.70, Electronic Submission and Processing of Payment 
Requests, and the underlying sections 332.7001, 332.7002, and 332.7003, 
we make minor editorial formatting and capitalization corrections. In 
section 332.7003, Contract clause, we add language that states the 
clause at 352.232-71, Electronic Submission of Payment Requests, is to 
be used in all solicitations and contracts, unless an exception at 
HHSAR 332.7002(a) or (b) applies.

HHSAR Part 333--Protests, Disputes, and Appeals

    We propose to revise the authority citations for part 333, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    We propose to revise HHSAR part 333 to revise text and add sections 
as described below.
    In subpart 333.1, Protests, we propose to revise section 333.102, 
General, to make minor typographical and editorial updates and remove 
the paragraph designation of (g)(1).
    In section 333.103, Protests to the agency, we propose to 
substantially revise the content to provide clarity by identifying that 
the contracting officer prepares the determination pursuant to FAR 
33.103(f)(1) and to state that the contracting activity's designated 
protest official control officer, in consultation with the cognizant 
HHS legal office, may approve the determination subject to the 
procedures in 333.103-70.
    We propose to add section 333.103-70, Procedures--protests to HHS, 
paragraphs (a) through (d), to provide agency procedures on how HHS 
will handle protests submitted to the agency. This includes providing 
information on protests to the contracting officer, and a higher-level 
independent review or appeal of a contracting officer decision for 
protests files directly with the

[[Page 80647]]

agency. We also propose to add language at paragraph (d) that if 
protests are pending with the contracting officer and have not been 
decided yet, an independent review of a protest filed pursuant to 
paragraph (a)(2) will not be considered.
    We propose to add section 333.103-71, Agency actions on specific 
protests, to provide that the following types of protests may be 
dismissed without consideration of the merits or may be forwarded to 
another agency for appropriate action:
     Contract administration. Disputes between a contractor and 
HHS are resolved under the disputes clause (see the Dispute statute, 41 
U.S.C. chapter 71).
     Small business size standards and standard industrial 
classification. These are handled by the Small Business Administration.
     Small business certificate of competency program. A 
protest made under section 8(b)(7) of the Small Business Act, or in 
regard to any issuance of a certificate of competency or refusal to 
issue a certificate under that section, is not reviewed in accordance 
with bid protest procedures unless there is a showing of possible fraud 
or bad faith on the part of Government officials.
     Decision not to set-aside under section 8(a) of the Small 
Business Act. The decision to place or not to place a procurement under 
the 8(a) program is not subject to review unless there is a showing of 
possible fraud or bad faith on the part of Government officials or that 
regulations may have been violated (see 15 U.S.C. 637(a)).
     Affirmative determination of responsibility by the 
contracting officer. An affirmative determination of responsibility 
will not be reviewed unless there is a showing that such determination 
was made fraudulently or in bad faith or that definitive responsibility 
criteria in the solicitation were not met.
     Contracts subject to FAR subpart 22.6--Contracts for 
Materials, Supplies, Articles, and Equipment. Challenges concerning the 
legal status of a firm as a regular dealer or manufacturer within the 
meaning of 41 U.S.C. chapter 65 are determined solely by the procuring 
agency, the SBA (if a small business is involved), and the Secretary of 
Labor (see FAR subpart 22.6).
     Subcontractor protests. The contracting agency will not 
consider subcontractor protests except where HHS determines it is in 
the interest of the Government.
     Judicial proceedings. The contracting agency will not 
consider protests where the matter involved is the subject of 
litigation before a court of competent jurisdiction.
     Alternative dispute resolution. Bidders/offerors and HHS 
contracting officers are encouraged to use alternative dispute 
resolution (ADR) procedures to resolve protests at any stage in the 
protest process. If ADR is used, HHS will not furnish any documentation 
in an ADR proceeding beyond what is required by FAR 33.103.
    In subpart 333.2, Disputes and Appeals, we propose to add section 
333.201, Definitions, to provide the definition for Agency board of 
contract appeals for HHS means the Civilian Board of Contract Appeals 
(CBCA).
    We propose to revise section 333.203, Applicability, to make minor 
editorial corrections, to use the acronym CBCA, and to provide an 
updated address for each method of filing--e-file, U.S. Postal Service, 
or Overnight or Courier Delivery.
    In section 333.209, Suspected fraudulent claims, we propose to add 
to the end of the existing sentence that the contracting officer may 
submit any instance of a contractor's suspected fraudulent claim for 
potential referral to the Department of Justice through the head of the 
contracting activity (HCA).
    We propose to add section 333.214, Alternative dispute resolution 
(ADR), to state that contracting officers and contractors are 
encouraged to use alternative dispute resolution (ADR) procedures, and 
that guidance on ADR may be obtained at the U.S. Civilian Board of 
Contract Appeals website at https://www.cbca.gsa.gov.
    And in section 333.215-70, Contract clauses, we propose to revise 
paragraph (b) to revise the phrase, ``commercial item'' to ``commercial 
product or commercial service'' to comport with the updated usage of 
the terms in the FAR.

HHSAR Part 334--Major System Acquisition

    We propose to revise the authority citations for part 334, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    We propose to revise HHSAR part 334 to make minor editorial changes 
to provide clarity to the sentence structure and to add needed 
references.
    In section 334.201, Policy, introductory sentence, we are adding 
the acronym ``(EVMS)'' after earned value management system to permit 
usage of the acronym later in the section. In paragraph (b), we remove 
the fully spelled out term and use the EVMS acronym.
    In section 334.202, Integrated Baseline Reviews (IBRs), we remove 
the acronym usage in the header. In paragraph (a), we reconstructed the 
sentence for clarity by adding the term ``Integrated Baseline Review 
(IBR)'' and a reference to FAR 34.201(a), and we remove the phrase 
``normally should read'' and replace it with ``is usually''.

HHSAR Part 335--Research and Development Contracting

    We propose to revise the authority citations for part 335, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    We propose to revise HHSAR part 335 to make minor editorial changes 
to provide clarity, to remove material more appropriate to internal 
agency procedures in the HHSAM, to add needed FAR references, and to 
remove two sections that are unnecessary.
    In section 335.070-1, Policy, paragraph (a), we propose to remove 
the last sentence as it contains a general statement concerning the 
Government's interest that is unnecessary and vague. We propose to 
remove paragraph (c) as more appropriate to internal agency procedures 
that may be revised and moved to the HHSAM.
    In section 335.070-2, Amount of cost-sharing, paragraph (a), we 
propose to add the phrase ``appropriate (see FAR 16.303 and FAR 
42.707)'' to provide key FAR references.
    We propose to remove sections 335.071, which is reserved, and 
335.072, Key personnel. Section 335.071 was reserved during a previous 
rulemaking and is no longer required to be reserved. Section 335.072, 
Key personnel, is removed as internal agency guidance more appropriate 
to be revised and moved to the HHSAM.

HHSAR Part 336--Construction and Architect-Engineer Contracts

    We propose to revise the authority citations for part 336, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    We propose to revise HHSAR part 336 to remove one subpart and add a 
new subpart and make other necessary editorial changes.
    We propose to remove subpart 336.1, General, and the underlying 
section 336.104, Policy, as the information repeats the FAR and also 
contains a

[[Page 80648]]

general reference to internal agency Facilities Management guidance 
that is vague and more appropriate to place in the HHSAM as internal 
operational procedures.
    We propose to add subpart 336.2, Special Aspects of Contracting for 
Construction, and sections 336.203 and 336.204, to provide policy on 
the use of Government estimates of construction costs and other policy 
and procedures on the disclosure of the magnitude of construction 
projects.
    In section 336.203, Government estimate of construction costs, 
paragraph (a), we propose to require that the Government estimate must 
be designated ``CUI Controlled by: HHS, [OPDIV/STAFFDIV designation'' 
unless the nature of the information therein requires a security 
classification or other classification, in which event it shall be 
handled in accordance with applicable security regulations. The 
designation would only be removed when the estimate is made public in 
accordance with the procedures outlined in the section. In paragraph 
(b), if the acquisition is by sealed bidding, a sealed copy of the 
detailed Government estimate must be filed with the bids until bid 
opening. After the bids are read and recorded, the ``CUI'' designation, 
or other classification, must be removed and the estimate read and 
recorded in the same detail as the bids. In paragraph (c), we propose 
procedures governing the use of the marking if the acquisition is by 
negotiation.
    In section 336.204, Disclosure of the magnitude of construction 
projects, we propose policy that requires the contracting officer to 
utilize the estimated price ranges defined in FAR 36.204(a) through (e) 
as further supplemented in paragraphs (f) through (h) in this section 
when identifying the magnitude of an HHS project in advance notices and 
solicitations. In paragraph (f), we propose that for estimated price 
ranges between $1,000,000 and $5,000,000, the contracting officer shall 
identify the magnitude of an HHS project in advance notices and 
solicitations in terms of the following price ranges:
     Between $1,000,000 and $2,000,000.
     Between $2,000,000 and $5,000,000.
    In paragraph (g), the estimated price ranges are between $5,000,000 
and $10,000,000. And in paragraph (h), for estimated price ranges 
greater than $10,000,000, the contracting officer shall identify the 
magnitude of an HHS project in advance notices and solicitations in 
terms of one of the following price ranges:
     Between $10,000,000 and $20,000,000.
     Between $20,000,000 and $50,000,000.
     Between $50,000,000 and $100,000,000.
     Between $100,000,000 and $150,000,000.
     Between $150,000,000 and $200,000,000.
     Between $200,000,000 and $250,000,000.
     More than $250,000,000.
    In subpart 336.5, Contract Clause, we propose to make minor 
editorial revisions and to revise the header title of the subpart to 
``Contract Clauses'' to align with the FAR.
    In section 336.570, Contract clause, paragraph (a), we remove the 
word ``all'' before ``design-build requirements'' as it is unnecessary. 
In paragraph (b), we make minor capitalization corrections. We propose 
to remove paragraph (c) in its entirety as internal agency guidance 
that will be considered for the HHSAM and is unnecessary in the HHSAR.

HHSAR Part 337--Service Contracting

    We propose to revise the authority citations for part 337, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    We propose to revise HHSAR part 337 to provide updated agency 
policy and procedures to implement specific requirements concerning 
performance on HHS service contracts, and to add a new subpart 337.70 
that provides the policy for the clauses prescribed by this part.
    We propose to revise the header title of HHSAR part 337 from 
``Service Contracting--General'' to ``Service Contracting'' to align 
with the FAR title.
    We propose to remove subpart 337.1, Service Contracting--General, 
which currently contains prescriptions of key clauses required to be 
inserted into certain HHS solicitations and contracts. This coverage is 
proposed to be revised and moved to another new section specifically 
pertaining to prescriptions for contract clauses, 337.3306, as 
described below, to comport with FAR drafting standards and guidance.
    We propose to add subpart 337.70, Services--Special Contract 
Requirements, to provide the policy and procedures applicable to the 
clauses prescribed under this part. We propose to add sections 
337.7000, 337.7001, 337.7002, 337.7003, 337.7004, 337.7005, and 
337.7006 as discussed below.
    We propose to add section 337.7000, Prohibition on smoking in 
facilities during delivery of services to children, to detail the 
policy prohibition on smoking in certain facilities where certain 
federally funded children's services are provided pursuant to 20 U.S.C. 
7181 (Pub. L. 107-110, the Pro-Children Act of 2001 (the Act)). 
Contractors are required to represent to the contracting officer and 
agree that by submission of its bid or offer and if awarded a contract 
for this requirement, the contractor agrees to comply with the 
requirements of the Act and the prohibition of smoking in facilities as 
specified in paragraph (a). The contractor shall enforce the provisions 
of the clause prescribed in 337.7006(a), and ensure that each of its 
employees, subcontractors, and any subcontractor staff, is made aware 
of, understands, and complies with the provisions of the Act. This 
section also outlines the penalties for failure to comply with the Act.
    We propose to add section 337.7001, Reporting of child abuse by 
covered professionals and key definitions, to implement the 
requirements of Public Law 101-647, known as the Crime Control Act of 
1990 (the Act) (34 U.S.C. 20341), which imposes responsibilities on 
certain individuals who, while engaged in a professional capacity or 
activity as a covered professional, as defined in the Act, on Federal 
land or in a federally-operated (or contracted) facility, learn of 
facts that give the individual reason to suspect that a child has 
suffered an incident of child abuse. Paragraph (c) details the 
reporting requirements, and paragraph (d) contains the requirement that 
the offeror shall represent that it understands that by submission of 
its bid or offer and if awarded a contract for a requirement, the 
Contractor agrees to comply with the requirements of the Act. 
Contracting officers shall ensure the requirements of clause 352.237-71 
are flowed down to subcontractors at any tier.
    We propose to add section 337.7002, Requirement for background 
checks--childcare services, to set forth the agency policy and 
requirement for background checks pursuant to Public Law 101-647, known 
as the Crime Control Act of 1990 (the Act) (34 U.S.C. 20351), requires 
that all individuals involved with the provision of childcare services 
to children under the age of 18 undergo a criminal background check. 
Any conviction for a sex crime, an offense involving a child victim, or 
a drug felony, may be grounds for denying employment or for dismissal 
of an employee providing any childcare services. This would require the 
contracting officer to provide the necessary information to the 
contractor

[[Page 80649]]

regarding the process for obtaining the background check. And it 
contains the representation requirement that the offeror shall 
represent that it understands that by submission of its bid or offer 
and if awarded a contract for a requirement, the contractor agrees to 
comply with the requirements of the Act. Contracting officers shall 
ensure the requirements of clause 352.237-72 are flowed down to 
subcontractors at any tier.
    We propose to add section 337.7003, Indian Child Protection and 
Family Violence Act-background investigations, to ensure protection of 
Indian children, and to implement requirements of the Indian Child 
Protection and Family Violence Act, Public Law 101-630 (25 U.S.C. 3201, 
et seq.), which prohibits employment, including personal service 
contracts, with anyone who has been convicted of any crime of violence 
when performance under a contract may require duties and 
responsibilities of a contractor, its employees, subcontractors, or 
third parties providing service under the contract that involve regular 
contact with or control over Indian children. The Act requires that a 
contractor and its employees and subcontractors, at any tier, be 
subject to a character and background investigation. This investigation 
is conducted by the Indian Health Service, Office of Human Resources. 
This section would require that as a prerequisite to providing services 
under a contract involving access to Indian children, contractors 
shall--
     Complete and sign a declaration concerning the background 
of employees or subcontractors providing such services as required by 
the terms and conditions of the contract;
     Provide information as required by the contracting officer 
to ascertain such information about its employees, subcontractors, and 
third parties providing services under the contract;
     Report convictions of any crime of violence immediately to 
the contracting officer that involve such employees, subcontractors, or 
third parties, who may be employed or are currently employed under the 
contract; and
     Flow down clause the clause prescribed at 337.7006(d), 
352.337-73, Indian Child Protection and Family Violence Act--Background 
Investigations, into all subcontracts, at any tier.
    We propose to add section 337.7004, Non-discrimination in service 
delivery, to implement HHS policy that no person otherwise eligible 
will be excluded from participation in, denied the benefits of, or 
subjected to discrimination in the administration of HHS programs and 
services based on non-merit factors such as race, color, national 
origin, religion, sex, gender identity, sexual orientation, or 
disability (physical or mental). It would include a representation 
requirement that the offeror shall represent that it understands that 
by submission of its bid or offer and if awarded a contract for a 
requirement, the contractor agrees to comply with the requirements of 
the policy. Contracting officers shall ensure the requirements of 
clause 352.237-74 are flowed down to subcontractors at any tier.
    We propose to add section 337.7005, Key personnel, to implement HHS 
policy on identification and use of key personnel when considered 
essential to work performance under an HHS contract. We propose to 
require contractors to provide notice if they divert proposed personnel 
deemed key personnel. At least 30 days prior to the contractor 
voluntarily diverting any of the specified individuals in a contract to 
other programs or contracts, the contractor shall notify the 
contracting officer and submit a justification for the diversion or 
replacement, and request to replace the individual. It would also 
outline notification, justification, and replacement requirements.
    We propose to add section 337.7006, Contract clauses, to provide 
the prescription for the use of the following clauses in both 
solicitations and contracts as required by each prescription:

 352.237-70, Nonsmoking Policy--Delivery of Services to 
Children
 352.237-71, Reporting of Child Abuse
 352.237-72, Requirement for Background Checks
 352.237-73, Indian Child Protection and Family Violence Act--
Background Investigations
 352.237-74, Non-Discrimination in Service Delivery
 352.237-75, Key Personnel

HHSAR Part 341--Acquisition of Utility Services

    We propose to add authority citations for part 341, for the reasons 
set forth in the discussion and analysis section, to read as follows: 5 
U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 
48 CFR 1.301 through 1.304.
    We propose to add HHSAR part 341, Acquisition of Utility Services, 
and subparts 341.1, General, and 341.5, Solicitation Provision and 
Contract Clauses, to provide policy on purchases of utility services 
from nonregulated and regulated utility suppliers, and the acquisition 
of energy when purchased as a commodity in accordance with FAR part 41.
    We propose to add subpart 341.1, General, and section 341.102, 
Applicability, paragraph (a), to implement FAR 41.102(a) and to state 
that this part applies to purchases of utility services from 
nonregulated and regulated utility suppliers when a delegation of 
authority from GSA for those services is requested and obtained. In 
paragraph (b)(4), we provide the explanation that the acquisition of 
energy, such as electricity, and natural or manufactured gas, when 
purchased as a commodity is considered to be acquisitions of supplies 
rather than utility services as described in FAR part 41.
    We propose to add subpart 341.5, Solicitation Provision and 
Contract Clauses, and sections 341.501 and 341.501-70. In section 
341.501, Solicitation provision and contract clauses, we propose to add 
the section header with no text for alignment with the FAR where HHS 
supplements coverage in an underlying section. In section 341.501-70, 
Disputes--utility contracts, we propose to require contracting officers 
to insert the clause at 352.241-70, Disputes--Utility Contracts, in 
solicitations and contracts for utility services subject to the 
jurisdiction and regulation of a utility rate commission, to provide 
the notice to the contractor on specific disputes requirements 
concerning utilities. In the clause, it provides that the requirements 
of the Disputes clause at FAR 52.233-1 are supplemented to provide that 
matters involving the interpretation of tariffed retail rates, tariff 
rate schedules, and tariffed terms provided under this contract are 
subject to any determinations by the independent regulatory body having 
jurisdiction (i.e., the Federal Energy Regulatory Commission, a state-
wide agency, or an agency with less than state-wide jurisdiction when 
operating pursuant to state authority. The body has the power to fix, 
establish, or control the rates and services of utility suppliers.).

HHSAR Part 342--Contract Administration and Audit Services

    We propose to revise the authority citations for part 342, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    We propose to revise HHSAR part 342 to update its header title, and 
to add subpart 342.2.
    We propose to revise and update the header title of part 342 from 
``Contract Administration'' to ``Contract

[[Page 80650]]

Administration and Audit Service'' to align with the FAR part title.
    We propose to add subpart 342.2, Contract Administration, and 
sections 342.270, 342.271, and 342.272, to set forth policy and 
procedures with respect to the use of Contracting Officer's 
Representatives (CORs) in contract administration, the Administrative 
Contracting Officer's (ACO) role in contract administration and 
delegated functions, and prescribed agency contract clauses.
    We propose to add section 342.270, Contracting Officer's 
Representatives role in contract administration, to establish that a 
contracting officer may designate a qualified person to be the 
Contracting Officer's Representative (COR) for the purpose of 
performing certain technical functions in administering a contract. 
Paragraph (b) would provide that the COR may act solely as a technical 
representative of the contracting officer and is not authorized to 
perform any function that results in a change in the scope, price, 
terms, or conditions of the contract, and that the designation must be 
in writing and a copy of the designation must be furnished to the 
contractor and the ACO.
    We propose to add section 342.271, Administrative Contracting 
Officer's role in contract administration and delegated functions, to 
provide the department's use of an Administrative Contracting Officer 
Letter of Delegation, which means a delegation of functions as set 
forth in FAR 42.202 and 42.302 and this section, that is issued by a 
contracting officer to delegate certain contract administration or 
specialized support services. This section would limit the ACO's 
authority to the actions detailed in the delegation, state that they 
shall be set forth in a written ACO Letter of Delegation issued by the 
contracting officer to the accepting contract administration office and 
designated administrative contracting officer. This section would 
require that the ACO Letter of Delegation shall contain the information 
required in FAR 42.202(a) through (c) and identify the responsibilities 
and limitations of the ACO. A copy of the delegation will be furnished 
to the contractor and the ACO.
    And we propose to add section 342.272, Contract clauses, to 
prescribe two clauses to be used: The clause at 352.242-70, 
Administrative Contracting Officer, to be inserted in solicitations and 
contracts expected to exceed the micro-purchase threshold, when 
contract administration is delegated, and the clause at 352.242-71, 
Government Construction Contract Administration, to be inserted in 
solicitations and contracts for construction expected to exceed the 
micro-purchase threshold, when contract administration is delegated

HHSAR Part 343--Contract Modifications

    We propose to add authority citations for part 343, for the reasons 
set forth in the discussion and analysis section, to read as follows: 5 
U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 
48 CFR 1.301 through 1.304.
    We propose to add HHSAR part 343, Contract Modifications, and 
subpart 343.2, Change Orders, to provide agency policy on the 
definitization of unpriced change orders with an estimated value 
exceeding $5 million.
    We propose to add subpart 342.2, Change Orders, and sections 
343.204, Administration; 343.204-70, Definitization; and 343.205, 
Contract clauses.
    We propose to add section 343.204, Administration, as a section 
header with no text, and the underlying section 343.204-70, 
Definitization, to establish policy with respect to the definitization 
of unpriced change orders with an estimated value exceeding $5 million. 
This section would require that unpriced change orders, when authorized 
by the contracting officer, shall contain a not-to-exceed price and 
requires a definitization schedules that provide for definitization 
by--
     The date after issuance of the change order may not exceed 
180 days after the contractor submits a qualifying proposal); or
     The date on which the amount of funds paid to the 
contractor under the contract action is equal to more than 50 percent 
of the not-to-exceed price.
    This section would also provide that if the contractor does not 
submit a timely qualifying proposal, the contracting officer may 
suspend or reduce progress payments under FAR 32.503-6 or take other 
appropriate action. The section would also provide a limitations on 
obligations in paragraph (b) that the Government shall not obligate 
more than 50 percent of the not-to-exceed price before definitization. 
However, if a contractor submits a qualifying proposal before 50 
percent of the not-to-exceed price has been obligated by the 
Government, the limitation on obligations before definitization may be 
increased to no more than 75 percent. Exceptions are provided as 
authorized by the head of the contracting activity (HCA). The HCA may 
waive the limitations for unpriced change orders if the HCA determines 
that the waiver is necessary to support an emergency acquisition 
operation.
    We propose to add section 343.205, Contract clauses, to provide 
agency policy that as authorized in the introductory text of clauses 
FAR 52.243-1, Changes--Fixed-Price; 52.243-2, Changes--Cost-
Reimbursement; and 52.243-4, Changes, and in the prescription at FAR 
43.205(c) for FAR 52.243-3, Changes--Time-and-Materials or Labor-Hours, 
the contracting officer may vary the period within which a contractor 
must assert its right to an equitable adjustment, but the extended 
period shall not exceed 60 calendar days, unless approval is one level 
above the contracting officer.

HHSAR Part 344--Subcontracting Policies and Procedures

    We propose to add authority citations for part 344, for the reasons 
set forth in the discussion and analysis section, to read as follows: 5 
U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 
48 CFR 1.301 through 1.304.
    We propose to add HHSAR part 344, Subcontracting Policies and 
Procedures, and underlying subparts 344.2, Consent to Subcontracts, and 
344.3, Contractors' Purchasing Systems Reviews.
    We propose to add subpart 344.2, Consent to Subcontracts, and 
section 344.202-2, Considerations, paragraph (a), to require, in 
addition to the considerations outlined in FAR 44.202-2(a), that the 
contracting officer responsible for consent must review the request and 
supporting data submitted by the contractor and document whether the 
contractor adequately substantiated the selection as being fair, 
reasonable, and representing the best value to the Government where 
other than the lowest price is the basis for subcontractor selection.
    We propose to add subpart 344.3, Contractors' Purchasing Systems 
Reviews, and section 344.303-70, Additional contractors' purchasing 
systems reviews, to identify that special attention shall also be paid 
to reviewing documentation of commercial products and commercial 
services determinations. Additionally, the section states that if the 
contractor has an approved purchasing system as defined in FAR 44.101, 
the contracting officer shall not withhold consent to subcontract 
without written coordination of the program manager or comparable 
requiring activity official. This ensures that a decision to withhold 
consent is made in concert with the full awareness of program officials 
who have overall programmatic, budget and schedule responsibilities for

[[Page 80651]]

acquisitions that may be impacted by a decision to withhold consent.

HHSAR Part 345--Government Property

    We propose to add authority citations for part 345, for the reasons 
set forth in the discussion and analysis section, to read as follows: 5 
U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 
48 CFR 1.301 through 1.304.
    We propose to add HHSAR part 345, Government Property, and subpart 
345.1, General, to provide agency policy and procedures on contractors' 
property management system compliance.
    In subpart 345.1, General, we propose to add sections 345.105-70 
and 345.107, Contract clauses. We propose to add section 345.105-70, 
Contractors' property management system compliance--policy and 
procedures, to provide definitions for acceptable property management 
system, property management system, and significant deficiency when 
complying with agency policies and procedures. In paragraph (a), policy 
is provided that the cognizant contracting officer, in consultation 
with the property administrator, shall determine the acceptability of 
the system and approve or disapprove the system, and pursue correction 
of any deficiencies. Paragraph (c) would provide that in evaluating the 
acceptability of a contractor's property management system, the 
contracting officer, in consultation with the property administrator, 
shall determine whether the contractor's property management system 
complies with the system criteria for an acceptable property management 
system as prescribed in the clause at 352.245-70, Contractor Property 
Management System Administration. The section also outlines in 
paragraph (d) the procedures for disposition of findings, including 
notification to the contractor, in writing, whether the contractor's 
property management system is acceptable and approved. If the 
contracting officer finds that there are one or more significant 
deficiencies (as defined in the clause at 352.245-70, Contractor 
Property Management System Administration) due to the contractor's 
failure to meet one or more of the property management system criteria 
in the clause at 352.245-70, the contracting officer shall--
     Promptly make an initial written determination on any 
significant deficiencies and notify the contractor, in writing, 
providing a description of each significant deficiency in sufficient 
detail to allow the contractor to understand the deficiency;
     Request the contractor to respond, in writing, to the 
initial determination within 30 days and;
     Evaluate the contractor's response to the initial 
determination, in consultation with the property administrator, and 
make a final determination.
    Paragraph (d)(3) of this section also provides the procedures for 
final determination and notification to the contractor in writing 
whether acceptable and approved, whether significant deficiencies 
remain and the requested corrective actions, disapproval, and 
monitoring of the system. Paragraphs (e) and (f) provide policy and 
procedures on system approval, and other contracting officer 
notifications.
    We propose to add section 345.107, Contract clauses, to prescribe 
the HHSAR clause at 352.245-70, Contractor Property Management System 
Administration, be inserted in solicitations and contracts containing 
the clause at FAR 52.245-1, Government Property.

HHSAR Part 347--Transportation

    We propose to add authority citations for part 347, for the reasons 
set forth in the discussion and analysis section, to read as follows: 5 
U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 
48 CFR 1.301 through 1.304.
    We propose to add part 347, Transportation, to provide unique HHS 
delivery information and marking requirements. Proposed underlying 
sections 347.303-6, F.o.b. destination; 347.303-670, Place of delivery, 
prescribe clause 352.247-70, Delivery Location, or a clause 
substantially the same as the clause at 352.247-70 in supply contracts 
when it is necessary to specify delivery locations.
    Section 347.305, Solicitation provisions, contract clauses, and 
transportation factors, and its underlying section 347.305-10, Packing, 
marking, and consignment instructions, prescribes two clauses:
     Paragraph (a) prescribes the clause 352.247-71, Marking 
Deliverables, or a clause substantially the same as 352.247-71 in 
solicitations and contracts if special marking on deliverables is 
required.
     Paragraph (b) prescribes the clause at 352.247-72, Packing 
for Domestic Shipment, in contracts when item(s) will be delivered for 
immediate use to a destination in the continental United States; when 
the material specification or purchase description does not provide 
preservation, packaging, packing, and/or marking requirements; and/or 
when the requiring activity has not cited a specific specification for 
packaging.

HHSAR Part 352--Solicitation Provisions and Contract Clauses

    We propose to revise the authority citations for part 352, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    We propose to revise subpart 352.1, Instructions for Using 
Provisions and Clauses, to update the underlying sections 352.100, 
Scope of subpart, and 351.101-70, Application of provisions and 
clauses, as follows:
    We propose to revise 352.100, Scope of subpart, to make a minor 
grammatical revision by adding the word ``supplemental'' before the 
words ``provisions and clauses'' in the text to provide clarity.
    We propose to add a section header with no text, 352.102, 
Incorporating provisions and clauses, to align the supplemental HHSAR 
section that follows it.
    And we propose to renumber section 352.101-70 to 352.102-70 as the 
topical coverage in the text more appropriately aligns under FAR 
52.102. We propose to add the phrase ``unless fill-ins are required'' 
at the end of paragraph (a) to add a caveat to the policy that it is 
not necessary to also include clauses in a task order or delivery order 
if it is included in the overarching master instrument.
    We propose to add clause 352.201-70, Contracting Officer's 
Representative, as prescribed in section 301.602-70, to provide that if 
the contracting officer designates a COR, the contractor will receive a 
copy of the written designation. It will specify the extent of the 
COR's authority to act on behalf of the contracting officer. The COR is 
not authorized to make any commitments or changes that will affect 
price, quality, quantity, delivery, or any other term or condition of 
the contract.
    We propose to revise clause 352.203-70, Anti-Lobbying, as 
prescribed in section 303.808-70, to make minor administrative and 
grammatical updates, including to the prescription. This clause 
provides that the contractor shall not use any HHS contract funds for:
     Publicity or propaganda purposes;
     The preparation, distribution, or use of any kit, 
pamphlet, booklet, publication, electronic communication, radio, 
television, or video presentation designed to support or defeat the 
enactment of legislation before the Congress or any State or local 
legislature

[[Page 80652]]

or legislative body, except in presentation to the Congress or any 
state or local legislature itself; or designed to support or defeat any 
proposed or pending regulation, administrative action, or order issued 
by the executive branch of any state or local government, except in 
presentation to the executive branch of any state or local government 
itself;
     Payment of salary or expenses of the Contractor, or any 
agent acting for the Contractor, related to any activity designed to 
influence the enactment of legislation, appropriations, regulation, 
administrative action, or Executive order proposed or pending before 
the Congress or any state government, state legislature or local 
legislature or legislative body, other than for normal and recognized 
executive-legislative relationships or participation by an agency or 
officer of a State, local, or Tribal government in policymaking and 
administrative processes within the executive branch of that 
government.
    We propose to revise clause 352.204-70, Prevention and Public 
Health Fund--Reporting Requirements, to update the prescription, and 
make minor administrative updates. In paragraph (a), we provide an 
updated citation to Public Law 112-74, section 220(b)(5). In paragraph 
(c), we correct grammar to move the word ``electronic'' after the words 
``508 compliant.'' And in paragraphs (c)(2) and (5), we are removing 
the words ``funds'' and ``funding'' respectively for clarity since the 
acronym ``PPHF'' contains the word ``fund'' in its name.
    We propose to add clause 352.205-70, Advertisements, Publicizing 
Awards, and Releases, to state that for HHS contracts and orders, the 
contractor shall not refer to the contract in commercial advertising or 
similar promotions in such a manner as to state or imply that the 
product or service provided is endorsed or preferred by the Federal 
Government or is considered by the Government to be superior to other 
products or services. An Alternate I version of the clause is proposed 
for use when a contract involves sensitive or classified information.
    We propose to revise clause 352.208-70, Printing and Duplication, 
to update the prescription to a FAR compliant format, to move all 
definitions under paragraph (a), to provide context to the clause, to 
add headers to each paragraph to comport with FAR style and convention, 
to rephrase paragraphs (b) through (d) for clarity, and to add 
paragraph (e) to require the clause is flowed down in subcontracts.
    We propose to add provision 352.209-70, Organizational Conflicts of 
Interest, to include the requirement that offerors shall provide a 
statement with its offer which describes, in a concise manner, all 
relevant facts concerning any past, present, or currently planned 
interest (financial, contractual, organizational, or otherwise) or 
actual or potential organizational conflicts of interest relating to 
the services to be provided under this solicitation.
    We propose to revise clause 352.211-1, Public Accommodations and 
Commercial Facilities, to renumber it to 352.211-70 to comport with FAR 
drafting standards, and to revise the prescription to comport with FAR 
style conventions.
    We propose to revise clause 352.211-2, Conference Sponsorship 
Requests and Conference Materials Disclaimer, to renumber it to 
352.211-71 to comport with FAR drafting standards, to update the 
prescription to comport with FAR style conventions, and to make minor 
grammatical updates to paragraphs (a) and (b) for clarity.
    We propose to revise clause 352.211-3, Paperwork Reduction Act, to 
renumber it to 352.211-72, update the title so it would read: 
``Paperwork Reduction Act Requirements,'' and update the prescription 
to comport with FAR style conventions.
    We propose to add clause 352.212-70, Gray Market and Counterfeit 
Items, to provide important protection for supplies or equipment 
offered to the Government to prevent unauthorized items from entering 
the HHS supply chain. HHS' critical mission is to enhance the health 
and well-being of all Americans, by providing for effective health and 
human services and by fostering sound, sustained advances in the 
sciences underlying medicine, public health, and social services. It is 
imperative that HHS have a high degree of fidelity in the supplies and 
equipment delivered to support the critical programs under its purview. 
This clause would importantly require that no used, refurbished, or 
remanufactured supplies or equipment/parts shall be provided, and that 
the procurement is for new Original Equipment Manufacturer (OEM) items 
only. As stated in paragraph (a), this clause would prohibit gray 
market items under the contract which are OEM goods intentionally or 
unintentionally sold outside an authorized sales territory or sold by 
non-authorized dealers in an authorized sales territory. Paragraph (b) 
provides that no counterfeit supplies or equipment/parts shall be 
provided. Counterfeit items include unlawful or unauthorized 
reproductions, substitutions, or alterations that have been mismarked, 
misidentified, or otherwise misrepresented to be an authentic, 
unmodified item from the original manufacturer, or a source with the 
express written authority of the original manufacturer or current 
design activity, including an authorized aftermarket manufacturer. 
Unlawful or unauthorized substitutions include used items represented 
as new, or the false identification of grade, serial number, lot 
number, date code, or performance characteristics. The clause would 
also state in paragraph (c) that the vendor is required to be an OEM, 
authorized dealer, authorized distributor, or authorized reseller for 
the proposed equipment, verified by an authorization letter or other 
documents from the OEM. All software licensing, warranty and service 
associated with the equipment shall be in accordance with the OEM terms 
and conditions.
    We propose to revise provision 352.215-70, Late Proposals and 
Revisions, by updating the title to add ``- R&D Solicitations'' to make 
clear the types of solicitations this clause involves. And we propose 
to update the prescription to comport with FAR style conventions, and 
to substantively revise the provision for clarity and standard FAR 
clause and provision construction that uses lists for ease of reading. 
This would include revising the introductory text so that it clarifies 
that notwithstanding the procedures contained in the provision at FAR 
52.215-1, Instructions to Offerors--Competitive Acquisition, paragraph 
(c)(3), the contracting officer may consider a proposal received for 
biomedical or behavioral research and development (R&D) solicitations 
after the date specified for receipt if the three conditions set forth 
in the clause are met.
    We propose to add provision 352.215-71, Use of Non-Federal 
Evaluators--Conditions for Evaluating Proposals, as prescribed in 
315.305-71, to provide terms and conditions pertaining to the use of 
non-Federal evaluators when evaluating proposals and offers. We propose 
to require that to participate in such role as a non-Federal evaluator, 
the Contractor shall agree that it and its employees, as well as any 
subcontractors and their employees as non-Federal evaluators will use 
the data (trade secrets, business data, and technical data) contained 
in any proposals under review for evaluation purposes only. Further, 
the Contractor, its employees, and subcontractors and their employees 
may not release, in whole or in part, any material received from the 
Government to evaluate and must protect and secure the data against

[[Page 80653]]

unauthorized disclosure. The provision requires each non-Federal 
evaluator to insert their name, title, company, signature, and date and 
provide to the HHS office providing the material and the contracting 
officer.
    We propose to remove clause 352.216-70, Additional Cost Principles 
for Hospitals (Profit and Non-Profit), as the requirement is being 
removed as a clause and placed in another part of the HHSAR--part 331. 
The clause number will be repurposed for a HHSAR part 316 related 
clause.
    We propose to add clause 352.216-70, Allowable Cost and Payment for 
Hospitals (Profit and Non-Profit), to stipulate that payment amounts 
requested by the Contractor and included in invoices submitted for 
payment in accordance with FAR clause 52.216-7, paragraph (a)(1), must 
be determined allowable by the Contracting Officer in accordance with 
the FAR clause at 52.216-7, 45 CFR part 75, appendix IX, and FAR 
subpart 31.2.
    We propose to remove two outdated clauses as they are no longer 
relevant to the HHS small business programs: 352.219-70, Mentor-
Prot[eacute]g[eacute] Program, and 352.219-71, Mentor-
Prot[eacute]g[eacute] Program Reporting Requirements. HHS does not 
currently have a mentor prot[eacute]g[eacute] program and the clauses 
are obsolete.
    We propose to add two clauses related to the 8(a) partnership 
program under HHSAR part 319: the clause at 352.219-70, Notification of 
Competition Limited to Eligible 8(a) Participants, and the clause at 
352.219-71, Notification of Section 8(a) Direct Award.
    We propose to add clause 352.219-70, Notification of Competition 
Limited to Eligible 8(a) Participants, as prescribed in 319.811-370. 
This clause provides that when FAR 52.219-18, Notification of 
Competition Limited to Eligible 8(a) Participants, is utilized in 
conjunction with the FAR clause at 52.219-18, any award resulting from 
a solicitation will be made directly by the contracting officer to the 
successful 8(a) offeror. The contractor shall comply with the 
limitations on subcontracting requirements as provided in 13 CFR 125.6 
and all other 8(a) program requirements, as set forth in 13 CFR part 
124.
    We propose to add clause 352.219-71, Notification of Section 8(a) 
Direct Award, as prescribed in 319.811-370. The clause alerts 8(a) 
firms of the direct contract authority and provides that by submission 
of its offer, the Offeror represents that it is in good standing and 
that it meets all the criteria for participation in the program in 
accordance with 13 CFR part 124, including compliance with the 
limitations on subcontracting, and the other 8(a) program principles 
and administrative requirement that are still under the SBA purview.
    We propose to revise clause 352.222-70, Contractor Cooperation in 
Equal Employment Opportunity Investigations, by revising the title to 
read ``Contractor Cooperation in Equal Employment and Anti-Harassment 
Opportunity Investigations'' to convey the additional important new 
content added to the clause. We propose to update the prescription to 
comport with FAR style conventions, and to substantively revise the 
provision for clarity and standard FAR clause and provision 
construction. We propose to substantively revise the flow and content 
of the paragraphs to provide clarity and add headers to each paragraph. 
We propose to retain the three definitions from the existing paragraph 
(a), include the header ``Definitions,'' and revise the definitions to 
comport with standard FAR drafting style and convention. We propose to 
redesignate the existing paragraph (a) as paragraph (b) and add the 
header ``Cooperation with investigations.'' In paragraph (b), we also 
add the requirement for contractors to cooperate in HHS internal Anti-
Harassment investigations. We also propose to redesignate paragraph (b) 
as paragraph (d) and add a header of ``Subcontract flowdown.'' We 
propose to update paragraph (c) and add the header ``Compliance.''
    We propose to revise clause 352.223-71, Instructions to Offerors--
Sustainable Acquisition, to renumber it as 352.223-70 to comport with 
FAR and agency supplement numbering conventions. We propose to revise 
the title to read: ``Instructions to Offerors--Sustainable Acquisition 
Plan,'' to identify the content of the provision more clearly. We 
propose to make minor updates to revise the prescription, correct a FAR 
citations, and make minor grammatical revisions.
    We propose to revise clause 352.223-70, Safety and Health, to 
renumber it as 352.223-71 to comport with FAR and agency supplement 
numbering conventions and to make other minor updates in the 
prescription.
    We propose to add clause 352.225-70, Made in America--Personal 
Protective Equipment, that provides new legislative requirements from 
the Make PPE in America Act (Pub. L. 117-58, sec. 70951, dated November 
15, 2021). This codifies a class deviation issued by HHS, Department of 
Health and Human Services (HHS) Class Deviation from the Health and 
Human Services Acquisition Regulation (HHSAR)--Implementation of the 
Make Personal Protective Equipment (PPE) in America Act Requirements, 
issued on February 9. 2023. The clause requires contractors to deliver 
only domestic personal protective equipment, unless the solicitation 
specifies delivery of foreign-made domestic personal protective 
equipment in the provision of the solicitation entitled ``Made in 
America Certificate--Personal Protective Equipment.'' The clause is to 
be inserted in solicitations and contracts for PPE as prescribed in 
325.7103(a), above the micro-purchase threshold, when the clause at FAR 
52.212-5, Contract Terms and Conditions Required To Implement Statutes 
or Executive Orders--Commercial Products and Commercial Services, is 
included in a solicitation or contract for PPE. Contracting officers 
shall include the full text of the clause at 352.225-70.
    We propose to add provision 352.225-71, Made in America 
Certificate--Personal Protective Equipment, in solicitations containing 
the clause at 352.225-70. The provision requires the offeror to certify 
that each item of personal protective equipment, except those listed in 
paragraph (b) of this provision, is domestic personal protective 
equipment. The clause also requires the offeror to list offered 
foreign-made domestic personal protective equipment items in paragraph 
(b). The provision is to be inserted in solicitations as prescribed in 
325.7103(b), above the micro-purchase threshold, when the provision at 
FAR 52.212-3, Offeror Representations and Certifications--Commercial 
Products and Commercial Services is included in a solicitation for PPE. 
Contracting officers shall include the full text of the provision at 
352.225-71.
    We propose to revise clause 352.226-1, Indian Preference, to 
renumber the clause to 352.226-70 to comport with FAR drafting 
standards and to make minor updates to the clause prescription and 
citation.
    We propose to revise clause 352.226-2, Indian Preference Program, 
to renumber the clause to 352.226-71 to comport with FAR drafting 
standards and to make minor updates to the clause prescription and 
citation.
    We propose to revise clause 352.226-3, Native American Graves 
Protection and Repatriation Act, to renumber the clause to 352.226-72 
to comport with FAR drafting standards and to make minor updates to the 
clause prescription and citation.
    We propose to revise clause 352.226-4, Notice of Indian Small 
Business Economic Enterprise set-aside, to

[[Page 80654]]

renumber the clause to 352.226-73, and to capitalize ``Set-Aside'' in 
the title to comport with FAR drafting standards and to make minor 
updates to the clause prescription and citation. We also propose to 
update an HHSAR citation in the second sentence.
    We propose to revise clause 352.226-5, Notice of Indian Economic 
Enterprise set-aside, to renumber the clause to 352.226-74, and to 
capitalize ``Set-Aside'' in the title to comport with FAR drafting 
standards and to make minor updates to the clause prescription and 
citation. We also propose to align the Public Law citation in paragraph 
(a), in the definition for ``Alaska Native Claims Settlement Act 
(ANCSA)'' to reflect the ``Pub. L.'' abbreviation and to update the 
HHSAR reference from the ``subpart'' to the ``section'' to standardize 
with FAR drafting standards. We also propose to spell out ``contracting 
officer'' in lieu of ``CO'' throughout the clause, as well as update 
any HHSAR section citations as these have been renumbered to comport 
with FAR standard numbering conventions.
    We propose to revise clause 352.226-6, Indian Economic Enterprise 
Subcontracting Limitations, to renumber the clause to 352.226-75, to 
comport with FAR drafting standards and to make minor updates to the 
clause prescription and citation. We also propose to spell out 
``contracting officer'' in lieu of ``CO'' throughout the clause and 
other minor administrative abbreviation update.
    We propose to revise clause 352.226-7, Indian Economic Enterprise 
Representation, to renumber the clause to 352.226-76, to comport with 
FAR drafting standards and to make minor updates to the clause 
prescription and citation.
    We propose to revise clause 352.227-11, Patent Rights--Exceptional 
Circumstances, to renumber the clause to 352.227-70, and to add the 
word ``Supplement'' in the title so it now reads: ``Patent Rights--
Supplement--Exceptional Circumstances,'' to comport with FAR drafting 
standards and to make minor updates to the clause prescription and 
citation. We propose to remove the first introductory sentence in the 
clause and move it to a new paragraph (b). We propose to update the 
definition of ``Agency'' in paragraph (a) to make reference to HHS 
operating division or agency, and provide examples (i.e., Centers for 
Disease Control and Prevention, Food and Drug Administration, etc.). We 
propose to renumber the existing paragraph (b) to (c) and update the 
FAR clause 52.227-11 title in paragraph (c)(2)(ii) to read ``Patent 
Rights-Ownership by the Contractor'' to reflect the correct FAR title. 
We also propose to make minor grammatical and FAR citation reference 
updates in paragraphs (c)(2)(ii) and (c)(3), and add paragraphs 
(c)(3)(i) and (ii) to the existing text to appropriately break up the 
text for ease of reading and reference. And we propose to make other 
minor citation reference numbering updates in the clause to reflect the 
correct paragraph numbers and to correct the FAR clause referenced in 
paragraph (e)(2) to read ``FAR 52.227-11'' versus ``52.227-13.'' And we 
propose to make other minor non-substantive administrative updates, and 
to update HHSAR clause reference cited in the prescription for 
Alternate I of the clause.
    We propose to revise clause 352.227-14, Rights in Data--Exceptional 
Circumstances, to renumber the clause to 352.227-71, and to add the 
word ``Supplement'' in the title so it now reads: ``Rights in Data--
Supplement--Exceptional Circumstances,'' to comport with FAR drafting 
standards and to make minor updates to the clause prescription and 
citation. We propose to revise clause 352.227-14, Rights in Data--
Exceptional Circumstances, as a supplemental HHSAR clause to FAR clause 
at 52.227-14, Rights in Data. The current clause, 352.227-14, 
duplicates the FAR clause at 52.227-14 except for paragraphs (d)(4) 
through (6). These paragraphs were added to provide HHS-specific 
direction when a Decision of Exceptional Circumstances was issued 
(paragraphs (d)(4) and (5)), and to provide additional policy at 
paragraph (d)(6) regarding confidential information. We propose to 
remove paragraphs (a) through (d)(3) as redundant to the FAR clause and 
unnecessary in the proposed revision to the HHS supplemental clause. We 
propose to retain the existing paragraphs (d)(4) and (5), with minor 
administrative updates to citations referenced in the text. 
Additionally, we propose to remove paragraphs (d)(6), (e), (f), (g), 
(h), and (i) and the Alternate I through V paragraphs of the existing 
clause.
    We propose to revise clause 352.227-70, Publications and Publicity, 
to renumber the clause to 352.227-72, to comport with FAR drafting 
standards and to make minor updates to the clause prescription and 
citation. We propose to revise paragraph (a) to reformat the paragraph 
to use a list of items the contractor shall send to the contracting 
officer's representative. And we propose to make minor administrative 
and editorial revisions in paragraphs (b) through (d) for clarity.
    We propose to revise clause 352.231-70, Salary Rate Limitation, to 
comport with FAR drafting standards and to make minor updates to the 
clause prescription and citation and to include a subcontract flowdown 
requirements in a new paragraph (f).
    We propose to revise provision 352.232-70, Incremental Funding, to 
comport with FAR drafting standards and to make minor updates to the 
provision prescription and citation.
    We propose to revise clause 352.232-71, Electronic submission of 
payment requests, to capitalize the major words in the title and make 
minor updates to the clause prescription and citation to comport with 
FAR drafting standards.
    We propose to revise clause 352.233-70, Choice of Law (Overseas), 
to make minor updates to the clause prescription and citation to 
comport with FAR drafting standards.
    We propose to revise clause 352.233-71, Litigation and Claims, to 
make minor updates to the clause prescription and citation to comport 
with FAR drafting standards.
    We propose to revise clause 352.236-70, Design-Build Contracts, to 
make minor updates to the clause prescription and citation to comport 
with FAR drafting standards.
    We propose to revise clause 352.237-70, Pro-Children Act, to revise 
the title of the clause to read: Nonsmoking Policy--Delivery of 
Services to Children, to make substantive updates to add needed content 
and bring reference citations up to date, and to make minor updates to 
the clause prescription and citation to comport with FAR drafting 
standards. We propose to revise each paragraph in the clause to add 
headers. In paragraph (a), the paragraph is revised to make clear that 
smoking is prohibited in facilities where certain federally funded 
children's services are provided pursuant to the Pro-Children Act, 20 
U.S.C. 7181, Public Law 107-100, sec. 4301 (the Act). Other edits for 
grammatical clarity are made. In paragraph (b), the text is updated to 
make clear that the offeror represents and understands that by 
submission of its bid or offer and if awarded a contract for this 
requirement the contractor agrees to comply with the requirements of 
the Act and the prohibition of smoking in facilities as specified in 
paragraph (a) of the clause. Paragraph (c) is updated to provide 
information concerning penalties for each violation. And a 
subcontractor flowdown clause is added as paragraph (d).
    We propose to revise 352.237-71, Crime Control Act--Reporting of 
Child Abuse, to revise the title of the clause

[[Page 80655]]

to read: Reporting of Child Abuse, to make substantive updates to add 
needed content and bring reference citations up to date, and to make 
minor updates to the clause prescription and citation to comport with 
FAR drafting standards. We propose to redesignate the existing 
paragraph (a) as paragraph (b) and move two existing definitions for 
``child abuse'' and ``covered professionals'' from paragraph (b) into a 
new paragraph (a), and to add a header titled ``Definitions.'' We 
propose to add a header to the redesignated paragraph (b), 
Responsibility to report child abuse, and to update the statute 
citation. We propose to remove the existing paragraph (b) in its 
entirety as the definitions previously in this paragraph have been 
moved to paragraph (a), Definitions, to align such definition placement 
at the beginning of the clause to comport with FAR drafting 
conventions. We propose to add headers to paragraphs (c) and (d), and 
we propose to add a new paragraph (e) to provide subcontract flow down 
requirements.
    We propose to revise clause 352.237-72, Crime Control Act--
Requirement for Background Checks, to revise the title of the clause to 
read: Requirement for Background Checks, to make substantive updates to 
add needed content and bring reference citations up to date, and to 
make minor updates to the clause prescription and citation to comport 
with FAR drafting standards. We propose to redesignate the existing 
paragraph (a) as paragraph (b) and move an existing definition for 
``child care'' from paragraph (b) into a new paragraph (a), and to add 
a header titled ``Definition.'' We propose to add a header to the 
redesignated paragraph (b), Requirement for background checks, and to 
update the statute citation. We propose to add headers to redesignated 
paragraphs (c) and (d), and we propose to add a new paragraph (e) to 
provide subcontract flow down requirements.
    We propose to revise clause 352.237-73, Indian Child Protection and 
Family Violence Act, to revise the title of the clause to read: Indian 
Child Protection and Family Violence Act--Background Investigation, to 
make substantive updates to add needed content and bring reference 
citations up to date, and to make minor updates to the clause 
prescription and citation to comport with FAR drafting standards. We 
propose to redesignate the paragraphs by adding a designation for 
paragraph (b) to break up the existing paragraph (a), and to 
redesignate paragraph (b) as paragraph (c), and add a paragraph (d) to 
provide subcontract flow down requirements.
    We propose to revise clause 352.237-74, Non-Discrimination in 
Service Delivery, to make substantive updates to add needed content and 
bring reference citations up to date, and to make minor updates to the 
clause prescription and citation to comport with FAR drafting 
standards. We propose to add paragraph designations and headers to the 
clause, which will now contain paragraphs (a) through (c). We propose 
paragraph (a), Policy, to provide the policy of HHS that no person 
otherwise eligible will be excluded from participation in, denied the 
benefits of, or subjected to discrimination in the administration of 
HHS programs and services based on non-merit factors such as race, 
color, national origin, religion, sex, gender identity, sexual 
orientation, or disability (physical or mental). We propose to add 
paragraphs (b) and (c) to provide that the offeror represents and 
understands that by submission of its bid or offer and if awarded a 
contract for this requirement the contractor agrees to comply with this 
policy in supporting the program and in performing the services called 
for under this contract in a non-discriminatory manner. And in 
paragraph (c) we propose to add a subcontract flow down requirement.
    We propose to revise clause 352.237-75, Key Personnel, to make 
minor administrative and grammatical updates, and to update the clause 
prescription and citation to comport with FAR drafting standards.
    We propose to add clause 352.241-70, Disputes--Utility Contracts, 
to provide that the requirements of the Disputes clause at FAR 52.233-1 
are supplemented to provide that matters involving the interpretation 
of tariffed retail rates, tariff rate schedules, and tariffed terms 
provided under this contract are subject to any determinations by the 
independent regulatory body having jurisdiction.
    We propose to add clause 352.242-70, Administrative Contracting 
Officer, to stipulate that the contracting officer reserves the right 
to designate an Administrative Contracting Officer (ACO) for the 
purpose of performing certain tasks/duties in the administration of the 
contract. It also states that such designation will be in writing 
through an ACO Letter of Delegation and will identify the 
responsibilities and limitations of the ACO, with a copy to be 
furnished to the contractor.
    We propose to add clause 352.242-71, Government Construction 
Contract Administration, to detail certain delegated contract 
administration functions, for construction contracts, set forth in FAR 
42.302 that are delegated, if any, and to stipulate express functions 
that are not delegated.
    We propose to add clause 352.245-70, Contractor Property Management 
System Administration, that would be inserted in solicitations and 
contracts containing the clause at FAR 52.245-1, Government Property, 
to require the contractor to establish and maintain an acceptable 
property management system and that failure to maintain an acceptable 
property management system, as defined in this clause, may result in 
disapproval of the system by the contracting officer and/or withholding 
of payments. The clause provides three definitions, and details what 
criteria will be utilized by the Government in its review of the 
contractor's property management system how system deficiencies will be 
handled, and how the contracting officer will evaluate the contractor's 
response, and the contracting officer's notification on resolution or 
disapproval. The clause provides for a contracting officer's final 
determination and requires the contractor to, within 45 days of receipt 
of final determination, either correct the significant deficiencies or 
submit an acceptable corrective action plan showing milestones and 
actions to eliminate the significant deficiencies.
    We propose to add clause 352.247-70, Delivery Location, to be used 
in supply contracts when it is necessary to specify delivery locations 
and provides an insert in the clause for the address and identifying 
data for shipment of deliverable items other than reports.
    We propose to add clause 352.247-71, Marking Deliverables, as 
prescribed at 347.305-10(a), Packing, marking, and consignment 
instructions, or a clause substantially the same as the proposed clause 
at 352.247-71, in solicitations and contracts if special marking on 
deliverables is required.
    We propose to add clause 352.247-72, Packing for Domestic Shipment, 
as prescribed at 347.205-10(b), in contracts when item(s) will be 
delivered for immediate use to a destination in the continental United 
States; when the material specification or purchase description does 
not provide preservation, packaging, packing, and/or marking 
requirements; and/or when the requiring activity has not cited a 
specific specification for packaging. This clause requires that 
material shall be packed for shipment in such a manner that will ensure 
acceptance by common carriers and safe delivery at destination. 
Containers and closures shall comply with regulations of carriers as 
applicable to the mode of transportation.

[[Page 80656]]

    We propose to revise the provisions and clauses related to HHSAR 
part 370, as follows, in the order currently reflected in the Code of 
Federal Regulations:
    We propose to revise provision 352.270-4a, Notice to Offerors, 
Protection of Human Subjects, to make minor administrative corrections 
to renumber the provision to 352.270-70, revise the HHSAR citation 
referencing the prescription, provide the current electronic Code of 
Federal Regulations website address for 45 CFR part 46, update other 45 
CFR part 46 citations where included in the provision, and add 
paragraph (h) to provide the registration processes.
    We propose to revise clause 352.270-4b, Protection of Human 
Subjects, to make minor administrative corrections to renumber to 
352.270-72 and to revise the HHSAR citation referencing the 
prescription.
    We propose to revise 352.270-5a, Notice to Offerors of Requirement 
for Compliance with Public Health Service Policy on Humane Care and the 
Use of Laboratory Animals, to make administrative corrections. This 
includes revising the provision to a clause, renumbering the clause to 
352.270-77, revising the title to ``Compliance with the Public Health 
Service Policy on Humane Care and Use of Laboratory Animals,'' and 
revising the HHSAR citation referencing the prescription. These 
revisions would add paragraph (a), Definitions, and three definitions, 
as well as additional content to paragraph (b) that the contract will 
not be awarded without the approval of the Office of Laboratory Animal 
Welfare, National Institutes of Health upon receipt of the contractor's 
assurance. We propose to revise paragraphs (b) and (c) to combine the 
current content into paragraph (b), and revise paragraph (c) to permit 
the contracting officer to immediately suspend, in whole or in part, 
work performance and further payments if the contractor is not in 
compliance with any of the requirements and standards in the clause.
    We propose to revise clause 352.270-5b, Care of Live Vertebrate 
Animals, to make minor administrative corrections to renumber the 
clause to 352.270-78, revise the HHSAR citation referencing the 
prescription, remove duplicative content in paragraph (c), change the 
``Note'' to new paragraph (e), and other minor edits for clarification.
    We propose to revise clause 352.270-6, Restriction on Use of Human 
Subjects, to make minor administrative corrections to renumber the 
clause to 352.270-73, revise the HHSAR citation referencing the 
prescription, and other minor edits for clarification.
    We propose to remove the ``352.270-7--352.270-8 [Reserved]'' 
annotation as it is no longer needed with the revision, renumbering, 
and retitling of the clauses and provisions under this part.
    We propose to revise provision 352.270-9, Non-Discrimination for 
Conscience, to make minor administrative corrections to renumber the 
clause to 352.270-79, revise the HHSAR citation referencing the 
prescription, and to add ``The PEPFAR Stewardship Act of 2013, and The 
PEPFAR Extension Act of 2018,'' to paragraph (a).
    We propose to revise provision 352.270-10, Notice to Offerors--
Protection of Human Subjects, Research Involving Human Subjects 
Committee (RIHSC) Approval of Research Protocols Required, to make 
minor administrative corrections to renumber the clause to 352.270-71, 
slightly revise the title and the HHSAR citation referencing the 
prescription, update the citation of the HHSAR provision number in 
paragraph (a), and other minor punctuation edits.
    We propose to revise clause 352.270-11, Protection of Human 
Subjects--Research Involving Human Subjects Committee (RIHSC) Approval 
of Research Protocols Required, to make minor administrative 
corrections to renumber the clause to 352.270-74, revise the HHSAR 
citation referencing the prescription, update the citation of the HHSAR 
provision number in paragraph (a), and other minor punctuation edits.
    We propose to revise clause 352.270-12, Needle Exchange, to make 
minor administrative corrections to renumber the clause to 352.270-75 
and revise the HHSAR citation referencing the prescription.
    We propose to revise clause 352.270-13, Continued Ban on Funding 
Abortion and Continued Ban on Funding of Human Embryo Research, to make 
minor administrative corrections to renumber the clause to 352.270-76 
and revise the HHSAR citation referencing the prescription.
    This table reflects the above proposed revisions and renumbering of 
the HHSAR part 370 prescribed clauses and provisions:

----------------------------------------------------------------------------------------------------------------
                                                                                  Proposed revised prescription
  Existing subpart prescription (in order of                                     for each solicitation provision
                   sequence)                     Existing No.    Proposed No.       and contract clause Note:
                                                                                    (P)=Provision, (C)=Clause
----------------------------------------------------------------------------------------------------------------
370.303(a)....................................      352.270-4a      352.270-70  370.304(a): 352.270-70, Notice
                                                                                 to Offerors, Protection of
                                                                                 Human Subjects (P).
370.303(d)....................................      352.270-10      352.270-71  370.304(b): 352.270-71, Notice
                                                                                 to Offerors--Protection of
                                                                                 Human Subjects, Research
                                                                                 Involving Human Subjects
                                                                                 Committee (RIHSC) Approval of
                                                                                 Research Protocols Required
                                                                                 (P).
370.304(b)....................................       352.270-6      352.270-73  370.304(d): 352.270-73,
                                                                                 Restriction on Use of Human
                                                                                 Subjects (C).
370.304(a)....................................      352.270-4b      352.270-72  370.304(c): 352.270-72,
                                                                                 Protection of Human Subjects
                                                                                 (C).
370.304(c)....................................      352.270-11      352.270-74  370.304(e): 352.270-74,
                                                                                 Protection of Human Subjects--
                                                                                 Research Involving Human
                                                                                 Subjects Committee (RIHSC)
                                                                                 Approval of Research Protocols
                                                                                 Required (C).
370.304(d)....................................      352.270-12      352.270-75  370.304(f): 352.270-75, Needle
                                                                                 Exchange (C).
370.304(e)....................................      352.270-13      352.270-76  370.304(g): 352.270-76,
                                                                                 Continued Ban on Funding
                                                                                 Abortion and Continued Ban on
                                                                                 Funding of Human Embryo
                                                                                 Research (C).
370.403(a)....................................      352.270-5a      352.270-77  370.403(a): 352.270-77,
                                                                                 Requirement for Compliance with
                                                                                 the Public Health Service
                                                                                 Policy on Humane Care and Use
                                                                                 of Laboratory Animals (C).
370.404.......................................      352.270-5b      352.270-78  370.403(b): 352.270-78, Care of
                                                                                 Live Vertebrate Animals (C).
370.701.......................................       352.270-9      352.270-79  370.701: 352.270-79, Non-
                                                                                 Discrimination for Conscience
                                                                                 (P).
----------------------------------------------------------------------------------------------------------------

    We propose to add subpart 352.3, Provision and Clause Matrix, and 
section 352.301, Solicitation provisions and contract clauses (Matrix). 
Section 352.301 identifies that the HHSAR matrix is not published in 
the Code of Federal Regulations and will be available on the 
Acquisition.gov website.

[[Page 80657]]

Subchapter M--HHS Supplementations

    We propose to redesignate and retitle subchapter M, HHS 
Supplementations, title 48, chapter 3, to subchapter I, Department 
Supplementary Regulations, to better align with other FAR system 
regulatory subchapter placements under similar agency supplements to 
title 48.

HHSAR Part 370--Special Programs Affecting Acquisition

    We propose to revise the authority citations for part 370, for the 
reasons set forth in the discussion and analysis section, to read as 
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
    We propose to revise the title of part 370 to ``Special Programs 
Affecting Acquisitions,'' to comport with the plural usage of 
``Acquisitions'' in the subpart titles.
    In subpart 370.3, Acquisitions Involving Human Subjects, we propose 
in section 370.300, Scope of subpart, to add a reference to 45 CFR part 
46 policy scope and update the references to the 2018 Requirements 
revisions. Specifically, we are adding a reference to 45 CFR 46.102, 
which defines the applicability of the HHS policy in general. We are 
also removing the reference to the old Sec.  46.102(d) and (f), which 
defined ``Human Subject'' and ``Research'' respectively and replacing 
them with the new 2018 paragraphs (e) and (l). In section 370.301, 
Policy, we propose to add a reference to the 2018 exemption for certain 
research as set forth in 45 CFR 46.104. We also propose administrative 
edits in the second sentence for further clarification.
    We propose in section 370.302, Federal-wide Assurance (FWA), to 
revise the title to ``Federal-wide assurance'' and make other minor 
edits for clarification.
    In section 370.303, Notice to offerors/Provisions, we propose to 
revise the section title to ``Notice to offerors,'' moving the two 
provisions prescribed in paragraphs (a) and (d) to revised section 
370.304, Solicitation provisions and contract clause, paragraphs (a) 
and (b). We also propose in section 370.303 to add a statement at 
paragraph (a) to reinforce the 2018 Requirements that unless exempt, no 
contract can start without the required certifications.
    We propose in section 370.304, Contract clauses, to revise the 
title to ``Solicitation provisions and contract clause.'' The following 
revisions to the text under this section are proposed:
     Move provision 352.270-4a, Notice to Offerors--Protection 
of Human Subjects, from section 370.303, paragraph (a), to be 
renumbered as 352.270-70, to comport with FAR numbering conventions. 
The provision is prescribed to be inserted in solicitations that 
involve human subjects.
     Move propose provision 352.270-10, Notice to Offerors--
Protection of Human Subjects, Research Involving Human Subjects 
Committee (RIHSC) Approval of Research Protocols Required, from section 
370.303, paragraph (d), to be renumbered as 352.270-71, to comport with 
FAR numbering conventions. The provision is prescribed to be inserted 
in solicitations that involve human subjects when the research is 
subject to RIHSC review and approval.
     Redesignate the existing paragraph (a) to paragraph (c), 
and renumber the clause 352.270-4b, Protection of Human Subjects, to 
352.270-72, to comport with FAR numbering conventions. The clause is 
prescribed to be inserted in solicitations, contracts, and orders 
involving human subjects.
     Redesignate the existing paragraph (b) to paragraph (d), 
and renumber the clause 352.270-6, Restriction of Use of Human 
Subjects, to 352.270-73, to comport with FAR numbering conventions. The 
clause is prescribed to be inserted in solicitations, contracts, and 
orders involving human subjects. In contracts and orders if the 
contractor has an approved FWA of compliance in place but cannot 
certify prior to award that an IRB registered with OHRP reviewed and 
approved the research, because definite plans for involvement of human 
subjects are not set forth in the proposal (e.g., projects in which 
human subjects' involvement will depend upon completion of instruments, 
prior animal studies, or purification of compounds). Under these 
conditions, the contracting officer may make the award without the 
requisite certification, as long as the contracting officer includes 
appropriate conditions in the contract or order.
     Redesignate the existing paragraph (c) to paragraph (e), 
and renumber the clause 352.270-11, Protection of Human Subjects--
Research Involving Human Subjects Committee (RIHSC) Approval of 
Research Protocols Required, to 352.270-74, to comport with FAR 
numbering conventions. The clause is prescribed to be inserted in 
solicitations, contracts, and orders that involve human subjects when 
the research is subject to RIHSC review and approval.
     Redesignate the existing paragraph (e) to paragraph (f), 
and renumber the clause 352.270-12, Needle Exchange, to 352.270-75, to 
comport with FAR numbering conventions. The clause is prescribed to be 
inserted in solicitations, contracts, and orders that involve human 
subjects.
     Redesignate the existing paragraph (e) to paragraph (e), 
and renumber the clause 352.270-13, Continued Ban on Funding Abortion 
and Continued Ban on Funding of Human Embryo Research, to 352.270-76, 
to comport with FAR numbering conventions. The clause is prescribed to 
be inserted in solicitations, contracts, and orders that involve human 
subjects.
    In subpart 370.4, Acquisitions Involving the Use of Laboratory 
Animals, we propose minor edits for clarification, and to move the 
citation regarding the Public Health Service (PHS) Policy on Humane 
Care and Use of Laboratory Animals (PHS Policy) to new section 370.402, 
Policy. We propose in new section 370.401, Definitions, to define three 
definitions used in this subpart, ``Animal,'' ``Animal Welfare 
Assurance or assurance,'' and ``Institutional Animal Care and Use 
Committee.''
    We propose to redesignate section 370.401 as section 370.402 to 
comport with FAR conventions and have made conforming revisions in the 
section to comport with the revised Public Health Service (PHS) Policy 
on Humane Care and Use of Laboratory Animals, which implements Public 
Law 99-158. We also propose to redesignate paragraph (b) to paragraph 
(c), and remove content to the HHSAM as internal procedures, as well as 
submission requirements that have more appropriately been moved to 
clause 352.270.77, Compliance with the Public Health Policy on Humane 
Care and Use of Laboratory Animals, which is prescribed at section 
370.403(a).
    We propose to remove section 370.402 and move the details of the 
assurance and approval requirements to clause 352.270.77, Compliance 
with the Public Health Policy on Humane Care and Use of Laboratory 
Animals, which is prescribed at section 370.403(a).
    We propose to rename section 370.403 as ``Contract clauses,'' to 
reflect that only clauses are prescribed in the section. The following 
revisions are proposed:
     In paragraph (a), change the prescription to renumbered 
clause 352.270-77, Compliance with the Public Health Policy on Humane 
Care and Use of Laboratory Animals, which comports with FAR numbering 
convention. The clause is prescribed to be inserted in solicitations, 
contracts, and orders that involve live vertebrate animals.
     Move the prescription currently at section 370.304 for 
clause 352.270-5b, Care of Live Vertebrate Animals, to

[[Page 80658]]

paragraph (b) of section 370.403, Contract clauses, and renumber the 
clause to 352.270-76, which comports with FAR numbering convention. The 
clause is prescribed to be inserted in solicitations and contracts that 
involve live vertebrate animals.
     Remove the remaining content in section 370.403 as the 
language is duplicative of the prescribed clauses.
    We propose to remove section 370.404, Contract clause, as the 
content has been moved to section 370.403.
    In subpart 370.7, Acquisitions Under the Leadership Act, we propose 
to revise the title of the subpart to ``Acquisitions Under the 
President's Emergency Plan for AIDS Relief,'' as this is the more 
commonly used title of Public Law 108-25, in addition to the fact the 
short title, ``Leadership Act,'' is no longer widely used.
    In section 370.700, Scope of subpart, we propose to add the 
``PEPFAR'' (``President's Emergency Plan for AIDS Relief'') acronym and 
update the amended public law references to include Public Law 115-305, 
the PEPFAR Extension Act.
    In section 370.701, Solicitation provision, we propose to number 
provision 352.270-9, Non-Discrimination for Conscience, to 352.270-79, 
to comport with FAR numbering convention. We also propose to revise the 
prescription language at paragraphs (a) to update with the enacted 
PEPFAR Stewardship and Oversight Act of 2013 (Pub. L. 113-56) in lieu 
of the PEPFAR Extension Act of 2018 (Pub. L. 115-305). We also propose 
to move the content of paragraph (b) to the HHSAM as agency procedures.

Regulatory Reviews

Executive Order 12866 and 13563

    Executive Orders (E.O.) 12866 and 13563 direct agencies to assess 
all costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). Executive Order 13563 (Improving Regulation and Regulatory 
Review) emphasizes the importance of quantifying both costs and 
benefits, reducing costs, harmonizing rules, and promoting flexibility.
    The Office of Information and Regulatory Affairs has examined the 
economic, interagency, budgetary, legal, and policy implications of 
this regulatory action, and has determined that this rule is not a 
significant regulatory action under E.O. 12866.
    HHS's impact analysis can be found as a supporting document at 
https://www.regulations.gov, usually within 48 hours after the 
rulemaking document is published.

Paperwork Reduction Act

    This proposed rule includes provisions constituting collections of 
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521) that require approval by the Office of Management and Budget 
(OMB). Accordingly, under 44 U.S.C. 3507(d), HHS has submitted a copy 
of this rulemaking action to OMB for its review.
    OMB assigns control numbers to collections of information it 
approves. HHS may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number. HHS is revising 12 currently 
approved collections of information proposed in this rule under the 
HHSAR, 48 CFR part 352, Solicitation Provisions and Contract Clauses, 
that are prescribed under and related to the following HHSAR parts:
     48 CFR part 370, Special Programs Affecting Acquisition;
     48 CFR part 327, Patents, Data, and Copyrights;
     48 CFR part 337, Service Contracting--General; and
     48 CFR part 311, Describing Agency Needs.
    The 12 existing approved information collections followed by their 
currently designated numbers and titles are reflected below. (Note: The 
following existing section (clause or provision) numbers may be updated 
by number or title as reflected later in this section via a table 
describing the updated burden information.)
     48 CFR 352.270-4a, Notice to Offerors, Protection of Human 
Subjects.
     48 CFR 352.270-10, Notice to Offerors--Protection of Human 
Subjects, Research Involving Human Subjects Committee (RIHSC) Approval 
of Research Protocols Required.
     48 CFR 352.270-4b, Protection of Human Subjects.
     48 CFR 352.270-11, Protection of Human Subjects--Research 
Involving Human Subjects Committee (RIHSC) Approval of Research 
Protocols Required.
     48 CFR 352.237-73, Indian Child Protection and Family 
Violence Act.
     48 CFR 352.270-5a, Notice to Offerors of Requirement for 
Compliance with Public Health Service Policy on Humane Care and the Use 
of Laboratory Animals.
     48 CFR 352.270-5b, Care of Live Vertebrate Animals.
     48 CFR 352.211-1, Public Accommodations and Commercial 
Facilities.
     48 CFR 352.211-2, Conference Sponsorship Request and 
Conference Materials Disclaimer.
     48 CFR 352.227-11, Patent Rights--Exceptional 
Circumstances.
     48 CFR 52.227-14, Rights in Data--Exceptional 
Circumstances.
     48 CFR 352.237-72, Crime Control Act--Requirement for 
Background Checks.
    Additionally, HHS is proposing to add six (6) new collections of 
information in this proposed rule under the HHSAR, 48 CFR part 352, 
Solicitation Provisions and Contract Clauses, that are prescribed under 
and related to the following HHSAR parts:
     48 CFR part 304, Administrative Matters (proposed to be 
revised to a new header to comport with the FAR: Administrative and 
Information Matters);
     48 CFR part 308, Required Sources of Supplies and 
Services;
     48 CFR part 309, Contractor Qualifications;
     48 CFR part 323, Environment, Energy and Water Efficiency, 
Renewable Energy Technologies, Occupational Safety, and Drug-Free 
Workplace (proposed to be revised to a new header to comport with the 
FAR: Environment, Sustainable Acquisition, and Material Safety);
     48 CFR part 333, Protests, Disputes, and Appeals; and
     48 CFR part 345, Government Property.
    The six new proposed approved information collections are as 
follows (Note: Based on the number of respondents for two of the 
associated information collections falling under 10 that do not require 
OMB approval due to exception, HHS is requesting four (4) new approved 
OMB control numbers for items 1 through 4 as follows out of the six new 
identified collections of information.):
    1. 48 CFR 352.204-70, Prevention and Public Health Fund--Reporting 
Requirements.
    2. 48 CFR 352.209-70, Organizational Conflicts of Interest.
    3. 48 CFR 352.208-70, Printing and Duplication.
    4. 48 CFR 352.245-70, Contractor Property Management System 
Administration.
    5. 48 CFR 352.223-70, Instructions to Offerors--Sustainable 
Acquisition Plan. (OMB approval not required at this time.)

[[Page 80659]]

    6. 48 CFR 352.233-71, Litigation and Claims. (OMB approval not 
required at this time.)
    If OMB does not approve the collections of information as 
requested, HHS will immediately remove the provisions containing a 
collection of information or take such other action as is directed by 
OMB.
    Comments on the collections of information contained in this 
proposed rule should be submitted to the Office of Management and 
Budget, Attention: Desk Officer for the Department of Health and Human 
Services, Office of Information and Regulatory Affairs, Washington, DC 
20503, with copies sent by mail or hand delivery to the U.S. Department 
of Health and Human Services, Office of the Chief Information Officer, 
Attn: Sherrette Funn, 200 Independence Ave. SW, Room 336E, Washington, 
DC 20201; or email to [email protected]; and email to https://www.regulations.gov. Comments should indicate that they are submitted 
in response to ``RIN 0991-AC36--HHS Acquisition Regulation: Regulatory 
Review (HHSAR Case 2023-002).''
    OMB is required to make a decision concerning the collections of 
information contained in this proposed rule between 30 and 60 days 
after publication of this document in the Federal Register. Therefore, 
a comment to OMB is best assured of having its full effect if OMB 
receives it within 30 days of publication. This does not affect the 
deadline for the public to comment on the proposed rule.
    The Department considers comments by the public on proposed 
collections of information in--
     Evaluating whether the proposed collections of information 
are necessary for the proper performance of the functions of the 
Department, including whether the information will have practical 
utility;
     Evaluating the accuracy of the Department's estimate of 
the burden of the proposed collections of information, including the 
validity of the methodology and assumptions used;
     Enhancing the quality, usefulness, and clarity of the 
information to be collected; and
     Minimizing the burden of the collections of information on 
those who are to respond, including through the use of appropriate 
automated, electronic, mechanical, or other technological collection 
techniques or other forms of information technology, e.g., permitting 
electronic submission of responses.
    The collection of information on currently approved OMB control 
numbers can be accessed on reginfo.gov. The following table provides a 
summary of the proposed revisions of the 12 currently approved 
collections of information. The proposed revisions do not change 
information collection requirements and the estimated burden hours. But 
the proposed revision made changes in the Information Collection 
Instruments/Instructions. HHS has submitted them to OMB for review and 
approval.

----------------------------------------------------------------------------------------------------------------
                                                       Proposed clause/
 Existing clause/provision number    Approved OMB    provision number and      Proposed other      Burden hours
         and header title           control number       header title             changes
----------------------------------------------------------------------------------------------------------------
352.270-4a, Notice to Offerors,          0990-0431  352.270-70, Notice to  Revise the HHSAR                  450
 Protection of Human Subjects.                       Offerors--Protection   citation referencing
                                                     of Human Subjects.     the prescription.
352.270-10 Notice to Offerors--          0990-0431  352.270-71, Notice to  N/A..................             450
 Protection of Human Subjects,                       Offerors--Protection
 Research Involving Human Subjects                   of Human Subjects,
 Committee (RIHSC) Approval of                       Research Involving
 Research Protocols Required.                        Human Subjects
                                                     Committee (RIHSC)
                                                     Approval of Research
                                                     Protocols Required.
352.270-4b, Protection of Human          0990-0431  352.270-72,            Revise the HHSAR                  450
 Subjects.                                           Protection of Human    citation referencing
                                                     Subjects.              the prescription.
352.270-11 Protection of Human           0990-0431  352.270-74 Protection  Revise the HHSAR                  450
 Subjects--Research Involving                        of Human Subjects--    citation referencing
 Human Subjects Committee (RIHSC)                    Research Involving     the prescription.
 Approval of Research Protocols                      Human Subjects
 Required.                                           Committee (RIHSC)
                                                     Approval of Research
                                                     Protocols Required.
352.237-72, Crime Control Act--          0990-0430  352.237-72,            Update the                        160
 Requirement for Background Checks.                  Requirement for        prescription and the
                                                     Background Checks.     title.
352.270-5a, Notice to Offerors of        0990-0432  352.270-77,            Revise the title and               54
 Requirement for Compliance with                     Compliance with the    HHSAR citation
 Public Health Service Policy on                     Public Health          referencing the
 Humane Care and the Use of                          Service Policy on      prescription. Adding
 Laboratory Animals.                                 Humane Care and Use    new content.
                                                     of Laboratory
                                                     Animals.
352.270-5b, Care of Live                 0990-0432  352.270-78, Care of    Revise the HHSAR                   54
 Vertebrate Animals.                                 Live Vertebrate        citation referencing
                                                     Animals.               the prescription and
                                                                            remove duplicative
                                                                            content.
352.211-1, Public Accommodations         0990-0434  352.211-70, Public     Revise the                      533.5
 and Commercial Facilities.                          Accommodations and     prescription to
                                                     Commercial             comport with FAR
                                                     Facilities.            style conventions.
352.211-2, Conference Sponsorship        0990-0434  352.211-71,            Update the                      533.5
 Request and Conference Materials                    Conference             prescription to
 Disclaimer.                                         Sponsorship Requests   comport with FAR
                                                     and Conference         style conventions.
                                                     Materials Disclaimer.
352.227-11, Patent Rights--              0990-0419  352.227-70, Patent     Make minor updates to         5,449.5
 Exceptional Circumstances.                          Rights--Supplement--   the clause
                                                     Exceptional            prescription and
                                                     Circumstances.         citation.
352.227-14, Rights in Data--             0990-0419  352.227-71, Rights in  Make minor updates to         5,449.5
 Exceptional Circumstances.                          Data--Supplement--Ex   the clause
                                                     ceptional              prescription and
                                                     Circumstances.         citation and remove
                                                                            duplicate content.

[[Page 80660]]

 
352.237-73, Indian Child                 0990-0433  352.237-73, Indian     Revise title of the                67
 Protection and Family Violence                      Child Protection and   clause. Add needed
 Act.                                                Family Violence Act--  content and bring
                                                     Background             reference citations
                                                     Investigations.        up to date. Updates
                                                                            to the clause
                                                                            prescription and
                                                                            citation.
----------------------------------------------------------------------------------------------------------------

    HHSAR parts 308, 309, 304, 323, 333, and 345 related new 
collections of information: Individual summaries of collection of 
information, description of need for information and proposed use of 
information, along with supporting estimated data are described below.
    The following table summarizes HHS request for four (4) new OMB 
control numbers for the four proposed clauses/provisions containing 
collections of information with burdens on the public.

----------------------------------------------------------------------------------------------------------------
                                                   HHSAR clause                     BLS hourly    Estimated cost
            OMB control # requesting                 provision    Estimated hour     wage rate     to the public
----------------------------------------------------------------------------------------------------------------
1...............................................      352.208-70             500          $42.89         $21,445
1...............................................      352.209-70             150           42.89           6,434
N/A *...........................................      352.233-71             N/A           42.89             N/A
N/A *...........................................      352.223-70             N/A           42.89             N/A
1...............................................      352.204-70             260           42.89          11,151
1...............................................      352.245-70              66           42.89           2,831
----------------------------------------------------------------------------------------------------------------
* No OMB Control Number is requested because currently, the estimated number of respondents falls below 10.
  While HHS will collect information it does not meet the threshold for submitting to OMB for approval. As HHS
  captures more information in the future when the rule is published as final, HHS will continue to examine how
  much the proposed new collections of information are utilized in HHS procurements.

    The Bureau of Labor Statistics (BLS) gathers information on full-
time wage and salary workers. The BLS hourly wage rate is using the 
latest (May 2023) available BLS data, the mean hourly wage is $31.48 on 
BLS wage code--``00-0000 All Occupations'' plus 36.25% fringe benefits 
per OMB Memo M-08-13 dated March 11, 2008.
    The 6 new clauses/provisions containing collections of information 
are described below:
     The first new OMB Control number request is for 352.208-
70, Printing and Duplication.
    The collection of information contained in section 308.870, 
Contract clauses, and part 352 at proposed clause 352.208-70, is 
described immediately following this paragraph.
    Summary of collection of information: We propose the use of 
352.208-70, Printing and Duplication, as prescribed at 308.870, 
Contract clauses.
    The proposed HHSAR clause 352.208-70, Printing and Duplication, is 
required in all solicitations and contracts for supplies or services 
over the simplified acquisition threshold, unless printing or increased 
duplication is authorized by statute. It is intended to prohibit 
contractors and subcontractors from performing printing, to acquire 
related supplies, or to provide other printing-related services without 
prior authorization from the contracting officer. When printing 
supplies or services are required, and specified under the contract, 
the Contractor shall submit camera-ready copies of such deliverables to 
the Contracting Officer's Representative for printing. The information 
collection requirement is necessary to ensure deliverables are not 
duplicated and/or printed without prior approval from the contracting 
officer.
    Description of need for information and proposed use of 
information: Public Law 90-620, (44 U.S.C. 101), Public Printing and 
Document, was passed to centralize in the United States Government 
Publishing Office the printing, binding, and distribution of U.S. 
Government documents.
    To comply with Public Law 90-620, and to establish parameters on 
allowable printing under HHS contracts, HHS developed clause 352.208-
70, Printing and Duplication. The clause contains the following 
information collection requirements: the contractor shall submit 
camera-ready copies of such deliverables to the Contracting Officer's 
Representative for printing.

                                             Burden Hour Calculation
----------------------------------------------------------------------------------------------------------------
                                                x Number of
            Number of respondents              responses per     x Number of      / by 60 min/      Number of
                                                 respondent        minutes            hour         burden hours
----------------------------------------------------------------------------------------------------------------
5,000.......................................               1               10   ...............             500
----------------------------------------------------------------------------------------------------------------

     The second new OMB control number request is for 352.209-
70, Organizational Conflicts of Interest.
    The collection of information contained in section 309.507-1, 
Solicitation provision, and part 352 at proposed provision 352.209-70, 
is described immediately following this paragraph.
    Summary of collection of information: We propose to add 352.209-70, 
Organizational Conflicts of Interest, as prescribed at 309.507-1, 
Solicitation provision.
    The proposed rule HHSAR provision 352.209-70, Organizational 
Conflicts of Interest, is required in all solicitations for the 
services addressed at FAR 9.502 and is intended to avoid situations 
which might create an organizational conflict of interest or where the 
offeror's

[[Page 80661]]

performance of work under the contract may provide the contractor with 
an unfair competitive advantage. HHS would use the information 
collection requirements to assess whether an organizational conflict of 
interest exists with the contractor. The information collection 
requirement is necessary to ensure that the offeror's performance of 
work under the contract may not provide the contractor with an unfair 
competitive advantage.
    Description of need for information and proposed use of 
information: Under Public Law 117-324, Preventing Organizational 
Conflicts of Interest in Federal Acquisition Act, each agency of the 
Federal Government must prevent organizational conflicts of interest in 
Federal acquisitions. To comply, HHS developed provision 352.209-70, 
Organizational Conflicts of Interest. The provision contains the 
following information collection requirements: The offeror shall 
provide (1) a statement with its offer which describes all relevant 
facts concerning any past, present, or currently planned interest 
(financial, contractual, organizational, or otherwise) or actual or 
potential organizational conflicts of interest relating to the services 
to be provided under this solicitation; (2) same information as (1) for 
any consultants and subcontractors identified in its proposal and which 
will provide services under the solicitation; (3) relevant facts that 
show how its organizational and/or management system or other actions 
would avoid or mitigate any actual or potential organizational 
conflicts of interest.

                                             Burden Hour Calculation
----------------------------------------------------------------------------------------------------------------
                                                x Number of
            Number of respondents              responses per     x Number of      / by 60 min/      Number of
                                                 respondent        minutes            hour         Burden Hours
----------------------------------------------------------------------------------------------------------------
150.........................................               1               60   ...............             150
----------------------------------------------------------------------------------------------------------------

     The third information collection added in the rule is for 
352.233-71, Litigation and Claims. Due to the estimated projected 
respondents falling under 10, a new OMB control number will not be 
requested at this time. The information on the collection of 
information that falls within the exception is provided here for the 
public's information and use. HHS will continue to examine in the 
future after publication of a final rule whether or not the use of the 
clause increases over 10 in a given fiscal year and proceed with 
requesting OMB approval if needed at that time.
    The collection of information contained in section 333.215-70, 
Contract clauses, and part 352 at proposed clause 352.233-71, is 
described immediately following this paragraph.
    Summary of collection of information: We propose to add 352.233-71, 
Litigation and Claims, as prescribed at 333.215-70, Contract clauses.
    The proposed rule HHSAR clause 352.233-71, Litigation and Claims, 
is required in solicitations and contracts when a cost-reimbursement, 
time-and-materials, or labor-hour contract is contemplated and is 
intended to require contractors to notify the Department of Health and 
Human Services (HHS) immediately for any litigation or claims that may 
be filed against the contractor arising out of the performance of the 
contract. The information collection requirement is necessary to 
determine the need of assigning representatives of HHS to settle or 
defend any such action or claim.
    Description of need for information and proposed use of 
information: To ensure HHS is not liable for the expense of defending 
any action or for any costs resulting from the loss thereof to the 
extent that the contractor would have been compensated by insurance due 
to the contractor failing to secure, through its own fault or 
negligence, appropriate insurance coverage, HHS developed clause 
352.233-71, Litigation and Claims. The clause contains the following 
information collection requirements: (1) The contractor shall provide 
written notification immediately to the contracting officer of any 
action, including any proceeding before an administrative agency, filed 
against the contractor arising out of the performance of this contract; 
(2) the contractor shall furnish immediately to the contracting officer 
copies of all pertinent documents received by the contractor with 
respect to such action or claim.

                                             Burden Hour Calculation
----------------------------------------------------------------------------------------------------------------
                                                x Number of
            Number of respondents              responses per     x Number of      / by 60 min/      Number of
                                                 respondent        minutes            hour         burden hours
----------------------------------------------------------------------------------------------------------------
2 (N/A) *...................................         2 (N/A)               60   ...............         2 (N/A)
----------------------------------------------------------------------------------------------------------------
* Note: Due to the estimated low number of projected respondents, no formal OMB information collection approval
  is required at this time. HHS will continue monitoring the use of the clause after publication of the final
  rule.

     The fourth information collection added in the rule is for 
352.223-70, Instructions to Offerors--Sustainable Acquisition Plan.
    The collection of information contained in section 323.109-70, 
Solicitation provision, and part 352 at proposed provision 352.223-70, 
is described immediately following this paragraph.
    Summary of collection of information: We propose to add 352.223-70, 
Instructions to Offerors--Sustainable Acquisition Plan, as prescribed 
at 323.109-70, Solicitation provision.
    The proposed rule would add HHSAR provision 352.223-70, 
Instructions to Offerors--Sustainable Acquisition Plan. It is required 
in solicitations above the micro-purchase threshold when acquiring a 
product or service that include sustainable acquisition attributes and 
is intended to apply FAR subpart 23.1, Sustainable Products and 
Services. The information collection requirement is necessary to comply 
with the requirements of Executive Order 13423.
    Description of need for information and proposed use of 
information: Executive Order (E.O.) 13423 requires in agency 
acquisitions of goods and

[[Page 80662]]

services (i) the use of sustainable environmental practices, including 
acquisition of biobased, environmentally preferable, energy-efficient, 
water-efficient, and recycled-content products, and (ii) the use of 
paper of at least 30 percent post-consumer fiber content. To comply 
with E.O. 13423, HHS developed provision 352.223-70, Instructions to 
Offerors--Sustainable Acquisition Plan. The provision contains the 
following information collection requirements: Offerors shall include a 
Sustainable Acquisition Plan in their technical proposals.

                                             Burden Hour Calculation
----------------------------------------------------------------------------------------------------------------
                                                x Number of
            Number of respondents              responses per     x Number of      / by 60 min/      Number of
                                                 respondent        minutes            hour         burden hours
----------------------------------------------------------------------------------------------------------------
6 (N/A) *...................................         1 (N/A)              120   ...............        12 (N/A)
----------------------------------------------------------------------------------------------------------------
* Note: Due to the estimated low number of projected respondents, no formal OMB information collection approval
  is required at this time. HHS will continue monitoring the use of the clause after publication of the final
  rule.

     The fifth new information collection, and third request 
for an OMB control number is for 352.204-70, Prevention and Public 
Health Fund--Reporting Requirements.
    The collection of information contained in section 304.7202, 
Contract clause, and part 352 at proposed clause 352.204-70, is 
described immediately following this paragraph.
    Summary of collection of information: We propose to add of 352.204-
70, Prevention and Public Health Fund--Reporting Requirements, as 
prescribed at 304.7202, Contract clause.
    Proposed rule added HHSAR clause 352.204-70, Prevention and Public 
Health Fund--Reporting Requirements, is required in all solicitations 
and contract actions with a value of $25,000 or more funded in whole or 
in part with Prevention and Public Health Funds (PPHFs), except 
classified solicitations and contracts and is intended to implement 
section 220 of Public Law 112-74, FY 2012 Labor, HHS and Education 
Appropriations Act. The information collection requirement is necessary 
to comply with the requirements of semi-annual reporting on the use of 
funds from the Prevention and Public Health Fund (PPHF), Public Law 
111-148, sec. 4002.
    Description of need for information and proposed use of 
information: Under Public Law 112-74, Consolidated Appropriations Act, 
2012, section 220(b)(5), requires each contractor to report on its use 
of Prevention and Public Health Fund under the contract. To comply with 
the public law, HHS developed clause 352.204-70, Prevention and Public 
Health Fund--Reporting Requirements. The clause contains the following 
information collection requirements: Semi-annual reports from the 
contractor for all work funded, in whole or in part, by the PPHF, are 
due no later than 20 days following the end of each 6-month period.

                                             Burden Hour Calculation
----------------------------------------------------------------------------------------------------------------
                                                x Number of
            Number of respondents              responses per     x Number of      / by 60 min/      Number of
                                                 respondent        minutes            hour         burden hours
----------------------------------------------------------------------------------------------------------------
260.........................................               2               30   ...............             260
----------------------------------------------------------------------------------------------------------------

     The sixth new information collection requirement is for 
352.245-70, Contractor Property Management System Administration.
    The collection of information contained in section 345.107, 
Contract clauses, and part 352 at proposed clause 352.245-70, 
Contractor Property Management System Administration, is described 
immediately following this paragraph.
    Summary of collection of information: We propose to add 352.245-70, 
Contractor Property Management System Administration, as prescribed at 
345.107, Contract clauses.
    Proposed rule added HHSAR clause 352.245-70, Contractor Property 
Management System Administration, is required in solicitations and 
contracts containing the clause at FAR 52.245-1, Government Property, 
and is intended to protect HHS's property. The information collection 
requirement is necessary to ensure the Contractor's system or systems 
for managing and controlling Government property is acceptable by HHS.
    Description of need for information and proposed use of 
information: To ensure the contractor is establishing and maintaining 
an acceptable property management system, HHS developed clause 352.245-
70, Contractor Property Management System Administration. The clause 
contains the following information collection requirements: The 
contractor shall respond within 30 days to a written initial 
determination from the contracting officer that identifies significant 
deficiencies in the contractor's property management system. HHS 
estimates that of the 26,128 total contract actions over the Simplified 
Acquisition Threshold during FY 2018-FY 2022, that no more than 5% 
(1,306) would require the required contractor property management 
system administration, and no more than 10% of that subset (131) would 
be submitting information in any one fiscal year during performance 
under the contract. We have entered the data below and as HHS obtains 
more data for future renewals, we will update the estimated burden.

[[Page 80663]]



                                             Burden Hour Calculation
----------------------------------------------------------------------------------------------------------------
                                                x Number of
            Number of respondents              responses per     x Number of      / by 60 min/      Number of
                                                 respondent        minutes            hour         Burden Hours
----------------------------------------------------------------------------------------------------------------
131.........................................               1               30   ...............              66
----------------------------------------------------------------------------------------------------------------

Regulatory Flexibility Act

    The Secretary hereby certifies that this proposed rule would not 
have a significant economic impact on a substantial number of small 
entities as they are defined in the Regulatory Flexibility Act (5 
U.S.C. 601-612). Therefore, pursuant to 5 U.S.C. 605(b), the initial 
and final regulatory flexibility analysis requirements of 5 U.S.C. 603 
and 604 do not apply.
    HHS expects that the overall impact of the proposed rule would 
benefit small businesses because HHS proposes to update the HHSAR to, 
among other things, revise outdated information, remove extraneous 
procedural information that applies only to HHS's internal operating 
procedures, and remove policy or procedures duplicative of FAR 
requirements. Any additional costs associated with the rule, such as 
costs to implement the substantive new and revised requirements 
concerning Made in America Act, can be factored into the contract 
price. On this basis, the Secretary hereby certifies that this proposed 
rule will not have a significant economic impact on a substantial 
number of small entities as they are defined in the Regulatory 
Flexibility Act, 5 U.S.C. 601-612. Therefore, pursuant to 5 U.S.C. 
605(b), the initial and final regulatory flexibility analysis 
requirements of sections 603 and 604 do not apply.
    While based on the foregoing, HHS has determined that the agency is 
not required to prepare an Initial Regulatory Flexibility Analysis 
(IRFA), HHS has prepared an IRFA that is summarized here. Comments are 
solicited from small businesses and other interested parties and will 
be considered in the development of the final rule.

Initial Regulatory Flexibility Analysis

    This Initial Regulatory Flexibility Analysis has been prepared 
consistent with 5 U.S.C. 603.
1. Description of the Reasons why the Action is Being Taken
    This proposed rule would amend the Health and Human Services 
Acquisition Regulation (HHSAR) to implement updates to the HHSAR, 
remove extraneous procedural information that applies only to HHS's 
internal operating procedures, and remove policy or procedures 
duplicative of FAR requirements. The proposed rule also includes 
substantive new and revised requirements concerning due process rights 
on debarments and suspensions. Based on a review of the potential 
impact on small business entities, HHS has determined that the 
requirements specified in the proposed rule are inherent to successful 
performance on any Federal contract and are required for both large and 
small businesses.
2. Succinct Statement of the Objectives of, and Legal Basis for, the 
Proposed Rule
    In addition to updating the HHSAR to remove outdated information, 
remove extraneous procedural information that applies only to HHS's 
internal operating procedures, and to remove policy or procedures 
duplicative of FAR requirements, the proposed rule implements important 
agency policies and procedures to implement Executive orders and 
specific requirements of the FAR specified for agency implementation. 
This must be implemented in the HHSAR in accordance with 41 U.S.C. 1707 
and FAR subpart 1.5, which require publication of a proposed rule for 
public comment.
3. Description of and, Where Feasible, Estimate of the Number of Small 
Entities to Which the Proposed Rule Will Apply
    This proposed rule will impact small businesses that provide 
supplies, services, and construction to HHS as prime contractors or 
subcontractors, as well as those small business entities that would 
like to support HHS and who submit quotations, offers and proposals to 
compete for future opportunities. To estimate the number of small 
businesses that could potentially be impacted by the proposed rule, HHS 
focused on those contract award actions over the Simplified Acquisition 
Threshold (SAT) (in most instances the SAT was $150,000 before June 1, 
2018, and $250,000 after June 1, 2018, when the SAT was increased). 
This is because it is likely that the most impact to small business 
entities as a result of this important HHSAR update would be at the SAT 
or above, as the FAR already provides agencies more streamlined 
policies and procedures under the SAT to ease the burden, both on the 
public as well as the acquisition workforce, for actions that fall 
under the SAT. Across the thirteen main Operating Divisions and Staff 
Divisions we examined the Federal Procurement Data System for HHS 
contract award actions over the SAT for Fiscal Years (FY) 2018-2022. 
This data reflects the following HHS contract awards to small business 
entities as shown in the table below:

                                   HHS Contract Action Awards to Small Business Entities Over the SAT: FY 2018-FY 2022
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                       FY 2018          FY 2019          FY 2020          FY 2021          FY 2022           Total           Average
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Total........................            2536             2405             2502             2426             2551           12,420             2484
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 80664]]

    As shown, HHS awarded over 12,420 contracts to small business 
entities over the SAT during the period FY 2018 through FY 2022. Using 
this figure to project the potential impact to small business entities 
that may be affected by the proposed rule, the Department estimates 
that on average each fiscal year, 2,484 small business entities or more 
may perform under HHS contracts and be impacted by the acquisition 
regulations contained in this rulemaking.
4. Description of Projected Reporting, Recordkeeping, and Other 
Compliance Requirements of the Proposed Rule, Including an Estimate of 
the Classes of Small Entities Which Will be Subject to the Requirement 
and the Type of Professional Skills Necessary for Preparation of the 
Report Or Record
    The proposed rule includes reporting or recordkeeping requirements. 
The revised record keeping and reporting requirements and estimated 
impacts are described in the Paperwork Reduction Act section of the 
rulemaking.
5. Identification, to the Extent Practicable, of all Relevant Federal 
Rules Which May Duplicate, Overlap, or Conflict With the Proposed Rule
    The proposed rule does not duplicate, overlap, or conflict with any 
other Federal rules.
6. Description of any Significant Alternatives to the Proposed Rule 
Which Accomplish the Stated Objectives of Applicable Statutes and Which 
Minimize Any Significant Economic Impact of the Rule on Small Entities
    HHS considered whether any other alternatives would reduce the 
impact on small businesses but concluded that the proposed rule was 
necessary for consistency with the FAR, for compliance with new 
statutes such as Made in America, and to ensure the protection of 
children entrusted under the care of HHS through unique agency 
acquisition requirements with respect to important issues such as 
compliance with reporting of child abuse, non-smoking, and required 
background checks.

Comments on the Economic Impacts of the Proposed Rule

    HHS has submitted a copy of the IRFA to the Chief Counsel for 
Advocacy of the Small Business Administration. HHS will consider 
comments from small entities concerning the affected HHSAR parts that 
pertain to this proposed rule. Interested parties should cite 5 U.S.C 
601, et seq. and reference ``RIN 0991-AC36--HHS Acquisition Regulation: 
Regulatory Review (HHSAR Case 2023-002),'' in comments on the 
certification or the IRFA presented in this proposed rule.

Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 
1532, that agencies prepare an assessment of anticipated costs and 
benefits before issuing any rule that may result in the expenditure by 
State, local, and Tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation) in any one year. HHS has determined that this proposed rule 
would have no such effect on State, local, and Tribal governments or on 
the private sector. Therefore, the analytical requirements of UMRA do 
not apply.

List of Subjects

48 CFR Parts 301, 302, 303, 304, 305, 306, 308, 309, 311, 312, 313, 
314, 315, 316, 318, 319, 322, 323, 324, 327, 330, 331, 332, 333, 334, 
335, 336, 337, 343, 345, 352, and 370

    Government procurement.

48 CFR Part 325

    Customs duties and inspection, Foreign currencies, Foreign trade, 
Government procurement.

48 CFR Part 326

    Government procurement, Indians, Indians-business and finance, 
Reporting and recordkeeping requirements.

48 CFR Part 341

    Government procurement, Reporting and recordkeeping requirements, 
Utilities.

48 CFR Parts 342 and 344

    Government procurement, Reporting and recordkeeping requirements.

48 CFR Part 347

    Freight, Government procurement, Reporting and recordkeeping 
requirements, Transportation.

Xavier Becerra,
Secretary, Department of Health and Human Services.

    For the reasons set out in the preamble, HHS proposes to amend 48 
CFR chapter 3 as follows:

0
1. Revise parts 301 through 303 to read as follows:
* * * * *
PART 301 HHS ACQUISITION REGULATION SYSTEM
PART 302 DEFINITIONS OF WORDS AND TERMS
PART 303 IMPROPER BUSINESS PRACTICES AND PERSONAL CONFLICTS OF 
INTEREST
* * * * *

PART 301--HHS ACQUISITION REGULATION SYSTEM

Sec.
301.000 Scope of part.
Subpart 301.1--Purpose, Authority, Issuance
301.101 Purpose.
301.103 Authority.
301.104 Applicability.
301.105 Issuance.
301.105-1 Publication and code arrangement.
301.105-2 Arrangement of regulations.
301.105-3 Copies.
301.106 OMB approval under the Paperwork Reduction Act.
301.107 Certifications.
Subpart 301.3--Agency Acquisition Regulations
301.301 Policy.
301.301-70 Amendment of the HHSAR.
301.303-70 Publication and codification--HHSAR.
301.304 Agency control and compliance procedures.
Subpart 301.470--Deviations from the FAR and HHSAR
301.402 Policy.
301.403 Individual deviations.
301.404 Class deviations.
Subpart 301.6--Career Development, Contracting Authority, and 
Responsibilities
301.601 General.
301.602 Contracting officers.
301.602-3 Ratification of unauthorized commitments.
301.603 Selection, appointment, and termination of appointment of 
contracting officers.
301.603-1 General.
301.603-3 Appointment.
301.604 Contracting Officer's Representative (COR).
301.604-70 Contract clause.
Subpart 301.7--Determination and Findings
301.707 Signatory authority.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(b), 
(c)(3); 41 U.S.C. 1303(a)(2); 41 U.S.C. 1702, 1707; and 48 CFR 1.301 
through 1.304.


301.000  Scope of part.

    This part sets out general Department of Health and Human Services 
Acquisition Regulation (HHSAR) policies, including information 
regarding the purpose, authority, issuance, arrangement, applicability, 
numbering, implementation, supplementation, and maintenance and 
administration of the HHSAR. The HHSAR is an integral part of the 
Federal Acquisition Regulations System. It also includes Health and 
Human Services

[[Page 80665]]

(HHS) acquisition policies and procedures for deviation from the HHSAR 
and the Federal Acquisition Regulation (FAR).

Subpart 301.1--Purpose, Authority, Issuance


301.101  Purpose.

    The HHSAR establishes uniform acquisition policies and procedures, 
which implement and supplement the Federal Acquisition Regulation 
(FAR). This subpart also provides the explanation of the authorities 
under which the HHSAR is issued.


301.103  Authority.

    (b) The Senior Procurement Executive (SPE), as delegated by the 
Secretary of HHS, prescribes the HHSAR under the authority of 41 U.S.C. 
1707, 5 U.S.C. 301, section 205(c) of the Federal Property and 
Administrative Services Act of 1949, 40 U.S.C. 121(c)(2), FAR 1.301 
through 1.304, and other authorities as cited.


301.104  Applicability.

    The FAR and the HHSAR apply to all HHS acquisitions as defined in 
FAR 2.101.


301.105  Issuance.


301.105-1  Publication and code arrangement.

    (b) The HHSAR is issued as chapter 3 of title 48 in the Code of 
Federal Regulations (CFR) and referenced as 48 CFR chapter 3.


301.105-2  Arrangement of regulations.

    (a) General. The HHSAR conforms with the arrangement and numbering 
system prescribed by FAR 1.105-2.
    (b) Numbering. (1) The numbering illustrations at FAR 1.105-2(b) 
apply to the HHSAR. Coverage in the HHSAR is identified by the prefix 
``3'' followed by the complete HHSAR citation. For example, 301.105-
2(b).
    (2) Subdivisions below the section or subsection level follow the 
FAR in this sequence: (a)(1)(i)(A)(1)(i).
    (c) References and citations. (1) Cross reference to the FAR in the 
HHSAR will be cited by ``FAR'' followed by the FAR numbered citation. 
References to specific citations with the HHSAR will be referenced by 
the numbered citation only, e.g., 301.105-2.
    (2) This chapter may be referred to as the Health and Human 
Services Acquisition Regulation or the HHSAR.
    (3) Using the HHSAR coverage at 301.105-2(b) as a typical 
illustration, reference to the--
    (i) Part would be ``HHSAR part 301'' outside the HHSAR and ``part 
301'' within the HHSAR.
    (ii) Subpart would be ``HHSAR subpart 301.1'' outside the HHSAR and 
``subpart 301.1'' within the HHSAR.
    (iii) Section would be ``HHSAR 301.105'' outside the HHSAR and 
``301.105'' within the HHSAR.
    (iv) Subsection would be ``HHSAR 301.105-1'' outside the HHSAR and 
``301.105-1'' within the HHSAR.
    (v) Paragraph would be ``HHSAR 301.105-1(b)'' outside the HHSAR and 
``301.105-1(b)'' within the HHSAR.


301.105-3  Copies.

    The HHSAR is available on the internet at https://www.ecfr.gov/current/title-48/chapter-3 or https://acquisition.gov.

------------------------------------------------------------------------
                                                            OMB Control
                      HHSAR segment                             No.
------------------------------------------------------------------------
304.7202................................................       0990-XXXX
308.870.................................................       0990-XXXX
309.507-1...............................................       0990-XXXX
311.7102................................................       0990-0434
311.7202................................................       0990-0434
327.303-70..............................................       0990-0419
327.407-70..............................................       0990-0419
337.7006................................................      0990-0430,
                                                               0990-0433
345.107.................................................       0990-XXXX
370.304.................................................       0990-0431
370.403.................................................       0990-0432
352.204-70..............................................       0990-XXXX
352.208-70..............................................       0990-XXXX
352.209-70..............................................       0990-XXXX
352.211-70..............................................       0990-0434
352.211-71..............................................       0990-0434
352.227-70..............................................       0990-0419
352.227-71..............................................       0990-0419
352.237-72..............................................       0990-0430
352.237-73..............................................       0990-0433
352.245-70..............................................       0990-XXXX
352.270-70..............................................       0990-0431
352.270-71..............................................       0990-0431
352.270-72..............................................       0990-0431
352.270-74..............................................       0990-0431
352.270-77..............................................       0990-0432
352.270-78..............................................       0990-0432
------------------------------------------------------------------------

301.106  OMB approval under the Paperwork Reduction Act.

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3521), the Office of Management and Budget (OMB) has approved the 
reporting or recordkeeping provisions that are included in the HHSAR 
and has given HHS the following approval numbers:


301.107  Certifications.

    In accordance with 41 U.S.C. 1304, a new requirement for a 
certification by a contractor or offeror may not be included in the 
HHSAR unless--
    (a) The certification is specifically imposed by statute; or
    (b) Written justification for the certification requirement is 
provided to the Secretary of HHS by the SPE, and the Secretary of HHS 
approves, in writing, the inclusion of such certification requirement.

Subpart 301.3--Agency Acquisition Regulations


301.301  Policy.

    (a)(1) HHS implementation and supplementation of the FAR is issued 
in the HHSAR under authorization and subject to the authority, 
direction, and control of the HHS Secretary. The HHSAR contains HHS 
policies that govern the acquisition process or otherwise control 
acquisition relationships between HHS' contracting activities and 
contractors. The HHSAR contains--
    (i) Requirements of law;
    (ii) HHS-wide policies;
    (iii) Deviations from FAR requirements; and
    (iv) Policies that have a significant effect beyond the internal 
procedures of HHS or a significant cost or administrative impact on 
contractors or offerors.
    (2) Relevant internal policy, procedures, guidance, and 
instructions not meeting the criteria in paragraph (a)(1) of this 
section are issued by HHS in the HHSAM. The HHSAM contains internal 
operating procedures providing supplementary guidance and instructions 
for carrying out FAR and HHSAR requirements and contains references to 
other agency policy and guidance issuances.


301.301-70  Amendment of the HHSAR.

    (a) Changes to the HHSAR may be the result of recommendations from 
HHS personnel, other Government agencies, or the public. Proposed 
changes shall be submitted in the following format to the Assistant 
Secretary for Financial Resources, Office of Acquisitions, Acquisition 
Policy Division, U.S. Department of Health and Human Services, 200 
Independence Ave. SW, Washington, DC 20201:
    (1) Problem. Succinctly state the problems created by current HHSAR 
language and describe the factual or legal reasons necessitating 
regulatory change.
    (2) Recommendation. Identify the recommended change by using the 
current language (if applicable) and striking through the proposed 
deleted words with a horizontal line. Insert proposed language in bold 
and brackets. If the change is extensive, reflect proposed deleted 
language in strikethrough and proposed new or revised language with 
complete paragraphs in bold and brackets.
    (3) Discussion. Explain why the change is necessary and how it will

[[Page 80666]]

solve the problem. Address any cost or administrative impact on 
Government activities, offerors, and contractors, to include potential 
impact to small businesses. Provide any other information and 
documents, such as statutes, legal decisions, regulations, and reports, 
that may be helpful.
    (4) Point of contact. Provide a point of contact who can answer 
questions regarding the recommendation, including an email and 
telephone number.
    (b) The HHSAR is maintained by the SPE through the HHSAR and HHSAM 
change process. This process consists of input from various HHS staff 
and operating divisions specifically designated to formulate 
Departmental acquisition policies and procedures.
    (c) HHSAR Acquisition Circulars will be used to publish updates to 
the HHSAR throughout HHS.


301.303-70  Publication and codification--HHSAR.

    (a) Codification. The HHSAR is codified under chapter 3 in title 
48, Code of Federal Regulations. The HHSAR shall parallel the FAR in 
format, arrangement, and numbering system in accordance with FAR 
1.303(a). The HHSAM is non-codified but will also parallel the FAR and 
the HHSAR in format, arrangement, and numbering system.
    (b) Implementing the FAR. This paragraph (b) describes language and 
coverage in the HHSAR that relates to coverage in a FAR part, subpart, 
section, or subsection. The HHSAR titles and numbering shall conform 
with the FAR to the maximum extent practicable. Coverage in the HHSAR 
that implements the FAR uses the identical number sequence and caption 
of the FAR subpart, section, or subsection being implemented, which may 
be to the paragraph level. Paragraph numbers and letters are not always 
shown sequentially but may be shown by the specific FAR paragraph 
implemented. For example, HHSAR 301.105-1 contains only paragraph (b) 
because only this paragraph, correlated with the FAR, is implemented in 
the HHSAR.
    (c) Supplementing the FAR. This paragraph (c) describes policy, 
guidance, and/or procedures that are placed in the HHSAR for which 
there is no direct counterpart in the FAR (potentially no corresponding 
specific part, subpart, section, or subsection of the FAR and 
associated titles). Coverage in the HHSAR that supplements the FAR will 
use part, subpart, section, and subsection numbers ending in ``70'' or 
higher, sequentially. A series of numbers beginning with ``70'' is used 
for provisions and clauses. For example, HHSAR text supplementing FAR 
1.301 would be numbered 301.301-70. See table 1 to this section.

                 Table 1 to 301.303-70--HHSAR Numbering
------------------------------------------------------------------------
                                                                Is
                   FAR                    Is implemented   supplemented
                                                as              as
------------------------------------------------------------------------
19......................................             319          319.70
19.5....................................           319.5         319.570
19.501..................................         319.501      319.501-70
19.501-1................................       319.501-1     319.501-170
------------------------------------------------------------------------

301.304  Agency control and compliance procedures.

    The SPE is responsible for amending the HHSAR for compliance with 
FAR 1.304.

Subpart 301.470--Deviations From the FAR and HHSAR


301.402  Policy.

    Contracting officers shall not deviate from the FAR or HHSAR 
without obtaining written approval in accordance with 301.403 and 
301.404. With full acknowledgement of FAR 1.102(d) regarding innovative 
approaches, any deviation from the FAR or the HHSAR requires SPE 
approval.


301.403  Individual deviations.

    Authority to authorize individual deviations from the FAR and HHSAR 
is delegated to the SPE.


301.404  Class deviations.

    (a) Authority to authorize class deviations from the FAR and HHSAR 
is delegated to the SPE. The SPE may authorize class deviations from 
the FAR and HHSAR when a class deviation is in the best interest of the 
Government. The SPE must comply with the provisions of FAR 1.404.

Subpart 301.6--Career Development, Contracting Authority, and 
Responsibilities


301.601  General.

    (a) The Secretary has delegated to the Chief Acquisition Officer 
and the SPE (see definitions at 302.101) broad authority to manage HHS' 
contracting functions. Except as otherwise provided by statute, HHS 
regulations, the FAR or the HHSAR, or other specific delegations that 
may be issued by the Secretary, the authority vested in the Secretary 
to do the following is delegated to the SPE:
    (1) Ensure compliance with the FAR and Office of Management and 
Budget guidance.
    (2) Develop, implement, update, and distribute the HHSAR and other 
acquisition policies, procedures, and guidance.
    (3) Serve as Department's functional manager for acquisition, 
including acquisition guidance, internal controls, systems, training 
and certification, major investments, reviews, audits, and interagency 
acquisitions issued under the authority of FAR subpart 17.5 or 17.7.
    (4) Approve the selection of heads of the contracting activities 
(HCAs) and issue contracting officer warrants to HCAs.
    (5) Revoke HCA acquisition authority.
    (6) Manage HHS Acquisition Workforce Development Program and 
implement the Office of Federal Procurement Policy (OFPP) Act and 
Federal Acquisition Institute training and certification programs.
    (7) Redirect Operating and Staff Division acquisition staff to 
support the preparation for, or response to, potential or actual 
emergencies, e.g., terrorist strike, natural disaster, epidemic.
    (8) The SPE may further delegate authority to execute, award, and 
administer contracts, purchase orders, and other agreements to other 
HHS officials, such as HCAs and contracting officers. At HHS, 
delegation of certain contract functions and management of the 
contracting activities of the agency within their approved delegations 
is made to designated HCAs. A list of HCAs is available at https://www.hhs.gov/grants/grants-business-contacts/hca-and-key-managers/.
    (9) HCAs may authorize the use of ordering officers to order 
supplies and services in accordance with the ordering limits identified 
in the contract or agreement or the specific ordering guide.


301.602  Contracting officers.


301.602-3  Ratification of unauthorized commitments.

    (b) Policy. (1) The Government is not bound by agreements with, or 
contractual commitments made to, prospective contractors by individuals 
who do not have delegated contracting authority. Unauthorized 
commitments do not follow the appropriate process for the expenditure 
of Government funds. Consequently, the Government may not be able to 
ratify certain actions, putting a contractor at risk for taking 
direction from a Federal official other than the contracting officer 
(see FAR 1.602-1). Government employees responsible for unauthorized 
commitments are subject to disciplinary

[[Page 80667]]

action. Contractors perform at their own risk when accepting direction 
from unauthorized officials. Acquisitions can only be made by a 
contracting officer having authority to enter into such acquisitions. 
Acquisitions made by other than authorized personnel are contrary to 
departmental policy and may be considered matters of serious misconduct 
on the part of an employee making an unauthorized commitment and may 
result in disciplinary action being taken against an employee who makes 
an unauthorized commitment.
    (2) The HCA is the official authorized to ratify an unauthorized 
commitment. No other re-delegations are authorized.


301.603  Selection, appointment, and termination of appointment of 
contracting officers.


301.603-1  General.

    The agency head has delegated broad authority to the Chief 
Acquisition Officer, who in turn has further delegated this authority 
to the SPE. The SPE has redelegated specific acquisition authority to 
the Operating and Staff Division heads and the HCAs to select, appoint, 
and terminate the appointment of contracting officers. This authority 
is non-delegable.


301.603-3  Appointment.

    (a) All contracting officer appointments and delegations of 
authority will be made in writing. To ensure proper control of 
redelegated acquisition authorities, HCAs shall maintain a file 
containing successive delegations of HCA authority through the 
contracting officer level.
    (b) HCAs may delegate micro-purchase authority to HHS employees 
under the HHS Governmentwide Purchase Card Program in accordance with 
agency procedures.


301.604  Contracting Officer's Representative (COR).


301.604-70  Contract clause.

    When the contracting officer intends to designate a representative 
under this section for a solicitation or contract, the contracting 
officer must include the clause at 352.201-70, Contracting Officer's 
Representative, in the solicitation and contract.

Subpart 301.7--Determinations and Findings


301.707  Signatory authority.

    Signature authority for determination and findings, when delegable 
in the FAR, are prescribed in applicable HHSAR parts or the 
corresponding HHSAM part.

PART 302--DEFINITIONS OF WORDS AND TERMS

Sec.
302.000 Scope of part.
Subpart 302.1--Definitions
302.101 Definitions.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 
41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.


302.000  Scope of part.

    (a) This part--
    (1) Defines words and terms that are frequently used in the HHSAR;
    (2) Provides cross-references to other definitions in the HHSAR of 
the same word or term; and
    (3) Provides for the incorporation of these definitions in 
solicitations and contracts by reference.
    (b) Other parts, subparts, and sections of this chapter may define 
other words or terms and those definitions only apply to the part, 
subpart, or section where the word or term is defined.

Subpart 302.1--Definitions


302.101  Definitions.

    As used in this chapter--
    Agency head or head of the agency, unless otherwise stated, means 
the Secretary of Health and Human Services or specified designee. When 
delegated by the Secretary, the specific designee will be reflected in 
the specific part, subpart, or section where a specified designee other 
than the Secretary has been designated.
    Chief Acquisition Officer (CAO) means the Assistant Secretary for 
Financial Resources.
    Head of the contracting activity (HCA) means an official having 
overall responsibility for managing a contracting activity, i.e., the 
organization within an Operating Division (OPDIV) or Staff Division 
(STAFFDIV) or other HHS organization which has been delegated broad 
authority regarding the conduct of acquisition functions (see 301.603-
1).
    Ordering officer means the HHS official authorized to order 
supplies and services against a FAR-based contract or agreement in 
accordance with 301.601(a)(10) and agency procedures.
    Senior Procurement Officer (SPE) means the Deputy Assistant 
Secretary for Acquisitions. The SPE is responsible for the management 
and oversight of the acquisition function for the Department.

PART 303--IMPROPER BUSINESS PRACTICES AND PERSONAL CONFLICTS OF 
INTEREST

Subpart 303.1--Safeguards
Sec.
303.101 Standards of conduct.
303.101-3 Agency regulations.
Subpart 303.2--Contractor Gratuities to Government Personnel
303.203 Reporting suspected violations of the Gratuities clause.
303.204 Treatment of violations.
Subpart 303.6--Contracts With Government Employees or Organizations 
Owned or Controlled by Them
303.602 Exceptions.
Subpart 303.7--Voiding and Rescinding Contracts
303.704 Policy.
Subpart 303.8--Limitation on the Payment of Funds to Influence Federal 
Transactions
303.808-70 Solicitation provision and contract clause.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 
41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 303.1--Safeguards


303.101  Standards of conduct.


303.101-3  Agency regulations.

    (a) The HHS Standards of Conduct are prescribed in 45 CFR part 73, 
which apply to all employees of the Department and to special 
Government employees to the extent described therein.

Subpart 303.2--Contractor Gratuities to Government Personnel


303.203  Reporting suspected violations of the Gratuities clause.

    HHS personnel shall report suspected violations of the clause at 
FAR 52.203-3, Gratuities, to the contracting officer, who will in turn 
report the matter to the Office of General Counsel (OGC), Ethics 
Division for disposition.


303.204  Treatment of violations.

    (a) The Suspending and Debarring Official (SDO) shall determine 
whether or not a violation of the Gratuities clause, FAR 52.203-3, has 
occurred and what action will be taken under FAR 3.204(c).
    (c) When the SDO determines that a violation has occurred and that 
debarment is being considered, the SDO shall follow procedures at 
309.406-3.

Subpart 303.6--Contracts With Government Employees or Organizations 
Owned or Controlled by Them


303.602  Exceptions.

    The head of contracting activity (HCA) is the official authorized 
to approve an exception to the policy stated in FAR 3.601. This 
authority is non-delegable.

[[Page 80668]]

Subpart 303.7--Voiding and Rescinding Contracts


303.704  Policy.

    (a) The Senior Procurement Executive is delegated the authority to 
declare void and rescind contracts in accordance with FAR 3.704. This 
authority is further delegated to the HCA.

Subpart 303.8--Limitation on the Payment of Funds To Influence 
Federal Transactions


303.808-70  Solicitation provision and contract clause.

    The contracting officer shall insert the clause at 352.203-70, 
Anti-Lobbying, in solicitations and contracts that exceed the 
simplified acquisition threshold.

PART 304--ADMINISTRATIVE AND INFORMATION MATTERS

0
2. The authority citation for part 304 is revised to read as follows:

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2); 41 U.S.C. 
1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

0
3. Revise the heading for part 304 to read as set forth above.

Subparts 304.6 and 304.16 [Removed]

0
4. Remove subparts 304.6 and 304.16.

Subpart 304.71 [Removed and Reserved]

0
5. Remove and reserve subpart 304.71.
0
6. Revise subpart 304.72 to read as follows:
Subpart 304.72--Affordable Care Act Prevention and Public Health Fund--
Reporting Requirements
Sec.
304.7200 Scope of subpart.
304.7201 Policy.
304.7202 Contract clause.

Subpart 304.72--Affordable Care Act Prevention and Public Health 
Fund--Reporting Requirements


304.7200  Scope of subpart.

    This subpart implements section 220 of Pub. L. 112-74, FY 2012 
Labor, HHS and Education Appropriations Act, which requires, semi-
annual reporting on the use of funds from the Prevention and Public 
Health Fund (PPHF), Pub. L. 111-148, sec. 4002.


304.7201  Policy.

    Contractors that receive awards (or modifications to existing 
awards) with a value of $25,000 or more funded, in whole or in part, 
from the PPHF, shall report information specified in the clause at 
352.204-70, Prevention and Public Health Fund--Reporting Requirements, 
including, but not limited to--
    (a) The dollar amount of contractor invoices;
    (b) The supplies delivered and services performed; and
    (c) Specific information on subcontracts with a value of $25,000 or 
more.
    (d) The contracting officer shall make the contractor's failure to 
comply with the reporting requirements in this section a part of the 
contractor's performance information under FAR subpart 42.15.


304.7202  Contract clause.

    Insert the clause at 352.204-70, Prevention and Public Health 
Fund--Reporting Requirements, in all solicitations and contract actions 
with a value of $25,000 or more funded in whole or in part with 
Prevention and Public Health Funds (PPHFs), except classified 
solicitations and contracts. This includes, but is not limited to, 
awarding, or modifying orders against existing or new contracts issued 
under FAR subparts 8.4 and 16.5 that will be funded with PPHFs. 
Contracting officers shall include this clause in any existing contract 
or order that will be funded with PPHFs. This clause is not required 
for any contract or order which contains a prior version of the clause 
at 352.204-70.
0
7. Revise subchapters B and C to read as follows:
SUBCHAPTER B--ACQUISITION PLANNING
PART 305 PUBLICIZING CONTRACT ACTIONS
PART 306 COMPETITION REQUIREMENTS
PART 307 [RESERVED]
PART 308 REQUIRED SOURCES OF SUPPLIES AND SERVICES
PART 309 CONTRACTOR QUALIFICATIONS
PART 310 [RESERVED]
PART 311 DESCRIBING AGENCY NEEDS
PART 312 ACQUISITION OF COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES
SUBCHAPTER C--CONTRACTING METHODS AND CONTRACT TYPES
PART 313 SIMPLIFIED ACQUISITION PROCEDURES
PART 314 SEALED BIDDING
PART 315 CONTRACTING BY NEGOTIATION
PART 316 TYPES OF CONTRACTS
PART 317 [RESERVED]
PART 318 EMERGENCY ACQUISITIONS

SUBCHAPTER B--ACQUISITION PLANNING

PART 305--PUBLICIZING CONTRACT ACTIONS

Subpart 305.4--Release of Information
Sec.
305.402 General public.
305.470 Contractor award announcements, advertisements, and 
releases.
305.470-1 Policy.
305.470-2 Contract clause.
Subpart 305.70--Publicizing Requirements Funded From the Affordable 
Care Act Prevention and Public Health Fund
305.7001 Scope.
305.7002 Applicability.
305.7003 Publicizing preaward.
305.7004 Publicizing postaward.

    Authority:  5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 
1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 305.4--Release of Information


305.402  General public.

    Requests from the public for specific records pertaining to 
contract actions shall be processed according to the Freedom of 
Information Act (FOIA), 5 U.S.C. 552.


305.470  Contractor award announcements, advertisements, and releases.


305.470-1  Policy.

    (a) Contracting officers should restrict contractors from referring 
to its HHS contract(s) in its commercial advertising in a manner that 
states or implies the Government approves or endorses the contractor's 
products or services or considers them superior to other products or 
services. The intent of this policy is to prevent the appearance of 
Government bias toward any product or service.
    (b) The Department's contractors share the responsibility for 
protecting sensitive and classified information related to efforts 
under their contracts. For any contract that involves sensitive or 
classified information, prior to the release of any contract award 
announcement, advertisement, or other information pertaining to the 
contract, the contractor must obtain the approval of the responsible 
contracting officer.


305.470-2  Contract clause.

    (a) Insert the clause at 352.205-70, Advertisements, Publicizing 
Awards, and Releases, in all solicitations and contracts that exceed 
the simplified acquisition threshold.
    (b) If the contract involves sensitive or classified information, 
use the clause at 352.205-70 with its Alternate I.

[[Page 80669]]

Subpart 305.70--Publicizing Requirements Funded From the Affordable 
Care Act Prevention and Public Health Fund


305.7001  Scope.

    Pursuant to appropriations acts, this subpart prescribes 
requirements for posting presolicitation and award notices for actions 
funded in whole or in part from the Prevention and Public Health Fund 
(PPHF). The requirements of this subpart enhance transparency to the 
public.


305.7002  Applicability.

    This subpart applies to all actions funded in whole or in part by 
the PPHF.


305.7003  Publicizing preaward.

    Notices of all proposed contract actions, funded in whole or in 
part by the PPHF, shall be identified on HHS' Prevention and Public 
Health Fund website at https://www.hhs.gov/open/prevention/ 
no later than one business day after issuance of the solicitation or 
other request for proposal or quotation document. When applicable, the 
notice shall provide a link to the full text; for example, a link to 
the Contract Opportunities notice required by FAR 5.201.


305.7004  Publicizing postaward.

    Notices of contract actions valued at or above $25,000, funded in 
whole or in part by the PPHF, shall be identified on HHS' PPHF website 
at https://www.hhs.gov/open/prevention/ no later than five 
business days after the contract action occurs.

PART 306--COMPETITION REQUIREMENTS

Subpart 306.2--Full and Open Competition After Exclusion of Sources
Sec.
306.202 Establishing or maintaining alternative sources.
Subpart 306.3--Other Than Full and Open Competition
306.302 Circumstances permitting other than full and open 
competition.
306.302-1 Only one responsible source and no other supplies or 
services will satisfy agency requirements.
306.302-2 Unusual and compelling urgency.
Subpart 306.5--Advocates for Competition
306.501 Requirement.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 
41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 306.2--Full and Open Competition After Exclusion of Sources


306.202  Establishing or maintaining alternative sources.

    (b)(1) The Senior Procurement Executive (SPE) is designated to make 
the required determination and sign the determination and findings 
(D&F) pursuant to FAR 6.202(b).

Subpart 306.3--Other Than Full and Open Competition


306.302  Circumstances permitting other than full and open competition.


306.302-1  Only one responsible source and no other supplies or 
services will satisfy agency requirements.

    (a)(2) For acquisitions covered by 42 U.S.C. 247d-6a(b)(2)(A) 
concerning conducting and supporting countermeasure research and 
development activities, ``available from only one responsible source'' 
shall be deemed to mean ``available from only one responsible source or 
only from a limited number of responsible sources''.


306.302-2  Unusual and compelling urgency.

    (d)(1)(ii) The period of performance shall be limited to the 
minimum period necessary to meet the urgent and compelling requirements 
of the work to be performed and to enter into another contract for the 
required goods or services through the use of competitive procedures, 
but in no event shall the period of performance exceed one year, 
including all options pursuant to FAR 6.302-2(d)(1)(ii), unless the 
Secretary determines that exceptional circumstances apply, approving 
the determination and the written justifications and approvals 
described in FAR 6.303 and 6.304 (see FAR 6.303-2(c)) and HHS internal 
procedures.

Subpart 306.5--Advocates for Competition


306.501  Requirement.

    The Executive Director, Acquisition Policy, Legislation, Oversight 
& Workforce, Assistant Secretary for Financial Resources (ASFR), Office 
of Acquisitions is designated as the HHS Advocate for Competition. The 
Executive Director may further delegate this authority and appoint an 
alternate agency advocate for competition. The Executive Director shall 
designate procuring activity advocates for competition in accordance 
with FAR 6.501. A complete list of HHS procuring activity advocates for 
competition can be found at: https://www.hhs.gov/grants/grants-business-contacts/competition-advocates/.

PART 307 [RESERVED]

PART 308--REQUIRED SOURCES OF SUPPLIES AND SERVICES

Subpart 308.8--Acquisition of Printing and Related Supplies

Sec.
308.802 Policy.
308.870 Contract clause.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 
41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 308.8--Acquisition of Printing and Related Supplies


308.802  Policy.

    Government printing must be done by or through the Government 
Publishing Office (GPO) in accordance with FAR 8.802. Unless 
specifically authorized in HHS contracts, no printing by the Contractor 
or any subcontractor is authorized under HHS contracts, whether to 
support Government printing, to acquire related supplies, or to provide 
other printing-related services. Contracting officers may authorize 
limited printing under HHS contracts pursuant to the clause prescribed 
at 308.870 within the stated limits in the clause.


308.870  Contract clause.

    The contracting officer shall insert the clause at 352.208-70, 
Printing and Duplication, in all solicitations, contracts, and orders 
for supplies or services over the simplified acquisition threshold, 
unless printing or increased duplication is authorized by statute.

PART 309--CONTRACTOR QUALIFICATIONS

Subpart 309.1--Responsible Prospective Contracts
Sec.
309.104 Standards.
309.104-1 General standards.
Subpart 309.4--Debarment, Suspension, and Ineligibility
309.400 Scope of subpart.
309.403 Definitions.
309.405 Effect of listing.
309.405-1 Continuation of current contracts.
309.405-2 Restrictions on subcontracting.
309.406 Debarment.
309.406-1 General.
309.406-3 Procedures.
309.407 Suspension.
309.407-1 General.
309.407-3 Procedures.
309.470 Reporting of suspected causes for debarment or suspension or 
the taking of evasive actions.

[[Page 80670]]

309.470-1 Situations where reports are required.
309.471 Fact-finding procedures.
Subpart 309.5--Organizational and Consultant Conflicts of Interest
309.503 Waiver.
309.507 Solicitation provisions and contract clause.
309.507-1 Solicitation provisions.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2); 41 U.S.C. 
1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 309.1--Responsible Prospective Contracts


309.104  Standards.


309.104-1  General standards.

    (e) For cost-reimbursement or incentive type contracts, or 
contracts which provide for progress payments based on costs or on a 
percentage or stage of completion, the prospective contractor's 
accounting system and related internal controls must provide reasonable 
assurance that--
    (1) Applicable laws and regulations are complied with;
    (2) The accounting system and cost data are reliable;
    (3) Risk of misallocations and mischarges are minimized; and
    (4) Contract allocations and charges are consistent with invoice 
procedures.

Subpart 309.4--Debarment, Suspension, and Ineligibility


309.400  Scope of subpart.

    This subpart implements FAR subpart 9.4 and prescribes HHS 
procedures and related actions for the suspension and debarment of 
contractors.


309.403  Definitions.

    As used in this subpart:
    Suspending and Debarring Official (SDO) means the individual 
responsible for final decisions regarding suspension and debarment, as 
appointed by the agency. The HHS SDO is the Deputy Assistant Secretary 
for Acquisitions, and Senior Procurement Executive.
    Suspension & Debarment (S&D) Committee means a committee authorized 
by the SDO to assist the SDO with suspension and debarment related 
matters.


309.405  Effect of listing.

    (a) The authority under FAR 9.405(a) and (e)(2) and (3) to 
determine where to solicit from, evaluate bids or proposals from, or 
award contracts to contractors with active exclusions in the System for 
Award Management (SAM) is delegated to the SDO. This authority is 
further delegated to the HCA.


309.405-1  Continuation of current contracts.

    (a) Notwithstanding the suspensions, proposed debarment, or 
debarment of a contractor, HHS may continue contracts or subcontracts 
in existence at the time the contractor was suspended, proposed for 
debarment, or debarred, unless the cognizant HCA directs otherwise.
    (b) Authority to make the determinations under FAR 9.405-1(a)(2) is 
delegated to the SDO and is further delegated to the HCA. The HCA must 
make a written determination of the compelling reasons in accordance 
with FAR 9.405-1(a)(2). Compelling reasons for the purposes of FAR 
9.405-1(a)(2) include, but are not limited to, urgency of the need for 
new or continued work and/or, lengthy period to acquire the new work 
from other sources.


309.405-2  Restrictions on subcontracting.

    Authority to make the written determination required under FAR 
9.405-2 consenting to a contractor's use of a subcontractor who is 
suspended, proposed for debarment, or debarred is delegated to the SDO. 
This authority is further delegated to the HCA.


309.406  Debarment.


309.406-1  General.

    (a) In addition to the factors listed in FAR 9.406-1, the SDO may 
consider the following additional factors before arriving at a 
debarment decision:
    (1) Whether the contractor had a mechanism, such as a hotline, by 
which employees could have reported suspected instances of improper 
conduct, and instructions in place that encouraged employees to make 
such reports; or
    (2) Whether the contractor conducted periodic reviews of company 
business practices, procedures, policies, and internal controls for 
compliance with standards of conduct and the special requirements of 
Government contracting.
    (c) As provided in FAR 9.406-1(c), authority to determine whether 
to continue business dealings between HHS and a contractor suspended, 
proposed for debarment, or debarred is delegated to the SDO.


309.406-3  Procedures.

    (a) HHS procedures are set forth in the HHS Discretionary 
Suspension and Debarment Handbook for Contracts and Grants (S&D 
Handbook) at (Link To Be Determined (TBD)). The procedures in this 
subpart supplement HHS' internal operational procedures. Any individual 
may submit a referral to debar an individual or contractor to the SDO 
or to the S&D Committee. The S&D Committee is an advisory committee to 
the SDO who retains the final approval authority to debar.
    (1) The referral for debarment shall be supported with evidence of 
a cause for debarment listed in FAR 9.406-2.
    (2) The SDO shall forward referrals for debarment to the S&D 
Committee. If the referring individual is an HHS employee and the 
referral for debarment is based on possible criminal or fraudulent 
activities, the HHS employee shall also refer the matter to the HHS 
Office of Inspector General.
    (b) When the S&D Committee finds preponderance of the evidence for 
a cause for debarment, as listed in FAR 9.406-2, it shall prepare a 
recommendation and draft notice of proposed debarment for the SDO's 
consideration.
    (c) The notice of proposal to debar shall be issued by the SDO to 
the contractor and any specifically named affiliates. A notice of 
proposed debarment shall be issued by the SDO in accordance with FAR 
9.406-3(c), by certified mail, return receipt requested, unless one of 
the flexible procedures set forth in this paragraph (c) is necessary to 
meet emergency or exigent circumstances which shall be documented in 
the file. In such cases as approved by the SDO--
    (1) The written notice shall be sent--
    (i) By mail, to the last known street address;
    (ii) To the last known facsimile number; or
    (iii) To the last known email address.
    (2) The notice shall be sent--
    (i) To the contractor, the contractor's identified counsel for 
purposes of the administrative proceedings, or the contractor's agent 
for service of protest. If sent by email, it shall be sent to the last 
known email address for all three, if known; and
    (ii) For each specifically named affiliate, to the affiliate 
itself, the affiliate's identified counsel for purposes of the 
administrative proceedings, or the affiliate's agent for service of 
process. If sent by email, it shall be sent to the last known email 
addresses for all three, if known.
    (3) The notice shall include the requirements set forth in FAR 
9.406-3(c)(1) through (7). Additionally, in the case of a contractor, 
HHS may send the notice of proposed debarment to any partner, 
principal, officer, director, owner or co-owner, or joint venture. The 
S&D Committee shall concurrently list the appropriate parties as 
excluded in the SAM in accordance with FAR 9.404.
    (d) If HHS does not receive a reply from the contractor within 30 
days after sending the notice of proposed

[[Page 80671]]

debarment, the S&D Committee shall prepare a recommendation and refer 
the case to the SDO for a decision on whether or not to debar based on 
the information available.
    (e) If HHS receives a reply from the contractor within 30 days 
after sending the notice of proposed debarment, the S&D Committee shall 
consider the information in the reply before the S&D Committee makes 
its recommendation to the SDO.
    (f) The S&D Committee, upon the request of the contractor proposed 
for debarment, shall, as soon as practicable, allow the contractor an 
opportunity to appear before the S&D Committee to present information 
or argument personally or through a representative. The contractor may 
supplement the oral presentation with written information and argument. 
HHS shall conduct the proceedings in an informal manner and without 
requirement for a transcript.
    (g) The S&D Committee will review the contractor's or individual's 
submission in opposition to the proposed debarment to determine whether 
it raises a genuine dispute over facts material to the proposed 
debarment and the debarment action is not based on a conviction or 
civil judgment. The S&D Committee will submit its analyses to the SDO 
for review. If the SDO finds there is a genuine dispute of material 
facts, the SDO shall refer the dispute to a designee for a resolution 
pursuant to 309.470. The SDO shall provide the contractor or individual 
with the disputed material fact(s).


309.407  Suspension.


309.407-1  General.

    (a) As provided in FAR 9.407-1(d), authority to determine whether 
to continue business dealings between HHS and a suspended contractor is 
delegated to the SDO. Compelling reasons include, but are not limited 
to, urgency of the need for new or continued work, lengthy time period 
to acquire the new work from other sources and meeting estimated 
quantities for requirements contracts.
    (b) For the purposes of FAR 9.407-1, the SDO is the suspending 
official.


309.407-3  Procedures.

    (a) HHS procedures are set forth in the HHS Discretionary 
Suspension and Debarment Handbook for Contracts and Grants (S&D 
Handbook) at (Link TBD). The procedures in this subpart supplement HHS' 
internal operational procedures. Any individual may submit a referral 
to suspend an individual or contractor to the SDO or to the S&D 
Committee. The S&D Committee is an advisory committee to the SDO who 
retains the final approval authority to issue suspensions. Referrals 
shall include supporting evidence of a cause for suspension listed in 
FAR 9.407-2. The SDO will forward the referral to the S&D Committee for 
analysis. If the referring individual is an HHS employee and the 
referral for suspension is based on possible criminal or fraudulent 
activities, the HHS employee shall also refer the matter to the HHS 
Office of Inspector General.
    (b) The S&D Committee will forward its analyses to the SDO. When 
the SDO finds adequate evidence of a cause for suspension, as listed in 
FAR 9.407-2, the S&D Committee will prepare a recommendation and draft 
notice of suspension for the SDO's consideration and approval.
    (c) In accordance with FAR 9.407-3(c) regarding the notice of 
suspension, when a contractor or any specifically named affiliates are 
suspended, they shall be immediately advised by means of delivery set 
forth in FAR 9.406-3(c) and 309.406-3(c). In the case of a contractor, 
HHS may send a notice of suspension to any partner, principal, officer, 
director, owner or co-owner, or joint venture. The S&D Committee 
concurrently shall list the appropriate parties as excluded in SAM in 
accordance with FAR 9.404.
    (d) If HHS receives a reply from the contractor within 30 days 
after receipt of the notice of suspension, the S&D Committee shall 
consider the information in the reply before the Committee makes 
further recommendations to the SDO. The S&D Committee, upon the request 
of a suspended contractor, shall, as soon as practicable, allow the 
contractor an opportunity to appear before the S&D Committee to present 
information or argument personally or through a representative. The 
contractor may supplement the oral presentation with written 
information and argument. The proceedings will be conducted in an 
informal manner and without requirement for a transcript.
    (e) For the purposes of FAR 9.407-3(b)(2), in actions not based on 
an indictment, if the SDO finds that the contractor's submission in 
opposition to the suspension raises a genuine dispute over facts 
material to the suspension, the S&D Committee will submit to the SDO 
the information received establishing the dispute of material facts. 
However, the SDO may first coordinate any further proceeding regarding 
the material facts in dispute with the Department of Justice or with a 
State prosecuting authority in a case involving a State jurisdiction. 
HHS shall take no further action to determine disputed material facts 
pursuant to this section or 309.470 if the Department of Justice or a 
State prosecuting authority advises HHS in writing that additional 
proceedings to make such a determination would prejudice Federal or 
State legal proceedings.
    (f) If the SDO finds that there is a genuine dispute of material 
facts, the SDO shall refer the dispute to the designee for resolution 
pursuant to 309.470.


309.470  Reporting of suspected causes for debarment or suspension or 
the taking of evasive actions.


309.470-1  Situations where reports are required.

    The contracting officer shall report to the HCA and the SDO 
whenever the contracting officer--
    (a) Knows or suspects that a contractor is committing or has 
committed any of the acts described in FAR 9.406-2 or 9.407-2; or
    (b) Suspects a contractor is attempting to evade the prohibitions 
of debarment or suspension imposed under FAR 9.405, or any other 
comparable regulation, by changes of address, multiple addresses, 
formation of new companies, or by other devices.


309.471  Fact-finding procedures.

    The provisions of this section constitute the procedures to be used 
to resolve genuine disputes of material fact pursuant to 309.406-3 and 
309.407-3. The SDO shall appoint a designee to conduct the fact-
finding. The proceedings before the fact-finder will be limited to a 
finding of the facts in dispute, as determined by the SDO. The fact-
finder shall establish the date for the fact-finding hearing, normally 
to be held within 30 days after the S&D Committee notifies the 
contractor or individual that the SDO has established a genuine dispute 
of material fact(s) exists.
    (a) The Government's representative and the contractor will have an 
opportunity to present evidence relevant to the material fact(s) 
identified by the SDO. The contractor or individual may appear in 
person or through a representative at the fact-finding hearing. The 
contractor or individual may submit documentary evidence, present 
witnesses, and confront any person the agency presents.
    (b) Witnesses may testify in person. Witnesses will be reminded of 
the official nature of the proceedings and that any false testimony 
given is subject to criminal prosecution. Witnesses are

[[Page 80672]]

subject to cross-examination. Hearsay evidence may be presented and 
will be given appropriate weight by the fact-finder.
    (c) The proceedings shall be transcribed, and a copy of the 
transcript shall be made available at cost to the contractor upon 
request, unless the contractor and the fact-finder, by mutual 
agreement, waive the requirement for a transcript.
    (d) The fact-finder shall determine the disputed fact(s) by a 
preponderance of the evidence for proposed debarments, and by adequate 
evidence for suspensions. Written findings of fact shall be prepared by 
the fact-finder. A copy of the findings of fact shall be provided to 
the SDO, the Government's representative, and the contractor or 
individual. The SDO will consider the written findings of fact in the 
decision regarding the suspension or proposed debarment.

Subpart 309.5--Organizational and Consultant Conflicts of Interest


309.503  Waiver.

    The Senior Procurement Executive is the designee under FAR 9.503.


309.507  Solicitation provisions and contract clause.


309.507-1  Solicitation provisions.

    (a) While conflicts of interest may not presently exist, award of 
certain types of contracts may create potential future organizational 
conflicts of interest (see FAR 9.508 for examples). If a solicitation 
may create a potential future organizational conflict of interest, the 
contracting officer shall insert a provision in the solicitation 
imposing an appropriate restraint on the contractor's eligibility for 
award of contracts in the future. Under FAR 9.507-1, the restraint must 
be appropriate to the nature of the conflict and may exclude the 
contractor from award of one or more contracts in the future.
    (b) The provision at 352.209-70, Organizational Conflicts of 
Interest, must be included in any solicitation for the services 
addressed in FAR 9.502.

PART 310 [RESERVED]

PART 311--DESCRIBING AGENCY NEEDS

Subpart 311.1--Selecting and Developing Requirements Documents
Sec.
311.103 Market acceptance.
Subpart 311.5--Liquidated Damages
311.501 Policy.
Subpart 311.6--Priorities and Allocations
311.600 Scope of subpart.
311.601 Definitions.
311.602 General.
311.602-70 The Health Resources Priorities and Allocation System.
311.603 Procedures.
311.603-70 Agency program.
Subpart 311.70--[Reserved]
Subpart 311.71--Public Accommodations and Commercial Facilities
311.7100 Policy.
311.7101 Responsibilities.
311.7102 Contract clause.
Subpart 311.72--Conference Funding and Sponsorship
311.7200 Policy.
311.7201 Funding and sponsorship.
311.7202 Contract clause.
Subpart 311.73--Contractor Collection of Information
311.7300 Policy.
311.7301 Contract clause.

    Authority:  5 U.S.C. 301; 40 U.S.C. 121(c)(2); 41 U.S.C. 
1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 311.1--Selecting and Developing Requirement Documents


311.103  Market acceptance.

    (a) The head of the contracting activity (HCA) is delegated this 
authority.

Subpart 311.5--Liquidated Damages


311.501  Policy.

    (d) The HCA may reduce or waive the amount of liquidated damages 
assessed under a contract, if the Commissioner, Financial Management 
Service, or designee approves.

Subpart 311.6--Priorities and Allocations


311.600  Scope of subpart.

    This subpart details information on the Health and Human Services 
(HHS') Health Resources Priorities and Allocation System (HRPAS) that 
is part of the Federal Priorities and Allocations System. This subpart 
references guidance and procedures for use of the Defense Production 
Act (DPA) priorities and allocations authority with respect to health 
resources necessary or appropriate to promote the national defense as 
delegated to the Secretary of HHS.


311.601  Definitions.

    As used in this subpart--
    National defense means programs for military and health resources 
production or construction, military or critical infrastructure 
assistance to any foreign nation, homeland security, stockpiling, 
space, and any directly related activity. Such term includes emergency 
preparedness activities conducted pursuant to title VI of the Robert T. 
Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5195, 
et seq.) and critical infrastructure protection and restoration. The 
term national defense is defined broadly and can include critical 
infrastructure protection and restoration, emergency preparedness and 
response, and recovery from natural and man-made disasters.
    Rated order means a prime contract, a subcontract, or a purchase 
order in support of an approved program issued in accordance with the 
provisions of this part.


311.602  General.


311.602-70  The Health Resources Priorities and Allocation System.

    As set forth in Executive Order 13603, National Defense Resources 
Preparedness, March 16, 2012, the authority to require acceptance and 
priority performance of contracts or orders (other than contracts of 
employment) to promote the national defense over performance of any 
other contracts or orders, and to allocate materials, services, and 
facilities as deemed necessary or appropriate to promote the national 
defense, with respect to health resources is delegated to the Secretary 
of HHS.


311.603  Procedures.


311.603-70  Agency program.

    Agency procedures are set forth in the HRPAS regulations at 45 CFR 
part 101. The regulation provides guidance and procedures for use of 
the DPA priorities and allocations authority with respect to health 
resources, including the use of priority rated orders, necessary or 
appropriate to promote the national defense.

Subpart 311.70--[Reserved]

Subpart 311.71--Public Accommodations and Commercial Facilities


311.7100  Policy.

    (a) It is HHS policy that all contractors comply with current and 
any future changes to 28 CFR part 36. For the purpose of this subpart, 
accessibility is defined as both physical access to public 
accommodations and commercial facilities, and access to aids and 
services enabling individuals with sensory disabilities to fully 
participate in events in public accommodations and commercial 
facilities.

[[Page 80673]]

    (b) This subpart applies to all contracts requiring contractors to 
conduct events in public accommodations and commercial facilities open 
to the public or involving HHS personnel, but not ad hoc meetings 
necessary or incidental to contract performance.


311.7101  Responsibilities.

    The contractor shall submit a plan assuring that any event held 
will meet or exceed the minimum accessibility standards set forth in 28 
CFR part 36. A consolidated or master plan for contracts requiring 
numerous events in public accommodations and commercial facilities is 
acceptable.


311.7102  Contract clause.

    The contracting officer shall insert the clause at 352.211-70, 
Public Accommodations and Commercial Facilities, in solicitations, 
contracts, and orders requiring the contractor to conduct events in 
accordance with 311.7100(b).

Subpart 311.72--Conference Funding and Sponsorship


311.7200  Policy.

    HHS policy requires that all conferences the agency funds or 
sponsors shall be consistent with HHS missions, objectives, and 
policies; represent an efficient and effective use of taxpayer funds; 
and withstand public scrutiny.


311.7201  Funding and sponsorship.

    A conference funded through an HHS contract does not automatically 
imply HHS sponsorship, unless the conference is funded entirely by the 
agency. Also, HHS staff attendance or participation at a conference 
does not imply HHS conference sponsorship. Accordingly, for non-
conference contracts funded entirely by HHS prior to a contractor 
claiming HHS sponsorship, the contractor must provide the contracting 
officer a written request for permission to designate HHS the 
conference sponsor. The operating division or staff division head, or 
designee, shall approve such requests. The determination on what 
constitutes a ``conference contract'' or a ``non-conference contract'' 
shall be made by the contracting officer.


311.7202  Contract clause.

    To ensure that a contractor:
    (a) Properly requests approval to designate HHS the conference 
sponsor, where HHS is not the sole provider of conference funding; and
    (b) The contracting officer shall include the clause at 352.211-71, 
Conference Sponsorship Request and Conference Materials Disclaimer, in 
solicitations, contracts, and orders providing funding which partially 
or fully supports a conference.

Subpart 311.73--Contractor Collection of Information


311.7300  Policy.

    In accordance with the Paperwork Reduction Act, contractors shall 
not proceed with collecting information from surveys, questionnaires, 
or interviews until the contracting officer's representative obtains an 
Office of Management and Budget (OMB) clearance and the contracting 
officer issues written approval to proceed. For any contract involving 
a requirement to collect or record information calling either for 
answers to identical questions from 10 or more persons other than 
Federal employees, or information from Federal employees which is 
outside the scope of their employment, for use by the Federal 
Government or disclosure to third parties, the contracting officer must 
comply with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et 
seq.).


311.7301  Contract clause.

    The contracting officer shall insert the clause at 352.211-72, 
Paperwork Reduction Act Requirements, in solicitations, contracts, and 
orders that require a contractor to collect the same information from 
10 or more persons.

PART 312--ACQUISITION OF COMMERCIAL PRODUCTS AND COMMERCIAL 
SERVICES

Subpart 312.3--Solicitation Provisions and Contract Clauses for the 
Acquisition of Commercial Products and Commercial Services
Sec.
312.301 Solicitation provisions and contract clauses for the 
acquisition of commercial products and commercial services.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 
41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 312.3--Solicitation Provisions and Contract Clauses for the 
Acquisition of Commercial Products and Commercial Services


312.301  Solicitation provisions and contract clauses for the 
acquisition of commercial products and commercial services.

    (f) Contracting officers shall insert the clause 352.212-70, Gray 
Market and Counterfeit Items, in solicitations and contracts for new 
medical supplies, new medical equipment, new information technology 
equipment, and maintenance of medical or information technology 
equipment that includes replacement parts, if used, refurbished, or 
remanufactured parts are unacceptable, when the associated solicitation 
includes the provisions at FAR 52.212-1, Instructions to Offerors--
Commercial Products and Commercial Services, and 52.212-2, Evaluation--
Commercial Products and Commercial Services.

SUBCHAPTER C--CONTRACTING METHODS AND CONTRACT TYPES

PART 313--SIMPLIFIED ACQUISITION PROCEDURES

Subpart 313.3--Simplified Acquisition Methods
Sec.
313.301-70 Governmentwide commercial purchase card--purchases of 
PPE.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 
41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 313.3--Simplified Acquisition Methods


313.301-70  Governmentwide commercial purchase card--purchases of PPE.

    The Infrastructure Investment and Jobs Act (IIJA), Pub. L. 117-58, 
Subtitle C, Make Personal Protective Equipment (PPE) in America 
(MPPEIA), applies to all purchases of PPE including those transactions 
made using the Governmentwide commercial purchase card (GPC) under the 
micro-purchase threshold. See subpart 325.71 for definitions, 
restrictions, and exceptions when procuring PPE.

PART 314--SEALED BIDDING

Subpart 314.4--Opening of Bids and Award of Contract
Sec.
314.404 Rejection of bids.
314.404-1 Cancellation of invitations after opening.
314.407 Mistakes in bids.
314.407-3 Other mistakes disclosed before award.
314.407-4 Mistakes after award.
314.408 Award.
314.408-70 Award when only one bid is received.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2); 41 U.S.C. 
1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 314.4--Opening of Bids and Award of Contract


314.404  Rejection of bids.


314.404-1  Cancellation of invitations after opening.

    (c) The head of the contracting activity (HCA) shall make the

[[Page 80674]]

determinations specified in FAR 14.404-1(c).


314.407  Mistakes in bids.


314.407-3  Other mistakes disclosed before award.

    (e) The HCA is delegated, without redelegation, the authority to 
make determinations under FAR 14.407-3(a) through (d).


314.407-4  Mistakes after award.

    (c) The HCA is delegated, without redelegation, the authority to 
make administrative determinations in connection with alleged post-
award mistakes.


314.408  Award.


314.408-70  Award when only one bid is received.

    When only one bid is received in response to an invitation for 
bids, such bid may be considered and accepted if the contracting 
officer makes a written determination, approved one level above the 
contracting officer, and documents the contract file that--
    (a) The specifications were clear and not unduly restrictive;
    (b) Adequate competition was solicited, and it could have been 
reasonably assumed that more than one bid would have been submitted;
    (c) The price is fair and reasonable; and
    (d) The bid is otherwise in accordance with the invitation for 
bids. Such a determination shall be placed in the file.

PART 315--CONTRACTING BY NEGOTIATION

Subpart 315.2--Solicitation and Receipt of Proposals and Information
Sec.
315.208 Submission, modification, revision, and withdrawal of 
proposals.
315.208-70 Submission, modification, revision, and withdrawal of 
proposals--R&D acquisitions.
315.209-70 Solicitation provision.
Subpart 315.3--Source Selection
315.303-70 Policy.
315.304 Evaluation factors and significant subfactors.
315.305 Proposal evaluation.
315.305-70 Proposal evaluation--use of non-Federal evaluators.
315.305-71 Solicitation provision.
Subpart 315.4--Contract Pricing
315.404 Proposal analysis.
315.404-2 Data to support proposal analysis.
Subpart 315.6--Unsolicited Proposals
315.604 Agency points of contact.
315.605-70 Content of unsolicited proposals--warranty by offeror.
315.606 Agency procedures.
315.606-1 Receipt and initial review.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2); 41 U.S.C. 
1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 315.2--Solicitation and Receipt of Proposals and 
Information


315.208  Submission, modification, revision, and withdrawal of 
proposals.


315.208-70  Submission, modification, revision, and withdrawal of 
proposals--R&D acquisitions.

    (a) The provision prescribed at 315.209-70 may be used in 
competitive solicitations when--
    (1) The head of contracting activity (HCA) determines that 
biomedical or behavioral research and development acquisitions may be 
subject to conditions that could impact timely submission and receipt 
of proposals other than those specified in FAR 52.215-1(c)(3);
    (2) Use of the provision is authorized by the HCA; and
    (3) The provision at FAR 52.215-1, Instructions to Offerors--
Competitive Acquisition, is included in the solicitation.
    (b) When the provision at 315.209-70 is inserted in the 
solicitation, notwithstanding the procedures contained in the provision 
at FAR 52.215-1(c)(3), Instructions to Offerors--Competitive 
Acquisition, the contracting officer may consider a proposal received 
concerning biomedical or behavioral research and development (R&D) 
acquisitions after the date specified for receipt if--
    (1) It appears to offer significant cost or technical advantage to 
the Government; and
    (2) It was received before proposals were distributed for 
evaluation; or
    (3) It was received within five calendar days after the exact time 
specified for receipt, whichever is earlier.
    (c) When the provision at 352.215-70 is included in the 
solicitation and if the contracting officer intends to consider a 
proposal or proposals received after the exact time specified for 
receipt, the contracting officer, with the assistance of cost or 
technical personnel as appropriate, shall determine in writing that the 
proposal(s) meets the requirements of the provision at 352.215-70.


315.209-70  Solicitation provision.

    The contracting officer shall insert the provision at 352.215-70, 
Late Proposals and Revisions--R&D Solicitations, in biomedical or 
behavioral R&D competitive acquisition solicitations subject to the 
requirements of 315.208-70(a) and the authorization of the HCA.

Subpart 315.3--Source Selection


315.303-70  Policy.

    (a) When an operating division (OPDIV) of the Department of Health 
and Human Services (HHS) is required by statute to use peer review for 
technical review of proposals, the requirements of those statutes, any 
implementing regulatory requirements, and the Federal Advisory 
Committee Act (5 U.S.C. chapter 10), takes precedence over the 
otherwise applicable requirements of this subpart.
    (b) The applicable OPDIV peer review and implementing regulations 
include--
    (1) National Institutes of Health--42 U.S.C. 289a and 42 CFR part 
52h;
    (2) Substance Abuse and Mental Health Services Administration--42 
U.S.C. 290aa-3; and
    (3) Agency for Healthcare Research and Quality--42 U.S.C. 299c-1.


315.304  Evaluation factors and significant subfactors.

    When acquiring information and communication technology (ICT) 
supplies and services using negotiated procedures, contracting officers 
shall include a separate technical evaluation factor, or subfactor, 
concerning compliance with section 508 of the Rehabilitation Act of 
1973, as amended (see 339.203).


315.305  Proposal evaluation.


315.305-70  Proposal evaluation--use of non-Federal evaluators.

    (a) Except when peer review is required by statute as provided in 
315.303-70, decisions to disclose proposals to non-Federal evaluators 
shall be made by the Source Selection Authority or the contracting 
officer, as applicable, responsible for appointing Source Selection 
Evaluation Team members in accordance with agency procedures. The 
avoidance of organizational and personal conflicts of interest must be 
taken into consideration when making the decision to use non-Federal 
evaluators (see FAR 15.305(c)).
    (b) When an offeror's or contractor's proposal will be disclosed 
outside the Government to a contractor or a contractor employee for 
evaluation purposes, the provision prescribed at 315.305-71 requires 
that the contractor and its employees, as well as any subcontractors 
and their employees, to agree that when performing work as an evaluator 
under a Government contract that they will use the data (trade secrets, 
business data, and technical data)

[[Page 80675]]

contained in the proposal for evaluation purposes only.
    (1) This paragraph (b) does not apply to data obtained from another 
source without restriction.
    (2) Upon completion of the evaluation, the non-Federal evaluator 
shall return to the Government the furnished copy of the proposal or 
abstract, and all copies thereof, to the HHS office which initially 
furnished the proposal for evaluation.
    (3) All electronic records of proposals or proposal-related 
material shall be provided to the Government and immediately be 
destroyed and/or deleted from all electronic media.
    (4) Evaluators shall not contact the offeror concerning any aspects 
of a proposal's contents.
    (c) The agreement shall be signed by the contractor and the 
assigned contractor employee, subcontractor, or consultant (i.e., the 
non-Federal evaluator) and filed in the contract file prior to 
disclosure of an offeror's proposal.


315.305-71  Solicitation provision.

    Insert the provision at 352.215-71, Use of Non-Federal Evaluators--
Conditions for Evaluating Proposals, in solicitations when the 
Government may use non-Federal evaluators to evaluate an offeror's or 
contractor's proposals and offers.

Subpart 315.4--Contract Pricing


315.404  Proposal analysis.


315.404-2  Data to support proposal analysis.

    (a)(2) When some or all information sufficient to determine the 
reasonableness of the proposed cost or price is already available or 
can be obtained from the cognizant audit agency, or by other means 
including data obtained through market research (see FAR part 10) the 
contracting officer may request partial field pricing support as 
outlined in FAR 15.404-2(a)(2).

Subpart 315.6--Unsolicited Proposals


315.604  Agency points of contact.

    (a) Each HCA is responsible for disseminating the information 
required at FAR 15.604(a).


315.605-70  Content of unsolicited proposals--warranty by offeror.

    (a) To ensure against contacts between HHS personnel and 
prospective offerors that would exceed the limits of advance guidance 
set forth in FAR 15.604 and potentially result in an unfair advantage 
to an offeror, the prospective offeror of an unsolicited proposal must 
include a supporting document in the form of a warranty statement in 
accordance with paragraph (c) of this section with any unsolicited 
proposal.
    (b) Unsolicited proposals submitted without the warranty statement 
will not be processed by the Government. Contracting officers receiving 
an unsolicited proposal without this warranty shall not process the 
proposal until the offeror is notified of the missing language and 
given an opportunity to submit the supporting documentation. If no 
warranty statement is provided in a reasonable time, the contracting 
officer shall reject the unsolicited proposal, notify the offeror of 
the rejection, and document the actions in the file.
    (c) Prospective offerors shall submit a supporting document with 
any submitted unsolicited proposal in the form of a warranty statement 
as follows:

UNSOLICITED PROPOSAL--WARRANTY BY OFFEROR

    This is to warrant that--
    (a) This proposal has not been prepared under Government 
supervision;
    (b) The methods and approaches stated in the proposal were 
developed by this offeror;
    (c) Any contact with HHS personnel has been within the limits of 
appropriate advance guidance set forth in FAR 15.604;
    (d) No prior commitments were received from HHS personnel regarding 
acceptance of this proposal; and
    (e) This proposal was not previously submitted for an HHS grant 
award consideration that was rejected for lack of scientific merit.
Date:------------------------------------------------------------------
Organization:----------------------------------------------------------
Name:------------------------------------------------------------------
Title:-----------------------------------------------------------------
    [This warranty shall be signed by a responsible management official 
of the proposing organization who is a person authorized to 
contractually obligate the organization.]


315.606  Agency procedures.

    (a) The HCA is responsible for establishing procedures to comply 
with FAR 15.606(a).
    (b) The HCA or designee shall be the point of contact for 
coordinating the receipt and processing of unsolicited proposals.


315.606-1  Receipt and initial review.

    (a)(2) Operating Divisions (OPDIVs) may consider an unsolicited 
proposal for award of a contract even though an organization initially 
submitted it as a grant application. However, contracting officers 
shall not award contracts based on unsolicited proposals that have been 
rejected for grant awards due to lack of scientific merit.

PART 316--TYPES OF CONTRACTS

Subpart 316.3--Cost-Reimbursement Contracts
Sec.
316.307 Contract clauses.
Subpart 316.5--Indefinite-Delivery Contracts
316.505 Ordering.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2); 41 U.S.C. 
1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 316.3--Cost-Reimbursement Contracts


316.307  Contract clauses.

    (a)(1) The contracting officer shall insert the clause at 352.216-
70, Allowable Cost and Payment for Hospitals (Profit and Non-Profit), 
in solicitations and contracts, when a cost-reimbursement contract with 
a hospital (profit or non-profit) is contemplated and when the clause 
at FAR 52.216-7 is inserted in the contract.

Subpart 316.5--Indefinite-Delivery Contracts


316.505  Ordering.

    (b)(8) The Department of Health and Human Services Advocate for 
Competition is designated as the task-order and delivery-order 
ombudsman. Each HHS HCA shall designate, in writing, a task-order and 
delivery-order ombudsman. The list of HHS Task-order and Delivery-order 
ombudsmen is at https://www.hhs.gov/grants/grants-business-contacts/competition-advocates/.

PART 317--[RESERVED]

PART 318--EMERGENCY ACQUISITIONS

Sec.
318.000 Scope of part.
318.001 Definition.
318.001-70 Agency delegation of determination.
Subpart 318.1--Available Acquisition Flexibilities
318.109 Priorities and allocations.
318.109-70 The Health Resources Priorities and Allocation System.
Subpart 318.2--Emergency Acquisition Flexibilities
318.202 Defense or recovery from certain events.
318.202-70 Specific HHS flexibilities.
318.270 Head of the agency delegations.


[[Page 80676]]


    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2); 41 U.S.C. 
1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.


318.000  Scope of part.

    This part sets forth additional emergency acquisition flexibilities 
found in FAR part 18.


318.001  Definition.


318.001-70  Agency delegation of determination.

    The Secretary delegates to the head of the contracting activity 
(HCA) the authority to utilize emergency acquisition flexibilities and 
make the agency head determinations as set forth in FAR part 18 and as 
defined in subpart 318.2.

Subpart 318.1--Available Acquisition Flexibilities


318.109  Priorities and allocations.


318.109-70  The Health Resources Priorities and Allocation System.

    The HHS Health Resources Priorities and Allocation System was 
established to require acceptance and priority performance of contracts 
or orders (other than contracts of employment) to promote the national 
defense over performance of any other contracts or orders, and to 
allocate materials, services, and facilities as deemed necessary or 
appropriate to promote the national defense, with respect to health 
resources. (See subpart 311.6.)

Subpart 318.2--Emergency Acquisition Flexibilities


318.202  Defense or recovery from certain events.


318.202-70  Specific HHS flexibilities.

    (a) Micro-purchase threshold. The threshold increases when the SPE 
determines the supplies or services are to be used to facilitate 
defense against or recovery from cyber, nuclear, biological, chemical, 
or radiological attack; to facilitate provision of international 
disaster assistance; or to support response to an emergency or major 
disaster. (See FAR 2.101.)
    (b) Simplified acquisition threshold. The threshold increases when 
the SPE determines the supplies or services are to be used to 
facilitate defense against or recovery from cyber, nuclear, biological, 
chemical, or radiological attack; to facilitate provision of 
international disaster assistance; or to support response to an 
emergency or major disaster. (See FAR 2.101.)
    (c) Commercial product or commercial service treatment. Contracting 
officers may treat any acquisition of supplies or services as an 
acquisition of commercial products or commercial services if the SPE 
determines the acquisition is to be used to facilitate the defense 
against or recovery from cyber, nuclear, biological, chemical, or 
radiological attack. (See FAR 12.102(f)(1) and 13.500(c)(2).)
    (d) Simplified procedures for certain commercial products and 
commercial services. The threshold limits authorized for use of this 
authority may be increased when it is determined by the SPE the 
acquisition is to facilitate defense against or recovery from cyber, 
nuclear, biological, chemical, or radiological attack; to facilitate 
provision of international disaster assistance; or to support response 
to an emergency or major disaster. (See FAR 13.500(c).)


318.270  Head of the agency delegations.

    The Secretary delegates to the SPE the authority to make the 
determinations identified in the following FAR references:
    (a) FAR 2.101, definitions of ``Simplified acquisition threshold'' 
and ``Micro-purchase threshold'';
    (b) FAR 12.102(f);
    (c) FAR 13.201(g); and
    (d) FAR 13.500(c)(1).
0
8. Revise parts 319 through 323 to read as follows:
* * * * *
PART 319 SMALL BUSINESS PROGRAMS
PARTS 320-321 [RESERVED]
PART 322 APPLICATION OF LABOR LAWS TO GOVERNMENT ACQUISITIONS
PART 323 ENVIRONMENT, SUSTAINABLE ACQUISITION, AND MATERIAL SAFETY
* * * * *

PART 319--SMALL BUSINESS PROGRAMS

Subpart 319.2--Policies
Sec.
319.201 General policy.
319.202 Specific policies.
Subpart 319.7--The Small Business Subcontracting Program
319.705 Responsibilities of the contracting officer under the 
subcontracting assistance program.
319.705-6 Postaward responsibilities of the contracting officer.
Subpart 319.8--Contracting With the Small Business Administration (the 
8(a) Program)
319.800 General.
319.811 Preparing the contracts.
319.811-370 SBA Partnership Agreement and contract clauses.

    Authority: 5 U.S.C. 301; 15 U.S.C. 631, et seq.; 40 U.S.C. 
121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 
through 1.304.

Subpart 319.2--Policies


319.201  General policy.

    (c) The functional management responsibilities for the Department 
of Health and Human Services' (HHS) small business program are 
delegated to the Office of Small and Disadvantaged Business Utilization 
(OSDBU) Executive Director.
    (d)(1) The HHS OSDBU Executive Director shall exercise full 
management authority over the small business program and appoints small 
business specialists (SBS). The SBS shall review and make set-aside 
recommendations in accordance with Federal Acquisition Regulation (FAR) 
19.502, and OSDBU guidance and agency procedures. The review must take 
place prior to issuing the solicitation.
    (2) Within the Indian Health Service (IHS), the primary SBS is 
responsible for IHS' overall implementation of the HHS small business 
program; however, each IHS contracting office will assign a small 
business technical advisor (SBTA) to perform those functions and 
responsibilities necessary to implement the small business program. The 
primary IHS SBS shall assist and provide guidance to respective SBTAs.


319.202  Specific policies.

    Contracting officers shall use HHS Form 653, Small Business Program 
Review, to document set-aside decisions in accordance with agency 
procedures.

Subpart 319.7--The Small Business Subcontracting Program


319.705  Responsibilities of the contracting officer under the 
subcontracting assistance program.


319.705-6  Postaward responsibilities of the contracting officer.

    (h) The contracting officer shall coordinate with the small 
business specialist assigned to the contracting activity (and the SBA 
procurement center representative (PCR), if one is assigned) on all 
potential determinations to assess liquidated damages pursuant to FAR 
19.705-7(a) and (b). OSDBU should also be alerted prior to a final 
determination.

Subpart 319.8--Contracting With the Small Business Administration 
(the 8(a) Program)


319.800  General.

    (e) The Small Business Administration (SBA) and HHS have entered 
into a Partnership Agreement delegating SBA's contract execution and 
administrative functions to HHS. Contracting officers shall follow the

[[Page 80677]]

alternate procedures in the Partnership Agreement and this subpart, as 
applicable, to award an 8(a) contract. In the event the Partnership 
Agreement ceases to be in effect, contracting officers shall follow the 
procedures in FAR subpart 19.8.


319.811  Preparing the contracts.


319.811-370  SBA Partnership Agreement and contract clauses.

    When an 8(a) acquisition is processed pursuant to the Partnership 
Agreement, the contracting officer shall:
    (a) For competitive solicitations and awards, use the clause at FAR 
52.219-18, Notification of Competition Limited to Eligible 8(a) 
Participants, and clause 352.219-70, Notification of Competition 
Limited to Eligible 8(a) Participants, substituting paragraph (c) of 
FAR 52.219-18 with paragraph (c) contained in 352.219-70.
    (b) For noncompetitive solicitations and awards insert the clause 
at 352.219-71, Notification of Section 8(a) Direct Awards, instead of 
the prescribed clauses at FAR 52.219-11, Special 8(a) Contract 
Conditions; 52.219-12, Special 8(a) Subcontract Conditions; and 52.219-
17, Section 8(a) Award.
    (c) In all instances, include the clause at FAR 52.219-14, 
Limitations on Subcontracting, or if applicable 52.219-33, 
Nonmanufacturer Rule.

PARTS 320-321 [RESERVED]

PART 322--APPLICATION OF LABOR LAWS TO GOVERNMENT ACQUISITIONS

Subpart 322.1--Basic Labor Policies
Sec.
322.101 Labor relations.
322.101-70 Admittance of union representatives to HHS facilities.
Subpart 322.8--Equal Employment Opportunity
322.808 Complaints.
322.810 Solicitation provisions and contract clauses.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2); 41 U.S.C. 
1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 322.1--Basic Labor Policies


322.101  Labor relations.


322.101-70  Admittance of union representatives to HHS facilities.

    (a) Admittance policy and procedures. It is HHS policy to admit 
labor union representatives of contractor employees to HHS facilities 
to visit work sites and transact labor union business with contractors, 
their employees, or union stewards pursuant to existing union 
collective bargaining agreements. Their presence shall not interfere 
with the contractor's work progress under an HHS contract, nor violate 
the safety or security regulations that may be applicable to persons 
visiting the facility. The union representatives will not be permitted 
to conduct meetings, collect union dues, or make speeches concerning 
union matters while visiting a work site.
    (b) Denied entry reporting. Whenever a union representative is 
denied entry to a facility or work site, the person denying entry shall 
make a written report to the HHS labor coordinator, the Office of the 
General Counsel (OGC), or corresponding labor advisor, with a copy to 
the cognizant contracting officer within two working days after the 
request for entry is denied. The report shall include the reason(s) for 
the denial, the name of the representative denied entry, the union 
affiliation and number, and the name and title of the person that 
denied the entry.

Subpart 322.8--Equal Employment Opportunity


322.808  Complaints.

    Contractors shall, in good faith, cooperate with the Department of 
Health and Human Services (HHS) in investigations of Equal Employment 
Opportunity (EEO) complaints processed pursuant to 29 CFR part 1614 and 
in accordance with clause 352.222-70 as prescribed in this subpart.


322.810  Solicitation provisions and contract clauses.

    (e) The contracting officer shall insert the clause at 352.222-70, 
Contractor Cooperation in Equal Employment Opportunity and Anti-
Harassment Investigations, in solicitations, contracts, and orders that 
include the clause at FAR 52.222-26, Equal Opportunity.

PART 323--ENVIRONMENT, SUSTAINABLE ACQUISITION, AND MATERIAL SAFETY

Subpart 323.1--Sustainable Products and Services
Sec.
323.103-70 Policy--Sustainable Acquisition Plan.
323.109-70 Solicitation provision.
Subpart 323.3--Hazardous Material Identification, Material Safety Data, 
and Notice of Radioactive Materials
323.300 Scope of subpart.
323.304-70 Contract clause.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2); 41 U.S.C. 
1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 323.1--Sustainable Products and Services


323.103-70  Policy--Sustainable Acquisition Plan.

    (a) For new contracts and orders above the micro-purchase 
threshold, contracting officers shall insert an evaluation factor on 
the offeror's Sustainable Action Plan in the solicitation, when a 
Sustainable Action Plan is required.
    (b) When a solicitation includes the provision at 352.223-70, 
Instructions to Offerors--Sustainable Acquisition Plan, offerors shall 
include a Sustainable Acquisition Plan in their technical proposal 
addressing sustainable products for services for delivery under any 
resulting contract.
    (c) The contracting officer shall incorporate the final Sustainable 
Acquisition Plan into the contract.


323.109-70  Solicitation provision.

    The contracting officer shall insert the provision at 352.223-70, 
Instructions to Offerors--Sustainable Acquisition Plan, in 
solicitations above the micro-purchase threshold when acquiring a 
product or service that include sustainable acquisition attributes.

Subpart 323.3--Hazardous Material Identification, Material Safety 
Data, and Notice of Radioactive Materials


323.300  Scope of subpart.

    This subpart provides procedures for administering safety and 
health requirements.


323.304-70  Contract clause.

    Insert the clause at 352.223-71, Safety and Health, in 
solicitations and contracts that involve hazardous materials or 
hazardous operations for the following types of requirements:
    (a) Services or products.
    (b) Research, development, or test projects.
    (c) Transportation of hazardous materials.
    (d) Construction, including construction of facilities on the 
contractor's premises.

PART 324--PROTECTION OF PRIVACY AND FREEDOM OF INFORMATION

0
9. The authority citation for part 324 is revised to read as follows:

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 
41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

[[Page 80678]]

Subpart 324.1--Protection of Individual Privacy


324.103, 324.104, and 324.105  [Redesignated as 324.103-70, 324.103-71, 
and 324.104]

0
10. Redesignate sections 324.103, 324.104, and 324.105 as sections 
324.103-70, 324.103-71, and 324.104.
0
11. Amend newly redesignated section 324.104 by revising paragraph (b) 
to read as follows:


324.104  Contract clauses.

* * * * *
    (b) The contracting officer shall insert the clause at 352.224-71, 
Confidential Information, in solicitations, contracts, and orders that 
require access to Government or third party confidential information, 
and in solicitations, contracts, and orders that include the clause at 
352.227-71, Rights in Data--Supplement--Exceptional Circumstances.
0
12. Add part 325 to read as follows:

PART 325--FOREIGN ACQUISITION

Subpart 325.71--Make PPE in America Act Restrictions on Foreign 
Acquisition of Personal Protective Equipment
Sec.
325.7100 Scope of subpart.
325.7101 Definitions.
325.7102 Restrictions on certain personal protective equipment.
325.7102-1 Restrictions.
325.7102-2 Exceptions.
325.7103 Solicitation provisions and contract clauses.

    Authority:  5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 
1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 325.71--Make PPE in America Act Restrictions on Foreign 
Acquisition of Personal Protective Equipment


325.7100  Scope of subpart.

    This subpart contains restrictions on the acquisition of certain 
personal protective equipment (PPE) as required by the Make PPE in 
America Act (Pub. L. 117-58) for applicable solicitations and contracts 
issued by HHS.


325.7101  Definitions.

    As used in this subpart--
    Component, as applied to an item described in 325.7102-1, means an 
article, material, or supply incorporated directly into an item of 
personal protective equipment.
    Domestic personal protective equipment, as applied to an item 
described in 325.7102-1, means personal protective equipment, including 
the materials and components thereof, that is grown, reprocessed, 
reused, or produced in the United States.
    Foreign-made domestic personal protective equipment, as applied to 
an item described in 325.7102-2, means personal protective equipment 
that is assembled outside the United States containing only materials 
and components that are grown, reprocessed, reused, or produced in the 
United States.
    Foreign personal protective equipment means personal protective 
equipment other than domestic personal protective equipment or foreign-
made domestic personal protective equipment.
    Personal protective equipment, as applied to an item described in 
325.7102-1, means surgical masks, respirator masks and powered air 
purifying respirators and required filters, face shields and protective 
eyewear, gloves, disposable and reusable surgical and isolation gowns, 
head and foot coverings, and other gear or clothing used to protect an 
individual from the transmission of disease.
    United States, as applied to an item described in 325.7102-1, means 
the 50 States, the District of Columbia, and the possessions of the 
United States.


325.7102  Restrictions on certain personal protective equipment.


325.7102-1  Restrictions.

    The following restrictions implement section 70953 of the Make PPE 
in America Act, and they apply to all contracts and orders for the 
purchase of PPE.
    (a) Except as provided in subsection 325.7102-2, contracting 
officers shall purchase domestic PPE.
    (b) Any contract for PPE shall have a base period of performance of 
at least two years, plus any option periods.


325.7102-2  Exceptions.

    Acquisitions of PPE in the following categories are not subject to 
the restrictions in 325.7102-1:
    (a) Acquisitions of an item of PPE, or component thereof, otherwise 
covered by 325.7102-1 when the HHS Secretary:
    (1) Maximizes sources for foreign-made domestic PPE; and
    (2) Certifies every 120 days that it is necessary to procure PPE 
under alternative procedures to respond to the immediate needs of a 
public health emergency.
    (b) Acquisitions of an item of PPE, or component thereof, including 
those described in paragraph (a) of this section--
    (1) That is, or that includes, a material listed in FAR 25.104 as 
one for which a nonavailability determination has been made; or
    (2) As to which the HHS Secretary--
    (i) Determines that a sufficient quantity of a satisfactory quality 
that is grown, reprocessed, reused, or produced in the United States 
cannot be procured as, and when, needed at United States market prices; 
and
    (ii) Certifies every 120 days that it is necessary to procure PPE 
to respond to the immediate needs of a public health emergency.
    (c) When either of the exceptions in paragraph (a) or (b) of this 
section are used:
    (1) Only the HHS Secretary is authorized to make the certification 
in paragraphs (a)(2) and (b)(2)(ii) or the nonavailability or 
unreasonable cost determination in paragraph (b) of this section.
    (2) The supporting documentation for the Senior Procurement 
Executive shall be prepared by the HHS Operating or Staff Division 
and--
    (i) For the certification in paragraphs (a)(2) and (b)(2)(ii) of 
this section, the contracting officer shall--
    (A) Include a written justification documenting the immediate 
public health emergency requiring use of alternative procedures; and
    (B) Obtain written approval of the justification from the head of 
the contracting activity (HCA) before submission to the Senior 
Procurement Executive.
    (ii) For the nonavailability or unreasonable cost determination in 
paragraph (b) of this section, the contracting officer shall--
    (A) Include a written justification documenting why a 
nonavailability or unreasonable cost exception is required; and
    (B) Obtain written approval of the justification from the HCA 
before submission to the Senior Procurement Executive.


325.7103  Solicitation provisions and contract clauses.

    (a) Insert the clause at 352.225-70, Made in America--Personal 
Protective Equipment, in solicitations and contracts, above the micro-
purchase threshold, when procuring any item covered under 325.7102-
1(a). When the clause at FAR 52.212-5, Contract Terms and Conditions 
Required To Implement Statutes or Executive Orders--Commercial Products 
and Commercial Services, is included in a solicitation or contract for 
PPE, contracting officers shall include the full text of the clause at 
352.225-70.
    (b) Insert the provision at 352.225-71, Made in America 
Certificate--Personal

[[Page 80679]]

Protective Equipment, in solicitations containing the clause at 
352.225-70. When the provision at FAR 52.212-3, Offeror Representations 
and Certifications--Commercial Products and Commercial Services, is 
included in a solicitation for PPE, contracting officers shall include 
the full text of the provision at 352.225-71.
0
13. Revise part 326 to read as follows:

PART 326--OTHER SOCIOECONOMIC PROGRAMS

Subpart 326.70--Indian Preference in Employment, Training, and 
Subcontracting Opportunities
Sec.
326.7001 Statutory requirements.
326.7002 Additional definitions.
326.7003 Compliance enforcement.
326.7004 Tribal preference requirements.
326.7005 Contract clauses.
Subpart 326.71--Acquisitions Under the Buy Indian Act
326.7100 General.
326.7100-1 Scope of subpart.
326.7100-2 Buy Indian Act acquisition regulations.
326.7101 Definitions.
326.7102 Applicability.
326.7102-1 Restrictions on the use of the Buy Indian Act.
326.7103 Policy.
326.7103-1 Requirement to give preference to Indian Economic 
Enterprises.
326.7103-2 Delegations and responsibility.
326.7103-3 Deviations.
326.7104 Procedures.
326.7104-1 General.
326.7104-2 Procedures for acquisitions under the Buy Indian Act.
326.7104-3 Debarment and suspension.
326.7104-4 Performance and payment bonds.
326.7105 Solicitation provisions and contract clauses.
326.7106 Representation by an Indian Economic Enterprise offeror.
326.7106-1 General.
326.7106-2 Representation provision.
326.7106-3 Representation process.
326.7107 Challenges to representation.
326.7107-1 Procedure.
326.7107-2 Receipt of challenge.
326.7107-3 Award in the face of challenge.
326.7107-4 Challenge not timely.
Subpart 326.72--Acquisitions Requiring the Native American Graves 
Protection and Repatriation Act
326.7200 Scope of subpart.
326.7201 Contract clauses.

    Authority: 5 U.S.C. 301, 25 U.S.C. 47, 25 U.S.C. 1633, 25 U.S.C. 
5301 et seq.; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 
1702; 42 U.S.C. 2003; and 48 CFR 1.301 through 1.304.

Subpart 326.70--Indian Preference in Employment, Training, and 
Subcontracting Opportunities


326.7001  Statutory requirements.

    Any contract or subcontract pursuant to 25 U.S.C. chapter 46, the 
Act of April 16, 1934 (48 Stat. 596), as amended (25 U.S.C. 5301, et 
seq.), or any other Act authorizing Federal contracts with or grants to 
Indian organizations or for the benefit of Indians, shall, to the 
greatest extent feasible, comply with section 7(b) of the Indian Self-
Determination and Education Assistance Act, Public Law 93-638, 88 Stat. 
2205 (25 U.S.C. 5307(b)), which provides preferences and opportunities 
for training and employment in connection with the administration of 
such contracts, and preference in the award of subcontracts in 
connection with the administration of such contracts to Indian 
organizations and to Indian-owned economic enterprises as defined in 25 
U.S.C. 1452.


326.7002  Additional definitions.

    As used in this subpart--
    (a) Construction contract means a fixed-price or cost-reimbursement 
self-determination contract for a construction project, except that 
such term does not include any contract--
    (1) That is limited to providing planning services and construction 
management services (or a combination of such services);
    (2) For the Housing Improvement Program or roads maintenance 
program of the Bureau of Indian Affairs administered by the Secretary 
of the Interior; or
    (3) For the health facility maintenance and improvement program 
administered by the Secretary of Health and Human Services. (Pub. L. 
116-180, title II, sec. 201(a), 134 Stat. 878.)
    (b) Contract funding base means the base level from which contract 
funding needs are determined, including all contract costs.
    (c) Indian means a person who is a member of an Indian Tribe. If 
the contractor has reason to doubt that a person seeking employment 
preference is an Indian, the contractor shall grant the preference but 
shall require the individual provide evidence within 30 days from the 
Tribe concerned that the person is a member of the Tribe.
    (d) Indian reservation includes Indian reservations, public domain 
Indian allotments, former Indian reservations in Oklahoma, and land 
held by incorporated Native groups, regional corporations, and village 
corporations under the provisions of the Alaska Native Claims 
Settlement Act (85 Stat. 688; 43 U.S.C. 1601 et seq.).
    (e) Indian Tribe means any Indian Tribe, band, nation, or other 
organized group or community, including any Alaska Native village or 
regional or village corporation as defined in or established pursuant 
to the Alaska Native Claims Settlement Act (85 Stat. 688; 43 U.S.C. 
1601 et seq.), which is recognized as eligible for special programs and 
services provided by the United States to Indians because of their 
status as Indians.
    (f) Indirect costs means costs incurred for a common or joint 
purpose benefiting more than one contract objective, or which are not 
readily assignable to the contract objectives specifically benefited 
without effort disproportionate to the results achieved.
    (g) On or near an Indian reservation means on a reservation or 
reservations or within that area surrounding an Indian reservation(s) 
where a person seeking employment could reasonably commute to and from 
in the course of a work day.
    (h) Secretary, unless otherwise designated, means either the 
Secretary of Health and Human Services or the Secretary of the Interior 
or both.
    (i) Self-determination contract means a contract entered into under 
25 U.S.C. subchapter I (or a grant or cooperative agreement used under 
25 U.S.C. 5308) between a Tribal organization and the appropriate 
Secretary for the planning, conduct, and administration of programs or 
services that are otherwise provided to Indian Tribes and members of 
Indian Tribes pursuant to Federal law, subject to the condition that, 
except as provided in 25 U.S.C. 5324(a)(3), no contract entered into 
under 25 U.S.C. subchapter I (or grant or cooperative agreement used 
under 25 U.S.C. 5308) shall be--
    (1) Considered to be a procurement contract; or
    (2) Except as provided in 25 U.S.C. 5328(a)(1), subject to any 
Federal procurement law (including regulations).
    (j) Tribal organization means the recognized governing body of any 
Indian Tribe; any legally established organization of Indians which is 
controlled, sanctioned, or chartered by such governing body or which is 
democratically elected by the adult members of the Indian community to 
be served by such organization and which includes the maximum 
participation of Indians in all phases of its activities: Provided, 
that in any case where a contract is let or grant made to an 
organization to perform services benefiting more than one Indian Tribe, 
the approval of each such Indian Tribe

[[Page 80680]]

shall be a prerequisite to the letting or making of such contract or 
grant.


326.7003  Compliance enforcement.

    The contracting officer shall promptly investigate and resolve 
written complaints of noncompliance with the requirements of the 
clauses at 352.226-70, Indian Preference, and 352.226-71, Indian 
Preference Program, filed with the contracting activity.


326.7004  Tribal preference requirements.

    (a) When the contractor will perform work under a contract on an 
Indian reservation, the contracting officer may supplement the clause 
at 352.226-71, Indian Preference Program, by adding specific Indian 
preference requirements of the Tribe on whose reservation the 
contractor will work. The contracting activity and the Tribe shall 
jointly develop supplemental requirements for the contract. 
Supplemental preference requirements shall represent a further 
implementation of the requirements of section 7(b) of Public Law 93-638 
and require the approval of the affected program director and the 
appropriate legal office, or a regional attorney, before the 
contracting officer adds them to a solicitation and resultant contract. 
Any supplemental preference requirements the contracting officer adds 
to the clause at 352.226-71, Indian Preference Program shall also 
clearly identify in the solicitation the additional requirements.
    (b) Nothing in this subpart shall preclude Tribes from 
independently developing and enforcing their own Tribal preference 
requirements. Such independently-developed Tribal preference 
requirements shall not, except as provided in paragraph (a) of this 
section, become a requirement in contracts covered under this subpart, 
and shall not conflict with any Federal statutory or regulatory 
requirement concerning the award and administration of contracts.


326.7005  Contract clauses.

    The contracting officer shall insert the clause at 352.226-70, 
Indian Preference, and the clause at 352.226-71, Indian Preference 
Program, in solicitations and contracts to implement section 7(b) of 
Public Law 93-638 for all Department of Health and Human Services (HHS) 
offices. Contracting officers shall use the clauses as follows, except 
for those exempted solicitations and contracts issued and or awarded 
pursuant to title I of Public Law 93-638 (25 U.S.C. 450 et seq.):
    (a) The contracting officer shall insert the clause at 352.226-70, 
Indian Preference, in solicitations, contracts, and orders when--
    (1) The award is (or will be) pursuant to an act specifically 
authorizing such awards with Indian organizations; or
    (2) The work is specifically for the benefit of Indians and is in 
addition to any incidental benefits which might otherwise accrue to the 
general public.
    (b) The contracting officer shall insert the clause at 352.226-71, 
Indian Preference Program, in solicitations, contracts, and orders 
when--
    (1) The dollar amount of the acquisition is expected to equal or 
exceed $750,000 for non-construction work or $1.5 million for 
construction work;
    (2) The solicitation, contract, or order includes the clause at 
352.226-70; and
    (3) The contracting officer makes the determination, prior to 
solicitation, that performance will take place in whole or in 
substantial part on or near an Indian reservation(s). In addition, the 
contracting officer may insert the clause at 352.226-71 in 
solicitations, contracts, and orders below the $750,000 threshold or 
$1.5 million threshold level for non-construction or construction 
contracts, respectively, but which meet the requirements of paragraphs 
(b)(2) and (3) of this section, and in the opinion of the contracting 
officer, offer substantial opportunities for Indian employment, 
training, and subcontracting.

Subpart 326.71--Acquisitions Under the Buy Indian Act


326.7100  General.


326.7100-1  Scope of subpart.

    This subpart implements policies and procedures for the procurement 
of supplies, general services, architect-engineer (A-E) services, or 
construction while giving preference to Indian Economic Enterprises 
under authority of the Buy Indian Act (25 U.S.C. 47).


326.7100-2  Buy Indian Act acquisition regulations.

    (a) This subpart supplements Federal Acquisition Regulation (FAR) 
and Health and Human Services Acquisition Regulation (HHSAR) 
requirements to meet the needs of the Department of Health and Human 
Services (HHS), Indian Health Service (IHS) in implementing the Buy 
Indian Act.
    (b) This subpart is under the direct oversight and control of the 
head of contracting activity (HCA), within the Office of Management 
Services (OMS)--IHS, HHS. The HCA, in consultation with the Assistant 
Secretary for Financial Resources (ASFR) and the Senior Procurement 
Executive (SPE), is responsible for promulgating this subpart, and 
following its enactment, will be primarily responsible for implementing 
its terms.
    (c) Acquisitions conducted under this subpart are subject to all 
applicable requirements of the FAR and HHSAR, as well as internal 
policies, procedures, or instructions issued by IHS. After the FAR, 
this subpart would take precedence over any inconsistent IHS policies, 
procedures, or instructions.


326.7101  Definitions.

    As used in this subpart--
    Alaska Native Claims Settlement Act (ANCSA) means Public Law 92-
203, 85 Stat. 688, codified at 43 U.S.C. 1601-1629h.
    Alaska Native Corporation means any Regional Corporation, any 
Village Corporation, any Urban Corporation, and any Group Corporation 
as those terms are defined by ANCSA.
    Buy Indian Act means section 23 of the Act of June 25, 1910, 
codified at 25 U.S.C. 47.
    Chief Contracting Officer (CCO) means a person with authority to 
enter into, administer, or terminate contracts and make related 
determinations and findings on behalf of the U.S. Government for the 
respective IHS Areas.
    Construction means the planning, design, construction and 
renovation, including associated architecture and engineering services, 
of IHS facilities pursuant to 25 U.S.C. 1631 and in the construction of 
safe water and sanitary waste disposal facilities pursuant to 25 U.S.C. 
1632.
    Deviation means an exception to the requirement to use the Buy 
Indian Act in fulfilling an acquisition requirement subject to the Buy 
Indian Act.
    Fair market price means a price based on reasonable costs under 
normal competitive conditions and not on lowest possible cost, as 
determined in accordance with FAR 19.202-6(a).
    Indian means a person who is an enrolled member of an Indian Tribe 
or ``Native'' as defined in the Alaska Native Claims Settlement Act.
    Indian Economic Enterprise (IEE) means any business activity owned 
by one or more Indians or Indian Tribes that is established for the 
purpose of profit provided that: The combined Indian or Indian Tribe 
ownership must constitute not less than 51 percent of the enterprise; 
the Indians or Indian Tribes must, together, receive at least a 
majority of the earnings from the contract; and the management and 
daily business operations of an enterprise must be controlled by one or 
more individuals who are Indians. To ensure

[[Page 80681]]

actual control over the enterprise, the individuals must possess 
requisite management or technical capabilities directly related to the 
primary industry in which the enterprise conducts business. The 
enterprise must meet these requirements throughout the following time 
periods:
    (1) At the time an offer is made in response to a written 
solicitation;
    (2) At the time of the contract award; and
    (3) During the full term of the contract.
    Indian Health Service (IHS) means operations at all administrative 
levels of IHS, including Headquarters, Area Offices, and Service Units 
(inclusive of clinics).
    Indian Small Business Economic Enterprise (ISBEE) means an IEE that 
is also a small business concern established in accordance with the 
criteria and size standards of 13 CFR part 121.
    Indian Tribe means an Indian Tribe, band, nation, or other 
recognized group or community that is recognized as eligible for the 
special programs and services provided by the United States to Indians 
because of their status as Indians, including any Alaska Native village 
or regional or village corporation under the Alaska Native Claims 
Settlement Act (Pub. L. 92-203, 85 Stat. 688; 43 U.S.C. 1601).
    Interested party means an IEE that is an actual or prospective 
offeror whose direct economic interest would be affected by the 
proposed or actual award of a particular contract set-aside pursuant 
the Buy Indian Act.
    List of Federally Recognized Tribes means the list published 
annually in the Federal Register identifying Indian entities that are 
recognized by and eligible to receive services from the United States 
Department of the Interior (DOI), Bureau of Indian Affairs (BIA).
    Transfer Act of 1954 means the authority of transferred 
responsibility and other health care ``functions, responsibilities, 
authorities and duties of the Department of the Interior'' (including 
the Snyder Act) to Health, Education and Welfare, the predecessor of 
the HHS (see Pub. L. 83-568, 68 Stat. 674 (1954) (codified at 42 U.S.C. 
2001 et seq.)). The Transfer Act authorizes IHS to use the Buy Indian 
Act (25 U.S.C. 47) to carry out its health care responsibilities.


326.7102  Applicability.

    Except as provided in 326.7102-1, this subpart applies to all 
acquisitions above the micro-purchase threshold, including simplified 
acquisitions, made by IHS, and any HHS operating or staff divisions or 
agency outside of HHS conducting acquisitions on behalf of IHS.


326.7102-1  Restrictions on the use of the Buy Indian Act.

    (a) IHS may not use the authority of the Buy Indian Act and the 
procedures contained in this subpart to award intergovernmental 
contracts to Tribal organizations to plan, operate, or administer 
authorized IHS programs (or parts thereof) that are within the scope 
and intent of the Indian Self-Determination and Education Assistance 
Act (ISDEAA) (Pub. L. 93-638). IHS must use the Buy Indian Act solely 
to award procurement contracts to IEEs. Contracts subject to ISDEAA are 
not covered under the FAR and are codified separately under 25 CFR part 
900 and 42 CFR part 137.
    (b) Contract health services (referred to administratively as 
Purchased/Referred Care services) are defined at 25 U.S.C. 1603 as 
excluding services provided by Buy Indian Act contractors. Accordingly, 
the Buy Indian Act may not be used to obtain services through the 
Purchased/Referred Care program (previously Contract Health Services). 
Purchase orders for care authorized pursuant to 42 CFR part 136, 
subpart C, may be issued without regard to the provisions of this 
subpart.


326.7103  Policy.


326.7103-1  Requirement to give preference to Indian Economic 
Enterprises.

    (a) Except as provided by 25 U.S.C. 1633, IHS must use the 
negotiation authority of the Buy Indian Act to give preference to IEEs 
whenever the use of that authority is practicable. Thus, IHS may use 
the Buy Indian Act to give preference to IEEs through set-asides when 
acquiring supplies, general services, architect-engineer (A-E) 
services, or construction to meet IHS needs and requirements. The Buy 
Indian Act does not apply when mandatory government sources are 
available, as required by FAR 8.002.
    (b) Contract awards under the authority of the Buy Indian Act can 
be pursued via the acquisition procedures prescribed in this subpart in 
conjunction with the procedures from FAR parts 12, 13, 14, 15 and/or 
16.
    (c) The contracting officer will give priority to ISBEEs for all 
purchases, regardless of dollar value, by utilizing ISBEE set-aside to 
the maximum extent possible. Contracting officers when prioritizing 
ISBEEs may consider either--
    (1) A set-aside for ISBEEs; or
    (2) A sole source award to an ISBEE, as authorized under the FAR.
    (d) If the contracting officer determines after market research 
that there is no reasonable expectation of obtaining offers from two or 
more ISBEEs that will be competitive in terms of market price, product 
quality, and delivery capability, the contracting officer may consider 
either--
    (1) A set-aside for IEEs; or
    (2) A sole source award to an IEE, as authorized under the FAR.
    (e) If the contracting officer determines after market research 
that there is no reasonable expectation of obtaining two or more offers 
that will be competitive in terms of market price, product quality, and 
delivery capability, from ISBEEs and/or IEEs, then the contracting 
officer shall follow the Deviation process under 326.7103-3.
    (f) Price analysis technique(s) provided in FAR 15.404-1(b) shall 
be used in determination of price fair and reasonableness when only one 
offer is received from a responsible ISBEE or IEE in response to an 
acquisition set-aside under paragraph (c)(1) or (d)(1) of this section:
    (1) If the offer meets the technical capability requirements and is 
not at a reasonable and fair market price, then the contracting officer 
may negotiate with that enterprise for a reasonable and fair market 
price, as authorized under the FAR.
    (2) If the offer meets the technical capability requirements and is 
at a reasonable and fair market price, then the contracting officer 
must--
    (i) Make an award to that enterprise;
    (ii) Document the reason only one offer was considered; and
    (iii) Initiate action to increase competition in future 
solicitations.
    (g) If the offers received in response to an acquisition set-aside 
under paragraph (c) or (d) of this section are determined to be 
unreasonable or otherwise unacceptable upon price and/or technical 
evaluations, then the contracting officer must follow the Deviation 
process under 326.7103-3. The contracting officer must document in the 
deviation determination the reasons why the IEE offeror(s) were not 
reasonable or otherwise unacceptable.
    (1) If a deviation determination is approved, the contracting 
officer must cancel the current ISBEE or IEE set-aside solicitation and 
inform all offerors in writing.
    (2) If a deviation determination is approved, the contracting 
officer must identify, based on current available market research, an 
alternate set-aside or procurement method.
    (3) When the solicitation of the same requirement is posted, the 
contracting

[[Page 80682]]

officer must inform all previous offerors in writing of the 
solicitation number.
    (h) With respect to construction, the provisions of 25 U.S.C. 1633 
shall apply. Under 25 U.S.C. 1633, IHS may give a preference to an IEE 
unless the agency finds, after considering the evaluation criteria 
listed in 25 U.S.C. 1633, that the project to be contracted for will 
not be satisfactory or cannot be properly completed or maintained under 
the proposed contract.


326.7103-2  Delegations and responsibility.

    (a) The Director, IHS--exercises the authority of the Buy Indian 
Act pursuant to the Transfer Act of 1954, as delegated pursuant to 25 
U.S.C. 1661. Under 25 U.S.C. 1661, the Director is authorized to enter 
into contracts for the procurement of goods and services to carry out 
the functions of the IHS. IHS exercises this authority in support of 
its mission and program activities and as a means of fostering Indian 
employment and economic development.
    (b) The IHS HCA is responsible for ensuring that all IHS 
acquisitions under the Buy Indian Act comply with the requirements of 
this subpart.


326.7103-3  Deviations.

    (a) There are certain instances where the application of the Buy 
Indian Act to an acquisition may not be appropriate. In these 
instances, the contracting officer must detail the reasons in writing 
or via email and make a deviation determination.
    (b) Some acquisitions by their very nature would make such a 
written determination unnecessary. For example, any order or call 
placed against an indefinite delivery vehicle that already has an 
approved deviation from the requirements of the Buy Indian Act.
    (c) Deviation determinations shall be required for all other 
acquisitions where the Buy Indian Act is applicable and must be 
approved as follows:

                        Table 1 to 326.7103-3(c)
------------------------------------------------------------------------
                                            The following official may
     For a proposed contract action           authorize a deviation
------------------------------------------------------------------------
Exceeding the micro-purchase threshold   Contracting Officer.
 and up to $25,000.
Exceeding $25,000 but not exceeding      Chief Contracting Officer (CCO)
 $750,000.                                (or the IHS Division of
                                          Acquisition Policy (DAP)
                                          Director, absent a CCO).
Exceeding $750,000 but not exceeding     IHS Advocate for Competition.
 $15 million.
Exceeding $15 million but not exceeding  Head of Contracting Activity.
 $75 million.
Exceeding $75 million..................  HHS Office of Small &
                                          Disadvantaged Business
                                          Utilization (OSDBU), Office of
                                          the General Counsel (OGC), HHS
                                          Department Advocate for
                                          Competition and the HHS Senior
                                          Procurement Executive.
------------------------------------------------------------------------

    (d) Deviations may be authorized prior to issuing the solicitation 
when the contracting officer makes the following determinations and 
takes the following actions:
    (1) The contracting officer determines after market research that 
there is no reasonable expectation of obtaining offers that will be 
competitive in terms of market price, quality, and delivery from two or 
more responsible ISBEEs or IEEs.
    (2) The deviation determination is authorized by the official 
listed at paragraph (c) of this section for the applicable contract 
action.
    (e) If a deviation determination has been approved, the contracting 
officer must follow the FAR and HHSAR unless specified otherwise.
    (f) Acquisitions made under an authorized deviation from the 
requirements of the Buy Indian Act must be made in conformance with the 
order of precedence required by FAR 8.002.


326.7104  Procedures.


326.7104-1  General.

    All acquisitions under the authority of the Buy Indian Act, must 
conform to all applicable requirements of the FAR and HHSAR.


326.7104-2  Procedures for acquisitions under the Buy Indian Act.

    (a) Each acquisition of commercial products, commercial services 
and construction that is subject to FAR part 12 or 13 must be set-aside 
exclusively for ISBEEs, except as otherwise set forth in this subpart. 
IHS will use ISBEE commercial products and commercial services, or 
simplified acquisition set-asides to accomplish this preference action.
    (b) Commercial products and commercial services, or simplified 
acquisitions under this section must conform to the competition and 
price reasonableness documentation requirements of FAR 12.209 for 
commercial products and commercial services acquisitions and FAR 13.106 
for simplified acquisitions.
    (c) When acquiring construction and architect-engineer (A-E) 
services, solicit proposals and evaluate potential contractors in 
accordance with FAR part 36.
    (d) This paragraph (d) applies to solicitations that are not 
restricted to participation of IEEs.
    (1) If an interested IEE is identified after a solicitation has 
been issued, but before the date established for receipt of offers, the 
contracting office must provide a copy of the solicitation to this 
enterprise. In this case, the contracting officer:
    (i) Will not give preference under the Buy Indian Act to the IEE; 
and
    (ii) May extend the date for receipt of offers when practical.
    (2) If more than one IEE is identified after issuing a 
solicitation, but prior to the date established for receipt of offers, 
the contracting officer may cancel the solicitation and re-compete it 
as an IEE set-aside.


326.7104-3  Debarment and suspension.

    A misrepresentation by an offeror of its status as an IEE, failure 
to notify the contracting officer of any change in IEE status that 
would make the contractor ineligible as an IEE, or any violation of the 
regulations in this subpart by an offeror or an awardee may lead to 
debarment or suspension in accordance with FAR 9.406 and 9.407 and 
309.406 and 309.407.


326.7104-4  Performance and payment bonds.

    Solicitations requiring performance and payment bonds must conform 
to FAR part 28 and authorize use of any of the types of security 
acceptable in accordance with FAR subpart 28.2 or section 11 of Public 
Law 98-449, the Indian Financing Act Amendments of 1984 (25 U.S.C. 
47a). In accordance with FAR 28.102 and 25 U.S.C. 47a, the contracting 
officer may accept alternative forms of security in lieu of performance 
and payment bonds if a determination is made that such forms of 
security provide the Government with adequate security for performance 
and payment.


326.7105  Solicitation provisions and contract clauses.

    (a) The contracting officer shall insert the provision at 352.226-
73, Notice of

[[Page 80683]]

Indian Small Business Economic Enterprise Set-Aside, in solicitations 
for acquisitions that are set-aside to ISBEE concerns under 326.7103-
1(c).
    (b) The contracting officer shall insert the provision at 352.226-
74, Notice of Indian Economic Enterprise Set-Aside, in solicitations 
for acquisitions that are set-aside to IEE concerns in accordance with 
326.7103-1(d).
    (c) The contracting officer shall insert the clause at 352.226-75, 
Indian Economic Enterprise Subcontracting Limitations, in all 
solicitations and contracts when the contract award is to be made under 
the authority of the Buy Indian Act.
    (d) The contracting officer shall insert the provision at 352.226-
76, Indian Economic Enterprise Representation, in all solicitations 
when the contract award is to be made under the authority of the Buy 
Indian Act.
    (e) The contracting officer shall insert the clause at FAR 52.219-
14, Limitations on Subcontracting, as prescribed at FAR 19.507(e), in 
solicitations and contracts for supplies, services, and construction, 
if any portion of the requirement is to be set-aside for ISBEEs and 
IEEs.
    (f) The contracting officer must also insert the clause 352.226-76, 
Indian Economic Enterprise Subcontracting Limitations, in all awards to 
ISBEEs and IEEs pursuant to this subpart.


326.7106  Representation by an Indian Economic Enterprise offeror.


326.7106-1  General.

    (a) The contracting officer must insert the provision at 352.226-
76, Indian Economic Enterprise Representation, in all solicitations 
regardless of dollar value solicited under 326.7103-1(c) or (d) and in 
accordance with this subpart.
    (b) To be considered for an award under 326.7103-1(c) or (d), an 
offeror must--
    (1) Certify that it meets the definition of Indian Economic 
Enterprise in response to a specific solicitation set-aside in 
accordance with the Buy Indian Act and this subpart; and
    (2) Identify the Indian Tribe(s) upon which the offeror relies for 
its IEE status.
    (c) The enterprise must meet the definition of Indian Economic 
Enterprise throughout the following time periods--
    (1) At the time an offer is made in response to a solicitation;
    (2) At the time of contract award; and
    (3) During the full term of the contract.
    (d) If, after award, a contractor no longer meets the eligibility 
requirements as it has certified and as set forth in this section, then 
the contractor must provide the contracting officer with written 
notification within 3 calendar days of its failure to comply with the 
eligibility requirements. The notification must include--
    (1) Full disclosure of circumstances causing the contractor to lose 
eligibility status; and
    (2) A description of actions, if any, that must be taken to regain 
eligibility.
    (e) Failure to maintain eligibility under the Buy Indian Act or to 
provide written notification required by paragraph (d) of this section 
means that--
    (1) The contractor may be declared ineligible for future contract 
awards under this subpart;
    (2) The contracting officer may consider termination for default of 
the ongoing contract; and
    (3) The contracting officer may pursue debarment or suspension of 
the contractor.
    (f) The contracting officer will review the offeror's 
representation that it is an IEE in a specific bid or proposal and 
verify that the Indian Tribe(s) that the offeror identified in the 
representation is either on the List of Federally Recognized Tribes or 
is an Alaska Native Corporation. A contracting officer will also 
investigate the representation if an interested party challenges the 
IEE representation or if the contracting officer has any other reason 
to question the representation. The contracting officer may ask the 
offeror for more information to substantiate the representation. 
Challenges of and questions concerning a specific representation must 
be referred to the contracting officer or CCO in accordance with 
326.7107.
    (g) Participation in the Mentor-Prot[eacute]g[eacute] Program 
established under section 831 of the National Defense Authorization Act 
for Fiscal Year 1991 (25 U.S.C. 47 note) does not render an IEE 
ineligible for contracts awarded under the Buy Indian Act.


326.7106-2  Representation provision.

    (a) Contracting offices must provide copies of the awardees' IEE 
representation to any interested parties upon written request. IHS will 
make awardees' IEE representations available via IHS public sites and/
or other means.
    (b) Any false or misleading information submitted by an enterprise 
when submitting an offer in consideration for an award set-aside under 
the Buy Indian Act may be a violation of the law punishable under 18 
U.S.C. 1001. False claims submitted as part of contract performance may 
be subject to the penalties enumerated in 31 U.S.C. 3729 to 3731 and 18 
U.S.C. 287.
    (c) The contracting officer shall inform the head of the 
contracting activity, in writing, within 10 business days, of all 
suspected IEE misrepresentation by an offeror or failure to provide 
written notification of a change in IEE eligibility. This shall be 
included in the contract file.


326.7106-3  Representation process.

    (a) Only IEEs may participate in acquisitions set-aside in 
accordance with the Buy Indian Act and this subpart. The procedures in 
this subpart are intended to support responsible IEEs and prevent 
circumvention or abuse of the Buy Indian Act.
    (b) The contracting officer shall review the ownership information 
furnished under 352.226-76(b) and verify that the Indian Tribe(s) 
identified is either on the List of Federally Recognized Tribes or is 
an Alaska Native Corporation.
    (c) If the contracting officer cannot verify from the offeror 
submission that the Indian Tribe(s) identified is either on the List of 
Federally Recognized Tribes or is an Alaska Native Corporation, the 
contracting officer must allow the offeror to correct information 
submitted under 352.226-76(b). The contracting officer should make 
every effort to allow the offeror to correct the information. If the 
requirement is time sensitive the contracting officer must specify to 
the offeror the time and date by which a response is required.
    (1) If the contracting officer determines the offeror is not 
responsive, the contracting officer must document the circumstances and 
inform the offeror of the determination.
    (2) The contracting officer may ask the appropriate regional Office 
of the General Counsel to review the IEE representation.
    (3) The IEE representation does not relieve the contracting officer 
of the obligation for determining contractor responsibility, as 
required by FAR subpart 9.1.


326.7107  Challenges to representation.


326.7107-1  Procedure.

    (a) The contracting officer can accept an offeror's written 
representation of being an ISBEE or IEE (as defined in 326.7101) only 
when it is submitted in response to a Sources Sought Notice, Request 
for Information (RFI) or with an offer in response to a solicitation 
under the Buy Indian Act. Another interested party may challenge the 
representation

[[Page 80684]]

of an offeror or awardee by filing a written challenge.
    (b) Upon receipt of the challenge, the contracting officer shall 
re-verify the representation of the offeror or awardee in accordance 
with the requirements of this subpart, including the provisions of 
326.7106.


326.7107-2  Receipt of challenge.

    (a) An interested party must file any challenges against an 
offeror's representation with the cognizant contracting officer.
    (b) The challenge must be in writing and must contain the basis for 
the challenge with accurate, complete, specific, and detailed evidence. 
The evidence must support the allegation that the offeror fails to meet 
the definition of Indian Economic Enterprise or Indian Small Business 
Economic Enterprise as defined in 326.7101 or is otherwise ineligible. 
The contracting officer will dismiss any challenge that is deemed 
frivolous or that does not meet the conditions in this section.
    (c) To be considered timely, a challenge must be received by the 
contracting officer no later than 10 calendar days after the basis of 
challenge is known or should have been known, whichever is earlier.
    (1) A challenge may be made orally if it is confirmed in writing 
within the 10-day period after the basis of challenge is known or 
should have been known, whichever is earlier.
    (2) A written challenge may be delivered by hand, email, or letter 
postmarked within the 10-day period after the basis of challenge is 
known or should have been known, whichever is earlier.
    (3) A contracting officer's challenge to a certification is always 
considered timely, whether filed before or after award.
    (d) Upon receiving a timely challenge, the contracting officer 
must:
    (1) Notify the challenger of the date it was received, and that the 
representation of the enterprise being challenged is under 
consideration; and
    (2) Furnish to the offeror (whose representation is being 
challenged) a request to provide detailed information on its 
eligibility by certified mail, return receipt requested or email.
    (e) Within 3 calendar days after receiving a copy of the challenge 
and the contracting officer's request for detailed information, the 
challenged offeror must file, as specified at paragraph (d)(2) of this 
section, with the contracting officer a complete statement answering 
the allegations in the challenge and furnish evidence to support its 
position on representation. If the offeror does not submit the required 
material within the 3 calendar days, or another period of time granted 
by the contracting officer, the contracting officer may assume that the 
offeror does not intend to dispute the challenge and must not award to 
the challenged offeror.
    (f) Within 10 calendar days after receiving a challenge, the 
challenged offeror's response, and any other pertinent information, the 
contracting officer must determine the representation status of the 
challenged offeror and notify the challenger and the challenged offeror 
of the decision by certified mail, return receipt requested or email, 
and make known to all parties the option to appeal the determination to 
IHS DAP.
    (g) If the representation accompanying an offer is challenged and 
subsequently upheld by DAP, the written notification of this action 
must state the reason(s).


326.7107-3  Award in the face of challenge.

    (a) Award of a contract in the face of challenge only may be made 
on the basis of the contracting officer's written determination that 
the challenged offeror's representation is valid.
    (1) This determination is final unless it is appealed to DAP, and 
the contracting officer is notified of the appeal before award.
    (2) If an award was made before the contracting officer received 
notice of appeal, the contract is presumed to be valid.
    (b) After receiving a challenge involving an offeror being 
considered for award, the contracting officer must not award the 
contract until the contracting officer has determined the validity of 
the representation. Award may be made in the face of a timely challenge 
when the contracting officer determines in writing that an award must 
be made to protect the public interest, is urgently required, or a 
prompt award will otherwise be advantageous to the Government.
    (c) If a timely challenge on representation is filed with the 
contracting officer and received before award in response to a specific 
offer and solicitation, the contracting officer must notify eligible 
offerors within one day that the award will be withheld. The 
contracting officer also may ask eligible offerors to extend the period 
for acceptance of their proposals.
    (d) If a challenge on representation is filed with the contracting 
officer and received after award in response to a specific offer and 
solicitation, the contracting officer need not suspend contract 
performance or terminate the awarded contract unless the contracting 
officer believes that an award may be invalidated, and a delay would 
prejudice the Government's interest. However, if contract performance 
is to be suspended, the contracting officer would follow those 
guidelines as outlined in FAR part 49.


326.7107-4  Challenge not timely.

    If a contracting officer receives an untimely filed challenge of a 
representation, the contracting officer must notify the challenger that 
the challenge cannot be considered on the instant acquisition but will 
be considered in any future actions. However, the contracting officer 
may question at any time, before or after award, the representation of 
an IEE.

Subpart 326.72--Acquisitions Requiring the Native American Graves 
Protection and Repatriation Act


326.7200  Scope of subpart.

    Public Law 101-601, dated November 16, 1990, also known as the 
Native American Graves Protection and Repatriation Act, imposes certain 
responsibilities on individuals and organizations when they discover 
Native American cultural items (including human remains) on Federal or 
Tribal lands.


326.7201  Contract clauses.

    The contracting officer shall insert the clause at 352.226-72, 
Native American Graves Protection and Repatriation Act, in 
solicitations, contracts, and orders requiring performance on Tribal 
lands or those for construction projects on Federal or Tribal lands.
0
14. Revise subchapter E to read as follows:
SUBCHAPTER E--GENERAL CONTRACTING REQUIREMENTS
PART 327 PATENTS, DATA, AND COPYRIGHTS
PARTS 328-329 [RESERVED]
PART 330 COST ACCOUNTING STANDARDS ADMINISTRATION
PART 331 CONTRACT COST PRINCIPLES AND PROCEDURES
PART 332 CONTRACT FINANCING
PART 333 PROTESTS, DISPUTES, AND APPEALS

PART 327--PATENTS, DATA, AND COPYRIGHTS

Subpart 327.3--Patent Rights Under Government Contracts
Sec.
327.303-70 Contract clause.
Subpart 327.4--Rights in Data and Copyrights
327.409-70 Contract clauses.


[[Page 80685]]


    Authority:  5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 
1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 327.3--Patent Rights Under Government Contracts


327.303-70  Contract clause.

    The contracting officer shall insert the clause at 352.227-70, 
Patent Rights--Supplement--Exceptional Circumstances, in solicitations, 
contracts, and orders that include the clause at FAR 52.227-11, Patent 
Rights--Ownership by the Contractor, and a Determination of Exceptional 
Circumstances (DEC) involving the provision of materials has been 
executed and Agency policies and procedures prescribe its use.

Subpart 327.4--Rights in Data and Copyrights


327.409-70  Contract clauses.

    (a) The contracting officer shall insert the clause at 352.227-71, 
Rights in Data--Supplement--Exceptional Circumstances, in 
solicitations, contracts, and orders that include the clause at FAR 
52.227-14, Rights in Data-General, a Determination of Exceptional 
Circumstances (DEC) has been executed and agency policies and 
procedures prescribe its use.
    (b) The contracting officer shall insert the clause at 352.227-72, 
Publications and Publicity, in solicitations, contracts, and orders 
involving requirements which could lead to the contractor publishing 
the results of its work under the contract.

PARTS 328-329 [RESERVED]

PART 330--COST ACCOUNTING STANDARDS

Subpart 330.2--CAS Program Requirements
Sec.
330.201 Contract requirements.
330.201-5 Waiver.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 
41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 330.2--CAS Program Requirements


330.201  Contract requirements.


330.201-5  Waiver.

    The Senior Procurement Executive is authorized to exercise the 
waiver authority under FAR 30.201-5(a)(1) when the conditions at FAR 
30.201-5(a)(1) are met. This authority cannot be redelegated.

PART 331--CONTRACT COST PRINCIPLES AND PROCEDURES

Subpart 331.1--Applicability
Sec.
331.170 Salary rate limitation.
331.171 Contract clause.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 
41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 331.1--Applicability


331.170  Salary rate limitation.

    Congress has stipulated in the Department of Health and Human 
Services appropriations acts and continuing resolutions that, under 
certain contracts (and subcontracts thereunder), appropriated funds 
cannot be used to pay the direct salary of an individual above the 
Rates of Basic Pay for the Executive Schedule (EX), Level II, contained 
on the Office of Personnel Management website. The applicable rates for 
each year are identified in the EX Salary Table found at www.opm.gov.


331.171  Contract clause.

    The contracting officer shall insert the clause at 352.231-70, 
Salary Rate Limitation, in solicitations and contracts when a cost-
reimbursement, fixed-price level-of-effort, time-and-materials, or 
labor-hour contract is contemplated.

PART 332--CONTRACT FINANCING

Sec.
332.006 Reduction or suspension of contract payments upon finding of 
fraud.
332.006-1 General.
332.006-4 Procedures.
Subpart 332.2--Commercial Product and Commercial Service Purchase 
Financing
332.202 General.
Subpart 332.4--Advance Payments for Other Than Commercial Acquisitions
332.402 General.
Subpart 332.5--Progress Payments Based on Costs
332.501 General.
332.501-2 Unusual progress payments.
Subpart 332.7--Contract Funding
332.703 Contract funding requirements.
332.703-1 General.
332.703-70 Incrementally funded cost-reimbursement contracts.
332.703-71 Incremental funding table.
332.706 Contract clauses.
332.706-2 Clauses for limitation of cost or funds.
Subpart 332.70--Electronic Submission and Processing of Payment 
Requests
332.7000 Scope of subpart.
332.7001 Definition.
332.7002 Policy.
332.7003 Contract clause.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 
41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.


332.006  Reduction or suspension of contract payments upon finding of 
fraud.


332.006-1  General.

    (b) The Senior Procurement Executive (SPE) is authorized to make 
the determination there is substantial evidence that a contractor's 
request for advance, partial, or progress payments is based on fraud, 
and may direct further payments to the contractor be reduced or 
suspended, in accordance with FAR 32.006. This authority may not be 
redelegated.


332.006-4  Procedures.

    (b) The Remedy Coordination Official (RCO) for HHS is the SPE, who 
shall carry out the responsibilities in FAR 32.006-4(b).
    (e) The RCO shall carry out the responsibilities of the agency head 
in FAR 32.006-4(e) to notify the contractor of the reasons for the 
recommended action and of its right to submit information within a 
reasonable period of time in response to the proposed action under FAR 
32.006.
    (1) The notice of proposed action will be sent to the last known 
address of the contractor, the contractor's counsel, or agent for 
service of process, by certified mail, return receipt requested, or any 
other method that provides signed evidence of receipt. In the case of a 
business, the notice of proposed action may be sent to any partner, 
principal, officer, director, owner or co-owner, or joint venture. The 
contractor will be afforded an opportunity to appear before the RCO to 
present information or argument in person or through a representative 
and may supplement the oral presentation with written information and 
argument.
    (2) The proceedings will be conducted in an informal manner and 
without the requirement for a transcript. If the RCO does not receive a 
reply from the contractor within 30 calendar days, the RCO will base 
his or her recommendations on the information available. Any 
recommendation of the RCO under FAR 31.006-4(a) and paragraph (b) of 
this section, must address the results of this notification and the 
information, if any, provided by the contractor. After reviewing all 
the information, the RCO shall make a determination whether or not 
substantial evidence of fraud exists.
    (g) In addition to following the procedures in FAR 32.006-4, the 
SPE shall provide a copy of each final determination and the supporting 
documentation to the contractor, the

[[Page 80686]]

RCO, the contracting officer, and the HHS Office of the Inspector 
General (OIG). The contracting officer will place a copy of the 
determination and the supporting documentation in the contract file.

Subpart 332.2--Commercial Product and Commercial Service Purchase 
Financing


332.202  General.

    The SPE is authorized to approve actions for commercial item 
purchase financing pursuant to FAR 32.202.

Subpart 332.4--Advance Payments for Other Than Commercial 
Acquisitions


332.402  General.

    (e) The head of the contracting activity (HCA) is authorized to 
make determinations related to advanced payments and shall ensure 
compliance with FAR 32.402. This authority may not be redelegated.

Subpart 332.5--Progress Payments Based on Costs


332.501  General.


332.501-2  Unusual progress payments.

    (a)(3) The HCA is authorized to approve unusual progress payments. 
This authority may not be redelegated.

Subpart 332.7--Contract Funding


332.703  Contract funding requirements.


332.703-1  General.

    (b) The following requirements govern all solicitations and 
contracts using incremental funding, as appropriate:
    (1) The contracting officer shall consider the estimated total cost 
of the contract, including all planned increments of performance when 
determining the requirements that must be met before contract execution 
(e.g., Justification and Approvals, clearances, and approvals).
    (2) The solicitation and resultant contract shall include a 
statement of work or performance work statement that describes the 
total project, covers all proposed increments of performance, and 
contains a schedule of planned increments of performance. No funding 
increment may exceed 1 year, and the services rendered during each 
increment of performance must provide a specific material benefit that 
can stand alone if the remaining effort is not funded. The resultant 
contract shall also include the corresponding amount of funds planned 
for obligation for each increment of performance.
    (3) The contracting officer shall request that offerors respond to 
the solicitation with technical and cost proposals for the entire 
project, and shall require distinct technical and cost break-outs of 
the planned increments of performance.
    (4) Proposals shall be evaluated, and any discussions and 
negotiations shall be conducted based upon the total project, including 
all planned increments of performance.


332.703-70  Incrementally funded cost-reimbursement contracts.

    Incremental funding may be used in cost-reimbursement contracts for 
severable services only when all of the following circumstances are 
present:
    (a) Funding of increments after the initial increment of 
performance is provided from the appropriation account available for 
obligation at that time;
    (b) The project represents a bona fide need of the fiscal year in 
which the contract is awarded and initially funded (i.e., the initial 
increment of performance) and is also a bona fide need of each 
subsequent fiscal year whose appropriation will be used; and
    (c) The project's significance provides reasonable assurance that 
subsequent year appropriations will be made available to fund the 
project's continuation and completion.


332.703-71  Incremental funding table.

    (a) The contracting officer shall insert substantially the language 
in figure 1 to this section in ``Section B: Supplies or Services and 
Prices or Costs,'' ``Table 1,'' in all cost-reimbursement contracts for 
severable services using incremental funding. The language requires the 
contracting officer to:
    (1) Insert the initial funding obligated by the award;
    (2) Identify the increment of performance covered by the funding 
provided; and
    (3) Specify the start and end dates for each increment of 
performance, as required by the ``Limitation of Funds'' clause at FAR 
52.232-22.
    (b) Modification of the language is permitted to fit specific 
circumstances of the contract, including but not limited to language 
necessary to reflect the specific type of cost reimbursement contract 
awarded, but the language may not be omitted completely.

Figure 1 to 332.703-71--Incremental Funding Table

Table 1-B. Estimated Cost--Incrementally Funded Contract

    (a) The total estimated cost to the Government for full performance 
of this contract, including all allowable direct and indirect costs, is 
$__[insert full amount].
    (b) The following represents the schedule* by which the Government 
expects to allot funds to this contract:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Start date of    End date of                                         Estimated cost
                CLIN, task number, or description                  increment of    increment of   Estimated cost      Fee ($) (as      plus fee  ($) (as
                                                                    performance     performance         ($)          appropriate)        appropriate)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  ..............  ..............         [Total]             [Total]             [Total]
--------------------------------------------------------------------------------------------------------------------------------------------------------

    * To be inserted after negotiation
    (c) Total funds currently obligated and available for payment under 
this contract are $__[insert amount funded to date].
    (d) The contracting officer may issue unilateral modifications to 
obligate additional funds to the contract and make related changes to 
paragraphs (b) and/or (c) above.
    (e) Until this contract is fully funded, the requirements of the 
clause at FAR 52.232-22, Limitation of Funds, shall govern. Once the 
contract is fully funded, the requirements of the clause at FAR 52.232-
20, Limitation of Cost, govern.


332.706  Contract clauses.


332.706-2  Clauses for limitation of cost or funds.

    (b) In addition to the clause at FAR 52.232-22, Limitation of 
Funds, the contracting officer shall insert the provision at 352.232-
70, Incremental Funding, in all solicitations when a cost-reimbursement 
contract for severable services using incremental funding is 
contemplated. The provision requires the contracting officer to insert 
a specific increment of performance that the initial funding is 
expected to cover.

[[Page 80687]]

Subpart 332.70--Electronic Submission and Processing of Payment 
Requests


332.7000  Scope of subpart.

    This subpart prescribes policies and procedures for electronic 
submission and processing of payment requests.


332.7001  Definition.

    As used in this subpart, payment request means a bill, voucher, 
invoice, or request for contract financing payment with associated 
supporting documentation. The payment request must comply with the 
requirements identified in FAR 32.905(b) and the applicable Payment 
clause included in the contract.


332.7002  Policy.

    (a) Contracts shall require the electronic submission of payment 
requests, except for--
    (1) Purchases paid for with a Governmentwide commercial purchase 
card; and
    (2) Classified contracts or purchases when electronic submission 
and processing of payment requests could compromise classified 
information or national security.
    (b) Where a contract otherwise requires the electronic submission 
of invoices, the contracting officer may authorize alternate procedures 
only if the contracting officer makes a written determination that--
    (1) The Department of Health and Human Services (HHS) is unable to 
receive electronic payment requests or provide acceptance 
electronically;
    (2) The contractor has demonstrated that electronic submission 
would be unduly burdensome; or
    (3) The contractor is in the process of transitioning to electronic 
submission of payment requests but needs additional time to complete 
such transition. Authorizations granted on the basis of this paragraph 
(b)(3) must specify a date by which the contractor will transition to 
electronic submission.
    (c) Except as provided in paragraphs (a) and (b) of this section, 
HHS officials shall process electronic payment submissions through the 
Department of the Treasury Invoice Processing Platform or successor 
system.
    (d) If the requirement for electronic submission of payment 
requests is waived under paragraph (a)(2) or (b) of this section, the 
contract or alternate payment authorization, as applicable, shall 
specify the form and method of payment request submission.


332.7003  Contract clause.

    Except as provided in 332.7002(a), use the clause at 352.232-71, 
Electronic Submission of Payment Requests, in all solicitations and 
contracts, unless an exception at 332.7002(a) or (b) applies.

PART 333--PROTESTS, DISPUTES, AND APPEALS

Subpart 333.1--Protests

Sec.
333.102 General.
333.103 Protests to the agency.
333.103-70 Procedures--protests to HHS.
333.103-71 Agency action on specific protests.
Subpart 333.2--Disputes and Appeals
333.201 Definitions.
333.203 Applicability.
333.209 Suspected fraudulent claims.
333.214 Alternative dispute resolution (ADR).
333.215-70 Contract clauses.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 
41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 333.1--Protests


333.102  General.

    The Office of General Counsel-General Law Division serves as the 
liaison for protests lodged with the Government Accountability Office 
(GAO), is designated as the office responsible for all protests within 
the Department of Health and Human Services and serves as the 
notification point with GAO for all protests.


333.103  Protests to the agency.

    (f)(1) The contracting officer prepares the determination pursuant 
to FAR 33.103(f)(1), to award a contract notwithstanding the protest. 
The contracting activity's designated protest official, in consultation 
with the cognizant HHS legal office, may approve the determination 
subject to the procedures in 333.103-70.


333.103-70  Procedures--protests to HHS.

    (a) Agency protests. Pursuant to FAR 33.103(d)(4), an interested 
party may protest to the contracting officer or, as an alternative, may 
request an independent review at a level above the contracting officer 
as provided in this section. An interested party may also appeal to HHS 
a contracting officer's decision on a protest.
    (1) Protests to the contracting officer. Protests to the 
contracting officer shall be in writing and shall be addressed where 
the offer/bid is to be submitted or as indicated in the solicitation.
    (2) Independent review or appeal of a contracting officer 
decision--protest filed directly with the agency. Protests requesting 
an independent review one level above the contracting officer and 
appeals within HHS to a designated official above the level of the 
contracting officer, shall be addressed to the applicable designated 
official specified, and as instructed, in the solicitation.
    (b) Pending protests filed with contracting officer not considered. 
An independent review of a protest filed pursuant to paragraph (a)(2) 
of this section will not be considered if the interested party has a 
protest on the same or similar issues pending with the contracting 
officer.


333.103-71  Agency actions on specific protests.

    (a) Agency actions on specific types of protests. The following 
types of protests may be dismissed without consideration of the merits 
or may be forwarded to another agency for appropriate action:
    (1) Contract administration. Disputes between a contractor and HHS 
are resolved under the disputes clause (see the Dispute statute, 41 
U.S.C. chapter 71).
    (2) Small business size standards and standard industrial 
classification. Challenges of established size standards, ownership and 
control, or the size status of particular firm, and challenges of the 
selected standard industrial classification are for review solely by 
the Small Business Administration (SBA) (see 15 U.S.C. 637(b)(6); 13 
CFR 121.1002).
    (3) Small business certificate of competency program. A protest 
made under section 8(b)(7) of the Small Business Act, or in regard to 
any issuance of a certificate of competency or refusal to issue a 
certificate under that section, is not reviewed in accordance with bid 
protest procedures unless there is a showing of possible fraud or bad 
faith on the part of Government officials.
    (4) Decision not to set-aside under section 8(a) of the Small 
Business Act. The decision to place or not to place a procurement under 
the 8(a) program is not subject to review unless there is a showing of 
possible fraud or bad faith on the part of Government officials or that 
regulations may have been violated (see 15 U.S.C. 637(a)).
    (5) Affirmative determination of responsibility by the contracting 
officer. An affirmative determination of responsibility will not be 
reviewed unless there is a showing that such determination was made 
fraudulently or in bad faith or that definitive responsibility criteria 
in the solicitation were not met.
    (6) Contracts subject to FAR subpart 22.6. Challenges concerning 
the legal status of a firm as a regular dealer or manufacturer within 
the meaning of 41

[[Page 80688]]

U.S.C. chapter 65 are determined solely by the procuring agency, the 
SBA (if a small business is involved), and the Secretary of Labor (see 
FAR subpart 22.6).
    (7) Subcontractor protests. The contracting agency will not 
consider subcontractor protests except where HHS determines it is in 
the interest of the Government.
    (8) Judicial proceedings. The contracting agency will not consider 
protests where the matter involved is the subject of litigation before 
a court of competent jurisdiction.
    (b) Alternative dispute resolution. Bidders/offerors and HHS 
contracting officers are encouraged to use alternative dispute 
resolution (ADR) procedures to resolve protests at any stage in the 
protest process. If ADR is used, HHS will not furnish any documentation 
in an ADR proceeding beyond what is required by FAR 33.103.

Subpart 333.2--Disputes and Appeals


333.201  Definitions.

    Agency board of contract appeals for HHS means the Civilian Board 
of Contract Appeals (CBCA) (see https://cbca.gov).


333.203  Applicability.

    (c) The CBCA is the authorized board to hear and determine disputes 
for the Department. All filings must be submitted to the Clerk of the 
Board. Filings may be made in the following ways and the board's 
address for each method of filing is as follows (the public should 
verify current operating procedures and delivery instructions with the 
CBCA, found at https://cbca.gov/howto/filing.html#where):
    (1) In person or by courier: These filings should be made in the 
Clerk's office, located in room 6006, 6th Floor, of 1800 M Street NW, 
Washington, DC 20036. Check with the Clerk of the Board for any impacts 
due to national emergencies or other exigent circumstances to confirm 
whether in-person deliveries are accepted.
    (2) By United States Postal Service mail: 1800 F Street NW, 
Washington, DC 20405.
    (3) By facsimile transmission: These filings should be sent to the 
Clerk at (202) 606-0019.
    (4) By electronic mail (e-file): [email protected]. Specific e-
file instructions and prohibitions can be found at https://cbca.gov/howto/efiling.html.


333.209  Suspected fraudulent claims.

    The contracting officer shall submit any instance of a contractor's 
suspected fraudulent claim to the Office of Inspector General for 
investigation and potential referral to the Department of Justice 
through the head of the contracting activity (HCA).


333.214  Alternative dispute resolution (ADR).

    Contracting officers and contractors are encouraged to use 
alternative dispute resolution (ADR) procedures. Guidance on ADR may be 
obtained at the U.S. Civilian Board of Contract Appeals website at 
https://www.cbca.gsa.gov.


333.215-70  Contract clauses.

    (a) The contracting officer shall insert the clause at 352.233-70, 
Choice of Law (Overseas), in solicitations and contracts when 
performance will be outside the United States, its possessions, and 
Puerto Rico, except as otherwise provided in a government-to-government 
agreement.
    (b) The contracting officer shall insert the clause at 352.233-71, 
Litigation and Claims, in solicitations and contracts when a cost-
reimbursement, time-and-materials, or labor-hour contract is 
contemplated (other than a contract for a commercial product or 
commercial service).
0
15. Revise parts 334 through 337 to read as follows:
* * * * *
PART 334 MAJOR SYSTEM ACQUISITION
PART 335 RESEARCH AND DEVELOPMENT CONTRACTING
PART 336 CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS
PART 337 SERVICE CONTRACTING
* * * * *

PART 334--MAJOR SYSTEM ACQUISITION

Subpart 334.2--Earned Value Management System

Sec.
334.201 Policy.
334.202 Integrated Baseline Reviews.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 
41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 334.2--Earned Value Management System


334.201  Policy.

    The Department of Health and Human Services applies the earned 
value management system (EVMS) requirement as follows:
    (a) For cost or incentive contracts and subcontracts valued at $20 
million or more, the contractor's earned value management system shall 
comply with the guidelines in the American National Standards 
Institute/Electronic Industries Alliance Standard 748, Earned Value 
Management Systems (ANSI/EIA-748).
    (b) For cost or incentive contracts and subcontracts valued at $50 
million or more, the contractor shall have an EVMS that has been 
determined by the cognizant Federal agency to be in compliance with the 
guidelines in ANSI/EIA-748.
    (c) For cost or incentive contracts and subcontracts valued at less 
than $20 million--
    (1) The application of earned value management is optional at the 
discretion of the program/project manager and is a risk-based decision 
that must be supported by a cost/benefit analysis; and
    (2) A decision to apply earned value management shall be documented 
in the contract file.
    (d) For firm-fixed-price contracts and subcontracts of any dollar 
value the application of earned value management is discouraged.


334.202  Integrated Baseline Reviews.

    (a) An Integrated Baseline Review (IBR) is usually conducted as a 
post-award activity when an EVMS is required in accordance with FAR 
34.201(a). A pre-award IBR may be conducted only if--
    (1) The acquisition plan contains documentation that demonstrates 
the need and rationale for a pre-award IBR, including an assessment of 
the impact on the source selection schedule and the expected benefits;
    (2) The use of a pre-award IBR is approved in writing by the head 
of the contracting activity prior to the issuance of the solicitation;
    (3) The source selection plan and solicitation specifically address 
how the results of a pre-award IBR will be used during source 
selection, including any weight to be given to it in source evaluation; 
and
    (4) Specific arrangements are made, and budget authority is 
provided, to compensate all offerors who prepare for or participate in 
a pre-award IBR; and the solicitation informs prospective offerors of 
the means for and conditions of such compensation.

PART 335--RESEARCH AND DEVELOPMENT CONTRACTING

Sec.
335.070 Cost-sharing.
335.070-1 Policy.
335.070-2 Amount of cost-sharing.
335.070-3 Method of cost-sharing.


[[Page 80689]]


    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 
41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.


335.070  Cost-sharing.


335.070-1  Policy.

    (a) Contracting activities should encourage contractors to 
contribute to the cost of performing research and development (R&D), 
through the use of cost-sharing contracts, where there is a probability 
that the contractor will receive present or future benefits from 
participation as described in Federal Acquisition Regulation (FAR) 
16.303. Examples include increased technical know-how, training for 
employees, acquisition of goods or services, development of a 
commercially viable product that can be sold in the commercial market 
and use of background knowledge in future contracts. Cost-sharing is 
intended to serve the mutual interests of the Government and its 
contractors by helping to ensure efficient utilization of the resources 
available for the conduct of R&D projects and by promoting sound 
planning and prudent fiscal policies of the contractor.
    (b) The contracting officer should use a cost-sharing contract for 
R&D contracts unless the contracting officer determines that a request 
for cost-sharing would not be appropriate.


335.070-2  Amount of cost-sharing.

    When cost-sharing is appropriate, the contracting officer shall use 
the following guidelines to determine the amount of cost participation 
by the contractor:
    (a) The amount of cost participation depends on the extent to which 
the R&D effort or results are likely to enhance the contractor's 
capability, expertise, or competitive position, and the value of this 
enhancement to the contractor. Therefore, contractor cost participation 
could reasonably range from as little as one percent or less of the 
total project cost to more than 50 percent of the total project cost. 
Ultimately, cost-sharing is a negotiable item. As such, the amount of 
cost-sharing shall be proportional to the anticipated value of the 
contractor's gain.
    (b) If the contractor will not acquire title to, or the right to 
use, inventions, patents, or technical information resulting from the 
R&D project, it is normally appropriate to obtain less cost-sharing 
than in cases in which the contractor acquires these rights.
    (c) If the R&D is expected to be of only minor value to the 
contractor, and if a statute does not require cost-sharing, it may be 
appropriate for the contractor to make a contribution in the form of a 
reduced fee or profit rather than sharing costs of the project. 
Alternatively, a limitation on indirect cost rates might be appropriate 
(see FAR 16.303 and 42.707).
    (d) The contractor's participation may be considered over the total 
term of the project, so that a relatively high contribution in one year 
may be offset by a relatively low contribution in another. Care must be 
exercised that the intent to cost-share in future years does not become 
illusory. Redetermination of the cost sharing arrangement might be 
appropriate depending on future circumstances.
    (e) A relatively low degree of cost-sharing may be appropriate if 
an area of R&D requires special stimulus in the national interest.


335.070-3  Method of cost-sharing.

    Cost-sharing on individual contracts may be accomplished either by 
a contribution of part or all of one or more elements of allowable cost 
of the work being performed or by a fixed amount or stated percentage 
of the total allowable costs of the project. Contractors shall not 
charge costs contributed to the Government under any other instrument 
(e.g., grant or contract), including allocations to other instruments 
as part of any independent R&D program.

PART 336--CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS

Subpart 336.2--Special Aspects of Contracting for Construction

Sec.
336.203 Government estimate of construction costs.
336.204 Disclosure of the magnitude of construction projects.
Subpart 336.5--Contract Clauses
336.570 Contract clause.

    Authority:  5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 
1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 336.2--Special Aspects of Contracting for Construction


336.203  Government estimate of construction costs.

    (a) The Government estimate must be designated ``CUI Controlled by: 
HHS, [OPDIV/STAFFDIV]'' unless the nature of the information therein 
requires a security classification or other classification, in which 
event it shall be handled in accordance with applicable security 
regulations. The ``CUI Controlled by: HHS, [OPDIV/STAFFDIV]'' 
designation, or other classification, must be removed only when the 
estimate is made public in accordance with the instructions in 
paragraphs (b) and (c) of this section.
    (b) If the acquisition is by sealed bidding, a sealed copy of the 
detailed Government estimate must be filed with the bids until bid 
opening. After the bids are read and recorded, the ``CUI Controlled by: 
HHS, [OPDIV/STAFFDIV]'' designation, or other classification, must be 
removed and the estimate read and recorded in the same detail as the 
bids.
    (c) If the acquisition is by negotiation, the following procedures 
apply:
    (1) The overall amount of the Government estimate must not be 
disclosed prior to award;
    (2) At the time of award, the ``CUI Controlled by: HHS, [OPDIV/
STAFFDIV]'' designation, or other classification, on the Government 
estimate must be removed; and
    (3) After award, the Government estimate may be revealed, upon 
request, at the discretion of the contracting officer.


336.204  Disclosure of the magnitude of construction projects.

    The contracting officer shall utilize the estimated price ranges 
defined in FAR 36.204(a) through (e) as further supplemented by 
paragraphs (f) through (h) of this section when identifying the 
magnitude of an HHS project in advance notices and solicitations:
    (f) For estimated price ranges between $1,000,000 and $5,000,000, 
the contracting officer shall identify the magnitude of an HHS project 
in advance notices and solicitations in terms of the following price 
ranges:
    (1) Between $1,000,000 and $2,000,000.
    (2) Between $2,000,000 and $5,000,000.
    (g) Between $5,000,000 and $10,000,000.
    (h) For estimated price ranges greater than $10,000,000, the 
contracting officer shall identify the magnitude of an HHS project in 
advance notices and solicitations in terms of one of the following 
price ranges:
    (1) Between $10,000,000 and $20,000,000.
    (2) Between $20,000,000 and $50,000,000.
    (3) Between $50,000,000 and $100,000,000.
    (4) Between $100,000,000 and $150,000,000.
    (5) Between $150,000,000 and $200,000,000.
    (6) Between $200,000,000 and $250,000,000.
    (7) More than $250,000,000.

[[Page 80690]]

Subpart 336.5--Contract Clauses


336.570  Contract clause.

    (a) The contracting officer shall insert the clause at 352.236-70, 
Design-Build Contracts, in all solicitations and contracts for design-
build requirements.
    (b) The contracting officer shall use Alternate I to the clause at 
352.236-70, Design-Build Contracts, in all solicitations and contracts 
for construction when fast-track procedures are being used.

PART 337--SERVICE CONTRACTING

Subpart 337.70--Services--Special Contract Requirements

Sec.
337.7000 Prohibition on smoking in facilities during delivery of 
services to children.
337.7001 Reporting of child abuse by covered professionals.
337.7002 Requirement for background checks--childcare services.
337.7003 Indian Child Protection and Family Violence Act--background 
investigations.
337.7004 Non-discrimination in service delivery.
337.7005 Key personnel.
337.7006 Contract clauses.

    Authority:  5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 
1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 337.70--Services--Special Contract Requirements


337.7000  Prohibition on smoking in facilities during delivery of 
services to children.

    (a) Policy-prohibition on smoking in certain facilities where 
certain federally funded children's services are provided. When 
performing services under contracts awarded by the U.S. Department of 
Health and Human Services (HHS) where children's services are provided, 
contractors including employees, subcontractors, and third-parties 
performing services on behalf of a contractor are prohibited from 
smoking in facilities where certain federally funded children's 
services are provided pursuant to 20 U.S.C. 7181 (Pub. L. 107-110, the 
Pro-Children Act of 2001 (the Act)). Smoking is prohibited within any 
indoor facility (or portion thereof), whether owned, leased, or 
contracted for, or involving indoor facilities that are constructed, 
operated, or maintained with Federal funds, that is used for the 
routine or regular provision of--
    (1) Kindergarten, elementary, or secondary education or library 
services; or
    (2) Health or day care services that are provided to children under 
the age of 18.
    (b) Representation and agreement. Contractors are required to 
represent to the contracting officer and agree that by submission of 
its bid or offer and if awarded a contract, the contractor agrees to 
comply with the requirements of the Act and the prohibition of smoking 
in facilities as specified in paragraph (a) of this section. The 
contractor shall enforce the provisions of the clause prescribed in 
337.7006(a), and ensure that each of its employees, subcontractors, and 
any subcontractor staff, is made aware of, understands, and complies 
with the provisions of the Act.
    (c) Penalties. Failure to comply with the Act may result in the 
imposition of a civil monetary penalty in an amount not to exceed 
$1,000 for each violation and/or the imposition of an administrative 
compliance order on the responsible entity after proper notice in 
accordance with agency procedures.


337.7001  Reporting of child abuse by covered professionals.

    (a) Definitions. As used in this subpart--
    Child abuse means the physical or mental injury, sexual abuse or 
exploitation, or negligent treatment of a child.
    Covered professionals means those persons engaged in professions 
and activities in eight different categories including, but not limited 
to, teachers, social workers, physicians, dentists, medical residents 
or interns, hospital personnel and administrators, nurses, health care 
practitioners, chiropractors, osteopaths, pharmacists, optometrists, 
podiatrists, emergency medical technicians, ambulance drivers, alcohol 
or drug treatment personnel, psychologists, psychiatrists, mental 
health professionals, childcare workers and administrators, and 
commercial film and photo processors.
    (b) Responsibility to report child abuse. Public Law 101-647, known 
as the Crime Control Act of 1990 (the Act) (34 U.S.C. 20341), imposes 
responsibilities on certain individuals who, while engaged in a 
professional capacity or activity as a covered professional, as defined 
in the Act, on Federal land or in a federally-operated (or contracted) 
facility, learn of facts that give the individual reason to suspect 
that a child has suffered an incident of child abuse.
    (c) Reporting requirements. Accordingly, any person engaged in a 
covered profession or activity under an HHS contract or subcontract 
(i.e., a covered professional), regardless of the purpose of the 
contract or subcontract, shall immediately report a suspected child 
abuse incident in accordance with the provisions of the Act. If a child 
is suspected of being harmed, the appropriate State Child Abuse 
Hotline, local child protective services (CPS), or law enforcement 
agency shall be contacted. For more information about where and how to 
file a report, Contractors may contact the Childhelp USA, National 
Child Abuse Hotline (1-800-4-A-CHILD). Any covered professional failing 
to make a timely report of such incident shall be guilty of a Class B 
misdemeanor.
    (d) Representation. The offeror shall represent that it understands 
that by submission of its bid or offer and if awarded a contract for a 
requirement, the Contractor agrees to comply with the requirements of 
the Act. Contracting officers shall ensure the requirements of clause 
352.237-71 are flowed down to subcontractors at any tier.


337.7002  Requirement for background checks--childcare services.

    (a) Definition. As used in this subpart, childcare services means 
and include, but are not limited to, social services, health and mental 
health care, child (day) care, education (whether or not directly 
involved in teaching), and rehabilitative programs.
    (b) Requirement for background checks. Public Law 101-647, known as 
the Crime Control Act of 1990 (the Act) (34 U.S.C. 20351), requires 
that all individuals involved with the provision of childcare services 
to children under the age of 18 undergo a criminal background check. 
Any conviction for a sex crime, an offense involving a child victim, or 
a drug felony, may be grounds for denying employment or for dismissal 
of an employee providing any childcare services.
    (c) Background check protocols. The contracting officer will 
provide the necessary information to the contractor regarding the 
process for obtaining the background check. The contractor may hire a 
staff person provisionally prior to the completion of a background 
check, if at all times prior to the receipt of the background check 
during which children are in the care of the newly-hired person, the 
person is within the sight and under the supervision of a previously 
investigated staff person.
    (d) Representation. The offeror shall represent that it understands 
that by submission of its bid or offer and if awarded a contract for a 
requirement, the contractor agrees to comply with the requirements of 
the Act. Contracting officers shall ensure the requirements of

[[Page 80691]]

clause 352.237-72 are flowed down to subcontractors at any tier.


337.7003  Indian Child Protection and Family Violence Act--background 
investigations.

    (a) To ensure protection of Indian children, the Indian Child 
Protection and Family Violence Act, Public Law 101-630 (25 U.S.C. 3201, 
et seq.), prohibits employment, including personal service contracts, 
with anyone who has been convicted of any crime of violence when 
performance under a contract may require duties and responsibilities of 
a contractor, its employees, subcontractors, or third parties providing 
service under the contract that involve regular contact with or control 
over Indian children. The Act requires that a contractor and its 
employees and subcontractors, at any tier, be subject to a character 
and background investigation. This investigation is conducted by the 
Indian Health Service, Office of Human Resources.
    (b) Until such time as the contractor or its employees and 
subcontractors have been notified of completion of the investigation, 
the contractor and its employees and subcontractors shall have no 
unsupervised contact with Indian children. In order to initiate this 
background investigation, the contractor and its employees and 
subcontractors must provide information as required in the contract or 
as directed by the contracting officer.
    (c) As a prerequisite to providing services under a contract 
involving access to Indian children, contractors shall--
    (1) Complete and sign a declaration concerning the background of 
employees or subcontractors providing such services as required by the 
terms and conditions of the contract;
    (2) Provide information as required by the contracting officer to 
ascertain such information about its employees, subcontractors, and 
third parties providing services under the contract;
    (3) Report convictions of any crime of violence immediately to the 
contracting officer that involve such employees, subcontractors, or 
third parties, who may be employed or are currently employed under the 
contract; and
    (4) Flow down clause the clause prescribed at 337.7006(d), 352.337-
73, Indian Child Protection and Family Violence Act--Background 
Investigations, into all subcontracts, at any tier.


337.7004  Non-discrimination in service delivery.

    (a) Policy. It is the policy of the HHS that no person otherwise 
eligible will be excluded from participation in, denied the benefits 
of, or subjected to discrimination in the administration of HHS 
programs and services based on non-merit factors such as race, color, 
national origin, religion, sex, gender identity, sexual orientation, or 
disability (physical or mental).
    (b) Representation. The offeror shall represent that it understands 
that by submission of its bid or offer and if awarded a contract for a 
requirement, the contractor agrees to comply with the requirements of 
the policy. Contracting officers shall ensure the requirements of 
clause 352.237-74 are flowed down to subcontractors at any tier.


337.7005  Key personnel.

    (a) To ensure successful performance under an HHS contract, it may 
be necessary for the contracting officer to require contractors to 
identify certain positions as key personnel when considered to be 
essential to work performance.
    (b) Contractors must provide notice if they divert proposed 
personnel deemed key personnel. At least 30 days prior to the 
contractor voluntarily diverting any of the specified individuals in a 
contract to other programs or contracts, the contractor shall notify 
the contracting officer and submit a justification for the diversion or 
replacement, and request to replace the individual. The request must 
identify the proposed replacement and provide an explanation of how the 
replacement's skills, experience, and credentials meet or exceed the 
requirements of the contract. The contract should be modified to add or 
delete key personnel as necessary to reflect the agreement of the 
parties.
    (c) If the employee of the contractor is terminated for cause or 
separates from the contractor voluntarily with less than 30 days' 
notice, the contractor must provide the maximum notice practicable 
under the circumstances. The contractor shall not divert, replace, or 
announce any such change to key personnel without the written consent 
of the contracting officer.


337.7006  Contract clauses.

    (a) The contracting officer shall insert the clause at 352.237-70, 
Nonsmoking Policy--Delivery of Services to Children, in solicitations, 
contracts, and orders that involve health or daycare services that are 
provided to children under the age of 18 on a routine or regular basis 
pursuant to the Pro-Children Act of 2001 as set forth in 337.7000.
    (b) The contracting officer shall insert the clause at 352.237-71, 
Reporting of Child Abuse, in solicitations, contracts, and orders that 
require performance on Federal land or in a federally operated (or 
contracted) facility and involve ``covered professionals'' performed by 
persons specified in the Crime Control Act of 1990 (34 U.S.C. 20341) 
engaged in a covered profession or activity under an HHS contract or 
subcontract, regardless of the purpose of the contract or subcontract, 
including, but not limited to those performed by--
    (1) Teachers;
    (2) Social workers;
    (3) Physicians, nurses, dentists, health care practitioners, 
optometrists, psychologists, emergency medical technicians, alcohol or 
drug treatment personnel; and
    (4) Childcare workers and administrators, emergency medical 
technicians and ambulance drivers.
    (c) The contracting officer shall insert the clause at 352.237-72, 
Requirement for Background Checks, in solicitations, contracts, and 
orders that involve providing childcare services to children under the 
age of 18, including social services, health and mental health care, 
child-(day) care, education (whether or not directly involved in 
teaching), and rehabilitative programs covered under the Crime Control 
Act of 1990 (34 U.S.C. 20351).
    (d) The contracting officer shall insert the clause at 352.237-73, 
Indian Child Protection and Family Violence Act--Background 
Investigations, in all solicitations, contracts, and orders when 
performance of the contract may involve regular contact with or control 
over Indian children. The required declaration shall also be included 
in section J of the solicitation and contract. This clause shall be 
included by all contracting officers supporting the Indian Health 
Service, whether issued by IHS or through or by use of an interagency 
agreement.
    (e) The contracting officer shall insert the clause at 352.237-74, 
Non-Discrimination in Service Delivery, in solicitations, contracts, 
and orders involving delivery of services under HHS' programs directly 
to the public.
    (f) The contracting officer shall insert the clause at 352.237-75, 
Key Personnel, in solicitations, contracts, and orders when the 
contracting officer will require the contractor to designate contractor 
key personnel.

PART 338 [ADDED AND RESERVED]

0
16. Add reserved part 338 to subchapter F.

PART 340 [ADDED AND RESERVED]

0
17. Add reserved part 340 to subchapter F.

[[Page 80692]]

0
18. Add part 341 to subchapter F to read as follows:

PART 341--ACQUISITION OF UTILITY SERVICES

Subpart 341.1--General
Sec.
341.102 Applicability.
Subpart 341.5--Solicitation Provision and Contract Clauses
341.501 Solicitation provision and contract clauses.
341.501-70 Disputes--utility contracts.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 
41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 341.1--General


341.102  Applicability.

    (a) This part applies to purchases of utility services from 
nonregulated and regulated utility suppliers when a delegation of 
authority from the General Services Administration (GSA) for those 
services is requested and obtained.
    (b)(4) The acquisition of energy, such as electricity, and natural 
or manufactured gas, when purchased as a commodity is considered to be 
acquisitions of supplies rather than utility services as described in 
FAR part 41.

Subpart 341.5--Solicitation Provision and Contract Clauses


341.501  Solicitation provision and contract clauses.


341.501-70  Disputes--utility contracts.

    The contracting officer shall insert the clause at 352.241-70, 
Disputes--Utility Contracts, in solicitations and contracts for utility 
services subject to the jurisdiction and regulation of a utility rate 
commission.
0
19. Revise subchapter G to read as follows:
SUBCHAPTER G--CONTRACT MANAGEMENT
PART 342 CONTRACT ADMINISTRATION AND AUDIT SERVICES
PART 343 CONTRACT MODIFICATIONS
PART 344 SUBCONTRACTING POLICIES AND PROCEDURES
PART 345 GOVERNMENT PROPERTY
PART 346 [RESERVED]
PART 347 TRANSPORTATION
PARTS 348-351 [RESERVED]
SUBCHAPTER G--CONTRACT MANAGEMENT

PART 342--CONTRACT ADMINISTRATION AND AUDIT SERVICES

Subpart 342.2--Contract Administration
Sec.
342.270 Contracting Officer's Representatives role in contract 
administration.
342.271 Administrative Contracting Officer's role in contract 
administration and delegated functions.
342.272 Contract clauses.
Subpart 342.7--Indirect Cost Rates
342.705 Final indirect cost rates.

    Authority:  5 U.S.C. 301; 40 U.S.C. 121(c)(2); 41 U.S.C. 
1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 342.2--Contract Administration


342.270  Contracting Officer's Representatives role in contract 
administration. (a) A contracting officer may designate a qualified 
person to be the Contracting Officer's Representative (COR) for the 
purpose of performing certain technical functions in administering a 
contract.

    (b) The COR acts solely as a technical representative of the 
contracting officer and is not authorized to perform any function that 
results in a change in the scope, price, terms, or conditions of the 
contract.
    (c) A COR designation must be made in writing by the contracting 
officer. The designation shall identify the responsibilities and 
limitations of the COR. A copy of the designation must be furnished to 
the contractor and the Administrative Contracting Officer (ACO), when 
applicable.


342.271  Administrative Contracting Officer's role in contract 
administration and delegated functions.

    (a) As used in this subpart, Administrative Contracting Officer 
(ACO) Letter of Delegation means a delegation of functions as set forth 
in FAR 42.202 and 42.302 and this section that is issued by a 
contracting officer to delegate certain contract administration or 
specialized support services.
    (b) Contracting officers are authorized to delegate certain 
contract administration or specialized support services in accordance 
with FAR 42.202 and 42.302 to ACOs.
    (c) The ACO's authority is limited to the actions detailed in the 
delegation.
    (d) The delegations of authority shall be set forth in a written 
ACO Letter of Delegation issued by the contracting officer to the 
accepting contract administration office and designated administrative 
contracting officer. The ACO Letter of Delegation shall contain the 
information required in FAR 42.202(a) through (c) and identify the 
responsibilities and limitations of the ACO. A copy of the delegation 
will be furnished to the contractor and the ACO.


342.272  Contract clauses.

    (a) The contracting officer shall insert the clause at 352.242-70, 
Administrative Contracting Officer, in solicitations and contracts 
expected to exceed the micro-purchase threshold, when contract 
administration is delegated.
    (b) The contracting officer shall insert the clause at 352.242-71, 
Government Construction Contract Administration, in solicitations and 
contracts for construction expected to exceed the micro-purchase 
threshold, when contract administration is delegated.

Subpart 342.7--Indirect Cost Rates


342.705  Final indirect cost rates.

    Contract actions for which the Department of Health and Human 
Services is the cognizant Federal agency:
    (a) The Financial Management Services, Division of Cost Allocation, 
Program Support Center, shall establish facilities and administration 
costs, also known as indirect cost rates, research patient care rates, 
and, as necessary, fringe benefits, computer, and other special costing 
rates for use in contracts awarded to State and local governments, 
colleges and universities, hospitals, and other nonprofit 
organizations.
    (b) The National Institute of Health, Division of Financial 
Advisory Services, shall establish indirect cost rates and similar 
rates for use in contracts awarded to for profit organizations.

PART 343--CONTRACT MODIFICATIONS

Subpart 343.2--Change Orders
Sec.
343.204 Administration.
343.204-70 Definitization.
343.205 Contract clauses.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 
41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 343.2--Change Orders


343.204  Administration.


343.204-70  Definitization.

    (a) Applicability. This section applies to unpriced change orders 
with an estimated value exceeding $5 million.
    (b) Price ceiling. Unpriced change orders shall include a not-to-
exceed price.
    (c) Definitization schedule. (1) Unpriced change orders shall 
contain definitization schedules that provide for definitization by--
    (i) The date after issuance of the change order may not exceed 180 
days after the contractor submits a qualifying proposal); or

[[Page 80693]]

    (ii) The date on which the amount of funds paid to the contractor 
under the contract action is equal to more than 50 percent of the not-
to-exceed price.
    (2) Submission of a qualifying proposal in accordance with the 
definitization schedule is a material element of the contract. If the 
contractor does not submit a timely qualifying proposal, the 
contracting officer may suspend or reduce progress payments under FAR 
32.503-6 or take other appropriate action.
    (d) Limitations on obligations. (1) The Government shall not 
obligate more than 50 percent of the not-to-exceed price before 
definitization. However, if a contractor submits a qualifying proposal 
before 50 percent of the not-to-exceed price has been obligated by the 
Government, the limitation on obligations before definitization may be 
increased to no more than 75 percent.
    (2) Obligations should be consistent with the contractor's 
requirements for the undefinitized period.
    (e) Exception. The head of the contracting activity (HCA) may waive 
the limitations in paragraph (c) of this section for unpriced change 
orders if the HCA determines that the waiver is necessary to support an 
emergency acquisition operation.


343.205  Contract clauses.

    As authorized in the introductory text of clauses at FAR 52.243-1, 
Changes--Fixed-Price; 52.243-2, Changes--Cost-Reimbursement; and 
52.243-4, Changes, and in the prescription at FAR 43.205(c) for FAR 
52.243-3, Changes--Time-and-Materials or Labor-Hours, the contracting 
officer may vary the period within which a contractor must assert its 
right to an equitable adjustment, but the extended period shall not 
exceed 60 calendar days, unless approval is one level above the 
contracting officer.

PART 344--SUBCONTRACTING POLICIES AND PROCEDURES

Subpart 344.2--Consent to Subcontracts
Sec.
344.201 Consent and advance notification requirements.
344.201-1 Consent requirements.
344.202 Contracting officer's evaluation.
344.202-2 Considerations.
Subpart 344.3--Contractors' Purchasing Systems Reviews
344.303-70 Additional contractors' purchasing system review 
considerations.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 
41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 344.2--Consent to Subcontracts


344.201  Consent and advance notification requirements.


344.201-1  Consent requirements.

    (a) In accordance with section 824 of the National Defense 
Authorization Act for Fiscal Year 2019 (Pub. L. 115-232), 
notwithstanding the requirements in FAR 44.201-1(a), the contracting 
officer shall not withhold consent to subcontract without the written 
approval of the contracting officer's representative, if the contractor 
has an approved purchasing system, as defined in FAR 44.101.


344.202  Contracting officer's evaluation.


344.202-2  Considerations.

    (a) In addition to the considerations outlined in FAR 44.202-2(a), 
the contracting officer responsible for consent must review the request 
and supporting data and document in writing whether the contractor 
adequately substantiated the selection as being fair, reasonable, and 
representing the best value to the Government where other than the 
lowest price is the basis for subcontractor selection.

Subpart 344.3--Contractors' Purchasing Systems Reviews


344.303-70  Additional contractors' purchasing system review 
considerations.

    (a) During contractor purchasing systems reviews (CPSRs), special 
attention shall also be paid to reviewing documentation of commercial 
products and commercial services determinations to ensure compliance 
with the definition of commercial products and commercial services in 
FAR 2.101.
    (b) The contracting officer shall not withhold consent to 
subcontract without the written coordination of the program manager, or 
comparable requiring activity official exercising program management 
responsibilities, if the contractor has an approved purchasing system 
as defined in FAR 44.101.

PART 345--GOVERNMENT PROPERTY

Subpart 345.1--General
Sec.
345.105-70 Contractors' property management system compliance--
policy and procedures.
345.107 Contract clauses.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 
41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 345.1--General


345.105-70  Contractors' property management system compliance--policy 
and procedures.

    (a) Definitions. As used in this part--
    Acceptable property management system means a property system that 
complies with the system criteria in accordance with paragraph (f) of 
the clause at FAR 52.245-1.
    Property management system means the contractor's system or systems 
for managing and controlling Government property.
    Significant deficiency means a shortcoming in the system that 
materially affects the ability of officials of the Department of Health 
and Human Services to rely upon information produced by the system that 
is needed for management purposes.
    (b) Policy. The cognizant contracting officer, in consultation with 
the property administrator, shall--
    (1) Determine the acceptability of the system and approve or 
disapprove the system; and
    (2) Pursue correction of any deficiencies.
    (c) Acceptable property management system. In evaluating the 
acceptability of a contractor's property management system, the 
contracting officer, in consultation with the property administrator, 
shall determine whether the contractor's property management system 
complies with the system criteria for an acceptable property management 
system as prescribed in the clause at 352.245-70, Contractor Property 
Management System Administration.
    (d) Disposition of findings--(1) Reporting of findings. The 
property administrator shall document findings and recommendations in a 
report to the contracting officer. If the property administrator 
identifies any significant property system deficiencies, the report 
shall describe the deficiencies in sufficient detail to allow the 
contracting officer to understand the deficiencies.
    (2) Initial determination. (i) The contracting officer shall review 
findings and recommendations and, if there are no significant 
deficiencies, shall promptly notify the contractor, in writing, that 
the contractor's property management system is acceptable and approved; 
or
    (ii) If the contracting officer finds that there are one or more 
significant deficiencies (as defined in the clause at 352.245-70, 
Contractor Property Management System Administration) due to the 
contractor's failure to meet one or more of the property management 
system criteria in the

[[Page 80694]]

clause at 352.245-70, the contracting officer shall--
    (A) Promptly make an initial written determination on any 
significant deficiencies and notify the contractor, in writing, 
providing a description of each significant deficiency in sufficient 
detail to allow the contractor to understand the deficiency;
    (B) Request the contractor to respond, in writing, to the initial 
determination within 30 days; and
    (C) Evaluate the contractor's response to the initial 
determination, in consultation with the property administrator, and 
make a final determination.
    (3) Final determination. (i) The contracting officer shall make a 
final determination and notify the contractor, in writing, that--
    (A) The contractor's property management system is acceptable and 
approved, and no significant deficiencies remain; or
    (B) Significant deficiencies remain. The notice shall identify any 
remaining significant deficiencies, and indicate the adequacy of any 
proposed or completed corrective action. The contracting officer 
shall--
    (1) Request that the contractor, within 45 days of receipt of the 
final determination, either correct the deficiencies or submit an 
acceptable corrective action plan showing milestones and actions to 
eliminate the deficiencies;
    (2) Disapprove the system in accordance with the clause at 352.245-
70, Contractor Property Management System Administration; and
    (3) Take other remedies such as withholding payments as appropriate 
in accordance with the terms and conditions of the contract.
    (ii) Monitor a contractor's corrective action and the correction of 
significant deficiencies.
    (e) System approval. The contracting officer shall promptly approve 
a previously disapproved property management system and notify the 
contractor when the contracting officer determines, in consultation 
with the property administrator, that there are no remaining 
significant deficiencies.
    (f) Contracting officer notifications. The cognizant contracting 
officer shall promptly distribute copies of a determination to approve 
a system, disapprove a system and withhold payments, or approve a 
previously disapproved system and release withheld payments to the 
auditor; payment office; affected contracting officers at the buying 
activities; and cognizant contracting officers in contract 
administration activities, as appropriate.


345.107  Contract clauses.

    The contracting officer shall insert the clause at 352.245-70, 
Contractor Property Management System Administration, in solicitations 
and contracts containing the clause at FAR 52.245-1, Government 
Property.

PART 346 [RESERVED]

PART 347--TRANSPORTATION

Subpart 347.3--Transportation in Supply Contracts
Sec.
347.303-6 F.o.b. destination.
347.303-670 Place of delivery.
347.305 Solicitation provisions, contract clauses, and 
transportation factors.
347.305-10 Packing, marking, and consignment instructions.
347.306 Transportation factors in the evaluation of offers.
347.306-70 Records of claims.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 
41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 347.3--Transportation in Supply Contracts


347.303-6  F.o.b. destination.


347.303-670  Place of delivery.

    The contracting officer shall insert clause 352.247-70, Delivery 
Location, or a clause substantially the same as the clause at 352.247-
70, in supply contracts when it is necessary to specify delivery 
locations. If necessary, the clause may reference an attachment which 
lists various delivery locations and other delivery details (e.g., 
quantities to be delivered to each location, etc.).


347.305  Solicitation provisions, contract clauses, and transportation 
factors.


347.305-10  Packing, marking, and consignment instructions.

    (a) The contracting officer shall insert clause 352.247-71, Marking 
Deliverables, or a clause substantially the same as 352.247-71, in 
solicitations and contracts if special marking on deliverables is 
required.
    (b) The contracting officer shall insert the clause at 352.247-72, 
Packing for Domestic Shipment, in contracts when item(s) will be 
delivered for immediate use to a destination in the continental United 
States; when the material specification or purchase description does 
not provide preservation, packaging, packing, and/or marking 
requirements; and/or when the requiring activity has not cited a 
specific specification for packaging.


347.306  Transportation factors in the evaluation of offers.


347.306-70  Records of claims.

    When contracting for transportation, and consistent with FAR 
15.304, contracting officers should consider using offerors' record of 
claims involving loss or damage as an evaluation factor or subfactor.

PARTS 348-351 [RESERVED]

PART 352--SOLICITATION PROVISIONS AND CONTRACT CLAUSES

0
20. The authority citation for part 352 is revised to read as follows:

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 
41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.
0
21. Revise subpart 352.1 to read as follows:
Subpart 352.1--Instructions for Using Provisions and Clauses
Sec.
352.100 Scope of subpart.
352.102 Incorporating provisions and clauses.
352.102-70 Application of provisions and clauses.

Subpart 352.1--Instructions for Using Provisions and Clauses


352.100  Scope of subpart.

    This subpart provides guidance for applying the Department of 
Health and Human Services supplemental provisions and clauses in 
solicitations, contracts, and orders.


352.102  Incorporating provisions and clauses.


352.102-70  Application of provisions and clauses.

    (a) If a clause is included in the master instrument (e.g., in an 
indefinite-delivery, indefinite-quantity contract, or a blanket 
purchase agreement), it is not necessary to also include the clause in 
a task order or delivery order thereunder, unless fill-ins are 
required.
    (b) When a dollar amount or dollar threshold is specified (e.g., 
$25 million or simplified acquisition threshold), the dollar amount of 
the award (contract or order) includes any options thereunder.

Subpart 352.2--Text of Provisions and Clauses

0
22. Add section 352.201-70 to read as follows:


352.201-70  Contracting Officer's Representative.

    As prescribed in 301.604-70, insert the following clause:

Contracting Officer's Representative (DATE)


[[Page 80695]]


    (a) Definition. Contracting officer's representative (COR) means 
an individual designated in accordance with FAR 1.602-2(d) and 
authorized in writing by the Contracting Officer to perform specific 
technical or administrative functions.
    (b) If the Contracting Officer designates a COR, the Contractor 
will receive a copy of the written designation. It will specify the 
extent of the COR's authority to act on behalf of the Contracting 
Officer. The COR is not authorized to make any commitments or 
changes that will affect price, quality, quantity, delivery, or any 
other term or condition of the contract.

(End of clause)

0
23. Revise sections 352.203-70 and 352.204-70 to read as follows:


352.203-70  Anti-Lobbying.

    As prescribed in 303.808-70, insert the following clause:

Anti-Lobbying (DATE)

    Pursuant to the HHS annual appropriations acts, except for 
normal and recognized executive-legislative relationships, the 
Contractor shall not use any HHS contract funds for--
    (a) Publicity or propaganda purposes;
    (b) The preparation, distribution, or use of any kit, pamphlet, 
booklet, publication, electronic communication, radio, television, 
or video presentation designed to support or defeat the enactment of 
legislation before the Congress or any State or local legislature or 
legislative body, except in presentation to the Congress or any 
state or local legislature itself; or designed to support or defeat 
any proposed or pending regulation, administrative action, or order 
issued by the executive branch of any state or local government, 
except in presentation to the executive branch of any state or local 
government itself; or
    (c) Payment of salary or expenses of the Contractor, or any 
agent acting for the Contractor, related to any activity designed to 
influence the enactment of legislation, appropriations, regulation, 
administrative action, or Executive order proposed or pending before 
the Congress or any state government, state legislature or local 
legislature or legislative body, other than for normal and 
recognized executive-legislative relationships or participation by 
an agency or officer of a state, local, or tribal government in 
policymaking and administrative processes within the executive 
branch of that government.
    (d) The prohibitions in paragraphs (a), (b), and (c) shall 
include any activity to advocate or promote any proposed, pending, 
or future federal, state, or local tax increase, or any proposed, 
pending, or future requirement for, or restriction on, any legal 
consumer product, including its sale or marketing, including, but 
not limited to, the advocacy or promotion of gun control.

(End of clause)


352.204-70  Prevention and Public Health Fund--Reporting Requirements.

    As prescribed in 304.7202, insert the following clause:

Prevention and Public Health Fund--Reporting Requirements (DATE)

    (a) Pursuant to public law this contract requires the contractor 
to provide products or services or both that are funded from the 
Prevention and Public Health Fund (PPHF), Public Law 111-148, sec. 
4002. Public Law 112-74, section 220(b)(5), requires each contractor 
to report on its use of these funds under this contract. These 
reports will be made available to the public.
    (b) Semi-annual reports from the Contractor for all work funded, 
in whole or in part, by the PPHF, are due no later than 20 days 
following the end of each 6-month period. The 6-month reporting 
periods are January through June and July through December. The 
first report is due no later than 20 days after the end of the 6-
month period following contract award. Subsequent reports are due no 
later than 20 days after the end of each reporting period. If 
applicable, the Contractor shall submit its final report for the 
remainder of the contract period no later than 20 days after the end 
of the reporting period in which the contract ended.
    (c) The Contractor shall provide the following information in a 
Section 508 compliant electronic format to the Contracting Officer.
    (1) The Government contract and order number, as applicable.
    (2) The amount of PPHFs invoiced by the contractor for the 
reporting period and the cumulative amount invoiced for the contract 
or order.
    (3) A list of all significant services performed, or supplies 
delivered, including construction, for which the contractor invoiced 
in the reporting period.
    (4) Program or project title, if any.
    (5) The Contractor shall report any subcontract funded in whole 
or in part with PPHFs valued at $25,000 or more. The Contractor 
shall advise the subcontractor that the information will be made 
available to the public. The Contractor shall report:
    (i) Name and address of the subcontractor.
    (ii) Amount of the subcontract award.
    (iii) Date of the subcontract award.
    (iv) A description of the products or services (including 
construction) being provided under the subcontract.

(End of clause)

0
24. Add section 352.205-70 to read as follows:


352.205-70  Advertisements, Publicizing Awards, and Releases.

    As prescribed in 305.470-2, insert the following clause:

Advertisements, Publicizing Awards, and Releases (DATE)

    The Contractor shall not refer to this contract in commercial 
advertising or similar promotions in such a manner as to state or 
imply that the product or service provided is endorsed or preferred 
by the Federal Government or is considered by the Government to be 
superior to other products or services.

(End of clause)

    Alternate I (DATE). If a contract involves sensitive or classified 
information, designate the paragraph in the base clause as (a) and add 
the following paragraph (b) to the clause:
    (b) All advertisements, releases, announcements, or other 
publication regarding this contract or the agency programs and projects 
covered under it, or the results or conclusions made pursuant to 
performance, must be approved by the Contracting Officer. Under no 
circumstances shall the Contractor, or anyone acting on behalf of the 
Contractor, refer to the supplies, services, or equipment furnished 
pursuant to the provisions of this contract in any publicity, release, 
or commercial advertising without first obtaining explicit written 
consent to do so from the Contracting Officer.
0
25. Revise section 352.208-70 to read as follows:


352.208-70  Printing and Duplication.

    As prescribed in 308.870, insert the following clause:

Printing and Duplication (DATE)

    (a) Definitions. As used in this clause--
    Duplicating/copying means the term as defined in the Government 
Printing and Binding Regulations published by the Joint Committee on 
Printing, U.S. Congress, Title I: Definitions.
    Government printing means printing, binding, and blank book work 
for the use of an executive department, independent agency, or 
establishment of the Government (see Government Printing and Binding 
Regulations published by the Joint Committee on Printing, U.S. 
Congress, Title I: Definitions).
    Printing means the term as defined in the Government Printing 
and Binding Regulations published by the Joint Committee on 
Printing, U.S. Congress, Title I: Definitions.
    Related supplies means supplies that are used and equipment that 
is usable in printing and binding operations.
    Other printing-related services means composition, platemaking, 
presswork, binding, and micrographics when used as a substitute for 
printing.
    (b) Prohibitions. Unless otherwise specified, no printing by the 
Contractor or any subcontractor is authorized for performance under 
the contract, whether to support Government printing, to acquire 
related supplies, or to provide other printing-related services. 
When printing supplies or services are required, and specified under 
the contract, the Contractor shall submit camera-ready copies of 
such deliverables to the Contracting Officer's Representative for 
printing through, or by the Government Printing Office, except as 
authorized by the Contracting Officer.
    (c) Limited printing authorized. If necessary for performance of 
the contract, the Contractor may duplicate or copy less than 5,000 
production units of any one page, or less than 25,000 production 
units in the aggregate of multiple pages for the use of a department 
or agency. A production unit is

[[Page 80696]]

defined as one sheet, size 8.5 x 11 inches, one side only, and one 
color. The pages may not exceed a maximum image size of 10 \3/4\ by 
14 \1/4\ inches. This page limit applies to each printing 
requirement and not for all printing requirements under the entire 
contract.
    (d) Approval procedures for printing, duplication, and other 
printing-related services. Contractors must obtain approval from the 
Contracting Officer for all printing, as well as duplicating/copying 
in excess of the limited printing authorized stated limits in 
paragraph (c). The cost of any unauthorized printing or duplicating/
copying under this contract is unallowable and the Contractor will 
not be reimbursed.
    (e) Subcontracts. The Contractor shall include the substance of 
this clause, including this paragraph (e), in subcontracts under 
this contract (including subcontracts for the acquisition of 
commercial products and commercial services).

(End of clause)
0
26. Add section 352.209-70 to read as follows:


352.209-70  Organizational Conflicts of Interest.

    As prescribed in 309.507-1(b), insert the following provision:

Organizational Conflicts of Interest (DATE)

    (a) It is in the best interest of the Government to avoid 
situations which might create an organizational conflict of interest 
or where the Offeror's performance of work under the contract may 
provide the Contractor with an unfair competitive advantage. The 
term ``organizational conflict of interest'' means that because of 
other activities or relationships with other persons, a person is 
unable to render impartial assistance or advice to the Government, 
or the person's objectivity in performing the contract work is or 
might be otherwise impaired, or the person has an unfair competitive 
advantage.
    (b) The Offeror shall provide a statement with its offer which 
describes, in a concise manner, all relevant facts concerning any 
past, present, or currently planned interest (financial, 
contractual, organizational, or otherwise) or actual or potential 
organizational conflicts of interest relating to the services to be 
provided under this solicitation. The Offeror shall also provide 
statements with its offer containing the same information for any 
consultants and subcontractors identified in its proposal and which 
will provide services under the solicitation. The Offeror may also 
provide relevant facts that show how its organizational and/or 
management system or other actions would avoid or mitigate any 
actual or potential organizational conflicts of interest.
    (c) Based on this information and any other information 
solicited or obtained by the Contracting Officer, the Contracting 
Officer may determine that an organizational conflict of interest 
exists which would warrant disqualifying the Contractor for award of 
the contract unless the organizational conflict of interest can be 
mitigated to the Contracting Officer's satisfaction by negotiating 
terms and conditions of the contract to that effect. If the conflict 
of interest cannot be mitigated and if the Contracting Officer finds 
that it is in the best interest of the United States to award the 
contract, the Contracting Officer shall request a waiver in 
accordance with FAR 9.503.
    (d) Nondisclosure or misrepresentation of actual or potential 
organizational conflicts of interest at the time of the offer or 
arising as a result of a modification to the contract, may result in 
the termination of the contract at no expense to the Government.

(End of provision)


352.211-1 through 352.211-3  [Redesignated as 352.211-70 through 
352.211-72]

0
27. Redesignate sections 352.211-1 through 352.211-3 as sections 
352.211-70 through 352.211-72.
0
28. Revise newly redesignated sections 352.211-70 through 352.211-72 to 
read as follows:


352.211-70  Public Accommodations and Commercial Facilities.

    As prescribed in 311.7102, insert the following clause:

Public Accommodations and Commercial Facilities (DATE)

    The Contractor agrees as follows:
    (a) Except for ad hoc meetings necessary or incidental to 
contract performance, the Contractor shall develop a plan to assure 
that any event held pursuant to this contract will meet or exceed 
the minimum accessibility standards set forth in 28 CFR part 36--
Nondiscrimination on the Basis of Disability by Public 
Accommodations and in Commercial Facilities. The Contractor shall 
submit the plan to the Contracting Officer and must receive approval 
prior to the event. The Contractor may submit a consolidated or 
master plan for contracts requiring numerous events in lieu of 
separate plans.
    (b) The Contractor shall manage the contract in accordance with 
the standards set forth in 28 CFR part 36.

(End of clause)


352.211-71  Conference Sponsorship Requests and Conference Materials 
Disclaimer.

    As prescribed in 311.7202, insert the following clause:

Conference Sponsorship Request and Conference Materials Disclaimer 
(DATE)

    (a) If HHS is not the sole provider of funding under this 
contract, then the Contractor shall submit a written request 
(including rationale) to the Contracting Officer for permission to 
claim such HHS sponsorship, prior to the Contractor claiming HHS 
conference sponsorship.
    (b) The Contractor shall include the following statement on 
conference materials, including promotional materials, agendas, and 
websites, whether or not HHS is the conference sponsor:
    ``This conference was funded, in whole or in part, through a 
contract (insert contract number) with the Department of Health and 
Human Services (HHS) (insert name of OPDIV or STAFFDIV). The views 
expressed in written conference materials and by speakers and 
moderators at this conference, do not necessarily reflect the 
official policies of HHS, nor does mention of trade names, 
commercial practices, or organizations imply endorsement by the U.S. 
Government.''
    (c) Unless authorized in writing by the Contracting Officer, the 
Contractor shall not display the HHS logo on any conference 
materials.

(End of clause)


352.211-72  Paperwork Reduction Act Requirements.

    As prescribed in 311.7301, insert the following clause:

Paperwork Reduction Act Requirements (DATE)

    (a) This contract involves a requirement to collect or record 
information calling either for answers to identical questions from 
10 or more persons other than Federal employees, or information from 
Federal employees which is outside the scope of their employment, 
for use by the Federal government or disclosure to third parties; 
therefore, the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et 
seq.) shall apply to this contract. No plan, questionnaire, 
interview guide or other similar device for collecting information 
(whether repetitive or single time) may be used without the Office 
of Management and Budget (OMB) first providing clearance. 
Contractors and the Contracting Officer's Representative shall be 
guided by the provisions of 5 CFR part 1320, Controlling Paperwork 
Burdens on the Public, and seek the advice of the HHS operating 
division or Office of the Secretary Reports Clearance Officer to 
determine the procedures for acquiring OMB clearance.
    (b) The Contractor shall not expend any funds or begin any data 
collection until the Contracting Officer provides the Contractor 
with written notification authorizing the expenditure of funds and 
the collection of data. The Contractor shall allow at least 120 days 
for OMB clearance. The Contracting Officer will consider excessive 
delays caused by the Government which arise out of causes beyond the 
control and without the fault or negligence of the Contractor in 
accordance with the Excusable Delays or Default clause of this 
contract.

(End of clause)
0
29. Add section 352.212-70 to read as follows:


352.212-70  Gray Market and Counterfeit Items.

    As prescribed in 312.301(f), insert the following clause:

Gray Market and Counterfeit Items (DATE)

    (a) No used, refurbished, or remanufactured supplies or 
equipment/parts shall be provided. This procurement is for new 
Original Equipment Manufacturer (OEM) items only. No gray market 
items shall be provided. Gray market items are OEM goods 
intentionally or unintentionally sold outside an authorized sales 
territory or sold

[[Page 80697]]

by non-authorized dealers in an authorized sales territory.
    (b) No counterfeit supplies or equipment/parts shall be 
provided. Counterfeit items include unlawful or unauthorized 
reproductions, substitutions, or alterations that have been 
mismarked, misidentified, or otherwise misrepresented to be an 
authentic, unmodified item from the original manufacturer, or a 
source with the express written authority of the original 
manufacturer or current design activity, including an authorized 
aftermarket manufacturer. Unlawful or unauthorized substitutions 
include used items represented as new, or the false identification 
of grade, serial number, lot number, date code, or performance 
characteristics.
    (c) The vendor shall be an OEM, authorized dealer, authorized 
distributor or authorized reseller for the proposed equipment/
system, verified by an authorization letter or other documents from 
the OEM. All software licensing, warranty and service associated 
with the equipment/system shall be in accordance with the OEM terms 
and conditions.

(End of clause)
0
30. Revise section 352.215-70 to read as follows:


352.215-70  Late Proposals and Revisions--R&D Solicitations.

    As prescribed in 315.209-70, insert the following provision:

Late Proposals and Revisions--R&D Solicitations (DATE)

    Notwithstanding the procedures contained in the provision at FAR 
52.215-1, Instructions to Offerors-Competitive Acquisition, 
paragraph (c)(3), the Contracting Officer may consider a proposal 
received for biomedical or behavioral research and development (R&D) 
solicitations after the date specified for receipt if--
    (a) It appears to offer significant cost or technical advantage 
to the Government; and
    (b) It was received before proposals were distributed for 
evaluation; or
    (c) It was received within five calendar days after the exact 
time specified for receipt, whichever is earlier.

(End of provision)
0
31. Add section 352.215-71 to read as follows:


352.215-71  Use of Non-Federal Evaluators--Conditions for Evaluating 
Proposals.

    As prescribed in 315.305-71, insert the following provision:

Non-Federal Evaluators--Conditions for Evaluating Proposals (DATE)

    (a) Prohibition on the use and release of proposal data. The 
contractor agrees that it and its employees, as well as any 
subcontractors and their employees as non-Federal evaluators will 
use the data (trade secrets, business data, and technical data) 
contained in any proposals under review for evaluation purposes 
only. Further, the contractor, its employees, and subcontractors and 
their employees may not release, in whole or in part, any material 
received from the Government to evaluate and must protect and secure 
the data against unauthorized disclosure. This does not apply to 
data obtained from another source without restriction.
    (b) Notices, legends, and return of materials. Any notice or 
legend placed on the proposal by either HHS, or the offeror shall be 
applied to any reproduction or abstract provided to the evaluator or 
made by the evaluator. Upon completion of the evaluation, the 
evaluator shall return the furnished copy of the proposal or 
abstract furnished by the Government, and all copies thereof, to the 
HHS office which initially furnished the proposal for evaluation.
    (c) Electronic records. All electronic records of proposals or 
proposal-related material shall be provided to the Government and 
immediately be destroyed and/or deleted from all electronic media.
    (d) Non-contact with offerors of proposals under evaluation. The 
evaluator shall not contact the offeror concerning any aspects of a 
proposal's contents.
    (e) Requirement to sign agreement. Each non-Federal evaluator 
shall complete, sign, and provide to the HHS office furnishing the 
proposal for review and the Contracting Officer, a signed 
acknowledgement of this agreement and insert the name, title, 
company, signature, and date set forth in paragraph (f) of this 
clause.
    (f) Agreement. By signing the agreement as shown in this 
paragraph, the non-Federal evaluator agrees, in order to participate 
under an HHS contract providing services to HHS as a non-Federal 
evaluator, to adhere to the terms and conditions set forth in 
paragraphs (a)-(e) of this provision. The agreement will be retained 
by the HHS office providing the proposal data and the Contracting 
Officer.

Name:------------------------------------------------------------------
Title:-----------------------------------------------------------------
Company:---------------------------------------------------------------
Signature:-------------------------------------------------------------
Date:------------------------------------------------------------------

(End of provision)
0
32. Revise section 352.216-70 to read as follows:


352.216-70  Allowable Cost and Payment for Hospitals (Profit and Non-
Profit).

    As prescribed in 316.307(a)(1), insert the following clause:

Allowable Cost and Payment for Hospitals (Profit and Non-Profit) 
(DATE)

    Payment amounts requested by the Contractor and included in 
invoices submitted for payment in accordance with Federal 
Acquisition Regulation (FAR) clause 52.216-7, paragraph (a)(1), must 
be determined allowable by the Contracting Officer in accordance 
with the FAR clause at 52.216-7, 45 CFR part 75, appendix IX, and 
FAR subpart 31.2, in effect on the date of this contract and in 
accordance with the terms of this contract.

(End of clause)
0
33. Revise sections 352.219-70 and 352.219-71 to read as follows:


352.219-70  Notification of Competition Limited to Eligible 8(a) 
Participants.

    As prescribed in 319.811-370(a), insert the following clause and 
use in conjunction with the clause at FAR 52.219-18:

Notification of Competition Limited to Eligible 8(a) Participants 
(DATE)

    Substitute paragraph (c) in FAR Clause 52.219-18 as follows:
    (c) Any award resulting from this solicitation will be made 
directly by the Contracting Officer to the successful 8(a) offeror. 
Although SBA is not identified as such in the award form, SBA is 
still the Prime Contractor. Contractor shall comply with the 
limitations on subcontracting as provided in 13 CFR 125.6 and all 
other 8(a) program requirements, as set forth in 13 CFR part 124.

(End of clause)


352.219-71  Notification of Section 8(a) Direct Award.

    As prescribed in 319.811-70(b), insert the following clause:

Notification of Section 8(a) Direct Award (DATE)

    (a) Offers are solicited only from small business concerns 
expressly certified by the Small Business Administration (SBA) for 
participation in the SBA's 8(a) Program. By submission of its offer, 
the Offeror represents that it is in good standing and that it meets 
all of the criteria for participation in the program in accordance 
with 13 CFR part 124.
    (b) Any award resulting from this solicitation will be made 
directly by the Contracting Officer to the successful 8(a) offeror. 
Although SBA is not identified as such in the award form, SBA is 
still the Prime Contractor.
    (c) This contract is issued as a direct award between the 
contracting activity and the 8(a) Contractor pursuant to the 
Partnership Agreement (PA) between the Small Business Administration 
(SBA) and the Department of Health and Human Services.
    (d) SBA retains responsibility for 8(a) certification, 8(a) 
eligibility determinations and related issues, and providing 
counseling and assistance to the 8(a) Contractor under the 8(a) 
program. The cognizant SBA district office is: ________[To be 
completed by the Contracting Officer at the time of award].
    (e) The contracting activity is responsible for administering 
the contract and taking any action on behalf of the Government under 
the terms and conditions of the contract. However, the contracting 
activity shall give advance notice to the SBA before it issues a 
final notice terminating performance, either in whole or in part, 
under the contract. The contracting activity shall obtain SBA's 
approval prior to processing any novation agreement(s). The 
contracting activity may assign contract administration functions to 
a contract administration office.
    (f) The Contractor agrees:
    (1) To notify the Contracting Officer, simultaneous with its 
notification to SBA (as required by SBA's 8(a) regulations), when 
the owner or owners upon whom 8(a) eligibility

[[Page 80698]]

is based plan to relinquish ownership or control of the concern.
    (2) Consistent with 15 U.S.C. 637(a)(21), transfer of ownership 
or control shall result in termination of the contract for 
convenience, unless SBA waives the requirement for termination prior 
to the actual relinquishing of ownership and control.
    (3) It will adhere to the requirements of FAR 52.219-14, 
Limitations of Subcontracting, and other requirements in 13 CFR part 
124 and 13 CFR 125.6, as applicable
    (g) Any proposed joint venture involving an 8(a) Participant 
must be approved by SBA before contracts are awarded.

(End of clause)
0
34. Revise section 352.222-70 to read as follows:


352.222-70  Contractor Cooperation in Equal Employment Opportunity and 
Anti-Harassment Investigations.

    As prescribed in 322.810(e), insert the following clause:

Contractor Cooperation in Equal Employment Opportunity and Anti-
Harassment Investigations (DATE)

    (a) Definitions. As used in this clause--
    Complaint means a formal or informal complaint that has been 
filed with Health and Human Services (HHS), HHS agency Equal 
Employment Opportunity (EEO) officials, the Equal Employment 
Opportunity Commission (EEOC), the Office of Federal Contract 
Compliance Programs (OFCCP) or a court of competent jurisdiction.
    Contractor employee means all current Contractor employees who 
work or worked under this contract. The term also includes current 
employees of subcontractors who work or worked under this contract. 
In the case of Contractor and subcontractor employees who worked 
under this contract, but who are no longer employed by the 
Contractor or subcontractor, or who have been assigned to another 
entity within the Contractor's or subcontractor's organization, the 
Contractor shall provide HHS with that employee's last known mailing 
address, email address, and telephone number, if that employee has 
been identified as a witness in an EEO or Anti-Harassment complaint 
or investigation.
    Good faith cooperation means, but is not limited to, making 
Contractor employees available, with the presence or assistance of 
counsel as deemed appropriate by the Contractor, for--
    (1) Formal and informal interviews by EEO counselors, the OFCCP, 
or other Agency officials processing EEO or Anti-Harassment 
complaints;
    (2) Formal or informal interviews by EEO investigators charged 
with investigating complaints of unlawful discrimination filed by 
Federal employees;
    (3) Reviewing and signing appropriate affidavits or declarations 
summarizing statements provided by such Contractor employees during 
EEO or Anti-Harassment investigations;
    (4) Producing documents requested by EEO counselors, EEO 
investigators, OFCCP investigators, Agency employees, or the EEOC in 
connection with a pending EEO or Anti-Harassment complaint; and
    (5) Preparing for and providing testimony in depositions or in 
hearings before the Merit Systems Protection Board, EEOC, OFCCP, and 
U.S. District Court.
    (b) Cooperation with investigations. In addition to complying 
with the clause at FAR 52.222-26, Equal Opportunity, the Contractor 
shall, in good faith, cooperate with the Department of Health and 
Human Services (HHS) in investigations of Equal Employment 
Opportunity (EEO) complaints processed pursuant to 29 CFR part 1614 
and internal Anti-Harassment investigations.
    (c) Compliance. Failure on the part of the Contractor or its 
subcontractors to comply with the terms of this clause may be 
grounds for the Contracting Officer to terminate this contract for 
default (or for cause when using FAR part 12 procedures) in 
accordance with the termination clause contained in the contract.
    (d) Subcontract flowdown. The Contractor shall include the terms 
and conditions of this clause in its entirety in all subcontract 
solicitations and subcontracts awarded, at any tier, under this 
contract.

(End of clause)
0
35. Revise sections 352.223-70 and 352.223-71 to read as follows:


352.223-70  Instructions to Offerors--Sustainable Acquisition Plan.

    As prescribed in 323.109-70, insert the following provision:

Instructions to Offerors--Sustainable Acquisition Plan (DATE)

    Offerors shall include a Sustainable Acquisition Plan in their 
technical proposals. The Plan must describe their approach and the 
quality assurance mechanisms in place for applying FAR subpart 23.1, 
Sustainable Products and Services, and other Federal laws, 
regulations and Executive Orders governing sustainable acquisition. 
The Plan shall clearly identify those products and services included 
in Federal sustainable acquisition preference programs by 
categorizing them along with their respective price/cost in the 
following eight groups: Recycled Content, Energy Efficient, 
Biobased, Environmentally Preferable, Electronic Product Environment 
Assessment Tool, Water-Efficient, Non-Ozone Depleting Substances, 
and Alternative Fuel Vehicle and Alternative Fuels.

(End of provision)


352.223-71  Safety and Health.

    As prescribed in 323.304-70, insert the following clause:

Safety and Health (DATE)

    (a) To help ensure the protection of the life and health of all 
persons, and to help prevent damage to property, the Contractor 
shall comply with all Federal, State, and local laws and regulations 
applicable to the work being performed under this contract. These 
laws are implemented or enforced by the Environmental Protection 
Agency, Occupational Safety and Health Administration (OSHA) and 
other regulatory/enforcement agencies at the Federal, State, and 
local levels.
    (1) In addition, the Contractor shall comply with the following 
regulations when developing and implementing health and safety 
operating procedures and practices for both personnel and facilities 
involving the use or handling of hazardous materials and the conduct 
of research, development, or test projects:
    (i) 29 CFR 1910.1030, Bloodborne pathogens; 29 CFR 1910.1450, 
Occupational exposure to hazardous chemicals in laboratories; and 
other applicable occupational health and safety standards issued by 
OSHA and included in 29 CFR part 1910. These regulations are 
available at https://www.osha.gov/.
    (ii) Nuclear Regulatory Commission Standards and Regulations, 
pursuant to the Energy Reorganization Act of 1974 (42 U.S.C. 5801 et 
seq.). The Contractor may obtain copies from the U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001.
    (2) The following Government guidelines are recommended for 
developing and implementing health and safety operating procedures 
and practices for both personnel and facilities:
    (i) Biosafety in Microbiological and Biomedical Laboratories, 
CDC. This publication is available at https://www.cdc.gov/biosafety/publications/index.htm.
    (ii) Prudent Practices for Safety in Laboratories (1995), 
National Research Council, National Academy Press, 500 Fifth Street 
NW, Lockbox 285, Washington, DC 20055 (ISBN 0-309-05229-7). This 
publication is available at https://www.nap.edu/catalog/4911/prudent-practices-in-the-laboratory-han.
    (b) Further, the Contractor shall take or cause to be taken 
additional safety measures as the Contracting Officer, in 
conjunction with the Contracting Officer's Representative or other 
appropriate officials, determines to be reasonably necessary. If 
compliance with these additional safety measures results in an 
increase or decrease in the cost or time required for performance of 
any part of work under this contract, the Contracting Officer will 
make an equitable adjustment in accordance with the applicable 
``Changes'' clause set forth in this contract.
    (c) The Contractor shall maintain an accurate record of, and 
promptly report to the Contracting Officer, all accidents or 
incidents resulting in the exposure of persons to toxic substances, 
hazardous materials or hazardous operations; the injury or death of 
any person; or damage to property incidental to work performed under 
the contract resulting from toxic or hazardous materials and 
resulting in any or all violations for which the Contractor has been 
cited by any Federal, State or local regulatory/enforcement agency. 
The report citing all accidents or incidents resulting in the 
exposure of persons to toxic substances, hazardous materials or 
hazardous operations; the injury or death of any person; or damage 
to property incidental to work performed under the contract 
resulting from toxic or hazardous materials and resulting in any or 
all violations for which the Contractor has been cited shall include 
a copy of the notice

[[Page 80699]]

of violation and the findings of any inquiry or inspection, and an 
analysis addressing the impact these violations may have on the work 
remaining to be performed. The report shall also state the required 
action(s), if any, to be taken to correct any violation(s) noted by 
the Federal, State, or local regulatory/enforcement agency and the 
time frame allowed by the agency to accomplish the necessary 
corrective action.
    (d) If the Contractor fails or refuses to comply with the 
Federal, State or local regulatory/enforcement agency's directive(s) 
regarding any violation(s) and prescribed corrective action(s), the 
Contracting Officer may issue an order stopping all or part of the 
work until satisfactory corrective action (as approved by the 
Federal, State, or local regulatory/enforcement agencies) has been 
taken and documented to the Contracting Officer. No part of the time 
lost due to any such stop work order shall form the basis for a 
request for extension or costs or damages by the Contractor.
    (e) The Contractor shall insert the substance of this clause in 
each subcontract involving toxic substances, hazardous materials, or 
hazardous operations. The Contractor is responsible for the 
compliance of its subcontractors with the provisions of this clause.

(End of clause)
0
36. Add sections 352.225-70 and 352.225-71 to read as follows:


352.225-70  Made in America--Personal Protective Equipment.

    As prescribed in 325.7103(a), insert the following clause:

Made in America--Personal Protective Equipment (DATE)

    (a) Definitions. As used in this clause--
    Component, as applied to an item described in subsection (b) of 
this clause, means an article, material, or supply incorporated 
directly into personal protective equipment.
    Domestic personal protective equipment, as applied to an item 
described in subsection (b) of this clause, means personal 
protective equipment, including the materials and components 
thereof, that is grown, reprocessed, reused, or produced in the 
United States.
    Foreign-made domestic personal protective equipment, as applied 
to an item described in subsection (b) of this clause, means 
personal protective equipment that is assembled outside the United 
States containing only materials and components that are grown, 
reprocessed, reused, or produced in the United States.
    Foreign personal protective equipment means personal protective 
equipment other than domestic personal protective equipment or 
foreign-made domestic personal protective equipment.
    Personal protective equipment, as applied to an item described 
in subsection (b) of this clause, means surgical masks, respirator 
masks and powered air purifying respirators and required filters, 
face shields and protective eyewear, gloves, disposable and reusable 
surgical and isolation gowns, head and foot coverings, and other 
gear or clothing used to protect an individual from the transmission 
of disease.
    United States, as applied to an item described in subsection (b) 
of this clause, means the 50 States, the District of Columbia, and 
the possessions of the United States.
    (b) Requirement. The Contractor shall deliver only domestic 
personal protective equipment, unless it specified delivery of 
foreign-made domestic personal protective equipment in the provision 
of the solicitation entitled ``Made in America Certificate--Personal 
Protective Equipment.''

(End of clause)


352.225-71  Made in America Certificate--Personal Protective Equipment.

    As prescribed in 325.7103(b), insert the following provision:

Made In America Certificate--Personal Protective Equipment (DATE)

    (a)(1) The Offeror certifies that each item of personal 
protective equipment, except those listed in paragraph (b) of this 
provision, is domestic personal protective equipment.
    (2) The Offeror shall list offered foreign-made domestic 
personal protective equipment items in paragraph (b).
    (3) The terms ``domestic personal protective equipment,'' 
``foreign-made domestic personal protective equipment,'' foreign 
personal protective equipment,'' and ``personal protective 
equipment,'' are defined in the clause of this solicitation entitled 
``Made in America--Personal Protective Equipment.''
    (b) Foreign-made Domestic Personal Protective Equipment:

------------------------------------------------------------------------
               Line-Item No.                      Country of origin
------------------------------------------------------------------------
                                            ............................
                                            ............................
                                            ............................
------------------------------------------------------------------------

    [List as necessary]

(End of provision)


352.226-1 through 352.226-7  [Redesignated as 352.226-70 through 
352.226-76]

0
37. Redesignate sections 352.226-1 through 352.226-7 as sections 
352.226-70 through 352.226-76.
0
38. Revise newly redesignated sections 352.226-70 through 352.226-76 to 
read as follows:
Sec.
* * * * *
352.226-70 Indian Preference.
352.226-71 Indian Preference Program.
352.226-72 Native American Graves Protection and Repatriation Act.
352.226-73 Notice of Indian Small Business Economic Enterprise Set-
Aside.
352.226-74 Notice of Indian Economic Enterprise Set-Aside.
352.226-75 Indian Economic Enterprise Subcontracting Limitations.
352.226-76 Indian Economic Enterprise Representation.
* * * * *


352.226-70  Indian Preference.

    As prescribed in 326.7005(a), insert the following clause:

Indian Preference (DATE)

    (a) The Contractor agrees to give preference in employment 
opportunities under this contract to Indians who can perform 
required work, regardless of age (subject to existing laws and 
regulations), sex, religion, or tribal affiliation. To the extent 
feasible and consistent with the efficient performance of this 
contract, the Contractor further agrees to give preference in 
employment and training opportunities under this contract to Indians 
who are not fully qualified to perform regardless of age (subject to 
existing laws and regulations), sex, religion, or tribal 
affiliation. The Contractor also agrees to give preference to Indian 
organizations and Indian-owned economic enterprises in the awarding 
of any subcontracts to the extent feasible and consistent with the 
efficient performance of this contract. The Contractor shall 
maintain the necessary statistical records to demonstrate compliance 
with this paragraph.
    (b) In connection with the Indian employment preference 
requirements of this clause, the Contractor shall provide reasonable 
opportunities for training, incident to such employment. Such 
training shall include on-the-job, classroom, or apprenticeship 
training designed to increase the vocational effectiveness of an 
Indian employee.
    (c) If the Contractor is unable to fill its employment and 
training opportunities after giving full consideration to Indians as 
required by this clause, the Contractor may satisfy those needs by 
selecting non-Indian persons in accordance with the clause of this 
contract entitled ``Equal Opportunity.''
    (d) If no Indian organizations or Indian-owned economic 
enterprises are available under reasonable terms and conditions, 
including price, for awarding of subcontracts in connection with the 
work performed under this contract, the Contractor agrees to comply 
with the provisions of this contract involving utilization of small 
businesses; HUBZone small businesses; service-disabled, veteran-
owned small businesses; 8(a) small businesses; veteran-owned small 
businesses; women-owned small businesses; or small disadvantaged 
businesses.
    (e) As used in this clause,
    (1) Indian means a person who is a member of an Indian tribe. If 
the Contractor has reason to doubt that a person seeking employment 
preference is an Indian, the Contractor shall grant the preference 
but shall require the individual provide evidence within 30 days 
from the tribe concerned that the person is a member of the tribe.
    (2) Indian tribe means an Indian tribe, pueblo, band, nation, or 
other organized group or community, including Alaska Native village 
or regional or village corporation as defined in or established 
pursuant to the Alaska Native Claims Settlement Act (85 Stat. 688; 
43 U.S.C. 1601) which the United States recognizes as eligible for 
the special programs and services provided to Indians because of its 
status as Indians.
    (3) Indian organization means the governing body of any Indian 
Tribe or entity

[[Page 80700]]

established or recognized by such governing body in accordance with 
the Indian Financing Act of 1974 (88 Stat. 77; 25 U.S.C. 1451).
    (4) Indian-owned economic enterprise means any Indian-owned 
commercial, industrial, or business activity established or 
organized for the purpose of profit, provided that such Indian 
ownership shall constitute not less than 51 percent of the 
enterprise, and that ownership shall encompass active operation and 
control of the enterprise.
    (f) The Contractor agrees to include the provisions of this 
clause, including this paragraph (f), in each subcontract awarded at 
any tier under this contract.
    (g) In the event of noncompliance with this clause, the 
Contracting Officer may terminate the contract in whole or in part 
or may pursue any other remedies authorized by law or by other 
provisions of the contract.

(End of clause)


352.226-71  Indian Preference Program.

    As prescribed in 326.7005(b), insert the following clause:

Indian Preference Program (DATE)

    (a) In addition to the requirements of the clause of this 
contract entitled ``Indian Preference,'' the Contractor agrees to 
establish and conduct an Indian preference program which will expand 
opportunities for Indians to receive preference for employment and 
training in connection with the work performed under this contract, 
and which will expand the opportunities for Indian organizations and 
Indian-owned economic enterprises to receive a preference in the 
awarding of subcontracts. In this connection, the Contractor shall 
perform the following:
    (1) Designate a liaison officer who will maintain liaison with 
the Government and the Tribe(s) on Indian preference matters; 
supervise compliance with the provisions of this clause; and 
administer the Contractor's Indian preference program.
    (2) Advise its recruitment sources in writing and include a 
statement in all employment advertisements that Indian applicants 
receive preference in employment and training incident to such 
employment.
    (3) Not more than 20 calendar days after award of the contract, 
post a written notice setting forth the Contractor's employment 
needs and related training opportunities in the tribal office of any 
reservations on or near the contract work location. The notice shall 
include the approximate numbers and types of employees needed; the 
approximate dates of employment; any experience or special skills 
required for employment; training opportunities available; and other 
pertinent information necessary to advise prospective employees of 
any other employment requirements. The Contractor shall also request 
the tribe(s) on or near whose reservation(s) the Contractor will 
perform contract work to provide assistance filling its employment 
needs and training opportunities. The Contracting Officer will 
advise the Contractor of the name, location, and phone number of the 
Tribal officials to contact regarding the posting of notices and 
requests for Tribal assistance.
    (4) Establish and conduct a subcontracting program which gives 
preference to Indian organizations and Indian-owned economic 
enterprises as subcontractors (including suppliers) under this 
contract. The Contractor shall give public notice of existing 
subcontracting opportunities and, to the extent feasible and 
consistent with the efficient performance of this contract, shall 
solicit bids or proposals from Indian organizations or Indian-owned 
economic enterprises only. The Contractor shall request assistance 
and information on Indian firms qualified as subcontractors 
(including suppliers) from the Tribe(s) on or near whose 
reservation(s) the Contractor will perform contract work. The 
Contracting Officer will advise the Contractor of the name, 
location, and phone number of the Tribal officials to contact 
regarding the request for assistance and information. Public notices 
and solicitations for existing subcontracting opportunities shall 
provide an equitable opportunity for Indian firms to submit bids or 
proposals by including--
    (i) A clear description of the supplies or services required, 
including quantities, specifications, and delivery schedules that 
facilitate the participation of Indian firms;
    (ii) A statement indicating that Indian organizations and 
Indian-owned economic enterprises will receive preference in 
accordance with section 7(b) of Public Law 93-638; 88 Stat. 2205; 25 
U.S.C. 450e(b);
    (iii) Definitions for the terms ``Indian organization'' and 
``Indian-owned economic enterprise'' prescribed under the ``Indian 
Preference'' clause of this contract;
    (iv) A statement that the bidder or offeror shall complete 
certifying that it is an Indian organization or Indian-owned 
economic enterprise; and
    (v) A closing date for receipt of bids or proposals which 
provides sufficient time for preparation and submission of a bid or 
proposal. If, after soliciting bids or proposals from Indian 
organizations and Indian-owned economic enterprises, the Contractor 
receives no responsive bid or acceptable proposal, the Contractor 
shall comply with the requirements of paragraph (d) of the ``Indian 
Preference'' clause of this contract. If the Contractor receives one 
or more responsive bids or conforming proposals, the Contractor 
shall award the contract to the low, responsive, responsible bidder 
or conforming offer from a responsible offeror if the price is 
reasonable. If the Contractor determines the low responsive bid or 
conforming proposal's price is unreasonable, the Contractor shall 
attempt to negotiate a reasonable price and award a subcontract. If 
parties cannot agree on a reasonable price, the Contractor shall 
comply with the requirements of paragraph (d) of the ``Indian 
Preference'' clause of this contract.
    (5) Maintain written records under this contract which 
demonstrate--
    (i) The numbers of Indians seeking employment for each 
employment position available under this contract;
    (ii) The number and types of positions filled by Indians and 
non-Indians;
    (iii) The total number of Indians employed under this contract;
    (iv) For those positions having both Indian and non-Indian 
applicants, and a non-Indian is selected for employment, the 
reason(s) why the Contractor did not select the Indian applicant;
    (v) Actions taken to give preference to Indian organizations and 
Indian-owned economic enterprises for subcontracting opportunities 
which exist under this contract;
    (vi) Reasons why Indian subcontractors and or suppliers did not 
receive preference for each requirement where the Contractor 
determined that such preference was inconsistent with efficient 
contract performance; and
    (vii) The number of Indian organizations and Indian-owned 
economic enterprises contacted, and the number receiving subcontract 
awards under this contract.
    (6) Submit to the Contracting Officer for approval a quarterly 
report summarizing the Contractor's Indian preference program and 
indicating the number and types of available positions filled by 
Indians and non-Indians, and the dollar amounts of all subcontracts 
awarded to Indian organizations and Indian-owned economic 
enterprises, and to all other firms.
    (7) Maintain records pursuant to this clause and keep them 
available for review by the Government for one year after final 
payment under this contract, or for such longer period in accordance 
with requirements of any other clause of this contract or by 
applicable law or regulation.
    (b) For purposes of this clause, the following definitions of 
terms shall apply:
    (1) The terms Indian, Indian tribe, Indian organization, and 
Indian-owned economic enterprise are defined in the clause of this 
contract entitled Indian Preference.
    (2) Indian reservation includes Indian reservations, public 
domain Indian allotments, former Indian reservations in Oklahoma, 
and land held by incorporated Native groups, regional corporations, 
and village corporations under the provisions of the Alaska Native 
Claims Settlement Act (85 Stat. 688; 43 U.S.C. 1601 et seq.)
    (3) On or near an Indian reservation means on a reservation or 
reservations or within that area surrounding an Indian 
reservation(s) where a person seeking employment could reasonably 
expect to commute to and from in the course of a work day.
    (c) Nothing in the requirements of this clause shall preclude 
Indian tribes from independently developing and enforcing their own 
Indian preference requirements. Such requirements must not conflict 
with any Federal statutory or regulatory requirement dealing with 
the award and administration of contracts.
    (d) The Contractor agrees to include the provisions of this 
clause, including this paragraph (d), in each subcontract awarded at 
any tier under this contract and to notify the Contracting Officer 
of such subcontracts.
    (e) In the event of noncompliance with this clause, the 
Contracting Officer may terminate the contract in whole or in part 
or may pursue any other remedies authorized by law or by other 
provisions of the contract.

(End of clause)

[[Page 80701]]

352.226-72  Native American Graves Protection and Repatriation Act.

    As prescribed in 326.7201, insert the following clause:

Native American Graves Protection and Repatriation Act (DATE)

    (a) Public Law 101-601, dated November 16, 1990, also known as 
the Native American Graves Protection and Repatriation Act, imposes 
certain responsibilities on individuals and organizations when they 
discover Native American cultural items (including human remains) on 
Federal or tribal lands.
    (b) In the event the Contractor discovers Native American 
cultural items (including human remains, associated funerary 
objects, unassociated funerary objects, sacred objects and cultural 
patrimony), as defined in the Act during contract performance, the 
Contractor shall--
    (1) Immediately cease activity in the area of the discovery;
    (2) Notify the Contracting Officer of the discovery; and
    (3) Make a reasonable effort to protect the items discovered 
before resuming such activity. Upon receipt of the Contractor's 
discovery notice, the Contracting Officer will notify the 
appropriate authorities as required by the Act.
    (c) Unless otherwise specified by the Contracting Officer, the 
Contractor may resume activity in the area on the 31st calendar day 
following the date that the appropriate authorities certify receipt 
of the discovery notice. The Contracting Officer shall provide to 
the Contractor the date that the appropriate authorities certify 
receipt of the discovery notice and the date on which the Contractor 
may resume activities.

(End of clause)


352.226-73  Notice of Indian Small Business Economic Enterprise Set-
Aside.

    As prescribed in 326.7105(a), and in lieu of the requirements of 48 
CFR 19.508, insert the following provision:

Notice of Indian Small Business Economic Enterprise Set-Aside (DATE)

    Under the Buy Indian Act, 25 U.S.C. 47, offers are solicited 
only from Indian Economic Enterprises (see 326.7106) that are also 
small business concerns. Any acquisition resulting from this 
solicitation will be from such a concern. As required by 352.226-
76(b), offerors shall include a completed Indian Economic Enterprise 
Representation form in response to Sources Sought Notices, Request 
for Information (RFI) and as part of the proposal submission. The 
Indian Economic Enterprise Representation form, available on the IHS 
DAP public website (www.IHS.gov/DAP), shall be included in synopses, 
presolicitation notices, and solicitations for the acquisitions 
under the Buy Indian Act. Offers received from enterprises that are 
not both Indian Economic Enterprises and small business concerns 
will not be considered and will be rejected.

(End of clause)


352.226-74  Notice of Indian Economic Enterprise Set-Aside.

    As prescribed in 326.7105(b), insert the following clause:

Notice of Indian Economic Enterprise Set-Aside (DATE)

    (a) Definitions. As used in this clause:
    Alaska Native Claims Settlement Act (ANCSA) means Pub. L. 92-203 
(December 18, 1971), 85 Stat. 688, codified at 43 U.S.C. 1601-1629h.
    Indian means a person who is an enrolled member of an Indian 
Tribe or ``Native'' as defined in the Alaska Native Claims 
Settlement Act.
    Indian Economic Enterprise means any business activity owned by 
one or more Indians or Indian Tribes that is established for the 
purpose of profit provided that: The combined Indian or Indian Tribe 
ownership must constitute not less than 51 percent of the 
enterprise; the Indians or Indian Tribes must, together, receive at 
least a majority of the earnings from the contract; and the 
management and daily business operations of an enterprise must be 
controlled by one or more individuals who are Indians. To ensure 
actual control over the enterprise, the individuals must possess 
requisite management or technical capabilities directly related to 
the primary industry in which the enterprise conducts business. The 
enterprise must meet these requirements throughout the following 
time periods--
    (1) At the time an offer is made in response to a written 
solicitation;
    (2) At the time of the contract award; and
    (3) During the full term of the contract.
    Indian Tribe means an Indian Tribe, band, nation, or other 
recognized group or community that is recognized as eligible for the 
special programs and services provided by the United States to 
Indians because of their status as Indians, including any Alaska 
Native village or regional or village corporation under the Alaska 
Native Claims Settlement Act (Pub. L. 92-203, 85 Stat. 688; 43 
U.S.C. 1601).
    Representation means the positive statement by an enterprise of 
its eligibility for preferential consideration and participation for 
acquisitions conducted under the Buy Indian Act, 25 U.S.C. 47, in 
accordance with the procedures in section 326.7106.
    (b) General. (1) Under the Buy Indian Act, offers are solicited 
only from Indian Economic Enterprises.
    (2) The Contracting Officer will reject all offers received from 
ineligible enterprises.
    (3) Any award resulting from this solicitation will be made to 
an Indian Economic Enterprise, as defined in paragraph (a) of this 
clause.
    (c) Required submissions. In response to this solicitation, an 
offeror must also provide the following:
    (1) A description of the required percentage of the work/costs 
to be provided by the offeror over the contract term as required by 
the clause at 352.226-75, Subcontracting Limitations; and
    (2) Qualifications of the key personnel (if any) that will be 
assigned to the contract.
    (d) Required assurance. The offeror must provide written 
assurance to the Contracting Officer that the offeror is and will 
remain in compliance with the requirements of this clause. It must 
do this before the Contracting Officer awards the Buy Indian Act 
contract and upon successful and timely completion of the contract, 
but before the Contracting Officer accepts the work or product.
    (e) Non-responsiveness. Failure to provide the information 
required by paragraphs (c) and (d) of this clause may cause the 
Contracting Officer to find an offer non-responsive and reject it.
    (f) Eligibility. (1) Participation in the Mentor-
Prot[eacute]g[eacute] Program established under section 831 of the 
National Defense Authorization Act for Fiscal Year 1991 (25 U.S.C. 
47 note) does not render an Indian Economic Enterprise ineligible 
for contracts awarded under the Buy Indian Act.
    (2) If a contractor no longer meets the definition of an Indian 
Economic Enterprise after award, the contractor must notify the 
Contracting Officer immediately and in writing. The notification 
must include full disclosure of circumstances causing the contractor 
to lose eligibility status and a description of any actions that the 
contractor will take to regain eligibility. Failure to give the 
Contracting Officer immediate written notification means that:
    (i) The economic enterprise may be declared ineligible for 
future contract awards under this part; and
    (ii) The Contracting Officer may consider termination for 
default if it is in the best interest of the government.
    (g) Representation. Under the Buy Indian Act, 25 U.S.C. 47, 
offers are solicited only from Indian Economic Enterprises (see 
326.7106). As required by 352.226-76(b), offerors shall include a 
completed Indian Economic Enterprise Representation form in response 
to Sources Sought Notices, Request for Information (RFI) and as part 
of the proposal submission. The Indian Economic Enterprise 
Representation form, available on the IHS DAP public website 
(www.IHS.gov/DAP), shall be included in synopses, presolicitation 
notices, and solicitations for the acquisitions under the Buy Indian 
Act. Offers received from enterprises that are not Indian Economic 
Enterprises shall not be considered.

(End of clause)


352.226-75  Indian Economic Enterprise Subcontracting Limitations.

    As prescribed in 326.7105(c), insert the following clause:

Indian Economic Enterprise Subcontracting Limitations (DATE)

    (a) Definitions. As used in this clause--
    (1) Indian Economic Enterprise means any business activity owned 
by one or more Indians or Indian Tribes that is established for the 
purpose of profit provided that: The combined Indian or Indian Tribe 
ownership must constitute not less than 51 percent of the 
enterprise; the Indians or Indian Tribes must, together, receive at 
least a majority of the earnings from the contract; and the 
management and daily business operations of an enterprise must be 
controlled by one or more individuals who are Indians. To ensure 
actual control over the enterprise, the

[[Page 80702]]

individuals must possess requisite management or technical 
capabilities directly related to the primary industry in which the 
enterprise conducts business. The enterprise must meet these 
requirements throughout the following time periods:
    (i) At the time an offer is made in response to a written 
solicitation;
    (ii) At the time of the contract award; and
    (iii) During the full term of the contract.
    (2) Subcontract means any contract, as defined in FAR subpart 
2.1, entered into by a subcontractor to furnish supplies or services 
for performance of the prime contractor or subcontractor. It 
includes, but is not limited to, purchase orders, and changes and 
modifications to purchase orders.
    (3) Subcontractor means any supplier, distributor, vendor, or 
firm that furnishes supplies or services to or for a prime 
contractor or another subcontractor.
    (b) Required percentages of work by the concern. The contractor 
must comply with FAR 52.219-14, Limitations on Subcontracting, 
clause in allocating what percentage of work to subcontract. The 
contractor shall not subcontract work exceeding the subcontract 
limitations in FAR 52.219-14 to a concern other than a responsible 
Indian Economic Enterprise.
    (c) Work performed by non-IEE subcontractor employees. Any work 
that an IEE subcontractor does not perform with its own employee 
shall be considered subcontracted work for the purpose of 
calculating percentages of subcontract work in accordance with FAR 
52.219-14, Limitations on Subcontracting.
    (d) Cooperation. The Contractor must--
    (1) Carry out the requirements of this clause to the fullest 
extent; and
    (2) Cooperate in any study or survey that the Contracting 
Officer, Indian Health Service or its agents may conduct to verify 
the contractor's compliance with this clause.
    (e) Incorporation in subcontracts. The contractor must 
incorporate the substance of this clause, including this paragraph 
(e), in all subcontracts for general services, architect-engineer 
(A-E) services and construction awarded under this contract.

(End of clause)


352.226-76  Indian Economic Enterprise Representation.

    As prescribed in 326.7105(d), insert the following provision:

Indian Economic Enterprise Representation (DATE)

    (a) The offeror must represent as part of its offer that it does 
meet the definition of Indian Economic Enterprise (IEE) as defined 
in 326.7101 and that it intends to meet the definition of an IEE 
throughout the performance of the contract. The offeror must notify 
the contracting officer immediately, via email, if there is any 
ownership change affecting compliance with this representation.
    (b) The representation must be made on the designated IHS Indian 
Economic Enterprise Representation form or any successor forms 
through which the offeror will certify that the ownership 
requirements defined by 326.7101 are met.
    (c) Any false or misleading information submitted by an 
enterprise when submitting an offer in consideration for an award 
set-aside under the Buy Indian Act is a violation of the law 
punishable under 18 U.S.C. 1001. False claims submitted as part of 
contract performance are subject to the penalties enumerated in 31 
U.S.C. 3729 to 3731 and 18 U.S.C. 287.

(End of provision)


352.227-11, 352.227-14, and 352.227-70  [Redesignated as 352.227-70, 
352.227-71, and 352.227-72]

0
39. Redesignate sections 352.227-11, 352.227-14, and 352.227-70 as 
sections 352.227-70, 352.227-71, and 352.227-72.
0
40. Revise newly redesignated sections 352.227-70 through 352.227-72 to 
read as follows:


352.227-70  Patent Rights--Supplement--Exceptional Circumstances.

    As prescribed in 327.303-70, insert the following clause:

Patent Rights--Supplement--Exceptional Circumstances (DATE)

    (a) Definitions. As used in this clause--
    Agency means the U.S. Department of Health and Human Services 
operating division or agency (i.e., Centers for Disease Control and 
Prevention, Food and Drug Administration, etc.) that is entering 
into this contract.
    Class 1 Subject Invention means a Subject Invention described 
and defined in the Determination of Exceptional Circumstances (DEC) 
that will be assigned to a third party assignee, or assigned as 
directed by the Agency.
    Class 2 Subject Invention means a Subject Invention described 
and defined in the DEC.
    Class 3 Subject Invention means a Subject Invention that does 
not fall into Class 1 or Class 2 as defined in this clause.
    DEC means the Determination of Exceptional Circumstances signed 
by ______[insert approving official] on ____ [insert date] and 
titled ``______[insert description].''
    Invention means any invention or discovery, which is or may be 
patentable or otherwise protectable under Title 35 of United States 
Code, or any novel variety of plant that is or may be protectable 
under the Plant Variety Protection Act (7 U.S.C. 2321, et seq.)
    Made means, when used in relation to any invention other than a 
plant variety, the conception or first actual reduction to practice 
of such invention; or when used in relation to a plant variety, that 
the Contractor has at least tentatively determined that the variety 
has been reproduced with recognized characteristics.
    Material means any proprietary material, method, product, 
composition, compound, or device, whether patented or unpatented, 
which is provided to the Contractor under this contract.
    Nonprofit organization means a university or other institution 
of higher education or an organization of the type described in 
section 501(c)(3) of the Internal Revenue Code of 1954 (26 U.S.C. 
501(c)) and exempt from taxation under section 501(a) of the 
Internal Revenue Code (26 U.S.C. 501(a)) or any nonprofit scientific 
or educational organization qualified under a state nonprofit 
organization statute.
    Practical application means to manufacture, in the case of a 
composition or product; to practice, in the case of a process or 
method, or to operate, in the case of a machine or system; and, in 
each case, under such conditions as to establish that the invention 
is being utilized and that its benefits are, to the extent permitted 
by law or Government regulations, available to the public on 
reasonable terms.
    Small business firm means a small business concern as defined at 
section 2 of Public Law 85-536, 15 U.S.C. 632 et seq., and FAR 
19.102. For the purpose of this clause, the size standards for small 
business concerns involved in Government procurement and 
subcontracting at 13 CFR 121.401 through 413, will be used.
    Subject invention means any invention of the Contractor made in 
the performance of work under this contract.
    Third party assignee means any entity or organization that may, 
as described in the DEC, be assigned Class 1 inventions.
    (b) General. This clause applies to all Contractor and 
subcontractor (at all tiers) Subject Inventions.
    (c) Allocation of principal rights. (1) Retention of pre-
existing rights. Third party assignees shall retain all preexisting 
rights to Material in which the third party assignee has a 
proprietary interest.
    (2) Allocation of Subject Invention rights. (i) Disposition of 
Class 1 Subject Inventions. (A) Assignment to the third party 
assignee or as directed by the Agency. The Contractor shall assign 
to the third party assignee designated by the Agency the entire 
right, title, and interest throughout the world to each Subject 
Invention, or otherwise dispose of or transfer those rights as 
directed by the Agency, except to the extent that rights are 
retained by the Contractor under paragraph (c)(3) of this clause. 
Any such assignment or other disposition or transfer of rights will 
be subject to a nonexclusive, nontransferable, irrevocable, paid-up 
license to the U.S. Government to practice or have practiced the 
Subject Invention for or on behalf of the U.S. throughout the world. 
Any assignment shall additionally be subject to the ``March-in 
rights'' of 35 U.S.C. 203. If the Contractor is a U.S. nonprofit 
organization it may retain a royalty free, nonexclusive, 
nontransferable license to practice the invention for all nonprofit 
research including for educational purposes, and to permit other 
U.S. nonprofit organizations to do so.
    (B) [Reserved]
    (ii) Disposition of Class 2 and 3 Subject Inventions. Class 2 
Subject Inventions shall be governed by FAR clause 52.227-11, Patent 
Rights-Ownership by the Contractor. However, the Contractor shall 
grant a license in the Class 2 Subject Inventions to the provider of 
the Material or other party designated by the Agency as set forth in 
Alternate I of this clause, if incorporated.

[[Page 80703]]

    (iii) Class 3 Subject Inventions shall be governed by FAR clause 
52.227-11, Patent Rights--Ownership by the Contractor.
    (3) Greater rights determinations. The Contractor, or an 
employee-inventor after consultation by the Agency with the 
Contractor, may request greater rights than are provided in 
paragraph (c)(1) of this clause in accordance with the procedures of 
FAR 27.304-1(c). In addition to the considerations set forth in FAR 
27.304-1(c), the Agency may consider whether granting the requested 
greater rights will interfere with rights of the Government or any 
third party assignee or otherwise impede the ability of the 
Government or the third party assignee to, for example, develop and 
commercialize new compounds, dosage forms, therapies, preventative 
measures, technologies, or other approaches with potential for the 
diagnosis, prognosis, prevention, and treatment of human diseases.
    (i) A request for a determination of whether the Contractor or 
the employee-inventor is entitled to retain such greater rights must 
be submitted to the Agency Contracting Officer at the time of the 
first disclosure of the invention pursuant to paragraph (d)(1) of 
this clause, and in accordance with the procedures of FAR 27.304-
1(c) or not later than 8 months thereafter, unless a longer period 
is requested in writing by the Contractor and authorized in writing 
by the Contracting Officer for good cause. Each determination of 
greater rights under this contract shall be subject to FAR clause 
52.227-13, paragraph (c) and to any reservations and conditions 
deemed to be appropriate by the Agency such as the requirement to 
assign or exclusively license the rights to Subject Inventions to 
the third party assignee.
    (ii) A determination by the Agency denying a request by the 
Contractor for greater rights in a Subject Invention may be appealed 
within 30 days of the date the Contractor is notified of the 
determination to an Agency official at a level above the individual 
who made the determination. If greater rights are granted, the 
Contractor must file a patent application on the invention. Upon 
request, the Contractor shall provide the filing date, serial number 
and title, a copy of the patent application (including an English-
language version if filed in a language other than English), and 
patent number and issue date for any Subject Invention in any 
country for which the Contractor has retained title. Upon request, 
the Contractor shall furnish the Government an irrevocable power to 
inspect and make copies of the patent application file.
    (d) Invention disclosure by Contractor. The Contractor shall 
disclose in writing each Subject Invention to the Contracting 
Officer and to the Director, Division of Extramural Inventions and 
Technology Resources (DEITR), if directed by the Contracting 
Officer, as provided in paragraph (j) of this clause within 2 months 
after the inventor discloses it in writing to Contractor personnel 
responsible for patent matters.
    (1) The disclosure to the Contracting Officer shall be in the 
form of a written report and shall identify the contract under which 
the invention was made and all inventors. It shall be sufficiently 
complete in technical detail to convey a clear understanding to the 
extent known at the time of the disclosure, of the nature, purpose, 
operation, and the physical, chemical, biological, or electrical 
characteristics of the invention. The disclosure shall also identify 
any publication, on sale (offer for sale), or public use of the 
invention and whether a manuscript describing the invention has been 
submitted for publication, and if so, whether it has been accepted 
for publication at the time of disclosure.
    (2) In addition, after disclosure to the Agency, the Contractor 
will promptly notify the Contracting Officer and DEITR of the 
acceptance of any manuscript describing the invention for 
publication or of any on sale or public use planned by the 
Contractor. If the Contractor assigns a Subject Invention to the 
third party assignee, then the Contractor and its employee inventors 
shall assist the third party assignee in securing patent protection. 
All costs of securing the patent, including the cost of the 
Contractor's assistance, are at the third party's expense. Any 
assistance provided by the Contractor and its employee inventors to 
the third party assignee or other costs incurred in securing patent 
protection shall be solely at the third party's expense and not 
billable to the contract.
    (e) Contractor action to protect the third party assignee's and 
the Government's interest. (1) The Contractor agrees to execute or 
to have executed and promptly deliver to the Agency all instruments 
necessary to: Establish or confirm the rights the Government has 
throughout the world in Subject Inventions pursuant to paragraph (c) 
of this clause; convey title to a third party assignee in accordance 
with paragraph (b) of this clause; and enable the third party 
assignee to obtain patent protection throughout the world in that 
Subject Invention.
    (2) The Contractor agrees to require, by written agreement, its 
employees, other than clerical and nontechnical employees, to 
disclose promptly in writing to personnel identified as responsible 
for the administration of patent matters and in a format suggested 
by the Contractor, each Subject Invention ``made'' under contract in 
order that the Contractor can comply with the disclosure provisions 
of paragraph (c) of this clause, and to execute all papers necessary 
to file patent applications on Subject Inventions and to establish 
the Government's rights or a third party assignee's rights in the 
Subject Inventions. This disclosure format should require, as a 
minimum, the information required by subparagraph (c)(1) of this 
clause. The Contractor shall instruct such employees, through 
employee agreements or other suitable educational programs, on the 
importance of reporting inventions in sufficient time to permit the 
filing of patent applications prior to U.S. or foreign statutory 
bars.
    (3) If the Contractor is granted greater rights, the Contractor 
agrees to include, within the specification of any United States 
non-provisional patent application it files, and any patent issuing 
thereon, covering a Subject Invention the following statement: 
``This invention was made with Government support under (identify 
the Contract) awarded by (identify the specific Agency). The 
Government has certain rights in the invention.''
    (4) The Contractor agrees to provide a final invention statement 
and certification prior to the closeout of the contract listing all 
Subject Inventions or stating that there were none.
    (f) Subcontracts. (1) The Contractor shall include this clause 
in all subcontracts, regardless of tier, for experimental, 
developmental, or research work. At all tiers, the clause must be 
modified to identify the parties with the statement: ``References to 
the Government are not changed, and the subcontractor has all rights 
and obligations of the Contractor in the clause.'' The Contractor 
will not, as part of the consideration for awarding the contract, 
obtain rights in the subcontractor's Subject Inventions.
    (2) In subcontracts, at any tier, the Agency, the subcontractor, 
and the Contractor agree that the mutual obligations of the parties 
created by this clause constitute a contract between the 
subcontractor and the Agency with respect to the matters covered by 
the clause; provided, however, that nothing in this paragraph is 
intended to confer any jurisdiction under the Contract Disputes Act 
in connection with proceedings under paragraph (k)(1)(4) of FAR 
clause 52.227-11.
    (g) Reporting on utilization of Subject Inventions in the event 
greater rights are granted to the Contractor. The Contractor agrees 
to submit, on request, periodic reports no more frequently than 
annually on the utilization of a Subject Invention or on efforts at 
obtaining such utilization that are being made by the Contractor or 
its licensees or assignees when a request under paragraph (c)(3). 
has been granted by the Agency. Such reports shall include 
information regarding the status of development, date of first 
commercial sale or use, gross royalties received by the Contractor, 
and such other data and information as the Agency may reasonably 
specify. The Contractor also agrees to provide additional reports as 
may be requested by the Agency in connection with any march-in 
proceeding undertaken by the Agency in accordance with paragraph (h) 
of this clause. As required by 35 U.S.C. 202(c)(5), the Agency 
agrees it will not disclose such information to persons outside the 
Government without permission of the Contractor.
    (h) Preference for United States industry in the event greater 
rights are granted to the Contractor. Notwithstanding any other 
provision of this clause, the Contractor agrees that neither it nor 
any assignee will grant to any person the exclusive right to use or 
sell any Subject Invention in the United States unless such person 
agrees that any product embodying the Subject Invention or produced 
through the use of the Subject Invention will be manufactured 
substantially in the United States. However, in individual cases, 
the requirement for such an agreement may be waived by the Agency 
upon a showing by the Contractor or its assignee that reasonable but 
unsuccessful efforts have been made to grant licenses on similar 
terms to potential licensees that would be likely to manufacture 
substantially in the United

[[Page 80704]]

States or that under the circumstances domestic manufacture is not 
commercially feasible.
    (i) March-in rights in the event greater rights are granted to 
the Contractor. The Contractor acknowledges that, with respect to 
any Subject Invention in which it has acquired ownership through the 
exercise of the rights specified in paragraph (c)(3) of this clause, 
the Agency has the right to require licensing pursuant to 35 U.S.C. 
203 and 210(c), and in accordance with the procedures in 37 CFR 
401.6 and any supplemental regulations of Agency in effect on the 
date of contract award.
    (j) Special provisions for contracts with nonprofit 
organizations in the event greater rights are granted to the 
Contractor. If the Contractor is a nonprofit organization, it 
shall--
    (1) Not assign rights to a Subject Invention in the United 
States without the written approval of the Agency, except where an 
assignment is made to an organization that has as one of its primary 
functions the management of inventions, provided that the assignee 
shall be subject to the same provisions as the Contractor;
    (2) Share royalties collected on a Subject Invention with the 
inventor, including Federal employee co-inventors (but through their 
Agency if the Agency deems it appropriate) when the Subject 
Invention is assigned in accordance with 35 U.S.C. 202(e) and 37 CFR 
401.10;
    (3) Use the balance of any royalties or income earned by the 
Contractor with respect to Subject Inventions, after payment of 
expenses (including payments to inventors) incidental to the 
administration of Subject Inventions for the support of scientific 
research or education;
    (4) Make efforts that are reasonable under the circumstances to 
attract licensees of Subject Inventions that are small business 
concerns, and give a preference to a small business concern when 
licensing a Subject Invention if the Contractor determines that the 
small business concern has a plan or proposal for marketing the 
invention which, if executed, is equally as likely to bring the 
invention to practical application as any plans or proposals from 
applicants that are not small business concerns; provided, that the 
Contractor is also satisfied that the small business concern has the 
capability and resources to carry out its plan or proposal. The 
decision whether to give a preference in any specific case will be 
at the discretion of the Contractor; and
    (5) Allow the Secretary of Commerce to review the Contractor's 
licensing program and decisions regarding small business applicants, 
and negotiate changes to its licensing policies, procedures, or 
practices with the Secretary of Commerce when the Secretary's review 
discloses that the Contractor could take reasonable steps to more 
effectively implement the requirements of paragraph (i)(4) of this 
clause.
    (k) Communications. All invention disclosures and requests for 
greater rights shall be sent to the Agency Contracting Officer, as 
directed by the Contracting Officer. Additionally, a copy of all 
disclosures, confirmatory licenses to the Government, face page of 
the patent applications, waivers and other routine communications 
under this funding agreement at all tiers must be sent to:

[______ Insert Agency Address]
Agency Invention Reporting website: https://public.era.nih.gov/iedison.

(End of clause)

    Alternate I (DATE). As prescribed in 327.303-70, the license to 
Class 2 inventions recited in 352.227-70(c)(2)(ii) is as follows:
[______ Insert description of license to Class 2 inventions]


352.227-71  Rights in Data--Supplement--Exceptional Circumstances.

    As prescribed in 327.409-70(a), insert the following clause:

Rights in Data--Supplement--Exceptional Circumstances (DATE)

    (a) In addition to any other provisions, set forth in this 
contract, the Contractor shall ensure that information concerning 
possible inventions made under this contract is not prematurely 
published thereby adversely affecting the ability to obtain patent 
protection on such inventions. Accordingly, the Contractor will 
provide the Contracting Officer a copy of any publication or other 
public disclosure relating to the work performed under this contract 
at least 30 days in advance of the disclosure. Upon the Contracting 
Officer's request, the Contractor agrees to delay the public 
disclosure of such data or publication of a specified paper for a 
reasonable time specified by the Contracting Officer, not to exceed 
6 months, to allow for the filing of domestic and international 
patent applications in accordance with HHSAR clause at 352.227-70, 
Patent Rights--Supplement--Exceptional Circumstances. (See FAR 
clause at 52.227-14, Rights in Data-General.)
    (b) The Contractor agrees that in accordance with FAR clause 
52.214-14, paragraph (d)(2), proprietary data on material(s) 
provided to the Contractor under or through this contract shall be 
used only for the purpose for which they were provided, including 
screening, evaluation or optimization and for no other purpose.

(End of clause)


352.227-72  Publications and Publicity.

    As prescribed in 327.409-70(b), insert the following clause:

Publications and Publicity (DATE)

    (a) Unless otherwise specified in this contract, the Contractor 
may publish the results of its work under this contract. The 
Contractor shall promptly send to the Contracting Officer's 
Representative--
    (1) A copy of each article submitted for publication;
    (2) Information of when the article or other publication is 
published; and,
    (3) A copy of the published article.
    (b) Unless authorized in writing by the Contracting Officer, the 
Contractor shall not display the HHS logo or the official HHS seal, 
including HHS Operating Division or Staff Division logos, on any 
publications.
    (c) The Contractor shall not reference the product(s) or 
service(s) awarded under this contract in advertising, as defined in 
FAR 31.205-1, in any manner which states or implies HHS approval or 
endorsement of the product(s) or service(s) provided.
    (d) The contractor shall include this clause in all subcontracts 
where the subcontractor may propose publishing the results of its 
work under a subcontract.

(End of clause)

0
41. Revise sections 352.231-70 through 352.237-75 to read as follows:
* * * * *
Sec.
352.231-70 Salary Rate Limitation.
352.232-70 Incremental Funding.
352.232-71 Electronic Submission of Payment Requests.
352.233-70 Choice of Law (Overseas).
352.233-71 Litigation and Claims.
352.236-70 Design-Build Contracts.
352.237-70 Nonsmoking Policy--Delivery of Services to Children.
352.237-71 Reporting of Child Abuse.
352.237-72 Requirement for Background Checks.
352.237-73 Indian Child Protection and Family Violence Act--
Background Investigations.
352.237-74 Non-Discrimination in Service Delivery.
352.237-75 Key Personnel.
* * * * *


352.231-70  Salary Rate Limitation.

    As prescribed in 331.171, insert the following clause:

Salary Rate Limitation (DATE)

    (a) The Contractor shall not use contract funds to pay the 
direct salary of an individual at a rate in excess of the Federal 
Executive Schedule Level II in effect on the date the contract was 
awarded.
    (b) For purposes of the salary rate limitation, the terms 
``direct salary,'' ``salary,'' and ``institutional base salary,'' 
have the same meaning and are collectively referred to as ``direct 
salary,'' in this clause. An individual's direct salary is the 
annual compensation that the Contractor pays for an individual's 
direct effort (costs) under the contract. Direct salary excludes any 
income that an individual may be permitted to earn outside of duties 
to the Contractor. Direct salary also excludes fringe benefits, 
overhead, and general and administrative expenses (also referred to 
as indirect costs or facilities and administrative costs). The 
salary rate limitation does not restrict the salary that an 
organization may pay an individual working under a Department of 
Health and Human Services contract or order; it merely limits the 
portion of that salary that may be paid with contract funds.
    (c) The salary rate limitation also applies to individuals under 
subcontracts.
    (d) If this is a multiple-year contract or order, it may be 
subject to unilateral modification by the Contracting Officer to 
ensure that an individual is not paid at a rate that exceeds the 
salary rate limitation provision established in the HHS 
appropriations act used to fund this contract.

[[Page 80705]]

    (e) See the salaries and wages pay tables on the Office of 
Personnel Management website for Federal Executive Schedule salary 
levels.
    (f) Contractors shall flow down this clause into any resulting 
subcontract(s).

(End of clause)


352.232-70  Incremental Funding.

    As prescribed in 332.706-2(b), insert the following provision:

Incremental Funding (DATE)

    The Government intends to negotiate and award a cost-
reimbursement contract using incremental funding as described in the 
clause at FAR 52.232-22, ``Limitation of Funds''. The initial 
obligation of funds under the contract is expected to cover 
______[insert the appropriate increment of performance]. The 
Government intends to obligate additional funds up to and including 
the full estimated cost of the contract for the remaining periods of 
performance by unilateral contract modification. However, the 
Government is not required to reimburse the Contractor for costs 
incurred in excess of the total amount obligated, nor is the 
Contractor required to perform beyond the level supported by the 
total amount obligated.

(End of provision)


352.232-71  Electronic Submission of Payment Requests.

    As prescribed in 332.7003, insert the following clause:

Electronic Submission of Payment Requests (DATE)

    (a) Definitions. As used in this clause--
    Payment request means a bill, voucher, invoice, or request for 
contract financing payment with associated supporting documentation. 
The payment request must comply with the requirements identified in 
FAR 32.905(b), ``Content of Invoices'', and the applicable Payment 
clause included in this contract.
    (b) Submission instructions. Except as provided in paragraph (c) 
of this clause, the Contractor shall submit payment requests 
electronically using the Department of Treasury Invoice Processing 
Platform (IPP) or successor system. Information regarding IPP, 
including IPP Customer Support contact information, is available at 
www.ipp.gov or any successor site.
    (c) Alternate submission procedures. The Contractor may submit 
payment requests using other than IPP only when the Contracting 
Officer authorizes alternate procedures in writing in accordance 
with HHS procedures.
    (d) Submission of alternate payment procedures authorization. If 
alternate payment procedures are authorized, the Contractor shall 
include a copy of the Contracting Officer's written authorization 
with each payment request.

(End of clause)


352.233-70  Choice of Law (Overseas).

    As prescribed in 333.215-70(a), insert the following clause:

Choice of Law (Overseas) (DATE)

    This contract shall be construed in accordance with the 
substantive laws of the United States of America. By the execution 
of this contract, the Contractor expressly agrees to waive any 
rights to invoke the jurisdiction of local national courts where 
this contract is performed and agrees to accept the exclusive 
jurisdiction of the United States Civilian Board of Contract Appeals 
or the United States Court of Federal Claims for hearing and 
determination of any and all disputes that may arise under the 
Disputes clause of this contract.

(End of clause)


352.233-71  Litigation and Claims.

    As prescribed in 333.215-70(b), insert the following clause:

Litigation and Claims (DATE)

    (a) The Contractor shall provide written notification 
immediately to the Contracting Officer of any action, including any 
proceeding before an administrative agency, filed against the 
Contractor arising out of the performance of this contract, 
including, but not limited to the performance of any subcontract 
hereunder; and any claim against the Contractor the cost and expense 
of which is allowable under the clause entitled ``Allowable Cost and 
Payment.''
    (b) Except as otherwise directed by the Contracting Officer, the 
Contractor shall furnish immediately to the Contracting Officer 
copies of all pertinent documents received by the Contractor with 
respect to such action or claim. To the extent not in conflict with 
any applicable policy of insurance, the Contractor may, with the 
Contracting Officer's approval, settle any such action or claim. If 
required by the Contracting Officer, the Contractor shall effect an 
assignment and subrogation in favor of the Government of all the 
Contractor's rights and claims (except those against the Government) 
arising out of any such action or claim against the Contractor; and 
authorize representatives of the Government to settle or defend any 
such action or claim and to represent the Contractor in, or to take 
charge of, any action.
    (c) If the Government undertakes a settlement or defense of an 
action or claim, the Contractor shall furnish all reasonable 
assistance in effecting a settlement or asserting a defense. Where 
an action against the Contractor is not covered by a policy of 
insurance, the Contractor shall, with the approval of the 
Contracting Officer, proceed with the defense of the action in good 
faith. The Government shall not be liable for the expense of 
defending any action or for any costs resulting from the loss 
thereof to the extent that the Contractor would have been 
compensated by insurance which was required by other terms or 
conditions of this contract, by law or regulation, or by written 
direction of the Contracting Officer, but which the Contractor 
failed to secure through its own fault or negligence. In any event, 
unless otherwise expressly provided in this contract, the Government 
shall not reimburse or indemnify the Contractor for any liability 
loss, cost, or expense, which the Contractor may incur or be subject 
to by reason of any loss, injury or damage, to the person or to real 
or personal property of any third parties as may accrue during, or 
arise from, the performance of this contract.

(End of clause)


352.236-70  Design-Build Contracts.

    As prescribed in 336.570(a), insert the following clause:

Design-Build Contracts (DATE)

    (a) General. (1) The contract constitutes and defines the entire 
agreement between the Contractor and the Government. This contract 
includes the standard or special contract clauses and schedules 
included at the time of award. This contract incorporates by 
reference:
    (i) The solicitation in its entirety (with the exception of 
instructions to offerors and evaluation criteria which do not become 
part of the award document);
    (ii) The specifications and statement of work;
    (iii) All drawings, cuts and illustrations, included in the 
solicitation and any amendments during all proposal phases leading 
up to award;
    (iv) Exhibits and other attachments; and
    (v) The successful Offeror's accepted proposal.
    (2) In the event of conflict or inconsistency between any of the 
requirements of the various portions of this contract, precedence 
shall be given in the following order:
    (i) Betterments: Any portions of the Offeror's proposal which 
exceed the requirements of the solicitation and which go beyond 
repair and improve the value of the property.
    (ii) The contract clauses and schedules included during the 
solicitation or at the time of award.
    (iii) All requirements (other than betterments) of the accepted 
proposal.
    (iv) Any design products, including but not limited to plans, 
specifications, engineering studies and analyses, shop drawings, 
equipment installation drawings, etc. These are ``deliverables'' 
under the contract and are not part of the contract itself.
    (3) Design products must conform to all requirements of the 
contract, in the order of precedence stated here.
    (b) Responsibility of the contractor for design. (1) The 
Contractor shall be responsible for the professional quality, 
technical accuracy, and the coordination of all designs, drawings, 
specifications, and other non-construction services furnished by the 
Contractor under this contract. The Contractor shall, without 
additional compensation, correct or revise any errors or deficiency 
in its designs, drawings, specifications, and other non-construction 
services and perform any necessary rework or modifications, 
including any damage to real or personal property, resulting from 
the design error or omission.
    (2) Neither the Government's review, approval or acceptance of, 
nor payment for, the services required under this contract shall be 
construed to operate as a waiver of any rights under this contract 
or of any cause of action arising out of the performance of this 
contract. The Contractor shall be and remain liable to the 
Government in

[[Page 80706]]

accordance with applicable law for all damages to the Government 
caused by the Contractor's negligent performance of any of these 
services furnished under this contract.
    (3) The rights and remedies of the Government provided for under 
this contract are in addition to any other rights and remedies 
provided by law.
    (4) If the Contractor is comprised of more than one legal entity 
each such entity shall be jointly and severally liable with respect 
to all rights and remedies of the Government.
    (c) Sequence of design--construction. (1) After receipt of the 
Contract Award, the Contractor shall initiate design, comply with 
all design submission requirements, and obtain Government review of 
each submission. No construction may be started until the Government 
reviews the Final Design submission and determines it satisfactory 
for purposes of beginning construction. The Contracting Officer will 
notify the Contractor when the design is cleared for construction. 
The Government will not grant any time extension for any design 
resubmittal required when, in the opinion of the Contracting 
Officer, the initial submission failed to meet the minimum quality 
requirements as set forth in the Contract.
    (2) If the Government allows the Contractor to proceed with 
limited construction based on pending minor revisions to the 
reviewed Final Design submission, no payment will be made for any 
completed or in-progress construction related to the pending 
revisions until they are completed, resubmitted, and are 
satisfactory to the Government.
    (3) No payment will be made for any completed or in-progress 
construction until all required submittals have been made, reviewed, 
and are satisfactory to the Government.
    (d) Constructor's role during design. The Contractor's 
construction management key personnel shall be actively involved 
during the design process to effectively integrate the design and 
construction requirements of this contract. In addition to the 
typical required construction activities, the constructor's 
involvement includes, but is not limited to actions such as: 
integrating the design schedule into the Master Schedule to maximize 
the effectiveness of fast-tracking design and construction (within 
the limits, if any, allowed in the contract), ensuring 
constructability and economy of the design, integrating the shop 
drawing and installation drawing process into the design, executing 
the material and equipment acquisition programs to meet critical 
schedules, effectively interfacing the construction Quality Control 
(QC) program with the design QC program, and maintaining and 
providing the design team with accurate, up-to-date redline and as-
built documentation. The Contractor shall require and manage the 
active involvement of key trade subcontractors in the above 
activities.
    (e) Preconstruction conference. (1) A preconstruction conference 
will be arranged by the Contracting Officer after award of contract 
and before commencement of work. The Contracting Officer or 
designated representative will notify the Contractor of the time, 
date, and location for the meeting. At this conference, the 
Contractor shall be oriented with respect to Government procedures 
and line of authority, contractual, administrative, and construction 
matters.
    (2) The Contractor shall bring to this conference, in completed 
form, a Certificate of Insurance, plus the following items in either 
completed or draft form--
    (i) Accident Prevention Plan;
    (ii) Quality Control Plan;
    (iii) Letter Appointing Superintendent;
    (iv) Transmittal Register;
    (v) Power of Attorney and Certified Copy of Resolution;
    (vi) Network Analysis System, (when identified in the contract 
schedule as applicable);
    (vii) List of Subcontractors;
    (viii) SF 1413;
    (ix) Performance and Payment Bonds; and
    (x) Schedule of Values.
    (3) A letter of record will be written documenting all items 
discussed at the conference, and a copy will be furnished by the 
Contracting Officer to all in attendance.
    (f) Payment for design under fixed-price design-build contracts. 
(1) The Contracting Officer may approve progress payments for work 
performed during the project design phase up to the maximum amount 
of __ [Contracting Officer to insert percent figure up to 6%.] If 
none stated, the amount is four (4) percent of the contract price.
    (2) Contractor invoices for payment must be accompanied by 
satisfactory documentation supporting the amounts for which payments 
are requested. Progress payments approved by the Contracting Officer 
during the project design phase in no way constitute an acceptance 
of functional and aesthetic design elements nor acceptance of a 
final settlement amount in the event of a buy-out nor a waiver of 
any contractual requirements.
    (g) Unscheduled jobsite shutdowns. Due to security reasons 
during the life of this contract the Government may on an 
unscheduled basis require the contractor to shut down its jobsite 
for two days per year at no additional cost. This shall not 
constitute a suspension of work under FAR 52.242-14, Suspension of 
Work.

(End of clause)

    Alternate I (DATE). When fast track procedures are being used, 
replace paragraph (c) of the basic clause with the following:
    (c) Sequence of design build. (1) After receipt of the Contract 
Award the Contractor shall initiate design, comply with all design 
submissions requirements and obtain Government review of each 
submission. The contractor may begin construction on portions of the 
work for which the Government has reviewed the final design submission 
and has determined satisfactory for purposes of beginning construction. 
The Contracting Officer will notify the Contractor when the design is 
cleared for construction. The Government will not grant any time 
extension for any design resubmittal required when, in the opinion of 
the Contracting Officer, the initial submission failed to meet the 
minimum quality requirements as set forth in the Contract.
    (2) If the Government allows the Contractor to proceed with the 
construction based on pending minor revisions to the reviewed Final 
Design submission, no payment will be made for any in-place 
construction related to the pending revisions until they are completed, 
resubmitted, and are satisfactory to the Government.
    (3) No payment will be made for any in-place construction until all 
required submittals have been made, reviewed, and are satisfactory to 
the Government.


352.237-70  Nonsmoking Policy--Delivery of Services to Children.

    As prescribed in 337.7006(a), insert the following clause:

Nonsmoking Policy--Delivery of Services to Children (DATE)

    (a) Prohibition. Smoking is prohibited in facilities where 
certain federally funded children's services are provided pursuant 
to the Pro-Children Act of 2001 (20 U.S.C. 7181, Public Law 107-110, 
sec. 4301 (the Act)). Accordingly, smoking is prohibited within any 
indoor facility (or portion thereof), whether owned, leased, or 
contracted for, or involving indoor facilities that are constructed, 
operated, or maintained with Federal funds, that is used for the 
routine or regular provision of--
    (1) Kindergarten, elementary, or secondary education or library 
services, or
    (2) Health or day care services that are provided to children 
under the age of 18.
    (b) Agreement. The offeror represents and understands that by 
submission of its bid or offer and if awarded a contract for this 
requirement, the Contractor agrees to comply with the requirements 
of the Act and the prohibition of smoking in facilities as specified 
in paragraph (a) of this clause. The Contractor shall enforce the 
provisions of this clause and ensure that each of its employees, 
subcontractors and any subcontractor staff, is made aware of, 
understands, and complies with the provisions of the Act.
    (c) Penalties. Failure to comply with the Act may result in the 
imposition of a civil monetary penalty in an amount not to exceed 
$1,000 for each violation and/or the imposition of an administrative 
compliance order on the responsible party. Each day a violation 
continues constitutes a separate violation. In the case of any civil 
penalty assessed, the total amount shall not exceed 50 percent of 
the amount of Federal funds received by the Contractor for the 
fiscal year in which the continuing violation occurred. Penalties 
will be imposed only after appropriate written notice, or an 
administrative compliance order may be issued by the designated HHS 
official only after an opportunity for a hearing in accordance with 
5 U.S.C. 554. Before making such assessment or issuing such order, 
or both, the Secretary of HHS or designee shall

[[Page 80707]]

give written notice of the assessment or order to the Contractor by 
certified mail with return receipt and provide information in the 
notice of an opportunity to request in writing, not later than 30 
days after the date of receipt of such notice, such hearing. 
Notwithstanding any specific civil penalties and compliance orders 
referenced herein, the Contracting Officer may take other remedies 
under the contract for failure to comply with the terms and 
conditions of the contract.
    (d) Subcontract flow down. The Contractor shall insert the text 
of this clause, including this paragraph (d), in subcontracts at any 
tier. The Contractor shall be responsible for compliance by any 
subcontractor or lower-tier subcontractor with the provisions set 
forth in paragraphs (a) through (c) of this clause.

(End of clause)


352.237-71  Reporting of Child Abuse.

    As prescribed in 337.7006(b), insert the following clause:

Reporting of Child Abuse (DATE)

    (a) Definitions. As used in this clause--
    Child abuse means the physical or mental injury, sexual abuse or 
exploitation, or negligent treatment of a child.
    Covered professionals means those persons engaged in professions 
and activities in eight different categories including, but not 
limited to, teachers, social workers, physicians, dentists, medical 
residents or interns, hospital personnel and administrators, nurses, 
health care practitioners, chiropractors, osteopaths, pharmacists, 
optometrists, podiatrists, emergency medical technicians, ambulance 
drivers, alcohol or drug treatment personnel, psychologists, 
psychiatrists, mental health professionals, child care workers and 
administrators, and commercial film and photo processors.
    (b) Responsibility to report child abuse. Public Law 101-647, 
known as the Crime Control Act of 1990 (the Act) (34 U.S.C. 20341), 
imposes responsibilities on certain individuals (i.e., covered 
professionals) to report child abuse who, while engaged in a 
professional capacity or activity, as defined in the Act, on Federal 
land or in a federally-operated (or contracted) facility, learn of 
facts that give the individual reason to suspect that a child has 
suffered an incident of child abuse.
    (c) Reporting protocols. Accordingly, any person engaged in a 
covered profession or activity under an HHS contract or subcontract, 
regardless of the purpose of the contract or subcontract, shall 
immediately report a suspected child abuse incident in accordance 
with the provisions of the Act. If a child is suspected of being 
harmed, the appropriate State Child Abuse Hotline, local child 
protective services (CPS), or law enforcement agency shall be 
contacted. For more information about where and how to file a 
report, contact the Childhelp USA, National Child Abuse Hotline (1-
800-4-A-CHILD). Any covered professional failing to make a timely 
report of such incident shall be guilty of a Class B misdemeanor.
    (d) Agreement. The offeror represents and understands that by 
submission of its bid or offer and if awarded a contract for this 
requirement, the Contractor agrees to comply with the requirements 
of the Act. The Act also applies to all applicable subcontracts 
awarded under this contract. Accordingly, the Contractor shall 
ensure that each of its employees, and any subcontractor staff, is 
made aware of, understands, and complies with the provisions of the 
Act.
    (e) Subcontract flow down. The Contractor shall insert the text 
of this clause, including this paragraph (d), in subcontracts at any 
tier. The Contractor shall be responsible for compliance by any 
subcontractor or lower-tier subcontractor with the provisions set 
forth in paragraphs (a) through (d) of this clause.

(End of clause)


352.237-72  Requirement for Background Checks.

    As prescribed in 337.7006(c), insert the following clause:

Requirement for Background Checks (DATE)

    (a) Definition. As used in this clause--
    Child care services means and include, but are not limited to, 
social services, health and mental health care, child (day) care, 
education (whether or not directly involved in teaching), and 
rehabilitative programs.
    (b) Requirement for background checks. Public Law 101-647, known 
as the Crime Control Act of 1990 (the Act) (34 U.S.C. 20351), 
requires that all individuals involved with the provision of child 
care services to children under the age of 18 undergo a criminal 
background check. Any conviction for a sex crime, an offense 
involving a child victim, or a drug felony, may be grounds for 
denying employment or for dismissal of an employee providing any 
child care services.
    (c) Background check protocols. The Contracting Officer will 
provide the necessary information to the Contractor regarding the 
process for obtaining the background check. The Contractor may hire 
a staff person provisionally prior to the completion of a background 
check, if at all times prior to the receipt of the background check 
during which children are in the care of the newly-hired person, the 
person is within the sight and under the supervision of a previously 
investigated staff person.
    (d) Agreement. The offeror represents and understands that by 
submission of its bid or offer and if awarded a contract for this 
requirement, the Contractor agrees to comply with the requirements 
of the Act. The Act also applies to all applicable subcontracts 
awarded under this contract. Accordingly, the Contractor shall 
ensure that each of its employees, and any subcontractor staff, is 
made aware of, understands, and complies with the provisions of the 
Act.
    (e) Subcontract flow down. The Contractor shall insert the text 
of this clause, including this paragraph (d), in subcontracts at any 
tier. The Contractor shall be responsible for compliance by any 
subcontractor or lower-tier subcontractor with the provisions set 
forth in paragraphs (a) through (d) of this clause.

(End of clause)


352.237-73  Indian Child Protection and Family Violence Act--Background 
Investigations.

    As prescribed in 337.7006(d), insert the following clause:

Indian Child Protection and Family Violence Act--Background 
Investigations (DATE)

    (a) Requirement for background checks. This contract is subject 
to the Indian Child Protection and Family Violence Act, Public Law 
101-630 (25 U.S.C. 3201, et seq.). The duties and responsibilities 
required by this contract may involve regular contact with or 
control over Indian children. Public Law 101-630 prohibits 
employment, including Personal Service Contracts, with anyone who 
has been convicted of any crime of violence. Any such conviction 
should immediately be brought to the attention of the Contracting 
Officer. Performance under this contract requires a Contractor and 
its employees and subcontractors to be subject to a background 
investigation.
    (b) Background check protocols. The Contractor and its employees 
and subcontractors, at any tier, will be subject to a character and 
background investigation, conducted by the Indian Health Service, 
Office of Human Resources. Until such time as the Contractor or its 
employees and subcontractors have been notified of completion of the 
investigation, the Contractor and its employees and subcontractors 
shall have no unsupervised contact with Indian children. In order to 
initiate this background investigation, the Contractor and its 
employees and subcontractors must provide information as required in 
this contract or as directed by the Contracting Officer.
    (c) Signed declaration prerequisite. As a prerequisite to 
providing services under this contract, the Contractor is required 
to complete and sign the declaration found in Section J of this 
contract.
    (d) Subcontract flow down. The Contractor shall insert the text 
of this clause, including this paragraph (d), in subcontracts at any 
tier. The Contractor shall be responsible for compliance by any 
subcontractor or lower-tier subcontractor with the provisions set 
forth in paragraphs (a) through (c) of this clause.

(End of clause)


352.237-74  Non-Discrimination in Service Delivery.

    As prescribed in 337.7006(e), insert the following clause:

Non-Discrimination In Service Delivery (DATE)

    (a) Policy. It is the policy of the Department of Health and 
Human Services (HHS) that no person otherwise eligible will be 
excluded from participation in, denied the benefits of, or subjected 
to discrimination in the administration of HHS programs and services 
based on non-merit factors such as race, color, national origin, 
religion, sex, gender identity, sexual orientation, or disability 
(physical or mental). This includes the requirement for non-
discrimination in contracts involving delivery of services under 
HHS' programs directly to the public.

[[Page 80708]]

    (b) Agreement. The offeror represents and understands that by 
submission of its bid or offer and if awarded a contract for this 
requirement, the Contractor agrees to comply with this policy in 
supporting the program and in performing the services called for 
under this contract in a non-discriminatory manner. The contractor 
shall ensure that each of its employees, and any subcontractor 
staff, is made aware of, understands, and complies with this policy.
    (c) Subcontract flow down. The Contractor shall insert the text 
of this clause, including this paragraph (c), in subcontracts at any 
tier, in subcontracts that support or perform the specified program 
and services. The Contractor shall be responsible for compliance by 
any subcontractor or lower-tier subcontractor with the provisions 
set forth in paragraphs (a) through (c) of this clause.

(End of clause)


352.237-75  Key Personnel.

    As prescribed in 337.7006(f), insert the following clause:
Key Personnel (DATE)

    The key personnel specified in this contract are essential to 
work performance under the contract. At least 30 days prior to the 
Contractor voluntarily diverting any of the specified individuals to 
other programs or contracts, the Contractor shall notify the 
Contracting Officer and submit a justification for the diversion or 
replacement and request to replace the individual. The request must 
identify the proposed replacement and provide an explanation of how 
the replacement's skills, experience, and credentials meet or exceed 
the requirements of the contract. If the employee of the contractor 
is terminated for cause or separates from the Contractor voluntarily 
with less than 30 days' notice, the Contractor must provide the 
maximum notice practicable under the circumstances. The Contractor 
shall not divert, replace, or announce any such change to key 
personnel without the written consent of the Contracting Officer. 
The contract should be modified to add or delete key personnel as 
necessary to reflect the agreement of the parties.

(End of clause)
0
42. Add sections 352.241-70, 352.242-70, 352.242-71, 352.245-70, 
352.247-70, 352.247-71, and 352.247-72 to read as follows:
* * * * *
Sec.
352.241-70 Disputes--Utility Contracts.
352.242-70 Administrative Contracting Officer.
352.242-71 Government Construction Contract Administration.
352.245-70 Contractor Property Management System Administration.
352.247-70 Delivery Location.
352.247-71 Marking Deliverables.
352.247-72 Packing for Domestic Shipment.
* * * * *


352.241-70  Disputes--Utility Contracts.

    As prescribed in 341.501-70, insert the following clause:

Disputes--Utility Contracts (DATE)

    (a) Definition. As used in this clause, Independent regulatory 
body means the Federal Energy Regulatory Commission, a state-wide 
agency, or an agency with less than state-wide jurisdiction when 
operating pursuant to state authority. The body has the power to 
fix, establish, or control the rates and services of utility 
suppliers.
    (b) Independent Regulatory Body determinations. The requirements 
of the Disputes clause at FAR 52.233-1 are supplemented to provide 
that matters involving the interpretation of tariffed retail rates, 
tariff rate schedules, and tariffed terms provided under this 
contract are subject to any determinations by the independent 
regulatory body having jurisdiction.

(End of clause)


352.242-70  Administrative Contracting Officer.

    As prescribed in 342.272(a), insert the following clause:

Administrative Contracting Officer (DATE)

    The Contracting Officer reserves the right to designate an 
Administrative Contracting Officer (ACO) for the purpose of 
performing certain tasks/duties in the administration of the 
contract. Such designation will be in writing through an ACO Letter 
of Delegation and will identify the responsibilities and limitations 
of the ACO. A copy of the ACO Letter of Delegation will be furnished 
to the Contractor.

(End of clause)


352.242-71  Government Construction Contract Administration.

    As prescribed in 342.272(b), insert the following clause. This is a 
fill-in clause.

Government Construction Contract Administration (DATE)

    (a) Contract administration functions set forth in FAR 42.302 
are hereby delegated to:
    ________[Insert name and office address of Administrative 
Contracting Officer (ACO)]
    (b) The following functions will be retained by the Contracting 
Officer and are not redelegable:
    ________[Contracting Officer to list all functions set forth in 
FAR 42.302 that are not redelegable to the ACO, revise the following 
or enter ``None,'' when applicable]
    (1) Award of contract modifications either through supplemental 
agreements or change orders that exceed the ACO's appointed warrant 
limitations.
    (2) Issuance of default letters.
    (3) Issuance of Cure or Show-Cause Notices.
    (4) Suspension of work letters and/or modifications.
    (5) Issuance of Contracting Officer final determination letters.
    (6) Issuance of termination notices.
    (7) Authorization of final payment.
    (c) The work will be under the direction Contracting Officer or 
delegated Administrative Contracting Officer as identified in 
paragraph (a), who may further delegate support services 
responsibilities to a Contracting Officer's Representative (COR), as 
identified below. A copy of the COR Appointment Letter shall be 
furnished to the Contractor:
    ________[Contracting Officer or ACO to insert name and office 
address of COR and list the COR's delegated authority.]

(End of clause)


352.245-70  Contractor Property Management System Administration.

    As prescribed in 345.107, insert the following clause:

Contractor Property Management System Administration (DATE)

    (a) Definitions. As used in this clause--
    Acceptable property management system means a property system 
that complies with the system criteria in paragraph (c) of this 
clause.
    Property management system means the Contractor's system or 
systems for managing and controlling Government property.
    Significant deficiency means a shortcoming in the system that 
materially affects the ability of officials of the Department of 
Health and Human Services to rely upon information produced by the 
system that is needed for management purposes.
    (b) General. The Contractor shall establish and maintain an 
acceptable property management system. Failure to maintain an 
acceptable property management system, as defined in this clause, 
may result in disapproval of the system by the Contracting Officer 
and/or withholding of payments.
    (c) System criteria. The Contractor's property management system 
shall be in accordance with paragraph (f) of the contract clause at 
Federal Acquisition Regulation 52.245-1.
    (d) Significant deficiencies. (1) The Contracting Officer will 
provide an initial determination to the Contractor, in writing, of 
any significant deficiencies. The initial determination will 
describe the deficiency in sufficient detail to allow the Contractor 
to understand the deficiency.
    (2) The Contractor shall respond within 30 days to a written 
initial determination from the Contracting Officer that identifies 
significant deficiencies in the Contractor's property management 
system. If the Contractor disagrees with the initial determination, 
the Contractor shall state, in writing, its rationale for 
disagreeing.
    (3) The Contracting Officer will evaluate the Contractor's 
response and notify the Contractor, in writing, of the Contracting 
Officer's final determination concerning--
    (i) Remaining significant deficiencies;
    (ii) The adequacy of any proposed or completed corrective 
action; and
    (iii) System disapproval, if the Contracting Officer determines 
that one or more significant deficiencies remain.
    (e) Contracting Officer's final determination. If the Contractor 
receives the Contracting Officer's final determination of 
significant deficiencies, the Contractor shall, within 45 days of 
receipt of the final determination, either correct the significant

[[Page 80709]]

deficiencies or submit an acceptable corrective action plan showing 
milestones and actions to eliminate the significant deficiencies.

(End of clause)


352.247-70  Delivery Location.

    As prescribed in 347.303-670, insert a clause substantially the 
same as the following:

Delivery Location (DATE)

    Shipment of deliverable items, other than reports, shall be to: 
______[Contracting Officer shall insert appropriate identifying 
data].

(End of clause)


352.247-71  Marking Deliverables.

    As prescribed in 347.305-10(a) insert a clause substantially the 
same as the following:

Marking Deliverables (DATE)

    (a) The contract number shall be placed on or adjacent to all 
exterior mailing or shipping labels of deliverable items called for 
by the contract.
    (b) Mark deliverables, except reports, for: ________[Contracting 
Officer shall insert appropriate identifying data].

(End of clause)


352.247-72  Packing for Domestic Shipment.

    As prescribed in 347.305-10(b), insert a clause substantially the 
same as the following:

Packing for Domestic Shipment (DATE)

    Material shall be packed for shipment in such a manner that will 
ensure acceptance by common carriers and safe delivery at 
destination. Containers and closures shall comply with regulations 
of carriers as applicable to the mode of transportation.

(End of clause)


352.270-1 through 352.270-3  [Removed]

0
43. Remove reserved sections 352.270-1 through 352.270-3.


352.270-4a, 352.270-4b, 352.270-5a, 352.270-5b, 352.270-6, 352.270-9, 
352.270-10, 352.270-11, 352.270-12, and 352.270-13  [Redesignated]

0
44. Redesignate sections 352.270-4a, 352.270-4b, 352.270-5a, 352.270-
5b, 352.270-6, 352.270-9, 352.270-10, 352.270-11, 352.270-12, and 
352.270-13 as follows:

------------------------------------------------------------------------
                       Old section                          New section
------------------------------------------------------------------------
352.270-4a..............................................      352.270-70
352.270-4b..............................................      352.270-72
352.270-5a..............................................      352.270-77
352.270-5b..............................................      352.270-78
352.270-6...............................................      352.270-73
352.270-9...............................................      352.270-79
352.270-10..............................................      352.270-71
352.270-11..............................................      352.270-74
352.270-12..............................................      352.270-75
352.270-13..............................................      352.270-76
------------------------------------------------------------------------

352.270-7 and 352.270-8  [Removed]

0
45. Remove reserved sections 352.270-7 and 352.270-8.
0
46. Revise newly redesignated sections 352.270-70 through 352.270-79 to 
read as follows:
* * * * *
Sec.
352.270-70 Notice to Offerors--Protection of Human Subjects.
352.270-71 Notice to Offerors--Protection of Human Subjects, 
Research Involving Human Subjects Committee (RIHSC) Approval of 
Research Protocols Required.
352.270-72 Protection of Human Subjects.
352.270-73 Restriction on Use of Human Subjects.
352.270-74 Protection of Human Subjects--Research Involving Human 
Subjects Committee (RIHSC) Approval of Research Protocols Required.
352.270-75 Needle Exchange.
352.270-76 Continued Ban on Funding Abortion and Continued Ban on 
Funding of Human Embryo Research.
352.270-77 Compliance with the Public Health Service Policy on 
Humane Care and Use of Laboratory Animals.
352.270-78 Care of Live Vertebrate Animals.
352.270-79 Non-Discrimination for Conscience.
* * * * *


352.270-70  Notice to Offerors--Protection of Human Subjects.

    As prescribed in 370.304(a), insert the following provision:

Notice to Offerors--Protection of Human Subjects (DATE)

    (a) The Department of Health and Human Services (HHS) 
regulations for the protection of human subjects, 45 CFR part 46, 
are available on the Office for Human Research Protections (OHRP) 
website at: https://www.hhs.gov/ohrp/. These regulations 
provide a systematic means, based on established ethical principles, 
to safeguard the rights and welfare of human subjects participating 
in research activities supported or conducted by HHS. The regulation 
is also available at https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46.
    (b) The regulations at 45 CFR 46.102, among other things, define 
a human subject as a living individual about whom an investigator 
(whether professional or student) conducting research obtains 
information or biospecimens through intervention or interaction with 
the individual, and uses, studies, or analyzes the information or 
biospecimens; or obtains, uses, studies, analyzes, or generates 
identifiable private information or identifiable biospecimens. In 
most cases, the regulations extend to the use of human organs, 
tissue, and body fluids from individually identifiable human 
subjects as well as to graphic, written, or recorded information 
derived from individually identifiable human subjects. 45 CFR part 
46 does not directly regulate the use of autopsy materials; instead, 
applicable state and local laws govern their use.
    (c) Activities which involve human subjects in one or more of 
the categories set forth in 45 CFR 46.104, Exempt research, are 
exempt from complying with 45 CFR part 46. See https://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.
    (d) Inappropriate designations of the noninvolvement of human 
subjects or of exempt categories of research in a project may result 
in delays in the review of a proposal.
    (e) In accordance with 45 CFR part 46, offerors considered for 
award shall file an acceptable Federal-wide Assurance (FWA) of 
compliance with OHRP specifying review procedures and assigning 
responsibilities for the protection of human subjects. The FWA is 
the only type of assurance that OHRP accepts or approves. The 
initial and continuing review of a research project by an 
institutional review board shall ensure that: The risks to subjects 
are minimized; risks to subjects are reasonable in relation to 
anticipated benefits, if any, to subjects, and the importance of the 
knowledge that may reasonably be expected to result; selection of 
subjects is equitable; and informed consent will be obtained and 
documented by methods that are adequate and appropriate. Depending 
on the nature of the research, additional requirements may apply; 
see 45 CFR 46.111 at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/#46.111 for additional requirements regarding initial and 
continuing review. HHS regulations for the protection of human 
subjects (45 CFR part 46), information regarding OHRP registration 
and assurance requirements/processes, and OHRP contact information 
is available at the OHRP website (at https://www.hhs.gov/ohrp/assurances/).
    (f) Offerors may consult with OHRP only for general advice or 
guidance concerning either regulatory requirements or ethical issues 
pertaining to research involving human subjects. Only the 
contracting officer may offer information concerning a solicitation.
    (g) The offeror shall document in its proposal the approved FWA 
from OHRP, related to the designated Institutional Review Board 
(IRB) reviewing and overseeing the research. If the offeror does not 
have an approved FWA from OHRP, the offeror must obtain an FWA 
before the deadline for proposal submission. When possible, the 
offeror shall also certify the IRB's review and approval of the 
research. If the offeror cannot obtain this certification by the 
time of proposal submission they must include an explanation in 
their proposal. Never conduct research covered by 45 CFR part 46 
prior to receiving certification of the research's review and 
approval by the IRB.
    (h) Registering an IRB and obtaining an FWA are related but 
separate processes. The web page for electronic submission of new 
IRB registrations and FWAs, or update/

[[Page 80710]]

renewal of existing IORGs/IRBs and FWAs is at https://ohrp.cit.nih.gov/efile/Default.aspx.

(End of provision)

    Alternate I (DATE). As prescribed in 370.304(a), the Contracting 
Officer shall substitute the following paragraph (g) for paragraph (g) 
of the basic provision.
    (g) The offeror's proposal shall document that it has an approved 
or active FWA from OHRP, related to the designated IRB reviewing and 
overseeing the research.
    (1) When possible, the offeror shall also certify the IRB has 
reviewed and approved the research. If the offeror cannot make this 
certification at the time of proposal submission, its proposal must 
include an explanation. Never conduct research covered by 45 CFR part 
46 prior to receiving certification of the research's review and 
approval by the IRB.
    (2) If the offeror does not have an active FWA from OHRP, the 
offeror shall take all necessary steps to obtain an FWA prior to the 
deadline for proposal submission. If the offeror cannot obtain an FWA 
before the proposal submission date, the proposal shall indicate the 
steps/actions the offeror will take to obtain OHRP approval within 
[Contracting Officer must insert a time period in which the FWA must be 
obtained]. Upon obtaining FWA approval, submit the approval notice to 
the Contracting Officer.


352.270-71  Notice to Offerors--Protection of Human Subjects, Research 
Involving Human Subjects Committee (RIHSC) Approval of Research 
Protocols Required.

    As prescribed in 370.304(b), insert the following provision:

    Notice to Offerors--Protection of Human Subjects, Research 
Involving Human Subjects Committee (RIHSC) Approval of Research 
Protocols Required (DATE)

    (a) All Offerors proposing research expected to involve human 
subjects shall comply with the regulations set forth in 45 CFR part 
46, and with the provision at HHSAR 352.270-70.
    (b) The Offeror shall have an acceptable Assurance of Compliance 
on file with the Office for Human Research Protections (OHRP), 
whenever it submits a proposal to the FDA for research expected to 
involve human subjects. Direct questions regarding Federal-wide 
Assurance to OHRP. The Offeror's proposal shall include a copy of 
the acceptable Assurance of Compliance.
    (c) After the contract has been awarded, the Contractor shall 
take the following actions:
    (1) The Institutional Review Board (IRB) specified in the 
Offeror's Assurance of Compliance, hereafter referred to as ``the 
local IRB,'' shall review the proposed research protocol. A letter 
from the local IRB stating that the proposed research protocol has 
been reviewed and approved, and thus adequately protects the rights 
and welfare of human subjects involved, or a letter stating that the 
proposed research is exempt under 45 CFR 46.101(b) shall be 
submitted to the Contracting Officer.
    (2) Upon award, the successful Offeror, hereafter ``the 
Contractor,'' shall submit its proposed research protocol to the 
FDA's Research Involving Human Subjects Committee (RIHSC). The RIHSC 
or its designee will review and approve the research protocol to 
assure it adequately protects the rights and welfare of human 
subjects involved. The RIHSC or designee will also determine whether 
the proposed research is exempt under 45 CFR 46.101(b). The 
Contractor shall submit, to the Contracting Officer of record, a 
copy of the RIHSC's or its designee's letter stating that it 
reviewed and approved the proposed research protocol.
    (d) The Contractor shall not advertise for, recruit, or enroll 
human subjects, or otherwise commence any research involving human 
subjects until RIHSC or its designee reviews and approves its 
research. The Contractor may begin other limited aspects of contract 
performance prior to receiving RIHSC's or designee's approval of the 
proposed research protocol. Research involving human subjects may 
commence immediately upon the Contractor's receipt of RIHSC's or 
designee's approval; however, the Contractor shall submit a copy of 
RIHSC's or its designee's approval to the Contracting Officer within 
three business days of its receipt.
    (e) A Contractor's failure to obtain RIHSC's or its designee's 
approval of its proposed research may result in termination of its 
contract. However, failure to obtain RIHSC's or its designee's 
approval during initial review will not automatically result in 
termination of the contract. Instead, the Contractor may correct any 
deficiencies identified during the initial RIHSC or designee review 
and resubmit the proposed research protocol to RIHSC or its designee 
for a second review. The Contractor is encouraged to solicit the 
RIHSC's or its designee's input during the resubmission process.
    (f) The Contractor shall seek RIHSC's or its designee's and 
local IRB review and approval whenever making modifications, 
amendments, or other changes to the research protocol. Such 
modifications, amendments and changes include, but are not limited 
to changes in investigators, informed consent forms, and recruitment 
advertisements. The Contractor may institute changes immediately 
after receiving both the local IRB and RIHSC or its designee 
approval (except when necessary to eliminate apparent immediate 
hazards to the subject); however, the Contractor shall submit a copy 
of the letter evidencing RIHSC's or its designee's approval of the 
proposed changes to the Contracting Officer within three business 
days of its receipt.

(End of provision)


352.270-72  Protection of Human Subjects.

    As prescribed in 370.304(c), insert the following clause:

Protection of Human Subjects (DATE)

    (a) The Contractor agrees that the rights and welfare of human 
subjects involved in research under this contract shall be protected 
in accordance with 45 CFR part 46 and with the Contractor's current 
Federal-wide Assurance (FWA) on file with the Office for Human 
Research Protections (OHRP), Department of Health and Human 
Services. The Contractor further agrees to provide certification at 
least annually that the Institutional Review Board has reviewed and 
approved the procedures, which involve human subjects in accordance 
with 45 CFR part 46 and the Assurance of Compliance.
    (b) The Contractor shall bear full responsibility for the 
performance of all work and services involving the use of human 
subjects under this contract and shall ensure that work is conducted 
in a proper manner and as safely as is feasible. The parties hereto 
agree that the Contractor retains the right to control and direct 
the performance of all work under this contract. Nothing in this 
contract shall create an agency or employee relationship between the 
Government and the Contractor, or any subcontractor, agent or 
employee of the Contractor, or any other person, organization, 
institution, or group of any kind whatsoever. The Contractor agrees 
that it has entered into this contract and will discharge its 
obligations, duties, and undertakings and the work pursuant thereto, 
whether requiring professional judgment or otherwise, as an 
independent Contractor without creating liability on the part of the 
Government for the acts of the Contractor or its employees.
    (c) Contractors involving other agencies or institutions in 
activities considered to be engaged in research involving human 
subjects must ensure that such other agencies or institutions obtain 
their own FWA if they are routinely engaged in research involving 
human subjects or ensure that such agencies or institutions are 
covered by the Contractors' FWA via designation as agents of the 
institution or via individual investigator agreements (see OHRP 
website at: https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/).
    (d) If at any time during the performance of this contract the 
Contractor is not in compliance with any of the requirements and or 
standards stated in paragraphs (a) and (b) above, the Contracting 
Officer may immediately suspend, in whole or in part, work and 
further payments under this contract until the Contractor corrects 
the noncompliance. The Contracting Officer may communicate the 
notice of suspension by telephone with confirmation in writing. If 
the Contractor fails to complete corrective action within the period 
of time designated in the Contracting Officer's written notice of 
suspension, the Contracting Officer may, after consultation with 
OHRP, terminate this contract in whole or in part.

(End of clause)


352.270-73  Restriction on Use of Human Subjects.

    As prescribed in 370.304(d), insert the following clause:

Restriction on Use of Human Subjects (DATE)


[[Page 80711]]


    Pursuant to 45 CFR part 46, Protection of Human Research 
Subjects, the Contractor shall not expend funds under this award for 
research involving human subjects or engage in any human subjects 
research activity prior to the Contracting Officer's receipt of a 
certification that the research has been reviewed and approved by 
the Institutional Review Board registered with the Office for Human 
Research Protections (OHRP). This restriction applies to all 
collaborating sites, whether domestic or foreign, and 
subcontractors. The Contractor must ensure compliance by 
collaborators and subcontractors.

(End of clause)


352.270-74  Protection of Human Subjects--Research Involving Human 
Subjects Committee (RIHSC) Approval of Research Protocols Required.

    As prescribed in 370.304(e), insert the following clause:

Protection of Human Subjects--Research Involving Human Subjects 
Committee (RIHSC) Approval of Research Protocols Required (DATE)

    (a) The Contractor agrees to protect the rights and welfare of 
human subjects involved in research under this contract by complying 
with 45 CFR part 46 and the clause at HHSAR 352.270-72.
    (b) Initial proof of compliance with 45 CFR part 46 shall 
consist of -
    (1) A copy of a current Federal-wide Assurance on file with 
OHRP. The copy of a current Federal-wide Assurance shall be included 
with the Contractor's proposal;
    (2) A letter from the Contractor's local IRB (the Institutional 
Review Board (IRB) specified in the Offeror's Assurance of 
Compliance) stating that it has reviewed and approved the proposed 
research protocol. The letter from the local IRB shall be submitted 
to the Contracting Office; and
    (3) A copy of a letter from the RIHSC stating that it or its 
designee has reviewed and approved the proposed research protocol. 
This shall be submitted to the Contracting Officer within three 
business days of its issuance. The Contractor shall not advertise 
for, recruit, or enroll human subjects, or otherwise commence any 
research involving human subjects under this contract, until RIHSC 
has reviewed and approved its research. The Contractor may commence 
other limited aspects of contract performance prior to receiving 
RIHSC or its designee approval of its proposed research protocol. 
Research involving human subjects may commence immediately upon the 
Contractor's receipt of RIHSC or its designee approval; however, the 
Contractor shall submit a copy of RIHSC's or its designee's letter 
of approval to the Contracting Officer within three business days of 
its receipt. Failure to obtain RIHSC or its designee approval of 
proposed research protocols may result in the termination of this 
contract.
    (c) The Contractor further agrees that:
    (1) The Contractor will provide a letter from RIHSC, at least 
annually, stating that RIHSC or its designee has reviewed and 
approved the research protocols for research performed under this 
contract. This shall be submitted to the Contracting Officer for 
inclusion in the contract file.
    (2) The Contractor will submit all proposed modifications and 
amendments to research protocols for research performed under this 
contract to RIHSC for review and approval. Modifications and 
amendments include, but are not limited, to changes to consent forms 
and advertising materials, and the addition or deletion of 
investigators. Changes may be instituted immediately after the 
Contractor has received both the local IRB and RIHSC or its designee 
approval (except when necessary to eliminate apparent immediate 
hazards to the subject); however, the Contractor shall submit a copy 
of the letter evidencing RIHSC's or its designee's approval of the 
proposed changes to the Contracting Officer within three business 
days of its receipt.

(End of clause)


352.270-75  Needle Exchange.

    As prescribed in 370.304(f), insert the following clause:

Needle Exchange (DATE)

    The Contractor shall not use any funds obligated under this 
contract to carry out any program of distributing sterile needles or 
syringes for the hypodermic injection of any illegal drug.

(End of clause)


352.270-76  Continued Ban on Funding Abortion and Continued Ban on 
Funding of Human Embryo Research.

    As prescribed in 370.304(g), insert the following clause:

Continued Ban on Funding Abortion and Continued Ban on Funding of 
Human Embryo Research (DATE)

    (a) The Contractor shall not use any funds obligated under this 
contract for any abortion.
    (b) The Contractor shall not use any funds obligated under this 
contract for the following--
    (1) The creation of a human embryo or embryos for research 
purposes; or
    (2) Research in which a human embryo or embryos are destroyed, 
discarded, or knowingly subjected to risk of injury of death greater 
than that allowed for research on fetuses in utero under 45 CFR part 
46 and Section 498(b) of the Public Health Service Act (42 U.S.C. 
289g(b)).
    (c) The term ``human embryo or embryos'' includes any organism, 
not protected as a human subject under 45 CFR part 46 as of the date 
of the enactment of this Act, that is derived by fertilization, 
parthenogenesis, cloning, or any other means from one or more human 
gametes of human diploid cells.
    (d) The Contractor shall not use any Federal funds for the 
cloning of human beings.

(End of clause)


352.270-77  Compliance with the Public Health Service Policy on Humane 
Care and Use of Laboratory Animals.

    As prescribed in 370.403(a), insert the following clause:

Compliance with the Public Health Service Policy on Humane Care and 
Use of Laboratory Animals (DATE)

    (a) Definitions.
    Animal means any live, vertebrate animal used or intended for 
use in research, research training, experimentation, or biological 
testing for related purposes.
    Animal Welfare Assurance or Assurance means the documentation 
from an institution assuring institutional compliance with the 
Public Health Service Policy on Human Care and Use of Laboratory 
Animals available at https://olaw.nih.gov/policies-laws/phs-policy.htm.
    Institutional Animal Care and Use Committee (IACUC) means an 
intended generic term for a committee whose function is to ensure 
that the care and use of animals in PHS-conducted or supported 
activities are appropriate and humane in accordance with this 
Policy. However, each institution may identify the committee by 
whatever name it chooses. An appropriate IACUC performs the 
functions described in the Public Health Service Policy on Human 
Care and Use of Laboratory Animals, section IV, paragraph B.
    (b) Requirement for Written Animal Welfare Assurance and IACUC 
approval. This contract includes research, research training, 
biological testing, housing and maintenance, and other activities 
involving live vertebrate animals and is subject to the Public 
Health Service (PHS) Policy on Humane Care and Use of Laboratory 
Animals (PHS Policy). The PHS Policy establishes a number of 
requirements for research activities involving animals. The contract 
will not be awarded without the approval of the Office of Laboratory 
Animal Welfare (OLAW), National Institutes of Health (NIH) on the 
successful offeror's written Animal Welfare Assurance and 
verification of the proposed institution(s) IACUC approval.
    (1) Offerors shall include in their proposal a written Animal 
Welfare Assurance (assurance), committing the proposed 
institution(s) to comply with the provisions of the PHS Policy, the 
Animal Welfare Act, and the Guide for the Care and Use of Laboratory 
Animals (National Academy Press, Washington, DC).
    (2) Pursuant to the PHS Policy, section IV.A.3., offerors shall 
establish an IACUC, qualified through the experience and expertise 
of its members, to oversee the institution's animal program, 
facilities, and procedures. Offerors shall provide verification of 
IACUC approval in their proposals. Offerors shall review and comply 
with the PHS Policy details regarding assurance and IACUC 
requirements.
    (3) The contract will not be awarded without OLAW approval of 
the successful offeror's written Animal Welfare Assurance.
    (c) If at any time during performance of this contract, the 
Contracting Officer determines, in consultation with the OLAW, NIH, 
that the Contractor is not in compliance with any of the 
requirements and standards stated in paragraphs (a) through (c) 
above, the Contracting Officer may immediately suspend, in whole or 
in part, work performance and further payments under this contract 
until the noncompliance is corrected. Notice of the suspension may 
be

[[Page 80712]]

communicated by telephone and confirmed in writing. If the 
Contractor fails to come into compliance within the period of time 
designated by the Contracting Officer, the Contracting Officer may, 
in consultation with OLAW, NIH, terminate the contract in whole or 
in part, and the Contractor's name may be removed from the list of 
those contractors with Animal Welfare Assurances.

(End of clause)


352.270-78  Care of Live Vertebrate Animals.

    As prescribed in 370.403(b), insert the following clause:

Care of Live Vertebrate Animals (DATE)

    (a) Before performance of any contract involving animal-related 
activities where the species is regulated by the United Sates 
Department of Agriculture (USDA), the Contractor shall register with 
the Secretary of Agriculture of the United States in accordance with 
7 U.S.C. 2136 and 9 CFR 2.25 through 2.28. The Contractor shall 
furnish evidence of the registration to the Contracting Officer.
    (b) The Contractor shall acquire vertebrate animals used in 
research from a dealer licensed by the Secretary of Agriculture 
under 7 U.S.C. 2133 and 9 CFR 2.1 through 2.11, or from a source 
that is exempt from licensing under those sections.
    (c) The Contractor shall comply with USDA pertinent laws and 
regulations of the USDA (see 7 U.S.C. 2131 et seq. and 9 CFR chapter 
I, subchapter A, parts 1 through 4). Where a conflict exists within 
the standards, the more stringent standard shall govern.
    (d) If at any time during performance of this contract, the 
Contracting Officer determines, in consultation with the Office of 
Laboratory Animal Welfare, National Institutes of Health, that the 
Contractor is not in compliance with any of the requirements and 
standards stated in paragraphs (a) through (c) above, the 
Contracting Officer may immediately suspend, in whole or in part, 
work performance and further payments under this contract until the 
noncompliance is corrected. Notice of the suspension may be 
communicated by telephone and confirmed in writing. If the 
Contractor fails to come into compliance within the period of time 
designated by the Contracting Officer, the Contracting Officer may, 
in consultation with OLAW, NIH, terminate the contract in whole or 
in part.
    (e) The Contractor may request registration of its facility and 
a current listing of licensed dealers from the Regional Office of 
the Animal and Plant Health Inspection Service (APHIS), USDA, for 
the region in which its research facility is located. The location 
of the appropriate APHIS Regional Office, as well as information 
concerning this program may be obtained by contacting the Animal 
Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737 
(email: [email protected]; website: https://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalwelfare).

(End of clause)


352.270-79  Non-Discrimination for Conscience.

    As prescribed in 370.701, insert the following provision:

Non-Discrimination for Conscience (DATE)

    (a) Section 301(d) of the United States Leadership Against HIV/
AIDS, Tuberculosis, and Malaria Act, as amended, provides that an 
organization, including a faith-based organization, that is 
otherwise eligible to receive assistance under section 104A of the 
Foreign Assistance Act of 1961, under the United States Leadership 
Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003, under the 
Tom Lantos and Henry J. Hyde United States Global Leadership Against 
HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, The 
PEPFAR Stewardship Act of 2013, and The PEPFAR Extension Act of 
2018, or under any amendment to the foregoing Acts for HIV/AIDS 
prevention, treatment, or care--
    (1) Shall not be required, as a condition of receiving such 
assistance, to--
    (i) Endorse or utilize a multisectoral or comprehensive approach 
to combating HIV/AIDS; or
    (ii) Endorse, utilize, make a referral to, become integrated 
with, or otherwise participate in any program or activity to which 
the organization has a religious or moral objection.
    (2) Shall not be discriminated against under the provisions of 
law in paragraph (a) for refusing to meet any requirement described 
in paragraph (a)(1) in this solicitation.
    (b) Accordingly, an offeror who believes this solicitation 
contains work requirements requiring it endorse or utilize a 
multisectoral or comprehensive approach to combating HIV/AIDS, or 
endorse, utilize, make referral to, become integrated with, or 
otherwise participate in a program or activity to which it has a 
religious or moral objection, shall identify those work requirements 
it excluded in its technical proposal.
    (c) The Government acknowledges that an offeror has specific 
rights, as cited in paragraph (b), to exclude certain work 
requirements in this solicitation from its proposal. However, the 
Government reserves the right to not make an award to an offeror 
whose proposal does not comply with the salient work requirements of 
the solicitation. Any exercise of that Government right will be made 
by the Head of the Contracting Activity.

(End of provision)
0
47. Add subpart 352.3 to read as follows:

Subpart 352.3--Provision and Clause Matrix


352.301  Solicitation provisions and contract clauses (Matrix).

    The HHSAR matrix is not published in the CFR. It is available on 
the Acquisition.gov website at https://www.acquisition.gov/hhsar.

PART 353--[REMOVED AND RESERVED]

0
48. Remove and reserve part 353.

PARTS 354 through 369 [ADDED AND RESERVED]

0
49. Add reserved parts 354 through 369 to subchapter H.

Subchapter M [Redesignated as Subchapter I]

0
50. Redesignate subchapter M as subchapter I.
0
51. Revise newly redesignated subchapter I to read as follows:

SUBCHAPTER I--DEPARTMENT SUPPLEMENTARY REGULATIONS

PART 370 SPECIAL PROGRAMS AFFECTING ACQUISITIONS
PARTS 371-399 [RESERVED]

PART 370--SPECIAL PROGRAMS AFFECTING ACQUISITIONS

Subparts 370.1-370.2 [Reserved]

Subpart 370.3--Acquisitions Involving Human Subjects

Sec.
370.300 Scope of subpart.
370.301 Policy.
370.302 Federal-wide assurance.
370.303 Notice to offerors.
370.304 Solicitation provisions and contract clauses.
Subpart 370.4--Acquisitions Involving the Use of Laboratory Animals
370.400 Scope of subpart.
370.401 Definitions.
370.402 Policy.
370.403 Contract clauses.
Subparts 370.5-370.6 [Reserved]
Subpart 370.7--Acquisitions Under the President's Emergency Plan for 
AIDS Relief
370.700 Scope of subpart.
370.701 Solicitation provision.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 
41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subparts 370.1-370.2 [Reserved]

Subpart 370.3--Acquisitions Involving Human Subjects


370.300  Scope of subpart.

    This subpart implements the Basic HHS Policy for Protection of 
Human Research Subjects under 45 CFR part 46 and applies to all 
research activities conducted under contracts involving human subjects. 
See 45 CFR 46.101 (for scope of the policy) and 46.102(e) and (l) (for 
pertinent definitions).

[[Page 80713]]

370.301  Policy.

    It is the Department of Health and Human Services (HHS) policy that 
the contracting officer shall not award a contract involving human 
subjects until the prospective contractor provides assurance that the 
activity will undergo initial and continuing review by an appropriate 
Institutional Review Board (IRB) in accordance with HHS regulations at 
45 CFR 46.103. Except for research eligible for exemption under 45 CFR 
46.104, the contracting officer shall require a Federal-wide assurance 
(FWA) of each, approved by the HHS Office for Human Research 
Protections (OHRP), of each contractor, subcontractor, or institution 
engaged in human subjects research in performance of a contract. OHRP 
administers the assurance covering all HHS-supported or HHS-conducted 
activities involving human subjects.


370.302  Federal-wide assurance.

    (a) OHRP-Approved FWAs are found at the following website: https://ohrp.cit.nih.gov/search/search.aspx?styp=bsc.
    (b) Normally a contractor, subcontractor, or institution must 
provide approval of a FWA before a contract is awarded. If a 
contractor, subcontractor, or institution does not currently hold an 
approved FWA, it shall submit an explanation with its proposal and an 
FWA application prior to submitting a proposal. The contracting 
officer, on a case-by-case basis, may make award without an approved 
assurance in consultation with OHRP.
    (c) A contractor, subcontractor, or institution must submit all 
FWAs, including new FWAs, using the electronic submission system 
available through the OHRP website at https://ohrp.cit.nih.gov/efile/, 
unless an institution lacks the ability to do so electronically. If an 
institution believes it lacks the ability to submit its FWA 
electronically, it must contact OHRP by telephone or email (see https://www.hhs.gov/ohrp/assurances/) and explain why it is unable 
to submit its FWA electronically.


370.303  Notice to offerors.

    (a) The contracting officer shall notify offerors of the HHS Basic 
Policy for Protection of Human Subjects and required certifications. 
Unless otherwise exempted by 45 CFR part 46, no contract involving 
human subjects may start without these certifications. See 370.304 for 
applicable provisions and clauses.
    (b) Institutions having an OHRP-approved FWA shall certify IRB 
approval of submitted proposals in the manner required by instructions 
for completion of the contract proposal; by completion of an OMB Form 
No. 0990-0263, Protection of Human Subjects Assurance Identification/
IRB Certification/Declaration of Exemption (Common Rule); or by letter 
indicating the institution's OHRP-assigned FWA number, the date of IRB 
review and approval, and the type of review (convened or expedited). 
The date of IRB approval must not be more than 12 months prior to the 
deadline for proposal submission.
    (c) The contracting officer generally will not request FWAs for 
contractors, subcontractors, or institutions prior to selecting a 
contract proposal for negotiation. When a contractor submits an FWA, it 
provides certification for the initial contract period; no additional 
documentation is required. If the contract provides for additional 
years to complete the project, the contractor shall certify annually in 
the manner described in paragraph (a) of this section.


370.304  Solicitation provisions and contract clauses.

    (a) The contracting officer shall insert the provision at 352.270-
70, Notice to Offerors--Protection of Human Subjects, in solicitations 
that involve human subjects. The contracting officer shall use the 
clause with its Alternate I when the agency is prescribing a date later 
than the proposal submission by which the offeror must have an approved 
FWA.
    (b) For the Food and Drug Administration (FDA), the contracting 
officer shall insert the provision at 352.270-71, Notice to Offerors--
Protection of Human Subjects, Research Involving Human Subjects 
Committee (RIHSC) Approval of Research Protocols Required, in 
solicitations that involve human subjects when the research is subject 
to RIHSC review and approval.
    (c) The contracting officer shall insert the clause at 352.270-72, 
Protection of Human Subjects, in solicitations, contracts and orders 
involving human subjects.
    (d) The contracting officer shall insert the clause at 352.270-73, 
Restriction on Use of Human Subjects, in contracts and orders if the 
contractor has an approved FWA of compliance in place, but cannot 
certify prior to award that an IRB registered with OHRP reviewed and 
approved the research, because definite plans for involvement of human 
subjects are not set forth in the proposal (e.g., projects in which 
human subjects' involvement will depend upon completion of instruments, 
prior animal studies, or purification of compounds). Under these 
conditions, the contracting officer may make the award without the 
requisite certification, as long as the contracting officer includes 
appropriate conditions in the contract or order.
    (e) For FDA, the contracting officer shall insert the clause at 
352.270-74, Protection of Human Subjects--Research Involving Human 
Subjects Committee (RIHSC) Approval of Research Protocols Required, in 
contracts and orders that involve human subjects when the research is 
subject to RIHSC review and approval.
    (f) The contracting officer shall insert the clause at 352.270-75, 
Needle Exchange, in solicitations, contracts, and orders involving 
human subjects.
    (g) The contracting officer shall insert the clause at 352.270-76, 
Continued Ban on Funding Abortion and Continued Ban on Funding of Human 
Embryo Research, in solicitations, contracts, and orders involving 
human subjects.

Subpart 370.4--Acquisitions Involving the Use of Laboratory Animals


370.400  Scope of subpart.

    This subpart applies to HHS contracts that include research, 
research training, biological testing, housing and maintenance, and 
other activities involving live vertebrate animals.


370.401  Definitions.

    As used in this subpart--
    Animal means any live, vertebrate animal used or intended for use 
in research, research training, experimentation, or biological testing 
for related purposes.
    Animal Welfare Assurance or assurance means the documentation from 
an institution assuring institutional compliance with the Public Health 
Service Policy on Human Care and Use of Laboratory Animals at https://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf.
    Institutional Animal Care and Use Committee (IACUC) means an 
intended generic term for a committee whose function is to ensure that 
the care and use of animals in PHS-conducted or supported activities 
are appropriate and humane in accordance with the policy in 370.402. 
However, each institution may identify the committee by whatever name 
it chooses. An appropriate IACUC performs the functions described in 
the Public Health Service Policy on Human Care and Use of Laboratory 
Animals, section IV, paragraph B.


370.402  Policy.

    (a) Proposals submitted in response to solicitations involving 
research on

[[Page 80714]]

animals administered by the National Institutes of Health (NIH) or any 
national research institute shall include satisfactory assurances from 
the offeror or submitter to the Government, pursuant to the Health 
Research Extension Act of 1975 (Pub. L. 99-158, sec. 495(c)), that the 
contract work will be subject to initial and continuing review by an 
appropriate IACUC. See the Public Health Service Policy on Human Care 
and Use of Laboratory Animals at https://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf implements (Pub. L. 99-158) for 
additional information.
    (b) The contracting officer shall ensure that offerors and 
contractors comply with the assurance and review requirements of the 
Public Health Service Policy on Human Care and Use of Laboratory 
Animals on all actions involving research on animals.
    (c) The contracting officer shall not award a contract involving 
research on animals without an applicable Animal Welfare Assurance 
approved by the Office of Laboratory Animal Welfare (OLAW), NIH, for 
any institution proposed involved in research on animals to be 
performed under the contract.


370.403  Contract clauses.

    (a) The contracting officer shall insert the clause at 352.270-77, 
Requirement for Compliance with the Public Health Service Policy on 
Humane Care and Use of Laboratory Animals, in solicitations and 
contracts involving live vertebrate animals.
    (b) The contracting officer shall insert the clause at 352.270-78, 
Care of Live Vertebrate Animals, in solicitations and contracts that 
involve live vertebrate animals.

Subparts 370.5-370.6 [Reserved]

Subpart 370.7--Acquisitions Under the President's Emergency Plan 
for AIDS Relief


370.700  Scope of subpart.

    This subpart applies to contracts involving Human Immunodeficiency 
Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) programs under the 
President's Emergency Plan for AIDS Relief (PEPFAR) as established by 
the United States Leadership Against HIV/AIDS, Tuberculosis and Malaria 
Act of 2003, as amended (Pub. L. 108-25, Pub. L. 110-293, Pub. L. 113-
56, and Pub. L. 115-305).


370.701  Solicitation provision.

    The contracting officer shall insert the provision at 352.270-79, 
Non-Discrimination for Conscience, in solicitations valued at more than 
the micro-purchase threshold, which include work associated with the 
implementation of HIV/AIDS programs under PEPFAR.

PARTS 371-399 [RESERVED]

Subchapters J through L [Removed]

0
52. Remove reserved subchapters J through L.

[FR Doc. 2024-17095 Filed 10-2-24; 8:45 am]
BILLING CODE 4151-19-P
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