Health and Human Services Acquisition Regulation, 11265-11311 [2015-03391]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 80, Number 40 (Monday, March 2, 2015)]
[Proposed Rules]
[Pages 11265-11311]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03391]



[[Page 11265]]

Vol. 80

Monday,

No. 40

March 2, 2015

Part II





Department of Health and Human Services





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48 CFR Chapter 3





Health and Human Services Acquisition Regulation; Proposed Rule

Federal Register / Vol. 80 , No. 40 / Monday, March 2, 2015 / 
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

48 CFR Chapter 3


Health and Human Services Acquisition Regulation

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 its Federal Acquisition Regulation (FAR) Supplement, the HHS 
Acquisition Regulation (HHSAR), to update its regulation to current FAR 
requirements; to remove information from the HHSAR that consists of 
material that is internal administrative and procedural in nature; to 
add or revise definitions; to correct certain terminology; and to 
delete outdated material or material duplicative of the FAR.

DATES: Comments are due on or before May 1, 2015.

ADDRESSES: Submit comments in response to Health and Human Services 
Acquisition Regulation, parts 301 through 370 by any of the following 
methods:
    Regulations.gov: https://www.regulations.gov. Submit comments via 
the Federal eRulemaking portal by entering ``Health and Human Services 
Acquisition Regulation, parts 301 through 370'' under the heading 
``Enter Keyword or ID'' and selecting ``Search.'' Select the link 
``Submit a Comment'' that corresponds with ``Health and Human Services 
Acquisition Regulation, parts 301 through 370.'' Follow the 
instructions provided at the ``Submit a Comment'' screen. Please 
include your name, company name (if any), and ``Health and Human 
Services Acquisition Regulation, parts 301 through 370'' on your 
attached document.
    Fax: 202-260-4823.
    Mail: HHS/ASFR/OGAPA/Division of Acquisition, ATTN: Deborah 
Griffin, Room 537H, Hubert Humphrey Building, 200 Independence Avenue 
SW., Washington, DC 20201.
    Instructions: Please submit comments only and cite Health and Human 
Services Acquisition Regulation, parts 301 through 370, in all 
correspondence related to this case. All comments received will be 
posted without change to https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Deborah Griffin, Procurement Analyst, 
Department of Health and Human Services, Office of the Assistant 
Secretary for Financial Resources, Office of Grants and Acquisition 
Policy and Accountability, Division of Acquisition, 
Deborah.griffin@hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    The HHS made substantive changes in its Federal Acquisition 
Regulation (FAR) Supplement, the HHS Acquisition Regulation or HHSAR, 
in November 2009 (74 FR 62396 on November 27, 2009). On April 26, 2010, 
HHS published in the Federal Register correcting amendments at 75 FR 
2150. Since then numerous changes have been made to both statutory and 
regulatory (FAR) framework and requirements. Some of these new 
requirements were included in specific appropriations acts. This 
proposed rule changes the HHSAR to conform to these new requirements 
and to align the requirements with the current FAR. In addition, the 
procedural materials that were deemed internal or non-regulatory in 
nature are moved to internal procedures. Further changes are proposed 
to permit the various HHS operational divisions (OPDIVs) or staff 
divisions (STAFFDIVs) the necessary flexibility in meeting their 
respective missions. OPDIV provisions and clauses were collected and 
are tailored for department-wide application.
    The updated HHSAR includes HHS initiatives designed to change the 
purpose and content of the HHSAR. The objective is to improve the 
efficiency and effectiveness of various phases of the acquisition 
lifecycle, creating the framework for innovation and maximum 
flexibility. The updated HHSAR will contain only requirements of law, 
HHS policies, delegations of FAR authorities, deviations from FAR 
requirements, and policies/procedures that have a significant effect 
beyond the internal procedures of HHS or a significant cost or 
administrative impact on entities pursuing business opportunities with 
HHS. The information removed from the HHSAR consists of internal 
administrative and procedural information, referred to as internal 
procedures. In addition, the information removed does not have a 
significant effect beyond HHS internal operating procedures. The 
internal procedures will contain internal guidance, procedures, 
processes, and instructions but they will not be published in the Code 
of Federal Regulations. This framework which separates laws, policies, 
and other requirements impacting our industry partners from internal 
operating procedures will enable HHS to more rapidly convey internal 
administrative and procedural information to the acquisition workforce.

II. Proposed Rule

    The following summarizes changes to the HHSAR.

Part 301--HHS Acquisition Regulation System

    Part 301 is revised as follows:
    The nomenclature of the Contracting Officer's Technical 
Representative (COTR) was changed to Contracting Officer's 
Representative (COR) throughout the HHSAR. The training requirements 
for both Contracting Officers and CORs were deleted. The use of the 
term ``project officer'' has been removed throughout the HHSAR. The 
authority citations are corrected for all HHSAR parts.
    The prescription at Section 301.106(c) (Office of Management and 
Budget approval under the Paperwork Reduction Act) regarding the 
Paperwork Reduction Act was moved to Part 311 and OMB clearance numbers 
were updated.
    Section 301.270 (Executive Committee for Acquisition) is deleted as 
unnecessary for the regulation and reflecting only internal procedures.
    Subpart 301.4 (Deviations from the FAR) is strengthened to enforce 
the appropriate use of deviations.
    Subsection 301.602-3 (Ratification of unauthorized commitments), 
paragraph (b), is modified to strengthen the language.
    Subpart 301.6 (Career Development, Contracting Authority, and 
Responsibilities) is extensively modified to make clear that all 
procurement authority stems from the SPE by delegation, ultimately, 
from the Head of the Agency, who can delegate authority to issue 
warrants to a level no lower than the HCA. The internal procedures were 
deleted.

Part 302--Definitions of Words and Terms

    Part 302 is revised as follows:
    Section 302.101 (Definitions) is revised to clarify roles and 
responsibilities with HHS organizational changes. Definitions that 
already appear in the FAR were removed as duplicative.
    Subparts 302.70 (Common HHSAR Acronyms and Abbreviations) and 
302.71 (HHS Standard Templates and Formats) are removed as unnecessary.

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

    Part 303 is revised as follows:
    Subsection 303.104-7 (Violations or possible violations of the 
Procurement

[[Page 11267]]

Integrity Act) is revised to remove internal procedures for processing 
a Procurement Integrity Act violation and to remove the requirement for 
a review by a Senior Executive Service employee.
    Section 303.203 (Reporting suspected violations of the Gratuities 
clause) is revised to remove internal procedures for processing a 
report of a suspected violation.
    Section 303.303 (Reporting suspected antitrust violations) is 
removed as internal procedures.
    Subpart 303.4 (Contingent Fees) is deleted as unnecessary.
    Subpart 303.10 (Contractor Code of Business Ethics and Conduct) is 
added to move Section 303.1003 (Requirements) to its proper subject 
placement and Section 303.1003 is revised to remove internal procedures 
for processing a report of a suspected violation of criminal law.

Part 304--Administrative Matters

    Part 304 is revised as follows:
    Section 304.602 (General) is modified to remove the internal 
procedures regarding contract reporting.
    Section 304.604 (Responsibilities) is revised to remove the 
internal procedures and to note the importance of accuracy and 
timeliness in the Federal Procurement Data System reporting.
    Subsection 304.803-70 (Contract/order file organization and use of 
checklists) is removed as unnecessary.
    Subsection 304.804-70 (Contract closeout audits) is removed as 
unnecessary.
    Subpart 304.13 (Personal Identity Verification) is removed as 
unnecessary and a policy statement is added for clarification.
    Subpart 304.70 (Acquisition Instrument Identification Numbering 
System) is revised and renumbered as 304.16 (Unique Procurement 
Instrument Identifiers).
    Subpart 304.71 (Review and Approval of Proposed Contract Actions) 
and Section 304.7100 (Policy) is revised to clarify contract reviews 
and to remove internal procedures.
    Subpart 304.72 (Affordable Care Act Prevention and Public Health 
Fund--Reporting Requirements) is added to address information required 
by the Prevention and Public Health Fund (PPHF).

Part 305--Publicizing Contract Actions

    Part 305 is revised as follows:
    Subpart 305.2 (Synopsis of Proposed Contract Actions) is removed as 
unnecessary.
    Section 305.303 (Announcement of contract awards), paragraph (a), 
is revised to remove a separate threshold for HHS and rely on the FAR. 
The internal procedures are removed.
    Section 305.502 (Authority) is revised to remove language redundant 
to the FAR and to specify that published advertisements in print media 
require approval above the contracting officer.
    Subpart 305.70 (Publicizing Requirements Funded from the Affordable 
Care Act Prevention and Public Health Fund) is added.

Part 306--Competition Requirements

    Part 306 is revised as follows:
    Section 306.202 (Establishing or maintaining alternative sources) 
is revised to include reference to the HHS Department Competition 
Advocate.
    Subsection 306.302-1 (Only one responsible source and no other 
supplies or services will satisfy agency requirements), paragraph 
(a)(2)(iv), is deleted; the information is considered internal 
procedures. Also, information is added for the Bioshield Program.
    Subsection 306.302-7 (Public interest) is revised to clarify the 
procedures for the signature of the Secretary for a determination and 
findings for public interest.
    Section 306.303 (Justifications) is deleted; the information is 
considered internal procedures.
    Section 306.304 (Approval of the justification) is deleted; the 
information is considered internal procedures.
    Section 306.501 (Requirement) is revised to identify the HHS 
Department Competition Advocate.
    Section 306.502 (Duties and responsibilities) is deleted; the 
information is considered internal procedures.

Part 307--Acquisition Planning

    Part 307 is revised as follows:
    Sections 307.104 (General procedures), 307.104-70 (Acquisition 
strategy), and 307.104-71 (Purpose and timing) are deleted.
    Section 307.105 (Contents of written acquisition plans) is revised 
to clarify that HHS requires a written acquisition plan for all 
acquisitions above the simplified acquisition threshold.
    Subsection 307.108-70 (Telecommuting of contractor employees) is 
deleted; this language is redundant; the FAR language is sufficient.
    Subpart 307.70 (Considerations in Selecting an Award Instrument) is 
deleted; this information is considered internal procedures.
    Subpart 307.71 (Acquisition Plan) is deleted; this information is 
considered internal procedures.

Part 308--Required Sources of Supplies and Services

    Part 308 is revised as follows:
    Section 308.404 (Use of Federal Supply Schedule) is deleted; the 
FAR language is sufficient.
    Section 308.405-6 (Limited source justification and approval) is 
revised; information considered internal procedures is removed.
    Subpart 308.8 (Acquisition of Printing and Related Supplies) is 
added to provide guidance on Government printing and electronic 
communications.

Part 309--Contractor Qualifications

    Part 309 is revised as follows:
    Section 309.402 (Policy) is deleted.
    Section 309.403 (Definitions) is updated to provide current HHS 
definitions.
    Section 309.404 (List of parties excluded from Federal procurement 
and non-procurement programs) is revised to change the title to System 
for Award Management (SAM) Exclusions. This revision reflects the 
current FAR language.
    Section 309.405 (Effect of listing. Compelling Reason 
Determinations) is revised to change the title and updated to reflect 
current HHS terminology.
    Sections 309.406 (Debarment) and 306.407 (Suspension) are revised.
    Section 309.470 (Reporting of suspected causes for debarment or 
suspension or the taking of evasive actions) is revised to clarify and 
update the contracting officer's responsibilities to report and 
coordinate suspected causes for debarment or suspension or the taking 
of evasive actions.
    Subsection 309.470-1 (Situations where reports are required) is 
revised and Subsection 309.470-2 (Contents of reports) is deleted; the 
information deleted is considered internal procedures.

Part 310--Market Research

    Part 310 is revised as follows:
    Section 310.001 (Policy) is revised to instruct contracting offices 
to follow the FAR.

Part 311--Describing Agency Needs

    Part 311 is revised as follows:
    Section 311.7000 (Defining electronic information technology (EIT) 
requirements) is revised to clarify the contracting officer's role in 
identifying the agency needs for EIT supplies and services; information 
considered internal procedures is deleted.
    Section 311.7001 (Section 508 accessibility standards for HHS Web 
site content and communications materials) is moved to Part 339 and 
updated.

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    Subpart 311.71 (Accessibility of Meetings, Conferences, and 
Seminars to Persons with Disabilities) is relocated from Part 370.
    Subpart 311.72 (Conference Funding and Sponsorship) is relocated 
from Part 370.
    Subpart 311.73 (Contractor Collection of Information) is relocated 
from Part 301.

Part 312--Acquisition of Commercial Items

    Part 312 is revised as follows:
    Section 312.101 (Policy) is revised to emphasize that the HHS 
Strategic Sourcing Program shall be utilized when possible.
    Section 312.202(d) (Market research and description of agency need) 
is revised to identify that the requiring activity specifies electronic 
and information technology (EIT) supplies and services subject to 
Section 508 and to move Section 508 requirements to Part 339.

Part 313--Simplified Acquisition Procedures

    Part 313 is revised as follows:
    Section 313.003 (Policy) is revised by moving language related to 
Section 508 to Part 339.
    Subpart 313.1 (Procedures) is deleted; this language is duplicative 
of the FAR.
    Section 313.301 (Government-wide commercial purchase card), 
paragraph (b), is revised to reference the HHS Purchase Card Program; 
the remaining procedural language is removed.
    Section 313.303 (Blanket purchase agreements) and Subsection 
313.305-5 (Purchases under blanket purchase agreements) are deleted; 
this information is not current.
    Subpart 313.5 (Test Program for Certain Commercial Items) is 
deleted; this is considered procedural information.

Part 314--Sealed Bidding

    Part 314 is revised as follows:
    Section 314.103 (Policy) is revised by moving language related to 
Section 508 to Part 339.
    Subpart 314.2 (Solicitation of Bids) is deleted; the FAR language 
is sufficient.
    Subsection 314.404-1 (Cancellation of invitations after opening) in 
Section 314.404 (Rejection of bids) is revised to retain and clarify 
the HCA authority for rejection of bids and cancellations of 
invitations after opening.
    Section 314.407 (Mistakes in bids) is revised to retain and clarify 
the head of the contracting activity authority for mistakes in bid both 
before award and afterward and information considered internal 
procedures is removed.

Part 315--Contracting By Negotiation

    Part 315 is revised as follows:
    The term ``Technical Evaluation Panel'' is removed and replaced 
with ``Source Selection Evaluation Team'' throughout this part and 
material that is deemed redundant to the FAR has been deleted.
    Section 315.201 (Exchanges with industry before receipt of 
proposals) is determined to be internal procedures and is removed.
    Subsection 315.204-5 (Part IV--Representations and instructions), 
paragraph (c)(2), is deleted and the internal procedures are removed.
    Section 315.208 (Submission, modification, revision, and withdrawal 
of proposals) is revised to update how the Government will handle 
proposals after the exact time specified for receipt.
    Section 315.209 (Solicitation Provisions and Contract Clauses) is 
deleted.
    Section 315.304 (Evaluation factors and significant subfactors) is 
revised to move the text related to EIT acquisitions to Part 339, and 
the internal procedures are removed.
    Section 315.305 (Proposal evaluation) is revised and the internal 
procedures are removed.
    Sections 315.306 (Exchanges with offerors after receipt of 
proposals) and 315.307 (Proposal revisions) are removed.
    Section 315.370 (Finalization of details with the selected source) 
is deleted as unnecessary; it is redundant to FAR 15.206.
    Section 315.371 (Contract preparation and award) contains internal 
procedures which are removed.
    Section 315.372 (Preparation of negotiation memorandum) contains 
internal procedures which are removed.
    Subsection 315.404-2 (Information to support proposal analysis) is 
revised and internal procedures are removed.
    Subsection 315.404-4 (Profit) is revised and the internal 
procedures related to developing weighted guidelines are removed.
    Section 315.605 (Content of unsolicited proposals) is revised to 
clarify the requirements on the submitter of an unsolicited proposal. 
The requirement for a certification has been deleted and a warranty has 
been added to conform to current Federal law. This changes the 
government's remedy from a criminal sanction to a contract remedy.
    Subsection 315.606-1 (Receipt and initial review) is revised for 
clarity.
    Section 315.609 (Limited Use of Data) is deleted.
    Subpart 315.70 (Acquisition of Electronic Information Technology) 
is moved to Part 339.

Part 316--Types of Contracts

    Part 316 is revised as follows:
    Section 316.603 (Letter contracts) is revised to limit letter 
contract modifications as prescribed in the FAR.
    Section 316.307 (Contract clauses) is revised to clarify the 
application of the cost principle in accordance with the governing 
statute.
    Section 316.505 (Ordering) is revised to clarify the role of the 
Competition Advocate as the task order ombudsman.
    Subsection 316.603-70 (Procedure for requesting authority to issue 
a letter contract) is deleted as unnecessary.
    Subsection 316.603-71 (Approval for modifications to letter 
contracts) is moved to 316.603-3 in part and is otherwise deleted as 
unnecessary.
    Subpart 316.7 (Agreements) is deleted as unnecessary.

Part 317--Special Contracting Methods

    Part 317 is revised as follows:
    Section 317.104 (General) is revised to identify the Senior 
Procurement Executive as the designated agency approving official.
    Subsection 317.105-1 (Uses), paragraph (a), is revised to update 
current thresholds for cancellation ceilings.
    Section 317.107 (Options) is revised to update guidance on the use 
of options for multi-year contracts.
    Section 317.204 (Contracts), paragraph (e), is revised to provide 
guidance on contract periods exceeding the 5-year limitation provided 
in FAR 17.204(e).
    Section 317.207 (Exercise of Options) is deleted; the information 
for current Section 508 policy is provided in Part 339.
    Subpart 317.5 (Interagency Acquisitions Under the Economy Act) is 
deleted; this information is considered internal procedures.
    Subpart 317.70 (Multi-agency and Intra-agency Contracts) is 
deleted; this information is considered internal procedures.

Part 319--Small Business Programs

    Part 319 is revised as follows:
    Section 319.201 (General policy) language is revised to align with 
the FAR.
    Subsection 319.202-2 (Locating small business sources) is removed 
as unnecessary.
    Subsection 319.270-1 (Mentor Prot[eacute]g[eacute] Program) is 
revised to change the section heading to ``Mentor Prot[eacute]g[eacute] 
Program Solicitation provision and contract clause.''

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    Subpart 319.5 (Set-asides for Small Business) is deleted; the FAR 
coverage is sufficient.
    Subpart 319.7 (Subcontracting with Small Business, Small 
Disadvantaged Business, and Women-Owned Small Business Concerns) is 
removed as unnecessary.

Part 322--Application of Labor Laws to Government Acquisitions

    Part 322 is revised as follows:
    Section 322.810 (Solicitation provisions and contract clauses) is 
revised to correct the clause prescriptions.

Part 323--Environment, Energy and Water Efficiency, Renewable Energy 
Technologies, Occupational Safety, and Drug-Free Workplace

    Part 323 is revised as follows:
    Section 323.7000 (Scope of subpart) is revised to clarify the 
applicable policy for safety and health situations.
    Section 323.7001 (Policy) is revised to clarify guidance for safety 
and health situations.
    Section 323.7002 (Actions required) is revised by removing 
information regarding roles other than the contracting officer.
    Subpart 323.71 (Sustainable Acquisition Requirements) is revised by 
adding sustainable acquisition requirements. This additional 
information provides policy and a new provision prescription for 
offerors to describe their approaches for meeting the requirements of 
FAR 23.1 (Sustainable Acquisition Policy).

Part 324--Protection of Privacy and Freedom of Information

    Part 324 is revised as follows:
    Sections 324.000 (Scope of subpart) and 324.102 (General) are 
removed; this information is considered internal procedures.
    Section 324.103 (Procedures) is revised to change the section 
heading to ``Procedures for the Privacy Act'' and to ensure that the 
statement of work/performance work schedule specifies the system of 
record and the disposition of the system of record.
    Section 324.104 (Restrictions on Contractor Access to Government or 
Third Party Information) is added to provide information on 
restrictions on contractor access to Government or third party 
information.
    Section 324.105 (Contract clauses) is added to prescribe the clause 
at 352.224-70 (Privacy Act) and 352.224-71 (Confidential Information).
    Subpart 324.2 (Freedom of Information Act) is deleted; the FAR is 
sufficient.
    Subpart 324.70 (Health Insurance Portability and Accountability Act 
of 1996 (HIPAA)) is added to provide coverage for the Health Insurance 
Portability and Accountability Act of 1996 and subtitle D of title IV 
of the Health Information Technology for Economic and Clinical Health 
Act (HITECH Act).
    Pursuant to the Health Insurance Portability and Accountability Act 
of 1996, Public Law 104-191 (August 21, 1996) and the Health 
Information Technology for Economic and Clinical Health (HITECH) Act, 
enacted as part of the American Recovery and Investment Act, Public Law 
111-5 (February 17, 2009), the Department issued regulations at 45 CFR 
parts 160 to 164 (HIPAA Rules).
    The HIPAA Rules apply to ``covered entities'' and in part to 
``business associates,'' as defined at 160.103. Covered entities are 
health plans, health care clearinghouses, and any health care provider 
who transmits health information in electronic form in connection with 
transactions for which the Secretary of HHS has adopted standards under 
the HIPAA statute. In general, business associates are persons or 
organizations that perform certain functions or activities on behalf 
of, or provides certain services to, covered entities that involve the 
use or disclosure of protected health information. When covered 
entities use contractors to perform services or activities that involve 
protected health information, the HIPAA Privacy and Security Rules 
require that covered entities enter into an agreement with business 
associates, commonly called business associate agreements, which must 
include specified terms set forth in these rules.
    A covered entity that is a single legal entity and that conducts 
both covered and non-covered functions may elect to be a ``hybrid 
entity,'' as defined at 164.103. A covered function is an activity that 
makes a person or organization a covered entity. To be a hybrid entity, 
a covered entity must designate in writing its operations that perform 
covered functions as one or more ``health care components,'' as defined 
at 164.103. After making this designation, most of the requirements of 
the HIPAA rules will apply only to the health care components. A 
covered entity that is a hybrid entity must include a component that 
performs business associate-like activities within its health care 
component(s) so that such component is directly subject to the HIPAA 
Rules.
    The Department is a covered entity. However, because the Department 
has elected to be a hybrid entity, most Department activities are not 
subject to the HIPAA Rules. At this time, the designated HHS' HCCs fall 
into the following categories: the CMS Medicare fee-for-service 
program, the Indian Health Service, the Commissioned Corps and the CDC 
World Trade Center Health Program. Even when a covered entity is a 
hybrid entity, the duty to enter into agreements or contracts that 
include certain terms remains with the covered entity rather than the 
health care component. For operational purposes it may be the covered 
entity's HCC(s) that perform the contract function on behalf of the 
covered entity.
    This proposed rule references the terms that the HHS HCCs on behalf 
of the Department must include in their contracts with their business 
associates. In complying with the HIPAA Rules, the HCCs and their 
business associates shall interpret the HIPAA Rules consistent with the 
Department's interpretations as found on the HHS Office for Civil 
Rights Web site at https://www.hhs.gov/ocr/privacy. In particular, HCCs 
should reference the Sample Business Associate Agreement (BAA) 
Provisions at https://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/contractprov.html as they develop their business 
associate contracts.
    The required business associate contract terms apply where the 
Department is required to enter into a business associate contract 
pursuant to the HIPAA Rules. We note that the definition of business 
associate includes ``subcontractors.'' However, under 45 CFR 
164.502(e)(1)(i), a covered entity is not required to have a business 
associate contract with a subcontractor; this would be the 
responsibility of the business associate. Also, under 45 CFR 
164.504(e)(3)(i)(A) and (B), the business associate contract terms are 
not required if the business associate is another government agency 
(e.g., a state agency) and certain conditions are met. Also, under 
164.504(e)(3)(ii), the business associate contract terms are not 
required where the business associate is required by law to perform 
business associate functions or activities on behalf of the HCC or to 
provide certain services to a HCC, and certain other conditions are 
met. For example the Department of Justice is required by law to 
provide legal services to HHS.

Part 326--Other Socioeconomic Programs

    Part 326 is added as follows:
    Subpart 326.5 (Indian Preference in Employment, Training, and 
Subcontracting Opportunities) is added to provide information on the 
Indian

[[Page 11270]]

preference in employment, training, and subcontracting opportunities. 
This information is moved from part 370.
    Subpart 326.6 (Acquisitions Under the Buy Indian Act) is added to 
provide information on acquisitions under the Buy Indian Act. This 
information is moved from part 370.
    Subpart 326.7 (Acquisitions Requiring the Native American Graves 
Protection and Repatriation Act) is added to provide information on 
acquisitions requiring the Native American Graves Protection and 
Repatriation Act. This information is moved from part 342.

Part 327--Rights, Data, and Copyrights

    Part 327 is revised as follows:
    Subsection 327.404-70 (Solicitation provision and contract clause), 
is revised to clarify that the contractor may publish results of its 
work.

Part 328--Bonds and Insurance

    Part 328 is deleted; the FAR is deemed sufficient.

Part 330--Cost Accounting Standards

    Part 330 is revised as follows:
    Subsection 330.201-5 (Waiver) is revised and internal procedures 
are removed.

Part 331--Contract Cost Principles and Procedures

    Part 331 is revised as follows:
    Section 331.101-70 (Salary Rate Limitation) is revised to update 
how HHS appropriated funds are to be used, and direct users to Office 
of Personnel Management for the rate tables.
    Section 331.102-70 (Pricing of adjustments) contains internal 
procedures and is removed.

Part 332--Contract Financing

    Part 332 is revised as follows:
    Section 332.402 (General) is revised to clarify the HCA 
responsibility for advance payments.
    Section 332.403 (Applicability) is deleted as unnecessary.
    Section 332.407 (Interest) is revised and internal procedures are 
removed.
    Section 332.409 (Contracting Officer action) and Subsection 
332.409-1 (Recommendation for approval) are deleted as unnecessary.
    Section 332.702 (Policy), Section 332.703 (Contract funding 
requirements), and Subsection 332.703-71 (Incrementally funded cost-
reimbursement contracts) are added to address contract funding issues.
    Subsection 332.703-70 (Funding contracts during a continuing 
resolution) is removed since continuing resolution and their associated 
requirements change with each resolution.
    Subsection 332.703-71 (Incrementally funded cost-reimbursement 
contracts) is added.
    Subsection 332.703-72 (Incremental Funding Table) is added to 
provide a contract mechanism to track funding on an incrementally 
funded contract.
    Section 332.704 (Limitation of cost or funds) is deleted as 
unnecessary.
    Section 332.706 (Solicitation provision and contract clauses) is 
added to prescribe the clause at 352.232-70 (Incremental Funding).
    Subsection 332.706-2 (Provision and clauses for limitation of cost 
or funds) is added to prescribe additional requirements for cost-
reimbursement contract for severable services using incremental 
funding.

Part 333--Protests, Disputes, and Appeals

    Part 333 is revised as follows:
    Sections 333.102 (General) and 333.103 (Protests to the agency) are 
revised to remove internal procedures.
    Sections 333.104 (Protests to GAO), 333.211 (Contracting Officer's 
decision), 333.212 (Contracting Officer's duties upon appeal), 333.212-
70 (Formats), and 333.213 (Obligation to continue performance) are 
internal procedures and are deleted.
    Subsection 333.215-70 (Contract clauses) is revised to reference 
the clause at 352.233-72 in all solicitations and contracts and to 
correct the clause prescriptions.

Part 334--Major System Acquisition

    Part 334 is revised as follows:
    Section 334.200 (Definitions) is deleted.
    Section 334.201 (Policy) is revised to provide the HHS contract 
value thresholds for the requirement of EVMS.
    Section 334.203 (Solicitation provisions and contract clauses) and 
Subsection 334.203-70 (HHS solicitation provisions and contract 
clauses) are deleted.

Part 335--Research and Development Contracting

    Part 335 is revised as follows:
    Subsection 335.070-1 (Policy) is revised to relax the prior 
mandates in order to provide the contracting officer more flexibility 
regarding cost-sharing contracts.
    Subsection 335.070-2 (Amount of cost-sharing) is revised to provide 
the contracting officer more flexibility regarding fees or profits in 
cost-sharing contracts.
    Subsection 335.070-4 (Contract award) is deleted as unnecessary.
    Section 335.071 (Special determinations and findings affecting 
research and development contracting) is deleted as an unnecessary 
determinations and findings.
    Section 335.072 (Key Personnel) is added to emphasize the 
importance of Key Personnel in research and development contracting.

Part 336--Construction and Architect-Engineer Contracts

    Part 336 is added.

Part 337--Service Contracting--General

    Part 337 is revised as follows:
    Section 337.103 (Contracting Officer Responsibility) is revised as 
follows:
     Paragraphs (d)(1), (2), and (3), are revised to prescribe 
clauses to comply with Federal law.
     Paragraph (d)(4) is added to provide direction to the 
Indian Health Service contracting officers in complying with the Indian 
Child Protection And Family Violence Act (25 U.S.C. 3201 et seq.).
     Paragraph (e) is added to prescribe a clause that requires 
contractors who deliver services to beneficiaries of HHS programs to do 
so in a non-discriminatory fashion.
     Paragraph (f) is added to prescribe the use of the new key 
personnel clause at 352.237-75.
    Section 337.103-70 (Solicitation provision and contract clause) is 
moved to Section 337.103 (Contracting Officer Responsibility) to align 
with FAR numbering.

Part 339--Acquisition of Information Technology

    Revised Part 339 as follows:
    Section 339.101 (Policy) is revised to clarify that contracting 
officers shall collaborate with the requiring activity for the 
acquisition of information technology supplies, services, and systems.
    Section 339.201 (Clarification) and Subsection 339.201-70 (Required 
provision and contract clause) are deleted; the information is 
obsolete.
    Section 339.203 (Approval of exceptions) is revised and the title 
is changed to (Applicability) to align with the FAR.
    Sections 339.203-70 (Contract clauses), 339.204 (Exceptions), 
339.204-1 (Approval of exceptions), and 339.205 (Section 508 
accessibility standards for contracts) are added to provide updated 
information for electronic and information technology supplies and 
services and the requirements for compliance with Section 508 of the 
Rehabilitation Act.
    Subparts 339.70 (Use of General Services Administration Blanket 
Purchase Agreements for Independent Risk Analysis Services) and 339.71

[[Page 11271]]

(Information Security Management) are internal procedures and are 
deleted.

Part 342--Contract Administration

    Part 342 is revised as follows:
    Section 342.302 (Contract administration functions) is revised as 
follows:
     Paragraph (c)(1) is deleted;
     Paragraph (c)(2) is deleted and the clause prescription is 
moved to Part 337 and renumbered;
     Paragraph (c)(3) is deleted because it prescribes the use 
of clause 352.242-71 (Tobacco-Free Facilities) which is also deleted; 
and
     Paragraph (c)(4) is deleted and the clause prescription is 
moved to Part 326 and renumbered.
    Section 342.705 (Final indirect cost rates) is revised to clarify 
the HHS component named as the cognizant Federal agency within HHS.
    Subpart 342.70 (Contract Monitoring) is revised by removing 
information from Sections 342.7000 (Purpose), 342.7001 (Contract 
monitoring responsibilities), and 342.7002 (Procedures to be followed 
when a contractor fails to perform); this information is considered 
internal procedures.
    Section 342.7003 (Withholding of contract payments) is deleted; the 
FAR is sufficient.
    Subpart 342.71 (Administrative Actions for Cost Overruns) is 
removed.

Part 352--Solicitation Provisions and Contract Clauses

    Part 352 is revised as follows:
    Clause 352.201-70 (Paperwork Reduction Act) is re-numbered 352.211-
3 and relocated to Part 311.
    Clause 352.202-1 (Definitions) is deleted.
    Clause 352.203-70 (Anti-Lobbying) related to Subpart 303.8 
(Limitation on the Payment of Funds to Influence Federal Transactions) 
is updated.
    Clause 352.204-70 (Prevention and Public Health Fund--Reporting 
Requirements) is added.
    Clause 352.208-70 (Printing and Duplication) is added.
    Clause 352.211-1 (Accessibility of meetings, conferences, and 
seminars to persons with disabilities) formerly 352.270-7 is relocated 
from part 370.
    Clause 352.211-2 (Conference sponsorship request and conference 
materials disclaimer) formerly 352.270-1 is relocated from Part 370.
    Clause 352.211-3 (Paperwork Reduction Act) formerly 352.201-70 is 
relocated from part 301.
    Clause 352.215-1 (Instructions to offerors--competitive 
acquisition) is deleted.
    Clause 352.215-70 (Late Proposals and Revisions) is revised.
    Clause 352.216-70 (Additional Cost Principles) is revised to 
correct the prescription citation.
    Clause 352.219-70 (Mentor-prot[eacute]g[eacute] program) is 
revised.
    Clause 352.222-70 (Contractor cooperation in equal employment 
opportunity investigations) is corrected.
    Clause 352.223-70 (Safety and health) is updated.
    Provision 352.223-71 (Instructions to Offerors--Sustainable 
Acquisition) is added.
    Clause 352.224-70 (Privacy Act) is updated.
    Clause 352.224-71 (Confidential Information) is added.
    Clauses 352.226-1 (Indian Preference), 352.226-2 (Indian Preference 
Program), and 352.226-3 (Native American Graves Protection and 
Repatriation Act) are added. These clauses are moved from Parts 370 and 
342 and renumbered.
    Clause 352.227-70 (Publications and Publicity) is revised to 
clarify that the contractor may publish results of its work. In 
addition, paragraph (b) of the clause is revised. Paragraph ``c'' is 
added to clarify the advertising of products or services provided under 
the contract.
    Clause at 352.231-70 (Salary Rate Limitation) is revised.
    Clause 352.231-71 (Pricing of adjustments) is deleted as 
unnecessary.
    Clause 352.232-70 (Incremental funding) is revised.
    Clauses 352.233-70 (Choice of Law (overseas)) and 352.233-71 
(Litigation and claims) are revised.
    Provisions 352.234-1 (Notice of Earned Value Management System--
Pre-Award Integrated Baseline Review) and 352.234-2 (Notice of Earned 
Value Management System--Post-Award Integrated Baseline Review) are 
deleted; the FAR provisions are sufficient.
    Clauses 352.234-3 (Full Earned Value Management System) and 
352.234-4 (Partial Earned Value Management System) are deleted; the FAR 
clauses are sufficient.
    Clause 352.236-70 (Design-Build Contracts) is added with an 
Alternate I to be used for Fast Track procedures.
    Clauses 352.237-70 (Pro-Children Act), 352.237-71 (Crime Control 
Act--reporting of child abuse), and 352.237-72 (Crime Control Act--
requirement for background checks) are updated. Clauses 352.237-73 
(Indian Child Protection and Family Violence Act), 352.237-74 (Non-
discrimination in Service Delivery), and 352.237-75 (Key Personnel) are 
added.
    Clause 352.239-70 (Standard for Security Configurations) is 
deleted; the clause is obsolete.
    Clause 352.239-71 (Standard for Encryption Language) is deleted; 
the clause is obsolete.
    Clause 352.239-72 (Security Requirements for Federal Information 
Technology Resources) is deleted; the clause is obsolete.
    Provision 352.239-73 (Electronic and Information Technology and 
Accessibility Notice) is revised to provide updated information for 
electronic and information technology supplies and services and the 
requirements for compliance with Section 508 of the Rehabilitation Act.
    Clause 352.239-74 (Electronic and Information Technology 
Accessibility) is added.
    Clause 352.242-70 (Key Personnel) is renumbered as 352.237-75.
    Clause 352.242-71 (Tobacco Free Facilities) is deleted. The clause 
is no longer necessary.
    Clause at 352.242-72 (Native American Graves Protection and 
Repatriation Act) is renumbered as 352.236-3.
    Clause 352.242-73 (Withholding of Contract Payments) is deleted; 
the FAR is sufficient.
    Clause 352.242-74 (Final decisions on audit findings) is deleted; 
the FAR is sufficient.
    Clause 352.270-1 (Accessibility of Meetings, Conferences, and 
Seminars to Persons with Disabilities) is moved to 352.211-1;
    Clause 352.270-2 (Indian preference) is moved to 352.226-1.
    Clause 352.270-3 (Indian preference program) is moved to 352.226-2.
    Provision 352.270-4a (Notice to Offerors, Protection of Human 
Subjects) is revised to update the Federal-wide assurance requirement 
and provide for the inclusion of an Alternate to this provision.
    Clause at 352.270-4b (Protection of Human Subjects) is revised to 
update the Federal-wide assurance requirement.
    Provision 352.270-5a (Notice to Offerors of Requirement for 
Compliance with the Public Health Service Policy on Humane Care and Use 
of Laboratory Animals) is updated.
    Clause 352.270-5b (Care of Live Vertebrate Animals) is updated.
    Clause 352.270-6 (Restrictions on Use of Human Subjects) is revised 
to update the reference to the Institutional Review Board.
    Clause 352.270-7 (Conference Sponsorship Request and Conference 
Materials Disclaimer) is moved to 352.211-2.
    Clause 352.270-8 (Prostitution and related activities) is deleted.

[[Page 11272]]

    Clause 352.270-9 (Non-discrimination for conscience) is updated.
    Provision 352.270-10 (Notice to Offerors--Protection of Human 
Subjects, Research Involving Human Subjects Committee (RIHSC) Approval 
of Research Protocols Required) is added.
    Clause 352.270-11 (Protection of Human Subjects, Research Involving 
Human Subjects Committee (RIHSC) Approval of Research Protocols 
Required) is added.
    Clause 352.270-12 (Needle Exchange) is added.
    Clause 352.270-13 (Continued Ban on Funding Abortion and Continued 
Ban on Funding of Human Embryo Research) is added.

Part 353--Forms

    Form HHS 674, Structured Approach Profit/Fee Objective is deleted. 
There are no forms; therefore, the part is reserved.

Part 370--Special Programs Affecting Acquisition

    Part 370 is revised as follows:
    Subpart 370.1 (Accessibility of Meetings, Conferences, and Seminars 
to Persons with Disabilities) is moved to part 311.
    Subpart 370.2 (Indian Preference in Employment, Training, and 
Subcontracting Opportunities) is moved to part 326.
    Subpart 370.3 (Acquisitions Involving Human Subjects) is revised to 
update the policy in section 370.301 and the Federal-wide assurance in 
370.302.
    Section 370.303 (Notice to offerors) is revised as follows:
     Paragraph (a) is revised to provide for the inclusion of 
an Alternate to the provision at 352.270-4a (Notice to Offerors, 
Protection of Human Subjects).
     Paragraph (d) is added to provide a prescription for the 
provision added at 352.270-10 (Notice to Offerors--Protection of Human 
Subjects, Research Involving Human Subjects Committee (RIHSC) Approval 
of Research Protocols Required) in FDA solicitations that involve human 
subjects research such that the research will be reviewed and approved 
by the Research Involving Human Subjects Committee (RIHSC).
    Section 370.304 (Contract clauses) is revised as follows:
     Paragraph (c) is added to provide a prescription for the 
clause added at 352.270-11 (Protection of Human Subjects, Research 
Involving Human Subjects Committee (RIHSC) Approval of Research 
Protocols Required) in FDA solicitations that involve human subjects 
research such that the research will be reviewed and approved by the 
Research Involving Human Subjects Committee (RIHSC).
     Paragraph (d) is added to provide a prescription for the 
clause added at 352.270-12 (Needle Exchange).
     Paragraph (e) is added to provide a prescription for the 
clause added at 352.270-13 (Continued Ban on Funding Abortion and 
Continued Ban on Funding of Human Embryo Research).
    Subpart 370.4 (Acquisitions Involving the Use of Laboratory 
Animals) is revised to update the policy in Section 370.401 (Policy) 
and the assurances in Section 370.402 (Assurances).
    Sections 370.403 (Notice to offerors) and 370.404 (Contract clause) 
are revised to correct the provision and clause prescriptions.
    Subpart 370.5 (Acquisitions Under the Buy Indian Act) is moved to 
part 326.
    Subpart 370.6 (Conference Funding and Sponsorship) is moved to part 
311.
    Subpart 370.7 (Acquisitions under the Leadership Act) is revised 
for editorial corrections.

III. Executive Order 12866 and 13563

    Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess 
all costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). E.O. 
13563 emphasizes the importance of quantifying both costs and benefits, 
of reducing costs, of harmonizing rules, and of promoting flexibility.
    This is not a significant regulatory action and, therefore, is not 
subject to review under section 6(b) of Executive Order 12866, 
Regulatory Planning and Review, dated September 30, 1993. This rule is 
not a major rule under 5 U.S.C. 804.

IV. Regulatory Flexibility Act

    These changes to the HHSAR will not have a significant economic 
impact on a substantial number of small entities within the meaning of 
the Regulatory Flexibility Act 5 U.S.C. 601, et seq. The proposed rule 
improves HHS acquisition by removing duplicative regulatory language, 
provisions and clauses, and procedural information, and provides 
departmental level regulation and provisions and clauses. Businesses, 
both small and large, can respond to uniform acquisition regulation, 
reducing their costs. As a result of these changes, the proposed rule 
should have a positive effect on small businesses allowing them to more 
readily compete for HHS contracts.
    The Initial Regulatory Flexibility Analysis (IRFA) is summarized as 
follows:

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 action is being taken.
    The Department of Health and Human Services (HHS) is proposing to 
amend its Federal Acquisition Regulation (FAR) Supplement, the HHS 
Acquisition Regulation (HHSAR), to update its regulation to current FAR 
requirements; to move internal guidance which is procedural in nature 
to Procedures, Guidance and Instructions (PGI), to add or revise 
definitions; to correct certain terminology and to delete outdated 
material or material duplicative of the FAR.
    2. Statement of the objectives of, and the legal basis for, the 
rule.
    HHS made substantive changes in its Federal Acquisition Regulation 
(FAR) Supplement, the HHS Acquisition Regulation or HHSAR, in November, 
2009, (74 FR 62396 on November 27, 2009). On April 26, 2010, HHS 
published in the Federal Register correcting amendments at 75 FR 2150. 
Since then numerous changes have been made to both statutory and 
regulatory (FAR) framework and requirements. Some of these new 
requirements were included in specific appropriations acts. This 
publication of the proposed rule changes the HHSAR to conform to these 
new requirements and to align the requirements with the current FAR. In 
addition, the procedural materials that were deemed internal or non-
regulatory in nature are moved to procedures, guidance, and 
instructions documents. Further changes are proposed to permit the 
various HHS operational divisions (OPDIVS) or staff divisions 
(STAFFDIVS) the necessary flexibility in meeting their respective 
missions. OPDIV provisions and clauses were collected and are tailored 
for department-wide application.
    3. Description of and, where feasible, an estimate of the number of 
small entities to which the rule will apply.
    HHS awarded approximately 95 thousand contract actions in FY2014; 
over 44 percent (42,232) of those actions were for small businesses 
acting as prime contractors; therefore, it is estimated that the rule 
will apply to over 42,000 small entities. The primary industry sectors 
affected are as represented in the chart below:

[[Page 11273]]



          HHS FY2014 3-Digit NAICS Total Small Business Dollars
------------------------------------------------------------------------
 
------------------------------------------------------------------------
221 (UTILITIES)................................              $485,385.87
236 (CONSTRUCTION OF BUILDINGS)................           164,277,302.92
325 (CHEMICAL MANUFACTURING) Total.............           262,207,229.87
334 (COMPUTER AND ELECTRONIC PRODUCT                      313,625,169.91
 MANUFACTURING)................................
336 (TRANSPORTATION EQUIPMENT MANUFACTURING)...            66,756,387.08
339 (MISCELLANEOUS MANUFACTURING)..............            29,127,192.37
423 (MERCHANT WHOLESALERS, DURABLE GOODS)......            33,254,853.30
424 (MERCHANT WHOLESALERS, NONDURABLE GOODS)...            21,355,796.73
443 (ELECTRONICS AND APPLIANCE STORES).........            69,190,516.74
493 (WAREHOUSING AND STORAGE)..................            16,489,155.73
511 (PUBLISHING INDUSTRIES (EXCEPT INTERNET))..            49,671,265.41
517 (TELECOMMUNICATIONS).......................             9,648,511.61
518 (DATA PROCESSING, HOSTING AND RELATED                 104,142,979.21
 SERVICES).....................................
519 (OTHER INFORMATION SERVICES)...............            36,729,861.34
524 (INSURANCE CARRIERS AND RELATED ACTIVITIES)             7,734,506.42
531 (REAL ESTATE)..............................             2,107,755.53
541 (PROFESSIONAL, SCIENTIFIC, AND TECHNICAL            2,812,475,258.21
 SERVICES).....................................
561 (ADMINISTRATIVE AND SUPPORT SERVICES)......           221,619,313.74
611 (EDUCATIONAL SERVICES).....................            19,831,346.95
621 (AMBULATORY HEALTH CARE SERVICES)..........            86,140,044.62
                                                ------------------------
    Total......................................         4,326,869,833.56
------------------------------------------------------------------------

    4. Description and estimate of compliance requirements including 
differences in cost, if any, for different groups of small entities.
    The proposed rule will improve HHS acquisition by removing 
duplicative regulatory language, provisions and clauses, and 
procedures, guidance, and information (PGI) from HHS OPDIVS, and 
provides departmental level regulation, provisions and clauses, and 
PGI. This will enable businesses, both small and large, to respond to a 
uniform acquisition regulation and PGI, reducing their costs and 
decreasing their burden for compliance. After removing outdated 
reporting requirements, HHS found there were fewer data collections 
with less burden than the current HHSAR contains. The remaining 
compliance requirements do not require an update to computer software, 
nor does it impose additional recordkeeping or reporting 
responsibilities. As a result of these changes, the proposed rule 
should have a positive effect on small businesses allowing them to more 
readily compete for HHS contracts. There are no differences anticipated 
for the costs for compliance requirements for small businesses.
    5. Identification, to the extent practicable, of all relevant 
Federal rules which may duplicate, overlap, or conflict with the rule.
    The proposed rule does not duplicate, overlap, or conflict with any 
other Federal rules. As detailed in #2 above, language has been updated 
to comply with current FAR requirements, added where appropriate and 
necessary to supplement FAR, and removed where duplicative of FAR.
    6. Description of any significant alternatives to the rule which 
accomplish the stated objectives of applicable statutes and which 
minimize any significant economic impact of the rule on small entities.
    There are no viable alternatives. The rule is being amended to 
update the regulation to current FAR requirements and to delete 
outdated material so that the rule as a whole will be statutorily 
correct. As cited in paragraph 4 above, the economic burden on both 
large and small businesses will be decreased. Consideration was given 
to amending the HHSAR by prioritizing parts. It was determined that 
this would leave regulations in place that were outdated and 
inconsistent with FAR requirements governing one aspect of an 
acquisition, while another aspect would be done in accordance with 
updated regulation consistent with the FAR. The outdated and the 
updated regulation could be contradictory and certainly could result in 
acquisitions open to legal controversy leading not only to delays in 
acquisitions, but also improper acquisitions. This would be beneficial 
to neither the Government nor industry, including small businesses. 
Therefore, it is believed that the approach taken of amending of the 
HHSAR in whole is the most practical and benefits both Government and 
industry.
    The Department of HHS, Division of Acquisition (DA), will submit a 
copy of the Initial Regulatory Flexibility Analysis (IRFA) to the Chief 
Counsel for Advocacy of the Small Business Administration. A copy of 
the IRFA may be obtained from the DA. HHS invites comments from small 
business concerns and other interested parties on the expected impact 
of this rule on small entities.
    HHS will also consider comments from small entities concerning the 
existing regulations in subparts affected by this rule in accordance 
with 5 U.S.C. 610. Interested parties must submit such comments 
separately and should cite 5 U.S.C. 610 in correspondence.

V. Paperwork Reduction Act

    A. The Paperwork Reduction Act (44 U.S.C. chapter 35) applies. The 
proposed rule contains 6 information collection requirements. 
Accordingly, HHS has submitted requests for approval of the new 
information collection requirements concerning this rule to the Office 
of Management and Budget. The information collection requirements are 
discussed as follows:
    1. HHSAR 311.7101(a) (Responsibilities) and the clause at 352.211-1 
(Accessibility of meetings, conferences and seminars to persons with 
disabilities) require contractors to provide a plan describing the 
contractor's ability to meet the accessibility standards in 28 CFR part 
36.
    HHSAR 311.7202(b) (Responsibilities) and the clause at 352.211-2 
(Conference sponsorship request and conference materials disclaimer) 
require contractors to provide funding disclosure and a content 
disclaimer statement on conference materials. As a result of these 
clauses, HHS contractors providing conference, meeting, or seminars 
services are required to provide specific information to HHS.
    Public reporting burden for this collection of information is 
estimated to average 1 hour per response, including

[[Page 11274]]

the time for reviewing instructions, searching existing data sources, 
gathering and maintaining the data needed, and completing and reviewing 
the collection of information.
    The annual reporting burden is estimated as follows:
    Respondents: 1,157.
    Responses per respondent: 1.
    Total annual responses: 1,157.
    Preparation hours per response: 1 hour.
    Total response burden hours: 1,157 hours.
    Total annual cost of compliance: $47,668.
    2. HHSAR 311.7300 (Policy) and the clause at 352.211-3 (Paperwork 
Reduction Act) require contractors to not proceed with the collection 
of information on surveys, questionnaires, and other information 
requests until the contractor is provided an Office of Management and 
Budget (OMB) clearance from the contracting officer.
    Public reporting burden for this collection of information is 
estimated to average 2.2 hours per response, including the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information.
    The annual reporting burden is estimated as follows:
    Respondents: 20,088,262.
    Responses per respondent: 1.
    Total annual responses: 20,088,262.
    Preparation hours per response: 2.2.
    Total response burden hours: 9,021,953.
    Total annual cost of compliance: $371,704,464.
    3. HHSAR 337.103(d)(3) (Contracting Officer Responsibility) and the 
clause at 352.237-72 (Crime Control Act-Requirement for Background 
Checks) require persons engaged in a covered profession or activity 
under an HHS contract or subcontract to report any suspected child 
abuse incident. The report requirement is provided by the Childhelp 
USA, National Child Abuse Hotline.
    Public reporting burden for this collection of information is 
estimated to average 1 hour per response, including the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information.
    The annual reporting burden is estimated as follows:
    Respondents: 40.
    Responses per respondent: 4.
    Total annual responses: 160.
    Preparation hours per response: 1.
    Total response burden hours: 160.
    Total annual cost of compliance: $6,592.
    4. HHSAR 337.103(d)(4) (Contracting Officer Responsibility) and the 
clause at 352.237-73 (Indian Child Protection and Family Violence Act) 
require contractors to provide information for a background check.
    Public reporting burden for this collection of information is 
estimated to average 1 hour per response, including the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information.
    The annual reporting burden is estimated as follows:
    Respondents: 40.
    Responses per respondent: 4.
    Total annual responses: 160.
    Preparation hours per response: 1.
    Total response burden hours: 160.
    Total annual cost of compliance: $6,592.
    5 HHSAR 370.301 (Policy), the provision at 352.270-4a (Protection 
of Human Subjects), the clause at 352.270-4b (Protection of Human 
Subjects), the provision at 352.270-10 (Notice to Offerors--Protection 
of Human Subjects, Research Involving Human Subjects Committee (RIHSC) 
Approval of Research Protocols Required), and the clause at 352.270-11 
(Protection of Human Subjects--Research Involving Human Subjects 
Committee (RIHSC) Approval of Research Protocols Required), require 
contractors to provide an acceptable federal-wide assurance to HHS when 
engaging in human subject research in performance of a contract.
    Public reporting burden for this collection of information is 
estimated to average .50 hours per response, including the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information.
    The annual reporting burden is estimated as follows:
    Respondents: 4,644.
    Responses per respondent: 1.
    Total annual responses: 4,644.
    Preparation hours per response: .50.
    Total response burden hours: 2,322.
    Total annual cost of compliance: $95,666.
    6. HHSAR 370.401 (Policy), the provision at 352.270-5a (Notice to 
Offerors of Requirement for Compliance with the Public Health Service 
Policy on Humane Care and Use of Laboratory Animals), and the clause at 
352.270-5b (Care of Live Vertebrate Animals) require contractors to 
provide an acceptable animal welfare assurance.
    Public reporting burden for this collection of information is 
estimated to average 2.7 hours per response, including the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information.
    The annual reporting burden is estimated as follows:
    Respondents: 36.
    Responses per respondent: 4.
    Total annual responses: 41.
    Preparation hours per response: 2.7.
    Total response burden hours: 111.
    Total annual cost of compliance: $4,573.
    B. Public comment is sought regarding: Whether the proposed 
collections of information are necessary for the proper performance of 
the functions of the Agency, including whether the information shall 
have practical utility; the accuracy of the burden estimate; ways to 
enhance the quality, utility, and clarity of the information to be 
collected; and ways to minimize the burden of the collection of 
information, including through the use of automated collection 
techniques or other forms of information technology.
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, email your 
request, including your address, phone number, and document identifier, 
to Information.collectionclearance@hhs.gov. Written comments and 
recommendations for the proposed information collections must be 
directed to the Office of the Secretary, Paperwork Clearance Officer at 
the above email address within 60-days of this notice.
    Notwithstanding any other provision of the law, no person is 
required to respond to, nor shall any person be subject to a penalty 
for failure to comply with, a collection of information subject to the 
requirements of the Paperwork Reduction Act, unless that collection of 
information displays a currently valid OMB Control Number.

List of Subjects in 48 CFR Parts 301 Through 370

    Government procurement.

    Dated: February 10, 2015.
Angela Billups,
Associate Deputy Assistant Secretary for Acquisition.

    For the reasons stated in the preamble, HHS proposes revising 48 
CFR chapter 3, parts 301 through 370, as set forth below.

[[Page 11275]]

Title 48--Federal Acquisition Regulations System

CHAPTER 3--HEALTH AND HUMAN SERVICES

SUBCHAPTER A--GENERAL

PART 301--HHS ACQUISITION REGULATION SYSTEM
PART 302--DEFINITIONS OF WORDS AND TERMS
PART 303--IMPROPER BUSINESS PRACTICES AND PERSONAL CONFLICTS OF 
INTEREST
PART 304--ADMINISTRATIVE MATTERS

SUBCHAPTER B--COMPETITION AND ACQUISITION PLANNING

PART 305--PUBLICIZING CONTRACT ACTIONS
PART 306--COMPETITION REQUIREMENTS
PART 307--ACQUISITION PLANNING
PART 308--REQUIRED SOURCES OF SUPPLIES AND SERVICES
PART 309--CONTRACTOR QUALIFICATIONS
PART 310--MARKET RESEARCH
PART 311--DESCRIBING AGENCY NEEDS
PART 312--ACQUISITION OF COMMERCIAL ITEMS

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--SPECIAL CONTRACTING METHODS

SUBCHAPTER D--SOCIOECONOMIC PROGRAMS

PART 319--SMALL BUSINESS PROGRAMS
PART 322--APPLICATION OF LABOR LAWS TO GOVERNMENT ACQUISITIONS
PART 323--ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY 
TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE
PART 324--PROTECTION OF PRIVACY AND FREEDOM OF INFORMATION
PART 326--OTHER SOCIOECONOMIC PROGRAMS

SUBCHAPTER E--GENERAL CONTRACTING REQUIREMENTS

PART 327--PATENTS, DATA, AND COPYRIGHTS
PART 328--BONDS AND INSURANCE
PART 330--COST ACCOUNTING STANDARDS
PART 331--CONTRACT COST PRINCIPLES AND PROCEDURES
PART 332--CONTRACT FINANCING
PART 333--PROTESTS, DISPUTES, AND APPEALS

SUBCHAPTER F--SPECIAL CATEGORIES OF CONTRACTING

PART 334--MAJOR SYSTEM ACQUISITION
PART 335--RESEARCH AND DEVELOPMENT CONTRACTING
PART 336--CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS
PART 337--SERVICE CONTRACTING--GENERAL
PART 339--ACQUISITION OF INFORMATION TECHNOLOGY

SUBCHAPTER G--CONTRACT MANAGEMENT

PART 342--CONTRACT ADMINISTRATION

SUBCHAPTER H--CLAUSES AND FORMS

PART 352--SOLICITATION PROVISIONS AND CONTRACT CLAUSES
PART 353--FORMS

SUBCHAPTERS I, J, K AND L [RESERVED]

SUBCHAPTER M--HHS SUPPLEMENTATIONS

PART 370--SPECIAL PROGRAMS AFFECTING ACQUISITION

SUBCHAPTER A--GENERAL

PART 301--HHS ACQUISITION REGULATION SYSTEM

Subpart 301.1 Purpose, Authority, and Issuance
Sec.
301.101 Purpose.
301.103 Authority.
301.106 Office of Management and Budget approval under the Paperwork 
Reduction Act.
Subpart 301.2--[Reserved]
Subpart 301.4--Deviations From the FAR
301.401 Deviations.
Subpart 301.6--Career Development, Contracting Authority, and 
Responsibilities


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.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).

Subpart 301.1--Purpose, Authority, and Issuance


301.101  Purpose.

    (a) The Department of Health and Human Services (HHS) Acquisition 
Regulation (HHSAR) establishes uniform HHS acquisition policies and 
procedures that implement and supplement the Federal Acquisition 
Regulation (FAR).
    (b)(1) 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 procedures, guidance, and information not 
meeting the criteria in paragraph (b)(1) of this section are issued by 
HHS in other announcements, internal procedures, guidance, or 
information.


301.103  Authority.

    (b) The Assistant Secretary for Financial Resources (ASFR) 
prescribes the HHSAR under the authority of 5 U.S.C. 301 and section 
205(c) of the Federal Property and Administrative Services Act of 1949, 
as amended (40 U.S.C. 121(c)(2)), as delegated by the Secretary).
    (c) The HHSAR is issued in the Code of Federal Regulations (CFR) as 
chapter 3 of title 48, Department of Health and Human Services 
Acquisition Regulation. It may be referenced as ``48 CFR chapter 3.''


301.106  Office of Management and Budget approval under the Paperwork 
Reduction Act.

    (a) The Paperwork Reduction Act of 1980 (44 U.S.C 3501 et seq.) 
imposes a requirement on Federal agencies to obtain approval from the 
Office of Management and Budget (OMB) before collecting the same 
information from 10 or more members of the public.
    (b) The following OMB control numbers apply to the information 
collection and recordkeeping requirements contained in this chapter:

------------------------------------------------------------------------
              HHSAR Segment                       OMB Control No.
------------------------------------------------------------------------
311.7101(a)..............................  TBD
311.7300.................................  TBD
327.404-70(c)............................  TBD
337.103(d)(3)............................  TBD
337.103(d)(4)............................  TBD
370.301..................................  TBD
370.401..................................  TBD
352.211-1................................  TBD
352.211-3................................  TBD
352.227-71...............................  TBD
352.237-72...............................  TBD
352.237-73...............................  TBD
352.270-4a...............................  TBD
352.270-4b...............................  TBD
352.270-10...............................  TBD
352.270-11...............................  TBD
352.270-5a...............................  TBD
352.270-5b...............................  TBD
------------------------------------------------------------------------


[[Page 11276]]

Subpart 301.2--[Reserved]

Subpart 301.4--Deviations from the FAR


301.401  Deviations.

    Contracting officers are not permitted to deviate from the FAR or 
HHSAR without seeking proper approval. With full acknowledgement of FAR 
1.102(d) regarding innovative approaches, any deviation to FAR or the 
HHSAR requires approval by the Senior Procurement Executive (SPE).

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


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 action. Contractors perform at 
their own risk when accepting direction from unauthorized officials. 
Failure to follow statutory and regulatory processes for the 
expenditure of Government funds is a very serious matter.
    (2) The head of the contracting activity (HCA) is the official 
authorized to ratify an unauthorized commitment. No other re-
delegations are authorized.
    (c) Limitations. (5) The HCA shall coordinate the request for 
ratification with the Office of General Counsel, General Law Division 
and submit a copy to the Department SPE.


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


301.603-1  General.

    (a) 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 further delegated specific acquisition 
authority to the Operating and Staff Division heads and the HCAs. The 
HCA (non-delegable) shall select, appoint, and terminate the 
appointment of contracting officers.
    (b) To ensure proper control of redelegated acquisition 
authorities, HCAs shall maintain a file containing successive 
delegations of HCA authority through the contracting officer level.

PART 302--DEFINITIONS OF WORDS AND TERMS

Subpart 302.1--Definitions
Sec.
302.101 Definitions.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).

Subpart 302.1--Definitions


302.101  Definitions.

    (a) Agency head or head of the agency, unless otherwise stated, 
means the head of the Staff Division (STAFFDIV) or Operating Division 
(OPDIV).
    (b) Contracting Officer's Representative (COR) is a Federal 
employee designated in writing by a contracting officer to act as the 
contracting officer's representative in monitoring and administering 
specified aspects of contractor performance after award of a contract 
or order. In accordance with local procedures, STAFFDIV or OPDIVs may 
designate CORs for firm fixed-price contracts or orders. COR's 
responsibilities may include verifying that:
    (1) The contractor's performance meets the standards set forth in 
the contract or order;
    (2) The contractor meets the contract or order's technical 
requirements by the specified delivery date(s) or within the period of 
performance; and
    (3) The contractor performs within cost ceiling stated in the 
contract or order. CORs must meet the training and certification 
requirements specified in 301.604.
    (c) Head of the Contracting Activity (HCA) is an official having 
overall responsibility for managing a contracting activity--i.e., the 
organization within a STAFFDIV or OPDIV or other HHS organization which 
has been delegated broad authority regarding the conduct of acquisition 
functions.

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.
303.104-7 Violations or possible violations of the Procurement 
Integrity Act.
Subpart 303.2--Contractor Gratuities to Government Personnel
303.203 Reporting suspected violations of the Gratuities clause.
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.
Subpart 303.10--Contractor Code of Business Ethics and Conduct
303.1003 Requirements.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).

Subpart 303.1--Safeguards


303.101  Standards of conduct.


303.101-3  Agency regulations.

    (a)(3) The HHS Standards of Conduct are prescribed in 45 CFR part 
73.


303.104-7  Violations or possible violations of the Procurement 
Integrity Act.

    (a)(1) The contracting officer shall submit to the head of the 
contracting activity (HCA) for review and concurrence the determination 
(along with supporting documentation) that a reported violation or 
possible violation of the statutory prohibitions has no impact on the 
pending award or selection of a contractor for award.
    (2) The contracting officer shall refer the determination that a 
reported violation or possible violation of the statutory prohibitions 
has an impact on the pending award or selection of a contractor, along 
with all related information available, to the HCA. The HCA shall--
    (i) Refer the matter immediately to the Associate Deputy Assistant 
Secretary (DAS) for Acquisition for review, who may consult with the 
appropriate legal office representative and the Office of Inspector 
General as appropriate; and
    (ii) Determine the necessary action in accordance with FAR 3.104-
7(c) and (d). The HCA shall obtain the approval or concurrence of the 
Associate DAS for Acquisition before proceeding with an action.
    (b) The HCA (non-delegable) shall act with respect to actions taken 
under the Federal Acquisition Regulation (FAR) clause at 52.203-10, 
Price or Fee Adjustment for Illegal or Improper Authority.

[[Page 11277]]

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 OGC Ethics Division for disposition.

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


303.602  Exceptions.

    The HCA (non-delegable) is the official authorized to approve an 
exception to the policy stated in FAR 3.601.

Subpart 303.7--Voiding and Rescinding Contracts


303.704  Policy.

    (a) For purposes of implementing FAR subpart 3.7, the HCA (non-
delegable) shall exercise the authorities granted to the ``agency head 
or designee.''

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.

Subpart 303.10--Contractor Code of Business Ethics and Conduct


303.1003  Requirements.

    (b) The contracting officer, when notified of a possible contractor 
violation, in accordance with FAR 3.1003(b), shall notify the Office of 
Inspector General and the HCA.
    (c)(2) The contracting officer shall specify the title of HHS' OIG 
hotline poster and the Web site where the poster can be obtained in 
paragraph (b)(3) of the clause at FAR 52.203-14.

PART 304--ADMINISTRATIVE MATTERS

Subpart 304.6--Contract Reporting
Sec.
304.602 General.
304.604 Responsibilities.
Subpart 304.13--Personal Identity Verification
304.1300 Policy.
Subpart 304.16 Unique Procurement Instrument Identifiers
304.1600 Scope of subpart.
Subpart 304.70--[Reserved]
Subpart 304.71--Review and Approval of Proposed Contract Actions
304.7100 Policy.
Subpart 304.72 Affordable Care Act Prevention and Public Health Fund--
Reporting Requirements
Sec.
304.7200 Scope of subpart.
304.7201 Procedures.
304.7202 Contract clause.

    Authority:  5 U.S.C. 301; 40 U.S.C. 121(c)(2).

Subpart 304.6--Contract Reporting


304.602  General.

    Follow internal department procedures for reporting information to 
the Federal Procurement Data System (FPDS) and for resolving technical 
or policy issues relating to FPDS contract reporting.


304.604  Responsibilities.

    The Department of Health and Human Services (HHS) acquisition 
officials and staff shall report their contract information in FPDS 
accurately and timely.

Subpart 304.13--Personal Identity Verification


304.1300   Policy.

    To ensure compliance with Homeland Security Presidential Directive-
12: Policy for a Common Identification Standard for Federal Employees 
and Contractors (HSPD-12) and the Presidential Cross Agency Priority 
for strong authentication, contracting officers shall provide in each 
acquisition those HSPD-12 requirements necessary for contract 
performance.

Subpart 304.16--Unique Procurement Instrument Identifiers


304.1600  Scope of subpart.

    This subpart provides guidance for assigning identification numbers 
to solicitation or contract actions. The Senior Procurement Executive 
shall be responsible for establishing a numbering system within the 
department that conforms to Federal Acquisition Regulation subpart 
4.16.

Subpart 304.70--[Reserved]

Subpart 304.71--Review and Approval of Proposed Contract Actions


304.7100  Policy.

    In accordance with internal Operating Division or Staff Division 
policy the head of the contracting activity (non-delegable) shall 
establish review and approval procedures for proposed contract actions 
to ensure that--
    (a) Contractual documents are in conformance with law, established 
policies and procedures, and sound business practices;
    (b) Contract actions properly reflect the mutual understanding of 
the parties; and
    (c) The contracting officer is informed of deficiencies and items 
of questionable acceptability, and takes corrective action.

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. 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 Prevention and 
Public Health Fund, shall report information specified in the clause at 
352.204-70, 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.


304.7201  Procedures.

    (a) In any contract action funded in whole or in part by the PPHF, 
the contracting officer shall indicate that the contract action is 
being made under the PPHF, and indicate which products or services are 
funded under the PPHF. This requirement applies whenever PPHF funds are 
used, regardless of the contract instrument.
    (b) To maximize transparency of PPHF funds that shall be reported 
by the contractor, the contracting officer shall structure contract 
awards to allow for separately tracking PPHF funds. For example, the 
contracting officer may consider awarding dedicated separate contracts 
when using PPHF funds or establishing contract line item number 
structures to prevent commingling of PPHF funds with other funds.
    (c) Contracting officers shall ensure that the contractor complies 
with the reporting requirements of 352.204-70, Prevention and Public 
Health Fund--Reporting Requirements. Upon receipt of each report, the 
contracting officer shall review it for completeness, address

[[Page 11278]]

any clarity or completeness issues with the contractor, and submit the 
final approved report in Section 508 compliant format to an Assistant 
Secretary for Public Affairs point-of-contact for posting on HHS' PPHF 
Web site at https://www.hhs.gov/open/recordsandreports/prevention/ no later than 30 days after the end of the reporting period. 
If the contractor fails to comply with the reporting requirements, the 
contracting officer shall exercise appropriate contractual remedies.
    (d) The contracting officer shall make the contractor's failure to 
comply with the reporting requirements 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 
funded in whole or in part with PPHF funds, 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 PPHF funds. 
Contracting officers shall include this clause in any existing contract 
or order that will be funded with PPHF funds. This clause is not 
required for any contract or order which contains a prior version of 
the clause at 352.204-70.

SUBCHAPTER B--COMPETITION AND ACQUISITION PLANNING

PART 305--PUBLICIZING CONTRACT ACTIONS

Subpart 305.3--Synopses of Contract Awards
Sec.
305.303 Announcement of contract awards.
Subpart 305.5--Paid Advertisements
305.502 Authority.
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)(2).

Subpart 305.3--Synopses of Contract Awards


305.303  Announcement of contract awards.

    (a) Public announcement. The contracting officer shall report 
awards, not exempt under Federal Acquisition Regulation (FAR) 5.303, to 
the Office of the Assistant Secretary for Legislation (Congressional 
Liaison Office.)

Subpart 305.5--Paid Advertisements


305.502  Authority.

    Written approval at least one level above the contracting officer 
shall be obtained prior to placing advertisements or notices in 
newspapers.

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 Web site at https://www.hhs.gov/open/recordsandreports/prevention/ no later than 1 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 FedBizOpps notice required by FAR 5.201.


305.7004  Publicizing postaward.

    Notices of contract actions exceeding $25,000, funded in whole or 
in part by the PPHF, shall be identified on HHS' PPHF Web site at 
https://www.hhs.gov/open/recordsandreports/prevention/ no 
later than 5 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.
306.302-7 Public interest.
Subpart 306.5--Competition Advocates
306.501 Requirement.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).

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


306.202  Establishing or maintaining alternative sources.

    (a) The reference to the ``agency head'' in FAR 6.202(a) shall mean 
the Department Competition Advocate (CA).
    (b)(1) The contracting officer shall prepare the required 
determination and findings (D&F). See FAR 6.202(b)(1) based on the data 
provided by program personnel. The appropriate CA (non-delegable) shall 
sign the D&F.

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. See FAR 6.302-1.

    For acquisitions covered by 42 U.S.C. 247d-6a(b)(2)(A), ``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''.


306.302-7  Public interest.

    (a) Authority. (2) Agency head, in this instance, means the 
Secretary.
    (c) Limitations. The contracting officer shall prepare a written 
request for approval and provide it through appropriate acquisition 
channels, including the head of the contracting activity and Associate 
Deputy Assistant Secretary for Acquisition, to the Secretary. The 
request shall include a D&F for the Secretary's signature that contains 
all pertinent information to support the justification for using the 
authority in 41 U.S.C. 3304(a)(7), and a letter for the Secretary's 
signature notifying Congress of the determination to award a contract 
under that authority.

Subpart 306.5--Competition Advocates


306.501  Requirement.

    The Department Competition Advocate for Health and Human Services 
(HHS) is located in the Division of Acquisition.

PART 307--ACQUISITION PLANNING

Sec.
307.105 Contents of written acquisition plans.


[[Page 11279]]


    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).


307.105  Contents of written acquisition plans.

    Federal Acquisition Regulation 7.105 specifies the content 
requirements for a written Acquisition Plan (AP). The Department of 
Health and Human Services requires a written AP for all acquisitions 
above the simplified acquisition threshold.

PART 308--REQUIRED SOURCES OF SUPPLIES AND SERVICES

Subpart 308.4--Federal Supply Schedules
Sec.
308.405-6 Limited source justification and approval.
Subpart 308.8--Acquisition of Printing and Related Supplies
308.800 Scope of subpart.
308.801 Definitions.
308.802 Policy.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).

Subpart 308.4--Federal Supply Schedules


308.405-6  Limited source justification and approval.

    (d)(1) As required by Federal Acquisition Regulation (FAR) 8.405-1 
or 8.405-2, the responsible program office must provide a written 
justification whenever it requests an acquisition under the Federal 
Supply Service program that restricts consideration of the number of 
schedule contractors or to an item peculiar to one manufacturer.

Subpart 308.8--Acquisition of Printing and Related Supplies


308.800  Scope of subpart.

    This subpart provides the Department of Health and Human Services 
(HHS) policy for the acquisition of Government printing and related 
supplies. The HHS Office of the Assistant Secretary for Public Affairs 
is responsible for the review and clearance of print and electronic 
publications, printing and related supplies, audiovisual products, and 
communication service contracts. See FAR 8.802 for exceptions.


308.801   Definitions.

    The terms ``printing'' and ``duplicating/copying'' are defined in 
the Government Printing and Binding Regulations of the Joint Committee 
on Printing. The regulations are available at https://www.gpo.gov.


308.802   Policy.

    In accordance with FAR 8.802(b), the Central Printing and 
Publications Management Organization at Program Support Center is the 
HHS designated central printing authority.


308.803   Solicitation provision and contract clause.

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

PART 309--CONTRACTOR QUALIFICATIONS

Subpart 309.4--Debarment, Suspension, and Ineligibility
Sec.
309.403 Definitions.
309.404 System for Award Management (SAM) exclusions.
309.405 Effect of listing (compelling reason determinations).
309.406 Debarment.
309.406-3 Procedures.
309.407 Suspension.
309.407-3 Procedures.
309.470 Reporting of suspected causes for debarment or suspension or 
the taking of evasive actions.
309.470-1 Situations where reports are required.

    Authority:  5 U.S.C. 301; 40 U.S.C. 121(c)(2).

Subpart 309.4--Debarment, Suspension, and Ineligibility


309.403   Definitions.

    The following definitions apply to this subpart:
    Acquiring agency's head or designee, as used in this subpart is the 
head of the contracting activity (HCA). The HCA may make the required 
justifications or determinations and take the necessary actions 
specified in FAR 9.405, 9.406, and 9.407, only after obtaining the 
written approval of the Suspension or Debarment Official, as 
appropriate.
    Suspension and Debarment Official means the Deputy Assistant 
Secretary for Grants and Acquisition Policy and Accountability.


309.404   System for Award Management (SAM) exclusions.

    (c) For actions made by HHS pursuant to FAR 9.406 and 9.407, the 
Office of Recipient Integrity Coordination shall perform the actions 
required by FAR 9.404(c).


309.405   Effect of listing (compelling reason determinations).

    (a) The HCA (non-delegable) may, with the written concurrence of 
the Suspension and Debarment Official, make the determinations 
referenced in FAR 9.405(a) regarding contracts.
    (1) If a contracting officer considers it necessary to award a 
contract, or consent to a subcontract with a debarred or suspended 
contractor, the contracting officer shall prepare a determination, 
including all pertinent documentation, and submit it through 
appropriate acquisition channels to the HCA. The documentation shall 
include the date by which approval is required and a compelling reason 
for the proposed action. Compelling reasons for award of a contract or 
consent to a subcontract with a debarred or suspended contractor 
include the following:
    (i) Only the cited contractor can provide the property or services, 
and
    (ii) The urgency of the requirement dictates that HHS conduct 
business with the cited contractor.
    (2) If the HCA decides to approve the requested action, the HCA 
shall request the concurrence of the Suspension and Debarment Official 
and, if given, shall inform the contracting officer in writing of the 
determination within the required time period.


309.406   Debarment.


309.406-3   Procedures.

    Refer all matters appropriate for consideration by an agency 
Suspension and Debarment Official as soon as practicable to the 
appropriate Suspension and Debarment Official identified in 309.403. 
Any person may refer a matter to the Suspension and Debarment Official.


309.407   Suspension.


309.407-3   Procedures.

    Refer all matters appropriate for consideration by an agency 
Suspension and Debarment Official as soon as practicable to the 
appropriate Suspension and Debarment Official identified in 309.403. 
Any person may refer a matter to the Suspension and Debarment Official.


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 Associate 
Deputy Assistant Secretary for Acquisition 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,

[[Page 11280]]

multiple addresses, formation of new companies, or by other devices.

PART 310--MARKET RESEARCH

Sec.
310.001 Policy.

    Authority:  5 U.S.C. 301; 40 U.S.C. 121(c)(2).


310.001   Policy.

    The HHS contracting offices shall conduct market research as 
prescribed in Federal Acquisition Regulation part 10.

PART 311--DESCRIBING AGENCY NEEDS

Subpart 311.70--Section 508 Accessibility Standards
Sec.
311.7000 Defining electronic information technology Requirements 
(see part 339).
Subpart 311.71--Accessibility of Meetings, Conferences, and Seminars to 
Persons with Disabilities
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).

Subpart 311.70--Section 508 Accessibility Standards


311.7000   Defining electronic and information technology requirements 
(see part 339).

    The contracting officer shall ensure that requiring activities 
specify agency needs for electronic and information technology (EIT) 
supplies and services, and document market research document EIT 
requirements, and identify the applicable Section 508 accessibility 
standards. See FAR 11.002(f) and subpart 39.2.

Subpart 311.71--Accessibility of Meetings, Conferences, and 
Seminars to Persons with Disabilities


311.7100   Policy.

    (a) It is HHS policy that all meetings, conferences, and seminars 
be accessible to persons with disabilities. For the purpose of this 
policy, accessibility is defined as both physical access to meeting, 
conference, and seminar sites, and access to aids and services enabling 
individuals with sensory disabilities to fully participate in meetings, 
conferences, and seminars.
    (b) This policy applies to all contracts requiring contractors to 
conduct meetings, conferences, or seminars open to the public or 
involving HHS personnel, but not ad hoc meetings necessary or 
incidental to contract performance.


311.7101   Responsibilities.

    (a) The contractor shall submit a plan assuring that any meeting, 
conference, or seminar held will meet or exceed the minimum 
accessibility standards set forth in 28 CFR part 36.
    (b) The contracting officer representative (COR) shall obtain, 
review, and approve the contractor's plan submitted in response to 
paragraph (a) of the contract clause at 352.211-1, Accessibility of 
Meetings, Conferences, and Seminars to Persons with Disabilities; a 
consolidated or master plan for contracts requiring numerous meetings, 
conferences, or seminars is acceptable. Prior to approving the plan, 
the COR shall consult with the operating division (OPDIV) or other 
designated organization responsible for monitoring compliance with the 
Architectural Barriers Act of 1968 and the Americans with Disabilities 
Act of 1990, to ensure that the contractor's plan meets the 
accessibility requirements of the contract clause. The COR shall 
request the responsible organization review and determine the adequacy 
of the contractor's plan, and respond to the COR, in writing, within 10 
working days of receiving the request.


311.7102   Contract clause.

    The contracting officer shall insert the clause at 352.211-1, 
Accessibility of Meetings, Conferences, and Seminars to Persons with 
Disabilities, in solicitations, contracts, and orders requiring the 
contractor to conduct meetings, conferences, or seminars 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.

    Funding a conference through a 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 OPDIV or STAFFDIV (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) Includes an appropriate Federal funding disclosure and content 
disclaimer statement for conference materials, the contracting officer 
shall include the clause at 352.211-2, 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 (PRA), contractors 
shall not proceed with collecting information from surveys, 
questionnaires, or interviews until the COR obtains an Office of 
Management and Budget 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 PRA of 1995 (44 U.S.C. 3501 et seq.).


311.7301   Contract clause.

    The contracting officer shall insert the clause at 352.211-3, 
Paperwork Reduction Act, in solicitations, contracts, and orders that 
require a contractor to collect the same information from 10 or more 
persons.

[[Page 11281]]

PART 312--ACQUISITION OF COMMERCIAL ITEMS

Subpart 312.1--Acquisition of Commercial Items--General
Sec.
312.101 Policy.
Subpart 312.2--Special Requirements for the Acquisition of Commercial 
Items


312.202(d)   Market research and description of agency need.

    Authority:  5 U.S.C. 301; 40 U.S.C. 121(c)(2).

Subpart 312.1--Acquisition of Commercial Items--General


312.101   Policy.

    Contracting offices shall use the HHS Strategic Sourcing Program to 
the maximum extent possible. See HHSAR part 307 (Acquisition Planning).

Subpart 312.2--Special Requirements for the Acquisition of 
Commercial Items


312.202(d)   Market research and description of agency need.

    Whenever a requiring activity specifies electronic and information 
technology (EIT) supplies and services subject to Section 508 of the 
Rehabilitation Act of 1973, as amended, the requiring activity shall 
acquire commercially available supplies and services to the maximum 
extent possible while ensuring Section 508 compliance. See part 339.

SUBCHAPTER C--CONTRACTING METHODS AND CONTRACT TYPES

PART 313--SIMPLIFIED ACQUISITION PROCEDURES

Sec.
313.003 Policy.
Subpart 313.3--Simplified Acquisition Methods
313.301 Government-wide commercial purchase card.

    Authority:  5 U.S.C. 301; 40 U.S.C. 121(c)(2).


313.003   Policy.

    Electronic and information technology (EIT) supplies and services 
acquired pursuant to Federal Acquisition Regulation part 13 shall 
comply with Section 508 of the Rehabilitation Act of 1973, as amended. 
See part 339.

Subpart 313.3--Simplified Acquisition Methods


313.301   Government-wide commercial purchase card.

    (b) Make all HHS transactions utilizing the Government-wide 
commercial purchase card in accordance with the HHS Purchase Card 
Program.

PART 314--SEALED BIDDING

Subpart 314.1--Use of Sealed Bidding
Sec.
314.103 Policy.
Subpart 314.4--Opening of Bids and Award of Contract
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.

    Authority:  5 U.S.C. 301; 40 U.S.C. 121(c)(2).

Subpart 314.1--Use of Sealed Bidding


314.103   Policy.

    Electronic and information technology (EIT) supplies and services 
acquired using sealed-bid procedures shall comply with Section 508 of 
the Rehabilitation Act of 1973, as amended. See part 339.

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 
agency head determinations specified in FAR 14.404-1.


314.407   Mistakes in bids.


314.407-3   Other mistakes disclosed before award.

    (e) The HCA has the authority to make determinations under 
paragraphs (a), (b), (c), and (d) of FAR 14.407-3.


314.407-4   Mistakes after award.

    (c) The HCA has the authority to make administrative determinations 
in connection with alleged post-award mistakes.

PART 315--CONTRACTING BY NEGOTIATION

Subpart 315.2--Solicitation and Receipt of Proposals and Information
Sec.
315.204-5 Part IV--Representations and instructions.
315.208 Submission, modification, revision, and withdrawal of 
proposals.
Subpart 315.3--Source Selection
315.303-70 Policy.
315.304 Evaluation factors and significant subfactors.
315.305 Proposal evaluation.
Subpart 315.4--Contract Pricing
315.404 Proposal analysis.
315.404-2 Information to support proposal analysis.
Subpart 315.6--Unsolicited Proposals
315.605 Content of unsolicited proposals.
315.606 Agency procedures.
315.606-1 Receipt and initial review.

    Authority:  5 U.S.C. 301; 40 U.S.C. 121(c)(2).

Subpart 315.2--Solicitation and Receipt of Proposals and 
Information


315.204-5   Part IV--Representations and instructions.

    (c) Section M, Evaluation factors for award. (1) The requiring 
activity shall develop technical evaluation factors and submit them to 
the contracting officer as part of the acquisition plan or other 
acquisition request documentation for inclusion in a solicitation. The 
requiring activity shall indicate the relative importance or weight of 
the evaluation factors based on the requirements of an individual 
acquisition.
    (2) Only a formal amendment to a solicitation can change the 
evaluation factors.


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

    (b) In addition to the provision in Federal Acquisition Regulation 
(FAR) 52.215-1, Instructions to Offerors--Competitive Acquisition, if 
the head of the contracting activity (HCA) determines that biomedical 
or behavioral R & D acquisitions are subject to conditions other than 
those specified in FAR 52.215-1(c)(3), the HCA may authorize for use in 
competitive solicitations for R & D, the provision at 352.215-70, Late 
Proposals and Revisions. This is an authorized FAR deviation.
    (2) When the provision at 352.215-70 is included in the 
solicitation and if the HCA 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.

[[Page 11282]]

Subpart 315.3--Source Selection


315.303-70   Policy.

    (a) If an operating division (OPDIV) is required by statute to use 
peer review for technical review of proposals, the requirements of 
those statutes, any implementing regulatory requirements, the Federal 
Advisory Committee Act, and as applicable, any approved Department of 
Health and Human Services (HHS) Acquisition Regulation (HHSAR) 
deviation(s) from this subpart take precedence over the otherwise 
applicable requirements of this subpart.
    (b) The statutes that require such review and implementing 
regulations are as follows: National Institutes of Health--42 U.S.C. 
289a and 42 CFR part 52h; Substance Abuse and Mental Health Services 
Administration--42 U.S.C. 290aa-3, and Agency for Healthcare Research 
and Quality--42 U.S.C. 299c-1.


315.304   Evaluation factors and significant subfactors.

    When acquiring Electronic and Information Technology supplies and 
services (EIT) using negotiated procedures, contracting officers shall 
comply with Section 508 of the Rehabilitation Act of 1973, as amended.


315.305   Proposal evaluation.

    (c) Use of non-Federal evaluators. (1) Except when peer review is 
required by statute as provided in 315.303-70(a), decisions to disclose 
proposals to non-Federal evaluators shall be made by the official 
responsible for appointing Source Selection Evaluation Team members in 
accordance with OPDIV procedures. The avoidance of organizational and 
personal conflicts of interest must be taken into consideration when 
making the decision to use non-Federal evaluators.
    (2) When a solicited proposal will be disclosed outside the 
Government to a contractor or a contractor employee for evaluation 
purposes, the following or similar conditions shall be part of the 
written agreement with the contractor prior to disclosure:
CONDITIONS FOR EVALUATING PROPOSALS
    The contractor agrees that it and its employees, as well as any 
subcontractors and their employees (in these Conditions, ``evaluator'') 
will use the data (trade secrets, business data, and technical data) 
contained in the proposal for evaluation purposes only. The foregoing 
requirement does not apply to data obtained from another source without 
restriction. 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 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. 
The evaluator shall not contact the offeror concerning any aspects of a 
proposal's contents.

Subpart 315.4--Contract Pricing


315.404   Proposal analysis.


315.404-2   Information 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 and 
HHSAR part 310) the contracting officer may request less-than-complete 
field pricing support (specifying in the request the information 
needed) or may waive in writing the requirement for audit and field 
pricing support by documenting the file to indicate what information 
will be used. When field-pricing support is required, contracting 
officers shall make the request through the HCA.

Subpart 315.6--Unsolicited Proposals


315.605   Content of unsolicited proposals.

    (d) Warranty by offeror. 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 the following warranty in any 
unsolicited proposal. 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 a proper warranty. If no warranty 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.
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 Department of Health and Human Services 
personnel has been within the limits of appropriate advance guidance 
set forth in FAR 15.604; and
    (d) No prior commitments were received from HHS personnel regarding 
acceptance of this proposal.

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.

    (d) OPDIVs may consider an unsolicited proposal even though an 
organization initially submitted it as a grant application. However, 
OPDIVs 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 315.5--Indefinite Delivery Contracts
316.505 Ordering.
Subpart 316.6--Time-and Materials, Labor-Hour, and Letter Contracts
316.603 Letter Contracts.
316.603-3 Limitations.

    Authority:  5 U.S.C. 301; 40 U.S.C. 121(c)(2).

Subpart 316.3--Cost-Reimbursement Contracts


316.307   Contract clauses.

    (a)(1) If a contract for research and development is with a 
hospital (profit or nonprofit), the contracting officer shall modify 
the ``Allowable Cost and Payment'' clause at FAR 52.216-7 by deleting 
from paragraph (a) the words ``Federal Acquisition Regulation (FAR) 
subpart 31.2'' and substituting ``45 CFR part 75.''

[[Page 11283]]

    (2) The contracting officer shall also insert the clause at 
352.216-70, Additional Cost Principles, in solicitations and contracts 
with a hospital (profit or non-profit) when a cost-reimbursement 
contract is contemplated.

Subpart 316.5--Indefinite-Delivery Contracts


316.505  Ordering.

    (b)(8) The Department of Health and Human Services (HHS) 
Competition Advocate is the task-order and delivery-order ombudsman for 
the department. Ombudsmen for each of the HHS contracting activities 
shall be designated in writing by the head of the contracting activity. 
See part 306.

Subpart 316.6--Time-and-Materials, Labor-Hour, and Letter Contracts


316.603  Letter contracts.


316.603-3  Limitations.

    An official one level above the contracting officer shall make the 
written determination, to be included in the contract file, that no 
other contract type is suitable and to approve all letter contract 
modifications. No letter contract or modification can exceed the limits 
prescribed in FAR 16.603-2(c).

PART 317--SPECIAL CONTRACTING METHODS

Subpart 317.1--Multi-Year Contracting
Sec.
317.104 General.
317.105 Policy.
317.105-1 Uses.
317.107 Options.
317.108 Congressional notification.
Subpart 317.2--Options
317.204 Contracts.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).

Subpart 317.1--Multi-Year Contracting


317.104  General.

    (b) The Senior Procurement Executive (SPE) is the agency approving 
official for determinations under Federal Acquisition Regulation (FAR) 
17.104(b).


317.105  Policy.


317.105-1  Uses.

    (a) Each head of the contracting activity determination to use 
multi-year contracting, as defined in FAR 17.103, is limited to 
individual acquisitions where the full estimated cancellation ceiling 
does not exceed 20 percent of the total contract value over the multi-
year term or $12.5 million, whichever is less. Cancellation ceiling 
provisions shall conform to the requirements of FAR 17.106-1(c). The 
determination is not delegable and shall address the issues in FAR 
17.105-1(a).
    (b)(1) SPE approval is required for any--
    (i) Individual determination to use multi-year contracting with a 
cancellation ceiling in excess of the limits in 317.105-1(a); or
    (ii) Class determination (see FAR subpart 1.7).
    (2) A determination involving a cancellation ceiling in excess of 
the limits in 317.105-1(a) shall present a well-documented 
justification for the estimated cancellation ceiling. When the 
estimated cancellation ceiling exceeds $12.5 million, the determination 
shall accompany a draft congressional notification letter pursuant to 
FAR 17.108 and 317.108.


317.107  Options.

    When included as part of a multi-year contract, use of options 
shall not extend the performance of the original requirement beyond 5 
years. Options may serve as a means to acquire related services 
(severable or non-severable) and, upon their exercise, shall receive 
funding from the then-current fiscal year's appropriation.


317.108  Congressional notification.

    (a) The SPE is the agency head for the purposes of FAR 17.108(a). 
Upon SPE approval of the determination required by 317.105-1(b)(1), the 
SPE will finalize and sign the congressional notification letter and 
provide it to the appropriate House and Senate committees.

Subpart 317.2--Options


317.204  Contracts.

    (e)(1) Information technology contracts. Notwithstanding FAR 
17.204(e), the 5-year limitations apply also to information technology 
contracts unless a longer period is authorized by statute.
    (2) Requests to exceed 5-year limitation. A request to exceed the 
5-year limitation specified in FAR 17.204(e) must provide all the 
following information:
    (i) Clearly explain the contract(s) and organization(s) covered by 
the request.
    (ii) Support the need for and reasonableness of the extension.
    (3) Approval authority. Requests to exceed the 5-year limitations 
specified in FAR 17.204(e) must be approved by:
    (i) The HCA; and
    (ii) The HHS SPE.

SUBCHAPTER D--SOCIOECONOMIC PROGRAMS

PART 319--SMALL BUSINESS PROGRAMS

Subpart 319.2--Policies
Sec.
319.201 General policy.
319.270-1 Mentor Prot[eacute]g[eacute] Program Solicitation 
provision and contract clause.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).

Subpart 319.2--Policies


319.201  General policy.

    (d) The functional management responsibilities for HHS' small 
business program are delegated to the Office of Small and Disadvantaged 
Business Utilization (OSDBU) Director.
    (e)(1) The Department of Health and Human Services (HHS) OSDBU 
Director shall exercise full management authority over the small 
business program. The small business specialist (SBS) shall review and 
make recommendations for all acquisitions, unless exempted by statute, 
that are not being set aside for small business in accordance with 
Federal Acquisition Regulation (FAR) 19.502. The review must take place 
prior to issuing the solicitation.
    (2) Within the Indian Health Service (IHS), the primary SBSs are 
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.


319.270-1  Mentor Prot[eacute]g[eacute] Program Solicitation provision 
and contract clause.

    (a) The contacting officer shall insert the provision at 352.219-
70, Mentor-Prot[eacute]g[eacute] Program, in solicitations that include 
the clause at FAR 52.219-9, Small Business Subcontracting Plan. The 
provision requires offerors to provide the Contracting Officer a copy 
of their HHS Office of OSDBU-approved mentor-prot[eacute]g[eacute] 
agreement in response to a solicitation.
    (b) The contacting officer shall insert the clause at 352.219-71, 
Mentor-Prot[eacute]g[eacute] Program Reporting Requirements, in 
contracts that include the clause at FAR 52.219-9, Small Business 
Subcontracting Plan, and which are awarded to a contractor with an HHS 
OSDBU-approved mentor-prot[eacute]g[eacute] agreement.

[[Page 11284]]

PART 322--APPLICATION OF LABOR LAWS TO GOVERNMENT ACQUISITIONS

Subpart 322.8--Equal Employment Opportunity
Sec.
322.810 Solicitation provisions and contract clauses.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).

Subpart 322.8--Equal Employment Opportunity


322.810  Solicitation provisions and contract clauses.

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

PART 323--ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE 
ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE

Subpart 323.70--Safety and Health
Sec.
323.7000 Scope of subpart.
323.7001 Policy.
323.7002 Actions required.
Subpart 323.71--Sustainable Acquisition Requirements
323.7100 Policy.
323.7101 Applicability.
323.7102 Procedures.
323.7103 Solicitation Provision.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).


323.7000  Scope of subpart.

    This subpart provides procedures for administering safety and 
health requirements.


323.7001  Policy.

    The contracting officer shall follow the guidance in this subpart 
when additional requirements for safety and health are necessary for an 
acquisition.


323.7002  Actions required.

    Contracting activities. The contracting officer shall insert the 
clause at 352.223-70, Safety and Health, or a clause substantially the 
same, 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 323.71--Sustainable Acquisition Requirements


323.7100  Policy.

    This subpart provides procedures for sustainable acquisitions and 
use of the following: Designated recycled content; energy efficient, 
environmentally preferred, Electronic Product Environmental Assessment 
Tool (EPEAT)-registered, bio-based, water efficient, non-ozone 
depleting products and services; and alternate fuel vehicles and fuels. 
The Department of Health and Human Services (HHS) has designated 
product and service codes for supplies and services having sustainable 
acquisition attributes. See FAR part 23.


323.7101  Applicability.

    It is HHS policy to include a solicitation provision and to include 
an evaluation factor for an offeror' Sustainable Action Plan when 
acquiring sustainable products and services. This applies only to new 
contracts and orders above the micro-purchase threshold. Such contracts 
and orders include, but are not limited to: Office supplies; 
construction, renovation or repair; building operations and 
maintenance; landscaping services; pest management; electronic 
equipment, including leasing; fleet maintenance; janitorial services; 
laundry services; cafeteria operations; and meetings and conference 
services. If using a product or service code designated for supplies or 
services having sustainable acquisition attributes, but a review of the 
requirement determines that no opportunity exists to acquire 
sustainable acquisition supplies or services, document the 
determination in the contract file and make note in the solicitation.


323.7102  Procedures.

    (a) When required by the solicitation, offerors or quoters must 
include a Sustainable Acquisition Plan in their technical proposal 
addressing the environmental products and services for delivery under 
the resulting contract.
    (b) The contracting officer shall incorporate the final Sustainable 
Acquisition Plan into the contract.
    (c) The contracting officer shall ensure that sustainability is 
included as an evaluation factor in all applicable new contracts and 
orders when the acquisition utilizes a product or service code 
designated by HHS for supplies or services having sustainable 
acquisition attributes.


323.7103  Solicitation Provision.

    The contracting officer shall insert the provision at 352.223-71, 
Instruction to Offerors--Sustainable Acquisition, in solicitations 
above the micro-purchase threshold when the acquisition utilizes a 
product or service code designated by HHS as having sustainable 
acquisition attributes.

PART 324--PROTECTION OF PRIVACY AND FREEDOM OF INFORMATION

Subpart 324.1--Protection of Individual Privacy
Sec.
324.103 Procedures for the Privacy Act.
324.104 Restrictions on Contractor Access to Government or Third 
Party Information.
324.105 Contract clauses.
Subpart 324.70--Health Insurance Portability and Accountability Act of 
1996 (HIPAA)
324.7000 Scope of subpart.
324.7001 Policy on Compliance with HIPAA Business Associate Contract 
Requirements.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).

Subpart 324.1--Protection of Individual Privacy


324.103  Procedures for the Privacy Act.

    (a) The contracting officer shall review all acquisition request 
documentation to determine whether the requirements of the Privacy Act 
of 1974 (5 U.S.C. 552a) are applicable. The Privacy Act requirements 
apply when a contract or order requires the contractor to design, 
develop, or operate any Privacy Act system of records on individuals to 
accomplish an agency function. When applicable, the contracting officer 
shall include the two Privacy Act clauses required by FAR 24.104 in the 
solicitation and contract or order. In addition, the contracting 
officer shall include the two FAR Privacy Act clauses, and other 
pertinent information specified in this subpart, in any modification 
which results in the Privacy Act requirements becoming applicable to a 
contract or order.
    (b) The contracting officer shall ensure that the statement of work 
or performance work statement (SOW or PWS) specifies the system(s) of 
records or proposed system(s) of records to which the Privacy Act and 
the implementing regulations are applicable or may be applicable. The 
contracting officer shall send the contractor a copy of 45 CFR part 5b, 
which includes the rules of conduct and other Privacy Act requirements.
    (c) The contracting officer shall ensure that the contract SOW or 
PWS

[[Page 11285]]

specifies for both the Privacy Act and the Federal Records Act the 
disposition to be made of the system(s) of records upon completion of 
contract performance. The contract SOW or PWS may require the 
contractor to destroy the records, remove personal identifiers, or turn 
the records over to the contracting officer. If there is a legitimate 
need for a contractor to keep copies of the records after completion of 
a contract, the contractor must take measures, as approved by the 
contracting officer, to keep the records confidential and protect the 
individuals' privacy.
    (d) For any acquisition subject to Privacy Act requirements, the 
requiring activity prior to award, or the COR, after award, shall 
prepare and have published in the Federal Register a ``system notice,'' 
describing the Department of Health and Human Services' (HHS) intent to 
establish a new system of records on individuals, to make modifications 
to an existing system, or to disclose information in regard to an 
existing system. The requiring activity shall attach a copy of the 
system notice to the acquisition plan or other acquisition request 
documentation. If a system notice is not attached, the contracting 
officer shall inquire about its status and shall obtain a copy from the 
requiring activity for inclusion in the contract file. If a notice for 
the system of records has not been published in the Federal Register, 
the contracting officer may proceed with the acquisition but shall not 
award the contract until the system notice is published and the 
contracting officer verifies its publication.


324.104  Restrictions on Contractor Access to Government or Third Party 
Information.

    The contracting officer shall establish the restrictions that 
govern the contractor employees' access to Government or third party 
information in order to protect the information from unauthorized use 
or disclosure.


324.105  Contract clauses.

    (a) The contracting officer shall insert the clause at 352.224-70, 
Privacy Act, in solicitations, contracts, and orders that require the 
design, development, or operation of a system of records to notify the 
contractor that it and its employees are subject to criminal penalties 
for violations of the Privacy Act (5 U.S.C. 552a(i)) to the same extent 
as HHS employees. The clause also requires the contractor to ensure 
each of its employees knows the prescribed rules of conduct in 45 CFR 
part 5b and each contractor employee is aware that he or she is subject 
to criminal penalties for violations of the Privacy Act. These 
requirements also apply to all subcontracts awarded under the contract 
or order that require the design, development, or operation of a system 
of records.
    (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 to third party information.

Subpart 324.70--Health Insurance Portability and Accountability Act 
of 1996


324.7000  Scope of subpart.

    All individually identifiable health information that is Protected 
Health Information or ``PHI'', as defined in 45 CFR 160.103 shall be 
administered in accordance with the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA) as amended, subtitle D of title IV 
of the Health Information Technology for Economic and Clinical Health 
Act (HITECH Act), and the corresponding implementing regulations at 45 
CFR parts 160 and 164. The term ``HIPAA'' is used in this part to refer 
to the HIPAA and HITECH statutes and the implementing regulations. 
HIPAA includes standards and implementation specifications for the 
security and privacy of certain individually identifiable health 
information known as Protected Health Information (PHI).


324.7001  Policy on Compliance with HIPAA business associate contract 
requirements.

    ``HIPAA'' refers to the provisions of part C of title XI of the 
Social Security Act, 42 U.S.C. 1320d et seq., section 264 of the Health 
Insurance Portability and Accountability Act of 1996, as amended, and 
subtitle D of title IV of the Health Information Technology for 
Economic and Clinical Health Act (HITECH Act), as amended, and the 
HIPAA Rules at 45 CFR parts 160 through 164. HHS is a HIPAA ``covered 
entity'' that is a ``hybrid entity'' as these terms are defined at 
Sec. Sec.  160.103 and 164.103 respectively. As such, only the portions 
of HHS that the Secretary has designated as ``health care components'' 
(HCC) as defined at Sec.  164.103, are subject to HIPAA. HHS' HCCs may 
utilize persons or entities known as ``business associates,'' as 
defined at Sec.  160.103. Generally, ``business associate'' means a 
``person'' as defined by Sec.  160.103 (including contractors, and 
third-party vendors, etc.) if or when the person or entity:
    (a) Creates, receives, maintains, or transmits ``protected health 
information'' (PHI), as the term is defined at 160.103, on behalf of an 
HHS HCC to carry out HHS HIPAA-covered functions; or
    (b) Provides certain services to an HHS HCC that involves PHI. 
Where the Department as a covered entity is required by 45 CFR 
164.502(e)(1) and 164.504(e) and, if applicable, Sec. Sec.  
164.308(b)(3) and 164.314(a), to enter into a HIPAA business associate 
contract, the relevant HCC contracting officer, acting on behalf of the 
Department, shall ensure that such contract meets the requirements at 
Sec.  164.504(e)(2) and, if applicable, Sec.  164.314(a)(2).

PART 326--OTHER SOCIOECONOMIC PROGRAMS

Subpart 326.5--Indian Preference in Employment, Training, and 
Subcontracting Opportunities
Sec.
326.501 Statutory requirements.
Subpart 326.6--Acquisitions Under the Buy Indian Act
326.600 Scope of subpart.
326.601 Policy.
326.602 Definitions.
326.603 Requirements.
326.604 Competition.
326.605 Responsibility determinations.
Subpart 326.7--Acquisitions Requiring the Native American Graves 
Protection and Repatriation Act
326.700 Scope of subpart.
326.701 Applicability.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).

Subpart 326.5--Indian Preference in Employment, Training, and 
Subcontracting Opportunities


326.501  Statutory requirements.

    Any contract or subcontract pursuant to subchapter II, chapter 14, 
title 25 United States Code, the Act of April 16, 1934 (48 Stat. 596), 
as amended, 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, Pub. L. 93-638, 88 
Stat. 2205, 25 U.S.C. 450e(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

[[Page 11286]]

in section 1452 of title 25, United States Code.


326.502  Definitions.

    For purposes of this subpart, the following definitions shall 
apply:
    (a) 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.
    (b) Indian tribe means an Indian tribe, pueblo, 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), which the United States recognizes as eligible for 
special programs and services because of its status as Indian.
    (c) Indian organization means the governing body of any Indian 
tribe, or entity established or recognized by such governing body, in 
accordance with the Indian Financing Act of 1974 (88 Stat. 77, 25 
U.S.C. 1451).
    (d) 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 the 
ownership shall encompass active operation and control of the 
enterprise.
    (e) 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.)
    (f) 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.


326.503  Compliance enforcement.

    The contracting officer shall promptly investigate and resolve 
written complaints of noncompliance with the requirements of the 
clauses at 352.226-1, Indian Preference and 352.226-2, Indian 
Preference Program filed with the contracting activity.


326.504  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 352.226-2, 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 Pub. L. 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 352.226-2, Indian Preference Program shall also 
clearly identify in the solicitation the additional requirements.
    (b) Nothing in this part 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.


326.505  Applicability.

    The contracting officer shall insert the clause at 352.226-1, 
Indian Preference, and the clause at 352.226-2, Indian Preference 
Program, in contracts to implement section 7(b) of Pub. L. 93-638 for 
all Department of Health and Human Services (HHS) activities. 
Contracting activities shall use the clauses as follows, except for 
those exempted solicitations and contracts issued and or awarded 
pursuant to Title I of Pub. L. 93-638 (25 U.S.C. 450 et seq.):
    (a) The contracting officer shall insert the clause at 352.226-1, 
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 352.226-2, 
Indian Preference Program, in solicitations, contracts, and orders 
when--
    (1) The dollar amount of the acquisition is expected to equal or 
exceed $650,000 for non-construction work or $1.5 million for 
construction work;
    (2) The solicitation, contract, or order includes the Indian 
Preference clause; 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 Indian Preference Program clause in 
solicitations, contracts, and orders below the $650,000 or $1.5 million 
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 326.6--Acquisitions Under the Buy Indian Act


326.600  Scope of subpart.

    This subpart sets forth the policy on preferential acquisition from 
Indians under the negotiation authority of the Buy Indian Act. This 
subpart applies only to acquisitions made by or on behalf of Indian 
Health Service (IHS).


326.601  Policy.

    (a) IHS shall utilize the negotiation authority of the Buy Indian 
Act to give preference to Indians whenever authorized and practicable. 
The Buy Indian Act, 25 U.S.C. 47, prescribes the application of the 
advertising requirements of 41 U.S.C. 6101 to the acquisition of Indian 
supplies. As specified in 25 U.S.C. 47, the Buy Indian Act provides 
that, so far as practicable, the Government shall employ Indian labor 
and, at the discretion of the Secretary of the Interior, purchase 
products of Indian industry (including, but not limited to printing, 
notwithstanding any other law) from the open market.
    (b) Due to the transfer of authority from the Department of the 
Interior to HHS, the Secretary of HHS may use the Buy Indian Act to 
acquire products of Indian industry in connection with the maintenance 
and operation of Indian hospital and health facilities, and for the 
overall conservation of Indian health. This authority is exclusively 
delegated to IHS and is not available for use by any other HHS 
component (unless that component makes an acquisition on behalf of 
IHS). However, the Buy Indian Act itself does not exempt IHS from 
meeting the statutorily mandated small business goals.

[[Page 11287]]

    (c) Subsequent legislation, particularly Pub. L. 94-437 and Pub. L. 
96-537, emphasize using the Buy Indian Act negotiation authority.


326.602  Definitions.

    (a) Buy Indian contract means any contract involving activities 
covered by the Buy Indian Act and negotiated under the provisions of 41 
U.S.C. 3104 and 25 U.S.C. 47 between an Indian firm and a contracting 
officer representing IHS.
    (b) Indian means a member of any tribe, pueblo, band, group, 
village, or community recognized by the Secretary of the Interior as 
being Indian or any individual or group of individuals recognized by 
the Secretary of the Interior or the Secretary of HHS. The Secretary of 
HHS in making determinations may take into account the determination of 
the tribe with which affiliation is claimed.
    (c) Indian firm means a sole enterprise, partnership, corporation, 
or other type of business organization owned, controlled, and operated 
by:
    (1) One or more Indians (including, for the purpose of sections 301 
and 302 of Pub. L. 94-437, former or currently federally recognized 
Indian tribes in the State of New York); or
    (2) By an Indian firm (as defined in paragraph (1) of this 
definition); or
    (3) A nonprofit firm organized for the benefit of Indians and 
controlled by Indians (see 326.601(a)).
    (d) Product of Indian industry means anything produced by Indians 
through either physical labor or intellectual effort involving the use 
and application of their skills. To classify as a product of Indian 
industry, the total cost of the item's production must equal or exceed 
51 percent Indian effort.


326.603  Requirements.

    (a) Indian ownership. Indian ownership shall constitute at least 51 
percent of an Indian firm during the period covered by a Buy Indian 
contract.
    (b) Joint ventures. An Indian firm may enter into a joint venture 
with other entities for specific projects as long as the Indian firm is 
the managing partner. However, the contracting officer shall approve 
the joint venture prior to the award of a contract under the Buy Indian 
Act.
    (c) Bonds. In the case of contracts for the construction, 
alteration, or repair of public buildings or public works, the Miller 
Act (40 U.S.C. 3131 et seq.) and Federal Acquisition Regulation (FAR) 
Part 28 require performance and payment bonds. Bonds are not required 
in the case of contracts with Indian tribes or public nonprofit 
organizations serving as governmental instrumentalities of an Indian 
tribe. However, bonds are required when dealing with private business 
entities owned by an Indian tribe or members of an Indian tribe. The 
contracting officer may require bonds of private business entities that 
are joint ventures with, or subcontractors of, an Indian tribe or a 
public nonprofit organization serving as a governmental instrumentality 
of an Indian tribe. A bid guarantee or bid bond is required only when a 
performance or payment bond is required.
    (d) Indian preference in employment, training and subcontracting. 
Contracts awarded under the Buy Indian Act are subject to the 
requirements of section 7(b) of the Indian Self-Determination and 
Education Assistance Act 25 U.S.C. 450e, which requires giving 
preference to Indians in employment, training, and subcontracting. The 
contracting officer shall include the Indian Preference clause 
specified in 326.505(a) in all Buy Indian solicitations and resultant 
contracts. The contracting officer shall use the Indian Preference 
Program clause specified in 326.505(b). The contracting officer shall 
follow all requirements specified in subpart 326.2 which apply to a Buy 
Indian acquisition (e.g., 326.604 and 326.605).
    (e) Subcontracting. A contractor shall not subcontract more than 50 
percent of the work under a prime contract awarded pursuant to the Buy 
Indian Act to non-Indian firms. For this purpose, contract work does 
not include the provision of materials, supplies, or equipment.
    (f) Wage rates. The contracting officer shall include a 
determination of the minimum wage rates by the Secretary of Labor as 
required by the Davis-Bacon Act (40 U.S.C. 276a) in all contracts 
awarded under the Buy Indian Act for over $2,000 for construction, 
alteration, or repair, including painting and decorating, of public 
buildings and public works, except contracts with Indian tribes or 
public nonprofit organizations serving as governmental 
instrumentalities of an Indian tribe. The contracting officer shall 
include the wage rate determination in contracts with private business 
entities, even when owned by an Indian tribe or a member of an Indian 
tribe and in connection with joint ventures with, or subcontractors of, 
an Indian tribe or a public nonprofit organization serving as a 
governmental instrumentality of an Indian tribe.


326.604  Competition.

    (a) Contracts awarded under the Buy Indian Act are subject to 
competition among Indians or Indian firms to the maximum extent 
practicable. When the contracting officer determines that competition 
is not practicable, a justification and approval is required in 
accordance with subpart 306.3.
    (b) The contracting officer shall: synopsize and publicize 
solicitations in the Government point of entry and provide copies of 
the synopses to the tribal office of the Indian tribal government 
directly concerned with the proposed acquisition as well as to Indian 
firms and others having a legitimate interest. The synopses shall state 
that the acquisitions are restricted to Indian firms under the Buy 
Indian Act.


326.605  Responsibility determinations.

    (a) The contracting officer may award a contract under the Buy 
Indian Act only if it is determined that the contractor will likely 
perform satisfactorily and properly complete or maintain the contracted 
project or function.
    (b) The contracting officer shall make the written determination 
specified in paragraph (a) of this section prior to the award of a 
contract. The determination shall reflect an analysis of FAR 9.104-1 
standards.

Subpart 326.7--Acquisitions Requiring the Native American Graves 
Protection and Repatriation Act


326.700  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.


326.701  Applicability.

    The contracting officer shall insert the clause at 352.226-3, 
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.

SUBCHAPTER E--GENERAL CONTRACTING REQUIREMENTS

PART 327--RIGHTS, DATA, AND COPYRIGHTS

Subpart 327.3--Patent Rights Under Government Contracts
Sec.

[[Page 11288]]

327.303 Solicitation provision and contract clause.
Subpart 327.4--Rights in Data and Copyrights
327.404-70 Solicitation provision and contract clause.
327.409 Solicitation provision and contract clause.

    Authority:  5 U.S.C. 301; 40 U.S.C. 121(c)(2).

Subpart 327.3--Patent Rights Under Government Contracts


327.303  Solicitation provision and contract clause.

    The contracting officer shall insert the clause at 352.227-11, 
Patent Rights--Exceptional Circumstances and any appropriate alternates 
in lieu of Federal Acquisition Regulation (FAR) 52.227-11 whenever a 
Determination of Exceptional Circumstances (DEC) involving the 
provision of materials that has been executed in accordance with Agency 
policy and procedures calls for its use and clause 352.227-11, Patent 
Rights--Exceptional Circumstances, appropriately covers the 
circumstances. The contracting officer should reference the DEC in the 
solicitation and shall attach a copy of the executed DEC to the 
contract.

Subpart 327.4--Rights in Data and Copyrights


327.404-70  Solicitation provision and contract clause.

    The contracting officer shall insert the clause at 352.227-70, 
Publications and Publicity, in solicitations, contracts, and orders 
that involve requirements which could lead to the contractor's 
publishing the results of its work under the contract.


327.409  Solicitation provision and contract clause.

    The contracting officer shall insert the clause at 352.227-14, 
Rights in Data--Exceptional Circumstances and any appropriate 
alternates in lieu of FAR 52.227-14 whenever a DEC executed in 
accordance with Agency policy and procedures calls for its use. Prior 
to using this clause, a DEC must be executed in accordance with Agency 
policy and procedures. The contracting officer should reference the DEC 
in the solicitation and shall attach a copy of the executed DEC to the 
contract.

PART 328--[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)(2).

Subpart 330.2--CAS Program Requirements


330.201   Contract requirements.


330.201-5   Waiver.

    The Associate Deputy Assistant Secretary for Acquisition shall 
exercise the waiver authority under Federal Acquisition Regulation 
30.201-5(a)(2). Operating Divisions and Staff Divisions shall forward 
waiver requests to the Senior Procurement Executive.

PART 331--CONTRACT COST PRINCIPLES AND PROCEDURES

Subpart 331.1--Applicability
Sec.
331.101-70 Salary rate limitation.

    Authority:  5 U.S.C. 301; 40 U.S.C. 121(c)(2).

Subpart 331.1--Applicability


331.101-70   Salary rate limitation.

    (a) Beginning in fiscal year 1990, Congress has stipulated in the 
Department of Health and Human Services appropriations acts and 
continuing resolutions that, under applicable contracts, appropriated 
funds cannot be used to pay the direct salary of an individual above 
the stipulated rates. The applicable rates for each year are identified 
at www.opm.gov.
    (b) 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

Subpart 332.4--Advance Payments for Non-Commercial Items
Sec.
332.402 General.
332.407 Interest.
Subpart 332.5--Progress Payments Based on Cost
332.501 General.
332.501-2 Unusual progress payments.
Subpart 332.7--Contract Funding
332.702 Policy.
332.703 Contract funding requirements.
332.703-1 General.
332.703-71 Incrementally funded cost-reimbursement contracts.
332.703-72 Incremental Funding Table.
332.706 Solicitation provision and contract clauses.
332.706-2 Provision and clauses for limitation of cost or funds.

    Authority:  5 U.S.C. 301; 40 U.S.C. 121(c)(2).

Subpart 332.4--Advance Payments for Non-Commercial Items


332.402  General.

    (e) The head of the contracting activity (HCA) (non-delegable) is 
the person responsible for compliance with Federal Acquisition 
Regulation (FAR) 32.402(e) and shall determine whether advance payments 
are in accordance with FAR 32.402.


332.407  Interest.

    (d) The HCA (non-delegable) shall make the determinations in FAR 
32.407(d).

Subpart 332.5--Progress Payments Based on Cost


332.501  General.


332.501-2  Unusual progress payments.

    (a)(3) The HCA (non-delegable) shall approve unusual progress 
payments.

Subpart 332.7--Contract Funding


332.702  Policy.

    Departmental employees shall report any suspected violation of the 
Anti-Deficiency Act (31 U.S.C. 1341, 13 U.S.C. 1342, and 31 U.S.C. 
1517) immediately to the OPDIV Chief Financial Officer (CFO), who in 
turn will report the matter to the HHS Deputy CFO.


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.

[[Page 11289]]

    (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.


332.703-71  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.


332.703-72  Incremental Funding Table.

    The contracting officer shall insert substantially the following 
language 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:
    (a) Insert the initial funding obligated by the award;
    (b) Identify the increment of performance covered by the funding 
provided; and
    (c) Specify the start and end dates for each increment of 
performance, as required by the ``Limitation of Funds'' clause at FAR 
52.232-22.
    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.
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:
---------------------------------------------------------------------------

    * To be inserted after negotiation.

----------------------------------------------------------------------------------------------------------------
                     Start date of       End date of                                             Estimated cost
 CLIN, Task No.,      increment of       increment of      Estimated cost      Fee ($) (as      plus fee ($) (as
  or description      performance        performance            ($)            appropriate)       appropriate)
----------------------------------------------------------------------------------------------------------------
                   .................  .................  .................  .................  .................
                  ----------------------------------------------------------------------------------------------
                   .................  .................  .................  .................  .................
                  ----------------------------------------------------------------------------------------------
                   .................  .................  .................  .................  .................
                  ----------------------------------------------------------------------------------------------
                   .................  .................  .................  .................  .................
                  ----------------------------------------------------------------------------------------------
                   .................  .................  .................  .................  .................
                  ----------------------------------------------------------------------------------------------
                   .................  .................          [Total]            [Total]            [Total]
----------------------------------------------------------------------------------------------------------------

    (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  Solicitation provision and contract clauses.


332.706-2  Provision and 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.

PART 333--PROTESTS, DISPUTES, AND APPEALS

Subpart 333.1--Protests
Sec.
333.102 General.
333.103 Protests to the agency.
Subpart 333.2--Disputes and Appeals
333.203 Applicability.
333.209 Suspected fraudulent claims.
333.215-70 Contract clauses.

    Authority:  5 U.S.C. 301; 40 U.S.C. 121(c)(2).

Subpart 333.1--Protests


333.102  General.

    (g)(1) 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 (HHS); and serves as 
the notification point with GAO for all protests.
    (2) The contracting officer will follow the direction of the 
Operating Division's (OPDIV) protest control officer for responding to 
protests whether they are filed with GAO or directly with the 
contracting officer.


333.103  Protests to the agency.

    (f)(1) Protests to the contracting officer must be in writing. The 
contracting officer is authorized to make the

[[Page 11290]]

determination, using the criteria in FAR 33.104(b), to award a contract 
notwithstanding the protest after obtaining the concurrence of the 
contracting activity's protest control officer and consulting with the 
appropriate legal office.

Subpart 333.2--Disputes and Appeals


333.203  Applicability.

    (c) The Civilian Board of Contract Appeals (CBCA) is the authorized 
``Board'' to hear and determine disputes for the Department.


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.


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 item.)

SUBCHAPTER F--SPECIAL CATEGORIES OF CONTRACTING

PART 334--MAJOR SYSTEM ACQUISITION

Subpart 334.2--Earned Value Management System
Sec.
334.201 Policy.
334.202 Integrated Baseline Reviews (IBRs).

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).

Subpart 334.2--Earned Value Management System


334.201  Policy.

    The Department of Health and Human Services applies the earned 
value management system 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 earned value management 
system 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 (IBRs).

    (a) An IBR normally should be conducted as a post-award activity. 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 
addresses 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.
335.071 [Reserved]
335.072 Key personnel.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).


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 FAR 16.303. Examples include increased 
technical know-how, training for employees, acquisition of equipment, 
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. The Government's interest includes positive impact on the 
community at large.
    (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.
    (c) Any determination made by a contracting officer as described in 
this section shall be evidenced by appropriate documentation in the 
contract file.


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

[[Page 11291]]

be appropriate. See FAR 42.707. See also, FAR 16.303.
    (d) The contractor's participation may be considered over the total 
term of the project, so that a relatively high contribution in 1 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.


335.071  [Reserved]


335.072  Key personnel.

    If the contracting officer determines that the personnel to be 
assigned to perform effort on an R&D contract are critical to the 
success of the R&D effort, or were a critical factor in the award of 
the contract, then the contracting officer should consider using the 
key personnel clause at 352.237-75, Key Personnel.

PART 336--CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS

Subpart 336.1--General
Sec.
336.104 Policy.
Subpart 336.5--Contract Clause
336.570 Contract Clause.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).

Subpart 336.1--General


336.104  Policy.

    Contracting officers shall follow the policies described in Federal 
Acquisition Regulation 36.104 and the guidance promulgated by the 
Department of Health and Human Services Facilities Management.

Subpart 336.5--Contract Clause


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 all 
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.
    (c) Due to the importance of maintaining consistency in the 
contractor's personnel during design-build construction, the 
contracting officer should consider including the clause at 352.237-75, 
Key personnel.

PART 337--SERVICE CONTRACTING--GENERAL

Subpart 337.1--Service Contracts--General
Sec.
337.103 Contracting officer responsibility.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).

Subpart 337.1--Service Contracts--General


337.103  Contracting officer responsibility.

    (d)(1) The contracting officer shall insert the clause at 352.237-
70, Pro-Children Act, in solicitations, contracts, and orders that 
involve:
    (i) Kindergarten, elementary, or secondary education or library 
services; or
    (ii) 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 1994 (20 U.S.C. 6081-6084).
    (2) The contracting officer shall insert the clause at 352.237-71, 
Crime Control Act--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 the 
professions/activities performed by persons specified in the Crime 
Control Act of 1990 (42 U.S.C. 13031) including, but not limited to, 
teachers, social workers, physicians, nurses, dentists, health care 
practitioners, optometrists, psychologists, emergency medical 
technicians, alcohol or drug treatment personnel, child care workers 
and administrators, emergency medical technicians and ambulance 
drivers.
    (3) The contracting officer shall insert the clause at 352.237-72, 
Crime Control Act--Requirement for Background Checks, in solicitations, 
contracts, and orders that involve providing child care 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 (42 U.S.C. 13041).
    (4) Contracting officers supporting IHS shall insert the clause at 
352.237-73, Indian Child Protection and Family Violence Act 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.
    (e) The contracting officer shall insert the clause at 352.237-74, 
Non-Discrimination in Service Delivery, in solicitations, contracts, 
and orders to deliver services under HHS' programs directly to the 
public.
    (f) The contracting officer shall insert the clause at 352.237-75, 
Key Personnel, in solicitations and contracts when the contracting 
officer will require the contractor to designate contractor key 
personnel.

PART 339--ACQUISITION OF INFORMATION TECHNOLOGY

Subpart 339.1--General
Sec.
339.101 Policy.
Subpart 339.2--Electronic and Information Technology
339.203 Applicability.
339.203-70 Contract clauses for electronic and information 
technology (EIT) acquisitions.
339.204 Exceptions.
339.204-1 Approval of exceptions.
339.205 Section 508 accessibility standards for contracts.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).

Subpart 339.1--General


339.101  Policy.

    In addition to the regulatory guidance in Federal Acquisition 
Regulation part 39, contracting officers shall collaborate with the 
requiring activity to ensure information technology (IT) acquisitions 
for supplies, services, and systems meet the requirements established 
by the Department of Health and Human Services (HHS).

Subpart 339.2--Electronic and Information Technology


339.203  Applicability.

    (a) Electronic and information technology (EIT) supplies and 
services must comply with Section 508 of the Rehabilitation Act (the 
Act) of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment 
Act of 1998, and the Architectural and Transportation Barriers 
Compliance Board (Access Board) Electronic and Information

[[Page 11292]]

Accessibility Standards (36 CFR part 1194). Requiring activities must 
consult with their Section 508 Official or designee to determine if the 
contractor should be responsible for compliance with EIT accessibility 
standards which apply to Web site content and communications material 
(in any format, such as reports, documents, charts, posters, 
presentations, or video material) that is specifically intended for 
publication on, or delivery via, an HHS-owned or -funded Web site, or 
whether these types of deliverables can be made compliant by the 
Government through other means. For deliverables made compliant by the 
Government through other means, the contract should not include 
accessibility standards.
    (1) When conducting a procurement and employing the Best Value 
Continuum, the solicitation shall include a separate technical 
evaluation factor developed by the Contracting Officer, requiring 
activity, and the Operating Division (OPDIV) Section 508 Official or 
designee.
    (2) At a minimum, solicitations for supplies and services shall 
require the submission of a Section 508 Product Assessment Template 
(See https://hhs.gov/web/508 for the template). Solicitations for 
services shall include any other pertinent information that the 
contracting officer deems necessary to evaluate the offeror's ability 
to meet the applicable Section 508 accessibility standards.
    (3) The HHS Operating Division/Staff Division (OPDIV/STAFFDIV) 
Section 508 Official or designee is responsible for providing technical 
assistance in development of Section 508 evaluation factors.
    (4) Before conducting negotiations or making an award, the 
contracting officer shall provide a summary of the Source Selection 
Evaluation Team's (SSET) assessment of offeror responses to the 
solicitation's Section 508 evaluation factor. This summary shall be 
submitted for review by the Section 508 Official or designee. The 
Section 508 Official or designee shall indicate approval/disapproval of 
the SSET assessment. The contracting officer shall coordinate the 
resolution of any issues raised by the Section 508 Official or designee 
with the chair of the SSET or requiring activity representative, as 
appropriate. The acquisition process shall not proceed until the 
Section 508 Official or designee approves the SSET assessment. The 
contracting officer shall include the assessment in the official 
contract file. See 339.204-1 regarding processing exception 
determination requests.
    (b) When acquiring commercial items, if no commercially available 
supplies or services meet all of the applicable Section 508 
accessibility standards, OPDIVs or STAFFDIVs shall, under the direction 
and approval of the Section 508 Official or designee, acquire the 
supplies and services that best meet the applicable Section 508 
accessibility standards. Process exception determinations for EIT 
supplies and services not meeting applicable Section 508 accessibility 
standards in accordance with 339.204-1.


339.203-70  Contract clauses for electronic and information technology 
(EIT) acquisitions.

    (a) The contracting officer shall insert the provision at 352.239-
73, Electronic and Information Technology Accessibility Notice, in all 
solicitations.
    (b) The contracting officer shall insert the clause at 352.239-74, 
Electronic and Information Technology Accessibility, in all contracts 
and orders.


339.204  Exceptions.


339.204-1  Approval of exceptions.

    (a) Procedures to document exception and determination requests are 
set by the OPDIV Section 508 Official.
    (b) In the development of an acquisition plan (AP) or other 
acquisition request document, the contracting officer shall ensure that 
all Section 508 exception determination requests for applicable EIT 
requirements are:
    (1) Documented and certified in accordance with the requirements of 
paragraph 4.3, Section 508 Compliance Exceptions, of the HHS Section 
508 policy;
    (2) Signed by the requestor in the requiring activity;
    (3) approved by the OPDIV Section 508 Official or designee; and
    (4) Included in the AP or other acquisition request document 
provided by the requiring activity to the contracting office.
    (c) For instances with an existing technical evaluation and no 
organization's proposed supplies or services meet all of the Section 
508 accessibility standards; in order to proceed with the acquisition, 
the requiring activity shall provide an exception determination request 
along with the technical evaluation team's assessment of the Section 
508 evaluation factor to the designated Section 508 Official or 
designee for review and approval or disapproval. The contracting 
officer shall include the Section 508 Official's or designee's approval 
or disapproval of the exception determination request in the official 
contract file and reference it, as appropriate, in all source selection 
documents. For further information, see HHS Section 508 Policy on 
https://hhs.gov/web/508.


339.205  Section 508 accessibility standards for contracts.

    (a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 
794(d)), as amended by the Workforce Investment Act of 1998 (Section 
508), specifies the applicable accessibility standards for all new 
solicitations and new or existing contracts or orders, regardless of 
EIT dollar amount.
    (b) The requiring activity shall consult with the OPDIV or STAFFDIV 
Section 508 Official or designee, as necessary, to determine the 
applicability of Section 508, identify applicable Section 508 
accessibility standards, and resolve any related issues before 
forwarding a request to the contracting or procurement office for the 
acquisition of EIT supplies and services--including Web site content 
and communications material for which the contractor must meet EIT 
accessibility standards.
    (c) Based on those discussions, the requiring activity shall 
provide a statement in the AP (or other acquisition request document) 
for Section 508 applicability. See 307.105. If Section 508 applies to 
an acquisition, include the provision at 352.239-73, Electronic and 
Information Technology and Accessibility Notice, language in a 
separate, clearly designated, section of the statement of work or 
performance work statement, along with any additional information 
applicable to the acquisition's Section 508 accessibility standards 
(e.g., the list of applicable accessibility standards of the Access 
Board EIT Accessibility Standards (36 CFR part 1194)). If an AP does 
not address Section 508 applicability and it appears an acquisition 
involves Section 508, or if the discussion of Section 508 applicability 
to the acquisition is inadequate or incomplete, the contracting officer 
shall request the requiring activity modify the AP accordingly.
    (d) Items provided incidental to contract administration are not 
subject to this section.
    (e) The OPDIV Section 508 Official or designee may, at his or her 
discretion, require review and approval of solicitations and contracts 
for EIT supplies and services.

[[Page 11293]]

SUBCHAPTER G--CONTRACT MANAGEMENT

PART 342--CONTRACT ADMINISTRATION

Subpart 342.7--Indirect Cost Rates
Sec.
342.705 Final indirect cost rates.

    Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).

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 (FMS), Division of Cost 
Allocation, Program Support Center (PSC)), 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 Institutes of Health (NIH) Division of Financial 
Advisory Services, shall establish indirect cost rates and similar 
rates for use in contracts awarded to for profit organizations.

SUBCHAPTER H--CLAUSES AND FORMS

PART 352--SOLICITATION PROVISIONS AND CONTRACT CLAUSES

Subpart 352.1--Instructions for Using Provisions and Clauses
Sec.
352.100 Scope of subpart.
352.101-70 Application of provisions and clauses.
Subpart 352.2--Texts of Provisions and Clauses
352.203-70 Anti-lobbying.
352.204-70 Prevention and Public Health Fund-Reporting Requirements.
352.208-70 Printing and Duplication.
352.211-1 Accessibility of meetings, conferences, and seminars to 
persons with disabilities.
352.211-2 Conference sponsorship request and conference materials 
disclaimer.
352.211-3 Paperwork Reduction Act.
352.215-70 Late proposals and revisions.
352.216-70 Additional cost principles.
352.219-70 Mentor-prot[eacute]g[eacute] program.
352.219-71 Mentor-prot[eacute]g[eacute] program reporting 
requirements.
352.222-70 Contractor cooperation in equal employment opportunity 
investigations.
352.223-70 Safety and health.
352.223-71 Instructions to Offerors-Sustainable Acquisition.
352.224-70 Privacy Act.
352.224-71 Confidential Information.
352.226-1 Indian preference.
352.226-2 Indian preference program.
352.226-3 Native American Graves Protection and Repatriation Act.
352.227-11 Patent Rights--Exceptional Circumstances.
352.227-14 Rights in Data--Exceptional Circumstances.
352.227-70 Publications and publicity.
352.231-70 Salary rate limitation.
352.232-70 Incremental Funding.
352.233-70 Choice of law (overseas).
352.233-71 Litigation and claims.
352.236-70 Design-Build Contracts.
352.237-70 Pro-Children Act.
352.237-71 Crime Control Act--reporting of child abuse.
352.237-72 Crime Control Act--requirement for background checks.
352.237-73 Indian Child Protection and Family Violence Act.
352.237-74 Non-Discrimination in Service Delivery.
352.237-75 Key personnel.
352.239-73 Electronic Information and Technology Accessibility 
Notice.
352.239-74 Electronic Information and Technology Accessibility.
352.270-1 [Reserved]
352.270-2 [Reserved]
352.270-3 [Reserved]
352.270-4a Notice to Offerors, Protection of Human Subjects.
352.270-4b Protection of Human Subjects.
352.270-5a Notice to Offerors of Requirement for Compliance with the 
Public Health Service Policy on Humane Care and Use of Laboratory 
Animals.
352.270-5b Care of Live Vertebrate Animals.
352.270-6 Restriction on use of Human Subjects.
352.270-7 [Reserved]
352.270-8 [Reserved]
352.270-9 Non-discrimination for conscience.
352.270-10 Notice to Offerors--Protection of Human Subjects, 
Research Involving Human Subjects Committee (RIHSC) Approval of 
Research Protocols Required.
352.270-11 Protection of Human Subjects, Research Involving Human 
Subjects Committee (RIHSC) Approval of Research Protocols Required.
352.270-12 Needle Exchange.
352.270-13 Continued Ban on Funding Abortion and Continued Ban on 
Funding of Human Embryo Research.

    Authority:  5 U.S.C. 301; 40 U.S.C. 121(c)(2).

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 provisions and clauses in solicitations, 
contracts, and orders.


352.101-70  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.
    (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--Texts of Provisions and Clauses


352.203-70  Anti-lobbying.

    As prescribed in 303.808-70, the Contracting Officer shall 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 subsections (a), (b), and (c) above 
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 HHSAR 304.7201, insert the following clause:

[[Page 11294]]

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), Pub. L. 111-148, sec. 
4002. 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 six-
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 an 
electronic and Section 508 compliant format to the Contracting 
Officer.
    (1) The Government contract and order number, as applicable.
    (2) The amount of PPHF funds 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 PPHF funding, that is 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)


352.208-70   Printing and Duplication.

    As prescribed in 308.803, the Contracting Officer shall insert the 
following clause:

Printing and Duplication (Date)

    (a) Unless otherwise specified in this contract, no printing by the 
Contractor or any subcontractor is authorized under this contract. All 
printing required must be performed by the Government Publishing Office 
except as authorized by the Contracting Officer. The Contractor shall 
submit camera-ready copies to the Contracting Officer's Representative 
(COR). The terms ``printing'' and ``duplicating/copying'' are defined 
in the Government Printing and Binding Regulations of the Joint 
Committee on Printing.
    (b) If necessary for performance of the contract, the Contractor 
may duplicate or copy less than 5,000 production units of only one 
page, or less than 25,000 production units in aggregate of multiple 
pages for the use of a department or agency. A production unit is 
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.
    (c) Approval for all printing, as well as duplicating/copying in 
excess of the stated limits, shall be obtained from the COR who will 
consult with the designated publishing services office and provide 
direction to the contractor. The cost of any unauthorized printing or 
duplicating/copying under this contract will be considered an 
unallowable cost for which the Contractor will not be reimbursed.


352.211-1  Accessibility of meetings, conferences, and seminars to 
persons with disabilities.

    As prescribed in 311.7102, the Contracting Officer shall insert the 
following clause:

Accessibility of Meetings, Conferences, and Seminars to Persons with 
Disabilities (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 meeting, conference, or seminar held pursuant to this 
contract will meet or exceed the minimum accessibility standards set 
forth in 28 CFR part 36. The Contractor shall submit the plan to the 
Contracting Officer Representative for approval prior to initiating 
action. The Contractor may submit a consolidated or master plan for 
contracts requiring numerous meetings, conferences, or seminars in 
lieu of separate plans.
    (b) The Contractor shall manage the contract in accordance with 
the standards set forth in 28 CFR part 36.


352.211-2  Conference sponsorship request and conference materials 
disclaimer.

    As prescribed in 311.7202, the Contracting Officer shall 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, prior to the Contractor claiming HHS conference 
sponsorship, the Contractor shall submit a written request 
(including rationale) to the Contracting Officer for permission to 
claim such HHS sponsorship.
    (b) Whether or not HHS is the conference sponsor, the Contractor 
shall include the following statement on conference materials, 
including promotional materials, agendas, and Web sites:
    ``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)


352.211-3  Paperwork Reduction Act.

    As prescribed in 311.7301, the Contracting Officer shall insert the 
following clause:

Paperwork Reduction Act (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)


352.215-70  Late proposals and revisions.

    As prescribed in 315.208, the Contracting Officer shall insert the 
following provision:

Late Proposals and Revisions (Date) Deviation

    Notwithstanding the procedures contained in FAR 52.215-1(c)(3) 
of the provision of this solicitation entitled Instructions to 
Offerors--Competitive Acquisition, the Government

[[Page 11295]]

may consider a proposal received after the date specified for 
receipt if it appears to offer significant cost or technical 
advantage to the Government and it was received before proposals 
were distributed for evaluation, or within 5 calendar days after the 
exact time specified for receipt, whichever is earlier.

(End of provision)


352.216-70  Additional cost principles.

    As prescribed in 316.307(a)(2), the Contracting Officer shall 
insert the following clause:

Additional Cost Principles (Date)

    (a) Bid and proposal (B&P) costs. (1) B&P costs are the 
immediate costs of preparing bids, proposals, and applications for 
potential Federal and non-Federal contracts, grants, and agreements, 
including the development of scientific, cost, and other data needed 
to support the bids, proposals, and applications.
    (2) B&P costs of the current accounting period are allowable as 
indirect costs.
    (3) B&P costs of past accounting periods are unallowable in the 
current period. However, if the organization's established practice 
is to treat these costs by some other method, they may be accepted 
if they are found to be reasonable and equitable.
    (4) B&P costs do not include independent research and 
development (IR&D) costs covered by the following paragraph, or pre-
award costs covered by paragraph 36 of Attachment B to OMB Circular 
A-122.
    (b) IR&D costs. (1) IR&D is research and development conducted 
by an organization which is not sponsored by Federal or non-Federal 
contracts, grants, or other agreements.
    (2) IR&D shall be allocated its proportionate share of indirect 
costs on the same basis as the allocation of indirect costs to 
sponsored research and development.
    (3) The cost of IR&D, including its proportionate share of 
indirect costs, is unallowable.

(End of clause)


352.219-70  Mentor-prot[eacute]g[eacute] program.

    As prescribed in 319.270-1(a), the Contracting Officer shall insert 
the following provision:

Mentor-Prot[eacute]g[eacute] Program (Date)

    (a) Large business prime contractors serving as mentors in the 
HHS Mentor-Prot[eacute]g[eacute] Program are eligible for HHS 
subcontracting plan credit, and shall submit a copy of their HHS 
Office of Small and Disadvantaged Business Utilization (OSDBU)-
approved mentor-prot[eacute]g[eacute] agreements as part of their 
offers. The amount of credit provided by the Contracting Officer to 
a mentor firm for prot[eacute]g[eacute] firm developmental 
assistance costs shall be calculated on a dollar for dollar basis 
and reported by the mentor firm in the Summary Subcontract Report 
via the Electronic Subcontracting Reporting System (eSRS) at 
www.esrs.gov. The mentor firm and prot[eacute]g[eacute] firm shall 
submit to the Contracting Officer a signed joint statement agreeing 
on the dollar value of the developmental assistance the mentor firm 
provided. (For example, a mentor firm would report a $10,000 
subcontract awarded to a prot[eacute]g[eacute] firm and provision of 
$5,000 of developmental assistance as $15,000 of subcontracting plan 
credit.) The mentor firm may use this additional credit towards 
attaining its subcontracting plan participation goal under this 
contract.
    (b) The program consists of--
    (1) Mentor firms--large businesses that:
    (i) Demonstrate the interest, commitment, and capability to 
provide developmental assistance to small business 
prot[eacute]g[eacute] firms; and
    (ii) Have a Mentor-Prot[eacute]g[eacute] agreement approved by 
HHS' OSDBU;
    (2) Prot[eacute]g[eacute] firms--firms that:
    (i) Seek developmental assistance;
    (ii) Qualify as small businesses, veteran-owned small 
businesses, service-disabled veteran-owned small businesses, HUBZone 
small businesses, small disadvantaged businesses, or woman-owned 
small businesses; and
    (iii) Have a Mentor-Prot[eacute]g[eacute] agreement approved by 
HHS' OSDBU; and
    (3) Mentor-Prot[eacute]g[eacute] agreements--joint agreements, 
approved by HHS' OSDBU, which detail the specific terms, conditions, 
and responsibilities of the mentor-prot[eacute]g[eacute] 
relationship.

(End of provision)


352.219-71  Mentor-prot[eacute]g[eacute] program reporting 
requirements.

    As prescribed in 319.270-1(b), the Contracting Officer shall insert 
the following clause:

Mentor-Prot[eacute]g[eacute] Program Reporting Requirements (January 
2010)

    The Contractor shall comply with all reporting requirements 
specified in its Mentor-Prot[eacute]g[eacute] agreement approved by 
HHS' OSDBU.

(End of clause)


352.222-70  Contractor cooperation in equal employment opportunity 
investigations.

    As prescribed in 322.810(h), the Contracting Officer shall insert 
the following clause:

Contractor Cooperation in Equal Employment Opportunity Investigations 
(Date)

    (a) 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 (Agency) in 
investigations of Equal Employment Opportunity (EEO) complaints 
processed pursuant to 29 CFR part 1614. For purposes of this clause, 
the following definitions apply:
    (1) Complaint means a formal or informal complaint that has been 
lodged with Agency management, Agency EEO officials, the Equal 
Employment Opportunity Commission (EEOC), or a court of competent 
jurisdiction.
    (2) 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 the Agency 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 complaint or 
investigation.
    (3) Good faith cooperation cited in paragraph (a) includes, but 
is not limited to, making Contractor employees available for:
    (i) Formal and informal interviews by EEO counselors or other 
Agency officials processing EEO complaints;
    (ii) Formal or informal interviews by EEO investigators charged 
with investigating complaints of unlawful discrimination filed by 
Federal employees;
    (iii) Reviewing and signing appropriate affidavits or 
declarations summarizing statements provided by such Contractor 
employees during the course of EEO investigations;
    (iv) Producing documents requested by EEO counselors, EEO 
investigators, Agency employees, or the EEOC in connection with a 
pending EEO complaint; and
    (v) Preparing for and providing testimony in depositions or in 
hearings before the MSPB, EEOC and U.S. District Court.
    (b) The Contractor shall include the provisions of this clause 
in all subcontract solicitations and subcontracts awarded at any 
tier under this contract.
    (c) 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.

(End of clause)


352.223-70  Safety and health.

    As prescribed in 323.7002, the Contracting Officer shall 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

[[Page 11296]]

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.html.
    (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 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)


352.223-71  Instructions to Offerors--Sustainable Acquisition.

    As prescribed in 323.7103, the Contracting Officer shall insert the 
following provision:

Instructions to Offerors--Sustainable Acquisition (Date)

    Offerors must 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 23.1, 
Sustainable Acquisition Policy (and other Federal laws, regulations 
and Executive Orders governing sustainable acquisition purchasing) 
to this 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)


352.224-70  Privacy Act.

    As prescribed in 324.105(a), the Contracting Officer shall insert 
the following clause:

Privacy Act (Date)

    This contract requires the Contractor to perform one or more of 
the following: (a) design; (b) develop; or (c) operate a Federal 
agency system of records to accomplish an agency function in 
accordance with the Privacy Act of 1974 (Act) (5 U.S.C. 552a(m)(1)) 
and applicable agency regulations.
    The term system of records means a group of any records under 
the control of any agency from which information is retrieved by the 
name of the individual or by some identifying number, symbol, or 
other identifying particular assigned to the individual. Violations 
of the Act by the Contractor and/or its employees may result in the 
imposition of criminal penalties (5 U.S.C. 552a(i)).
    The Contractor shall ensure that each of its employees knows the 
prescribed rules of conduct in 45 CFR part 5b and that each employee 
is aware that he/she is subject to criminal penalties for violation 
of the Act to the same extent as Department of Health and Human 
Services employees. These provisions also apply to all subcontracts 
the Contractor awards under this contract which require the design, 
development or operation of the designated system(s) of records (5 
U.S.C. 552a(m)(1)). The contract work statement:
    (a) Identifies the system(s) of records and the design, 
development, or operation work the Contractor is to perform; and
    (b) Specifies the disposition to be made of such records upon 
completion of contract performance.

(End of clause)


352.224-71   Confidential Information.

    As prescribed in 324.105(b), insert the following clause:

Confidential Information (Date)

    (a) Confidential Information, as used in this clause, means 
information or data of a personal nature about an individual, or 
proprietary information or data submitted by or pertaining to an 
institution or organization.
    (b) Specific information or categories of information that the 
Government will furnish to the contractor, or that the contractor is 
expected to generate, which are confidential may be identified 
elsewhere in this contract. The Contracting Officer may modify this 
contract to identify Confidential Information from time to time 
during performance.
    (c) Confidential Information or records shall not be disclosed 
by the Contractor until:
    (1) Written advance notice of at least 45 days shall be provided 
to the Contracting Officer of the Contractor's intent to release 
findings of studies or research, to which an agency response may be 
appropriate to protect the public interest or that of the agency.
    (2) For information provided by or on behalf of the government,
    (i) The publication or dissemination of the following types of 
information are restricted under this contract: [INSERT RESTRICTED 
TYPES OF INFORMATION. IF NONE, SO STATE.]
    (ii) The reason(s) for restricting the types of information 
identified in subparagraph (i) is/are: [STATE WHY THE PUBLIC OR 
GOVERNMENT INTEREST REQUIRES THE RESTRICTION OF EACH TYPE OF 
INFORMATION. ANY BASIS FOR NONDISCLOSURE WHICH WOULD BE VALID UNDER 
THE FREEDOM OF INFORMATION ACT IS SUFFICIENT UNDER THIS CLAUSE.]
    (iii) Written advance notice of at least 45 days shall be 
provided to the Contracting Officer of the Contractor's intent to 
disseminate or publish information identified in subparagraph 
(2)(i). The contractor shall not disseminate or publish such 
information without the written consent of the Contracting Officer.
    (d) Whenever the Contractor is uncertain with regard to the 
confidentiality of or a property interest in information under this 
contract, the Contractor should consult with the Contracting Officer 
prior to any release, disclosure, dissemination, or publication.

[[Page 11297]]

352.226-1  Indian Preference.

    As prescribed in 326.505(a), the Contracting Officer shall 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 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) of this clause, 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)


352.226-2  Indian Preference Program.

    As prescribed in 326.505(b), the Contracting Officer shall 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 Pub. L. 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;

[[Page 11298]]

    (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)


352.226-3  Native American Graves Protection and Repatriation Act.

    As prescribed in 326.701, the Contracting Officer shall 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--
    (i) Immediately cease activity in the area of the discovery;
    (ii) Notify the Contracting Officer of the discovery; and
    (iii) 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.


352.227-11  Patent Rights--Exceptional Circumstances.

Patent Rights--Exceptional Circumstances (Sept 2014)

    This clause applies to all Contractor and subcontractor (at all 
tiers) Subject Inventions.
    (a) Definitions. As used in this clause--
    Agency means the Agency of the U.S. Department of Health and 
Human Services that is entering into this contract.
    Class 1 Subject Invention means a Subject Invention described 
and defined in the 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) and implementing 
regulations of the Administrator of the Small Business 
Administration. For the purpose of this clause, the size standards 
for small business concerns involved in Government procurement and 
subcontracting at 13 CFR 121.3-8 and 13 CFR 121.3-12, respectively, 
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) 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 (b)(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

[[Page 11299]]

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 (December 2007) (incorporated herein by reference). 
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.
    (iii) Class 3 Subject Inventions shall be governed by FAR clause 
52.227-11, Patent Rights-Ownership by the Contractor (December 2007) 
(previously incorporated herein by reference).
    (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 (b)(1) of this clause in accordance with the procedures of 
FAR paragraph 27.304-1(c). In addition to the considerations set 
forth in paragraph 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.
    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 (c)(1) of this 
clause, or not later than 8 months thereafter, unless a longer 
period is authorized in writing by the Contracting Officer for good 
cause shown in writing by the Contractor. Each determination of 
greater rights under this contract shall be subject to paragraph (c) 
of the FAR clause at 52.227-13 (incorporated herein by reference), 
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.
    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.
    (c) Invention disclosure by Contractor. The Contractor shall 
disclose in writing each Subject Invention to the Agency 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. The disclosure to the Agency 
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.
    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.
    (d) 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 (b) 
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.
    (e) Subcontracts. (1) The Contractor will 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 as follows: 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 (c)(1)(ii) of FAR 
clause 52.227-13.
    (f) 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 subparagraph b.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.
    (g) 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

[[Page 11300]]

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 States or that under the circumstances domestic manufacture 
is not commercially feasible.
    (h) 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 (b)(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.
    (i) 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.
    (j) 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 Web site: https://www.iEdison.gov.
    Alternate I (Sept 2014). As prescribed in 327.303, the license 
to Class 2 inventions recited in 352.227-11(b)(2)(a) is as follows:
    [Insert description of license to Class 2 inventions]

(End of clause)


352.227-14  Rights in Data--Exceptional Circumstances.

    As prescribed in 327.409(b)(1), insert the following clause with 
any appropriate alternates:

Rights in Data--Exceptional Circumstances (Sept 2014)

    (a) Definitions. As used in this clause--Definitions may be 
added or modified in paragraph (a) as applicable.
    Computer database or database means a collection of recorded 
information in a form capable of, and for the purpose of, being 
stored in, processed, and operated on by a computer. The term does 
not include computer software.
    Computer software--(i) Means (A) Computer programs that comprise 
a series of instructions, rules, routines, or statements, regardless 
of the media in which recorded, that allow or cause a computer to 
perform a specific operation or series of operations; and
    (B) Recorded information comprising source code listings, design 
details, algorithms, processes, flow charts, formulas, and related 
material that would enable the computer program to be produced, 
created, or compiled.
    (ii) Does not include computer databases or computer software 
documentation.
    Computer software documentation means owner's manuals, user's 
manuals, installation instructions, operating instructions, and 
other similar items, regardless of storage medium, that explain the 
capabilities of the computer software or provide instructions for 
using the software.
    Data means recorded information, regardless of form or the media 
on which it may be recorded. The term includes technical data and 
computer software. The term does not include information incidental 
to contract administration, such as financial, administrative, cost 
or pricing, or management information.
    Form, fit, and function data means data relating to items, 
components, or processes that are sufficient to enable physical and 
functional interchangeability, and data identifying source, size, 
configuration, mating and attachment characteristics, functional 
characteristics, and performance requirements. For computer software 
it means data identifying source, functional characteristics, and 
performance requirements but specifically excludes the source code, 
algorithms, processes, formulas, and flow charts of the software.
    Limited rights means the rights of the Government in limited 
rights data as set forth in the Limited Rights Notice in Alternate 
II paragraph (g)(3) if included in this clause. ``Limited rights 
data'' means data, other than computer software, that embody trade 
secrets or are commercial or financial and confidential or 
privileged, to the extent that such data pertain to items, 
components, or processes developed at private expense, including 
minor modifications.
    Restricted computer software means computer software developed 
at private expense and that is a trade secret, is commercial or 
financial and confidential or privileged, or is copyrighted computer 
software, including minor modifications of the computer software.
    Restricted rights, as used in this clause, means the rights of 
the Government in restricted computer software, as set forth in a 
Restricted Rights Notice of Alternate III paragraph (g)(4) if 
included in this clause, or as otherwise may be provided in a 
collateral agreement incorporated in and made part of this contract, 
including minor modifications of such computer software.
    Technical data means recorded information (regardless of the 
form or method of the recording) of a scientific or technical nature 
(including computer databases and computer software documentation). 
This term does not include computer software or financial, 
administrative, cost or pricing, or management data or other 
information incidental to contract administration. The term includes 
recorded information of a scientific or technical nature that is 
included in computer databases (See 41 U.S.C. 403(8)).
    Unlimited rights means the rights of the Government to use, 
disclose, reproduce, prepare derivative works, distribute copies to 
the public, and perform publicly and display publicly, in any manner 
and for any purpose, and to have or permit others to do so.
    (b) Allocation of rights. (1) Except as provided in paragraph 
(c) of this clause, the Government shall have unlimited rights in--
    (i) Data first produced in the performance of this contract;
    (ii) Form, fit, and function data delivered under this contract;
    (iii) Data delivered under this contract (except for restricted 
computer software) that constitute manuals or instructional and 
training material for installation, operation, or routine 
maintenance and repair of items, components, or processes delivered 
or furnished for use under this contract; and
    (iv) All other data delivered under this contract unless 
provided otherwise for limited rights data or restricted computer 
software in accordance with paragraph (g) of this clause.
    (2) The Contractor shall have the right to--

[[Page 11301]]

    (i) Assert copyright in data first produced in the performance 
of this contract to the extent provided in paragraph (c)(1) of this 
clause;
    (ii) Use, release to others, reproduce, distribute, or publish 
any data first produced or specifically used by the Contractor in 
the performance of this contract, unless provided otherwise in 
paragraph (d) of this clause;
    (iii) Substantiate the use of, add, or correct limited rights, 
restricted rights, or copyright notices and to take other 
appropriate action, in accordance with paragraphs (e) and (f) of 
this clause; and
    (iv) Protect from unauthorized disclosure and use those data 
that are limited rights data or restricted computer software to the 
extent provided in paragraph (g) of this clause.
    (c) Copyright. (1) Data first produced in the performance of 
this contract. (i) Unless provided otherwise in paragraph (d) of 
this clause, the Contractor may, without prior approval of the 
Contracting Officer, assert copyright in scientific and technical 
articles based on or containing data first produced in the 
performance of this contract and published in academic, technical or 
professional journals, symposia proceedings, or similar works. The 
prior, express written permission of the Contracting Officer is 
required to assert copyright in all other data first produced in the 
performance of this contract.
    (ii) When authorized to assert copyright to the data, the 
Contractor shall affix the applicable copyright notices of 17 U.S.C. 
401 or 402, and an acknowledgment of Government sponsorship 
(including contract number).
    (iii) For data other than computer software, the Contractor 
grants to the Government and others acting on its behalf, a paid-up, 
nonexclusive, irrevocable, worldwide license in such copyrighted 
data to reproduce, prepare derivative works, distribute copies to 
the public, and perform publicly and display publicly by or on 
behalf of the Government. For computer software, the Contractor 
grants to the Government, and others acting on its behalf, a paid-
up, nonexclusive, irrevocable, worldwide license in such copyrighted 
computer software to reproduce, prepare derivative works, and 
perform publicly and display publicly (but not to distribute copies 
to the public) by or on behalf of the Government.
    (2) Data not first produced in the performance of this contract. 
The Contractor shall not, without the prior written permission of 
the Contracting Officer, incorporate in data delivered under this 
contract any data not first produced in the performance of this 
contract unless the Contractor--
    (i) Identifies the data; and
    (ii) Grants to the Government, or acquires on its behalf, a 
license of the same scope as set forth in paragraph (c)(1) of this 
clause or, if such data are restricted computer software, the 
Government shall acquire a copyright license as set forth in 
paragraph (g)(4) of this clause (if included in this contract) or as 
otherwise provided in a collateral agreement incorporated in or made 
part of this contract.
    (3) Removal of copyright notices. The Government will not remove 
any authorized copyright notices placed on data pursuant to this 
paragraph (c), and will include such notices on all reproductions of 
the data.
    (d) Release, publication, and use of data. The Contractor shall 
have the right to use, release to others, reproduce, distribute, or 
publish any data first produced or specifically used by the 
Contractor in the performance of this contract, except--
    (1) As prohibited by Federal law or regulation (e.g., export 
control or national security laws or regulations);
    (2) As expressly set forth in this contract; or
    (3) If the Contractor receives or is given access to data 
necessary for the performance of this contract that contain 
restrictive markings, the Contractor shall treat the data in 
accordance with such markings unless specifically authorized 
otherwise in writing by the Contracting Officer or in the following 
paragraphs.
    (4) 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 Clause 352.227-11, Patent 
Rights--Exceptional Circumstances (abbreviated month and year of 
Final Rule publication).
    (5) Data on Material(s). The Contractor agrees that in 
accordance with 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.
    (6) Confidentiality. (i) The Contractor shall take all 
reasonable precautions to maintain Confidential Information as 
confidential, but no less than the steps Contractor takes to secure 
its own confidential information.
    (ii) Contractor shall maintain Confidential Information as 
confidential unless specifically authorized otherwise in writing by 
the Contracting Officer. Confidential Information includes/does not 
include [Government may define confidential information here.]
    (e) Unauthorized marking of data. (1) Notwithstanding any other 
provisions of this contract concerning inspection or acceptance, if 
any data delivered under this contract are marked with the notices 
specified in paragraph (g)(3) or (4) of this clause (if those 
alternate paragraphs are included in this clause), and use of the 
notices is not authorized by this clause, or if the data bears any 
other restrictive or limiting markings not authorized by this 
contract, the Contracting Officer may cancel or ignore the markings. 
However, pursuant to 41 U.S.C. 253d, the following procedures shall 
apply prior to canceling or ignoring the markings.
    (i) The Contracting Officer will make written inquiry to the 
Contractor affording the Contractor 60 days from receipt of the 
inquiry to provide written justification to substantiate the 
propriety of the markings;
    (ii) If the Contractor fails to respond or fails to provide 
written justification to substantiate the propriety of the markings 
within the 60-day period (or a longer time approved in writing by 
the Contracting Officer for good cause shown), the Government shall 
have the right to cancel or ignore the markings at any time after 
said period and the data will no longer be made subject to any 
disclosure prohibitions.
    (iii) If the Contractor provides written justification to 
substantiate the propriety of the markings within the period set in 
paragraph (e)(1)(i) of this clause, the Contracting Officer will 
consider such written justification and determine whether or not the 
markings are to be cancelled or ignored. If the Contracting Officer 
determines that the markings are authorized, the Contractor will be 
so notified in writing. If the Contracting Officer determines, with 
concurrence of the head of the contracting activity, that the 
markings are not authorized, the Contracting Officer will furnish 
the Contractor a written determination, which determination will 
become the final Agency decision regarding the appropriateness of 
the markings unless the Contractor files suit in a court of 
competent jurisdiction within 90 days of receipt of the Contracting 
Officer's decision. The Government will continue to abide by the 
markings under this paragraph (e)(1)(iii) until final resolution of 
the matter either by the Contracting Officer's determination 
becoming final (in which instance the Government will thereafter 
have the right to cancel or ignore the markings at any time and the 
data will no longer be made subject to any disclosure prohibitions), 
or by final disposition of the matter by court decision if suit is 
filed.
    (2) The time limits in the procedures set forth in paragraph 
(e)(1) of this clause may be modified in accordance with Agency 
regulations implementing the Freedom of Information Act (5 U.S.C. 
552) if necessary to respond to a request there under.
    (3) Except to the extent the Government's action occurs as the 
result of final disposition of the matter by a court of competent 
jurisdiction, the Contractor is not precluded by this paragraph (e) 
from bringing a claim, in accordance with the Disputes clause of 
this contract, that may arise as the result of the Government 
removing or ignoring authorized markings on data delivered under 
this contract.
    (f) Omitted or incorrect markings. (1) Data delivered to the 
Government without any restrictive markings shall be deemed to have 
been furnished with unlimited rights. The Government is not liable 
for the disclosure, use, or reproduction of such data.
    (2) If the unmarked data has not been disclosed without 
restriction outside the Government, the Contractor may request, 
within 6 months (or a longer time approved

[[Page 11302]]

by the Contracting Officer in writing for good cause shown) after 
delivery of the data, permission to have authorized notices placed 
on the data at the Contractor's expense. The Contracting Officer may 
agree to do so if the Contractor--
    (i) Identifies the data to which the omitted notice is to be 
applied;
    (ii) Demonstrates that the omission of the notice was 
inadvertent;
    (iii) Establishes that the proposed notice is authorized; and
    (iv) Acknowledges that the Government has no liability for the 
disclosure, use, or reproduction of any data made prior to the 
addition of the notice or resulting from the omission of the notice.
    (3) If data has been marked with an incorrect notice, the 
Contracting Officer may--
    (i) Permit correction of the notice at the Contractor's expense 
if the Contractor identifies the data and demonstrates that the 
correct notice is authorized; or
    (ii) Correct any incorrect notices.
    (g) Protection of limited rights data and restricted computer 
software. (1) The Contractor may withhold from delivery qualifying 
limited rights data or restricted computer software that are not 
data identified in paragraphs (b)(1)(i) through (iii) of this 
clause. As a condition to this withholding, the Contractor shall--
    (i) Identify the data being withheld; and
    (ii) Furnish form, fit, and function data instead.
    (2) Limited rights data that are formatted as a computer 
database for delivery to the Government shall be treated as limited 
rights data and not restricted computer software.
    (3) [Reserved]
    (h) Subcontracting. The Contractor shall obtain from its 
subcontractors all data and rights therein necessary to fulfill the 
Contractor's obligations to the Government under this contract. If a 
subcontractor refuses to accept terms affording the Government those 
rights, the Contractor shall promptly notify the Contracting Officer 
of the refusal and shall not proceed with the subcontract award 
without authorization in writing from the Contracting Officer.
    (i) Relationship to patents or other rights. Nothing contained 
in this clause shall imply a license to the Government under any 
patent or be construed as affecting the scope of any license or 
other right otherwise granted to the Government.

(End of clause)

    Alternate I (Sept 2014). As prescribed in 327.409, substitute 
the following definition for ``limited rights data'' in paragraph 
(a) of the basic clause:
    Limited rights data means data, other than computer software, 
developed at private expense that embody trade secrets or are 
commercial or financial and confidential or privileged.
    Alternate II (Sept 2014). As prescribed in 327.409, insert the 
following paragraph (g)(3) in the basic clause:
    (g)(3) Notwithstanding paragraph (g)(1) of this clause, the 
contract may identify and specify the delivery of limited rights 
data, or the Contracting Officer may require by written request the 
delivery of limited rights data that has been withheld or would 
otherwise be entitled to be withheld. If delivery of that data is 
required, the Contractor shall affix the following ``Limited Rights 
Notice'' to the data and the Government will treat the data, subject 
to the provisions of paragraphs (e) and (f) of this clause, in 
accordance with the notice:

Limited Rights Notice (Sept 2014)

    (a) These data are submitted with limited rights under 
Government Contract No. __(and subcontract __, if appropriate). 
These data may be reproduced and used by the Government with the 
express limitation that they will not, without written permission of 
the Contractor, be used for purposes of manufacture nor disclosed 
outside the Government; except that the Government may disclose 
these data outside the Government for the following purposes, if 
any; provided that the Government makes such disclosure subject to 
prohibition against further use and disclosure: Agencies may list 
additional purposes or if none, so state.
    (b) This notice shall be marked on any reproduction of these 
data, in whole or in part.

(End of notice)

    Alternate III (Sept 2014). As prescribed in 327.409, insert the 
following paragraph (g)(4) in the basic clause: (g)(4)(i) 
Notwithstanding paragraph (g)(1) of this clause, the contract may 
identify and specify the delivery of restricted computer software, 
or the Contracting Officer may require by written request the 
delivery of restricted computer software that has been withheld or 
would otherwise be entitled to be withheld. If delivery of that 
computer software is required, the Contractor shall affix the 
following ``Restricted Rights Notice'' to the computer software and 
the Government will treat the computer software, subject to 
paragraphs (e) and (f) of this clause, in accordance with the 
notice:

Restricted Rights Notice (Sept 2014)

    (a) This computer software is submitted with restricted rights 
under Government Contract No. ____ (and subcontract ____, if 
appropriate). It may not be used, reproduced, or disclosed by the 
Government except as provided in paragraph (b) of this notice or as 
otherwise expressly stated in the contract.
    (b) This computer software may be--
    (1) Used or copied for use with the computer(s) for which it was 
acquired, including use at any Government installation to which the 
computer(s) may be transferred;
    (2) Used or copied for use with a backup computer if any 
computer for which it was acquired is inoperative;
    (3) Reproduced for safekeeping (archives) or backup purposes;
    (4) Modified, adapted, or combined with other computer software, 
provided that the modified, adapted, or combined portions of the 
derivative software incorporating any of the delivered, restricted 
computer software shall be subject to the same restricted rights;
    (5) Disclosed to and reproduced for use by support service 
Contractors or their subcontractors in accordance with paragraphs 
(b)(1) through (4) of this notice; and
    (6) Used or copied for use with a replacement computer.
    (c) Notwithstanding the foregoing, if this computer software is 
copyrighted computer software, it is licensed to the Government with 
the minimum rights set forth in paragraph (b) of this notice.
    (d) Any other rights or limitations regarding the use, 
duplication, or disclosure of this computer software are to be 
expressly stated in, or incorporated in, the contract.
    (e) This notice shall be marked on any reproduction of this 
computer software, in whole or in part.

(End of notice)

    (ii) Where it is impractical to include the Restricted Rights 
Notice on restricted computer software, the following short-form 
notice may be used instead:

Restricted Rights Notice Short Form (Sept 2014)

    Use, reproduction, or disclosure is subject to restrictions set 
forth in Contract No. __ (and subcontract, if appropriate) with __ 
(name of Contractor and subcontractor).

(End of notice)

    (iii) If restricted computer software is delivered with the 
copyright notice of 17 U.S.C. 401, it will be presumed to be 
licensed to the Government without disclosure prohibitions, with the 
minimum rights set forth in paragraph (b) of this clause.
    Alternate IV (Sept 2014). As prescribed in 327.409, substitute 
the following paragraph (c)(1) for paragraph (c)(1) of the basic 
clause:
    (c) Copyright--(1) Data first produced in the performance of the 
contract. Except as otherwise specifically provided in this 
contract, the Contractor may assert copyright in any data first 
produced in the performance of this contract. When asserting 
copyright, the Contractor shall affix the applicable copyright 
notice of 17 U.S.C. 401 or 402, and an acknowledgment of Government 
sponsorship (including contract number), to the data when such data 
are delivered to the Government, as well as when the data are 
published or deposited for registration as a published work in the 
U.S. Copyright Office. For data other than computer software, the 
Contractor grants to the Government, and others acting on its 
behalf, a paid-up, nonexclusive, irrevocable, worldwide license for 
all such data to reproduce, prepare derivative works, distribute 
copies to the public, and perform publicly and display publicly, by 
or on behalf of the Government. For computer software, the 
Contractor grants to the Government and others acting on its behalf, 
a paid-up, nonexclusive, irrevocable, worldwide license for all such 
computer software to reproduce, prepare derivative works, and 
perform publicly and display publicly (but not to distribute copies 
to the public), by or on behalf of the Government.
    Alternate V (Sept 2014). As prescribed in 327.409, add the 
following paragraph (j) to the basic clause:
    (j) The Contractor agrees, except as may be otherwise specified 
in this contract for specific data deliverables listed as not 
subject to this paragraph, that the Contracting Officer may, up to 3 
years after acceptance of all deliverables under this contract, 
inspect at

[[Page 11303]]

the Contractor's facility any data withheld pursuant to paragraph 
(g)(1) of this clause, for purposes of verifying the Contractor's 
assertion of limited rights or restricted rights status of the data 
or for evaluating work performance. When the Contractor whose data 
are to be inspected demonstrates to the Contracting Officer that 
there would be a possible conflict of interest if a particular 
representative made the inspection, the Contracting Officer shall 
designate an alternate inspector.

(End of clause)

352.227-70   Publications and publicity.

    As prescribed in 327.404-70(a), the Contracting Officer shall 
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 a copy of each article submitted for 
publication to the Contracting Officer's Representative. The 
Contractor shall also inform the Contracting Officer's 
Representative when the article or other publication is published, 
and furnish a copy of it as finally published.
    (b) Unless authorized in writing by the Contracting Officer, the 
Contractor shall not display the HHS logo including 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 commercial 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, including this 
section (d) in all subcontracts where the subcontractor may propose 
publishing the results of its work under the subcontract.

(End of clause)

352.231-70   Salary rate limitation.

    As prescribed in 331.101-70(b), the Contracting Officer shall 
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 funding was 
obligated.
    (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) See the salaries and wages pay tables on the Office of 
Personnel Management Web site for Federal Executive Schedule salary 
levels.

(End of clause)

352.232-70   Incremental Funding.

    As prescribed in 332.706-2(b), the Contracting Officer shall insert 
the provision provided below in all solicitations when a cost-
reimbursement contract for severable services using incremental funding 
is contemplated.

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)

352.233-70   Choice of law (overseas).

    As prescribed in 333.215-70(a), the Contracting Officer shall 
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), the Contracting Officer shall 
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), the Contracting Officer shall 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:

[[Page 11304]]

    (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 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. If none 
stated, the amount is four (4) percent) 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 2 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.

(End of clause)

352.237-70  Pro-Children Act.

    As prescribed in 337.103-70(d)(1), the Contracting Officer shall 
insert the following clause:

[[Page 11305]]

Pro-Children Act (Date)

    (a) Public Law 103-227, Title X, Part C, also known as the Pro-
Children Act of 1994 (Act), 20 U.S.C. 7183, imposes restrictions on 
smoking in facilities where certain federally funded children's 
services are provided. The Act prohibits smoking within any indoor 
facility (or portion thereof), whether owned, leased, or contracted 
for, that is used for the routine or regular provision of: (i) 
Kindergarten, elementary, or secondary education or library services 
or (ii) health or day care services that are provided to children 
under the age of 18. The statutory prohibition also applies to 
indoor facilities that are constructed, operated, or maintained with 
Federal funds.
    (b) By acceptance of this contract or order, the Contractor 
agrees to comply with the requirements of the Act. The Act also 
applies to all subcontracts awarded under this contract for the 
specified children's services. 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. 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. Each day a violation continues 
constitutes a separate violation.


352.237-71  Crime Control Act--Reporting of Child Abuse.

    As prescribed in 337.103-70(d)(2), the Contracting Officer shall 
insert the following clause:

Crime Control Act of 1990--Reporting of Child Abuse (Date)

    (a) Public Law 101-647, also known as the Crime Control Act of 
1990 (Act), imposes responsibilities on certain individuals 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.
    (b) The Act designates ``covered professionals'' as 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. The Act defines the term ``child abuse'' 
as the physical or mental injury, sexual abuse or exploitation, or 
negligent treatment of a child.
    (c) 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, the Childhelp USA, National 
Child Abuse Hotline (1-800-4-A-CHILD) shall be called. Any covered 
professional failing to make a timely report of such incident shall 
be guilty of a Class B misdemeanor.
    (d) By acceptance of this contract or order, 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.

(End of clause)


352.237-72  Crime Control Act--Requirement for Background Checks.

    As prescribed in 337.103-70(d)(3), the Contracting Officer shall 
insert the following clause:

Crime Control Act of 1990--Requirement for Background Checks (Date)

    (a) Public Law 101-647, also known as the Crime Control Act of 
1990 (Act), requires that all individuals involved with the 
provision of child care services to children under the age of 18 
undergo a criminal background check. ``Child care services'' 
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. 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 of the services listed above.
    (b) 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.
    (c) By acceptance of this contract or order, 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.

(End of clause)


352.237-73  Indian Child Protection and Family Violence Act.

    As prescribed in 337.103-(d)(4) the Contracting Officer shall 
insert the following clause:

Indian Child Protection and Family Violence Act (Date)

    (a) This contract is subject to the Indian Child Protection and 
Family Violence Act, Pub. L. 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. Pub. L. 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. The contractor will be subject to a character 
investigation, conducted by the Indian Health Service, Office of 
Human Resources. Until such time as the contractor has been notified 
of completion of the investigation, the contractor shall have no 
unsupervised contact with Indian children. In order to initiate this 
background investigation, the contractor must provide information as 
required in this contract or as directed by the Contracting Officer.
    (b) 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.

(End of clause)


352.237-74  Non-Discrimination in Service Delivery.

    As prescribed in 337.103-70(e), the Contracting Officer shall 
insert the following clause in solicitations and contracts:

Non-Discrimination in Service Delivery (Date)

    It is the policy of the Department of Health and Human Services 
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). By acceptance of this contract, the contractor 
agrees to comply with this policy in supporting the program and in 
performing the services called for under this contract. The 
contractor shall include this clause in all sub-contracts awarded 
under this contract for supporting or performing the specified 
program and services. Accordingly, the contractor shall ensure that 
each of its employees, and any sub-contractor staff, is made aware 
of, understands, and complies with this policy.

(End of clause)


352.237-75  Key Personnel.

    As prescribed in 337.103(f), the Contracting Officer shall insert 
the following clause:

Key Personnel (Date)

    The key personnel specified in this contract are considered to 
be essential to work performance. 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 shall submit a justification for the 
diversion or replacement and a request to replace the individual. 
The request must identify the proposed replacement and provide an 
explanation of

[[Page 11306]]

how the replacement's skills, experience, and credentials meet or 
exceed the requirements of the contract (including, when applicable, 
Human Subjects Testing requirements). If the employee of the 
contractor is terminated for cause or separates from the contractor 
voluntarily with less than thirty days notice, the Contractor shall 
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 will be modified to add or delete key 
personnel as necessary to reflect the agreement of the parties.

(End of clause)


352.239-73  Electronic Information and Technology Accessibility Notice.

    (a) As prescribed in 339.203-70(a), the Contracting Officer shall 
insert the following provision:

Electronic and Information Technology Accessibility Notice (Date)

    (a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 
794d), as amended by the Workforce Investment Act of 1998 and the 
Architectural and Transportation Barriers Compliance Board 
Electronic and Information (EIT) Accessibility Standards (36 CFR 
part 1194), require that when Federal agencies develop, procure, 
maintain, or use electronic and information technology, Federal 
employees with disabilities have access to and use of information 
and data that is comparable to the access and use by Federal 
employees who are not individuals with disabilities, unless an undue 
burden would be imposed on the agency. Section 508 also requires 
that individuals with disabilities, who are members of the public 
seeking information or services from a Federal agency, have access 
to and use of information and data that is comparable to that 
provided to the public who are not individuals with disabilities, 
unless an undue burden would be imposed on the agency.
    (b) Accordingly, any offeror responding to this solicitation 
must comply with established HHS EIT accessibility standards. 
Information about Section 508 is available at https://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can 
be accessed at https://www.access-board.gov/sec508/standards.htm.
    (c) The Section 508 accessibility standards applicable to this 
solicitation are stated in the clause at 352.239-74, Electronic and 
Information Technology Accessibility.
    In order to facilitate the Government's determination whether 
proposed EIT supplies meet applicable Section 508 accessibility 
standards, offerors must submit an HHS Section 508 Product 
Assessment Template, in accordance with its completion instructions. 
The purpose of the template is to assist HHS acquisition and program 
officials in determining whether proposed EIT supplies conform to 
applicable Section 508 accessibility standards. The template allows 
offerors or developers to self-evaluate their supplies and 
document--in detail--whether they conform to a specific Section 508 
accessibility standard, and any underway remediation efforts 
addressing conformance issues. Instructions for preparing the HHS 
Section 508 Evaluation Template are available under Section 508 
policy on the HHS Web site https://hhs.gov/web/508.
    In order to facilitate the Government's determination whether 
proposed EIT services meet applicable Section 508 accessibility 
standards, offerors must provide enough information to assist the 
Government in determining that the EIT services conform to Section 
508 accessibility standards, including any underway remediation 
efforts addressing conformance issues.
    (d) Respondents to this solicitation must identify any exception 
to Section 508 requirements. If a offeror claims its supplies or 
services meet applicable Section 508 accessibility standards, and it 
is later determined by the Government, i.e., after award of a 
contract or order, that supplies or services delivered do not 
conform to the described accessibility standards, remediation of the 
supplies or services to the level of conformance specified in the 
contract will be the responsibility of the Contractor at its 
expense.

(End of provision)


352.239-74  Electronic and Information Technology Accessibility.

    As prescribed in 339.203-70(b), insert the following clause:

Electronic and Information Technology Accessibility (Date)

    (a) Pursuant to Section 508 of the Rehabilitation Act of 1973 
(29 U.S.C. 794d), as amended by the Workforce Investment Act of 
1998, all electronic and information technology (EIT) supplies and 
services developed, acquired, or maintained under this contract or 
order must comply with the ``Architectural and Transportation 
Barriers Compliance Board Electronic and Information Technology 
(EIT) Accessibility Standards'' set forth by the Architectural and 
Transportation Barriers Compliance Board (also referred to as the 
``Access Board'') in 36 CFR part 1194. Information about Section 508 
is available at https://www.hhs.gov/web/508. The complete text of 
Section 508 Final Provisions can be accessed at https://www.access-board.gov/sec508/standards.htm.
    (b) The Section 508 accessibility standards applicable to this 
contract or order are identified in the Statement of Work or 
Specification or Performance Work Statement. The contractor must 
provide any necessary updates to the submitted HHS Product 
Assessment Template(s) at the end of each contract or order 
exceeding the simplified acquisition threshold (see FAR 2.101) when 
the contract or order duration is one year or less. If it is 
determined by the Government that EIT supplies and services provided 
by the Contractor do not conform to the described accessibility 
standards in the contract, remediation of the supplies or services 
to the level of conformance specified in the contract will be the 
responsibility of the Contractor at its own expense.
    (c) The Section 508 accessibility standards applicable to this 
contract are:
-----------------------------------------------------------------------
    (Contract staff must list applicable standards)
    (d) In the event of a modification(s) to this contract or order, 
which adds new EIT supplies or services or revises the type of, or 
specifications for, supplies or services, the Contracting Officer 
may require that the contractor submit a completed HHS Section 508 
Product Assessment Template and any other additional information 
necessary to assist the Government in determining that the EIT 
supplies or services conform to Section 508 accessibility standards. 
Instructions for documenting accessibility via the HHS Section 508 
Product Assessment Template may be found under Section 508 policy on 
the HHS Web site: (https://hhs.gov/web/508). If it is determined by 
the Government that EIT supplies and services provided by the 
Contractor do not conform to the described accessibility standards 
in the contract, remediation of the supplies or services to the 
level of conformance specified in the contract will be the 
responsibility of the Contractor at its own expense.
    (e) If this is an Indefinite Delivery contract, a Blanket 
Purchase Agreement or a Basic Ordering Agreement, the task/delivery 
order requests that include EIT supplies or services will define the 
specifications and accessibility standards for the order. In those 
cases, the Contractor may be required to provide a completed HHS 
Section 508 Product Assessment Template and any other additional 
information necessary to assist the Government in determining that 
the EIT supplies or services conform to Section 508 accessibility 
standards. Instructions for documenting accessibility via the HHS 
Section 508 Product Assessment Template may be found at https://hhs.gov/web/508. If it is determined by the Government that EIT 
supplies and services provided by the Contractor do not conform to 
the described accessibility standards in the provided documentation, 
remediation of the supplies or services to the level of conformance 
specified in the contract will be the responsibility of the 
Contractor at its own expense.

(End of clause)


352.270-1  [Reserved]


352.270-2  [Reserved]


352.270-3  [Reserved]


352.270-4a  Notice to Offerors, Protection of Human Subjects.

    (a) As prescribed in 370.303(a), the Contracting Officer shall 
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) 
Web site at: https://www.hhs.gov/ohrp/.
    These regulations provide a systematic means, based on 
established ethical principles, to safeguard the rights and

[[Page 11307]]

welfare of human subjects participating in research activities 
supported or conducted by HHS.
    (b) The regulations define a human subject as a living 
individual about whom an investigator (whether professional or 
student) conducting research obtains data or identifiable public 
information through intervention or interaction with the individual, 
or identifiable private information. 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 46.101(b)(1)-(6) 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 https://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.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 Web site (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 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.

(End of provision)

    Alternate I (DATE). As prescribed in 370.303(a), the Contracting 
Officer shall substitute the following paragraph (g) for paragraph 
(g) of the basic clause.
    (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. 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.
    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.


352.270-4b  Protection of Human Subjects.

    (b) As prescribed in 370.304(a), the Contracting Officer shall 
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 Web 
site at: https://www.hhs.gov/ohrp/policy/guidanceonalternativetofwa.pdf).
    (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)


352.270-5a  Notice to Offerors of Requirement for Compliance with the 
Public Health Service Policy on Humane Care and Use of Laboratory 
Animals.

    As prescribed in 370.403(a), the Contracting Officer shall insert 
the following provision:

Notice to Offerors of Requirement for Compliance With the Public Health 
Service Policy on Humane Care and Use of Laboratory Animals (Date)

    The Public Health Service (PHS) Policy on Humane Care and Use of 
Laboratory Animals (PHS Policy) establishes a number of requirements 
for research activities involving animals. Before awarding a 
contract to an offeror, the organization shall file, with the Office 
of Laboratory Animal Welfare (OLAW), National Institutes of Health 
(NIH), a written Animal Welfare Assurance (Assurance) which commits 
the organization 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). In 
accordance with the PHS Policy, offerors must establish an 
Institutional Animal Care and Use Committee (IACUC), qualified 
through the experience and expertise of its members, to oversee the 
institution's animal program, facilities, and procedures. Offerors 
must provide verification of IACUC approval prior to receiving an 
award involving live vertebrate animals. No award involving the use 
of animals shall be made unless OLAW approves the Assurance and 
verification of IACUC approval for the proposed animal activities 
has been provided to the

[[Page 11308]]

Contracting Officer. Prior to award, the Contracting Officer will 
notify Contractor(s) selected for projects involving live vertebrate 
animals of the Assurance and verification of IACUC approval 
requirement. The Contracting Officer will request that OLAW 
negotiate an acceptable Assurance with those Contractor(s) and 
request verification of IACUC approval. For further information, 
contact OLAW at NIH, 6705 Rockledge Drive, RKL1, Suite 360, MSC 7982 
Bethesda, Maryland 20892-7982 (Email: olaw@od.nih.gov; Phone: 301-
496-7163).

(End of provision)


352.270-5b  Care of Live Vertebrate Animals.

    As prescribed in 370.404, the Contracting Officer shall insert the 
following clause:

Care of Live Vertebrate Animals (Date)

    (a) Before undertaking 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 CFRs 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 CFRs 2.1-2.11, or from a source that is 
exempt from licensing under those sections.
    (c) The Contractor agrees that the care, use, and intended use 
of any live vertebrate animals in the performance of this contract 
shall conform with the Public Health Service (PHS) Policy on Humane 
Care of Use of Laboratory Animals (PHS Policy), the current Animal 
Welfare Assurance (Assurance), the Guide for the Care and Use of 
Laboratory Animals (National Academy Press, Washington, DC) and the 
pertinent laws and regulations of the United States Department of 
Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR subchapter A, Parts 
1-4). In case of conflict between 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 (OLAW), National Institutes of Health 
(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 and further payments under this contract until the 
Contractor corrects the noncompliance. Notice of the suspension may 
be communicated by telephone and confirmed 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, in consultation with OLAW, 
NIH, terminate this contract in whole or in part, and the 
Contractor's name may be removed from the list of those contractors 
with Animal Welfare Assurances.
    Note: 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; Web site: (https://www.aphis.usda.gov/animal_welfare).

(End of clause)


352.270-6  Restriction on Use of Human Subjects.

    As prescribed in 370-304(b), the Contracting Officer shall insert 
the following clause:

Restriction on Use of Human Subjects (Date)

    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 (IRB)registered with 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)


352.270-7  [Reserved]


352.270-8  [Reserved]


352.270-9  Non-Discrimination for Conscience.

    As prescribed in 370.701, the Contracting Officer shall 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, 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 subparagraph (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)


352.270-10  Notice to Offerors--Protection of Human Subjects, Research 
Involving Human Subjects Committee (RIHSC) Approval of Research 
Protocols Required.

    As prescribed in 370.303(d), the Contracting Officer shall 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 provisions at HHSAR 352.270-4a.
    (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

[[Page 11309]]

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)


352.270-11  Protection of Human Subjects--Research Involving Human 
Subjects Committee (RIHSC) Approval of Research Protocols Required.

    As prescribed in 370.304(c), the Contracting Officer shall 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 352.270-4b.
    (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)


352.270-12  Needle Exchange.

    As prescribed in 370.304(d), the Contracting Officer shall 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)


352.270-13  Continued Ban on Funding Abortion and Continued Ban on 
Funding of Human Embryo Research.

    As prescribed in 370.304(e), the Contracting Officer shall 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)).
    The term ``human embryo or embryos'' includes any organism, not 
protected as a human subject under 45 CFR 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.
    (c) The Contractor shall not use any Federal funds for the 
cloning of human beings.

(End of Clause)

PART 353--FORMS

Subpart 353.3--[Reserved]

SUBCHAPTERS I, J, K AND L--[RESERVED]

SUBCHAPTER M--HHS SUPPLEMENTATIONS

PART 370--SPECIAL PROGRAMS AFFECTING ACQUISITION

Subpart 370.1--[Reserved]

Subpart 370.2--[Reserved]

Subpart 370.3--Acquisitions Involving Human Subjects
Sec.
370.300 Scope of subpart.
370.301 Policy.
370.302 Federal-wide Assurance (FWA).
370.303 Notice to offerors.
370.304 Contract clauses.
Subpart 370.4--Acquisitions Involving the Use of Laboratory Animals
370.400 Scope of subpart.
370.401 Policy.
370.402 Assurances.
370.403 Notice to offerors.
370.404 Contract clause.

[[Page 11310]]

Subpart 370.5--[Reserved]
Subpart 370.6--[Reserved]
Subpart 370.7--Acquisitions Under the Leadership Act
370.700 Scope of subpart.
370.701 Contract clause.
370.702 Solicitation provision.

    Authority:  5 U.S.C. 301; 40 U.S.C. 121(c)(2).

Subpart 370.3--Acquisitions Involving Human Subjects


370.300  Scope of subpart.

    This subpart applies to all research activities conducted under 
contracts involving human subjects. See 45 CFR 46.102(d) and (f).


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. The contracting officer shall require a Federal-wide 
assurance (FWA), 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 (FWA).

    (a) OHRP-Approved FWAs are found at the following Web site: 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 Web site 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 insert the provision at 352.270-
4a, 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) 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 370.303(b).
    (d) For the Food and Drug Administration (FDA), the contracting 
officer shall insert the provision at 352.270-10, 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.


370.304  Contract clauses.

    (a) The contracting officer shall insert the clause at 352.270-4b, 
Protection of Human Subjects, in solicitations, contracts and orders 
involving human subjects.
    (b) The contracting officer shall insert the clause at 352.270-6, 
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.
    (c) For FDA, the contracting officer shall insert the clause at 
352.270-11, 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.
    (d) The contracting officer shall insert the clause at 352.270-12, 
Needle Exchange, in solicitations, contracts, and orders involving 
human subjects.
    (e) The contracting officer shall insert the clause at 352.270-13, 
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 all research, research training, biological 
testing, housing and maintenance, and other activities involving live 
vertebrate animals conducted under contract. Additional information can 
be found in Public Health Service (PHS) Policy on Humane Care and Use 
of Laboratory Animals https://grants.nih.gov/grants/olaw/references/phspolicylabanimals.pdf.


370.401  Policy.

    (a) It is HHS policy that contracting activities shall not award a 
contract involving live vertebrate animals until the Contractor 
provides acceptable assurance the contract work is subject to initial 
and continuing review by an appropriate Institutional Animal Care and 
Use Committee (IACUC) as described in the PHS Policy at IV.B.6 and 7. 
The contracting officer shall require an applicable Animal Welfare 
Assurance approved by the Office of Laboratory Animal Welfare (OLAW), 
National Institutes of Health (NIH), of each contractor, subcontractor, 
or institution having responsibility for animal care and use involved 
in performance of the contract. Normally the assurance shall be 
approved before

[[Page 11311]]

award. The contracting officer, on a case-by-case basis, may make award 
without an approved assurance in consultation with OLAW. For additional 
information see PHS Policy II., IV.A, and V.B.
    (b) The OLAW, NIH, is responsible for negotiating assurances 
covering all HHS/PHS-supported or HHS/PHS-conducted activities 
involving the care and use of live vertebrate animals. OLAW shall 
provide guidance to contracting officers regarding adequate animal care 
and use, approval, disapproval, restriction, or withdrawal of approval 
of assurances. For additional information see PHS Policy V.A.
    (c) If using live vertebrate animals, HHS policy requires that 
offerors address the points in the Vertebrate Animal Section (VAS) of 
the Technical Proposal. Each of the points must be addressed in the VAS 
portion of the Technical Proposal. For additional information see PHS 
Policy and use Contract Proposal VAS Worksheet. https://grants.nih.gov/grants/olaw/references/phspol.htm#InformationRequiredinApplications-ProposalsforAwardsSubmittedtoPHS and https://grants.nih.gov/grants/olaw/VAScontracts.pdf.


370.402  Assurances.

    (a) Animal Welfare Assurances may be one of three types:
    (1) Domestic Assurance (DA). A DA describes the institution's 
animal care and use program, including but not limited to the lines of 
authority and responsibility, veterinary care, IACUC composition and 
procedures, occupational health and safety, training, facilities, and 
species housed. A DA listed in OLAW's list of institutions with an 
approved DA is acceptable for purposes of this policy.
    (2) Inter-institutional Assurance (IA). The offeror, its proposed 
subcontractor, or institution shall submit an IA when it does not have 
a proprietary animal care and use program, facilities to house animals 
or IACUC, and does not conduct animal research on-site. The offeror 
will perform the animal activity at an institution with an Animal 
Welfare Assurance named as a performance site. An IA approval extends 
to the full period of contract performance (up to 5 years) limited to 
the specific award or single project.
    (3) Foreign Assurance (FA). The Foreign Assurance is required for 
institutions outside the U.S. that receive PHS funds directly through a 
contract award. The Foreign Assurance also applies to institutions 
outside the U.S. that receive PHS funds indirectly (named as a 
performance site). An FA listed in OLAW's list of institutions with an 
approved FA is acceptable for purposes of this policy.
    (b) The contracting officer shall forward copies of proposals 
selected for negotiation and requiring an assurance to 
OLAW_at_olawdoa@od.nih.gov, as early as possible to secure the 
necessary assurances.
    (c) A contractor providing animal care services at an institution 
with an Animal Welfare Assurance, such as a Government-owned, 
Contractor-operated (GOCO) site, does not need a separate assurance. 
GOCO site assurances normally cover such contractor services.


370.403  Notice to offerors.

    (a) The contracting officer shall insert the provision at 352.270-
5a, Notice to Offerors of Requirement for Compliance with the Public 
Health Service Policy on Humane Care and Use of Laboratory Animals, in 
solicitations involving live vertebrate animals.
    (b) Offerors having a DA on file with OLAW shall submit IACUC 
approval of the use of animals in the manner required by the 
solicitation, but prior to award. The date of IACUC approval must not 
be more than 36 months prior to award.
    (c) It is not necessary for offerors lacking an Animal Welfare 
Assurance to submit assurances or IACUC approval with proposals. OLAW 
shall contact contractors, subcontractors, and institutions to 
negotiate necessary assurances and verify IACUC approvals when 
requested by the contracting officer.


370.404  Contract clause.

    The contracting officer shall insert the clause at 352.270-5b, Care 
of Live Vertebrate Animals, in solicitations, contracts, and orders 
that involve live vertebrate animals.

Subpart 370.5--[Reserved]

Subpart 370.6--[Reserved]

Subpart 370.7--Acquisitions Under the Leadership Act


370.700  Scope of subpart.

    This subpart sets forth the acquisition requirements regarding 
implementation of Human Immunodeficiency Virus/Acquired Immune 
Deficiency Syndrome (HIV/AIDS) programs under the President's Emergency 
Plan for AIDS Relief 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).


370.701  Solicitation provision.

    The contracting officer shall insert the provision at 352.270-9, 
Non-discrimination for Conscience, in solicitations valued at more than 
the micro-purchase threshold:
    (a) In connection with the implementation of HIV/AIDS programs 
under the President's Emergency Plan for AIDS Relief established by the 
United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act 
of 2003, as amended; or
    (b) Where the contractor will receive funding under the United 
States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 
2003, as amended. In resolving any issues or complaints that offerors 
may raise regarding meeting the requirements specified in the 
provision, the contracting officer shall consult with the Office of 
Global Health Affairs, Office of the General Counsel, the Program 
Manager, and other HHS officials, as appropriate.

[FR Doc. 2015-03391 Filed 2-27-15; 8:45 am]
BILLING CODE 4150-28-P