Tribal Self-Governance Negotiation Cooperative Agreement Program, 26569-26577 [2023-09097]

Download as PDF Federal Register / Vol. 88, No. 83 / Monday, May 1, 2023 / Notices comment. FDA is not seeking comment on the content of Chapter 1. Chapter 2 in this document is the first new Chapter, which provides draft designs of data elements and terminologies, in some cases new and in other cases updated from Chapter 1, associated with PQ/CMC subject areas and concepts and scoped to some of what is currently submitted in Module 3 of the eCTD submission. Since the data elements and terminologies in Chapter 2 are new and/ or updated, review of Chapter 1, solely as a reference, is highly recommended. After publication of this notice with Chapter 2 of the PQ/CMC Data Elements and Terminologies document, subsequent Chapters will be posted on FDA’s PQ/CMC web page (https:// www.fda.gov/industry/fda-datastandards-advisory-board/ pharmaceutical-qualitychemistrymanufacturing-controls-pqcmc). Public comments, specifying to which Chapter the comments are submitted, can be made to the open docket. Comments may be submitted to this docket at any time, but comments should be submitted on new Chapters within 60 days of being posted on FDA’s PQ/CMC web page to ensure that the Agency considers your comment before it begins work on the final version of the Chapter. FDA will aim to provide a new Chapter of the PQ/CMC Data Elements and Terminologies periodically. FDA is targeting posting updates to this content to FDA’s PQ/CMC web page by the end of the calendar months of March, June, September, and December of each year. This update may consist of a note that there is no new content for review in this period or, alternatively, that there is new content to be reviewed for comment, along with a link to the relevant documentation, background, and instructions on submitting comments. III. Electronic Access lotter on DSK11XQN23PROD with NOTICES1 Persons with access to the internet may obtain the draft data elements and terminologies at either https:// www.fda.gov/industry/fda-datastandards-advisory-board/ pharmaceutical-qualitychemistrymanufacturing-controls-pqcmc or https://www.regulations.gov. Dated: April 26, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–09173 Filed 4–28–23; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:10 Apr 28, 2023 Jkt 259001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–N–1358] FDA Science Forum 2023; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ‘‘FDA Science Forum 2023.’’ The purpose of the public workshop is to inform the public about the breadth of research underway at the Agency, and to show how cutting-edge science informs FDA’s regulatory decision-making to protect and promote public health. DATES: The public workshop will be held on June 13, 2023 (Day 1), from 9 a.m. to 3:30 p.m. Eastern Time, and June 14, 2023 (Day 2), from 9 a.m. to 2 p.m. Eastern Time. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public workshop will be held via webcast. FOR FURTHER INFORMATION CONTACT: Rokhsareh Shahidzadeh, Office of Scientific Professional Development, Office of the Chief Scientist, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 2383, Silver Spring, MD 20993, 301–796–8740, FDASciProDev@fda.hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background The FDA Science Forum is held biennially to inform the public about the groundbreaking science conducted at the Agency, and to show how scientific research is used in FDA’s regulatory decisions to protect and promote public health. Open to the public, industry, academia, patient advocates, government agencies, and current and potential collaborators, the 2-day event offers an opportunity to hear FDA scientific experts and nationally renowned scientists speak on a range of topics associated with regulatory science. II. Topics for Discussion at the Public Workshop The theme for the 2023 FDA Science Forum, ‘‘Advancing Regulatory Science Through Innovation,’’ will highlight areas of FDA research, including: (1) improving clinical and postmarket PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 26569 evaluation, (2) tools to effectively use big data, (3) product development tools and manufacturing, and (4) medical countermeasures (MCMs), infectious disease and pathogen reduction technologies. III. Participating in the Public Workshop Registration: To register for the public workshop, please visit the following website: https://www.fda.gov/ scienceforum. Registration is free. Persons interested in attending this public workshop must register by June 12, 2023, at 5 p.m. Eastern Time. Registrants will receive confirmation when they have been accepted. If you need special accommodations due to a disability, please contact Rokhsareh Shahidzadeh (see FOR FURTHER INFORMATION CONTACT) no later than June 5, 2023, by 5 p.m. Eastern Time. Streaming Webcast of the public workshop: This public workshop will be webcast. To register, please visit the following website: https://www.fda.gov/ scienceforum. Participants interested in viewing via webcast must register by June 12, 2023, at 5 p.m. Eastern Time. Dated: April 26, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–09175 Filed 4–28–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Tribal Self-Governance Negotiation Cooperative Agreement Program Announcement Type: New. Funding Announcement Number: HHS–2023–IHS–TSGN–0001. Assistance Listing (Catalog of Federal Domestic Assistance or CFDA) Number: 93.444. Key Dates Application Deadline Date: May 1, 2023. Earliest Anticipated Start Date: July 31, 2023. I. Funding Opportunity Description Statutory Authority The Indian Health Service (IHS) is accepting applications for cooperative agreements for the Tribal SelfGovernance Negotiation Cooperative Agreement Program. This program is authorized under the Snyder Act, 25 U.S.C. 13; the Transfer Act, 42 U.S.C. E:\FR\FM\01MYN1.SGM 01MYN1 26570 Federal Register / Vol. 88, No. 83 / Monday, May 1, 2023 / Notices lotter on DSK11XQN23PROD with NOTICES1 2001(a); and Title V of the Indian SelfDetermination and Education Assistance Act (ISDEAA), 25 U.S.C. 5383(e). The Assistance Listings section of SAM.gov (https://same.gov/content/ home) describes this program under 93.444. Background The Tribal Self-Governance Program (TSGP) is more than an IHS program; it is an expression of the government-togovernment relationship between the United States (U.S.) and Indian Tribes. Through the TSGP, Tribes negotiate with the IHS to assume Programs, Services, Functions, and Activities (PSFAs), or portions thereof, which gives Tribes the authority to manage and tailor health care programs in a manner that best fits the needs of their communities. Participation in the TSGP affords Tribes the most flexibility to tailor their health care needs by choosing one of three ways to obtain health care from the Federal government for their citizens. Specifically, Tribes can choose to: (1) receive health care services directly from the IHS; (2) contract with the IHS to administer individual programs and services the IHS would otherwise provide (referred to as Title I Self-Determination Contracting); and (3) compact with the IHS to assume control over health care programs the IHS would otherwise provide (referred to as Title V Self-Governance Compacting or the TSGP). These options are not exclusive and Tribes may choose to combine options based on their individual needs and circumstances. The TSGP is a tribally-driven initiative and strong Federal-Tribal partnerships are essential to the program’s success. The IHS established the Office of Tribal Self-Governance (OTSG) to implement the Tribal SelfGovernance authorities under the ISDEAA. The primary OTSG functions are to: (1) serve as the primary liaison and advocate for Tribes participating in the TSGP; (2) develop, direct, and implement TSGP policies and procedures; (3) provide information and technical assistance to Self-Governance Tribes; and (4) advise the IHS Director on compliance with TSGP policies, regulations, and guidelines. Each IHS Area has an Agency Lead Negotiator (ALN), designated by the IHS Director to act on his or her behalf, who has authority to negotiate Self-Governance Compacts and Funding Agreements (FA). Tribes interested in participating in the TSGP should contact their respective ALN to begin the SelfGovernance planning and negotiation process. Tribes currently participating VerDate Sep<11>2014 17:10 Apr 28, 2023 Jkt 259001 in the TSGP that are interested in expanding existing or adding new PSFAs should also contact their respective ALN to discuss the best methods for expanding or adding new PSFAs. Purpose The purpose of this Negotiation Cooperative Agreement is to provide Tribes with resources to help defray the costs associated with preparing for and engaging in TSGP negotiations. TSGP negotiations are a dynamic, evolving, and tribally-driven process that requires careful planning, preparation, and sharing of precise, up-to-date information by both Tribal and Federal parties. Because each Tribal situation is unique, a Tribe’s successful transition into the TSGP, or expansion of their current program, requires focused discussions between the Federal and Tribal negotiation teams about the Tribe’s specific health care concerns and plans. One of the hallmarks of the TSGP is the collaborative nature of the negotiations process, which is designed to: (1) enable a Tribe to set its own priorities when assuming responsibility for IHS PSFAs; (2) observe and respect the government-to-government relationship between the U.S. and each Tribe; and (3) involve the active participation of both Tribal and IHS representatives, including the OTSG. Negotiations are a method of determining and agreeing upon the terms and provisions of a Tribe’s Compact and FA, the implementation documents required for the Tribe to enter into the TSGP. The Compact sets forth the general terms of the government-to-government relationship between the Tribe and the Secretary of the U.S. Department of Health and Human Services (HHS). The FA: (1) describes the length of the agreement (whether it will be annual or multiyear); (2) identifies the PSFAs, or portions thereof, the Tribe will assume; (3) specifies the amount of funding associated with the Tribal assumption; and (4) includes terms required by Federal statutes and other terms agreed to by the parties. Both documents are required to participate in the TSGP and they are mutually negotiated agreements that become legally binding and mutually enforceable after both parties sign the documents. Either document can be renegotiated at the request of the Tribe. The negotiation process has four major stages, including: (1) planning; (2) pre-negotiations; (3) negotiations; and (4) post-negotiations. Title V of the ISDEAA requires that a Tribe or Tribal Organization (T/TO) complete a PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 planning phase to the satisfaction of the Tribe. The planning phase must include legal and budgetary research and internal Tribal government planning and organizational preparation relating to the administration of health care programs. See 25 U.S.C. 5383(d). The planning phase is critical to the negotiation process and assists Tribes with making informed decisions about which PSFAs to assume and what organizational changes or modifications are necessary to support those PSFAs. A thorough planning phase improves timeliness and efficient negotiations and ensures that the Tribe is fully prepared to assume the transfer of IHS PSFAs to the Tribal health program. During pre-negotiations, the Tribal and Federal negotiation teams review and discuss issues identified during the planning phase. Pre-negotiations provide an opportunity for the Tribe and the IHS to identify and discuss issues directly related to the Tribe’s Compact, FA, and Tribal shares. In advance of final negotiations, the Tribe should work with the IHS to secure the following: (1) program titles and descriptions; (2) financial tables and information; (3) information related to the identification and justification of residuals; and (4) the basis for determining Tribal shares (distribution formula). The Tribe may also wish to discuss financial materials that show estimated funding for next year and the increases or decreases in funding it may receive in the current year, as well as the basis for those changes. During the final negotiation, both the Federal and Tribal negotiation teams work together in good faith to determine and agree upon the terms and provisions of the Tribe’s Compact and FA. Negotiations are not an allocation process; they provide an opportunity to mutually review and discuss budget and program issues to reach agreement and finalize documents. There are various entities involved throughout the negotiation process. For example, a Tribal government selects its representative(s) for the Tribal negotiation team, which may include a Tribal leader from the governing body, a Tribal health director, technical and program staff, legal counsel, and other consultants. Regardless of the composition of the Tribal team, Tribal representatives must have decisionmaking authority from the Tribal governing body to successfully negotiate and agree to the provisions within the agreements. The Federal negotiation team is led by the ALN and may include area and headquarters subject matter experts, OTSG staff, the Office of Finance and Accounting, and the Office E:\FR\FM\01MYN1.SGM 01MYN1 Federal Register / Vol. 88, No. 83 / Monday, May 1, 2023 / Notices of the General Counsel. The ALN is the only member of the Federal negotiation team with delegated authority to negotiate on behalf of the IHS Director. The ALN is the designated official that provides Tribes with Self-Governance information, assists Tribes in planning, organizes meetings between the Tribe and the IHS, and coordinates the agency’s response to Tribal questions during the negotiation process. The ALN role requires detailed knowledge of the IHS, awareness of current policy and practice, and understanding of the rights and authorities available to a Tribe under Title V of the ISDEAA. In post-negotiations, the mutually agreed to and negotiated Compact and FA are signed by the authorizing Tribal official and submitted to the OTSG in preparation for the IHS Director’s signature. Once the Compact and FA have been signed by both parties, they become legally binding and enforceable agreements. A signed Compact and FA are necessary for the payment process to begin. The negotiating Tribe then becomes a ‘‘Self-Governance Tribe’’ and a participant in the TSGP. Acquiring a Negotiation Cooperative Agreement is not a prerequisite to enter the TSGP. A Tribe may use other resources to develop and negotiate its Compact and FA. See 42 CFR 137.26. Tribes that receive a Negotiation Cooperative Agreement are not obligated to participate in Title V and may choose to delay or decline participation or expansion in the TSGP. II. Award Information Funding Instrument—Cooperative Agreement Estimated Funds Available The total funding identified for fiscal year (FY) 2023 is approximately $420,000. The IHS anticipates individual award amounts will be $84,000. The funding available for competing awards issued under this announcement is subject to the availability of appropriations and budgetary priorities of the Agency. The IHS is under no obligation to make awards to applicants selected for funding under this announcement. lotter on DSK11XQN23PROD with NOTICES1 Anticipated Number of Awards The IHS anticipates issuing approximately five awards under this program announcement. Period of Performance The period of performance is for 1 year. VerDate Sep<11>2014 17:10 Apr 28, 2023 Jkt 259001 Cooperative Agreement Cooperative agreements awarded by the Department of Health and Human Services (HHS) are administered under the same policies as grants. However, the funding agency, IHS, is anticipated to have substantial programmatic involvement in the project during the entire period of performance. Below is a detailed description of the level of involvement required of the IHS. Substantial Agency Involvement Description for Cooperative Agreement A. Provide descriptions of PSFAs and associated funding at all organizational levels (service unit, area, and headquarters) including funding formulas and methodologies related to determining Tribal shares. B. Meet with Negotiation Cooperative Agreement recipients to provide program information and discuss methods currently used to manage and deliver health care. C. Identify and provide statutes, regulations, and policies that provide authority for administering IHS programs. D. Provide technical assistance on the IHS budget, Tribal shares, and other topics as needed. III. Eligibility Information 1. Eligibility To be eligible for this opportunity, an applicant must meet the following criteria: • Applicant must be an ‘‘Indian Tribe’’ as defined in 25 U.S.C. 5304(e); a ‘‘Tribal Organization’’ as defined in 25 U.S.C. 5304(l); or an ‘‘Inter-Tribal Consortium’’ as defined at 42 CFR 137.10. Please note that Tribes prohibited from contracting pursuant to the ISDEAA are not eligible. See section 424(a) of the Consolidated Appropriations Act, 2014, Public Law 113–76, as amended by section 445 of the Consolidated Appropriations Act, 2023, Public Law 117–328. • Pursuant to 25 U.S.C. 5383(c)(1)(B), applicant must request participation in self-governance by resolution or other official action by the governing body of each Indian Tribe to be served. • Pursuant to 25 U.S.C. 5383(c)(1)(C), applicant must demonstrate financial stability and financial management capability for 3 fiscal years. Meeting the eligibility criteria for a Negotiation Cooperative Agreement does not mean that a T/TO is eligible for participation in the IHS TSGP under Title V of the ISDEAA. See 25 U.S.C. 5383, 42 CFR 137.15–23. For additional information on the eligibility for the IHS TSGP, please visit the ‘‘Eligibility and PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 26571 Funding’’ page on the OTSG website located at https://www.ihs.gov/ SelfGovernance. The Division of Grants Management (DGM) will notify any applicants deemed ineligible. 2. Additional Information on Eligibility The IHS does not fund concurrent projects. If an applicant is successful under this announcement, any subsequent applications in response to other Tribal Self-Governance Negotiation Cooperative Agreement Program announcements from the same applicant will not be funded. Applications on behalf of individuals (including sole proprietorships) and foreign organizations are not eligible and will be disqualified from competitive review and funding under this funding opportunity. Note: Please refer to Section IV.2 (Application and Submission Information/ Subsection 2, Content and Form of Application Submission) for additional proof of applicant status documents required, such as Tribal Resolutions, proof of nonprofit status, etc. 3. Cost Sharing or Matching The IHS does not require matching funds or cost sharing for grants or cooperative agreements. 4. Other Requirements Applications with budget requests that exceed the highest dollar amount outlined under Section II Award Information, Estimated Funds Available, or exceed the period of performance outlined under Section II Award Information, Period of Performance, are considered not responsive and will not be reviewed. The DGM will notify the applicant. Additional Required Documentation Tribal Resolution The DGM must receive an official, signed Tribal Resolution prior to issuing a Notice of Award (NoA) to any T/TO selected for funding. An applicant that is proposing a project affecting another Indian Tribe must include resolutions from all affected Tribes to be served. However, if an official signed Tribal Resolution cannot be submitted with the application prior to the application deadline date, a draft Tribal Resolution must be submitted with the application by the deadline date in order for the application to be considered complete and eligible for review. The draft Tribal Resolution is not in lieu of the required signed resolution but is acceptable until a signed resolution is received. If an application without a signed Tribal Resolution is selected for funding, the applicant will be contacted by the E:\FR\FM\01MYN1.SGM 01MYN1 26572 Federal Register / Vol. 88, No. 83 / Monday, May 1, 2023 / Notices Grants Management Specialist (GMS) listed in this funding announcement and given 90 days to submit an official signed Tribal Resolution to the GMS. If the signed Tribal Resolution is not received within 90 days, the award will be forfeited. Applicants organized with a governing structure other than a Tribal council may submit an equivalent document commensurate with their governing organization. IV. Application and Submission Information Grants.gov uses a Workspace model for accepting applications. The Workspace consists of several online forms and three forms in which to upload documents—Project Narrative, Budget Narrative, and Other Documents. Give your files brief descriptive names. The filenames are key in finding specific documents during the merit review and in processing awards. Upload all requested and optional documents individually, rather than combining them into a single file. Creating a single file creates confusion when trying to find specific documents. Such confusion can contribute to delays in processing awards, and could lead to lower scores during the merit review. 1. Obtaining Application Materials The application package and detailed instructions for this announcement are available at https://www.Grants.gov. Please direct questions regarding the application process to DGM@ihs.gov. lotter on DSK11XQN23PROD with NOTICES1 2. Content and Form Application Submission Mandatory documents for all applicants include: • Application forms: 1. SF–424, Application for Federal Assistance. 2. SF–424A, Budget Information— Non-Construction Programs. 3. SF–424B, Assurances—NonConstruction Programs. 4. Project Abstract Summary form. • Project Narrative (not to exceed 10 pages). See Section IV.2.A, Project Narrative for instructions. 1. Background information on the organization. 2. Proposed scope of work, objectives, and activities that provide a description of what the applicant plans to accomplish. • Budget Narrative (not to exceed 5 pages). See Section IV.2.B, Budget Narrative for instructions. • One-page Timeframe of award activities. • Tribal Resolution(s) as described in Section III, Eligibility. VerDate Sep<11>2014 17:10 Apr 28, 2023 Jkt 259001 • Biographical sketches for all Key Personnel. • Contractor/Consultant resumes or qualifications and scope of work. • Disclosure of Lobbying Activities (SF–LLL), if applicant conducts reportable lobbying. • Certification Regarding Lobbying (GG-Lobbying Form). • Copy of current Negotiated Indirect Cost (IDC) rate agreement (required in order to receive IDC). • Organizational Chart (optional). • Documentation sufficient to demonstrate financial stability and financial management capability for 3 fiscal years. The Indian Tribe must provide evidence that, for the 3 fiscal years prior to requesting participation in the TSGP, the Indian Tribe has had no uncorrected significant and material audit exceptions in the required annual audit of the Indian Tribe’s SelfDetermination Contracts or SelfGovernance Funding Agreements with any Federal agency. See 25 U.S.C. 5383, 42 CFR 137.15–23. For T/TO that expended $500,000 or more in Federal awards, the OTSG shall retrieve the audits directly from the Federal Audit Clearinghouse. For T/TO that expended less than $500,000 in Federal awards, the T/TO must provide evidence of the program review correspondence from the IHS or Bureau of Indian Affairs officials. See 42 CFR 137.21–23. • Documentation of current Office of Management and Budget (OMB) Financial Audit. Acceptable forms of documentation include: 1. Email confirmation from Federal Audit Clearinghouse (FAC) that audits were submitted; or 2. Face sheets from audit reports. Applicants can find these on the FAC website at https://facdissem. census.gov/. tables); (3) be single-spaced; and (4) be formatted to fit standard letter paper (81⁄2 x 11 inches). Do not combine this document with any others. Be sure to succinctly answer all questions listed under the evaluation criteria (refer to Section V.1, Evaluation Criteria), and place all responses and required information in the correct section noted below or they will not be considered or scored. If the narrative exceeds the overall page limit, the reviewers will be directed to ignore any content beyond the page limit. The 10page limit for the project narrative does not include the work plan, standard forms, Tribal Resolutions, budget, budget narratives, and/or other items. Page limits for each section within the project narrative are guidelines, not hard limits. There are three parts to the project narrative: Part 1—Program Information; Part 2—Program Planning and Evaluation; and Part 3—Program Report. See below for additional details about what must be included in the narrative. The page limits below are for each narrative and budget submitted. Public Policy Requirements All Federal public policies apply to IHS grants and cooperative agreements. Pursuant to 45 CFR 80.3(d), an individual shall not be deemed subjected to discrimination by reason of their exclusion from benefits limited by Federal law to individuals eligible for benefits and services from the IHS. See https://www.hhs.gov/grants/grants/ grants-policies-regulations/. Part 2: Program Planning and Evaluation (Limit—4 Pages) Requirements for Project and Budget Narratives A. Project Narrative: This narrative should be a separate document that is no more than 10 pages and must: (1) have consecutively numbered pages; (2) use black font 12 points or larger (applicants may use 10-point font for PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 Part 1: Program Information (Limit—4 Pages) Section 1: Needs Demonstrate that the Tribe has conducted previous Self-Governance planning activities by clearly stating the results of what was learned during the planning process. Explain how the Tribe has determined it has the knowledge and expertise to assume or expand PSFAs and the administrative infrastructure to support the assumption of PSFAs. Identify the need for assistance and how the Negotiation Cooperative Agreement would benefit the health activities the Tribe is preparing to assume or expand. Section 1: Program Plans State in measurable terms the objectives and appropriate activities to achieve the following Negotiation Cooperative Agreement recipient award activities: (A) Determine the PSFAs that will be negotiated into the Tribe’s Compact and FA. Prepare and discuss each PSFA in comparison to the current level of services provided so that an informed decision can be made on new or expanded program assumption. (B) Identify Tribal shares associated with the PSFAs that will be included in the FA. (C) Develop the terms and conditions that will be set forth in both the E:\FR\FM\01MYN1.SGM 01MYN1 Federal Register / Vol. 88, No. 83 / Monday, May 1, 2023 / Notices Compact and FA to submit to the ALN prior to negotiations. Describe fully and clearly how the Tribe’s proposal will result in an improved approach to managing the PSFAs to be assumed or expanded. Include how the Tribe plans to demonstrate improved health services to the community and incorporate the proposed timelines for negotiations. Section 2: Program Evaluation Describe fully and clearly how the goals and proposed activities will improve the health care system and identify the anticipated or expected benefits for the Tribe. Define the criteria to be used to evaluate objectives associated with the project using a model for tracking. Part 3: Program Report (Limit—2 Pages) Section 1 Describe your organization’s significant program activities and accomplishments over the past several years associated with the goals of this announcement and leading up to the negotiation phase. Please identify and describe significant program activities and achievements associated with the delivery of quality health services. Provide a comparison of the actual accomplishments to the goals established for the project period or, if applicable, provide justification for the lack of progress. lotter on DSK11XQN23PROD with NOTICES1 B. Budget Narrative (Limit—5 Pages) Provide a budget narrative that explains the amounts requested for each line item of the budget from the SF– 424A (Budget Information for NonConstruction Programs) for the project. The applicant can submit with the budget narrative a more detailed spreadsheet than is provided by the SF– 424A (the spreadsheet will not be considered part of the budget narrative). The budget narrative should specifically describe how each item would support the achievement of proposed objectives. Be very careful about showing how each item in the ‘‘Other’’ category is justified. Do NOT use the budget narrative to expand the project narrative. 3. Submission Dates and Times Applications must be submitted through Grants.gov by 11:59 p.m. Eastern Time on the Application Deadline Date. Any application received after the application deadline will not be accepted for review. Grants.gov will notify the applicant via email if the application is rejected. If technical challenges arise and assistance is required with the VerDate Sep<11>2014 17:10 Apr 28, 2023 Jkt 259001 application process, contact Grants.gov Customer Support (see contact information at https://www.Grants.gov). If problems persist, contact Mr. Paul Gettys, Deputy Director, DGM, by email at DGM@ihs.gov. Please be sure to contact Mr. Gettys at least 10 days prior to the application deadline. Please do not contact the DGM until you have received a Grants.gov tracking number. In the event you are not able to obtain a tracking number, call the DGM as soon as possible. The IHS will not acknowledge receipt of applications. 4. Intergovernmental Review Executive Order 12372 requiring intergovernmental review is not applicable to this program. 5. Funding Restrictions • Pre-award costs are not allowable. • The available funds are inclusive of direct and indirect costs. • Only one cooperative agreement may be awarded per applicant. 6. Electronic Submission Requirements All applications must be submitted via Grants.gov. Please use the https:// www.Grants.gov website to submit an application. Find the application by selecting the ‘‘Search Grants’’ link on the homepage. Follow the instructions for submitting an application under the Package tab. No other method of application submission is acceptable. If you cannot submit an application through Grants.gov, you must request a waiver prior to the application due date. You must submit your waiver request by email to DGM@ihs.gov. Your waiver request must include clear justification for the need to deviate from the required application submission process. The IHS will not accept any applications submitted through any means outside of Grants.gov without an approved waiver. If the DGM approves your waiver request, you will receive a confirmation of approval email containing submission instructions. You must include a copy of the written approval with the application submitted to the DGM. Applications that do not include a copy of the waiver approval from the DGM will not be reviewed. The Grants Management Officer of the DGM will notify the applicant via email of this decision. Applications submitted under waiver must be received by the DGM no later than 5:00 p.m. Eastern Time on the Application Deadline Date. Late applications will not be accepted for processing. Applicants that do not register for both the System for Award Management (SAM) and Grants.gov and/or fail to request timely assistance PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 26573 with technical issues will not be considered for a waiver to submit an application via alternative method. Please be aware of the following: • Please search for the application package in https://www.Grants.gov by entering the Assistance Listing number or the Funding Opportunity Number. Both numbers are located in the header of this announcement. • If you experience technical challenges while submitting your application, please contact Grants.gov Customer Support (see contact information at https://www.Grants.gov). • Upon contacting Grants.gov, obtain a tracking number as proof of contact. The tracking number is helpful if there are technical issues that cannot be resolved and a waiver from the agency must be obtained. • Applicants are strongly encouraged not to wait until the deadline date to begin the application process through Grants.gov as the registration process for SAM and Grants.gov could take up to 20 working days. • Please follow the instructions on Grants.gov to include additional documentation that may be requested by this funding announcement. • Applicants must comply with any page limits described in this funding announcement. • After submitting the application, you will receive an automatic acknowledgment from Grants.gov that contains a Grants.gov tracking number. The IHS will not notify you that the application has been received. System for Award Management Organizations that are not registered with the System for Award Management (SAM) must access the SAM online registration through the SAM home page at https://sam.gov. Organizations based in the U.S. will also need to provide an Employer Identification Number from the Internal Revenue Service that may take an additional 2–5 weeks to become active. Please see SAM.gov for details on the registration process and timeline. Registration with the SAM is free of charge but can take several weeks to process. Applicants may register online at https://sam.gov. Unique Entity Identifier Your SAM.gov registration now includes a Unique Entity Identifier (UEI), generated by SAM.gov, which replaces the DUNS number obtained from Dun and Bradstreet. SAM.gov registration no longer requires a DUNS number. Check your organization’s SAM.gov registration as soon as you decide to apply for this program. If your SAM.gov E:\FR\FM\01MYN1.SGM 01MYN1 26574 Federal Register / Vol. 88, No. 83 / Monday, May 1, 2023 / Notices registration is expired, you will not be able to submit an application. It can take several weeks to renew it or resolve any issues with your registration, so do not wait. Check your Grants.gov registration. Registration and role assignments in Grants.gov are self-serve functions. One user for your organization will have the authority to approve role assignments, and these must be approved for active users in order to ensure someone in your organization has the necessary access to submit an application. The Federal Funding Accountability and Transparency Act of 2006, as amended (‘‘Transparency Act’’), requires all HHS recipients to report information on sub-awards. Accordingly, all IHS recipients must notify potential first-tier sub-recipients that no entity may receive a first-tier sub-award unless the entity has provided its UEI number to the prime recipient organization. This requirement ensures the use of a universal identifier to enhance the quality of information available to the public pursuant to the Transparency Act. Additional information on implementing the Transparency Act, including the specific requirements for SAM, are available on the DGM Grants Management, Policy Topics web page at https://www.ihs.gov/dgm/policytopics/. assistance and how the Negotiation Cooperative Agreement would benefit the health activities the Tribe is preparing to assume or expand. V. Application Review Information C. Program Evaluation (25 Points) Possible points assigned to each section are noted in parentheses. The project narrative and budget narrative should include only the first year of activities. The project narrative should be written in a manner that is clear to outside reviewers unfamiliar with prior related activities of the applicant. It should be well organized, succinct, and contain all information necessary for reviewers to fully understand the project. Attachments requested in the criteria do not count toward the page limit for the narratives. Points will be assigned to each evaluation criteria adding up to a total of 100 possible points. Points are assigned as follows: Describe fully the improvements that will be made by the Tribe to manage the health care system and identify the anticipated or expected benefits for the Tribe. Define the criteria to be used to evaluate objectives associated with the project and how they will be measured. 1. Evaluation Criteria lotter on DSK11XQN23PROD with NOTICES1 A. Introduction and Need for Assistance (25 Points) Demonstrate that the Tribe has conducted previous Self-Governance planning activities by clearly stating the results of what was learned during the planning process. Explain how the Tribe has determined it has the knowledge and expertise to assume or expand PSFAs and the administrative infrastructure to support the assumption of PSFAs. Identify the need for VerDate Sep<11>2014 17:10 Apr 28, 2023 Jkt 259001 B. Project Objective(s), Work Plan and Approach (25 Points) State in measurable terms the objectives and appropriate activities to achieve the following Negotiation Cooperative Agreement recipient award activities: 1. Determine the PSFAs that will be negotiated into the Tribe’s Compact and FA. Prepare and discuss each PSFA in comparison to the level of services provided so that an informed decision can be made on new or expanded program assumption. 2. Identify Tribal shares associated with the PSFAs that will be included in the FA. 3. Develop the terms and conditions that will be set forth in both the Compact and FA to submit to the ALN prior to negotiations. Clearly describe how the Tribe’s proposal will result in an improved approach to managing the PSFAs to be assumed or expanded. Include how the Tribe plans to demonstrate improved health care services to the community and incorporate the proposed timelines for negotiations. D. Organizational Capabilities, Key Personnel, and Qualifications (15 Points) Describe the organizational structure of the Tribe and its ability to manage the proposed project. Include resumes or position descriptions of key staff showing requisite experience and expertise. If applicable, include resumes and scope of work for consultants that demonstrate experience and expertise relevant to the project. E. Categorical Budget and Budget Justification (10 Points) Submit a budget with a narrative describing the budget request and matching the scope of work described in the project narrative. Justify all expenditures identifying reasonable and allowable costs necessary to accomplish the goals and objectives as outlined in the project narrative. PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 Additional documents can be uploaded as Other Attachments in Grants.gov. These can include: • Work plan, logic model, and/or timeline for proposed objectives. • Position descriptions for key staff. • Resumes of key staff that reflect current duties. • Consultant or contractor proposed scope of work and letter of commitment (if applicable). • Current Indirect Cost Rate Agreement. • Organizational chart. • Map of area identifying project location(s). • Additional documents to support narrative (i.e., data tables, key news articles, etc.). 2. Review and Selection Each application will be prescreened for eligibility and completeness as outlined in the funding announcement. Applications that meet the eligibility criteria shall be reviewed for merit by the Review Committee (RC) based on the evaluation criteria. Incomplete applications and applications that are not responsive to the administrative thresholds (budget limit, period of performance limit) will not be referred to the RC and will not be funded. The DGM will notify the applicant of this determination. Applicants must address all program requirements and provide all required documentation. 3. Notifications of Disposition All applicants will receive an Executive Summary Statement from the OTSG within 30 days of the conclusion of the RC outlining the strengths and weaknesses of their application. The summary statement will be sent to the Authorizing Official identified on the face page (SF–424) of the application. A. Award Notices for Funded Applications The NoA is the authorizing document for which funds are dispersed to the approved entities and reflects the amount of Federal funds awarded, the purpose of the award, the terms and conditions of the award, the effective date of the award, the budget period, and period of performance. Each entity approved for funding must have a user account in GrantSolutions in order to retrieve the NoA. Please see the Agency Contacts list in Section VII for the systems contact information. B. Approved but Unfunded Applications Approved applications not funded due to lack of available funds will be E:\FR\FM\01MYN1.SGM 01MYN1 Federal Register / Vol. 88, No. 83 / Monday, May 1, 2023 / Notices held for 1 year. If funding becomes available during the course of the year, the application may be reconsidered. Note: Any correspondence, other than the official NoA executed by an IHS grants management official announcing to the project director that an award has been made to their organization, is not an authorization to implement their program on behalf of the IHS. VI. Award Administration Information lotter on DSK11XQN23PROD with NOTICES1 1. Administrative Requirements Awards issued under this announcement are subject to, and are administered in accordance with, the following regulations and policies: A. The criteria as outlined in this program announcement. B. Administrative Regulations for Awards: • Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards currently in effect or implemented during the period of award, other Department regulations and policies in effect at the time of award, and applicable statutory provisions. At the time of publication, this includes 45 CFR part 75, at https://www.govinfo.gov/ content/pkg/CFR-2021-title45-vol1/pdf/ CFR-2021-title45-vol1-part75.pdf. • Please review all HHS regulatory provisions for Termination at 45 CFR 75.372, at the time of this publication located at https://www.govinfo.gov/ content/pkg/CFR-2021-title45-vol1/pdf/ CFR-2021-title45-vol1-sec75-372.pdf. C. Grants Policy: • HHS Grants Policy Statement, Revised January 2007, at https:// www.hhs.gov/sites/default/files/grants/ grants/policies-regulations/ hhsgps107.pdf. D. Cost Principles: • Uniform Administrative Requirements for HHS Awards, ‘‘Cost Principles,’’ at 45 CFR part 75 subpart E, at the time of this publication located at https://www.govinfo.gov/content/pkg/ CFR-2021-title45-vol1/pdf/CFR-2021title45-vol1-part75-subpartE.pdf. E. Audit Requirements: • Uniform Administrative Requirements for HHS Awards, ‘‘Audit Requirements,’’ at 45 CFR part 75 subpart F, at the time of this publication located at https://www.govinfo.gov/ content/pkg/CFR-2021-title45-vol1/pdf/ CFR-2021-title45-vol1-part75subpartF.pdf. F. As of August 13, 2020, 2 CFR part 200 was updated to include a prohibition on certain telecommunications and video surveillance services or equipment. This prohibition is described in 2 CFR part VerDate Sep<11>2014 17:10 Apr 28, 2023 Jkt 259001 200.216. This will also be described in the terms and conditions of every IHS grant and cooperative agreement awarded on or after August 13, 2020. 2. Indirect Costs This section applies to all recipients that request reimbursement of IDC in their application budget. In accordance with HHS Grants Policy Statement, Part II–27, the IHS requires applicants to obtain a current IDC rate agreement and submit it to the DGM prior to the DGM issuing an award. The rate agreement must be prepared in accordance with the applicable cost principles and guidance as provided by the cognizant agency or office. A current rate covers the applicable award activities under the current award’s budget period. If the current rate agreement is not on file with the DGM at the time of award, the IDC portion of the budget will be restricted. The restrictions remain in place until the current rate agreement is provided to the DGM. Per 2 CFR 200.414(f) Indirect (F&A) costs, any non-Federal entity (NFE) [i.e., applicant] that does not have a current negotiated rate, . . . may elect to charge a de minimis rate of 10 percent of modified total direct costs which may be used indefinitely. As described in Section 200.403, costs must be consistently charged as either indirect or direct costs, but may not be double charged or inconsistently charged as both. If chosen, this methodology once elected must be used consistently for all Federal awards until such time as the NFE chooses to negotiate for a rate, which the NFE may apply to do at any time. Electing to charge a de minimis rate of 10 percent can be used by applicants that have received an approved negotiated indirect cost rate from HHS or another cognizant Federal agency. Applicants awaiting approval of their indirect cost proposal may request the 10 percent de minimis rate. When the applicant chooses this method, costs included in the indirect cost pool must not be charged as direct costs to the award. Available funds are inclusive of direct and appropriate indirect costs. Approved indirect funds are awarded as part of the award amount, and no additional funds will be provided. Generally, IDC rates for IHS recipients are negotiated with the Division of Cost Allocation at https://rates.psc.gov/ or the Department of the Interior (Interior Business Center) at https://ibc.doi.gov/ ICS/tribal. For questions regarding the indirect cost policy, please write to DGM@ihs.gov. PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 26575 3. Reporting Requirements The recipient must submit required reports consistent with the applicable deadlines. Failure to submit required reports within the time allowed may result in suspension or termination of an active award, withholding of additional awards for the project, or other enforcement actions such as withholding of payments or converting to the reimbursement method of payment. Continued failure to submit required reports may result in the imposition of special award provisions and/or the non-funding or non-award of other eligible projects or activities. This requirement applies whether the delinquency is attributable to the failure of the recipient organization or the individual responsible for preparation of the reports. Per DGM policy, all reports must be submitted electronically by attaching them as a ‘‘Grant Note’’ in GrantSolutions. Personnel responsible for submitting reports will be required to obtain a login and password for GrantSolutions. Please use the form under the Recipient User section of https://www.grantsolutions.gov/home/ getting-started-request-a-user-account/. Download the Recipient User Account Request Form, fill it out completely, and submit it as described on the web page and in the form. The reporting requirements for this program are noted below. A. Progress Reports Program progress reports are required semi-annually. The progress reports are due within 30 days after the reporting period ends (specific dates will be listed in the NoA Terms and Conditions). These reports must include a brief comparison of actual accomplishments to the goals established for the period, a summary of progress to date or, if applicable, provide sound justification for the lack of progress, and other pertinent information as required. A final report must be submitted within 120 days of the period of performance end date. B. Financial Reports Federal Financial Reports are due 90 days after the end of each budget period, and a final report is due 120 days after the end of the period of performance. Recipients are responsible and accountable for reporting accurate information on all required reports: the Progress Reports and the Federal Financial Report. Failure to submit timely reports may result in adverse award actions blocking access to funds. E:\FR\FM\01MYN1.SGM 01MYN1 26576 Federal Register / Vol. 88, No. 83 / Monday, May 1, 2023 / Notices C. Federal Sub-Award Reporting System (FSRS) This award may be subject to the Transparency Act sub-award and executive compensation reporting requirements of 2 CFR part 170. The Transparency Act requires the OMB to establish a single searchable database, accessible to the public, with information on financial assistance awards made by Federal agencies. The Transparency Act also includes a requirement for recipients of Federal awards to report information about firsttier sub-awards and executive compensation under Federal assistance awards. The IHS has implemented a Term of Award into all IHS Standard Terms and Conditions, NoAs, and funding announcements regarding the FSRS reporting requirement. This IHS Term of Award is applicable to all IHS grant and cooperative agreements issued on or after October 1, 2010, with a $25,000 sub-award obligation threshold met for any specific reporting period. For the full IHS award term implementing this requirement and additional award applicability information, visit the DGM Grants Management website at https:// www.ihs.gov/dgm/policytopics/. lotter on DSK11XQN23PROD with NOTICES1 D. Non-Discrimination Legal Requirements for Recipients of Federal Financial Assistance (FFA) The recipient must administer the project in compliance with Federal civil rights laws, where applicable, that prohibit discrimination on the basis of race, color, national origin, disability, age, and comply with applicable conscience protections. The recipient must comply with applicable laws that prohibit discrimination on the basis of sex, which includes discrimination on the basis of gender identity, sexual orientation, and pregnancy. Compliance with these laws requires taking reasonable steps to provide meaningful access to persons with limited English proficiency and providing programs that are accessible to and usable by persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https:// www.hhs.gov/civil-rights/for-providers/ provider-obligations/ and https://www.hhs.gov/civil-rights/forindividuals/nondiscrimination/ index.html. • Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting your legal obligation to take reasonable steps to VerDate Sep<11>2014 17:10 Apr 28, 2023 Jkt 259001 ensure meaningful access to your programs or activities by limited English proficiency individuals, see https:// www.hhs.gov/civil-rights/forindividuals/special-topics/limitedenglish-proficiency/fact-sheet-guidance/ index.html and https://www.lep.gov. • For information on your specific legal obligations for serving qualified individuals with disabilities, including reasonable modifications and making services accessible to them, see https:// www.hhs.gov/civil-rights/forindividuals/disability/. • HHS funded health and education programs must be administered in an environment free of sexual harassment. See https://www.hhs.gov/civil-rights/forindividuals/sex-discrimination/ index.html. • For guidance on administering your program in compliance with applicable Federal religious nondiscrimination laws and applicable Federal conscience protection and associated antidiscrimination laws, see https:// www.hhs.gov/conscience/conscienceprotections/ and https:// www.hhs.gov/conscience/religiousfreedom/. • Pursuant to 45 CFR 80.3(d), an individual shall not be deemed subjected to discrimination by reason of their exclusion from benefits limited by Federal law to individuals eligible for benefits and services from the IHS. E. Federal Awardee Performance and Integrity Information System (FAPIIS) The IHS is required to review and consider any information about the applicant that is in the FAPIIS at https://www.fapiis.gov/fapiis/#/home before making any award in excess of the simplified acquisition threshold (currently $250,000) over the period of performance. An applicant may review and comment on any information about itself that a Federal awarding agency previously entered. The IHS will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgment about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants, as described in 45 CFR 75.205. As required by 45 CFR part 75 Appendix XII of the Uniform Guidance, NFEs are required to disclose in FAPIIS any information about criminal, civil, and administrative proceedings, and/or affirm that there is no new information to provide. This applies to NFEs that receive Federal awards (currently active grants, cooperative agreements, and procurement contracts) greater than $10 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 million for any period of time during the period of performance of an award/ project. Mandatory Disclosure Requirements As required by 2 CFR part 200 of the Uniform Guidance, and HHS implementing regulations at 45 CFR part 75, the IHS must require an NFE or an applicant for a Federal award to disclose, in a timely manner, in writing to the IHS or pass-through entity all violations of Federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the Federal award. All applicants and recipients must disclose in writing, in a timely manner, to the IHS and to the HHS Office of Inspector General all information related to violations of Federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the Federal award. 45 CFR 75.113. Disclosures must be sent in writing to: U.S. Department of Health and Human Services, Indian Health Service, Division of Grants Management, ATTN: Marsha Brookins, Director, 5600 Fishers Lane, Mail Stop: 09E70, Rockville, MD 20857, (Include ‘‘Mandatory Grant Disclosures’’ in subject line), Office: (301) 443–5204, Fax: (301) 594–0899, Email: DGM@ ihs.gov AND U.S. Department of Health and Human Services, Office of Inspector General, ATTN: Mandatory Grant Disclosures, Intake Coordinator, 330 Independence Avenue SW, Cohen Building, Room 5527, Washington, DC 20201, URL: https://oig.hhs.gov/fraud/reportfraud/, (Include ‘‘Mandatory Grant Disclosures’’ in subject line), Fax: (202) 205–0604 (Include ‘‘Mandatory Grant Disclosures’’ in subject line) or, Email: MandatoryGrantee Disclosures@oig.hhs.gov Failure to make required disclosures can result in any of the remedies described in 45 CFR 75.371 Remedies for noncompliance, including suspension or debarment (see 2 CFR part 180 and 2 CFR part 376). VII. Agency Contacts 1. Questions on the program matters may be directed to: Roxanne Houston, Program Officer, Indian Health Service, Office of Tribal Self-Governance, 5600 Fishers Lane, Mail Stop: 08E09B, Rockville, MD 20857, Phone: (301) 443– 7821, Email: Roxanne.Houston@ihs.gov, Website: https://www.ihs.gov/ SelfGovernance/. 2. Questions on awards management and fiscal matters may be directed to: E:\FR\FM\01MYN1.SGM 01MYN1 Federal Register / Vol. 88, No. 83 / Monday, May 1, 2023 / Notices Indian Health Service, Division of Grants Management, 5600 Fishers Lane, Mail Stop: 09E70, Rockville, MD 20857, Email: DGM@ihs.gov. 3. For technical assistance with Grants.gov, please contact the Grants.gov help desk at 800–518–4726, or by email at support@grants.gov. 4. For technical assistance with GrantSolutions, please contact the GrantSolutions help desk at (866) 577– 0771, or by email at help@ grantsolutions.gov. VIII. Other Information The Public Health Service strongly encourages all grant, cooperative agreement, and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103– 227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of the facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the HHS mission to protect and advance the physical and mental health of the American people. P. Benjamin Smith, Deputy Director, Indian Health Service. Agenda: To review and evaluate grant applications. Place: National Center for Advancing Translational Sciences, National Institutes of Health, 6701 Democracy Boulevard, Room 1080, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Jing Chen, Ph.D., Scientific Review Officer, Office of Scientific Review, National Center for Advancing Translational Sciences, National Institutes of Health, 6701 Democracy Boulevard, Room 1080, Bethesda, MD 20892–4874, chenjing@mail.nih.gov, (301) 827–3268. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.350, B—Cooperative Agreements; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS) Dated: April 26, 2023. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–09149 Filed 4–28–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health [FR Doc. 2023–09097 Filed 4–28–23; 8:45 am] National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting BILLING CODE 4165–16–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health lotter on DSK11XQN23PROD with NOTICES1 National Center for Advancing Translational Sciences; Notice of Closed Meeting Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Center for Advancing Translational Sciences Special Emphasis Panel; Basket Clinical Trial U44. Date: May 5, 2023. Time: 12:00 p.m. to 2:00 p.m. VerDate Sep<11>2014 17:10 Apr 28, 2023 Jkt 259001 Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory Council for Biomedical Imaging and Bioengineering. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend in person should register at (https://www.nibib.nih.gov/about-nibib/ advisory-council/registration) in advance of the meeting so that the meeting organizers can plan accordingly. The meeting will be videocast and can be accessed from the NIH Videocasting website at (https://videocast.nih.gov/ watch=49359). The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications and/or contract proposals, PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 26577 the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Advisory Council for Biomedical Imaging and Bioengineering NACBIB, May 2023. Date: May 16, 2023. Open: 09:00 a.m. to 12:30 p.m. Agenda: Report from the Institute Director, Council Members and other Institute Staff. Place: William F. Bolger Center, 9600 Newbridge Drive, Franklin Building, Classroom 1, Potomac, MD 20854. Closed: 2:15 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications and/or proposals. Place: William F. Bolger Center, 9600 Newbridge Drive, Franklin Building, Classroom 1, Potomac, MD 20854. Contact Person: David T. George, Ph.D., Associate Director for Research Administration, Office of Research Administration, National Institute of Biomedical Imaging and Bioengineering, 6707 Democracy Boulevard, Room 920, Bethesda, MD 20892, georged@mail.nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Information is also available on the Institute’s/Center’s home page: https:// www.nibib.nih.gov/about-nibib/ advisory-council where an agenda and any additional information for the meeting will be posted when available. Dated: April 25, 2023. Victoria E. Townsend, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–09131 Filed 4–28–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meeting Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which E:\FR\FM\01MYN1.SGM 01MYN1

Agencies

[Federal Register Volume 88, Number 83 (Monday, May 1, 2023)]
[Notices]
[Pages 26569-26577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09097]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Indian Health Service


Tribal Self-Governance Negotiation Cooperative Agreement Program

    Announcement Type: New.
    Funding Announcement Number: HHS-2023-IHS-TSGN-0001.
    Assistance Listing (Catalog of Federal Domestic Assistance or CFDA) 
Number: 93.444.

Key Dates

    Application Deadline Date: May 1, 2023.
    Earliest Anticipated Start Date: July 31, 2023.

I. Funding Opportunity Description

Statutory Authority

    The Indian Health Service (IHS) is accepting applications for 
cooperative agreements for the Tribal Self-Governance Negotiation 
Cooperative Agreement Program. This program is authorized under the 
Snyder Act, 25 U.S.C. 13; the Transfer Act, 42 U.S.C.

[[Page 26570]]

2001(a); and Title V of the Indian Self-Determination and Education 
Assistance Act (ISDEAA), 25 U.S.C. 5383(e). The Assistance Listings 
section of SAM.gov (https://same.gov/content/home) describes this 
program under 93.444.

Background

    The Tribal Self-Governance Program (TSGP) is more than an IHS 
program; it is an expression of the government-to-government 
relationship between the United States (U.S.) and Indian Tribes. 
Through the TSGP, Tribes negotiate with the IHS to assume Programs, 
Services, Functions, and Activities (PSFAs), or portions thereof, which 
gives Tribes the authority to manage and tailor health care programs in 
a manner that best fits the needs of their communities.
    Participation in the TSGP affords Tribes the most flexibility to 
tailor their health care needs by choosing one of three ways to obtain 
health care from the Federal government for their citizens. 
Specifically, Tribes can choose to: (1) receive health care services 
directly from the IHS; (2) contract with the IHS to administer 
individual programs and services the IHS would otherwise provide 
(referred to as Title I Self-Determination Contracting); and (3) 
compact with the IHS to assume control over health care programs the 
IHS would otherwise provide (referred to as Title V Self-Governance 
Compacting or the TSGP). These options are not exclusive and Tribes may 
choose to combine options based on their individual needs and 
circumstances.
    The TSGP is a tribally-driven initiative and strong Federal-Tribal 
partnerships are essential to the program's success. The IHS 
established the Office of Tribal Self-Governance (OTSG) to implement 
the Tribal Self-Governance authorities under the ISDEAA. The primary 
OTSG functions are to: (1) serve as the primary liaison and advocate 
for Tribes participating in the TSGP; (2) develop, direct, and 
implement TSGP policies and procedures; (3) provide information and 
technical assistance to Self-Governance Tribes; and (4) advise the IHS 
Director on compliance with TSGP policies, regulations, and guidelines. 
Each IHS Area has an Agency Lead Negotiator (ALN), designated by the 
IHS Director to act on his or her behalf, who has authority to 
negotiate Self-Governance Compacts and Funding Agreements (FA). Tribes 
interested in participating in the TSGP should contact their respective 
ALN to begin the Self-Governance planning and negotiation process. 
Tribes currently participating in the TSGP that are interested in 
expanding existing or adding new PSFAs should also contact their 
respective ALN to discuss the best methods for expanding or adding new 
PSFAs.

Purpose

    The purpose of this Negotiation Cooperative Agreement is to provide 
Tribes with resources to help defray the costs associated with 
preparing for and engaging in TSGP negotiations. TSGP negotiations are 
a dynamic, evolving, and tribally-driven process that requires careful 
planning, preparation, and sharing of precise, up-to-date information 
by both Tribal and Federal parties. Because each Tribal situation is 
unique, a Tribe's successful transition into the TSGP, or expansion of 
their current program, requires focused discussions between the Federal 
and Tribal negotiation teams about the Tribe's specific health care 
concerns and plans. One of the hallmarks of the TSGP is the 
collaborative nature of the negotiations process, which is designed to: 
(1) enable a Tribe to set its own priorities when assuming 
responsibility for IHS PSFAs; (2) observe and respect the government-
to-government relationship between the U.S. and each Tribe; and (3) 
involve the active participation of both Tribal and IHS 
representatives, including the OTSG. Negotiations are a method of 
determining and agreeing upon the terms and provisions of a Tribe's 
Compact and FA, the implementation documents required for the Tribe to 
enter into the TSGP. The Compact sets forth the general terms of the 
government-to-government relationship between the Tribe and the 
Secretary of the U.S. Department of Health and Human Services (HHS). 
The FA: (1) describes the length of the agreement (whether it will be 
annual or multi-year); (2) identifies the PSFAs, or portions thereof, 
the Tribe will assume; (3) specifies the amount of funding associated 
with the Tribal assumption; and (4) includes terms required by Federal 
statutes and other terms agreed to by the parties. Both documents are 
required to participate in the TSGP and they are mutually negotiated 
agreements that become legally binding and mutually enforceable after 
both parties sign the documents. Either document can be renegotiated at 
the request of the Tribe.
    The negotiation process has four major stages, including: (1) 
planning; (2) pre-negotiations; (3) negotiations; and (4) post-
negotiations. Title V of the ISDEAA requires that a Tribe or Tribal 
Organization (T/TO) complete a planning phase to the satisfaction of 
the Tribe. The planning phase must include legal and budgetary research 
and internal Tribal government planning and organizational preparation 
relating to the administration of health care programs. See 25 U.S.C. 
5383(d). The planning phase is critical to the negotiation process and 
assists Tribes with making informed decisions about which PSFAs to 
assume and what organizational changes or modifications are necessary 
to support those PSFAs. A thorough planning phase improves timeliness 
and efficient negotiations and ensures that the Tribe is fully prepared 
to assume the transfer of IHS PSFAs to the Tribal health program.
    During pre-negotiations, the Tribal and Federal negotiation teams 
review and discuss issues identified during the planning phase. Pre-
negotiations provide an opportunity for the Tribe and the IHS to 
identify and discuss issues directly related to the Tribe's Compact, 
FA, and Tribal shares.
    In advance of final negotiations, the Tribe should work with the 
IHS to secure the following: (1) program titles and descriptions; (2) 
financial tables and information; (3) information related to the 
identification and justification of residuals; and (4) the basis for 
determining Tribal shares (distribution formula). The Tribe may also 
wish to discuss financial materials that show estimated funding for 
next year and the increases or decreases in funding it may receive in 
the current year, as well as the basis for those changes.
    During the final negotiation, both the Federal and Tribal 
negotiation teams work together in good faith to determine and agree 
upon the terms and provisions of the Tribe's Compact and FA. 
Negotiations are not an allocation process; they provide an opportunity 
to mutually review and discuss budget and program issues to reach 
agreement and finalize documents.
    There are various entities involved throughout the negotiation 
process. For example, a Tribal government selects its representative(s) 
for the Tribal negotiation team, which may include a Tribal leader from 
the governing body, a Tribal health director, technical and program 
staff, legal counsel, and other consultants. Regardless of the 
composition of the Tribal team, Tribal representatives must have 
decision-making authority from the Tribal governing body to 
successfully negotiate and agree to the provisions within the 
agreements. The Federal negotiation team is led by the ALN and may 
include area and headquarters subject matter experts, OTSG staff, the 
Office of Finance and Accounting, and the Office

[[Page 26571]]

of the General Counsel. The ALN is the only member of the Federal 
negotiation team with delegated authority to negotiate on behalf of the 
IHS Director. The ALN is the designated official that provides Tribes 
with Self-Governance information, assists Tribes in planning, organizes 
meetings between the Tribe and the IHS, and coordinates the agency's 
response to Tribal questions during the negotiation process. The ALN 
role requires detailed knowledge of the IHS, awareness of current 
policy and practice, and understanding of the rights and authorities 
available to a Tribe under Title V of the ISDEAA.
    In post-negotiations, the mutually agreed to and negotiated Compact 
and FA are signed by the authorizing Tribal official and submitted to 
the OTSG in preparation for the IHS Director's signature. Once the 
Compact and FA have been signed by both parties, they become legally 
binding and enforceable agreements. A signed Compact and FA are 
necessary for the payment process to begin. The negotiating Tribe then 
becomes a ``Self-Governance Tribe'' and a participant in the TSGP.
    Acquiring a Negotiation Cooperative Agreement is not a prerequisite 
to enter the TSGP. A Tribe may use other resources to develop and 
negotiate its Compact and FA. See 42 CFR 137.26. Tribes that receive a 
Negotiation Cooperative Agreement are not obligated to participate in 
Title V and may choose to delay or decline participation or expansion 
in the TSGP.

II. Award Information

Funding Instrument--Cooperative Agreement

Estimated Funds Available
    The total funding identified for fiscal year (FY) 2023 is 
approximately $420,000. The IHS anticipates individual award amounts 
will be $84,000. The funding available for competing awards issued 
under this announcement is subject to the availability of 
appropriations and budgetary priorities of the Agency. The IHS is under 
no obligation to make awards to applicants selected for funding under 
this announcement.
Anticipated Number of Awards
    The IHS anticipates issuing approximately five awards under this 
program announcement.
Period of Performance
    The period of performance is for 1 year.
Cooperative Agreement
    Cooperative agreements awarded by the Department of Health and 
Human Services (HHS) are administered under the same policies as 
grants. However, the funding agency, IHS, is anticipated to have 
substantial programmatic involvement in the project during the entire 
period of performance. Below is a detailed description of the level of 
involvement required of the IHS.
Substantial Agency Involvement Description for Cooperative Agreement
    A. Provide descriptions of PSFAs and associated funding at all 
organizational levels (service unit, area, and headquarters) including 
funding formulas and methodologies related to determining Tribal 
shares.
    B. Meet with Negotiation Cooperative Agreement recipients to 
provide program information and discuss methods currently used to 
manage and deliver health care.
    C. Identify and provide statutes, regulations, and policies that 
provide authority for administering IHS programs.
    D. Provide technical assistance on the IHS budget, Tribal shares, 
and other topics as needed.

III. Eligibility Information

1. Eligibility

    To be eligible for this opportunity, an applicant must meet the 
following criteria:
     Applicant must be an ``Indian Tribe'' as defined in 25 
U.S.C. 5304(e); a ``Tribal Organization'' as defined in 25 U.S.C. 
5304(l); or an ``Inter-Tribal Consortium'' as defined at 42 CFR 137.10. 
Please note that Tribes prohibited from contracting pursuant to the 
ISDEAA are not eligible. See section 424(a) of the Consolidated 
Appropriations Act, 2014, Public Law 113-76, as amended by section 445 
of the Consolidated Appropriations Act, 2023, Public Law 117-328.
     Pursuant to 25 U.S.C. 5383(c)(1)(B), applicant must 
request participation in self-governance by resolution or other 
official action by the governing body of each Indian Tribe to be 
served.
     Pursuant to 25 U.S.C. 5383(c)(1)(C), applicant must 
demonstrate financial stability and financial management capability for 
3 fiscal years.
    Meeting the eligibility criteria for a Negotiation Cooperative 
Agreement does not mean that a T/TO is eligible for participation in 
the IHS TSGP under Title V of the ISDEAA. See 25 U.S.C. 5383, 42 CFR 
137.15-23. For additional information on the eligibility for the IHS 
TSGP, please visit the ``Eligibility and Funding'' page on the OTSG 
website located at https://www.ihs.gov/SelfGovernance. The Division of 
Grants Management (DGM) will notify any applicants deemed ineligible.

2. Additional Information on Eligibility

    The IHS does not fund concurrent projects. If an applicant is 
successful under this announcement, any subsequent applications in 
response to other Tribal Self-Governance Negotiation Cooperative 
Agreement Program announcements from the same applicant will not be 
funded. Applications on behalf of individuals (including sole 
proprietorships) and foreign organizations are not eligible and will be 
disqualified from competitive review and funding under this funding 
opportunity.

    Note:  Please refer to Section IV.2 (Application and Submission 
Information/Subsection 2, Content and Form of Application 
Submission) for additional proof of applicant status documents 
required, such as Tribal Resolutions, proof of nonprofit status, 
etc.

3. Cost Sharing or Matching

    The IHS does not require matching funds or cost sharing for grants 
or cooperative agreements.

4. Other Requirements

    Applications with budget requests that exceed the highest dollar 
amount outlined under Section II Award Information, Estimated Funds 
Available, or exceed the period of performance outlined under Section 
II Award Information, Period of Performance, are considered not 
responsive and will not be reviewed. The DGM will notify the applicant.
Additional Required Documentation
Tribal Resolution
    The DGM must receive an official, signed Tribal Resolution prior to 
issuing a Notice of Award (NoA) to any T/TO selected for funding. An 
applicant that is proposing a project affecting another Indian Tribe 
must include resolutions from all affected Tribes to be served. 
However, if an official signed Tribal Resolution cannot be submitted 
with the application prior to the application deadline date, a draft 
Tribal Resolution must be submitted with the application by the 
deadline date in order for the application to be considered complete 
and eligible for review. The draft Tribal Resolution is not in lieu of 
the required signed resolution but is acceptable until a signed 
resolution is received. If an application without a signed Tribal 
Resolution is selected for funding, the applicant will be contacted by 
the

[[Page 26572]]

Grants Management Specialist (GMS) listed in this funding announcement 
and given 90 days to submit an official signed Tribal Resolution to the 
GMS. If the signed Tribal Resolution is not received within 90 days, 
the award will be forfeited.
    Applicants organized with a governing structure other than a Tribal 
council may submit an equivalent document commensurate with their 
governing organization.

IV. Application and Submission Information

    Grants.gov uses a Workspace model for accepting applications. The 
Workspace consists of several online forms and three forms in which to 
upload documents--Project Narrative, Budget Narrative, and Other 
Documents. Give your files brief descriptive names. The filenames are 
key in finding specific documents during the merit review and in 
processing awards. Upload all requested and optional documents 
individually, rather than combining them into a single file. Creating a 
single file creates confusion when trying to find specific documents. 
Such confusion can contribute to delays in processing awards, and could 
lead to lower scores during the merit review.

1. Obtaining Application Materials

    The application package and detailed instructions for this 
announcement are available at https://www.Grants.gov.
    Please direct questions regarding the application process to 
[email protected].

2. Content and Form Application Submission

    Mandatory documents for all applicants include:
     Application forms:
    1. SF-424, Application for Federal Assistance.
    2. SF-424A, Budget Information--Non-Construction Programs.
    3. SF-424B, Assurances--Non-Construction Programs.
    4. Project Abstract Summary form.
     Project Narrative (not to exceed 10 pages). See Section 
IV.2.A, Project Narrative for instructions.
    1. Background information on the organization.
    2. Proposed scope of work, objectives, and activities that provide 
a description of what the applicant plans to accomplish.
     Budget Narrative (not to exceed 5 pages). See Section 
IV.2.B, Budget Narrative for instructions.
     One-page Timeframe of award activities.
     Tribal Resolution(s) as described in Section III, 
Eligibility.
     Biographical sketches for all Key Personnel.
     Contractor/Consultant resumes or qualifications and scope 
of work.
     Disclosure of Lobbying Activities (SF-LLL), if applicant 
conducts reportable lobbying.
     Certification Regarding Lobbying (GG-Lobbying Form).
     Copy of current Negotiated Indirect Cost (IDC) rate 
agreement (required in order to receive IDC).
     Organizational Chart (optional).
     Documentation sufficient to demonstrate financial 
stability and financial management capability for 3 fiscal years. The 
Indian Tribe must provide evidence that, for the 3 fiscal years prior 
to requesting participation in the TSGP, the Indian Tribe has had no 
uncorrected significant and material audit exceptions in the required 
annual audit of the Indian Tribe's Self-Determination Contracts or 
Self-Governance Funding Agreements with any Federal agency. See 25 
U.S.C. 5383, 42 CFR 137.15-23. For T/TO that expended $500,000 or more 
in Federal awards, the OTSG shall retrieve the audits directly from the 
Federal Audit Clearinghouse. For T/TO that expended less than $500,000 
in Federal awards, the T/TO must provide evidence of the program review 
correspondence from the IHS or Bureau of Indian Affairs officials. See 
42 CFR 137.21-23.
     Documentation of current Office of Management and Budget 
(OMB) Financial Audit.
    Acceptable forms of documentation include:
    1. Email confirmation from Federal Audit Clearinghouse (FAC) that 
audits were submitted; or
    2. Face sheets from audit reports. Applicants can find these on the 
FAC website at https://facdissem.census.gov/.
Public Policy Requirements
    All Federal public policies apply to IHS grants and cooperative 
agreements. Pursuant to 45 CFR 80.3(d), an individual shall not be 
deemed subjected to discrimination by reason of their exclusion from 
benefits limited by Federal law to individuals eligible for benefits 
and services from the IHS. See https://www.hhs.gov/grants/grants/grants-policies-regulations/.
Requirements for Project and Budget Narratives
    A. Project Narrative: This narrative should be a separate document 
that is no more than 10 pages and must: (1) have consecutively numbered 
pages; (2) use black font 12 points or larger (applicants may use 10-
point font for tables); (3) be single-spaced; and (4) be formatted to 
fit standard letter paper (8\1/2\ x 11 inches). Do not combine this 
document with any others.
    Be sure to succinctly answer all questions listed under the 
evaluation criteria (refer to Section V.1, Evaluation Criteria), and 
place all responses and required information in the correct section 
noted below or they will not be considered or scored. If the narrative 
exceeds the overall page limit, the reviewers will be directed to 
ignore any content beyond the page limit. The 10-page limit for the 
project narrative does not include the work plan, standard forms, 
Tribal Resolutions, budget, budget narratives, and/or other items. Page 
limits for each section within the project narrative are guidelines, 
not hard limits.
    There are three parts to the project narrative: Part 1--Program 
Information; Part 2--Program Planning and Evaluation; and Part 3--
Program Report. See below for additional details about what must be 
included in the narrative.
    The page limits below are for each narrative and budget submitted.
Part 1: Program Information (Limit--4 Pages)
Section 1: Needs
    Demonstrate that the Tribe has conducted previous Self-Governance 
planning activities by clearly stating the results of what was learned 
during the planning process. Explain how the Tribe has determined it 
has the knowledge and expertise to assume or expand PSFAs and the 
administrative infrastructure to support the assumption of PSFAs. 
Identify the need for assistance and how the Negotiation Cooperative 
Agreement would benefit the health activities the Tribe is preparing to 
assume or expand.
Part 2: Program Planning and Evaluation (Limit--4 Pages)
Section 1: Program Plans
    State in measurable terms the objectives and appropriate activities 
to achieve the following Negotiation Cooperative Agreement recipient 
award activities:
    (A) Determine the PSFAs that will be negotiated into the Tribe's 
Compact and FA. Prepare and discuss each PSFA in comparison to the 
current level of services provided so that an informed decision can be 
made on new or expanded program assumption.
    (B) Identify Tribal shares associated with the PSFAs that will be 
included in the FA.
    (C) Develop the terms and conditions that will be set forth in both 
the

[[Page 26573]]

Compact and FA to submit to the ALN prior to negotiations.
    Describe fully and clearly how the Tribe's proposal will result in 
an improved approach to managing the PSFAs to be assumed or expanded. 
Include how the Tribe plans to demonstrate improved health services to 
the community and incorporate the proposed timelines for negotiations.
Section 2: Program Evaluation
    Describe fully and clearly how the goals and proposed activities 
will improve the health care system and identify the anticipated or 
expected benefits for the Tribe. Define the criteria to be used to 
evaluate objectives associated with the project using a model for 
tracking.
Part 3: Program Report (Limit--2 Pages)
Section 1
    Describe your organization's significant program activities and 
accomplishments over the past several years associated with the goals 
of this announcement and leading up to the negotiation phase.
    Please identify and describe significant program activities and 
achievements associated with the delivery of quality health services. 
Provide a comparison of the actual accomplishments to the goals 
established for the project period or, if applicable, provide 
justification for the lack of progress.
B. Budget Narrative (Limit--5 Pages)
    Provide a budget narrative that explains the amounts requested for 
each line item of the budget from the SF-424A (Budget Information for 
Non-Construction Programs) for the project. The applicant can submit 
with the budget narrative a more detailed spreadsheet than is provided 
by the SF-424A (the spreadsheet will not be considered part of the 
budget narrative). The budget narrative should specifically describe 
how each item would support the achievement of proposed objectives. Be 
very careful about showing how each item in the ``Other'' category is 
justified. Do NOT use the budget narrative to expand the project 
narrative.

3. Submission Dates and Times

    Applications must be submitted through Grants.gov by 11:59 p.m. 
Eastern Time on the Application Deadline Date. Any application received 
after the application deadline will not be accepted for review. 
Grants.gov will notify the applicant via email if the application is 
rejected.
    If technical challenges arise and assistance is required with the 
application process, contact Grants.gov Customer Support (see contact 
information at https://www.Grants.gov). If problems persist, contact 
Mr. Paul Gettys, Deputy Director, DGM, by email at [email protected]. Please 
be sure to contact Mr. Gettys at least 10 days prior to the application 
deadline. Please do not contact the DGM until you have received a 
Grants.gov tracking number. In the event you are not able to obtain a 
tracking number, call the DGM as soon as possible.
    The IHS will not acknowledge receipt of applications.

4. Intergovernmental Review

    Executive Order 12372 requiring intergovernmental review is not 
applicable to this program.

5. Funding Restrictions

     Pre-award costs are not allowable.
     The available funds are inclusive of direct and indirect 
costs.
     Only one cooperative agreement may be awarded per 
applicant.

6. Electronic Submission Requirements

    All applications must be submitted via Grants.gov. Please use the 
https://www.Grants.gov website to submit an application. Find the 
application by selecting the ``Search Grants'' link on the homepage. 
Follow the instructions for submitting an application under the Package 
tab. No other method of application submission is acceptable.
    If you cannot submit an application through Grants.gov, you must 
request a waiver prior to the application due date. You must submit 
your waiver request by email to [email protected]. Your waiver request must 
include clear justification for the need to deviate from the required 
application submission process. The IHS will not accept any 
applications submitted through any means outside of Grants.gov without 
an approved waiver.
    If the DGM approves your waiver request, you will receive a 
confirmation of approval email containing submission instructions. You 
must include a copy of the written approval with the application 
submitted to the DGM. Applications that do not include a copy of the 
waiver approval from the DGM will not be reviewed. The Grants 
Management Officer of the DGM will notify the applicant via email of 
this decision. Applications submitted under waiver must be received by 
the DGM no later than 5:00 p.m. Eastern Time on the Application 
Deadline Date. Late applications will not be accepted for processing. 
Applicants that do not register for both the System for Award 
Management (SAM) and Grants.gov and/or fail to request timely 
assistance with technical issues will not be considered for a waiver to 
submit an application via alternative method.
    Please be aware of the following:
     Please search for the application package in https://www.Grants.gov by entering the Assistance Listing number or the Funding 
Opportunity Number. Both numbers are located in the header of this 
announcement.
     If you experience technical challenges while submitting 
your application, please contact Grants.gov Customer Support (see 
contact information at https://www.Grants.gov).
     Upon contacting Grants.gov, obtain a tracking number as 
proof of contact. The tracking number is helpful if there are technical 
issues that cannot be resolved and a waiver from the agency must be 
obtained.
     Applicants are strongly encouraged not to wait until the 
deadline date to begin the application process through Grants.gov as 
the registration process for SAM and Grants.gov could take up to 20 
working days.
     Please follow the instructions on Grants.gov to include 
additional documentation that may be requested by this funding 
announcement.
     Applicants must comply with any page limits described in 
this funding announcement.
     After submitting the application, you will receive an 
automatic acknowledgment from Grants.gov that contains a Grants.gov 
tracking number. The IHS will not notify you that the application has 
been received.
System for Award Management
    Organizations that are not registered with the System for Award 
Management (SAM) must access the SAM online registration through the 
SAM home page at https://sam.gov. Organizations based in the U.S. will 
also need to provide an Employer Identification Number from the 
Internal Revenue Service that may take an additional 2-5 weeks to 
become active. Please see SAM.gov for details on the registration 
process and timeline. Registration with the SAM is free of charge but 
can take several weeks to process. Applicants may register online at 
https://sam.gov.
Unique Entity Identifier
    Your SAM.gov registration now includes a Unique Entity Identifier 
(UEI), generated by SAM.gov, which replaces the DUNS number obtained 
from Dun and Bradstreet. SAM.gov registration no longer requires a DUNS 
number.
    Check your organization's SAM.gov registration as soon as you 
decide to apply for this program. If your SAM.gov

[[Page 26574]]

registration is expired, you will not be able to submit an application. 
It can take several weeks to renew it or resolve any issues with your 
registration, so do not wait.
    Check your Grants.gov registration. Registration and role 
assignments in Grants.gov are self-serve functions. One user for your 
organization will have the authority to approve role assignments, and 
these must be approved for active users in order to ensure someone in 
your organization has the necessary access to submit an application.
    The Federal Funding Accountability and Transparency Act of 2006, as 
amended (``Transparency Act''), requires all HHS recipients to report 
information on sub-awards. Accordingly, all IHS recipients must notify 
potential first-tier sub-recipients that no entity may receive a first-
tier sub-award unless the entity has provided its UEI number to the 
prime recipient organization. This requirement ensures the use of a 
universal identifier to enhance the quality of information available to 
the public pursuant to the Transparency Act.
    Additional information on implementing the Transparency Act, 
including the specific requirements for SAM, are available on the DGM 
Grants Management, Policy Topics web page at https://www.ihs.gov/dgm/policytopics/.

V. Application Review Information

    Possible points assigned to each section are noted in parentheses. 
The project narrative and budget narrative should include only the 
first year of activities. The project narrative should be written in a 
manner that is clear to outside reviewers unfamiliar with prior related 
activities of the applicant. It should be well organized, succinct, and 
contain all information necessary for reviewers to fully understand the 
project. Attachments requested in the criteria do not count toward the 
page limit for the narratives. Points will be assigned to each 
evaluation criteria adding up to a total of 100 possible points. Points 
are assigned as follows:

1. Evaluation Criteria

A. Introduction and Need for Assistance (25 Points)
    Demonstrate that the Tribe has conducted previous Self-Governance 
planning activities by clearly stating the results of what was learned 
during the planning process. Explain how the Tribe has determined it 
has the knowledge and expertise to assume or expand PSFAs and the 
administrative infrastructure to support the assumption of PSFAs. 
Identify the need for assistance and how the Negotiation Cooperative 
Agreement would benefit the health activities the Tribe is preparing to 
assume or expand.
B. Project Objective(s), Work Plan and Approach (25 Points)
    State in measurable terms the objectives and appropriate activities 
to achieve the following Negotiation Cooperative Agreement recipient 
award activities:
    1. Determine the PSFAs that will be negotiated into the Tribe's 
Compact and FA. Prepare and discuss each PSFA in comparison to the 
level of services provided so that an informed decision can be made on 
new or expanded program assumption.
    2. Identify Tribal shares associated with the PSFAs that will be 
included in the FA.
    3. Develop the terms and conditions that will be set forth in both 
the Compact and FA to submit to the ALN prior to negotiations. Clearly 
describe how the Tribe's proposal will result in an improved approach 
to managing the PSFAs to be assumed or expanded. Include how the Tribe 
plans to demonstrate improved health care services to the community and 
incorporate the proposed timelines for negotiations.
C. Program Evaluation (25 Points)
    Describe fully the improvements that will be made by the Tribe to 
manage the health care system and identify the anticipated or expected 
benefits for the Tribe. Define the criteria to be used to evaluate 
objectives associated with the project and how they will be measured.
D. Organizational Capabilities, Key Personnel, and Qualifications (15 
Points)
    Describe the organizational structure of the Tribe and its ability 
to manage the proposed project. Include resumes or position 
descriptions of key staff showing requisite experience and expertise. 
If applicable, include resumes and scope of work for consultants that 
demonstrate experience and expertise relevant to the project.
E. Categorical Budget and Budget Justification (10 Points)
    Submit a budget with a narrative describing the budget request and 
matching the scope of work described in the project narrative. Justify 
all expenditures identifying reasonable and allowable costs necessary 
to accomplish the goals and objectives as outlined in the project 
narrative.
    Additional documents can be uploaded as Other Attachments in 
Grants.gov.
    These can include:
     Work plan, logic model, and/or timeline for proposed 
objectives.
     Position descriptions for key staff.
     Resumes of key staff that reflect current duties.
     Consultant or contractor proposed scope of work and letter 
of commitment (if applicable).
     Current Indirect Cost Rate Agreement.
     Organizational chart.
     Map of area identifying project location(s).
     Additional documents to support narrative (i.e., data 
tables, key news articles, etc.).

2. Review and Selection

    Each application will be prescreened for eligibility and 
completeness as outlined in the funding announcement. Applications that 
meet the eligibility criteria shall be reviewed for merit by the Review 
Committee (RC) based on the evaluation criteria. Incomplete 
applications and applications that are not responsive to the 
administrative thresholds (budget limit, period of performance limit) 
will not be referred to the RC and will not be funded. The DGM will 
notify the applicant of this determination.
    Applicants must address all program requirements and provide all 
required documentation.

3. Notifications of Disposition

    All applicants will receive an Executive Summary Statement from the 
OTSG within 30 days of the conclusion of the RC outlining the strengths 
and weaknesses of their application. The summary statement will be sent 
to the Authorizing Official identified on the face page (SF-424) of the 
application.
A. Award Notices for Funded Applications
    The NoA is the authorizing document for which funds are dispersed 
to the approved entities and reflects the amount of Federal funds 
awarded, the purpose of the award, the terms and conditions of the 
award, the effective date of the award, the budget period, and period 
of performance. Each entity approved for funding must have a user 
account in GrantSolutions in order to retrieve the NoA. Please see the 
Agency Contacts list in Section VII for the systems contact 
information.
B. Approved but Unfunded Applications
    Approved applications not funded due to lack of available funds 
will be

[[Page 26575]]

held for 1 year. If funding becomes available during the course of the 
year, the application may be reconsidered.

    Note: Any correspondence, other than the official NoA executed 
by an IHS grants management official announcing to the project 
director that an award has been made to their organization, is not 
an authorization to implement their program on behalf of the IHS.

VI. Award Administration Information

1. Administrative Requirements

    Awards issued under this announcement are subject to, and are 
administered in accordance with, the following regulations and 
policies:
    A. The criteria as outlined in this program announcement.
    B. Administrative Regulations for Awards:
     Uniform Administrative Requirements, Cost Principles, and 
Audit Requirements for HHS Awards currently in effect or implemented 
during the period of award, other Department regulations and policies 
in effect at the time of award, and applicable statutory provisions. At 
the time of publication, this includes 45 CFR part 75, at https://www.govinfo.gov/content/pkg/CFR-2021-title45-vol1/pdf/CFR-2021-title45-vol1-part75.pdf.
     Please review all HHS regulatory provisions for 
Termination at 45 CFR 75.372, at the time of this publication located 
at https://www.govinfo.gov/content/pkg/CFR-2021-title45-vol1/pdf/CFR-2021-title45-vol1-sec75-372.pdf.
    C. Grants Policy:
     HHS Grants Policy Statement, Revised January 2007, at 
https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf.
    D. Cost Principles:
     Uniform Administrative Requirements for HHS Awards, ``Cost 
Principles,'' at 45 CFR part 75 subpart E, at the time of this 
publication located at https://www.govinfo.gov/content/pkg/CFR-2021-title45-vol1/pdf/CFR-2021-title45-vol1-part75-subpartE.pdf.
    E. Audit Requirements:
     Uniform Administrative Requirements for HHS Awards, 
``Audit Requirements,'' at 45 CFR part 75 subpart F, at the time of 
this publication located at https://www.govinfo.gov/content/pkg/CFR-2021-title45-vol1/pdf/CFR-2021-title45-vol1-part75-subpartF.pdf.
    F. As of August 13, 2020, 2 CFR part 200 was updated to include a 
prohibition on certain telecommunications and video surveillance 
services or equipment. This prohibition is described in 2 CFR part 
200.216. This will also be described in the terms and conditions of 
every IHS grant and cooperative agreement awarded on or after August 
13, 2020.

2. Indirect Costs

    This section applies to all recipients that request reimbursement 
of IDC in their application budget. In accordance with HHS Grants 
Policy Statement, Part II-27, the IHS requires applicants to obtain a 
current IDC rate agreement and submit it to the DGM prior to the DGM 
issuing an award. The rate agreement must be prepared in accordance 
with the applicable cost principles and guidance as provided by the 
cognizant agency or office. A current rate covers the applicable award 
activities under the current award's budget period. If the current rate 
agreement is not on file with the DGM at the time of award, the IDC 
portion of the budget will be restricted. The restrictions remain in 
place until the current rate agreement is provided to the DGM.
    Per 2 CFR 200.414(f) Indirect (F&A) costs,

any non-Federal entity (NFE) [i.e., applicant] that does not have a 
current negotiated rate, . . . may elect to charge a de minimis rate 
of 10 percent of modified total direct costs which may be used 
indefinitely. As described in Section 200.403, costs must be 
consistently charged as either indirect or direct costs, but may not 
be double charged or inconsistently charged as both. If chosen, this 
methodology once elected must be used consistently for all Federal 
awards until such time as the NFE chooses to negotiate for a rate, 
which the NFE may apply to do at any time.

    Electing to charge a de minimis rate of 10 percent can be used by 
applicants that have received an approved negotiated indirect cost rate 
from HHS or another cognizant Federal agency. Applicants awaiting 
approval of their indirect cost proposal may request the 10 percent de 
minimis rate. When the applicant chooses this method, costs included in 
the indirect cost pool must not be charged as direct costs to the 
award.
    Available funds are inclusive of direct and appropriate indirect 
costs. Approved indirect funds are awarded as part of the award amount, 
and no additional funds will be provided.
    Generally, IDC rates for IHS recipients are negotiated with the 
Division of Cost Allocation at https://rates.psc.gov/ or the Department 
of the Interior (Interior Business Center) at https://ibc.doi.gov/ICS/tribal. For questions regarding the indirect cost policy, please write 
to [email protected].

3. Reporting Requirements

    The recipient must submit required reports consistent with the 
applicable deadlines. Failure to submit required reports within the 
time allowed may result in suspension or termination of an active 
award, withholding of additional awards for the project, or other 
enforcement actions such as withholding of payments or converting to 
the reimbursement method of payment. Continued failure to submit 
required reports may result in the imposition of special award 
provisions and/or the non-funding or non-award of other eligible 
projects or activities. This requirement applies whether the 
delinquency is attributable to the failure of the recipient 
organization or the individual responsible for preparation of the 
reports. Per DGM policy, all reports must be submitted electronically 
by attaching them as a ``Grant Note'' in GrantSolutions. Personnel 
responsible for submitting reports will be required to obtain a login 
and password for GrantSolutions. Please use the form under the 
Recipient User section of https://www.grantsolutions.gov/home/getting-started-request-a-user-account/. Download the Recipient User Account 
Request Form, fill it out completely, and submit it as described on the 
web page and in the form.
    The reporting requirements for this program are noted below.
A. Progress Reports
    Program progress reports are required semi-annually. The progress 
reports are due within 30 days after the reporting period ends 
(specific dates will be listed in the NoA Terms and Conditions). These 
reports must include a brief comparison of actual accomplishments to 
the goals established for the period, a summary of progress to date or, 
if applicable, provide sound justification for the lack of progress, 
and other pertinent information as required. A final report must be 
submitted within 120 days of the period of performance end date.
B. Financial Reports
    Federal Financial Reports are due 90 days after the end of each 
budget period, and a final report is due 120 days after the end of the 
period of performance.
    Recipients are responsible and accountable for reporting accurate 
information on all required reports: the Progress Reports and the 
Federal Financial Report.
    Failure to submit timely reports may result in adverse award 
actions blocking access to funds.

[[Page 26576]]

C. Federal Sub-Award Reporting System (FSRS)
    This award may be subject to the Transparency Act sub-award and 
executive compensation reporting requirements of 2 CFR part 170.
    The Transparency Act requires the OMB to establish a single 
searchable database, accessible to the public, with information on 
financial assistance awards made by Federal agencies. The Transparency 
Act also includes a requirement for recipients of Federal awards to 
report information about first-tier sub-awards and executive 
compensation under Federal assistance awards.
    The IHS has implemented a Term of Award into all IHS Standard Terms 
and Conditions, NoAs, and funding announcements regarding the FSRS 
reporting requirement. This IHS Term of Award is applicable to all IHS 
grant and cooperative agreements issued on or after October 1, 2010, 
with a $25,000 sub-award obligation threshold met for any specific 
reporting period.
    For the full IHS award term implementing this requirement and 
additional award applicability information, visit the DGM Grants 
Management website at https://www.ihs.gov/dgm/policytopics/.
D. Non-Discrimination Legal Requirements for Recipients of Federal 
Financial Assistance (FFA)
    The recipient must administer the project in compliance with 
Federal civil rights laws, where applicable, that prohibit 
discrimination on the basis of race, color, national origin, 
disability, age, and comply with applicable conscience protections. The 
recipient must comply with applicable laws that prohibit discrimination 
on the basis of sex, which includes discrimination on the basis of 
gender identity, sexual orientation, and pregnancy. Compliance with 
these laws requires taking reasonable steps to provide meaningful 
access to persons with limited English proficiency and providing 
programs that are accessible to and usable by persons with 
disabilities. The HHS Office for Civil Rights provides guidance on 
complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/ 
and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/.
     Recipients of FFA must ensure that their programs are 
accessible to persons with limited English proficiency. For guidance on 
meeting your legal obligation to take reasonable steps to ensure 
meaningful access to your programs or activities by limited English 
proficiency individuals, see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/ and https://www.lep.gov.
     For information on your specific legal obligations for 
serving qualified individuals with disabilities, including reasonable 
modifications and making services accessible to them, see https://www.hhs.gov/civil-rights/for-individuals/disability/.
     HHS funded health and education programs must be 
administered in an environment free of sexual harassment. See https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/.
     For guidance on administering your program in compliance 
with applicable Federal religious nondiscrimination laws and applicable 
Federal conscience protection and associated anti-discrimination laws, 
see https://www.hhs.gov/conscience/conscience-protections/ 
and https://www.hhs.gov/conscience/religious-freedom/.
     Pursuant to 45 CFR 80.3(d), an individual shall not be 
deemed subjected to discrimination by reason of their exclusion from 
benefits limited by Federal law to individuals eligible for benefits 
and services from the IHS.
E. Federal Awardee Performance and Integrity Information System 
(FAPIIS)
    The IHS is required to review and consider any information about 
the applicant that is in the FAPIIS at https://www.fapiis.gov/fapiis/#/home before making any award in excess of the simplified acquisition 
threshold (currently $250,000) over the period of performance. An 
applicant may review and comment on any information about itself that a 
Federal awarding agency previously entered. The IHS will consider any 
comments by the applicant, in addition to other information in FAPIIS, 
in making a judgment about the applicant's integrity, business ethics, 
and record of performance under Federal awards when completing the 
review of risk posed by applicants, as described in 45 CFR 75.205.
    As required by 45 CFR part 75 Appendix XII of the Uniform Guidance, 
NFEs are required to disclose in FAPIIS any information about criminal, 
civil, and administrative proceedings, and/or affirm that there is no 
new information to provide. This applies to NFEs that receive Federal 
awards (currently active grants, cooperative agreements, and 
procurement contracts) greater than $10 million for any period of time 
during the period of performance of an award/project.
Mandatory Disclosure Requirements
    As required by 2 CFR part 200 of the Uniform Guidance, and HHS 
implementing regulations at 45 CFR part 75, the IHS must require an NFE 
or an applicant for a Federal award to disclose, in a timely manner, in 
writing to the IHS or pass-through entity all violations of Federal 
criminal law involving fraud, bribery, or gratuity violations 
potentially affecting the Federal award.
    All applicants and recipients must disclose in writing, in a timely 
manner, to the IHS and to the HHS Office of Inspector General all 
information related to violations of Federal criminal law involving 
fraud, bribery, or gratuity violations potentially affecting the 
Federal award. 45 CFR 75.113.
    Disclosures must be sent in writing to:

U.S. Department of Health and Human Services, Indian Health Service, 
Division of Grants Management, ATTN: Marsha Brookins, Director, 5600 
Fishers Lane, Mail Stop: 09E70, Rockville, MD 20857, (Include 
``Mandatory Grant Disclosures'' in subject line), Office: (301) 443-
5204, Fax: (301) 594-0899, Email: [email protected]

AND

U.S. Department of Health and Human Services, Office of Inspector 
General, ATTN: Mandatory Grant Disclosures, Intake Coordinator, 330 
Independence Avenue SW, Cohen Building, Room 5527, Washington, DC 
20201, URL: https://oig.hhs.gov/fraud/report-fraud/, (Include 
``Mandatory Grant Disclosures'' in subject line), Fax: (202) 205-0604 
(Include ``Mandatory Grant Disclosures'' in subject line) or, Email: 
[email protected]

    Failure to make required disclosures can result in any of the 
remedies described in 45 CFR 75.371 Remedies for noncompliance, 
including suspension or debarment (see 2 CFR part 180 and 2 CFR part 
376).

VII. Agency Contacts

    1. Questions on the program matters may be directed to: Roxanne 
Houston, Program Officer, Indian Health Service, Office of Tribal Self-
Governance, 5600 Fishers Lane, Mail Stop: 08E09B, Rockville, MD 20857, 
Phone: (301) 443-7821, Email: [email protected], Website: https://www.ihs.gov/SelfGovernance/.
    2. Questions on awards management and fiscal matters may be 
directed to:

[[Page 26577]]

Indian Health Service, Division of Grants Management, 5600 Fishers 
Lane, Mail Stop: 09E70, Rockville, MD 20857, Email: [email protected].
    3. For technical assistance with Grants.gov, please contact the 
Grants.gov help desk at 800-518-4726, or by email at 
[email protected].
    4. For technical assistance with GrantSolutions, please contact the 
GrantSolutions help desk at (866) 577-0771, or by email at 
[email protected].

VIII. Other Information

    The Public Health Service strongly encourages all grant, 
cooperative agreement, and contract recipients to provide a smoke-free 
workplace and promote the non-use of all tobacco products. In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of the facility) in 
which regular or routine education, library, day care, health care, or 
early childhood development services are provided to children. This is 
consistent with the HHS mission to protect and advance the physical and 
mental health of the American people.

P. Benjamin Smith,
Deputy Director, Indian Health Service.
[FR Doc. 2023-09097 Filed 4-28-23; 8:45 am]
BILLING CODE 4165-16-P


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