National Institute on Minority Health and Health Disparities Research Endowment Programs

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <CFR>42 CFR Part 52i</CFR> <DEPDOC>[Docket No. NIH-2022-0001]</DEPDOC> <RIN>RIN 0925-AA70</RIN> <SUBJECT>National Institute on Minority Health and Health Disparities Research Endowment Programs</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> National Institutes of Health, HHS. <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Department of Health and Human Services (HHS or Department), through the National Institutes of Health (NIH), is amending the regulation governing the National Institute on Minority Health and Health Disparities (NIMHD) Research Endowment Programs (REP) to update the heading of the regulation to reflect the new name of the program, the eligibility requirements for the program to indicate the new expanded eligibility for research endowment awards that is mandated by statute, the heading of one section of the regulation, and certain references to regulations and policies cited in the regulation that apply to program grant awards. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This final rule is effective January 3, 2025. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Daniel Hernandez, NIH Regulations Officer, Office of Management Assessment, NIH, Rockledge 1, 6705 Rockledge Drive, Suite 601, Room 601-T, Bethesda, MD 20817, MSC 7901, by email at <E T="03">dhernandez@mail.nih.gov,</E> or by telephone at 301-435-3343 (not a toll-free number). For program information contact: Dr. Nathan Stinson, Director, Division of Community Health and Population Sciences, NIMHD, by email <E T="03">stinsonn@nih.gov,</E> or telephone 301-594-8704. Information concerning the requirements, application deadline dates, and an on-line application for NIMHD REP awards may be obtained from the NIMHD via <E T="03">https://www.nimhd.nih.gov/programs/extramural/research-endowment.html.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background and Statutory Mandate</HD> On March 18, 2022, the President signed into law the John Lewis NIMHD Research Endowment Revitalization Act of 2021, Public Law (Pub. L.) 117-104. Section 2 of this law amended section 464z-3(h) of the Public Health Service (PHS) Act, as amended (42 U.S.C. 285t(h)) by revising program eligibility requirements to include eligible current or former Health Resources and Services Administration (HRSA) centers of excellence under section 736 of the PHS Act and eligible current or former NIMHD centers of excellence under section 464z-4 of the PHS Act. The program was originally authorized under the Minority Health and Health Disparities Research and Education Act of 2000 (Pub. L. 106-525). The law provided annual funding for up to five years to the endowments of active eligible HRSA centers of excellence. In 2010, the Patient Protection and Affordable Care Act (Pub. L. 111-148) expanded eligibility to include active eligible NIMHD centers of excellence. Public Law 117-104, enacted in 2022, expanded the eligibility for NIMHD Research Endowment Program awards to eligible current or former HRSA and NIMHD centers of excellence. Endowment funds must be invested and maintained for at least 20 years after the award period ends. The objective of the program and its awards is to build research and training capacity and infrastructure at eligible HRSA or NIMHD centers of excellence to facilitate minority health and other health disparities research and to close the disparity gap in the burden of illness and death experienced by racial and ethnic minority Americans and other health disparity populations. Program activities may include strengthening the research infrastructure through the renovation of facilities, purchasing of state-of-the-art instruments and equipment, and enhancing information technology; enhancing the academic environment by recruiting faculty and creating relevant training courses focused on minority health and health disparities, in addition to the existing curriculum, such as research methodology and health disparities; and/or other relevant activities. The expansion of eligibility for the program, recently renamed the <E T="03">John Lewis</E> NIMHD Research Endowment Program, to include eligible current or former HRSA and NIMHD centers of excellence will serve to expand the national capacity of academic institutions to conduct research to improve minority health and reduce health disparities. Implementation of Public Law 17-104 necessitates HHS, through NIH, to update the regulation codified at 42 CFR part 52i that governs the program. Specifically, paragraph (a)(1) of § 52i.3 “Who is eligible to apply?” needs to be updated to specify the expanded statutory eligibility for program awards, such that eligible current or former centers of excellence under section 736 (42 U.S.C. 293) or section 464z-4 (42 U.S.C. 285t-1) of the PHS Act, respectively, may now apply. Additionally, following enactment of Public Law 117-104, NIMHD changed the name of the program from the NIMHD Research Endowment Program to the <E T="03">John Lewis</E> NIMHD Research Endowment Program to reflect the honor that the United States Congress bestowed upon John Lewis by naming the legislation expanding eligibility for the program after him. John Robert Lewis served in the U.S. House of Representatives, representing Georgia's 5th Congressional District from 1987 until his death in 2020 with longstanding commitment to improving minority health and health disparities. Consequently, the heading of the regulation that governs the program must be amended to reflect the new name of the program. Other aspects of the regulation also need to be updated. In the heading for § 52i.1 and in the accompanying Table of Contents reference to § 52i.1, the word “programs” in “To what programs does this part apply?” needs to be changed to “program” to correctly indicate that there is only one program to which part 52i applies, not multiple programs as the current heading incorrectly indicates. Additionally, in § 52i.13, “Other HHS policies and regulations that apply”, there are outdated references to several regulations and policies with URLs that are not operational. The current references in paragraph (f) “45 CFR part 74—Uniform administrative requirements for awards and subawards to institutions of higher education, hospitals, other nonprofit organizations, and commercial organizations; and the certain grants and agreements with states, local governments and Indian tribal governments”, and paragraph (m) “45 CFR part 92—Uniform administrative requirements for grants and cooperative agreements to State, local and tribal governments” are outdated and must be revised. The current references in paragraphs (o) concerning NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, (p) concerning NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, (q) concerning NIH Grants Policy Statement, and (r) concerning Public Health Service Policy on Humane Care and Use of Laboratory Animals contain outdated information and, in some cases, the URLs are not operational. These paragraphs need to be updated. Previously, HHS issued a direct final rule on November 16, 2020 (85 FR 72899-72912) amending certain regulations as part of its Regulatory Clean Up Initiative to make miscellaneous corrections, including correcting references to other regulations, misspellings, and other typographical errors. These corrections included several changes in 42 CFR part 52i. However, the revisions that now are necessary in § 52i.13 were not included in the direct final rule. HHS announced its intentions to initiate this rulemaking action in the notice of proposed rulemaking (NPRM) titled “National Institute on Minority Health and Health Disparities Research Endowment Programs” that was published in the <E T="04">Federal Register</E> on October 4, 2023 (88 FR 68553). The NPRM provided a sixty-day public comment period. The comment period ended December 4, 2023. In the NPRM, we proposed to amend the Code of Federal Regulations by revising the heading for 42 CFR part 52i to read “Part 52i— <E T="03">John Lewis</E> NIMHD Research Endowment Program” to reflect the new name of the program, the <E T="03">John Lewis</E> NIMHD Research Endowment Program. We proposed to amend the heading for § 52i.1 “To what programs does this part apply?” by removing the word “programs” and adding the word “program” in its place to indicate that there is only one program, the <E T="03">John Lewis</E> NIMHD Research Endowment Program, to which part 52i applies. Additionally, we proposed to amend § 52i.3 “Who is eligible to apply?” by revising paragraph (a)(1) to read as follows: “Must be a current or former center of excellence under section 736 (42 U.S.C. 293) or section 464z-4 (42 U.S.C. 285t-1) of the Act, and”. We further proposed to amend § 52i.13 “Other HHS policies and regulations that apply” by: (1) Revising current paragraph (f), (2) Removing current paragraph (m), and redesignating current paragraph (n) as new paragraph (m), (3) Redesignating current paragraph (o) as new paragraph (n) and revising it, (4) Redesignating current paragraph (p) as new paragraph (o) and revising it, (5) Redesignating current paragraph (q) as new paragraph (p) and revising it, (6) Redesignating current paragraph (r) as new paragraph (q) and revising it, and (7) Removing paragraph (r). We stated in the NPRM that making these changes was necessary to implement Public Law 117-104 and would ensure the regulation is up to date. We added that the rule, when finalized, would add transparency for potential applicants regarding who is eligible to apply for a grant under the <E T="03">John Lewis</E> NIMHD Research Endowment Program. <HD SOURC ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 29k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━