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 Department of Health and Human Services 42 CFR Part 52i
[Docket No. NIH-2022-0001]
RIN 0925-AA70
 AGENCY: National Institutes of Health, HHS.
 ACTION: Notice of proposed rulemaking.
 SUMMARY: The Department of Health and Human Services (HHS or Department), through the National Institutes of Health (NIH), is proposing to amend 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.
 DATES: Comments must be received on or before December 4, 2023.
 ADDRESSES: You may send comments, identified by Docket Number NIH 2022-0001 and/or RIN 0925-AA70, by any of the following methods: Electronic Submissions You may send comments electronically in the following way: *Federal eRulemaking Portal: www.regulations.gov.*
                     Follow the instructions for sending comments. Written Submissions You may send written comments in the following ways: Please allow enough time for mailed comments to be received before the close of the comment period. *Mail (for paper or CD-ROM submissions):*
                     Daniel Hernandez, NIH Regulations Officer, National Institutes of Health, Office of Management Assessment, Rockledge 1, 6705 Rockledge Drive, Suite 601, Room 601-T, MSC 7901, Bethesda, Maryland 20892-7901.
*Hand Delivery/Courier (for paper or CD-ROM submissions):*
                     Daniel Hernandez, Rockledge 1, 6705 Rockledge Drive, Suite 601, Room 601-T, MSC 7901, Bethesda, Maryland 20892-7901. *Instructions:*
                     All submissions received must include the agency name and docket number or Regulatory Information Number (RIN) for this rulemaking. All comments will be posted without change to 
                    *www.regulations.gov,*
                     including any personal information provided. *Docket:*
                     For access to the docket to read background documents or comments received, go to the eRulemaking Portal at 
                    *www.regulations.gov*
                     and insert the docket number provided in brackets in the heading on page one of this document into the: “Search” box and follow the prompts.
 FOR FURTHER INFORMATION CONTACT: 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 
                        *dhernandez@mail.nih.gov,*
                         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 
                        *stinsonn@nih.gov,*
                         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 
                        *https://www.nimhd.nih.gov/​programs/​extramural/​research-endowment.html.*


SUPPLEMENTARY INFORMATION:  I. Background and Statutory Mandate 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. The recently enacted Pub. L. 117-104 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 a diverse faculty and creating relevant courses, in addition to the existing curriculum, such as research methodology and health disparities; enhancing recruitment of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences; and/or other relevant activities. The expansion of eligibility for the program, recently renamed the 
                    *John Lewis*
                     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. Public Law 117-104 did not change program goals, which remain the same: assist institutions to build minority health and health disparities research capacity and infrastructure; increase the diversity and quality of the scientific workforce; and enhance the training in research methods to improve minority health and decrease health disparities. Also unchanged is the requirement that awardees provide a 5-year strategic plan that establishes priorities for the use and growth of endowment fund income that reflects these goals. Implementation of Public Law 117-104 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 
                    *John Lewis*
                     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. II. Summary of Proposed Changes With this NPRM, we propose to amend the Code of Federal Regulations by revising the heading for 42 CFR part 52i to read “Part 52i—
                    *John Lewis*
                     NIMHD Research Endowment Program” to reflect the new name of the program, the 
                    *John Lewis*
                     NIMHD Research Endowment Program. We propose 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 
                    *John Lewis*
                     NIMHD Research Endowment Program, to which part 52i applies. We propose 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 propose to amend § 52i.13 “Other HHS policies and regulations that apply” by: (1) Revising current paragraph (f);
                    ( print page 68555) (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). Making the changes that are necessary to implement Public Law 117-104 and the other changes will ensure the regulation is up to date. This rule, if and when finalized, will add transparency for potential applicants regarding who is eligible to apply for a grant under the 
                    *John Lewis*
                     NIMHD Research Endowment Program. Regulatory Impact Analysis We examined the impacts of this proposed rule under Executive Order (E.O.) 12866, Regulatory Planning and Review; E.O. 13563, Improving Regulation and Regulatory Review; E.O. 14094, Modernizing Regulatory Review; E.O. 13132, Federalism; the Regulatory Flexibility Act (5 U.S.C. 601-612); and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866, 13563, and 14094 E.O. 12866 and E.O. 13563, as supplemented and reaffirmed by E.O. 14094, direct Federal agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity) for all significant regulatory actions. A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects of $200 million or more in any one year, adjusted every 3 years by the Administrator of the Office of Information and Regulatory Affairs (OIRA). Based on our analysis, this rule which proposes changes of a technical nature does not constitute a significant or economically significant regulatory action, and an RIA is unnecessary. Executive Order 13132 Executive Order 13132, Federalism, requires Federal agencies to consult with State and local government officials in the development of regulatory policies with federalism implications. We reviewed the rulemaking as required under the Order and determined that it does not have any federalism implications. This rulemaking will not have effect on the states or on the distribution of power and responsibilities among the various levels of government. Regulatory Flexibility Act The Regulatory Flexibility Act (5 U.S.C. 601-612) requires agencies to analyze regulatory options that would minimize any significant impact of the rule on small entities. For this analysis, small entities include small business concerns as defined by the Small Business Administration (SBA), usually businesses with fewer than 500 employees. Also, a not-for-profit entity is defined by the Regulatory Flexibility Act as small if it is independently owned and operated and not dominant in its field, regardless of the number of employees. Eligibility requirements of the 
                    *John Lewis*
                     NIMHD Research Endowment Program, as codified in Public Law 117-104, limits the universe of potential applicants to an estimated maximum of 42 institutions of higher education (IHEs). Utilizing sources of information such as local business bureaus, workforce statistics, and institution websites, a reasonable determination can be made from the approximate number of employees of eligible institutions. The range estimates are from 51-200 employees for the smallest institution to 10,600 employees for the largest. While most eligible institutions are considered small entities, the impact of this rulemaking will not exceed 5 percent of revenues of the entities. Accordingly, the Secretary certifies this rulemaking will not have a significant impact on a significant number of small entities. Unfunded Mandates Reform Act of 1995 Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires agencies to prepare a written statement, to include an assessment of anticipated costs and benefits, before proposing any rule that includes a Federal mandate that may result in the expenditure by State, local and tribal governments or more, in the aggregate or by the private sector, of $100,000,000 [adjusted annually for inflation (with base year 1995)] in any 1 year. The current inflation-adjusted statutory threshold is approximately $156 million based on the Bureau of Labor Statistics inflation calculator. The Secretary certifies that this rulemaking does not mandate any spending by State, local, or tribal government in the aggregate or by the private sector. Participation in the 
                    *John Lewis*
                     NIMHD Research Endowment Program is voluntary and not mandated. Paperwork Reduction Act This proposed rule does not contain any new information collection requirements that are subject to Office of Management and Budget (OMB) approval under the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35). However, part 52i contains information collection and recordkeeping requirements. Specifically, §§ 52i.3(b)(2), 52i.4(a), 52i.4(c), 52i.5(a), 52i.9(b), 52i.11(b), and 52i.11(d) of part 52i contain reporting requirements, and §§ 52i.10, 52i.11(a)(1), 52i.11(a)(2), 52i.11(a)(3), 52i.11(a)(4), and 52i.11(b) of part 52i contain recordkeeping requirements. These reporting and recordkeeping requirements are addressed in the grant application forms per OMB Control Number 0925-0001 and 0925-0002, which address the instructions for SF-424 and SF-2590. There is nothing that needs to be done regarding the burden associated with these requirements in part 52i, because it is already estimated based upon the data that is collected through the various eRA systems that grantees use. The approvals under OMB Control Number 0925-0001 and OMB Control Number 0925-0002 expire January 2026. We do not expect an increase in average burden per respondent because of the enactment of Public Law 117-104 and the new expanded eligibility for research endowment awards that it mandates, or implementation of the program's new expanded eligibility requirements through this proposed rule. Also, we do not expect a change in the number of responses per respondent. However, there likely will be a change in the number of respondents from 4 to 22, and the total of burden hours will need to be adjusted based on the number of respondents. We estimate the annualized burden to the respondents for reporting and recordkeeping under the John Lewis NIMHD Endowment Program as:
                    ( print page 68556) Estimated Annualized Burden to the Respondents for Reporting and Recordkeeping Under the John Lewis NIMHD Research Endowment Program
Citations
Number of
                             
                                respondents 1
Number of 
                             responses per  
                             respondent
Average
                             burden per  
                             respondents  
                             (in hours)
Total burden
                             
                                hours 2Reporting§ 52i.3(b)(2)
22
1
4
88§ 52i.4(a)
22
1
1
22§ 52i.4(c)
22
1
1
22§ 52i.5(a)
22
1
22
484§ 52i.9(b)
22
1
4
88§ 52i.11(b)
6
1
15
90§ 52i.11(d)
6
1
2
12Subtotal


49
806Recordkeeping§ 52i.10
6
1
2
12§ 52i.11(a)(1)
6
1
2
12§ 52i.11(a)(2)
6
1
2
12§ 52i.11(a)(3)
6
1
2
12§ 52i.11(a)(4)
6
1
2
12§ 52i.11(b)
6
1
8
48Subtotal


67
108Total

158

9141
                         There is currently a total of 42 institutions eligible for the 
                        *John Lewis*
                         NIMHD Research Endowment Program, we estimate 22 institutions will apply. Historically, requests for applications are solicited every 5 years.2
                         Annual number of respondents × annual number of responses × average burden per response.
 When it is time to renew pre/post grant application forms, NIH will reach out to community members in a 2-3-year timeframe to determine if burden is the same, or if it has increased or decreased and provide additional input. The burden has already been accounted for at this time. We estimate the current annualized cost burden to the respondents for reporting and recordkeeping under the 
                    *John Lewis*
                     NIMHD Endowment Program as: Estimated Annualized Cost Burden to the Respondents for Reporting and Recordkeeping Under the John Lewis NIMHD Research Endowment Program
Final rule citations
Number of 
                             
                                respondents 1
Number of 
                             responses per  
                             respondent
Average 
                             burden per  
                             respondents  
                             (in hours)
Hourly wage rate 2
Total burden 3Reporting§ 52i.3(b)(2)
22
1
4
4
                             39.72
$3,495.10§ 52i.4(a)
22
1
1
39.72
873.78§ 52i.4(c)
22
1
1
39.72
873.78§ 52i.5(a)
22
1
22
5
                             193.25
93,533.25§ 52i.9(b)
22
1
4
6
                            101.97
8,973.02§ 52i.11(b)
6
1
15
7
                             139.66
12,569.84§ 52i.11(d)
6
1
2
8
                             118.03
1,416.36Subtotal


49

121,735.13Recordkeeping§ 52i.10
6
1
2
9
                            236.06
2,832.72§ 52i.11(a)(1)
6
1
2
39.72
476.61§ 52i.11(a)(2)
6
1
2
39.72
476.61§ 52i.11(a)(3)
6
1
2
39.72
476.61§ 52i.11(a)(4)
6
1
2
39.72
476.61§ 52i.11(b)
6
1
8
39.72
1,906.42Subtotal


18
39.72
6,645.56Total


67

128,380.691
                         There is currently a total of 42 institutions eligible for the 
                        *John Lewis*
                         NIMHD Research Endowment Program, we estimate 22 institutions will apply. Historically, requests for applications are solicited every 5 years.2
                         Average cost per hour.3
                         Number of respondents × average burden per response × hourly wage rate.4
                         Based on contracts/grants staff costs.
                        ( print page 68557)5
                         Based on the contributions of the principal investigator, participating faculty, contracts/grants staff, financial investment advisors, and administrative support. Aggregate cost is $205.05/hour.6
                         Based on principal investigator costs.7
                         Based on the contributions of the principal investigator, participating faculty, contracts/grants staff, financial investment advisors, and administrative support. Aggregate cost is $139.66/hour.8
                         Based on financial analyst/auditor costs.9
                         Based on financial investment advisor costs.
 Federal Assistance Listings The Federal Assistance Listings numbered program affected by this rulemaking is: 93.307—Minority Health and Health Disparities. List of Subjects in 42 CFR Part 52i Grant programs—Health
Medical research
 For reasons described in the preamble, the Department of Health and Human Services proposes to amend 42 CFR part 52i as set forth below: PART 52i—
                        JOHN LEWIS
                         NIMHD RESEARCH ENDOWMENT PROGRAM
 1.The authority citation for part 52i continues to read as follows: Authority:
                    42 U.S.C. 216, 285t-285t-1. 2.Revise the heading to part 52i to read as set forth above. 3.Revise the heading to § 52i.1 to read as follows: § 52i.1
 4.Amend § 52i.3 by revising paragraph (a)(1) to read as follows: § 52i.3
  (a) * * * (1) 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
 5.Amend § 52i.13 by: a.Revising paragraph (f); b.Removing paragraph (m); c.Redesignating paragraphs (n) through (q) as paragraphs (m) through (p), respectively; d.Revising newly redesignated paragraphs (n) through (q); and e.Removing paragraph (r). The revisions read as follows: § 52i.13
  
 (f) 45 CFR part 75—Uniform administrative requirements, cost principles, and audit requirements for HHS awards. 
 (n) NIH Guidelines for Research Involving Recombinant for Synthetic Nucleic Acid Molecules at 
                        *https://osp.od.nih.gov/​wp-content/​uploads/​NIH_​Guidelines.pdf.*
                         Further information may be obtained from the NIH Office of Science Policy (OSP) via email at 
                        *NIHguidelines@od.nih.gov*
                         or the OSP website at 
                        *https://osp.od.nih.gov/​.* (o) NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research at 
                        *https://grants.nih.gov/​grants/​guide/​notice-files/​NOT-OD-02-001.html,*
                         Amendment: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research at 
                        *https://grants.nih.gov/​grants/​guide/​notice-files/​NOT-OD-18-014.html,*
                         and the revised NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects at 
                        *https://grants.nih.gov/​grants/​guide/​notice-files/​NOT-OD-18-116.html.*
                         Further information may be obtained from the NIH Office of Research on Women's Health via email at 
                        *orwhinfo@nih.gov.* (p) NIH Grants Policy Statement. The current version is located on the NIH website at 
                        *https://grants.nih.gov/​policy/​nihgps/​index.htm.*
                         [Note: this policy is subject to change and interested persons should contact the Division of Grants Policy in the Office of Policy for Extramural Research Administration (OPERA), Office of Extramural Research, NIH, via email at 
                        *GrantsPolicy@nih.gov].* (q) Public Health Service Policy on Humane Care and Use of Laboratory Animals, Office of Laboratory Animal Welfare, NIH (Revised 2015). [Note: this policy is subject to change and interested persons should contact the Office of Laboratory Animal Welfare, NIH, 6700B Rockledge Drive, Suite 2500, MSC 6910, Bethesda, MD 20892-6910 (telephone 301-496-7163, not a toll-free number), to obtain references to the current version and any amendments.Information may be obtained also by emailing 
                        *olaw@mail.nih.gov*
                         or via the OLAW website at 
                        *https://olaw.nih.gov*].
 Xavier Becerra, Secretary, Department of Health and Human Services.


[FR Doc. 2023-21750 Filed 10-3-23; 8:45 am] BILLING CODE 4140-01-P