[Federal Register Volume 88, Number 191 (Wednesday, October 4, 2023)]
[Proposed Rules]
[Pages 68553-68557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21750]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 52i

[Docket No. NIH-2022-0001]
RIN 0925-AA70


National Institute on Minority Health and Health Disparities 
Research Endowment Programs

AGENCY: National Institutes of Health, HHS.

ACTION: Notice of proposed rulemaking.

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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 [email protected], 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 [email protected], 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.

[[Page 68554]]


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 Sec.  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 Sec.  52i.1 and in the accompanying Table of Contents 
reference to Sec.  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 Sec.  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 Sec.  
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 Sec.  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 Sec.  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 Sec.  52i.13 ``Other HHS policies and 
regulations that apply'' by:
    (1) Revising current paragraph (f);

[[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, Sec. Sec.  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 Sec. Sec.  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:

[[Page 68556]]



    Estimated Annualized Burden to the Respondents for Reporting and Recordkeeping Under the John Lewis NIMHD
                                           Research Endowment Program
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                                                                                  Average burden
                                                     Number of       Number of          per        Total burden
                    Citations                       respondents    responses per    respondents      hours \2\
                                                        \1\         respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Reporting
    Sec.   52i.3(b)(2)..........................              22               1               4              88
    Sec.   52i.4(a).............................              22               1               1              22
    Sec.   52i.4(c).............................              22               1               1              22
    Sec.   52i.5(a).............................              22               1              22             484
    Sec.   52i.9(b).............................              22               1               4              88
    Sec.   52i.11(b)............................               6               1              15              90
    Sec.   52i.11(d)............................               6               1               2              12
                                                 ---------------------------------------------------------------
        Subtotal................................  ..............  ..............              49             806
Recordkeeping
    Sec.   52i.10...............................               6               1               2              12
    Sec.   52i.11(a)(1).........................               6               1               2              12
    Sec.   52i.11(a)(2).........................               6               1               2              12
    Sec.   52i.11(a)(3).........................               6               1               2              12
    Sec.   52i.11(a)(4).........................               6               1               2              12
    Sec.   52i.11(b)............................               6               1               8              48
                                                 ---------------------------------------------------------------
        Subtotal................................  ..............  ..............              67             108
                                                 ---------------------------------------------------------------
            Total...............................  ..............             158  ..............             914
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\1\ 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 x annual number of responses x 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
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                                                                      Average
                                     Number of       Number of      burden per      Hourly wage    Total burden
      Final rule citations          respondents    responses per    respondents      rate \2\           \3\
                                        \1\         respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Reporting
    Sec.   52i.3(b)(2)..........              22               1               4       \4\ 39.72       $3,495.10
    Sec.   52i.4(a).............              22               1               1           39.72          873.78
    Sec.   52i.4(c).............              22               1               1           39.72          873.78
    Sec.   52i.5(a).............              22               1              22      \5\ 193.25       93,533.25
    Sec.   52i.9(b).............              22               1               4       \6\101.97        8,973.02
    Sec.   52i.11(b)............               6               1              15      \7\ 139.66       12,569.84
    Sec.   52i.11(d)............               6               1               2      \8\ 118.03        1,416.36
                                 -------------------------------------------------------------------------------
        Subtotal................  ..............  ..............              49  ..............      121,735.13
Recordkeeping
    Sec.   52i.10...............               6               1               2       \9\236.06        2,832.72
    Sec.   52i.11(a)(1).........               6               1               2           39.72          476.61
    Sec.   52i.11(a)(2).........               6               1               2           39.72          476.61
    Sec.   52i.11(a)(3).........               6               1               2           39.72          476.61
    Sec.   52i.11(a)(4).........               6               1               2           39.72          476.61
    Sec.   52i.11(b)............               6               1               8           39.72        1,906.42
                                 -------------------------------------------------------------------------------
        Subtotal................  ..............  ..............              18           39.72        6,645.56
                                 -------------------------------------------------------------------------------
            Total...............  ..............  ..............              67  ..............      128,380.69
----------------------------------------------------------------------------------------------------------------
\1\ 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 x average burden per response x hourly wage rate.
\4\ Based on contracts/grants staff costs.

[[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

0
1. The authority citation for part 52i continues to read as follows:

    Authority:  42 U.S.C. 216, 285t-285t-1.

0
2. Revise the heading to part 52i to read as set forth above.
0
3. Revise the heading to Sec.  52i.1 to read as follows:


Sec.  52i.1  To what program does this part apply?

0
4. Amend Sec.  52i.3 by revising paragraph (a)(1) to read as follows:


Sec.  52i.3  Who is eligible to apply?

    (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
* * * * *
0
5. Amend Sec.  52i.13 by:
0
a. Revising paragraph (f);
0
b. Removing paragraph (m);
0
c. Redesignating paragraphs (n) through (q) as paragraphs (m) through 
(p), respectively;
0
d. Revising newly redesignated paragraphs (n) through (q); and
0
e. Removing paragraph (r).
    The revisions read as follows:


Sec.  52i.13  Other HHS policies and regulations that apply.

* * * * *
    (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 [email protected] 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 
[email protected].
    (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 [email protected]].
    (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 [email protected] 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