National Institute on Minority Health and Health Disparities Research Endowment Programs, 96119-96123 [2024-28082]
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96119
TABLE 10 TO SUBPART AAAAA OF PART 63—APPLICABILITY OF GENERAL PROVISIONS TO SUBPART AAAAA—Continued
[As required in § 63.7140, you must comply with the applicable General Provisions requirements according to the following table.]
Citation
Summary of requirement
§ 63.10(d)(5)(i) ...............................
Periodic Startup, Shutdown, Malfunction Reports.
§ 63.10(d)(5)(ii) ...............................
Immediate Startup, Shutdown,
Malfunction Reports.
§ 63.10(e) .......................................
Additional CMS Reports ...............
§ 63.10(f) ........................................
Waiver for Recordkeeping/Reporting.
Control Device and Work Practice
Requirements.
State Authority and Delegations ...
State/Regional Addresses ............
Incorporation by Reference ..........
Availability of Information and
Confidentiality.
Performance Track Provisions .....
§ 63.11(a)–(b) .................................
§ 63.12(a)–(c)
§ 63.13(a)–(c)
§ 63.14(a)–(b)
§ 63.15(a)–(b)
.................................
.................................
.................................
.................................
§ 63.16 ...........................................
BILLING CODE 6560–50–P
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
National Institutes of Health,
HHS.
ACTION:
Final rule.
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.
DATES: This final rule is effective
January 3, 2025.
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SUMMARY:
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Explanations
Yes before the relevant compliance date for your source as
specified in § 63.7083(g).
No on and after the relevant compliance date for your source as
specified in § 63.7083(g).
Yes before the relevant compliance date for your source as
specified in § 63.7083(g).
No on and after the relevant compliance date for your source as
specified in § 63.7083(g).
No .................................................
On and after the relevant compliance date for your source as
specified in § 63.7083(g), see
§ 63.7131 for malfunction reporting requirements.
No .................................................
Yes ................................................
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.
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Flares not applicable.
Yes ................................................
Yes ................................................
No .................................................
Yes ................................................
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.
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See specific requirements in subpart AAAAA, see § 63.7131.
Yes ................................................
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2024–27874 Filed 12–3–24; 8:45 am]
AGENCY:
Am I subject to this requirement?
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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
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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 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.
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 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
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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 Federal Register 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—John Lewis NIMHD
Research Endowment Program’’ to
reflect the new name of the program, the
John Lewis 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 John
Lewis 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’’.
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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
John Lewis NIMHD Research
Endowment Program.
II. Summary of Public Comments
We received five comments in
response to the NPRM. One of the
commenters agreed with the proposed
rule, noting that implementation of
Public Law 117–104 will lead to an
increase in eligible applicants and will
have a positive impact in addressing
minority health disparities.
A second commenter stated that the
proposed rule was acceptable because it
is more in line with the new name of the
program recognized after the late John
Lewis, and because the program aims to
build more training and research
capacity to reduce disparities in
minority health treatment, the program
eligibility requirements should mirror
such to become more inclusive for
minority applicants to apply.
A third commenter thought the
proposed rule should be expanded to
create new medical schools at
Historically Black Colleges and
Universities (HBCUs), noting that it
missed the opportunity to expand the
number of Black doctors. Additionally,
the commenter noted that there are only
six Black medical schools in the
country, and that with major health
disparities in the Black community, it is
essential to expand the number of
providers who are committed to serving
that population, The commenter noted
that out of 10 states with the highest
Black populations, only three have
HBCUs with medicals schools. The
commenter reiterated his belief that the
proposed rule also should expand to
include establishing medical schools in
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these states at HBCUs to expand the
provider pool.
We appreciate the commenter taking
the time to extensively comment on the
proposed rule and we acknowledge the
importance of addressing health
disparities through a diverse healthcare
workforce. The John Lewis NIMHD
Research Endowment Program provides
funding for endowments to invest in
research infrastructure and training
capacity at eligible institutions. The
comment advocating expanding the
criteria beyond the scope of the Program
was determined to exceed the stated
limited purpose of the proposed rule
and beyond the authority provided by
the Program’s authorizing statute.
A fourth commenter stated the
regulation should not be amended. No
rationale was provided.
Finally, a fifth comment was deemed
not pertinent to the proposed rule, and
thus is not discussed here.
After considering these comments, we
did not adopt any suggested changes.
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III. Regulatory Impact Analysis
We examined the impacts of this rule
under Executive Order 12866,
Regulatory Planning and Review;
Executive Order 13563, Improving
Regulation and Regulatory Review;
Executive Order 14094, Modernizing
Regulatory Review; Executive Order
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
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). The Executive Order 14094
entitled ‘‘Modernizing Regulatory
Review’’ amends section 3(f) of
Executive Order 12866 (Regulatory
Planning and Review). The amended
section 3(f) of Executive Order 12866
defines a ‘‘significant regulatory action’’
as an action that is likely to result in a
rule that may: (1) have an annual effect
on the economy of $200 million or more
in any 1 year (adjusted every 3 years by
the Administrator of OIRA for changes
in gross domestic product); or adversely
affect in a material way the economy, a
sector of the economy, productivity,
competition, jobs, the environment,
public health or safety, or State, local,
territorial, or tribal governments or
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communities; (2) create a serious
inconsistency or otherwise interfere
with an action taken or planned by
another agency; (3) materially alter the
budgetary impacts of entitlements,
grants, user fees, or loan programs or the
rights and obligations of recipients
thereof; or (4) raise legal or policy issues
for which centralized review would
meaningfully further the President’s
priorities or the principles set forth in
this Executive order, as specifically
authorized in a timely manner by the
Administrator of OIRA in each case.
A regulatory impact analysis (RIA)
must be prepared for major rules with
significant regulatory action/s and/or
with significant effects as per section
3(f)(1) ($200 million or more in any 1
year). OMB’s Office of Information and
Regulatory Affairs has determined that
this rulemaking is ‘‘not significant’’
under section 3(f) and does not meet the
criteria set forth in 5 U.S.C. 804(2)
under Subtitle E of the Small Business
Regulatory Enforcement Fairness Act of
1996 (also known as the Congressional
Review Act). Thus, 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
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96121
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 $183 million based on
the Bureau of Labor Statistics inflation
calculator. The Secretary certifies that
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 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
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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 Research Endowment Program
as:
ESTIMATED ANNUALIZED BURDEN TO THE RESPONDENTS FOR REPORTING AND RECORDKEEPING UNDER THE John Lewis
NIMHD RESEARCH ENDOWMENT PROGRAM
Average
burden per
respondents
(in hours)
Number of
responses per
respondent
Number of
respondents 1
Citations
Total burden
hours 2
Reporting
§ 52i.3(b)(2) ....................................................................................................
§ 52i.4(a) ........................................................................................................
§ 52i.4(c) ........................................................................................................
§ 52i.5(a) ........................................................................................................
§ 52i.9(b) ........................................................................................................
§ 52i.11(b) ......................................................................................................
§ 52i.11(d) ......................................................................................................
22
22
22
22
22
6
6
1
1
1
1
1
1
1
4
1
1
22
4
15
2
88
22
22
484
88
90
12
Subtotal ...................................................................................................
..........................
..........................
49
806
Recordkeeping
§ 52i.10 ...........................................................................................................
§ 52i.11(a)(1) ..................................................................................................
§ 52i.11(a)(2) ..................................................................................................
§ 52i.11(a)(3) ..................................................................................................
§ 52i.11(a)(4) ..................................................................................................
§ 52i.11(b) ......................................................................................................
6
6
6
6
6
6
1
1
1
1
1
1
2
2
2
2
2
8
12
12
12
12
12
48
Subtotal ...................................................................................................
..........................
..........................
67
108
Total .................................................................................................
..........................
158
......................
914
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 × 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 2–3year 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
Number of
responses per
respondent
Number of
respondents 1
Final rule citations
Average
burden per
respondents
(in hours)
Hourly
wage rate 2
Total
burden 3
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Reporting
4 39.72
§ 52i.3(b)(2) ..............................................................................
§ 52i.4(a) ..................................................................................
§ 52i.4(c) ..................................................................................
§ 52i.5(a) ..................................................................................
§ 52i.9(b) ..................................................................................
§ 52i.11(b) ................................................................................
§ 52i.11(d) ................................................................................
22
22
22
22
22
6
6
1
1
1
1
1
1
1
4
1
1
22
4
15
2
39.72
39.72
5 193.25
6 101.97
7 139.66
8 118.03
$3,495.10
873.78
873.78
93,533.25
8,973.02
12,569.84
1,416.36
Subtotal .............................................................................
..........................
..........................
49
......................
121,735.13
1
2
9 236.06
2,832.72
Recordkeeping
§ 52i.10 .....................................................................................
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Federal Register / Vol. 89, No. 233 / Wednesday, December 4, 2024 / Rules and Regulations
96123
ESTIMATED ANNUALIZED COST BURDEN TO THE RESPONDENTS FOR REPORTING AND RECORDKEEPING UNDER THE John
Lewis NIMHD RESEARCH ENDOWMENT PROGRAM—Continued
Number of
responses per
respondent
Number of
respondents 1
Final rule citations
Average
burden per
respondents
(in hours)
Hourly
wage rate 2
Total
burden 3
§ 52i.11(a)(1) ............................................................................
§ 52i.11(a)(2) ............................................................................
§ 52i.11(a)(3) ............................................................................
§ 52i.11(a)(4) ............................................................................
§ 52i.11(b) ................................................................................
6
6
6
6
6
1
1
1
1
1
2
2
2
2
8
39.72
39.72
39.72
39.72
39.72
476.61
476.61
476.61
476.61
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 × average burden per response × hourly wage rate.
4 Based on contracts/grants staff costs.
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
5. Section 52i.13 is amended by
revising paragraphs (f), and (m) through
(q) and removing paragraph (r) to read
as follows:
§ 52i.13 Other HHS policies and
regulations that apply.
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 amends 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. The heading to part 52i is revised
to read as set forth above.
■ 3. The heading to § 52i.1 is revised to
read as follows:
■
§ 52i.1 To what program does this part
apply?
*
*
*
*
*
4. Section 52i.3 is amended by
revising paragraph (a)(1) to read as
follows:
ddrumheller on DSK120RN23PROD with RULES1
■
§ 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
*
*
*
*
*
VerDate Sep<11>2014
15:51 Dec 03, 2024
Jkt 265001
*
*
*
*
(f) 45 CFR part 75—Uniform
administrative requirements, cost
principles, and audit requirements for
HHS awards.
*
*
*
*
*
(m) 45 CFR part 93—New restrictions
on lobbying.
(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
PO 00000
Frm 00035
Fmt 4700
Sfmt 9990
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. 2024–28082 Filed 12–3–24; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\04DER1.SGM
04DER1
]]>Agencies
[Federal Register Volume 89, Number 233 (Wednesday, December 4, 2024)]
[Rules and Regulations]
[Pages 96119-96123]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28082]
=======================================================================
-----------------------------------------------------------------------
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: Final rule.
-----------------------------------------------------------------------
SUMMARY: 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.
DATES: This final rule is effective January 3, 2025.
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.
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.
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
[[Page 96120]]
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 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.
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 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.
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 Federal Register 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--John
Lewis NIMHD Research Endowment Program'' to reflect the new name of the
program, the John Lewis NIMHD Research Endowment Program.
We proposed 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.
Additionally, we proposed 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 further proposed to amend Sec. 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 John Lewis NIMHD Research Endowment Program.
II. Summary of Public Comments
We received five comments in response to the NPRM. One of the
commenters agreed with the proposed rule, noting that implementation of
Public Law 117-104 will lead to an increase in eligible applicants and
will have a positive impact in addressing minority health disparities.
A second commenter stated that the proposed rule was acceptable
because it is more in line with the new name of the program recognized
after the late John Lewis, and because the program aims to build more
training and research capacity to reduce disparities in minority health
treatment, the program eligibility requirements should mirror such to
become more inclusive for minority applicants to apply.
A third commenter thought the proposed rule should be expanded to
create new medical schools at Historically Black Colleges and
Universities (HBCUs), noting that it missed the opportunity to expand
the number of Black doctors. Additionally, the commenter noted that
there are only six Black medical schools in the country, and that with
major health disparities in the Black community, it is essential to
expand the number of providers who are committed to serving that
population, The commenter noted that out of 10 states with the highest
Black populations, only three have HBCUs with medicals schools. The
commenter reiterated his belief that the proposed rule also should
expand to include establishing medical schools in
[[Page 96121]]
these states at HBCUs to expand the provider pool.
We appreciate the commenter taking the time to extensively comment
on the proposed rule and we acknowledge the importance of addressing
health disparities through a diverse healthcare workforce. The John
Lewis NIMHD Research Endowment Program provides funding for endowments
to invest in research infrastructure and training capacity at eligible
institutions. The comment advocating expanding the criteria beyond the
scope of the Program was determined to exceed the stated limited
purpose of the proposed rule and beyond the authority provided by the
Program's authorizing statute.
A fourth commenter stated the regulation should not be amended. No
rationale was provided.
Finally, a fifth comment was deemed not pertinent to the proposed
rule, and thus is not discussed here.
After considering these comments, we did not adopt any suggested
changes.
III. Regulatory Impact Analysis
We examined the impacts of this rule under Executive Order 12866,
Regulatory Planning and Review; Executive Order 13563, Improving
Regulation and Regulatory Review; Executive Order 14094, Modernizing
Regulatory Review; Executive Order 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
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). The
Executive Order 14094 entitled ``Modernizing Regulatory Review'' amends
section 3(f) of Executive Order 12866 (Regulatory Planning and Review).
The amended section 3(f) of Executive Order 12866 defines a
``significant regulatory action'' as an action that is likely to result
in a rule that may: (1) have an annual effect on the economy of $200
million or more in any 1 year (adjusted every 3 years by the
Administrator of OIRA for changes in gross domestic product); or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, territorial, or tribal governments
or communities; (2) create a serious inconsistency or otherwise
interfere with an action taken or planned by another agency; (3)
materially alter the budgetary impacts of entitlements, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; or (4) raise legal or policy issues for which centralized
review would meaningfully further the President's priorities or the
principles set forth in this Executive order, as specifically
authorized in a timely manner by the Administrator of OIRA in each
case.
A regulatory impact analysis (RIA) must be prepared for major rules
with significant regulatory action/s and/or with significant effects as
per section 3(f)(1) ($200 million or more in any 1 year). OMB's Office
of Information and Regulatory Affairs has determined that this
rulemaking is ``not significant'' under section 3(f) and does not meet
the criteria set forth in 5 U.S.C. 804(2) under Subtitle E of the Small
Business Regulatory Enforcement Fairness Act of 1996 (also known as the
Congressional Review Act). Thus, 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 $183 million based on the Bureau of Labor
Statistics inflation calculator. The Secretary certifies that 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 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
[[Page 96122]]
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 Research Endowment Program
as:
Estimated Annualized Burden to the Respondents for Reporting and Recordkeeping Under the John Lewis NIMHD
Research Endowment Program
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Citations respondents \1\ responses per respondents hours \2\
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
----------------------------------------------------------------------------------------------------------------
\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
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Hourly wage Total
Final rule citations respondents \1\ responses per respondents rate \2\ burden \3\
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
[[Page 96123]]
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.
\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 amends 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. The heading to part 52i is revised to read as set forth above.
0
3. The heading to Sec. 52i.1 is revised to read as follows:
Sec. 52i.1 To what program does this part apply?
* * * * *
0
4. Section 52i.3 is amended 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. Section 52i.13 is amended by revising paragraphs (f), and (m)
through (q) and removing paragraph (r) to 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.
* * * * *
(m) 45 CFR part 93--New restrictions on lobbying.
(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. 2024-28082 Filed 12-3-24; 8:45 am]
BILLING CODE 4140-01-P
