National Institute on Minority Health and Health Disparities Research Endowment Programs, 68553-68557 [2023-21750]
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for the voluntary consensus standard
search and determinations can be found
in the memorandum titled, Voluntary
Consensus Standard Results for Review
of Standards of Performance for Volatile
Organic Liquid Storage Vessels
(Including Petroleum Liquid Storage
Vessels). All potential standards were
reviewed to determine the practicality
of the voluntary consensus standards
(VCS) for this rule. Although there were
no applicable voluntary consensus
standards identified, we are amending
40 CFR 60.17 to incorporate by
reference two ASTM methods as
discussed in section III.M. These
include the following:
• ASTM D6377–20, ‘‘Standard Test
Method for Determination of Vapor
Pressure of Crude Oil:
VPCRx (Expansion Method). The method
is an automated device method for
measuring vapor pressures for crude oils
samples between 29 kPa and 180 kPa at
37.8 °C. The method is suitable for
testing with a 4:1 vapor-liquid ratio.
• ASTM D6378–22, ‘‘Standard Test
Method for Determination of Vapor
Pressure (VPX) of Petroleum Products,
Hydrocarbons, and HydrocarbonOxygenate Mixtures (Triple Expansion
Method). The method is an automated
device method for measuring vapor
pressures between 7 kPa and 150 kPa at
37.8 °C for tested samples with boiling
points at 0 °C. The method is suitable
for volatile organic liquids,
hydrocarbons and liquid petroleum
products sampled at a 4:1 vapor-liquid
ratio.
The ASTM standards are available
from the American Society for Testing
and Materials (ASTM), 100 Barr Harbor
Drive, Post Office Box C700, West
Conshohocken, PA 19428–2959. See
https://www.astm.org.
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations and Executive
Order 14096: Revitalizing our Nation’s
Commitment to Environmental Justice
for All
The EPA believes that it is not
practicable to assess whether the human
health or environmental conditions that
exist prior to this action result in
disproportionate and adverse effects on
communities with EJ concerns. Over the
next 5 years, the EPA estimates that
1,440 new tanks and 27 modified tanks
will be subject to NSPS subpart Kc.
However, the locations of any new VOL
storage vessels that would be subject to
NSPS subpart Kc are not known.
Furthermore, there is insufficient data
available regarding the locations of
existing VOL storage vessels is also not
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known. The EPA estimates that there are
approximately more than 10,000
existing vessels subject to NSPS subpart
Kb, but do not have a list of specific
units and their locations. Therefore, we
cannot perform a proximity
demographic analysis of populations
near existing units as a proxy for units
that may be modified or reconstructed
and become subject to NSPS subpart Kc.
Finally, because we based the analysis
of the impacts and emission reductions
on model plants, we are not able to
ascertain specifically how the potential
benefits of this rule would be
distributed across the population. Thus,
we are limited in our ability to estimate
the potential EJ impacts of this rule.
The information supporting this
Executive Order review is contained in
in section IV.E. All pertinent supporting
documents such as the technical memo,
‘‘Control Options for Storage Vessels’’
which discusses the costs and
environmental impacts of the regulatory
options considered have been placed in
the docket.
Michael S. Regan,
Administrator.
[FR Doc. 2023–21976 Filed 10–3–23; 8:45 am]
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
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice of proposed rulemaking.
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.
SUMMARY:
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68553
You may send comments,
identified by Docket Number NIH 2022–
0001 and/or RIN 0925–AA70, by any of
the following methods:
ADDRESSES:
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.
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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
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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
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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);
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(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).
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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
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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.
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.
Regulatory Flexibility Act
Paperwork Reduction 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.
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:
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
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68556
Federal Register / Vol. 88, No. 191 / Wednesday, October 4, 2023 / Proposed Rules
ESTIMATED ANNUALIZED BURDEN TO THE RESPONDENTS FOR REPORTING AND RECORDKEEPING UNDER THE JOHN LEWIS
NIMHD RESEARCH ENDOWMENT PROGRAM
Number of
respondents 1
Citations
Reporting
§ 52i.3(b)(2) ...............................................................................................
§ 52i.4(a) ...................................................................................................
§ 52i.4(c) ...................................................................................................
§ 52i.5(a) ...................................................................................................
§ 52i.9(b) ...................................................................................................
§ 52i.11(b) .................................................................................................
§ 52i.11(d) .................................................................................................
Number of
responses per
respondent
Average
burden per
respondents
(in hours)
Total burden
hours 2
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 .............................................................................................
Recordkeeping
§ 52i.10 .....................................................................................................
§ 52i.11(a)(1) .............................................................................................
§ 52i.11(a)(2) .............................................................................................
§ 52i.11(a)(3) .............................................................................................
§ 52i.11(a)(4) .............................................................................................
§ 52i.11(b) .................................................................................................
........................
........................
49
806
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
respondents 1
Final rule citations
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Reporting
§ 52i.3(b)(2) ...................................................................
§ 52i.4(a) .......................................................................
§ 52i.4(c) .......................................................................
§ 52i.5(a) .......................................................................
§ 52i.9(b) .......................................................................
§ 52i.11(b) .....................................................................
§ 52i.11(d) .....................................................................
Number of
responses per
respondent
Average
burden per
respondents
(in hours)
Hourly wage
rate 2
4 39.72
Total burden 3
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
6101.97
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 ..................................................................
Recordkeeping
§ 52i.10 ..........................................................................
§ 52i.11(a)(1) .................................................................
§ 52i.11(a)(2) .................................................................
§ 52i.11(a)(3) .................................................................
§ 52i.11(a)(4) .................................................................
§ 52i.11(b) .....................................................................
........................
........................
49
........................
121,735.13
6
6
6
6
6
6
1
1
1
1
1
1
2
2
2
2
2
8
9236.06
39.72
39.72
39.72
39.72
39.72
2,832.72
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.
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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 To what program does this part
apply?
4. Amend § 52i.3 by revising
paragraph (a)(1) to read as follows:
■
§ 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
*
*
*
*
*
■ 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 Other HHS policies and
regulations that apply.
lotter on DSK11XQN23PROD with PROPOSALS1
*
*
*
*
*
(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
VerDate Sep<11>2014
18:06 Oct 03, 2023
Jkt 262001
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
PO 00000
Frm 00058
Fmt 4702
Sfmt 4702
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 73
[MB Docket No. 23–285; RM–11959; DA 23–
904; FR ID 176385]
Television Broadcasting Services
Jacksonville, Oregon
Federal Communications
Commission.
ACTION: Proposed rule.
AGENCY:
The Video Division, Media
Bureau has before it a petition for
rulemaking (Petition) filed by theDove
Media, Inc. (Petitioner), requesting the
allotment of reserved noncommercial
educational (NCE) television channel *4
to Jacksonville, Oregon as the
community’s first local television
service and its first NCE television
service.
SUMMARY:
Comments must be filed on or
before November 3, 2023 and reply
comments on or before November 20,
2023.
DATES:
Federal Communications
Commission, Office of the Secretary, 45
L Street, NE, Washington, DC 20554. In
addition to filing comments with the
FCC, interested parties should serve
counsel for the Petitioner as follows:
Howard M. Liberman, Esq., Wilkinson
Barker Knauer, LLP, 1800 M Street, NW,
Suite 800N, Washington, DC 20036.
FOR FURTHER INFORMATION CONTACT:
Joyce Bernstein, Media Bureau, at (202)
418–1647; or Joyce Bernstein, Media
Bureau, at Joyce.Bernstein@fcc.gov.
SUPPLEMENTARY INFORMATION: The
Petitioner states that Jacksonville,
Oregon qualifies as a community for
allotment purposes. In support, it states
that Jacksonville was incorporated in
1860 and had a population of 3,020 as
of the 2020 Census. Jacksonville has a
mayor and six council members, police,
fire, public works, planning, and other
government departments, an elementary
school; a historic district; and a chamber
of commerce. The Petitioner states its
intention to file an application for
channel *4, if allotted, and take all
necessary steps to obtain a construction
permit. The Petitioner’s proposal would
result in a first local service to
Jacksonville under Priority (2) of the
Commission’s television allotment
ADDRESSES:
E:\FR\FM\04OCP1.SGM
04OCP1
]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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 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
