Proposed Collection; 60-Day Comment Request; PHS Applications and Pre-Award Reporting Requirements (OD), 45001-45003 [2024-11251]
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Federal Register / Vol. 89, No. 100 / Wednesday, May 22, 2024 / Notices
report forms and associated instructions
will be updated to align with these new
requirements. The RPPR is required to
be used by all NIH, Food and Drug
Administration (FDA), Centers for
Disease Control and Prevention, and
Agency for Healthcare Research and
Quality (AHRQ) grantees. Interim
progress reports are required to continue
support of a PHS grant for each budget
year within a competitive segment. This
collection also includes other PHS postaward reporting requirements: PHS
416–7 National Research Service Award
(NRSA) Termination Notice, PHS 2271
Statement of Appointment, 6031–1
NRSA Annual Payback Activities
Certification, HHS 568 Final Invention
Statement and Certification, and PHS
3734 Statement Relinquishing Interests
and Rights in a PHS Research Grant.
The PHS 416–7, 2271, and 6031–1 are
used by NRSA recipients to activate,
terminate, and provide for payback of an
NRSA. Closeout of an award requires a
Final Invention Statement (HHS 568)
and a Final Progress Report. The PHS
3734 serves as the official record of
grantee relinquishment of a PHS award
when an award is transferred from one
grantee institution to another. Pre-award
reporting requirements are
simultaneously consolidated under
0925–0001 and the changes to the
collection here are related.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
579,365.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Information collection forms
Average
burden per
response
(in hours)
Number of
responses per
respondent
Total annual
burden hours
REPORTING
PHS 416–7 ......................................................................................................
PHS 6031–1 ....................................................................................................
PHS 568 ..........................................................................................................
PHS 2271 ........................................................................................................
PHS 2590 ........................................................................................................
RPPR–Core Data ............................................................................................
Biosketch (Part of RPPR) ................................................................................
Data Tables (Part of RPPR) ............................................................................
Trainee Diversity Report (Part of RPPR) ........................................................
PHS Human Subjects and Clinical Trial Information .......................................
Publication Reporting .......................................................................................
Final RPPR—Core Data ..................................................................................
Data Tables (Part of Final RPPR) ...................................................................
Trainee Diversity Report (Part of Final RPPR) ...............................................
PHS Human Subjects and Clinical Trial Information (Part of Final RPPR) ....
PHS 3734 ........................................................................................................
Data Management and Sharing Plan (Part of RPPR) .....................................
Data Management and Sharing Plan (Part of Final RPPR) ............................
12,580
1,778
11,180
22,035
243
32,098
2,544
758
480
6,420
97,023
18,000
758
480
3,600
479
15,649
8,621
1
1
1
1
1
1
1
1
1
1
3
1
1
1
1
1
1
1
30/60
20/60
5/60
15/60
18
8
2
4
15/60
3
5/60
10
4
15/60
4
30/60
2
2
6,290
593
932
5,509
4,374
256,784
5,088
3,032
120
25,680
24,256
180,000
3,032
120
14,400
240
31,298
17,242
Reporting Burden Total ............................................................................
........................
........................
........................
578,990
RECORDKEEPING
SBIR/STTR Life Cycle Certification .................................................................
1,500
1
15/60
375
Grand Total ...............................................................................................
236,226
........................
........................
579,365
Dated: May 9, 2024.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2024–11256 Filed 5–21–24; 8:45 am]
BILLING CODE 4140–01–P
khammond on DSKJM1Z7X2PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, for opportunity
for public comment on proposed data
collection projects, the National
Institutes of Health (NIH) will publish
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
SUMMARY:
Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
DATES:
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; PHS Applications and PreAward Reporting Requirements (OD)
To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
FOR FURTHER INFORMATION CONTACT:
AGENCY:
ACTION:
National Institutes of Health.
Notice.
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information on the proposed project,
contact: Ms. Mikia P. Currie, Program
Analyst, Office of Policy for Extramural
Research Administration, 6705
Rockledge Drive, Suite 350, Bethesda,
Maryland 20892, or call a non-toll-free
number 301–435–0941 or email your
request, including your address to
ProjectClearanceBranch@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
SUPPLEMENTARY INFORMATION: Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
E:\FR\FM\22MYN1.SGM
22MYN1
45002
Federal Register / Vol. 89, No. 100 / Wednesday, May 22, 2024 / Notices
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
Ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Proposed Collection Title: Public
Health Service (PHS) Applications and
Pre-Award Reporting Requirements,
Revision, OMB 0925–0001, Expiration
Date 01/31/2026, Office of the Director,
National Institutes of Health (NIH).
Need and Use of Information
Collection: Effective for due dates on or
after January 25, 2025, NIH will be
implementing several trans-NIH
initiatives to simplify the grants process
for applicants and recipients as well as
for peer review. NIH will be updating
fellowship applications to improve
fellowship peer review to facilitate the
mission of these programs to identify
the most promising candidates and
individualized training opportunities
that will assist them along their paths to
support the advancement of the
biomedical research enterprise. NIH will
be reducing the number of required
attachments and updating instructions
for the PHS Fellowship Supplemental
Form to align with the revised scored
review criteria. NIH will also be
updating institutional training grant
applications, including adding a new
attachment field to the PHS 398
Research Training Program Plan form
for the transparent collection of the
Recruitment Plan to Enhance Diversity
while also providing additional space
for applicants within the Program Plan
[electronic]; PHS 416–1 Ruth L.
Kirschstein National Research Service
Award (NRSA) Individual Fellowship
Application Instructions and Forms
used only for a change of sponsoring
institution application [paper];
Instructions for a Change of Sponsoring
Institution for NRSA Fellowships (F30,
F31, F32 and F33) and non-NRSA
Fellowships; PHS 416–5 Ruth L.
Kirschstein National Research Service
Award Individual Fellowship
Activation Notice; and PHS 6031
Payback Agreement. The PHS 398
(paper and electronic are currently
approved under 0925–0001. All forms
expire 01/31/2026. Post-award reporting
requirements are simultaneously
consolidated under 0925–0002 and
include the RPPR. The PHS 398 and
SF424 applications are used by
applicants to request Federal assistance
funds for traditional investigatorinitiated research projects and to request
access to databases and other PHS
resources. The PHS 416–1 is used only
for a change of sponsoring institution
application. PHS Fellowship
Supplemental Form and agency-specific
instructions are used in combination
with the SF424 (R&R) forms/
instructions for Fellowships and are
used by individuals to apply for direct
research training support. Awards are
made to individual applicants for
specified training proposals in
biomedical and behavioral research,
selected as a result of a national
competition. The PHS 416–5 is used by
individuals to indicate the start of their
NRSA awards. The PHS 6031 Payback
Agreement is used by individuals at the
time of activation to certify the
agreement to fulfill the payback
provisions.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
2,175,670.
page limit where this information was
previously collected. The Training Data
Tables will also be updated to reduce
the burden and promote consistent
information collection, including
limiting the scope of information
collection to data only relevant to the
training stage(s) of the proposed
program in Table 1 and removing
instructions in Table 8 that are reported
within the Research Performance
Progress Report (RPPR). Effective for
due dates on or after May 25, 2025, NIH
will be adopting the Common Forms for
Biographical Sketch and Current and
Pending (Other) Support as part of the
directive from Guidance for
Implementing National Security
Presidential Memorandum (NSPM)–33.
The Common Forms are part of a
separate OMB collection, currently
approved under 3145–0279. As such,
elements collected within the Common
Forms will be removed from NIH’s
current NIH Biosketch and Other
Support formats. NIH will continue to
collect additional information not
captured on the Common Forms to
adhere to the agency’s implementation
of the NIH Peer Review Regulations at
42 CFR part 52 as part of the NIH
Biosketch form, which will be renamed
the NIH Biosketch Supplement to reflect
the supplemental information
requested. The application and progress
report forms and associated instructions
will be updated to align with these new
requirements. This collection also
continues to include PHS applications
and pre-award reporting requirements:
PHS 398 [paper] Public Health Service
Grant Application forms and
instructions; PHS 398 [electronic] PHS
Grant Application component forms and
agency-specific instructions used in
combination with the SF424 (R&R); PHS
Fellowship Supplemental Form and
agency-specific instructions used in
combination with the SF424 (R&R)
forms/instructions for Fellowships
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Information collection forms
PHS 398—Paper .............................................................................................
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
burden hours
4,247
1
35
148,645
37,120
74,239
56,693
1,122
561
70,866
1,122
1,515
1
1
1
1
1
1
1
1
30/60
1
1
2
90/60
10
10
4
18,560
74,239
56,693
2,244
842
708,660
11,220
6,060
khammond on DSKJM1Z7X2PROD with NOTICES
PHS 398/424—Electronic
PHS Assignment Request Form ......................................................................
PHS 398 Cover Page Supplement ..................................................................
PHS 398 Modular Budget ................................................................................
PHS 398 Training Budget ................................................................................
PHS 398 Training Subaward Budget Attachment(s) Form .............................
PHS 398 Research Plan .................................................................................
PHS 398 Research Training Program Plan ....................................................
Data Tables .....................................................................................................
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Federal Register / Vol. 89, No. 100 / Wednesday, May 22, 2024 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Information collection forms
PHS 398 Career Development Award Supplemental Form ............................
PHS Human Subjects and Clinical Trial Information .......................................
Biosketch (424 Electronic) ...............................................................................
Data Management and Sharing Plan ..............................................................
Average
burden per
response
(in hours)
Number of
responses per
respondent
2,251
54,838
80,946
73,117
Total annual
burden hours
1
1
1
1
10
13
2
2
22,510
712,894
161,892
146,234
6,707
6,707
29
6,707
6,217
6
1,500
1
1
1
1
1
1
1
13
2
10
5/60
5/60
5/60
15/60
87,191
13,414
290
559
518
1
375
239
........................
1
486,749
11
........................
2,629
2,175,670
PHS Fellowship—Electronic
PHS Fellowship Supplemental Form (includes F reference letters) ...............
Biosketch (Fellowship) .....................................................................................
416–1 ...............................................................................................................
PHS 416–5 ......................................................................................................
PHS 6031 ........................................................................................................
VCOC Certification ..........................................................................................
SBIR/STTR Funding Agreement Certification .................................................
NIH Other Transaction
NIH Other Transaction Application Form ........................................................
Total Annual Burden Hours ......................................................................
Dated: May 13, 2024.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2024–11251 Filed 5–21–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meeting
khammond on DSKJM1Z7X2PROD with NOTICES
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; HEAL Initiative: Nonaddictive Analgesic Therapeutics
Development [Small Molecules and
Biologics] to Treat Pain.
Date: June 17, 2024.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate
cooperative agreement applications.
VerDate Sep<11>2014
17:06 May 21, 2024
Jkt 262001
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: W. Ernest Lyons, Ph.D.,
Scientific Review Administrator, Scientific
Review Branch, Division of Extramural
Activities, NINDS/NIH/DHHS, NSC, 6001
Executive Boulevard, Rockville, MD 20852,
301–496–4056, lyonse@ninds.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS).
Dated: May 16, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–11187 Filed 5–21–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health (NIH)
Office of Science Policy (OSP):
Request for Information on Draft NIH
Intramural Research Program Policy:
Promoting Equity Through Access
Planning
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Institutes of
Health (NIH) is proposing to develop
and implement a new policy within its
Intramural Research Program (IRP) to
promote access to products stemming
SUMMARY:
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
from taxpayer-funded inventions. NIH
seeks input on this draft policy and
accompanying draft license agreement
language that incorporates patient
access in the commercialization process
for NIH-owned inventions.
DATES: To ensure consideration,
comments must be submitted in writing
by July 22, 2024.
ADDRESSES: Comments may be
submitted electronically to Https://osp.
od.nih.gov/comment-form-draft-nihintramural-research-program-policypromoting-equity-through-accessplanning/. Responses to this request for
information are voluntary and may be
submitted anonymously. You may
voluntarily include your name and
contact information with your response.
Other than your name and contact
information, please do not include in
the response any personally identifiable
information or any information that you
do not wish to make public. Proprietary,
classified, confidential, or sensitive
information should not be included in
your response. After the Office of
Science Policy (OSP) has finished
reviewing the responses, the responses
may be posted to the OSP website
without redaction.
FOR FURTHER INFORMATION CONTACT:
Abby Rives, Director of the Technology
Transfer and Innovation Policy, at (301)
496–9838 or SciencePolicy@od.nih.gov.
SUPPLEMENTARY INFORMATION:
Background
As the world’s largest public funder of
biomedical research, NIH seeks to drive
effective partnerships that foster a
shared commitment to transforming
E:\FR\FM\22MYN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 100 (Wednesday, May 22, 2024)]
[Notices]
[Pages 45001-45003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11251]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; PHS Applications and
Pre-Award Reporting Requirements (OD)
AGENCY: National Institutes of Health.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, for opportunity for public comment on proposed data
collection projects, the National Institutes of Health (NIH) will
publish periodic summaries of proposed projects to be submitted to the
Office of Management and Budget (OMB) for review and approval.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 60 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, submit comments in writing, or
request more information on the proposed project, contact: Ms. Mikia P.
Currie, Program Analyst, Office of Policy for Extramural Research
Administration, 6705 Rockledge Drive, Suite 350, Bethesda, Maryland
20892, or call a non-toll-free number 301-435-0941 or email your
request, including your address to [email protected].
Formal requests for additional plans and instruments must be requested
in writing.
SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: written comments and/or suggestions
from the public and affected agencies are invited on one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proper
[[Page 45002]]
performance of the function of the agency, including whether the
information will have practical utility; (2) The accuracy of the
agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) Ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) Ways to minimize the burden of the
collection of information on those who are to respond, including the
use of appropriate automated, electronic, mechanical, or other
technological collection techniques or other forms of information
technology.
Proposed Collection Title: Public Health Service (PHS) Applications
and Pre-Award Reporting Requirements, Revision, OMB 0925-0001,
Expiration Date 01/31/2026, Office of the Director, National Institutes
of Health (NIH).
Need and Use of Information Collection: Effective for due dates on
or after January 25, 2025, NIH will be implementing several trans-NIH
initiatives to simplify the grants process for applicants and
recipients as well as for peer review. NIH will be updating fellowship
applications to improve fellowship peer review to facilitate the
mission of these programs to identify the most promising candidates and
individualized training opportunities that will assist them along their
paths to support the advancement of the biomedical research enterprise.
NIH will be reducing the number of required attachments and updating
instructions for the PHS Fellowship Supplemental Form to align with the
revised scored review criteria. NIH will also be updating institutional
training grant applications, including adding a new attachment field to
the PHS 398 Research Training Program Plan form for the transparent
collection of the Recruitment Plan to Enhance Diversity while also
providing additional space for applicants within the Program Plan page
limit where this information was previously collected. The Training
Data Tables will also be updated to reduce the burden and promote
consistent information collection, including limiting the scope of
information collection to data only relevant to the training stage(s)
of the proposed program in Table 1 and removing instructions in Table 8
that are reported within the Research Performance Progress Report
(RPPR). Effective for due dates on or after May 25, 2025, NIH will be
adopting the Common Forms for Biographical Sketch and Current and
Pending (Other) Support as part of the directive from Guidance for
Implementing National Security Presidential Memorandum (NSPM)-33. The
Common Forms are part of a separate OMB collection, currently approved
under 3145-0279. As such, elements collected within the Common Forms
will be removed from NIH's current NIH Biosketch and Other Support
formats. NIH will continue to collect additional information not
captured on the Common Forms to adhere to the agency's implementation
of the NIH Peer Review Regulations at 42 CFR part 52 as part of the NIH
Biosketch form, which will be renamed the NIH Biosketch Supplement to
reflect the supplemental information requested. The application and
progress report forms and associated instructions will be updated to
align with these new requirements. This collection also continues to
include PHS applications and pre-award reporting requirements: PHS 398
[paper] Public Health Service Grant Application forms and instructions;
PHS 398 [electronic] PHS Grant Application component forms and agency-
specific instructions used in combination with the SF424 (R&R); PHS
Fellowship Supplemental Form and agency-specific instructions used in
combination with the SF424 (R&R) forms/instructions for Fellowships
[electronic]; PHS 416-1 Ruth L. Kirschstein National Research Service
Award (NRSA) Individual Fellowship Application Instructions and Forms
used only for a change of sponsoring institution application [paper];
Instructions for a Change of Sponsoring Institution for NRSA
Fellowships (F30, F31, F32 and F33) and non-NRSA Fellowships; PHS 416-5
Ruth L. Kirschstein National Research Service Award Individual
Fellowship Activation Notice; and PHS 6031 Payback Agreement. The PHS
398 (paper and electronic are currently approved under 0925-0001. All
forms expire 01/31/2026. Post-award reporting requirements are
simultaneously consolidated under 0925-0002 and include the RPPR. The
PHS 398 and SF424 applications are used by applicants to request
Federal assistance funds for traditional investigator-initiated
research projects and to request access to databases and other PHS
resources. The PHS 416-1 is used only for a change of sponsoring
institution application. PHS Fellowship Supplemental Form and agency-
specific instructions are used in combination with the SF424 (R&R)
forms/instructions for Fellowships and are used by individuals to apply
for direct research training support. Awards are made to individual
applicants for specified training proposals in biomedical and
behavioral research, selected as a result of a national competition.
The PHS 416-5 is used by individuals to indicate the start of their
NRSA awards. The PHS 6031 Payback Agreement is used by individuals at
the time of activation to certify the agreement to fulfill the payback
provisions.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 2,175,670.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Information collection forms Number of responses per per response Total annual
respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
PHS 398--Paper.................................. 4,247 1 35 148,645
----------------------------------------------------------------------------------------------------------------
PHS 398/424--Electronic
----------------------------------------------------------------------------------------------------------------
PHS Assignment Request Form..................... 37,120 1 30/60 18,560
PHS 398 Cover Page Supplement................... 74,239 1 1 74,239
PHS 398 Modular Budget.......................... 56,693 1 1 56,693
PHS 398 Training Budget......................... 1,122 1 2 2,244
PHS 398 Training Subaward Budget Attachment(s) 561 1 90/60 842
Form...........................................
PHS 398 Research Plan........................... 70,866 1 10 708,660
PHS 398 Research Training Program Plan.......... 1,122 1 10 11,220
Data Tables..................................... 1,515 1 4 6,060
[[Page 45003]]
PHS 398 Career Development Award Supplemental 2,251 1 10 22,510
Form...........................................
PHS Human Subjects and Clinical Trial 54,838 1 13 712,894
Information....................................
Biosketch (424 Electronic)...................... 80,946 1 2 161,892
Data Management and Sharing Plan................ 73,117 1 2 146,234
----------------------------------------------------------------------------------------------------------------
PHS Fellowship--Electronic
----------------------------------------------------------------------------------------------------------------
PHS Fellowship Supplemental Form (includes F 6,707 1 13 87,191
reference letters).............................
Biosketch (Fellowship).......................... 6,707 1 2 13,414
416-1........................................... 29 1 10 290
PHS 416-5....................................... 6,707 1 5/60 559
PHS 6031........................................ 6,217 1 5/60 518
VCOC Certification.............................. 6 1 5/60 1
SBIR/STTR Funding Agreement Certification....... 1,500 1 15/60 375
----------------------------------------------------------------------------------------------------------------
NIH Other Transaction
----------------------------------------------------------------------------------------------------------------
NIH Other Transaction Application Form.......... 239 1 11 2,629
Total Annual Burden Hours................... .............. 486,749 .............. 2,175,670
----------------------------------------------------------------------------------------------------------------
Dated: May 13, 2024.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2024-11251 Filed 5-21-24; 8:45 am]
BILLING CODE 4140-01-P
