30-Day Notice_0990-0278_ 90 FR 25058_ 13Jun2025

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Federal Register / Vol. 90, No. 113 / Friday, June 13, 2025 / Notices

—if relevant, related FDA guidances or
existing programs addressing the
challenge highlighted in the
submission.
Notice of this meeting series is given
pursuant to 21 CFR 10.65.
Dated: June 9, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2025–10801 Filed 6–12–25; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Sudden Unexpected Infant Death
Prevention
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Announcing period of
performance extension with funding for
the Sudden Unexpected Infant Death
(SUID) Prevention Program.
AGENCY:

HRSA will provide additional
award funds to the one recipient of the
SUID Prevention Program with period of
performance ending in fiscal year 2025
to extend the current period of
performance by 12 months to continue
the activities of the program related to
reducing infant deaths.
FOR FURTHER INFORMATION CONTACT:
Diane Pilkey, Senior Nurse Consultant,
Division of Child Adolescent and
Family Health, Maternal and Child
Health Bureau, Health Resources and
Services Administration, at dpilkey@
hrsa.gov and 301–500–9637.
SUPPLEMENTARY INFORMATION:
Intended Recipient(s) of the Award:
American Academy of Pediatrics (AAP).
Amount of Non-Competitive
Award(s): One Award of $500,000.
Project Period: July 1, 2025, through
June 30, 2026.
Assistance Listing (CFDA) Number:
93.110.
Award Instrument: Cooperative
Agreement.
Authority: This non-competitive
supplemental funding is authorized by
42 U.S.C. 701(a)(2) (title V, sec. 501(a)(2)
of the Social Security Act).
Purpose/Justification: HRSA will
provide a non-competitive supplement
of $500,000 to the SUID Prevention
Program recipient, AAP, to extend the
period of performance by an additional
year, July 1, 2025, to June 30, 2026, to
connect families with the resources that

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SUMMARY:

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they need and to help improve family
capacity to practice safe sleep. This
Program was awarded on July 1, 2022,
for a 3-year period (HRSA 22–082). The
purpose of the program is to reduce
overall rates of SUID by supporting
pediatric health care practitioners to
provide evidence-based counseling and
education to infant caregivers and
families; to guide system improvements;
and to identify and support policy
changes that address state- and
community-specific SUID risks. The
awardee has demonstrated progress
during this period and will be able to
expand that progress if extended by 1
year.
Funds are available for award for this
non-competitive supplement. A noncompetitive supplement is necessary to
ensure on time, high-quality
implementation of best practices for
reducing infant deaths that the current
recipient is uniquely positioned to
continue. The recipient is in good
standing with current HRSA grant
requirements and has been a leader in
Sudden Infant Death Syndrome (SIDS)
and SUID prevention for decades,
starting with the initial Back to Sleep
campaign in the 1990s that urged
parents and caregivers to place infants
to sleep supine following the emergence
of data that supported this
recommendation. More recently, the
AAP Task Force on SIDS has published
comprehensive recommendations for
the prevention of SIDS, Accidental
Suffocation and Strangulation in Bed,
and other sleep-related deaths, based on
a detailed and impartial analysis of all
available evidence. In addition, AAP
directs several initiatives aimed at
improving child health outcomes.
The current recipient will use their
existing infrastructure to maintain
implementation without disruption and
they are the only organization with a
unique existing network of practicing
pediatricians and related professionals
who are part of a National Safe Sleep
Champion Network, a network of
pediatrician experts in safe sleep to
promote safe sleep recommendations
and education for providers to better
serve families.
The recipient will be expected to
ensure continued efforts around
reducing infant deaths by disseminating
and implementing best practices,
increasing connections with state and
local infant fatality review teams and
AAP Chapters, supporting
implementation of a community

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engagement toolkit, and expanding their
National Safe Sleep Champion Network.
Thomas J. Engels,
Administrator.
[FR Doc. 2025–10738 Filed 6–12–25; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0278]

Agency Information Collection
Request. 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.

AGENCY:
ACTION:

In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before July 14, 2025.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Natalie Klein, Natalie.Klein@hhs.gov or
(240) 453–6900. When submitting
comments or requesting information,
please include the document identifier
0990–0278–30D and project title,
Federalwide Assurance (FWA) Form, for
reference.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Federalwide
Assurance (FWA) Form.
Type of Collection: Revision.
OMB No.: 0990–0278.
Abstract: The Office of the Assistant
Secretary for Health, Office for Human
SUMMARY:

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Federal Register / Vol. 90, No. 113 / Friday, June 13, 2025 / Notices
Research Protections (OHRP) is
requesting a revision of the currently
approved collection for the OMB No.
0990–0278, Federalwide Assurance
(FWA) Form. The form is currently
approved through October 31, 2026. The
purpose of the FWA form is to provide
a simplified procedure for institutions
engaged in research conducted or
supported by the Department of Health
and Human Services (HHS) to satisfy
the assurance requirements of (1)
Section 491(a) of the Public Health
Service Act (the PHS Act) (42 U.S.C.
289); and (2) HHS regulations for the
protection of human subjects at 45 CFR
46.103. The respondents for this

information collection are institutions
engaged in HHS-conducted or
supported research involving human
subjects. With this revision, OHRP is
seeking to remove information from the
FWA form to adopt the changes for
assurances at 45 CFR 46.103 of the 2018
Requirements and reduce burden on
respondents. The proposed changes to
the FWA form include: (1) removing the
Pre-2018 Common Rule requirement
that institutions provide a statement of
ethical principles; (2) removing the Pre2018 Common Rule requirement that an
institution designate one or more IRBs
to review the research to which the
FWA applies; (3) removing ‘‘check the

25059

box’’, or the option for U.S. institutions
to voluntarily apply the Common Rule,
or the Common Rule and subparts B, C,
and D of the HHS regulations at 45 CFR
part 46, to all of an institution’s
nonexempt human subjects research
regardless of the source of support; and
(4) eliminating the requirement for
institutions outside the U.S. to provide
procedural standards they apply for
human subjects research when assuring
compliance with the Terms of the
Federalwide Assurance. Updates to the
software applications OHRP uses to
manage the FWA application process
will be deployed to enable such
changes.

ANNUALIZED BURDEN HOUR TABLE
Form name

Number of
respondents

Number of
responses per
respondent

Average
burden per
response

Federalwide Assurance (FWA) ........................................................................
Total ..........................................................................................................

13,000
........................

1.0
........................

0.33
........................

Catherine Howard,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2025–10739 Filed 6–12–25; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health

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Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory Child
Health and Human Development
Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting. The meeting
can be accessed from the NIH Videocast
at the following link: https://
videocast.nih.gov/.
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,

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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 Advisory
Child Health and Human Development
Council.
Date: September 9–10, 2025.
Open: September 09, 2025, 9:30 a.m. to
10:30 a.m.
Agenda: NICHD Director’s Report and
other Council Business.
Address: National Institutes of Health,
Natcher Building, 45 Center Drive, Bethesda,
MD 20892 (In Person and Virtual Meeting).
Open: September 09, 2025, 12:45 p.m. to
5:00 p.m.
Agenda: Council Business.
Address: National Institutes of Health,
Natcher Building, 45 Center Drive, Bethesda,
MD 20892, (In Person and Virtual Meeting).
Closed: September 10, 2025, 9:45 a.m. to
12:45 p.m.
Agenda: To review and evaluate grant
applications.
Address: National Institutes of Health,
Natcher Building, 45 Center Drive, Bethesda,
MD 20892, (In Person and Virtual Meeting).
Contact Person: Rebekah S. Rasooly, Ph.D.,
Director, Division of Extramural Activities,
Eunice Kennedy Shriver National Institute of
Child Health and Human Development, NIH,
6710B Rockledge Drive, Room 2316,
Bethesda, MD 20817, Phone: 301–827–2599,
Email: Rebekah.rasooly@nih.gov.
Information is also available on the
Institute’s/Center’s home page: https://
www.nichd.nih.gov/about/advisory/council,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;

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Total
burden
hours
4,290
4,290

93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: June 10, 2025.
Bruce A. George,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2025–10779 Filed 6–12–25; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Cancellation of Meeting
Notice is hereby given of the
cancellation of the National Institute of
General Medical Sciences Special
Emphasis Panel, Review of the Centers
of Biomedical Research Excellence
(COBRE) Phase 1, July 09, 2025, 9:30
a.m. to July 10, 2025, 6:00 p.m.,
National Institute of Health, National
Institute of General Medical Sciences,
Natcher Building, 45 Center Drive,
Bethesda, Maryland 20892 which was
published in the Federal Register on
April 4, 2025, FR Doc. 2025–05832, 90
FR 14842.
This meeting has been transferred
from National Institute of General
Medical Sciences (NIGMS) to Center for
Scientific Review CSR.

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