Federal Register Agency Information Collection Request 60-Day Public Comment Request

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Federal Register / Vol. 90, No. 97 / Wednesday, May 21, 2025 / Notices
remove the IRB roster membership
information from the IRB registration
form. This change will align the IRB
registration form with the 2018
Requirements at 45 CFR 46.103. The
change, when implemented, is
anticipated to result in a shorter,
simplified IRB registration process for
respondents. Updates to the software
applications OHRP uses to manage IRB
registration will be deployed to enable
such changes.
The current form is approved through
June 30, 2025. The purpose of the form
is to provide a simplified procedure for:
(1) IRBs to satisfy the requirements for
IRB registration at 45 CFR part 46,
subpart E; and (2) IRBs in the United

States (US) to satisfy the FDA
requirements for IRB registration at 21
CFR 56.106.
Institutions engaged in nonexempt
human subjects research conducted or
supported by HHS, or another Common
Rule department or agency, are required
by the terms of the Federalwide
Assurance (FWA) to rely upon only
IRBs registered with OHRP for review of
research to which the FWA applies, and
must designate a registered IRB on the
institution’s FWA submission to OHRP.
In this way, OHRP’s FWA submission
process, established pursuant to the
requirements for assurances at 45 CFR
46.103, is linked to the regulatory
requirements for IRB registration.

The respondents for this information
collection are institutions or
organizations operating IRBs that review
human subjects research conducted or
supported by HHS; or, in the case of
FDA’s requirements, each IRB in the
United States that reviews clinical
investigations regulated by FDA under
sections 505(i) or 520(g) of the Federal
Food, Drug and Cosmetic Act; and each
IRB in the United States that reviews
clinical investigations that are intended
to support applications for research or
marketing permits for FDA-regulated
products. Many of the IRBs also review
research conducted or supported by
other Common Rule departments and
agencies.

ANNUALIZED BURDEN HOUR TABLE
Number of
respondents

Form name

Average
burden per
response
(in hours)

Total burden
hours

IRB Registration 0990–0279 Update and Renew ...............................................
IRB-Registration 0990–0279 Initial and Update ..................................................

5,350
350

1
2

0.33
0.5/0.33

1,766
291

Total ..............................................................................................................

......................

..........................

....................

2,057

Susan R. Little,
Department Information Collection Clearance
Officer, Paperwork Reduction Act Program,
Department of Health and Human Services.
[FR Doc. 2025–09001 Filed 5–20–25; 8:45 am]
BILLING CODE 4150–36–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–new]

Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Assistant
Secretary for Technology Policy/Office
of the National Coordinator for Health
IT, Office of the Secretary, HHS.
ACTION: Notice.
AGENCY:

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 21, 2025.
ADDRESSES: Submit your comments to
[email protected].
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
SUMMARY:

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Number of
responses per
respondent

VerDate Sep<11>2014

18:43 May 20, 2025

Jkt 265001

requesting information, please include
the document identifier 0990–New–60D
and project title for reference to ASTP_
[email protected] and Meghan Gabriel at
[email protected], [email protected]
or call 202–465–0597.
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: National
Survey of Digital Health Companies.
Type of Collection: New Data
Collection.
OMB No.
Abstract:
The 21st Century Cures Act (Cures
Act) aimed to advance the exchange of
electronic health information by
promoting patient access through
standardized application programming
interfaces (APIs). Digital health
companies develop apps and health IT

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Fmt 4703

Sfmt 4703

tools that enable human interaction
with APIs to exchange electronic health
information. Prior studies indicate
widespread adoption of standardized
APIs for interoperability with electronic
health records (EHRs). Ongoing
assessment of these technologies is
crucial to examining the impacts of the
Cures Act’s health IT provisions and is
critical to informing the Assistant
Secretary for Technology Policy/Office
of the National Coordinator for Health
IT’s (ASTP/ONC’s) policy efforts. With
ASTP/ONC’s support, the University of
California, San Francisco (UCSF)
conducted a 2022 survey of digital
health companies assessing
implementation of and experiences with
healthcare APIs; findings from this
survey work are published in the
Journal of the American Medical
Informatics Association. ASTP/ONC
finds it essential to continue efforts to
survey digital health companies to
assess ASTP/ONC’s implementation of
statutorily mandated information
blocking (42 U.S.C. 300jj–52) and APIs
‘‘without special effort’’ policies (42
U.S.C. 300jj–11) under the Cures Act.
Information gathered from this effort
will help inform ongoing ASTP/ONC
efforts to help nurture an ecosystem of
innovation and transparency in health
care.

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21786

Federal Register / Vol. 90, No. 97 / Wednesday, May 21, 2025 / Notices
ANNUALIZED BURDEN HOUR TABLE

Total ....................

U.S. based Digital Health Companies ...............................

282

1

60

282

Total ....................

............................................................................................

......................

..........................

....................

282

[FR Doc. 2025–09004 Filed 5–20–25; 8:45 am]
BILLING CODE 4150–45–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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.

ddrumheller on DSK120RN23PROD with NOTICES1

Average
burden per
response
(minutes)

Respondents
(if necessary)

Susan R. Little,
Department Information Collection Clearance
Officer, Paperwork Reduction Act Program,
Department of Health and Human Services.

Name of Committee: Center for Scientific
Review Special Emphasis Panel; Imaging and
Bioengineering Technology for Visual
Systems (IBV).
Date: June 17–18, 2025.
Time: 8:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Address: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Susan Gillmor, Ph.D.,
Scientific Review Officer, National Institutes
of Health, Center for Scientific Review, 6701
Rockledge Drive, Bethesda, MD 20892, 240–
762–3076, [email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel; RFA Panel:
HIV and Substance Use.
Date: June 17, 2025.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Address: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: Virtual Meeting.

VerDate Sep<11>2014

18:43 May 20, 2025

Jkt 265001

Number of
respondents

Number of
responses per
respondents

Forms
(if necessary)

Contact Person: Kaitlyn N. Hardell, MPH,
Ph.D., Scientific Review Officer, SRB, NIA,
Scientific Review Branch, 5601 Fishers Lane,
Suite 8B, Rockville, MD 20892, (301) 594–
7945, [email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Program
Projects: Cancer Biology.
Date: June 17–18, 2025.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Address: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: E. Tian, Ph.D., Scientific
Review Officer, Research Program Review
Branch, Division of Extramural Activities,
National Cancer Institute, NIH, 9609 Medical
Center Drive, Room7W618, ROCKVILLE, MD
20850, (240) 276–7246, [email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel; P50
SPORE’s in Human Cancer.
Date: June 17–18, 2025.
Time: 9:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Address: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: John Paul Cairns, Ph.D.,
Scientific Review Officer, Research Programs
Review Branch, Division of Extramural
Activities, 9609 Medical Center Drive, Room
7W244, National Cancer Institute, NIH,
Bethesda, MD 20892, 240–276–5415,
[email protected].
Name of Committee: Biological Chemistry
and Macromolecular Biophysics Integrated
Review Group, Macromolecular Structure
and Function B Study Section.
Date: June 17–18, 2025.
Time: 9:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Address: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Alexei A Yeliseev, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 443–0552, yeliseeva@
mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Special
Topics: Institutional Training and Education
Study Section.
Date: June 17–18, 2025.

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Total
burden hours

Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Address: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Adriana Stoica, Ph.D.,
Scientific Review Officer, Resources and
Training Review Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 9609 Medical Center Drive,
7W234, Bethesda, MD 20892–9750, 240–276–
6368, [email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Bidirectional Influences Between Adolescent
Social Media Use and Mental Health.
Date: June 18, 2025.
Time: 12:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Address: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Regina T. Dolan-Sewell,
Ph.D., Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Boulevard, Bethesda, MD
20852, (240) 796–6785, regina.dolan-sewell@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: May 15, 2025.
Bruce A. George,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2025–09074 Filed 5–20–25; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Center for Scientific
Review Special Emphasis Panel Small
Business Activities: Cardiovascular and
Hematology, June 19, 2025, 09:00 a.m.
to June 20, 2025, 06:00 p.m., National

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