30 D FRN Sterilzation Consent Form

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Federal Register / Vol. 90, No. 109 / Monday, June 9, 2025 / Notices
certification from their NTA to be
eligible for fee waivers or reductions.
Additionally, FDA intends to
consolidate the forms previously known
as FDA 3602 and FDA 3602A into a
single webform, the ‘‘MDUFA Small
Business Request’’ (MDUFA SBR, FDA
3602N) to be completed by foreign as
well as U.S. businesses/applicants via
FDA’s Center for Devices and
Radiological Health Customer

Collaboration Portal (CDRH Portal). We
have also added to the MDUFA SBR a
‘‘Registration & Listing Waiver’’ section
which asks if the business/applicant
will apply for a registration and listing
fee waiver and whether they have
applied in the past. Applicants seeking
this waiver will be asked to include
proof of bankruptcy documentation in
the supporting documentation section.

In the Federal Register of February
22, 2024 (89 FR 13349), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. Three comments were
received, but they were not related to
the information collection.
FDA estimates the burden of this
collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA form No.

Number of
respondents

Number of
responses per
respondent

Total annual
responses

Average
burden per
response

Total hours

MDUFA Small Business Request webform—FDA 3602N ..

4,500

1

4,500

1

4,500

1 There

are no capital costs or operating and maintenance costs associated with this collection of information.

As discussed previously in this
document, we have proposed updates to
the guidance document, ‘‘Medical
Device User Fee Small Business
Qualification and Certification
Guidance for Industry, Food and Drug
Administration Staff and Foreign
Governments,’’ (August 2018) consistent
with amendments to section 738(a)(3)(B)
of the FD&C Act. Because we assume
that current bankruptcy documentation
is readily available to applicants, we
assume no change to the Average
Burden per Response for this
information collection.
Aside from the changes already
discussed, the total burden estimate
remains unchanged from the last OMB
approval.
Dated: June 3, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2025–10387 Filed 6–6–25; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0937–0166]

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

AGENCY:

khammond on DSK9W7S144PROD with NOTICES

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 9, 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:
Michelle Jasczynski,
Michelle.Jasczynski@hhs.gov, (301) 284–
6813. When submitting comments or
requesting information, please include
the document identifier 0937–0166–30D
and project title 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
SUMMARY:

(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: HHS 42 CFR
subpart B; Sterilization of Persons in
Federally Assisted Family Planning
Projects.
Type of Collection: Renewal.
OMB No. 0937–0166.
Abstract: The Department of Health
and Human Service, Office of
Population Affairs is requesting an
extension of a currently approved
collection for the disclosure and
recordkeeping requirements codified at
42 CFR part 50, subpart B (‘‘Sterilization
of Persons in Federally Assisted Family
Planning Projects’’). The consent form
solicits information to assure voluntary
and informed consent to persons
undergoing sterilization in programs of
health services which are supported by
federal financial assistance
administered by the United States
Public Health Service (PHS). It provides
additional procedural protection to the
individual and the regulation requires
that the consent form be a copy of the
form that is appended to the PHS
regulation. In 2003, the PHS
sterilization consent form was revised to
conform to OMB government-wide
standards for the collection of race/
ethnicity data and to incorporate the
PRA burden statement as part of the
consent form. We are requesting a threeyear extension.

ANNUALIZED BURDEN HOUR TABLE
Forms
(if necessary)

Respondents
(if necessary)

Information Disclosure for Sterilization Consent Form.

Citizens Seeking Sterilization ...........

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16:25 Jun 06, 2025

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Frm 00015

Fmt 4703

Number of
respondents

Sfmt 4703

Number of
responses per
respondents

100,000

E:\FR\FM\09JNN1.SGM

1

09JNN1

Average
burden per
response

Total burden
hours
1

100,000

24282

Federal Register / Vol. 90, No. 109 / Monday, June 9, 2025 / Notices
ANNUALIZED BURDEN HOUR TABLE—Continued

Record-keeping for Sterilization Consent Form.

Citizens Seeking Sterilization ...........

100,000

1

15/60

25,000

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

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

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

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

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

125,000

[FR Doc. 2025–10404 Filed 6–6–25; 8:45 am]
BILLING CODE 4150–34–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.

khammond on DSK9W7S144PROD with NOTICES

Average
burden per
response

Respondents
(if necessary)

Catherine Howard,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.

Name of Committee: Center for Scientific
Review Special Emphasis Panel; NIH
Support for Conferences and Scientific
Meetings.
Date: July 8–9, 2025.
Time: 10:00 a.m. to 6:30 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: Heidi B. Friedman, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 907–H,
Bethesda, MD 20892, (301) 379–5632,
hfriedman@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business—Anti-Infective Therapeutics.
Date: July 9–10, 2025.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Address: National Institute of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
Meeting Format: Virtual Meeting.

VerDate Sep<11>2014

16:25 Jun 06, 2025

Jkt 265001

Number of
respondents

Number of
responses per
respondents

Forms
(if necessary)

Contact Person: Marcus Ferrone,
PHARMD, Scientific Review Officer, Center
for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 402–2371, marcus.ferrone@
nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Assay Development, Drug
Discovery Tools, and Imaging.
Date: July 9–10, 2025.
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: Angela Monique Boutte,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Dr., Bethesda, MD
20892, (301) 594–0063, boutteam@
csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Clinical Care and Health
Interventions.
Date: July 10–11, 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: Trina Colleen Salm Ward,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 594–5254, salmwardtc@
csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Genes, Genomes and Genetics.
Date: July 10–11, 2025.
Time: 10:00 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: Linda Wagner Jurata,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 496–8032, linda.jurata@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Applied Immunology and Vaccine
Development.
Date: July 10–11, 2025.

PO 00000

Frm 00016

Fmt 4703

Sfmt 4703

Total burden
hours

Time: 10:00 a.m. to 6:30 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: Dayadevi Jirage, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4422,
Bethesda, MD 20892, (301) 867–5309,
jiragedb@csr.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: June 4, 2025.
Bruce A. George,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2025–10426 Filed 6–6–25; 8:45 am]
BILLING CODE 4140–01–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.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Maximizing Investigators’ Research Award.
Date: July 9–10, 2025.
Time: 9:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.

E:\FR\FM\09JNN1.SGM

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