Notice2025-12408

Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals

Primary source

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Published
July 3, 2025

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Full Text

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<title>Federal Register, Volume 90 Issue 126 (Thursday, July 3, 2025)</title>
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[Federal Register Volume 90, Number 126 (Thursday, July 3, 2025)]
[Notices]
[Pages 29567-29568]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-12408]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-D-2335; FDA-2024-N-2888; FDA-2018-N-0180; FDA-
2024-N-2149]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approvals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a list of 
information collections that have been approved by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
<a href="/cdn-cgi/l/email-protection#e0b0b2a1b394818686a0868481ce888893ce878f96"><span class="__cf_email__" data-cfemail="d686849785a2b7b0b096b0b2b7f8bebea5f8b1b9a0">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: The following is a list of FDA information 
collections recently approved by OMB under section 3507 of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control 
number and expiration date of OMB approval for each information 
collection are shown in table 1. Copies of the supporting statements 
for the information collections are available on the internet at 
<a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. An Agency may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number.

        Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
                                                         Date approval
       Title of collection          OMB control No.         expires
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Food Labeling Regulations.......  0910-0381.........  4/30/2028
Substantial Equivalence Reports   0910-0673.........  4/30/2028
 for Tobacco Products.
Generic Clearance for the         0910-0810.........  4/30/2028
 Collection of Quantitative Data
 on Tobacco Products and
 Communications.
De Novo Classification Process    0910-0844.........  4/30/2028
 (Evaluation of Automatic Class
 III Designation).
Human Drug Compounding,           0910-0858.........  4/30/2028
 Repackaging, and Related
 Activities Regarding Sections
 503A and 503B of the Federal
 Food, Drug, and Cosmetic Act.
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[[Page 29568]]

    Dated: June 26, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-12408 Filed 7-2-25; 8:45 am]
BILLING CODE 4164-01-P


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Indexed from Federal Register on July 3, 2025.

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