Notice2025-18621
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Primary source
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Published
September 25, 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 184 (Thursday, September 25, 2025)</title>
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[Federal Register Volume 90, Number 184 (Thursday, September 25, 2025)]
[Notices]
[Page 46225]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18621]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2024-N-3902; FDA-2024-N-4754; FDA-2018-D-1873; FDA-
2024-N-4146; FDA-2021-N-0862; FDA-2008-D-0053; FDA-2024-N-5338; FDA-
2024-N-3112; FDA-2024-N-4167; FDA-2024-N-3675; FDA-2025-N-0338; FDA-
2025-N-2193]
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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#f9a9abb8aa8d989f9fb99f9d98d791918ad79e968f"><span class="__cf_email__" data-cfemail="2f7f7d6e7c5b4e49496f494b4e0147475c01484059">[email 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
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OMB Control Date approval
Title of collection No. expires
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Registration of Producers of Drugs and 0910-0045 07/31/2028
Listing of Drugs in Commercial
Distribution...........................
Financial Disclosure by Clinical 0910-0396 07/31/2028
Investigators..........................
MDUFMA Small Business Qualification 0910-0508 07/31/2028
Certification..........................
Biosimilar User Fee Program............. 0910-0718 07/31/2028
General Drug Labeling Provisions and OTC 0910-0340 07/31/2028
Monograph Drug User Fee Submissions....
Applications for FDA Approval to Market 0910-0001 07/31/2027
a New Drug.............................
Prescription Drug Advertisements and 0910-0686 07/31/2028
Product Communications.................
Medical Device Labeling Requirements.... 0910-0485 07/31/2028
Interstate Shellfish Dealer's 0910-0021 07/31/2028
Certificate............................
Postmarketing Adverse Drug Experience 0910-0230 07/31/2028
Reporting..............................
Labeling Requirements for Human 0910-0572 07/31/2028
Prescription Drug and Biological
Products...............................
Pharmaceutical Distribution Supply Chain 0910-0806 08/31/2028
Export Notification and Recordkeeping 0910-0482 09/30/2028
Requirements...........................
Tobacco Products, User Fees, 0910-0749 09/30/2028
Requirements for the Submission of Data
Needed to Calculate User Fees for
Domestic Manufacturers and Importers of
Tobacco Products.......................
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Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-18621 Filed 9-24-25; 8:45 am]
BILLING CODE 4164-01-P
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