The eRulemaking Program

09/25/2025 | Press release | Distributed by Public on 09/25/2025 08:11

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

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.

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, [email protected].

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 https://www.reginfo.gov/public/do/PRAMain. 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
Title of collection OMB Control No. Date approval expires
Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution 0910-0045 07/31/2028
Financial Disclosure by Clinical Investigators 0910-0396 07/31/2028
MDUFMA Small Business Qualification Certification 0910-0508 07/31/2028
Biosimilar User Fee Program 0910-0718 07/31/2028
General Drug Labeling Provisions and OTC Monograph Drug User Fee Submissions 0910-0340 07/31/2028
Applications for FDA Approval to Market a New Drug 0910-0001 07/31/2027
Prescription Drug Advertisements and Product Communications 0910-0686 07/31/2028
Medical Device Labeling Requirements 0910-0485 07/31/2028
Interstate Shellfish Dealer's Certificate 0910-0021 07/31/2028
Postmarketing Adverse Drug Experience Reporting 0910-0230 07/31/2028
Labeling Requirements for Human Prescription Drug and Biological Products 0910-0572 07/31/2028
Pharmaceutical Distribution Supply Chain 0910-0806 08/31/2028
Export Notification and Recordkeeping Requirements 0910-0482 09/30/2028
Tobacco Products, User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products 0910-0749 09/30/2028
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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