The eRulemaking Program

08/17/2026 | Press release | Distributed by Public on 08/17/2026 09:41

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-2025-N-1560; FDA-2021-N-1351; FDA-2025-N-2549; FDA-2025-N-0426; FDA-2026-N-0746; FDA-2026-N-0497; FDA-2025-N-0953; FDA-2024-N-4467; FDA-2025-N-4942; FDA-2025-N-2195; FDA-2025-N-0354; FDA-2025-N-3215; FDA-2025-N-1108; FDA-2025-N-0419; FDA-2025-N-1210; FDA-2025-N-0414; FDA-2025-N-1115; FDA-2025-N-1109; FDA-2025-N-1330; FDA-2024-N-5943; FDA-2025-N-0351; FDA-2025-N-3656; FDA-2025-N-2220; FDA-2024-N-5890; FDA-2012-D-0429; FDA-2025-N-0348; FDA-2025-N-1812; FDA-2025-N-2548; FDA-2025-N-4348; FDA-2024-N-1055; FDA-2025-N-0615; FDA-2024-N-3762; FDA-2023-N-0894; FDA-2025-N-0308; FDA-2024-N-0668; FDA-2025-N-1732]

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:

Amber Barrett, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [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 number Date approval expires
Electronic Products Requirements 0910-0025 5/31/2029
Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution 0910-0045 5/31/2029
Investigational Device Exemptions 0910-0078 5/31/2029
Agreement for Shipments of Devices for Sterilization 0910-0131 6/30/2029
Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including API), and AMT Designation 0910-0139 7/31/2029
Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions 0910-0233 7/31/2029
Export of Medical Devices; Foreign Letters of Approval 0910-0264 3/31/2029
Prescription Drug User Fee Program 0910-0297 1/31/2029
Mammography Standards Quality Act Requirements 0910-0309 5/31/2029
Medical Devices; Humanitarian Use Devices 0910-0332 6/30/2029
Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed 0910-0339 5/31/2029
Food Safety, Health, and Diet Survey 0910-0345 3/31/2029
510(k) Third-Party Review Program 0910-0375 6/30/2029
Medical Device Reporting 0910-0437 2/28/2029
Postmarket Surveillance of Medical Devices 0910-0449 6/30/2029
Guidance for Reagents for Detection of Specific Novel Influenza A Viruses 0910-0584 6/30/2029
Authorization of Medical Products for Use Emergencies 0910-0595 5/31/2029
Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization 0910-0607 6/30/2029
Electronic Submission of Medical Device Registration and Listing 0910-0625 4/30/2029
Tobacco Product Establishment Registration and Submission of Certain Health Information 0910-0650 4/30/2029
Tobacco Health Document Submission 0910-0654 4/30/2029
Current Good Manufacturing Practices for Positron Emission Tomography (PET) Drugs 0910-0667 6/30/2029
Testing Communications on Medical Devices and Radiation-Emitting Products 0910-0678 7/31/2029
Generic Drug User Fee Program 0910-0727 1/31/2029
Guidance on Meetings with Industry and Investigators on the Research and Development of Tobacco Products 0910-0731 4/30/2029
Center for Devices and Radiological Health Appeals Processes 0910-0738 6/30/2029
Q-Submission and Early Payor Feedback Request Programs and Medical Device Development Tools 0910-0756 5/31/2029
Animal Food and Egg Regulatory Program Standards 0910-0760 5/31/2029
Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act 0910-0800 5/31/2029
Medical Device Accessories 0910-0823 3/31/2029
Data To Support Social and Behavioral Research as Used by the Food and Drug Administration 0910-0847 5/31/2029
Generic Clearance for Quick Turnaround Testing of Communication Effectiveness 0910-0876 4/30/2029
Obtaining Information to Understand and Challenges and Opportunities Encountered by Compounding Outsourcing Facilities 0910-0883 3/31/2029
The Real Cost Monthly Implementation Assessment 0910-0935 3/31/2029
Emerging Drug Safety Technology Program 0910-0936 5/31/2029
Small Dispensers Assessment Under the Drug Supply Chain Security Act 0910-0937 6/30/2029
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-16716 Filed 8-14-26; 8:45 am]
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