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Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting
Read on FederalRegister.gov · Official PDF · Docket on Regulations.gov · Add to calendar (.ics)
Summary (from the Federal Register abstract)
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on postmarketing reporting and recordkeeping of adverse experiences for drug and biological products.
- Document type
- Notice
- Federal Register document number
- 2026-09543
- Published
- May 13, 2026
- Action
- Notice.
- Docket
- FDA-2026-N-3098
- Comments posted on Regulations.gov (at last check)
- 1
- DATES section (from the document)
- Either electronic or written comments on the collection of information must be submitted by July 13, 2026.
- Topics (auto-tagged)
- Other FDA topics
Source: Federal Register API, document 2026-09543. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.