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Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing.
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 (the 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 the information collection requirements relating to the reporting of biological product deviations and human cells, tissues, and cellular and tissue-based product (HCT/P) deviations in manufacturing, and Forms FDA 3486 and 3486A.
- Document type
- Notice
- Federal Register document number
- 2026-03773
- Published
- Feb 25, 2026
- Action
- Notice.
- Docket
- FDA-2026-N-0027
- Comments posted on Regulations.gov (at last check)
- 1
- DATES section (from the document)
- Submit either electronic or written comments on the collection of information by April 27, 2026.
- Topics (auto-tagged)
- Vaccines / biologics
Source: Federal Register API, document 2026-03773. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.