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Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Active Pharmaceutical Ingredients) and the Advanced Manufacturing Technologies Designation Program

Comment period closed: closed 179 days ago (Apr 21, 2026).

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 the information collection associated with CGMP for drugs, finished pharmaceuticals, including active pharmaceutical ingredients (APIs), and the advanced manufacturing technologies (AMT) designation program.

Document type
Notice
Federal Register document number
2026-03326
Published
Feb 20, 2026
Action
Notice.
Docket
FDA-2026-N-0746
Comments posted on Regulations.gov (at last check)
3
DATES section (from the document)
Either electronic or written comments on the collection of information must be submitted by April 21, 2026.
Topics (auto-tagged)
GMP / manufacturing

Source: Federal Register API, document 2026-03326. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.