FDA Reviews Drug Factory Record-Keeping Forms
Published Date: 5/21/2026
Notice
Summary
The FDA is updating how it collects info about drug making to keep medicines safe and high-quality. This affects drug makers who must follow good manufacturing rules and may see some changes in paperwork. Comments on these updates are open until June 22, 2026, so industry folks have time to weigh in before any new rules kick in.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 2 costs, 0 mixed.
Medical Gas Burden Removed
FDA removed medical gas information-collection requirements from this OMB control number, shifting them to 0910-0906. That removal reduces annual burden by 396,293 hours and 639,491 responses.
Recordkeeping Burden for Drug Makers
FDA estimates API manufacturers (1,260 recordkeepers) have 322,560 records requiring 264,499 hours annually (0.82 hours per record). Finished pharmaceuticals manufacturers (3,270 recordkeepers) have 977,730 records requiring 625,747 hours annually (0.64 hours per record), for a total of 1,300,319 records and 890,455 hours per year.
AMT Designation Information Burden
The information collection covers FDA's Advanced Manufacturing Technologies (AMT) Designation Program and estimates 20 designation requests totaling 200 hours (10 hours per request). FDA notes the AMT activity was omitted from a prior summary and is now included.
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Key Dates
Department and Agencies
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