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.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-13047 — Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-13778 — Medical Device User Fee Amendments; Public Meeting; Request for Comments
The FDA is planning a public meeting on August 5, 2026, to talk about renewing fees that medical device makers pay to help speed up device reviews from 2028 to 2032. This affects companies making medical devices and could impact how much they pay and how fast their products get approved. The current fee program ends in September 2027, so the FDA wants your thoughts before finalizing new rules and fees.
2026-13716 — New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor
The FDA just updated the rules for new animal drugs, approving several new and generic medicines for pets and farm animals from early 2026. These changes help keep animal treatments safe and effective, and the updates take effect right away on July 7, 2026. If you’re a drug maker or animal caretaker, these approvals and sponsor changes could impact what medicines are available and when.
2026-13616 — Endo Operations Limited, et al.; Withdrawal of Approval of 34 New Drug Applications
The FDA is officially pulling the plug on 34 drug approvals because the companies stopped selling these medicines. This change kicks in on August 5, 2026, and it mainly affects drug makers like Endo Operations and Pfizer. No money penalties here—just a clean break, but companies can ask to reapply if they want to bring the drugs back.
2026-13534 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Practices and Procedures; Formal Hearings
The FDA is asking for public feedback on how it collects information for formal hearings and administrative rules. This affects businesses and people who interact with the FDA, with no new costs but a chance to improve paperwork processes. Comments are due by August 5, 2026, so don’t miss your chance to weigh in!
2026-13519 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Approval of Medical Devices
The FDA is asking for public feedback on their paperwork rules for approving the most important and risky medical devices, like life-support machines. This review helps keep devices safe and effective before they hit the market. If you have thoughts, you’ve got until August 5, 2026, to share them—no cost changes, just a check-in on the info they collect.
Previous / Next Documents
Previous: 2026-10187 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Required Warnings for Cigarette Packages and Advertisements
The FDA is asking for public comments on continuing to collect info about the required health warnings on cigarette packs and ads. This affects tobacco companies who must keep using these graphic warnings to show smoking’s dangers. Comments are due by June 22, 2026, and this review helps keep the rules clear without adding extra costs.
Next: 2026-10189 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience/Events With Approved New Animal Drugs
The FDA is asking for approval to keep collecting info about problems with approved new animal drugs, like side effects or manufacturing issues. This helps make sure animal medicines stay safe and effective. Drug companies need to keep reporting these issues, and the public can comment until June 22, 2026. There’s no new cost, just a continuation of current rules.