FDA Seeks Comments on Paperwork Nobody Reads
Published Date: 7/6/2026
Notice
Summary
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!
Analyzed Economic Effects
5 provisions identified: 1 benefits, 4 costs, 0 mixed.
Citizen Petitions: 24 Hours Each
FDA estimates 330 citizen petitions or related petitions (including certain ANDAs, NDAs, and BLAs) at 24 hours per submission, totaling 7,920 annual burden hours for petition filers.
Total FDA Paperwork Burden: 9,440 Hours
The FDA estimates the annual paperwork burden for these administrative practices and formal hearings at 9,440 total hours and states the collection reflects an increase of 3,080 annual burden hours. The agency also says there are no capital costs or operating and maintenance costs for this information collection.
External Speaker Requests: 3,900 at 10 Minutes
FDA reports 3,900 external requests for FDA speakers annually, at an average burden of 0.17 hours (10 minutes) each, totaling 663 annual hours for requesters.
No Capital or Ongoing Monetary Costs
The FDA states there are no capital costs or operating and maintenance costs associated with this collection of information.
10.19 Waiver Requests: 1 Response, 1 Hour
FDA includes an estimate for Sec. 10.19 waiver/suspension/modification requests of 1 response annually at 1 hour of burden, noting that the agency has not received such requests but accounts for the possible burden.
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Key Dates
Department and Agencies
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