FDA wants comments on animal drug fee paperwork—yawn.
Published Date: 8/28/2026
Notice
Summary
The FDA is asking for feedback on their plan to keep collecting info about fees for animal drug companies. This affects businesses that make or test animal drugs, helping the FDA manage fees through 2028. Comments are due by September 28, 2026, so now’s the time to speak up if you’re involved!
Analyzed Economic Effects
4 provisions identified: 1 benefits, 3 costs, 0 mixed.
Ongoing User Fee Programs Through 2028
The ADUFA and AGDUFA user fee programs are currently reauthorized through September 30, 2028, and FDA will continue to assess and collect user fees for certain new animal drug and abbreviated generic animal drug submissions. FDA estimates the total annual paperwork burden for these collections at 349.5 hours across respondents.
Mandatory ADUFA Cover Sheet Filing
If you sponsor a new animal drug application, you must complete the Animal Drug User Fee cover sheet (Form FDA 3546) and submit it electronically through FDA Center for Veterinary Medicine's eSubmitter. The form generates a unique payment ID and FDA estimates the cover sheet takes 0.5 hours (30 minutes) per submission (FDA estimates 14 total responses annually for this form).
Mandatory AGDUFA Cover Sheet Filing
If you sponsor an abbreviated (generic) new animal drug application, you must complete the Animal Generic Drug User Fee cover sheet (Form FDA 3728) and submit it electronically through CVM's eSubmitter. FDA estimates this cover sheet takes 0.5 hours (30 minutes) per submission and estimates 53 total responses annually for this form (26.5 hours total).
Fee Waivers and Reductions Available
FDA has statutory waivers, reductions, and exemptions for ADUFA and AGDUFA fees and provides guidance to help you request them (GFI #170 for ADUFA, April 2023; GFI #199 for AGDUFA, May 2009). FDA's burden estimates show a range of waiver-related submissions (for example, 4 small business waiver requests estimated at 2 hours each and other waiver categories with estimated response counts and hours).
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Key Dates
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