FDA Calls for Input on Pet Drug Fee Reporting Rules
Published Date: 3/23/2026
Notice
Summary
The FDA wants your thoughts on how it collects info about fees for animal drugs and generic animal drugs. This affects companies that pay these fees and helps the FDA keep things fair and clear. You’ve got until May 22, 2026, to share your comments, so don’t miss out on shaping the rules!
Analyzed Economic Effects
3 provisions identified: 0 benefits, 3 costs, 0 mixed.
You must file fee cover sheets
If you sponsor a new animal drug or an abbreviated (generic) animal drug application, you must submit a user fee cover sheet through FDA Center for Veterinary Medicine’s eSubmitter (Form FDA 3546 for animal drugs; Form FDA 3728 for generics). FDA estimates each cover sheet takes about 0.5 hours (30 minutes) to complete; the notice reports 14 annual responses for FDA 3546 (7 respondents × 2 responses) and 53 annual responses for FDA 3728 (22 respondents × 2.4 responses). The cover sheet generates a unique payment identification number that FDA uses to link fee payments to the application or submission.
Fee waiver and reduction requests require paperwork
If you request a waiver or reduction of ADUFA/AGDUFA user fees, you must submit supporting information and FDA will use that information to decide the request. The notice lists waiver categories (for example: significant barrier to innovation; fees exceed cost; free-choice feeds; minor use/minor species; small business) and estimates typical burdens — many waiver requests are estimated at 2 hours each (e.g., 65 significant-barrier requests = 130 hours, 78 minor-use requests = 156 hours), with other categories shown at 0.5 or 2 hours per request.
ADUFA/AGDUFA remain in force through 2028
The Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA) programs are currently reauthorized through September 30, 2028, and FDA is engaging stakeholders on the 2028 reauthorization. That means the statutory user-fee programs and associated information collections (including the cover sheets and waiver processes described) will continue under the current reauthorization period.
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