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.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
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.
2025-01840, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA’s new rule about nonprescription drugs needing extra conditions before use was set to start on January 27, 2025, but it’s now delayed until March 21, 2025. This delay follows a presidential order to pause and review new rules before they take effect. Drug makers, sellers, and consumers should note the new start date and get ready for the updated rules soon.
2026-20075, Medical Devices; Gastroenterology-Urology Devices; Classification of the Flushing and Storage Solution for Vascular Autografts at Room Temperature
The FDA is officially putting the flushing and storage solution for vascular autografts at room temperature into class II, meaning it now has special safety rules but fewer regulatory hurdles. This change helps companies bring these devices to patients faster and safer, starting from September 30, 2026, with the classification effective since October 4, 2023. Medical device makers and patients will benefit from easier access to these important solutions without extra costs or delays.
2026-19968, Determination That ISTURISA (Osilodrostat) Tablets, 10 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The FDA has decided that ISTURISA (osilodrostat) 10 mg tablets were not taken off the market because of safety or effectiveness problems. This means generic drug makers can now apply to sell their own versions of ISTURISA, as long as they meet all the rules. Patients and pharmacies could see more affordable options soon, with no safety worries involved.
Previous / Next Documents
Previous: 2026-05619, Permanent Advisory Committee To Advise the U.S. Commissioners to the Western and Central Pacific Fisheries Commission; Meeting Announcement
The U.S. is holding a public online meeting on May 27, 2026, to get advice on managing fish stocks in the Western and Central Pacific Ocean. This meeting affects fishermen, local island communities, and anyone interested in ocean conservation. It’s a chance to share ideas and help shape smart fishing rules without any cost to join.
Next: 2026-05621, Application for Renewal of Authorization To Export Electric Energy; MAG Energy Solutions, Inc.
MAG Energy Solutions, Inc. wants to renew its permission to send electricity from the U.S. to Canada for another five years. This affects energy buyers and sellers on both sides of the border and keeps the electric flow steady without changing prices. If you want to speak up, you’ve got until April 22, 2026, to send your comments or concerns.