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.
2026-16666, Determination That ANSAID (Flurbiprofen) Tablets, 50 Milligrams and 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that ANSAID (flurbiprofen) tablets, 50 milligrams (mg) and 100 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for flurbiprofen tablets, 50 mg and 100 mg, if all other legal and regulatory requirements are met.
2026-16648, Determination That LASIX (Furosemide) Tablets, 20 Milligrams, 40 Milligrams, and 80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that LASIX (furosemide) tablets, 20 milligrams (mg), 40 mg, and 80 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
2026-16650, Reauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is hosting a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2028 through 2032. PDUFA authorizes FDA to collect user fees to support the process for the review of human drug applications. The current legislative authority for PDUFA expires in September 2027. At that time, new legislation will be required for FDA to continue collecting prescription drug user fees in future fiscal years. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations, as necessary.
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.