Bark Up the Right Tree: FDA Seeks Animal Drug Fee Feedback
Published Date: 4/17/2026
Notice
Summary
The FDA is hosting a virtual meeting on May 27, 2026, to hear your thoughts on the Animal Drug User Fee Act (ADUFA), which helps fund animal drug reviews. This affects drug makers and animal health folks who pay fees to speed up approvals. You can share ideas now through December 1, 2027, as the FDA plans updates that might change fees and how the program works.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
ADUFA Fee Authority Expires 2028
If you make or sell animal drugs, the FDA's authority to collect Animal Drug User Fees expires on September 30, 2028. Without new legislation after that date, FDA will no longer have authority to collect user fees that help fund the animal drug review process for future fiscal years.
Opportunity to Shape ADUFA Reauthorization
If you are a drug maker or other animal health stakeholder, FDA is holding a virtual public meeting on May 27, 2026 (2 p.m.–4 p.m. ET) and is accepting comments on ADUFA through December 1, 2027. Register by midnight ET on May 22, 2026; request oral presentation by May 1, 2026; submit slide decks by May 15, 2026; and note comments suggesting changes received by July 1, 2026 will also be published on FDA's website.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-09767 — Oscar Bobo: Final Debarment Order
Oscar Bobo is officially banned for 5 years from importing any drugs into the U.S. because he repeatedly brought in mislabeled medicines that don’t follow FDA rules. He didn’t respond to the FDA’s warning, so the ban started on May 15, 2026. If he wants to end the ban early, he can apply anytime, but must follow special rules to keep his info private.
2026-09533 — Biomarker Incubator: Urinary Kidney Safety Biomarkers; Request for Information
The FDA wants your help to improve tests that spot kidney damage caused by medicines. They’re asking researchers, doctors, and companies to share data by July 13, 2026, so they can make these kidney safety markers better and faster. This could lead to safer drugs and smarter health checks, benefiting patients and the medical community alike.
2026-09508 — Azodicarbonamide (ADA); Request for Information
The FDA is asking for info about azodicarbonamide (ADA), a chemical used in some foods and food packaging, to check if it’s still safe. Food makers, scientists, and anyone with data should share what they know by July 13, 2026. This review could lead to changes in how ADA is used, affecting food companies and possibly costs down the line.
2026-09543 — Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting
The FDA wants your thoughts on how drug companies report problems after their products hit the market. This update affects drug makers and helps keep medicine safe by improving how side effects are tracked. You’ve got until July 13, 2026, to share your comments—no cost to join, just your voice!
2026-09544 — Modified Risk Tobacco Product Application: Renewal Applications for VLN® King and VLN® Menthol King, Cigarette Products Submitted by 22nd Century Group Inc.
The FDA is inviting the public to comment on the renewal of special approval for two cigarette products by 22nd Century Group Inc. These products claim to lower health risks compared to regular cigarettes. If renewed, the company can keep marketing them this way, with the comment period starting May 13, 2026.
2026-09507 — Butylated Hydroxytoluene (BHT); Request for Information
The FDA wants to know more about how butylated hydroxytoluene (BHT), a chemical used in food and food packaging, is being used and if it’s still safe. They’re asking companies, scientists, and the public to share any info by July 13, 2026. This could lead to changes in rules that affect food makers and might impact what’s allowed in your snacks and packaging.
Previous / Next Documents
Previous: 2026-07497 — Animal Generic Drug User Fee Act; Public Meeting; Request for Comments
The FDA is hosting a virtual meeting on May 27, 2026, to talk about the Animal Generic Drug User Fee Act (AGDUFA) and wants your ideas for improving it. This affects companies making generic animal medicines and could change fees and rules in the future. You can share your thoughts online until December 1, 2027, so don’t miss your chance to help shape the program!
Next: 2026-07499 — Proposed Information Collection Activity; Personal Responsibility Education Program (PREP) Performance Measures
The government wants to update how it collects data from groups running teen education programs about health and life skills. These changes will make surveys easier to fill out and better match what’s really needed, helping programs work smarter without extra hassle. If you run or work with these programs, get ready to share feedback by June 16, 2026!