FDA Calls Vets and Drug Makers to Animal Fee Renewal Talks
Published Date: 5/11/2026
Notice
Summary
The FDA is inviting vets, animal drug makers, and animal lovers to join meetings about renewing the Animal Drug User Fee Act before it expires in 2028. These meetings, starting June 2026 and happening every four months, will help decide how fees for animal drug reviews are set and used. If you want to have a say, let the FDA know by June 1, 2026!
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
ADUFA Authority Ends September 30, 2028
The current Animal Drug User Fee Act authority (ADUFA V) expires September 30, 2028. The notice states that without new legislation to reauthorize the program, FDA will no longer be able to collect user fees for future fiscal years to fund the new animal drug review process.
Stakeholder Sign‑up Deadline: June 1, 2026
If you represent a stakeholder group (veterinary professionals, patient and consumer advocacy groups, or scientific and academic experts) and want to join FDA’s ADUFA reauthorization discussions, notify FDA by email at [email protected] by June 1, 2026. Stakeholders who notify will be included in future stakeholder discussions while FDA negotiates with the regulated industry.
Scheduled Consultation Meetings Starting June 2026
FDA will hold stakeholder consultation meetings beginning in June 2026 and will continue meeting at least once every 4 months during ADUFA reauthorization negotiations. Meetings will be held in person at the FDA Harvey W. Wiley Federal Building, 5001 Campus Drive, College Park, MD 20740, and virtually via Microsoft Teams.
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
2026-13047 — 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.
2026-13346 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medication Guides for Prescription Drug Products
The FDA is updating how it collects info about Medication Guides—those important leaflets that come with some prescription drugs to keep patients safe. This affects drug makers who must follow new rules about what info to include and how to share it. Comments on these changes are open until July 31, 2026, and the update aims to keep patients informed without adding extra costs.
2026-13140 — Medical Devices; Anesthesiology Devices; Classification of the Monitor for Opioid Induced Impairment of Oxygenation
The FDA is officially putting the monitor for opioid-induced oxygen problems into a safer, easier-to-manage category called Class II. This change helps make sure the device works well and is safe, while also speeding up patient access to this important tech. The new rules took effect on June 30, 2026, and could lower costs and delays for companies making these monitors.
2026-13139 — Medical Devices; General and Plastic Surgery Devices; Classification of the Skin Patch for Treatment of Hyperhidrosis
The FDA is officially classifying the skin patch that treats excessive sweating (hyperhidrosis) as a Class II device, meaning it has special safety rules but fewer hurdles than the strictest category. This change helps patients get access to this cool new treatment faster and safer, starting June 30, 2026. Companies making these patches will find it easier and less costly to bring their products to market.
2026-13006 — Determination of Regulatory Review Period for Purposes of Patent Extension; VYALEV
The FDA has officially set the review period for the drug VYALEV, which helps the company extend its patent protection. This means the patent clock can be paused, giving the drug maker more time to sell VYALEV exclusively. If anyone thinks the dates are wrong or the company wasn’t diligent, they can speak up by late 2026.
2026-13005 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Minor Use and Minor Species
The FDA is asking for public feedback on their plan to keep collecting info about new animal drugs for rare uses and less common species. This affects drug makers who want special approval and incentives for these unique animal medicines. Comments are open until July 29, 2026, and the process helps keep these important drugs safe and available without extra costs.
Previous / Next Documents
Previous: 2026-09281 — Submission for OMB Review; Comment Request
The Department of Agriculture is asking for public feedback on a plan to improve markets for American farmers by making it easier to sell their products directly and build stronger local food networks. This update aims to boost farming communities and streamline how information is collected, with comments due by June 10, 2026. Farmers, co-ops, and anyone involved in agriculture will feel the positive changes, with no new costs announced yet.
Next: 2026-09284 — Animal Generic Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Generic Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intent To Participate
The FDA is gearing up to renew the Animal Generic Drug User Fee Act (AGDUFA) before it expires in September 2028. They’re inviting vets, scientists, and animal drug makers to join regular meetings starting June 2026 to help shape the next phase. This means ongoing teamwork and funding to keep affordable animal medicines coming!