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.
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.
2026-16728, Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer
The Food and Drug Administration (FDA) is proposing to reclassify diagnostic endoscopic light source systems (product code OAY), which are postamendments class III devices, from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name "Cystoscopic system intended as an aid for detection of bladder cancer," along with special controls that FDA believes are necessary to provide a reasonable assurance of the safety and effectiveness of these devices.
2026-16712, Agency Information Collection Activities; Proposed Collection; Comment Request; Imports and Electronic Import Entries
The FDA wants your thoughts on how they collect info about imports and electronic import entries. If you’re involved in importing goods, this could affect you! They’re asking for comments by October 16, 2026, to help improve the process without adding extra costs or hassle.
2026-16727, Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order reclassifying in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK), all postamendments class III (premarket approval) devices, into class II (special controls), subject to premarket notification. FDA is also establishing a new device classification regulation, along with the special controls that are necessary to provide a reasonable assurance of safety and effectiveness of this device type.
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!