FDA Announces 2026 Virtual Public Meetings and Comment Periods on Reauthorization of User Fee Programs for Animal Drugs and Generic Animal Drugs

April 28, 2026

The U.S. Food and Drug Administration will hold virtual public meetings on May 27, 2026, to discuss the Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA) programs and suggestions regarding the features the FDA should consider for the next reauthorization of these user fee programs. Interested parties can share their comments at the meetings or by submitting them to the public docket electronically or by mail as described below under Submitting Written or Electronic Comments.

ADUFA and AGDUFA give the FDA the authority to collect user fees that provide some of the funding to support the new animal drug and generic new animal drug review processes, respectively. These resources help support the FDA’s responsibility to review these drugs for safety and effectiveness and to enhance the timeliness and predictability of application reviews. These programs expire on September 30, 2028.

Date
May 27, 2026

Times
AGDUFA Public Meeting: 11:00 a.m. to 1:00 p.m. Eastern time
ADUFA Public Meeting: 2:00 p.m. to 4:00 p.m. Eastern time

Location: The public meetings will be hosted via a live virtual webcast.

Registration and Oral Public Comment
People interested in attending this public meeting must register no later than midnight Eastern time on May 22, 2026, by emailing complete contact information for each attendee, including name, title, affiliation, address, email, telephone number, and if you need reasonable accommodations due to a disability (e.g., closed captioning) to ADUFAReauth@fda.hhs.gov for the ADUFA Public Meeting and AGDUFAReauth@fda.hhs.gov for the AGDUFA Public Meeting. Registration is free and early registration is recommended. Registrants will receive confirmation when their registration has been received, and FDA will provide the webcast link.

During registration you may indicate if you wish to make an oral presentation during the public meeting. To facilitate agenda development, registrants requesting to present will be asked to provide information regarding which topics they intend to address and the title of their presentation. The FDA will do its best to accommodate requests to make an oral presentation. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate. All requests to make oral presentations must be received by May 1, 2026.

Submitting Written or Electronic Comments
To permit the widest possible opportunity to obtain comments on all aspects of the public meetings, the dockets will remain open for comment during the reauthorization process for ADUFA and AGDUFA until December 1, 2027.

All ADUFA comment submissions must reference Docket No. FDA-2011-N-0656, and all AGDUFA comments must reference Docket No. FDA-2011-N-0655.

For detailed instructions on how to submit electronic, written, and confidential comments, see:

Additional Information