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Meeting | Virtual

Event Title
Animal Drug User Fee Act Virtual Public Meeting
May 27, 2026

Date:
May 27, 2026
Time:
2:00 p.m. - 4:00 p.m. ET
Organized By:
Organizer

On This Page:

Background

ADUFA gives the FDA the authority to collect user fees that provide some of the funding to support the new animal drug review process. 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 review for animal drugs. The ADUFA program began in FY 2004 and is currently in the fifth authorization (ADUFA V). The program expires on September 30, 2028. 

The FDA has published a number of reports that provide useful background on ADUFA I, ADUFA II, ADUFA III, ADUFA IV and ADUFA V. ADUFA-related Federal Register notices, guidances, legislation, and performance and financial reports can be found at: Animal Drug User Fee Act (ADUFA). Additionally, the FDA-TRACK Animal Drug User Fee Act (ADUFA) Performance Dashboards provide information about ADUFA Current Performance, ADUFA Historical Performance, and ADUFA Goals Summary.

For more information about the ADUFA authorizations and enhancements towards supporting that mission, please see the Federal Register notice announcing the public meeting. 

Public Meeting Information

The purpose of the public meeting is to invite public comments on the ADUFA program and suggestions regarding the features FDA should consider for the next reauthorization of the ADUFA program. 

The FDA is interested in responses from the public on the following two general questions and welcomes other pertinent information that stakeholders would like to share: 

  1. What is your assessment of the overall performance of the ADUFA program thus far?
  2. What aspects of ADUFA should be retained, changed, or discontinued to further strengthen and improve the program?

Registration

People interested in attending this public meeting must register no later than midnight ET 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. Registration is free and early registration is recommended. Registrants will receive confirmation when their registration has been received and will be provided the webcast link.

Requests for Oral Presentations

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. 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 meeting, the docket will remain open for comment during the reauthorization process for ADUFA until December 1, 2027.

All ADUFA comment submissions must reference Docket No. FDA-2011-N-0656. 

For detailed instructions on how to submit electronic, written, and confidential comments, see: Notice of Public Meeting; Animal Drug User Fee Act; Request for Comments.
 

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