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  5. CVM Public Meeting: Third Annual Animal Drug User Fee Educational Conference - 07/07/2026
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Event Title
CVM Public Meeting: Third Annual Animal Drug User Fee Educational Conference
July 7, 2026

Date:
July 7, 2026
Time:
9:00 a.m. - 1:00 p.m. ET
Organized By:
Organizer

On This Page:

Background

On Tuesday, July 7, 2026, the FDA’s Center for Veterinary Medicine will host the Third Annual Animal Drug User Fee Educational Conference. The conference provides educational sessions for stakeholders who are interested in the new animal drug approval process. The series of five annual educational conferences hosted by the FDA are described in the Animal Drug User Fee Act Reauthorization Performance Goals and Procedures Fiscal Years 2024 Through 2028.
  
The Animal Drug User Fee Act (ADUFA) was originally signed into law in 2003 and was subsequently reauthorized by Congress in 2008, 2013, 2018, and 2023. ADUFA authorizes the FDA to collect fees for certain new animal drug applications, products, establishments, and sponsors. Resources generated under ADUFA supplement the agency's funding to enhance the performance of the drug review process. The animal drug review process ensures  that new animal drug products are safe and effective for animals, and that food derived from treated animals will be safe for consumption. The FDA considers the timely review of the safety and effectiveness of new animal drug applications to be central to the agency’s mission to protect and promote human and animal health.

The Animal Drug User Fee Amendments of 2023 (ADUFA V), the most recent reauthorization of ADUFA, authorizes the FDA to collect user fees through fiscal year 2028. Animal Drug User Fee Act Reauthorization Performance Goals and Procedures Fiscal Years 2024 Through 2028 sets forth the agency's performance goals for the period covered by ADUFA V. Among other goals, the document commits the agency to hosting triannual meetings (three meetings per calendar year) with Animal Health Institute members. Each year, during one of these meetings, the FDA will commit up to 8 hours for an educational conference intended for the animal drug industry. 

Public Meeting Information

The third annual educational conference will be available in-person or virtually. The in-person conference will be held at the Harvey W. Wiley Federal Building, 5001 Campus Drive, College Park, MD 20740. For building, parking and security information, please refer to Wiley Building Visitor Information on this page. The virtual conference will be available via a webcast link registrants will receive after completing registration.

This conference will provide presentations on the following areas:

  • Available regulatory pathways 
  • Conditional approval and indexing for Minor Use/Minor Species 
  • Expanded conditional approval and reasonable expectation of effectiveness
  • Real world example of regulatory flexibility during a public health emergency
  • Animal biotechnology products and the Veterinary Innovation Program
  • Protocol quality and best practices

The conference will also contain a Q&A session during which the FDA will address specific questions from the in-person and virtual audience, as time allows. Future educational conferences will include topics based on questions and comments received during this meeting and submitted to the docket.

Registration

This educational conference is open to the public and attendance will be available virtually and in-person. When registering, please provide complete contact information for each attendee, including name, title, affiliation (if any), address, email, and telephone. Please self-identify as a member of one of the following stakeholder categories, as applicable: regulated industry, scientific or academic experts, veterinary professionals, consumer advocacy groups, press/media relations, FDA, other government/Congress, or other. Registrants will receive confirmation when their registration has been received and will be provided the webcast link.

If you need reasonable accommodations due to a disability (e.g., closed captioning), please contact adufa_v_edu_conference@fda.hhs.gov no later than June 25, 2026.

Submitting Written or Electronic Comments

The FDA has opened a docket and is accepting electronic or written comments. You may submit comments at any time for this series of educational conferences; however, we request that you submit comments within 90 days of each annual educational conference to ensure that the agency considers your comment on a topic discussed at that conference.

To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2024-N-2602 in the search box.

To submit a comment to the docket by mail or to submit a comment with confidential information that you do not wish to be made publicly available, follow the instructions in the Federal Register Notice.

All submissions received must include the Docket No. FDA-2024-N-2602 for “Animal Drug User Fee Educational Conference.” All comments received will be placed in the docket.

Wiley Building Visitor Information

Address

Harvey W. Wiley Federal Building 
5001 Campus Drive 
College Park, MD 20740

Parking

The entrance to the Wiley Building parking lot is on River Road (past the corner of Campus Drive and River Road). All visitors need to present their ID at the guard station as they enter the parking lot. Visitors can park in any spot that is not reserved. After parking, visitors should walk up to the main building entrance, also on River Road.

Visitors using a driving service (taxi, rideshare, etc.) can be dropped off at the building entrance on River Road.

Building Information

After entering the Harvey W. Wiley Federal Building, visitors are required to show a REAL ID or valid form of identification to the security guards. For additional information regarding REAL ID, please refer to https://www.dhs.gov/real-id/real-id-faqs. Visitors will be given a visitor badge to be always worn inside the building.

Please note that as part of the security screening process, visitors will be required to:

  • Show REAL ID prior to signing in at the Guard Station for a visitor badge
  • Put all electronics (i.e., laptops, tablets, headphones, earbuds, cell phones, etc.) in their own tray
  • Remove keys, car fobs, coins and other metal items from pockets and put the items in another tray
  • Remove hats and coats
  • Remove belts, if necessary, to avoid magnetometer alert
  • Fasten closures on bags and cases before putting them on the x-ray belt
  • Walk through magnetometer

For questions, please contact adufa_v_edu_conference@fda.hhs.gov.

Event Materials

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