Event Title

CVM Public Meeting: Second Annual Animal Drug User Fee Educational Conference

July 15, 2025

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On  This Page:

• Background
• Public Meeting Information
• Registration
• Submitting Electronic or Written Comments
• Recording
• Event Materials

Background

On Tuesday, July 15, 2025, the FDA’s Center for Veterinary Medicine (CVM) will host the second meeting in a series of five public meetings to provide educational sessions for stakeholders who are interested in the new animal drug approval process. The annual educational conferences the FDA will host over the next three years 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, ensuring 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. “The 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 (AHI) 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 next educational conference will be available in-person or virtually. The in-person conference will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Great Room Conference Center, Silver Spring, MD 20993–0002. The entrance for conference participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. Participants must be REAL ID compliant to access federal facilities. For additional information regarding REAL ID, refer to https://www.dhs.gov/real-id/real-id-faqs. For parking and security information, please refer to https://www.fda.gov/about-fda/visitor-information. The virtual conference will be available via a webcast link that registrants will receive after completing registration (see Registration section below for more details).Registration section below for more details).

This initial conference will provide a high-level overview of the following areas:

• an overview of user fees and waivers,
• foreign data,
• real world data/evidence,
• what makes a high-quality submission
• adaptive study designs 

The conference will also contain Q&A sessions 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 also 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, government/Congress, or other.

Early registration is recommended for persons who wish to attend the conference in-person. Persons interested in attending this conference in-person are encouraged to register online at https://www.surveymonkey.com/r/ADUFAV_2025External Link Disclaimer no later than July 8, 2025. 

Persons attending this conference virtually may register until the start time of the meeting. Virtual attendees will receive a confirmation email containing the website link after their registration has been submitted.

On-site registration will open at the meeting site at 8:00 a.m. on the day of the meeting and will be provided on a first-come, first-served basis, until the room capacity is reached If you need special accommodations due to a disability, please contact adufa_v_edu_conference@fda.hhs.gov no later than July 8, 2025.

Submitting Electronic or Written 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 by 90 days after 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 comments to the docket by mail, 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.

Do not electronically submit any information you consider Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. 

Recording 

Event Materials