First animal drug user fee educational conference kicks off next month

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The US Food and Drug Administration announced the first in a series of 5 public meetings. The first will take place on July 17, 2024, and will provide attendees with educational sessions for those interested in the new animal drug approval process. The conferences will be hosted by the FDA and occur over the next 4 years as described in the “Animal Drug User Fee Act Reauthorization Performance Goals and Procedures Fiscal Years 2024 Through 2028.”

According to an organizational release, the Animal Drug User Fee Act (ADUFA) was signed into law in 2003 and was later subsequently reauthorized by Congress in in 2008, 2013, and 2023.¹ The ADUFA authorizes the FDA to collect fees for certain new animal drug applications, establishments, products, and sponsors. Resources that are generated under ADUFA supplement the agency’s funding to improve the drug review process performance to better ensure new animal drug products are safe and effective for both animals and the food that is attained from treated animals, making it safe for consumption.

The most recent reauthorization of ADUFA, The Animal Drug User Fee Amendments of 2023 (ADUFA V), granted the FDA permission to collect user fees through fiscal year 2028 and “The Animal Drug User Fee Act Reauthorization Performance Goals and Procedures Fiscal Years 2024 Through 2028” sets the agency’s performance goals for the time period of ADUFA V.¹ This document commits the agency to host triannual meetings with the Animal Health Institute and during the meetings, the FDA will be committing up to 8 hours for an educational conference intended for the animal drug industry, but open to the public.

The conference this year will give attendees a high-level overview of the approval process for animal drugs, communicate pathways with the FDA’s Center for Veterinary Medicine, best practices within the process, target animal safety technical section overview, environmental impact technical section overview, and more. There will also be Q&A sessions where the FDA will address specific questions from both virtual and in-person attendees. The release disclosed that future conferences will take a more in-depth approach to the topics as well as others based on attendee questions and comments received during this first meeting, and questions and comments submitted to the docket.¹

Stakeholders are encouraged to submit comments to the docket to request topics to be included for future conferences and the FDA will accept public comments at any time for these conferences. The FDA is only asking anyone submitting comments to do so written or electronic 90 days after each educational conference to make sure the agency considers your comment on a topic discussed at that conference.

The conference will be held in person at the FDA White Oak Campus located at 10903 New Hampshire Ave, Bldg 31, Great Room Conference Center, Silver Spring, MD 20993–0002 or virtually.² Early registration is recommended by the FDA for anyone who plans to attend in person and those attending virtually can register until the start time of the meeting. In person attendees are encouraged to register no later than July 10, 2024 and on-site registration will be available on a first come first serve bases.²

References

1. FDA announces first annual Animal Drug User Fee Educational Conference. News release. US Food and Drug Administration. June 17, 2024. Accessed June 17, 2024. https://www.fda.gov/animal-veterinary/cvm-updates/fda-announces-first-annual-animal-drug-user-fee-educational-conference?utm_medium=email&utm_source=govdelivery
2. VM public meeting: First Annual Animal Drug User Fee Educational Conference. News release. June 17, 2024. Accessed June 17, 2024. https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/cvm-public-meeting-first-annual-animal-drug-user-fee-educational-conference-07172024