Animal Drug and Animal Generic Drug User Fee Amendments of 2023

This bill reauthorizes user fees for animal drug and generic animal drug applications, which will be collected from manufacturers and sponsors to fund the Food and Drug Administration's review process. The fees will generate approximately $33.5 million annually for animal drugs and $25 million annually for generic animal drugs from fiscal years 2024 through 2028. The bill requires the FDA to provide annual reports to Congress on how these fees are used, including staffing, review times, and progress on antimicrobial stewardship. It also includes provisions to expedite the review of applications for animal drugs and generic animal drugs, with specific sunset dates for the fee authority (October 1, 2028) and reporting requirements (January 31, 2029).