Bill > S1844

This bill, the Animal Drug and Animal Generic Drug User Fee Amendments of 2023, reauthorizes the user fee programs for new animal drugs and generic new animal drugs at the Food and Drug Administration (FDA). The key provisions of the bill include: - Reauthorizing the Animal Drug User Fee program and the Animal Generic Drug User Fee program, which allow the FDA to collect fees from drug manufacturers to help fund the review and approval processes for new animal drugs and generic new animal drugs. The bill extends these programs through fiscal year 2028. - Adjusting the fee revenue amounts and establishing new fees, such as a generic investigational new animal drug file fee, to help support the FDA's review activities. - Making changes to the fee calculations, including inflation and workload adjustments, to ensure the fees keep pace with rising costs. - Providing reporting requirements for the FDA to Congress on the use of the user fee funds and progress on supporting antimicrobial stewardship in veterinary settings. - Defining and regulating "zootechnical animal food substances" as a new category of food additives that can alter the gastrointestinal microbiome of animals, requiring them to go through the food additive petition process. Overall, the bill aims to provide stable funding and support for the FDA's review of new and generic animal drugs to help expedite their development and approval.

Health and Social Services

https://www.congress.gov/bill/118th-congress/senate-bill/1844/all-info