Bill > HR1418

This bill reauthorizes and makes amendments to the Animal Drug User Fee Amendments and the Animal Generic Drug User Fee Amendments. The key provisions include: - Reauthorizing and adjusting the fee revenue amounts and fee setting process for the review of new animal drug applications and supplemental applications. - Establishing a new fee for requests to establish a generic investigational new animal drug file, and adjusting the fee revenue amount and fee setting process for the review of abbreviated applications for generic new animal drugs. - Requiring reporting on activities related to antimicrobial stewardship in veterinary settings and the development of new drugs for bacterial diseases in animals. - Updating the definition of "major species" to allow the FDA to add or remove species from that category. - Extending the authorization and reporting requirements for these user fee programs through fiscal year 2028. Overall, the bill aims to provide stable funding and improve the efficiency of the FDA's review processes for both new animal drugs and generic new animal drugs, while also supporting antimicrobial stewardship and the development of new treatments for animal diseases.

Business and Industry, Health and Social Services

https://www.congress.gov/bill/118th-congress/house-bill/1418/all-info