FDA Announces FY 2022 Animal Drug User Fee Rates for ADUFA and AGDUFA The U.S. Food and Drug Administration has announced in the Federal Register the fiscal year (FY) 2022 fee rates and payment procedures for animal drugs subject to user fees under the Animal Drug User Fee Amendments of 2018 (ADUFA IV) and Animal Generic Drug User Fee Amendments of 2018 (AGDUFA III). ADUFA, originally signed into law in 2003 and reauthorized in 2008, 2013 and 2018, amends the Federal Food, Drug, and Cosmetic Act (FD&C Act), and authorizes the FDA to collect fees for certain animal drug applications and supplemental applications, products, establishments, and sponsors of animal drug applications and/or investigational animal drug submissions. These resources supplement funding provided by Congressional budget authority 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. ADUFA IV reauthorizes the FDA to collect user fees through FY 2023. AGDUFA, originally signed into law in 2008 and reauthorized in 2013 and 2018, was designed to supplement the Congressional budget authority to enhance the performance of the generic new animal drug review process, which enables the FDA to ensure that generic new animal drug products are safe and effective. AGDUFA III reauthorizes the FDA to collect user fees for certain abbreviated applications for generic new animal drugs, generic new animal drug products, and from certain sponsors of abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. The user fees for sponsors are prorated based on the number of approved abbreviated applications the sponsor currently holds. AGDUFA III reauthorizes the FDA to collect user fees through FY 2023.
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