Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2025
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The Food and Drug Administration (FDA or the Agency) is announcing the fee rates and payment procedures for fiscal year (FY) 2025 generic new animal drug program user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2023 (AGDUFA IV), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs (JINAD's), and for certain submissions related to JINAD files. This notice establishes the fee rates for FY 2025.
Abstract as published in the Federal Register.
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