Federal Register #FDA-2026-N-2365

FDA Requests Public Comment on Information Collection for Animal Drug and Generic Drug User Fees

This opportunity involves the Food and Drug Administration (FDA), under the Department of Health and Human Services, seeking public comment on its information collection process for animal drug and generic drug user fees. - Government Buyer: - Food and Drug Administration (FDA) - Department of Health and Human Services - No OEMs or vendors are specified in this notice - Products/Services Requested: - No products or services are being procured - The notice pertains to information collection for user fee programs under the Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA) - Unique/Notable Requirements: - Stakeholder input is requested regarding reporting requirements for animal drug and generic drug user fees - Information collected is used to determine fee requirements, waivers, reductions, and exemptions - Supports safety and effectiveness of new animal drugs - Guidance is provided for industry on fee waivers and reductions - No procurement or contract opportunity is present; this is a request for public comment

Description

The Food and Drug Administration (FDA) is requesting comments on the collection of information related to reporting associated with animal drug and animal generic drug user fees. This information collection supports the implementation of the Animal Drug User Fee Act of 2003 and the Animal Generic Drug User Fee Act of 2008, which involve assessing and collecting user fees for certain new animal drug applications and generic drug applications. The FDA uses this information to ensure the safety and effectiveness of new animal drugs and to administer fee waivers, reductions, and exemptions. Written comments are due by September 28, 2026.

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