Federal Register #FDA-2011-N-0655

FDA Request for Public Comment on Animal Generic Drug User Fee Act (AGDUFA) Reauthorization

The Food and Drug Administration (FDA) is seeking public input on the reauthorization of the Animal Generic Drug User Fee Act (AGDUFA): - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - Purpose: - Request for public comments and stakeholder feedback on the AGDUFA program's performance and future reauthorization - Includes a virtual public meeting for discussion - Products/Services Requested: - No procurement of goods or services; this is a request for information and public input only - OEMs and Vendors: - No OEMs or vendors are mentioned or involved - Unique Requirements: - Open comment period for stakeholders and the public - Procedures for confidential submissions are outlined - Comments received by a specified date will be published on the FDA website - Participation is encouraged via electronic or written submissions - Place of Performance/Submission: - FDA headquarters in Rockville, MD, is the official address for submissions

Description

The Food and Drug Administration (FDA) is announcing a virtual public meeting titled "Animal Generic Drug User Fee Act" to invite public comment on the AGDUFA program and suggestions for its next reauthorization. The meeting will be held virtually on May 27, 2026, from 11 a.m. to 1 p.m. Eastern Time. Comments can be submitted throughout the reauthorization process until December 1, 2027, with comments received by July 1, 2026, being published on the FDA website. The FDA seeks input on the overall performance of the AGDUFA program and suggestions for improvements.

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