Generic Drug User Fees; Consultation Meetings on Reauthorization of Generic Drug User Fee Amendments for Fiscal Years 2028-2032; Request for Notification of Intention to Participate

The Food and Drug Administration (FDA or Agency) is issuing this notice to request that interested parties, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for Fiscal Years (FYs) 2028-2032. At the end of September 2027, new legislation will be required for FDA to continue collecting generic drug user fees for subsequent fiscal years for the generic drug program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of interested parties in developing recommendations for the next GDUFA program. The FD&C Act also requires that FDA hold continued discussions with patient and consumer advocacy groups at least monthly during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent representation by interested parties.

Abstract as published in the Federal Register.

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