Biosimilar User Fee Act; Stakeholder Consultation Meetings on Biosimilar User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate

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The Food and Drug Administration (FDA or Agency) is issuing this notice to request that public stakeholders--including patient and consumer advocacy groups--notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Biosimilar User Fee Act (BsUFA). The statutory authority for BsUFA expires in September 2027. At that time, new legislation will be required for FDA to continue collecting biosimilar biological product user fees in future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next BsUFA program. The FD&C Act also requires that FDA hold discussions at least once every month with patient and consumer advocacy groups 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 stakeholder representation.