Health and Human Services Department Docket FDA-2015-N-3326 Notice

2026-19660: Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments

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Summary

The Food and Drug Administration (FDA, the Agency, or we) is hosting a hybrid public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2028 through 2032. The BsUFA authorizes FDA to collect user fees to support the process for the review of biosimilar biological product applications. The current legislative authority for BsUFA expires in September 2027. At that time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations, as necessary.

The agency’s own summary, as published.

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