Health and Human Services Department, Food and Drug Administration
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 products. 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. FDA begins the BsUFA reauthorization process by publishing a notice in the Federal Register requesting public input and holding a public meeting where the public may present its views on the reauthorization. FDA invites public comment as the Agency begins the process to reauthorize the program for FYs 2028 through 2032. These comments will be published and available on FDA's website.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2015-N-3326] AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. 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 products. 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. FDA begins the BsUFA reauthorization process by publishing a notice in the Federal Register requesting public input and holding a public meeting where the public may present its views on the reauthorization. FDA invites public comment as the Agency begins the process to reauthorize the program for FYs 2028 through 2032. These comments will be published and available on FDA's website. DATES: The public meeting will be held on December 3, 2025, from 9 a.m. to 12 p.m. Eastern Time, and will take place in person and virtually. Either electronic or written comments on this public meeting must be submitted by January 2, 2026. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public meeting will be held in-per…
Other Federal Register documents from the same docket.
Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments
Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments
Biosimilar User Fee Act; Public Meeting; Correction
Biosimilar User Fee Act; Public Meeting
Biosimilar User Fee Act; Public Meeting
Citation: 90 FR 52967
