federal_register: 2020-24028

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2020-24028 Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments Notice The Food and Drug Administration (FDA or Agency) is hosting a virtual public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2023 through 2027. 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 2022. 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 2023 through 2027. These comments will be published and available on FDA's website. 2020-10-30 2020 10 https://www.federalregister.gov/documents/2020/10/30/2020-24028/reauthorization-of-the-biosimilar-user-fee-act-public-meeting-request-for-comments https://www.govinfo.gov/content/pkg/FR-2020-10-30/pdf/2020-24028.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is hosting a virtual public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2023 through 2027. BsUFA authorizes FDA to collect user fees to support the...  

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