federal_register: 2015-24524

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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
2015-24524 Biosimilar User Fee Act; Public Meeting Notice The Food and Drug Administration (FDA or Agency) is announcing a public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2018 through 2022. BsUFA authorizes FDA to collect user fees for the process for the review of biosimilar biological products. The current legislative authority for BsUFA expires in September 2017. At that time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA begin 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 on the BsUFA performance goals as the Agency begins the process to reauthorize the program in FYs 2018-2022. 2015-09-28 2015 9 https://www.federalregister.gov/documents/2015/09/28/2015-24524/biosimilar-user-fee-act-public-meeting https://www.govinfo.gov/content/pkg/FR-2015-09-28/pdf/2015-24524.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing a public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2018 through 2022. BsUFA authorizes FDA to collect user fees for the process for the...  

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