{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is announcing the rates for biosimilar user fees for fiscal year (FY) 2024. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar biological product approved in a biosimilar biological product application. BsUFA III directs FDA to establish, before the beginning of each fiscal year, the amount of initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application and program fees for such year. These fees apply to the period from October 1, 2023, through September 30, 2024.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2023/07/28/2023-15918.html","cfr_references":[],"citation":"88 FR 48855","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"(1) no later than 7 calendar days after FDA grants the sponsor's request for a BPD meeting for that product or (2) upon the date of submission by the sponsor of an IND describing an investigation that FDA determines is intended to support a biosimilar biological product application for that product. The sponsor will be assessed an annual BPD fee beginning in the next fiscal year after payment of the reactivation fee.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-N-2966"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-07-28","updated_at":"2023-07-28T09:56:49.126-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-N-2966-0001","allow_late_comments":null,"id":"FDA-2023-N-2966-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2023-N-2966","title":"Biosimilar User Fee Rates for Fiscal Year 2024"}],"document_number":"2023-15918","effective_on":null,"end_page":48861,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/07/28/2023-15918.xml","html_url":"https://www.federalregister.gov/documents/2023/07/28/2023-15918/biosimilar-user-fee-rates-for-fiscal-year-2024","images":{"EN28JY23.040":{"large":"https://img.federalregister.gov/EN28JY23.040/EN28JY23.040_large.png","medium":"https://img.federalregister.gov/EN28JY23.040/EN28JY23.040_medium.png","original_size":"https://img.federalregister.gov/EN28JY23.040/EN28JY23.040_original_size.png"},"EN28JY23.041":{"large":"https://img.federalregister.gov/EN28JY23.041/EN28JY23.041_large.png","medium":"https://img.federalregister.gov/EN28JY23.041/EN28JY23.041_medium.png","original_size":"https://img.federalregister.gov/EN28JY23.041/EN28JY23.041_original_size.png"},"EN28JY23.042":{"large":"https://img.federalregister.gov/EN28JY23.042/EN28JY23.042_large.png","medium":"https://img.federalregister.gov/EN28JY23.042/EN28JY23.042_medium.png","original_size":"https://img.federalregister.gov/EN28JY23.042/EN28JY23.042_original_size.png"},"EN28JY23.043":{"large":"https://img.federalregister.gov/EN28JY23.043/EN28JY23.043_large.png","medium":"https://img.federalregister.gov/EN28JY23.043/EN28JY23.043_medium.png","original_size":"https://img.federalregister.gov/EN28JY23.043/EN28JY23.043_original_size.png"},"EN28JY23.044":{"large":"https://img.federalregister.gov/EN28JY23.044/EN28JY23.044_large.png","medium":"https://img.federalregister.gov/EN28JY23.044/EN28JY23.044_medium.png","original_size":"https://img.federalregister.gov/EN28JY23.044/EN28JY23.044_original_size.png"},"EN28JY23.045":{"large":"https://img.federalregister.gov/EN28JY23.045/EN28JY23.045_large.png","medium":"https://img.federalregister.gov/EN28JY23.045/EN28JY23.045_medium.png","original_size":"https://img.federalregister.gov/EN28JY23.045/EN28JY23.045_original_size.png"},"EN28JY23.046":{"large":"https://img.federalregister.gov/EN28JY23.046/EN28JY23.046_large.png","medium":"https://img.federalregister.gov/EN28JY23.046/EN28JY23.046_medium.png","original_size":"https://img.federalregister.gov/EN28JY23.046/EN28JY23.046_original_size.png"},"EN28JY23.038":{"large":"https://img.federalregister.gov/EN28JY23.038/EN28JY23.038_large.png","medium":"https://img.federalregister.gov/EN28JY23.038/EN28JY23.038_medium.png","original_size":"https://img.federalregister.gov/EN28JY23.038/EN28JY23.038_original_size.png"},"EN28JY23.039":{"large":"https://img.federalregister.gov/EN28JY23.039/EN28JY23.039_large.png","medium":"https://img.federalregister.gov/EN28JY23.039/EN28JY23.039_medium.png","original_size":"https://img.federalregister.gov/EN28JY23.039/EN28JY23.039_original_size.png"}},"images_metadata":{"EN28JY23.040":{"large":{"identifier":"EN28JY23.040","content_type":"image/png","size":17256,"width":823,"sha":"fd88c0d91c9e8ce51fe6b61568fc482c","url":"https://img.federalregister.gov/EN28JY23.040/EN28JY23.040_large.png","height":186},"medium":{"identifier":"EN28JY23.040","content_type":"image/png","size":7353,"width":467,"sha":"a14692c051e8d6c99987682044dbbe44","url":"https://img.federalregister.gov/EN28JY23.040/EN28JY23.040_medium.png","height":105},"original_size":{"identifier":"EN28JY23.040","content_type":"image/png","size":14418,"width":1763,"sha":"be9183456dc3e0cad4aa9e82fa0bd43b","url":"https://img.federalregister.gov/EN28JY23.040/EN28JY23.040_original_size.png","height":398}},"EN28JY23.041":{"large":{"identifier":"EN28JY23.041","content_type":"image/png","size":45289,"width":823,"sha":"325082ed75fa3a857b1e5bab5117f640","url":"https://img.federalregister.gov/EN28JY23.041/EN28JY23.041_large.png","height":443},"medium":{"identifier":"EN28JY23.041","content_type":"image/png","size":23166,"width":517,"sha":"c6f3878ab30cf360289f76c9010f9c50","url":"https://img.federalregister.gov/EN28JY23.041/EN28JY23.041_medium.png","height":278},"original_size":{"identifier":"EN28JY23.041","content_type":"image/png","size":43799,"width":1951,"sha":"1754a120a01becff55770fe68d43a0dc","url":"https://img.federalregister.gov/EN28JY23.041/EN28JY23.041_original_size.png","height":1050}},"EN28JY23.042":{"large":{"identifier":"EN28JY23.042","content_type":"image/png","size":8561,"width":823,"sha":"128f8be906f6f10eb1ff55fd4714a84b","url":"https://img.federalregister.gov/EN28JY23.042/EN28JY23.042_large.png","height":67},"medium":{"identifier":"EN28JY23.042","content_type":"image/png","size":2909,"width":457,"sha":"b123966e25d7c3b414e4b5ec3e5cdaa3","url":"https://img.federalregister.gov/EN28JY23.042/EN28JY23.042_medium.png","height":37},"original_size":{"identifier":"EN28JY23.042","content_type":"image/png","size":6717,"width":1726,"sha":"c6100f58dbbe1f1c0bfd278ab8a8b5a9","url":"https://img.federalregister.gov/EN28JY23.042/EN28JY23.042_original_size.png","height":141}},"EN28JY23.043":{"large":{"identifier":"EN28JY23.043","content_type":"image/png","size":8726,"width":819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