{"abstract":"The Food and Drug Administration (FDA) is announcing the rates for biosimilar user fees for fiscal year (FY) 2015. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Act of 2012 (BsUFA), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development, certain applications and supplements for approval of biosimilar biological products, establishments where approved biosimilar biological product products are made, and biosimilar biological products after approval. BsUFA directs FDA to establish, before the beginning of each fiscal year, the initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application, establishment, and product fees. These fees are effective on October 1, 2014, and will remain in effect through September 30, 2015.","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/2014/08/01/2014-18112.html","cfr_references":[],"citation":"79 FR 44795","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"No later than 5 calendar days after FDA grants the sponsor's request for a BPD meeting for that product; or upon the date of submission of an IND describing an investigation that FDA determines is intended to support a biosimilar biological product application. Annual BPD fees will be due beginning for the fiscal year after the year in which the reactivation fee was paid.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-0007"],"dockets":[],"document_number":"2014-18112","effective_on":null,"end_page":44797,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/08/01/2014-18112.xml","html_url":"https://www.federalregister.gov/documents/2014/08/01/2014-18112/biosimilar-user-fee-rates-for-fiscal-year-2015","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-18112?publication_date=2014-08-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-08-01/2014-18112/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":434,"last_updated":"2026-07-27 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-08-01/pdf/2014-18112.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-18112.pdf?1406811073","publication_date":"2014-08-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/08/01/2014-18112.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-N-0007","supporting_documents_count":0,"docket_id":"FDA-2013-N-0007","regulation_id_number":null,"title":"User Fee Rates, Facility Fee Rates, and Reinspection Fee Rates","checked_regulationsdotgov_at":"2014-08-21T06:00:28Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":44795,"subtype":null,"title":"Biosimilar User Fee Rates for Fiscal Year 2015","toc_doc":"Biosimilar User Fee Rates for Fiscal Year 2015","toc_subject":null,"topics":[],"type":"Notice","volume":79}