{"abstract":"The Food and Drug Administration (FDA) is announcing the rates for biosimilar user fees for fiscal year (FY) 2016. 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 products are made, and a biosimilar biological product fee for each biosimilar biological product approved in a biosimilar biological product application. 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, 2015, and will remain in effect through September 30, 2016.","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/2015/08/03/2015-18908.html","cfr_references":[],"citation":"80 FR 46005","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. The sponsor will be assessed an annual BPD fee beginning with the first fiscal year after payment of the reactivation fee.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-0007"],"dockets":[],"document_number":"2015-18908","effective_on":null,"end_page":46007,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/08/03/2015-18908.xml","html_url":"https://www.federalregister.gov/documents/2015/08/03/2015-18908/biosimilar-user-fee-rates-for-fiscal-year-2016","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-18908?publication_date=2015-08-03","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-08-03/2015-18908/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":924,"last_updated":"2026-07-26 04:15:02 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-08-03/pdf/2015-18908.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-18908.pdf?1438346768","publication_date":"2015-08-03","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/08/03/2015-18908.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-2015-N-0007","supporting_documents_count":0,"docket_id":"FDA-2015-N-0007","regulation_id_number":null,"title":"Prescription Drug User Fee Act IV-Drug Safety","checked_regulationsdotgov_at":"2015-08-23T06:00:13Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":46005,"subtype":null,"title":"Biosimilar User Fee Rates for Fiscal Year 2016","toc_doc":"Biosimilar User Fee Rates for Fiscal Year 2016","toc_subject":null,"topics":[],"type":"Notice","volume":80}