{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Interpretation of the `Deemed To Be a License' Provision of the Biologics Price Competition and Innovation Act of 2009.\" This guidance describes FDA's interpretation of the statutory provision under which an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, will be deemed to be a license for the biological product under the Public Health Service Act (PHS Act) on March 23, 2020. Specifically, this guidance describes FDA's interpretation of the \"deemed to be a license\" provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) for biological products that are approved under the FD&C Act as of March 23, 2020. This guidance also provides recommendations to sponsors of proposed protein products intended for submission in an application that may not receive final approval under the FD&C Act on or before March 23, 2020, to facilitate alignment of product development plans with FDA's interpretation of the transition provision of the BPCI Act.","action":"Notice of availability.","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/2018/12/12/2018-26854.html","cfr_references":[],"citation":"83 FR 63896","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on December 12, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-D-4750"],"dockets":[],"document_number":"2018-26854","effective_on":null,"end_page":63898,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/12/12/2018-26854.xml","html_url":"https://www.federalregister.gov/documents/2018/12/12/2018-26854/interpretation-of-the-deemed-to-be-a-license-provision-of-the-biologics-price-competition-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-26854?publication_date=2018-12-12","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-12-12/2018-26854/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1594,"last_updated":"2026-08-23 18:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-12-12/pdf/2018-26854.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-26854.pdf?1544535924","publication_date":"2018-12-12","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/12/12/2018-26854.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Attachment 1 Draft Guidance \" Implementation of the\n''Deemed to be a License'' Provision of the Biologics Price Competition and Innovation Act of 2009\" re: Comment from Biotechnology Innovation Organization","document_id":"FDA-2015-D-4750-0012"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-D-4750","supporting_documents_count":1,"docket_id":"FDA-2015-D-4750","regulation_id_number":null,"title":"Implementation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009","checked_regulationsdotgov_at":"2019-01-01T11:00:24Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":63896,"subtype":null,"title":"Interpretation of the “Deemed To Be a License” Provision of the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability","toc_doc":"Interpretation of the Deemed to be a License Provision of the Biologics Price Competition and Innovation Act","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":83}