{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act.\" This draft guidance is intended to assist sponsors developing biological products, sponsors holding biologics license applications (BLAs), and other interested parties in providing information and data that will help the Agency determine the date of first licensure for a reference product under 351(k)(7)(C) of the Public Health Service Act (PHS Act), as added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act amends the PHS Act and other statutes to create an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product.","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/2014/08/05/2014-18169.html","cfr_references":[],"citation":"79 FR 45448","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 6, 2014. Submit either electronic or written comments concerning the proposed collection of information by October 6, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-1165"],"dockets":[],"document_number":"2014-18169","effective_on":null,"end_page":45450,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/08/05/2014-18169.xml","html_url":"https://www.federalregister.gov/documents/2014/08/05/2014-18169/draft-guidance-for-industry-on-reference-product-exclusivity-for-biological-products-filed-under","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-18169?publication_date=2014-08-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-08-05/2014-18169/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1657,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-08-05/pdf/2014-18169.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-18169.pdf?1407183641","publication_date":"2014-08-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/08/05/2014-18169.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-D-1165","supporting_documents_count":0,"docket_id":"FDA-2013-D-1165","regulation_id_number":null,"title":"Draft Guidance for Industry on Reference Product Exclusivity for Biological Products Filed Under 351(a) of the PHS Act; Availability","checked_regulationsdotgov_at":"2014-10-07T05:00:57Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":45448,"subtype":null,"title":"Draft Guidance for Industry on Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the Public Health Service Act; Availability","toc_doc":"Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the Public Health Service Act; Availability","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":79}