{"abstract":"The Food and Drug Administration (FDA) is announcing a 2-day public hearing to obtain input on specific issues and challenges associated with the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act establishes an abbreviated approval pathway for biological products that are demonstrated to be \"highly similar\" (biosimilar) to, or \"interchangeable\" with, an FDA-licensed biological product. The purpose of this public hearing is to create a forum for interested stakeholders to provide input regarding the agency's implementation of the statute. FDA will take the information it obtains from the public hearing into account in its implementation of the BPCI Act.","action":"Notice of public hearing; request for comments.","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/2010/10/05/2010-24853.html","cfr_references":[],"citation":"75 FR 61497","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The public hearing will be held November 2 and 3, 2010, from 8:30 a.m. to 4:30 p.m. Individuals who wish to present at the public hearing must register on or before October 11, 2010. Section III of this document provides attendance and registration information. Electronic or written comments will be accepted after the public hearing until December 31, 2010.","disposition_notes":null,"docket_ids":["Docket No. FDA-2010-N-0477"],"dockets":[],"document_number":"2010-24853","effective_on":null,"end_page":61501,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2010/10/05/2010-24853.xml","html_url":"https://www.federalregister.gov/documents/2010/10/05/2010-24853/approval-pathway-for-biosimilar-and-interchangeable-biological-products-public-hearing-request-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2010-24853?publication_date=2010-10-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2010-10-05/2010-24853/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":3718,"last_updated":"2026-08-26 08:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2010-10-05/pdf/2010-24853.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2010-10-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2010/10/05/2010-24853.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2010-10-25T12:48:38Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":61497,"subtype":null,"title":"Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request for Comments","toc_doc":"Approval Pathway for Biosimilar and Interchangeable Biological Products; Hearing","toc_subject":null,"topics":[],"type":"Notice","volume":75}