{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulation that defines \"biological product\" to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and the Further Consolidated Appropriations Act, 2020 (FCA Act), and to provide its interpretation of the statutory term \"protein.\" Under this final rule, the term protein means any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. This final rule is intended to clarify the statutory framework under which such products are regulated.","action":"Final rule.","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/2020/02/21/2020-03505.html","cfr_references":[{"chapter":null,"citation_url":null,"part":600,"title":21}],"citation":"85 FR 10057","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective March 23, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-N-2732"],"dockets":[],"document_number":"2020-03505","effective_on":"2020-03-23","end_page":10063,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/02/21/2020-03505.xml","html_url":"https://www.federalregister.gov/documents/2020/02/21/2020-03505/definition-of-the-term-biological-product","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-03505?publication_date=2020-02-21","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-02-21/2020-03505/mods.xml","not_received_for_publication":null,"page_length":7,"page_views":{"count":18314,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-02-21/pdf/2020-03505.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-03505.pdf?1582206330","publication_date":"2020-02-21","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/02/21/2020-03505.txt","regulation_id_number_info":{"0910-AH57":{"issue":"201910","html_url":"https://www.federalregister.gov/regulations/0910-AH57/definition-of-the-term-biological-product-","title":"Definition of the Term \"Biological Product\"","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201910&RIN=0910-AH57&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["0910-AH57"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 3 FDA - Regulatory Impact Analysis, “Definition of the Term `Biological Product\"","document_id":"FDA-2018-N-2732-0022"},{"title":"Reference 2 -  Peptides Encoded by Short ORFs Control Development and Define a New Eukaryotic Gene Family","document_id":"FDA-2018-N-2732-0021"},{"title":"Reference 1 - Small Proteins Untapped Area of Potential Biological Importance re: Definition of the Term ‘‘Biological Product’’","document_id":"FDA-2018-N-2732-0020"},{"title":"013-Reference 012- Preliminary Regulatory Impact Analysis, Initial Regulatory Flexibility Analysis, and Unfunded Mandates Reform Act Analysis for Definition of the Term “Biological Product”","document_id":"FDA-2018-N-2732-0014"},{"title":"012-Reference 011- Molecular Biology of the Cell","document_id":"FDA-2018-N-2732-0013"},{"title":"011-Reference 010- Molecular Cell Biology 6ed","document_id":"FDA-2018-N-2732-0012"},{"title":"010-Reference 09- Cell Biology","document_id":"FDA-2018-N-2732-0011"},{"title":"09-Reference 08- Biochemistry_Voet","document_id":"FDA-2018-N-2732-0010"},{"title":"08-Reference 07- Biochemistry_Berg","document_id":"FDA-2018-N-2732-0009"},{"title":"07-Reference 06- Dorlands Illustrated Medical Dictionary 28ed","document_id":"FDA-2018-N-2732-0008"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-N-2732","supporting_documents_count":16,"docket_id":"FDA-2018-N-2732","regulation_id_number":null,"title":"Definition of the Term “Biological Product”","checked_regulationsdotgov_at":"2020-02-24T04:30:13Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":10057,"subtype":null,"title":"Definition of the Term “Biological Product”","toc_doc":"Definition of the Term Biological Product","toc_subject":null,"topics":["Biologics","Reporting and recordkeeping requirements"],"type":"Rule","volume":85}