{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to address the use of master files by applications licensed under the Public Health Service Act (PHS Act). This final rule codifies FDA's existing approach that former approved applications for certain biological products under the Federal Food, Drug, and Cosmetic Act (FD&C Act) that have been deemed to be licenses for the biological products under the PHS Act may continue to incorporate by reference drug substance, drug substance intermediate, or drug product (DS/DSI/DP) information contained in a drug master file (DMF) if such information was being referenced at the time the application was deemed to be a license. This final rule also codifies FDA's general practices regarding the referencing of information in master files by applications licensed under the PHS Act, including applications for combination products licensed under the PHS Act, and by investigational new drug applications (INDs) for products that would be subject to licensure under the PHS Act.","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/2024/02/12/2024-02741.html","cfr_references":[{"chapter":null,"citation_url":null,"part":601,"title":21}],"citation":"89 FR 9743","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective March 13, 2024.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-N-1363"],"dockets":[{"supporting_documents":[{"title":"Reference 7 BLAs and Master Files Final Reg Impact Analysis","document_id":"FDA-2019-N-1363-0037"},{"title":"Reference 6 Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications","document_id":"FDA-2019-N-1363-0036"},{"title":"Reference 5 Drug Master Files Guidance for Industry","document_id":"FDA-2019-N-1363-0035"},{"title":"Reference 4 Biosimilars Action Plan","document_id":"FDA-2019-N-1363-0034"},{"title":"Reference 3 Bundling Multiple Devices or Multiple Indications in a Single Submission Guidance for Industry and Food and Drug Administration Staff","document_id":"FDA-2019-N-1363-0033"},{"title":"Referece 2 Cooperative-Manufacturing Arrangements for Licensed Biologics","document_id":"FDA-2019-N-1363-0032"},{"title":"Reference 1 Interpretation of the Deemed to be a License Provision of the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry","document_id":"FDA-2019-N-1363-0031"},{"title":"List of References","document_id":"FDA-2019-N-1363-0030"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-02-12","updated_at":"2024-02-12T09:57:37.456-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2019-N-1363-0029","allow_late_comments":null,"id":"FDA-2019-N-1363-0029","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":8,"id":"FDA-2019-N-1363","title":"Biologics License Applications and Master Files"}],"document_number":"2024-02741","effective_on":"2024-03-13","end_page":9757,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/02/12/2024-02741.xml","html_url":"https://www.federalregister.gov/documents/2024/02/12/2024-02741/biologics-license-applications-and-master-files","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-02741?publication_date=2024-02-12","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-02-12/2024-02741/mods.xml","not_received_for_publication":null,"page_length":15,"page_views":{"count":3260,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-02-12/pdf/2024-02741.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-02741.pdf?1707486321","publication_date":"2024-02-12","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/02/12/2024-02741.txt","regulation_id_number_info":{"0910-AH50":{"issue":"202310","html_url":"https://www.federalregister.gov/regulations/0910-AH50/biologics-license-applications-and-master-files","title":"Biologics License Applications and Master Files","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202310&RIN=0910-AH50&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["0910-AH50"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 7 BLAs and Master Files Final Reg Impact Analysis","document_id":"FDA-2019-N-1363-0037"},{"title":"Reference 6 Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications","document_id":"FDA-2019-N-1363-0036"},{"title":"Reference 5 Drug Master Files Guidance for Industry","document_id":"FDA-2019-N-1363-0035"},{"title":"Reference 4 Biosimilars Action Plan","document_id":"FDA-2019-N-1363-0034"},{"title":"Reference 3 Bundling Multiple Devices or Multiple Indications in a Single Submission Guidance for Industry and Food and Drug Administration Staff","document_id":"FDA-2019-N-1363-0033"},{"title":"Referece 2 Cooperative-Manufacturing Arrangements for Licensed Biologics","document_id":"FDA-2019-N-1363-0032"},{"title":"Reference 1 Interpretation of the Deemed to be a License Provision of the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry","document_id":"FDA-2019-N-1363-0031"},{"title":"List of References","document_id":"FDA-2019-N-1363-0030"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2019-N-1363","supporting_documents_count":8,"docket_id":"FDA-2019-N-1363","document_id":"FDA-2019-N-1363-0029","regulation_id_number":null,"title":"Biologics License Applications and Master Files","checked_regulationsdotgov_at":"2024-02-13T14:00:13Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":9743,"subtype":null,"title":"Biologics License Applications and Master Files","toc_doc":"Biologics License Applications and Master Files","toc_subject":null,"topics":["Administrative practice and procedure","Biologics","Confidential business information"],"type":"Rule","volume":89}