{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing publication of a discussion paper providing information for stakeholders and soliciting public comments on specific areas of emerging and advanced manufacturing technologies. The discussion paper presents areas for consideration and policy development identified by the Center for Drug Evaluation and Research (CDER) scientific and policy experts associated with distributed manufacturing (DM) and point-of-care (POC) manufacturing for drugs, including biological products regulated by CDER and the Center for Biologics Evaluation and Research (CBER). FDA recognizes that regulatory policies and programs may need to evolve to enable the timely adoption of these technologies. The discussion paper includes a series of questions for each technology to stimulate feedback from the public.","action":"Notice; request for information and 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/2022/10/14/2022-22386.html","cfr_references":[],"citation":"87 FR 62416","comment_url":null,"comments_close_on":"2022-12-13","correction_of":null,"corrections":[],"dates":"Either electronic or written comments and information on the discussion paper must be submitted by December 13, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-N-2316"],"dockets":[{"supporting_documents":[{"title":"Distributed Manufacturing and Point-of-Care Manufacturing of Drugs RE Discussion Paper: Distributed Manufacturing and Point-of-Care Manufacturing of Drugs; Request for Information and Comments","document_id":"FDA-2022-N-2316-0002"}],"agency_name":"FDA","documents":[{"comment_count":68,"comment_start_date":"2022-10-14","updated_at":"2023-02-27T20:09:46.691-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-N-2316-0001","allow_late_comments":null,"id":"FDA-2022-N-2316-0001","comment_end_date":"2022-12-14","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":1,"id":"FDA-2022-N-2316","title":"Discussion Paper: Distributed Manufacturing and Point-of-Care Manufacturing of Drugs, Notice; request for information and comments"}],"document_number":"2022-22386","effective_on":null,"end_page":62417,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/10/14/2022-22386.xml","html_url":"https://www.federalregister.gov/documents/2022/10/14/2022-22386/discussion-paper-distributed-manufacturing-and-point-of-care-manufacturing-of-drugs-request-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-22386?publication_date=2022-10-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-10-14/2022-22386/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1421,"last_updated":"2026-10-22 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-10-14/pdf/2022-22386.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-22386.pdf?1665665133","publication_date":"2022-10-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/10/14/2022-22386.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Distributed Manufacturing and Point-of-Care Manufacturing of Drugs RE Discussion Paper: Distributed Manufacturing and Point-of-Care Manufacturing of Drugs; Request for Information and Comments","document_id":"FDA-2022-N-2316-0002"}],"comments_count":68,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2022-N-2316","supporting_documents_count":1,"docket_id":"FDA-2022-N-2316","document_id":"FDA-2022-N-2316-0001","regulation_id_number":null,"title":"Discussion Paper: Distributed Manufacturing and Point-of-Care Manufacturing of Drugs, Notice; request for information and comments","checked_regulationsdotgov_at":"2023-02-28T01:09:45Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":62416,"subtype":null,"title":"Discussion Paper: Distributed Manufacturing and Point-of-Care Manufacturing of Drugs; Request for Information and Comments","toc_doc":"Discussion Paper:  Distributed Manufacturing and Point of Care Manufacturing of Drugs","toc_subject":"Request for Information:\n","topics":[],"type":"Notice","volume":87}