{"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 a specific area 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 application of artificial intelligence (AI) to pharmaceutical manufacturing. The discussion paper includes a series of questions to stimulate feedback from the public, including CDER and the Center for Biologics Evaluation and Research (CBER) stakeholders.","action":"Notice; establishment of a public docket; 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/2023/03/01/2023-04206.html","cfr_references":[],"citation":"88 FR 12943","comment_url":"http://www.regulations.gov/commenton/FDA-2023-N-0487-0001","comments_close_on":"2023-05-01","correction_of":null,"corrections":[],"dates":"Submit either written or electronic comments and information by May 1, 2023.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-N-0487"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":6,"comment_start_date":"2023-03-01","updated_at":"2023-11-25T00:01:10.191-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-N-0487-0001","allow_late_comments":null,"id":"FDA-2023-N-0487-0001","comment_end_date":"2023-11-28","regulations_dot_gov_open_for_comment":true}],"supporting_documents_count":0,"id":"FDA-2023-N-0487","title":"Discussion Paper: Artificial Intelligence in Drug Manufacturing, Notice; request for information and comments."}],"document_number":"2023-04206","effective_on":null,"end_page":12944,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/03/01/2023-04206.xml","html_url":"https://www.federalregister.gov/documents/2023/03/01/2023-04206/discussion-paper-artificial-intelligence-in-drug-manufacturing-notice-request-for-information-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-04206?publication_date=2023-03-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-03-01/2023-04206/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":5557,"last_updated":"2026-09-21 04:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-03-01/pdf/2023-04206.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-04206.pdf?1677591935","publication_date":"2023-03-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/03/01/2023-04206.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":6,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2023-N-0487","supporting_documents_count":0,"docket_id":"FDA-2023-N-0487","document_id":"FDA-2023-N-0487-0001","regulation_id_number":null,"title":"Discussion Paper: Artificial Intelligence in Drug Manufacturing, Notice; request for information and comments.","checked_regulationsdotgov_at":"2023-11-26T02:00:08Z"},"regulations_dot_gov_url":"http://www.regulations.gov/commenton/FDA-2023-N-0487-0001","significant":null,"signing_date":null,"start_page":12943,"subtype":null,"title":"Discussion Paper: Artificial Intelligence in Drug Manufacturing, Notice; Request for Information and Comments","toc_doc":"Discussion Paper: Artificial Intelligence in Drug Manufacturing","toc_subject":"Request for Information:\n","topics":[],"type":"Notice","volume":88}