{"abstract":"The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice, published in the Federal Register of March 1, 2023, establishing a public docket and requesting information and comments. FDA is reopening the comment period to update comments and to receive any new information.","action":"Notice; establishment of a public docket; request for information and comments; reopening of the comment period.","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/2023/09/27/2023-20902.html","cfr_references":[],"citation":"88 FR 66460","comment_url":null,"comments_close_on":"2023-11-27","correction_of":null,"corrections":[],"dates":"FDA is reopening the comment period on the notice published March 1, 2023 (88 FR 12943). Either electronic or written comments must be submitted by November 27, 2023.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-N-0487"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-09-27","updated_at":"2023-09-27T13:56:30.072-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-N-0487-0040","allow_late_comments":null,"id":"FDA-2023-N-0487-0040","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"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":"2023-20902","effective_on":null,"end_page":66461,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/09/27/2023-20902.xml","html_url":"https://www.federalregister.gov/documents/2023/09/27/2023-20902/discussion-paper-artificial-intelligence-in-drug-manufacturing-notice-request-for-information-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-20902?publication_date=2023-09-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-09-27/2023-20902/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1523,"last_updated":"2026-07-28 12:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-09-27/pdf/2023-20902.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-20902.pdf?1695732323","publication_date":"2023-09-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/09/27/2023-20902.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"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-2023-N-0487","supporting_documents_count":0,"docket_id":"FDA-2023-N-0487","document_id":"FDA-2023-N-0487-0040","regulation_id_number":null,"title":"Discussion Paper: Artificial Intelligence in Drug Manufacturing, Notice; request for information and comments.","checked_regulationsdotgov_at":"2023-10-26T22:00:14Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":66460,"subtype":null,"title":"Discussion Paper: Artificial Intelligence in Drug Manufacturing, Notice; Request for Information and Comments; Reopening of the Comment Period","toc_doc":"Discussion Paper: Artificial Intelligence in Drug Manufacturing","toc_subject":"Request for Information:\n","topics":[],"type":"Notice","volume":88}