{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is requesting comments on the topics discussed at a public workshop entitled \"Advancing Premarket Safety Analytics Workshop\" held on September 14, 2022. The purpose of the public workshop was to present FDA's work and perspective on premarket review of safety data.","action":"Notice; request for 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/2022/11/03/2022-23925.html","cfr_references":[],"citation":"87 FR 66306","comment_url":null,"comments_close_on":"2022-12-05","correction_of":null,"corrections":[],"dates":"Either electronic or written comments on this public workshop must be submitted by December 5, 2022. See the SUPPLEMENTARY INFORMATION section for information.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-N-1961"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":5,"comment_start_date":"2022-11-03","updated_at":"2023-02-27T20:02:33.233-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-N-1961-0038","allow_late_comments":null,"id":"FDA-2022-N-1961-0038","comment_end_date":"2022-12-06","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-N-1961","title":"Public Workshop: Advancing Premarket Safety Analytics Workshop"}],"document_number":"2022-23925","effective_on":null,"end_page":66307,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/11/03/2022-23925.xml","html_url":"https://www.federalregister.gov/documents/2022/11/03/2022-23925/advancing-premarket-safety-analytics-workshop-request-for-comments","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-23925?publication_date=2022-11-03","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-11-03/2022-23925/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":375,"last_updated":"2026-07-26 04:15:02 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-11-03/pdf/2022-23925.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-23925.pdf?1667393132","publication_date":"2022-11-03","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/11/03/2022-23925.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":5,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2022-N-1961","supporting_documents_count":0,"docket_id":"FDA-2022-N-1961","document_id":"FDA-2022-N-1961-0038","regulation_id_number":null,"title":"Public Workshop: Advancing Premarket Safety Analytics Workshop","checked_regulationsdotgov_at":"2023-02-28T01:02:32Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":66306,"subtype":null,"title":"Advancing Premarket Safety Analytics Workshop; Request for Comments","toc_doc":"Advancing Premarket Safety Analytics Workshop","toc_subject":"Request for Comments:\n","topics":[],"type":"Notice","volume":87}