{"abstract":"The Food and Drug Administration (FDA or the Agency) is extending the comment period for the draft guidance for industry entitled \"Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics\" that appeared in the Federal Register of December 6, 2024. In the notice of availability for the draft guidance, FDA requested comments on the draft guidance. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.","action":"Notice of availability; extension of 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/2025/01/17/2025-01179.html","cfr_references":[],"citation":"90 FR 5899","comment_url":null,"comments_close_on":"2024-12-06","correction_of":null,"corrections":[],"dates":"FDA is extending the comment period on the draft guidance for industry published December 6, 2024 (89 FR 97011). Either electronic or written comments must be submitted by March 6, 2025.","disposition_notes":null,"docket_ids":["Docket No. FDA-2024-D-2033"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-01-17","updated_at":"2025-01-21T11:58:01.327-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-D-2033-0008","allow_late_comments":false,"id":"FDA-2024-D-2033-0008","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-D-2033","title":"Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Availability"}],"document_number":"2025-01179","effective_on":null,"end_page":5900,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/01/17/2025-01179.xml","html_url":"https://www.federalregister.gov/documents/2025/01/17/2025-01179/expedited-program-for-serious-conditions-accelerated-approval-of-drugs-and-biologics-draft-guidance","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-01179?publication_date=2025-01-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-01-17/2025-01179/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":720,"last_updated":"2026-04-04 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-17/pdf/2025-01179.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-01179.pdf?1737035134","publication_date":"2025-01-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/01/17/2025-01179.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-2024-D-2033","supporting_documents_count":0,"docket_id":"FDA-2024-D-2033","document_id":"FDA-2024-D-2033-0008","regulation_id_number":null,"title":"Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2026-02-07T19:55:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":5899,"subtype":null,"title":"Expedited Program for Serious Conditions-Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Extension of Comment Period","toc_doc":"Expedited Program for Serious Conditions; Accelerated Approval of Drugs and Biologics","toc_subject":"Guidance","topics":[],"type":"Notice","volume":90}