{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment.\" The purpose of this draft guidance is to provide information and recommendations to assist sponsors and other interested parties in the development of drugs to prevent or treat acute radiation syndrome (ARS) caused by exposure to ionizing radiation from accidental or deliberate events. Generally, drugs developed for such indications will require approval under the regulations commonly referred to as the Animal Rule.","action":"Notice of availability.","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/2023/04/20/2023-08331.html","cfr_references":[],"citation":"88 FR 24427","comment_url":null,"comments_close_on":"2023-07-19","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by July 19, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-D-1146"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2023-04-20T09:56:25.261-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-D-1146-0001","allow_late_comments":null,"id":"FDA-2023-D-1146-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2023-D-1146","title":"Acute Radiation Syndrome:  Developing Drugs for Prevention and Treatment; Availability"}],"document_number":"2023-08331","effective_on":null,"end_page":24429,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/04/20/2023-08331.xml","html_url":"https://www.federalregister.gov/documents/2023/04/20/2023-08331/acute-radiation-syndrome-developing-drugs-for-prevention-and-treatment-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-08331?publication_date=2023-04-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-04-20/2023-08331/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":366,"last_updated":"2026-08-23 22:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-04-20/pdf/2023-08331.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-08331.pdf?1681908323","publication_date":"2023-04-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/04/20/2023-08331.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-D-1146","supporting_documents_count":0,"docket_id":"FDA-2023-D-1146","document_id":"FDA-2023-D-1146-0001","regulation_id_number":null,"title":"Acute Radiation Syndrome:  Developing Drugs for Prevention and Treatment; Availability","checked_regulationsdotgov_at":"2023-04-21T13:00:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":24427,"subtype":null,"title":"Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment; Availability","toc_doc":"Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":88}