{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention.\" The purpose of this guidance is to assist sponsors in the clinical development of drugs for treating or preventing smallpox (variola virus) infection. This guidance finalizes the draft guidance of the same name issued on July 11, 2018.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health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/2019/11/18/2019-24916.html","cfr_references":[],"citation":"84 FR 63659","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on November 18, 2019.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-D-1835"],"dockets":[],"document_number":"2019-24916","effective_on":null,"end_page":63660,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/11/18/2019-24916.xml","html_url":"https://www.federalregister.gov/documents/2019/11/18/2019-24916/smallpox-variola-virus-infection-developing-drugs-for-treatment-or-prevention-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-24916?publication_date=2019-11-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-11-18/2019-24916/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":272,"last_updated":"2026-10-24 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-11-18/pdf/2019-24916.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-24916.pdf?1573825520","publication_date":"2019-11-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/11/18/2019-24916.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-D-1835","supporting_documents_count":0,"docket_id":"FDA-2018-D-1835","regulation_id_number":null,"title":"Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2019-11-20T11:00:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":63659,"subtype":null,"title":"Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention; Guidance for Industry; Availability","toc_doc":"Smallpox (Variola Virus) Infection:  Developing Drugs for Treatment or Prevention","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":84}