{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Stimulant Use Disorders: Developing Drugs for Treatment.\" The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of stimulant use disorders. Specifically, this guidance addresses FDA's current recommendations regarding the overall development program and clinical trial designs for the development of drugs to support indications of treatment of moderate to severe cocaine use disorder, treatment of moderate to severe methamphetamine use disorder, or treatment of moderate to severe prescription stimulant use disorder.","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/2023/10/05/2023-22189.html","cfr_references":[],"citation":"88 FR 69205","comment_url":null,"comments_close_on":"2023-12-04","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by December 4, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-1848"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2023-10-05T10:57:17.939-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-D-1848-0001","allow_late_comments":null,"id":"FDA-2023-D-1848-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2023-D-1848","title":"Stimulant Use Disorders:  Developing Drugs for Treatment; Draft Guidance for Industry; Availability"}],"document_number":"2023-22189","effective_on":null,"end_page":69207,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/10/05/2023-22189.xml","html_url":"https://www.federalregister.gov/documents/2023/10/05/2023-22189/stimulant-use-disorders-developing-drugs-for-treatment-draft-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-22189?publication_date=2023-10-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-10-05/2023-22189/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":2090,"last_updated":"2026-10-24 20:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-10-05/pdf/2023-22189.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-22189.pdf?1696423650","publication_date":"2023-10-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/10/05/2023-22189.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-1848","supporting_documents_count":0,"docket_id":"FDA-2023-D-1848","document_id":"FDA-2023-D-1848-0001","regulation_id_number":null,"title":"Stimulant Use Disorders:  Developing Drugs for Treatment; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-10-06T14:00:19Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":69205,"subtype":null,"title":"Stimulant Use Disorders: Developing Drugs for Treatment; Draft Guidance for Industry; Availability","toc_doc":"Stimulant Use Disorders: Developing Drugs for Treatment","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":88}