{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment.\" The purpose of this draft guidance is to assist sponsors in the development of drug products for the treatment of chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME).","action":"Notice.","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/2014/03/11/2014-05189.html","cfr_references":[],"citation":"79 FR 13658","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 12, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-D-0264"],"dockets":[],"document_number":"2014-05189","effective_on":null,"end_page":13659,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/03/11/2014-05189.xml","html_url":"https://www.federalregister.gov/documents/2014/03/11/2014-05189/draft-guidance-for-industry-on-chronic-fatigue-syndromemyalgic-encephalomyelitis-developing-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-05189?publication_date=2014-03-11","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-03-11/2014-05189/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":351,"last_updated":"2026-10-25 10:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-03-11/pdf/2014-05189.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-05189.pdf?1394456301","publication_date":"2014-03-11","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/03/11/2014-05189.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-2014-D-0264","supporting_documents_count":0,"docket_id":"FDA-2014-D-0264","regulation_id_number":null,"title":"Draft Guidance for Industry on Chronic Fatigue Syndrome/Myalgic Encephalomyelitis:  Developing Drug Products for Treatment; Availability","checked_regulationsdotgov_at":"2020-04-28T03:30:18Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":13658,"subtype":null,"title":"Draft Guidance for Industry on Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment; Availability","toc_doc":"Chronic Fatigue Syndrome/Myalgic Encephalomyelitis; Development of Drug Products for Treatment; Availability","toc_subject":"Draft Guidance for Industry","topics":[],"type":"Notice","volume":79}