{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Pulmonary Tuberculosis: Developing Drugs for Treatment.\" The purpose of the draft guidance is to assist sponsors in the development of antimycobacterial drugs for the treatment of pulmonary tuberculosis. This guidance applies to the development of a single investigational drug as well as development of two or more unmarketed investigational drugs for use in combination.","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/2013/11/06/2013-26549.html","cfr_references":[],"citation":"78 FR 66744","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 4, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-1319"],"dockets":[],"document_number":"2013-26549","effective_on":null,"end_page":66745,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/11/06/2013-26549.xml","html_url":"https://www.federalregister.gov/documents/2013/11/06/2013-26549/draft-guidance-for-industry-on-pulmonary-tuberculosis-developing-drugs-for-treatment-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-26549?publication_date=2013-11-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-11-06/2013-26549/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":379,"last_updated":"2026-07-28 04:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-11-06/pdf/2013-26549.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-26549.pdf?1383659345","publication_date":"2013-11-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/11/06/2013-26549.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":4,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-D-1319","supporting_documents_count":0,"docket_id":"FDA-2013-D-1319","document_id":"FDA-2013-D-1319-0001","regulation_id_number":null,"title":"Draft Guidance for Industry on Pulmonary Tuberculosis:  Developing Drugs for Treatment; Availability","checked_regulationsdotgov_at":"2020-07-30T08:30:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":66744,"subtype":null,"title":"Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; Availability","toc_doc":"Pulmonary Tuberculosis; Developing Drugs for Treatment","toc_subject":"Draft Guidance for Industry; Availability:","topics":[],"type":"Notice","volume":78}