{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Pulmonary Tuberculosis: Developing Drugs for Treatment.\" The purpose of this draft guidance is to assist sponsors in the clinical development of new antibacterial drugs for the treatment of pulmonary tuberculosis (TB). This draft guidance does not address the development of drugs for latent TB infection or for extrapulmonary TB. This draft guidance revises and replaces the draft guidance for industry of the same name published on November 6, 2013.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2022/12/15/2022-27186.html","cfr_references":[],"citation":"87 FR 76629","comment_url":null,"comments_close_on":"2023-02-13","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by February 13, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2013-D-1319"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2023-02-27T19:49:44.044-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2013-D-1319-0009","allow_late_comments":null,"id":"FDA-2013-D-1319-0009","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2013-D-1319","title":"Draft Guidance for Industry on Pulmonary Tuberculosis:  Developing Drugs for Treatment; Availability"}],"document_number":"2022-27186","effective_on":null,"end_page":76630,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/12/15/2022-27186.xml","html_url":"https://www.federalregister.gov/documents/2022/12/15/2022-27186/pulmonary-tuberculosis-developing-drugs-for-treatment-draft-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-27186?publication_date=2022-12-15","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-12-15/2022-27186/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":283,"last_updated":"2026-08-25 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-12-15/pdf/2022-27186.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-27186.pdf?1671025522","publication_date":"2022-12-15","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/12/15/2022-27186.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-2013-D-1319","supporting_documents_count":0,"docket_id":"FDA-2013-D-1319","document_id":"FDA-2013-D-1319-0009","regulation_id_number":null,"title":"Draft Guidance for Industry on Pulmonary Tuberculosis:  Developing Drugs for Treatment; Availability","checked_regulationsdotgov_at":"2023-02-28T00:49:43Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":76629,"subtype":null,"title":"Pulmonary Tuberculosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability","toc_doc":"Pulmonary Tuberculosis: Developing Drugs for Treatment","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":87}