{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing a public meeting and an opportunity for public comment on Patient- Focused Drug Development for nontuberculous mycobacterial (NTM) lung infections. Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of NTM lung infections on daily life and patient views on treatment approaches. FDA is also interested in discussing issues related to scientific challenges in developing drugs to treat NTM lung infections. In the afternoon, FDA will hold a workshop and provide information for and gain perspective from patients and patient advocacy organizations, health care providers, academic experts, and industry on various aspects of clinical development of drug products intended to treat NTM lung infections. The input from this public meeting will help in developing topics for further discussion.","action":"Notice of public meeting; request for comments.","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/2015/08/03/2015-18919.html","cfr_references":[],"citation":"80 FR 46026","comment_url":null,"comments_close_on":"2015-09-28","correction_of":null,"corrections":[],"dates":"The public meeting will be held on October 15, 2015, from 9 a.m. to 5 p.m. Please register for the meeting by October 7, 2015. Registration from those individuals interested in presenting comments as part of the panel discussions should be received by September 28, 2015. See the SUPPLEMENTARY INFORMATION section for instructions on how to register for the meeting. Submit electronic or written comments to the public docket by December 15, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-N-0967"],"dockets":[{"supporting_documents":[],"agency_name":null,"documents":[{"comment_count":38,"comment_start_date":"2015-08-03","updated_at":"2023-03-01T00:02:13.674-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2012-N-0967-0748","allow_late_comments":null,"id":"FDA-2012-N-0967-0748","comment_end_date":"2015-12-16","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2012-N-0967","title":"PDUFA V Patient-Focused Drug Development; Public Meeting and Request for Comments"}],"document_number":"2015-18919","effective_on":null,"end_page":46027,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/08/03/2015-18919.xml","html_url":"https://www.federalregister.gov/documents/2015/08/03/2015-18919/patient-focused-drug-development-for-nontuberculous-mycobacterial-lung-infections-public-meeting","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-18919?publication_date=2015-08-03","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-08-03/2015-18919/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1057,"last_updated":"2026-10-24 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-08-03/pdf/2015-18919.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-18919.pdf?1438346779","publication_date":"2015-08-03","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/08/03/2015-18919.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":38,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2012-N-0967","supporting_documents_count":0,"docket_id":"FDA-2012-N-0967","document_id":"FDA-2012-N-0967-0748","regulation_id_number":null,"title":"PDUFA V Patient-Focused Drug Development; Public Meeting and Request for Comments","checked_regulationsdotgov_at":"2023-03-01T05:02:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":46026,"subtype":null,"title":"Patient-Focused Drug Development for Nontuberculous Mycobacterial Lung Infections; Public Meeting","toc_doc":"Patient-Focused Drug Development for Nontuberculous Mycobacterial Lung Infections","toc_subject":"Meetings:","topics":[],"type":"Notice","volume":80}