{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Hospital- Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment.\" The purpose of this final guidance is to help sponsors and investigators in the clinical development of antibacterial drugs for the treatment of hospital- acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) based on comments that were received and current recommendations. This guidance finalizes the draft guidance of the same title issued on May 7, 2014.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health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/2020/06/25/2020-13745.html","cfr_references":[],"citation":"85 FR 38142","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on June 25, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2010-D-0589"],"dockets":[],"document_number":"2020-13745","effective_on":null,"end_page":38143,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/06/25/2020-13745.xml","html_url":"https://www.federalregister.gov/documents/2020/06/25/2020-13745/hospital-acquired-bacterial-pneumonia-and-ventilator-associated-bacterial-pneumonia-developing-drugs","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-13745?publication_date=2020-06-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-06-25/2020-13745/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":369,"last_updated":"2026-07-26 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-06-25/pdf/2020-13745.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-13745.pdf?1593002738","publication_date":"2020-06-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/06/25/2020-13745.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Attachment 6 Statistical Tables and Data re: Comment from Foundation for the National Institutes of Health","document_id":"FDA-2010-D-0589-0032"},{"title":"Attachment 5 Statistical Tables and Data re: Comment from Foundation for the National Institutes of Health","document_id":"FDA-2010-D-0589-0031"},{"title":"Attachment 4 ICU I Hospital-Acquired Bacterial Pneumonia (HABP) and VentilatorAssociated Bacterial Pneumonia (VABP) re: Comment from Foundation for the National Institutes of Health","document_id":"FDA-2010-D-0589-0030"},{"title":"Attachment 2 Theravance Biopharma Medicines that make a difference® ATTAIN Studies Overview May 15, 2015 re: Comment from Foundation for the National Institutes of Health","document_id":"FDA-2010-D-0589-0029"},{"title":"Attachment 1 Statistical Analysis Plan Biomarkers Consortium of the Foundation for the National Institutes of Health HABP/NABP Working Group Part 2 Analysis Version 6.0 re: Comment from Foundation for the National Institutes of Health","document_id":"FDA-2010-D-0589-0028"},{"title":"See Docket FDA-2010-D-0434","document_id":"FDA-2010-D-0589-0016"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2010-D-0589","supporting_documents_count":6,"docket_id":"FDA-2010-D-0589","regulation_id_number":null,"title":"Draft Guidance for Industry on Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia:  Developing Drugs for Treatment; Availability","checked_regulationsdotgov_at":"2020-06-28T03:30:06Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":38142,"subtype":null,"title":"Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment; Guidance for Industry; Availability","toc_doc":"Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":85}