{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Hospital- Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment.\" The purpose of this draft guidance is to assist clinical trial sponsors and investigators in the development of antibacterial drugs for the treatment of hospital- acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). The science of clinical trial design and our understanding of this disease have advanced in recent years, and this draft guidance informs sponsors of our current recommendations for clinical development. FDA is specifically requesting comment on critical areas of scientific interest including the appropriate primary efficacy endpoints, the use of an intent-to-treat (ITT) population for the primary analysis population, and the use of antibacterial therapy by patients before participating in clinical trials. This draft guidance revises the draft guidance of the same name that published November 29, 2010.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and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/2014/05/07/2014-10409.html","cfr_references":[],"citation":"79 FR 26257","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 5, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2010-D-0589"],"dockets":[],"document_number":"2014-10409","effective_on":null,"end_page":26258,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/05/07/2014-10409.xml","html_url":"https://www.federalregister.gov/documents/2014/05/07/2014-10409/draft-guidance-for-industry-on-hospital-acquired-bacterial-pneumonia-and-ventilator-associated","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-10409?publication_date=2014-05-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-05-07/2014-10409/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":395,"last_updated":"2026-07-25 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-05-07/pdf/2014-10409.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-10409.pdf?1399381191","publication_date":"2014-05-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/05/07/2014-10409.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":"2020-04-28T03:30:18Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":26257,"subtype":null,"title":"Draft Guidance for Industry on Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment; Availability","toc_doc":"Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia; Drug Development for Treatment","toc_subject":"Draft Guidances for Industry; Availability:","topics":[],"type":"Notice","volume":79}