{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases--Questions and Answers (Revision 1).\" The purpose of this draft guidance is to assist sponsors in the clinical development of new antibacterial drugs, and it provides updates to the options for development programs, given the availability of some new therapeutic options. This draft guidance will provide necessary updates to the final guidance entitled \"Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases\" published on August 2, 2017.","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/2022/05/24/2022-11117.html","cfr_references":[],"citation":"87 FR 31568","comment_url":null,"comments_close_on":"2022-07-25","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by July 25, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-0744"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":3,"comment_start_date":"2022-05-24","updated_at":"2023-02-28T12:14:12.912-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2013-D-0744-0015","allow_late_comments":null,"id":"FDA-2013-D-0744-0015","comment_end_date":"2022-07-26","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2013-D-0744","title":"Antibacterial Therapies for Patients With Unmet Medical Needs for the Treatment of Serious Bacterial Diseases; Availability"}],"document_number":"2022-11117","effective_on":null,"end_page":31569,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/05/24/2022-11117.xml","html_url":"https://www.federalregister.gov/documents/2022/05/24/2022-11117/antibacterial-therapies-for-patients-with-an-unmet-medical-need-for-the-treatment-of-serious","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-11117?publication_date=2022-05-24","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-05-24/2022-11117/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":425,"last_updated":"2026-10-24 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-05-24/pdf/2022-11117.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-11117.pdf?1653309924","publication_date":"2022-05-24","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/05/24/2022-11117.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":3,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-D-0744","supporting_documents_count":0,"docket_id":"FDA-2013-D-0744","document_id":"FDA-2013-D-0744-0015","regulation_id_number":null,"title":"Antibacterial Therapies for Patients With Unmet Medical Needs for the Treatment of Serious Bacterial Diseases; Availability","checked_regulationsdotgov_at":"2023-02-28T17:14:11Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":31568,"subtype":null,"title":"Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases-Questions and Answers (Revision 1); Draft Guidance for Industry; Availability","toc_doc":"Antibacterial Therapies for Patients with an Unmet Medical Need for the Treatment of Serious Bacterial DiseasesQuestions and Answers (Revision 1)","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":87}