{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Complicated Intra-Abdominal Infections: Developing Drugs for Treatment.\" The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of complicated intra-abdominal infections (cIAIs). Specifically, this guidance addresses FDA's current thinking regarding the overall drug development program for the treatment of cIAIs, including clinical trial designs to support approval of drugs.","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/2012/10/01/2012-24036.html","cfr_references":[],"citation":"77 FR 59928","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 31, 2012.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-D-0973"],"dockets":[],"document_number":"2012-24036","effective_on":null,"end_page":59929,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/10/01/2012-24036.xml","html_url":"https://www.federalregister.gov/documents/2012/10/01/2012-24036/draft-guidance-for-industry-on-complicated-intra-abdominal-infections-developing-drugs-for-treatment","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-24036?publication_date=2012-10-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-10-01/2012-24036/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":143,"last_updated":"2026-07-26 00:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-10-01/pdf/2012-24036.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-24036.pdf?1348836757","publication_date":"2012-10-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/10/01/2012-24036.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2012-D-0973","supporting_documents_count":0,"docket_id":"FDA-2012-D-0973","regulation_id_number":null,"title":"Draft Guidance for Industry on Complicated Intra-Abdominal Infections: Developing Drugs for Treatment; Availability","checked_regulationsdotgov_at":"2012-11-18T05:01:36Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":59928,"subtype":null,"title":"Draft Guidance for Industry on Complicated Intra-Abdominal Infections: Developing Drugs for Treatment; Availability","toc_doc":"Developing Drugs for Treatment of Complicated Intra-Abdominal Infections","toc_subject":"Draft Guidance for Industry; Availability:","topics":[],"type":"Notice","volume":77}