{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled \"Development of Non- Traditional Therapies for Bacterial Infections.\" The purpose of the public workshop is to discuss the general development considerations of non-traditional therapies, including pre-clinical development, early clinical studies, and phase 3 clinical trial designs to evaluate safety and efficacy.","action":"Notice of public workshop; 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/2018/06/29/2018-14048.html","cfr_references":[],"citation":"83 FR 30742","comment_url":null,"comments_close_on":"2018-08-15","correction_of":null,"corrections":[],"dates":"The public workshop will be held on August 21, 2018, from 8:30 a.m. to 4:30 p.m. and August 22, 2018, from 8:30 a.m. to 12 noon. Submit either electronic or written comments on this public workshop by August 15, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-N-2398"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-06-29","updated_at":"2023-03-01T01:40:23.129-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-N-2398-0001","allow_late_comments":null,"id":"FDA-2018-N-2398-0001","comment_end_date":"2018-08-16","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2018-N-2398","title":"Development of Non-Traditional Therapies for Bacterial Infections; Public Workshop; Request for Comments"}],"document_number":"2018-14048","effective_on":null,"end_page":30744,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/06/29/2018-14048.xml","html_url":"https://www.federalregister.gov/documents/2018/06/29/2018-14048/development-of-non-traditional-therapies-for-bacterial-infections-public-workshop-request-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-14048?publication_date=2018-06-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-06-29/2018-14048/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":226,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-06-29/pdf/2018-14048.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-14048.pdf?1530189934","publication_date":"2018-06-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/06/29/2018-14048.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-N-2398","supporting_documents_count":0,"docket_id":"FDA-2018-N-2398","document_id":"FDA-2018-N-2398-0001","regulation_id_number":null,"title":"Development of Non-Traditional Therapies for Bacterial Infections; Public Workshop; Request for Comments","checked_regulationsdotgov_at":"2023-03-01T06:40:22Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":30742,"subtype":null,"title":"Development of Non-Traditional Therapies for Bacterial Infections; Public Workshop; Request for Comments","toc_doc":"Development of Non-Traditional Therapies for Bacterial Infections; Public Workshop","toc_subject":"Meetings:","topics":[],"type":"Notice","volume":83}