{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Limited Population Pathway for Antibacterial and Antifungal Drugs.\" This guidance provides information on the implementation of the limited population pathway provision of the 21st Century Cures Act (Cures Act), which established the limited population pathway for antibacterial and antifungal drugs (LPAD pathway). This guidance finalizes the draft guidance of the same name issued on June 13, 2018.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health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/2020/08/06/2020-17109.html","cfr_references":[],"citation":"85 FR 47799","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on August 6, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-D-2032"],"dockets":[],"document_number":"2020-17109","effective_on":null,"end_page":47801,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/08/06/2020-17109.xml","html_url":"https://www.federalregister.gov/documents/2020/08/06/2020-17109/limited-population-pathway-for-antibacterial-and-antifungal-drugs-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-17109?publication_date=2020-08-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-08-06/2020-17109/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":415,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-08-06/pdf/2020-17109.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-17109.pdf?1596631517","publication_date":"2020-08-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/08/06/2020-17109.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-D-2032","supporting_documents_count":0,"docket_id":"FDA-2018-D-2032","document_id":"FDA-2018-D-2032-0021","regulation_id_number":null,"title":"Limited Population Pathway for Antibacterial and Antifungal Drugs; Draft Guidance for Industry; Availability ","checked_regulationsdotgov_at":"2020-08-09T03:30:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":47799,"subtype":null,"title":"Limited Population Pathway for Antibacterial and Antifungal Drugs; Guidance for Industry; Availability","toc_doc":"Limited Population Pathway for Antibacterial and Antifungal Drugs","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":85}