{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Qualified Infectious Disease Product Designation--Questions and Answers.\" The Food and Drug Administration Safety and Innovation Act (FDASIA) created incentives for the development of antibacterial and antifungal drug products that treat serious or life-threatening infections. The purpose of this final guidance is to provide a resource for information on FDA's policies and procedures related to the designation of a qualified infectious disease product (QIDP). This guidance finalizes the draft guidance of the same name issued on January 30, 2018.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2021/05/12/2021-09986.html","cfr_references":[],"citation":"86 FR 26045","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on May 12, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2017-D-7001"],"dockets":[],"document_number":"2021-09986","effective_on":null,"end_page":26046,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/05/12/2021-09986.xml","html_url":"https://www.federalregister.gov/documents/2021/05/12/2021-09986/qualified-infectious-disease-product-designation-questions-and-answers-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-09986?publication_date=2021-05-12","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-05-12/2021-09986/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":778,"last_updated":"2026-07-26 00:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-05-12/pdf/2021-09986.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-09986.pdf?1620737121","publication_date":"2021-05-12","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/05/12/2021-09986.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-2017-D-7001","supporting_documents_count":0,"docket_id":"FDA-2017-D-7001","document_id":"FDA-2017-D-7001-0007","regulation_id_number":null,"title":"Qualified Infections Disease Product Designation","checked_regulationsdotgov_at":"2021-05-13T03:30:08Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":26045,"subtype":null,"title":"Qualified Infectious Disease Product Designation-Questions and Answers; Guidance for Industry; Availability","toc_doc":"Qualified Infectious Disease Product DesignationQuestions and Answers","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":86}