{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Qualified Infectious Disease Product Designation Questions and Answers.\" The Food and Drug Administration Safety and Innovation Act (FDASIA) creates incentives for the development of antibacterial and antifungal drug products that treat serious or life-threatening infections. The purpose of this draft guidance is to provide a resource for information on FDA's policies and procedures related to the designation of a qualified infectious disease product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).","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/2018/01/30/2018-01662.html","cfr_references":[],"citation":"83 FR 4216","comment_url":null,"comments_close_on":"2018-04-02","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by April 2, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2017-D-7001"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":3,"comment_start_date":"2018-01-30","updated_at":"2023-02-28T21:33:22.656-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-D-7001-0001","allow_late_comments":null,"id":"FDA-2017-D-7001-0001","comment_end_date":"2018-04-03","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-D-7001","title":"Qualified Infections Disease Product Designation"}],"document_number":"2018-01662","effective_on":null,"end_page":4218,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/01/30/2018-01662.xml","html_url":"https://www.federalregister.gov/documents/2018/01/30/2018-01662/qualified-infectious-disease-product-designation-questions-and-answers-draft-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-01662?publication_date=2018-01-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-01-30/2018-01662/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1581,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-01-30/pdf/2018-01662.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-01662.pdf?1517233538","publication_date":"2018-01-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/01/30/2018-01662.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-2017-D-7001","supporting_documents_count":0,"docket_id":"FDA-2017-D-7001","document_id":"FDA-2017-D-7001-0001","regulation_id_number":null,"title":"Qualified Infections Disease Product Designation","checked_regulationsdotgov_at":"2023-03-01T02:33:21Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":4216,"subtype":null,"title":"Qualified Infectious Disease Product Designation Questions and Answers; Draft Guidance for Industry; Availability","toc_doc":"Qualified Infectious Disease Product Designation Questions and Answers","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":83}