{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act.\" This draft guidance provides recommendations for industry and review staff on the formal dispute resolution and administrative hearings procedures for resolving scientific and/or medical disputes between the Center for Drug Evaluation and Research (CDER) and requestors and sponsors of drugs that will be subject to a final administrative order (final order) under section 505G of the Federal Food, Drug, and Cosmetic Act (FD&C Act).","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/2023/06/23/2023-13331.html","cfr_references":[],"citation":"88 FR 41107","comment_url":null,"comments_close_on":"2023-08-22","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by August 22, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2023-D-2204"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-06-23","updated_at":"2023-06-23T09:56:17.192-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-D-2204-0001","allow_late_comments":null,"id":"FDA-2023-D-2204-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2023-D-2204","title":"Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability"}],"document_number":"2023-13331","effective_on":null,"end_page":41108,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/06/23/2023-13331.xml","html_url":"https://www.federalregister.gov/documents/2023/06/23/2023-13331/formal-dispute-resolution-and-administrative-hearings-of-final-administrative-orders-under-section","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-13331?publication_date=2023-06-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-06-23/2023-13331/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":481,"last_updated":"2026-05-17 06:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-06-23/pdf/2023-13331.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-13331.pdf?1687437919","publication_date":"2023-06-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/06/23/2023-13331.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-2023-D-2204","supporting_documents_count":0,"docket_id":"FDA-2023-D-2204","document_id":"FDA-2023-D-2204-0001","regulation_id_number":null,"title":"Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-06-24T13:00:15Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":41107,"subtype":null,"title":"Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability","toc_doc":"Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":88}