{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is issuing a direct final rule amending the Scope section of our regulation that provides for a regulatory hearing before the Agency in order to clarify when such hearings are available. We are revising the list of statutory provisions enumerated in the Scope section of the regulation by adding one statutory reference and removing a different statutory reference. The Agency is issuing these amendments directly as a final rule because we believe they are noncontroversial and FDA anticipates no significant adverse comments.","action":"Direct final rule.","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/2024/09/20/2024-21231.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"16","title":21}],"citation":"89 FR 77019","comment_url":null,"comments_close_on":"2024-12-04","correction_of":null,"corrections":[],"dates":"This rule is effective February 3, 2025. Either electronic or written comments on the direct final rule or its companion proposed rule must be submitted by December 4, 2024. If FDA receives no significant adverse comments within the specified comment period, the Agency intends to publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, the Agency will publish a document in the Federal Register withdrawing this direct final rule within 30 days after the comment period on this direct final rule ends.","disposition_notes":null,"docket_ids":["Docket No. FDA-2024-N-3654"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":3,"comment_start_date":"2024-09-20","updated_at":"2024-12-06T00:01:16.876-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-N-3654-0002","allow_late_comments":false,"id":"FDA-2024-N-3654-0002","comment_end_date":"2024-12-05","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-N-3654","title":"Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments"}],"document_number":"2024-21231","effective_on":"2025-02-03","end_page":77023,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/09/20/2024-21231.xml","html_url":"https://www.federalregister.gov/documents/2024/09/20/2024-21231/regulatory-hearing-before-the-food-and-drug-administration-general-provisions-amendments","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-21231?publication_date=2024-09-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-09-20/2024-21231/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":982,"last_updated":"2026-10-23 08:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-20/pdf/2024-21231.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-21231.pdf?1726749927","publication_date":"2024-09-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/09/20/2024-21231.txt","regulation_id_number_info":{"0910-AI97":{"issue":"202404","html_url":"https://www.federalregister.gov/regulations/0910-AI97/amendments-to-regulatory-hearing-before-the-food-and-drug-administration","title":"Amendments to Regulatory Hearing Before the Food and Drug Administration","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202404&RIN=0910-AI97&operation=OPERATION_EXPORT_XML","priority_category":"Info./Admin./Other"}},"regulation_id_numbers":["0910-AI97"],"regulations_dot_gov_info":{"supporting_documents":[],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AI97/amendments-to-regulatory-hearing-before-the-food-and-drug-administration","title":"Amendments to Regulatory Hearing Before the Food and Drug Administration"},"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-2024-N-3654","supporting_documents_count":0,"docket_id":"FDA-2024-N-3654","document_id":"FDA-2024-N-3654-0002","regulation_id_number":"0910-AI97","title":"Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments","checked_regulationsdotgov_at":"2024-12-07T02:00:09Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":77019,"subtype":null,"title":"Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments","toc_doc":"Regulatory Hearing Before the Food and Drug Administration; General Provisions","toc_subject":null,"topics":["Administrative practice and procedure"],"type":"Rule","volume":89}