{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is proposing to amend the Scope section of our regulation that provides for a regulatory hearing before the Agency to clarify when such hearings are available. We are proposing to revise the list of statutory provisions enumerated in the Scope section of the regulation by removing one statutory reference and adding a different statutory reference.","action":"Proposed 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/2024/09/20/2024-21232.html","cfr_references":[{"chapter":null,"citation_url":null,"part":16,"title":21}],"citation":"89 FR 77058","comment_url":null,"comments_close_on":"2024-12-04","correction_of":null,"corrections":[],"dates":"Either electronic or written comments on the proposed rule or its companion direct final rule must be submitted by December 4, 2024. If FDA receives any timely significant adverse comments on the direct final rule with which this proposed rule is associated, we will publish a document withdrawing the direct final rule within 30 days after the comment period ends, and we will then proceed to respond to comments under this proposed rule using the usual notice and comment procedures.","disposition_notes":null,"docket_ids":["Docket No. FDA-2024-N-3654"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":7,"comment_start_date":"2024-09-20","updated_at":"2024-12-06T00:01:14.256-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-N-3654-0001","allow_late_comments":false,"id":"FDA-2024-N-3654-0001","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":"2024-21232","effective_on":null,"end_page":77061,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/09/20/2024-21232.xml","html_url":"https://www.federalregister.gov/documents/2024/09/20/2024-21232/regulatory-hearing-before-the-food-and-drug-administration-general-provisions-amendments","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-21232?publication_date=2024-09-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-09-20/2024-21232/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":147,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-20/pdf/2024-21232.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-21232.pdf?1726749928","publication_date":"2024-09-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/09/20/2024-21232.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":7,"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-3654-0001","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":77058,"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":"Proposed Rule","volume":89}