{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is reopening the comment period for the proposed administrative order (proposed order) entitled \"Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use\", announced in the Federal Register of June 14, 2024. We are taking this action due to technical difficulties with the OTC Monographs@FDA portal. Because comments cannot be submitted to the OTC Monographs@FDA portal at this time, submit comments on proposed order (OTC000035) to the Federal eRulemaking portal (Docket No. FDA- 2024-N-2422).","action":"Notice of availability; reopening the comment period.","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/2024/08/08/2024-17645.html","cfr_references":[],"citation":"89 FR 64929","comment_url":null,"comments_close_on":"2024-06-14","correction_of":null,"corrections":[],"dates":"FDA is reopening the comment period on proposed order (OTC000035) announced in the Federal Register of June 14, 2024 (89 FR 50593). Electronic comments or written comments must be submitted by September 27, 2024.","disposition_notes":null,"docket_ids":["Docket No. FDA-2024-N-2422"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-08-08","updated_at":"2024-09-03T17:17:43.542-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-N-2422-0002","allow_late_comments":false,"id":"FDA-2024-N-2422-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-N-2422","title":"Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use"}],"document_number":"2024-17645","effective_on":null,"end_page":64930,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/08/08/2024-17645.xml","html_url":"https://www.federalregister.gov/documents/2024/08/08/2024-17645/amending-over-the-counter-monograph-m013-internal-analgesic-antipyretic-and-antirheumatic-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-17645?publication_date=2024-08-08","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-08-08/2024-17645/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":252,"last_updated":"2026-08-25 06:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-08-08/pdf/2024-17645.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-17645.pdf?1723034813","publication_date":"2024-08-08","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/08/08/2024-17645.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-2024-N-2422","supporting_documents_count":0,"docket_id":"FDA-2024-N-2422","document_id":"FDA-2024-N-2422-0002","regulation_id_number":null,"title":"Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use","checked_regulationsdotgov_at":"2024-08-09T16:00:11Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":64929,"subtype":null,"title":"Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Reopening the Comment Period","toc_doc":"Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use","toc_subject":"Amending Over-the-Counter Monograph M013:\n","topics":[],"type":"Notice","volume":89}