{"abstract":"The Food and Drug Administration, with the Department of the Treasury's concurrence, proposes amending its regulations to require that the Submission Tracking Number for Electronic Nicotine Delivery System tobacco products that are being imported or offered for import be submitted in the Automated Commercial Environment or any other electronic data interchange system authorized by U.S. Customs and Border Protection, at the time of entry.","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/2024/08/16/2024-18343.html","cfr_references":[{"chapter":null,"citation_url":null,"part":1,"title":21}],"citation":"89 FR 66647","comment_url":null,"comments_close_on":"2024-10-15","correction_of":null,"corrections":[],"dates":"Either electronic or written comments on the proposed rule must be submitted by October 15, 2024. Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by October 15, 2024.","disposition_notes":null,"docket_ids":["Docket No. FDA-2024-N-1111"],"dockets":[{"supporting_documents":[{"title":"PRIA Ref 1 - U.S Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, \"Guidelines for Regulatory Impact Analysis,\" 2016.","document_id":"FDA-2024-N-1111-0003"},{"title":"FDA, Submission of Food and Drug Administration Import Data in the Automated Commercial Environment (Proposed Rule) Preliminary Regulatory\nImpact Analysis. Economic Impact Analyses of FDA Regulations.","document_id":"FDA-2024-N-1111-0002"}],"agency_name":"FDA","documents":[{"comment_count":40,"comment_start_date":"2024-08-16","updated_at":"2024-10-17T01:01:03.637-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-N-1111-0001","allow_late_comments":false,"id":"FDA-2024-N-1111-0001","comment_end_date":"2024-10-16","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":2,"id":"FDA-2024-N-1111","title":"Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products"}],"document_number":"2024-18343","effective_on":null,"end_page":66655,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/08/16/2024-18343.xml","html_url":"https://www.federalregister.gov/documents/2024/08/16/2024-18343/submission-of-food-and-drug-administration-import-data-in-the-automated-commercial-environment-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-18343?publication_date=2024-08-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-08-16/2024-18343/mods.xml","not_received_for_publication":null,"page_length":9,"page_views":{"count":1156,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-08-16/pdf/2024-18343.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-18343.pdf?1723725937","publication_date":"2024-08-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/08/16/2024-18343.txt","regulation_id_number_info":{"0910-AI64":{"issue":"202410","html_url":"https://www.federalregister.gov/regulations/0910-AI64/submission-of-food-and-drug-administration-import-data-in-the-automated-commercial-environment-for-c","title":"Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202410&RIN=0910-AI64&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["0910-AI64"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"PRIA Ref 1 - U.S Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, \"Guidelines for Regulatory Impact Analysis,\" 2016.","document_id":"FDA-2024-N-1111-0003"},{"title":"FDA, Submission of Food and Drug Administration Import Data in the Automated Commercial Environment (Proposed Rule) Preliminary Regulatory\nImpact Analysis. Economic Impact Analyses of FDA Regulations.","document_id":"FDA-2024-N-1111-0002"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AI64/submission-of-food-and-drug-administration-import-data-in-the-automated-commercial-environment-for-c","title":"Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products"},"comments_count":40,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2024-N-1111","supporting_documents_count":2,"docket_id":"FDA-2024-N-1111","document_id":"FDA-2024-N-1111-0001","regulation_id_number":"0910-AI64","title":"Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products","checked_regulationsdotgov_at":"2024-10-18T01:00:11Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":66647,"subtype":null,"title":"Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products","toc_doc":"Submission of Import Data in the Automated Commercial Environment for Certain Tobacco Products","toc_subject":null,"topics":["Cosmetics","Drugs","Exports","Food labeling","Imports","Labeling","Reporting and recordkeeping requirements"],"type":"Proposed Rule","volume":89}