{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is proposing to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by the U.S. Customs and Border Protection Agency (CBP), in order for the filing to be processed by CBP and to help FDA in determining admissibility of that product. ACE is a commercial trade processing system operated by CBP that is designed to implement the International Trade Data System (ITDS), automate import and export processing, enhance border security, foster U.S. economic security through lawful international trade and policy, and to replace the Automated Commercial System (ACS). FDA is a Partner Government Agency (PGA) in the initiative to establish ITDS, the \"single window\" for the submission of import and export data to the United States Government. The proposed rule would also update certain sections of FDA regulations related to imports. This rule, as proposed, does not affect the ability of filers to continue to submit their import entries and entry summaries by paper for FDA-regulated products that are being imported or offered for import. Once finalized, this action will facilitate effective and efficient admissibility review by the Agency and protect public health by allowing FDA to focus its limited resources on those FDA-regulated products being imported or offered for import that may be associated with a greater public health risk.","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/2016/07/01/2016-15684.html","cfr_references":[{"chapter":null,"citation_url":null,"part":1,"title":21},{"chapter":null,"citation_url":null,"part":1005,"title":21},{"chapter":null,"citation_url":null,"part":1271,"title":21}],"citation":"81 FR 43155","comment_url":null,"comments_close_on":"2016-08-30","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the proposed rule by August 30, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-1487"],"dockets":[{"supporting_documents":[{"title":"Reference 1 Final Regulatory Flexibility Analysis, and Final Unfunded Mandates Reform Act Analysis for Submission of Food and Drug Administration Import 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Environment","document_id":"FDA-2016-N-1487-0002"}],"agency_name":"FDA","documents":[{"comment_count":13,"comment_start_date":"2016-07-01","updated_at":"2023-03-01T01:01:46.640-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2016-N-1487-0001","allow_late_comments":null,"id":"FDA-2016-N-1487-0001","comment_end_date":"2016-08-31","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":6,"id":"FDA-2016-N-1487","title":"Submission of FDA Import Data in the Automated Commercial Environment"}],"document_number":"2016-15684","effective_on":null,"end_page":43178,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/07/01/2016-15684.xml","html_url":"https://www.federalregister.gov/documents/2016/07/01/2016-15684/submission-of-food-and-drug-administration-import-data-in-the-automated-commercial-environment","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-15684?publication_date=2016-07-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-07-01/2016-15684/mods.xml","not_received_for_publication":null,"page_length":24,"page_views":{"count":2585,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-07-01/pdf/2016-15684.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-15684.pdf?1467291004","publication_date":"2016-07-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/07/01/2016-15684.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 1 Final Regulatory Flexibility Analysis, and Final Unfunded Mandates Reform Act Analysis for Submission of Food and Drug Administration Import Data in the Automated Commercial Environment","document_id":"FDA-2016-N-1487-0023"},{"title":"Reference 4 re Submission of FDA Import Data in the Automated Commercial Environment","document_id":"FDA-2016-N-1487-0006"},{"title":"Reference 3 FDA Draft Guidance for Industry: Implementation of the \"Deemed to be a License\" Provision re Submission of FDA Import Data in the Automated Commercial Environment","document_id":"FDA-2016-N-1487-0005"},{"title":"Reference 2 FDA Guidance for Industry: Submitting Form FDA 2541 re Submission of FDA Import Data in the Automated Commercial Environment","document_id":"FDA-2016-N-1487-0004"},{"title":"Reference 1 Automated Commercial System and ABI CATAIR re Submission of FDA Import Data in the Automated Commercial Environment","document_id":"FDA-2016-N-1487-0003"},{"title":"E.O. 13659 re Submission of FDA Import Data in the Automated Commercial Environment","document_id":"FDA-2016-N-1487-0002"}],"comments_count":13,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-N-1487","supporting_documents_count":6,"docket_id":"FDA-2016-N-1487","document_id":"FDA-2016-N-1487-0001","regulation_id_number":null,"title":"Submission of FDA Import Data in the Automated Commercial Environment","checked_regulationsdotgov_at":"2023-03-01T06:01:45Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":43155,"subtype":null,"title":"Submission of Food and Drug Administration Import Data in the Automated Commercial Environment","toc_doc":"Submission of Food and Drug Administration Import Data in the Automated Commercial Environment","toc_subject":null,"topics":["Administrative practice and procedure","Biologics","Cosmetics","Drugs","Electronic products","Exports","Food labeling","Human cells and tissue-based products","Imports","Labeling","Medical devices","Radiation protection","Reporting and recordkeeping requirements","Surety bonds"],"type":"Proposed Rule","volume":81}