{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is amending its electronic import entries regulation to correct the statutory citation in the sections of that regulation requiring submission of the Drug Registration Number for human drugs and for animal drugs. The present revisions are necessary to correct editorial errors and to ensure that the codified cites the correct section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The electronic import entries regulation provides that the Drug Registration Number, which must be submitted at the time of entry 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), is the unique facility identifier specified in the FD&C Act. This rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.","action":"Final rule; technical amendments.","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/2021/04/01/2021-06679.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"1","title":21}],"citation":"86 FR 17059","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective April 1, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-1487"],"dockets":[],"document_number":"2021-06679","effective_on":"2021-04-01","end_page":17060,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/04/01/2021-06679.xml","html_url":"https://www.federalregister.gov/documents/2021/04/01/2021-06679/electronic-import-entries-technical-amendments","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-06679?publication_date=2021-04-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-04-01/2021-06679/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":347,"last_updated":"2026-07-26 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-04-01/pdf/2021-06679.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-06679.pdf?1617194727","publication_date":"2021-04-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/04/01/2021-06679.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":0,"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-1487-0024","regulation_id_number":null,"title":"Submission of FDA Import Data in the Automated Commercial Environment","checked_regulationsdotgov_at":"2021-04-02T03:30:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":17059,"subtype":null,"title":"Electronic Import Entries; Technical Amendments","toc_doc":"Electronic Import Entries; Technical Amendments","toc_subject":null,"topics":["Cosmetics","Drugs","Exports","Food labeling","Imports","Labeling","Reporting and recordkeeping requirements"],"type":"Rule","volume":86}