{"abstract":"The Food and Drug Administration (FDA or we) is amending its regulations for registration of food facilities that require domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States to register with FDA. This rule amends and updates FDA's registration regulations and is part of our implementation of the FDA Food Safety Modernization Act (FSMA), which added new provisions for the registration of food facilities. These amendments will further enhance FDA's capabilities with respect to responding to food safety issues, and in addition, provide FDA with information that we can use to focus and better utilize our limited inspection resources.","action":"Final 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/2016/07/14/2016-16531.html","cfr_references":[{"chapter":null,"citation_url":null,"part":1,"title":21}],"citation":"81 FR 45912","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective September 12, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2002-N-0323"],"dockets":[],"document_number":"2016-16531","effective_on":"2016-09-12","end_page":45954,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/07/14/2016-16531.xml","html_url":"https://www.federalregister.gov/documents/2016/07/14/2016-16531/amendments-to-registration-of-food-facilities","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-16531?publication_date=2016-07-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-07-14/2016-16531/mods.xml","not_received_for_publication":null,"page_length":43,"page_views":{"count":16021,"last_updated":"2026-08-24 06:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-07-14/pdf/2016-16531.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-16531.pdf?1468413970","publication_date":"2016-07-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/07/14/2016-16531.txt","regulation_id_number_info":{"0910-AG69":{"issue":"201604","html_url":"https://www.federalregister.gov/regulations/0910-AG69/registration-of-food-facilities-amendments-to-food-facility-registration-requirements","title":"Registration of Food Facilities: Amendments to Food Facility Registration Requirements","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201604&RIN=0910-AG69&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AG69"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 13 Amendments to Registration of Food Facilities - Final RIA re Amendments to Registration of Food Facilities","document_id":"FDA-2002-N-0323-0247"},{"title":"Reference 12 FDA’s Voluntary Qualified Importer Program, Draft Guidance for Industry re Amendments to Registration of Food Facilities","document_id":"FDA-2002-N-0323-0246"},{"title":"Reference 11 Specially Designated List (SDN) re Amendments to Registration of Food Facilities","document_id":"FDA-2002-N-0323-0245"},{"title":"Reference 10 GAO Memo Government Is Analyzing Alternatives for Contractor Identification Numbers re Amendments to Registration of Food Facilities","document_id":"FDA-2002-N-0323-0244"},{"title":"Reference 9 Memo to File DUNS and Registered Facilities re Amendments to Registration of Food Facilities","document_id":"FDA-2002-N-0323-0243"},{"title":"Reference 8 Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration, Guidance for Industry re Amendments to Registration of Food Facilities","document_id":"FDA-2002-N-0323-0242"},{"title":"Reference 7 USDA Agricultural Marketing Service, Regional Food Hub Resource Guide re Amendments to Registration of Food Facilities","document_id":"FDA-2002-N-0323-0241"},{"title":"Reference 6 Guidance for Industry Questions and Answers Regarding Food Facility Registration (Sixth Edition) re Amendments to Registration of Food Facilities","document_id":"FDA-2002-N-0323-0240"},{"title":"Reference 5 Guidance for Industry  Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories re Amendments to Registration of Food Facilities","document_id":"FDA-2002-N-0323-0239"},{"title":"Reference 4 Food CGMP Modernization--A Focus on Food Safety re Amendments to Registration of Food Facilities","document_id":"FDA-2002-N-0323-0238"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AG69/registration-of-food-facilities-amendments-to-food-facility-registration-requirements","title":"Registration of Food Facilities: Amendments to Food Facility Registration Requirements"},"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2002-N-0323","supporting_documents_count":48,"docket_id":"FDA-2002-N-0323","regulation_id_number":"0910-AG69","title":"Bioterrorism Preparedness; Registration of Food Facilities","checked_regulationsdotgov_at":"2016-08-03T06:00:13Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":45912,"subtype":null,"title":"Amendments to Registration of Food Facilities","toc_doc":"Amendments to Registration of Food Facilities","toc_subject":null,"topics":["Cosmetics","Drugs","Exports","Food labeling","Imports","Labeling","Reporting and recordkeeping requirements"],"type":"Rule","volume":81}