{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is revising our infant formula regulations to establish requirements for current good manufacturing practices (CGMP), including audits; to establish requirements for quality factors; and to amend FDA's quality control procedures, notification, and record and reporting requirements for infant formula. FDA is taking this action to improve the protection of infants who consume infant formula products.","action":"Interim final rule; request for comments.","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/2014/02/10/2014-02148.html","cfr_references":[{"chapter":null,"citation_url":null,"part":106,"title":21},{"chapter":null,"citation_url":null,"part":107,"title":21}],"citation":"79 FR 7934","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Effective date: This interim final rule is effective July 10, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-1995-N-0036 (formerly 95N-0309)"],"dockets":[],"document_number":"2014-02148","effective_on":"2014-07-10","end_page":8075,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/02/10/2014-02148.xml","html_url":"https://www.federalregister.gov/documents/2014/02/10/2014-02148/current-good-manufacturing-practices-quality-control-procedures-quality-factors-notification","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-02148?publication_date=2014-02-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-02-10/2014-02148/mods.xml","not_received_for_publication":null,"page_length":142,"page_views":{"count":12139,"last_updated":"2026-07-28 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-02-10/pdf/2014-02148.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-02148.pdf?1391694430","publication_date":"2014-02-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/02/10/2014-02148.txt","regulation_id_number_info":{"0910-AF27":{"issue":"201310","html_url":"https://www.federalregister.gov/regulations/0910-AF27/infant-formula-current-good-manufacturing-practices-quality-control-procedures-notification-requirem","title":"Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201310&RIN=0910-AF27&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AF27"],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2014-03-11T05:04:48Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":7934,"subtype":null,"title":"Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula","toc_doc":"Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula","toc_subject":null,"topics":["Food grades and standards","Food labeling","Incorporation by reference","Infants and children","Nutrition","Reporting and recordkeeping requirements","Signs and symbols"],"type":"Rule","volume":79}