{"abstract":"The Food and Drug Administration (FDA or we) is issuing a final rule that adopts, with some modifications, the interim final rule (IFR) entitled \"Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula\" (February 10, 2014). This final rule affirms the IFR's changes to FDA's regulations and provides additional modifications and clarifications. The final rule also responds to certain comments submitted in response to the request for comments in the IFR.","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/2014/06/10/2014-13384.html","cfr_references":[{"chapter":null,"citation_url":null,"part":106,"title":21},{"chapter":null,"citation_url":null,"part":107,"title":21}],"citation":"79 FR 33057","comment_url":null,"comments_close_on":"2014-07-10","correction_of":null,"corrections":[],"dates":"This final rule is effective July 10, 2014. The compliance date for manufacturers to meet the requirements of Sec. Sec. 106.96(a), 106.96(e), 106.96(i)(5), 106.100(p)(2) and 106.100(q)(2) related to quality factors for eligible infant formulas is November 12, 2015. The compliance date for the remaining provisions of this final rule is September 8, 2014. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by July 10, 2014 (see section VII, the \"Paperwork Reduction Act of 1995\" section of this document).","disposition_notes":null,"docket_ids":["Docket No. FDA-1995-N-0063 (formerly 95N-0309)"],"dockets":[],"document_number":"2014-13384","effective_on":"2014-07-10","end_page":33072,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/06/10/2014-13384.xml","html_url":"https://www.federalregister.gov/documents/2014/06/10/2014-13384/current-good-manufacturing-practices-quality-control-procedures-quality-factors-notification","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-13384?publication_date=2014-06-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-06-10/2014-13384/mods.xml","not_received_for_publication":null,"page_length":16,"page_views":{"count":15168,"last_updated":"2026-06-07 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-06-10/pdf/2014-13384.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-13384.pdf?1402318454","publication_date":"2014-06-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/06/10/2014-13384.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":"2014-06-30T06:02:36Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":33057,"subtype":null,"title":"Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula","toc_doc":"Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, etc.","toc_subject":"Guidance for Industry and Staff:","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}