United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2016_register executive 2016-07-14 article Part VI Rules and Regulations D09002ee1c7f5931b D09002ee1c7f5941d United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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. 81 FR 45912 https://www.govinfo.gov/app/details/FR-2016-07-14/2016-16531 2016-16531 fr14jy16-20 RIN 0910-AG69 4164-01-P Docket No. FDA-2002-N-0323 https://www.govinfo.gov/app/details/FR-2016-07-14/2016-16531 https://www.govinfo.gov/content/pkg/FR-2016-07-14/html/2016-16531.htm https://www.govinfo.gov/content/pkg/FR-2016-07-14/pdf/2016-16531.pdf Cosmetics Drugs Exports Food Labeling Imports Labeling Reporting and Recordkeeping Requirements 43 p. 45912 45954 81 FR 45912 Title 21 Part 1 21 CFR Part 1 RIN 0910-AG69 Amendments to Registration of Food Facilities; Federal Register Vol. 81, Issue RULE 2016-16531 VI DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2016-09-12 Docket No. FDA-2002-N-0323 4164-01-P 2016-16531 Final rule.

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.

This rule is effective September 12, 2016. Courtney Buchanan, Center for Food Safety and Applied Nutrition (HFS-615), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2487. Cosmetics Drugs Exports Food Labeling Imports Labeling Reporting and Recordkeeping Requirements Amendments to Registration of Food Facilities , http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM444325.pdf http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm421827.pdf http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM448558.pdf http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM332460.pdf http://www.fda.gov/Food/GuidanceRegulation/CGMP/ucm207458.htm http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm324778.htm http://www.fda.gov/furls http://www.gao.gov/assets/600/591551.pdf http://www.regulations.gov https://www.ams.usda.gov/sites/default/files/media/Regional%20Food%20Hub%20Resource%20Guide.pdf https://www.treasury.gov/resource-center/sanctions/SDN-List/Pages/default.aspx Vol. 81, no. 135 Office of the Federal Register, National Archives and Records Administration 2016-07-14 continuing daily deposited born digital 585 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-07-14 P0b002ee1904166b3 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr14jy16 https://www.govinfo.gov/app/details/FR-2016-07-14 https://www.govinfo.gov/content/pkg/FR-2016-07-14/pdf/FR-2016-07-14.pdf https://www.govinfo.gov/content/pkg/FR-2016-07-14/xml/FR-2016-07-14.xml fdlp 45387 45962 DGPO 2016-07-14 2024-06-01 FR-2016-07-14 machine generated eng FR FR-2016-07-14 81 135