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 2014_register executive 2017-01-26 article Part IV Proposed Rules D09002ee1c7f869ee D09002ee1c7f86acd 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 proposing to amend our 2013 proposed rule for Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Human Food. In that 2013 proposed rule, we proposed to amend the CGMP requirements to modernize them and to add requirements for certain domestic and foreign facilities to establish and implement hazard analysis and risk-based preventive controls for human food. We also proposed to revise certain definitions in our current regulation for Registration of Food Facilities to clarify the scope of an exemption from registration requirements for "farms" and, in so doing, to clarify which domestic and foreign facilities would be subject to the proposed requirements for hazard analysis and risk-based preventive controls for human food. We are taking this action because the extensive input we have received from public comments has led to significant changes in our current thinking on certain key provisions of these proposed rules. We are reopening the comment period only with respect to specific issues identified in this proposed rule. 79 FR 58524 https://www.govinfo.gov/app/details/FR-2014-09-29/2014-22446 2014-22446 fr29se14-17 RIN 0910-AG36 4164-01-P Docket No. FDA-2011-N-0920 https://www.govinfo.gov/app/details/FR-2014-09-29/2014-22446 https://www.govinfo.gov/content/pkg/FR-2014-09-29/html/2014-22446.htm https://www.govinfo.gov/content/pkg/FR-2014-09-29/pdf/2014-22446.pdf Cosmetics Drugs Exports Food Labeling Imports Labeling Reporting and Recordkeeping Requirements Administrative Practice and Procedure Food Packaging Foods 49 p. 58524 58572 79 FR 58524 Title 21 Part 117 21 CFR Part 117 Title 21 Part 16 21 CFR Part 16 Title 21 Part 1 21 CFR Part 1 RIN 0910-AG36 Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Federal Register Vol. 79, Issue PRORULE 2014-22446 IV DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2014-12-15 Docket No. FDA-2011-N-0920 4164-01-P 2014-22446 Proposed rule; supplemental notice of proposed rulemaking.

The Food and Drug Administration (FDA or we) is proposing to amend our 2013 proposed rule for Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Human Food. In that 2013 proposed rule, we proposed to amend the CGMP requirements to modernize them and to add requirements for certain domestic and foreign facilities to establish and implement hazard analysis and risk-based preventive controls for human food. We also proposed to revise certain definitions in our current regulation for Registration of Food Facilities to clarify the scope of an exemption from registration requirements for "farms" and, in so doing, to clarify which domestic and foreign facilities would be subject to the proposed requirements for hazard analysis and risk-based preventive controls for human food. We are taking this action because the extensive input we have received from public comments has led to significant changes in our current thinking on certain key provisions of these proposed rules. We are reopening the comment period only with respect to specific issues identified in this proposed rule.

Submit either electronic or written comments on the proposed rule by December 15, 2014 Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by December 15, 2014 (see the "Paperwork Reduction Act of 1995" section of this document). Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2166. Cosmetics Drugs Exports Food Labeling Imports Labeling Reporting and Recordkeeping Requirements Administrative Practice and Procedure Food Packaging Foods Human Foods: Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls , oira_submission@omb.eop.gov http://blogs.fda.gov/fdavoice/index.php/2013/12/your-input-is-bringing-change-to-food-safety-rules http://entomology.k-state.edu/doc/extension-crop-pests/E912_All_Stored_Product_May3.pdf http://monographs.iarc.fr/ENG/Classification/ClassificationsAlphaOrder.pdf http://webarchive.nationalarchives.gov.uk/20111206002505/http://www.food.gov.uk/safereating/chemsafe/sudani/sudanitimeline http://www.fas.org/sgp/crs/misc/R43358.pdf http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm336329.htm http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm339096.htm http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm339097.htm http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm379397.htm http://www.fda.gov/safety/recalls/ucm371042.htm http://www.lead.org.au/lanv3n3/lanv3n3-6.html http://www.regulations.gov http://www.regulatons.gov http://www.usp.org/food-ingredients/food-fraud-database Vol. 79, no. 188 Office of the Federal Register, National Archives and Records Administration 2014-09-29 continuing daily deposited born digital 420 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-09-29 P0b002ee193827752 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr29se14 https://www.govinfo.gov/app/details/FR-2014-09-29 https://www.govinfo.gov/content/pkg/FR-2014-09-29/pdf/FR-2014-09-29.pdf https://www.govinfo.gov/content/pkg/FR-2014-09-29/xml/FR-2014-09-29.xml fdlp 58241 58653 DGPO 2017-01-26 2024-06-02 FR-2014-09-29 machine generated eng FR FR-2014-09-29 79 188