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 2016-08-24 article Rules and Regulations D09002ee1c7f4698f D09002ee1c7f46f50 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 extending the dates for compliance with certain provisions in four final rules. We are extending the compliance dates to address concerns about the practicality of compliance with certain provisions, consider changes to the regulatory text, and better align compliance dates across the rules. In addition, we are clarifying certain compliance dates in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule. 81 FR 57784 https://www.govinfo.gov/app/details/FR-2016-08-24/2016-20176 2016-20176 fr24au16-6 RIN 0910-AG10 RIN 0910-AG35 RIN 0910-AG36 RIN 0910-AG64 4164-01-P Docket Nos. FDA-2011-N-0920, FDA-2011-N-0921, FDA-2011-N-0922, FDA-2011-N-0143 https://www.govinfo.gov/app/details/FR-2016-08-24/2016-20176 https://www.govinfo.gov/content/pkg/FR-2016-08-24/html/2016-20176.htm https://www.govinfo.gov/content/pkg/FR-2016-08-24/pdf/2016-20176.pdf 13 p. 57784 57796 81 FR 57784 Title 21 Part 1 21 CFR Part 1 Title 21 Part 106 21 CFR Part 106 Title 21 Part 11 21 CFR Part 11 Title 21 Part 110 21 CFR Part 110 Title 21 Part 111 21 CFR Part 111 Title 21 Part 112 21 CFR Part 112 Title 21 Part 114 21 CFR Part 114 Title 21 Part 117 21 CFR Part 117 Title 21 Part 120 21 CFR Part 120 Title 21 Part 123 21 CFR Part 123 Title 21 Part 129 21 CFR Part 129 Title 21 Part 16 21 CFR Part 16 Title 21 Part 179 21 CFR Part 179 Title 21 Part 211 21 CFR Part 211 Title 21 Part 507 21 CFR Part 507 RIN 0910-AG10 RIN 0910-AG35 RIN 0910-AG36 RIN 0910-AG64 The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules; Federal Register Vol. 81, Issue RULE 2016-20176 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2016-08-24 Docket Nos. FDA-2011-N-0920, FDA-2011-N-0921, FDA-2011-N-0922, FDA-2011-N-0143 4164-01-P 2016-20176 Final rule; extension and clarification of compliance dates for certain provisions.

The Food and Drug Administration (FDA or we) is extending the dates for compliance with certain provisions in four final rules. We are extending the compliance dates to address concerns about the practicality of compliance with certain provisions, consider changes to the regulatory text, and better align compliance dates across the rules. In addition, we are clarifying certain compliance dates in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule.

This final rule is effective August 24, 2016. See sections III.C, IV.A.2, IV.B, and V through VIII for the extended compliance dates. For questions relating to Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food: Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2166. Food Safety Modernization Act: Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules , http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM472330.pdf http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM472884.pdf http://www.fda.gov/fsma http://www.regulations.gov Vol. 81, no. 164 Office of the Federal Register, National Archives and Records Administration 2016-08-24 continuing daily deposited born digital 650 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-08-24 P0b002ee190cf94e9 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr24au16 https://www.govinfo.gov/app/details/FR-2016-08-24 https://www.govinfo.gov/content/pkg/FR-2016-08-24/pdf/FR-2016-08-24.pdf https://www.govinfo.gov/content/pkg/FR-2016-08-24/xml/FR-2016-08-24.xml fdlp 57743 58380 DGPO 2016-08-24 2024-06-01 FR-2016-08-24 machine generated eng FR FR-2016-08-24 81 164