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 2018_register executive 2020-10-06 article Proposed Rules D09002ee1c7ece502 D09002ee1c7ece55e 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, we, or Agency) is announcing the availability of another draft chapter of a multichapter guidance for industry entitled "Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry." This multichapter draft guidance is intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk- based preventive controls under our rule entitled "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food." The newly available draft chapter is entitled "Chapter 15--Supply-Chain Program for Human Food Products." 83 FR 3449 https://www.govinfo.gov/app/details/FR-2018-01-25/2018-01299 2018-01299 fr25ja18-13 4164-01-P Docket No. FDA-2016-D-2343 https://www.govinfo.gov/app/details/FR-2018-01-25/2018-01299 https://www.govinfo.gov/content/pkg/FR-2018-01-25/html/2018-01299.htm https://www.govinfo.gov/content/pkg/FR-2018-01-25/pdf/2018-01299.pdf 2 p. 3449 3450 83 FR 3449 Title 21 Part 117 21 CFR Part 117 Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability; Federal Register Vol. 83, Issue PRORULE 2018-01299 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2018-05-25 Docket No. FDA-2016-D-2343 4164-01-P 2018-01299 Notification of availability.

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of another draft chapter of a multichapter guidance for industry entitled "Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry." This multichapter draft guidance is intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk- based preventive controls under our rule entitled "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food." The newly available draft chapter is entitled "Chapter 15--Supply-Chain Program for Human Food Products."

Submit either electronic or written comments by May 25, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. 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. Guidance: Hazard Analysis and Risk-Based Preventive Controls for Human Food , https://www.fda.gov/FoodGuidances https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 83, no. 17 Office of the Federal Register, National Archives and Records Administration 2018-01-25 continuing daily deposited born digital 168 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2018-01-25 P0b002ee1a88b2e3f 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr25ja18 https://www.govinfo.gov/app/details/FR-2018-01-25 https://www.govinfo.gov/content/pkg/FR-2018-01-25/pdf/FR-2018-01-25.pdf https://www.govinfo.gov/content/pkg/FR-2018-01-25/xml/FR-2018-01-25.xml fdlp 3401 3562 DGPO 2020-10-06 2024-06-01 FR-2018-01-25 machine generated eng FR FR-2018-01-25 83 17