Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA, the Agency, or we) is removing instruction 13 from the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (Preventive Controls for Human Food) regulation. Instruction 13 directs the Federal Register to remove and reserve as of September 17, 2018, the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (Human Food CGMP) regulation. Removal of instruction 13 is necessary because the compliance dates for certain facilities subject to the modernized current good manufacturing practice requirements in the Preventive Controls for Human Food regulation have been extended. Retaining the Human Food CGMP regulation will maintain the status quo while these facilities prepare for compliance with the new CGMP requirements and will avoid an unintended gap in public health protection.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Part 110 [Docket No. FDA-2011-N-0920] AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; partial withdrawal. SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is removing instruction 13 from the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (Preventive Controls for Human Food) regulation. Instruction 13 directs the Federal Register to remove and reserve as of September 17, 2018, the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (Human Food CGMP) regulation. Removal of instruction 13 is necessary because the compliance dates for certain facilities subject to the modernized current good manufacturing practice requirements in the Preventive Controls for Human Food regulation have been extended. Retaining the Human Food CGMP regulation will maintain the status quo while these facilities prepare for compliance with the new CGMP requirements and will avoid an unintended gap in public health protection. DATES: Effective September 12, 2018, FDA withdraws amendatory instruction 13 on page 56144 of the final rule published at 80 FR 55908 at 56144 on September 17, 2015. Submit either electronic or written comments by October 12, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted …
Other Federal Register documents from the same docket.
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Supply-Chain Programs and Onsite Audits; Announcement of Effective Date
Implementing the Food and Drug Administration Food Safety Modernization Act; Technical Amendment
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
What You Need To Know About the Food and Drug Administration Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Small Entity Compliance Guide; Availability
Citation: 83 FR 46104
