Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability

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 [Docket No. FDA-2016-D-2343] AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of two additional draft chapters of a multichapter draft guidance for industry entitled “Hazard Analysis and Risk-Based Preventive Controls for Human Food.” This multichapter draft guidance, when finalized, will explain FDA's current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under FDA's regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.” The newly available draft chapters are entitled “Chapter 11—Food Allergen Program” and “Chapter 16—Acidified Foods.” This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by March 25, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way: Federal eRulemaking Portal: https://www.regulations.gov . Follow the instructions for submitting comments. Comments submitted electr…