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Proposed Rule2024-019112024-02-02

Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability

Health and Human Services Department, Food and Drug Administration

Abstract

The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a revised draft Introduction, and a revised draft Appendix 1, within a multichapter guidance for industry entitled "Hazard Analysis and Risk-Based Preventive Controls for Human Food." This multichapter draft guidance, when finalized, will explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under our rule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." We revised the draft Introduction and draft Appendix 1: Known or Reasonably Foreseeable Hazards ("Potential Hazards") to address comments submitted on drafts that we made available in 2016. This draft guidance is not final nor is it in effect at this time.

Action & Dates

Action
Notification of availability.
Dates
Submit either electronic or written comments on the draft guidance by June 3, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

CFR References

Public Comment

Comments Close
2024-06-03

Document Excerpt

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 117 [Docket No. FDA-2016-D-2343] AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a revised draft Introduction, and a revised draft Appendix 1, within a multichapter guidance for industry entitled “Hazard Analysis and Risk-Based Preventive Controls for Human Food.” This multichapter draft guidance, when finalized, will explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under our rule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.” We revised the draft Introduction and draft Appendix 1: Known or Reasonably Foreseeable Hazards (“Potential Hazards”) to address comments submitted on drafts that we made available in 2016. 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 June 3, 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: ( printed page 7316) Electronic Submissions Submit electronic comments in the following way: Federal eRulemaking Portal: …

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Full Document

Citation: 89 FR 7315