2025-09653: Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event: Draft Guidance for Industry; Reopening of Comment Period

Federal Register, Volume 90 Issue 102 (Thursday, May 29, 2025) [Federal Register Volume 90, Number 102 (Thursday, May 29, 2025)] [Proposed Rules] [Pages 22675-22676] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2025-09653] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 106 and 117 [Docket No. FDA-2024-D-2604] Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event: Draft Guidance for Industry; Reopening of Comment Period

Agency

Food and Drug Administration, Department of Health and Human Services (HHS).

Action

Notification of availability; reopening of comment period. -----------------------------------------------------------------------

Summary

The Food and Drug Administration (FDA or we) is reopening the comment period for a draft guidance entitled ``Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event: Guidance for Industry,'' which was announced in the Federal Register of January 7, 2025. We are taking this action in response to requests to allow interested persons additional time to submit comments before FDA begins work on the final guidance.

Dates

FDA is reopening the comment period on our draft guidance published January 7, 2025 (90 FR 1052). Submit either electronic or written comments by July 28, 2025, to ensure that we consider your comment on this draft guidance before we begin work on the final guidance.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 electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2024-D-2604 for ``Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240- 402-7500. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS [[Page 22676]] CONFIDENTIAL INFORMATION.'' We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

For Further Information Contact

Benjamin Warren, Office of Microbiological Food Safety, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-645-7004, [email protected].

Supplementary Information

In the Federal Register of January 7, 2025 (90 FR 1052), we published a document announcing the availability of a draft guidance entitled ``Establishing Sanitation Programs for Low- Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event.'' The notice of availability opened a docket with a 120-day comment period, that closed on May 7, 2025. We have received requests to extend the comment period for the draft guidance. The requests conveyed concern that a 120-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the draft guidance. We have considered the requests and have concluded that an extension of the comment period by 60 days is appropriate. The extension will allow adequate time for interested persons to submit comments without significantly delaying the final guidance. Dated: May 22, 2025. Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2025-09653 Filed 5-28-25; 8:45 am] BILLING CODE 4164-01-P