90 FR 102 pgs. 22675-22676 - 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for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event: Draft Guidance for Industry; Reopening of Comment Period
Type: PRORULEVolume: 90Number: 102Pages: 22675 - 22676
Pages: 22675, 22676Docket number: [Docket No. FDA-2024-D-2604]
FR document: [FR Doc. 2025-09653 Filed 5-28-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event: Draft Guidance for Industry; Reopening of Comment Period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The Food and Drug Administration (FDA or we) is reopening the comment period for a draft guidance entitled "Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event: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FDA is reopening the comment period on our draft guidance published January 7, 2025 (90 FR 1052). Submit either electronic or written comments by July 28, 2025, to ensure that we consider your comment on this draft guidance before we begin work on the final guidance.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.
[top] • 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
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, Benjamin.Warren@fda.hhs.gov.
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