Proposed Rule2025-09653
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for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event: Draft Guidance for Industry; Reopening of Comment Period
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 29, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is reopening the comment period for a draft guidance entitled "Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event: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.
Full Text
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<title>Federal Register, Volume 90 Issue 102 (Thursday, May 29, 2025)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-09653]
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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Contamination Event: Draft Guidance for Industry; Reopening of Comment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.
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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comment period for a draft guidance entitled ``Establishing Sanitation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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#e2a0878c88838f8b8cccb5839090878ca2848683cc8a8a91cc858d94"><span class="__cf_email__" data-cfemail="1b597e75717a767275354c7a69697e755b7d7f7a35737368357c746d">[email protected]</span></a>.
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
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