[Federal Register Volume 89, Number 213 (Monday, November 4, 2024)]
[Notices]
[Pages 87589-87590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-25567]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0055]
Voluntary Sodium Reduction Goals: Target Mean and Upper Bound
Concentrations for Sodium in Commercially Processed, Packaged, and
Prepared Foods (Edition 2); Draft Guidance for Industry; Extension of
Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA or we) is extending the
comment period for a draft guidance for industry entitled ``Voluntary
Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for
Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition
2).'' The draft guidance, when finalized, will describe our views on
the next voluntary goals (Phase II (3-year)) for sodium reduction in a
variety of identified categories of
[[Page 87590]]
foods that are commercially processed, packaged, or prepared. These
goals are intended to address the excessive intake of sodium in the
current population to help reduce the burden of diet-related chronic
disease, promote improvements in public health, and advance health
equity by supporting a healthier food supply. The Agency is taking this
action in response to requests for an extension to allow interested
persons additional time to submit comments.
DATES: Submit either electronic or written comments on the draft
guidance by January 13, 2025, to ensure that we consider your comment
on the draft guidance before we begin work on the final version of the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
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-2014-D-0055 for ``Voluntary Sodium Reduction Goals: Target Mean and
Upper Bound Concentrations for Sodium in Commercially Processed,
Packaged, and Prepared Foods (Edition 2).'' 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 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)).
Submit written requests for single copies of the draft guidance to
the Nutrition Center of Excellence, Human Foods Program, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance.
FOR FURTHER INFORMATION CONTACT: Kasey Heintz, Nutrition Center of
Excellence, Human Foods Program, Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-1376.
SUPPLEMENTARY INFORMATION:
In the Federal Register of August 16, 2024 (89 FR 66727), we
published a notice announcing the availability of a draft guidance
entitled, ``Voluntary Sodium Reduction Goals: Target Mean and Upper
Bound Concentrations for Sodium in Commercially Processed, Packaged,
and Prepared Foods; Draft Guidance for Industry (Edition 2).'' The
draft guidance, when finalized, will describe our views on the next
voluntary goals (Phase II (3-year)) for sodium reduction in a variety
of identified categories of foods that are commercially processed,
packaged, or prepared. We provided a 90-day comment period for the
draft guidance.
We have received requests for a 90-day extension of the comment
period. In general, the requests explained that industry needed more
time to thoroughly review the draft guidance against numerous product
lines and that industry also anticipates a need to manage multiple
critical initiatives from FDA, including a final rule on ``healthy''
labeling and a proposed rule on front-of-package nutrition labeling.
We have considered the requests and are extending the comment
period for an additional 60 days until January 13, 2025. We believe
that this extension will allow adequate time for interested persons to
submit comments without significantly delaying finalizing the guidance.
Dated: October 29, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-25567 Filed 11-1-24; 8:45 am]
BILLING CODE 4164-01-P