[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Prepared Foods (Edition 2); Draft Guidance for Industry; Extension of 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comment period for a draft guidance for industry entitled ``Voluntary 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 The draft guidance, when finalized, will describe our views on 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DATES: Submit either electronic or written comments on the draft 
guidance by January 13, 2025, to ensure that we consider your comment 
on the draft guidance before we begin work on the final version of the 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:
    <bullet> 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.
    <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-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.
    <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 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