[Federal Register Volume 87, Number 228 (Tuesday, November 29, 2022)]
[Proposed Rules]
[Pages 73267-73268]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26002]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2016-D-2335]
RIN 0910-AI13


Food Labeling: Nutrient Content Claims; Definition of Term 
``Healthy;'' Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the proposed rule entitled ``Food Labeling: Nutrient 
Content Claims; Definition of Term `Healthy' '' that appeared in the 
Federal Register of September 29, 2022. We are taking this action in 
response to a request from stakeholders to extend the comment period to 
allow interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the proposed rule 
published September 29, 2022 (87 FR 59168). Either electronic or 
written comments must be submitted on the proposed rule by February 16, 
2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of February 16, 2023. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

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-2016-D-2335 for ``Food Labeling: Nutrient Content Claims; 
Definition of Term `Healthy'.'' Received comments, those filed in a 
timely manner (see ADDRESSES), 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

[[Page 73268]]

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.

FOR FURTHER INFORMATION CONTACT: Vincent de Jesus, Office of Nutrition 
and Food Labeling, Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-1450, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of September 29, 
2022 (87 FR 59168), we published a proposed rule entitled ``Food 
Labeling: Nutrient Content Claims; Definition of Term `Healthy'.'' This 
action opened a docket with a 90-day comment period to receive 
information and comments related to the definition for the implied 
nutrient content claim ``healthy.''
    FDA has received a request for a 90-day extension for this comment 
period in order to allow additional time for interested persons to 
develop and submit comments. The request conveyed concern that the 
current 90-day comment period does not allow sufficient time to develop 
meaningful comments to the proposed rule. In the interest of balancing 
the public health importance of the nutrient content claim and 
definition of the term ``healthy'' and granting additional time to 
submit comments before we finalize the proposed rule, we have concluded 
that it is reasonable to extend the comment period for 50 days, until 
February 16, 2023. We believe that this extension allows adequate time 
for interested persons to submit comments.

    Dated: November 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26002 Filed 11-28-22; 8:45 am]
BILLING CODE 4164-01-P


