
[Federal Register Volume 81, Number 251 (Friday, December 30, 2016)]
[Proposed Rules]
[Pages 96404-96405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31734]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2016-D-2335]


Use of the Term ``Healthy'' in the Labeling of Human Food 
Products; Request for Information and Comments; Extension of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for a docket to receive information and comments on the 
use of the term ``healthy'' in the labeling of human food products. We 
established the docket through a notice that appeared in the Federal 
Register of September 28, 2016. In the notice, we requested comments on 
the term ``healthy'', generally, and as a nutrient content claim in the 
context of food labeling; we also requested comments on specific 
questions contained in the notice. We are taking this action in 
response to requests for an extension to allow interested persons 
additional time to submit comments.

DATES: FDA is extending the comment period on the notice that published 
in the Federal Register of September 28, 2016 (81 FR 66562). Submit 
either electronic or written comments by April 26, 2017.

ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 ``Use of the Term 'Healthy' in the Labeling of 
Human Food Products; Request for Information and Comments.'' 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 Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     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 Division of Dockets Management. 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

[[Page 96405]]

comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Vincent de Jesus, Center for Food 
Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 240-402-1450.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 28, 
2016, we published a notice announcing the establishment of a docket to 
receive information and comments on the use of the term ``healthy'' in 
the labeling of human food products. The notice discussed FDA's 
position regarding the use of the term ``healthy'', the events that 
prompted us to establish a docket to request information and comments 
on this issue, and specific issues for consideration. We provided a 
120-day comment period that was scheduled to end on January 26, 2017.
    We have received requests to extend the comment period. The 
requests conveyed concern that the current 120-day comment period does 
not allow sufficient time to develop meaningful or thoughtful comments 
to the questions and issues we presented in the notice.
    We have considered the requests and are extending the comment 
period for 90 days, until April 26, 2017. We believe that a 90-day 
extension allows adequate time for interested persons to submit 
comments.

    Dated: December 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31734 Filed 12-29-16; 8:45 am]
 BILLING CODE 4164-01-P


