
[Federal Register Volume 80, Number 248 (Monday, December 28, 2015)]
[Proposed Rules]
[Pages 80718-80719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32471]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2014-N-1207]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; 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 ``natural'' in the labeling of human food products, 
including foods that are genetically engineered or contain ingredients 
produced through the use of genetic engineering. A notice requesting 
comments on this topic appeared in the Federal Register of November 12, 
2015. We initially established February 10, 2016, as the deadline for 
the submission of comments. We are taking this action

[[Page 80719]]

in response to requests for an extension to allow interested persons 
additional time to submit comments.

DATES: FDA is extending the comment period for a docket to receive 
information and comments on the use of the term ``natural'' in the 
labeling of human food products. We established the docket in a notice 
published on November 12, 2015 (80 FR 69905). Submit either electronic 
or written comments to the docket by May 10, 2016.

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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-2014-N-1207 for ``Use of the Term `Natural' 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 http://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.'' The Agency will 
review this copy, including the claimed confidential information, in 
its 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 http://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 
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 http://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: Margaret-Hannah Emerick, Center for 
Food Safety and Applied Nutrition (HFS-820), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-2371.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 12, 2015 
(80 FR 69905), we published a notice announcing the establishment of a 
docket to receive information and comments on the use of the term 
``natural'' in the labeling of human food products, including foods 
that are genetically engineered or contain ingredients produced through 
the use of genetic engineering. The notice discussed FDA's position 
regarding the use of the term ``natural'', the events that prompted us 
to establish a docket to request comment on this issue, and specific 
questions. We provided a 90-day comment period that was scheduled to 
end on February 10, 2016.
    We received requests for a 90-day extension of the comment period. 
The requests conveyed concern that the current 90-day comment period 
does not allow sufficient time to develop meaningful or thoughtful 
comments to the questions and issues we presented in the notice.
    FDA has considered the requests and is extending the comment period 
for 90 days, until May 10, 2016. We believe that a 90-day extension 
allows adequate time for interested persons to submit comments.

    Dated: December 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32471 Filed 12-24-15; 8:45 am]
 BILLING CODE 4164-01-P


