
[Federal Register Volume 80, Number 202 (Tuesday, October 20, 2015)]
[Proposed Rules]
[Pages 63477-63478]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26636]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2012-N-1210]
RIN 0910-AF22


Food Labeling: Revision of the Nutrition and Supplement Facts 
Labels; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
reopening of the comment period for certain documents associated with 
the proposed rule to amend FDA's labeling regulations for conventional 
foods and dietary supplements to provide updated nutrition information 
on the Nutrition Facts and Supplement Facts labels to assist consumers 
in maintaining healthy dietary practices. We also are reopening the 
comment period for a supplemental proposed rule to revise the Nutrition 
Facts and Supplement Facts labels. We are taking this action due to 
technical difficulties at the Federal eRulemaking Portal.

DATES: Submit either electronic or written comments on the supplemental 
proposed rule and related documents by October 23, 2015.

ADDRESSES: You may submit comments as follows:

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-2012-N-1210 for this rulemaking. 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

[[Page 63478]]

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: Philip L. Chao, Center for Food Safety 
and Applied Nutrition (HFS-24), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-2112, email: 
Philip.Chao@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 3, 2014 (79 FR 11879), we 
published a proposed rule that would amend our labeling regulations for 
conventional foods and dietary supplements to provide updated nutrition 
information. In the Federal Register of July 27, 2015 (80 FR 44302), we 
reopened the comment period through September 25, 2015, for the 
proposed rule for the sole purpose of inviting public comments on two 
consumer studies being added to the administrative record. The consumer 
studies pertained to proposed changes to the Nutrition Facts label 
formats. We also issued a supplemental proposed rule (80 FR 44303) with 
a comment period through October 13, 2015. The supplemental proposal 
included two additional consumer studies pertaining to the declaration 
of added sugars and alternative footnote statements. We proposed text 
for the footnotes to be used on the Nutrition Facts label, after 
completing our consumer research in which we tested various footnote 
text options for the label. We also proposed to establish a Daily 
Reference Value of 10 percent of total energy intake from added sugars 
and to require the declaration of the percent Daily Value for added 
sugars on the label. The supplemental proposed rule also provided 
additional rationale for the declaration of the amount of added sugars 
on the label. We explained that we were taking these actions based, in 
part, on the science underlying a new report released by the 2015 
Dietary Guidelines Advisory Committee.
    More recently, in the Federal Register of September 10, 2015 (80 FR 
54446), we issued a notice clarifying: (1) The consumer studies on the 
added sugars declaration and the alternative footnote statements in the 
supplemental proposal relate to topics on which we sought comment and 
(2) the consumer studies on the format published in a separate notice 
in July 2015 were included for comment, and were placed in the docket 
at that time. We also stated that, in response to requests for the raw 
data for each of these consumer studies that are relevant to the 
summary memoranda for the studies, we were making the raw data 
available for comment. We extended the comment period for the two 
consumer studies pertaining to the proposed changes to the Nutrition 
Facts label formats (originally scheduled to close on September 25, 
2015) to October 13, 2015, to coincide with the end of the comment 
period for the supplemental proposed rule.
    However, on October 13 and 14, 2015, the Federal eRulemaking 
Portal, http://www.regulations.gov, experienced technical difficulties 
which sometimes prevented the electronic submission of comments. 
Therefore, we are reopening the comment period for the consumer studies 
and the supplemental proposal; the reopened comment period will close 
on October 23, 2015.

    Dated: October 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-26636 Filed 10-19-15; 8:45 am]
BILLING CODE 4164-01-P


