
[Federal Register Volume 81, Number 35 (Tuesday, February 23, 2016)]
[Proposed Rules]
[Pages 8869-8870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03716]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2014-N-1021]


Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed 
Foods; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of the comment period.

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SUMMARY: In the Federal Register of November 18, 2015, the Food and 
Drug Administration (FDA) published a proposed rule entitled ``Food 
Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods.'' The 
proposed rule would establish requirements concerning ``gluten-free'' 
labeling for foods that are fermented or hydrolyzed or that contain 
fermented or hydrolyzed ingredients. We are taking this action to 
reopen the comment period in response to requests to allow interested 
persons additional time to submit comments.

DATES: FDA is reopening the comment period on the proposed rule 
published November 18, 2015 (80 FR 71990). Submit either electronic or 
written comments by April 25, 2016.

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-2014-N-1021 for ``Food Labeling; Gluten-Free Labeling of Fermented 
or Hydrolyzed Foods.'' 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: Carol D'Lima, Center for Food Safety 
and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-2371, FAX: 301-436-
2636.

SUPPLEMENTARY INFORMATION: The proposed rule would establish 
requirements concerning ``gluten-free'' labeling for foods that are 
fermented or hydrolyzed or that contain fermented or hydrolyzed 
ingredients. These additional requirements for the ``gluten-free'' 
labeling rule are needed to help ensure that individuals with celiac 
disease are not misled and receive truthful and accurate information 
with respect to fermented or hydrolyzed foods labeled as ``gluten-
free.'' We provided a 90-day comment period for the proposed rule.
    We received multiple requests for a 60-day extension of the comment 
period and one request for a 90-day extension of the comment period for 
the proposed rule. Each request conveyed concern that the original 90-
day comment period does not allow sufficient time to develop a 
meaningful or thoughtful response to the proposed rule. We have 
considered the requests and are reopening the comment period for the

[[Page 8870]]

proposed rule until April 25, 2016. We believe that an additional 60-
day period allows adequate time for interested persons to submit 
comments without significantly delaying rulemaking on these important 
issues. The period for comments regarding information collection issues 
under the Paperwork Reduction Act of 1995 remains unchanged, where 
comments were to be submitted until February 22, 2016 (see 81 FR 3751, 
January 22, 2016).

    Dated: February 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03716 Filed 2-22-16; 8:45 am]
 BILLING CODE 4164-01-P


