
[Federal Register Volume 82, Number 39 (Wednesday, March 1, 2017)]
[Proposed Rules]
[Pages 12184-12185]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03929]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2016-D-4120]


Fruit Juice and Vegetable Juice as Color Additives in Food; Draft 
Guidance for Industry; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is reopening the 
comment period for the notice entitled ``Fruit Juice and Vegetable 
Juice as Color Additives in Food; Draft Guidance for Industry'' that 
appeared in the Federal Register of December 14, 2016. The draft 
guidance, when finalized, will help manufacturers determine whether a 
color additive derived from a plant material meets the specifications 
under certain FDA color additive regulations. We are taking this action 
in response to requests to allow interested persons additional time to 
submit comments.

DATES: FDA is reopening the comment period for the proposed rule 
published December 14, 2016 (81 FR 90267). Submit either electronic or 
written comments by May 1, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:

[[Page 12185]]

     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-4120 for ``Fruit Juice and Vegetable Juice as Color 
Additives in Food; Draft Guidance for Industry.'' 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 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 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 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: Laura A. Dye, Center for Food Safety 
and Applied Nutrition (HFS-265), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-1275.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 14, 2016 
(81 FR 90267), we published a notice of availability of a draft 
guidance for industry entitled ``Fruit Juice and Vegetable Juice as 
Color Additives in Food.'' The draft guidance, when finalized, will 
help manufacturers determine whether a color additive derived from a 
plant material meets the specifications for fruit juice under Sec.  
73.250 (21 CFR 73.250) or vegetable juice under Sec.  73.260 (21 CFR 
73.260). Although you can comment on any guidance at any time, to 
ensure that we consider comments on this draft guidance before we begin 
work on the final version, interested persons were originally given 
until February 13, 2017, to comment on the draft guidance.
    We have received requests to extend the comment period for the 
draft guidance. The requests conveyed concern that the original 60-day 
comment period would not allow sufficient time to develop a meaningful 
or thoughtful response to various issues presented in the draft 
guidance and to our interpretation of our regulations. We have 
considered the requests but were unable to issue a document extending 
the comment period for the draft guidance before February 13, 2017. 
Consequently, we are reopening the comment period for an additional 60 
days. Interested parties have until May 1, 2017. We believe that this 
action allows adequate time for interested persons to submit comments 
on the draft guidance without significantly delaying finalizing the 
guidance.

    Dated: February 23, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-03929 Filed 2-28-17; 8:45 am]
 BILLING CODE 4164-01-P


