Document ID: FDA-2013-N-1317-0092
Agency: fda
Document Type: Notice
Title: Tentative Determination Regarding Partially Hydrogenated Oils; Request
for Comments and for Scientific Data and Information; Extension of
Comment Period
Posted Date: 2013-12-31T05:00Z

[Federal Register Volume 78, Number 251 (Tuesday, December 31, 2013)]
[Notices]
[Page 79701]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-31294]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1317]

Tentative Determination Regarding Partially Hydrogenated Oils; 
Request for Comments and for Scientific Data and Information; 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 the notice that appeared in the Federal Register of 
November 8, 2013 (78 FR 67169). In the notice, we requested comments on 
our tentative determination that partially hydrogenated oils (PHOs) are 
not generally recognized as safe (GRAS) for any use in food based on 
current scientific evidence, and therefore are subject to regulation as 
food additives. We are taking this action in response to multiple 
requests for an extension to allow interested persons additional time 
to submit comments.

DATES: FDA is extending the comment period on the notice. Submit either 
electronic or written comments by March 8, 2014.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-1317 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.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2013-N-1317 for this rulemaking. All comments 
received may be posted without change to http://www.regulations.gov, 
including any personal information provided. For additional information 
on submitting comments, see the ``Comments'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number(s), 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: Mical Honigfort, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1278, FAX: 
301-436-2972, email: mical.honigfort@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of November 8, 2013 (78 FR 67169), FDA 
published a notice announcing our tentative determination that PHOs, 
which are the primary dietary source of industrially-produced trans 
fatty acids, or trans fat, are not GRAS for any use in food based on 
current scientific evidence establishing the health risks associated 
with the consumption of trans fat with a 60-day comment period ending 
on January 7, 2014. The notice also invited comments and additional 
scientific data and information related to this tentative determination 
and, in particular, requested comment on a number of specific questions 
(78 FR 67169 at 67174).
    We have received multiple requests for a 60-day extension of the 
comment period for the notice. Each request conveyed concern that the 
current 60-day comment period does not allow sufficient time to collect 
data and information and develop a comprehensive and thoughtful 
response to the notice.
    FDA has considered the requests and is extending the comment period 
for the notice for 60 days, until March 8, 2014. We believe that a 60-
day extension allows adequate time for interested persons to submit 
comments without significantly delaying our final determination on this 
important issue.

II. Request for Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: December 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-31294 Filed 12-30-13; 8:45 am]
BILLING CODE 4160-01-P