Document ID: FDA-2016-D-3401-0023
Agency: fda
Document Type: Proposed Rule
Title: Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition; Draft Guidance for Industry; Extension of Comment Period
Posted Date: 2017-01-13T05:00Z

[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Proposed Rules]
[Pages 4225-4226]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00724]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2016-D-3401]

Scientific Evaluation of the Evidence on the Beneficial 
Physiological Effects of Isolated or Synthetic Non-Digestible 
Carbohydrates Submitted as a Citizen Petition; Draft Guidance for 
Industry; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability; 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comment period for the notice of availability of a draft guidance 
entitled ``Scientific Evaluation of the Evidence on the Beneficial 
Physiological Effects of Isolated or Synthetic Non-Digestible 
Carbohydrates Submitted as a Citizen Petition'' that appeared in the 
Federal Register of November 23, 2016. The draft guidance, when 
finalized, will describe our views on the scientific evidence needed 
and the approach to evaluating the scientific evidence on the 
physiological effects of isolated or synthetic non-digestible 
carbohydrates that are added to foods that are beneficial to human 
health. We are taking this action in response to requests for an 
extension to allow interested persons additional time to submit 
comments.

DATES: We are extending the comment period on the notice that published 
in the Federal Register of November 23, 2016 (81 FR 84516). Submit 
either electronic or written comments by February 13, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     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

[[Page 4226]]

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-3401 for ``Scientific Evaluation of the Evidence on the 
Beneficial Physiological Effects of Isolated or Synthetic Non-
Digestible Carbohydrates Submitted as a Citizen Petition; 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 our 
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: Paula R. Trumbo, Center for Food 
Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 240-402-2579.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 23, 2016 
(81 FR 84516), we published a notice announcing the availability of a 
draft guidance entitled ``Scientific Evaluation of the Evidence on the 
Beneficial Physiological Effects of Isolated or Synthetic Non-
Digestible Carbohydrates Submitted as a Citizen Petition.'' The draft 
guidance explains the scientific review approach we plan to use for 
evaluating scientific evidence submitted to us in citizen petitions to 
determine whether a particular isolated or synthetic non-digestible 
carbohydrate that is added to food should be added to our definition of 
``dietary fiber'' that is found in the Nutrition and Supplement Facts 
label final rule, which appeared in the Federal Register of May 27, 
2016 (81 FR 33742). Only those isolated or synthetic non-digestible 
carbohydrates that meet the definition can be declared as a dietary 
fiber on a Nutrition and Supplement Facts label. We provided a 60-day 
comment period that was scheduled to close on January 23, 2017.
    Elsewhere in this issue of the Federal Register, we have published 
a notice to reopen the comment period for a related notice that 
appeared in the Federal Register of November 23, 2016 (81 FR 84595). We 
requested scientific data, information and comments in the related 
November 23, 2016, notice to help us evaluate the potential beneficial 
physiological effects on human health of 26 specific isolated or 
synthetic non-digestible carbohydrates that are added to food so that 
we may determine whether any of them should be added to our definition 
of dietary fiber in our Nutrition Facts and Supplement Facts label 
final rule. The November 23, 2016, notice also announced the 
availability of a document entitled ``Science Review of Isolated and 
Synthetic Non-Digestible Carbohydrates,'' which summarizes a scientific 
literature review that we conducted of clinical studies associated with 
the 26 specific isolated or synthetic non-digestible carbohydrates. The 
original comment period for this notice closed on January 9, 2017.
    We have received requests to extend the comment period for the 
isolated or synthetic non-digestible carbohydrates draft guidance. The 
requests conveyed concern that the current 60-day comment period does 
not allow sufficient time to develop meaningful or thoughtful comments 
to the draft guidance.
    We have considered the requests and are extending the comment 
period for the draft guidance until February 13, 2017. We believe that 
this extension allows adequate time for interested persons to submit 
comments without significantly delaying finalizing the guidance. The 
extended comment period deadline February 13, 2017, for the draft 
guidance also coincides with the reopened comment period for our 
related request for scientific data, information, and comments for the 
November 23, 2016, notice.

    Dated: January 10, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00724 Filed 1-12-17; 8:45 am]
BILLING CODE 4164-01-P