[Federal Register Volume 81, Number 224 (Monday, November 21, 2016)]
[Notices]
[Pages 83243-83244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27941]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2241]


Substantiation for Structure/Function Claims Made in Infant 
Formula Labels and Labeling: Draft Guidance for Industry; Reopening of 
the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is reopening the 
comment period for the notice, published in the Federal Register of 
September 9, 2016 (81 FR 62509), announcing the availability of the 
draft guidance for industry entitled ``Substantiation for Structure/
Function Claims Made in Infant Formula Labels and Labeling.'' We are 
reopening the comment period in response to a request

[[Page 83244]]

for an extension to allow interested persons additional time to submit 
comments.

DATES: Submit either electronic or written comments by February 21, 
2017.

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-2016-D-2241 for ``Substantiation for Structure/Function Claims Made 
in Infant Formula Labels and Labeling.'' 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.'' 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 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: Gillian Robert-Baldo, Center for Food 
Safety and Applied Nutrition (HFS-850), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 240-402-1451.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 9, 2016 
(81 FR 62509), we published a notice announcing the availability of a 
draft guidance entitled, ``Substantiation for Structure/Function Claims 
Made in Infant Formula Labels and Labeling.'' 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 November 8, 2016, to 
comment on the draft guidance.
    Following publication of the September 9, 2016, notice of 
availability, we received a request for a 90-day extension of the 
comment period. The request expressed concern that the current 60-day 
comment period does not allow sufficient time to develop a thoughtful 
and comprehensive response to the draft guidance. We have considered 
the request and are reopening the comment period for an additional 90 
days, until February 21, 2017. We believe that this reopening allows 
adequate time for interested persons to submit comments without 
significantly delaying finalizing the guidance.

    Dated: November 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-27941 Filed 11-18-16; 8:45 am]
 BILLING CODE 4164-01-P