[Federal Register Volume 81, Number 168 (Tuesday, August 30, 2016)]
[Notices]
[Pages 59640-59641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20780]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0055]


Voluntary Sodium Reduction Goals: Target Mean and Upper Bound 
Concentrations for Sodium in Commercially Processed, Packaged, and 
Prepared Foods; Draft Guidance for Industry; Extension of Comment 
Periods

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment periods.

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SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment periods for the Draft Guidance entitled, ``Voluntary Sodium 
Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium 
in Commercially Processed, Packaged, and Prepared Foods'' that appeared 
in the Federal Register of June 2, 2016. In the notice, we requested 
comments on developing the sodium targets and for implementation of the 
guidance document. We are taking this action in response to requests to 
extend the two comment periods to allow interested persons additional 
time to submit comments.

DATES: We are extending the comment periods on the draft guidance 
published June 2, 2016 (81 FR 35363). Submit either electronic or 
written comments on Issues 1 through 4 in section IV of the notice of 
availability that published on June 2, 2016, by October 17, 2016. 
Submit either electronic or written comments on Issues 5 through 8 in 
section IV of the notice of availability that published on June 2, 
2016, by December 2, 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-D-0055 for ``Voluntary Sodium Reduction Goals: Target Mean and 
Upper Bound Concentrations for Sodium in Commercially Processed, 
Packaged, and Prepared Foods; Draft Guidance for Industry.'' 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

[[Page 59641]]

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: Kasey Heintz, Center for Food Safety 
and Applied Nutrition (HFS-255), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-1376.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 2, 2016 (81 
FR 35363), we published a notice announcing the availability of a draft 
guidance entitled, ``Voluntary Sodium Reduction Goals: Target Mean and 
Upper Bound Concentrations for Sodium in Commercially Processed, 
Packaged, and Prepared Foods.'' Section IV of the notice, ``Issues for 
Consideration,'' listed eight specific questions (or ``issues'') and 
provided two comment periods for the submission of comments pertaining 
to these issues (81 FR 35363 at 35366). The comment period for Issues 
related primarily to short-term goals (Issues 1 through 4) was 
scheduled to end on August 31, 2016, and the comment period for issues 
related primarily to long-term goals (Issues 5 through 8) was scheduled 
to end on October 31, 2016. Comments on Issues 1 through 8 will inform 
our final guidance on the voluntary sodium reduction goals.
    We received requests for 90- and 30-day extensions of these comment 
periods, respectively. In general, the requests expressed concern that 
the current 90- and 150-day comment periods do not allow sufficient 
time to develop a meaningful or thoughtful response to the draft 
guidance. Some requests mentioned a need for companies to review the 
sodium concentration in their products, to consider what technology 
might be needed to meet the sodium reduction goals, and to address FDA 
requirements. The requested extensions would result in a 180-day 
comment period for all eight Issues for Consideration. We also received 
comments opposed to any extensions of the comment period related to the 
short-term goals. These comments expressed their view that the initial 
comment period provided sufficient time for stakeholders to review the 
draft guidance and to contribute informed comments and that it is 
important for FDA to move forward in finalizing the short-term goals 
for public health reasons.
    We considered the requests and are extending the comment periods 
for the draft guidance as follows: For Issues 1 through 4, we are 
extending the comment period until October 17, 2016, and for Issues 5 
through 8 we are extending the comment period until December 2, 2016. 
We believe that these extensions allow adequate time for interested 
persons to submit comments without significantly delaying finalizing 
the guidance.

    Dated: August 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-20780 Filed 8-29-16; 8:45 am]
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