[Federal Register Volume 81, Number 158 (Tuesday, August 16, 2016)]
[Rules and Regulations]
[Pages 54501-54502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19493]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR part 101

[Docket No. FDA-2011-F-0171]


Calorie Labeling of Articles of Food in Vending Machines; Draft 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance for industry, entitled ``Calorie 
Labeling of Articles of Food in Vending Machines.'' The draft guidance, 
when finalized, will help covered vending machine operators and 
industry to better understand and comply with the final rule entitled 
``Food Labeling: Calorie Labeling of Articles of Food in Vending 
Machines.''

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that we consider your comment on the draft 
guidance before we begin work on the final version of the guidance, 
submit either electronic or written comments on the draft guidance by 
September 30, 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-2011-F-0171 for Calorie Labeling of Articles of Food in Vending 
Machines; 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 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.
    Submit written requests for single copies of the guidance to Food 
Labeling and Standards Staff, Office of Nutrition and Food Labeling, 
Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your 
request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance.

FOR FURTHER INFORMATION CONTACT: Felicia B. Billingslea, Center for 
Food Safety and Applied Nutrition (HFS-820), Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2371.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Calorie Labeling of Articles of Food in Vending Machines.'' 
We are issuing the draft guidance consistent with our good guidance 
practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of the FDA on this 
topic. It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternate approach if it 
satisfies the requirements of the applicable statutes and regulations.
    In the Federal Register of December 1, 2014 (79 FR 71259), we 
issued a final rule entitled ``Food Labeling: Calorie Labeling of 
Articles of Food in Vending Machines'' (``the rule''). The rule is 
codified at 21 CFR 101.8. The rule requires vending machine operators 
who own or operate 20 or more vending

[[Page 54502]]

machines, or who voluntarily register with FDA to be covered, to 
declare calories for those vending machine foods for which the 
Nutrition Facts label cannot be examined before purchase or for which 
visible nutrition information is not otherwise provided at the point of 
purchase. Covered vending machine operators must comply with the rule 
by December 1, 2016. However, in the Federal Register of August 1, 2016 
(81 FR 50303), we issued a final rule entitled ``Food Labeling; Calorie 
Labeling of Articles of Food in Vending Machines; Extension of 
Compliance Date.'' This rule provides that the compliance date for type 
size front-of-pack labeling requirements (Sec.  101.8(b)(2) (21 CFR 
101.8(b)(2))) and calorie disclosure requirements (Sec.  101.8(c)(2)) 
for certain gums, mints, and roll candy products in glass-front 
machines in the final rule published December 1, 2014 (79 FR 71259) is 
extended to July 26, 2018. The compliance date for all other 
requirements in the final rule (79 FR 71259) remains December 1, 2016.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 101.8 have been approved under OMB 
Control No. 0910-0782.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous 
sentence to find the most current version of the guidance.

    Dated: August 11, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2016-19493 Filed 8-15-16; 8:45 am]
BILLING CODE 4164-01-P