
[Federal Register Volume 81, Number 158 (Tuesday, August 16, 2016)]
[Rules and Regulations]
[Pages 54499-54501]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19492]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 11 and 101

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


Calorie Labeling of Articles of Food in Vending Machines: 
Guidance for Industry; Small Entity Compliance Guide; 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 guidance for industry entitled ``Calorie Labeling of 
Articles of Food in Vending Machines--Small Entity Compliance Guide.'' 
The small entity compliance guide (SECG) is intended to help small 
entities comply with the final rule entitled ``Food Labeling; Calorie 
Labeling of Articles of Food in Vending Machines.''

DATES: Submit either electronic or written comments on FDA guidances at 
any time.

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

[[Page 54500]]

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--Small Entity Compliance Guide.'' 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 the 
Office of Nutrition and Food Labeling, Food Labeling and Standards 
Staff, Center for Food Safety and Applied Nutrition (HFS-305), 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: Ashley N. Rulffes, 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

    In the Federal Register of December 1, 2014 (79 FR 71259), we 
issued a final rule requiring vending machine operators who own or 
operate 20 or more vending machines, or who voluntarily register to be 
covered, to provide calorie declarations for those foods sold from 
vending machines 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 (the final rule). 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.
    We examined the economic implications of the final rule as required 
by the Regulatory Flexibility Act (5 U.S.C. 601-612) and determined 
that the final rule will have a significant economic impact on a 
substantial number of small entities. In compliance with section 212 of 
the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-
121, as amended by Pub. L. 110-28), we are making available the SECG to 
explain the actions that a small entity must take to comply with the 
rule.
    We are issuing the SECG consistent with our good guidance practices 
regulation (21 CFR 10.115(c)(2)). The SECG represents our current 
thinking on calorie labeling for foods sold in vending machines 
operated by a person engaged in the business of owning or operating 20 
or more vending machines, or a person who voluntarily registers with 
FDA to be covered by the rule. It does not create or confer any rights 
for or on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This SECG refers to collections of information described in FDA's 
final rule that published in the Federal Register of December 1, 2014, 
and that will be effective on December 1, 2016. As stated in the final 
rule, these collections of information are subject to review by the 
Office of Management and Budget (OMB) under the Paperwork Reduction Act 
of 1995 (the PRA) (44 U.S.C. 3501-3520). The collections of information 
in the final rule have been approved under OMB control number 0910-
0782. An Agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number.

III. Electronic Access

    Persons with access to the Internet may obtain the SECG at either 
http://www.fda.gov/Food/GuidanceRegulation/

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GuidanceDocumentsRegulatoryInformation/default.htm 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. 2016-19492 Filed 8-15-16; 8:45 am]
 BILLING CODE 4164-01-P


