81 FR 54501 - Calorie Labeling of Articles of Food in Vending Machines; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 158 (August 16, 2016)

Page Range		54501-54502
FR Document		2016-19493

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry, entitled ``Calorie Labeling of Articles of Food in Vending Machines.'' The draft guidance, when finalized, will help covered vending machine operators and industry to better understand and comply with the final rule entitled ``Food Labeling: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

Federal Register, Volume 81 Issue 158 (Tuesday, August 16, 2016)

[Federal Register Volume 81, Number 158 (Tuesday, August 16, 2016)]
[Rules and Regulations]
[Pages 54501-54502]
From the Federal Register Online [www.thefederalregister.org]
[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Calorie Labeling of Articles of Food in Vending Machines; Draft
Guidance for Industry; Availability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availability of a draft guidance for industry, entitled ``Calorie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 The draft guidance,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10.115(g)(5)), to ensure that we consider your comment on the draft
guidance before we begin work on the final version of the guidance,
submit either electronic or written comments on the draft guidance by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

54502 Federal Register / Vol. 81, No. 158 / Tuesday, August 16, 2016 / Rules and Regulations

machines, or who voluntarily register ENVIRONMENTAL PROTECTION Publicly available docket materials are
with FDA to be covered, to declare AGENCY available electronically at
calories for those vending machine www.regulations.gov and at EPA Region
foods for which the Nutrition Facts label 40 CFR Part 52 7, 11201 Renner Boulevard, Lenexa,
cannot be examined before purchase or [EPA–R07–OAR–2014–0213; FRL–9950–65– Kansas 66219. Please schedule an
for which visible nutrition information Region 7] appointment during normal business
is not otherwise provided at the point of hours with the contact listed in the FOR
purchase. Covered vending machine Approval and Promulgation of FURTHER INFORMATION CONTACT section.
operators must comply with the rule by Implementation Plans; State of Iowa; FOR FURTHER INFORMATION CONTACT:
December 1, 2016. However, in the Infrastructure State Implementation Heather Hamilton, Environmental
Plan (SIP) Requirements for the 1997 Protection Agency, Air Planning and
Federal Register of August 1, 2016 (81
and 2006 Fine Particulate Matter Development Branch, 11201 Renner
FR 50303), we issued a final rule
(PM2.5) National Ambient Air Quality Boulevard, Lenexa, Kansas 66219 at
entitled ‘‘Food Labeling; Calorie Standards (NAAQS), and the Adoption
Labeling of Articles of Food in Vending (913) 551–7039, or by email at
of the 1997 PM2.5 Standard Hamilton.heather@epa.gov.
Machines; Extension of Compliance
Date.’’ This rule provides that the AGENCY: Environmental Protection SUPPLEMENTARY INFORMATION:
compliance date for type size front-of- Agency (EPA). Throughout this document ‘‘we,’’ ‘‘us,’’
pack labeling requirements ACTION: Final rule. or ‘‘our’’ refer to EPA. This section
(§ 101.8(b)(2) (21 CFR 101.8(b)(2))) and provides additional information by
SUMMARY: The Environmental Protection addressing the following:
calorie disclosure requirements Agency (EPA) is approving elements of
(§ 101.8(c)(2)) for certain gums, mints, I. What is being addressed in this document?
two State Implementation Plan (SIP) II. EPA’s Response to Comments
and roll candy products in glass-front submissions from the State of Iowa for III. Final Action
machines in the final rule published the Infrastructure SIP Requirements for IV. Statutory and Executive Order Reviews
December 1, 2014 (79 FR 71259) is the 1997 and 2006 Fine Particulate
extended to July 26, 2018. The Matter (PM2.5) National Ambient Air I. What is being addressed in this
compliance date for all other Quality Standards (NAAQS). document?
requirements in the final rule (79 FR Infrastructure SIPs address the The EPA is approving two
71259) remains December 1, 2016. applicable requirements of Clean Air submissions from the State of Iowa: The
Act (CAA) section 110, which requires
II. Paperwork Reduction Act of 1995 infrastructure SIP submissions for the
that each state adopt and submit a SIP
1997 and 2006 PM2.5 NAAQS received
This draft guidance refers to for the implementation, maintenance,
on March 31, 2008 and July 29, 2013.
previously approved collections of and enforcement of each new or revised
The SIP submissions from Iowa
information found in FDA regulations. NAAQS promulgated by the EPA. The
addressed the requirements of CAA
infrastructure requirements are designed
These collections of information are sections 110(a)(1) and (2) as applicable
to ensure that the structural components
subject to review by the Office of to the 1997 and 2006 PM2.5 NAAQS.
of each state’s air quality management
Management and Budget (OMB) under The March 31, 2008 SIP submission also
program are adequate to meet the state’s
the Paperwork Reduction Act of 1995 included the state adoption of the 1997
responsibilities under the CAA. This
(44 U.S.C. 3501–3520). The collections PM2.5 standard. The EPA is also
action also approves the adoption of the
of information in 21 CFR 101.8 have approving the 1997 PM2.5 standard in
1997 PM2.5 standard.
been approved under OMB Control No. On September 8, 2011, EPA issued a today’s action.
0910–0782. For the 1997 PM2.5 NAAQS, the EPA
Finding of Failure to Submit a Complete
took previous action to address section
III. Electronic Access State Implementation Plan for several
110(a)(2)(D)(i)(I)—prongs 1 and 2 for
states, including Iowa. With respect to
Iowa. (72 FR 10380, March 8, 2007, as
Persons with access to the Internet Iowa, the Finding of Failure to Submit
revised in 76 FR 48208, August 8, 2011).
may obtain the draft guidance at either included the following 2006 PM2.5
Therefore, in this final action, we are
http://www.fda.gov/FoodGuidances or NAAQS infrastructure requirements:
not acting on these portions since they
http://www.regulations.gov. Use the 110(a)(2)(A)–(C), (D)(i)(II) (prong 3
have already been acted upon by the
FDA Web site listed in the previous only), (E)–(H) and (J)–(M). This approval
EPA.
sentence to find the most current of Iowa’s infrastructure SIP for the 2006 A Technical Support Document is
version of the guidance. PM2.5 NAAQS addresses the September included as part of the docket to discuss
8, 2011 finding. the details of this final action.
Dated: August 11, 2016. DATES: This final rule is effective on
Jeremy Sharp, September 15, 2016. II. EPA’s Response to Comment
Deputy Commissioner for Policy, Planning, ADDRESSES: EPA has established a The public comment period on EPA’s
Legislation, and Analysis. docket for this action under Docket ID proposed regulation opened June 23,
[FR Doc. 2016–19493 Filed 8–15–16; 8:45 am] No. EPA–R07–OAR–2014–0213. All 2016, the date of its publication in the
BILLING CODE 4164–01–P documents in the docket are listed on Federal Register, and closed on July 25,
the www.regulations.gov Web site. 2016. 81 FR 40825. During this period,
asabaliauskas on DSK3SPTVN1PROD with RULES

Although listed in the index, some EPA received one comment that is
information is not publicly available, addressed as follows:
i.e., CBI or other information whose Comment: The commenter stated that
disclosure is restricted by statute. EPA must disapprove the Prevention of
Certain other material, such as Significant Deterioration (PSD) portions
copyrighted material, is not placed on of the infrastructure SIP, 110(a)(2)(C),
the Internet and will be publicly (D)(i)(II) (prong 3) and (J), because the
available only in hard copy form. local air agencies in Iowa with their

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Document Created: 2016-08-16 03:20:21
Document Modified: 2016-08-16 03:20:21

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Notification of availability.
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.
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.
FR Citation		81 FR 54501

81 FR 54501 - Calorie Labeling of Articles of Food in Vending Machines; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 158 (August 16, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration