[Federal Register Volume 85, Number 234 (Friday, December 4, 2020)]
[Notices]
[Pages 78334-78336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26695]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6397]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Food Labeling; Calorie Labeling of Articles of Food in 
Vending Machines and Nutrition Labeling of Standard Menu Items in 
Restaurants and Similar Retail Food Establishments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on information collection provisions for 
calorie labeling of articles of food in vending machines and nutrition 
labeling of standard menu items in restaurants and similar retail food 
establishments.

DATES: Submit either electronic or written comments on the collection 
of information by February 2, 2021.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before February 2, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of February 2, 2021. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://www.regulations.gov.
    <bullet> 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:
    <bullet> Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, 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-2017-N-6397 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Food Labeling; Calorie Labeling 
of Articles of Food in Vending Machines and Nutrition Labeling of 
Standard Menu Items in Restaurants and Similar Retail Food 
Establishments.'' Received comments, those filed in a timely manner 
(see ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
    <bullet> 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

[[Page 78335]]

second copy, which will have the claimed confidential information 
redacted/blacked out, will be available for public viewing and posted 
on https://www.regulations.gov. Submit both copies to the Dockets 
Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
<a href="/cdn-cgi/l/email-protection#a3f3f1e2f0d7c2c5c5e3c5c7c28dcbcbd08dc4ccd5"><span class="__cf_email__" data-cfemail="67373526341306010127010306490f0f1449000811">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Food Labeling; Calorie Labeling of Articles of Food in Vending Machines 
and Nutrition Labeling of Standard Menu Items in Restaurants and 
Similar Retail Food Establishments

OMB Control Number 0910-0782--Extension

    This information collection supports FDA regulations under part 101 
(21 CFR part 101) and the associated collection instrument Form FDA 
3757. The Federal Food, Drug, and Cosmetic Act requires the disclosure 
of certain calorie labeling of articles of food in vending machines, as 
well as nutrition information for standard menu items in certain 
restaurants and retail food establishments. Sections 101.8 and 101.11 
provides that respondents with a chain of 20 or more locations will 
disclose nutritional information of certain foods for consumers of food 
products for the purpose of making informed dietary choices. We also 
offer registration for respondents who wish to voluntarily participate 
with this information collection activity, for which we developed Form 
FDA 3757 entitled, ``DHHS/FDA Menu and Vending Machine Labeling 
Voluntary Registration'' to assist respondents in this regard. To keep 
the registration active, a respondent renews their registration every 
other year within 60 days prior to the expiration of the respondent's 
current registration with FDA, or it will automatically expire.
    We use the collection of information to help determine compliance 
with regulatory requirements. Third-party disclosure requirements are 
used by consumers of food products for the purpose of making informed 
dietary choices.
    Description of Respondents: Respondents to this collection of 
information are vending machine operators and restaurants or other 
similar food establishments that are subject to the requirements of 
part 101 as well as those entities that voluntarily participate with 
the provisions of this collection of information.

[[Page 78336]]

    We estimate the burden of the collection of information as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                 Number of
    Activity using form FDA 3757; 21 CFR         Number of     responses per   Total annual     Average burden  per response (in hours)     Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Initial Registration for Vending Machine                  13               1              13  2.........................................              26
 Labeling; 101.8(d).
Registration Renewal for Vending Machine                  19               1              19  0.5 (30 minutes)..........................             9.5
 Labeling; 101.8(d).
Initial Registration for Menu Labeling;                3,559               1           3,559  2.........................................           7,118
 101.11(d).
Registration Renewal for Menu Labeling;                5,340               1           5,340  0.5 (30 minutes)..........................           2,670
 101.11(d).
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................         9,823.5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                       Table 2--Estimated Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
              Activity; 21 CFR                   Number of      records per    Total annual      Average burden  per record (in hours)      Total hours
                                               recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                        Initial Burden (Annualized over 3 years)
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Initial Nutrition Analysis;                           69,017               1          69,017  0.25 (15 minutes).........................          17,254
 101.8(c)(2)(i)(A).
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                                                                      Annual Burden
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Recurring Nutrition Analysis;                         30,059               1          30,059  0.25 (15 minutes).........................           7,515
 101.8(c)(2)(i)(A).
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................          24,769
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
              Activity; 21 CFR                  Number of     disclosures per    Total annual      Average burden  per disclosure (in       Total hours
                                               respondents       respondent       disclosures                    hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Calorie Analysis; 101.8(c)(2)(i)...........             282                 11           3,102  1.......................................           3,102
Calorie Declaration Signage;                          3,279              2,122       6,958,038  0.21 (12.5 minutes).....................       1,461,188
 101.8(c)(2)(ii).
Vending Operator Contact Information;                 3,279                125         409,875  0.025 (1.5 minutes).....................          10,247
 101.8(e)(1).
                                            ------------------------------------------------------------------------------------------------------------
    Total..................................  ..............  .................  ..............  ........................................       1,474,537
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: November 30, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26695 Filed 12-3-20; 8:45 am]
BILLING CODE 4164-01-P


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