[Federal Register Volume 86, Number 63 (Monday, April 5, 2021)]
[Notices]
[Pages 17607-17609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06933]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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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[[Page 17608]]

SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by May 5, 2021.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0782. Also include the FDA docket 
number found in brackets in the heading of this document.

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, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 
(21 CFR 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.
    In the Federal Register of December 4, 2020 (85 FR 78334), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although some general comments were received 
regarding the applicable labeling requirements, no comments suggested 
we revise the information collection burden we estimate under 5 CFR 
1320.5(a)(1)(B).
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                  Number of       Total
Activity using Form FDA 3757; 21   Number of    responses per     annual      Average  burden per    Total hours
           CFR section            respondents    respondent     responses           response
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Initial Registration for Vending           13               1           13  2......................           26
 Machine Labeling; 101.8(d).
Registration Renewal for Vending           19               1           19  0.5 (30 minutes).......          9.5
 Machine Labeling; 101.8(d).
Initial Registration for Menu           3,559               1        3,559  2......................        7,118
 Labeling; 101.11(d).
Registration Renewal for Menu           5,340               1        5,340  0.5 (30 minutes).......        2,670
 Labeling; 101.11(d).
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    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\
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                                                   Number of       Total
    Activity; 21 CFR section       Number of      records per      annual      Average  burden per   Total hours
                                 recordkeepers   recordkeeper     records         recordkeeping
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Initial Burden (Annualized over
 3 years):
    Initial Nutrition Analysis;        69,017                1       69,017  0.25 (15 minutes).....       17,254
     101.8(c)(2)(i)(A).
Annual Burden:
    Recurring Nutrition                30,059                1       30,059  0.25 (15 minutes).....        7,515
     Analysis;
     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\
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                                                  Number of       Total
    Activity; 21 CFR section       Number of     disclosures      annual      Average  burden per    Total hours
                                  respondents  per respondent  disclosures         disclosure
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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).

[[Page 17609]]

 
Vending Operator Contact                3,279             125      409,875  0.025 (1.5 minutes)....       10,247
 Information; 101.8(e)(1).
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        Total...................  ...........  ..............  ...........  .......................    1,474,537
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\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: March 30, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06933 Filed 4-2-21; 8:45 am]
BILLING CODE 4164-01-P