[Federal Register Volume 83, Number 60 (Wednesday, March 28, 2018)]
[Notices]
[Pages 13288-13290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06154]


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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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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget

[[Page 13289]]

(OMB) for review and clearance under the Paperwork Reduction Act of 
1995.

DATES: Fax written comments on the collection of information by April 
27, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 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.

Calorie Labeling of Articles of Food in Vending Machines and Nutrition 
Labeling of Standard Menu Items in Restaurants and Similar Retail Food 
Establishments--21 CFR Part 101

OMB Control Numbers 0910-0782 and 0910-0783--Consolidation

    This information collection supports FDA regulations under 21 CFR 
101. As published in the Federal Register of December 1, 2014 (79 FR 
71156 and 71259), regulations at 21 CFR 101.8 and 101.11 were revised 
to provide for the nutritional analysis of certain foods and for the 
disclosure of that information on applicable products purchased by 
consumers. The regulations also provide for the registration of certain 
individuals who become subject to the requirements, 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, respondents must renew the 
registration every other year within 60 days prior to the expiration of 
the establishment's current registration with FDA, or it will 
automatically expire.
    In the Federal Register of December 12, 2017 (82 FR 58425), we 
published a 60-day notice requesting public comment on the proposed 
information collection. A number of comments were received in response 
to the notice. The comments were generally supportive of the 
information collection, but included concerns about the potential 
effect the ongoing or delayed rulemaking to establish specific 
packaging requirements (e.g., font-size of labeling, compliance dates) 
might have on the associated third-party disclosure burden. Other 
comments questioned whether FDA needed all data currently being sought 
by the applicable regulations and suggested the registration schedule 
be relaxed, especially given the small number of respondents.
    We are very appreciative of these comments. At the same time, upon 
our own review of the information collection, we are seeking to 
consolidate the burden currently approved under OMB control number 
0910-0783 with 0910-0782 because it is intended to account for similar 
collection activities and is supported by the same collection 
instrument (Form FDA 3757) identified above. Also, as neither the 
public comments we received nor our own evaluation suggested we revise 
our original figures, we are retaining the currently approved estimated 
burden for the information collection, which is as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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    21 CFR 101.8 and 101.11                        Number of                     Average burden
  registration using form FDA      Number of     responses per   Total annual   per response (in    Total hours
             3757                 respondents     respondent       responses         hours)
----------------------------------------------------------------------------------------------------------------
Sec.   101.8(d); initial                    13               1              13  2...............              26
 registration.
Sec.   101.8(d); registration               19               1              19  .5 (30 minutes).             9.5
 renewal.
Sec.   101.11(d) initial                 3,559               1           3,559  2...............           7,118
 registration.
Sec.   101.11(d) registration            5,340               1           5,340  .5 (30 minutes).           2,670
 reviewal.
                               ---------------------------------------------------------------------------------
    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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                                                    Annual
        21 CFR part 101            Number of     frequency per   Total annual   Hours per record    Total hours
                                 recordkeepers   recordkeeper       records
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                                    Initial Burden (Annualized over 3 years)
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Sec.   101.8(c)(2)(i)(A);               69,017               1          69,017  .25 (15 minutes)          17,254
 Initial nutrition analysis.
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                                                  Annual Burden
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Sec.   101.8(c)(2)(i)(A);               30,059               1          30,059  .25 (15 minutes)           7,515
 Recurring nutrition analysis.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................          24,769
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 13290]]


                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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                                                   Number of                     Average burden
        21 CFR part 101            Number of      disclosures    Total annual    per disclosure     Total hours
                                  respondents   per respondent    disclosures      (in hours)
----------------------------------------------------------------------------------------------------------------
Sec.   101.8(c)(2)(i); calorie             282              11           3,102  1...............           3,102
 analysis.
Sec.   101.8(c)(2)(ii);                  3,279           2,122       6,958,038  .21 (12.5              1,461,188
 calorie declaration signage.                                                    minutes).
Sec.   101.8(e)(1); vending              3,279             125         409,875  .025 (1.5                 10,247
 operator contact information.                                                   minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................       1,474,537
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\1\ There are no capital costs or operating and maintenance costs associated with the information collection.

    These figures are based on our analyses in support of the 
underlying rulemaking cited above and there is no burden increase since 
the previous OMB approvals. Because these are newly established 
information collection provisions, we continue to evaluate the 
collection burden and solicit public comment, noting that the effective 
dates and/or compliance dates for certain provisions have not yet been 
realized.

    Dated: March 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06154 Filed 3-27-18; 8:45 am]
 BILLING CODE 4164-01-P


