82 FR 58425 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Calorie Labeling of Articles of Food in Vending Machines

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 237 (December 12, 2017)

Page Range		58425-58428
FR Document		2017-26672
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.
Federal Register, Volume 82 Issue 237 (Tuesday, December 12, 2017)
[Federal Register Volume 82, Number 237 (Tuesday, December 12, 2017)]
[Notices]
[Pages 58425-58428]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-26672]


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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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.

DATES: Submit either electronic or written comments on the collection 
of information by February 12, 2018.

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 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of February 12, 2018. 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.

[[Page 58426]]

Electronic Submissions

    Submit electronic comments in the following way:
     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.
     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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     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.'' 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.
     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 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.thefederalregister.org/fdsys/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.

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: Under the PRA (44 U.S.C. 3501-3520), 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

OMB Control Number 0910-0782--Extension

    This information collection supports FDA regulations under Sec.  
101.8 (21 CFR 101.8) and Form FDA 3757. Under Sec.  101.8(d) vending 
machine operators not subject to the requirements of section 
403(q)(5)(H)(viii) (21 U.S.C. 343(q)(5)(H)(viii)) of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) may, through an authorized official, 
voluntarily register with FDA to be subject to those requirements. 
Those who do voluntarily register must provide FDA with contact 
information, the address of the location of each vending machine owned 
or operated by the vending machine operator that is being registered, 
the preferred mailing address (if different from the vending machine 
operator address) for purposes of receiving correspondence, and 
certification that the information submitted is true and accurate, that 
the person or firm submitting the information is authorized to do so, 
and that each registered vending machine will be subject to the 
requirements of Sec.  101.8(c)(2). We have developed Form FDA 3757 
entitled, ``DHHS/FDA Menu and Vending Machine Labeling Voluntary 
Registration,'' to assist respondents in this regard. To keep the 
establishment's registration active, the authorized official of the 
vending machine operator must register every other year within 60 days 
prior to the expiration of the vending machine operator's current 
registration with

[[Page 58427]]

FDA. Registration will automatically expire if not renewed.
    It should be noted that an article of food sold from a vending 
machine whose operator has voluntarily registered with FDA under the 
regulations is not required to provide calorie declarations for 
articles of food sold from a vending machine that permits the 
prospective purchaser to examine the Nutrition Facts label before 
purchasing the article as provided in Sec.  101.8(b)(1), or otherwise 
provides visible nutrition information at the point of purchase as 
provided in Sec.  101.8(b)(2).
    FDA estimates the burden of the collection of information as 
follows:
Reporting Burden

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
         21 CFR part 101.8/activity              Number of     responses per   Total annual     Average burden per response  (in hours)     Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   101.8(d); initial registration (Form               13               1              13  2.........................................              26
 FDA 3757).
Sec.   101.8(d); registration renewal (Form               19               1              19  0.5 (30 minutes)..........................             9.5
 FDA 3757).
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................            35.5  ..............  ..............  ..........................................  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    As reflected in table 1, we retain the currently approved reporting 
burden estimate for the information collection. At this time, we lack 
comprehensive data on the number of vending machine operators with 
fewer than 20 machines that might voluntarily register to comply with 
the regulations and, as indicated in our final rule of December 1, 2014 
(79 FR 71259) establishing the information collection, no vending 
machine operators have voluntarily registered with FDA. Therefore, 
while we expect relatively few submissions, we have provided a 
conservative estimate of the burden respondents may encounter.
    We estimate there are approximately 757 vending machine operators 
with fewer than 20 machines; this number is based on the mean estimate 
of the low and high counts of firms with less than $50,000 in annual 
revenue. We estimate that 5 percent of vending machine operators with 
fewer than 20 machines may voluntarily register to become subject to 
the final requirements, or 38 operators. We estimate a burden of 
approximately 2 hours per initial registration, which yields a total 
burden of 76 hours (38 total operators x 2 hours per response). 
Annualizing this number over 3 years yields a rounded 13 respondents 
per year (5 percent x 757 operators/3 years). With an annualized 
estimate of 13 vending machine operators and one registration per 
vending machine operator at 2 hours per registration, we estimate the 
initial hourly burden for these operators is 26 hours.
    We expect that renewal registrations after the first year will 
require substantially less time because operators are expected to be 
able to affirm or update the existing information in an online account 
in a way similar to other FDA firm registration systems. Therefore, we 
estimate that re-registration will take 0.5 hours for each registrant. 
This indicates that biennial registration would impose a burden of 19 
hours (38 operators x 0.5 hours) every 2 years, or 9.5 hours every year 
(19 operators every year x 0.5 hours).
Recordkeeping Requirements
    We have omitted providing a burden estimate associated with 
generating, providing, or maintaining records associated with calorie 
analysis and recording because the regulations do not require vending 
machine operators to maintain such records. However, we have considered 
the ``time, effort, or financial resources'' expended by covered 
vending machine operators to declare calories for covered vending 
machine food and have included the burden in table 2 as part of the 
third-party disclosure burden. We are particularly interested in 
hearing from respondents to the information collection regarding 
calorie declaration signage.
Third-Party Disclosure Requirements

                                               Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                                                 Number of      disclosures    Total annual
               21 CFR Part 101                  respondents         per         disclosures   Average burden  per disclosure  (in hours)    Total hours
                                                                respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   101.8(c)(2)(i); calorie analysis.....             282              11           3,102  1.........................................           3,102
Sec.   101.8(c)(2)(ii); calorie declaration            3,279           2,122       6,958,346  0.21 (12.5 minutes).......................       1,494,403
 signage.
Sec.   101.8(e)(1); vending operator contact           3,279             125         409,875  .025 (1.5 minutes)........................          10,248
 information.
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................       1,507,753
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with the information collection.

    As reflected in table 2, we have retained the currently approved 
third-party burden estimate for the information collection.
    Under the regulations, we calculate three types of third party 
disclosure burden. The first burden estimate reflects the time and 
effort we believe necessary for vending machine operators to determine 
the calorie content of covered vending machine food for the required 
calorie declarations as described in Sec.  101.8(c)(2)(i). We refer to 
this as a ``calorie analysis.'' A calorie analysis entails the burden 
of determining calorie content for covered vending machine food. Most 
foods sold from vending machines provide the nutrition labeling 
required by section 403(q) of the FD&C Act and 21 CFR 101.9, including 
calorie content information, which means that calorie content for many 
covered vending machine foods is

[[Page 58428]]

already available on the Nutrition Facts labels for such foods. In that 
case, vending machine operators will not need to determine the calorie 
content of such foods because they can simply declare the calorie 
information they find on the Nutrition Facts label. Nevertheless, some 
operators may need to determine calorie information for those vending 
machine foods that may not bear Nutrition Facts labels or otherwise 
provide visible nutrition information at the point of purchase in 
accordance with section 403(q)(5)(H)(viii)(I)(aa) of the FD&C Act and 
Sec.  101.8(b). An operator may obtain the necessary calorie 
information from nutrient databases, cookbooks, or laboratory analyses. 
Calorie analysis will most likely only be needed for vended food items 
such as refrigerated, frozen, can/bowl, or other shelf-stable main meal 
items, hot cup beverages, and cold cup beverages.
    We estimate the mean number of vending machine operators that need 
calorie analysis to be 847. Annualizing this estimate over 3 years 
yields 282 operators. We also estimate the range of products available 
in a typical machine for each of the three most commonly sold product 
categories that are likely to require a calorie analysis, or 3 percent 
of food items, 5 percent of hot beverages, and 1 percent of cold cup 
beverages. We estimate that food machines typically offer between 10 
and 25 different items, and both hot beverage and cold cup beverage 
machines typically offer between 5 and 10 items. From this, we estimate 
each vending machine operator will require a calorie analysis for 11 
items, on average. These estimates are based upon conversations with 
vending machine operators and our survey of various vending machine 
models that vend these types of food and beverage, as discussed in our 
final rule. Based on available data, we estimate the time needed to 
determine the calorie content of each covered vending machine food to 
be approximately 1 hour. Our estimate for the burden hours required for 
new calorie analysis is then 9,317 hours (847 operators x 11 products 
needing analysis x 1 hour per analysis). Annualizing this value over 3 
years yields 3,102 hours (847 operators/3 years x 11 products needing 
analysis x 4 hours per analysis). (847 operators/3 years = 282 
operators per year.) This is reflected in table 2, row 1.
    The second burden estimate reflects burden associated with calorie 
declaration signage as described in Sec.  101.8(c)(2)(ii). Covered 
vending machine operators with 20 or more vending machines and vending 
machine operators that voluntarily register to become subject to the 
Federal requirements must disclose calorie information by providing 
calorie declaration signs in, on, or adjacent to their vending machines 
to a third party who will most often be the prospective purchaser or 
consumer.
    We estimate there is an average of 9,838 (9,800 covered non-bulk + 
38 voluntary) vending machine operators subject to the regulations 
(9,838/3 = 3,279 annualized). Our estimate for the average number of 
non-bulk vending machines that will require declaration signage is 
based upon data relied upon in our final rule (see references 1, 6 to 8 
under Docket No. FDA-2011-F-0171). We estimate there is an average of 
5.61 million non-bulk vending machines. Digital signage is an emerging 
technology, and according to available sources, approximately 0.1 
percent of all vending machines in operation currently have electronic 
video displays capable of providing calorie information, or 
approximately 4,014 to 5,670 vending machines. Subtracting the number 
of vending machines with the electronic video from the total machine 
count yields an average of 5.61 million vending machines that will need 
signage. We expect the number of vending machines that will require 
signage to decline over time as manufacturers continue to add the 
required calorie information to the principal display panel of the 
package as part of ``front of package labeling,'' and because we 
anticipate greater use of electronic video displays on vending 
machines. In addition, to the extent that covered vending machines sell 
foods that permit prospective purchasers to examine the Nutrition Facts 
label before purchase or otherwise provide visible nutrition 
information at the point of purchase in accordance with section 
403(q)(5)(H)(viii)(I)(aa) of the FD&C Act and Sec.  101.8(b), this 
analysis may overestimate the burden estimate for calorie declaration 
signs.
    Vending machine operators can create one sign that contains all of 
the information for the products offered in the vending machine, and do 
not have to create individual signs for each item. The number of 
templates a given firm would need to design to produce signs that 
comply with the regulations may vary based upon the number of different 
types of products the firm purveys. In our estimate, we have considered 
the time it takes for template design, sign creation, sign 
installation, updates, replacement, and bulk machine signage. 
Cumulatively we estimate that those 3,279 (annualized) vending machine 
operators subject to the regulations will expend a total 1,494,403 
hours to fulfill the requirements under Sec.  101.8(c)(2)(ii) regarding 
signage for calorie declarations. This is reflected in table 2 row 2. 
We note that while we previously provided burden estimates for 
individual disclosure activities found under Sec.  101.8(c)(2)(ii) in 
our final rule of December 1, 2014 (79 FR 71259 at 71286), we have 
consolidated them here into one entry. Because this is the first 
extension request for this information collection and we have limited 
available data, we are specifically interested in respondents' 
experience with the third-party burden associated with the requirements 
under Sec.  101.8(c)(2)(ii).
    Finally, we have provided a burden estimate associated with Sec.  
101.8(e)(1) requiring a vending machine operator subject to section 
403(q)(5)(H)(viii) of the FD&C Act or a vending machine operator that 
voluntarily registers to provide contact information. We assume that 
venders that do not already have a sign or label with their contact 
information will add their contact information into the initial sign 
design. We estimate the time it takes to include contact information is 
1.5 minutes (0.025 hours) for each sign. We estimate the total initial 
burden for including contact information on the predesigned templates 
to be 30,744 hours (9,838 operators x 125 sign formats x 0.025 hours 
per sign). Annualized over 3 years, this burden becomes 10,248 hours 
(9,838 operators/3 years x 125 signs x 0.025 hours per sign). (Some 
States have licensing requirements for vending machine operators, and 
some of these licensing requirements already require the vending 
machine operator's license or contact information to be displayed on 
the vending machine.) If the contact information displayed on a vending 
machine due to State or local requirements includes some but not all of 
the contact information required under Sec.  101.8(e)(1), the vending 
machine operator is required to display the remaining contact 
information required under Sec.  101.8(e)(1) in a manner specified 
under Sec.  101.8(e)(1). We do not have an estimate of the number of 
machines already in compliance; to the extent that some operators are 
already in compliance, we overestimate the associated burden for third-
party disclosure.) This is reflected in table 2, row 3.

    Dated: December 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26672 Filed 12-11-17; 8:45 am]
 BILLING CODE 4164-01-P
Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices 58425

Section 316.24(a) specifies a reports on studies, a description of the disease or condition and satisfies the
requirement that sponsors respond to investigational plan, and a discussion of requirements for obtaining orphan drug
deficiency letters from FDA on changes that may affect orphan status. status. Secondly, the information will
designation requests within 1 year of Based on number of orphan-drug describe the medical and regulatory
issuance of the deficiency letter, unless designations, the number of respondents history of the drug. The respondents to
within that time frame, the sponsor is estimated as 744 requiring 2,232 this collection of information are
requests an extension of time to hours of human resources annually. biotechnology firms, drug companies,
respond. Based on past experience, FDA Finally, § 316.36 describes information and academic clinical researchers.
estimates 20 respondents requiring 40 required of sponsor when there is
In the Federal Register of June 19,
hours of human resources annually. insufficient quantity of approved
Section 316.27 specifies content of a 2017 (82 FR 27836), FDA published a
orphan drug. Based on past experience,
change in ownership of orphan-drug FDA estimates two respondents 60-day notice requesting public
designation. Based on past experience, requiring 90 hours of human resources comment on the proposed collection of
FDA estimates 63 respondents requiring annually. information. No comments were
315 hours of human resources annually. The information requested will received.
Section 316.30 requires submission of provide the basis for an FDA FDA estimates the burden of this
annual reports, including progress determination that the drug is for a rare collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Annual
Number of Total annual Hours per Total
21 CFR section/Form FDA frequency
respondents responses response hours
per response

Content and format when seeking written recommenda-
tions; results of studies; and amendments (§§ 316.10,
316.12, and 316.14) ......................................................... 1 1 1 50 50
Content and format of a request for designation; request
for verification of status; amendment to designation ....... 496 1.25 620 135 83,700
Form FDA 3671 or 4035 FDA Orphan Drug Designation
Request Form (§§ 316.20, 316.21, and 316.26) .............. 1.25 620 32 19,840
Notifications of changes in agents (§ 316.22) ..................... 70 1 70 2 140
Deficiency letters and granting orphan-drug designation
(§ 316.24(a)) ..................................................................... 20 1 20 2 40
Submissions to change ownership of orphan-drug des-
ignation (§ 316.27) ............................................................ 63 1 63 5 315
Annual reports (§ 316.30) .................................................... 744 1 744 3 2,232
Assurance of the availability of sufficient quantities of the
orphan drug; holder’s consent for the approval of other
marketing applications for the same drug (§ 316.36) ...... 2 3 6 15 90

Total .............................................................................. ........................ ........................ ........................ ........................ 106,407
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA has experienced increases in: (1) DEPARTMENT OF HEALTH AND including each proposed extension of an
The number of submissions to change HUMAN SERVICES existing collection of information, and
ownership of orphan-drug designation to allow 60 days for public comment in
(§ 316.27), (2) the number of annual Food and Drug Administration response to the notice. This notice
reports (§ 316.30), and (3) assurances of solicits comments on information
[Docket No. FDA–2017–N–6397]
the availability of sufficient quantities of collection provisions for calorie labeling
the orphan drug and the holder’s Agency Information Collection of articles of food in vending machines.
consent for the approval of other Activities; Proposed Collection; DATES: Submit either electronic or
marketing applications for the same Comment Request; Food Labeling; written comments on the collection of
drug (§ 316.36). Calorie Labeling of Articles of Food in information by February 12, 2018.
Dated: December 6, 2017. Vending Machines
ADDRESSES: You may submit comments
Leslie Kux, AGENCY: Food and Drug Administration, as follows. Please note that late,
Associate Commissioner for Policy. HHS. untimely filed comments will not be
[FR Doc. 2017–26669 Filed 12–11–17; 8:45 am] ACTION: Notice. considered. Electronic comments must
be submitted on or before February 12,
BILLING CODE 4164–01–P
SUMMARY: The Food and Drug 2018. The https://www.regulations.gov
Administration (FDA or Agency) is electronic filing system will accept
announcing an opportunity for public comments until midnight Eastern Time
ethrower on DSK3G9T082PROD with NOTICES

comment on the proposed collection of at the end of February 12, 2018.
certain information by the Agency. Comments received by mail/hand
Under the Paperwork Reduction Act of delivery/courier (for written/paper
1995 (PRA), Federal Agencies are submissions) will be considered timely
required to publish notice in the if they are postmarked or the delivery
Federal Register concerning each service acceptance receipt is on or
proposed collection of information, before that date.

VerDate Sep<11>2014 20:03 Dec 11, 2017 Jkt 244001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\12DEN1.SGM 12DEN1
Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices 58427

FDA. Registration will automatically calorie declarations for articles of food point of purchase as provided in
expire if not renewed. sold from a vending machine that § 101.8(b)(2).
It should be noted that an article of permits the prospective purchaser to FDA estimates the burden of the
food sold from a vending machine examine the Nutrition Facts label before collection of information as follows:
whose operator has voluntarily purchasing the article as provided in
registered with FDA under the § 101.8(b)(1), or otherwise provides Reporting Burden
regulations is not required to provide visible nutrition information at the

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average burden
Number of Total annual
21 CFR part 101.8/activity responses per per response Total hours
respondents responses
respondent (in hours)

§ 101.8(d); initial registration (Form FDA 3757) ...... 13 1 13 2 ................................ 26
§ 101.8(d); registration renewal (Form FDA 3757) .. 19 1 19 0.5 (30 minutes) ........ 9.5

Total .................................................................. 35.5 ........................ ........................ .................................... ........................
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

As reflected in table 1, we retain the subject to the final requirements, or 38 registration would impose a burden of
currently approved reporting burden operators. We estimate a burden of 19 hours (38 operators × 0.5 hours)
estimate for the information collection. approximately 2 hours per initial every 2 years, or 9.5 hours every year
At this time, we lack comprehensive registration, which yields a total burden (19 operators every year × 0.5 hours).
data on the number of vending machine of 76 hours (38 total operators × 2 hours
Recordkeeping Requirements
operators with fewer than 20 machines per response). Annualizing this number
that might voluntarily register to comply over 3 years yields a rounded 13 We have omitted providing a burden
with the regulations and, as indicated in respondents per year (5 percent × 757 estimate associated with generating,
our final rule of December 1, 2014 (79 operators/3 years). With an annualized providing, or maintaining records
FR 71259) establishing the information estimate of 13 vending machine associated with calorie analysis and
collection, no vending machine operators and one registration per recording because the regulations do not
operators have voluntarily registered vending machine operator at 2 hours per require vending machine operators to
with FDA. Therefore, while we expect registration, we estimate the initial maintain such records. However, we
relatively few submissions, we have hourly burden for these operators is 26 have considered the ‘‘time, effort, or
provided a conservative estimate of the hours. financial resources’’ expended by
burden respondents may encounter. covered vending machine operators to
We expect that renewal registrations
declare calories for covered vending
We estimate there are approximately after the first year will require
machine food and have included the
757 vending machine operators with substantially less time because operators
burden in table 2 as part of the third-
fewer than 20 machines; this number is are expected to be able to affirm or
party disclosure burden. We are
based on the mean estimate of the low update the existing information in an
particularly interested in hearing from
and high counts of firms with less than online account in a way similar to other
respondents to the information
$50,000 in annual revenue. We estimate FDA firm registration systems.
collection regarding calorie declaration
that 5 percent of vending machine Therefore, we estimate that re-
signage.
operators with fewer than 20 machines registration will take 0.5 hours for each
may voluntarily register to become registrant. This indicates that biennial Third-Party Disclosure Requirements

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average burden
Number of disclosures Total annual
21 CFR Part 101 per disclosure Total hours
respondents per disclosures (in hours)
respondent

§ 101.8(c)(2)(i); calorie analysis ............................... 282 11 3,102 1 ................................ 3,102
§ 101.8(c)(2)(ii); calorie declaration signage ............ 3,279 2,122 6,958,346 0.21 (12.5 minutes) ... 1,494,403
§ 101.8(e)(1); vending operator contact information 3,279 125 409,875 .025 (1.5 minutes) ..... 10,248

Total .................................................................. ........................ ........................ ........................ .................................... 1,507,753
1 There are no capital costs or operating and maintenance costs associated with the information collection.

As reflected in table 2, we have necessary for vending machine calorie content for covered vending
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retained the currently approved third- operators to determine the calorie machine food. Most foods sold from
party burden estimate for the content of covered vending machine vending machines provide the nutrition
information collection. food for the required calorie labeling required by section 403(q) of
Under the regulations, we calculate declarations as described in the FD&C Act and 21 CFR 101.9,
three types of third party disclosure § 101.8(c)(2)(i). We refer to this as a including calorie content information,
burden. The first burden estimate ‘‘calorie analysis.’’ A calorie analysis which means that calorie content for
reflects the time and effort we believe entails the burden of determining many covered vending machine foods is

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58428 Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices

already available on the Nutrition Facts operators that voluntarily register to expend a total 1,494,403 hours to fulfill
labels for such foods. In that case, become subject to the Federal the requirements under § 101.8(c)(2)(ii)
vending machine operators will not requirements must disclose calorie regarding signage for calorie
need to determine the calorie content of information by providing calorie declarations. This is reflected in table 2
such foods because they can simply declaration signs in, on, or adjacent to row 2. We note that while we previously
declare the calorie information they find their vending machines to a third party provided burden estimates for
on the Nutrition Facts label. who will most often be the prospective individual disclosure activities found
Nevertheless, some operators may need purchaser or consumer. under § 101.8(c)(2)(ii) in our final rule of
to determine calorie information for We estimate there is an average of December 1, 2014 (79 FR 71259 at
those vending machine foods that may 9,838 (9,800 covered non-bulk + 38 71286), we have consolidated them here
not bear Nutrition Facts labels or voluntary) vending machine operators into one entry. Because this is the first
otherwise provide visible nutrition subject to the regulations (9,838/3 = extension request for this information
information at the point of purchase in 3,279 annualized). Our estimate for the collection and we have limited available
accordance with section average number of non-bulk vending
data, we are specifically interested in
403(q)(5)(H)(viii)(I)(aa) of the FD&C Act machines that will require declaration
respondents’ experience with the third-
and § 101.8(b). An operator may obtain signage is based upon data relied upon
party burden associated with the
the necessary calorie information from in our final rule (see references 1, 6 to
8 under Docket No. FDA–2011–F–0171). requirements under § 101.8(c)(2)(ii).
nutrient databases, cookbooks, or
laboratory analyses. Calorie analysis We estimate there is an average of 5.61 Finally, we have provided a burden
will most likely only be needed for million non-bulk vending machines. estimate associated with § 101.8(e)(1)
vended food items such as refrigerated, Digital signage is an emerging requiring a vending machine operator
frozen, can/bowl, or other shelf-stable technology, and according to available subject to section 403(q)(5)(H)(viii) of
main meal items, hot cup beverages, and sources, approximately 0.1 percent of all the FD&C Act or a vending machine
cold cup beverages. vending machines in operation operator that voluntarily registers to
We estimate the mean number of currently have electronic video displays provide contact information. We assume
vending machine operators that need capable of providing calorie that venders that do not already have a
calorie analysis to be 847. Annualizing information, or approximately 4,014 to sign or label with their contact
this estimate over 3 years yields 282 5,670 vending machines. Subtracting information will add their contact
operators. We also estimate the range of the number of vending machines with information into the initial sign design.
products available in a typical machine the electronic video from the total We estimate the time it takes to include
for each of the three most commonly machine count yields an average of 5.61 contact information is 1.5 minutes
sold product categories that are likely to million vending machines that will (0.025 hours) for each sign. We estimate
require a calorie analysis, or 3 percent need signage. We expect the number of the total initial burden for including
of food items, 5 percent of hot vending machines that will require contact information on the predesigned
beverages, and 1 percent of cold cup signage to decline over time as templates to be 30,744 hours (9,838
beverages. We estimate that food manufacturers continue to add the operators × 125 sign formats × 0.025
machines typically offer between 10 and required calorie information to the hours per sign). Annualized over 3
25 different items, and both hot principal display panel of the package years, this burden becomes 10,248 hours
beverage and cold cup beverage as part of ‘‘front of package labeling,’’ (9,838 operators/3 years × 125 signs ×
machines typically offer between 5 and and because we anticipate greater use of 0.025 hours per sign). (Some States have
10 items. From this, we estimate each electronic video displays on vending licensing requirements for vending
vending machine operator will require a machines. In addition, to the extent that machine operators, and some of these
calorie analysis for 11 items, on average. covered vending machines sell foods
licensing requirements already require
These estimates are based upon that permit prospective purchasers to
the vending machine operator’s license
conversations with vending machine examine the Nutrition Facts label before
or contact information to be displayed
operators and our survey of various purchase or otherwise provide visible
on the vending machine.) If the contact
vending machine models that vend nutrition information at the point of
these types of food and beverage, as purchase in accordance with section information displayed on a vending
discussed in our final rule. Based on 403(q)(5)(H)(viii)(I)(aa) of the FD&C Act machine due to State or local
available data, we estimate the time and § 101.8(b), this analysis may requirements includes some but not all
needed to determine the calorie content overestimate the burden estimate for of the contact information required
of each covered vending machine food calorie declaration signs. under § 101.8(e)(1), the vending
to be approximately 1 hour. Our Vending machine operators can create machine operator is required to display
estimate for the burden hours required one sign that contains all of the the remaining contact information
for new calorie analysis is then 9,317 information for the products offered in required under § 101.8(e)(1) in a manner
hours (847 operators × 11 products the vending machine, and do not have specified under § 101.8(e)(1). We do not
needing analysis × 1 hour per analysis). to create individual signs for each item. have an estimate of the number of
Annualizing this value over 3 years The number of templates a given firm machines already in compliance; to the
yields 3,102 hours (847 operators/3 would need to design to produce signs extent that some operators are already in
years × 11 products needing analysis × that comply with the regulations may compliance, we overestimate the
4 hours per analysis). (847 operators/3 vary based upon the number of different associated burden for third-party
years = 282 operators per year.) This is types of products the firm purveys. In disclosure.) This is reflected in table 2,
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reflected in table 2, row 1. our estimate, we have considered the row 3.
The second burden estimate reflects time it takes for template design, sign Dated: December 5, 2017.
burden associated with calorie creation, sign installation, updates,
Leslie Kux,
declaration signage as described in replacement, and bulk machine signage.
§ 101.8(c)(2)(ii). Covered vending Cumulatively we estimate that those Associate Commissioner for Policy.
machine operators with 20 or more 3,279 (annualized) vending machine [FR Doc. 2017–26672 Filed 12–11–17; 8:45 am]
vending machines and vending machine operators subject to the regulations will BILLING CODE 4164–01–P

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Document Created: 2018-10-25 10:47:21
Document Modified: 2018-10-25 10:47:21
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		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by February 12, 2018.
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]
FR Citation		82 FR 58425
82 FR 58425 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Calorie Labeling of Articles of Food in Vending Machines

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 237 (December 12, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
