Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Calorie Labeling of Articles of Food in Vending Machines, 58425-58428 [2017-26672]
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Section 316.24(a) specifies a
requirement that sponsors respond to
deficiency letters from FDA on
designation requests within 1 year of
issuance of the deficiency letter, unless
within that time frame, the sponsor
requests an extension of time to
respond. Based on past experience, FDA
estimates 20 respondents requiring 40
hours of human resources annually.
Section 316.27 specifies content of a
change in ownership of orphan-drug
designation. Based on past experience,
FDA estimates 63 respondents requiring
315 hours of human resources annually.
Section 316.30 requires submission of
annual reports, including progress
reports on studies, a description of the
investigational plan, and a discussion of
changes that may affect orphan status.
Based on number of orphan-drug
designations, the number of respondents
is estimated as 744 requiring 2,232
hours of human resources annually.
Finally, § 316.36 describes information
required of sponsor when there is
insufficient quantity of approved
orphan drug. Based on past experience,
FDA estimates two respondents
requiring 90 hours of human resources
annually.
The information requested will
provide the basis for an FDA
determination that the drug is for a rare
disease or condition and satisfies the
requirements for obtaining orphan drug
status. Secondly, the information will
describe the medical and regulatory
history of the drug. The respondents to
this collection of information are
biotechnology firms, drug companies,
and academic clinical researchers.
In the Federal Register of June 19,
2017 (82 FR 27836), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Content and format when seeking written recommendations; results of studies; and amendments (§§ 316.10,
316.12, and 316.14) .........................................................
Content and format of a request for designation; request
for verification of status; amendment to designation .......
Form FDA 3671 or 4035 FDA Orphan Drug Designation
Request Form (§§ 316.20, 316.21, and 316.26) ..............
Notifications of changes in agents (§ 316.22) .....................
Deficiency letters and granting orphan-drug designation
(§ 316.24(a)) .....................................................................
Submissions to change ownership of orphan-drug designation (§ 316.27) ............................................................
Annual reports (§ 316.30) ....................................................
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) ......
Hours per
response
Total
hours
1
1
50
50
496
1.25
620
135
83,700
1.25
70
620
1
32
70
19,840
2
140
20
1
20
2
40
63
744
1
1
63
744
5
3
315
2,232
2
3
6
15
90
........................
........................
........................
........................
106,407
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA has experienced increases in: (1)
The number of submissions to change
ownership of orphan-drug designation
(§ 316.27), (2) the number of annual
reports (§ 316.30), and (3) assurances of
the availability of sufficient quantities of
the orphan drug and the holder’s
consent for the approval of other
marketing applications for the same
drug (§ 316.36).
Dated: December 6, 2017.
Leslie Kux,
Associate Commissioner for Policy.
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.
Notice.
[FR Doc. 2017–26669 Filed 12–11–17; 8:45 am]
ACTION:
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Total annual
responses
1
Total ..............................................................................
1 There
Annual
frequency
per response
Number of
respondents
21 CFR section/Form FDA
SUMMARY:
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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,
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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.
Submit either electronic or
written comments on the collection of
information by February 12, 2018.
DATES:
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.
ADDRESSES:
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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’’).
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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
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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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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, PRAStaff@
fda.hhs.gov.
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,
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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 § 101.8 (21 CFR
101.8) and Form FDA 3757. Under
§ 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
§ 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
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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
§ 101.8(b)(1), or otherwise provides
visible nutrition information at the
point of purchase as provided in
§ 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
respondents
21 CFR part 101.8/activity
Number of
responses per
respondent
Average burden
per response
(in hours)
Total annual
responses
Total hours
§ 101.8(d); initial registration (Form FDA 3757) ......
§ 101.8(d); registration renewal (Form FDA 3757) ..
13
19
1
1
13
19
2 ................................
0.5 (30 minutes) ........
26
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
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 × 2 hours
per response). Annualizing this number
over 3 years yields a rounded 13
respondents per year (5 percent × 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 reregistration will take 0.5 hours for each
registrant. This indicates that biennial
registration would impose a burden of
19 hours (38 operators × 0.5 hours)
every 2 years, or 9.5 hours every year
(19 operators every year × 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 thirdparty 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
disclosures
per
respondent
Number of
respondents
21 CFR Part 101
Average burden
per disclosure
(in hours)
Total annual
disclosures
Total hours
§ 101.8(c)(2)(i); calorie analysis ...............................
§ 101.8(c)(2)(ii); calorie declaration signage ............
§ 101.8(e)(1); vending operator contact information
282
3,279
3,279
11
2,122
125
3,102
6,958,346
409,875
1 ................................
0.21 (12.5 minutes) ...
.025 (1.5 minutes) .....
3,102
1,494,403
10,248
Total ..................................................................
........................
........................
........................
....................................
1,507,753
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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 thirdparty 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
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necessary for vending machine
operators to determine the calorie
content of covered vending machine
food for the required calorie
declarations as described in
§ 101.8(c)(2)(i). We refer to this as a
‘‘calorie analysis.’’ A calorie analysis
entails the burden of determining
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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
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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 § 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 × 11 products
needing analysis × 1 hour per analysis).
Annualizing this value over 3 years
yields 3,102 hours (847 operators/3
years × 11 products needing analysis ×
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
§ 101.8(c)(2)(ii). Covered vending
machine operators with 20 or more
vending machines and vending machine
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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 § 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
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expend a total 1,494,403 hours to fulfill
the requirements under § 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 § 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 thirdparty burden associated with the
requirements under § 101.8(c)(2)(ii).
Finally, we have provided a burden
estimate associated with § 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 × 125 sign formats × 0.025
hours per sign). Annualized over 3
years, this burden becomes 10,248 hours
(9,838 operators/3 years × 125 signs ×
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 § 101.8(e)(1), the vending
machine operator is required to display
the remaining contact information
required under § 101.8(e)(1) in a manner
specified under § 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
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]]>Agencies
[Federal Register Volume 82, Number 237 (Tuesday, December 12, 2017)]
[Notices]
[Pages 58425-58428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26672]
-----------------------------------------------------------------------
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.gpo.gov/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
