SS for Vending Machine Labeling Final Rule

Final Rule on Food Labeling; Calorie Labeling of
Articles of Food in Vending Machines
OMB Control No. 0910-NEW
SUPPORTING STATEMENT
A. Justification
1. Circumstances Making the Collection of Information Necessary
On March 23, 2010, the President signed into law the Patient Protection and Affordable Care
Act (”Affordable Care Act”) (P.L. 111-148). Section 4205 of the ACA amended sections
403(q) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as well as 403A, which
governs Federal preemption of State and local food labeling requirements.
Section 4205 of the ACA added section 403(q)(5)(H)(viii) of the FD&C Act to require that if
an article of food is sold from a vending machine that (1) “does not permit a prospective
purchaser to examine the Nutrition Facts Panel before purchasing the article or does not
otherwise provide visible nutrition information at the point of purchase;” and (2) “is operated
by a person who is engaged in the business of owning or operating 20 or more vending
machines,” then the vending machine operator must “provide a sign in close proximity to each
article of food or the selection button that includes a clear and conspicuous statement disclosing
the number of calories contained in the article.”
Under section 403(q)(5)(H)(ix) of the FD&C Act, vending machine operators who are not
subject to the new requirements of section 403(q)(5)(H)(viii) of the FD&C Act can register
voluntarily with FDA to become subject to the Federal requirements. In the Federal Register of
July 23, 2010 (75 FR 43182), we published a notice specifying the terms and conditions for
implementation of voluntary registration, pending issuance of regulations. Subsequently we
published a proposed rule on April 6, 2011 (76 FR 19237[8]) and a final rule on December 1,
2014 (79 FR 71259), to become effective December 1, 2016. FDA is requesting OMB
approval of the information collection provisions in its final rule.
2. Purpose and Use of the Information Collection
To help make calorie information for vending machine foods available to prospective
purchasers in a direct, accessible, and consistent manner to enable them to make informed and
healthful dietary choices, section 4205 of the ACA and the rule require that vending machine
operators who own or operate 20 or more vending machines, or who voluntarily elect to be
covered, must provide calorie declarations for those vending machine foods for which the
Nutrition Facts label cannot be examined prior to purchase or for which visible nutrition
information is not otherwise provided at the point of purchase. The agency is implementing
these regulations so that consumers might benefit from access to this dietary information.

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FDA’s July 23, 2010 notice requires that retail food establishments and vending machine
operators register with FDA using the agency’s Form FDA 3757 available at
http://www.fda.gov/menulabeling. FDA prefers that the information be submitted by e-mail
by typing complete information into the form (PDF), saving it on the registrant’s computer, and
sending it by e-mail to http:// menulawregistration@fda.hhs.gov . If email is not available, the
registrant can either fill in the form (PDF) and print it out (or print out the blank PDF and fill in
the information by hand or typewriter), and send it to FDA either by faxing the completed form
to 301–436–2804 or mailing it to the Center for Food Safety and Applied Nutrition,
Compliance Information Branch (HFS–681), 5600 Fishers Lane, Rockville, MD 20857.
Information FDA requires on the registration form for vending machine operators includes:
 The name, address, phone number, e-mail address, and contact information for the
vending machine operator;
 The address of each vending machine owned or operated by the vending machine
operator, and the name and contact information, including e-mail address, of the location in
which each vending machine is located;
 Preferred mailing address (if different from location address), for purposes of receiving
correspondence; and
 Certification that the information submitted is true and accurate, that the person or firm
submitting it is authorized to do so, and that each registered restaurant or similar retail food
establishment will be subject to the requirements of section 4205.
In addition to the initial registration, the authorized official must register every other year with
FDA, and the registration will automatically expire if not renewed.
Description of Respondents: Respondents to this collection of information are vending
machine operators that voluntarily elect to be subject to the Federal requirements of this rule by
registering with FDA.
3. Use of Improved Information Technology and Burden Reduction
FDA has implemented an interim registration process consisting of a downloadable form that
will indicate the required information and where to fax, send or email the completed document.
FDA estimates that all of the respondents (100%) will electronic means for reporting under this
interim process. FDA will also implement an online registration process that will allow firms
to manage their registration information, and will minimize the burden by allowing firms to reregister by either changing only the details that have changed, or by certifying that no
information has changed. FDA estimates that all of the respondents (100%) will use electronic
means for reporting once the system is in place.

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4. Efforts to Identify Duplication and Use of Similar Information
There are no existing data sources that indicate a small firm’s choice as to whether it wishes to
be covered under existing local and state menu or vending labeling rules, or under Section 4205
of the act.
5. Impact on Small Businesses or Other Small Entities
FDA estimates that no small businesses (0%) will be affected by the reporting. To the extent
that a small business may be impacted, the registration process is specifically designed to
minimize its regulatory burden by giving it a choice as to which rules it wishes to follow. The
registration process is voluntary, and is the minimum burden that the FDA can impose in order
to give firms this choice and to give regulatory authorities the information they need to enforce
the appropriate statutes. If a small business chooses to register, FDA can aid small businesses
in complying with nutrition labeling requirements through its Regional Small Business
Representatives and through the administrative and scientific staffs within the agency. FDA
has provided a Small Business Guide on the agency’s website at
http://www.fda.gov/oc/industry/.
6. Consequences of Collecting the Information Less Frequently
The act mandates a twice yearly registration. FDA has no authority to collect the information
less frequently.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances associated with this collection of information
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In the Federal Register of April 6, 2011, (76 FR 19237[8]) FDA published a proposed rule that
included a section entitled “Paperwork Reduction Act” in the preamble (76 FR 19238 at
19249–19251). We received a number of comments that are discussed in the final rule (79 FR
71259, at 71284) and have included that discussion here:
(Comment) One comment stated that we did not calculate the burdens to the suppliers of
vending machine food. The comment stated that these suppliers will bear the larger burden
from the requirements of the final rule.
(Response) Neither section 403(q)(5)(H)(viii) of the FD&C Act nor the final rule applies to
suppliers of vending machine food; instead, section 403(q)(5)(H)(viii) of the FD&C Act and
the final rule establish requirements for certain vending machine operators. We recognize that
a supplier of covered vending machine food may provide calorie information on front-ofpackage labeling and such calorie information may constitute visible nutrition information in
accordance with section 403(q)(5)(H)(viii)(I)(aa) of the FD&C Act provided that the applicable
requirements of § 101.8(b) are satisfied. However, neither section 403(q)(5)(H)(viii) of the
FD&C Act nor the final rule requires suppliers to provide such information. As such, the final
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rule does not impose burdens on suppliers of vending machine food.
(Comment) One comment stated that posting calories would not be burdensome, as most foods
sold in vending machines already provide calorie information on their Nutrition Facts labels,
and for foods that do not already have calorie information, labeling to disclose calories can be
accomplished easily by using stickers. Another comment stated that, in light of the major
beverage companies’ prior commitment to putting calorie information on selection buttons, we
should reduce our burden estimate.
(Response) To the extent that foods sold from covered vending machines permit a prospective
purchaser to examine the Nutrition Facts label before purchasing the food or otherwise provide
visible nutrition information at the point of purchase in accordance with section
403(q)(5)(H)(viii) of the FD&C Act and § 101.8(b), the vending machine operator would not
be required to provide calorie declarations for such foods. In addition, we recognize that the
“Clear on Calories” commitment by the American Beverage Association, which includes a
pledge that calories will be displayed on selection buttons of “company-controlled vending
machines,” may be consistent with the calorie declaration requirements of section
403(q)(5)(H)(viii) of the FD&C Act. Our estimates of the burdens already account for the fact
that many vending machine foods will not require additional nutrition analysis under this final
rule. For example, we estimate in the RIA that only 723 to 963 covered vending machine
operators will need to acquire nutrition information for at least some of their vending machine
food.
Our estimate of the burdens and cost of nutrition analysis also takes into consideration that
vending machine operators can comply with the requirements of the final rule by providing
calorie declarations through less burdensome and less expensive means (e.g., a poster affixed to
the front of the machine could cost, on average, $20 per machine per year) (Ref. 1). The final
rule does not prescribe the types of materials through which calories must be declared, and a
sticker, for example, could be an appropriate medium to convey a required calorie declaration.
(Comment) One comment stated that our estimate on how frequently labeling would need to
change is too low. The comment stated that in almost all cases, machines are restocked and
serviced every 5 weeks, with busier locations stocked once or more per week. The comment
stated that the restocking will require labeling changes because restocking may result in the
substitution of certain products for other products or the addition of new products. The
comment stated that relabeling would need to occur between 10 and 17 times per year for each
machine, with some machines requiring partial relabeling at least 50 times per year.
(Response) In the preliminary RIA, we estimated an average recurring burden of between 5
and 15 minutes per vending machine per year to install or refresh the calorie displays. We said
that signs would not always need to be updated every time a machine’s product mix (i.e., the
assortment of vending machine foods offered for sale in a vending machine at a particular time)
changed. We recognize that the product mix in a particular vending machine may change with
each restocking. For each machine, the rule requires operators to declare the calorie
information for those articles of food that are sold from that particular vending machine.
However, we would not object to a vending machine operator providing calorie declarations for
articles of food that are typically offered for sale in a vending machine but may not be offered
for sale at all times (for example, in cases where the article sells out, or is temporarily replaced
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by another item), provided that the calorie declarations are clear and conspicuous and placed
prominently. Thus, signs would not always need to be updated every time a machine’s product
mix changed, so long as the sign declares the calories for each article of food sold from the
covered vending machine. For example, if a particular article of food is sold out, the vending
machine operator would not need to design and print a new sign to remove the calorie
declaration for such food. In addition, to the extent that foods sold from covered vending
machines permit a prospective purchaser to examine the Nutrition Facts label before purchasing
the food 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), the vending
machine operator would not be required to provide calorie declarations for such foods.
Therefore, restocking of covered vending machines that sell such foods would not require the
vending machine operator to update signs. Furthermore, in order to accommodate the
occasional trial or experimental product, the sign template could, for example, be designed with
blank space, on which the operator could handwrite the experimental product’s name and
caloric value, or place a declarative sticker next to the new product within the machine (should
it have a glass/plexiglass front). The comment provided an estimate of the number of times a
vending machine’s sign would likely need to be replaced, or 10 to 17 times. We estimate that
in accordance to the factors described in the earlier paragraphs of this response, calorie
declaration signs would only need to be replaced between 1 and 4 times per year (or even zero
for some products). This estimate also takes into consideration that vending machine operators
have the flexibility to choose a medium (e.g., stickers, posters) and a format (e.g., individual
signs per covered vending machine food; sign(s) in, on, or adjacent to the vending machine) for
the calorie declaration that will make the most sense for a particular vending machine operator
depending on the variability of products that the operator carries and the frequency of
restocking.

9. Explanation of Any Payment or Gift to Respondents
FDA does not provide any gifts or payments to respondents.

10. Assurance of Confidentiality Provided to Respondents
The information collected is limited to addresses and contact information for authorized
individuals at firms volunteering to be covered under section 4205. The purpose of the
information collection is to give regulatory authorities the information they need to enforce the
appropriate statutes. Therefore, some or all of this information cannot be confidential.

11. Justification for Sensitive Questions
This information does not contain questions pertaining to sexual behavior and attitudes,
religious beliefs, or any other matter commonly considered private or of a sensitive nature.

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12. Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate
Reporting Burden
Table 1.--Estimated Annual Reporting Burden: Voluntary Registration1
Average Burden
No. of
Total Annual
No. of
per Response (in
Total Hours
Responses per
21 CFR Part 101
Responses
Respondents
hours)
Respondent
Initial Burden (annualized over 3 years)
§ 101.8(d) Initial
13
1
13
2
26
Registration
Annual Burden
§ 101.8(d)
0.5
Registration
19
1
19
9.5
(30 minutes)
Renewal
Total Burden Hours
35.5
1
There are no capital costs or operating and maintenance costs associated with this collection of information.

At this time, FDA lacks data on the number of vending machine operators with fewer than 20
machines that might voluntarily register to comply with this final rule. We do not expect the
net benefit for voluntary registration by any non-covered vending machine operators to be
positive and in the RIA of the final rule (references may be found in the agency’s docket (FDA2011-F-0171)) we indicate that as of the conducting our analysis, no vending machine
operators had voluntarily registered with FDA. Therefore we did not estimate a significant
burden. However, in the event that a few will register anyway, or find some positive incentive
to do so, for the purposes of this PRA analysis, we estimate the burden such operators will face.
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 from the RIA. 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 re-registration will take 0.5 hours for each registrant. This would indicate that biennial
registration would impose a burden of 19 hours (38 operators × 0.5 hours) every 2 years, or 9.5
hours every year (18 operators every year × 0.5 hours).

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Recordkeeping Burden
The preamble to the proposed rule (76 FR 19238 at 19249-19251) provided an estimate of the
recordkeeping burden, which consisted of the burden associated with calorie analysis and the
burden associated with generating, providing, or maintaining records. Upon further
consideration, we have omitted the burden estimate associated with generating, providing, or
maintaining records previously provided in table 3 of the proposed rule because the rule does
not require vending machine operators to generate, provide, or maintain records. Further, as
discussed in the final rule, we have included a burden estimate for calorie analysis as part of the
third party disclosure burden, since the “total time, effort, or financial resources expended by
[covered vending machine operators]” (5 CFR 1320.3(b)) to declare calories for covered
vending machine food likely includes time, effort, or financial resources to determine the
calorie content of such food.
Third-Party Disclosure Burden

21 CFR Part 101
§ 101.8(c)(2)(i)
Calorie Analysis

Table 2.--Third Party Disclosure Burden
No. of
Average
Disclosures
Burden per
Total
No. of
per
Annual
Disclosure
Respondents
Respondent
Disclosures
(in hours)

Total
Hours

282

11

3,102

1

3,102

§ 101.8(c)(2)(ii)
Template Design

3,279

5

16,395

2

32,790

§ 101.8(c)(2)(ii)
Sign Creation

3,279

125

409,875

0.475
(28.5 min.)

194,710

§ 101.8(e)(1)
Contact Information

3,279

125

409,875

0.025
(1.5 min.)

10,248

1,868,419

1

1,868,419

0.083
(5 min.)

155,079

511,576

2

1,023,152

0.5
(30 min.)

511,576

1,755,986

2

3,511,972

0.17
(10 min.)

597,035

128,533

1

128,533

0.025
(1.5 min.)

3,213

§ 101.8(c)(2)(ii)
Sign Installation
§ 101.8(c)(2)(ii)
Sign Information
Update
§ 101.8(c)(2)(ii)
Sign Replacement
§ 101.8(c)(2)(ii)
Bulk Machine
Signage
Total Burden

1,507,753

Capital Costs

$4,671,047

$4,671,047

Third-Party Disclosure Requirements: 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 §101.9, including calorie content information, which
means that calorie content for many covered vending machine foods is 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
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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 anticipate that vending machine operators are likely to generate and
maintain a record of the information on which they relied to determine the total calories posted
for the vending machine food.
As stated in the RIA, 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 were based upon conversations with vending machine operators and our survey of
various vending machine models that vend these types of food and beverage. Based on data
from FDA’s Recordkeeping Cost Model, 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 that would be 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.) There will not be capital costs
associated with a calorie analysis.
Third-Party Disclosure Requirements: Calorie Declaration Signs
Under this rule, 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. Our burden estimate for the calorie declaration signs is based on the
total time it takes for vending machine operators to produce and install the calorie declaration
signs. We separately estimate the burden for two kinds of vending machines, non-bulk and
bulk machines. For non-bulk vending machines, we estimate the burden to operators as the
initial time it takes them to develop the calorie disclosure signage, which includes the time for
the sign template design (i.e. the creation of generalized sign templates), sign creation (i.e.
using templates to design machine-specific signs), and installation; and then the time for the
recurring burden, which includes the time to update or change calorie information and the
physical replacement of the disclosure signage when the product mix of the machine changes.
For bulk machines, we estimate the burden to operators for the cost of individual calorie labels.
(We assume that individual calorie declaration stickers will be placed on the face of each
individual bulk vending machine, since each machine only vends a single product.) Recurring
updates to signage will only likely be required for non-bulk, non-beverage machines since the
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product mixes of these machines are changed regularly, while the product mix for bulk
machines is unlikely to change.
We estimate there is an average of 9,838 (9,800 covered non-bulk + 38 voluntary) vending
machine operators subject to the rule. (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 obtained from the Vending Times Survey and National Automatic Merchandising
Association (NAMA) and the Economic Census, and as summarized in table 8 of the final RIA.
We estimate there is an average of 5.61 million non-bulk vending machines. Digital signage is
an emerging technology, and according to NAMA 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
5.611 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.
We estimate the time it takes for the one-time design of a calorie disclosure sign template to be
2 hours. The number of templates a given firm would need to design to produce signs that
comply with the rule may vary based upon the number of different types of products the firm
purveys. We estimate a range of one to ten templates would be necessary. We base this range
on the eight general food and beverage vending categories monitored by the Vending Times
Census, plus two additional templates to account for the existence of combination machines,
which vend more than one general product type (e.g. snacks and cold canned beverages)--see
table 4 of the final RIA (Refs. 1, 6 of the final rule). Since not all firms will sell items from
each of the general food categories, we estimate that on average, firms will sell items from
approximately four general food categories and operate one set of combination machines,
requiring the need to develop (on average) five templates. At 2 hours per template, the total
initial burden for designing templates comes to an estimated 98,380 hours (9,838 operators × 5
templates × 2 hours per template). Annualizing this value over 3 years yields a burden of
32,790 hours (9,838 operators / 3 years × 5 templates × 2 hours per template). There are no
capital costs associated with template design.
We estimate the time it takes to enter calorie information into a single sign template and
prepare it for printing to be 0.475 hours. Again, we estimate the number of machine
configurations to be 125. The count of machine configurations is a general estimate of the
number of different types of machines an operator uses to sell its products, and takes into
account that fact that a machine’s specific product mix will depend on locational characteristics
(e.g. office vs. hotel) and the type of machine (e.g. beverage vs. snack). We estimate the total
initial burden for sign creation using the predesigned templates to be 584,131 hours (9,838
operators × 125 sign formats × 0.475 hours per sign). Annualized over 3 years, this burden
becomes 194,710 hours (9,838 operators / 3 years × 125 signs × 0.475 hours per sign). Capital
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costs associated with sign creation correspond to the cost of paper and ink for printing the
signs. As estimated in the RIA (Ref. 1 of the final rule), the capital costs are $2.50 per sign,
which results in a total capital cost of $14,013,143 [(5,604,914 covered non-bulk machines +
343 voluntarily registered machines) × $2.50 per machine]. Annualized over 3 years, this value
becomes $4,671,048 (5,605,257 machines / 3 years × $2.50 per machine).
Vending machine operators must also provide their contact information on each vending
machine selling covered vending machine food as required under §101.8(e)(1). 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).
There are no capital costs associated with adding contact information. (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 burden of third-party
disclosure.)
We estimate the time it takes to install a sign onto a single machine to be 5 minutes (0.083
hours) for each sign. With 5,605,257 machines (5,604,914 covered machines + 343 voluntarily
registered machines), we estimate the annual burden for initial sign installation to be 465,236
hours (5,605,257 machines × 1 sign per machine × 0.083 hours installation). Annualized over
3 years, this burden becomes 155,079 hours (5,605,257 machines / 3 years × 1 sign per
machine × 0.083 hours installation). (5,605,257 machines / 3 years = 1,868,419 machines per
year.) There are no capital costs associated with sign installation.
We divide the estimates for the recurring burden of non-bulk third-party disclosure into two
parts: updating calorie sign information for changes in the product mix (which involves
updating the digital format); and physical sign replacement (which involves printing and
installation). We estimate the average number of product configurations for machines that will
experience regular changes to their product mix to be 52. This value is lower than the overall
average of 125 since some machines (such as beverage machines) do not experience regular
changes to the product mix. We estimate the average number of times that calorie signs will
need to be updated to be twice per year. Finally, we estimate the time it takes to update a single
sign using the predesigned template to be 0.5 hours. Thus, the total burden for updating sign
information is 511,576 hours [511,576 records (made up of 9,838 operators × 52 product
configurations) × 2 updates per year × 0.5 hours per update].
We estimate the annual number of covered machines that will need regular sign replacement to
be 1,755,986 machines (1,755,879 covered machines + 107 voluntarily registered machines).
We estimate the time it takes to remove and replace old signs with new signs to be 0.17 hours
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(10 minutes). Thus, the total annual burden for replacing signs is 597,035 hours (1,755,986
machines × 2 replacements per year × 0.17 hours per replacement). There are no capital costs
associated with updating sign information or physical sign replacement.
We estimate there is an average of 385,600 covered bulk vending machines, based on data
obtained from the Vending Times Census and NAMA (Refs. 6, 8 of the final rule). We assume
each bulk machine vends a single bulk product, and we further assume they will choose the
most economical signage, which means they are likely to use a small sticker on the face of each
machine. We estimate the time to print and apply each sticker is 1.5 minutes (0.025 hours).
Thus, the total burden for bulk machine signage is 9,640 hours (385,600 bulk machines × 0.025
hours per machine). Annualized over 3 years, this value becomes 3,213 hours (385,600 /3
years × 0.025 hours per machine). (385,600 /3 years = 128,533 machines per year.)
12b. Annualized Cost Burden Estimate
FDA estimates an initial cost burden of $208 with a recurring cost burden of $228. The
analogous initial cost burden displayed in the third row of Table 2, $436, is a result of dividing
by three the burdens that occur only in the first year, to avoid double counting in the ROCIS
system. Hourly burdens are taken from the last column of Table 1. We use average hourly wage
of a non-supervisory employee of a vending machine operation as $16 per hour. Including a 50
percent increase for overhead costs and employee benefits, the average hourly cost of an
employee in this sector is approximately $24 per hour. (Ref. 9 of the final rule).
Table 2. – Estimated Costs of Hourly Burden1
21 CFR Part 101

Total Hours

Hourly Wage Rate

Total Respondent
Costs

26

$8.00

$208

Initial Burden (annualized over 3 years)
§ 101.8(d) Initial Registration
Annual Burden
§ 101.8(d) Registration Renewal

9.5
$24.00
$228
Total Burden Hours
35.5
$436
1
Actual first year burden costs have been divided by 3 to avoid double counting in the ROCIS system.

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
Estimated capital, start-up, operating or maintenance costs associated with this collection of
information total $4,671,047 as identified in Row 3 of Table 2 (Third Party Disclosure Burden)
above. These costs are associated with sign creation, where we approximate a cost of $2.50 per
sign, totalling $14,013,143 [(5,604,914 covered non-bulk machines + 343 voluntarily registered
machines) × $2.50 per machine]. Annualized over 3 years, this equals $4,671,048 (5,605,257
machines/3 years × $2.50 per machine).
14. Annualized Cost to the Federal Government
FDA estimates the initial cost of setting up the registration system to be approximately
$200,000, with recurring maintenance cost of $60,000 per year.
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15. Explanation for Program Changes or Adjustments
Because of substantial revisions since issuance of the underlying proposed rule (76 FR
19237[8]) for this collection, FDA discontinued its approval authority for the original
provisions found under OMB Control No. 0910-0664 upon its expiration in 2014. We are now,
therefore, submitting the request as a new information collection.
16. Plans for Tabulation and Publication and Project Time Schedule
There are no plans for tabulation or publication.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
There are no reasons why display of the expiration date for OMB approval of the information
collection would be inappropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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