0782 SSA 2018 Revision incorporating 0783

U.S. Food and Drug Administration
Food Labeling; Calorie Labeling of Articles of Food in Vending Machines
and Nutrition Labeling of Standard Menu Items in Restaurants
and Similar Retail Food Establishments
OMB Control No. 0910-0782
SUPPORTING STATEMENT Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, we or us)
regulations. The Federal Food, Drug, and Cosmetic Act (FD&C Act or the act), as
amended, requires the disclosure of certain calorie labeling of articles of food in vending
machines, as well as nutrition information for standard menu items in certain restaurants and
retail food establishments. Previously, we established distinct ICRs (OMB Control Nos.
0910-0782 and 0910-0783) for these collections, however, because regulations establishing
all information collection elements are codified under 21 CFR Part 101, include similar
collection activities, and utilize the same collection instrument, we consolidated them here.
Specifically, section 403(q)(5)(H)(viii) of the act requires 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.”
Section 403(q)(5)(H)(ix) also provides for the voluntary registration of vending machine
operators who are not otherwise subject to the new requirements of section
403(q)(5)(H)(viii). Finally, sections 201(n), 403(a)(1), 403(f), 403(q)(5)(H), and 701(a) of
the act requires restaurants and similar retail food establishments that are part of a chain with
20 or more locations doing business under the same name and offering for sale substantially
the same menu items to provide calorie and other nutrition information for standard menu
items, including food on display and self-service food. Again, the regulations also establish
the terms and conditions for voluntary registration by establishments that are not otherwise
subject to the requirements.
We therefore request OMB approval of the information collection provisions under 21 CFR
Part 101 as discussed below, and the associated collection instrument Form FDA 3757,
“DHHS/FDA MENU AND VENDING MACHINE LABELING VOLUNTARY REGISTRATION.”
2. Purpose and Use of the Information Collection
FDA uses the information collection to help determine compliance with regulatory
requirements. Third-party disclosure requirements are used by consumers of food products
for the purpose of making informed dietary choices. To assist respondents with the

reporting elements of the information collection, we developed Form FDA 3757 (referenced
above). The information collection also serves to fulfill FDA’s mandate under the act to
promote and protect the public health by ensuring the safety of food products available for
human consumption.
Description of Respondents: Respondents to this collection of information include
restaurants and similar retail food establishments that voluntarily elect to be subject to the
Federal requirements of this rule by registering with FDA. These establishments include
chain retail food establishments and eating and drinking places such as full- and limitedservice restaurants, snack bars (including, for example, ice cream, donut, and bagel shops
and similar establishments), cafeterias and drinking places, managed food service facilities,
grocery stores, supermarkets, convenience stores, general merchandise stores, lodging
facilities, recreational venues, sports venues, performing arts venues, and movie theaters.
3. Use of Improved Information Technology and Burden Reduction
Currently, FDA has established and implemented a registration process consisting of Form
FDA 3757 and associated instructions. We estimate all respondents (100%) will use
electronic means for reporting under this interim process. Additionally, we have issued the
following draft guidance documents to assist respondents with the information collection:
 Draft Guidance for Industry: Menu Labeling Supplemental Guidance
 Draft Guidance for Industry: Calorie Labeling of Articles of Food in Vending
Machines
 Guidance for Industry: Calorie Labeling of Articles of Food in Vending Machines;
Small Entity Compliance Guide
 Constituent Update: FDA Extends Menu Labeling Compliance Date to 2018
 Guidance for Industry: A Labeling Guide for Restaurants and Retail
Establishments Selling Away-From-Home Foods - Part I
 Guidance for Industry: A Labeling Guide for Restaurants and Retail
Establishments Selling Away-From-Home Foods - Part II (Menu Labeling
Requirements in Accordance with 21 CFR 101.11)
 Guidance for Industry: Nutrition Labeling of Standard Menu Items in Restaurants
and Similar Retail Food Establishments; Small Entity Compliance Guide
These guidance documents are available on our website at: www.fda.gov.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. Because OMB Control No. 09100783 contains similar information collection requirements and accompanying activity, we
have consolidated into the instant collection and have discontinued the former collection
upon this submission.

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5. Impact on Small Businesses or Other Small Entities
FDA estimates that no small businesses (0%) will be affected by the information collection.
To the extent that a small business may be impacted, the registration process is specifically
designed to minimize burden by giving a choice as to which rules the small business wishes
to follow. The registration process is voluntary, and is the minimal amount of burden that
FDA can impose in order to give firms this choice and to give regulatory authorities the
information they need to enforce applicable 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 information collection schedule is consistent with regulatory requirements.
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 accordance with 5 CFR 1320.8(d), FDA published a 60 day notice for public comment in
the Federal Register of December 12, 2017 (82 FR 58425). A number of comments were
received in response to the notice. The comments were generally supportive of the
information collection, but included concerns the potential effect ongoing or delayed
rulemaking to establish specific packaging requirements (e.g., font-size of labeling,
compliance dates) might have on the associated third-party disclosure burden. Other
comments questioned whether FDA needed all data currently being sought by the applicable
regulations and suggested the registration schedule be relaxed, especially given the small
number of respondents.
FDA appreciates these comments. We are also mindful of the substantive feedback
provided in the comments beyond the scope of those solicited under the PRA and have
included them in the appropriate agency dockets for consideration. At the same time, the
public comments we received nor our own evaluation suggested we revise our original
burden estimate figures and so retain those currently approved and identified in Question
12, below.
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

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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.
12. Estimates of Annualized Burden Hours and Costs
We estimate the burden of the information collection as follows:
12 a. Annualized Hour Burden Estimate
Table 1 – Estimated Annual Reporting Burden1
Avg. Burden
Total
No. of
No. of
21 CFR Part 101.8 and
per
Annual
101.11 Registration Using Respondents Responses
Responses Response (in
per
Form FDA 3757
hours)
Respondent
101.8(d); initial
13
1
13
2
registration
101.8(d); registration
19
1
19
0.5
renewal
(30 mins.)
101.11(d) initial
3,559
1
3,559
2
registration
101.11(d) registration
5,340
1
5,340
0.5
reviewal
(30 mins.)
Total
1

Total
Hours

26
9.5
7,118
2,670
9,823.5

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

Table 2.--Estimated Recordkeeping Burden1
Annual Frequency
Total Annual
21 CFR Part 101 Number of
per Recordkeeper
Records
Recordkeepers
Initial Burden (Annualized over 3 years)
§ 101.8(c)(2)(i)(A);
Initial nutrition
69,017
1
69,017
analysis
Annual Burden
§ 101.8(c)(2)(i)(A);
Recurring nutrition
30,059
1
30,059
analysis
Total
1

Hours per
Record

Total Hours

0.25
(15 minutes)

17,254

0.25
(15 minutes)

7,515

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

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24,769

Table 3 – Estimated Annual Third Party Disclosure Burden1
21 CFR Part 101

§ 101.8(c)(2)(i);
calorie analysis
§ 101.8(c)(2)(ii);
calorie declaration
signage
§ 101.8(e)(1); vending
operator contact
information
TOTAL
1

No. of
Respondents

No. of
Disclosures
per
Respondent

Total
Annual
Disclosures

Avg. Burden
per
Disclosure
(in hours)

Total Hours

282

11

3,102

1

3,102

3,279

2,122

6,958,346

.21
(12.5 mins.)

1,461,188

3,279

125

409,875

0.025
(1.5 mins.)

10,247

1,474,537

There are no capital costs or operating and maintenance costs associated with the information collection.

These figures are based on our analyses in support of the underlying rulemaking establishing
the information collections. We continue to evaluate the collection burden and solicit public
comment, noting that the effective dates and/or compliance dates for certain provisions have
not yet been realized.
12.b. Annualized Cost Burden
We believe any costs incurred by respondents to the information collection would be
nominal. Rather, costs associated with the labeling of food products for human consumption
are reflected under OMB Control No. 0910-0381: Food Labeling Regulations.
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, start-up, operating, or maintenance costs associated with this
collection.
14. Annualized Cost to the Federal Government
FDA assumes an estimates initial cost of setting up the registration system for both the
vending machine and menu labeling collections to be approximately $200,000, with
recurring maintenance cost of $60,000 per year. Having realized costs for registration
establishment, we retain a $60,000 annual cost estimate to the Federal government.
15. Explanation for Program Changes or Adjustments
This information collection has been revised to include burden previously accounted for
under OMB Control No. 0910-0783. The information collection also reflects nominal
adjustments where, upon consolidating collections, we refined our estimate to avoid
duplicative burden associated with like collection activities. As shown in reginfo.gov this
will reflect an overall increase to collection OMB Control No. 0910-0782 by 107,667 annual
responses and 1,341 hours. At the same time, the information collection burden from OMB

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Control No. 0910-0783 including 334,219 annual responses and 498,508 hours has been
eliminated.
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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