[Federal Register Volume 89, Number 71 (Thursday, April 11, 2024)]
[Notices]
[Pages 25633-25634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07661]



[[Page 25633]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0918]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Food Labeling 
Requirements: Calorie Labeling of Articles of Food in Vending Machines 
and Nutrition Labeling of Standard Menu Items in Restaurants and 
Similar Retail Food Establishments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by May 13, 2024.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0381. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Food Labeling Requirements: 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 Number 0910-0381--Revision

    This information collection supports statutory and regulatory 
requirements that govern food labeling, and information collection 
recommendations discussed in associated Agency guidance. Sections 4, 5, 
and 6 of the Fair Packaging Labeling Act (15 U.S.C. 1453, 1454, and 
1455) and sections 201, 301, 402, 403, 409, 411, 701, and 721 of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321, 331, 
342, 343, 348, 350, 371, and 379e), establish provisions under which a 
food product shall be deemed to be misbranded if, among other things, 
its label or labeling fails to bear certain required information 
concerning the food product, is false or misleading in any particular, 
or bears certain types of unauthorized claims. Implementing regulations 
are codified in parts 101, 102, 104, and 105 (21 CFR parts 101, 102, 
104, and 105). While regulations in part 101 set forth general food 
labeling provisions, requirements pertaining to the common or usual 
name for nonstandardized foods; guidelines for nutritional quality to 
prescribe the minimum level or range of nutrient composition 
appropriate for a given class of food; and requirements for foods for 
special dietary use are found in parts 102, 104, and 105, respectively. 
The requirements are intended to ensure the safety of food products 
produced or sold in the United States and enable consumers to be 
knowledgeable about the foods they purchase and include corresponding 
information disclosure requirements, along with the reporting and 
recordkeeping provisions, subject to enforcement by FDA.
    In the Federal Register of April 12, 2023 (88 FR 22045), we 
published a 60-day notice soliciting comment on the proposed collection 
of information. No comments were received. On our own initiative and 
for efficiency of Agency operations, we are revising the information 
collection to include burden we attribute to related collection 
activities described in sections 201(n), 403(a)(1), 403(f), 
403(q)(5)(H), and 701(a) of the FD&C Act, codified in Sec. Sec.  101.8 
and 101.11 (21 CFR 101.8 and 101.11), and currently approved under OMB 
control number 0910-0782. Sections 101.8 and 101.11 provide that 
respondents with a chain of 20 or more locations will disclose 
nutritional information of certain foods for consumers of food products 
for the purpose of making informed dietary choices. Section 101.8 
applies specifically to vending machines, and Sec.  101.11 applies to 
covered establishments such as restaurants. Sections 101.8(d) and 
101.11(d) provide for registration for respondents not otherwise 
subject to these regulations but who wish to voluntarily participate 
with this information collection activity, for which we developed Form 
FDA 3757 entitled ``DHHS/FDA Menu and Vending Machine Labeling 
Voluntary Registration'' to assist respondents in this regard. The form 
is available for download at https://www.fda.gov/about-fda/reports-manuals-forms/forms and entering ``3757'' into the search field. To 
keep the registration active, a respondent renews their registration 
every other year within 60 days prior to the expiration of the 
respondent's current registration with FDA, or it will automatically 
expire.
    We have also developed Agency guidance to communicate our 
interpretation of the regulatory requirements. The guidance document 
entitled ``Menu Labeling: Supplemental Guidance for Industry'' (May 
2018), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-menu-labeling-supplemental-guidance, provides a discussion of the regulations in Sec. Sec.  101.8 
and 101.11 in a question-and-answer format. We have recently issued a 
draft second edition of the guidance document (December 2023), 
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-menu-labeling-supplemental-guidance-edition-2. The draft guidance, when finalized, will update the 
May 2018 guidance to add two new questions and answers regarding 
voluntarily declaring added sugars as part of additional written 
nutrition information and voluntarily providing nutrition information 
consistent with the menu labeling requirements through third-party 
platforms. Because of the growing popularity of third-party platforms 
among consumers, such as third-party online ordering websites and 
delivery applications to order food for pickup and delivery from chain 
restaurants and similar retail food establishments, we discuss our 
recommendation that covered establishments provide third-party 
platforms nutrition information for standard menu items to help 
consumers make informed and healthy decisions when ordering their meals 
online using a third-party platform. All Agency guidance documents are 
issued consistent with our good guidance practice regulations in 21 CFR 
10.115, which provide for public comment at any time.
    Description of Respondents: Respondents to the collections of 
information in part 101 are manufacturers, packers, and distributors of 
food products, as well as certain food

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retailers, such as supermarkets and restaurants, subject to statutory 
and regulatory food labeling requirements. Respondents are from the 
private sector (including for-profit businesses, not-for-profit 
institutions, and farms). Collections of information found in 
Sec. Sec.  101.8 and 101.11 also include vending machine operators and 
restaurants or other similar food establishments that are subject to 
the requirements of part 101 as well as those entities who voluntarily 
participate with the provisions through registration with FDA.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
Activity using form FDA 3757; 21     Number of     responses per   Total annual   Average burden    Total hours
           CFR section              respondents     respondent       responses     per response
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Initial registration for Vending              13               1              13               2              26
 Machine Labeling; 101.8(d).....
Biennial registration renewal                 20               1              20           * 0.5              10
 for Vending Machine Labeling;
 101.8(d).......................
Initial registration for Menu              3,559               1           3,559               2           7,118
 Labeling; 101.11(d)............
Registration renewal for Menu              5,340               1           5,340           * 0.5           2,670
 Labeling; 101.11(d)............
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    Total.......................  ..............  ..............  ..............  ..............           9,824
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
* 30 minutes.


                                                       Table 2--Estimated Recordkeeping Burden \1\
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                                                                                         Number of                       Average burden
                      Activity; 21 CFR section                          Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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Nutrition analysis; 101.11(c)......................................         100,000                1          100,000                1          100,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimate of burden reflects adjustments. We have reorganized 
the information collection activities into reporting and recordkeeping 
categories, eliminating a separate summary burden estimate for third-
party disclosure. As defined in 5 CFR 1320.3(m), recordkeeping is a 
requirement to maintain specified records and includes activities such 
as disclosure of these records to third parties, the Federal 
government, or the public. We believe that vending machine operators 
and covered establishments who must demonstrate compliance with 
statutory and regulatory requirements applicable to food labeling would 
retain requisite records as a usual and customary business practice. 
(See 5 CFR 1320.3(b)(2).) At the same time, we have modified our 
recordkeeping burden estimates to account for effort that may be 
necessary to retain, as well as to ``transmit or otherwise disclose 
[the] information,'' to the Federal government and/or third parties 
(see 5 CFR 1320.3(b)(1)(ix)) as required by the regulations to the 
extent that they reflect on activities applicable to Sec. Sec.  101.8 
and 101.11. Included in our estimated number of recordkeepers are those 
who voluntarily elect to register with FDA through submissions in 
accordance with Sec. Sec.  101.8(d) and 101.11(d). Cumulatively, these 
adjustments result in a decrease of 1,399,306 hours and 7,370,090 
responses annually to the information collection.

    Dated: April 8, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-07661 Filed 4-10-24; 8:45 am]
BILLING CODE 4164-01-P