[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