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, 25633-25634 [2024-07661]
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Federal Register / Vol. 89, No. 71 / Thursday, April 11, 2024 / Notices
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.
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.
SUMMARY:
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.
ADDRESSES:
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
khammond on DSKJM1Z7X2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
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
VerDate Sep<11>2014
16:50 Apr 10, 2024
Jkt 262001
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 60day 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
§§ 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
§ 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
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
25633
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/aboutfda/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-fdaguidance-documents/guidanceindustry-menu-labeling-supplementalguidance, provides a discussion of the
regulations in §§ 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-fdaguidance-documents/draft-guidanceindustry-menu-labeling-supplementalguidance-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
E:\FR\FM\11APN1.SGM
11APN1
25634
Federal Register / Vol. 89, No. 71 / Thursday, April 11, 2024 / Notices
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-forprofit institutions, and farms).
those entities who voluntarily
participate with the provisions through
registration with FDA.
We estimate the burden of this
collection of information as follows:
Collections of information found in
§§ 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
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity using form FDA 3757; 21 CFR section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Initial registration for Vending Machine Labeling; 101.8(d)
Biennial registration renewal for Vending Machine Labeling; 101.8(d) .....................................................................
Initial registration for Menu Labeling; 101.11(d) ..................
Registration renewal for Menu Labeling; 101.11(d) ............
13
1
13
2
26
20
3,559
5,340
1
1
1
20
3,559
5,340
* 0.5
2
* 0.5
10
7,118
2,670
Total ..............................................................................
........................
........................
........................
........................
9,824
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
Activity; 21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Nutrition analysis; 101.11(c) ................................................
100,000
1
100,000
1
100,000
khammond on DSKJM1Z7X2PROD with NOTICES
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 §§ 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
§§ 101.8(d) and 101.11(d).
Cumulatively, these adjustments result
in a decrease of 1,399,306 hours and
VerDate Sep<11>2014
16:50 Apr 10, 2024
Jkt 262001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0026]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product;
DUVYZAT (givinostat)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act)
authorizes FDA to award priority review
vouchers to sponsors of approved rare
pediatric disease product applications
that meet certain criteria. FDA is
required to publish notice of the award
of the priority review voucher. FDA has
determined that DUVYZAT (givinostat),
approved on March 21, 2024,
SUMMARY:
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
manufactured by Italfarmaco S.p.A.,
meets the criteria for a priority review
voucher.
FOR FURTHER INFORMATION CONTACT:
Cathryn Lee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–1394.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), FDA will
award priority review vouchers to
sponsors of approved rare pediatric
disease product applications that meet
certain criteria. FDA has determined
that DUVYZAT (givinostat),
manufactured by Italfarmaco S.p.A.,
meets the criteria for a priority review
voucher. DUVYZAT (givinostat) oral
suspension is indicated for the
treatment of Duchenne muscular
dystrophy in patients 6 years of age or
older.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about DUVYZAT
(givinostat), go to the ‘‘Drugs@FDA’’
E:\FR\FM\11APN1.SGM
11APN1
]]>Agencies
[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]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 25634]]
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\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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)............
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 9,824
----------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity; 21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nutrition analysis; 101.11(c)...................................... 100,000 1 100,000 1 100,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
