
[Federal Register Volume 88, Number 153 (Thursday, August 10, 2023)]
[Notices]
[Pages 54326-54329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17145]


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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) 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 September 11, 2023.

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, 10 a.m.-12 p.m., 
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

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 and Labeling Act (FPLA) (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.
    We provide information resources regarding food labeling under the 
FD&C Act and its amendments on our website at https://www.fda.gov/food/food-labeling-nutrition. Food labeling is required for most prepared 
foods, such as breads, cereals, canned and frozen foods, snacks, 
desserts, drinks, etc. Nutrition labeling for raw produce (fruits and 
vegetables) and fish is voluntary. We refer to these products as 
``conventional'' foods. For detailed information on dietary supplement 
labeling requirements visit our website at https://www.fda.gov/food/dietary-supplements. Nutrition labeling provides information for use by 
consumers in selecting a nutritious diet. Other information enables 
consumers to comparison shop. Ingredient information also enables 
consumers to avoid substances to which they may be sensitive. Petitions 
or other requests submitted to us provide the basis for us to permit 
new labeling statements or to grant exemptions from certain labeling 
requirements. Recordkeeping requirements enable us to monitor the basis 
upon which certain label statements are made for food products and 
whether those statements are in compliance with the requirements of the 
FD&C Act or the FPLA. Requirements include general content and format 
for the labeling of food packaging, including nutrition and ingredient 
information. Additional regulations provide for specific nutrient 
content claims.
    The information collection includes Form FDA 3570 entitled, ``Small 
Business Nutrition Labeling Exemption Notice,'' for use as applicable 
and available for download from our website at https://www.fda.gov/food/labeling-nutrition-guidance-documents-regulatory-information/small-business-nutrition-labeling-exemption-notice-model-form. We have 
also developed the following guidance documents to assist respondents 
with various aspects of the information collection:
     ``Guidance for Industry: Notification of a Health Claim or 
Nutrient Content Claim Based on an Authoritative Statement of a 
Scientific Body'' (June 1998). The guidance document is available from 
our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-notification-health-claim-or-nutrient-content-claim-based-authoritative-statement. The guidance 
document

[[Page 54327]]

discusses section 403(r)(2) and (r)(3) (21 U.S.C. 343(r)(2) and (3)) of 
the FD&C Act and was issued to provide instruction on the submission of 
information to FDA during the initial phase of implementing these new 
provisions.
     ``Questions and Answers: Labeling of Dietary Supplements 
as Required by the Dietary Supplement and Nonprescription Drug Consumer 
Protection Act'' (September 2009). The guidance document is available 
from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-labeling-dietary-supplements-required-dietary. The guidance 
document communicates content elements and FDA enforcement of labeling 
requirements in section 403(y) of the FD&C Act.
     ``Substantiation for Dietary Supplement Claims Made Under 
Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act'' 
(January 2009). The guidance document is available from our website at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-substantiation-dietary-supplement-claims-made-under-section-403r-6-federal-food. The guidance document discusses 
FDA recommendations regarding claims under section 403(r)(6) of the 
FD&C Act.
    For operational efficiency, we are revising the information 
collection to account for burden that may result from activities 
associated with the labeling of certain beers, currently approved in 
OMB Control No. 0910-0728. The Tobacco Tax and Trade Bureau is 
responsible for the dissemination and enforcement of regulations with 
respect to the labeling of distilled spirits, certain wines, and malt 
beverages issued in the Federal Alcohol Administration Act. However, 
and as discussed in the guidance document ``Labeling of Certain Beers 
Subject to the Labeling Jurisdiction of the Food and Drug 
Administration'' (December 2014), certain bottled or otherwise packaged 
beers are subject to section 403 of the FD&C Act. The guidance document 
is available for download from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-labeling-certain-beers-subject-labeling-jurisdiction-food-and-drug-administration and provides recommendations regarding applicable 
labeling requirements for products under FDA's jurisdiction.
    We are also revising the information collection to include new 
requirements applicable to the gluten-free labeling of fermented or 
hydrolyzed foods established through rulemaking (RIN 0910-AH00) and 
approved in OMB Control No. 0910-0817.
    Description of Respondents: Respondents to this information 
collection are manufacturers, packers, and distributors of food 
products, as well as certain food retailers, such as supermarkets and 
restaurants, subject to statutory and regulatory food labeling 
requirements.
    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.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                        Number of
     21 CFR section; activity          Number of      responses per     Total annual   Average  burden    Total
                                      respondents       respondent       responses      per  response     hours
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101.9(c)(6)(i); dietary fiber.....               28                1               28                1        28
101.9(j)(18) and 101.36(h)(2);               10,000                1           10,000                8    80,000
 procedure for small business
 nutrition labeling exemption
 notice using Form FDA 3570.......
101.12(h); petitions to establish                 1                1                1               80        80
 or amend referenced amounts
 customarily consumed (RACC)......
101.69; petitions for nutrient                    3                1                3               25        75
 content claims...................
101.70; petitions for health                      5                1                5               80       400
 claims...........................
101.108; written proposal for                     1                1                1               40        40
 requesting temporary exemptions
 from certain regulations for the
 purpose of conducting food
 labeling experiments.............
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    Total.........................  ...............  ...............           10,038  ...............    80,623
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                                    Table 2--Estimated Annual Recordkeeping Burden\1\
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                                                                     Number of
            21 CFR section; activity                Number of       records per      Total annual        Average burden per recordkeeping         Total
                                                  recordkeepers     recordkeeper       records                                                    hours
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101.9(c)(6)(iii); added sugars \2\.............           31,283                1           31,283  1.........................................    31,283
101.9(c)(6)(i); dietary fiber \2\..............           31,283                1           31,283  1.........................................    31,283
101.9(c)(6)(i)(A) \2\; soluble fiber...........           31,283                1           31,283  1.........................................    31,283
101.9(c)(6)(i)(B); insoluble fiber \2\.........           31,283                1           31,283  1.........................................    31,283
101.9(c)(8); vitamin E \3\.....................           31,283                1           31,283  1.........................................    31,283
101.9(c)(8); folate/folic acid \3\.............           31,283                1           31,283  1.........................................    31,283
New Products...................................              216                1              216  1.........................................       216
101.12(e); recordkeeping to document the basis                25                1               25  1.........................................        25
 for density-adjusted RACC.
101.13(q)(5); recordkeeping to document the              300,000              1.5          450,000  0.75 (45 minutes).........................   337,500
 basis for nutrient content claims.
101.14(d)(2); recordkeeping to document                  300,000              1.5          450,000  0.75 (45 minutes).........................   337,500
 nutrition information related to health claims
 for food products.
101.22(i)(4); recordkeeping to document                       25                1               25  1.........................................        25
 supplier certifications for flavors designated
 as containing no artificial flavors.
101.100(d)(2); recordkeeping pertaining to                 1,000                1            1,000  1.........................................     1,000
 agreements that form the basis for an
 exemption from the labeling requirements of
 section 403(c), (e), (g)-(i), (k), and (q) of
 the FD&C Act.
101.7(t); recordkeeping pertaining to                        100                1              100  1.........................................       100
 disclosure requirements for food not
 accurately labeled for quality of contents.

[[Page 54328]]

 
101.91; Documentation necessary to verify                  5,000               56          280,000  0.45 (~27 minutes)........................   126,000
 compliance with gluten free labeling.
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    Total......................................  ...............  ...............        1,369,064  ..........................................   990,064
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimate reflects the cumulative average burden we attribute to 
the reporting and recordkeeping requirements found in the applicable 
regulations; individual collection activities may not be evenly 
distributed among respondents and/or the corresponding requirements.

                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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                                                    Number of
   21 CFR section; activity       Number of      disclosures per     Total annual    Average burden  Total hours
                                 respondents        respondent       disclosures     per disclosure
----------------------------------------------------------------------------------------------------------------
101.3, 101.22, parts 102 and            25,000               1.03           25,750  0.5 (30               12,875
 104; statement of identity                                                          minutes).
 labeling requirements.
101.4, 101.22, 101.100, parts           25,000               1.03           25,750  1..............       25,750
 102, 104 and 105; ingredient
 labeling requirements.
101.5; requirement to specify           25,000               1.03           25,750  0.25 (15               6,438
 the name and place of                                                               minutes).
 business of the
 manufacturer, packer, or
 distributor and, if the food
 producer is not the
 manufacturer of the food
 product, its connection with
 the food product.
101.9, 101.13(n),                       25,000               1.03           25,750  4..............      103,000
 101.14(d)(3), 101.62, and
 part 104; labeling
 requirements for disclosure
 of nutrition information.
101.9(g)(9) and 101.36(f)(2);               12                  1               12  4..............           48
 alternative means of
 compliance permitted.
101.10; requirements for               300,000                1.5          450,000  0.25 (15             112,500
 nutrition labeling of                                                               minutes).
 restaurant foods.
101.12(b); RACC for baking                  29                2.3               67  1..............           67
 powder, baking soda, and
 pectin.
101.12(e); adjustment to the                25                  1               25  1..............           25
 RACC of an aerated food
 permitted.
101.12(g); requirement to                5,000                  1            5,000  1..............        5,000
 disclose the serving size
 that is the basis for a
 claim made for the product
 if the serving size on which
 the claim is based differs
 from the RACC.
101.13(d)(1) and 101.67;                   200                  1              200  1..............          200
 requirements to disclose
 nutrition information for
 any food product for which a
 nutrient content claim is
 made.
101.13(j)(2) and (k), 101.54,            5,000                  1            5,000  1..............        5,000
 101.56, 101.60, 101.61, and
 101.62; additional
 disclosure required if the
 nutrient content claim
 compares the level of a
 nutrient in one food with
 the level of the same
 nutrient in another food..
101.13(q)(5); requirement              300,000                1.5          450,000  0.75 (45             337,500
 that restaurants disclose                                                           minutes).
 the basis for nutrient
 content claims made for
 their food.
101.14(d)(2); general                  300,000                1.5          450,000  0.75 (45             337,500
 requirements for disclosure                                                         minutes).
 of nutrition information
 related to health claims for
 food products.
101.15; requirements                       160                 10            1,600  8..............       12,800
 pertaining to prominence of
 required statements and use
 of foreign language.
101.22(i)(4); supplier                      25                  1               25  1..............           25
 certifications for flavors
 designated as containing no
 artificial flavors.
101.30 and 102.33; labeling              1,500                  5            7,500  1..............        7,500
 requirements for fruit or
 vegetable juice beverages.
101.36; nutrition labeling of              300                 40           12,000  4.025..........       48,300
 dietary supplements.
101.42 and 101.45; nutrition             1,000                  1            1,000  0.5 (30                  500
 labeling of raw fruits,                                                             minutes).
 vegetables, and fish.
101.45(c); databases of                      5                  4               20  4..............           80
 nutrient values for raw
 fruits, vegetables, and fish.
101.79(c)(2)(i)(D);                      1,000                  1            1,000  0.25 (15                 250
 disclosure requirements for                                                         minutes).
 food labels that contain a
 folate/neural tube defect
 health claim.
101.79(c)(2)(iv); disclosure               100                  1              100  0.25 (15                  25
 of amount of folate for food                                                        minutes).
 labels that contain a folate/
 neural tube defect health
 claim.
101.100(d); disclosure of                1,000                  1            1,000  1..............        1,000
 agreements that form the
 basis for exemption from the
 labeling requirements of
 section 403(c), (e), (g),
 (h), (i), (k), and (q) of
 the FD&C Act.
101.7 and 101.100(h);                   25,000               1.03           25,750  0.5 (30               12,875
 disclosure requirements for                                                         minutes).
 food not accurately labeled
 for quantity of contents and
 for claiming certain
 labeling exemptions.
Nutritional labeling for new               500                  1              500  2..............        1,000
 products.
``Labeling of Certain Beers                 12                  1               12  1..............           12
 Subject to the Labeling
 Jurisdiction of the Food and
 Drug Administration''.
                              ----------------------------------------------------------------------------------
    Total....................  ...............  .................  ...............  ...............    1,030,270
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    These estimates reflect our continued experience with the 
information collection. We have made nominal adjustments to reflect the 
addition of burden associated with gluten and certain bottled or 
otherwise packaged beer; petition submissions received since our last 
evaluation of the information collection; and informal communications 
with industry regarding food product labeling.


[[Page 54329]]


    Dated: August 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17145 Filed 8-9-23; 8:45 am]
BILLING CODE 4164-01-P


