Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling Requirements, 54326-54329 [2023-17145]
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54326
Federal Register / Vol. 88, No. 153 / Thursday, August 10, 2023 / Notices
The burden attributed to
recordkeeping activities is assumed to
be distributed among the individual
elements and averaged among
respondents. In the burden estimate, we
assume an average burden per record of
10 hours for the RDRC respondents to
maintain meeting minutes and 0.75
hours (45 minutes) for a subset of the
respondents (37 RDRCs) to obtain
consent of human research subjects.
Section 361.1(f) sets forth labeling
requirements for radioactive drugs.
These requirements are not in the
burden estimate because they are
information supplied by the Federal
Government to the recipient for the
purposes of disclosure to the public (5
CFR 1320.3(c)(2)).
Our estimated burden for the
information collection reflects an
overall decrease of 703 hours and a
corresponding decrease of 158
responses. We attribute this adjustment
to a decrease in the average burden per
response, from 3.5 hours to 3 hours per
response, associated with the public
reporting burden for Form FDA 2915.
The decrease is based on our program
experience and matches the burden
hours reflected on the form. In addition,
this adjustment is also attributable to
the Agency receiving fewer submissions
over the last few years.
Dated: August 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–17154 Filed 8–9–23; 8:45 am]
BILLING CODE 4164–01–P
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.
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.
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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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, 10 a.m.–12 p.m.,
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.
SUPPLEMENTARY INFORMATION:
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
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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/foodlabeling-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/dietarysupplements. 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/labelingnutrition-guidance-documentsregulatory-information/small-businessnutrition-labeling-exemption-noticemodel-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/regulatoryinformation/search-fda-guidancedocuments/guidance-industrynotification-health-claim-or-nutrientcontent-claim-based-authoritativestatement. The guidance document
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Federal Register / Vol. 88, No. 153 / Thursday, August 10, 2023 / Notices
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-fdaguidance-documents/guidanceindustry-questions-and-answersregarding-labeling-dietary-supplementsrequired-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-substantiationdietary-supplement-claims-made-undersection-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/regulatoryinformation/search-fda-guidancedocuments/guidance-industry-labeling-
certain-beers-subject-labelingjurisdiction-food-and-drugadministration 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 60day 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
101.9(c)(6)(i); dietary fiber ......................................................................................
101.9(j)(18) and 101.36(h)(2); procedure for small business nutrition labeling exemption notice using Form FDA 3570 ................................................................
101.12(h); petitions to establish or amend referenced amounts customarily consumed (RACC) ....................................................................................................
101.69; petitions for nutrient content claims ...........................................................
101.70; petitions for health claims ..........................................................................
101.108; written proposal for requesting temporary exemptions from certain regulations for the purpose of conducting food labeling experiments .....................
Total .................................................................................................................
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section; activity
Average
burden per
response
Total annual
responses
Total
hours
28
1
28
1
28
10,000
1
10,000
8
80,000
1
3
5
1
1
1
1
3
5
80
25
80
80
75
400
1
1
1
40
40
..........................
..........................
10,038
..........................
80,623
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
Number of
recordkeepers
ddrumheller on DSK120RN23PROD with NOTICES1
21 CFR section; activity
101.9(c)(6)(iii); added sugars 2 .....................................................................
101.9(c)(6)(i); dietary fiber 2 .........................................................................
101.9(c)(6)(i)(A) 2; soluble fiber ....................................................................
101.9(c)(6)(i)(B); insoluble fiber 2 .................................................................
101.9(c)(8); vitamin E 3 ................................................................................
101.9(c)(8); folate/folic acid 3 .......................................................................
New Products ...............................................................................................
101.12(e); recordkeeping to document the basis for density-adjusted
RACC.
101.13(q)(5); recordkeeping to document the basis for nutrient content
claims.
101.14(d)(2); recordkeeping to document nutrition information related to
health claims for food products.
101.22(i)(4); recordkeeping to document supplier certifications for flavors
designated as containing no artificial flavors.
101.100(d)(2); recordkeeping pertaining to 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 disclosure requirements for food not
accurately labeled for quality of contents.
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Number of
records per
recordkeeper
Total annual
records
Total
hours
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
31,283
31,283
31,283
31,283
31,283
31,283
216
25
31,283
31,283
31,283
31,283
31,283
31,283
216
25
1
1
1
1
1
1
1
1
31,283
31,283
31,283
31,283
31,283
31,283
216
25
300,000
1.5
450,000
0.75 (45 minutes) .......
337,500
300,000
1.5
450,000
0.75 (45 minutes) .......
337,500
25
1
25
1 ..................................
25
1,000
1
1,000
1 ..................................
1,000
100
1
100
1 ..................................
100
Sfmt 4703
E:\FR\FM\10AUN1.SGM
10AUN1
1
1
1
1
1
1
1
1
Average burden per
recordkeeping
54328
Federal Register / Vol. 88, No. 153 / Thursday, August 10, 2023 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued
Number of
records per
recordkeeper
Number of
recordkeepers
21 CFR section; activity
Total annual
records
Average burden per
recordkeeping
Total
hours
101.91; Documentation necessary to verify compliance with gluten free
labeling.
5,000
56
280,000
0.45 (∼27 minutes) .....
126,000
Total ......................................................................................................
..........................
..........................
1,369,064
.....................................
990,064
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
ddrumheller on DSK120RN23PROD with NOTICES1
101.3, 101.22, parts 102 and 104; statement of identity labeling requirements.
101.4, 101.22, 101.100, parts 102, 104 and 105; ingredient labeling requirements.
101.5; requirement to specify the name and place of 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), 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); alternative means of compliance permitted
101.10; requirements for nutrition labeling of restaurant foods .................
101.12(b); RACC for baking powder, baking soda, and pectin .................
101.12(e); adjustment to the RACC of an aerated food permitted ...........
101.12(g); requirement to 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; 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, 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 that restaurants disclose the basis for nutrient
content claims made for their food.
101.14(d)(2); general requirements for disclosure of nutrition information
related to health claims for food products.
101.15; requirements pertaining to prominence of required statements
and use of foreign language.
101.22(i)(4); supplier certifications for flavors designated as containing
no artificial flavors.
101.30 and 102.33; labeling requirements for fruit or vegetable juice
beverages.
101.36; nutrition labeling of dietary supplements ......................................
101.42 and 101.45; nutrition labeling of raw fruits, vegetables, and fish ..
101.45(c); databases of nutrient values for raw fruits, vegetables, and
fish.
101.79(c)(2)(i)(D); disclosure requirements for food labels that contain a
folate/neural tube defect health claim.
101.79(c)(2)(iv); disclosure of amount of folate for food labels that contain a folate/neural tube defect health claim.
101.100(d); disclosure of 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); disclosure requirements for food not accurately
labeled for quantity of contents and for claiming certain labeling exemptions.
Nutritional labeling for new products .........................................................
‘‘Labeling of Certain Beers Subject to the Labeling Jurisdiction of the
Food and Drug Administration’’.
Total ....................................................................................................
1 There
Number of
disclosures per
respondent
Number of
respondents
21 CFR section; activity
Total annual
disclosures
Average burden
per disclosure
Total hours
25,000
1.03
25,750
0.5 (30 minutes)
12,875
25,000
1.03
25,750
1 ..........................
25,750
25,000
1.03
25,750
0.25 (15 minutes)
6,438
25,000
1.03
25,750
4 ..........................
103,000
12
300,000
29
25
5,000
1
1.5
2.3
1
1
12
450,000
67
25
5,000
4 ..........................
0.25 (15 minutes)
1 ..........................
1 ..........................
1 ..........................
48
112,500
67
25
5,000
200
1
200
1 ..........................
200
5,000
1
5,000
1 ..........................
5,000
300,000
1.5
450,000
0.75 (45 minutes)
337,500
300,000
1.5
450,000
0.75 (45 minutes)
337,500
160
10
1,600
8 ..........................
12,800
25
1
25
1 ..........................
25
1,500
5
7,500
1 ..........................
7,500
300
1,000
5
40
1
4
12,000
1,000
20
4.025 ...................
0.5 (30 minutes)
4 ..........................
48,300
500
80
1,000
1
1,000
0.25 (15 minutes)
250
100
1
100
0.25 (15 minutes)
25
1,000
1
1,000
1 ..........................
1,000
25,000
1.03
25,750
500
12
1
1
500
12
2 ..........................
1 ..........................
1,000
12
..........................
..............................
..........................
.............................
1,030,270
0.5 (30 minutes)
12,875
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
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burden associated with gluten and
certain bottled or otherwise packaged
beer; petition submissions received
since our last evaluation of the
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information collection; and informal
communications with industry
regarding food product labeling.
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Federal Register / Vol. 88, No. 153 / Thursday, August 10, 2023 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2986]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Color Additive
Certification
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing an opportunity for
public comment on the proposed
collection of certain information by the
Agency. Under the Paperwork
Reduction Act of 1995 (PRA), Federal
Agencies are required to publish notice
in the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection provisions of FDA’s
regulations governing batch certification
of color additives manufactured for use
in foods, drugs, cosmetics, or medical
devices in the United States.
DATES: Either electronic or written
comments on the collection of
information must be submitted by
October 10, 2023.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
October 10, 2023. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
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comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2023–N–2986 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Color
Additive Certification.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
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54329
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
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]]>Agencies
[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]
-----------------------------------------------------------------------
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
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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''.
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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
