Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling Requirements, 22045-22049 [2023-07683]
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Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Notices
As a result of the foregoing finding,
Ms. Torres is permanently debarred
from providing services in any capacity
to a person with an approved or
pending drug product application,
applicable as of the date of this order
(see DATES) (see section 306(a)(2)(A) and
306(c)(2)(A)(ii) of the FD&C Act). Any
person with an approved or pending
drug product application who
knowingly employs or retains as a
consultant or contractor, or otherwise
uses the services of Ms. Torres in any
capacity during her debarment, will be
subject to civil money penalties (section
307(a)(6) of the FD&C Act (21 U.S.C.
335b(a)(6))). If Ms. Torres provides
services in any capacity to a person with
an approved or pending drug product
application during her period of
debarment, she will be subject to civil
money penalties (section 307(a)(7) of the
FD&C Act). In addition, FDA will not
accept or review any abbreviated new
drug application from Ms. Torres during
her period of debarment, other than in
connection with an audit under section
306 of the FD&C Act (section
306(c)(1)(B) of the FD&C Act). Note that,
for purposes of sections 306 and 307 of
the FD&C Act, a ‘‘drug product’’ is
defined as a ‘‘drug subject to regulation
under section 505, 512, or 802 of this
Act (21 U.S.C. 355, 360b, 382) or under
section 351 of the Public Health Service
Act (42 U.S.C. 262)’’ (section 201(dd) of
the FD&C Act (21 U.S.C. 321(dd))).
Dated: April 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–07670 Filed 4–11–23; 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; Proposed Collection;
Comment Request; Food Labeling
Requirements
AGENCY:
Food and Drug Administration,
HHS.
ddrumheller on DSK120RN23PROD with NOTICES1
ACTION:
Notice.
19:25 Apr 11, 2023
Either electronic or written
comments on the collection of
information must be submitted by June
12, 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
June 12, 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.
DATES:
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
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
The Food and Drug
Administration (FDA or Agency) 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
SUMMARY:
VerDate Sep<11>2014
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 information
collection activity associated with
statutory and regulatory food labeling
requirements.
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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
PO 00000
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22045
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–0918 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Food
Labeling Regulations.’’ 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
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.
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Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Notices
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.
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
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
ddrumheller on DSK120RN23PROD with NOTICES1
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
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19:25 Apr 11, 2023
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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 sets 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/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 ena ble 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.
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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
discusses sections 403(r)(3) and
403(r)(2) (21 U.S.C. 343(r)(3) and (2)) 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 number 0910–0728. The
Tobacco Tax and Trade Bureau is
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Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Notices
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-labelingcertain-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 number 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.
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 BURDEN 1
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.
101.91; Documentation necessary to verify compliance with gluten free labeling.
Total .......................................................................
1 There
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
1
1
1
1
1
1
1
1
...........................
...........................
...........................
...........................
...........................
...........................
...........................
...........................
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
5,000
56
280,000
0.45 (∼27 minutes)
126,000
........................
........................
1,369,064
..............................
990,064
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Sep<11>2014
19:25 Apr 11, 2023
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PO 00000
Total hours
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12APN1
31,283
31,283
31,283
31,283
31,283
31,283
216
25
22048
Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Notices
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’’.
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19:25 Apr 11, 2023
Jkt 259001
Number of
disclosures per
respondent
Number of
respondents
21 CFR section; activity
PO 00000
Frm 00088
Average
burden per
disclosure
Total annual
disclosures
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)
25,000
1.03
25,750
4 ...........................
103,000
12
1
12
4 ...........................
48
300,000
1.5
450,000
29
2.3
67
1 ...........................
67
25
1
25
1 ...........................
25
5,000
1
5,000
1 ...........................
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
40
1
12,000
1,000
4.025 ....................
0.5 (30 minutes) ...
48,300
500
5
4
20
4 ...........................
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
0.5 (30 minutes) ...
12,875
500
12
1
1
500
12
2 ...........................
1 ...........................
1,000
12
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0.25 (15 minutes)
12APN1
6,438
112,500
Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Notices
22049
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
21 CFR section; activity
Total .....................................................................
1 There
Number of
respondents
Number of
disclosures per
respondent
Total annual
disclosures
Average
burden per
disclosure
........................
..........................
........................
..............................
1,030,270
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.
Center for Advancing Translational Sciences,
National Institutes of Health, 6701
Democracy Blvd., Suite 101, Bethesda, MD
20892, 301–827–4905, brownnac@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.350, B—Cooperative
Agreements; 93.859, Biomedical Research
and Research Training, National Institutes of
Health, HHS)
Dated: April 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–07683 Filed 4–11–23; 8:45 am]
Dated: April 7, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
BILLING CODE 4164–01–P
[FR Doc. 2023–07656 Filed 4–11–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Center for Advancing
Translational Sciences; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
ddrumheller on DSK120RN23PROD with NOTICES1
Total hours
Name of Committee: National Center for
Advancing Translational Sciences Special
Emphasis Panel; NCATS CTSA Training
Grants Review Meeting.
Date: May 17, 2023.
Time: 9:30 a.m. to 6:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Office of Grants Management and
Scientific Review National Center for
Advancing Translational Sciences, National
Institutes of Health, 6701 Democracy
Boulevard, Suite 1001 Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Nakia C. Brown, Ph.D.,
Scientific Review Officer, Office of Grants
Management and Scientific Review, National
VerDate Sep<11>2014
19:25 Apr 11, 2023
Jkt 259001
Proposed Collection; 60-Day Comment
Request; Specimen Resource Locator
(National Cancer Institute)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide an
opportunity for public comment on
proposed data collection projects, the
National Institutes of Health, National
Cancer Institute (NCI) will publish
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Joanne Demchok, Program
Director, Cancer Diagnosis Program,
Division of Cancer Treatment and
Diagnosis, 9609 Medical Center Drive,
Rockville, Md. 20892 or call non-tollfree number 240–276–5959 or Email
SUMMARY:
PO 00000
Frm 00089
Fmt 4703
Sfmt 4703
your request, including your address to:
peterjo@mail.nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
SUPPLEMENTARY INFORMATION: Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: written
comments and/or suggestions from the
public, and affected agencies are invited
to address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimizes the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Proposed Collection Title: Specimen
Resource Locator (NCI), 0925–0703:
Expiration Date 11/30/2023,
EXTENSION, National Cancer Institute
(NCI), National Institutes of Health
(NIH).
Need and Use of Information
Collection: The availability of
specimens and associated data is critical
to increase our knowledge of cancer
biology and to translate important
research discoveries into clinical
applications. The development of
molecular technologies in cancer
patients with defined molecular
abnormalities advances the
identification and development of
clinically useful biomarkers and
diagnostic assays that guide treatment.
The discovery and validation of
cancer prevention markers require
researchers’ access to quality clinical
biospecimens. In response to this need,
NCI’s Cancer Diagnosis Program
developed, and is expanding, a
searchable database: Specimen Resource
Locator (SRL) https://
specimens.cancer.gov/tissue/
default.htm. The SRL allows scientists
in the research community and the NCI
E:\FR\FM\12APN1.SGM
12APN1
]]>Agencies
[Federal Register Volume 88, Number 70 (Wednesday, April 12, 2023)]
[Notices]
[Pages 22045-22049]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07683]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0918]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food Labeling Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) 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 information collection activity associated
with statutory and regulatory food labeling requirements.
DATES: Either electronic or written comments on the collection of
information must be submitted by June 12, 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 June 12, 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.
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 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-0918 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Food Labeling Regulations.''
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 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-2015-09-18/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.
[[Page 22046]]
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: 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
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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 sets 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 ena ble 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 discusses sections 403(r)(3) and 403(r)(2) (21 U.S.C.
343(r)(3) and (2)) 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 number 0910-0728. The Tobacco Tax and Trade Bureau is
[[Page 22047]]
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 number 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.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section; activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
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 1 1 1 80 80
establish 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...........
-------------------------------------------------------------------------------
Total....................... .............. .............. 10,038 .............. 80,623
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
101.91; Documentation necessary to verify 5,000 56 280,000 0.45 (~27 minutes)...................... 126,000
compliance with gluten free labeling.
---------------------------------------------------------------------------------------------------------
Total..................................... .............. .............. 1,369,064 ........................................ 990,064
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 22048]]
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of disclosures per Total annual Average burden per disclosure Total hours
respondents respondent disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.3, 101.22, parts 102 and 104; statement of 25,000 1.03 25,750 0.5 (30 minutes)....................... 12,875
identity labeling requirements.
101.4, 101.22, 101.100, parts 102, 104 and 25,000 1.03 25,750 1...................................... 25,750
105; ingredient labeling requirements.
101.5; requirement to specify the name and 25,000 1.03 25,750 0.25 (15 minutes)...................... 6,438
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 25,000 1.03 25,750 4...................................... 103,000
part 104; labeling requirements for
disclosure of nutrition information.
101.9(g)(9) and 101.36(f)(2); alternative 12 1 12 4...................................... 48
means of compliance permitted.
101.10; requirements for nutrition labeling of 300,000 1.5 450,000 0.25 (15 minutes)...................... 112,500
restaurant foods.
101.12(b); RACC for baking powder, baking 29 2.3 67 1...................................... 67
soda, and pectin.
101.12(e); adjustment to the RACC of an 25 1 25 1...................................... 25
aerated food permitted.
101.12(g); requirement to disclose the serving 5,000 1 5,000 1...................................... 5,000
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 200 1 200 1...................................... 200
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, 5,000 1 5,000 1...................................... 5,000
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 300,000 1.5 450,000 0.75 (45 minutes)...................... 337,500
disclose the basis for nutrient content
claims made for their food.
101.14(d)(2); general requirements for 300,000 1.5 450,000 0.75 (45 minutes)...................... 337,500
disclosure of nutrition information related
to health claims for food products.
101.15; requirements pertaining to prominence 160 10 1,600 8...................................... 12,800
of required statements and use of foreign
language.
101.22(i)(4); supplier certifications for 25 1 25 1...................................... 25
flavors designated as containing no
artificial flavors.
101.30 and 102.33; labeling requirements for 1,500 5 7,500 1...................................... 7,500
fruit or vegetable juice beverages.
101.36; nutrition labeling of dietary 300 40 12,000 4.025.................................. 48,300
supplements.
101.42 and 101.45; nutrition labeling of raw 1,000 1 1,000 0.5 (30 minutes)....................... 500
fruits, vegetables, and fish.
101.45(c); databases of nutrient values for 5 4 20 4...................................... 80
raw fruits, vegetables, and fish.
101.79(c)(2)(i)(D); disclosure requirements 1,000 1 1,000 0.25 (15 minutes)...................... 250
for food labels that contain a folate/neural
tube defect health claim.
101.79(c)(2)(iv); disclosure of amount of 100 1 100 0.25 (15 minutes)...................... 25
folate for food labels that contain a folate/
neural tube defect health claim.
101.100(d); disclosure of agreements that form 1,000 1 1,000 1...................................... 1,000
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 25,000 1.03 25,750 0.5 (30 minutes)....................... 12,875
for food not accurately labeled for quantity
of contents and for claiming certain labeling
exemptions.
Nutritional labeling for new products......... 500 1 500 2...................................... 1,000
``Labeling of Certain Beers Subject to the 12 1 12 1...................................... 12
Labeling Jurisdiction of the Food and Drug
Administration''.
---------------------------------------------------------------------------------------------------------
[[Page 22049]]
Total..................................... .............. ............... .............. ....................................... 1,030,270
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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.
Dated: April 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07683 Filed 4-11-23; 8:45 am]
BILLING CODE 4164-01-P
