Agency Information Collection Activities; Proposed Collection; Comment Request; Quantitative Research on a Voluntary Symbol Depicting the Nutrient Content Claim “Healthy” on Packaged Foods, 24629-24631 [2021-09622]
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Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Notices
were not responsive to the information
collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Center for Devices and Radiological Health 513(g) requests ...............................................................................
Center for Biologics Evaluation and Research 513(g) requests ...............................................................................
Total ..............................................................................
1 There
Dated: April 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–09624 Filed 5–6–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0336]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Quantitative
Research on a Voluntary Symbol
Depicting the Nutrient Content Claim
‘‘Healthy’’ on Packaged Foods
Food and Drug Administration,
HHS.
ACTION:
Average
burden per
response
Total annual
responses
Total hours
114
1
114
12
1,368
4
1
4
12
48
........................
........................
........................
........................
1,416
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
AGENCY:
Number of
responses per
respondent
Number of
respondents
Activity
Notice.
The Food and Drug
Administration (FDA, we, 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 and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on a new collection
of information for a study entitled
‘‘Quantitative Research on a Voluntary
Symbol Depicting the Nutrient Content
Claim ‘Healthy’ on Packaged Foods.’’
DATES: Submit either electronic or
written comments on the collection of
information by July 6, 2021.
ADDRESSES: You may submit comments
as follows. Please note that late,
SUMMARY:
VerDate Sep<11>2014
19:55 May 06, 2021
Jkt 253001
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before July 6, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of July 6, 2021. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is 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
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
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–
2021–N–0336 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Quantitative Research on a Voluntary
Symbol Depicting the Nutrient Content
Claim ‘Healthy’ on Packaged Foods.’’
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
E:\FR\FM\07MYN1.SGM
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Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Notices
‘‘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: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, 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
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,
VerDate Sep<11>2014
19:55 May 06, 2021
Jkt 253001
when appropriate, and other forms of
information technology.
Quantitative Research on a Voluntary
Symbol Depicting the Nutrient Content
Claim ‘‘Healthy’’ on Packaged Foods
OMB Control Number 0910–NEW
Section 403(r)(1)(A) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 343(r)(1)(A)) permits the
use of label and labeling claims that
characterize the level of a nutrient in a
food when the claims are made in
accordance with FDA’s regulations.
Such claims are referred to as ‘‘nutrient
content claims.’’ We have issued
regulations under section 403(r)(1)(A) of
the FD&C Act defining ‘‘implied
nutrient content claims’’ as those that
imply that a food, because of its nutrient
content, may be useful in achieving a
total diet that conforms to current
dietary recommendations (‘‘Food
Labeling: Nutrient Content Claims,
General Principles, Petitions, Definition
of Terms,’’ 58 FR 2302 at 2374, January
6, 1993). We have determined that a
claim that a food, because of its nutrient
content, may be useful in maintaining
healthy dietary practices is clearly a
claim that characterizes the level of
nutrients in that food. The claim is
essentially saying that the level of
nutrients in the food is such that the
food will contribute to good health (58
FR 2302 at 2375). In 1994, we issued a
definition of ‘‘healthy’’ as an implied
nutrient content claim (59 FR 24232,
May 10, 1994); the regulation is codified
at 21 CFR 101.65(d)(2).
In 2018, we announced our Nutrition
Innovation Strategy (https://
www.fda.gov/food/food-labelingnutrition/fda-nutrition-innovationstrategy) outlining key priorities the
Agency intended to pursue to reduce
the burden of chronic disease through
improved nutrition and advance its
public health mission. To help advance
these goals, we are exploring the
development of a graphic symbol to
help consumers identify packaged food
products that meet FDA’s definition of
‘‘healthy.’’ The symbol would be a
graphic representation of the nutrient
content claim ‘‘healthy’’ and, like the
implied nutrient content claim
‘‘healthy’’ itself, would be voluntary for
packaged food companies. Companies
could voluntarily use the symbol on
food products that meet FDA’s
definition of ‘‘healthy.’’
In 2019 and 2020, FDA conducted a
review of the literature on front-ofpackage (FOP) nutrition-related symbols
and conducted a series of focus groups
to test symbol concepts and draft FOP
symbols (see Docket No. FDA–2021–N–
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
0336 for a table of draft FOP symbols
and the literature review).
As part of its efforts to promote public
health, FDA proposes to conduct three
consecutive quantitative research
studies—an experimental study and two
surveys—to explore consumer responses
to the draft FOP symbols that
manufacturers could voluntarily use on
a food product as a graphic
representation of the nutrient content
claim ‘‘healthy.’’ If research results
suggest the need, the symbols will be
fine-tuned following the experimental
study and again fine-tuned following
each survey. The first study will be a
controlled, randomized experiment
(hereafter called Study 1). Study 1 will
use a 15-minute web-based
questionnaire to collect information
from 5,000 U.S. adult members of an
online consumer panel maintained by a
contractor. The surveys, Studies 2 and
3, will each utilize the same instrument,
a 10-minute questionnaire, to test sets of
draft FOP symbols. Studies 2 and 3 will
each draw a sample of 1,000 U.S. adult
participants from an online consumer
panel.
Conditions for Study 1 will be: (1) A
set of draft FOP symbols, including ‘‘nosymbol’’ controls; (2) three types of
mock food products (i.e., a breakfast
cereal, a frozen meal, and a canned
soup); (3) a ‘‘no-information’’ condition
where no explanation of the symbol is
provided; and; (4) a Uniform Resource
Locator (URL) condition, in which a
URL is tested alongside the symbol.
Each participant in Study 1 will be
randomly assigned to a condition,
which will include viewing a label
image and responding to various
measures of the symbol’s effectiveness.
Product perceptions (e.g., healthfulness
and contribution to a healthy diet), label
perceptions (e.g., believability and
trustworthiness), and purchase/choice
questions will constitute the measures
of response in the experiment. The
instrument will also collect information
from participants about their history of
purchasing or consuming similar
products; nutrition knowledge; dietary
interests; motivation regarding label use;
health status; and demographic
characteristics.
Studies 2 and 3 will utilize nonprobability survey methods, using a
web-based panel to draw a sample of
U.S. adults ages 18 and older who selfidentify as primary food shoppers. The
sample will be balanced to the
demographics of the U.S. population.
The survey instruments will focus on
clarity, relevance, and appeal of a small
subset of revised symbols.
The studies are part of our continuing
effort to enable consumers to make
E:\FR\FM\07MYN1.SGM
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Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Notices
informed dietary choices and construct
healthful diets. We intend to use the
results to inform our continued
exploration of a symbol manufacturers
could voluntarily use to represent the
nutrient content claim ‘‘healthy’’ on the
food label. We will not use the results
to develop population estimates.
Description of Respondents:
Respondents to this collection of
24631
information include members of the
general public.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Study
er.
Study
Study
Study
Study
Study
Study
Study
Study
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours
1 (Experiment) Cognitive interview screen-
75
1
75
0.083 (5 minutes) .........
6
(Survey) Cognitive interview screener 2 ..
(Experiment) Cognitive interview ............
(Survey) Cognitive interview ...................
(Experiment) Pretest ...............................
(Survey) Pretest 2 ....................................
(Experiment) ............................................
(Survey) ...................................................
(Survey) ...................................................
75
9
5
180
25
5,000
1,000
1,000
1
1
1
1
1
1
1
1
75
9
5
180
25
5,000
1,000
1,000
0.083 (5 minutes) .........
1 ....................................
1 ....................................
0.25 (15 minutes) .........
0.17 (10 minutes) .........
0.25 (15 minutes) .........
0.17 (10 minutes) .........
0.17 (10 minutes) .........
6
9
5
45
4
1,250
170
170
Total ...............................................................
........................
........................
........................
.......................................
1,665
2
1
2
1
2
1
2
3
1 There
2 Since
are no capital costs or operating and maintenance costs associated with this collection of information.
Study 3 is identical to Study 2, only one set of cognitive interviews and pretests are needed.
Dated: April 30, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–09622 Filed 5–6–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0357]
Pharmacy Compounding Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA or the Agency)
announces a forthcoming public
advisory committee meeting of the
Pharmacy Compounding Advisory
Committee. The general function of the
committee is to provide advice on
scientific, technical, and medical issues
concerning drug compounding under
the Federal Food, Drug, and Cosmetic
Act (FD&C Act), and, as required, any
other product for which FDA has
regulatory responsibility, and to make
appropriate recommendations to the
Agency. The meeting will be open to the
public. FDA is establishing a docket for
public comment on this document.
SUMMARY:
VerDate Sep<11>2014
19:55 May 06, 2021
Jkt 253001
The meeting will be held on June
9, 2021, from 10 a.m. to 5:05 p.m.
Eastern Time.
ADDRESSES: Please note that due to the
impact of the COVID–19 pandemic, all
meeting participants will be joining this
advisory committee meeting via an
online teleconferencing platform.
Answers to commonly asked questions
about FDA advisory committee meetings
may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2021–N–0357.
The docket will close on June 8, 2021.
Submit either electronic or written
comments on this public meeting by
June 8, 2021. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before June 8, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of June 8, 2021. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Comments received on or before May
26, 2021, will be provided to the
committee. Comments received after
that date will be taken into
consideration by FDA. In the event that
the meeting is cancelled, FDA will
continue to evaluate any relevant
applications or information, and
DATES:
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
consider any comments submitted to the
docket, as appropriate.
You may submit comments as
follows:
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
E:\FR\FM\07MYN1.SGM
07MYN1
]]>Agencies
[Federal Register Volume 86, Number 87 (Friday, May 7, 2021)]
[Notices]
[Pages 24629-24631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09622]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0336]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Quantitative Research on a Voluntary Symbol Depicting
the Nutrient Content Claim ``Healthy'' on Packaged Foods
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, we, 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 and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on a new collection of information for a study
entitled ``Quantitative Research on a Voluntary Symbol Depicting the
Nutrient Content Claim `Healthy' on Packaged Foods.''
DATES: Submit either electronic or written comments on the collection
of information by July 6, 2021.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 6, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 6, 2021. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is 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-2021-N-0336 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Quantitative Research on a
Voluntary Symbol Depicting the Nutrient Content Claim `Healthy' on
Packaged Foods.'' 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
[[Page 24630]]
``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.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[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 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.
Quantitative Research on a Voluntary Symbol Depicting the Nutrient
Content Claim ``Healthy'' on Packaged Foods
OMB Control Number 0910-NEW
Section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 343(r)(1)(A)) permits the use of label and
labeling claims that characterize the level of a nutrient in a food
when the claims are made in accordance with FDA's regulations. Such
claims are referred to as ``nutrient content claims.'' We have issued
regulations under section 403(r)(1)(A) of the FD&C Act defining
``implied nutrient content claims'' as those that imply that a food,
because of its nutrient content, may be useful in achieving a total
diet that conforms to current dietary recommendations (``Food Labeling:
Nutrient Content Claims, General Principles, Petitions, Definition of
Terms,'' 58 FR 2302 at 2374, January 6, 1993). We have determined that
a claim that a food, because of its nutrient content, may be useful in
maintaining healthy dietary practices is clearly a claim that
characterizes the level of nutrients in that food. The claim is
essentially saying that the level of nutrients in the food is such that
the food will contribute to good health (58 FR 2302 at 2375). In 1994,
we issued a definition of ``healthy'' as an implied nutrient content
claim (59 FR 24232, May 10, 1994); the regulation is codified at 21 CFR
101.65(d)(2).
In 2018, we announced our Nutrition Innovation Strategy (https://www.fda.gov/food/food-labeling-nutrition/fda-nutrition-innovation-strategy) outlining key priorities the Agency intended to pursue to
reduce the burden of chronic disease through improved nutrition and
advance its public health mission. To help advance these goals, we are
exploring the development of a graphic symbol to help consumers
identify packaged food products that meet FDA's definition of
``healthy.'' The symbol would be a graphic representation of the
nutrient content claim ``healthy'' and, like the implied nutrient
content claim ``healthy'' itself, would be voluntary for packaged food
companies. Companies could voluntarily use the symbol on food products
that meet FDA's definition of ``healthy.''
In 2019 and 2020, FDA conducted a review of the literature on
front-of-package (FOP) nutrition-related symbols and conducted a series
of focus groups to test symbol concepts and draft FOP symbols (see
Docket No. FDA-2021-N-0336 for a table of draft FOP symbols and the
literature review).
As part of its efforts to promote public health, FDA proposes to
conduct three consecutive quantitative research studies--an
experimental study and two surveys--to explore consumer responses to
the draft FOP symbols that manufacturers could voluntarily use on a
food product as a graphic representation of the nutrient content claim
``healthy.'' If research results suggest the need, the symbols will be
fine-tuned following the experimental study and again fine-tuned
following each survey. The first study will be a controlled, randomized
experiment (hereafter called Study 1). Study 1 will use a 15-minute
web-based questionnaire to collect information from 5,000 U.S. adult
members of an online consumer panel maintained by a contractor. The
surveys, Studies 2 and 3, will each utilize the same instrument, a 10-
minute questionnaire, to test sets of draft FOP symbols. Studies 2 and
3 will each draw a sample of 1,000 U.S. adult participants from an
online consumer panel.
Conditions for Study 1 will be: (1) A set of draft FOP symbols,
including ``no-symbol'' controls; (2) three types of mock food products
(i.e., a breakfast cereal, a frozen meal, and a canned soup); (3) a
``no-information'' condition where no explanation of the symbol is
provided; and; (4) a Uniform Resource Locator (URL) condition, in which
a URL is tested alongside the symbol. Each participant in Study 1 will
be randomly assigned to a condition, which will include viewing a label
image and responding to various measures of the symbol's effectiveness.
Product perceptions (e.g., healthfulness and contribution to a healthy
diet), label perceptions (e.g., believability and trustworthiness), and
purchase/choice questions will constitute the measures of response in
the experiment. The instrument will also collect information from
participants about their history of purchasing or consuming similar
products; nutrition knowledge; dietary interests; motivation regarding
label use; health status; and demographic characteristics.
Studies 2 and 3 will utilize non-probability survey methods, using
a web-based panel to draw a sample of U.S. adults ages 18 and older who
self-identify as primary food shoppers. The sample will be balanced to
the demographics of the U.S. population. The survey instruments will
focus on clarity, relevance, and appeal of a small subset of revised
symbols.
The studies are part of our continuing effort to enable consumers
to make
[[Page 24631]]
informed dietary choices and construct healthful diets. We intend to
use the results to inform our continued exploration of a symbol
manufacturers could voluntarily use to represent the nutrient content
claim ``healthy'' on the food label. We will not use the results to
develop population estimates.
Description of Respondents: Respondents to this collection of
information include members of the general public.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Study 1 (Experiment) Cognitive 75 1 75 0.083 (5 6
interview screener. minutes).
Study 2 (Survey) Cognitive 75 1 75 0.083 (5 6
interview screener \2\. minutes).
Study 1 (Experiment) Cognitive 9 1 9 1............... 9
interview.
Study 2 (Survey) Cognitive 5 1 5 1............... 5
interview.
Study 1 (Experiment) Pretest.. 180 1 180 0.25 (15 45
minutes).
Study 2 (Survey) Pretest \2\.. 25 1 25 0.17 (10 4
minutes).
Study 1 (Experiment).......... 5,000 1 5,000 0.25 (15 1,250
minutes).
Study 2 (Survey).............. 1,000 1 1,000 0.17 (10 170
minutes).
Study 3 (Survey).............. 1,000 1 1,000 0.17 (10 170
minutes).
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 1,665
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Since Study 3 is identical to Study 2, only one set of cognitive interviews and pretests are needed.
Dated: April 30, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-09622 Filed 5-6-21; 8:45 am]
BILLING CODE 4164-01-P
