[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]


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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.

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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, 
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, 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\
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                                                   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
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\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


