[Federal Register Volume 88, Number 17 (Thursday, January 26, 2023)]
[Notices]
[Pages 5005-5007]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01551]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0155]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Quantitative Research on Front of Package Labeling on 
Packaged Foods

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing an 
opportunity for public comment on a proposed collection of information. 
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 invites comments on an 
information collection associated with a study entitled ``Quantitative 
Research on Front of Package Labeling on Packaged Foods.''

DATES: Either electronic or written comments on the collection of 
information must be submitted by March 27, 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 March 27, 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'').

[[Page 5006]]

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-0155 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Quantitative Research on Front of 
Package Labeling 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.'' We will review 
this copy, including the claimed confidential information, in our 
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.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m., 
11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: 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 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 Front of Package Labeling on Packaged Foods

OMB Control Number 0910-NEW

    The United States continues to face an epidemic of diet-related 
chronic diseases, many of which are experienced disproportionately by 
racial and ethnic minority groups, those with lower socioeconomic 
status, and those living in rural areas.\1\ To help address this 
problem, FDA has continued to prioritize its nutrition activities \2\ 
to help empower consumers with nutrition information to make healthier 
choices more easily and encourage industry innovation by providing 
flexibility to facilitate the production of healthier foods. FDA is 
focused on: (1) creating a healthier food supply for all; (2) 
establishing a healthy start to set the foundation for a long, healthy 
life; and (3) empowering consumers through informative labeling and 
tailored education.\3\
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    \1\ https://www.cdc.gov/obesity/index.html.
    \2\ https://www.fda.gov/food/food-labeling-nutrition/fdas-nutrition-initiatives.
    \3\ https://www.whitehouse.gov/wp-content/uploads/2022/09/White-House-National-Strategy-on-Hunger-Nutrition-and-Health-FINAL.pdf.
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    FDA is exploring the development of a front of package system to 
help consumers interpret the nutrient information on food products. 
Front of Package (FOP) labeling is intended to complement the Nutrition 
Facts label by giving consumers a simple aid to provide additional 
context for making healthy food selections. As part of our food-
labeling efforts, we are exploring the establishment of a standardized, 
science-based FOP scheme that helps consumers, particularly those with 
lower nutrition literacy, quickly and easily identify foods that are 
part of a healthy eating pattern.
    The increased attention in recent years to FOP, and the experiences 
of countries that have adopted FOP labeling suggests that FOP labeling 
may aid nutrition comprehension and the ability to make healthier 
choices, especially for those with lower nutrition literacy. FOP 
schemes adopted in countries throughout the world include both 
mandatory and voluntary labeling schemes and include non-
interpretative, interpretative, nutrient specific, and summary schemes.
    In 2022, FDA conducted a review of the literature on FOP nutrition-
related labels and conducted a set of focus groups to test FOP concepts 
and draft FOP schemes (see Docket No. FDA-2023-N-0155 for the 
literature review). These focus group results provided insights into 
the varying ways that consumers interpret FOP nutrition information. As 
part of our efforts to promote public health, we intend to conduct an 
experimental study, informed by results of the focus group testing, to 
further explore consumer responses to various FOP schemes. In the 
experimental study, we will test a smaller subset of FOP schemes from 
the

[[Page 5007]]

focus group testing, with additional variations informed by, among 
other things, focus group results (see https://www.reginfo.gov/public/do/PRAViewIC?ref_nbr=202008-0910-021&icID=253321 for information about 
FDA's front-of-pack focus groups, including graphic FOP schemes 
tested). The study will be a controlled, randomized experiment that 
will use a 15-minute web-based questionnaire to collect information 
from 3,000 U.S. adult members of an online consumer panel maintained by 
a contractor. The sample will be balanced to reflect the U.S. Census on 
gender, education, age, and ethnicity/race. A measure of nutrition 
literacy will also be used to balance the sample to ensure a variety of 
literacy levels for each condition.
    Conditions for the study will be: (1) a set of draft FOP schemes, 
including ``no-scheme'' controls; (2) three types of mock food products 
(i.e., a breakfast cereal, a frozen meal, and a canned soup); and (3) a 
``no-information'' condition where no explanation of the FOP scheme is 
provided. Each participant will be randomly assigned to a condition, 
which will include viewing a label image and responding to various 
measures of the label's effectiveness. Some assignments may include 
making a choice between two label images. Product perceptions (e.g., 
healthfulness and contribution to a healthy diet), label perceptions 
(e.g., believability, trustworthiness, and effects perceptions), 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.
    The studies are part of our continuing effort to help enable 
consumers to make informed dietary choices and construct healthful 
diets. We intend to use the results to inform our continued exploration 
of an FOP labeling scheme. 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 per response           Total hours
                                                 respondents     respondent       responses
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Experiment Pretest 1.........................             180               1             180  0.25 (15 minutes)........................              45
Experiment Pretest 2.........................              25               1              25  0.25 (15 minutes)........................               6
Experiment...................................           3,000               1           3,000  0.25 (15 minutes)........................             750
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    Total....................................  ..............  ..............  ..............  .........................................             801
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: January 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01551 Filed 1-25-23; 8:45 am]
BILLING CODE 4164-01-P


