Notice2023-01551
Agency Information Collection Activities; Proposed Collection; Comment Request; Quantitative Research on Front of Package Labeling on Packaged Foods
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 26, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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."
Full Text
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<title>Federal Register, Volume 88 Issue 17 (Thursday, January 26, 2023)</title>
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[Federal Register Volume 88, Number 17 (Thursday, January 26, 2023)]
[Notices]
[Pages 5005-5007]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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:
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#643436253710050202240200054a0c0c174a030b12"><span class="__cf_email__" data-cfemail="6d3d3f2c3e190c0b0b2d0b090c4305051e430a021b">[email protected]</span></a>.
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\ <a href="https://www.cdc.gov/obesity/index.html">https://www.cdc.gov/obesity/index.html</a>.
\2\ <a href="https://www.fda.gov/food/food-labeling-nutrition/fdas-nutrition-initiatives">https://www.fda.gov/food/food-labeling-nutrition/fdas-nutrition-initiatives</a>.
\3\ <a href="https://www.whitehouse.gov/wp-content/uploads/2022/09/White-House-National-Strategy-on-Hunger-Nutrition-and-Health-FINAL.pdf">https://www.whitehouse.gov/wp-content/uploads/2022/09/White-House-National-Strategy-on-Hunger-Nutrition-and-Health-FINAL.pdf</a>.
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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
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focus group testing, with additional variations informed by, among
other things, focus group results (see <a href="https://www.reginfo.gov/public/do/PRAViewIC?ref_nbr=202008-0910-021&icID=253321">https://www.reginfo.gov/public/do/PRAViewIC?ref_nbr=202008-0910-021&icID=253321</a> 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
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