Federal Register, Volume 74 Issue 103 (Monday, June 1, 2009)

[Federal Register Volume 74, Number 103 (Monday, June 1, 2009)]
[Notices]
[Pages 26244-26246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-12669]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0220]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Experimental Study of Nutrition Symbols on Food
Packages

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the 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 the Experimental Study of Nutrition Symbols
on Food Packages.

DATES: Submit written or electronic comments on the collection of
information by July 31, 2009.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3794.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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.

Experimental Study of Nutrition Symbols on Food Packages

FDA has been following the emergence of front-of-package nutrition
symbols in the marketplace. These symbols are associated with programs
from sources including food manufacturers, retailers, and third party
organizations (e.g., trade and health organizations). The symbols are
intended to assist consumer choice by providing simplified and easily-
accessible information on the nutritional attributes of a food product.
Relevant and nonproprietary information about the effects of nutrition
symbols on consumers, however, is limited (see, for example, Feunekes
et al., 2008; ``FDA Comments on Symbols Public Hearing and Current
Plans for Addressing Issues,'' Docket

[[Page 26245]]

No. FDA-2007-N-0198).\1\ \2\ Therefore, FDA is proposing to conduct an
experimental study to assess quantitative consumer reactions to front-
of-package nutrition symbols.
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\1\ Feunekes, G. I. J., I. A. Gortemaker, A. A. Willems, and R.
Lion, Front-of-pack Nutrition Labeling: Testing Effectiveness of
Different Nutrition Labeling Formats Front-of-pack in Four European
Countries, Appetite 50(1): 57-70, 2008.
\2\ http://www.cfsan.fda.gov/~dms/cfsup196.html.
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FDA conducts research and educational and public information
programs relating to food safety under its broad statutory authority,
set forth in section 903(b)(2) of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 393 (b)(2)), to protect the public health by
ensuring that foods are ``safe, wholesome, sanitary, and properly
labeled,'' and in section 903(d)(2)(C) (21 U.S.C. 393 (d)(2)(C)), to
conduct research relating to foods, drugs, cosmetics and devices in
carrying out the act.
The purpose of the study is to help enhance FDA's understanding of
consumer understanding and use of a selected sample of nutrition
symbols in the domestic marketplace. The study is part of the agency's
continuing effort to enable consumers to make informed dietary choices
and construct healthful diets.
The proposed experimental study will use a Web-based survey to
collect information from a sample of adult members in an online
consumer panel established by a contractor. The study plans to randomly
assign each of 2,400 participants to view a label from a set of food
labels that vary in the presence and type of symbol, the type of food
product, and the quality of nutritional attributes of the product. The
study plans to make the mandatory Nutrition Facts label available to
all participants. The study will focus on the following types of
consumer reaction: (1) Judgments about a food product in terms of its
nutritional attributes, overall healthfulness, health benefits, and
other characteristics such as taste; (2) judgments about a label in
terms of its credibility in conveying the product's nutritional
attributes and helpfulness in product choices; (3) identification of
the more nutritious product in a pair of products; and (4) impact of
the symbol on the use of the Nutrition Facts label. To help understand
consumer reactions, the study will also collect information on
participants' background, including but not limited to consumption and
perceptions of food products, nutrition attitudes and practice, food
label use, health literacy, and health status.
In addition, the study will conduct a separate face-to-face eye-
tracking examination using a separate sample of 30 adult consumers to
explore their label viewing patterns when they are asked to judge
product attributes and to compare products. Participants will be
selected from a commercial database of consumers.
The study results will be used to help the agency in its continuing
evaluation of issues related to the use of nutrition symbols in food
labeling. The results of the experimental study will not be used to
develop population estimates.
FDA estimates the burden of this collection of information as
follows:

Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
Portion of Study Respondents per Response Responses Response Total Hours
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Cognitive interview screener 144 1 144 0.083 12
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Cognitive interview 18 1 18 1 18
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Pretest invitation 1,600 1 1,600 0.033 53
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Pretest 200 1 200 0.25 50
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Survey invitation 19,200 1 19,200 0.033 634
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Survey 2,400 1 2,400 0.25 600
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Eye-tracking screener 240 1 240 0.083 20
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Eye-tracking 30 1 30 1 30
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Total 1,417
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information..

To help design and refine the questionnaire to be used for the
experimental study, we plan to conduct cognitive interviews by
screening 144 adult consumers in order to obtain 18 participants in the
interviews. Each screening is expected to take 5 minutes (0.083 hours)
and each cognitive interview is expected to take 1 hour. The total for
cognitive interview activities is 30 hours (12 hours + 18 hours).
Subsequently, we plan to conduct pretests of the survey questionnaire
before it is administered in the study. We expect that 1,600
invitations, each taking 2 minutes (0.033 hours), will need to be sent
to adult members of an online consumer panel to have 200 of them
complete a 15-minute (0.025 hours) pretest. The total for the pretest
activities is 103 hours (53 hours + 50 hours). For the survey, we
estimate that 19,200 invitations, each taking 2 minutes (0.033 hours),
will need to be sent to adult members of an online consumer panel to
have 2,400 of them complete a 15-minute (0.025 hours) questionnaire.
The total for the survey activities is 1,234 hours (634 hours + 600
hours). To conduct the eye-tracking study, we expect to screen 240
adult consumers, each taking 5 minutes (0.083 hours), to have 30 of
them participate in an 1-hour interview. The total for the eye-tracking
activities is 50 hours (20 hours + 30 hours). Thus, the total estimated
burden is 1,417 hours. FDA's burden estimate is based on prior
experience with research that is similar to this proposed study.

[[Page 26246]]

Dated: May 26, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-12669 Filed 5-29-09; 8:45 am]
BILLING CODE 4160-01-S