[Federal Register Volume 74, Number 103 (Monday, June 1, 2009)]
[Notices]
[Pages 26244-26246]
From the Federal Register Online via the Government Printing 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