[Federal Register Volume 77, Number 116 (Friday, June 15, 2012)]
[Notices]
[Pages 35983-35985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-14631]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0593]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Eye Tracking Experimental Studies To Explore Consumer 
Use of Food Labeling Information and Consumer Response to Online 
Surveys

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 a study entitled ``Eye Tracking 
Experimental Studies to Explore Consumer Use of Food Labeling 
Information and Consumer Response to Online Surveys.''

DATES: Submit either electronic or written comments on the collection 
of information by August 14, 2012.

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: Domini Bean, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T, 
Rockville, MD 20850, [email protected].

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.

[[Page 35984]]

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.

Eye Tracking Experimental Studies To Explore Consumer Use of Food 
Labeling Information and Consumer Response to Online Surveys--(OMB 
Control Number 0910--NEW)

I. Background

    Eye tracking is a consumer research technique often used to 
determine where a person is looking while interacting with a visual 
display, such as a product package and elements of information on the 
package. The technique collects eye movement data, i.e., fixations and 
saccades (jumps of the eye), which may be superimposed on the display 
image to reveal: (1) Which parts of the display captured the viewer's 
attention; (2) the order and path in which visual elements were seen; 
and (3) the length of time they were viewed. These data provide 
detailed information on what individuals pay attention to on product 
packages, how long they spend looking at different package elements, 
and how visual attention may be related to their reaction to the images 
(Refs. 1-4, 7). Data from eye-tracking studies can also help improve 
questionnaire design. Different respondents may pay differing degrees 
of attention to the elements of a survey question or response options. 
Eye tracking data can help to identify the need and strategies for 
improving the design (Refs. 5 and 6). Finally, eye tracking data can 
provide information on the decision strategies that individuals use 
under different levels of time pressure, which can help reveal the 
influence of time on busy individuals' food choices (Refs. 4 and 7).
    As a public health agency, the FDA helps consumers make informed 
dietary decisions by regulating nutrition information on food labels, 
among other activities. An understanding of how visual elements (e.g., 
labeling statements such as claims, disclosure statements, logos, and 
Nutrition Facts label) influence consumers' perceptions and choices of 
products can assist the Agency in developing labeling information to 
help consumers make informed dietary decisions. In addition, FDA uses 
self-administered questionnaires in online experimental studies to 
assess consumer reactions to nutrition information on food packages. An 
understanding of how respondents react to survey materials that are 
presented visually will enhance the Agency's ability in collecting 
better consumer data to help it fulfill its missions.
    The proposed data collection will use eye tracking research to 
examine consumers' eye movements to achieve three goals: (1) To better 
understand consumer reaction to specific food labeling information; (2) 
to better understand survey respondent reaction to specific survey 
questions related to nutrition and health; and (3) to better understand 
how time pressure influences the priority and quality of decision 
making and survey response. In order to observe consumers' eye movement 
in different types of settings, we propose to conduct two separate 
studies, one in each of two different settings. Study 1 is a laboratory 
study that will ask participants to view on a computer screen mockups 
of food labels and perform tasks as well as answer other survey 
questions. Study 2 is an in-store study that will record eye movement 
data from grocery shoppers while they shop for preselected product 
categories. The studies will use two different survey instruments. 
Study participants will come from two separate convenience samples.
A. Study 1 (Laboratory Study)
    Study 1 is a controlled randomized experiment. It has two 
objectives. The first objective is to collect data on how consumers 
view and process label information. The data will be used to test the 
hypothesis that one or more label and information characteristics will 
cause variations in viewing and processing. Examples of these 
characteristics include: (1) The presence or absence of a specific 
component (e.g., a nutrition symbol); (2) the presence or absence of 
other labeling components on the panel (e.g., a ``Rich in Antioxidant 
Vitamins'' statement); (3) the degree of clutter on the panel (e.g., 
the number and prominence of pictorial images); (4) the relevance or 
irrelevance of the component (e.g., a ``cholesterol-free'' statement on 
a savory snack product versus the same statement on a vegetable oil 
product); and (5) the featured nutrient or health benefit (e.g., 
``helps protect immune system'' versus ``supports a healthy 
cardiovascular system'').
    Label images will be created to allow the study to focus on 
consumer reaction to specific components of information on a food 
label. All images will be mockups resembling food labels that may be 
found in the marketplace but without any real or fictitious brand name.
    The second objective of Study 1 is to examine how time pressure 
affects information processing. The data will be used to test the 
hypothesis that time pressure will cause variations in participant 
reactions (notice, attention, use, perception, and intention) to 
information. To test this hypothesis, the study will expose 
participants to 5 randomly assigned time conditions, such as 5 seconds 
per question versus 10 seconds per question.
    The study will also include certain questions selected from 
previous online research sponsored by the Agency in order to examine 
which part(s) of a question or which response options participants 
notice and pay attention to when they are asked to answer a question. 
Time conditions may also be applied to this part of the study to test 
the hypothesis that time pressure will cause variations in viewing 
patterns, response strategies, and quality of response.
    In the study, we plan to collect data from 200 participants using a 
15-minute computer-assisted self-administered questionnaire and a 5-
minute debriefing questionnaire. Forty interviews are planned for each 
of 5 locations across the contiguous 48 States. Participants will be 
recruited from residents at each location, and the study will aim to 
have a reasonable degree of diversity in participant gender, age, and 
education. On a computer screen, participants will first view a series 
of label images and answer questions about their perceptions and 
behavioral intention in response to the label that they see. Then 
participants will view a set of previously administered survey 
questions and provide answers to the questions they see. Each 
participant will be randomly assigned to an experimental condition that 
differs

[[Page 35985]]

primarily in label components and time limit. To help understand the 
data, the study will also collect information on each participant's 
background, such as health status, label reading behavior, and dietary 
preferences.
B. Study 2 (In-Store Study)
    In Study 2, we plan to collect observations of what information 
grocery shoppers notice and pay attention to while they do their 
shopping in the store. The study will gather eye-movement data to 
provide an indepth understanding of subconscious and conscious factors 
that influence food purchases. Specifically, the study will explore the 
role that the Principal Display Panel and other label information and 
components play in purchase decisions. The data will be used to test 
hypotheses such as whether product familiarity or personal needs will 
cause variations in information seeking and whether design elements 
(e.g., prominence, text vs. graphics) will cause variations in 
information seeking. To keep the study within a manageable scope, only 
shoppers who plan to shop for one or more of preselected product 
categories will be eligible to participate. Other than product 
categories, however, participants will not be restricted to which 
products they examine, what label information they view, or how much 
time they spend in completing any part of the study. To help understand 
the data, the study will also collect information on each participant's 
background, such as health status and shopping practices. Study 2 plans 
to collect data from 60 participants who will each spend an average of 
45 minutes in the study, including a practice session, the shopping 
trip, and a debriefing. The study will be conducted in two different 
locations. Participants will be recruited at storefronts.
    Both the laboratory study (Study 1) and the in-store study (Study 
2) are part of the Agency's continuing effort to enable consumers to 
make informed dietary choices. The Agency will use the studies to 
assess consumer attention to and use of various pieces of information 
on food packages and the information's influence on product perceptions 
and choices. The assessment will provide the Agency background 
information to help identify and develop more effective labeling 
information and education in the future. In addition, the Agency will 
use Study 1 to assess consumer behaviors when they are asked to respond 
to a sample of questions used in the Agency's consumer research. The 
assessment will help enhance FDA's ability to conduct research that 
provides useful information. Wherever possible, the Agency will also 
attempt to compare findings from the two studies to assess how much 
results observed in the laboratory reflect actual behaviors in the 
market. For example, do laboratory and in-store participants pay 
attention to different labeling elements when they make a shopping 
choice? The results of the studies will neither be used to develop 
population estimates nor be directly used to inform policy.
    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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Laboratory Pretest Invitation...............              30               1              30  .033 (2 minutes)..........................               1
Laboratory Pretest..........................              15               1              15  1.........................................              15
Laboratory Study Invitation.................             500               1             500  0.033 (2 minutes).........................              17
Laboratory Study............................             200               1             200  0.333 (20 minutes)........................              67
In-store Study Invitation...................             300               1             300  0.083 (5 minutes).........................              25
In-store Study..............................              60               1              60  0.75 (45 minutes).........................              45
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    Total...................................  ..............  ..............  ..............  ..........................................             170
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

II. References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES) and may be seen between 9 a.m. and 4 p.m., 
Monday through Friday.

1. Jones, G. and M. Richardson. An Objective Examination of Consumer 
Perception of Nutrition Information Based on Healthiness Ratings and 
Eye Movements. Public Health Nutrition 10: 238-244, 2007.
2. Bialkova, S. and H.C.M. van Trijp. What Determines Consumer 
Attention to Nutrition Labels? Food Quality and Preference 21: 1042-
1051, 2010.
3. van Herpen, E. and H.C.M. van Trijp. Front-of-Pack Nutrition 
Labels, Their Effect on Attention and Choices When Consumers Have 
Varying Goals and Time Constraints. Appetite 57: 148-160, 2011.
4. Fox, R.J., D.M. Krugman, J.E. Fletcher, and P.M. Fischer. 
Adolescents' Attention to Beer and Cigarette Print Ads and 
Associated Product Warnings. Journal of Advertising 27: 57-68, 1998.
5. Galesic, M., R. Tourangeau, M.P. Couper, and F.G. Conrad. Eye-
Tracking Data: New Insights on Response Order Effects and Other 
Cognitive Shortcuts in Survey Responding. Public Opinion Quarterly 
72: 892-913, 2008.
6. Graesser, A.C., Z. Cai, M.M. Louwerse, and F. Daniel. Question 
Understanding Aid (QUAID): A Web Facility That Tests Question 
Comprehensibility. Public Opinion Quarterly 70: 3-22, 2006
7. Reutskaja, E., R. Nagel, C.F. Camerer, and A. Rangel. Search 
Dynamics in Consumer Choice under Time Pressure: An Eye-Tracking 
Study. American Economic Review 101: 900-926, 2011.

    Dated: June 11, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14631 Filed 6-14-12; 8:45 am]
BILLING CODE 4160-01-P