[Federal Register Volume 78, Number 128 (Wednesday, July 3, 2013)]
[Notices]
[Pages 40153-40156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-16001]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August 
2, 2013.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-New and 
title ``Eye Tracking Experimental Studies to Explore Consumer Use of 
Food Labeling Information and Consumer Response to Online Surveys.'' 
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 to 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, 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 us in developing labeling information to help 
consumers make informed dietary decisions. In addition, we use 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 our ability in collecting better 
consumer data to help us fulfill our 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. In this proposed study, we 
will focus specifically on the following characteristics: (1) Presence 
and type of nutrition symbols, together with presence of claims, on the 
Principal Display Panel (PDP) of a conventional food; (2) presence of a 
disclosure statement (21 CFR 101.13(h)(1)-(3)) on the PDP of a 
conventional food that makes a nutrient content claim; (3) format of 
the Nutrition Facts label on a conventional food product; (4) presence 
of a Dietary Supplement Health and Education Act disclaimer on the PDP 
of

[[Page 40154]]

a dietary supplement product that makes a structure/function claim; (5) 
presence and length of a qualified health claim on the PDP of a dietary 
supplement product; and (6) type of product.
    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. We will use the data 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, at certain 
selected questions, expose participants to two randomly assigned time 
conditions, such as no time limit and 10 seconds per question.
    The study will also include certain questions selected from 
previous online research we have sponsored 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 the question.
    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. Then participants will answer a set of questions 
related to their reactions to the label images they see on the computer 
screen. Each participant will be randomly assigned to an experimental 
condition that differs 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. We will use the data to test the 
hypotheses that product familiarity or personal needs will cause 
variations in information seeking and that 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. In Study 2 we plan 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 our continuing effort to enable consumers to make 
informed dietary choices. We 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 us with background information to help identify 
and develop more effective labeling information and education in the 
future. In addition, we will use data from 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 our 
ability to conduct research that provides useful information. Wherever 
possible, we will also attempt to compare findings from the two studies 
to assess the degree to which 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? Results of the study will not be used to 
develop population estimates.
    In the Federal Register of June 15, 2012 (77 FR 35983), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received three comments. One comment 
addressed matters that were outside the scope of the information 
collection provisions and will not be discussed here. We respond to the 
remaining comments in this document. For ease of reading, we preface 
each comment with a numbered ``Comment;'' and each response by a 
corresponding ``Response.'' We have numbered each comment to help 
distinguish between different topics. The number assigned to each 
comment is for organizational purposes only and does not signify the 
comment's value, or importance, or the order in which it was received.
    (Comment 1) One comment recommended that we examine the accuracy of 
the eye tracking methodology in identifying label reading patterns 
before considering applying the methodology more broadly.
    (Response) FDA agrees that it is important to assess the degree of 
accuracy the methodology can provide and we have taken this into 
consideration.
    (Comment 2) One comment questioned whether the use of eye tracking 
methodology is essential to the regulation of food labeling.
    (Response) Part of our mission is to help the public get accurate 
and science-based information needed to use foods to maintain and 
improve health (Ref. 8). To help accomplish this mission, we state in 
our 2011-2015 Strategic Plan that we will strengthen social and 
behavioral sciences to help consumers make informed decisions about 
regulated products (Ref. 9). As part of the strategy, the plan 
identifies needs in knowing the audience, ensuring audience 
understanding of information, and evaluating effectiveness of 
communication about regulated products (Ref. 9). We will use the 
proposed 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. These findings can extend and 
compliment findings from other consumer research FDA conducts and help 
us identify and develop more effective food labeling information and 
education in the future. Therefore, the use of eye tracking methodology 
is valuable to our mission in providing the public accurate and 
science-based information.
    (Comment 3) One comment questioned the practical utility of the 
information to be collected in the proposed studies. The comment stated 
that Study 1 would not yield nationally representative results because 
it uses a convenience sample and suggests this limitation be noted in 
the supporting

[[Page 40155]]

statement accompanying the Federal Register 30-day notice. The comment 
also questioned whether the sample size of Study 2 (60 participants) 
would be sufficient to yield detailed conclusions.
    (Response) The 60-day notice stated that the studies would not be 
used to develop national estimates. We repeat this statement in the 
supporting statement. Though the sample size of Study 2 is constrained 
by the available resource, the study will provide preliminary yet 
useful insights into consumer viewing experiences with food shopping.
    (Comment 4) A comment asserted that wearing eye tracking eyeglasses 
and a headset for biometric measurement in Study 2 would cause study 
subjects to behave differently from how they shop typically, thus 
weakening the reliability of the data. Instead, the comment suggests 
using a virtual store methodology in a computer-assisted central 
location test.
    (Response) The comment did not provide evidence to support its 
concern or to illustrate the advantages of a virtual store methodology 
over an eye tracking methodology. Therefore, because we do not have a 
sufficient basis to conclude that the comment's suggested methodology 
would be better suited for our purposes than the eye tracking 
methodology described in the 60-day notice, we decline to change the 
methodology for Study 2.
    (Comment 5) A comment questioned the use of the word ``healthy'' in 
certain questions because the word has a regulatory meaning and 
consumers may not understand the regulatory criteria for the claim 
``healthy.'' The comment suggested replacing ``healthy'' with 
``nutritious.'' The comment also expressed concern about questions that 
ask participants their inferences about the relationships between a 
product and the risk of diabetes and obesity or overweight. The comment 
reasoned that these health conditions should not be asked about because 
there are no current authorized health claims permitted for these 
conditions.
    (Response) We disagree with the comment. The studies are not to 
examine whether or how consumers understand labeling regulations. 
Rather, part of the purpose of the studies is to better understand how 
consumers infer from labeling the characteristics of food products. As 
stated in the comment, consumers may not understand regulatory criteria 
for claims, including ``healthy,'' and there are no authorized health 
claims that link a food to diabetes or obesity. Yet consumers make 
product inferences and decisions based on their own experiences and 
knowledge, with or without any understanding about labeling 
regulations. Hence, for consumer research purposes, it is valid and 
meaningful to include these terms and product-risk relationships as a 
measure of consumer product inferences.
    (Comment 6) A comment questioned the relevance of a series of Study 
1 questions related to participants' inferences of what health 
conditions to which a product may be related. The comment explained 
that these questions are not consistent with established policy 
regarding health claims.
    (Response) We understand and acknowledge this concern. Upon further 
consideration of the purposes of the study and the time length of the 
interview, we have revised the content of the study and removed the 
questions the comment discussed.
    (Comment 7) A comment made several editorial suggestions and 
clarifications to the proposed questionnaires. For example, the comment 
suggested that ``lesser amount of fat'' in one Study 1 question be 
corrected grammatically, that ``if you are allowed to eat xx g of 
carbohydrate as a snack'' in another Study 1 question be revised to say 
``if you wish to eat a food with xx g of carbohydrate as a snack.'' The 
comment also asked that Study 2 clarify that the participants can 
select multiple items in a product category and revise the wording in 
one question to reflect this. The comment further asked that Study 2 
clarify that the interviewer will escort the participants to the store 
aisle for the target product category.
    (Response) We have considered and incorporated the suggestions, 
when appropriate, in the revised questionnaires. For example, in Study 
1 we did not make the suggested correction on ``less amount of fat'' or 
the suggested revision on carbohydrate. Instead, being mindful of the 
length of the study instrument, these questions were removed and 
replaced with other questions. At the same time, we have made the two 
clarifications in Study 2.
    (Comment 8) A comment suggested that we make the label and package 
designs available for public review.
    (Response) We have included the label and package designs in the 
supporting statement.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Laboratory pretest invitation.              30               1              30  0.033 (2                       1
                                                                                 minutes).
Laboratory pretest............              15               1              15  1...............              15
Laboratory study invitation...             500               1             500  0.033 (2                      17
                                                                                 minutes).
Laboratory study..............             200               1             200  0.333 (20                     67
                                                                                 minutes).
In-store study invitation.....             300               1             300  0.083 (5                      25
                                                                                 minutes).
In-store study................              60               1              60  0.75 (45                      45
                                                                                 minutes).
    Total.....................  ..............  ..............  ..............  ................             170
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

II. References

    The following references have been placed on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov. (FDA 
has verified all the Web site addresses in this reference section, but 
we are not responsible for any subsequent changes to the Web sites 
after this document publishes in the Federal Register.)

    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, vol. 10, pp. 
238-244, 2007.
    2. Bialkova, S. and H. C. M. van Trijp, ``What Determines 
Consumer Attention to Nutrition Labels?'' Food Quality and 
Preference, vol. 21, pp. 1042-1051, 2010.

[[Page 40156]]

    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, vol. 
57, pp. 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, vol. 27, pp. 
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, vol. 72, pp. 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, vol. 70, pp. 
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, vol. 101, pp. 900-926, 
2011.
    8. FDA, ``What We Do.'' Available at http://www.fda.gov/AboutFDA/WhatWeDo/default.htm.
    9. FDA, ``Strengthen Social and Behavioral Science to Help 
Consumers and Professionals Make Informed Decisions About Regulated 
Products,'' Section 8 in Strategic Plan for Regulatory Science. 
Available at http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm268150.htm.

    Dated: June 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16001 Filed 7-2-13; 8:45 am]
BILLING CODE 4160-01-P