[Federal Register Volume 79, Number 102 (Wednesday, May 28, 2014)]
[Notices]
[Pages 30614-30616]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-12281]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1422]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Eye Tracking Study of 
Direct-to-Consumer Prescription Drug Advertisement Viewing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) 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 June 
27, 2014.

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 Study of Direct-to-Consumer Prescription Drug 
Advertisement Viewing.'' Also include the FDA docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 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 Study of Direct-to-Consumer Prescription Drug 
Advertisement Viewing--(OMB Control Number 0910-NEW)

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 
300u(a)(4)) authorizes FDA to conduct research relating to health 
information. Section 1003(d)(2)(c) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 393(b)(2)(c)) authorizes FDA to 
conduct research relating to drugs and other FDA regulated products in 
carrying out the provisions of the FD&C Act.
    Current regulations require that a product's major risks be 
included in at least the audio of direct-to-consumer (DTC) prescription 
drug television ads; this disclosure of major risks is sometimes 
referred to as the major statement. FDA has proposed including such 
risk information in superimposed text as well as in the audio (75 FR 
15376, ``Direct-to-Consumer Prescription Drug Advertisements; 
Presentation of the Major Statement in Television and Radio 
Advertisements in a Clear, Conspicuous, and Neutral Manner''). In 
addition, Title IX of the Food and Drug Administration Amendments Act 
(Pub. L. 110-85) required a study to determine if the statement ``You 
are encouraged to report negative side effects of prescription drugs to 
FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088'' (the MedWatch 
statement) is appropriate for inclusion in DTC television ads. These 
communications have been tested separately by FDA. The first study 
found that participants were better able to recall the drug risks when 
they were presented in superimposed text as well as in audio (OMB 
Control Number 0910-0634; ``Experimental Evaluation of the Impact of 
Distraction''). The second study found that the inclusion of the 
MedWatch statement does not interfere with participants' understanding 
of the risk information (OMB Control Number 0910-0652; ``Experimental 
Study: Toll-Free Number for Consumer Reporting of Drug Product Side 
Effects in Direct-to-Consumer Television Advertisements for 
Prescription Drugs''). However, these two new communications have not 
been examined together.
    In addition, questions continue to arise about the use of 
potentially distracting images and sounds during the major statement of 
risks in DTC television ads. The first study referenced previously 
found no differences among ads that differed in the affective tone of 
static, non-moving visuals presented during the major statement of 
risks. Previous research has shown that factors such as multiple scene 
changes and music in advertising can be distracting. The effects of 
distraction during the major statement of risks on consumers' 
perceptions and risk recall has not been tested in the presence of 
risk-reinforcing superimposed text.
    This project is designed to use eye tracking technology to 
determine how superimposed risk information and the MedWatch statement 
are perceived in DTC ads and also the impact of distraction. Eye 
tracking technology is an effective method to determine the extent to 
which consumers attend to risk information presented in DTC television 
ads. This technology allows researchers to unobtrusively detect and 
measure where a participant looks while viewing a television ad and for 
how long, and the pattern of their eye movements may indicate attention 
to and processing of information in the ad.
    We plan to collect descriptive eye tracking data on participants' 
attention to (1) the superimposed text during the major statement of 
risk information and (2) the MedWatch statement. Further, we plan to 
examine experimentally the effect of distraction. We hypothesize that 
distracting audio and visuals during the major statement will decrease 
risk recall, risk perceptions, and attention to

[[Page 30615]]

superimposed text risk information. To test these hypotheses, we will 
conduct inferential statistical tests such as analysis of variance. 
With the sample size described further in this notice, we will have 
sufficient power to detect small-to-medium sized effects in the main 
study.
    We plan to conduct one 60-minute pilot study with 30 participants 
and then one 30-minute main study with 300 participants. All 
participants will be 18 years of age or older who self-identify as 
needing to lose more than 30 pounds. We will exclude individuals who 
work in healthcare or marketing or who wear bifocals or hard contact 
lenses to watch television. The studies will be conducted in person in 
at least five different cities across the United States.
    The pilot study and main study will have the same design and will 
follow the same procedure. Participants will be randomly assigned to 
one of two test conditions (low and high distraction in a DTC 
television ad). The ad will be for a fictitious weight loss 
prescription drug. The ads have been created and pretested to ensure 
that consumers perceive different levels of distraction across the ads 
(OMB Control Number 0910-0695; ``Stimuli Development and Pretests for 
an Attentional Effects Study''). For instance, as the distraction level 
increases, the number of scene changes and on-screen activity during 
the major statement increases. Pretesting led us to using two rather 
than three ads, as we proposed in the 60-day Federal Register notice.
    When participants start the study, we will explain the study 
procedure and calibrate the eye tracking device. To collect eye 
tracking data, we will use an unobtrusive computer-interfaced eye 
tracker with a minimum speed of 60 Hertz. The test images will be shown 
on a computer monitor with a minimum size of 23 inches and a minimum 
display resolution of 1,920 x 1,080. To simulate normal television ad 
viewing, participants will watch an approximately 5 minute video clip 
followed by a series of three ads. One of the ads will be the study ad. 
The video clip and non-study ads will be unrelated to health. The order 
of the non-study ads will be counterbalanced, and only eye tracking 
data from the study ad will be analyzed. Next, participants will 
complete a questionnaire that assesses risk perceptions, risk recall, 
recall of the MedWatch statement, and covariates such as demographics 
and health literacy. In the pilot study, participants will also answer 
questions as part of a debriefing interview to assess the study design 
and questionnaire. The questionnaire is available upon request.
    In the Federal Register of November 29, 2013 (78 FR 71621), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Two comments were received.

(Comment 1)

    The first suggestion in this comment was to avoid biasing 
participants by ensuring that at the beginning of the study 
participants are not aware that (1) the study is being conducted by or 
for FDA and (2) the advertisements are the subject of interest in the 
study. We are aware of these issues and have designed the wording of 
the study materials accordingly.
    The second suggestion was to increase the minimum display 
resolution from 1,280 x 1,024 to 1,920 x 1,080 and the minimum computer 
monitor size from 20 inches to 24 inches. We agree that a bigger screen 
is better and have changed the minimum conditions to the following 
specifications: A display resolution of 1,920 x 1,080 pixels on a 
monitor of at least 23 inches measured diagonally.
    The third suggestion was to exclude individuals who wear 
progressive or other multifocal lenses and individuals with any form of 
strabismus or nystagmus from participating in the study. We will 
exclude individuals who wear bifocals or hard contact lenses while 
watching television. In response to the next comment, we explain why 
these individuals need to be excluded. We do not believe we need to 
exclude participants who wear progressive or other multifocal lenses to 
collect usable data with the eye trackers in this study. Because we 
will use binocular tracking (where we track both eyes) we do not need 
to exclude individuals with strabismus or nystagmus; if we encounter 
these conditions in one eye, we will track the other eye. In addition, 
we cannot test for or diagnose these conditions and individuals may not 
know they have these conditions, making excluding these individuals 
difficult.

(Comment 2)

    The first request in this comment was to specify the study 
timeline, comment on whether the results of this study will be 
incorporated into the draft guidance, ``Presenting Risk Information in 
Prescription Drug and Medical Device Promotion,'' and state whether the 
draft guidance will be re-issued for public comment. Regarding the 
study timeline, data collection on the study cannot begin until OMB 
approval is received. We estimate that data collection will be 
completed within a year after OMB approval. If the results of the study 
suggest that changes are needed to the draft guidance we will consider 
that at the time. The draft guidance will be reissued for public 
comment if changes are necessary as a result of the study.
    The second request in this comment was to explain why individuals 
who wear bifocals or hard contact lenses would be excluded and to 
consider including such individuals in the study to avoid biasing the 
sample. First, only individuals who can only wear bifocals or hard 
contacts to watch television will be excluded from the study. If 
individuals can wear regular glasses or soft contacts during the study, 
they may participate. There are two reasons to exclude participants who 
wear only bifocals or contact lenses to watch television. The first is 
that the glasses themselves may have ``lines'' on them which impact the 
data being recorded by the eye tracker's camera. To record properly, 
the eye trackers must make accurate estimates of the pupil, and the 
``lines'' on the glasses distort these estimates. A similar problem 
exists with hard contact lenses, which are smaller than soft lenses and 
project sharp lines around their circumference. The second reason to 
exclude individuals who wear bifocals to watch television is that many 
people who wear bifocals move their heads up and down to get their best 
vision of a particular target. This head bobbing also impacts eye 
tracking because the cameras must constantly adjust to head movement. 
If we do not screen for these conditions and have several individuals 
who cannot be tracked well, we will have to discard their data, which 
will impact both the study design (which is based on the assumption of 
having equal sample sizes across conditions) and the power of our 
statistical tests. In an effort to measure any sampling bias, we will 
move this question to the end of the pilot study screener so we can 
compare the demographic information of those who are excluded with 
those who are not.
    This comment suggested that we create a more ``real world'' 
environment in the study by using a 30-minute video clip instead of a 2 
to 5 minute video clip as proposed. We understand the concern, but 
there are tradeoffs inherent in any study. Although a 30-minute video 
clip may be a stronger proxy for ``typical'' TV viewing, it would 
require more resources and a greater burden on participants. We have 
taken steps to try to increase the ecological validity of the 
experiment. First, we have created ads that are very realistic. Second, 
we will

[[Page 30616]]

use a real TV show clip that is closer to 5 minutes long, which is the 
length of a typical news story segment. Third, we will include two 
additional, ``real'' advertisements, rather than just showing the 
experimental ad.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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   Eye tracking study of DTC                       Number of
       prescription drug           Number of     responses per   Total annual    Average burden     Total hours
     advertisement viewing        respondents     respondent       responses      per response
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Pilot Study Screener..........             200               1             200  0.03 (2 minutes)               6
Main Study Screener...........           2,000               1           2,000  0.03 (2 minutes)              60
Pilot Study...................              30               1              30  1...............              30
Main Study....................             300               1             300  0.50 (30                     150
                                                                                 minutes).
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    Total.....................  ..............  ..............  ..............  ................             246
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: May 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12281 Filed 5-27-14; 8:45 am]
BILLING CODE 4160-01-P