
[Federal Register Volume 78, Number 230 (Friday, November 29, 2013)]
[Notices]
[Pages 71621-71623]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28599]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 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 research entitled, ``Eye Tracking Study of 
Direct-to-Consumer Prescription Drug Advertisement Viewing.'' This 
study is designed to use eye tracking technology to explore how 
consumers view direct-to-consumer (DTC) prescription drug 
advertisements (ads) that include text regarding risk information and 
reporting side effects and that vary in the amount of distracting audio 
and visual content during the presentation of the risk information.

DATES: Submit either electronic or written comments on the collection 
of information by January 28, 2014.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

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

[[Page 71622]]

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 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 the 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 major statement of the risks of 
prescription drugs be included in at least the audio of DTC television 
ads. FDA has proposed including the risk information in DTC television 
ads 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 the 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''). Thus, these two new communications may appear in 
future DTC television ads. However, they 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 above 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. However, the effects of 
this kind 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 these communications in DTC ads are perceived and 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 superimposed text risk 
information. To test these hypotheses, we will conduct inferential 
statistical tests such as analysis of variance. With the sample size 
described below, 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 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. 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 three test conditions (low, medium, and high distraction in a 
DTC television ad). The ad will be for a fictitious weight loss 
prescription drug. The ads are currently being 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 will increase.
    We will explain the study procedure to participants 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 20 inches and a minimum display resolution of 1,280 x 
1,024. To simulate normal television ad viewing, participants will 
watch a 2 to 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 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.
    FDA estimates the burden of this collection of information as 
follows:

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                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                  Number of
 Eye tracking study of DTC prescription drug      Number of    responses  per   Total  annual        Average  burden per  response          Total hours
            advertisement viewing                respondents      respondent      responses
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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 minutes)........................             150
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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: November 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-28599 Filed 11-27-13; 8:45 am]
BILLING CODE 4160-01-P


