[Federal Register Volume 78, Number 230 (Friday, November 29, 2013)]
[Notices]
[Pages 71621-71623]
From the Federal Register Online via the Government Publishing 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, [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. 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