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, 30614-30616 [2014-12281]
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Federal Register / Vol. 79, No. 102 / Wednesday, May 28, 2014 / Notices
Completed Exposure Pathway Site
Count Report. A completed exposure
pathway (CEP) links a contaminant
source to a receptor population. The
CEP ranking is similar to a
subcomponent of the substance priority
list algorithm’s potential-for-humanexposure component. The CEP ranking
is based on a site frequency count and
thus lists the number of sites at which
a substance has been found in a CEP.
This information is derived from
ATSDR public health assessments and
from ATSDR health consultations. The
CEP report therefore focuses on
documented exposure, and lists
hazardous substances according to
exposure frequency.
The substances in the CEP report are
similar to those in the Priority List of
Hazardous Substances. However, some
substances in the CEP report have a very
low toxicity and as a result are not
included in the substance priority list.
Since the substance priority list uses
toxicity, frequency of occurrence, and
potential for human exposure to
determine its priority substances, other
low-toxicity substances will not appear
on the list and, consequently, will not
become subjects of toxicological
profiles. In addition, because CERCLA
mandates the preparation of the Priority
List of Hazardous Substances, that list
only incorporates data from CERCLA
NPL sites. The CEP report, on the other
hand, uses data from all ATSDR-activity
sites at which a CEP has been detected.
Dated: May 21, 2014.
Sascha Chaney,
Acting Director, Office of Policy Planning and
Evaluation, National Center for
Environmental Health/Agency for Toxic
Substances and Disease Registry.
[FR Doc. 2014–12262 Filed 5–27–14; 8:45 am]
BILLING CODE 4163–70–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
emcdonald on DSK67QTVN1PROD with NOTICES
[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.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
SUMMARY:
VerDate Mar<15>2010
16:58 May 27, 2014
Jkt 232001
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 oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910—New and
title, ‘‘Eye Tracking Study of Direct-toConsumer 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,
PRAStaff@fda.hhs.gov.
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-toConsumer 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
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
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: TollFree Number for Consumer Reporting of
Drug Product Side Effects in Direct-toConsumer 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
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28MYN1
emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 102 / Wednesday, May 28, 2014 / Notices
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 selfidentify 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
VerDate Mar<15>2010
16:58 May 27, 2014
Jkt 232001
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.
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30615
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
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Federal Register / Vol. 79, No. 102 / Wednesday, May 28, 2014 / Notices
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
Eye tracking study of DTC prescription drug advertisement viewing
Number of
responses per
respondent
Number of
respondents
Total annual
responses
Average burden per response
Total hours
Pilot Study Screener .........................
Main Study Screener ........................
Pilot Study .........................................
Main Study ........................................
200
2,000
30
300
1
1
1
1
200
2,000
30
300
0.03 (2 minutes) ...............................
0.03 (2 minutes) ...............................
1 .......................................................
0.50 (30 minutes) .............................
6
60
30
150
Total ...........................................
........................
........................
........................
...........................................................
246
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.
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0606. The
approval expires on May 31, 2017. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
[FR Doc. 2014–12281 Filed 5–27–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1619]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Current Good Manufacturing Practice
in Manufacturing, Packaging, Labeling,
or Holding Operations for Dietary
Supplements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Current Good Manufacturing Practice
in Manufacturing, Packaging, Labeling,
or Holding Operations for Dietary
Supplements’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
February 27, 2014, the Agency
submitted a proposed collection of
information entitled ‘‘Current Good
Manufacturing Practice in
Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary
Supplements’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
emcdonald on DSK67QTVN1PROD with NOTICES
16:58 May 27, 2014
[FR Doc. 2014–12293 Filed 5–27–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0017]
SUMMARY:
VerDate Mar<15>2010
Dated: May 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
Jkt 232001
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Voluntary National
Retail Food Regulatory Program
Standards
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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.
SUMMARY:
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,
ADDRESSES:
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0621. 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, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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.
Voluntary National Retail Food
Regulatory Program Standards—(OMB
Control Number 0910–0621)—Extension
The Voluntary National Retail Food
Regulatory Program Standards (Program
Standards) define nine essential
elements of an effective regulatory
program for retail food establishments;
establish basic quality control criteria
for each element; and provide a means
of recognition for those State, local,
territorial, tribal, and Federal regulatory
programs that meet the Program
Standards. The program elements
addressed by the Program Standards are
as follows: (1) Regulatory foundation,
(2) trained regulatory staff, (3)
inspection program based on Hazard
Analysis and Critical Control Point
(HACCP) principles, (4) uniform
inspection program, (5) foodborne
illness and food defense preparedness
and response, (6) compliance and
enforcement, (7) industry and
community relations, (8) program
support and resources, and (9) program
assessment. Each standard includes a
list of records needed to document
conformance with the standard (referred
to in the Program Standards document
E:\FR\FM\28MYN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 102 (Wednesday, May 28, 2014)]
[Notices]
[Pages 30614-30616]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12281]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 oira_submission@omb.eop.gov. 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, PRAStaff@fda.hhs.gov.
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\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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).
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 246
----------------------------------------------------------------------------------------------------------------
\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
