Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study: Toll-Free Number for Consumer Reporting of Drug Product Side Effects in Direct-to-Consumer Television Advertisements for Prescription Drugs, 41703-41710 [E9-19782]
Download as PDF
Federal Register / Vol. 74, No. 158 / Tuesday, August 18, 2009 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0595]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Experimental
Study: Toll-Free Number for Consumer
Reporting of Drug Product Side Effects
in Direct-to-Consumer Television
Advertisements for Prescription Drugs
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 September
17, 2009.
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:
202–395–6974, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910—New and
the title ‘‘Experimental Study: Toll-Free
Number for Consumer Reporting of Drug
Product Side Effects in Direct-toConsumer Television Advertisements
for Prescription Drugs.’’ Also include
the FDA docket number found in
brackets in the heading of this
document.
jlentini on DSKJ8SOYB1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–796–3792.
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.
Experimental Study: Toll-Free Number
for Consumer Reporting of Drug
Product Side Effects in Direct-toConsumer Television Advertisements
for Prescription Drugs—(OMB Control
Number 0910—New)
The Federal Food, Drug, and Cosmetic
Act (the act) requires that
manufacturers, packers, and distributors
VerDate Nov<24>2008
16:30 Aug 17, 2009
Jkt 217001
(sponsors) who advertise prescription
human and animal drugs, including
biological products for humans, disclose
in advertisements certain information
about the advertised product’s uses and
risks. For prescription drugs and
biologics, the act requires
advertisements to contain ‘‘information
in brief summary relating to side effects,
contraindications, and effectiveness’’
(21 U.S.C. 352(n)). FDA is responsible
for enforcing the act and implementing
regulations.
On September 27, 2007, the President
signed into law the Food and Drug
Administration Amendments Act
(FDAAA) (Public Law 110–85). Title IX
of FDAAA amends section 502(n) of the
act (21 U.S.C. 352) by requiring printed
direct-to-consumer (DTC)
advertisements for prescription drug
products to include the following
statement printed in conspicuous text:
‘‘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.’’ Title IX of
FDAAA also requires the Secretary of
Health and Human Services (the
Secretary), in consultation with the Risk
Communication Advisory Committee
(RCAC), to conduct a study not later
than 6 months after the date of
enactment of FDAAA to determine if
this statement is appropriate for
inclusion in DTC television
advertisements for prescription drug
products. As part of this study, the
Secretary shall consider whether the
information in the statement described
previously in this paragraph would
detract from the presentation of risk
information in a DTC television
advertisement. If the Secretary
determines that the inclusion of such a
statement would be appropriate for
television advertisements, FDAAA
mandates the issuance of regulations
implementing this requirement, and for
the regulations to reflect a reasonable
length of time for displaying the
statement in television advertisements.
Finally, FDAAA requires the Secretary
to report the study’s findings and any
subsequent plans to issue regulations to
Congress.
In accordance with the requirements
of FDAAA, FDA convened a meeting of
the RCAC on May 15 and 16, 2008. A
draft design for studying this issue was
proposed at that time and discussed by
the advisory committee. Based on
comments received at that meeting,
changes were made to the proposed
study design. The transcripts and
materials from that meeting can be
found at https://www.fda.gov/ohrms/
dockets/ac/oc08.html#RCAC.
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
41703
I. Background
Section 17 of the Best
Pharmaceuticals for Children Act (the
BPCA) (Public Law 107–109, January 4,
2002) required FDA to issue a final rule
mandating the addition of a statement to
the labeling of each drug product for
which an application is approved under
section 505 of the act (21 U.S.C. 355).
Under the BPCA, the statements must
include: (1) A toll-free number
maintained by FDA for the purpose of
receiving reports of adverse events
regarding drugs, and (2) a statement that
the number is to be used only for
reporting purposes, and it should not be
used to seek or obtain medical advice
(the side effects statement).
On April 22, 2004, FDA published a
proposed rule with a proposed side
effects statement for certain prescription
drug product labeling and a proposed
side effects statement for certain overthe-counter drug product labeling (69
FR 21778). In the proposed rule, FDA
solicited comments on a proposed
statement that FDA believed comported
with the previously mentioned mandate
in the BPCA. The agency received 12
comments suggesting changes to the
specific wording proposed. The agency
also received several comments
suggesting that FDA engage in research
to study the wording of the proposed
side effects statement with consumers.
Among the reasons cited for testing the
statement were to: (1) Determine the
best and most precise wording for the
statement, (2) evaluate consumer
comprehension of the proposed
statement, and (3) address concerns that
consumers who read the statement will
mistakenly call FDA in search of
medical advice rather than seeking
appropriate medical treatment. In
addition, during the clearance process
for the proposed rule, both the Office of
Information and Regulatory Affairs of
OMB and the Office of the Assistant
Secretary for Planning and Evaluation of
the Department of Health and Human
Services suggested that FDA conduct
focus groups or other consumer studies
to inform the wording of the side effects
statement.
During the spring of 2006, to assist in
developing this study, FDA conducted
two focus groups to gauge consumer
understanding and preferences for a
number of proposed side effects
statements and to narrow the number of
statements to be tested in subsequent
experimental research. In addition to
the information collected on which
versions of the statements participants
preferred, discussions showed that
people varied in their understanding of
when to call FDA or their health care
E:\FR\FM\18AUN1.SGM
18AUN1
41704
Federal Register / Vol. 74, No. 158 / Tuesday, August 18, 2009 / Notices
jlentini on DSKJ8SOYB1PROD with NOTICES
practitioners and that some people
would not call FDA even if they
experienced a serious side effect.
Several people in the focus groups
suggested the addition of a Web site to
report adverse side effects. Based on the
findings from the focus groups, nine
statements were selected for
quantitative testing. A labeling
comprehension experiment was
conducted with 1,674 men and women
ranging in age from 21 to 95 with
varying levels of education (OMB
Control No. 0910–0497). The results
from that quantitative test found that
only one of the versions tested was rated
as significantly less clear than the
others, which were all rated as generally
clear and understandable. The results
also showed that participants reported
they would not call FDA seeking
medical advice. Further, among those
participants who said they would call
FDA, the majority indicated they would
call their doctor for medical advice,
rather than FDA, regardless of the
severity of the side effect. Finally,
participants indicated they could
distinguish between serious and nonserious side effects, reporting that they
would seek emergency medical care in
the case of serious side effects. The
report of the study is available in the
docket for the final rule (Docket No.
FDA–2003–N–0313). The final rule,
Toll-Free Number for Reporting Adverse
Events on Labeling for Human Drug
Products (TFNR) (73 FR 63886, October
28, 2008), is available at https://
www.fda.gov/OHRMS/DOCKETS/98fr/
E8–25670.pdf.
In the Federal Register of November
26, 2008 (73 FR 72058), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. FDA received six comments
in response to our initial Federal
Register notice, published on November
26, 2008. One of these comments, from
an anonymous citizen, did not require
specific responses, as it was outside the
scope of the project (e.g., FDA approves
too many drugs; harmful drugs are
‘‘being foisted on the population’’),
although it could be viewed as a
statement of support for conducting the
research.
II. Comments on the Information
Collection
In the following section, we outline
the issues raised in the comments and
provide our responses.
(Comment 1) Do not place the toll-free
statement in television ads because it is
better placed within written materials
that accompany prescription drugs.
Some system for enforcing the
legitimacy of calls is necessary,
VerDate Nov<24>2008
16:30 Aug 17, 2009
Jkt 217001
otherwise callers with an ‘‘agenda’’ or
‘‘the uninformed’’ could ‘‘doom
medicines for no reason.’’
(Response) This comment mostly
applies to MedWatch procedures that
are outside the scope of the proposed
research. This study is addressing the
understanding of information in the ad.
We have notified the appropriate parties
in the agency of this comment.
(Comment 2) The comment supports
DTC advertising that is educational and
‘‘delayed until postmarketing
surveillance data are collected and
assessed.’’ DTC television ads should
include a toll-free statement. Overall,
this comment supports the proposed
research, but includes the following
specific suggestions: (1) The toll-free
statement is best placed after the risk
information and (2) it should be placed
during the presentation of non-lifethreatening or minor side effects.
(Response) We agree that placement
during non-life-threatening or minor
side effects may be the best placement
for the toll-free statement. In a television
ad, however, that information is
presented in a very short amount of
time, sometimes only seconds (and this
varies depending on the drug product).
We have designed our study to allow
the data to show for us the best
placement of the statement.
(Comment 3) Neither of the proposed
toll-free statements addresses whether
consumers can distinguish between
serious and non-serious side effects. A
simulation study should be used to
assess this issue.
(Response) We refer this comment to
previous research conducted by FDA on
this topic, described previously. This
study found that participants were
easily able to distinguish between
serious and non-serious side effects and
that they reported an ability to take the
right action with regard to each one.
(Comment 4) FDA should post the
proposed questionnaire, the primary
endpoint(s) of the study with action
standards, and provide the mock
advertisement to interested parties for
use in their research.
(Response) The proposed
questionnaire has been and continues to
be available upon request. We agree that
threshold levels and primary endpoints
were not well explained in the 60-day
notice and have worked to correct that
in the 30-day notice. Please note the
addition of specific hypotheses and the
analysis plan. At the conclusion of our
data collection, we will make the
advertisement available to those who
request it.
(Comment 5) Adequate provision
issues may not be considered or
addressed. Multiple telephone numbers
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
or Web sites may confuse consumers.
Use alternate wording for the toll-free
statement: ‘‘For information about
PRODUCT X or to report side effects,
see our ad in ___ magazine.’’ Include
payment assistance information, as this
is often currently included in television
ads.
(Response) We have designed the
stimuli ad to closely approximate an
actual DTC ad, including adequate
provision measures and other supers.
Division of Drug Marketing,
Advertising, and Communications
reviewers have examined the script and
storyboard to ensure that the ad meets
regulatory requirements. The contractor
producing the ad has extensive
experience with this type of production
and provided additional quality control
measures. In directing us to complete
this research, Congress was likely
concerned about the same issues
expressed by this comment, i.e., that the
toll-free statement may be confusing.
That is one of the main research
questions we will address. In terms of
wording, Congress directed us to test
specific language. In addition to this
language, we propose to test another
version that was found most acceptable
in previous usability research
conducted by the agency. Finally,
because payment assistance information
is relatively new, not universal, and not
required by regulation, we have not
included this statement in our stimuli
ads.
FDA has contracted with a
professional multimedia company to
create ad stimuli. In addition, FDA has
instituted a procedure of extensive
pretesting of the ad stimuli to be used.
Our extensive experience with current
and past DTC ads, pretesting, and
collaboration with the contractor should
ensure realistic ads that will enable us
to successfully investigate our
experimental variables.
(Comment 6) Study multiple medical
conditions, including symptomatic and
asymptomatic conditions; diseases that
affect different age groups; sufferers and
non-sufferers; and consumers with
varying degrees of knowledge about
their medical conditions.
(Response) We do not have the
resources to create mock ads to test
multiple medical conditions. We have
no reason to suspect that the principles
we study in this medical condition (e.g.,
placement, duration, wording,
prominence) would be different when
applied to an ad for another medical
condition. We welcome other parties to
extend the current research by applying
it to other conditions. We will ask
respondents about their knowledge of
their medical conditions and will
E:\FR\FM\18AUN1.SGM
18AUN1
jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 158 / Tuesday, August 18, 2009 / Notices
conduct analyses to see if this variable
plays a role in their responses.
We have decided, however, to recruit
for the study two distinct populations:
Those who have been diagnosed with
high blood pressure and a general
population sample. This approach will
allow us to determine whether
diagnosed individuals and other people
who may be exposed to such television
advertising will differ in their responses
to the ad.
(Comment 7) Using the condition
where the toll-free statement is present
during the whole ad to control for
novelty will increase rather than
decrease the attention to the statement.
(Response) We agree that the
condition in which the toll-free
statement appears during the entire ad
may increase notice of it. We think there
is also a good possibility that it might
be ignored, in such a way that the
statement might be more prominent in
other conditions. To control for novelty,
participants will see an unrelated DTC
ad with the toll-free statement presented
the same way as the test ad before they
see the test ad. This may control for
novelty in the test ad and may attenuate
the belief that our test product has some
unique quality that causes it to need a
special toll-free statement.
(Comment 8) This protocol will take
much longer than 15 minutes.
(Response) Because we are also
concerned that this protocol will take
longer than 15 minutes, we have revised
our burden estimate to reflect a 20minute protocol. Also, to ensure that all
test parameters are met, including
timing of experiment, we have budgeted
for 2 pretests of 700 individuals each.
(Comment 9) The placement and
duration variables should be removed
from study because regardless of
placement, the statement may interrupt
the flow of the most important
information.
(Response) These are empirical
questions. We will not know the answer
to either of these questions until we
collect data.
(Comment 10) Remove the audio-only
condition because this eliminates the
hearing-impaired population. Include
visually and hearing-impaired persons
to more accurately represent the
population.
(Response) Even in our audio-only
condition as originally proposed, the
Web site and phone numbers were
placed on screen. Current requirements
for the most important risk information
(i.e., the major statement) are that it be
placed in the audio portion of the ad.
Thus, this is a reasonable condition to
test. Upon further discussion, however,
we agree that we do not need two
VerDate Nov<24>2008
16:30 Aug 17, 2009
Jkt 217001
distinct extra-prominent conditions, and
will test only one. We do not plan to
actively exclude people with audio or
visual impairments from the study but
we do not have the resources to actively
recruit them.
(Comment 11) High blood pressure
may not be the most representative
condition for a general sample of
consumers ‘‘over the age of 18.’’ The
tested sample population should be
representative of actual sufferers of the
condition being advertised.
(Response) We agree that this is an
important consideration. Upon further
discussion, we have decided to recruit
for the study two distinct populations:
Those who have been diagnosed with
high blood pressure and a general
population sample. This approach will
allow us to determine whether
diagnosed individuals and other people
who may be exposed to such television
advertising will differ in their responses
to the ad.
(Comment 12) Remove the fourth
commercial for an unrelated medical
condition because it does not contribute
to the study and may confound results.
(Response) Study participants will see
four ads—the second ad will be an
unrelated DTC ad and the fourth ad will
be the test ad. We propose to include
the other DTC ad with the matching tollfree statement parameters so that
consumers do not think that our test ad
reflects a special product that needs a
special warning. It also may attenuate
the effect of novelty.
(Comment 13) Because the toll-free
statement may artificially increase
impact of risk information, FDA should
test information gleaned from the
presence of the toll-free statement in
print ads first.
(Response) FDA has not collected any
information on the presence of the
statement in print ads, although we
agree this would be valuable
information. Moreover, Congress has
instructed us specifically to test the tollfree statement in television ads.
(Comment 14) Including the
manufacturer’s toll-free number instead
of the FDA contact number may help to
mitigate the possibility that the toll-free
statement artificially increases the
impact of risk information.
(Response) Sponsors already include
the manufacturer’s telephone number in
all ads as a way to fulfill one part of the
adequate provision requirement. The
current study does not examine the
replacement of that number with the
toll-free statement, but instead the
statement’s inclusion above and beyond
current requirements.
(Comment 15) The agency’s
expectation of yielding a sample of
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
41705
2,000 people from a total of 2,400 is
unrealistic based on a typical response
rate of 5 percent.
(Response) We do not expect to yield
a sample of 2,000 people from a total of
2,400. As shown in Table 1 of this
document, we have revised our sample
numbers.
(Comment 16) How well can an
Internet study simulate a television
environment?
(Response) We agree that simulating
an everyday television-watching
environment would increase the realism
of the study. Participation in an
experiment in any context, however, is
unlikely to perfectly do so. We do not
believe that a mall-intercept
administration would increase the
realism of the study and a phone-based
survey is not feasible, given the
modality of the advertisement in
question. Moreover, an Internet study
may be as close to the televisionwatching environment as any other
method because participants will be in
their own homes and some participants
already watch streaming video on their
computers.
(Comment 17) What are the
thresholds for interference
(‘‘detraction’’) in this study?
Specifically, will the statement be
included only if it does not affect risk
comprehension at all, or if it does not
affect risk comprehension ‘‘much’’—and
if this is the case, what is too much?
(Response) If the study demonstrates
that the inclusion of the toll-free
statement does not interfere with the
processing of the risk information, then
Congress is likely to mandate its
inclusion. If the data demonstrate some
detraction from risk information, then
the decision becomes more complicated.
As the interference between the toll-free
statement and the risk information
increases, the less likely it is that it will
be mandated. A tradeoff analysis will
have to be conducted and this study
will be only one part of the
determination. That is, the amount of
detraction will have to be weighed
against the benefit of including the
statement and this benefit will be
determined in part by public health
concerns and analysis of MedWatch
data.
(Comment 18) Participants will see
the test ad three times and this may
cause problems.
(Response) Participants will see the
test ad only once after seeing three other
filler ads, one of which will be an
unrelated DTC ad.
(Comment 19) The current proposed
study is comprehensive and appropriate
to address the primary research
questions under consideration.
E:\FR\FM\18AUN1.SGM
18AUN1
41706
Federal Register / Vol. 74, No. 158 / Tuesday, August 18, 2009 / Notices
(Response) Thank you.
(Comment 20) The toll-free statement
in the unrelated DTC ad should be
presented in the same way as in the test
ad.
(Response) We had planned to do so.
(Comment 21) The questionnaire does
not specifically address the risk of
nontreatment of the disease condition.
(Response) FDA acknowledges that
this study does not address this risk.
Nevertheless, this is outside the scope of
the current investigation.
(Comment 22) Ask if respondents
suffer from diabetes, high cholesterol,
obesity, or the condition treated in the
unrelated DTC ad.
(Response) We plan to ask about the
state of respondent’s health. In
considering this comment, we have
added additional questions to the
questionnaire. Please see the revised
questionnaire for details.
(Comment 23) Question 7 in the
questionnaire is vague and should be
placed earlier in the questionnaire.
(Response) Question 7, which
originally asked participants in an openended fashion to report on ‘‘some
information written on the screen’’ has
been changed. We now ask participants
which of several options they saw and
follow that up with an open-ended
question about what the statement
means to them. We do not wish to move
this question series earlier in the
questionnaire because it is not one of
our main dependent measures.
(Comment 24) It is unclear how FDA
plans to analyze results from this
research, particularly what action
consumers are expected to take after
they have heard and understood the
toll-free statement.
(Response) The purpose of this
research is not to determine what action
consumers will take after seeing the ad.
We addressed these issues in the
labeling comprehension study described
at the beginning of this notice (Docket
No. FDA–2003–N–0313). The purpose
of the current proposed study is to
determine whether the risk information
is adequately comprehended and
whether the toll-free statement is
noticeable and recalled.
jlentini on DSKJ8SOYB1PROD with NOTICES
III. Revised Study
Experimental Study: Toll-Free Number
for Consumer Reporting of Drug
Product Side Effects in Direct-toConsumer Television Advertisements
for Prescription Drugs—(OMB Control
Number 0910—New)
Based in part on these comments,
further research discussions, and the
input of the RCAC on May 16, 2008, we
propose the following revised design,
hypotheses, and analysis plan.
VerDate Nov<24>2008
16:30 Aug 17, 2009
Jkt 217001
not yet heard any risk information.
Thus, without context, the statement
This study will examine the
placement of the toll-free statement and lacks applicability.
Placing the toll-free statement during
the length of time the statement is
presented on screen in a DTC television the major statement likely reduces the
comprehension of the risk information
advertisement for a prescription drug.
for the drug because it divides viewer’s
The primary dependent measure of
attention between two competing pieces
interest is consumer comprehension of
of information. It is possible, however,
the important risk information in the
that the juxtaposition of these two
advertisement. This study will also
informational concepts are
examine potential differences in
comprehension based on the wording of complimentary and therefore do not
conflict.
the toll-free statement and the
The toll-free statement may serve the
prominence of the statement.
best role after the risk information has
The application of a new piece of
been presented. In this case,
information for viewers of DTC ads
participants have been told about the
presents logistical challenges. From a
risks and side effects of the drug before
research perspective, the primary issue
they are told they may report this
under investigation is how to impart
information. This essentially primes the
additional information without
toll-free statement with the major
increasing ‘‘cognitive load,’’ thus
statement. We do not expect this
leading to information overload.
placement to interfere with the
Cognitive load is an index of the
comprehension of risk information, as it
memory demands necessary to process
is not present during the voicing of risks
a set of information (Ref. 1). As
and has not been introduced to viewers
cognitive load increases, more mental
at this point. In addition, the usefulness
resources are necessary to process and
of the toll-free statement may improve
understand the information. DTC ads
are already quite dense when compared in this condition relative to those
discussed in the previous paragraphs
to ads for other products. The risk
because viewers have been provided
information in the major statement of
with context.
the ad should not be compromised by
Over time, it is likely that the toll-free
the addition of the toll-free statement.
At the same time, it is preferable that the statement will become part of the
background of the ads as people become
risk information and the toll-free
accustomed to seeing this statement in
statement information are presented in
all DTC ads. In this respect, people will
such a way that both are
understandable. We have chosen a set of have the statement as an option if
needed but may be able to disregard it
variables in the current study to
to focus on the risk information
investigate issues of cognitive load.
otherwise. Thus, we are testing a
They are described briefly below before
condition in which the toll-free
examining the details of the research
statement will be present during the
design.
entire ad. This test condition will
1. Placement
control for the effect of novelty arising
The location of the toll-free statement from the fact that consumers have not
previously seen this type of statement in
may facilitate or detract from the risk
TV ads. Presence of the statement
information in the major statement. We
during the entire ad may increase
have chosen three locations for this
noticeability of the toll-free statement
information to test which location
results in the greatest communication of initially, but will be unlikely to interfere
with risk information over time.
the risks of the drug and the concept
that side effects can be reported. It is
2. Statement Type
possible that locating the toll-free
The second variable, statement type,
statement before the major statement
will have two executions of statement
provides a ‘‘prime’’ for the risk
language: The language from the
information that follows; that is, the
FDAAA versus the language used in the
mention of side effects in the toll-free
final rule, Toll-Free Number for
statement will cause consumers to start
Reporting Adverse Events on Labeling
thinking about side effect-related
for Human Drug Products Rule (TFNR;
information, which facilitates
Public Law 107–109, January 4, 2002),
comprehension of the risk information
and previously tested by FDA. The
that follows. In this case, the two
wording from these two statements is as
conceptual pieces of information may
follows:
flow together easily. Conversely, it is
• ‘‘You are encouraged to report
possible that the toll-free statement
negative side effects of prescription
confuses consumers or provides no
information for them because they have drugs to the FDA. Visit www.fda.gov/
A. Overview
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
E:\FR\FM\18AUN1.SGM
18AUN1
41707
Federal Register / Vol. 74, No. 158 / Tuesday, August 18, 2009 / Notices
medwatch, or call 1–800–FDA–1088.’’
(FDAAA)
• ‘‘Call your doctor for medical
advice about side effects. You may
report side effects to FDA at 1–800–
FDA–1088 or www.fda.gov/medwatch.’’
(TFNR)
We think it is important to test both
the toll-free statement version in
FDAAA and the version that we have
previously tested with actual
consumers. The most obvious reason for
this is to make sure that the statement
is maximally readable and
understandable. It may be valuable,
however, to test two statements for
another reason.
If the toll-free statement is enacted in
broadcast ads, it is possible that because
of the boilerplate language, some
amount of habituation will occur. That
is, after viewers have seen the same
language in multiple ads for multiple
products, they may ‘‘tune out’’ and not
pay attention to the toll-free statement at
all. If we test two versions of the
statement and find both acceptable, it
would be possible to either allow
sponsors to choose one statement versus
another or to suggest some alternating of
the two statements. This is a long-term
idea, however, and finding appropriate
wording is the primary goal of
investigating this variable.
display of the toll-free statement. As
with placement, the length of time the
toll-free statement is presented on
screen may influence the cognitive load
in the ad. For experimental control, we
will look at the duration of the
statement while holding placement in
the ad (after the major statement of
risks) constant. Although this placement
should not interfere with the processing
of the risk information, it is possible
that the duration influences the takeaway message from the ad. For example,
having the statement on screen for a
short amount of time may not give
consumers enough time to read and
process the toll-free message. This may
result in lower comprehension of the
message but may have no impact on the
comprehension of the risk information.
Alternatively, displaying the toll-free
statement for a longer period of time
may remove memory traces of the risks
from the major statement, resulting in
lower risk comprehension. To
determine whether this longer duration
increases the usefulness of the toll-free
statement itself, we will compare these
short and long durations to instances
where the toll-free statement is present
during the entire ad and where there is
no toll-free statement at all.
3. Duration
Congress specifically mandates that
we investigate the duration of the
In addition to superimposing the tollfree statement on the screen during the
ad, there are other methods available to
4. Prominence
increase the prominence of the
statement. In particular, having the
statement read aloud in the ad voiceover
while the statement is on the screen
may be considered particularly
prominent. Does the additional
prominence of the statement
compromise the comprehension of the
risk information in the major statement?
If not, does the additional prominence
result in a greater understanding of the
toll-free statement itself? It is likely that
there is a tradeoff between the gains of
emphasizing the toll-free statement and
the comprehension of the risk
information. In examining this variable,
we are exploring the parameters of this
tradeoff.
B. Design
The design will consist of three parts.
Part one will be a between-subjects
factorial design examining the
placement of the toll-free statement by
the type of statement. The first variable,
placement, will have four levels: Before
the major statement of risks, during the
major statement of risks, after the major
statement of risks, or continuously
throughout the whole ad.
In each condition the toll-free
statement will appear in the ad as
superimposed text at the bottom of the
screen. We will also include a control
condition in which the statement does
not appear.
PART ONE: PLACEMENT BY STATEMENT TYPE
4x2+1
Statement Type
Placement
FDAAA
TFNR
Before major statement of risks
During major statement of risks
After major statement of risks
During the whole ad
Plus:
jlentini on DSKJ8SOYB1PROD with NOTICES
Control (no toll-free statement)
Part two of the study will examine
four variations in the duration of the
toll-free statement using the language
from FDAAA: Short (on screen for
approximately 3 seconds after the major
statement), long (on screen for
approximately 6 seconds after the major
VerDate Nov<24>2008
16:30 Aug 17, 2009
Jkt 217001
statement), on screen during the whole
ad, and the control condition of no tollfree statement included. These times
were adopted by calculating how long it
would take a person reading at an
average reading speed to read the
statement. As in the first part of this
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
study series, the toll-free statement will
appear as superimposed text and a
control condition in which the toll-free
statement does not appear will be
included.
E:\FR\FM\18AUN1.SGM
18AUN1
41708
Federal Register / Vol. 74, No. 158 / Tuesday, August 18, 2009 / Notices
PART TWO: DURATION*
4x1
Short (on screeen for approximately
3 seconds after major statement)
Long (on screen for approximately
6 seconds after major statement)
During the whole ad
Control (no toll-free statement)
*Using
Part three of the study will examine
two variations in the prominence of the
toll-free statement using the language
FDAAA statement
from the FDAAA: Spoken after the
major statement with only the Web site
and phone number in superimposed
text, and a control condition where the
toll-free statement is presented visually
after the major statement.
PART THREE: PROMINENCE*
2x1
Extra Prominent (spoken after major statement
of risks, Web site and phone number on screen)
Control (after major statement of risks)
*Using
jlentini on DSKJ8SOYB1PROD with NOTICES
We will investigate these issues in
one disease condition, high blood
pressure, because high blood pressure
has a high incidence rate in the
population, is a public health concern,
and is likely to occur in both males and
females. Further, because there is little
broadcast promotion for prescription
treatment of high blood pressure at this
time, participants should be less
familiar with DTC television ads for this
type of drug, reducing the potential
influence of prior experience.
Our primary dependent variable is
comprehension of the risk information
mentioned in the major statement. In
addition to this variable, we will also
examine comprehension of benefit
information. We will also examine the
noticeability and comprehension of the
toll-free statement.
C. Procedure
Participants will see a cluster of four
ads: Two 15-second non-DTC ads
(fillers), an approximately 60-second
DTC ad for a fictitious high blood
pressure medication, and a 30-second
DTC ad for an unrelated medical
condition with the same toll-free
statement included. We include two
DTC ads with the toll-free statement in
our protocol because this better
approximates what will happen if this
statement is enacted. That is, viewers
will see the statement in all DTC ads for
all products. In this study, we want to
avoid the suggestion that there is
something particular about the high
VerDate Nov<24>2008
16:30 Aug 17, 2009
Jkt 217001
FDAAA statement
blood pressure drug class that causes
the statement to be mandated. Thus, we
will show multiple DTC ads but ask
questions regarding only the ad which
has been manipulated to test our
hypotheses. To maximize response
information, the test ad will always be
the last ad they see.
After viewing the ads, a structured
interview will be conducted.
Participants will answer questions about
the high blood pressure DTC test ad
they have seen. Questions will examine
a number of important perceptions
about the advertised product, including
risk comprehension, risk recall, benefit
comprehension, benefit recall,
behavioral intention, noticeability of the
toll-free statement, and recall of the tollfree statement.
Finally, demographic and health care
utilization information will be collected.
The entire procedure is expected to last
approximately 20 minutes. A total of
6,000 interviews will be completed.
This will be a one-time (rather than
annual) information collection.
D. Participants
Data will be collected using an
Internet protocol. Two samples of
consumers will be recruited: One
sample of individuals diagnosed with
high blood pressure and another sample
of consumers over the age of 21. Both
groups will represent a range of
education levels. Because the task
presumes basic reading abilities, all
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
selected participants must speak English
as their primary language.
FDA proposes to conduct two rounds
of pretesting with 700 consumers in
each round to refine the questionnaire
and the stimuli before collecting data for
the main study.
Hypotheses
Overall, we expect effects to be
stronger in the high blood pressure
sample than in the general population
sample, as high blood pressure sufferers
will likely have higher involvement
with the medical condition.
1. Risk Comprehension
This section explains the following:
• Any inclusion of the toll-free
statement will reduce the
comprehension of risk information.
(Risk comprehension will be highest
in control condition for all
analyses)
• Placement:
Conditions in which the statement is
presented after the major statement
and the statement is present for the
whole ad will reduce
comprehension least.
(After control condition, risk
comprehension will be highest in
conditions where statement is
present for whole ad or after the
major statement; risk
comprehension will be lowest when
statement is presented during or
before the major statement).
E:\FR\FM\18AUN1.SGM
18AUN1
Federal Register / Vol. 74, No. 158 / Tuesday, August 18, 2009 / Notices
• Wording: Type of statement will not
influence risk comprehension.
• Placement x Wording: This analysis
is exploratory
• Duration:
Statement will interfere with risk
comprehension less when
presented in the whole ad than
when presented for briefer periods.
Short duration will result in lower
risk comprehension than long
duration because it will be
displayed for a short time, causing
attention to shift twice in quick
succession
(Risk comprehension highest in
control condition, followed by
whole ad condition followed by
long duration, and, finally, short
duration)
• Prominence: Prominence of
statement will not affect risk
comprehension.
2. Benefit Comprehension
jlentini on DSKJ8SOYB1PROD with NOTICES
This section explains the following:
• Any inclusion of the toll-free
statement will reduce the
comprehension of benefit information.
(Benefit comprehension will be
highest in control condition for all
analyses)
• Placement:
Conditions in which the statement is
presented after the major statement
and the statement is present for the
whole ad will reduce
comprehension least.
(After control condition, benefit
comprehension will be highest in
conditions where statement is
present for whole ad or after the
major statement; benefit
comprehension will be lowest when
statement is presented during or
before the major statement).
• Wording: Type of statement will not
influence benefit comprehension.
• Placement x Wording: This analysis
is exploratory
• Duration:
Statement will interfere with benefit
comprehension most when
presented in the whole ad than
when presented for briefer periods
after the major statement.
No prediction of differences between
short and long duration of
statement on benefit
comprehension.
(Benefit comprehension highest in
control condition, followed short
and long duration conditions
together, followed by condition
where statement is present in whole
ad)
VerDate Nov<24>2008
16:30 Aug 17, 2009
Jkt 217001
• Prominence: Prominence of
statement will not affect benefit
comprehension.
3.Toll-Free Statement Recall
This section explains the following:
• Toll-free statement recall will be
higher in any condition where it is
included in the ad.
• Placement:
Recall of statement will be highest in
conditions where it is on screen for
the whole ad and where it is placed
after the major statement.
• Wording: This analysis is
exploratory.
• Placement x Wording: This analysis
is exploratory
• Duration:
Recall of the statement will be greatest
in the condition where it is present
for the whole ad, followed by the
condition in which it is located
after the major statement.
• Prominence:
Recall of the statement will be higher
in the Extra Prominent condition
than in the condition in which it is
only in super form after the major
statement.
4. Behavioral Intention
This section explains the following:
• This analysis is exploratory and for
completeness.
Analysis Plan
We will conduct the following
analyses separately for the general
population sample and the high blood
pressure sufferers sample. Once these
separate analyses are completed, we
will conduct the analyses with the
samples combined, using the type of
sample as a moderator variable to
determine whether any effects differed
significantly between the groups.
Part 1: We will test whether there is
a main effect of placement on our main
dependent variables (i.e., risk
comprehension, benefit comprehension,
and behavioral intention) using one-way
Analysis of Variants (ANOVAs) (four
placement conditions, plus control
condition). We will conduct ANOVAs
that assess the main effect of placement
(four placement conditions), the main
effect of statement type, and the
interaction between placement and
statement type on our main dependent
variables. We will examine logistic
regression models predicting toll-free
statement recall from placement (four
placement conditions, plus control
condition), and from placement,
statement type, and the interaction
between placement and statement type.
We will conduct these analyses both
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
41709
with and without covariates (e.g.,
demographic and health characteristics)
included in the model. In addition, we
will test whether any main effects are
moderated by other measured variables
(e.g., time spent viewing the ad,
demographic and health characteristics).
If any main effects are significant, we
will conduct pairwise-comparisons to
determine which conditions are
significantly different from one another.
We will also conduct planned
comparisons in line with our
hypotheses (see Hypotheses in this
document).
Part 2: We will test whether there is
a main effect of duration on our main
dependent variables using one-way
ANOVAs and logistic regression
models. We will examine these analyses
both with and without covariates (e.g.,
demographic and health characteristics)
included in the model. In addition, we
will test whether the main effect is
moderated by other measured variables
(e.g., time spent viewing the ad,
demographic and health characteristics).
If the main effect is significant, we will
conduct pairwise-comparisons to
determine which conditions are
significantly different from one another.
We will also conduct planned
comparisons in line with our
hypotheses (see Hypotheses in this
document).
Part 3: We will test whether there is
a main effect of prominence on our
main dependent variables using oneway ANOVAs and logistic regression
models. We will examine these analyses
both with and without covariates (e.g.,
demographic and health characteristics)
included in the model. In addition, we
will test whether the main effect is
moderated by other measured variables
(e.g., time spent viewing the ad,
demographic and health characteristics).
5. Pretesting of Stimuli
The key to our study is the
reasonableness and appropriateness of
the stimuli we use to approximate
television DTC prescription drug ads.
Because the particular images are
subjective, we will conduct extensive
pretesting with consumers similar to our
main target audience. This pretesting
will involve 700 individuals in 2 waves.
The purpose of the pretesting is to
ensure that the stimuli are perceived as
realistic. During the pretesting stage, the
primary dependent variable will be the
success of the particular manipulation.
The pretesting will allow us to make
changes in the ad stimuli before the
actual study commences, thus making
participants’ time more valuable.
E:\FR\FM\18AUN1.SGM
18AUN1
41710
Federal Register / Vol. 74, No. 158 / Tuesday, August 18, 2009 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Screener, pretesting
2,800
1
2,800
.03
84
Questionnaire, pretesting
1,400
1
1,400
.25
350
12,000
1
12,000
.03
360
6,000
1
6,000
.33
1,980
Screener, study
Questionnaire, study
Total
2,774
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
IV. References
1. Chandler, P. and J. Sweller, ‘‘Cognitive
Load Theory and the Format of Instruction,’’
Cognition and Instruction, 8(4), 293–332,
1991.
Dated: August 11, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–19782 Filed 8–17–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2008–N–0637]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Financial Disclosure by Clinical
Investigators
Food and Drug Administration,
HHS.
jlentini on DSKJ8SOYB1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Financial Disclosure by Clinical
Investigators’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
Elizabeth.Berbakos@fda.hhs.gov, 301–
796–3792.
SUPPLEMENTARY INFORMATION: In the
Federal Register of April 22, 2009 (74
FR 18385), the agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
VerDate Nov<24>2008
16:30 Aug 17, 2009
Jkt 217001
Dated: August 11, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–19788 Filed 8–17–09; 8:45 am]
BILLING CODE 4160–01–S
Food and Drug Administration
AGENCY:
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 0910–0396. The
approval expires on August 31, 2012. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0354]
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Mental Models Study of Farmers’
Understanding and Implementation of
Good Agricultural Practices’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857,
Daniel.Gittleson@fda.hhs.gov, 301–796–
5156.
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
Dated: August 11, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–19787 Filed 8–17–09; 8:45 am]
BILLING CODE 4160–01–S
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Mental Models Study of Farmers’
Understanding and Implementation of
Good Agricultural Practices
AGENCY:
In the
Federal Register of March 24, 2009 (74
FR 12364), the agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, 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 0910–0639. The
approval expires on July 31, 2012. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0043]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Irradiation in the Production,
Processing, and Handling of Food
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Irradiation in the Production,
Processing, and Handling of Food’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
E:\FR\FM\18AUN1.SGM
18AUN1
Agencies
[Federal Register Volume 74, Number 158 (Tuesday, August 18, 2009)]
[Notices]
[Pages 41703-41710]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19782]
[[Page 41703]] Hammer: Menck 1,7002RMS impulse2Peak
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0595]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Experimental Study:
Toll-Free Number for Consumer Reporting of Drug Product Side Effects in
Direct-to-Consumer Television Advertisements for Prescription Drugs
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
September 17, 2009.
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: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910--New and
the title ``Experimental Study: Toll-Free Number for Consumer Reporting
of Drug Product Side Effects in Direct-to-Consumer Television
Advertisements for Prescription Drugs.'' Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3792.
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.
Experimental Study: Toll-Free Number for Consumer Reporting of Drug
Product Side Effects in Direct-to-Consumer Television Advertisements
for Prescription Drugs--(OMB Control Number 0910--New)
The Federal Food, Drug, and Cosmetic Act (the act) requires that
manufacturers, packers, and distributors (sponsors) who advertise
prescription human and animal drugs, including biological products for
humans, disclose in advertisements certain information about the
advertised product's uses and risks. For prescription drugs and
biologics, the act requires advertisements to contain ``information in
brief summary relating to side effects, contraindications, and
effectiveness'' (21 U.S.C. 352(n)). FDA is responsible for enforcing
the act and implementing regulations.
On September 27, 2007, the President signed into law the Food and
Drug Administration Amendments Act (FDAAA) (Public Law 110-85). Title
IX of FDAAA amends section 502(n) of the act (21 U.S.C. 352) by
requiring printed direct-to-consumer (DTC) advertisements for
prescription drug products to include the following statement printed
in conspicuous text: ``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.'' Title IX of FDAAA also requires the Secretary
of Health and Human Services (the Secretary), in consultation with the
Risk Communication Advisory Committee (RCAC), to conduct a study not
later than 6 months after the date of enactment of FDAAA to determine
if this statement is appropriate for inclusion in DTC television
advertisements for prescription drug products. As part of this study,
the Secretary shall consider whether the information in the statement
described previously in this paragraph would detract from the
presentation of risk information in a DTC television advertisement. If
the Secretary determines that the inclusion of such a statement would
be appropriate for television advertisements, FDAAA mandates the
issuance of regulations implementing this requirement, and for the
regulations to reflect a reasonable length of time for displaying the
statement in television advertisements. Finally, FDAAA requires the
Secretary to report the study's findings and any subsequent plans to
issue regulations to Congress.
In accordance with the requirements of FDAAA, FDA convened a
meeting of the RCAC on May 15 and 16, 2008. A draft design for studying
this issue was proposed at that time and discussed by the advisory
committee. Based on comments received at that meeting, changes were
made to the proposed study design. The transcripts and materials from
that meeting can be found at https://www.fda.gov/ohrms/dockets/ac/oc08.html#RCAC.
I. Background
Section 17 of the Best Pharmaceuticals for Children Act (the BPCA)
(Public Law 107-109, January 4, 2002) required FDA to issue a final
rule mandating the addition of a statement to the labeling of each drug
product for which an application is approved under section 505 of the
act (21 U.S.C. 355). Under the BPCA, the statements must include: (1) A
toll-free number maintained by FDA for the purpose of receiving reports
of adverse events regarding drugs, and (2) a statement that the number
is to be used only for reporting purposes, and it should not be used to
seek or obtain medical advice (the side effects statement).
On April 22, 2004, FDA published a proposed rule with a proposed
side effects statement for certain prescription drug product labeling
and a proposed side effects statement for certain over-the-counter drug
product labeling (69 FR 21778). In the proposed rule, FDA solicited
comments on a proposed statement that FDA believed comported with the
previously mentioned mandate in the BPCA. The agency received 12
comments suggesting changes to the specific wording proposed. The
agency also received several comments suggesting that FDA engage in
research to study the wording of the proposed side effects statement
with consumers. Among the reasons cited for testing the statement were
to: (1) Determine the best and most precise wording for the statement,
(2) evaluate consumer comprehension of the proposed statement, and (3)
address concerns that consumers who read the statement will mistakenly
call FDA in search of medical advice rather than seeking appropriate
medical treatment. In addition, during the clearance process for the
proposed rule, both the Office of Information and Regulatory Affairs of
OMB and the Office of the Assistant Secretary for Planning and
Evaluation of the Department of Health and Human Services suggested
that FDA conduct focus groups or other consumer studies to inform the
wording of the side effects statement.
During the spring of 2006, to assist in developing this study, FDA
conducted two focus groups to gauge consumer understanding and
preferences for a number of proposed side effects statements and to
narrow the number of statements to be tested in subsequent experimental
research. In addition to the information collected on which versions of
the statements participants preferred, discussions showed that people
varied in their understanding of when to call FDA or their health care
[[Page 41704]]
practitioners and that some people would not call FDA even if they
experienced a serious side effect. Several people in the focus groups
suggested the addition of a Web site to report adverse side effects.
Based on the findings from the focus groups, nine statements were
selected for quantitative testing. A labeling comprehension experiment
was conducted with 1,674 men and women ranging in age from 21 to 95
with varying levels of education (OMB Control No. 0910-0497). The
results from that quantitative test found that only one of the versions
tested was rated as significantly less clear than the others, which
were all rated as generally clear and understandable. The results also
showed that participants reported they would not call FDA seeking
medical advice. Further, among those participants who said they would
call FDA, the majority indicated they would call their doctor for
medical advice, rather than FDA, regardless of the severity of the side
effect. Finally, participants indicated they could distinguish between
serious and non-serious side effects, reporting that they would seek
emergency medical care in the case of serious side effects. The report
of the study is available in the docket for the final rule (Docket No.
FDA-2003-N-0313). The final rule, Toll-Free Number for Reporting
Adverse Events on Labeling for Human Drug Products (TFNR) (73 FR 63886,
October 28, 2008), is available at https://www.fda.gov/OHRMS/DOCKETS/98fr/E8-25670.pdf.
In the Federal Register of November 26, 2008 (73 FR 72058), FDA
published a 60-day notice requesting public comment on the information
collection provisions. FDA received six comments in response to our
initial Federal Register notice, published on November 26, 2008. One of
these comments, from an anonymous citizen, did not require specific
responses, as it was outside the scope of the project (e.g., FDA
approves too many drugs; harmful drugs are ``being foisted on the
population''), although it could be viewed as a statement of support
for conducting the research.
II. Comments on the Information Collection
In the following section, we outline the issues raised in the
comments and provide our responses.
(Comment 1) Do not place the toll-free statement in television ads
because it is better placed within written materials that accompany
prescription drugs. Some system for enforcing the legitimacy of calls
is necessary, otherwise callers with an ``agenda'' or ``the
uninformed'' could ``doom medicines for no reason.''
(Response) This comment mostly applies to MedWatch procedures that
are outside the scope of the proposed research. This study is
addressing the understanding of information in the ad. We have notified
the appropriate parties in the agency of this comment.
(Comment 2) The comment supports DTC advertising that is
educational and ``delayed until postmarketing surveillance data are
collected and assessed.'' DTC television ads should include a toll-free
statement. Overall, this comment supports the proposed research, but
includes the following specific suggestions: (1) The toll-free
statement is best placed after the risk information and (2) it should
be placed during the presentation of non-life-threatening or minor side
effects.
(Response) We agree that placement during non-life-threatening or
minor side effects may be the best placement for the toll-free
statement. In a television ad, however, that information is presented
in a very short amount of time, sometimes only seconds (and this varies
depending on the drug product). We have designed our study to allow the
data to show for us the best placement of the statement.
(Comment 3) Neither of the proposed toll-free statements addresses
whether consumers can distinguish between serious and non-serious side
effects. A simulation study should be used to assess this issue.
(Response) We refer this comment to previous research conducted by
FDA on this topic, described previously. This study found that
participants were easily able to distinguish between serious and non-
serious side effects and that they reported an ability to take the
right action with regard to each one.
(Comment 4) FDA should post the proposed questionnaire, the primary
endpoint(s) of the study with action standards, and provide the mock
advertisement to interested parties for use in their research.
(Response) The proposed questionnaire has been and continues to be
available upon request. We agree that threshold levels and primary
endpoints were not well explained in the 60-day notice and have worked
to correct that in the 30-day notice. Please note the addition of
specific hypotheses and the analysis plan. At the conclusion of our
data collection, we will make the advertisement available to those who
request it.
(Comment 5) Adequate provision issues may not be considered or
addressed. Multiple telephone numbers or Web sites may confuse
consumers. Use alternate wording for the toll-free statement: ``For
information about PRODUCT X or to report side effects, see our ad in --
---- magazine.'' Include payment assistance information, as this is
often currently included in television ads.
(Response) We have designed the stimuli ad to closely approximate
an actual DTC ad, including adequate provision measures and other
supers. Division of Drug Marketing, Advertising, and Communications
reviewers have examined the script and storyboard to ensure that the ad
meets regulatory requirements. The contractor producing the ad has
extensive experience with this type of production and provided
additional quality control measures. In directing us to complete this
research, Congress was likely concerned about the same issues expressed
by this comment, i.e., that the toll-free statement may be confusing.
That is one of the main research questions we will address. In terms of
wording, Congress directed us to test specific language. In addition to
this language, we propose to test another version that was found most
acceptable in previous usability research conducted by the agency.
Finally, because payment assistance information is relatively new, not
universal, and not required by regulation, we have not included this
statement in our stimuli ads.
FDA has contracted with a professional multimedia company to create
ad stimuli. In addition, FDA has instituted a procedure of extensive
pretesting of the ad stimuli to be used. Our extensive experience with
current and past DTC ads, pretesting, and collaboration with the
contractor should ensure realistic ads that will enable us to
successfully investigate our experimental variables.
(Comment 6) Study multiple medical conditions, including
symptomatic and asymptomatic conditions; diseases that affect different
age groups; sufferers and non-sufferers; and consumers with varying
degrees of knowledge about their medical conditions.
(Response) We do not have the resources to create mock ads to test
multiple medical conditions. We have no reason to suspect that the
principles we study in this medical condition (e.g., placement,
duration, wording, prominence) would be different when applied to an ad
for another medical condition. We welcome other parties to extend the
current research by applying it to other conditions. We will ask
respondents about their knowledge of their medical conditions and will
[[Page 41705]]
conduct analyses to see if this variable plays a role in their
responses.
We have decided, however, to recruit for the study two distinct
populations: Those who have been diagnosed with high blood pressure and
a general population sample. This approach will allow us to determine
whether diagnosed individuals and other people who may be exposed to
such television advertising will differ in their responses to the ad.
(Comment 7) Using the condition where the toll-free statement is
present during the whole ad to control for novelty will increase rather
than decrease the attention to the statement.
(Response) We agree that the condition in which the toll-free
statement appears during the entire ad may increase notice of it. We
think there is also a good possibility that it might be ignored, in
such a way that the statement might be more prominent in other
conditions. To control for novelty, participants will see an unrelated
DTC ad with the toll-free statement presented the same way as the test
ad before they see the test ad. This may control for novelty in the
test ad and may attenuate the belief that our test product has some
unique quality that causes it to need a special toll-free statement.
(Comment 8) This protocol will take much longer than 15 minutes.
(Response) Because we are also concerned that this protocol will
take longer than 15 minutes, we have revised our burden estimate to
reflect a 20-minute protocol. Also, to ensure that all test parameters
are met, including timing of experiment, we have budgeted for 2
pretests of 700 individuals each.
(Comment 9) The placement and duration variables should be removed
from study because regardless of placement, the statement may interrupt
the flow of the most important information.
(Response) These are empirical questions. We will not know the
answer to either of these questions until we collect data.
(Comment 10) Remove the audio-only condition because this
eliminates the hearing-impaired population. Include visually and
hearing-impaired persons to more accurately represent the population.
(Response) Even in our audio-only condition as originally proposed,
the Web site and phone numbers were placed on screen. Current
requirements for the most important risk information (i.e., the major
statement) are that it be placed in the audio portion of the ad. Thus,
this is a reasonable condition to test. Upon further discussion,
however, we agree that we do not need two distinct extra-prominent
conditions, and will test only one. We do not plan to actively exclude
people with audio or visual impairments from the study but we do not
have the resources to actively recruit them.
(Comment 11) High blood pressure may not be the most representative
condition for a general sample of consumers ``over the age of 18.'' The
tested sample population should be representative of actual sufferers
of the condition being advertised.
(Response) We agree that this is an important consideration. Upon
further discussion, we have decided to recruit for the study two
distinct populations: Those who have been diagnosed with high blood
pressure and a general population sample. This approach will allow us
to determine whether diagnosed individuals and other people who may be
exposed to such television advertising will differ in their responses
to the ad.
(Comment 12) Remove the fourth commercial for an unrelated medical
condition because it does not contribute to the study and may confound
results.
(Response) Study participants will see four ads--the second ad will
be an unrelated DTC ad and the fourth ad will be the test ad. We
propose to include the other DTC ad with the matching toll-free
statement parameters so that consumers do not think that our test ad
reflects a special product that needs a special warning. It also may
attenuate the effect of novelty.
(Comment 13) Because the toll-free statement may artificially
increase impact of risk information, FDA should test information
gleaned from the presence of the toll-free statement in print ads
first.
(Response) FDA has not collected any information on the presence of
the statement in print ads, although we agree this would be valuable
information. Moreover, Congress has instructed us specifically to test
the toll-free statement in television ads.
(Comment 14) Including the manufacturer's toll-free number instead
of the FDA contact number may help to mitigate the possibility that the
toll-free statement artificially increases the impact of risk
information.
(Response) Sponsors already include the manufacturer's telephone
number in all ads as a way to fulfill one part of the adequate
provision requirement. The current study does not examine the
replacement of that number with the toll-free statement, but instead
the statement's inclusion above and beyond current requirements.
(Comment 15) The agency's expectation of yielding a sample of 2,000
people from a total of 2,400 is unrealistic based on a typical response
rate of 5 percent.
(Response) We do not expect to yield a sample of 2,000 people from
a total of 2,400. As shown in Table 1 of this document, we have revised
our sample numbers.
(Comment 16) How well can an Internet study simulate a television
environment?
(Response) We agree that simulating an everyday television-watching
environment would increase the realism of the study. Participation in
an experiment in any context, however, is unlikely to perfectly do so.
We do not believe that a mall-intercept administration would increase
the realism of the study and a phone-based survey is not feasible,
given the modality of the advertisement in question. Moreover, an
Internet study may be as close to the television-watching environment
as any other method because participants will be in their own homes and
some participants already watch streaming video on their computers.
(Comment 17) What are the thresholds for interference
(``detraction'') in this study? Specifically, will the statement be
included only if it does not affect risk comprehension at all, or if it
does not affect risk comprehension ``much''--and if this is the case,
what is too much?
(Response) If the study demonstrates that the inclusion of the
toll-free statement does not interfere with the processing of the risk
information, then Congress is likely to mandate its inclusion. If the
data demonstrate some detraction from risk information, then the
decision becomes more complicated. As the interference between the
toll-free statement and the risk information increases, the less likely
it is that it will be mandated. A tradeoff analysis will have to be
conducted and this study will be only one part of the determination.
That is, the amount of detraction will have to be weighed against the
benefit of including the statement and this benefit will be determined
in part by public health concerns and analysis of MedWatch data.
(Comment 18) Participants will see the test ad three times and this
may cause problems.
(Response) Participants will see the test ad only once after seeing
three other filler ads, one of which will be an unrelated DTC ad.
(Comment 19) The current proposed study is comprehensive and
appropriate to address the primary research questions under
consideration.
[[Page 41706]]
(Response) Thank you.
(Comment 20) The toll-free statement in the unrelated DTC ad should
be presented in the same way as in the test ad.
(Response) We had planned to do so.
(Comment 21) The questionnaire does not specifically address the
risk of nontreatment of the disease condition.
(Response) FDA acknowledges that this study does not address this
risk. Nevertheless, this is outside the scope of the current
investigation.
(Comment 22) Ask if respondents suffer from diabetes, high
cholesterol, obesity, or the condition treated in the unrelated DTC ad.
(Response) We plan to ask about the state of respondent's health.
In considering this comment, we have added additional questions to the
questionnaire. Please see the revised questionnaire for details.
(Comment 23) Question 7 in the questionnaire is vague and should be
placed earlier in the questionnaire.
(Response) Question 7, which originally asked participants in an
open-ended fashion to report on ``some information written on the
screen'' has been changed. We now ask participants which of several
options they saw and follow that up with an open-ended question about
what the statement means to them. We do not wish to move this question
series earlier in the questionnaire because it is not one of our main
dependent measures.
(Comment 24) It is unclear how FDA plans to analyze results from
this research, particularly what action consumers are expected to take
after they have heard and understood the toll-free statement.
(Response) The purpose of this research is not to determine what
action consumers will take after seeing the ad. We addressed these
issues in the labeling comprehension study described at the beginning
of this notice (Docket No. FDA-2003-N-0313). The purpose of the current
proposed study is to determine whether the risk information is
adequately comprehended and whether the toll-free statement is
noticeable and recalled.
III. Revised Study
Experimental Study: Toll-Free Number for Consumer Reporting of Drug
Product Side Effects in Direct-to-Consumer Television Advertisements
for Prescription Drugs--(OMB Control Number 0910--New)
Based in part on these comments, further research discussions, and
the input of the RCAC on May 16, 2008, we propose the following revised
design, hypotheses, and analysis plan.
A. Overview
This study will examine the placement of the toll-free statement
and the length of time the statement is presented on screen in a DTC
television advertisement for a prescription drug. The primary dependent
measure of interest is consumer comprehension of the important risk
information in the advertisement. This study will also examine
potential differences in comprehension based on the wording of the
toll-free statement and the prominence of the statement.
The application of a new piece of information for viewers of DTC
ads presents logistical challenges. From a research perspective, the
primary issue under investigation is how to impart additional
information without increasing ``cognitive load,'' thus leading to
information overload. Cognitive load is an index of the memory demands
necessary to process a set of information (Ref. 1). As cognitive load
increases, more mental resources are necessary to process and
understand the information. DTC ads are already quite dense when
compared to ads for other products. The risk information in the major
statement of the ad should not be compromised by the addition of the
toll-free statement. At the same time, it is preferable that the risk
information and the toll-free statement information are presented in
such a way that both are understandable. We have chosen a set of
variables in the current study to investigate issues of cognitive load.
They are described briefly below before examining the details of the
research design.
1. Placement
The location of the toll-free statement may facilitate or detract
from the risk information in the major statement. We have chosen three
locations for this information to test which location results in the
greatest communication of the risks of the drug and the concept that
side effects can be reported. It is possible that locating the toll-
free statement before the major statement provides a ``prime'' for the
risk information that follows; that is, the mention of side effects in
the toll-free statement will cause consumers to start thinking about
side effect-related information, which facilitates comprehension of the
risk information that follows. In this case, the two conceptual pieces
of information may flow together easily. Conversely, it is possible
that the toll-free statement confuses consumers or provides no
information for them because they have not yet heard any risk
information. Thus, without context, the statement lacks applicability.
Placing the toll-free statement during the major statement likely
reduces the comprehension of the risk information for the drug because
it divides viewer's attention between two competing pieces of
information. It is possible, however, that the juxtaposition of these
two informational concepts are complimentary and therefore do not
conflict.
The toll-free statement may serve the best role after the risk
information has been presented. In this case, participants have been
told about the risks and side effects of the drug before they are told
they may report this information. This essentially primes the toll-free
statement with the major statement. We do not expect this placement to
interfere with the comprehension of risk information, as it is not
present during the voicing of risks and has not been introduced to
viewers at this point. In addition, the usefulness of the toll-free
statement may improve in this condition relative to those discussed in
the previous paragraphs because viewers have been provided with
context.
Over time, it is likely that the toll-free statement will become
part of the background of the ads as people become accustomed to seeing
this statement in all DTC ads. In this respect, people will have the
statement as an option if needed but may be able to disregard it to
focus on the risk information otherwise. Thus, we are testing a
condition in which the toll-free statement will be present during the
entire ad. This test condition will control for the effect of novelty
arising from the fact that consumers have not previously seen this type
of statement in TV ads. Presence of the statement during the entire ad
may increase noticeability of the toll-free statement initially, but
will be unlikely to interfere with risk information over time.
2. Statement Type
The second variable, statement type, will have two executions of
statement language: The language from the FDAAA versus the language
used in the final rule, Toll-Free Number for Reporting Adverse Events
on Labeling for Human Drug Products Rule (TFNR; Public Law 107-109,
January 4, 2002), and previously tested by FDA. The wording from these
two statements is as follows:
``You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/
[[Page 41707]]
medwatch, or call 1-800-FDA-1088.'' (FDAAA)
``Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.'' (TFNR)
We think it is important to test both the toll-free statement
version in FDAAA and the version that we have previously tested with
actual consumers. The most obvious reason for this is to make sure that
the statement is maximally readable and understandable. It may be
valuable, however, to test two statements for another reason.
If the toll-free statement is enacted in broadcast ads, it is
possible that because of the boilerplate language, some amount of
habituation will occur. That is, after viewers have seen the same
language in multiple ads for multiple products, they may ``tune out''
and not pay attention to the toll-free statement at all. If we test two
versions of the statement and find both acceptable, it would be
possible to either allow sponsors to choose one statement versus
another or to suggest some alternating of the two statements. This is a
long-term idea, however, and finding appropriate wording is the primary
goal of investigating this variable.
3. Duration
Congress specifically mandates that we investigate the duration of
the display of the toll-free statement. As with placement, the length
of time the toll-free statement is presented on screen may influence
the cognitive load in the ad. For experimental control, we will look at
the duration of the statement while holding placement in the ad (after
the major statement of risks) constant. Although this placement should
not interfere with the processing of the risk information, it is
possible that the duration influences the take-away message from the
ad. For example, having the statement on screen for a short amount of
time may not give consumers enough time to read and process the toll-
free message. This may result in lower comprehension of the message but
may have no impact on the comprehension of the risk information.
Alternatively, displaying the toll-free statement for a longer period
of time may remove memory traces of the risks from the major statement,
resulting in lower risk comprehension. To determine whether this longer
duration increases the usefulness of the toll-free statement itself, we
will compare these short and long durations to instances where the
toll-free statement is present during the entire ad and where there is
no toll-free statement at all.
4. Prominence
In addition to superimposing the toll-free statement on the screen
during the ad, there are other methods available to increase the
prominence of the statement. In particular, having the statement read
aloud in the ad voiceover while the statement is on the screen may be
considered particularly prominent. Does the additional prominence of
the statement compromise the comprehension of the risk information in
the major statement? If not, does the additional prominence result in a
greater understanding of the toll-free statement itself? It is likely
that there is a tradeoff between the gains of emphasizing the toll-free
statement and the comprehension of the risk information. In examining
this variable, we are exploring the parameters of this tradeoff.
B. Design
The design will consist of three parts. Part one will be a between-
subjects factorial design examining the placement of the toll-free
statement by the type of statement. The first variable, placement, will
have four levels: Before the major statement of risks, during the major
statement of risks, after the major statement of risks, or continuously
throughout the whole ad.
In each condition the toll-free statement will appear in the ad as
superimposed text at the bottom of the screen. We will also include a
control condition in which the statement does not appear.
Part One: Placement by Statement Type
4 x 2 + 1
------------------------------------------------------------------------
Statement Type
------------------------------------------------------------------------
Placement FDAAA TFNR
------------------------------------------------------------------------
Before major statement of .................... ....................
risks
------------------------------------------------------------------------
During major statement of .................... ....................
risks
------------------------------------------------------------------------
After major statement of .................... ....................
risks
------------------------------------------------------------------------
During the whole ad .................... ....................
------------------------------------------------------------------------
Plus:
-----------------------------------------------------------------------------------------------------------------
Control (no toll-free statement)
----------------------------------------------------------------------------------------------------------------
Part two of the study will examine four variations in the duration
of the toll-free statement using the language from FDAAA: Short (on
screen for approximately 3 seconds after the major statement), long (on
screen for approximately 6 seconds after the major statement), on
screen during the whole ad, and the control condition of no toll-free
statement included. These times were adopted by calculating how long it
would take a person reading at an average reading speed to read the
statement. As in the first part of this study series, the toll-free
statement will appear as superimposed text and a control condition in
which the toll-free statement does not appear will be included.
[[Page 41708]]
Part Two: Duration\*\
4 x 1
-------------------------------------------------------------------------
Short (on screeen for approximately
3 seconds after major statement)
------------------------------------------------------------------------
Long (on screen for approximately
6 seconds after major statement)
------------------------------------------------------------------------
During the whole ad
------------------------------------------------------------------------
Control (no toll-free statement)
------------------------------------------------------------------------
\*\Using FDAAA statement
Part three of the study will examine two variations in the
prominence of the toll-free statement using the language from the
FDAAA: Spoken after the major statement with only the Web site and
phone number in superimposed text, and a control condition where the
toll-free statement is presented visually after the major statement.
Part Three: Prominence\*\
2 x 1
Extra Prominent (spoken after major statement of risks, Web site and
phone number on screen)
------------------------------------------------------------------------
Control (after major statement of risks)
------------------------------------------------------------------------
\*\Using FDAAA statement
We will investigate these issues in one disease condition, high
blood pressure, because high blood pressure has a high incidence rate
in the population, is a public health concern, and is likely to occur
in both males and females. Further, because there is little broadcast
promotion for prescription treatment of high blood pressure at this
time, participants should be less familiar with DTC television ads for
this type of drug, reducing the potential influence of prior
experience.
Our primary dependent variable is comprehension of the risk
information mentioned in the major statement. In addition to this
variable, we will also examine comprehension of benefit information. We
will also examine the noticeability and comprehension of the toll-free
statement.
C. Procedure
Participants will see a cluster of four ads: Two 15-second non-DTC
ads (fillers), an approximately 60-second DTC ad for a fictitious high
blood pressure medication, and a 30-second DTC ad for an unrelated
medical condition with the same toll-free statement included. We
include two DTC ads with the toll-free statement in our protocol
because this better approximates what will happen if this statement is
enacted. That is, viewers will see the statement in all DTC ads for all
products. In this study, we want to avoid the suggestion that there is
something particular about the high blood pressure drug class that
causes the statement to be mandated. Thus, we will show multiple DTC
ads but ask questions regarding only the ad which has been manipulated
to test our hypotheses. To maximize response information, the test ad
will always be the last ad they see.
After viewing the ads, a structured interview will be conducted.
Participants will answer questions about the high blood pressure DTC
test ad they have seen. Questions will examine a number of important
perceptions about the advertised product, including risk comprehension,
risk recall, benefit comprehension, benefit recall, behavioral
intention, noticeability of the toll-free statement, and recall of the
toll-free statement.
Finally, demographic and health care utilization information will
be collected. The entire procedure is expected to last approximately 20
minutes. A total of 6,000 interviews will be completed. This will be a
one-time (rather than annual) information collection.
D. Participants
Data will be collected using an Internet protocol. Two samples of
consumers will be recruited: One sample of individuals diagnosed with
high blood pressure and another sample of consumers over the age of 21.
Both groups will represent a range of education levels. Because the
task presumes basic reading abilities, all selected participants must
speak English as their primary language.
FDA proposes to conduct two rounds of pretesting with 700 consumers
in each round to refine the questionnaire and the stimuli before
collecting data for the main study.
Hypotheses
Overall, we expect effects to be stronger in the high blood
pressure sample than in the general population sample, as high blood
pressure sufferers will likely have higher involvement with the medical
condition.
1. Risk Comprehension
This section explains the following:
Any inclusion of the toll-free statement will reduce the
comprehension of risk information.
(Risk comprehension will be highest in control condition for all
analyses)
Placement:
Conditions in which the statement is presented after the major
statement and the statement is present for the whole ad will reduce
comprehension least.
(After control condition, risk comprehension will be highest in
conditions where statement is present for whole ad or after the major
statement; risk comprehension will be lowest when statement is
presented during or before the major statement).
[[Page 41709]]
Wording: Type of statement will not influence risk
comprehension.
Placement x Wording: This analysis is exploratory
Duration:
Statement will interfere with risk comprehension less when
presented in the whole ad than when presented for briefer periods.
Short duration will result in lower risk comprehension than long
duration because it will be displayed for a short time, causing
attention to shift twice in quick succession
(Risk comprehension highest in control condition, followed by whole
ad condition followed by long duration, and, finally, short duration)
Prominence: Prominence of statement will not affect risk
comprehension.
2. Benefit Comprehension
This section explains the following:
Any inclusion of the toll-free statement will reduce the
comprehension of benefit information.
(Benefit comprehension will be highest in control condition for all
analyses)
Placement:
Conditions in which the statement is presented after the major
statement and the statement is present for the whole ad will reduce
comprehension least.
(After control condition, benefit comprehension will be highest in
conditions where statement is present for whole ad or after the major
statement; benefit comprehension will be lowest when statement is
presented during or before the major statement).
Wording: Type of statement will not influence benefit
comprehension.
Placement x Wording: This analysis is exploratory
Duration:
Statement will interfere with benefit comprehension most when
presented in the whole ad than when presented for briefer periods after
the major statement.
No prediction of differences between short and long duration of
statement on benefit comprehension.
(Benefit comprehension highest in control condition, followed short
and long duration conditions together, followed by condition where
statement is present in whole ad)
Prominence: Prominence of statement will not affect
benefit comprehension.
3.Toll-Free Statement Recall
This section explains the following:
Toll-free statement recall will be higher in any condition
where it is included in the ad.
Placement:
Recall of statement will be highest in conditions where it is on
screen for the whole ad and where it is placed after the major
statement.
Wording: This analysis is exploratory.
Placement x Wording: This analysis is exploratory
Duration:
Recall of the statement will be greatest in the condition where it
is present for the whole ad, followed by the condition in which it is
located after the major statement.
Prominence:
Recall of the statement will be higher in the Extra Prominent
condition than in the condition in which it is only in super form after
the major statement.
4. Behavioral Intention
This section explains the following:
This analysis is exploratory and for completeness.
Analysis Plan
We will conduct the following analyses separately for the general
population sample and the high blood pressure sufferers sample. Once
these separate analyses are completed, we will conduct the analyses
with the samples combined, using the type of sample as a moderator
variable to determine whether any effects differed significantly
between the groups.
Part 1: We will test whether there is a main effect of placement on
our main dependent variables (i.e., risk comprehension, benefit
comprehension, and behavioral intention) using one-way Analysis of
Variants (ANOVAs) (four placement conditions, plus control condition).
We will conduct ANOVAs that assess the main effect of placement (four
placement conditions), the main effect of statement type, and the
interaction between placement and statement type on our main dependent
variables. We will examine logistic regression models predicting toll-
free statement recall from placement (four placement conditions, plus
control condition), and from placement, statement type, and the
interaction between placement and statement type. We will conduct these
analyses both with and without covariates (e.g., demographic and health
characteristics) included in the model. In addition, we will test
whether any main effects are moderated by other measured variables
(e.g., time spent viewing the ad, demographic and health
characteristics). If any main effects are significant, we will conduct
pairwise-comparisons to determine which conditions are significantly
different from one another. We will also conduct planned comparisons in
line with our hypotheses (see Hypotheses in this document).
Part 2: We will test whether there is a main effect of duration on
our main dependent variables using one-way ANOVAs and logistic
regression models. We will examine these analyses both with and without
covariates (e.g., demographic and health characteristics) included in
the model. In addition, we will test whether the main effect is
moderated by other measured variables (e.g., time spent viewing the ad,
demographic and health characteristics). If the main effect is
significant, we will conduct pairwise-comparisons to determine which
conditions are significantly different from one another. We will also
conduct planned comparisons in line with our hypotheses (see Hypotheses
in this document).
Part 3: We will test whether there is a main effect of prominence
on our main dependent variables using one-way ANOVAs and logistic
regression models. We will examine these analyses both with and without
covariates (e.g., demographic and health characteristics) included in
the model. In addition, we will test whether the main effect is
moderated by other measured variables (e.g., time spent viewing the ad,
demographic and health characteristics).
5. Pretesting of Stimuli
The key to our study is the reasonableness and appropriateness of
the stimuli we use to approximate television DTC prescription drug ads.
Because the particular images are subjective, we will conduct extensive
pretesting with consumers similar to our main target audience. This
pretesting will involve 700 individuals in 2 waves. The purpose of the
pretesting is to ensure that the stimuli are perceived as realistic.
During the pretesting stage, the primary dependent variable will be the
success of the particular manipulation. The pretesting will allow us to
make changes in the ad stimuli before the actual study commences, thus
making participants' time more valuable.
[[Page 41710]]
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency Hours per
21 CFR Section No. of Respondents per Response Total Annual Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screener, pretesting 2,800 1 2,800 .03 84
--------------------------------------------------------------------------------------------------------------------------------------------------------
Questionnaire, pretesting 1,400 1 1,400 .25 350
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screener, study 12,000 1 12,000 .03 360
--------------------------------------------------------------------------------------------------------------------------------------------------------
Questionnaire, study 6,000 1 6,000 .33 1,980
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total ....................... ................. ....................... ........... 2,774
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
IV. References
1. Chandler, P. and J. Sweller, ``Cognitive Load Theory and the
Format of Instruction,'' Cognition and Instruction, 8(4), 293-332,
1991.
Dated: August 11, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-19782 Filed 8-17-09; 8:45 am]
BILLING CODE 4160-01-S