Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of Direct-to-Consumer Promotion Directed at Adolescents, 42333-42337 [2014-16998]
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42333
2 These figures were calculated by the U.S. Department of Health and Human Services, Administration for Children and Families, Office of
Community Services, Division of Energy Assistance by multiplying the estimated state median income for a four-person family for each state by
60 percent.
3 To adjust for different sizes of households for LIHEAP purposes, 45 CFR 96.85 calls for multiplying 60 percent of a state’s estimated median
income for a four-person family by the following percentages: 52 percent for a one-person household, 68 percent for a two-person household, 84
percent for a three-person household, 100 percent for a four-person household, 116 percent for a five-person household, and 132 percent for a
six-person household. For each additional household member above six people, 45 CFR 96.85 calls for adding 3 percentage points to the percentage for a six-person household (132 percent) and multiplying the new percentage by 60 percent of the median income for a four-person
family.
Note: FFY 2015 covers the period of
October 1, 2014, through September 30, 2015.
The estimated median income for fourperson families living in the United States for
this period is $76,365. Grantees that use SMI
for LIHEAP may, at their option, employ
such estimates at any time between the date
of this publication and the later of October
1, 2014 or the beginning of their fiscal year.
Statutory Authority: 45 CFR 96.85(b) and
42 U.S.C. 8624(b)(2)(B)(ii).
Dated: July 15, 2014.
Jeannie L. Chaffin,
Director, Office of Community Services.
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1151]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Experimental
Study of Direct-to-Consumer
Promotion Directed at Adolescents
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by August 20,
2014.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title, ‘‘Experimental Study of Direct-toConsumer (DTC) Promotion Directed at
Adolescents.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
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SUMMARY:
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In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Experimental Study of Direct-toConsumer (DTC) Promotion Directed at
Adolescents—(OMB Control Number
0910—NEW)
[FR Doc. 2014–17063 Filed 7–18–14; 8:45 a.m.]
AGENCY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct
research relating to health information.
Section 1003(d)(2)(C) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 393(d)(2)(C)
authorizes FDA to conduct research
relating to drugs and other FDA
regulated products in carrying out the
provisions of the FD&C Act.
Sponsors for several prescription drug
classes market their products directly to
vulnerable groups, including
adolescents. Such DTC marketing to
adolescents raises a variety of potential
concerns. Adolescents are a unique
audience for DTC drug marketing
because their cognitive abilities are
different than those of adults, and they
are usually dependent on adults for
health insurance coverage, health care
provider access, and prescription drug
payment. Despite this uniqueness,
research regarding how adolescents use
risk and benefit information for healthrelated decisions is limited. If
considered at all in healthcare
communication research, age is
typically treated as simply another
segment of the audience (Ref. 1), and
researchers fail to consider how
information processing (how people
understand information) in response to
advertisement (ad) exposure might
differ among adolescents versus older
viewers.
The FD&C Act requires
manufacturers, packers, and distributors
that advertise prescription drugs to
disclose certain information about a
product’s uses and risks to potential
consumers in all advertisements.
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Consumers must consider tradeoffs with
regard to the product’s risks and
benefits in deciding whether to ask their
health care professionals about the
product. Presenting technically factual
information is important, but other
factors can also affect potential
consumers. Information processing
capacity, the relevance and vividness of
the information, and contextual factors
such as family dynamics likely affect
how adolescent consumers weigh the
potential risks and benefits of using a
product.
Despite the lack of previous research
specific to DTC drug marketing to
adolescents, existing theoretical and
empirical data make a strong case for
treating adolescence as a unique life
stage during which vulnerabilities that
can affect informed decisionmaking
must be taken into account. Well-known
theories of adolescent development
have long pointed to developmental
changes that occur during the
transitional period as an individual
moves from childhood to young
adulthood (Ref. 2). For instance, Erikson
(Refs. 3, 4) describes an often turbulent
psychosocial crisis that occurs as
adolescents strive to develop their
unique identity. Piaget (Refs. 5, 6) and
Kohlberg (Ref. 7) describe changes in
stages relative to cognitive processing
and reasoning that occur in this period,
as the adolescent becomes increasingly
capable of more abstract thinking.
Different cognitive, social and
emotional, and developmental processes
in the adolescent brain mature
simultaneously and at different rates,
affecting decisionmaking by age. All of
these factors can influence how
adolescents perceive and process
information as well as weigh risks and
benefits.
The need for understanding how
adolescents weigh risks and benefits is
particularly critical given the potential
adverse events associated with use of
the drug classes that are marketed
directly to adolescents. Suicide and
suicidal ideation has been associated
with some of these classes, including a
commonly used class of acne
medications. The risk and benefit
information needs to be clearly
presented in ways that adolescents can
understand. Interpretation of more
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subtle messages in the advertisements,
along with the lens through which
adolescents view the message, must be
understood. For example, given the
potential stigma of acne and
adolescents’ heightened concerns about
peer perceptions, marketing that
emphasizes these two features in subtle
ways might minimize the attention
given to any risk information provided.
This suggests the need to systematically
explore the role of various factors that
would be expected to influence
adolescent decision-making, such as
peer and family perceptions of stigma.
We plan to conduct a randomized,
controlled study in two different
medical conditions that assesses
adolescents’ perceptions following
exposure to different types of DTC
prescription drug advertising. We plan
to compare adolescents’ perceptions to
those of young adult counterparts. Each
participant will view a Web-based
promotional campaign for either a
fictitious Attention Deficit Hyperactivity
Disorder (ADHD) medication or a
fictitious acne medication. Because
adolescents typically depend on their
parents for prescription drug purchases,
we also will include a sample of parents
matched to their adolescent children to
explore similarities and differences in
perceptions for these matched pairs.
Within the two medical conditions,
we propose to explore the role of three
different factors that may influence
adolescent understanding and
perceptions of DTC. Two of these factors
include timing issues: The timing of the
onset of benefits and the timing of the
onset of risks. Adolescents may be
particularly likely to give more credence
to benefits that occur immediately and
may be likely to discount risks that do
not occur immediately. Research
suggests that the frontal lobe, which
controls self-regulatory functions, is not
fully developed until the mid-20s (Ref.
8), which may lead to difficulty in
impulse control and planning, and thus
decisionmaking. Other research suggests
that adolescents are more likely to
engage in risky behavior, although
whether they do this because they
discount their own likelihood of
experiencing risks or if they cannot help
themselves despite having adequate
perceptions of their own vulnerability
has not been determined (Refs. 9, 10).
Given the variety of prescription drug
products on the market with varying
benefit and risk profiles, these factors
(benefit and risk timing) will enable us
to investigate its role in adolescent
processing of DTC ads.
We also propose to determine
whether the severity of the risk within
each condition influences adolescent
decisionmaking in relation to DTC ads.
Risk perceptions and risk taking have
been active topics of exploration with
regard to adolescents and thus the
severity of the risks may play a role in
determining whether and how
adolescents attend to the benefit-risk
profile of the prescription drugs they see
advertised. This factor will also help us
generalize further to different types of
products, although we recognize that it
will not cover the gamut of prescription
drug products.
Although the variables we are
examining are all attributes of the drug
products themselves and do not reflect
particular behaviors of sponsors, this
information will be crucial in
determining what types of prescription
drugs may require additional care when
advertising them to adolescents. One
strength of the proposed study is that
with two different medical conditions
and multiple different variations in the
benefit and risk profiles of the drugs, we
will obtain a good representation of
adolescent response to DTC ads.
Moreover, in comparing adolescents
with adults, we will have a better idea
of how perceptions and understanding
of benefits and risks in DTC ads differ
across this part of the lifespan.
Within each of the two medical
conditions, we will randomly assign
participants to one of a number of
experimental conditions. We propose
for each medical condition a 2 (risk
onset: immediate, delayed) × 2 (benefit
onset: immediate, delayed) × 2 (risk
severity: high, low) factorial design,
based on the rationale in the prior
section.
We will use the same risk (within
medical conditions) to control for
differences in severity (e.g. dry skin vs.
cancer) and avoid confounds.
TABLE 1—EXPERIMENTAL CONDITIONS WITH THREE INDEPENDENT VARIABLES
Variable 1: Timing of risk: Immediate
Variable 2:
Severity of risk
(low)
Comparison group
Variable 3:
Timing of
benefit
(immediate)
Variable 1: Timing of risk: Delayed
Variable 2:
Severity of risk
(high)
Variable 3:
Timing of
benefit
(delayed)
Variable 3:
Timing of
benefit
(immediate)
Variable 2:
Severity of risk
(low)
Variable 3:
Timing of
benefit
(delayed)
Variable 2:
Severity of risk
(high)
Variable 3:
Timing of
benefit
(immediate)
Variable 3:
Timing of
benefit
(delayed)
Variable 3:
Timing of
benefit
(immediate)
Variable 3:
Timing of
benefit
(delayed)
Group
Group
Group
Group
5 ....
13 ..
21 ..
29 ..
Group
Group
Group
Group
6 ....
14 ..
22 ..
30 ..
Group
Group
Group
Group
7 ....
15 ..
23 ..
31 ..
Group
Group
Group
Group
8.
16.
24.
32.
5 ....
13 ..
21 ..
29 ..
Group
Group
Group
Group
6 ....
14 ..
22 ..
30 ..
Group
Group
Group
Group
7 ....
15 ..
23 ..
31 ..
Group
Group
Group
Group
8.
16.
24.
32.
Study 1 (Medical Condition A, Acne)
Younger adolescents (13–15) ...
Older adolescents (16–19) .......
Young adults (25–30) ...............
Parents ......................................
Group
Group
Group
Group
1 ....
9 ....
17 ..
25 ..
Group
Group
Group
Group
2 ....
10 ..
18 ..
26 ..
Group
Group
Group
Group
3 ....
11 ..
19 ..
27 ..
Group
Group
Group
Group
4 ....
12 ..
20 ..
28 ..
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Study 2 (Medical Condition B, ADHD)
Younger adolescents (13–15) ...
Older adolescents (16–19) .......
Young adults (25–30) ...............
Parents ......................................
Group
Group
Group
Group
1 ....
9 ....
17 ..
25 ..
We will conduct the studies with two
medical conditions that have particular
relevance for adolescents—acne and
ADHD. For ADHD, we will target a
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Group
Group
Group
Group
2 ....
10 ..
18 ..
26 ..
Group
Group
Group
Group
3 ....
11 ..
19 ..
27 ..
Group
Group
Group
Group
4 ....
12 ..
20 ..
28 ..
Group
Group
Group
Group
sample that has been diagnosed with the
condition. If an appropriate sample size
cannot be obtained, we will extend the
sample by including adolescents with
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family members who have been
diagnosed with ADHD to help ensure
participants are interested in and paying
attention to the topic. Since acne is
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relevant for large numbers of people, it
seems reasonable to draw the study
sample from the general population.
Both conditions have particular
relevance for adolescents.
The study will enroll three specific
age groups (13 to 15, 16 to 19, and 25
to 30 year-olds). We propose to explore
differences in effects of the ad
manipulations across these three age
groups on a variety of outcomes,
including benefit and risk recall, benefit
and risk perceptions, and behavioral
intentions. Certain ads may
communicate more or less effectively
with specific age groups. The
presentation of immediate versus
delayed risks, for example, might
differentially affect teens and young
adults. Additionally, we propose to
examine factors unique to adolescent
healthcare including relationship
between parent and child, issues of
stigma, and risk taking.
We will also recruit parents of the two
younger age groups into the sample to
explore potential differences between
teen and parental perceptions. There are
three reasons for including parents in
the sample:
1. Adolescents and adults bring varied
experiences and developmental
capacities to everyday decisions. As a
result, they may differ both in their
perceptions of risks and benefits and in
their evaluations of DTC. Matching
parents and adolescents in the sample
will allow us to conduct additional
analyses to explore similarities and
differences between parental and
adolescent perceptions. By including
parents of both younger and older
adolescents, we can compare these
groups to see if there are differences in
parent-child risk-perception
concordance/discordance across
adolescence as a function of age.
2. Parents will serve as a fourth age
group, which will allow us to conduct
additional comparisons between the age
categories. Increasing the number of age
categories will allow us to look for
differences between a greater range of
age groups, and to see if clear patterns
of age differences exist (e.g., it could be
that the most significant differences are
observed when comparing young
adolescents and those over 30 years of
age).
3. Including parent-child dyads will
address the need for empirical data
comparing adolescents’ and their
parents’ evaluations of DTC prescription
drug advertising.
Select experimental conditions will
be pretested with 920 participants to
assess questionnaire wording and
implementation. Based on power
analyses, the main study will include
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5,120 completed participants, which
will allow us enough power to test
several possible covariates (factors other
than our manipulated variables) that
may have effects, such as demographic
information.
The protocol will take place via the
Internet. Participants will be randomly
assigned to view one Web site ad for a
fictitious prescription drug that treats
either acne or ADHD and will answer
questions about it. The entire process is
expected to take no longer than 35
minutes. This will be a one-time (rather
than annual) collection of information.
The questionnaire is available upon
request.
In the Federal Register of October 31,
2013 (78 FR 65326), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received two
comment submissions. We outline the
observations and suggestions raised in
the two submissions and provide our
responses:
(Comment 1) One comment
mentioned that the document states the
FDA will examine ‘‘adolescents’
perceptions following exposure to
different types of DTC prescription drug
advertising’’ and asked if the Agency
can clarify what ‘‘types’’ of ads will be
studied? In particular, will Internet
display ads, social media ads (e.g.,
Facebook), and mobile ads be
considered?
(Response) As stated in the 60-day
notice, participants will be randomly
assigned to view one Web site ad for a
fictitious prescription drug that treats
either acne or ADHD. This ad will be
similar to current Web site
advertisements produced for
pharmaceutical companies; however, all
content will be on a single page, without
active links to subpages. On the Web
page, there will be an embedded video
that resembles a television ad.
(Comment 2) One comment
mentioned that the document states
‘‘The protocol will take place via the
Internet. Participants will be randomly
assigned to view one Web site ad for a
fictitious prescription drug that treats
either acne or ADHD and will answer
questions about it.’’ The commenter
mentions that it appears that FDA will
be specifically looking at Internet
display ads and that FDA seems mainly
concerned with ‘‘timing issues’’ that are
not applicable to ‘‘Web based’’
promotional campaigns unless these are
video campaigns, which can be
YouTube campaigns or merely TV ads
embedded in Web pages. The
commenter asks for clarification.
(Response) To present the stimuli, we
will produce a series of fictitious
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42335
advertisements using a Web format with
embedded video that are comparable to
current advertisements produced for
pharmaceutical companies. The ‘‘timing
issues’’ that are being manipulated in
the study are not related to timing of the
presentation of the information in the
ads, but to the adolescents’ perception
of the timing of the onset of benefits and
the timing of the onset of risks of the
drugs. We are specifically interested in
learning whether adolescents are more
likely than adults to give more credence
to benefits that occur immediately and
to discount risks that do not occur
immediately.
(Comment 3) One comment mentions
modifying the sample by including
groups of symptomatic/undiagnosed
adolescents and their parents in the
study design because perception of risk
may vary depending on whether an
individual is diagnosed or not. The
commenter states that diagnosed
adolescents who are taking medication
and who experience no side effects may
be less sensitized to risk (just as their
adult counterparts tend to be), because
once they have experienced a
medication with no accompanying side
effects, the possibility of risk may seem
more remote.
(Response) We agree that perception
of risk may vary depending on whether
or not an individual is diagnosed with
the condition. In our design, adolescents
do not have to have a medical diagnosis
of acne to participate in the study.
Because acne is a visible and commonly
self-diagnosed condition, it is
reasonable to include non-diagnosed
individuals with acne in the study.
However, for the ADHD condition, we
aim to enroll only adolescents who are
diagnosed with ADHD to avoid the
potential confusions for ‘‘lay’’ or selfdiagnosis of the condition.
(Comment 4) One comment mentions
modifying the sample by including
groups of symptomatic/undiagnosed
adolescents and their parents in the
study design because it will help better
understand what the primary impact of
DTC is on teens and to what extent DTC
functions to help teens self-identify
with a condition vs. advocate for a
brand.
(Response) Although we agree that it
would be interesting to examine the
extent to which DTC advertising
functions to help teens self-identify
with a condition vs. advocate for a
brand, this question is beyond the scope
of this study. The ads used in this study
are intended to assess risk perceptions
in DTC ads, not to examine identity
measures, brand recognition or
advocacy.
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(Comment 5) One comment mentions
modifying the sample by including
subsets of diagnosed teens who are
currently medicating for ADHD, vs.
nonmedicating, and, as part of the exit
interview, capture data on those who
have experienced side effects from
medication, vs. those who have not.
(Response) We agree that we should
include teens who are both currently
medicating and nonmedicating.
Although we are not screening
participants based upon their
medication status, we will be asking
participants about their current and past
use of medications and will explore this
as part of our analysis. We also agree
that it would be interesting to explore
differences for teens who have
experienced side effects and those who
have not experienced side effects since
experience with side effects might affect
perception of the risk of the drugs in the
study. Based upon this
recommendation, we will add an item to
the instrument to measure the
participants’ previous experience with
side effects from medications. This item
will serve as a moderator variable.
(Comment 6) One comment mentions
not supplementing the sample with
siblings of teens diagnosed with ADHD
because they believe that adolescents
who do not suffer from the symptoms of
ADHD cannot truly evaluate the benefits
of a treatment vs. its risk, in the absence
of experiencing the symptoms first
hand.
(Response) We agree that it is
desirable to recruit a sample of
adolescents who have been diagnosed
with ADHD; therefore, we do not
currently plan to recruit adolescents
who have not been diagnosed with the
condition. Preliminary estimates lead us
to believe that we will be able to recruit
a sufficient sample of adolescents who
are diagnosed with ADHD. If, however,
an appropriate sample size cannot be
obtained, we plan to extend the sample
by including adolescents with family
members who have been diagnosed with
ADHD rather than adolescents who are
not at all familiar with the condition.
(Comment 7) One comment mentions
modifications to topic areas to include
questions about the role of teens in the
decision to seek diagnosis, to medicate
(or not), and the actual brand decision
because it is also important to
understand this processing within the
context of the entire patient pathway.
(Response) We agree that it is
important to know more about the role
of teens in the decision to seek
diagnosis, whether or not to medicate,
and the actual brand decision. It is
beyond the scope of this study to look
at decisions regarding teens’ roles in
seeking diagnosis and brand
decisionmaking. Our study does explore
teen roles in decisionmaking about use
of medication through the following
questions:
1. Who would make the final decision
about whether you would use this drug?
(you/your [PARENT RELATIONSHIP]/you
and your [PARENT RELATIONSHIP]
together);
2. My [PARENT RELATIONSHIP] lets me
decide what prescription medication I should
or shouldn’t take (scale ranging from always
to never); and
3. My [PARENT RELATIONSHIP] asks me
my preference when we discuss taking
different medications (scale ranging from
always to never).
(Comment 8) One comment mentions
modifications to topic areas to include
questions about the relative importance
of various sources of information that
impact teen perceptions of treatment
options because teens consume media
differently than their adult counterparts.
(Response) Although we agree that the
relative importance of and preferences
for various sources of information may
affect the perception of treatment
options, exploration of this topic is
outside the scope of our current study.
(Comment 9) One comment mentions
considering supplemental research
methodologies because direct
questioning does not always provide an
accurate reflection of real-world
behavior and to further bolster the
findings of this study, consider engaging
teen experts to study teens on behalf of
FDA.
(Response) We agree with the
comment that direct questioning does
not always provide an accurate
reflection of real-world behavior. To
that end, we engaged 19 to 20 year-old
college students as part of a teen
‘‘expert’’ work group during the
development of the measurement
instrument for this study in order to
obtain items that provide the most
accurate reflection possible. The teen/
young adult consultants provided
feedback on the measures and
suggestions for revisions. Further
involvement of teen ‘‘experts’’ would
require a formal qualitative component
of the study that we are unable to
conduct at this time. However, a
qualitative study to further explore
decision making among teens could be
a useful area for future research.
(Comment 10) One comment
mentions considering supplemental
research methodologies because in order
to gain an accurate read on the
processing of risk/benefit information,
the stimuli should be depicted as
realistically as possible and accurately
reflect typical DTC in the category
targeted to 13 to 17 year-olds.
(Response) We agree that it is
important to depict the stimuli as
realistically as possible. We will be
modeling the stimuli after DTC ads
being presented currently on the Web
and on television, using similar
language, graphic design techniques,
and voiceover scripts. In addition, we
will be attentive to current marketing
norms with regard to selection of
locations, wardrobe, and actors for the
video ads.
FDA estimates the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
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Cognitive interviews ..........................................................
Pretest 1 screener ............................................................
Pretest 2 screener ............................................................
Main study screener (acne) ..............................................
Main study screener (ADHD) ............................................
Pretest 1 (420/medical condition) .....................................
Pretest 2 (20/medical condition) .......................................
Main study, 13–15 year-olds (both acne and ADHD) ......
Main study, 16–19 year-olds (both acne and ADHD) ......
Main study, young adults (both acne and ADHD) ............
Main study, parents (both acne and ADHD) ....................
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Number of
responses per
respondent
Number of
respondents
Activity
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30
8,730
1,930
7,142
43,086
900
200
1,300
1,300
1,300
1,300
Fmt 4703
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1
1
1
1
1
1
1
1
1
1
1
Average
burden per
response
Total annual
responses
30
8,730
1,930
7,142
43,086
900
200
1300
1300
1300
1300
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1.5
.08
.08
.08
.08
0.5
0.5
0.5
0.5
0.5
0.5
21JYN1
(90 min.) .....
(5 min.) .......
(5 min.) .......
(5 min.) .......
(5 min.) .......
(30 min.) .....
(30 min.) .....
(30 min.) .....
(30 min.) .....
(30 min.) .....
(30 min.) .....
Total hours
45
698
154
571
3,447
450
100
650
650
650
650
Federal Register / Vol. 79, No. 139 / Monday, July 21, 2014 / Notices
42337
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
responses per
respondent
Number of
respondents
Activity
Total annual
responses
Average
burden per
response
Total hours
Number of pretest/study completes ..................................
6,300
........................
........................
...........................
........................
Total ...........................................................................
........................
........................
........................
...........................
8,065
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
References
emcdonald on DSK67QTVN1PROD with NOTICES
1. Southwell, B.G., ‘‘On the Need for a LifeSpan Approach to Health Campaign
Evaluation.’’ Health Communication, 25
(6–7), 525–528, 2010.
2. Lerner, R.M. and L. Steinberg, ‘‘The
Scientific Study of Adolescent
Development.’’ In R.M. Lerner and L.
Steinberg (Eds.), Handbook of
Adolescent Psychology (3rd ed., Vol. 1:
Individual Bases of Adolescent
Development). Hoboken, NJ: John Wiley
and Sons, 2009.
3. Erikson, E.H., The Child and Society. New
York: Norton, 1963.
4. Erikson, E.H., Dimensions of a New
Identity. New York: Norton, 1974.
5. Piaget, J., The Origins of Intelligence in
Children. New York: Internal University
Press, 1952.
6. Piaget, J., The Child’s Conception of the
World. Totowa, NJ: Littlefield, Adams,
1972.
7. Kohlberg, L., ‘‘Stage and Sequence. The
Cognitive Developmental Approach to
Socialization.’’ In D.A. Goslin (Ed.),
Handbook of Socialization Theory of
Research (pp. 347–380). Chicago: Rand
McNally, 1969.
8. Rubia, K., S. Overmeyer, E. Taylor, et al.,
‘‘Functional Frontalisation with Age:
Mapping Neurodevelopmental
Trajectories with fMRI.’’ [Clinical Trial
Research Support, Non-U.S. Gov’t.].
Neuroscience and Biobehavioral
Reviews, 24(1), 13–19, 2000.
9. Goldberg, J.H., B.L. Halpern-Felsher, and
S.G. Millstein, ‘‘Beyond Invulnerability:
The Importance of Benefits in
Adolescents’ Decision to Drink Alcohol.’’
Health Psychology, 21(5), 477–484. doi:
10.1037/0278–6133.21.5.477, 2002.
10. Albert, D. and L. Steinberg, ‘‘Judgment
and Decision Making in Adolescence.’’
Journal of Research on Adolescence,
21(1), 211–224. doi: 10.1111/j.1532–
7795.2010.00724.x, 2011.
Dated: July 15, 2014.
Peter Lurie,
Associate Commissioner for Policy and
Planning.
[FR Doc. 2014–16998 Filed 7–18–14; 8:45 am]
BILLING CODE 4164–01–P
VerDate Mar<15>2010
17:14 Jul 18, 2014
Jkt 232001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0998]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Regulations for In
Vivo Radiopharmaceuticals Used for
Diagnosis and Monitoring
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection in the
regulations for in vivo
radiopharmaceuticals used for diagnosis
and monitoring.
DATES: Submit either electronic or
written comments on the collection of
information by September 19, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA 305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
SUMMARY:
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Regulations for In Vivo
Radiopharmaceuticals Used for
Diagnosis and Monitoring—21 CFR Part
315—(OMB Control Number 0910–
0409)—Extension
FDA is requesting OMB approval of
the information collection requirements
contained in 21 CFR 315.4, 315.5, and
315.6. These regulations require
manufacturers of diagnostic
radiopharmaceuticals to submit
information that demonstrates the safety
and effectiveness of a new diagnostic
radiopharmaceutical or of a new
E:\FR\FM\21JYN1.SGM
21JYN1
]]>Agencies
[Federal Register Volume 79, Number 139 (Monday, July 21, 2014)]
[Notices]
[Pages 42333-42337]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16998]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1151]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Experimental Study of
Direct-to-Consumer Promotion Directed at Adolescents
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 August
20, 2014.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-NEW and
title, ``Experimental Study of Direct-to-Consumer (DTC) Promotion
Directed at Adolescents.'' Also include the FDA docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Experimental Study of Direct-to-Consumer (DTC) Promotion Directed at
Adolescents--(OMB Control Number 0910--NEW)
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(C) authorizes FDA to
conduct research relating to drugs and other FDA regulated products in
carrying out the provisions of the FD&C Act.
Sponsors for several prescription drug classes market their
products directly to vulnerable groups, including adolescents. Such DTC
marketing to adolescents raises a variety of potential concerns.
Adolescents are a unique audience for DTC drug marketing because their
cognitive abilities are different than those of adults, and they are
usually dependent on adults for health insurance coverage, health care
provider access, and prescription drug payment. Despite this
uniqueness, research regarding how adolescents use risk and benefit
information for health-related decisions is limited. If considered at
all in healthcare communication research, age is typically treated as
simply another segment of the audience (Ref. 1), and researchers fail
to consider how information processing (how people understand
information) in response to advertisement (ad) exposure might differ
among adolescents versus older viewers.
The FD&C Act requires manufacturers, packers, and distributors that
advertise prescription drugs to disclose certain information about a
product's uses and risks to potential consumers in all advertisements.
Consumers must consider tradeoffs with regard to the product's risks
and benefits in deciding whether to ask their health care professionals
about the product. Presenting technically factual information is
important, but other factors can also affect potential consumers.
Information processing capacity, the relevance and vividness of the
information, and contextual factors such as family dynamics likely
affect how adolescent consumers weigh the potential risks and benefits
of using a product.
Despite the lack of previous research specific to DTC drug
marketing to adolescents, existing theoretical and empirical data make
a strong case for treating adolescence as a unique life stage during
which vulnerabilities that can affect informed decisionmaking must be
taken into account. Well-known theories of adolescent development have
long pointed to developmental changes that occur during the
transitional period as an individual moves from childhood to young
adulthood (Ref. 2). For instance, Erikson (Refs. 3, 4) describes an
often turbulent psychosocial crisis that occurs as adolescents strive
to develop their unique identity. Piaget (Refs. 5, 6) and Kohlberg
(Ref. 7) describe changes in stages relative to cognitive processing
and reasoning that occur in this period, as the adolescent becomes
increasingly capable of more abstract thinking. Different cognitive,
social and emotional, and developmental processes in the adolescent
brain mature simultaneously and at different rates, affecting
decisionmaking by age. All of these factors can influence how
adolescents perceive and process information as well as weigh risks and
benefits.
The need for understanding how adolescents weigh risks and benefits
is particularly critical given the potential adverse events associated
with use of the drug classes that are marketed directly to adolescents.
Suicide and suicidal ideation has been associated with some of these
classes, including a commonly used class of acne medications. The risk
and benefit information needs to be clearly presented in ways that
adolescents can understand. Interpretation of more
[[Page 42334]]
subtle messages in the advertisements, along with the lens through
which adolescents view the message, must be understood. For example,
given the potential stigma of acne and adolescents' heightened concerns
about peer perceptions, marketing that emphasizes these two features in
subtle ways might minimize the attention given to any risk information
provided. This suggests the need to systematically explore the role of
various factors that would be expected to influence adolescent
decision-making, such as peer and family perceptions of stigma.
We plan to conduct a randomized, controlled study in two different
medical conditions that assesses adolescents' perceptions following
exposure to different types of DTC prescription drug advertising. We
plan to compare adolescents' perceptions to those of young adult
counterparts. Each participant will view a Web-based promotional
campaign for either a fictitious Attention Deficit Hyperactivity
Disorder (ADHD) medication or a fictitious acne medication. Because
adolescents typically depend on their parents for prescription drug
purchases, we also will include a sample of parents matched to their
adolescent children to explore similarities and differences in
perceptions for these matched pairs.
Within the two medical conditions, we propose to explore the role
of three different factors that may influence adolescent understanding
and perceptions of DTC. Two of these factors include timing issues: The
timing of the onset of benefits and the timing of the onset of risks.
Adolescents may be particularly likely to give more credence to
benefits that occur immediately and may be likely to discount risks
that do not occur immediately. Research suggests that the frontal lobe,
which controls self-regulatory functions, is not fully developed until
the mid-20s (Ref. 8), which may lead to difficulty in impulse control
and planning, and thus decisionmaking. Other research suggests that
adolescents are more likely to engage in risky behavior, although
whether they do this because they discount their own likelihood of
experiencing risks or if they cannot help themselves despite having
adequate perceptions of their own vulnerability has not been determined
(Refs. 9, 10). Given the variety of prescription drug products on the
market with varying benefit and risk profiles, these factors (benefit
and risk timing) will enable us to investigate its role in adolescent
processing of DTC ads.
We also propose to determine whether the severity of the risk
within each condition influences adolescent decisionmaking in relation
to DTC ads. Risk perceptions and risk taking have been active topics of
exploration with regard to adolescents and thus the severity of the
risks may play a role in determining whether and how adolescents attend
to the benefit-risk profile of the prescription drugs they see
advertised. This factor will also help us generalize further to
different types of products, although we recognize that it will not
cover the gamut of prescription drug products.
Although the variables we are examining are all attributes of the
drug products themselves and do not reflect particular behaviors of
sponsors, this information will be crucial in determining what types of
prescription drugs may require additional care when advertising them to
adolescents. One strength of the proposed study is that with two
different medical conditions and multiple different variations in the
benefit and risk profiles of the drugs, we will obtain a good
representation of adolescent response to DTC ads. Moreover, in
comparing adolescents with adults, we will have a better idea of how
perceptions and understanding of benefits and risks in DTC ads differ
across this part of the lifespan.
Within each of the two medical conditions, we will randomly assign
participants to one of a number of experimental conditions. We propose
for each medical condition a 2 (risk onset: immediate, delayed) x 2
(benefit onset: immediate, delayed) x 2 (risk severity: high, low)
factorial design, based on the rationale in the prior section.
We will use the same risk (within medical conditions) to control
for differences in severity (e.g. dry skin vs. cancer) and avoid
confounds.
Table 1--Experimental Conditions With Three Independent Variables
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Variable 1: Timing of risk: Immediate Variable 1: Timing of risk: Delayed
---------------------------------------------------------------------------------------------------------------------------------------------------------------
Variable 2: Severity of risk (low) Variable 2: Severity of risk (high) Variable 2: Severity of risk (low) Variable 2: Severity of risk (high)
Comparison group ---------------------------------------------------------------------------------------------------------------------------------------------------------------
Variable 3: Timing Variable 3: Timing Variable 3: Timing Variable 3: Timing Variable 3: Timing Variable 3: Timing Variable 3: Timing Variable 3: Timing
of benefit of benefit of benefit of benefit of benefit of benefit of benefit of benefit
(immediate) (delayed) (immediate) (delayed) (immediate) (delayed) (immediate) (delayed)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Study 1 (Medical Condition A, Acne)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Younger adolescents (13-15)..... Group 1........... Group 2........... Group 3........... Group 4........... Group 5........... Group 6........... Group 7........... Group 8.
Older adolescents (16-19)....... Group 9........... Group 10.......... Group 11.......... Group 12.......... Group 13.......... Group 14.......... Group 15.......... Group 16.
Young adults (25-30)............ Group 17.......... Group 18.......... Group 19.......... Group 20.......... Group 21.......... Group 22.......... Group 23.......... Group 24.
Parents......................... Group 25.......... Group 26.......... Group 27.......... Group 28.......... Group 29.......... Group 30.......... Group 31.......... Group 32.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Study 2 (Medical Condition B, ADHD)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Younger adolescents (13-15)..... Group 1........... Group 2........... Group 3........... Group 4........... Group 5........... Group 6........... Group 7........... Group 8.
Older adolescents (16-19)....... Group 9........... Group 10.......... Group 11.......... Group 12.......... Group 13.......... Group 14.......... Group 15.......... Group 16.
Young adults (25-30)............ Group 17.......... Group 18.......... Group 19.......... Group 20.......... Group 21.......... Group 22.......... Group 23.......... Group 24.
Parents......................... Group 25.......... Group 26.......... Group 27.......... Group 28.......... Group 29.......... Group 30.......... Group 31.......... Group 32.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
We will conduct the studies with two medical conditions that have
particular relevance for adolescents--acne and ADHD. For ADHD, we will
target a sample that has been diagnosed with the condition. If an
appropriate sample size cannot be obtained, we will extend the sample
by including adolescents with family members who have been diagnosed
with ADHD to help ensure participants are interested in and paying
attention to the topic. Since acne is
[[Page 42335]]
relevant for large numbers of people, it seems reasonable to draw the
study sample from the general population. Both conditions have
particular relevance for adolescents.
The study will enroll three specific age groups (13 to 15, 16 to
19, and 25 to 30 year-olds). We propose to explore differences in
effects of the ad manipulations across these three age groups on a
variety of outcomes, including benefit and risk recall, benefit and
risk perceptions, and behavioral intentions. Certain ads may
communicate more or less effectively with specific age groups. The
presentation of immediate versus delayed risks, for example, might
differentially affect teens and young adults. Additionally, we propose
to examine factors unique to adolescent healthcare including
relationship between parent and child, issues of stigma, and risk
taking.
We will also recruit parents of the two younger age groups into the
sample to explore potential differences between teen and parental
perceptions. There are three reasons for including parents in the
sample:
1. Adolescents and adults bring varied experiences and
developmental capacities to everyday decisions. As a result, they may
differ both in their perceptions of risks and benefits and in their
evaluations of DTC. Matching parents and adolescents in the sample will
allow us to conduct additional analyses to explore similarities and
differences between parental and adolescent perceptions. By including
parents of both younger and older adolescents, we can compare these
groups to see if there are differences in parent-child risk-perception
concordance/discordance across adolescence as a function of age.
2. Parents will serve as a fourth age group, which will allow us to
conduct additional comparisons between the age categories. Increasing
the number of age categories will allow us to look for differences
between a greater range of age groups, and to see if clear patterns of
age differences exist (e.g., it could be that the most significant
differences are observed when comparing young adolescents and those
over 30 years of age).
3. Including parent-child dyads will address the need for empirical
data comparing adolescents' and their parents' evaluations of DTC
prescription drug advertising.
Select experimental conditions will be pretested with 920
participants to assess questionnaire wording and implementation. Based
on power analyses, the main study will include 5,120 completed
participants, which will allow us enough power to test several possible
covariates (factors other than our manipulated variables) that may have
effects, such as demographic information.
The protocol will take place via the Internet. Participants will be
randomly assigned to view one Web site ad for a fictitious prescription
drug that treats either acne or ADHD and will answer questions about
it. The entire process is expected to take no longer than 35 minutes.
This will be a one-time (rather than annual) collection of information.
The questionnaire is available upon request.
In the Federal Register of October 31, 2013 (78 FR 65326), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received two comment submissions. We
outline the observations and suggestions raised in the two submissions
and provide our responses:
(Comment 1) One comment mentioned that the document states the FDA
will examine ``adolescents' perceptions following exposure to different
types of DTC prescription drug advertising'' and asked if the Agency
can clarify what ``types'' of ads will be studied? In particular, will
Internet display ads, social media ads (e.g., Facebook), and mobile ads
be considered?
(Response) As stated in the 60-day notice, participants will be
randomly assigned to view one Web site ad for a fictitious prescription
drug that treats either acne or ADHD. This ad will be similar to
current Web site advertisements produced for pharmaceutical companies;
however, all content will be on a single page, without active links to
subpages. On the Web page, there will be an embedded video that
resembles a television ad.
(Comment 2) One comment mentioned that the document states ``The
protocol will take place via the Internet. Participants will be
randomly assigned to view one Web site ad for a fictitious prescription
drug that treats either acne or ADHD and will answer questions about
it.'' The commenter mentions that it appears that FDA will be
specifically looking at Internet display ads and that FDA seems mainly
concerned with ``timing issues'' that are not applicable to ``Web
based'' promotional campaigns unless these are video campaigns, which
can be YouTube campaigns or merely TV ads embedded in Web pages. The
commenter asks for clarification.
(Response) To present the stimuli, we will produce a series of
fictitious advertisements using a Web format with embedded video that
are comparable to current advertisements produced for pharmaceutical
companies. The ``timing issues'' that are being manipulated in the
study are not related to timing of the presentation of the information
in the ads, but to the adolescents' perception of the timing of the
onset of benefits and the timing of the onset of risks of the drugs. We
are specifically interested in learning whether adolescents are more
likely than adults to give more credence to benefits that occur
immediately and to discount risks that do not occur immediately.
(Comment 3) One comment mentions modifying the sample by including
groups of symptomatic/undiagnosed adolescents and their parents in the
study design because perception of risk may vary depending on whether
an individual is diagnosed or not. The commenter states that diagnosed
adolescents who are taking medication and who experience no side
effects may be less sensitized to risk (just as their adult
counterparts tend to be), because once they have experienced a
medication with no accompanying side effects, the possibility of risk
may seem more remote.
(Response) We agree that perception of risk may vary depending on
whether or not an individual is diagnosed with the condition. In our
design, adolescents do not have to have a medical diagnosis of acne to
participate in the study. Because acne is a visible and commonly self-
diagnosed condition, it is reasonable to include non-diagnosed
individuals with acne in the study. However, for the ADHD condition, we
aim to enroll only adolescents who are diagnosed with ADHD to avoid the
potential confusions for ``lay'' or self-diagnosis of the condition.
(Comment 4) One comment mentions modifying the sample by including
groups of symptomatic/undiagnosed adolescents and their parents in the
study design because it will help better understand what the primary
impact of DTC is on teens and to what extent DTC functions to help
teens self-identify with a condition vs. advocate for a brand.
(Response) Although we agree that it would be interesting to
examine the extent to which DTC advertising functions to help teens
self-identify with a condition vs. advocate for a brand, this question
is beyond the scope of this study. The ads used in this study are
intended to assess risk perceptions in DTC ads, not to examine identity
measures, brand recognition or advocacy.
[[Page 42336]]
(Comment 5) One comment mentions modifying the sample by including
subsets of diagnosed teens who are currently medicating for ADHD, vs.
nonmedicating, and, as part of the exit interview, capture data on
those who have experienced side effects from medication, vs. those who
have not.
(Response) We agree that we should include teens who are both
currently medicating and nonmedicating. Although we are not screening
participants based upon their medication status, we will be asking
participants about their current and past use of medications and will
explore this as part of our analysis. We also agree that it would be
interesting to explore differences for teens who have experienced side
effects and those who have not experienced side effects since
experience with side effects might affect perception of the risk of the
drugs in the study. Based upon this recommendation, we will add an item
to the instrument to measure the participants' previous experience with
side effects from medications. This item will serve as a moderator
variable.
(Comment 6) One comment mentions not supplementing the sample with
siblings of teens diagnosed with ADHD because they believe that
adolescents who do not suffer from the symptoms of ADHD cannot truly
evaluate the benefits of a treatment vs. its risk, in the absence of
experiencing the symptoms first hand.
(Response) We agree that it is desirable to recruit a sample of
adolescents who have been diagnosed with ADHD; therefore, we do not
currently plan to recruit adolescents who have not been diagnosed with
the condition. Preliminary estimates lead us to believe that we will be
able to recruit a sufficient sample of adolescents who are diagnosed
with ADHD. If, however, an appropriate sample size cannot be obtained,
we plan to extend the sample by including adolescents with family
members who have been diagnosed with ADHD rather than adolescents who
are not at all familiar with the condition.
(Comment 7) One comment mentions modifications to topic areas to
include questions about the role of teens in the decision to seek
diagnosis, to medicate (or not), and the actual brand decision because
it is also important to understand this processing within the context
of the entire patient pathway.
(Response) We agree that it is important to know more about the
role of teens in the decision to seek diagnosis, whether or not to
medicate, and the actual brand decision. It is beyond the scope of this
study to look at decisions regarding teens' roles in seeking diagnosis
and brand decisionmaking. Our study does explore teen roles in
decisionmaking about use of medication through the following questions:
1. Who would make the final decision about whether you would use
this drug? (you/your [PARENT RELATIONSHIP]/you and your [PARENT
RELATIONSHIP] together);
2. My [PARENT RELATIONSHIP] lets me decide what prescription
medication I should or shouldn't take (scale ranging from always to
never); and
3. My [PARENT RELATIONSHIP] asks me my preference when we
discuss taking different medications (scale ranging from always to
never).
(Comment 8) One comment mentions modifications to topic areas to
include questions about the relative importance of various sources of
information that impact teen perceptions of treatment options because
teens consume media differently than their adult counterparts.
(Response) Although we agree that the relative importance of and
preferences for various sources of information may affect the
perception of treatment options, exploration of this topic is outside
the scope of our current study.
(Comment 9) One comment mentions considering supplemental research
methodologies because direct questioning does not always provide an
accurate reflection of real-world behavior and to further bolster the
findings of this study, consider engaging teen experts to study teens
on behalf of FDA.
(Response) We agree with the comment that direct questioning does
not always provide an accurate reflection of real-world behavior. To
that end, we engaged 19 to 20 year-old college students as part of a
teen ``expert'' work group during the development of the measurement
instrument for this study in order to obtain items that provide the
most accurate reflection possible. The teen/young adult consultants
provided feedback on the measures and suggestions for revisions.
Further involvement of teen ``experts'' would require a formal
qualitative component of the study that we are unable to conduct at
this time. However, a qualitative study to further explore decision
making among teens could be a useful area for future research.
(Comment 10) One comment mentions considering supplemental research
methodologies because in order to gain an accurate read on the
processing of risk/benefit information, the stimuli should be depicted
as realistically as possible and accurately reflect typical DTC in the
category targeted to 13 to 17 year-olds.
(Response) We agree that it is important to depict the stimuli as
realistically as possible. We will be modeling the stimuli after DTC
ads being presented currently on the Web and on television, using
similar language, graphic design techniques, and voiceover scripts. In
addition, we will be attentive to current marketing norms with regard
to selection of locations, wardrobe, and actors for the video ads.
FDA estimates the burden of this collection of information as
follows:
Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cognitive interviews........................... 30 1 30 1.5 (90 min.).......................... 45
Pretest 1 screener............................. 8,730 1 8,730 .08 (5 min.)........................... 698
Pretest 2 screener............................. 1,930 1 1,930 .08 (5 min.)........................... 154
Main study screener (acne)..................... 7,142 1 7,142 .08 (5 min.)........................... 571
Main study screener (ADHD)..................... 43,086 1 43,086 .08 (5 min.)........................... 3,447
Pretest 1 (420/medical condition).............. 900 1 900 0.5 (30 min.).......................... 450
Pretest 2 (20/medical condition)............... 200 1 200 0.5 (30 min.).......................... 100
Main study, 13-15 year-olds (both acne and 1,300 1 1300 0.5 (30 min.).......................... 650
ADHD).
Main study, 16-19 year-olds (both acne and 1,300 1 1300 0.5 (30 min.).......................... 650
ADHD).
Main study, young adults (both acne and ADHD).. 1,300 1 1300 0.5 (30 min.).......................... 650
Main study, parents (both acne and ADHD)....... 1,300 1 1300 0.5 (30 min.).......................... 650
[[Page 42337]]
Number of pretest/study completes.............. 6,300 .............. .............. ....................................... ..............
--------------------------------------------------------------------------------------------------------
Total...................................... .............. .............. .............. ....................................... 8,065
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
References
1. Southwell, B.G., ``On the Need for a Life-Span Approach to Health
Campaign Evaluation.'' Health Communication, 25 (6-7), 525-528,
2010.
2. Lerner, R.M. and L. Steinberg, ``The Scientific Study of
Adolescent Development.'' In R.M. Lerner and L. Steinberg (Eds.),
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doi: 10.1111/j.1532-7795.2010.00724.x, 2011.
Dated: July 15, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-16998 Filed 7-18-14; 8:45 am]
BILLING CODE 4164-01-P
