Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Direct-to-Consumer Promotion Directed at Adolescents, 65326-65329 [2013-25963]
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Federal Register / Vol. 78, No. 211 / Thursday, October 31, 2013 / Notices
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2013–25861 Filed 10–30–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1151]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Experimental
Study of Direct-to-Consumer
Promotion Directed at Adolescents
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 and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
research entitled, ‘‘Experimental Study
of Direct-to-Consumer (DTC) Promotion
Directed at Adolescents.’’ This study is
designed to examine how adolescents
interpret DTC advertising directed at
them.
SUMMARY:
Submit written or electronic
comments on the collection of
information by December 30, 2013.
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 Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
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DATES:
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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
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.
Experimental Study of Direct-toConsumer (DTC) Promotion Directed at
Adolescents—(0910—NEW)
Regulatory Background
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.
Adolescents and DTC
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
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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
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 decision-making
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 identify. 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 decision-making 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
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Federal Register / Vol. 78, No. 211 / Thursday, October 31, 2013 / Notices
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
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.
Research Purpose
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
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.
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
decision-making. 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
decision-making in relation to DTC.
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
Design Overview
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)
Variable 1: Timing of risk: Delayed
Variable 2: Severity of
risk (high)
Variable 2: Severity of
risk (low)
Variable 2: Severity of
risk (high)
Comparison group
Variable 3:
Timing of
benefit
(immediate)
Variable 3:
Timing of
benefit
(delayed)
Variable 3:
Timing of
benefit
(immediate)
Variable 3:
Timing of
benefit
(delayed)
Variable 3:
Timing of
benefit
(immediate)
Variable 3:
Timing of
benefit
(delayed)
Variable 3:
Timing of
benefit
(immediate)
Variable 3:
Timing of
benefit
(delayed)
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Study 1 (Medical condition A, Acne)
Younger adolescents
(13–15)
Older adolescents ...
(16–19)
Young adults ...........
(25–30)
Parents ....................
Group 1 ......
Group 2 .......
Group 3 ......
Group 4 .......
Group 5 ......
Group 6 .......
Group 7 ......
Group 8.
Group 9 ......
Group 10 .....
Group 11 ....
Group 12 .....
Group 13 ....
Group 14 .....
Group 15 ....
Group 16.
Group 17 ....
Group 18 .....
Group 19 ....
Group 20 .....
Group 21 ....
Group 22 .....
Group 23 ....
Group 24.
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)
Older adolescents ...
(16–19)
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Group 1 ......
Group 2 .......
Group 3 ......
Group 4 .......
Group 5 ......
Group 6 .......
Group 7 ......
Group 8.
Group 9 ......
Group 10 .....
Group 11 ....
Group 12 .....
Group 13 ....
Group 14 .....
Group 15 ....
Group 16.
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Federal Register / Vol. 78, No. 211 / Thursday, October 31, 2013 / Notices
TABLE 1—EXPERIMENTAL CONDITIONS WITH THREE INDEPENDENT VARIABLES—Continued
Variable 1: Timing of risk: Immediate
Variable 2: Severity of
risk (low)
Variable 1: Timing of risk: Delayed
Variable 2: Severity of
risk (high)
Variable 2: Severity of
risk (low)
Variable 2: Severity of
risk (high)
Comparison group
Variable 3:
Timing of
benefit
(immediate)
Young adults ...........
(25–30)
Parents ....................
Variable 3:
Timing of
benefit
(delayed)
Variable 3:
Timing of
benefit
(immediate)
Variable 3:
Timing of
benefit
(delayed)
Variable 3:
Timing of
benefit
(immediate)
Variable 3:
Timing of
benefit
(delayed)
Variable 3:
Timing of
benefit
(immediate)
Group 17 ....
Group 18 .....
Group 19 ....
Group 20 .....
Group 21 ....
Group 22 .....
Group 23 ....
Group 24.
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 acne, we will target a sample
that has been diagnosed with, or,
through self-report, has experienced the
condition. For ADHD, we will target a
sample that has been diagnosed with the
condition. If an appropriate sample size
cannot be obtained for ADHD, 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.
The study will enroll three specific
age groups (13–15, 16–19, and 25–30).
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 having
parents of two age groups, we can
compare these groups to see if there are
differences in parent-child riskperception 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
Variable 3:
Timing of
benefit
(delayed)
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 1061 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 30
minutes. This will be a one-time (rather
than annual) collection of information.
FDA estimates the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
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Activity
Number of
responses per
respondent
Pretest 1 screener (1⁄2 acne, 1⁄2 ADHD) ..................
Pretest 2 screener (all one illness) ..........................
Main study screener (acne) .....................................
Main study screener (ADHD) ...................................
Pretest 1 ...................................................................
Pretest 2 ...................................................................
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) ...........
2,812
6,400
6,400
25,600
450
700
1,300
1
1
1
1
1
1
1
2,812
6,400
6,400
25,600
450
700
1,300
1,300
1
1,300
1,300
Total pretest/study participants .........................
6,350
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Average
burden per
response
Total annual
responses
(5 min.) ................
(5 min.) ................
(5 min.) ................
(5 min.) ................
(30 min.) ..............
(30 min.) ..............
(30 min.) ..............
225
512
512
2,048
225
350
650
1,300
0.5 (30 min.) ..............
650
1
1
1,300
1,300
.5 (30 min.) ................
.5 (30 min.) ................
650
650
........................
........................
...................................
........................
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.08
.08
.08
.08
0.5
0.5
0.5
Total hours
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Federal Register / Vol. 78, No. 211 / Thursday, October 31, 2013 / Notices
65329
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Activity
Total ...........................................................
1 There
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
........................
........................
........................
...................................
6,472
are no capital costs or operating and maintenance costs associated with this collection of information.
The total respondent sample for this
data collection is 6,350, including the
two pretests. We estimate the response
burden to be 30 minutes, for a total
collection burden, including screeners,
of 6,472 hours.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
References
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Total hours
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Electronic
Products
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: October 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–25963 Filed 10–30–13; 8:45 am]
BILLING CODE 4160–01–P
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Jkt 232001
Food and Drug Administration
[Docket No. FDA–2013–N–0618]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by December
2, 2013.
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 0910–0025. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
FOR FURTHER INFORMATION CONTACT:
Electronic Products—21 CFR Parts 1002
Through 1010 (OMB Control Number
0910–0025)—Extension
Under sections 532 through 542 of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 360ii through
360ss), FDA has the responsibility to
protect the public from unnecessary
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exposure of radiation from electronic
products. The regulations issued under
these authorities are listed in Title 21 of
the Code of Federal Regulations, chapter
I, subchapter J, parts 1000 through 1050
(21 CFR parts 1000 through 1050).
Section 532 of the FD&C Act directs
the Secretary of the Department of
Health and Human Services (the
Secretary), to establish and carry out an
electronic product radiation control
program, including the development,
issuance, and administration of
performance standards to control the
emission of electronic product radiation
from electronic products. The program
is designed to protect the public health
and safety from electronic radiation, and
the FD&C Act authorizes the Secretary
to procure (by negotiation or otherwise)
electronic products for research and
testing purposes and to sell or otherwise
dispose of such products. Section 534(g)
of the FD&C Act directs the Secretary to
review and evaluate industry testing
programs on a continuing basis; and
section 535(e) and (f) of the FD&C Act
directs the Secretary to immediately
notify manufacturers of, and ensure
correction of, radiation defects or
noncompliance with performance
standards. Section 537(b) of the FD&C
Act contains the authority to require
manufacturers of electronic products to
establish and maintain records
(including testing records), make
reports, and provide information to
determine whether the manufacturer
has acted in compliance.
The regulations under parts 1002
through 1010 specify reports to be
provided by manufacturers and
distributors to FDA and records to be
maintained in the event of an
investigation of a safety concern or a
product recall. FDA conducts laboratory
compliance testing of products covered
by regulations for product standards in
parts 1020, 1030, 1040, and 1050.
FDA details product-specific
performance standards that specify
information to be supplied with the
product or require specific reports. The
information collections are either
specifically called for in the FD&C Act
or were developed to aid the Agency in
performing its obligations under the
FD&C Act. The data reported to FDA
and the records maintained are used by
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]]>Agencies
[Federal Register Volume 78, Number 211 (Thursday, October 31, 2013)]
[Notices]
[Pages 65326-65329]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25963]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1151]
Agency Information Collection Activities; Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on research entitled, ``Experimental Study of
Direct-to-Consumer (DTC) Promotion Directed at Adolescents.'' This
study is designed to examine how adolescents interpret DTC advertising
directed at them.
DATES: Submit written or electronic comments on the collection of
information by December 30, 2013.
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 Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Experimental Study of Direct-to-Consumer (DTC) Promotion Directed at
Adolescents--(0910--NEW)
Regulatory Background
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.
Adolescents and DTC
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 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 decision-making 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 identify. 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 decision-
making 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
[[Page 65327]]
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 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.
Research Purpose
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 decision-making. 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 decision-making in relation
to DTC. 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.
Design Overview
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.......... Group 1............ Group 2............ Group 3............ Group 4........... Group 5........... Group 6........... Group 7........... Group 8.
(13-15).....................
Older adolescents............ Group 9............ Group 10........... Group 11........... Group 12.......... Group 13.......... Group 14.......... Group 15.......... Group 16.
(16-19).....................
Young adults................. Group 17........... Group 18........... Group 19........... Group 20.......... Group 21.......... Group 22.......... Group 23.......... Group 24.
(25-30).....................
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.......... Group 1............ Group 2............ Group 3............ Group 4........... Group 5........... Group 6........... Group 7........... Group 8.
(13-15).....................
Older adolescents............ Group 9............ Group 10........... Group 11........... Group 12.......... Group 13.......... Group 14.......... Group 15.......... Group 16.
(16-19).....................
[[Page 65328]]
Young adults................. Group 17........... Group 18........... Group 19........... Group 20.......... Group 21.......... Group 22.......... Group 23.......... Group 24.
(25-30).....................
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 acne, we will
target a sample that has been diagnosed with, or, through self-report,
has experienced the condition. For ADHD, we will target a sample that
has been diagnosed with the condition. If an appropriate sample size
cannot be obtained for ADHD, 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.
The study will enroll three specific age groups (13-15, 16-19, and
25-30). 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 having
parents of two age groups, 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 1061
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 30 minutes.
This will be a one-time (rather than annual) collection of information.
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 Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Pretest 1 screener (\1/2\ 2,812 1 2,812 .08 (5 min.).... 225
acne, \1/2\ ADHD).
Pretest 2 screener (all one 6,400 1 6,400 .08 (5 min.).... 512
illness).
Main study screener (acne).... 6,400 1 6,400 .08 (5 min.).... 512
Main study screener (ADHD).... 25,600 1 25,600 .08 (5 min.).... 2,048
Pretest 1..................... 450 1 450 0.5 (30 min.)... 225
Pretest 2..................... 700 1 700 0.5 (30 min.)... 350
Main study, 13-15 year olds 1,300 1 1,300 0.5 (30 min.)... 650
(both acne and ADHD).
Main study, 16-19-year olds 1,300 1 1,300 0.5 (30 min.)... 650
(both acne and ADHD).
Main study, young adults (both 1,300 1 1,300 .5 (30 min.).... 650
acne and ADHD).
Main study, parents (both acne 1,300 1 1,300 .5 (30 min.).... 650
and ADHD).
------------------------------------------------ ---------------
Total pretest/study 6,350 .............. .............. ................ ..............
participants.
---------------------------------------------------------------------------------
[[Page 65329]]
Total................. .............. .............. .............. ................ 6,472
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The total respondent sample for this data collection is 6,350,
including the two pretests. We estimate the response burden to be 30
minutes, for a total collection burden, including screeners, of 6,472
hours.
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.),
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: October 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-25963 Filed 10-30-13; 8:45 am]
BILLING CODE 4160-01-P
