
[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]


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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.

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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
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                                                       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)
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                                                                               Study 1 (Medical Condition A, Acne)
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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.
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                                                                               Study 2 (Medical Condition B, ADHD)
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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.
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    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\
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                                                                    Number of
                    Activity                        Number of     responses per   Total annual         Average burden per response          Total hours
                                                   respondents     respondent       responses
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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
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\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 
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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


