Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Spousal Influence on Consumer Understanding of and Response to Direct-to-Consumer Prescription Drug Advertisements, 30077-30080 [2015-12582]
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Federal Register / Vol. 80, No. 100 / Tuesday, May 26, 2015 / Notices
policies to assist victims of human
trafficking.
Respondents: Individual participants
in TVAP projects.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Request for Information ...................................................................................
1250
1
.25
312.5
Estimated Total Annual Burden
Hours: 312.5.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–12591 Filed 5–22–15; 8:45 am]
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BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1819]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Spousal Influence
on Consumer Understanding of and
Response to Direct-to-Consumer
Prescription Drug Advertisements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by June 25,
2015.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
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 ‘‘Spousal Influence on Consumer
Understanding of and Response to
Direct-to-Consumer (DTC) Prescription
Drug Advertisements’’. 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.
ADDRESSES:
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:
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Spousal Influence on Consumer
Understanding of and Response to
Direct-to-Consumer Prescription Drug
Advertisements—(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.
Consumers are often thought of as
individual targets for prescription drug
advertisements (ads), as if they are
always exposed to DTC ads individually
and subsequently make judgments about
advertised products on their own.
However, judgments about prescription
drugs portrayed in DTC television ads
are likely made in social contexts much
of the time. For example, a potential
consumer and his or her spouse (e.g.,
marital or domestic partner) may view
an ad together and discuss drug
benefits, side effects, and risks. These
social interactions may result in unique
reactions relative to consumers who
view DTC prescription drug television
ads alone. For example, spouses may
influence their partner by expressing
concern about risks and side effects that
might occur, or pressuring their partner
to consider the drug despite its risks and
side effects. These outcomes have
important public health implications.
The Office of Prescription Drug
Promotion plans to examine differences
between consumers viewing
prescription drug ads with a spouse
versus alone through empirical research.
The main study will be preceded by
pretesting designed to delineate the
procedures and measures used in the
main study. Pretest and main study
participants will be couples who are
married or in a marital-like living
arrangement in which one member
(consumer) has asthma and the other
does not (spouse). All participants will
be 18 years of age or older and married
or cohabiting for 6 months or longer. We
will exclude individuals who work in
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Federal Register / Vol. 80, No. 100 / Tuesday, May 26, 2015 / Notices
healthcare or marketing settings because
their knowledge and experiences may
not reflect those of the average
consumer. Data collection will take
place in person.
Participants will be randomly
assigned to one of four experimental
conditions in a 2 x 2 design, as depicted
in Table 1. We will compare one version
of an ad that depicts a low benefit and
low risk drug with a second version that
depicts a high benefit and high risk
drug. Participants will be randomly
assigned to view the ad alone or
together with their spouse. Participants
in both viewing conditions will
individually complete a
prequestionnaire. In the ‘‘together’’
condition, participants will view the ad
with their spouse and then engage in a
brief discussion together about the ad.
In the ‘‘alone’’ condition, participants
will view the ad without their spouse,
take a short break, and then respond to
a postquestionnaire consisting of
questions about information in the ad.
The short break in the ‘‘alone’’
condition will facilitate reflection about
the ad to mirror discussion engaged in
by those in the ‘‘together’’ condition.
The consumer in the ‘‘together’’
condition will complete the same
postquestionnaire administered to those
in the ‘‘alone’’ condition, and the
spouse will complete a slightly different
questionnaire that assesses key
measures that relate to consumer
reactions. These procedures are
depicted in Table 2. Participation is
estimated to take approximately 60
minutes.
Measures are designed to assess
memory and understanding of risk and
benefit information as well as other ad
content, intention to seek more
information about the product, and
variables pertaining to the consumerspouse relationship such as relationship
closeness and communication style. The
questionnaire is available upon request.
TABLE 1—EXPERIMENTAL STUDY
DESIGN
Risk/benefit condition
Viewing
condition
Low risk/low
benefit
Alone ............
Together .......
Condition A ..
Condition C ..
High risk/high
benefit
Condition B
Condition D
TABLE 2—OVERVIEW OF DATA COLLECTION PROCESS FOR ALONE AND TOGETHER CONDITIONS
Viewing condition
Steps
Together
1 ...........................................
Consumer completes prequestionnaire ..........................
2 ...........................................
Consumer views advertising stimuli alone ......................
3 ...........................................
5 minute break ................................................................
4 ...........................................
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Alone
Consumer completes postquestionnaire .........................
Consumer and spouse complete prequestionnaire separately (spouse completes selected measures).
Consumer and spouse view advertising stimuli together.
Couples engage in a 5 minute semi-structured conversation related to the advertising stimuli.
Consumer and spouse complete postquestionnaire separately (spouse completes selected measures).
In the Federal Register of November
14, 2014 (79 FR 68278), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. FDA received comments
from two organizations in response to
our Federal Register notice. In the
following section, we outline the
observations and suggestions raised in
the comments and provide our
responses.
(Comment from Abbvie) It is difficult
to ascertain how the Agency will utilize
the results of this study should it
demonstrate that the perception of ads
differs when viewed alone or with
someone else. Regulating companion
versus solitary viewing practices would
present insurmountable legal and
practical hurdles. Rather than conduct
this study, we suggest that FDA
resources and tax payer dollars would
be better directed to research that
enhances the quality of how we
communicate benefit and risk
information to consumers regardless of
the setting in which the ad is viewed.
(Response) Much research in the
social sciences demonstrates the strong
influence of environmental and social
conditions under which humans think
and act. In regard to prescription drug
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advertising, it may be that when a risk
is perceived as particularly negative,
viewing with a partner reinforces this
perception. Conversely, it may be that
partners downplay risks or emphasize
benefits, leading to alternate perceptions
and intentions. These potential
outcomes have implications for public
health. Thus, it is important to generate
insight about not only the message
portrayed in DTC TV ads but also the
conditions under which these messages
are received and processed. Pending
findings from this research,
organizations involved in developing
DTC drug communications may be
encouraged to remain aware of the
social context in which DTC ads are
often viewed and the influence of this
context on consumer perceptions,
judgments, and decisions. Consideration
of this broader context may facilitate the
development of better DTC drug
communications that remain accurate
and balanced regardless of setting.
(Comment from Eli Lilly) Compelling
a discussion between the consumer and
spouse about the advertisement is likely
to generate data that may or may not be
applicable in a real-world setting.
Consider removing the prescribed
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interaction and allow a discussion to
occur if the couple so chooses.
(Response) Allowing a discussion to
occur if the couple chooses could
confound the research design and
undermine our ability to make
conclusive statements. Implementing
the procedures systematically across the
sample is a stronger study design (Ref.
1). There is a long tradition in the social
and behavioral sciences of studying
marital communication as proposed
(Ref. 2). This research tradition
continues because this method is more
objective than participant self-reports
(Ref. 3). Also, measures taken from these
spousal communications are linked
with important real world outcomes
including health behavior and wellbeing (Ref. 4, Ref. 5), divorce, and
marital satisfaction (Ref. 6, Ref. 2). This
research method compels a discussion
between partners as a way to
understand the content and style of
their communication. Thus, our
proposed study is in keeping with the
methods in this research area.
(Comment from Eli Lilly) We are
challenged to understand how this
research yields any useful, actionable
information when it is impractical to
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Federal Register / Vol. 80, No. 100 / Tuesday, May 26, 2015 / Notices
influence who is watching TV
advertisements at any given time.
(Response) As stated in response to a
previous comment, it is important to
generate insight about not only the
message portrayed in DTC TV ads but
also the conditions under which these
messages are received and processed.
Such insight may facilitate the
development of better DTC drug
communications regardless of setting.
(Comment from Eli Lilly) Include a
‘‘General Population’’ control group.
(Response) Researching each medical
condition, or general population
sample, requires significant resources.
We are interested in response to the ads
among consumers for whom the ad is
personally relevant (i.e., they or their
partner have been diagnosed with
asthma). We are committed to
conducting this research using our
available resources while ensuring the
integrity of the research by collecting
data on a high prevalence condition for
which participants might be thought of
as sufficiently representative of the
average consumer, thus allowing us to
draw conclusions about broad
perceptual and cognitive processing
outcomes.
(Comment from Eli Lilly) Q12 invites
speculation from respondents who may
be unable to evaluate what is or is not
a ‘‘serious’’ side effect. Consider
eliminating this question or re-phrasing
to: ‘‘Please rate the seriousness of the
side effects for [Drug X] that you
remember from the ad.’’
(Response) We have conducted
cognitive interviews to refine and
improve the survey questions. Through
this process, we found that a number of
participants had difficulty reading and/
or answering Q12 in its original form.
We also tested an alternative version of
this question that conforms to the
reviewer’s re-phrasing, ‘‘In your
opinion, how serious are the side effects
of [Drug X]?’’ Many cognitive interview
participants preferred this alternative
version, and we will adopt it for the
final questionnaire.
(Comment from Eli Lilly) Response
options in Q16 may be interpreted
qualitatively (i.e., on the whole, the
risks outweigh the benefits) or literally
(i.e., how many more risks were stated
than benefits). Rephrasing to reflect true
intent is recommended.
(Response) We appreciate this
comment. This item was tested in a
rigorous cognitive interview protocol
and there was no indication that
participants had difficulty interpreting
the response options. However, we will
also be conducting pretesting which
will provide an additional opportunity
to identify and remove questions that do
not function as intended, further
refining the questionnaire prior to the
main study.
(Comment from Eli Lilly) Q19b is
ambiguous and unclear. Rephrasing or
deletion is recommended.
(Response) We tested this item as part
of our cognitive interview protocol. The
majority of participants understood this
question, and their answers suggest that
the question did a good job of
distinguishing between those who
focused on the arguments and facts
presented in the ad versus those who
paid more attention to peripheral cues,
such as the visual narrative. Because the
item functioned as intended, we intend
to retain Q19b.
(Comment from Eli Lilly) Q20 is
ambiguous and unclear. Rephrasing or
deletion is recommended.
30079
(Response) In our cognitive
interviews, some participants had
difficulty understanding the meaning of
the introductory phrase ‘‘In these
thoughts’’. Due to the ambiguity of Q20
as a whole, we will remove this item
from the questionnaire.
(Comment from Eli Lilly) Q21
instructions could bias respondents to
evaluate each statement as risk-related.
Consider rephrasing to, ‘‘The following
statements describe how people deal
with various situations.’’
(Response) The Q21 battery is a
validated scale specifically designed to
measure attitudes toward risk (Ref. 7).
Respondents are meant to evaluate the
statements as though they are riskrelated. Therefore, we will retain the
Q21 battery.
(Comment from Eli Lilly) The scale
for Q25 should be made consistent with
other scales to ensure internal
consistency. A scale with a midpoint is
recommended.
(Response) When developing the
questionnaires, we included a number
of questions from existing multi-items
scales. The number and format of
response options differed from scale to
scale (e.g., 6-points vs. 10-points, fully
labelled vs. anchors-only, etc.). We will
revise the Likert-type response scales so
that the number of levels and labeling
formats across questions is consistent.
To examine differences between
experimental conditions, we will
conduct inferential statistical tests such
as analysis of variance. With the sample
size described in Table 3, we will have
sufficient power to detect small-tomedium sized effects in the main study.
FDA estimates the burden of this
collection of information as follows:
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses
per
respondent
Total annual
responses
1
1
700
120
0.08 (5 minutes)
1 .........................
56
120
Average burden
per response
Total hours
Pretesting
Number to Complete the Screener .................................................
Number of Completes .....................................................................
700
120
Main Study
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Number to Complete the Screener .................................................
Number of Completes .....................................................................
4,060
792
1
1
4,060
792
0.08 (5 minutes)
1 .........................
325
792
Total ..........................................................................................
....................
....................
....................
............................
1,293
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
References
The following references have been placed
on display in the Division of Dockets
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Management (see ADDRESSES) and may be
seen by interested persons between 9 a.m.
and 4 p.m., Monday through Friday, and are
available electronically at https://
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www.regulations.gov. (FDA has verified all
the Web site addresses in this reference
section, but we are not responsible for any
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Federal Register / Vol. 80, No. 100 / Tuesday, May 26, 2015 / Notices
subsequent changes to the Web sites after this
document publishes in the Federal Register.)
Reis, H., and C. Judd, Handbook of Research
Methods in Social and Personality
Psychology, 2nd Ed. New York:
Cambridge University Press (2014).
Kerig, P.K., and D.H. Baucom, (Eds.). Couple
Observational Coding Systems, Mahwah,
NJ: Erlbaum (2004).
Bakeman, R., Behavioral Observation and
Coding, In H.T. Reis & C.M. Judd (Eds.)
Handbook of Research Methods in Social
and Personality Psychology,pp. 138–159.
New York: Cambridge University Press
(2000).
Ewart, C.K., C.B. Taylor, H.C. Kraemer, and
W.S. Agras. ‘‘High Blood Pressure and
Marital Discord: Not Being Nasty Matters
More Than Being Nice,’’ Health
Psychology, 10, pp. 155–163 (1991).
Spitzberg, B.H., and W.R. Cupach, Handbook
of Interpersonal Competence Research,
NY: Springer-Verlag (1989).
Gottman, J.M., What Predicts Divorce? The
Relationship Between Marital Processes
and Marital Outcomes. Hillsdale, NJ:
Erlbaum (1994).
Rohrmann, B., ‘‘Risk Attitude Scales:
Concepts, Questionnaires, Utilizations
[Project Report],’’ University of
Melbourne, Australia. Retrieved from
https://www.rohrmannresearch.net/pdfs/
rohrmann-racreport.pdf (2005).
Dated: May 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–12582 Filed 5–22–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Mandatory Guidelines for Federal
Workplace Drug Testing Programs
Substance Abuse and Mental
Health Services Administration
(SAMHSA), Department of Health and
Human Services.
ACTION: HHS Approval of Entities That
Certify Medical Review Officers (MRO).
AGENCY:
The current version of the
Department of Health and Human
Services (HHS) Mandatory Guidelines
for Federal Workplace Drug Testing
Programs (Mandatory Guidelines),
effective on October 1, 2010, addresses
the role and qualifications of Medical
Review Officers (MROs) and HHS
approval of entities that certify MROs.
Subpart M—Medical Review Officer
(MRO), Section 13.1(b) of the Mandatory
Guidelines, ‘‘Who may serve as an
MRO?’’ states as follows: ‘‘Nationally
recognized entities that certify MROs or
subspecialty boards for physicians
performing a review of Federal
employee drug test results that seek
approval by the Secretary must submit
their qualifications and a sample
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SUMMARY:
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17:50 May 22, 2015
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examination. Based on an annual
objective review of the qualifications
and content of the examination, the
Secretary shall annually publish a list in
the Federal Register of those entities
and boards that have been approved.’’
HHS has completed its review of
entities that certify MROs, in
accordance with requests submitted by
such entities to HHS.
The HHS Secretary approves the
following MRO certifying entities that
offer MRO certification through
examination:
American Association of Medical
Review Officers (AAMRO), P.O. Box
12873, Research Triangle Park, NC
27709; Phone: (800) 489–1839; Fax:
(919) 490–1010; Email: cferrell@
aamro.com; Web site: https://
www.aamro.com/.
Medical Review Officer Certification
Council (MROCC), 836 Arlington
Heights Road, #327, Elk Grove
Village, IL 60007; Phone: (847) 631–
0599; Fax: (847) 483–1282; Email:
mrocc@mrocc.org; Web site: https://
www.mrocc.org/.
DATES: HHS approval is effective May
26, 2015.
FOR FURTHER INFORMATION CONTACT:
Jennifer Fan, Pharm.D., J.D., Division of
Workplace Programs (DWP), Center for
Substance Abuse Prevention (CSAP),
Substance Abuse and Mental Health
Services Administration (SAMHSA), 1
Choke Cherry Road, Room 7–1038,
Rockville, MD 20857; Telephone: (240)
276–1759; Email: jennifer.fan@
samhsa.hhs.gov
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
General Medical Sciences Initial Review
Group; Training and Workforce Development
Subcommittee—C.
Date: June 8, 2015.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Monaco Alexandria, 480 King
Street, Alexandria, VA 22314.
Contact Person: Mona R. Trempe, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3An.12A, Bethesda, MD
20892–4874, 301–594–3998, trempemo@
mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National
Institutes of Health, HHS)
Dated: May 19, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–12543 Filed 5–22–15; 8:45 am]
BILLING CODE 4140–01–P
Dated: May 15, 2015.
Sylvia M. Burwell,
Secretary.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2015–12559 Filed 5–22–15; 8:45 am]
National Institutes of Health
BILLING CODE 4160–20–P
Prospective Grant of Exclusive
License: Development of Autologous
Tumor Infiltrating Lymphocyte
Adoptive Cells for the Treatment of
Lung, Breast, Bladder, and HPVPositive Cancers
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
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AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR 404, that
the National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of
an exclusive patent license to the
current licensee, Lion Biotechnologies,
Inc., which is located in Woodland
Hills, California to practice the
inventions embodied in the following
patent applications and applications
claiming priority to these applications:
SUMMARY:
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]]>Agencies
[Federal Register Volume 80, Number 100 (Tuesday, May 26, 2015)]
[Notices]
[Pages 30077-30080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12582]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1819]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Spousal Influence on
Consumer Understanding of and Response to Direct-to-Consumer
Prescription Drug Advertisements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by June
25, 2015.
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 ``Spousal Influence on Consumer Understanding of and Response to
Direct-to-Consumer (DTC) Prescription Drug Advertisements''. 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.
Spousal Influence on Consumer Understanding of and Response to Direct-
to-Consumer Prescription Drug Advertisements--(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.
Consumers are often thought of as individual targets for
prescription drug advertisements (ads), as if they are always exposed
to DTC ads individually and subsequently make judgments about
advertised products on their own. However, judgments about prescription
drugs portrayed in DTC television ads are likely made in social
contexts much of the time. For example, a potential consumer and his or
her spouse (e.g., marital or domestic partner) may view an ad together
and discuss drug benefits, side effects, and risks. These social
interactions may result in unique reactions relative to consumers who
view DTC prescription drug television ads alone. For example, spouses
may influence their partner by expressing concern about risks and side
effects that might occur, or pressuring their partner to consider the
drug despite its risks and side effects. These outcomes have important
public health implications. The Office of Prescription Drug Promotion
plans to examine differences between consumers viewing prescription
drug ads with a spouse versus alone through empirical research.
The main study will be preceded by pretesting designed to delineate
the procedures and measures used in the main study. Pretest and main
study participants will be couples who are married or in a marital-like
living arrangement in which one member (consumer) has asthma and the
other does not (spouse). All participants will be 18 years of age or
older and married or cohabiting for 6 months or longer. We will exclude
individuals who work in
[[Page 30078]]
healthcare or marketing settings because their knowledge and
experiences may not reflect those of the average consumer. Data
collection will take place in person.
Participants will be randomly assigned to one of four experimental
conditions in a 2 x 2 design, as depicted in Table 1. We will compare
one version of an ad that depicts a low benefit and low risk drug with
a second version that depicts a high benefit and high risk drug.
Participants will be randomly assigned to view the ad alone or together
with their spouse. Participants in both viewing conditions will
individually complete a prequestionnaire. In the ``together''
condition, participants will view the ad with their spouse and then
engage in a brief discussion together about the ad. In the ``alone''
condition, participants will view the ad without their spouse, take a
short break, and then respond to a postquestionnaire consisting of
questions about information in the ad. The short break in the ``alone''
condition will facilitate reflection about the ad to mirror discussion
engaged in by those in the ``together'' condition. The consumer in the
``together'' condition will complete the same postquestionnaire
administered to those in the ``alone'' condition, and the spouse will
complete a slightly different questionnaire that assesses key measures
that relate to consumer reactions. These procedures are depicted in
Table 2. Participation is estimated to take approximately 60 minutes.
Measures are designed to assess memory and understanding of risk
and benefit information as well as other ad content, intention to seek
more information about the product, and variables pertaining to the
consumer-spouse relationship such as relationship closeness and
communication style. The questionnaire is available upon request.
Table 1--Experimental Study Design
------------------------------------------------------------------------
Risk/benefit condition
---------------------------------------
Viewing condition Low risk/low High risk/high
benefit benefit
------------------------------------------------------------------------
Alone........................... Condition A....... Condition B
Together........................ Condition C....... Condition D
------------------------------------------------------------------------
Table 2--Overview of Data Collection Process for Alone and Together
Conditions
------------------------------------------------------------------------
Viewing condition
Steps -------------------------------------------
Alone Together
------------------------------------------------------------------------
1........................... Consumer completes Consumer and spouse
prequestionnaire. complete
prequestionnaire
separately (spouse
completes selected
measures).
2........................... Consumer views Consumer and spouse
advertising stimuli view advertising
alone. stimuli together.
3........................... 5 minute break...... Couples engage in a
5 minute semi-
structured
conversation
related to the
advertising
stimuli.
4........................... Consumer completes Consumer and spouse
postquestionnaire. complete
postquestionnaire
separately (spouse
completes selected
measures).
------------------------------------------------------------------------
In the Federal Register of November 14, 2014 (79 FR 68278), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received comments from two organizations
in response to our Federal Register notice. In the following section,
we outline the observations and suggestions raised in the comments and
provide our responses.
(Comment from Abbvie) It is difficult to ascertain how the Agency
will utilize the results of this study should it demonstrate that the
perception of ads differs when viewed alone or with someone else.
Regulating companion versus solitary viewing practices would present
insurmountable legal and practical hurdles. Rather than conduct this
study, we suggest that FDA resources and tax payer dollars would be
better directed to research that enhances the quality of how we
communicate benefit and risk information to consumers regardless of the
setting in which the ad is viewed.
(Response) Much research in the social sciences demonstrates the
strong influence of environmental and social conditions under which
humans think and act. In regard to prescription drug advertising, it
may be that when a risk is perceived as particularly negative, viewing
with a partner reinforces this perception. Conversely, it may be that
partners downplay risks or emphasize benefits, leading to alternate
perceptions and intentions. These potential outcomes have implications
for public health. Thus, it is important to generate insight about not
only the message portrayed in DTC TV ads but also the conditions under
which these messages are received and processed. Pending findings from
this research, organizations involved in developing DTC drug
communications may be encouraged to remain aware of the social context
in which DTC ads are often viewed and the influence of this context on
consumer perceptions, judgments, and decisions. Consideration of this
broader context may facilitate the development of better DTC drug
communications that remain accurate and balanced regardless of setting.
(Comment from Eli Lilly) Compelling a discussion between the
consumer and spouse about the advertisement is likely to generate data
that may or may not be applicable in a real-world setting. Consider
removing the prescribed interaction and allow a discussion to occur if
the couple so chooses.
(Response) Allowing a discussion to occur if the couple chooses
could confound the research design and undermine our ability to make
conclusive statements. Implementing the procedures systematically
across the sample is a stronger study design (Ref. 1). There is a long
tradition in the social and behavioral sciences of studying marital
communication as proposed (Ref. 2). This research tradition continues
because this method is more objective than participant self-reports
(Ref. 3). Also, measures taken from these spousal communications are
linked with important real world outcomes including health behavior and
well-being (Ref. 4, Ref. 5), divorce, and marital satisfaction (Ref. 6,
Ref. 2). This research method compels a discussion between partners as
a way to understand the content and style of their communication. Thus,
our proposed study is in keeping with the methods in this research
area.
(Comment from Eli Lilly) We are challenged to understand how this
research yields any useful, actionable information when it is
impractical to
[[Page 30079]]
influence who is watching TV advertisements at any given time.
(Response) As stated in response to a previous comment, it is
important to generate insight about not only the message portrayed in
DTC TV ads but also the conditions under which these messages are
received and processed. Such insight may facilitate the development of
better DTC drug communications regardless of setting.
(Comment from Eli Lilly) Include a ``General Population'' control
group.
(Response) Researching each medical condition, or general
population sample, requires significant resources. We are interested in
response to the ads among consumers for whom the ad is personally
relevant (i.e., they or their partner have been diagnosed with asthma).
We are committed to conducting this research using our available
resources while ensuring the integrity of the research by collecting
data on a high prevalence condition for which participants might be
thought of as sufficiently representative of the average consumer, thus
allowing us to draw conclusions about broad perceptual and cognitive
processing outcomes.
(Comment from Eli Lilly) Q12 invites speculation from respondents
who may be unable to evaluate what is or is not a ``serious'' side
effect. Consider eliminating this question or re-phrasing to: ``Please
rate the seriousness of the side effects for [Drug X] that you remember
from the ad.''
(Response) We have conducted cognitive interviews to refine and
improve the survey questions. Through this process, we found that a
number of participants had difficulty reading and/or answering Q12 in
its original form. We also tested an alternative version of this
question that conforms to the reviewer's re-phrasing, ``In your
opinion, how serious are the side effects of [Drug X]?'' Many cognitive
interview participants preferred this alternative version, and we will
adopt it for the final questionnaire.
(Comment from Eli Lilly) Response options in Q16 may be interpreted
qualitatively (i.e., on the whole, the risks outweigh the benefits) or
literally (i.e., how many more risks were stated than benefits).
Rephrasing to reflect true intent is recommended.
(Response) We appreciate this comment. This item was tested in a
rigorous cognitive interview protocol and there was no indication that
participants had difficulty interpreting the response options. However,
we will also be conducting pretesting which will provide an additional
opportunity to identify and remove questions that do not function as
intended, further refining the questionnaire prior to the main study.
(Comment from Eli Lilly) Q19b is ambiguous and unclear. Rephrasing
or deletion is recommended.
(Response) We tested this item as part of our cognitive interview
protocol. The majority of participants understood this question, and
their answers suggest that the question did a good job of
distinguishing between those who focused on the arguments and facts
presented in the ad versus those who paid more attention to peripheral
cues, such as the visual narrative. Because the item functioned as
intended, we intend to retain Q19b.
(Comment from Eli Lilly) Q20 is ambiguous and unclear. Rephrasing
or deletion is recommended.
(Response) In our cognitive interviews, some participants had
difficulty understanding the meaning of the introductory phrase ``In
these thoughts''. Due to the ambiguity of Q20 as a whole, we will
remove this item from the questionnaire.
(Comment from Eli Lilly) Q21 instructions could bias respondents to
evaluate each statement as risk-related. Consider rephrasing to, ``The
following statements describe how people deal with various
situations.''
(Response) The Q21 battery is a validated scale specifically
designed to measure attitudes toward risk (Ref. 7). Respondents are
meant to evaluate the statements as though they are risk-related.
Therefore, we will retain the Q21 battery.
(Comment from Eli Lilly) The scale for Q25 should be made
consistent with other scales to ensure internal consistency. A scale
with a midpoint is recommended.
(Response) When developing the questionnaires, we included a number
of questions from existing multi-items scales. The number and format of
response options differed from scale to scale (e.g., 6-points vs. 10-
points, fully labelled vs. anchors-only, etc.). We will revise the
Likert-type response scales so that the number of levels and labeling
formats across questions is consistent.
To examine differences between experimental conditions, we will
conduct inferential statistical tests such as analysis of variance.
With the sample size described in Table 3, we will have sufficient
power to detect small-to-medium sized effects in the main study.
FDA estimates the burden of this collection of information as
follows:
Table 3--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses Total Average burden per
Activity respondents per annual response Total hours
respondent responses
----------------------------------------------------------------------------------------------------------------
Pretesting
----------------------------------------------------------------------------------------------------------------
Number to Complete the Screener..... 700 1 700 0.08 (5 minutes)...... 56
Number of Completes................. 120 1 120 1..................... 120
----------------------------------------------------------------------------------------------------------------
Main Study
----------------------------------------------------------------------------------------------------------------
Number to Complete the Screener..... 4,060 1 4,060 0.08 (5 minutes)...... 325
Number of Completes................. 792 1 792 1..................... 792
---------------------------------------------------------------------------
Total........................... ........... ........... ........... ...................... 1,293
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at https://www.regulations.gov. (FDA
has verified all the Web site addresses in this reference section,
but we are not responsible for any
[[Page 30080]]
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
Reis, H., and C. Judd, Handbook of Research Methods in Social and
Personality Psychology, 2nd Ed. New York: Cambridge University Press
(2014).
Kerig, P.K., and D.H. Baucom, (Eds.). Couple Observational Coding
Systems, Mahwah, NJ: Erlbaum (2004).
Bakeman, R., Behavioral Observation and Coding, In H.T. Reis & C.M.
Judd (Eds.) Handbook of Research Methods in Social and Personality
Psychology,pp. 138-159. New York: Cambridge University Press (2000).
Ewart, C.K., C.B. Taylor, H.C. Kraemer, and W.S. Agras. ``High Blood
Pressure and Marital Discord: Not Being Nasty Matters More Than
Being Nice,'' Health Psychology, 10, pp. 155-163 (1991).
Spitzberg, B.H., and W.R. Cupach, Handbook of Interpersonal
Competence Research, NY: Springer-Verlag (1989).
Gottman, J.M., What Predicts Divorce? The Relationship Between
Marital Processes and Marital Outcomes. Hillsdale, NJ: Erlbaum
(1994).
Rohrmann, B., ``Risk Attitude Scales: Concepts, Questionnaires,
Utilizations [Project Report],'' University of Melbourne, Australia.
Retrieved from https://www.rohrmannresearch.net/pdfs/rohrmann-racreport.pdf (2005).
Dated: May 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12582 Filed 5-22-15; 8:45 am]
BILLING CODE 4164-01-P
