Agency Information Collection Activities; Proposed Collection; Comment Request; Risk and Benefit Perception Scale Development, 22143-22146 [2014-08957]
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Federal Register / Vol. 79, No. 76 / Monday, April 21, 2014 / Notices
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
Email:
OIRA_SUBMISSION@OMB.EOP.GOV,
Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014–09016 Filed 4–18–14; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Child and Family Services Plan
(CFSP), Annual Progress and Services
Review (APSR), and Annual Budget
Expenses Request and Estimated
Expenditures (CFS–101).
OMB No.: 0970–0426.
Description: Under title IV–B,
subparts 1 and 2, of the Social Security
Act (the Act), States, Territories, and
Tribes are required to submit a Child
and Family Services Plan (CFSP). The
CFSP lays the groundwork for a system
of coordinated, integrated, and
culturally relevant family services for
the subsequent five years (45 CFR
1357.15(a)(1)). The CFSP outlines
initiatives and activities the State, Tribe
or territory will carry out in
administering programs and services to
promote the safety, permanency, and
well-being of children and families. By
June 30 of each year, States, Territories,
and Tribes are also required to submit
an Annual Progress and Services Report
(APSR) and a financial report called the
CFS–101. The APSR is a Yearly report
that discusses progress made by a State,
Territory or Tribe in accomplishing the
goals and objectives cited in its CFSP
(45 CFR 1357.16(a)). The APSR contains
new and updated information about
service needs and organizational
capacities throughout the five-year plan
period. The CFS–101 has three parts.
Part I is an annual budget request for the
upcoming fiscal year. Part II includes a
summary of planned expenditures by
program area for the upcoming fiscal
year, the estimated number of
individuals or families to be served, and
the geographical service area. Part III
includes actual expenditures by
program area, numbers of families and
individuals served by program area, and
the geographic areas served for the last
complete fiscal year.
The Child and Family Services
Improvement Act of 2006 amended Title
IV–B, subparts 1 and 2, adding a
number of requirements that affect
reporting through the APSR and the
CFS–101. Of particular note, the law
added a provision requiring States
(including Puerto Rico and the District
of Columbia) to report data on
caseworker visits (section 424(e) of the
Act). States must provide annual data
on 1) the percentage of children in foster
care under the responsibility of the State
who were visited on a monthly basis by
the caseworker handling the case of the
child; and 2) the percentage of the visits
that occurred in the residence of the
child. In addition, by June 30, 2008,
States must set target percentages and
establish strategies to meet the goal that;
by October 1, 2011; at least 90 percent
of the children in foster care are visited
by their caseworkers on a monthly basis
and that the majority of these visits
occur in the residence of the child
(section 424(e)(2)(A) of the Act).
Respondents: States, Territories, and
Tribes must complete the CFSP, APSR,
and CFS–101. Tribes and territories are
exempted from the monthly caseworker
visits reporting requirement of the
APSR. There are approximately 180
Tribal entities that are eligible for IV–B
funding. There are 52 States (including
Puerto Rico and the District of
Columbia) that must complete the CFSP,
APSR, and CFS–101. There are a total of
232 possible respondents.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
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APSR ...............................................................................................................
CFSP ...............................................................................................................
CFS–101, Parts I, II, and III ............................................................................
Caseworker Visits ............................................................................................
Estimated Total Annual Burden
Hours: 29,527 hours.
Additional Information: Copies of the
proposed collection may be obtained 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. All requests should be
identified by the title of the information
collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
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Number of
responses per
respondent
232
232
232
52
Average
burden hours
per response
1
1
1
1
Total burden
hours
76.58
120.25
4.38
99.33
17,766.56
5,579.60
1,016.16
5,165.16
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
Email: OIRA_SUBMISSION@
OMB.EOP.GOV, Attn: Desk Officer for
the Administration for Children and
Families.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Robert Sargis,
Reports Clearance Officer.
ACTION:
[FR Doc. 2014–08959 Filed 4–18–14; 8:45 am]
SUMMARY:
BILLING CODE 4184–01–P
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Food and Drug Administration
[Docket No. FDA–2014–N–0373]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Risk and Benefit
Perception Scale Development
AGENCY:
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
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Federal Register / Vol. 79, No. 76 / Monday, April 21, 2014 / Notices
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
a study, Risk and Benefit Perception
Scale Development. The study is
designed to test different ways of
measuring consumers’ benefit and risk
perceptions after exposure to direct-toconsumer (DTC) prescription drug
advertising.
Submit either electronic or
written comments on the collection of
information by June 20, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 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
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DATES:
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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.
Risk and Benefit Perception Scale
Development—(OMB Control Number
0910-New)
FDA requires that prescription drug
advertisements be balanced in their
presentation of risk and benefit
information. Patients receive
information on drugs not only from
their doctors and pharmacies, through
patient labeling and FDA-mandated
medication guides, but also online, on
social networks and via DTC television
and print advertising. Moreover,
research suggests that consumers
struggle with the concepts of risk and
efficacy (Ref. 1) and often overestimate
drug efficacy (Ref. 2). As a result, it is
important for FDA to understand and
accurately measure how consumers are
making sense of this information and
how it impacts decisions related to
prescription drugs.
FDA’s Office of Prescription Drug
Promotion has an active research
program that investigates how DTC
advertising influences consumer
knowledge, perceptions, and behavior.
Consequently, FDA needs a pool of
reliable and valid measurement items
for assessing consumers’ drug risk and
benefit perceptions—as well as other
elements of prescription drug decision
making—consistently across studies.
The purpose of this project is to create
that measurement pool, thus increasing
the rigor and efficiency of FDA’s
research.
Design: This research will be
conducted in two stages.
Stage 1: Pretests
The purpose of the first study stage is
to pretest the candidate measurement
items to assess their psychometric
properties and identify any
measurement challenges (e.g.,
misinterpretation, lack of variance). We
also will use the pretest to examine
factors that may affect future study
results and analyses (e.g., response scale
midpoints, moderating variables).
We will conduct two sequential
pretest waves (n = 500 per wave; n =
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1,000 total) with the following target
populations: (a) Individuals diagnosed
with chronic pain; and (b) individuals
diagnosed with hypertension. Each
participant will be randomly assigned to
view either a print ad or a television ad
for a fictitious prescription drug
indicated to treat chronic pain; or
hypertension and will be asked to
complete a brief online survey assessing
their benefit/risk recall, benefit/risk
perceptions, and attitudes toward the
drug. Based on the pretest findings, we
will revise and remove candidate items
prior to full-scale testing. The pretest
study design is outlined in Exhibit 1.
EXHIBIT 1—PRETEST STUDY DESIGN
Medical condition
Wave
Chronic
pain
Wave 1
Wave 2
Total
Hypertension
n = 250
n = 250
n = 250
n = 250
500
500
500
500
1,000
Stage 2: Iterative Tests
In the second stage, we will conduct
four sequential waves of iterative testing
to fully assess the measurement
properties of the candidate items and
create the final pool of measurements.
We will conduct the first two waves
with members of the target populations
(hypertension and chronic pain) to
refine the measurement items for those
groups and the second two waves with
members of the general population who
do not have the target health conditions
to determine if measurement reliability
and validity change when the advertised
drug addresses a condition that study
participants do not have (n = 2,500 per
wave; n = 10,000).
Each participant will be randomly
assigned to view either a print or
television ad for a fictitious prescription
drug for hypertension or chronic pain
and will be asked to complete a brief
online survey assessing their benefit/
risk recall, benefit/risk perceptions, and
attitudes toward the drug. In the first
two waves, participants will view an ad
that matches the sample’s medical
condition (chronic pain or
hypertension). In the final two waves,
half of the general population sample
will be exposed to the chronic pain
stimuli, and half will be exposed to the
high blood pressure stimuli.
The first two waves are outlined in
Exhibit 2, and the final two waves are
outlined in Exhibit 3.
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Federal Register / Vol. 79, No. 76 / Monday, April 21, 2014 / Notices
EXHIBIT 2—ITERATIVE TESTING DESIGN; ILLNESS POPULATION SAMPLE
Chronic pain ad
Drug
risk
level
Ad type
Hypertension ad
Drug benefit level
Control
High
Drug
risk
level
Ad type
Low
Drug benefit level
Control
High
Low
High ..
Low ...
High ..
Low ...
n
n
n
n
=
=
=
=
125
125
125
125
n
n
n
n
=
=
=
=
125
125
125
125
n = 125
High ..
Low ...
High ..
Low ...
n
n
n
n
=
=
=
=
125
125
125
125
n
n
n
n
=
=
=
=
125
125
125
125
n = 125
Wave 1
Print ................................
Television .......................
High ..
Low ...
High ..
Low ...
n
n
n
n
=
=
=
=
125
125
125
125
n
n
n
n
=
=
=
=
125
125
125
125
n = 125
Print ................................
n = 125
Television .......................
n = 125
Wave 2
Print ................................
Television .......................
High ..
Low ...
High ..
Low ...
n
n
n
n
=
=
=
=
125
125
125
125
n
n
n
n
=
=
=
=
125
125
125
125
n = 125
Print ................................
n = 125
Television .......................
n = 125
EXHIBIT 3—ITERATIVE TESTING DESIGN; GENERAL POPULATION SAMPLE
Chronic pain ad
Drug
risk
level
Ad type
Hypertension ad
Drug benefit level
Control
High
Drug
risk
level
Ad type
Low
Drug benefit level
Control
High
Low
High ..
Low ...
High ..
Low ...
n
n
n
n
=
=
=
=
125
125
125
125
n
n
n
n
=
=
=
=
125
125
125
125
n = 125
High ..
Low ...
High ..
Low ...
n
n
n
n
=
=
=
=
125
125
125
125
n
n
n
n
=
=
=
=
125
125
125
125
n = 125
Wave 3
Print ................................
Television .......................
High ..
Low ...
High ..
Low ...
n
n
n
n
=
=
=
=
125
125
125
125
n
n
n
n
=
=
=
=
125
125
125
125
n = 125
Print ................................
n = 125
Television .......................
n = 125
Wave 4
Print ................................
Television .......................
High ..
Low ...
High ..
Low ...
n
n
n
n
=
=
=
=
125
125
125
125
Participants and Burden Hours and
General Methods
Participants will be randomly
assigned to view one version of a
fictitious prescription drug ad (print or
television). The drug risks and benefits
in each ad will be manipulated into
high or low conditions, creating four
different ad versions: high benefit/high
risk, high benefit/low risk, low benefit/
high risk, and low benefit/low risk.
There also will be a control condition in
which the ad does not contain any risk
or benefit information (reminder ad).
The fictitious prescription drugs will be
modeled on real drugs used to treat the
n
n
n
n
=
=
=
=
125
125
125
125
n = 125
Print ................................
n = 125
Television .......................
same conditions and created with the
input of medical experts.
During the study, we will expose
participants to one of these fictitious ads
and ask them to answer a series of
questions about the fictitious drug. The
questions represent the candidate
measures we are testing in this study,
and we will examine which measures
are most sensitive/accurate in capturing
participants’ perceptions of the
advertised drug. (For example, an
accurate measure should detect different
perceptions in a participant who sees a
high benefit/high risk ad versus a
participant who sees a low benefit/low
n = 125
risk ad.) We have designed the study
and selected sample sizes (described
previously) so that we will have
sufficient statistical power to detect
small-to-medium sized differences
between the candidate measures and the
ability to refine and re-test measures to
ensure their accuracy.
For both the pretests and iterative
tests, the questionnaire is expected to
last no more than 20 minutes (the
questionnaire is available upon request).
This will be a one-time (rather than
annual) collection of information. FDA
estimates the burden of this collection
of information as follows:
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Screener ..........................................................................
Pretest .............................................................................
Main Study ......................................................................
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Number of
responses per
respondent
22,000
1,000
10,000
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1
1
1
Sfmt 4703
Total annual
responses
22,000
1,000
10,000
E:\FR\FM\21APN1.SGM
Average burden
per response
0.03 (2 minutes)
0.33 (20 minutes)
0.33 (20 minutes)
21APN1
Total hours
660
330
3,300
22146
Federal Register / Vol. 79, No. 76 / Monday, April 21, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Activity
Total .........................................................................
1 There
1. Lipkus, I.M. ‘‘Numeric, Verbal, and
Visual Formats of Conveying Health Risks:
Suggested Best Practices and Future
Recommendations.’’ Medical Decision
Making, 27(5), 696–713 (2007).
2. Aikin, K.J., J.L. Swasy, and A.C. Braman.
‘‘Patient and Physician Attitudes and
Behaviors Associated with DTC Promotion of
Prescription Drugs—Summary of FDA
Survey Research Results.’’ Food and Drug
Administration, Center for Drug Evaluation
and Research, 19 (2004).
Dated: April 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–08957 Filed 4–18–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Oncologic Drugs Advisory Committee;
Notice of Meeting
Food and Drug Administration,
HHS.
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ACTION:
Total annual
responses
Average burden
per response
........................
........................
........................
............................
Total hours
4,290
are no capital costs or operating and maintenance costs associated with this collection of information.
References
AGENCY:
Number of
responses per
respondent
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Oncologic Drugs
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on June 25, 2014, from 8:30 a.m.
to 3:30 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993–
0002. Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
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to the White Oak Campus must enter
through Building 1.
Contact Person: Caleb Briggs, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
ODAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last-minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The committee will discuss
new drug application (NDA) 206162,
olaparib capsules, application submitted
by AstraZeneca Pharmaceuticals LP.
The proposed indication (use) for this
product is as monotherapy for the
maintenance treatment of adult patients
with platinum-sensitive relapsed
ovarian cancer (including fallopian tube
or primary peritoneal) with germline
BRCA mutation as detected by an FDAapproved test, who are in response
(complete response or partial response)
to platinum-based chemotherapy.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
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before the committee. Written
submissions may be made to the contact
person on or before June 11, 2014. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before June 3,
2014. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by June 4, 2014.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Caleb Briggs
(see Contact Person) at least 7 days in
advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: April 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–08958 Filed 4–18–14; 8:45 am]
BILLING CODE 4160–01–P
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]]>Agencies
[Federal Register Volume 79, Number 76 (Monday, April 21, 2014)]
[Notices]
[Pages 22143-22146]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08957]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0373]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Risk and Benefit Perception Scale Development
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the
[[Page 22144]]
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 a
study, Risk and Benefit Perception Scale Development. The study is
designed to test different ways of measuring consumers' benefit and
risk perceptions after exposure to direct-to-consumer (DTC)
prescription drug advertising.
DATES: Submit either electronic or written comments on the collection
of information by June 20, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 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.
Risk and Benefit Perception Scale Development--(OMB Control Number
0910-New)
FDA requires that prescription drug advertisements be balanced in
their presentation of risk and benefit information. Patients receive
information on drugs not only from their doctors and pharmacies,
through patient labeling and FDA-mandated medication guides, but also
online, on social networks and via DTC television and print
advertising. Moreover, research suggests that consumers struggle with
the concepts of risk and efficacy (Ref. 1) and often overestimate drug
efficacy (Ref. 2). As a result, it is important for FDA to understand
and accurately measure how consumers are making sense of this
information and how it impacts decisions related to prescription drugs.
FDA's Office of Prescription Drug Promotion has an active research
program that investigates how DTC advertising influences consumer
knowledge, perceptions, and behavior. Consequently, FDA needs a pool of
reliable and valid measurement items for assessing consumers' drug risk
and benefit perceptions--as well as other elements of prescription drug
decision making--consistently across studies. The purpose of this
project is to create that measurement pool, thus increasing the rigor
and efficiency of FDA's research.
Design: This research will be conducted in two stages.
Stage 1: Pretests
The purpose of the first study stage is to pretest the candidate
measurement items to assess their psychometric properties and identify
any measurement challenges (e.g., misinterpretation, lack of variance).
We also will use the pretest to examine factors that may affect future
study results and analyses (e.g., response scale midpoints, moderating
variables).
We will conduct two sequential pretest waves (n = 500 per wave; n =
1,000 total) with the following target populations: (a) Individuals
diagnosed with chronic pain; and (b) individuals diagnosed with
hypertension. Each participant will be randomly assigned to view either
a print ad or a television ad for a fictitious prescription drug
indicated to treat chronic pain; or hypertension and will be asked to
complete a brief online survey assessing their benefit/risk recall,
benefit/risk perceptions, and attitudes toward the drug. Based on the
pretest findings, we will revise and remove candidate items prior to
full-scale testing. The pretest study design is outlined in Exhibit 1.
Exhibit 1--Pretest Study Design
------------------------------------------------------------------------
Medical condition
-------------------------
Wave Chronic
pain Hypertension
------------------------------------------------------------------------
Wave 1.............................. n = 250 n = 250 500
Wave 2.............................. n = 250 n = 250 500
-----------------------------------
Total........................... 500 500 1,000
------------------------------------------------------------------------
Stage 2: Iterative Tests
In the second stage, we will conduct four sequential waves of
iterative testing to fully assess the measurement properties of the
candidate items and create the final pool of measurements. We will
conduct the first two waves with members of the target populations
(hypertension and chronic pain) to refine the measurement items for
those groups and the second two waves with members of the general
population who do not have the target health conditions to determine if
measurement reliability and validity change when the advertised drug
addresses a condition that study participants do not have (n = 2,500
per wave; n = 10,000).
Each participant will be randomly assigned to view either a print
or television ad for a fictitious prescription drug for hypertension or
chronic pain and will be asked to complete a brief online survey
assessing their benefit/risk recall, benefit/risk perceptions, and
attitudes toward the drug. In the first two waves, participants will
view an ad that matches the sample's medical condition (chronic pain or
hypertension). In the final two waves, half of the general population
sample will be exposed to the chronic pain stimuli, and half will be
exposed to the high blood pressure stimuli.
The first two waves are outlined in Exhibit 2, and the final two
waves are outlined in Exhibit 3.
[[Page 22145]]
Exhibit 2--Iterative Testing Design; Illness Population Sample
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chronic pain ad Hypertension ad
--------------------------------------------------------------------------------------------------------------------------------------------------------
Drug benefit level Drug benefit level
Ad type Drug risk ---------------------- Control Ad type Drug risk ---------------------- Control
level High Low level High Low
--------------------------------------------------------------------------------------------------------------------------------------------------------
Wave 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Print............................. High......... n = 125 n = 125 n = 125 Print............... High......... n = 125 n = 125 n = 125
Low.......... n = 125 n = 125 Low.......... n = 125 n = 125
Television........................ High......... n = 125 n = 125 n = 125 Television.......... High......... n = 125 n = 125 n = 125
Low.......... n = 125 n = 125 Low.......... n = 125 n = 125
--------------------------------------------------------------------------------------------------------------------------------------------------------
Wave 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Print............................. High......... n = 125 n = 125 n = 125 Print............... High......... n = 125 n = 125 n = 125
Low.......... n = 125 n = 125 Low.......... n = 125 n = 125
Television........................ High......... n = 125 n = 125 n = 125 Television.......... High......... n = 125 n = 125 n = 125
Low.......... n = 125 n = 125 Low.......... n = 125 n = 125
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exhibit 3--Iterative Testing Design; General Population Sample
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chronic pain ad Hypertension ad
--------------------------------------------------------------------------------------------------------------------------------------------------------
Drug benefit level Drug benefit level
Ad type Drug risk ---------------------- Control Ad type Drug risk ---------------------- Control
level High Low level High Low
--------------------------------------------------------------------------------------------------------------------------------------------------------
Wave 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Print............................. High......... n = 125 n = 125 n = 125 Print............... High......... n = 125 n = 125 n = 125
Low.......... n = 125 n = 125 Low.......... n = 125 n = 125
Television........................ High......... n = 125 n = 125 n = 125 Television.......... High......... n = 125 n = 125 n = 125
Low.......... n = 125 n = 125 Low.......... n = 125 n = 125
--------------------------------------------------------------------------------------------------------------------------------------------------------
Wave 4
--------------------------------------------------------------------------------------------------------------------------------------------------------
Print............................. High......... n = 125 n = 125 n = 125 Print............... High......... n = 125 n = 125 n = 125
Low.......... n = 125 n = 125 Low.......... n = 125 n = 125
Television........................ High......... n = 125 n = 125 n = 125 Television.......... High......... n = 125 n = 125 n = 125
Low.......... n = 125 n = 125 Low.......... n = 125 n = 125
--------------------------------------------------------------------------------------------------------------------------------------------------------
Participants and Burden Hours and General Methods
Participants will be randomly assigned to view one version of a
fictitious prescription drug ad (print or television). The drug risks
and benefits in each ad will be manipulated into high or low
conditions, creating four different ad versions: high benefit/high
risk, high benefit/low risk, low benefit/high risk, and low benefit/low
risk. There also will be a control condition in which the ad does not
contain any risk or benefit information (reminder ad). The fictitious
prescription drugs will be modeled on real drugs used to treat the same
conditions and created with the input of medical experts.
During the study, we will expose participants to one of these
fictitious ads and ask them to answer a series of questions about the
fictitious drug. The questions represent the candidate measures we are
testing in this study, and we will examine which measures are most
sensitive/accurate in capturing participants' perceptions of the
advertised drug. (For example, an accurate measure should detect
different perceptions in a participant who sees a high benefit/high
risk ad versus a participant who sees a low benefit/low risk ad.) We
have designed the study and selected sample sizes (described
previously) so that we will have sufficient statistical power to detect
small-to-medium sized differences between the candidate measures and
the ability to refine and re-test measures to ensure their accuracy.
For both the pretests and iterative tests, the questionnaire is
expected to last no more than 20 minutes (the questionnaire is
available upon request). This will be a one-time (rather than annual)
collection of information. FDA estimates the burden of this collection
of information as follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screener....................................... 22,000 1 22,000 0.03 (2 minutes)....................... 660
Pretest........................................ 1,000 1 1,000 0.33 (20 minutes)...................... 330
Main Study..................................... 10,000 1 10,000 0.33 (20 minutes)...................... 3,300
--------------------------------------------------------------------------------------------------------
[[Page 22146]]
Total...................................... .............. .............. .............. ....................................... 4,290
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
References
1. Lipkus, I.M. ``Numeric, Verbal, and Visual Formats of
Conveying Health Risks: Suggested Best Practices and Future
Recommendations.'' Medical Decision Making, 27(5), 696-713 (2007).
2. Aikin, K.J., J.L. Swasy, and A.C. Braman. ``Patient and
Physician Attitudes and Behaviors Associated with DTC Promotion of
Prescription Drugs--Summary of FDA Survey Research Results.'' Food
and Drug Administration, Center for Drug Evaluation and Research, 19
(2004).
Dated: April 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-08957 Filed 4-18-14; 8:45 am]
BILLING CODE 4160-01-P
