
[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]


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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.

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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 http://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
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                                         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.

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                                             Exhibit 2--Iterative Testing Design; Illness Population Sample
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                                  Chronic pain ad                                                              Hypertension ad
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                                                    Drug benefit level                                                    Drug benefit level
              Ad type                 Drug risk   ----------------------  Control          Ad type          Drug risk   ----------------------  Control
                                        level         High       Low                                          level         High       Low
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                                                                         Wave 1
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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
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                                                                         Wave 2
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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
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                                             Exhibit 3--Iterative Testing Design; General Population Sample
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                                  Chronic pain ad                                                              Hypertension ad
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                                                    Drug benefit level                                                    Drug benefit level
              Ad type                 Drug risk   ----------------------  Control          Ad type          Drug risk   ----------------------  Control
                                        level         High       Low                                          level         High       Low
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         Wave 3
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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
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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\
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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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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
                                                --------------------------------------------------------------------------------------------------------

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    Total......................................  ..............  ..............  ..............  .......................................           4,290
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\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


