[Federal Register Volume 79, Number 224 (Thursday, November 20, 2014)]
[Notices]
[Pages 69121-69124]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-27431]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0373]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
December 22, 2014.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to <a href="/cdn-cgi/l/email-protection#84ebedf6e5dbf7f1e6e9edf7f7edebeac4ebe9e6aae1ebf4aae3ebf2"><span class="__cf_email__" data-cfemail="b2dddbc0d3edc1c7d0dfdbc1c1dbdddcf2dddfd09cd7ddc29cd5ddc4">[email protected]</span></a>. All 
comments should be identified with the OMB control number 0910-New and 
title, ``Risk and Benefit Perception Scale Development.'' 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, <a href="/cdn-cgi/l/email-protection#a0f0f2e1f3d4c1c6c6e0c6c4c18ec8c8d38ec7cfd6"><span class="__cf_email__" data-cfemail="78282a392b0c191e1e381e1c195610100b561f170e">[email protected]</span></a>.

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.

Risk and Benefit Perception Scale Development (OMB Control Number 0910-
New)

    Section 1701(a)(4) of the Public Health Service Act (PHS 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(b)(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.
    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 direct-to-consumer (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 (OPDP) has an active 
research program that investigates how DTC advertising influences 
consumer knowledge, perceptions, and behavior. As OPDP's research 
program has matured, the way in which we measure risk and benefit 
perception has evolved over time. This has resulted in perception 
measures that, while internally valid, tend to vary by study. 
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.

I. Design Overview

    We will conduct pretesting prior to main data collection to assess 
the psychometric properties and identify any measurement challenges 
(e.g., misinterpretation, lack of variance) with candidate measurement 
items. We also will use the pretesting 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: (1) Individuals diagnosed with chronic pain and (2) 
individuals diagnosed with hypertension.

                                         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
----------------------------------------------------------------------------------------------------------------


[[Page 69122]]

    In the main study phase, 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 of the main study 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).

                                             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
--------------------------------------------------------------------------------------------------------------------------------------------------------

II. Procedure

A. Pretests
    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 perceptions, 
intentions, and attitudes toward the drug. Based on the pretest 
findings, we will revise and remove candidate items prior to full-scale 
testing.
B. Main Study
    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 perceptions, intentions, and attitudes 
toward the drug. In the first two main study waves, participants will 
view an ad that matches the sample's medical condition (chronic pain or 
hypertension). In the final two main study waves, participants will be 
randomly assigned to view either the chronic pain stimuli or the high 
blood pressure stimuli.
    The entire procedure is expected to last approximately 30 minutes. 
This will be a one-time (rather than annual) information collection. 
Note: The survey length has changed from 20 minutes to 30 minutes since 
the 60-day notice was published. This is because cognitive interviews 
did not result in as much reduction in question numbers as originally 
expected. As this is a measurement validation study, it is important to 
include enough items on the questionnaire for sufficient comparison in 
order to identify those that perform the best. We have explained this 
change in survey length in responses to comments and have factored it 
in to the estimated burden.
    In the Federal Register of April 21, 2014 (79 FR 22143), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received from the company 
Eli Lilly, Inc. We respond to the points in Lilly's comment below.
    (Comment 1) ``Lilly seeks further clarity to better understand how 
FDA intends to apply the risk and benefit

[[Page 69123]]

measurement items being developed through this study. FDA suggests in 
the Federal Register notice that the measurement items would be only 
used to enhance future FDA research initiatives; however, the precise 
nature and purpose of such planned research is unclear. Lilly suggests 
that any intended use of the measurement items to evaluate the 
effectiveness of drug advertising disseminated by industry would be 
inappropriate and beyond the jurisdiction and authorities granted to 
FDA.''
    (Response) 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 903(d)(2)(C) of 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. We believe that these statutes provide a broad authority for FDA 
to conduct research related to prescription drug promotion as described 
in the information collection request. As already explained in the 
information collection request, the nature and purpose of this research 
is ``to understand and accurately measure how consumers are making 
sense of this information and how it impacts decisions related to 
prescription drugs.'' We believe that this research is crucial in 
ensuring that consumers are receiving prescription drug information 
that is truthful and nonmisleading, and that prescription drugs are not 
being misbranded. FDA expects that any other purpose of this research 
will become clear only upon its completion, and FDA intends to make the 
research results and the final scale publicly-available.
    (Comment 2) ``Although FDA intends to narrow the pool of survey 
questions during the pretesting stage of the research, we have concerns 
that the current questionnaire is extremely cumbersome and would likely 
exceed 20 minutes to complete. Further, based on the currently designed 
instrument, it is questionable whether in fact FDA would have success 
in respondents' fully completing the survey.''
    (Response) Since the submission of the 60-day notice, the cognitive 
interviews have been completed (OMB control number 0910-0695). We did 
not reduce the number of items as much as expected based on those 
interviews. Thus, we are recommending changing the questionnaire to 30-
minutes in length, and burden estimates have been calculated 
accordingly. Even so, no respondent would ever answer the full list of 
questions provided in the 60-day notice; instead, the full 
questionnaire is the pool of items from which the questionnaire will be 
developed. We will test subsets of these candidate items using a form 
A/form B approach so that no respondent ever answers more than a 30-
minute survey. In addition, some items may only be tested on one 
pretest and not the other or in one wave of a survey. No respondent 
would ever see all of these questions.
    We take the survey length very seriously. We will be conducting two 
rounds of pretesting to refine the questionnaire and reduce the number 
of items, resulting in 30-minute (or shorter) questionnaires for the 
pretests and main study. We are sensitive to issues regarding 
respondent fatigue and its impact upon completion rates. We have 
employed similar online surveys on several previous studies, and we 
have obtained high completion rates, typically 90 percent or higher. 
For example, on a recent study entitled ``Experimental Study: 
Examination of Corrective Direct-to-Consumer Television Advertising'' 
(OMB control number 0910-0737), we had a pool of 1,071 eligible 
respondents and only 14 of those respondents failed to complete the 
survey. We anticipate that the completion rate for this study will be 
similar.
    (Comment 3) ``In general, specific questions proposed in the draft 
questionnaire may be unanswerable by the respondent if not addressed 
specifically in the test stimulus. For example, Q23 ``How long will 
Drug X/Drug Y's negative side effects last once they begin?'' If the 
duration of a drug's side effects is not communicated in the stimulus, 
data captured would be purely speculative on the part of the consumer, 
especially without inclusion of a ``don't know or no opinion'' option 
for the respondent.''
    (Response) Respondents will be exposed to information about the 
drug's indication and side effects in the ad and will then be asked to 
provide their perceptions of the drug's effectiveness and risk 
profiles. The questions are not intended to measure factual knowledge 
about the fictitious drug. By definition, one's perception is a 
subjective assessment and thus, does not need to be tied directly to a 
verbatim statement in the advertisement. Whether or not participants 
are forming perceptions about other attributes of the drug, such as how 
long side effects last, is an empirical question and the purpose of 
this study. Refining the questions, such as adding a ``don't know'' 
option, will be further addressed by pretesting.
    (Comment 4) ``In addition to the redundant and overlapping 
questions, several proposed questions appear to be unanswerable. The 
drafted questionnaire creates a high burden in complexity and time for 
the consumer and may cause significant respondent fatigue that could 
result in unreliable or incomplete data collection. Given these 
significant design issues related to the draft study questionnaire, 
Lilly suggests that FDA provide further details on how the questions in 
the draft questionnaire will be narrowed from the pretest stage to the 
iterative stage of the research and further evaluate the burden and 
likelihood to complete for the iterative testing stage.''
    (Response) The pool of questions will be narrowed and refined 
through two methods. The first method involved cognitive testing of 
draft measures (for a full discussion of the cognitive interviews, see 
OMB control number 0910-0695). The goal of the cognitive interviews was 
to refine and narrow the measurement pool that will be subsequently 
pretested and then tested in an experimental study. The second method 
will involve iterative testing and analysis of draft measures to 
establish scale reliability and internal validity using survey methods. 
For a full discussion of the pretesting and experimental study, see 
Section I, Design and Section II, Procedure.
    (Comment 5) ``Additionally, it is not clear why some batteries of 
questions, such as those questions under the validity testing section 
(Q63-Q77) are included. These questions do not seem aligned with the 
research objective.''
    (Response) These items are included for the purpose of testing the 
convergent validity of the other items in our item pool (measures or 
risk and benefit perceptions). The items in Q63-Q77 come from the 
previously validated Beliefs about Medicines Questionnaire (BMQ) (Ref. 
3). As an example, if the benefit perception items perform as intended, 
they should be highly correlated with positive beliefs about medicines, 
as measured by the BMQ scale.
    (Comment 6) ``Finally, questions 78-82 seem better placed in a 
battery of questions for the screening or consumer selection phase.''
    (Response) We believe that the constructs captured by questions 78-
82 may moderate the relationship between ad content and respondents' 
risk and benefit perceptions. We include them on the survey to keep the 
screener as short as possible, which reduces the burden on individuals 
who ultimately do not qualify for the study. They will not be used for 
screening as we do not plan to include or exclude any

[[Page 69124]]

individuals based on their responses to these questions.
    (Comment 7) ``Lilly suggests that the survey design be improved to 
better align with the research objectives, to avoid bias and to 
mitigate extreme respondent fatigue. Lilly recommends that FDA modify 
the data collection instrument to address the points noted above and 
seek additional public comment on the revised design.''
    (Response) Given our responses and points of clarification above, 
we believe that the current design is rigorous and meets FDA's research 
objectives. The design allows us to test and validate measurement items 
for consumers' risk and benefit perceptions. By randomizing respondents 
to the various ads with different benefit and risk information, we have 
controlled for underlying differences in respondent demographics and 
thereby have reduced the potential for selection bias (Ref. 4) and 
enhanced study validity. As we have described above, we also have 
designed the study to minimize respondent fatigue by testing only the 
most promising candidate items and by ensuring a survey length of no 
more than 30 minutes.

                                  Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual       Hours per       Total hours
                                  respondents     respondent       responses      response \2\
----------------------------------------------------------------------------------------------------------------
Pretest screener..............           2,000               1           2,000  0.03 (2 minutes)              60
Main study screener...........          20,000               1          20,000  0.03 (2 minutes)             600
Pretest.......................       \2\ 1,100               1           1,100  .5 (30 minutes).             550
Main Study....................          10,200               1          10,200  .5 (30 minutes).           5,100
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................           6,310
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ With online surveys, several participants may be completing the survey at the time that the total target
  sample is reached. Those participants are allowed to complete the survey, which can result in the number of
  completes going slightly over the target number. Thus, if our target is 1,000, we have rounded up by an
  additional 100 to allow for some overage.

III. 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 http://www.regulations.gov.

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,'' FDA, 
Center for Drug Evaluation and Research, 19 (2004).
3. Horne, R., J. Weinman, and M. Hankins, ``The Beliefs About 
Medicines Questionnaire: The Development and Evaluation of a New 
Method for Assessing the Cognitive Representation of Medication,'' 
Psychology and Health, 14, 1-24 (1999).
4. Kunz, R., G. E. Vist, and A. D. Ochman, ``Randomization to 
Protect Against Selection Bias in Healthcare Trials,'' The Cochrane 
Library, Issue 2 (2008).

    Dated: November 14, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27431 Filed 11-19-14; 8:45 am]
BILLING CODE 4164-01-P


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