Federal Register / Vol. 79, No. 224 / Thursday, November 20, 2014 / Notices 69121 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Individuals (male and female) aged 18 years and 

older.

Survey Module ............. 3,583 1 30/60 1,792 

Total ............................................................... ....................................... ........................ ........................ ........................ 2,389 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2014–27467 Filed 11–19–14; 8:45 am] 

BILLING CODE 4163–18–P 

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. 

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 oira_

submission@omb.eop.gov. 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, 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. 

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-toconsumer (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

Wave 

Medical condition 

Chronic pain Hypertension 

Wave 1 ......................................................................................................................................... n=250 n=250 500 

Wave 2 ......................................................................................................................................... n=250 n=250 500 

Total ...................................................................................................................................... 500 500 1,000 


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69122 Federal Register / Vol. 79, No. 224 / Thursday, November 20, 2014 / Notices 

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 

Ad type Drug risk 

level 

Drug benefit level 

Control Ad type Drug risk 

level 

Drug benefit level 

Control 

High Low 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 

Ad type Drug risk 

level 

Drug benefit level 

Control Ad type Drug risk 

level 

Drug benefit level 

Control 

High Low 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 


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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 publiclyavailable. 

(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 


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69124 Federal Register / Vol. 79, No. 224 / Thursday, November 20, 2014 / Notices 

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 BURDEN1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses Hours per response 2 Total hours 

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 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2With 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Vaccine Injury Compensation 

Program: Revised Amount of the 

Average Cost of a Health Insurance 

Policy 

The Health Resources and Services 

Administration (HRSA) is publishing an 

updated monetary amount of the 

average cost of a health insurance policy 

as it relates to the National Vaccine 

Injury Compensation Program (VICP). 

Section 100.2 of the VICP’s 

implementing regulation (42 CFR Part 

100) states that the revised amounts of 

an average cost of a health insurance 

policy, as determined by the Secretary, 

are to be published periodically in a 

notice in the Federal Register and filed 

with the United States Court of Federal 

Claims (the Court). This figure is 

calculated using the most recent 

Medical Expenditure Panel Survey— 

Insurance Component (MEPS–IC) data 

available as the baseline for the average 

monthly cost of a health insurance 

policy. This baseline is adjusted by the 

annual percentage increase/decrease 

obtained from the most recent annual 

Kaiser Family Foundation and Health 

Research and Educational Trust (KFF/

HRET) Employer Health Benefits survey 

or other authoritative source that may be 

more accurate or appropriate. 

In 2014, MEPS–IC, available at 

www.meps.ahrq.gov, published the 

annual 2013 average total single 

premium per enrolled employee at 

private-sector establishments that 

provide health insurance. The figure 

published was $5,571. This figure is 

divided by 12-months to determine the 

cost per month of $464.25. The $464.25 

shall be increased or decreased by the 

percentage change reported by the most 

recent KFF/HRET, available at 

www.kff.org. The percentage increase 

from 2013 to 2014 was published at 2 

percent. By adding this percentage 

increase, the calculated average monthly 

cost of a health insurance policy is 

$473.54 for 2014. 

Therefore, the Secretary announces 

that the revised average cost of a health 

insurance policy under the VICP is 

$473.54 per month. In accordance with 

§ 100.2, the revised amount was 

effective upon its delivery by the 

Secretary to the Court. Such notice was 

delivered to the Court on November 13, 

2014. 

Dated: November 13, 2014. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. 2014–27432 Filed 11–19–14; 8:45 am] 

BILLING CODE 4165–15–P 


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