Federal Register / Vol. 74, No. 158 / Tuesday, August 18, 2009 / Notices 41703 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0595] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Experimental 

Study: Toll-Free Number for Consumer 

Reporting of Drug Product Side Effects 

in Direct-to-Consumer Television 

Advertisements for Prescription Drugs 

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 September 

17, 2009. 

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: 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910—New and 

the title ‘‘Experimental Study: Toll-Free 

Number for Consumer Reporting of Drug 

Product Side Effects in Direct-toConsumer Television Advertisements 

for Prescription Drugs.’’ Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management (HFA–710), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–796–3792. 

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. 

Experimental Study: Toll-Free Number 

for Consumer Reporting of Drug 

Product Side Effects in Direct-toConsumer Television Advertisements 

for Prescription Drugs—(OMB Control 

Number 0910—New) 

The Federal Food, Drug, and Cosmetic 

Act (the act) requires that 

manufacturers, packers, and distributors 

(sponsors) who advertise prescription 

human and animal drugs, including 

biological products for humans, disclose 

in advertisements certain information 

about the advertised product’s uses and 

risks. For prescription drugs and 

biologics, the act requires 

advertisements to contain ‘‘information 

in brief summary relating to side effects, 

contraindications, and effectiveness’’ 

(21 U.S.C. 352(n)). FDA is responsible 

for enforcing the act and implementing 

regulations. 

On September 27, 2007, the President 

signed into law the Food and Drug 

Administration Amendments Act 

(FDAAA) (Public Law 110–85). Title IX 

of FDAAA amends section 502(n) of the 

act (21 U.S.C. 352) by requiring printed 

direct-to-consumer (DTC) 

advertisements for prescription drug 

products to include the following 

statement printed in conspicuous text: 

‘‘You are encouraged to report negative 

side effects of prescription drugs to the 

FDA. Visit www.fda.gov/medwatch, or 

call 1–800–FDA–1088.’’ Title IX of 

FDAAA also requires the Secretary of 

Health and Human Services (the 

Secretary), in consultation with the Risk 

Communication Advisory Committee 

(RCAC), to conduct a study not later 

than 6 months after the date of 

enactment of FDAAA to determine if 

this statement is appropriate for 

inclusion in DTC television 

advertisements for prescription drug 

products. As part of this study, the 

Secretary shall consider whether the 

information in the statement described 

previously in this paragraph would 

detract from the presentation of risk 

information in a DTC television 

advertisement. If the Secretary 

determines that the inclusion of such a 

statement would be appropriate for 

television advertisements, FDAAA 

mandates the issuance of regulations 

implementing this requirement, and for 

the regulations to reflect a reasonable 

length of time for displaying the 

statement in television advertisements. 

Finally, FDAAA requires the Secretary 

to report the study’s findings and any 

subsequent plans to issue regulations to 

Congress. 

In accordance with the requirements 

of FDAAA, FDA convened a meeting of 

the RCAC on May 15 and 16, 2008. A 

draft design for studying this issue was 

proposed at that time and discussed by 

the advisory committee. Based on 

comments received at that meeting, 

changes were made to the proposed 

study design. The transcripts and 

materials from that meeting can be 

found at http://www.fda.gov/ohrms/ 

dockets/ac/oc08.html#RCAC. 

I. Background 

Section 17 of the Best 

Pharmaceuticals for Children Act (the 

BPCA) (Public Law 107–109, January 4, 

2002) required FDA to issue a final rule 

mandating the addition of a statement to 

the labeling of each drug product for 

which an application is approved under 

section 505 of the act (21 U.S.C. 355). 

Under the BPCA, the statements must 

include: (1) A toll-free number 

maintained by FDA for the purpose of 

receiving reports of adverse events 

regarding drugs, and (2) a statement that 

the number is to be used only for 

reporting purposes, and it should not be 

used to seek or obtain medical advice 

(the side effects statement). 

On April 22, 2004, FDA published a 

proposed rule with a proposed side 

effects statement for certain prescription 

drug product labeling and a proposed 

side effects statement for certain overthe-counter drug product labeling (69 

FR 21778). In the proposed rule, FDA 

solicited comments on a proposed 

statement that FDA believed comported 

with the previously mentioned mandate 

in the BPCA. The agency received 12 

comments suggesting changes to the 

specific wording proposed. The agency 

also received several comments 

suggesting that FDA engage in research 

to study the wording of the proposed 

side effects statement with consumers. 

Among the reasons cited for testing the 

statement were to: (1) Determine the 

best and most precise wording for the 

statement, (2) evaluate consumer 

comprehension of the proposed 

statement, and (3) address concerns that 

consumers who read the statement will 

mistakenly call FDA in search of 

medical advice rather than seeking 

appropriate medical treatment. In 

addition, during the clearance process 

for the proposed rule, both the Office of 

Information and Regulatory Affairs of 

OMB and the Office of the Assistant 

Secretary for Planning and Evaluation of 

the Department of Health and Human 

Services suggested that FDA conduct 

focus groups or other consumer studies 

to inform the wording of the side effects 

statement. 

During the spring of 2006, to assist in 

developing this study, FDA conducted 

two focus groups to gauge consumer 

understanding and preferences for a 

number of proposed side effects 

statements and to narrow the number of 

statements to be tested in subsequent 

experimental research. In addition to 

the information collected on which 

versions of the statements participants 

preferred, discussions showed that 

people varied in their understanding of 

when to call FDA or their health care 


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practitioners and that some people 

would not call FDA even if they 

experienced a serious side effect. 

Several people in the focus groups 

suggested the addition of a Web site to 

report adverse side effects. Based on the 

findings from the focus groups, nine 

statements were selected for 

quantitative testing. A labeling 

comprehension experiment was 

conducted with 1,674 men and women 

ranging in age from 21 to 95 with 

varying levels of education (OMB 

Control No. 0910–0497). The results 

from that quantitative test found that 

only one of the versions tested was rated 

as significantly less clear than the 

others, which were all rated as generally 

clear and understandable. The results 

also showed that participants reported 

they would not call FDA seeking 

medical advice. Further, among those 

participants who said they would call 

FDA, the majority indicated they would 

call their doctor for medical advice, 

rather than FDA, regardless of the 

severity of the side effect. Finally, 

participants indicated they could 

distinguish between serious and nonserious side effects, reporting that they 

would seek emergency medical care in 

the case of serious side effects. The 

report of the study is available in the 

docket for the final rule (Docket No. 

FDA–2003–N–0313). The final rule, 

Toll-Free Number for Reporting Adverse 

Events on Labeling for Human Drug 

Products (TFNR) (73 FR 63886, October 

28, 2008), is available at http:// 

www.fda.gov/OHRMS/DOCKETS/98fr/ 

E8–25670.pdf. 

In the Federal Register of November 

26, 2008 (73 FR 72058), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. FDA received six comments 

in response to our initial Federal 

Register notice, published on November 

26, 2008. One of these comments, from 

an anonymous citizen, did not require 

specific responses, as it was outside the 

scope of the project (e.g., FDA approves 

too many drugs; harmful drugs are 

‘‘being foisted on the population’’), 

although it could be viewed as a 

statement of support for conducting the 

research. 

II. Comments on the Information 

Collection 

In the following section, we outline 

the issues raised in the comments and 

provide our responses. 

(Comment 1) Do not place the toll-free 

statement in television ads because it is 

better placed within written materials 

that accompany prescription drugs. 

Some system for enforcing the 

legitimacy of calls is necessary, 

otherwise callers with an ‘‘agenda’’ or 

‘‘the uninformed’’ could ‘‘doom 

medicines for no reason.’’ 

(Response) This comment mostly 

applies to MedWatch procedures that 

are outside the scope of the proposed 

research. This study is addressing the 

understanding of information in the ad. 

We have notified the appropriate parties 

in the agency of this comment. 

(Comment 2) The comment supports 

DTC advertising that is educational and 

‘‘delayed until postmarketing 

surveillance data are collected and 

assessed.’’ DTC television ads should 

include a toll-free statement. Overall, 

this comment supports the proposed 

research, but includes the following 

specific suggestions: (1) The toll-free 

statement is best placed after the risk 

information and (2) it should be placed 

during the presentation of non-lifethreatening or minor side effects. 

(Response) We agree that placement 

during non-life-threatening or minor 

side effects may be the best placement 

for the toll-free statement. In a television 

ad, however, that information is 

presented in a very short amount of 

time, sometimes only seconds (and this 

varies depending on the drug product). 

We have designed our study to allow 

the data to show for us the best 

placement of the statement. 

(Comment 3) Neither of the proposed 

toll-free statements addresses whether 

consumers can distinguish between 

serious and non-serious side effects. A 

simulation study should be used to 

assess this issue. 

(Response) We refer this comment to 

previous research conducted by FDA on 

this topic, described previously. This 

study found that participants were 

easily able to distinguish between 

serious and non-serious side effects and 

that they reported an ability to take the 

right action with regard to each one. 

(Comment 4) FDA should post the 

proposed questionnaire, the primary 

endpoint(s) of the study with action 

standards, and provide the mock 

advertisement to interested parties for 

use in their research. 

(Response) The proposed 

questionnaire has been and continues to 

be available upon request. We agree that 

threshold levels and primary endpoints 

were not well explained in the 60-day 

notice and have worked to correct that 

in the 30-day notice. Please note the 

addition of specific hypotheses and the 

analysis plan. At the conclusion of our 

data collection, we will make the 

advertisement available to those who 

request it. 

(Comment 5) Adequate provision 

issues may not be considered or 

addressed. Multiple telephone numbers 

or Web sites may confuse consumers. 

Use alternate wording for the toll-free 

statement: ‘‘For information about 

PRODUCT X or to report side effects, 

see our ad in ___ magazine.’’ Include 

payment assistance information, as this 

is often currently included in television 

ads. 

(Response) We have designed the 

stimuli ad to closely approximate an 

actual DTC ad, including adequate 

provision measures and other supers. 

Division of Drug Marketing, 

Advertising, and Communications 

reviewers have examined the script and 

storyboard to ensure that the ad meets 

regulatory requirements. The contractor 

producing the ad has extensive 

experience with this type of production 

and provided additional quality control 

measures. In directing us to complete 

this research, Congress was likely 

concerned about the same issues 

expressed by this comment, i.e., that the 

toll-free statement may be confusing. 

That is one of the main research 

questions we will address. In terms of 

wording, Congress directed us to test 

specific language. In addition to this 

language, we propose to test another 

version that was found most acceptable 

in previous usability research 

conducted by the agency. Finally, 

because payment assistance information 

is relatively new, not universal, and not 

required by regulation, we have not 

included this statement in our stimuli 

ads. 

FDA has contracted with a 

professional multimedia company to 

create ad stimuli. In addition, FDA has 

instituted a procedure of extensive 

pretesting of the ad stimuli to be used. 

Our extensive experience with current 

and past DTC ads, pretesting, and 

collaboration with the contractor should 

ensure realistic ads that will enable us 

to successfully investigate our 

experimental variables. 

(Comment 6) Study multiple medical 

conditions, including symptomatic and 

asymptomatic conditions; diseases that 

affect different age groups; sufferers and 

non-sufferers; and consumers with 

varying degrees of knowledge about 

their medical conditions. 

(Response) We do not have the 

resources to create mock ads to test 

multiple medical conditions. We have 

no reason to suspect that the principles 

we study in this medical condition (e.g., 

placement, duration, wording, 

prominence) would be different when 

applied to an ad for another medical 

condition. We welcome other parties to 

extend the current research by applying 

it to other conditions. We will ask 

respondents about their knowledge of 

their medical conditions and will 


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conduct analyses to see if this variable 

plays a role in their responses. 

We have decided, however, to recruit 

for the study two distinct populations: 

Those who have been diagnosed with 

high blood pressure and a general 

population sample. This approach will 

allow us to determine whether 

diagnosed individuals and other people 

who may be exposed to such television 

advertising will differ in their responses 

to the ad. 

(Comment 7) Using the condition 

where the toll-free statement is present 

during the whole ad to control for 

novelty will increase rather than 

decrease the attention to the statement. 

(Response) We agree that the 

condition in which the toll-free 

statement appears during the entire ad 

may increase notice of it. We think there 

is also a good possibility that it might 

be ignored, in such a way that the 

statement might be more prominent in 

other conditions. To control for novelty, 

participants will see an unrelated DTC 

ad with the toll-free statement presented 

the same way as the test ad before they 

see the test ad. This may control for 

novelty in the test ad and may attenuate 

the belief that our test product has some 

unique quality that causes it to need a 

special toll-free statement. 

(Comment 8) This protocol will take 

much longer than 15 minutes. 

(Response) Because we are also 

concerned that this protocol will take 

longer than 15 minutes, we have revised 

our burden estimate to reflect a 20- 

minute protocol. Also, to ensure that all 

test parameters are met, including 

timing of experiment, we have budgeted 

for 2 pretests of 700 individuals each. 

(Comment 9) The placement and 

duration variables should be removed 

from study because regardless of 

placement, the statement may interrupt 

the flow of the most important 

information. 

(Response) These are empirical 

questions. We will not know the answer 

to either of these questions until we 

collect data. 

(Comment 10) Remove the audio-only 

condition because this eliminates the 

hearing-impaired population. Include 

visually and hearing-impaired persons 

to more accurately represent the 

population. 

(Response) Even in our audio-only 

condition as originally proposed, the 

Web site and phone numbers were 

placed on screen. Current requirements 

for the most important risk information 

(i.e., the major statement) are that it be 

placed in the audio portion of the ad. 

Thus, this is a reasonable condition to 

test. Upon further discussion, however, 

we agree that we do not need two 

distinct extra-prominent conditions, and 

will test only one. We do not plan to 

actively exclude people with audio or 

visual impairments from the study but 

we do not have the resources to actively 

recruit them. 

(Comment 11) High blood pressure 

may not be the most representative 

condition for a general sample of 

consumers ‘‘over the age of 18.’’ The 

tested sample population should be 

representative of actual sufferers of the 

condition being advertised. 

(Response) We agree that this is an 

important consideration. Upon further 

discussion, we have decided to recruit 

for the study two distinct populations: 

Those who have been diagnosed with 

high blood pressure and a general 

population sample. This approach will 

allow us to determine whether 

diagnosed individuals and other people 

who may be exposed to such television 

advertising will differ in their responses 

to the ad. 

(Comment 12) Remove the fourth 

commercial for an unrelated medical 

condition because it does not contribute 

to the study and may confound results. 

(Response) Study participants will see 

four ads—the second ad will be an 

unrelated DTC ad and the fourth ad will 

be the test ad. We propose to include 

the other DTC ad with the matching tollfree statement parameters so that 

consumers do not think that our test ad 

reflects a special product that needs a 

special warning. It also may attenuate 

the effect of novelty. 

(Comment 13) Because the toll-free 

statement may artificially increase 

impact of risk information, FDA should 

test information gleaned from the 

presence of the toll-free statement in 

print ads first. 

(Response) FDA has not collected any 

information on the presence of the 

statement in print ads, although we 

agree this would be valuable 

information. Moreover, Congress has 

instructed us specifically to test the tollfree statement in television ads. 

(Comment 14) Including the 

manufacturer’s toll-free number instead 

of the FDA contact number may help to 

mitigate the possibility that the toll-free 

statement artificially increases the 

impact of risk information. 

(Response) Sponsors already include 

the manufacturer’s telephone number in 

all ads as a way to fulfill one part of the 

adequate provision requirement. The 

current study does not examine the 

replacement of that number with the 

toll-free statement, but instead the 

statement’s inclusion above and beyond 

current requirements. 

(Comment 15) The agency’s 

expectation of yielding a sample of 

2,000 people from a total of 2,400 is 

unrealistic based on a typical response 

rate of 5 percent. 

(Response) We do not expect to yield 

a sample of 2,000 people from a total of 

2,400. As shown in Table 1 of this 

document, we have revised our sample 

numbers. 

(Comment 16) How well can an 

Internet study simulate a television 

environment? 

(Response) We agree that simulating 

an everyday television-watching 

environment would increase the realism 

of the study. Participation in an 

experiment in any context, however, is 

unlikely to perfectly do so. We do not 

believe that a mall-intercept 

administration would increase the 

realism of the study and a phone-based 

survey is not feasible, given the 

modality of the advertisement in 

question. Moreover, an Internet study 

may be as close to the televisionwatching environment as any other 

method because participants will be in 

their own homes and some participants 

already watch streaming video on their 

computers. 

(Comment 17) What are the 

thresholds for interference 

(‘‘detraction’’) in this study? 

Specifically, will the statement be 

included only if it does not affect risk 

comprehension at all, or if it does not 

affect risk comprehension ‘‘much’’—and 

if this is the case, what is too much? 

(Response) If the study demonstrates 

that the inclusion of the toll-free 

statement does not interfere with the 

processing of the risk information, then 

Congress is likely to mandate its 

inclusion. If the data demonstrate some 

detraction from risk information, then 

the decision becomes more complicated. 

As the interference between the toll-free 

statement and the risk information 

increases, the less likely it is that it will 

be mandated. A tradeoff analysis will 

have to be conducted and this study 

will be only one part of the 

determination. That is, the amount of 

detraction will have to be weighed 

against the benefit of including the 

statement and this benefit will be 

determined in part by public health 

concerns and analysis of MedWatch 

data. 

(Comment 18) Participants will see 

the test ad three times and this may 

cause problems. 

(Response) Participants will see the 

test ad only once after seeing three other 

filler ads, one of which will be an 

unrelated DTC ad. 

(Comment 19) The current proposed 

study is comprehensive and appropriate 

to address the primary research 

questions under consideration. 


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41706 Federal Register / Vol. 74, No. 158 / Tuesday, August 18, 2009 / Notices 

(Response) Thank you. 

(Comment 20) The toll-free statement 

in the unrelated DTC ad should be 

presented in the same way as in the test 

ad. 

(Response) We had planned to do so. 

(Comment 21) The questionnaire does 

not specifically address the risk of 

nontreatment of the disease condition. 

(Response) FDA acknowledges that 

this study does not address this risk. 

Nevertheless, this is outside the scope of 

the current investigation. 

(Comment 22) Ask if respondents 

suffer from diabetes, high cholesterol, 

obesity, or the condition treated in the 

unrelated DTC ad. 

(Response) We plan to ask about the 

state of respondent’s health. In 

considering this comment, we have 

added additional questions to the 

questionnaire. Please see the revised 

questionnaire for details. 

(Comment 23) Question 7 in the 

questionnaire is vague and should be 

placed earlier in the questionnaire. 

(Response) Question 7, which 

originally asked participants in an openended fashion to report on ‘‘some 

information written on the screen’’ has 

been changed. We now ask participants 

which of several options they saw and 

follow that up with an open-ended 

question about what the statement 

means to them. We do not wish to move 

this question series earlier in the 

questionnaire because it is not one of 

our main dependent measures. 

(Comment 24) It is unclear how FDA 

plans to analyze results from this 

research, particularly what action 

consumers are expected to take after 

they have heard and understood the 

toll-free statement. 

(Response) The purpose of this 

research is not to determine what action 

consumers will take after seeing the ad. 

We addressed these issues in the 

labeling comprehension study described 

at the beginning of this notice (Docket 

No. FDA–2003–N–0313). The purpose 

of the current proposed study is to 

determine whether the risk information 

is adequately comprehended and 

whether the toll-free statement is 

noticeable and recalled. 

III. Revised Study 

Experimental Study: Toll-Free Number 

for Consumer Reporting of Drug 

Product Side Effects in Direct-toConsumer Television Advertisements 

for Prescription Drugs—(OMB Control 

Number 0910—New) 

Based in part on these comments, 

further research discussions, and the 

input of the RCAC on May 16, 2008, we 

propose the following revised design, 

hypotheses, and analysis plan. 

A. Overview 

This study will examine the 

placement of the toll-free statement and 

the length of time the statement is 

presented on screen in a DTC television 

advertisement for a prescription drug. 

The primary dependent measure of 

interest is consumer comprehension of 

the important risk information in the 

advertisement. This study will also 

examine potential differences in 

comprehension based on the wording of 

the toll-free statement and the 

prominence of the statement. 

The application of a new piece of 

information for viewers of DTC ads 

presents logistical challenges. From a 

research perspective, the primary issue 

under investigation is how to impart 

additional information without 

increasing ‘‘cognitive load,’’ thus 

leading to information overload. 

Cognitive load is an index of the 

memory demands necessary to process 

a set of information (Ref. 1). As 

cognitive load increases, more mental 

resources are necessary to process and 

understand the information. DTC ads 

are already quite dense when compared 

to ads for other products. The risk 

information in the major statement of 

the ad should not be compromised by 

the addition of the toll-free statement. 

At the same time, it is preferable that the 

risk information and the toll-free 

statement information are presented in 

such a way that both are 

understandable. We have chosen a set of 

variables in the current study to 

investigate issues of cognitive load. 

They are described briefly below before 

examining the details of the research 

design. 

1. Placement 

The location of the toll-free statement 

may facilitate or detract from the risk 

information in the major statement. We 

have chosen three locations for this 

information to test which location 

results in the greatest communication of 

the risks of the drug and the concept 

that side effects can be reported. It is 

possible that locating the toll-free 

statement before the major statement 

provides a ‘‘prime’’ for the risk 

information that follows; that is, the 

mention of side effects in the toll-free 

statement will cause consumers to start 

thinking about side effect-related 

information, which facilitates 

comprehension of the risk information 

that follows. In this case, the two 

conceptual pieces of information may 

flow together easily. Conversely, it is 

possible that the toll-free statement 

confuses consumers or provides no 

information for them because they have 

not yet heard any risk information. 

Thus, without context, the statement 

lacks applicability. 

Placing the toll-free statement during 

the major statement likely reduces the 

comprehension of the risk information 

for the drug because it divides viewer’s 

attention between two competing pieces 

of information. It is possible, however, 

that the juxtaposition of these two 

informational concepts are 

complimentary and therefore do not 

conflict. 

The toll-free statement may serve the 

best role after the risk information has 

been presented. In this case, 

participants have been told about the 

risks and side effects of the drug before 

they are told they may report this 

information. This essentially primes the 

toll-free statement with the major 

statement. We do not expect this 

placement to interfere with the 

comprehension of risk information, as it 

is not present during the voicing of risks 

and has not been introduced to viewers 

at this point. In addition, the usefulness 

of the toll-free statement may improve 

in this condition relative to those 

discussed in the previous paragraphs 

because viewers have been provided 

with context. 

Over time, it is likely that the toll-free 

statement will become part of the 

background of the ads as people become 

accustomed to seeing this statement in 

all DTC ads. In this respect, people will 

have the statement as an option if 

needed but may be able to disregard it 

to focus on the risk information 

otherwise. Thus, we are testing a 

condition in which the toll-free 

statement will be present during the 

entire ad. This test condition will 

control for the effect of novelty arising 

from the fact that consumers have not 

previously seen this type of statement in 

TV ads. Presence of the statement 

during the entire ad may increase 

noticeability of the toll-free statement 

initially, but will be unlikely to interfere 

with risk information over time. 

2. Statement Type 

The second variable, statement type, 

will have two executions of statement 

language: The language from the 

FDAAA versus the language used in the 

final rule, Toll-Free Number for 

Reporting Adverse Events on Labeling 

for Human Drug Products Rule (TFNR; 

Public Law 107–109, January 4, 2002), 

and previously tested by FDA. The 

wording from these two statements is as 

follows: 

• ‘‘You are encouraged to report 

negative side effects of prescription 

drugs to the FDA. Visit www.fda.gov/ 


jlentini on DSKJ8SOYB1PROD with NOTICES
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medwatch, or call 1–800–FDA–1088.’’ 

(FDAAA) 

• ‘‘Call your doctor for medical 

advice about side effects. You may 

report side effects to FDA at 1–800– 

FDA–1088 or www.fda.gov/medwatch.’’ 

(TFNR) 

We think it is important to test both 

the toll-free statement version in 

FDAAA and the version that we have 

previously tested with actual 

consumers. The most obvious reason for 

this is to make sure that the statement 

is maximally readable and 

understandable. It may be valuable, 

however, to test two statements for 

another reason. 

If the toll-free statement is enacted in 

broadcast ads, it is possible that because 

of the boilerplate language, some 

amount of habituation will occur. That 

is, after viewers have seen the same 

language in multiple ads for multiple 

products, they may ‘‘tune out’’ and not 

pay attention to the toll-free statement at 

all. If we test two versions of the 

statement and find both acceptable, it 

would be possible to either allow 

sponsors to choose one statement versus 

another or to suggest some alternating of 

the two statements. This is a long-term 

idea, however, and finding appropriate 

wording is the primary goal of 

investigating this variable. 

3. Duration 

Congress specifically mandates that 

we investigate the duration of the 

display of the toll-free statement. As 

with placement, the length of time the 

toll-free statement is presented on 

screen may influence the cognitive load 

in the ad. For experimental control, we 

will look at the duration of the 

statement while holding placement in 

the ad (after the major statement of 

risks) constant. Although this placement 

should not interfere with the processing 

of the risk information, it is possible 

that the duration influences the takeaway message from the ad. For example, 

having the statement on screen for a 

short amount of time may not give 

consumers enough time to read and 

process the toll-free message. This may 

result in lower comprehension of the 

message but may have no impact on the 

comprehension of the risk information. 

Alternatively, displaying the toll-free 

statement for a longer period of time 

may remove memory traces of the risks 

from the major statement, resulting in 

lower risk comprehension. To 

determine whether this longer duration 

increases the usefulness of the toll-free 

statement itself, we will compare these 

short and long durations to instances 

where the toll-free statement is present 

during the entire ad and where there is 

no toll-free statement at all. 

4. Prominence 

In addition to superimposing the tollfree statement on the screen during the 

ad, there are other methods available to 

increase the prominence of the 

statement. In particular, having the 

statement read aloud in the ad voiceover 

while the statement is on the screen 

may be considered particularly 

prominent. Does the additional 

prominence of the statement 

compromise the comprehension of the 

risk information in the major statement? 

If not, does the additional prominence 

result in a greater understanding of the 

toll-free statement itself? It is likely that 

there is a tradeoff between the gains of 

emphasizing the toll-free statement and 

the comprehension of the risk 

information. In examining this variable, 

we are exploring the parameters of this 

tradeoff. 

B. Design 

The design will consist of three parts. 

Part one will be a between-subjects 

factorial design examining the 

placement of the toll-free statement by 

the type of statement. The first variable, 

placement, will have four levels: Before 

the major statement of risks, during the 

major statement of risks, after the major 

statement of risks, or continuously 

throughout the whole ad. 

In each condition the toll-free 

statement will appear in the ad as 

superimposed text at the bottom of the 

screen. We will also include a control 

condition in which the statement does 

not appear. 

PART ONE: PLACEMENT BY STATEMENT TYPE

4 x 2 + 1 

Statement Type 

Placement FDAAA TFNR 

Before major statement of risks 

During major statement of risks 

After major statement of risks 

During the whole ad 

Plus: 

Control (no toll-free statement) 

Part two of the study will examine 

four variations in the duration of the 

toll-free statement using the language 

from FDAAA: Short (on screen for 

approximately 3 seconds after the major 

statement), long (on screen for 

approximately 6 seconds after the major 

statement), on screen during the whole 

ad, and the control condition of no tollfree statement included. These times 

were adopted by calculating how long it 

would take a person reading at an 

average reading speed to read the 

statement. As in the first part of this 

study series, the toll-free statement will 

appear as superimposed text and a 

control condition in which the toll-free 

statement does not appear will be 

included. 


jlentini on DSKJ8SOYB1PROD with NOTICES
41708 Federal Register / Vol. 74, No. 158 / Tuesday, August 18, 2009 / Notices 

PART TWO: DURATION*

4 x 1 

Short (on screeen for approximately 

3 seconds after major statement) 

Long (on screen for approximately 

6 seconds after major statement) 

During the whole ad 

Control (no toll-free statement) 

*

Using FDAAA statement 

Part three of the study will examine 

two variations in the prominence of the 

toll-free statement using the language 

from the FDAAA: Spoken after the 

major statement with only the Web site 

and phone number in superimposed 

text, and a control condition where the 

toll-free statement is presented visually 

after the major statement. 

PART THREE: PROMINENCE*

2 x 1 

Extra Prominent (spoken after major statement 

of risks, Web site and phone number on screen) 

Control (after major statement of risks) 

*

Using FDAAA statement 

We will investigate these issues in 

one disease condition, high blood 

pressure, because high blood pressure 

has a high incidence rate in the 

population, is a public health concern, 

and is likely to occur in both males and 

females. Further, because there is little 

broadcast promotion for prescription 

treatment of high blood pressure at this 

time, participants should be less 

familiar with DTC television ads for this 

type of drug, reducing the potential 

influence of prior experience. 

Our primary dependent variable is 

comprehension of the risk information 

mentioned in the major statement. In 

addition to this variable, we will also 

examine comprehension of benefit 

information. We will also examine the 

noticeability and comprehension of the 

toll-free statement. 

C. Procedure 

Participants will see a cluster of four 

ads: Two 15-second non-DTC ads 

(fillers), an approximately 60-second 

DTC ad for a fictitious high blood 

pressure medication, and a 30-second 

DTC ad for an unrelated medical 

condition with the same toll-free 

statement included. We include two 

DTC ads with the toll-free statement in 

our protocol because this better 

approximates what will happen if this 

statement is enacted. That is, viewers 

will see the statement in all DTC ads for 

all products. In this study, we want to 

avoid the suggestion that there is 

something particular about the high 

blood pressure drug class that causes 

the statement to be mandated. Thus, we 

will show multiple DTC ads but ask 

questions regarding only the ad which 

has been manipulated to test our 

hypotheses. To maximize response 

information, the test ad will always be 

the last ad they see. 

After viewing the ads, a structured 

interview will be conducted. 

Participants will answer questions about 

the high blood pressure DTC test ad 

they have seen. Questions will examine 

a number of important perceptions 

about the advertised product, including 

risk comprehension, risk recall, benefit 

comprehension, benefit recall, 

behavioral intention, noticeability of the 

toll-free statement, and recall of the tollfree statement. 

Finally, demographic and health care 

utilization information will be collected. 

The entire procedure is expected to last 

approximately 20 minutes. A total of 

6,000 interviews will be completed. 

This will be a one-time (rather than 

annual) information collection. 

D. Participants 

Data will be collected using an 

Internet protocol. Two samples of 

consumers will be recruited: One 

sample of individuals diagnosed with 

high blood pressure and another sample 

of consumers over the age of 21. Both 

groups will represent a range of 

education levels. Because the task 

presumes basic reading abilities, all 

selected participants must speak English 

as their primary language. 

FDA proposes to conduct two rounds 

of pretesting with 700 consumers in 

each round to refine the questionnaire 

and the stimuli before collecting data for 

the main study. 

Hypotheses 

Overall, we expect effects to be 

stronger in the high blood pressure 

sample than in the general population 

sample, as high blood pressure sufferers 

will likely have higher involvement 

with the medical condition. 

1. Risk Comprehension 

This section explains the following: 

• Any inclusion of the toll-free 

statement will reduce the 

comprehension of risk information. 

(Risk comprehension will be highest 

in control condition for all 

analyses) 

• Placement: 

Conditions in which the statement is 

presented after the major statement 

and the statement is present for the 

whole ad will reduce 

comprehension least. 

(After control condition, risk 

comprehension will be highest in 

conditions where statement is 

present for whole ad or after the 

major statement; risk 

comprehension will be lowest when 

statement is presented during or 

before the major statement). 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 158 / Tuesday, August 18, 2009 / Notices 41709 

• Wording: Type of statement will not 

influence risk comprehension. 

• Placement x Wording: This analysis 

is exploratory 

• Duration: 

Statement will interfere with risk 

comprehension less when 

presented in the whole ad than 

when presented for briefer periods. 

Short duration will result in lower 

risk comprehension than long 

duration because it will be 

displayed for a short time, causing 

attention to shift twice in quick 

succession 

(Risk comprehension highest in 

control condition, followed by 

whole ad condition followed by 

long duration, and, finally, short 

duration) 

• Prominence: Prominence of 

statement will not affect risk 

comprehension. 

2. Benefit Comprehension 

This section explains the following: 

• Any inclusion of the toll-free 

statement will reduce the 

comprehension of benefit information. 

(Benefit comprehension will be 

highest in control condition for all 

analyses) 

• Placement: 

Conditions in which the statement is 

presented after the major statement 

and the statement is present for the 

whole ad will reduce 

comprehension least. 

(After control condition, benefit 

comprehension will be highest in 

conditions where statement is 

present for whole ad or after the 

major statement; benefit 

comprehension will be lowest when 

statement is presented during or 

before the major statement). 

• Wording: Type of statement will not 

influence benefit comprehension. 

• Placement x Wording: This analysis 

is exploratory 

• Duration: 

Statement will interfere with benefit 

comprehension most when 

presented in the whole ad than 

when presented for briefer periods 

after the major statement. 

No prediction of differences between 

short and long duration of 

statement on benefit 

comprehension. 

(Benefit comprehension highest in 

control condition, followed short 

and long duration conditions 

together, followed by condition 

where statement is present in whole 

ad) 

• Prominence: Prominence of 

statement will not affect benefit 

comprehension. 

3.Toll-Free Statement Recall 

This section explains the following: 

• Toll-free statement recall will be 

higher in any condition where it is 

included in the ad. 

• Placement: 

Recall of statement will be highest in 

conditions where it is on screen for 

the whole ad and where it is placed 

after the major statement. 

• Wording: This analysis is 

exploratory. 

• Placement x Wording: This analysis 

is exploratory 

• Duration: 

Recall of the statement will be greatest 

in the condition where it is present 

for the whole ad, followed by the 

condition in which it is located 

after the major statement. 

• Prominence: 

Recall of the statement will be higher 

in the Extra Prominent condition 

than in the condition in which it is 

only in super form after the major 

statement. 

4. Behavioral Intention 

This section explains the following: 

• This analysis is exploratory and for 

completeness. 

Analysis Plan 

We will conduct the following 

analyses separately for the general 

population sample and the high blood 

pressure sufferers sample. Once these 

separate analyses are completed, we 

will conduct the analyses with the 

samples combined, using the type of 

sample as a moderator variable to 

determine whether any effects differed 

significantly between the groups. 

Part 1: We will test whether there is 

a main effect of placement on our main 

dependent variables (i.e., risk 

comprehension, benefit comprehension, 

and behavioral intention) using one-way 

Analysis of Variants (ANOVAs) (four 

placement conditions, plus control 

condition). We will conduct ANOVAs 

that assess the main effect of placement 

(four placement conditions), the main 

effect of statement type, and the 

interaction between placement and 

statement type on our main dependent 

variables. We will examine logistic 

regression models predicting toll-free 

statement recall from placement (four 

placement conditions, plus control 

condition), and from placement, 

statement type, and the interaction 

between placement and statement type. 

We will conduct these analyses both 

with and without covariates (e.g., 

demographic and health characteristics) 

included in the model. In addition, we 

will test whether any main effects are 

moderated by other measured variables 

(e.g., time spent viewing the ad, 

demographic and health characteristics). 

If any main effects are significant, we 

will conduct pairwise-comparisons to 

determine which conditions are 

significantly different from one another. 

We will also conduct planned 

comparisons in line with our 

hypotheses (see Hypotheses in this 

document). 

Part 2: We will test whether there is 

a main effect of duration on our main 

dependent variables using one-way 

ANOVAs and logistic regression 

models. We will examine these analyses 

both with and without covariates (e.g., 

demographic and health characteristics) 

included in the model. In addition, we 

will test whether the main effect is 

moderated by other measured variables 

(e.g., time spent viewing the ad, 

demographic and health characteristics). 

If the main effect is significant, we will 

conduct pairwise-comparisons to 

determine which conditions are 

significantly different from one another. 

We will also conduct planned 

comparisons in line with our 

hypotheses (see Hypotheses in this 

document). 

Part 3: We will test whether there is 

a main effect of prominence on our 

main dependent variables using oneway ANOVAs and logistic regression 

models. We will examine these analyses 

both with and without covariates (e.g., 

demographic and health characteristics) 

included in the model. In addition, we 

will test whether the main effect is 

moderated by other measured variables 

(e.g., time spent viewing the ad, 

demographic and health characteristics). 

5. Pretesting of Stimuli 

The key to our study is the 

reasonableness and appropriateness of 

the stimuli we use to approximate 

television DTC prescription drug ads. 

Because the particular images are 

subjective, we will conduct extensive 

pretesting with consumers similar to our 

main target audience. This pretesting 

will involve 700 individuals in 2 waves. 

The purpose of the pretesting is to 

ensure that the stimuli are perceived as 

realistic. During the pretesting stage, the 

primary dependent variable will be the 

success of the particular manipulation. 

The pretesting will allow us to make 

changes in the ad stimuli before the 

actual study commences, thus making 

participants’ time more valuable. 


jlentini on DSKJ8SOYB1PROD with NOTICES
41710 Federal Register / Vol. 74, No. 158 / Tuesday, August 18, 2009 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of Respondents Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Screener, pretesting 2,800 1 2,800 .03 84 

Questionnaire, pretesting 1,400 1 1,400 .25 350 

Screener, study 12,000 1 12,000 .03 360 

Questionnaire, study 6,000 1 6,000 .33 1,980 

Total 2,774 

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

IV. References 

1. Chandler, P. and J. Sweller, ‘‘Cognitive 

Load Theory and the Format of Instruction,’’ 

Cognition and Instruction, 8(4), 293–332, 

1991. 

Dated: August 11, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–19782 Filed 8–17–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0637] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Financial Disclosure by Clinical 

Investigators 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Financial Disclosure by Clinical 

Investigators’’ has been approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management (HFA–710), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

Elizabeth.Berbakos@fda.hhs.gov, 301– 

796–3792. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of April 22, 2009 (74 

FR 18385), the agency announced that 

the proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0396. The 

approval expires on August 31, 2012. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/ 

public/do/PRAMain. 

Dated: August 11, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–19788 Filed 8–17–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0354] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Mental Models Study of Farmers’ 

Understanding and Implementation of 

Good Agricultural Practices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Mental Models Study of Farmers’ 

Understanding and Implementation of 

Good Agricultural Practices’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 

Daniel.Gittleson@fda.hhs.gov, 301–796– 

5156. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of March 24, 2009 (74 

FR 12364), the agency announced that 

the proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0639. The 

approval expires on July 31, 2012. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/ 

public/do/PRAMain. 

Dated: August 11, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–19787 Filed 8–17–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0043] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Irradiation in the Production, 

Processing, and Handling of Food 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Irradiation in the Production, 

Processing, and Handling of Food’’ has 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 


jlentini on DSKJ8SOYB1PROD with NOTICES