[Federal Register Volume 72, Number 162 (Wednesday, August 22, 2007)]
[Notices]
[Pages 47051-47053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-16603]



[[Page 47051]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0321]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Experimental Evaluation of the Impact of Distraction 
on Consumer Understanding of Risk and Benefit Information in Direct-to-
Consumer Prescription Drug Broadcast Advertisements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on a proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on a study of consumer 
evaluations of variations in communicating risk information in direct-
to-consumer (DTC) prescription drug broadcast advertisements.

DATES: Submit written or electronic comments on the collection of 
information by October 22, 2007.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments or http://www.regulations.gov. 
Submit written comments on the collection of information to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain 
approval from the Office of Management and Budget (OMB) for each 
collection of information they conduct or sponsor. ``Collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed extension of an existing collection of information, before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Experimental Evaluation of the Impact of Distraction on Consumer 
Understanding of Risk and Benefit Information in DTC Prescription Drug 
Broadcast Advertisements

    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(b)(2)(c) of the Federal Food, Drug, and 
Cosmetic Act (the 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 act.
    FDA regulations require that advertisements that make claims about 
a prescription drug include a ``fair balance'' of information about the 
benefits and risks of advertised products, in terms of both content and 
presentation. Ads can present information in ways that can optimize or 
skew the relative balance of risks and benefits. Both healthcare 
providers and consumers have expressed concerns to FDA about the 
effectiveness of its regulation of manufacturers' DTC prescription drug 
advertising, especially as it relates to assuring balanced 
communication of risks compared with benefits.
    One characteristic of DTC television broadcast ads is the use of 
compelling visuals. Many assert that the visuals present during the 
product risk presentation are virtually always positive in tone and 
often depict product benefits. A consistently raised question is 
whether advertising visuals of benefits interferes with consumers' 
understanding and processing of the risk information in the ad's audio 
or text.
    The purpose of the proposed study is, in part, to determine whether 
the use of competing, compelling visual information about potential 
drug benefits interferes with viewers' processing and comprehension of 
risk information about drugs in DTC advertising or with their cognitive 
representations of the drugs. Positive visual images could influence 
the processing of risk-related information and the final representation 
of the advertised drug in multiple ways. First, compelling visuals 
could simply distract consumers from carefully considering and encoding 
the risk information. To the extent that compelling visuals cause them 
to attend to or to process risk information less, participants exposed 
to risk information with simultaneous compelling positive visuals 
should recall fewer risks (and perhaps fewer benefits) than do 
participants exposed to the risk information without the positive 
visuals. Second, compelling visuals may affect the way consumers think 
about the brand, specifically their attitudes toward the advertised 
brand (Ref. 1). An attitude is simply an association between an object 
and a degree of positivity or negativity. Attitudes can be important 
determinants of behavior; in some contexts, they may have more impact 
than factual information. That is, under many circumstances, people 
rely much less on facts that they know, such as the number of risks 
associated with ibuprofen, and much more on general feelings they have, 
such as strong positivity toward Advil. Compelling visuals in DTC 
advertising have the potential to lead a consumer to form a positive 
opinion of a drug for no other reason than that it is presented in the 
same context as positive images.
    Another purpose of the present study is to examine the role of 
textual elements in the processing of risk information. Sponsors often 
place superimposed text (``supers'') onto the screen to clarify spoken 
information or to provide extra information that is not included in the 
audio. For example, information such as adequate provision

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statements (``See our ad in...'') and limits to indication statements 
may appear. This text potentially has the power to distract viewers 
from the more important audio information, although only if viewers pay 
attention to the text. Likewise, providing verbatim repetition of the 
audio risks in text format may facilitate the processing of the risks. 
We will examine the added distraction or facilitation of the text in 
the present study in addition to the role of visual information.
    We have limited data about how consumers perceive risk and benefit 
information in DTC broadcast ads as a function of exposure to different 
content and presentations. Therefore, we do not fully understand the 
influence of visual and textual factors on the conveyance of a balanced 
picture of the product.
    This study will investigate the impact of visual distraction and 
the interplay of different sensory modalities (verbal, visual) used to 
present risk and benefit information during a television prescription 
drug advertisement. Data from this study will provide useful 
information to help improve how broadcast ads present a prescription 
drug's risks and benefits.
    Design: This study will employ a between-subjects crossed 3 x 3 
factorial design with two independent variables. The first independent 
variable represents the consistency of the disclosure of risk 
information between the audio and text (superimposed text, or 
``supers'') portions of television ads. It will have three conditions: 
``Reinforcing'' text, ``competing'' text, and a ``control'' condition 
with no text. We define ``reinforcing'' text as a verbatim repetition 
of the audio risk; ``competing'' text will include contextual 
information for understanding usage and will not contain risk or 
benefit information. The second independent variable is the consistency 
of background visuals with the audio presentation of risk information. 
It will have three conditions: Consistent visuals, neutral visuals, and 
inconsistent visuals.
    Participants: Data will be collected using a mall-intercept 
protocol in multiple locations across the continental United States. 
Consumers over the age of 40 will be screened and recruited by the 
contractor to represent a range of education levels (some college or 
less vs. completed college or more). Because the task presumes basic 
reading abilities, all selected participants must speak English as 
their primary language and have reading glasses available as needed. In 
addition, due to the nature of one of our measures requiring a set of 
neutral stimuli, which we have designated as Chinese characters, it 
will be necessary for us to eliminate individuals who can read Chinese.
    We chose to limit our investigation to one disease condition: High 
blood pressure. High blood pressure remains a significant public health 
concern but because there is little DTC promotion for high blood 
pressure treatment, participants should be less familiar with 
television ads for these types of drugs, reducing the potential 
influence of prior experience. Further, many older people have or are 
at risk for high blood pressure, which should facilitate recruitment.
    Procedure: Participants will be shown one DTC ad for high blood 
pressure. Then a structured interview will be conducted with each 
participant to examine a number of important perceptions about the 
advertised product, including perceived riskiness of the drug, 
comprehension of risk and benefit information, perceived balance of 
risk and benefit information, and attitudes toward the drug product.
    Because attitudes are often a strong determinant of behavior, we 
will investigate this dependent variable in two ways. First, we will 
use an implicit measure to determine whether participants have an 
overall positive or negative attitude toward the drug product. Implicit 
measurement of attitudes is a relatively new but well-validated process 
for understanding people's feelings toward particular entities (Ref. 
1). The Affect Misattribution Procedure, in which participants are 
asked to respond to neutral characters (such as Chinese symbols) after 
viewing pictures of the object of interest, has been validated as an 
unobtrusive way to attain these measures. We expect attitudes toward 
the drug product to vary depending on each participant's experimental 
condition (i.e., whether they have adequately processed the risk 
information or not). This implicit method will be conducted after 
participants see the broadcast ad but before they are asked any other 
questions that might influence their responses. Second, we will assess 
attitudes and behavioral intentions using more traditional explicit 
measures, i.e. asking participants directly. Including both types of 
measures will allow us to further validate these measures in a DTC 
context.
    Finally, demographic and health care utilization information will 
be collected. The entire procedure is expected to last approximately 15 
minutes. A total of 1,020 interviews will be completed. This will be a 
one-time (rather than annual) information collection.
    FDA estimates the burden of this collection of information as 
follows:
    FDA estimates that 2,000 individuals will need to be screened to 
obtain a respondent sample of 1,020 for the study. The screener is 
expected to take 30 seconds, for a total screener burden of 16 hours. 
The 1,020 respondents in the study will then be asked to respond to a 
series of questions about the advertisement. The ad viewing and 
questionnaire are expected to take 15 minutes, for a study burden of 
255 hours. The estimated total burden for this data collection effort 
is 271 hours. The respondent burden is provided in table 1 of this 
document:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                    Annual Frequency       Total Annual         Hours per
       No. of Respondents             per Response          Responses           Response          Total Hours
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2,000 (screener)                                     1              2,000                .008                 16
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1,020 (study)                                        1              1,020                .25                 255
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Total                                                                                                        271
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


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II. References

    The following reference has been placed on public display in the 
Division of Dockets Management (see ADDRESSES), and may be seen between 
9 a.m. and 4 p.m., Monday through Friday.
    1. Payne, B.K., C.M. Cheng, O. Govorun, et al., ``An Inkblot for 
Attitudes: Affect Misattribution as Implicit Measurement,'' Journal 
of Personality and Social Psychology, vol. 89 (3), pp. 277-293, 
2005.

    Dated: August 16, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-16603 Filed 8-21-07; 8:45 am]
BILLING CODE 4160-01-S