[Federal Register: August 22, 2007 (Volume 72, Number 162)]
[Notices]
[Page 47051-47053]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22au07-120]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.
Submit written comments on the collection of information to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should
be identified with the docket number found in brackets in the heading
of this document.
FOR FURTHER INFORMATION CONTACT: 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