[Federal Register Volume 77, Number 40 (Wednesday, February 29, 2012)]
[Notices]
[Pages 12307-12308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4777]



[[Page 12307]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0176]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Experimental Study: Examination of Corrective Direct-
to-Consumer Television Advertising

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 the 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 and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on research entitled ``Experimental Study: 
Examination of Corrective Direct-to-Consumer (DTC) Television 
Advertising.'' The proposed research will examine how corrective 
advertising may impact consumer misperceptions about prescription drug 
product safety and efficacy.

DATES: Submit either electronic or written comments on the collection 
of information by April 30, 2012.

ADDRESSES: Submit electronic comments on the collection of information 
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: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651, 
[email protected].

SUPPLEMENTARY INFORMATION: 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 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 Study: Examination of Corrective DTC Television 
Advertising

I. Regulatory Background

    Section 1701(a)(4) of the Public Health Service Act (42 CFR 
300u(a)(4)) authorizes FDA to conduct research relating to health 
information. Section 903(d)(2)(C) of the Federal Food, Drug, and 
Cosmetic Act (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.

II. Description

    FDA regulations require prescription drug advertisements to contain 
accurate information about the benefits and risks of the drug 
advertised. When this is not the case, corrective advertising is 
designed to dissipate or correct erroneous beliefs resulting from a 
false claim (Refs. 1 and 2). Corrective advertising emerged in public 
debate in the United States in the 1970s as a hypothetical remedy for 
deceptive advertising, having first been proposed by Georgetown 
University law students in 1969 as a way of dispelling the effects of 
deceptive advertising (Ref. 3). Corrective advertising is one remedy 
FDA may request in response to false or misleading prescription drug 
promotion. In 2009, for example, Bayer HealthCare Pharmaceuticals 
produced and aired corrective DTC advertising for Yaz, a birth control 
pill, following a warning from FDA regarding misleading claims (Ref. 
4). Despite these developments, researchers and policymakers currently 
lack exhaustive empirical literature regarding the various impacts of 
corrective DTC advertisements on prescription drug consumers. The 
current project will examine how variations in corrective advertising 
may impact consumers' misleading product beliefs.

III. Design and Method Overview

    The study will involve three independent variables: Message 
exposure, similarity of original and corrective ads, and length of time 
between exposure to original and corrective ad in a medium prevalence 
medical condition (defined as between 5 percent and 10 percent of U.S. 
adult population). These variables will be examined in two phases. 
Participants will be recruited from an online Internet panel and will 
answer the survey questions online.
    Phase 1 will vary the exposure to the messages (original ad alone 
versus original + corrective versus corrective ad alone). The goal of 
Phase 1 is to examine how exposure to a combination of original and 
corrective DTC advertisements affects message recall, message 
comprehension, perceived drug efficacy, perceived drug risk, and 
intentions to ask about or use the drug. Specifically, we will compare 
consumers who see both the original and corrective ad with those who 
see only the original ad, only the corrective ad, and neither ad.

  Table 1--Design of Phase 1: Original Exposure by Corrective Exposure
------------------------------------------------------------------------
                                        Exposure to Corrective ad
    Exposure to Original ad     ----------------------------------------
                                         Yes                  No
------------------------------------------------------------------------
Yes............................  ...................  ..................
No.............................  ...................  (filler task only)
------------------------------------------------------------------------

    Phase 2 will examine the similarity of the corrective ad's theme 
and visual elements to those of the original ad (same ad elements 
versus some similar ad elements versus different ad elements) and the 
exposure delay (time) between viewing the original ad and the 
corrective ad (no delay versus 1 week delay versus 1 month delay). The 
purpose of Phase 2 is to examine whether a corrective advertisement's

[[Page 12308]]

ability to correct misinformation is related to (a) corrective ad 
similarity to the original ad and (b) time delay between original ad 
and corrective ad exposure.
    We will vary these two characteristics to create a study with a 4x3 
experimental design (see table 2).

       Table 2--Design of Phase 2: Ad Similarity by Exposure Delay
------------------------------------------------------------------------
                                             Exposure delay
   Corrective ad similarity    -----------------------------------------
                                    None         1 Week        1 Month
------------------------------------------------------------------------
Same ad elements..............
Some similar elements.........
Different ad elements.........
Control (Do not see
 corrective).
------------------------------------------------------------------------

    Prior to conducting the main study, we will pretest the stimuli, 
questionnaires, and data collection process. The first set of pretests 
will focus on the stimuli, and its purpose will be to (a) ensure the 
stimuli display properly, (b) ensure participants perceive the stimuli 
as realistic, and (c) ensure participants notice the original and 
corrective messages in the ads. The second pretest will focus on the 
questionnaires and data collection process. Its purpose will be to (a) 
ensure that survey questions solicit responses that meet the study's 
analytic goals and (b) ensure data are captured and stored accurately 
for each question.
    FDA estimates the burden of this collection of information as 
follows: 30 minutes in the pretests and each phase of the study, for a 
burden of 3,092 hours. This will be a one time (rather than annual) 
collection of information. The questionnaire is available upon request.

                                 Table 3--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    No. of
           Activity                 No. of       responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Pretests......................           1,250               1           1,250  0.5 (30 minutes)             625
Phase 1 Screener..............           3,228               1           3,228  0.033 (2                     108
                                                                                 minutes).
Phase 1.......................           1,000               1           1,000  0.5 (30 minutes)             500
Phase 2 Screener..............          10,768               1          10,768  0.033 (2                     359
                                                                                 minutes).
Phase 2.......................           3,000               1           3,000  0.5 (30 minutes)           1,500
                               ---------------------------------------------------------------------------------
    Total.....................          19,246  ..............  ..............  ................           3,092
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

IV. 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.

    1. Darke, P.R., L. Ashworth, and R.J.B. Ritchie, ``Damage From 
Corrective Advertising: Causes and Cures,'' Journal of Marketing, 
vol. 72, pp. 81-97, 2008.
    2. Mazis, M.B. and J.E. Adkinson, ``An Experimental Evaluation 
of a Proposed Corrective Advertising Remedy,'' Journal of Marketing 
Research, vol. 13, pp. 178-183, 1976.
    3. Mazis, M.B., D.L. McNeill, and K.L. Bernhardt, ``Day-After 
Recall of Listerine Corrective Commercials,'' Journal of Public 
Policy & Marketing, vol. 2, pp. 29-37, 1983.
    4. Singer, N., A Birth Control Pill That Promised Too Much, New 
York Times, February 11, 2009, p. B1.

    Dated: February 23, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4777 Filed 2-28-12; 8:45 am]
BILLING CODE 4160-01-P