
[Federal Register Volume 79, Number 218 (Wednesday, November 12, 2014)]
[Notices]
[Pages 67172-67174]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26698]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1794]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Impact of Ad Exposure Frequency on Perception and 
Mental Processing of Risk and Benefit Information in Direct-to-Consumer 
Prescription Drug Ads

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain

[[Page 67173]]

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, ``Impact of Ad Exposure 
Frequency on Perception and Mental Processing of Risk and Benefit 
Information in DTC Prescription Drug Ads.'' This project will examine 
the effects of variation in ad exposure frequency on perception and 
mental processing of risk and benefit information in direct-to-consumer 
(DTC) prescription drug ads.

DATES: Submit either electronic or written comments on the collection 
of information by January 12, 2015.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 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.

Impact of Ad Exposure Frequency on Perception and Mental Processing of 
Risk and Benefit Information in DTC Prescription Drug Ads--(OMB Control 
Number 0910--NEW)

    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 1003(d)(2)(C) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 393(b)(2)(c)) authorizes FDA to 
conduct research relating to drugs and other FDA regulated products in 
carrying out the provisions of the FD&C Act.
    In a typical promotional campaign, consumers may be exposed to a 
DTC prescription drug ad any number of times. Perceptual and cognitive 
effects of increased ad exposure frequency have been studied 
extensively using non-drug ads. For instance, one study demonstrated 
that a commercial message repeated twice generates better recall than a 
message broadcast only once (Ref. 1). Another study demonstrated that 
increased ad exposures improve product attitudes and recall for product 
attributes, particularly when the substance of the repeat messages is 
varied (Ref. 2). Generally, it has been argued that first exposure to 
an ad results in attention, second exposure affects learning of the 
advertised message, and third and subsequent exposures reinforce the 
learning effects of the second exposure (Ref. 3). To our knowledge, the 
literature concerning ad exposure frequency has not been extended to 
include specific attention to prescription drug ads. Prescription drug 
ads are unique in that they are required to provide both benefit and 
risk information whereas other ad types tend to include only benefit 
information. The Office of Prescription Drug Promotion plans to examine 
the effects of variation in ad exposure frequency on perception and 
mental processing of risk and benefit information in DTC prescription 
drug ads through empirical research.
    The main study will be preceded by up to two pretests designed to 
delineate the procedures and measures used in the main study. Across 
pretests and the main study, participants will be individuals who have 
been diagnosed with seasonal allergies. All participants will be 18 
years of age or older. We will exclude individuals who work in 
healthcare or marketing settings because their knowledge and 
experiences may not reflect those of the average consumer. Participants 
will be recruited in one of two geographic locations (Washington, DC 
and Raleigh-Durham, NC) for in-person administration of protocols.
    The experimental design is summarized in Table 1. Participants will 
be randomly assigned to view a prescription drug ad one, three, or six 
times as part of clutter reels embedded in a 42 minute TV program. They 
will then answer preprogrammed survey questions on laptops. Preliminary 
measures are designed to assess perception, memory, judgments about the 
ad, intentions to use the medication advertised, and possible 
moderators of effects, such as need for cognition and demographics. The 
questionnaire is available upon request. Participation is estimated to 
take up to 2 hours.

                                                              Table 1--Experimental Design
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        42 Minute television show, clutter reel No.
      Experimental Arm No.       -----------------------------------------------------------------------------------------------------------------------
                                           1                   2                   3                   4                   5                   6
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 (views ad 1 time).............  ..................  ..................  ..................  ..................  ..................  Mock DTC ad.
2 (views ad 3 times)............  Mock DTC ad.......  ..................  ..................  Mock DTC ad.......  ..................  Mock DTC ad.
3 (views ad 6 times)............  Mock DTC ad.......  Mock DTC ad.......  Mock DTC ad.......  Mock DTC ad.......  Mock DTC ad.......  Mock DTC ad.
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 67174]]

    To examine differences between experimental conditions, we will 
conduct inferential statistical tests such as analysis of variance. 
With the sample size described in the following table, we will have 
sufficient power to detect small-to-medium sized effects in the main 
study.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                   Activity                       Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent      respondents
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest 1 screener completes (assumes 10%               4,150               1           4,150  0.08 (5 minutes).........................             332
 eligible).
Pretest 2 screener completes (assumes 10%               4,150               1           4,150  0.08 (5 minutes).........................             332
 eligible).
Number of main study screener completes                   620               1             620  0.08 (5 minutes).........................              50
 (assumes 10% eligible).
Pretest 1 completes..........................             420               1             420  2........................................             840
Pretest 2 completes..........................             420               1             420  2........................................             840
Number of completes, main study..............             620               1             620  2........................................            1240
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................           3,634
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov.

1. Singh, S. N., D. Linville, and A. Sukhdial, ``Enhancing the 
Efficacy of Split Thirty-Second Television Commercials: An Encoding 
Variability Application,'' Journal of Advertising, 24, pp. 13-23 
(1995).
2. Haugtvedt, C. P., et al., ``Advertising Repetition and Variation 
Strategies: Implications for Understanding Attitude Strength,'' 
Journal of Consumer Research, 21, pp. 176-189 (1994).
3. Naples, M. J., ``Effective Frequency: Then and Now,'' Journal of 
Advertising Research, 37, pp. 7-12 (1997).

    Dated: November 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26698 Filed 11-10-14; 8:45 am]
BILLING CODE 4164-01-P


