[Federal Register Volume 81, Number 41 (Wednesday, March 2, 2016)]
[Notices]
[Pages 10867-10870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04569]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0538]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Animation in Direct-to-Consumer Advertising
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
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 ``Animation in Direct-to-
Consumer Advertising.'' This study will examine how animation affects
the comprehension of direct-to-consumer (DTC) television advertisements
for prescription drugs.
DATES: Submit either electronic or written comments on the collection
of information by May 2, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-N-0538 for ``Animation in Direct-to-Consumer Advertising.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, [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
[[Page 10868]]
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.
Animation in Direct-to-Consumer Advertising--(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(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.
Advertisers use many techniques to increase consumer interest in
their ads, including the use of animated spokes-characters. These
characters may be fictional or nonfictional and human or non-human
(Ref. 1). Despite variations in form, animated characters are often
used to grab attention, increase ad memorability, and enhance
persuasion to ultimately drive behavior (Refs. 2, 3, and 4). Although
animated characters have long been used for low-involvement products
(e.g., food products), animation has made its way into direct-to-
consumer prescription drug advertising. However, to our knowledge, no
studies have comprehensively examined how animation affects consumers'
benefit and risk perceptions in drug ads, how various animation
strategies (e.g., symbolizing the disease vs. the benefit) influence
these perceptions, and whether these effects are generalizable across
different patient populations.
Animation in Drug Ads. Animation is used in prescription drug ads
in a variety of ways. Perhaps the simplest way is the use of rotoscoped
animation, which involves tracing live-action images frame-by-frame to
create animated characters. Abilify has used this technique in
advertisements (Ref. 5). In this instance, the animated character was
not central to the informational content of the ad; instead, the
animation appeared to be a visual technique to attract attention.
Whether a drug ad with a rotoscoped human results in greater
comprehension of product benefit and risk information than an ad with a
human actor is unclear. The few studies that have examined this
technique in drug ads have found that animated human characters either
had no effect on perceived product risk (Ref. 6) or led to poorer
recognition of drug side effects (Ref. 5).
Animation also has been used in drug ads to symbolize the disease
(e.g., Imitrex and Lamisil ads), the sufferer (e.g., Mybetriq and
Zoloft), the benefit (e.g., Rozerem), the mode of administration (e.g.,
Fluzone), and the mechanism of action (e.g., Lunesta). Drug companies
may use a personified non-human character to illustrate, in a visually
memorable way, the medical condition or drug attributes. Using
secondary data from copy-testing studies, Pashupati found that drug ads
featuring animated characters led to much stronger brand recall and
brand association scores (Ref. 7); however, the other elements of these
studies (e.g., ad characteristics, presence of control group) are
unclear.
Animated characters may provide marketers with a way to explain
product benefits in an engaging and even humorous manner. Thus, the
majority of research on animated characters in advertising focuses on
outcomes such as product evaluations (Ref. 8), emotional responses
(Refs. 1, 9, and 10), brand attitudes (Ref. 11), and perceived product
value (Ref. 12). The extent to which emotional responses can be
fostered by animated characters is especially relevant to this study,
as the positive effects these animations induce might transfer to the
brands being advertised. It is also possible that animated characters
may lead to lower perceived risk by minimizing or camouflaging side
effects (Ref. 13).
Animation and Message Communication. Personifying animated
characters may interfere with message communication. Although
personification may increase involvement with the characters in the ad
(i.e., perceived as engaging and likeable), it may not increase
involvement with the message itself (e.g., risk and benefit
information). Whether personified characters lead to reduced
comprehension of risk and benefit information in drug ads is an
important and unanswered question. Based on a theory called the limited
capacity model of mediated message processing (Ref. 14), advertising
content that is engaging, relevant, and maximizes audio/visual
redundancy should improve learning and memory (Ref. 15). However,
others argue that the entertainment aspects can distract from learning
key information and may lead to message complexity that interferes with
message communication (Ref. 16).
It is important to examine whether animation in drug ads inflates
efficacy perceptions, minimizes risk, or otherwise hinders
comprehension of drug risks and benefits. To investigate these issues,
we will conduct a two-part experimental study to examine how: (1) Type
of animation and (2) non-human personification in drug ads influence
consumer comprehension, processing, and perception of risk and benefit
information. Understanding how issues of animation and personification
affect perceptions of both risks and benefits can inform FDA regarding
how prescription drug risk and benefit information is processed. These
strategies will be examined across two different medical conditions to
see if the findings are consistent across patient populations and
medications with different levels of risk.
General Research Questions
1. How does consumer processing of a DTC prescription drug ad
differ depending on whether the ad is live-action, rotoscoped, or
animated?
2. Does consumer processing differ depending on whether the
sufferer, the disease, or the benefit is the focus of the animation?
Design
To test these research questions, we will conduct two experiments.
Both experiments will be examined in two different medical conditions:
chronic dry eye, and psoriasis. The mock drugs we will create for these
conditions mimic currently available medications and were chosen for
their variance in serious side effects, i.e., medications for psoriasis
have very long, serious lists of risks and side effects, whereas
chronic dry eye medications have relatively few risks and side effects.
The first experiment will examine whether animation itself
influences consumer processing, defined as consumer recall of risks and
benefits, perceptions of risks and benefits, and attitudes and
emotional responses to the ad, the brand, the product, and the
character (table 1). We will examine two different types of animation
in addition
[[Page 10869]]
to a control ad which will be shot with live actors: An ``in-between''
animation technique, rotoscoping, in which live scenes are drawn to
look animated, and full animation with nonhuman characters. The live
action and rotoscoped ad will be identical except for the rotoscope
treatment. The animated ad will follow the theme and message as closely
as possible within the limitations of animation itself. The benefits
and risks of the product will be identical, although the ad's storyline
may vary somewhat to account for a nonhuman protagonist.
Table 1--Experiment 1 Animation Design
[Type of Animation]
----------------------------------------------------------------------------------------------------------------
Non-human Rotoscoped
Medical condition sufferer human sufferer Human sufferer
----------------------------------------------------------------------------------------------------------------
Chronic Dry Eye..............................................
Psoriasis....................................................
----------------------------------------------------------------------------------------------------------------
The second experiment will examine whether the object of the
animation influences consumer processing of the ad (table 2), defined
as consumer recall of risks and benefits, perceptions of risks and
benefits, and attitudes and emotional responses to the ad, the brand,
the product, and the character. The animation will focus on the
animated character who will personify either the sufferer of the
medical condition, the disease itself, or the benefit from the drug. In
this study, all ads will contain the same kind of full animation and
the general theme will be as similar as possible, accounting for the
variations in focus of character. The experiments will be conducted
concurrently, and the same participants in the nonhuman sufferer groups
will be part of both.
Table 2--Experiment 2 Personification Design
[Non-Human Personification]
----------------------------------------------------------------------------------------------------------------
Medical condition Sufferer Disease Benefit
-------------------------------------------------------------------------------------------------
Chronic Dry Eye...............................
Psoriasis.....................................
----------------------------------------------------------------------------------------------------------------
In both cases, a professional firm will create all ads such that
they are indistinguishable from currently running DTC ads.
Pretesting will take place before the main study to evaluate the
procedures and measures used in the main study. We will recruit adults
who fall into one of four age brackets shown in table 1. We will
exclude individuals who work in healthcare or marketing settings
because their knowledge and experiences may not reflect those of the
average consumer. A prior power analyses revealed that we need 300
participants for the pretest to obtain 80% power to detect a moderately
small effect size. Each experiment will include 30 participants per
condition for a total of 180 participants each, but 60 of those in the
nonhuman sufferer conditions will overlap between the two experiments.
We will need 1,500 unique participants for the main study to obtain 90%
power to detect a moderately small effect size. There will be 150
participants per condition for a total of 900 participants in each
experiment, with 300 participants in the overlapping nonhuman sufferer
conditions.
In both studies, participants who have been diagnosed with either
chronic dry eye or psoriasis will be recruited via opt-in Internet
panel to watch one ad for a prescription drug that treats their medical
condition. In study 1, participants will be randomly assigned to view
either a live-action, rotoscoped, or fully animated ad. All themes in
study 1 will focus on the main character as the sufferer of the
condition. In study 2, participants will be randomly assigned to a
personification condition: sufferer, disease, or benefit. All ads in
study 2 will be fully animated. Participants will watch the ad twice
and then answer an online survey with questions addressing recall of
risks and benefits, perceptions of risks and benefits, and attitudes
and emotional responses to the ad, the brand, the product, and the
character. The questionnaire is available upon request. Participation
is estimated to take approximately 25 minutes.
To examine differences between experimental conditions, we will
conduct inferential statistical tests such as analysis of variance
(ANOVA).
With online surveys, several participants may be completing the
survey at the time that the total target sample is reached. Those
participants are allowed to complete the survey, which can result in
the number of completes going slightly over the target number. Thus,
our target number of completes is 1,500, so we have rounded up by an
additional 150, or 10%, to allow for some overage.
FDA estimates the burden of this collection of information as
follows:
Table 3--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per Total Hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Pretesting
----------------------------------------------------------------------------------------------------------------
Number to complete the screener 660 1 660 0.08 (5 min.)......... 53
(assumes 50% eligible).
Number of completes............ 330 1 330 .42 (25 min.)......... 139
----------------------------------------------------------------------------------------------------------------
[[Page 10870]]
Main Study
----------------------------------------------------------------------------------------------------------------
Number to complete the screener 3,300 1 3,300 0.08 (5 min.)......... 264
(assumes 50% eligible).
Number of completes............ 1,650 1 1,650 .42 (25 min.)......... 693
--------------------------------------------------------------------------------
Total Hours................ ............ .............. ............ ...................... 1,149
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
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.
References
1. Callcott MF, Lee W. ``Establishing the Spokes-Character in
Academic Inquiry: Historical Overview and Framework for
Definition,'' Advances in Consumer Research, 1995;22:144-151.
2. Bell JA. Creativity, TV Commercial Popularity, and Advertising
Expenditures, Internationl Journal of Advertising, 1992;11(2):165-
72.
3. Heiser RS, Sierra JJ, Torres IM. ``Creativity Via Cartoon
Spokespeople in Print Ads: Capitalizing on the Distinctiveness
Effect,'' Journal of Advertising, 2008;37(4):75-85.
4. Luo JT, McGoldrick P, Beatty S, et al, ``On-Screen Characters:
Their Design and Influence on Consumer Trust,'' Journal of Services
Marketing, 2006;20(2):112-24.
5. Clayton RB, Lesher G. ``The Uncanny Valley: The Effects of
Rotoscope Animation on Motivational Processing of Depression Drug
Messages,'' Journal of Broadcasting and Electronic Media,
2015;59(1):57-75.
6. Bhutada NS, Rollins BL, Perri M. ``Animation in Print Direct-to-
Consumer Advertising of Prescription Drugs: Impact on Consumers,''
at the 32d Association for Marketing and Healthcare Research Annual
Meeting and Conference, February 27-March 1, 2013, Big Sky, MT.
7. Pashupati K. ``Beavers, Bubbles, Bees, and Moths: An Examination
of Animated Spokescharacters in DTC Prescription Drug Advertisements
and Web sites,'' Journal of Advertising Research, 2009;49(3):373-93.
8. Chandler J, Schwarz N. ``Use Does Not Wear Ragged the Fabric of
Friendship: Thinking of Objects as Alive Makes People Less Willing
to Replace Them,'' Journal of Consumer Psychology, 2010;20(2):138-
145.
9. Callcott MF, Phillips BJ., ``Observations: Elves Make Good
Cookies: Creating Likeable Spokescharacter Advertising,'' Journal of
Advertising Research, 1996;36(5):73-79.
10. Garretson JA, Niedrich RW., ``Spokes-Characters: Creating
Character Trust and Positive Brand Attitudes,'' Journal of
Advertising, 2004;33(2):25-36.
11. Delbaere M, McQuarrie EF, Phillips BJ, ``Personification in
Advertising: Using a Visual Metaphor to Trigger Anthropomorphism,''
Journal of Advertising, 2011;40(1):121-130.
12. Hart PM, Jones SR, Royne MB, ``The Human Lens: How
Anthropomorphic Reasoning Varies by Product Complexity and Enhances
Personal Value,'' Journal of Marketing Management, 2013;29(1-2):105-
121.
13. Moyer-Guse E, Mahood C, Brookes S., ``Entertainment-Education in
the Context of Humor: Effects on Safer Sex Intentions and Risk
Perceptions,'' Health Communication, 2011;26(8):765-774.
14. Lang A., ``The Limited Capacity Model of Motivated Mediated
Message Processing,'' The Sage Handbook of Mass Media Effects, New
York: Sage;2009:193-204.
15. Garretson JA, Burton S., ``The Role of Spokescharacters as
Advertisement and Package Cues in Integrated Marketing Campaigns,''
Journal of Marketing, 2005;69(4):118-132.
16. Lang A., ``Using the Limited Capacity Model of Motivated
Mediated Message Processing to Design Effective Cancer Communication
Messages,'' Journal of Communication, 2006;56:557-580.
Dated: February 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04569 Filed 3-1-16; 8:45 am]
BILLING CODE 4164-01-P