[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]


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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.

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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 ``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]
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                                                                  Non-human        Rotoscoped
                      Medical condition                            sufferer     human  sufferer  Human  sufferer
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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]
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               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\
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                                                  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