[Federal Register Volume 81, Number 206 (Tuesday, October 25, 2016)]
[Notices]
[Pages 73410-73416]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25727]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0538]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 or we) is announcing 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
November 25, 2016.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Animation in Direct-to-Consumer Advertising.'' Also include the 
FDA 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, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 the 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.
    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 nonhuman (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. 2-4). Animated characters have long 
been used for low-involvement products (e.g., food products) and have 
made their way into direct-to-consumer (DTC) prescription drug 
advertising. However, to our knowledge, one study (Ref. 5) has examined 
how animation affects attitudes toward products and risk perceptions in 
drug ads, and no studies have examined how various animation strategies 
(e.g., symbolizing the disease vs. the benefit) and product 
characteristics (e.g., low-risk medication vs. high-risk medication) 
influence these perceptions.

[[Page 73411]]

    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. 6). 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. 7) or led to poorer 
recognition of drug side effects (Ref. 6).
    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 nonhuman 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. 8); 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. 9), emotional responses 
(Refs. 1, 10-11), brand attitudes (Ref. 12), and perceived product 
value (Ref. 13). 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. 14).
    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. 15), advertising 
content that is engaging, relevant, and maximizes audio/visual 
redundancy should improve learning and memory (Ref. 16). 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. 17).
    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) nonhuman 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.

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 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
-----------------------------------------------------------------------------------------------------------------
                                                                   Nonhuman        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

[[Page 73412]]

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
----------------------------------------------------------------------------------------------------------------
                                            Nonhuman 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 have experienced chronic dry eye or psoriasis. We will exclude 
individuals who work in healthcare or marketing settings because their 
knowledge and experiences may not reflect those of the average 
consumer. We propose to test 300 participants for the pretest. 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 percent 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 experiments, participants who have been diagnosed with 
either chronic dry eye or psoriasis will be recruited via an opt-in 
Internet panel to watch one ad for a prescription drug that treats 
their medical condition. In experiment 1, participants will be randomly 
assigned to view either a live-action, rotoscoped, or fully animated 
ad. All themes in experiment 1 will focus on the main character as the 
sufferer of the condition. In experiment 2, participants will be 
randomly assigned to a personification condition: Sufferer, disease, or 
benefit. All ads in experiment 2 will be fully animated. Participants 
will watch the ad once 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.
    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 percent, to allow for some overage.
    In the Federal Register of March 2, 2016 (81 FR 10867), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received a number of comments as 
enumerated and discussed here. Of these comments, 22 were out of the 
scope of the proposed project (``Ban DTC'' or ``Ban animated DTC'').
1. AbbVie
    (Comment 1) Note that the accuracy of the findings will be highly 
dependent on the quality of the stimuli (i.e., the animation).
    (Response 1) We agree.
2. Lilly
    (Comment 2) Assume that stimuli will conform to FDA regulations and 
standards.
    (Response 2) Reviewers from the Office of Prescription Drug 
Promotion have been involved throughout the development of the stimuli 
to ensure that the mock ads conform to FDA regulations and standards.
    (Comment 3) Question the use of such a large (n = 300) pretest and 
recommends the use of a qualitative, in-person pretest.
    (Response 3) Before the pretests and main studies are conducted, we 
will conduct nine cognitive interviews to obtain verbal in-person 
feedback on the questionnaires and the stimuli. We believe this will 
accomplish what this commenter is suggesting. The pretest is designed 
to test procedures, verify that the online questionnaire is working as 
intended, identify and correct any challenges to nesting the stimuli 
within the questionnaire, and examine data trends to check that the 
manipulations and questionnaire items are appropriate. A qualitative 
in-person pretest would not meet those objectives.
    (Comment 4) Recommend screening and quotas by length of time since 
diagnosis as this may influence the urgency with which individuals 
watch the ads and their familiarity with previous treatments.
    (Response 4) We have included a question toward the end of the 
questionnaire to measure time since diagnosis, which will enable us to 
assess its association with attention to the ad and statistically 
control for it if necessary. However, statistical control will likely 
be unnecessary, since random assignment to conditions in our study 
design should prevent there from being systematic differences among 
groups in time since diagnosis or any other extraneous variable.
    (Comment 5) For question 5, the item ``think rather than feel'' 
seems out of place in the question bank and Lilly recommends deletion.
    (Response 5) The items in Question 5 make up a validated scale 
developed by Stephenson and Palmgreen (Ref. 18). Niederdeppe (Ref. 19) 
used the same scale items to measure cognitive processing. There may be 
psychometric consequences to deleting this item--in other words, the 
reliability of the scale may be reduced if we remove this item. Since 
it was previously validated as a scale, we will maintain the item.
    (Comment 6) Questions 6 and 8 (``In your opinion, if 100 people 
take [DRUG X], for how many will the drug work?'') may be difficult to 
answer, as pharmaceutical ads rarely have specific side effect 
information. Recommend changing to ask how frequently side effects will 
occur, from ``very frequent'' to ``never occurs.''
    (Response 6) We agree and will revise these questions to focus on 
perceived frequency or likelihood of side effects and efficacy in more 
general terms.
    (Comment 7) Questions 13 and 14 (overall comprehension closed-ended

[[Page 73413]]

questions) may be too difficult to answer because they are nuanced and 
involve multiple concepts. Recommend changing to an open-ended 
response.
    (Response 7) We appreciate the commenter's concerns about the 
complexity of the response options. We will examine the closed-ended 
questions in cognitive testing, with careful attention to participant's 
ability to understand and choose among the response options. If 
participants have notable difficulty with the closed-ended questions, 
we will revise them to enhance accessibility, or we will replace those 
items with open-ended items.
    (Comment 8) Question 16b for Chronic Dry Eye does not have any 
question or response options.
    (Response 8) We have since developed question and response options 
for this item.
    (Comment 9) Recommend moving questions 17-28 to before question 15 
because questions 15 and 16 are specific and starting with question 17, 
questions again refer to general ad perceptions.
    (Response 9) We always approach question ordering carefully, 
attempting to balance a number of considerations, including the 
reduction of bias from one question to another, flow, and importance of 
each item. In this case, we feel that specific claim comprehension is 
more important than the other more general questions in our 
questionnaire, which is why they are placed afterwards. We will examine 
this issue closer in cognitive testing.
    (Comment 10) Recommend reducing question 18 to only ``like/
dislike'' because the results will be too similar and will be 
confounded.
    (Response 10) We selected these items because they have been used 
consistently in past research. We use three items rather than one to 
achieve reliability, which provides a fuller understanding of the 
dependent variable. However, we will pay close attention to this in 
cognitive testing to ensure that participants are not confused or 
annoyed by the three questions.
    (Comment 11) For question 21, recommend adding clarifying language: 
``. . . in terms of dealing with your psoriasis/chronic dry eye'' to 
provide context for participant to understand how to compare themselves 
with the character.
    (Response 11) We will present the additional context as an 
alternative way of asking the question in cognitive interviews.
    (Comment 12) Recommend removing question 26 about how ``eerie'' the 
character is because the essence of this question is answered in 
question 25 and the question is leading, as it directs participants to 
respond only negatively about their perceptions of the character.
    (Response 12) Given the uncanny valley theory concerning rotoscoped 
images (Ref. 6), we feel it is crucial to maintain this specific 
question about the eeriness of the character.
    (Comment 13) Recommend adding an open-ended question, preferably 
near the beginning of the survey (e.g., after question 2), about how 
well they feel they took away all of the relevant information and 
understood the risks and benefits of the drug after viewing the ad.
    (Response 13) Although we do not include questions that directly 
measure perceived understanding of the overall message, risks, and 
benefits, much of the questionnaire is focused on measuring 
participants' memory and comprehension of that information in the ad.
    (Comment 14) Recommend adding demographic questions about how much 
television participants watch per week and whether English is their 
primary language to provide extra detail for analyses.
    (Response 14) We appreciate this suggestion and will add the 
recommended demographic items to the questionnaire.
    (Comment 15) Recommend adding another open-ended question about 
whether any additional information could have or should have been 
included in the ad (e.g., disease information, accessibility of the 
drug) to provide information on what participants feel could be added 
and communicated via DTC ads.
    (Response 15) This is a great question and may provide fruitful 
avenues for future research. We will include the item in the pretest 
and if timing is not an issue, we will maintain it in the main study.
3. Merck
    (Comment 16) Concerned that execution-specific learnings from this 
research may not translate readily into FDA DTC policy/guidance. The 
research may not have practical utility for the general public and may 
be unnecessary for the proper performance of FDA's functions.
    (Response 16) On the contrary, this particular study has the 
potential to directly influence policy in an area that we have no prior 
research on. We have attempted to address the execution-specific nature 
of the research by investigating our questions in two distinct medical 
conditions with two distinct products and ad executions. Although one 
research study cannot answer all questions, we believe we have designed 
the study in such a way that we will be able to provide information on 
the issue of animation in DTC ads. Because there is no previous 
research of this kind, this will be an informative study that will help 
FDA develop guidance and policy in the future, should the research 
reveal a need to.
    (Comment 17) FDA should conduct research on how all of the elements 
investigated previously combine to influence DTC viewing.
    (Response 17) We appreciate this suggestion and will look for 
opportunities to do so in the future. Note we have conducted research 
combining the results of two previous studies--toll-free wording and 
distraction--in our recent eye-tracking study.
4. GSK
    (Comment 18) Suggests a number of additional reasons for animation 
besides those stated in the FRN: Education, to help consumers quickly 
identify relevant ads, and to de-personalize an ad to make it more 
relevant to a variety of people.
    (Response 18) We will keep these in mind in writing up the results 
of the studies.
    (Comment 19) The proposed research may oversimplify animation by 
not incorporating multiple types of animation or examining ads that are 
100 percent versus partially animated, and thus be unlikely to yield 
any general conclusions about the use of animation.
    (Response 19) We acknowledge that we are not studying all types and 
executions of animation. As the first study of its kind, we feel the 
animation manipulations that we propose to examine will provide 
information on a reasonable number of variations (i.e., full animation, 
rotoscoping, and three different foci of animated character). We will 
ensure that our conclusions are reasonable with regard to the issues we 
studied.
    (Comment 20) The proposed methodology fails to measure the 
relevance of the ads. A copy-testing methodology, whereby the ads are 
embedded in a clutter reel, may more accurately gauge the recall of 
risks and benefits that might occur in the real world.
    (Response 20) We needed to make difficult choices in this study, as 
in all of our studies, regarding the tradeoff between experimental 
control and real-world generalizability. Given the lack of data 
available regarding animation in DTC, we chose to err on the side of 
experimental control in this study. Our

[[Page 73414]]

research questions involve the issue of recall and comprehension of the 
ads when people have watched the ads. Depending on the findings of the 
current study, further research examining the effects of animation 
within a clutter reel or considering other variables may be warranted.
    (Comment 21) Advertising concepts are generally not designed to be 
adapted or translated to different creative formats, and because 
whether an ad is animated or in live action is an integral part of the 
concept itself, this is an inherent limitation of the research.
    (Response 21) We agree that animated ads often have different 
storylines or different approaches to conveying information from live 
action ads. However, if we were to use completely different ads for our 
animated, rotoscoped, and live-action ads, we would be unable to 
determine what caused any differences in our dependent variables. 
Indeed, by maintaining as much similarity as possible among these three 
conditions, we will be able to determine whether it is the animation 
form per se that causes differences or not.
5. Regeneron Pharmaceuticals
    (Comment 22) Encourage FDA to acknowledge that this study is 
exploratory and that results will not be generalizable beyond the two 
medical conditions studied.
    (Response 22) We acknowledge that this is the first study to 
directly examine animation in DTC advertising. We are always mindful of 
how far we can extrapolate our research. We chose to examine two 
different medical conditions because this will provide some assurance 
that our findings are not exclusive to one medical condition or 
execution, if that is what we find. We note that the strength of the 
study is in its experimental design. Participants will be randomly 
assigned to cells, which will allow us to determine whether differences 
exist between different levels of our independent variables. Random 
assignment will somewhat allay concerns about demographic differences 
and other individual characteristics, which should even out across 
cells. However, we agree that other medical situations may cause 
different reactions and we will acknowledge the limitations of our 
study, which include not examining all medical conditions and levels of 
risk, in any writeup we produce.
    (Comment 24) The major statement is required to be in the audio and 
the amount and type of risk information will vary by drug. We request 
that the professional ad agency designing the TV ads ensure that the 
major statement is presented consistently across the ads studied for 
the given ``mock drug.''
    (Response 24) We have designed the fictitious ads to very closely 
align with both FDA policies and with the types of DTC ads that 
currently air on TV. Our ads have been reviewed by staffers in the 
Office of Prescription Drug Promotion multiple times throughout the 
ads' development. The mock products closely mimic existing drugs in 
their respective classes. We agree that the quality of the ads strongly 
influences the success of our research and the professional development 
of these ads is a high priority.
    (Comment 25) An imbalance of gender distribution in the diseases 
and study groups could skew the results due to potential gender 
differences in consumer processing and perception of information from 
drug ads. To ensure a gender balance between the study groups, we 
propose a randomization scheme stratified by gender. Also, please 
capture patient demographic information and important confounding 
factors and report on a comparison of the baseline patient 
characteristics.
    (Response 25) Stratified randomization by gender would be 
methodologically appropriate and conservative, but in practice would 
make our already complex survey even more complicated. We will 
acknowledge a potential gender-disease confound as a limitation of the 
design in reports of the results.
    (Comment 26) While the results from this proposed study may suggest 
hypotheses on difference in how prescription drug risk and benefit 
information may be perceived by consumers viewing live versus animation 
ads, the results from this study should not be used to guide or 
influence FDA's current thinking on the use of animation in DTC ads. 
More robust and controlled studies will be required in the future to 
test specific hypotheses generated from this two-part survey 
experiment.
    (Response 26) Although this is the first study to directly examine 
animation in DTC ads the way we have proposed here, the research we 
have designed is robust and well controlled. As trained research 
psychologists, we adhere to the highest standards in terms of rigorous 
control, prespecified hypotheses, appropriate statistical analyses, and 
reasonable and responsible interpretations. Our research undergoes many 
internal and external reviews before and after data collection, 
including a stringent OMB review (of which public comment is a part), 
multiple levels of internal clearance, and peer review at well-
respected academic journals in relevant fields. Although FDA never 
exclusively uses the findings of one scientific study to make policy 
decisions, the quantitative research we conduct is one part of the 
calculus that FDA uses to inform policy decisions.
6. AstraZeneca
    (Comment 27) Recommend that questions 18 and 19 be switched in 
order to avoid participants being confused by the questions. Also 
suggest some kind of bolding for emphasis.
    (Response 27) We agree that formatting these questions to emphasize 
and differentiate the target object will be useful and have no problem 
changing the order of questions 18 and 19 and will do so.
    (Comment 28) The term ``main character'' needs to be clarified. As 
it is, it could mean the human character or the animated character 
which may, or may not, be the human character.
    (Response 28) Participants will only view one version of the ad 
corresponding to the ad condition to which they've been randomized, and 
each ad will either be animated or live action. In terms of screen time 
and storyline, a single character will be dominant in each ad. We do 
not expect ambiguity surrounding who the main character is in each ad, 
but we will test this phrase in cognitive interviewing.
    (Comment 29) For question 23, the commenter agrees that trust is a 
useful metric to study but questions whether our options are valid 
measures of trust, particularly ``ethical.'' Suggest the use of the 
following adjectives instead: Exaggerated, deceptive, manipulative, 
trustworthy, informative, credible.
    (Response 29) The negative adjectives on the list are from an 
existing scale (Refs. 20-21) and we would like to keep those consistent 
with the prior literature. We will revise the positive adjectives to 
reflect the commenter's suggestion: Trustworthy, informative, credible, 
and reliable.
    (Comment 30) For questions 24 and 25, suggest the addition of 
``hopeful,'' ``empowered,'' and ``informed.''
    (Response 30) The emotional reaction questions were adapted from 
existing scales (Ref. 22), but we think it would be useful to test a 
longer set of emotions in cognitive interviews and narrow down from 
there.
    (Comment 31) We feel that question 26 should be deleted because it 
is a leading question. If not deleted, change ``eerie'' to ``strange.''
    (Response 31) We agree that this is an unusual question and may 
seem offputting without context. However,

[[Page 73415]]

previous research has compared live action and rotoscoped action in 
advertisements and has determined that people feel uncomfortable with 
rotoscoping because it is very similar to what we expect from live 
renditions, but not exactly. This theory is called the uncanny valley 
theory (Ref. 6). Question 26 comes directly from this previous research 
and we feel strongly that we need the question as it is to ground our 
comparison of live action and rotoscoping in the prior literature.
    (Comment 32) Question 29 about anthropomorphism seems inappropriate 
to gauge audience acceptance of the premise. Suggest using a question 
such as: ``To what extent do/can bodily organs or pills have 
personalities?''
    (Response 32) The purpose of question 29 is to measure an 
individual difference variable, namely to what extent people tend to 
anthropomorphize. The question is modified from a validated measure 
(Ref. 23). We do not intend to assess people's acceptance of animated 
DTC ads through this question. Instead, we are using this as a possible 
moderator variable to explain some of the variance we might find in 
responses to other questions. Indeed, another commenter wrote that we 
should measure demographics and other possibly confounding variables. 
This is one of these variables. The amount of humanization people 
ascribe to nonhuman objects may influence their attitudes and 
perceptions, and these items have been validated in past research. It 
is not an outcome measure.
    FDA estimates the burden of this collection of information as 
follows:

                                            Table 3--Estimated Burden
----------------------------------------------------------------------------------------------------------------
                                                   Number of                     Average burden
           Activity                Number of     responses per   Total annual   per response (in    Total hours
                                  respondents     respondent       responses         hours)
----------------------------------------------------------------------------------------------------------------
                                                   Pretesting
----------------------------------------------------------------------------------------------------------------
Number to complete the                     660               1             660  .08 (5 minutes).              53
 screener (assumes 50%
 eligible).
Number of completes...........             330               1             330  .42 (25 minutes)             139
----------------------------------------------------------------------------------------------------------------
                                                   Main Study
----------------------------------------------------------------------------------------------------------------
Number to complete the                   3,300               1           3,300  .08 (5 minutes).             264
 screener (assumes 50%
 eligible).
Number of completes...........           1,650               1           1,650  .42 (25 minutes)             693
                               ---------------------------------------------------------------------------------
    Total Hours...............  ..............  ..............  ..............  ................           1,149
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

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    Dated: October 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25727 Filed 10-24-16; 8:45 am]
 BILLING CODE 4164-01-P