[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