Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion, 78859-78865 [2020-26799]
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Federal Register / Vol. 85, No. 235 / Monday, December 7, 2020 / Notices
redelegations, provided they are
consistent with this reorganization.
IV. Funds, Personnel, and Equipment.
Transfer of organizations and functions
affected by this reorganization shall be
accompanied in each instance by direct
and support funds, positions, personnel,
records, equipment, supplies, and other
resources.
This reorganization will be effective
upon date of signature.
Authority: 42 U.S.C. 652
Dated: December 1, 2020.
Megan E. Steel,
Office of the Executive Secretariat,
Administration for Children and Families.
[FR Doc. 2020–26778 Filed 12–4–20; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0026]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act), as
amended by the Food and Drug
Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA is required to publish notice of the
award of the priority review voucher.
FDA has determined that DANYELZA
(naxitamab-gqgk) manufactured by YmAbs Therapeutics, Inc., (Cato Research
LLC., US Agent) meets the criteria for a
priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Althea Cuff, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4061, FAX: 301–796–9856,
email: althea.cuff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), which was
added by FDASIA, FDA will award
priority review vouchers to sponsors of
approved rare pediatric disease product
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SUMMARY:
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applications that meet certain criteria.
FDA has determined that DANYELZA
(naxitamab-gqgk) manufactured by YmAbs Therapeutics, Inc., (Cato Research
LLC., US Agent), meets the criteria for
a priority review voucher.
DANYELZA (naxitamab-gqgk)
indicated, in combination with
granulocyte-macrophage colonystimulating factor (GM–CSF), for the
treatment of pediatric patients 1 year of
age and older and adult patients with
relapsed or refractory high-risk
neuroblastoma in the bone or bone
marrow who have demonstrated a
partial response, minor response, or
stable disease to prior therapy.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about DANYELZA
(naxitamab) go to the ‘‘Drugs@FDA’’
website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: December 1, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–26801 Filed 12–4–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–5900]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Endorser Status
and Explicitness of Payment in Directto-Consumer Promotion
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, 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: Submit written comments
(including recommendations) on the
collection of information by January 6,
2021.
ADDRESSES: To ensure that comments on
the information collection are received,
SUMMARY:
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78859
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comment’’ or
by using the search function. The title
of this information collection is
‘‘Endorser Status and Explicitness of
Payment in Direct-to-Consumer
Promotion.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
For copies of the questionnaires
contact: Office of Prescription Drug
Promotion (OPDP) Research Team,
DTCresearch@fda.hhs.gov.
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.
Endorser Status and Explicitness of
Payment in Direct-to-Consumer
Promotion
OMB Control Number 0910—NEW
I. Background
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 (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.
The Office of Prescription Drug
Promotion’s (OPDP) mission is to
protect the public health by helping to
ensure that prescription drug promotion
is truthful, balanced, and accurately
communicated. OPDP’s research
program provides scientific evidence to
help ensure that our policies related to
prescription drug promotion will have
the greatest benefit to public health.
Toward that end, we have consistently
conducted research to evaluate the
aspects of prescription drug promotion
that are most central to our mission. Our
research focuses in particular on three
main topic areas: Advertising features,
including content and format; target
populations; and research quality.
Through the evaluation of advertising
features, we assess how elements such
as graphics, format, and disease and
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product characteristics impact the
communication and understanding of
prescription drug risks and benefits;
focusing on target populations allows us
to evaluate how understanding of
prescription drug risks and benefits may
vary as a function of audience, and our
focus on research quality aims at
maximizing the quality of our research
data through analytical methodology
development and investigation of
sampling and response issues. This
study will inform the first topic area,
advertising features.
Because we recognize that the
strength of data and the confidence in
the robust nature of the findings is
improved by utilizing the results of
multiple converging studies, we
continue to develop evidence to inform
our thinking. We evaluate the results
from our studies within the broader
context of research and findings from
other sources, and this larger body of
knowledge collectively informs our
policies as well as our research program.
Our research is documented on our
homepage, which can be found at:
https://www.fda.gov/aboutfda/
centersoffices/officeofmedicalproducts
andtobacco/cder/ucm090276.htm. The
website includes links to the latest
Federal Register notices and peerreviewed publications produced by our
office. The website maintains
information on studies we have
conducted, dating back to a survey on
direct-to-consumer (DTC)
advertisements conducted in 1999.
Advertisers have used celebrity
endorsers for years, and DTC
pharmaceutical promotion is no
different. As researchers studied the
influence of celebrity endorsers, they
theorized that a correspondence bias
occurs in which people believe that
endorsers truly believe what they are
saying. LaTour and Smith (Ref. 1)
examined whether a pharmacist,
physician, celebrity, or consumer would
be most persuasive in advertisements
for four different types of OTC products.
They found that endorsements by expert
physicians and pharmacists were the
most likely to lead to purchase
intentions, followed by endorsements
by consumers, and lastly, by celebrities.
The type of OTC product did not affect
the persuasiveness of an endorsement.
Bhutada and Rollins (Ref. 2) recently
completed a study examining the role of
endorser type (i.e., celebrity vs. expert
vs. non-celebrity), and endorser and
consumer gender in product DTC ads.
They found, like LaTour and Smith (Ref.
1), that expert endorsers were thought of
as higher in credibility and generally
resulted in the same amount of attention
as celebrities. The authors did not find
that endorsement by experts resulted in
greater consumer intention to pursue
the drug product.
We propose to extend previous
research by examining four types of
endorsers in two separate studies
(celebrity, physician, patient, noncelebrity influencer) 1 and examining
whether the presence of a disclosure of
their payment status influences
participant reactions. We propose to
also test two different types of
disclosure language—one direct and
more consumer-friendly, and one less
direct.
To complete this research, we propose
the following concurrent studies.2
Study 1
TABLE 1a—STUDY 1 DESIGN—PRETEST
[0.80 power, 0.10 alpha, small effect size f=.2]
Endorser
Payment disclosure
Total
Celebrity
Physician
Patient
Present .............................................................................................................
Absent ..............................................................................................................
50
33
50
33
50
33
150
99
Total ..........................................................................................................
83
83
83
249
TABLE 1b—STUDY 1 DESIGN—MAIN STUDY
[0.90 power, 0.05 alpha, small effect size f=.2]
Endorser
Payment disclosure
Total
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Celebrity
Physician
Patient
Present .............................................................................................................
Absent ..............................................................................................................
81
54
81
54
81
54
243
162
Total ..........................................................................................................
135
135
135
405
Study 1 will manipulate endorser
type (three levels: Celebrity, physician,
patient) and payment disclosure (two
levels: Present, absent) within a print
DTC ad for a fictitious acne product. For
this study, we will recruit 654 general
population individuals (249 pretest; 405
main study) from the Kantar Lightspeed
national nonprobability internet panel.
All participants must report familiarity
with the celebrity to be included in our
study. The celebrity will be one who has
publicly spoken out about acne. We are
not divulging the identity of the
celebrity in this public forum to
maintain the integrity of our research
process. Stock photos will be used to
depict a physician and a patient in the
other experimental conditions.
Participants will be randomly assigned
to see one of the endorsers and to see
the ad either with or without a payment
disclosure. The payment disclosure in
Study 1 will be determined in cognitive
1 A ‘‘non-celebrity influencer’’ is a person who
has gained a following on a blog, a Twitter feed, or
other social media outlet. In the 60-day notice, the
term ‘‘influencer’’ was used; we have added
language to specify influencers who were not
previously celebrities before their social media
activities.
2 For case allocation, the literature suggests that
some proportion of consumers may not recall seeing
the disclosure statement in the advertisement (see,
for example, Boerman et al.; Ref. 3). Rather than
allotting equal numbers of cases to each condition,
we will assign more cases to the disclosure present
condition to increase power in these cells.
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testing but will be similar to:
‘‘[Endorser] has been paid to appear in
this ad for Drug X.’’
Study 2
TABLE 2a—STUDY 2 DESIGN—PRETEST
[0.80 power, 0.10 alpha, small effect size f=.2]
Endorser
Payment disclosure
Total
Influencer
Patient
Present-Direct ..............................................................................................................................
Present-Indirect ............................................................................................................................
Absent ..........................................................................................................................................
50
50
33
50
50
33
100
100
66
Total ......................................................................................................................................
133
133
266
TABLE 2b—STUDY 2 DESIGN—MAIN STUDY
[0.90 power, 0.05 alpha, small effect size f=.2]
Endorser
Payment disclosure
Total
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Influencer
Patient
Present-Direct ..............................................................................................................................
Present-Indirect ............................................................................................................................
Absent ..........................................................................................................................................
81
81
54
81
81
54
162
162
108
Total ......................................................................................................................................
216
216
432
In Study 2, we will also manipulate
endorser type, examining a patient and
an internet influencer, one who
provides online content to a number of
followers. We will also manipulate the
explicitness of the payment disclosure,
resulting in a 2 (endorser: Influencer,
patient) by 3 (payment disclosure:
Present-direct, present-indirect, absent)
between-subjects design. The disclosure
will be direct (e.g., ‘‘Paid ad. . .’’),
indirect (e.g., #sp for ‘‘sponsored’’), or
absent. The setting for this study will be
an Instagram post for a fictitious
endometriosis product. This study
partially replicates Study 1 and extends
it by further examining the explicitness
of payment as another manipulated
variable and using a different set of
endorser types and in a different
promotional setting.
For Study 2, we will recruit 698 (266
pretest; 432 main study) followers of an
internet influencer who maintains an
Instagram page with more than 500,000
followers and has posted about
endometriosis. As in the first study, we
are not revealing the influencer’s
identity in this public forum to maintain
the integrity of the study.
In both studies, we are interested in
the role of endorsement and disclosure
of payment status on participants’
recall, benefit and risk perceptions, and
behavioral intentions. Participants will
view one promotional piece and answer
questions via the internet. The study is
expected to take less than 20 minutes to
complete. Dependent variables will
include attention to disclosure
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statement and risk/benefit information;
retention of risk/benefit information;
recognition of piece as promotion and
endorser as paid; perceived benefits and
risks, attitudes toward the product,
endorser, and ad; and behavioral
intentions, such as asking a doctor about
the drug.
In the Federal Register of January 28,
2020 (85 FR 4994), FDA published a 60day notice requesting public comment
on the proposed collection of
information. FDA received six
submissions that were PRA-related. One
submission (https://
www.regulations.gov/docketBrowser
?rpp=25&po=0&dct=PS&D=FDA-2019N-5900&refD=FDA-2019-N-5900-0001)
was a brief statement of support for the
research and is not addressed further.
Within the remaining five submissions,
FDA received multiple comments that
the Agency has addressed below. For
brevity, some public comments are
paraphrased and, therefore, may not
reflect the exact language used by the
commenter. We assure commenters that
the entirety of their comments was
considered even if not fully captured by
our paraphrasing in this document. The
following acronyms are used here: DTC
= direct-to-consumer; FDA and ‘‘The
Agency’’ = Food and Drug
Administration; OPDP = FDA’s Office of
Prescription Drug Promotion; and FTC =
Federal Trade Commission.
(Comment 1) One comment suggested
that the proposed research, at least in
part, is duplicative of information
otherwise reasonably available to FDA.
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The comment pointed out that the
Notice cites three scientific references,
and it does not address the other
literature that exists on the subject of
endorsers in advertising. The comment
recommended that FDA assemble and
review the relevant literature on
endorsement to ensure the research
questions have not already been
answered.
(Response) A literature review was
conducted as part of this project that
identified relevant literature. We
identified a significant gap in the
literature regarding the impact of social
media influencers in prescription drug
DTC advertisements, as well as a lack of
information about the impact of explicit
payment disclosure. The research
questions outlined in our proposed
research were designed to address this
gap.
(Comment 2) One comment suggested
that, although the studies contain clear
variables, they appear to lack clearly
defined primary outcomes and
prespecified hypotheses for testing. The
comment also noted that the studies do
not appear to be designed to account for
Type I error; thus, the results may be
uninterpretable. The comment
recommended that FDA propose a
primary endpoint for each study and
power each study to test it.
(Response) Specific hypotheses have
been developed for each of the outcome
variables, as described earlier in the
notice. We will adjust for multiple
comparisons using the Bonferroni
correction.
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(Comment 3) One comment suggested
that it is unclear how FDA came up
with the proposed sample sizes for the
two related studies. For example, the
comment stated that the chart for pretest
1 contains the following notation: ‘‘(0.80
power, 0.10 alpha, small effect size
f=.2),’’ but it is unclear what f=.2 means
in this context. The comment requested
that FDA explain what statistical model
it used to estimate the study size and
how it determined that the relevant
effect size is .2.
(Response) f=.2 is a common standard
used to calculate small effect size in
experimental studies (Ref. 4). We used
G*Power to estimate study size (Ref. 5).
(Comment 4) One comment suggested
that the proposed research is
unnecessary to the proper performance
of FDA’s functions because the FTC
takes the lead on regulating
endorsement. The comment stated that
FDA has not addressed the extensive
framework and guidance available from
the FTC on this topic. The comment
further stated that, although use of an
endorser might conceivably inform an
assessment of whether advertising or
promotion is false or misleading, it is
not clear how FDA views this new
research on endorser status as fitting
into its core regulatory jurisdiction or
activities.
(Response) FDA and the FTC have a
long history of working collaboratively
to protect American consumers. While
the FTC does regulate endorsement in
many types of commercial
advertisements, FDA has authority to
regulate prescription drug advertising
with respect to the safety and
effectiveness of such drugs. In line with
FDA’s responsibility to ensure that
prescription drug advertising and other
promotional communications are
truthful and non-misleading, the present
research will provide data on how
elements related to endorsement
presentations in prescription drug
promotion impact audience perception
and comprehension. Collecting this data
is critical to FDA’s science-based
approach to assessing prescription drug
promotion to determine whether it
communicates information about
prescription drugs to consumers in a
truthful, non-misleading way. We note
that as part of the process of developing
the present research, FDA carefully
evaluated the FTC guidance on endorser
issues.
(Comment 5) One comment
recommended that alignment and input
should be obtained from the FTC
regarding the design of the study and
usability of the results.
(Response) We evaluated the current
FTC guidance on endorsement
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disclosure when developing this study
and all relevant elements of its design,
including our hypotheses, test stimuli,
etc.
(Comment 6) One comment suggested
that the research may be skewed by the
influence of a particular celebrity. The
comment recommended that the study
be amended so it is not subject to bias
by the influence of one particular wellknown celebrity.
(Response) Familiarity with an
endorser has shown to be an important
factor in attention to DTC
advertisements, but the evidence is less
strong that familiarity uniquely affects
other outcomes such as behavioral
intention (see, for example, Refs. 2 and
6). The celebrity used in Study 1 will
have high levels of public recognition,
so we anticipate few participants will be
filtered out due to low levels of
familiarity with endorser. We recognize
that the individual characteristics of the
celebrity may drive responses. This
possibility is an unavoidable limitation
of the study design, and we will be
transparent when reporting results.
(Comment 7) One comment
recommended that FDA use #ad instead
of #sp. The comment noted that FTC has
stated that #ad is an effective disclosure
of sponsorship.
(Response) Our review of current
practices shows that vendors continue
to indicate endorsement by #sp online.
An indirect disclosure such as #sp
serves as a useful comparator to a direct
disclosure such as ‘‘Paid ad. . .’’,
helping us answer the research question
of whether direct and indirect
acknowledgements of endorsement vary
in their influence on attitudes and
perceptions.
(Comment 8) One comment
recommended that FDA incorporate
some type of control into each study.
(Response) We have designed these
studies to include a control. The
control, in both studies, is a duplicate
version of the promotion featuring
endorsement by a patient, as opposed to
a celebrity or influencer, without
inclusion of a payment disclosure.
(Comment 9) One comment suggested
that FDA should ensure that the
hypothetical products used in the
proposed surveys do not too closely
resemble real products. For example,
the conditions of use and the risk of the
hypothetical products should not mirror
FDA-approved labeling language for any
marketed products. In addition, FDA
should only present hypothetical drug
advertisements for diseases with many
treatment options from multiple
sponsors. Otherwise, the comment
states that FDA’s research could
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inadvertently harm one particular
sponsor.
(Response) The prescription drugs
used in this study, while based on
existing prescription treatments, are
fictitious with names and branding that
do not mirror any marketed products.
Although we have created the pieces to
be as realistic as possible, FDA does not
intend to single out any real product on
the basis of our fictional promotion. We
specifically use fictitious products and
materials to avoid the confound of prior
knowledge of actual products.
Moreover, it is the endorser type and
messaging around the endorsement
disclosure that are being investigated.
The fictional drug is not a study variable
and therefore is held constant.
(Comment 10) One comment
suggested that the route of drug
administration may influence the
participants’ responses, as oral
administration and inhaled medication
is preferable compared to injections.
Therefore, the comment suggested that
the study use fictitious drugs with
routes of administration that are similar
to top advertised DTC prescription
drugs.
(Response) This is outside the scope
of study objectives. The goal of the
studies is to understand the effect of
endorsement and payment disclosure on
perceived risks and benefits of DTC
promotion. Because the same drug is
being presented in each experimental
condition, the effects of mode of
administration are being held constant
in each study; therefore, any observed
effects are not related to the route of
administration chosen.
(Comment 11) One comment
suggested that in order to increase
internal validity, the location of the
disclosures in the promotional pieces
should be consistent across endorser
and/or disclosure type.
(Response) FDA will ensure that for
each study, disclosures will appear in
the same area of the promotional piece,
using similar font and style treatment.
(Comment 12) One comment
suggested that acne and endometriosis
drugs are not representative of the top
advertised prescription drugs and that
the current proposed study design,
therefore, may not represent the most
advertised DTC drugs in the market.
(Response) The purpose of the studies
is to understand the effect of
endorsement and payment disclosure on
perceived risks and benefits of DTC
promotion. The value of our approach is
random assignment to experimental
conditions and control of extraneous
variables. Choice of drug is not a study
variable and therefore held constant.
Although the type of drug may play a
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role in the perceptions of risks and
benefits, the value of our study is the
comparisons between experimental
conditions.
(Comment 13) Two comments
suggested that participants’
unfamiliarity with the proposed
conditions may bias their responses, so
it may be more useful to include only
patients with the condition as
participants in each study.
(Response) The study population is
those who are exposed to prescription
drug advertisements. For Study 1, we
chose a high incidence condition (acne)
so that it would be relatable to a large
segment of the population. Regardless of
whether or not the condition is
personally salient, the public is still
exposed to these advertisements.
For Study 2, we chose a condition
that is important to the influencer in the
study—and this information would be
known to many of her followers, who
are the research audience for Study 2.
Engagement and e-Word of Mouth have
been shown to be important behavioral
outcomes from social media promotion
(Ref. 3). Thus, in a real-world setting,
audience members may choose to
comment on or share the advertised
content with family or friends,
regardless of whether or not they have
the health condition themselves.
For both studies, we ask about
personal experience and involvement
with the health condition, and we will
assess whether these variables have any
effects.
(Comment 14) One comment
suggested ensuring that neutral language
is used when recruiting for Study 1’s
general population, so as not to select
for participants that are more
susceptible to the celebrity’s influence.
For example, the comment suggested
that the study ask participants if they
‘‘recognize’’ the celebrity vs. if they are
a ‘‘fan’’ of the celebrity.
(Response) In screeners for both
studies, we ask if participants are
‘‘familiar’’ with celebrities/influencers,
thus maintaining neutral language.
(Comment 15) Two comments
suggested participants’ familiarity with
the endorser may bias responses and
limit participant demographics. One
comment suggested that recruiting
participants from the follower list of an
Instagram influencer, as proposed in
Study 2, may skew the average age of
the participants to be younger,
especially if the influencer chosen for
this study is a ‘‘handheld name’’ versus
a ‘‘household name.’’ The comment also
suggested that the participants may have
a female skew. Another comment
suggested that the current inclusion
criteria should be expanded to also
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include followers of influencers with
similar content, recognition, and
follower demographics as the endorser
being tested, which will increase
external validity by encompassing
viewers that would likely see the post
through suggestions via Instagram’s
algorithm.
(Response) Familiarity with an
endorser has been shown to be an
important factor in attention given to
DTC advertisements (Ref. 2), and that is
one driver of an influencer’s value as an
endorser. By including endorser type as
an experimental condition, we seek to
isolate these effects. Thus, the biases
inherent in these relationships are a
necessary aspect of this topic area.
The study design is a betweensubjects design. Because participants are
only exposed to one promotional piece,
the specific effects from behavioral bias
can be isolated.
We agree with the commenter that
Study 2 will have a younger, female
skew. This is consistent with
Instagram’s audience more generally
(Ref. 7). Advertisers who use Instagram
influencers as endorsers will access the
same audience (i.e., Instagram
followers) as in our study. To minimize
confounds, we will limit the sample to
the influencer’s followers, who are
likely to be the most influenced by her.
Future research can be conducted on
whether our findings extrapolate to men
and older audiences.
(Comment 16) One comment
suggested that to account for the
potential bias in these studies, it would
be useful to include questions relating
to participant demographics in the
surveys, such as age, gender, and
attitude toward the celebrity or
influencer, if they are not already
included.
(Response) The survey includes
questions about participant
demographics and attitude toward
endorser.
(Comment 17) One comment
suggested that in order to prevent bias,
the study should exclude consumers
who work in healthcare or marketing
settings, primary care providers that
spend less than 50 percent of their time
on patient care, and Department of
Health and Human Service employees.
(Response) The studies in this
research do not include physician
participants. Consumers will be
excluded if they work for a
pharmaceutical company, an advertising
agency, a market research firm, or the
U.S. Department of Health and Human
Services. They will also be screened out
if they are not familiar with the
celebrity/influencer, and, for Study 2, if
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78863
they are biologically male, as men
cannot have endometriosis.
(Comment 18) One comment
suggested that the questionnaire is too
long and recommended deleting
questions or rewording.
(Response) We have had individuals
unfamiliar with the study test the
survey for length, and we found it takes
less than 20 minutes to complete.
Moreover, we will also conduct
pretesting to check timing and make
adjustments, if necessary, based on the
data from those pretests.
(Comment 19) One comment
suggested we should consistently use
balanced Likert scales with a neutral
midpoint.
(Response) This is a matter of debate
in the literature and has never been
resolved. Many of our measures derive
from previously validated scales, and
we prefer to maintain the scales on
which they were validated. However,
where appropriate, we do use 5-point
Likert scales with a neutral midpoint.
(Comment 20) One comment
recommended rewording Q17 (in both
study questionnaires) to state ‘‘What do
you remember about the safety
information presented?’’
(Response) Q17 is a validated (OMB
control number 0910–0861) closedended item asking how much risk
information was read (with a thumbnail
image highlighting the important safety
information). In order to increase
quality of response, we will keep the
closed-ended item. Moreover, openended questions take longer to answer,
and we want to maintain an appropriate
length of time to complete the survey.
(Comment 21) One comment
suggested that the adjectives that the
respondent is asked to rank in Q18a–
Q18e (Study 1) are redundant with only
nuanced differences that may not be
distinguishable to respondents, and
therefore suggested these items be
deleted. If they are retained, the
comment suggested labeling answer
choice #3 with ‘‘Neither unimportant
nor important.’’
(Response) These items were adapted
from Zaichowsky’s Disease State
Involvement scale (Ref. 8). The original
validated items used a 7-point scale
without a labeled midpoint. To be
consistent with most of the items and
with previous comments, we reduced
the scale to 5 points. However, we did
not include a labeled midpoint because
it could result in under-response for
values 2 and 4. This response applies to
Q20 (Study 2) as well, where we want
to ensure that individuals taking Study
2 on their mobile devices are not
overwhelmed.
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(Comment 22) One comment
suggested that Q20 and Q21 (Study 1)
may be redundant, and since Q20 uses
more consumer-friendly language to
seek respondent opinion on
effectiveness of drug, the comment
recommended removing Q21. This
comment also applies to Q22 and Q23
of Study 2.
(Response) We will remove Q21
(Study 1) and Q23 (Study 2).
(Comment 23) One comment
recommended that Q22 (Study 1) be
framed differently to help understand
how endorsers influence the
understanding of safety and risk and
that the answer choice should have an
option for respondents who do not
know.
(Response) We decline to make the
recommended change because this is a
validated item that FDA has used in
past survey experiments to measure
perceived risk likelihood.
(Comment 24) One comment
questioned the utility of asking whether
an endorser is ‘‘Attractive,’’ ‘‘Classy,’’
and ‘‘Elegant’’ (Q30, Study 1); whether
a drug name and endorser name ‘‘go
together’’ (Q31, Study 1); and how a
subject feels about the life and values of
the endorser (Q32, Study 1). The
comment recommended that FDA
consider deleting these questions.
(Response) In the marketing literature
on celebrity endorsements, these three
elements are well established as
important moderators in attitude toward
advertisement and behavioral intention.
‘‘Attractive,’’ ‘‘Classy,’’ and ‘‘Elegant’’
are elements in a 15-item scale validated
by Ohanian (1990) to measure endorser
credibility (Ref. 9). The literature refers
to ‘‘whether a drug name and endorser
go together’’ as ‘‘product match-up’’
(Ref. 10), and high match-up was
recently shown to be predictive of
behavioral intention for e-cigarettes
(Ref. 11). The level of identification that
consumers have with a celebrity
endorser has been shown to influence
how consumers attend to and process
information in an advertisement (Refs.
12 and13). Thus, we will maintain these
questions.
(Comment 25) One comment
suggested that, if the research is
intended to assess the influence of
endorsers or their payment status, Q15–
Q17 in both surveys and Q20–Q27 for
Study 1 and Q22–Q29 for Study 2
appear to be outside of the scope. With
these questions, subjects would be
asked to assess the risks and benefits of
a drug based on an advertisement. The
comment recommended that FDA delete
these questions or revise them so they
are focused instead on payment or
endorsement.
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(Response) As part of the examination
of the effect of the endorser, one
purpose of the study is to understand
the effect of endorsement and payment
disclosure in DTC promotion on
perceived risks and benefits of a
prescription drug. The questions
mentioned in this comment measure
these dependent variables—consumer
perceptions of risk and benefit
information presented in the promotion.
We will maintain these questions in
order to assess if endorsement and the
payment disclosure have any effects on
perceptions of risk and benefit
information.
(Comment 26) One comment
suggested that the structure of Q28
(Study 1) and Q30 (Study 2) should be
consistent with other questions in this
survey. It recommended changing each
question to include ‘‘What is the
likelihood’’ (e.g., What is the likelihood
that you would ask your doctor to
prescribe) and presenting answer
choices in a 5-point Likert scale.
(Response) We will assess how this
item functions in pretesting and make
any change that is warranted.
(Comment 27) One comment
suggested moving Q28a (Study 1) and
Q30a (Study 2) up in the survey, after
Q13, as this question could function as
a priming question after initial viewing
of ad.
(Response) Because this item is part of
a validated scale (Ref. 14), we will
maintain it at its current location in
both surveys.
(Comment 28) One comment
suggested that Q31 (Study 1) and Q33
(Study 2) construct and answer choices
should align with other similarly
constructed question and answer
choices in this section of the survey.
(Response) This is a validated item
(Ref. 15) to measure endorser-product
match-up. Therefore, we will maintain
the current format.
(Comment 29) One comment
suggested that Q33 (Study 1) and Q35
(Study 2) could cause respondent
confusion regarding what is meant by
‘‘background,’’ which could lead to
uninterpretable results. It recommended
explicitly stating what is meant by
‘‘background’’ (e.g., ‘‘I prefer a product
recommended by an endorser because of
his/her experience with this illness’’).
(Response) This is a validated item
(Ref. 16) that measures identification
with endorser; thus, we will maintain
its original form in both studies.
(Comment 30) One comment
mentioned that Q43–Q45 (Study 1) and
Q45–Q47 (Study 2) probe the level of
influence that endorsers have over
respondents and suggested adding a
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question asking if the respondent has
followed the advice of an endorser.
(Response) Q36–Q48 (Study 1) and
Q45–47 (Study 2) are validated items in
the celebrity-persona parasocialinvolvement scale (Ref. 17); thus, we
will maintain the integrity of the scale
and not add another question in this
series.
(Comment 31) One comment
suggested that the debriefing statements
in both questionnaires may serve the
respondent better if placed earlier in the
document as a disclaimer and suggested
placing the disclaimer language prior to
showing the promotional piece.
(Response) To maximize the attention
participants give to this survey task, we
do not wish to inform them of the
information in the debriefing statement
until they have completed the survey.
(Comment 32) One comment
suggested that Q18 and Q19 (Study 2)
are redundant, although respondents
may not define a paid endorser post as
advertising, and that the items seem
irrelevant. It recommended removing
Q18 from the questionnaire.
(Response) Previous experimental
studies on social media promotion have
found that participants did not
consistently notice a payment
disclosure or interpret a sponsored post
as advertising (Ref. 1). These issues are
central to the question of whether
consumers process payment disclosures.
Moreover, participants in cognitive
testing distinguished between the two
items.
(Comment 33) One comment noticed
that Q20 in Study 2 is similar to Q18 in
Study 1; however, answer choices are
not provided in a similar construct. The
comment recommended utilizing a 5point Likert scale to measure the
outcome.
(Response) We simplified the
response scale for Study 2 items, where
possible, to account for anticipated
higher usage of mobile devices. Because
we prefer a larger number of response
options in general, we plan to maintain
the 5-point Likert scale for Study 1, but
use the 3-point scale in Study 2 to
account for mobile devices.
(Comment 34) One comment
suggested that Q24 (Study 2) could be
framed differently to help understand
how endorsers influence the
understanding of safety and risk. The
comment recommended asking ‘‘Do you
recall the risk associated with the
medication?’’ and suggested that the
answer choice should have an option for
respondents who do not know.
(Response) Q24 and Q25 from Study
2 are closed-ended questions that ask
about recall of drug benefits and risks.
To be balanced, the question stem and
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response options should be parallel
between the two items. Moreover, we
cannot add additional open-ended
questions to the survey without
increasing participant fatigue. Thus, we
will maintain the closed-ended nature
of the question. We recognize that this
will be a difficult question for
participants, and therefore, we prefer
not to provide an option for ‘‘don’t
know.’’
FDA estimates the burden of this
collection of information as follows:
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1
Study
Study
Study
Study
Study
Study
1
1
1
2
2
2
Total annual
responses
Screener ..............................
Pretest .................................
Main Test .............................
Screener ..............................
Pretest .................................
Main Test .............................
933
249
405
1,417
266
432
1
1
1
1
1
1
933
249
405
1,417
266
432
Total ...........................................
........................
........................
........................
1 There
Average burden per response
0.08
0.33
0.33
0.08
0.33
0.33
Total hours
(5 minutes) ...............................
(20 minutes) .............................
(20 minutes) .............................
(5 minutes) ...............................
(20 minutes) .............................
(20 minutes) .............................
74.64
82.17
133.65
113.36
87.78
142.56
...........................................................
634.16
are no capital costs or operating and maintenance costs associated with this collection of information.
II. References
The following references are on
display with the Dockets Management
Staff (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240–402–
7500, and are available for viewing by
interested persons between 9 a.m. and 4
p.m., Monday through Friday; these are
not available electronically at https://
www.regulations.gov as these references
are copyright protected. Some may be
available at the website address, if
listed. FDA has verified the website
addresses, as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
Activity
1. LaTour, C. and M. Smith (1986). ‘‘A Study
of Expert Endorsement of OTC
Pharmaceutical Products.’’ Journal of
Pharmaceutical Marketing &
Management, vol. 1(2), pp. 117–128.
2. Bhutada, N.S. and B.L. Rollins (2015).
‘‘Disease-Specific Direct-to-Consumer
Advertising of Pharmaceuticals: An
Examination of Endorser Type and
Gender Effects on Consumers’ Attitudes
and Behaviors.’’ Research in Social
Administrative Pharmacy, vol. 11(6), pp.
891–900.
3. Boerman, S.C., L.M. Willemsen, and E.P.
Van Der Aa (2017). ‘‘ ‘This post is
sponsored’: Effects of Sponsorship
Disclosure on Persuasion Knowledge and
Electronic Word of Mouth in the Context
of Facebook.’’ Journal of Interactive
Marketing, vol. 38, pp. 82–92.
4. Cohen, J. (1988), ‘‘Statistical Power
Analysis for the Behavioral Sciences.’’
Routledge. ISBN 978–1–134–74270–7.
5. Faul, F., E. Erdfelder, A.G. Lang, et al.
(2007). ‘‘G*Power 3: A Flexible
Statistical Power Analysis Program for
the Social, Behavioral, and Biomedical
Sciences.’’ Behavior Research Methods,
vol. 39, pp. 175–191.
6. Woods, C.B., S. Baxter, E. King, et al.
(2017). ‘‘Celebrity? Doctor? Celebrity
doctor? Which Spokesperson Is Most
Effective for Cancer Prevention?’’ In E.
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Kendal and B. Diug (Eds.) Teaching
Medicine and Medical Ethics Using
Popular Culture (pp. 71–98). Palgrave
Studies in Science and Popular Culture.
Cham, Switzerland: Palgrave Macmillan.
doi:10.1007/978–3–319–65451–5_5.
7. https://www.statista.com/statistics/
398166/us-instagram-user-agedistribution/.
8. Zaichkowsky, J.L. (1994). ‘‘The Personal
Involvement Inventory: Reduction,
Revision, and Application to
Advertising.’’ Journal of Advertising, vol.
23(4), pp. 59–70.
9. Ohanian, R. (1990). ‘‘Construction and
Validation of a Scale to Measure
Celebrity Endorsers’ Perceived Expertise,
Trustworthiness, and Attractiveness.’’
Journal of Advertising, vol. 19(3), pp. 39–
52.
10. Kamins, M.A. and K. Gupta (1994).
‘‘Congruence Between Spokesperson and
Product Type: A Matchup Hypothesis
Perspective.’’ Psychology & Marketing,
vol. 11(6), pp. 569–586.
11. Phua, J., J.S.E. Lin, and D.J. Lim (2018).
‘‘Understanding Consumer Engagement
with Celebrity-Endorsed E-Cigarette
Advertising on Instagram.’’ Computers in
Human Behavior, vol. 84, pp. 93–102.
12. Brown, W.J. and M.C. Bocarnea (2007).
‘‘Celebrity-Persona Interaction Scale.’’ In
R.A. Reynolds, R. Woods, and J.D. Baker
(Eds.) Handbook of Research on
Electronic Surveys and Measurements
(pp. 302–305). Hershey, PA: Idea Group
Reference.
13. Brown, W.J. and M.A.C. De Matviuk
(2010). ‘‘Sports Celebrities and Public
Health: Diego Maradona’s Influence on
Drug Use Prevention.’’ Journal of Health
Communication, vol. 15(4), pp. 358–373.
14. Huh, J., D.E. DeLorme, and L.N. Reid
(2005). ‘‘Factors Affecting Trust in OnLine Prescription Drug Information and
Impact of Trust on Behavior Following
Exposure to DTC Advertising.’’ Journal
of Health Communication, vol. 10(8), pp.
711–731.
15. Till, B.D. and M. Busler (2000). ‘‘The
Match-Up Hypothesis: Physical
Attractiveness, Expertise, and the Role of
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Fit on Brand Attitude, Purchase Intent
and Brand Beliefs.’’ Journal of
Advertising, vol. 29(3), pp. 1–13.
16. Biswas, D., A. Biswas, and N. Das (2006).
‘‘The Differential Effects of Celebrity and
Expert Endorsements on Consumer Risk
Perceptions: The Role of Consumer
Knowledge, Perceived Congruency, and
Product Technology Orientation.’’
Journal of Advertising, vol. 35(2), pp. 17–
31.
17. Bocarnea, M.C. and W.J. Brown (2007).
‘‘Celebrity-Persona Parasocial Interaction
Scale.’’ In R.A. Reynolds, R. Woods, and
J.D. Baker (Eds.) Handbook of Research
on Electronic Surveys and Measurements
(pp. 309–312). Hershey, PA: Idea Group
Reference.
Dated: December 1, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–26799 Filed 12–4–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF THE INTERIOR
Bureau of Land Management
[19X.LLAK930000.L13100000. EI0000.241A]
Notice of 2021 Coastal Plain Alaska Oil
and Gas Lease Sale and Notice of
Availability of the Detailed Statement
of Sale
Bureau of Land Management,
Interior.
ACTION: Notice of sale.
AGENCY:
The Bureau of Land
Management (BLM) Alaska State Office
will hold an oil and gas lease sale bid
opening for tracts in the Coastal Plain of
the Arctic National Wildlife Refuge.
DATES: The oil and gas lease sale bid
opening will be at 10 a.m. Alaska
Standard Time (AKST) on January 6,
SUMMARY:
E:\FR\FM\07DEN1.SGM
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Agencies
[Federal Register Volume 85, Number 235 (Monday, December 7, 2020)]
[Notices]
[Pages 78859-78865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26799]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-5900]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Endorser Status and
Explicitness of Payment in Direct-to-Consumer Promotion
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, 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: Submit written comments (including recommendations) on the
collection of information by January 6, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comment'' or by using the search function. The title of this
information collection is ``Endorser Status and Explicitness of Payment
in Direct-to-Consumer Promotion.'' Also include the FDA docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
For copies of the questionnaires contact: Office of Prescription
Drug Promotion (OPDP) Research Team, [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.
Endorser Status and Explicitness of Payment in Direct-to-Consumer
Promotion
OMB Control Number 0910--NEW
I. Background
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 (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.
The Office of Prescription Drug Promotion's (OPDP) mission is to
protect the public health by helping to ensure that prescription drug
promotion is truthful, balanced, and accurately communicated. OPDP's
research program provides scientific evidence to help ensure that our
policies related to prescription drug promotion will have the greatest
benefit to public health. Toward that end, we have consistently
conducted research to evaluate the aspects of prescription drug
promotion that are most central to our mission. Our research focuses in
particular on three main topic areas: Advertising features, including
content and format; target populations; and research quality. Through
the evaluation of advertising features, we assess how elements such as
graphics, format, and disease and
[[Page 78860]]
product characteristics impact the communication and understanding of
prescription drug risks and benefits; focusing on target populations
allows us to evaluate how understanding of prescription drug risks and
benefits may vary as a function of audience, and our focus on research
quality aims at maximizing the quality of our research data through
analytical methodology development and investigation of sampling and
response issues. This study will inform the first topic area,
advertising features.
Because we recognize that the strength of data and the confidence
in the robust nature of the findings is improved by utilizing the
results of multiple converging studies, we continue to develop evidence
to inform our thinking. We evaluate the results from our studies within
the broader context of research and findings from other sources, and
this larger body of knowledge collectively informs our policies as well
as our research program. Our research is documented on our homepage,
which can be found at: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm. The website
includes links to the latest Federal Register notices and peer-reviewed
publications produced by our office. The website maintains information
on studies we have conducted, dating back to a survey on direct-to-
consumer (DTC) advertisements conducted in 1999.
Advertisers have used celebrity endorsers for years, and DTC
pharmaceutical promotion is no different. As researchers studied the
influence of celebrity endorsers, they theorized that a correspondence
bias occurs in which people believe that endorsers truly believe what
they are saying. LaTour and Smith (Ref. 1) examined whether a
pharmacist, physician, celebrity, or consumer would be most persuasive
in advertisements for four different types of OTC products. They found
that endorsements by expert physicians and pharmacists were the most
likely to lead to purchase intentions, followed by endorsements by
consumers, and lastly, by celebrities. The type of OTC product did not
affect the persuasiveness of an endorsement.
Bhutada and Rollins (Ref. 2) recently completed a study examining
the role of endorser type (i.e., celebrity vs. expert vs. non-
celebrity), and endorser and consumer gender in product DTC ads. They
found, like LaTour and Smith (Ref. 1), that expert endorsers were
thought of as higher in credibility and generally resulted in the same
amount of attention as celebrities. The authors did not find that
endorsement by experts resulted in greater consumer intention to pursue
the drug product.
We propose to extend previous research by examining four types of
endorsers in two separate studies (celebrity, physician, patient, non-
celebrity influencer) \1\ and examining whether the presence of a
disclosure of their payment status influences participant reactions. We
propose to also test two different types of disclosure language--one
direct and more consumer-friendly, and one less direct.
---------------------------------------------------------------------------
\1\ A ``non-celebrity influencer'' is a person who has gained a
following on a blog, a Twitter feed, or other social media outlet.
In the 60-day notice, the term ``influencer'' was used; we have
added language to specify influencers who were not previously
celebrities before their social media activities.
---------------------------------------------------------------------------
To complete this research, we propose the following concurrent
studies.\2\
---------------------------------------------------------------------------
\2\ For case allocation, the literature suggests that some
proportion of consumers may not recall seeing the disclosure
statement in the advertisement (see, for example, Boerman et al.;
Ref. 3). Rather than allotting equal numbers of cases to each
condition, we will assign more cases to the disclosure present
condition to increase power in these cells.
---------------------------------------------------------------------------
Study 1
Table 1a--Study 1 Design--Pretest
[0.80 power, 0.10 alpha, small effect size f=.2]
----------------------------------------------------------------------------------------------------------------
Endorser
Payment disclosure ------------------------------------------------ Total
Celebrity Physician Patient
----------------------------------------------------------------------------------------------------------------
Present......................................... 50 50 50 150
Absent.......................................... 33 33 33 99
---------------------------------------------------------------
Total....................................... 83 83 83 249
----------------------------------------------------------------------------------------------------------------
Table 1b--Study 1 Design--Main Study
[0.90 power, 0.05 alpha, small effect size f=.2]
----------------------------------------------------------------------------------------------------------------
Endorser
Payment disclosure ------------------------------------------------ Total
Celebrity Physician Patient
----------------------------------------------------------------------------------------------------------------
Present......................................... 81 81 81 243
Absent.......................................... 54 54 54 162
---------------------------------------------------------------
Total....................................... 135 135 135 405
----------------------------------------------------------------------------------------------------------------
Study 1 will manipulate endorser type (three levels: Celebrity,
physician, patient) and payment disclosure (two levels: Present,
absent) within a print DTC ad for a fictitious acne product. For this
study, we will recruit 654 general population individuals (249 pretest;
405 main study) from the Kantar Lightspeed national nonprobability
internet panel. All participants must report familiarity with the
celebrity to be included in our study. The celebrity will be one who
has publicly spoken out about acne. We are not divulging the identity
of the celebrity in this public forum to maintain the integrity of our
research process. Stock photos will be used to depict a physician and a
patient in the other experimental conditions. Participants will be
randomly assigned to see one of the endorsers and to see the ad either
with or without a payment disclosure. The payment disclosure in Study 1
will be determined in cognitive
[[Page 78861]]
testing but will be similar to: ``[Endorser] has been paid to appear in
this ad for Drug X.''
Study 2
Table 2a--Study 2 Design--Pretest
[0.80 power, 0.10 alpha, small effect size f=.2]
----------------------------------------------------------------------------------------------------------------
Endorser
Payment disclosure -------------------------------- Total
Influencer Patient
----------------------------------------------------------------------------------------------------------------
Present-Direct.................................................. 50 50 100
Present-Indirect................................................ 50 50 100
Absent.......................................................... 33 33 66
-----------------------------------------------
Total....................................................... 133 133 266
----------------------------------------------------------------------------------------------------------------
Table 2b--Study 2 Design--Main Study
[0.90 power, 0.05 alpha, small effect size f=.2]
----------------------------------------------------------------------------------------------------------------
Endorser
Payment disclosure -------------------------------- Total
Influencer Patient
----------------------------------------------------------------------------------------------------------------
Present-Direct.................................................. 81 81 162
Present-Indirect................................................ 81 81 162
Absent.......................................................... 54 54 108
-----------------------------------------------
Total....................................................... 216 216 432
----------------------------------------------------------------------------------------------------------------
In Study 2, we will also manipulate endorser type, examining a
patient and an internet influencer, one who provides online content to
a number of followers. We will also manipulate the explicitness of the
payment disclosure, resulting in a 2 (endorser: Influencer, patient) by
3 (payment disclosure: Present-direct, present-indirect, absent)
between-subjects design. The disclosure will be direct (e.g., ``Paid
ad. . .''), indirect (e.g., #sp for ``sponsored''), or absent. The
setting for this study will be an Instagram post for a fictitious
endometriosis product. This study partially replicates Study 1 and
extends it by further examining the explicitness of payment as another
manipulated variable and using a different set of endorser types and in
a different promotional setting.
For Study 2, we will recruit 698 (266 pretest; 432 main study)
followers of an internet influencer who maintains an Instagram page
with more than 500,000 followers and has posted about endometriosis. As
in the first study, we are not revealing the influencer's identity in
this public forum to maintain the integrity of the study.
In both studies, we are interested in the role of endorsement and
disclosure of payment status on participants' recall, benefit and risk
perceptions, and behavioral intentions. Participants will view one
promotional piece and answer questions via the internet. The study is
expected to take less than 20 minutes to complete. Dependent variables
will include attention to disclosure statement and risk/benefit
information; retention of risk/benefit information; recognition of
piece as promotion and endorser as paid; perceived benefits and risks,
attitudes toward the product, endorser, and ad; and behavioral
intentions, such as asking a doctor about the drug.
In the Federal Register of January 28, 2020 (85 FR 4994), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received six submissions that were PRA-
related. One submission (https://www.regulations.gov/docketBrowser?rpp=25&po=0&dct=PS&D=FDA-2019-N-5900&refD=FDA-2019-N-5900-0001) was a brief statement of support for the research and is not
addressed further. Within the remaining five submissions, FDA received
multiple comments that the Agency has addressed below. For brevity,
some public comments are paraphrased and, therefore, may not reflect
the exact language used by the commenter. We assure commenters that the
entirety of their comments was considered even if not fully captured by
our paraphrasing in this document. The following acronyms are used
here: DTC = direct-to-consumer; FDA and ``The Agency'' = Food and Drug
Administration; OPDP = FDA's Office of Prescription Drug Promotion; and
FTC = Federal Trade Commission.
(Comment 1) One comment suggested that the proposed research, at
least in part, is duplicative of information otherwise reasonably
available to FDA. The comment pointed out that the Notice cites three
scientific references, and it does not address the other literature
that exists on the subject of endorsers in advertising. The comment
recommended that FDA assemble and review the relevant literature on
endorsement to ensure the research questions have not already been
answered.
(Response) A literature review was conducted as part of this
project that identified relevant literature. We identified a
significant gap in the literature regarding the impact of social media
influencers in prescription drug DTC advertisements, as well as a lack
of information about the impact of explicit payment disclosure. The
research questions outlined in our proposed research were designed to
address this gap.
(Comment 2) One comment suggested that, although the studies
contain clear variables, they appear to lack clearly defined primary
outcomes and prespecified hypotheses for testing. The comment also
noted that the studies do not appear to be designed to account for Type
I error; thus, the results may be uninterpretable. The comment
recommended that FDA propose a primary endpoint for each study and
power each study to test it.
(Response) Specific hypotheses have been developed for each of the
outcome variables, as described earlier in the notice. We will adjust
for multiple comparisons using the Bonferroni correction.
[[Page 78862]]
(Comment 3) One comment suggested that it is unclear how FDA came
up with the proposed sample sizes for the two related studies. For
example, the comment stated that the chart for pretest 1 contains the
following notation: ``(0.80 power, 0.10 alpha, small effect size
f=.2),'' but it is unclear what f=.2 means in this context. The comment
requested that FDA explain what statistical model it used to estimate
the study size and how it determined that the relevant effect size is
.2.
(Response) f=.2 is a common standard used to calculate small effect
size in experimental studies (Ref. 4). We used G*Power to estimate
study size (Ref. 5).
(Comment 4) One comment suggested that the proposed research is
unnecessary to the proper performance of FDA's functions because the
FTC takes the lead on regulating endorsement. The comment stated that
FDA has not addressed the extensive framework and guidance available
from the FTC on this topic. The comment further stated that, although
use of an endorser might conceivably inform an assessment of whether
advertising or promotion is false or misleading, it is not clear how
FDA views this new research on endorser status as fitting into its core
regulatory jurisdiction or activities.
(Response) FDA and the FTC have a long history of working
collaboratively to protect American consumers. While the FTC does
regulate endorsement in many types of commercial advertisements, FDA
has authority to regulate prescription drug advertising with respect to
the safety and effectiveness of such drugs. In line with FDA's
responsibility to ensure that prescription drug advertising and other
promotional communications are truthful and non-misleading, the present
research will provide data on how elements related to endorsement
presentations in prescription drug promotion impact audience perception
and comprehension. Collecting this data is critical to FDA's science-
based approach to assessing prescription drug promotion to determine
whether it communicates information about prescription drugs to
consumers in a truthful, non-misleading way. We note that as part of
the process of developing the present research, FDA carefully evaluated
the FTC guidance on endorser issues.
(Comment 5) One comment recommended that alignment and input should
be obtained from the FTC regarding the design of the study and
usability of the results.
(Response) We evaluated the current FTC guidance on endorsement
disclosure when developing this study and all relevant elements of its
design, including our hypotheses, test stimuli, etc.
(Comment 6) One comment suggested that the research may be skewed
by the influence of a particular celebrity. The comment recommended
that the study be amended so it is not subject to bias by the influence
of one particular well-known celebrity.
(Response) Familiarity with an endorser has shown to be an
important factor in attention to DTC advertisements, but the evidence
is less strong that familiarity uniquely affects other outcomes such as
behavioral intention (see, for example, Refs. 2 and 6). The celebrity
used in Study 1 will have high levels of public recognition, so we
anticipate few participants will be filtered out due to low levels of
familiarity with endorser. We recognize that the individual
characteristics of the celebrity may drive responses. This possibility
is an unavoidable limitation of the study design, and we will be
transparent when reporting results.
(Comment 7) One comment recommended that FDA use #ad instead of
#sp. The comment noted that FTC has stated that #ad is an effective
disclosure of sponsorship.
(Response) Our review of current practices shows that vendors
continue to indicate endorsement by #sp online. An indirect disclosure
such as #sp serves as a useful comparator to a direct disclosure such
as ``Paid ad. . .'', helping us answer the research question of whether
direct and indirect acknowledgements of endorsement vary in their
influence on attitudes and perceptions.
(Comment 8) One comment recommended that FDA incorporate some type
of control into each study.
(Response) We have designed these studies to include a control. The
control, in both studies, is a duplicate version of the promotion
featuring endorsement by a patient, as opposed to a celebrity or
influencer, without inclusion of a payment disclosure.
(Comment 9) One comment suggested that FDA should ensure that the
hypothetical products used in the proposed surveys do not too closely
resemble real products. For example, the conditions of use and the risk
of the hypothetical products should not mirror FDA-approved labeling
language for any marketed products. In addition, FDA should only
present hypothetical drug advertisements for diseases with many
treatment options from multiple sponsors. Otherwise, the comment states
that FDA's research could inadvertently harm one particular sponsor.
(Response) The prescription drugs used in this study, while based
on existing prescription treatments, are fictitious with names and
branding that do not mirror any marketed products. Although we have
created the pieces to be as realistic as possible, FDA does not intend
to single out any real product on the basis of our fictional promotion.
We specifically use fictitious products and materials to avoid the
confound of prior knowledge of actual products. Moreover, it is the
endorser type and messaging around the endorsement disclosure that are
being investigated. The fictional drug is not a study variable and
therefore is held constant.
(Comment 10) One comment suggested that the route of drug
administration may influence the participants' responses, as oral
administration and inhaled medication is preferable compared to
injections. Therefore, the comment suggested that the study use
fictitious drugs with routes of administration that are similar to top
advertised DTC prescription drugs.
(Response) This is outside the scope of study objectives. The goal
of the studies is to understand the effect of endorsement and payment
disclosure on perceived risks and benefits of DTC promotion. Because
the same drug is being presented in each experimental condition, the
effects of mode of administration are being held constant in each
study; therefore, any observed effects are not related to the route of
administration chosen.
(Comment 11) One comment suggested that in order to increase
internal validity, the location of the disclosures in the promotional
pieces should be consistent across endorser and/or disclosure type.
(Response) FDA will ensure that for each study, disclosures will
appear in the same area of the promotional piece, using similar font
and style treatment.
(Comment 12) One comment suggested that acne and endometriosis
drugs are not representative of the top advertised prescription drugs
and that the current proposed study design, therefore, may not
represent the most advertised DTC drugs in the market.
(Response) The purpose of the studies is to understand the effect
of endorsement and payment disclosure on perceived risks and benefits
of DTC promotion. The value of our approach is random assignment to
experimental conditions and control of extraneous variables. Choice of
drug is not a study variable and therefore held constant. Although the
type of drug may play a
[[Page 78863]]
role in the perceptions of risks and benefits, the value of our study
is the comparisons between experimental conditions.
(Comment 13) Two comments suggested that participants'
unfamiliarity with the proposed conditions may bias their responses, so
it may be more useful to include only patients with the condition as
participants in each study.
(Response) The study population is those who are exposed to
prescription drug advertisements. For Study 1, we chose a high
incidence condition (acne) so that it would be relatable to a large
segment of the population. Regardless of whether or not the condition
is personally salient, the public is still exposed to these
advertisements.
For Study 2, we chose a condition that is important to the
influencer in the study--and this information would be known to many of
her followers, who are the research audience for Study 2. Engagement
and e-Word of Mouth have been shown to be important behavioral outcomes
from social media promotion (Ref. 3). Thus, in a real-world setting,
audience members may choose to comment on or share the advertised
content with family or friends, regardless of whether or not they have
the health condition themselves.
For both studies, we ask about personal experience and involvement
with the health condition, and we will assess whether these variables
have any effects.
(Comment 14) One comment suggested ensuring that neutral language
is used when recruiting for Study 1's general population, so as not to
select for participants that are more susceptible to the celebrity's
influence. For example, the comment suggested that the study ask
participants if they ``recognize'' the celebrity vs. if they are a
``fan'' of the celebrity.
(Response) In screeners for both studies, we ask if participants
are ``familiar'' with celebrities/influencers, thus maintaining neutral
language.
(Comment 15) Two comments suggested participants' familiarity with
the endorser may bias responses and limit participant demographics. One
comment suggested that recruiting participants from the follower list
of an Instagram influencer, as proposed in Study 2, may skew the
average age of the participants to be younger, especially if the
influencer chosen for this study is a ``handheld name'' versus a
``household name.'' The comment also suggested that the participants
may have a female skew. Another comment suggested that the current
inclusion criteria should be expanded to also include followers of
influencers with similar content, recognition, and follower
demographics as the endorser being tested, which will increase external
validity by encompassing viewers that would likely see the post through
suggestions via Instagram's algorithm.
(Response) Familiarity with an endorser has been shown to be an
important factor in attention given to DTC advertisements (Ref. 2), and
that is one driver of an influencer's value as an endorser. By
including endorser type as an experimental condition, we seek to
isolate these effects. Thus, the biases inherent in these relationships
are a necessary aspect of this topic area.
The study design is a between-subjects design. Because participants
are only exposed to one promotional piece, the specific effects from
behavioral bias can be isolated.
We agree with the commenter that Study 2 will have a younger,
female skew. This is consistent with Instagram's audience more
generally (Ref. 7). Advertisers who use Instagram influencers as
endorsers will access the same audience (i.e., Instagram followers) as
in our study. To minimize confounds, we will limit the sample to the
influencer's followers, who are likely to be the most influenced by
her. Future research can be conducted on whether our findings
extrapolate to men and older audiences.
(Comment 16) One comment suggested that to account for the
potential bias in these studies, it would be useful to include
questions relating to participant demographics in the surveys, such as
age, gender, and attitude toward the celebrity or influencer, if they
are not already included.
(Response) The survey includes questions about participant
demographics and attitude toward endorser.
(Comment 17) One comment suggested that in order to prevent bias,
the study should exclude consumers who work in healthcare or marketing
settings, primary care providers that spend less than 50 percent of
their time on patient care, and Department of Health and Human Service
employees.
(Response) The studies in this research do not include physician
participants. Consumers will be excluded if they work for a
pharmaceutical company, an advertising agency, a market research firm,
or the U.S. Department of Health and Human Services. They will also be
screened out if they are not familiar with the celebrity/influencer,
and, for Study 2, if they are biologically male, as men cannot have
endometriosis.
(Comment 18) One comment suggested that the questionnaire is too
long and recommended deleting questions or rewording.
(Response) We have had individuals unfamiliar with the study test
the survey for length, and we found it takes less than 20 minutes to
complete. Moreover, we will also conduct pretesting to check timing and
make adjustments, if necessary, based on the data from those pretests.
(Comment 19) One comment suggested we should consistently use
balanced Likert scales with a neutral midpoint.
(Response) This is a matter of debate in the literature and has
never been resolved. Many of our measures derive from previously
validated scales, and we prefer to maintain the scales on which they
were validated. However, where appropriate, we do use 5-point Likert
scales with a neutral midpoint.
(Comment 20) One comment recommended rewording Q17 (in both study
questionnaires) to state ``What do you remember about the safety
information presented?''
(Response) Q17 is a validated (OMB control number 0910-0861)
closed-ended item asking how much risk information was read (with a
thumbnail image highlighting the important safety information). In
order to increase quality of response, we will keep the closed-ended
item. Moreover, open-ended questions take longer to answer, and we want
to maintain an appropriate length of time to complete the survey.
(Comment 21) One comment suggested that the adjectives that the
respondent is asked to rank in Q18a-Q18e (Study 1) are redundant with
only nuanced differences that may not be distinguishable to
respondents, and therefore suggested these items be deleted. If they
are retained, the comment suggested labeling answer choice #3 with
``Neither unimportant nor important.''
(Response) These items were adapted from Zaichowsky's Disease State
Involvement scale (Ref. 8). The original validated items used a 7-point
scale without a labeled midpoint. To be consistent with most of the
items and with previous comments, we reduced the scale to 5 points.
However, we did not include a labeled midpoint because it could result
in under-response for values 2 and 4. This response applies to Q20
(Study 2) as well, where we want to ensure that individuals taking
Study 2 on their mobile devices are not overwhelmed.
[[Page 78864]]
(Comment 22) One comment suggested that Q20 and Q21 (Study 1) may
be redundant, and since Q20 uses more consumer-friendly language to
seek respondent opinion on effectiveness of drug, the comment
recommended removing Q21. This comment also applies to Q22 and Q23 of
Study 2.
(Response) We will remove Q21 (Study 1) and Q23 (Study 2).
(Comment 23) One comment recommended that Q22 (Study 1) be framed
differently to help understand how endorsers influence the
understanding of safety and risk and that the answer choice should have
an option for respondents who do not know.
(Response) We decline to make the recommended change because this
is a validated item that FDA has used in past survey experiments to
measure perceived risk likelihood.
(Comment 24) One comment questioned the utility of asking whether
an endorser is ``Attractive,'' ``Classy,'' and ``Elegant'' (Q30, Study
1); whether a drug name and endorser name ``go together'' (Q31, Study
1); and how a subject feels about the life and values of the endorser
(Q32, Study 1). The comment recommended that FDA consider deleting
these questions.
(Response) In the marketing literature on celebrity endorsements,
these three elements are well established as important moderators in
attitude toward advertisement and behavioral intention. ``Attractive,''
``Classy,'' and ``Elegant'' are elements in a 15-item scale validated
by Ohanian (1990) to measure endorser credibility (Ref. 9). The
literature refers to ``whether a drug name and endorser go together''
as ``product match-up'' (Ref. 10), and high match-up was recently shown
to be predictive of behavioral intention for e-cigarettes (Ref. 11).
The level of identification that consumers have with a celebrity
endorser has been shown to influence how consumers attend to and
process information in an advertisement (Refs. 12 and13). Thus, we will
maintain these questions.
(Comment 25) One comment suggested that, if the research is
intended to assess the influence of endorsers or their payment status,
Q15-Q17 in both surveys and Q20-Q27 for Study 1 and Q22-Q29 for Study 2
appear to be outside of the scope. With these questions, subjects would
be asked to assess the risks and benefits of a drug based on an
advertisement. The comment recommended that FDA delete these questions
or revise them so they are focused instead on payment or endorsement.
(Response) As part of the examination of the effect of the
endorser, one purpose of the study is to understand the effect of
endorsement and payment disclosure in DTC promotion on perceived risks
and benefits of a prescription drug. The questions mentioned in this
comment measure these dependent variables--consumer perceptions of risk
and benefit information presented in the promotion. We will maintain
these questions in order to assess if endorsement and the payment
disclosure have any effects on perceptions of risk and benefit
information.
(Comment 26) One comment suggested that the structure of Q28 (Study
1) and Q30 (Study 2) should be consistent with other questions in this
survey. It recommended changing each question to include ``What is the
likelihood'' (e.g., What is the likelihood that you would ask your
doctor to prescribe) and presenting answer choices in a 5-point Likert
scale.
(Response) We will assess how this item functions in pretesting and
make any change that is warranted.
(Comment 27) One comment suggested moving Q28a (Study 1) and Q30a
(Study 2) up in the survey, after Q13, as this question could function
as a priming question after initial viewing of ad.
(Response) Because this item is part of a validated scale (Ref.
14), we will maintain it at its current location in both surveys.
(Comment 28) One comment suggested that Q31 (Study 1) and Q33
(Study 2) construct and answer choices should align with other
similarly constructed question and answer choices in this section of
the survey.
(Response) This is a validated item (Ref. 15) to measure endorser-
product match-up. Therefore, we will maintain the current format.
(Comment 29) One comment suggested that Q33 (Study 1) and Q35
(Study 2) could cause respondent confusion regarding what is meant by
``background,'' which could lead to uninterpretable results. It
recommended explicitly stating what is meant by ``background'' (e.g.,
``I prefer a product recommended by an endorser because of his/her
experience with this illness'').
(Response) This is a validated item (Ref. 16) that measures
identification with endorser; thus, we will maintain its original form
in both studies.
(Comment 30) One comment mentioned that Q43-Q45 (Study 1) and Q45-
Q47 (Study 2) probe the level of influence that endorsers have over
respondents and suggested adding a question asking if the respondent
has followed the advice of an endorser.
(Response) Q36-Q48 (Study 1) and Q45-47 (Study 2) are validated
items in the celebrity-persona parasocial-involvement scale (Ref. 17);
thus, we will maintain the integrity of the scale and not add another
question in this series.
(Comment 31) One comment suggested that the debriefing statements
in both questionnaires may serve the respondent better if placed
earlier in the document as a disclaimer and suggested placing the
disclaimer language prior to showing the promotional piece.
(Response) To maximize the attention participants give to this
survey task, we do not wish to inform them of the information in the
debriefing statement until they have completed the survey.
(Comment 32) One comment suggested that Q18 and Q19 (Study 2) are
redundant, although respondents may not define a paid endorser post as
advertising, and that the items seem irrelevant. It recommended
removing Q18 from the questionnaire.
(Response) Previous experimental studies on social media promotion
have found that participants did not consistently notice a payment
disclosure or interpret a sponsored post as advertising (Ref. 1). These
issues are central to the question of whether consumers process payment
disclosures. Moreover, participants in cognitive testing distinguished
between the two items.
(Comment 33) One comment noticed that Q20 in Study 2 is similar to
Q18 in Study 1; however, answer choices are not provided in a similar
construct. The comment recommended utilizing a 5-point Likert scale to
measure the outcome.
(Response) We simplified the response scale for Study 2 items,
where possible, to account for anticipated higher usage of mobile
devices. Because we prefer a larger number of response options in
general, we plan to maintain the 5-point Likert scale for Study 1, but
use the 3-point scale in Study 2 to account for mobile devices.
(Comment 34) One comment suggested that Q24 (Study 2) could be
framed differently to help understand how endorsers influence the
understanding of safety and risk. The comment recommended asking ``Do
you recall the risk associated with the medication?'' and suggested
that the answer choice should have an option for respondents who do not
know.
(Response) Q24 and Q25 from Study 2 are closed-ended questions that
ask about recall of drug benefits and risks. To be balanced, the
question stem and
[[Page 78865]]
response options should be parallel between the two items. Moreover, we
cannot add additional open-ended questions to the survey without
increasing participant fatigue. Thus, we will maintain the closed-ended
nature of the question. We recognize that this will be a difficult
question for participants, and therefore, we prefer not to provide an
option for ``don't know.''
FDA estimates the burden of this collection of information as
follows:
Table 3--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Study 1 Screener.............. 933 1 933 0.08 (5 minutes) 74.64
Study 1 Pretest............... 249 1 249 0.33 (20 82.17
minutes).
Study 1 Main Test............. 405 1 405 0.33 (20 133.65
minutes).
Study 2 Screener.............. 1,417 1 1,417 0.08 (5 minutes) 113.36
Study 2 Pretest............... 266 1 266 0.33 (20 87.78
minutes).
Study 2 Main Test............. 432 1 432 0.33 (20 142.56
minutes).
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 634.16
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
II. References
The following references are on display with the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240-402-7500, and are available for viewing
by interested persons between 9 a.m. and 4 p.m., Monday through Friday;
these are not available electronically at https://www.regulations.gov
as these references are copyright protected. Some may be available at
the website address, if listed. FDA has verified the website addresses,
as of the date this document publishes in the Federal Register, but
websites are subject to change over time.
1. LaTour, C. and M. Smith (1986). ``A Study of Expert Endorsement
of OTC Pharmaceutical Products.'' Journal of Pharmaceutical
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2. Bhutada, N.S. and B.L. Rollins (2015). ``Disease-Specific Direct-
to-Consumer Advertising of Pharmaceuticals: An Examination of
Endorser Type and Gender Effects on Consumers' Attitudes and
Behaviors.'' Research in Social Administrative Pharmacy, vol. 11(6),
pp. 891-900.
3. Boerman, S.C., L.M. Willemsen, and E.P. Van Der Aa (2017). ``
`This post is sponsored': Effects of Sponsorship Disclosure on
Persuasion Knowledge and Electronic Word of Mouth in the Context of
Facebook.'' Journal of Interactive Marketing, vol. 38, pp. 82-92.
4. Cohen, J. (1988), ``Statistical Power Analysis for the Behavioral
Sciences.'' Routledge. ISBN 978-1-134-74270-7.
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Flexible Statistical Power Analysis Program for the Social,
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Physical Attractiveness, Expertise, and the Role of Fit on Brand
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16. Biswas, D., A. Biswas, and N. Das (2006). ``The Differential
Effects of Celebrity and Expert Endorsements on Consumer Risk
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17. Bocarnea, M.C. and W.J. Brown (2007). ``Celebrity-Persona
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Baker (Eds.) Handbook of Research on Electronic Surveys and
Measurements (pp. 309-312). Hershey, PA: Idea Group Reference.
Dated: December 1, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26799 Filed 12-4-20; 8:45 am]
BILLING CODE 4164-01-P