Agency Information Collection Activities; Proposed Collection; Comment Request; Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion, 4994-4997 [2020-01408]
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4994
Federal Register / Vol. 85, No. 18 / Tuesday, January 28, 2020 / Notices
(Pub. L. 111–148) and the Health Care
and Education Reconciliation Act of
2010 (Pub. L. 111–152) (collectively, the
Patient Protection and Affordable Care
Act (PPACA)) were signed into law in
2010. The PPACA established
competitive private health insurance
markets, called Marketplaces or
Exchanges, which give millions of
Americans and small businesses access
to qualified health plans (QHPs),
including stand-alone dental plans
(SADPs)—private health and dental
insurance plans that are certified as
meeting certain standards. The PPACA
added section 1150A of the Social
Security Act, which requires pharmacy
benefit managers (PBMs) to report
prescription benefit information to the
Department of Health and Human
Services (HHS). PBMs are third-party
administrators of prescription programs
for a variety of types of health plans,
including QHPs. The Centers for
Medicare and Medicaid Services (CMS)
files this information collection request
(ICR) in connection with the
prescription benefit information that
PBMs must provide to HHS under
section 1150A. The burden estimate for
this ICR reflects the time and effort for
PBMs to submit the information
regarding PBMs and prescription drugs.
Form Number: CMS–10725 (OMB
control number: 0938–NEW);
Frequency: Annually; Affected Public:
Private Sector (business or other forprofits), Number of Respondents: 40;
Number of Responses: 275. Total
Annual Hours: 1,400. For questions
regarding this collection contact Ken
Buerger at 410–786–1190.
Dated: January 23, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2020–01463 Filed 1–27–20; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
jbell on DSKJLSW7X2PROD with NOTICES
[Docket No. FDA–2019–N–5900]
Agency Information Collection
Activities; Proposed Collection;
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 or Agency) is
17:02 Jan 27, 2020
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
SUMMARY:
VerDate Sep<11>2014
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on a proposed study
entitled ‘‘Endorser Status and
Explicitness of Payment in Direct-toConsumer Promotion.’’
DATES: Submit either electronic or
written comments on the collection of
information by March 30, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before March 30,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of March 30, 2020. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
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Submit written/paper submissions as
follows:
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• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–N–5900 for ‘‘Endorser Status and
Explicitness of Payment in Direct-toConsumer Promotion.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
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Federal Register / Vol. 85, No. 18 / Tuesday, January 28, 2020 / Notices
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
Endorser Status and Explicitness of
Payment in Direct-to-Consumer
Promotion; OMB Control Number 0910–
NEW
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 questionnaire
contact: Office of Prescription Drug
Promotion (OPDP) Research Team,
DTCResearch@fda.hhs.gov.
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
promotional material is truthful,
balanced, and accurately
communicated, so that patients and
healthcare providers can make informed
decisions about treatment options.
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, focusing 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
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 research data
through analytical methodology
development and investigation of
sampling and response issues. This
study will inform the first topic area.
Because we recognize the strength of
data and the confidence in the robust
nature of the findings is improved
through 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
FOR FURTHER INFORMATION CONTACT:
Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
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SUPPLEMENTARY INFORMATION:
1 ‘‘Influencer’’ is a ‘‘regular’’ person who has
gained a following on a blog, a Twitter feed, or
other social media medium.
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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
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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 direct-toconsumer (DTC) survey 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 the
endorser truly believes 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 physicians and
pharmacists were the most likely to lead
to purchase intentions, followed by
consumers, and lastly, by celebrities.
There were no differences among types
of OTC product.
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 these endorsers resulted in greater
intentions to pursue the drug product.
We propose to extend previous
research by examining four types of
endorsers in two separate studies
(celebrity, physician, patient,
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 A
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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Federal Register / Vol. 85, No. 18 / Tuesday, January 28, 2020 / Notices
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
Celebrity
Physician
Patient
Present .............................................................................................................
Absent ..............................................................................................................
81
54
81
54
81
54
243
162
Total ..........................................................................................................
135
135
135
405
Study A 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 a national
nonprobability internet panel called
Dynata, formerly ResearchNow. 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
testing, but will be similar to:
‘‘[Endorser] has been paid to appear in
this ad for Drug X.’’
Study B
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
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Payment Disclosure
Total
Influencer
Patient
Present-Direct ..............................................................................................................................
Present-Indirect ............................................................................................................................
Absent ..........................................................................................................................................
81
81
54
81
81
54
162
162
108
Total ......................................................................................................................................
216
216
432
In Study B 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
in addition to its presence, resulting in
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a two (endorser: Influencer, patient) by
three (payment disclosure: Presentdirect, 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
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an Instagram post for a fictitious
endometriosis product. This study
partially replicates Study A and extends
it by further tweaking the explicitness of
payment as another manipulated
variable and using a different set of
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Federal Register / Vol. 85, No. 18 / Tuesday, January 28, 2020 / Notices
endorser types and in a different
promotional setting.
For Study B, 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 to maintain the integrity of the
study.
In both studies, we are interested in
the role of endorsement and 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;
4997
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.
FDA estimates the burden of this
collection of information as follows:
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Study
Study
Study
Study
Study
Study
1
1
1
2
2
2
Average
burden per
response
Total annual
respondents
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
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 (see ADDRESSES) 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.
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Number of
responses per
respondent
1. LaTour, C. and M. Smith, (1986). ‘‘A
Study of Expert Endorsement of OTC
Pharmaceutical Products.’’ Journal of
Pharmaceutical Marketing & Management,
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, 11(6), pp. 891–
910.
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, 38, pp. 82–
92.
Dated: January 21, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–01408 Filed 1–27–20; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–5606]
Arthroscopy Pump Tubing Sets
Intended for Multiple Patient Use—
Premarket Notification (510(k))
Submissions; Draft Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Arthroscopy Pump
Tubing Sets Intended for Multiple
Patient Use—Premarket Notification
(510(k)) Submissions.’’ FDA has
developed this draft guidance document
to assist in the preparation of premarket
notification submissions (510(k)) for
arthroscopy pump tubing sets intended
for multiple patient use. This draft
guidance outlines the device design
considerations, risk mitigation
strategies, and testing recommendations
for arthroscopy pump tubing sets
intended for multiple patient use. This
draft guidance document also clarifies
the terminology used to describe
arthroscopy pump tubing sets intended
for multiple patient use. This draft
guidance is not final nor is it in effect
at this time.
SUMMARY:
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Submit either electronic or
written comments on the draft guidance
by March 30, 2020 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
DATES:
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
E:\FR\FM\28JAN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 18 (Tuesday, January 28, 2020)]
[Notices]
[Pages 4994-4997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01408]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-5900]
Agency Information Collection Activities; Proposed Collection;
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 or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on a proposed study entitled ``Endorser Status and
Explicitness of Payment in Direct-to-Consumer Promotion.''
DATES: Submit either electronic or written comments on the collection
of information by March 30, 2020.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 30, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 30, 2020. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2019-N-5900 for ``Endorser Status and Explicitness of Payment in
Direct-to-Consumer Promotion.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the
[[Page 4995]]
``Search'' box and follow the prompts and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
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 questionnaire contact: Office of Prescription
Drug Promotion (OPDP) Research Team, [email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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
promotional material is truthful, balanced, and accurately
communicated, so that patients and healthcare providers can make
informed decisions about treatment options. 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, focusing 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 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 research data through analytical methodology development and
investigation of sampling and response issues. This study will inform
the first topic area.
Because we recognize the strength of data and the confidence in the
robust nature of the findings is improved through 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 direct-to-consumer (DTC)
survey 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 the endorser truly believes
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 physicians and pharmacists were the most likely to lead to
purchase intentions, followed by consumers, and lastly, by celebrities.
There were no differences among types of OTC product.
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 these
endorsers resulted in greater intentions to pursue the drug product.
We propose to extend previous research by examining four types of
endorsers in two separate studies (celebrity, physician, patient,
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\ ``Influencer'' is a ``regular'' person who has gained a
following on a blog, a Twitter feed, or other social media medium.
---------------------------------------------------------------------------
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 A
[[Page 4996]]
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 A 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 a national nonprobability internet panel called
Dynata, formerly ResearchNow. 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 testing, but will
be similar to: ``[Endorser] has been paid to appear in this ad for Drug
X.''
Study B
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 B 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 in addition to its presence, resulting in a two
(endorser: Influencer, patient) by three (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 A and extends it by further tweaking the
explicitness of payment as another manipulated variable and using a
different set of
[[Page 4997]]
endorser types and in a different promotional setting.
For Study B, 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 to
maintain the integrity of the study.
In both studies, we are interested in the role of endorsement and
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.
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 respondents 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 (see ADDRESSES) 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 Marketing & Management, 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, 11(6),
pp. 891-910.
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, 38, pp. 82-92.
Dated: January 21, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01408 Filed 1-27-20; 8:45 am]
BILLING CODE 4164-01-P
