Agency Information Collection Activities; Proposed Collection; Comment Request; Endorser Status and Actual Use in Direct-to-Consumer Television Ads, 58099-58102 [2022-20617]
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Federal Register / Vol. 87, No. 184 / Friday, September 23, 2022 / Notices
Center for Adoption Support and
Education (C.A.S.E) for the continued
expansion and use of the National
Adoption Competency Mental Health
Training Initiative across the nation.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The ACF, ACYF, Children’s
Bureau, Division of Capacity Building
announces the intent to award a singlesource cooperative agreement in the
amount of up to $10,000,000 to the
Center for Adoption Support and
Education in Burtonsville, MD. The
purpose of this award is to continue to
scale the web-based National Training
Initiative for Adoption Competent
Mental Health Training program to
remaining states in the nation, refine
and update the curriculum as needed
and perform an updated evaluation
regarding current use of the curriculum.
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Endorser Status
and Actual Use in Direct-to-Consumer
Television Ads
Food and Drug Administration
[Docket No. FDA–2022–N–1886]
SUMMARY:
The proposed period of
performance is September 30, 2022 to
September 29, 2027.
DATES:
June
Dorn, National Adoption Specialist,
Division of Capacity Building, 333 C St.
SW, Suite 3521B, Washington, DC
20201. Telephone: (202) 205–9450;
Email: June.Dorn@acf.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Award
funds will support the continued
expansion and use of the National
Training Initiative on Mental Health
Competency across the nation. This
curriculum was developed through an
initial 5-year grant to C.A.S.E. and pilot
tested prior to being supplemented and
extended for 3 additional years for the
further dissemination and integration of
this important web-based training in the
state child welfare training systems so
there would be consistent use of the
knowledge imparted by it across all
child welfare systems.
This funding will allow for the
continued scale up of the web-based
trainings for the child welfare workforce
and mental health practitioners to
remaining states in the nation; the
refinement and update of the curricula
as needed; and additional and updated
evaluation of the curricula.
Statutory Authority: Title II, section
203 of the Child Abuse Prevention and
Treatment and Adoption Reform Act of
1978 (42 U.S.C. 5113(b)), as amended by
CAPTA Reauthorization Act of 2010.
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SUPPLEMENTARY INFORMATION:
Elizabeth A. Leo,
Senior Grants Policy Specialist, Office of
Grants Policy, Office of Administration.
[FR Doc. 2022–20587 Filed 9–22–22; 8:45 am]
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AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 Actual
Use in Direct-to-Consumer Television
Ads.’’
SUMMARY:
Submit either electronic or
written comments on the collection of
information by November 22, 2022.
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 November 22,
2022. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of November 22, 2022.
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.
DATES:
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
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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–
2022–N–1886 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Endorser
Status and Actual Use in Direct-toConsumer Television Ads.’’ 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, 240–402–7500.
• 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
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Federal Register / Vol. 87, No. 184 / Friday, September 23, 2022 / Notices
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
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Regarding the collection of information:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
For copies of the questionnaire: Amie
O’Donoghue, Office of Prescription Drug
Promotion (OPDP) Research Team,
DTCresearch@fda.hhs.gov.
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
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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 Actual Use in
Direct-to-Consumer Television Ads
OMB Control Number 0910—NEW
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct
research relating to health information.
Section 1003(d)(2)(C) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 393(d)(2)(C))
authorizes FDA to conduct research
relating to drugs and other FDAregulated products in carrying out the
provisions of the FD&C Act.
The mission of the OPDP is to protect
the public health by helping to ensure
that prescription drug promotional
material 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, 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 the
characteristics of the disease and
product 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, advertising features.
Because we recognize that the
strength of data and the confidence in
the robust nature of the findings are
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
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other sources, and this larger body of
knowledge collectively informs our
policies as well as our research program.
Our research is documented on our
home page at https://www.fda.gov/
about-fda/center-drug-evaluation-andresearch-cder/office-prescription-drugpromotion-opdp-research. The website
includes links to the latest Federal
Register notices and peer-reviewed
publications produced by our office.
The objective of the present research
is to conduct experimental studies to
examine issues related to endorsers in
DTC prescription drug promotion. This
study complements one that is currently
in progress (FDA–2019–N–5900, OMB
control number 0910–0894, Expiration
Date: February 29, 2024). As that study
examined a number of different
endorser types in print or internet
settings and focused on examining how
various disclosures of the payment
status of the endorser influenced
audience reactions, this proposed
research extends the prior research by
examining actual-use disclosures and a
different medium, television ads. Prior
research has shown 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
(Refs. 1 and 2).
For healthcare providers (HCPs)
endorsing a prescription drug product,
guiding industry principles advise that
advertisements should contain a
disclosure that the HCP has been
compensated for the endorsement (Ref.
3). Industry guiding principles further
recommend that an advertisement
disclose when an actor is being used as
an HCP to promote direct-to-consumer
(DTC) prescription drugs.
Pharmaceutical firms also often use
everyday people, either actual patients
or actors portraying patients, in DTC
promotion, relying on qualities of
identification with the individual
endorsing the product and perceived
credibility (Ref. 4). While industry
guidelines recommend that companies
choosing to feature actors in the roles of
HCPs in a DTC television or print ad
acknowledge in the ad that actors are
being used, the guidelines do not
mention disclosures that the ‘‘patient’’
in an ad is being portrayed by an actor
(Ref. 3). Some advertisers endeavor to
gain credibility among viewers by using
actual patients to endorse the product,
with a disclosure that states they are
actual users of the product (‘‘actual-use
disclosure’’) (Ref. 5).
The present research will specifically
examine the influence of two
independent variables—endorser type
(patient, physician) and an actual-use
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Federal Register / Vol. 87, No. 184 / Friday, September 23, 2022 / Notices
disclosure (utilizer, actor, none)—in
television advertisements. Dependent
variables will include perceptions of the
risks and benefits of the promoted
prescription drug, attitudes toward and
perceptions of the endorser, attention
paid to the ad, and behavioral
intentions. Because age and education
level may affect perceptions of the ad,
we plan to explore whether age and
education level influence these effects.
This research will involve two
studies. Studies 1 and 2 will use a 2×3
factorial design run concurrently and
independently with a sample of
consumers who have been diagnosed
with diabetes (Study 1) or rheumatoid
arthritis (Study 2), each watching a DTC
television ad for a fictitious drug
indicated to treat the corresponding
medical conditions. The ad will be
manipulated to assess the impact of two
categories of commonly used industry
spokespeople: a patient and a physician.
We will test three actual-use disclosure
conditions: (1) an actual-use disclosure
that indicates that the endorser either
uses or prescribes the prescription drug
in real life (i.e., utilizer), (2) an actualuse disclosure that specifies the
endorser is an actor, and (3) a control
with no actual-use disclosure. The
design for Studies 1 and 2 is presented
in table 1.
TABLE 1—STUDY 1 AND STUDY 2
EXPERIMENTAL DESIGN
Endorser type
Actual-use disclosure
Patient
Physician
Utilizer ......................
Actor .........................
None .........................
In both studies, participants will be
randomly assigned to one of six
experimental conditions (see table 1),
view their assigned stimulus, complete
a survey, and provide feedback on one
of the other ad versions. We will
conduct pretests with 126 consumers
who self-identify as having been
diagnosed with diabetes and 126
consumers who self-identify as having
been diagnosed with rheumatoid
arthritis, recruited from a web-based
research vendor. For the main study, we
will then recruit 648 consumers who
self-identify as having been diagnosed
with diabetes and 648 consumers who
self-identify as having been diagnosed
with rheumatoid arthritis. Each
participant will see one of six versions
of a television ad for a fictitious
prescription diabetes or rheumatoid
arthritis treatment, as reflected in table
1. They will answer a questionnaire
designed to take no more than 20
minutes.
FDA estimates the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
respondents
Activity
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
(in hours) 2
Total hours
Study 1 Pretest
Study 1 Pretest Screener Completes ..........................
630
1
630
.03 (2 minutes) ......
18.9
Study 1 Pretest Questionnaire Completes ..................
126
1
126
.30 (18 minutes) .....
38
Study 2 Pretest
Study 2 Pretest Screener Completes ..........................
420
1
420
.03 (2 minutes) ......
12.6
Study 2 Pretest Questionnaire Completes ..................
126
1
126
.30 (18 minutes) .....
38
Study 1 Main Study
Study 1 Main Study Screener Completes ...................
3,240
1
3,240
.03 (2 minutes) .......
97.2
Study 1 Main Study Questionnaire Completes ...........
648
1
648
.30 (18 minutes) .....
194
Study 2 Main Study
Study 2 Main Study Screener Completes ...................
2,160
1
2,160
.03 (2 minutes) .......
64.8
Study 2 Main Study Questionnaire Completes ...........
648
1
648
.30 (18 minutes) .....
194
Total ......................................................................
........................
........................
........................
................................
657.50
1
2
There are no capital costs or operating and maintenance costs associated with this collection of information.
Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60.’’
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References
The following references marked with
an asterisk (*) are on display at the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852 and are available for viewing by
interested persons between 9 a.m. and 4
p.m., Monday through Friday; they also
are available electronically at https://
www.regulations.gov. References
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without asterisks are not on public
display at https://www.regulations.gov
because they have copyright restriction.
Some may be available at the website
address, if listed. References without
asterisks are available for viewing only
at the Dockets Management Staff. 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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1. LaTour, C. and M. Smith, ‘‘A Study of
Expert Endorsement of OTC
Pharmaceutical Products,’’ Journal of
Pharmaceutical Marketing &
Management, Vol. 1, Issue 2, pp. 117–
128, 1986.
2. Bhutada, N.S. and B.L. Rollins, ‘‘DiseaseSpecific Direct-to-Consumer Advertising
of Pharmaceuticals: An Examination of
Endorser Type and Gender Effects on
Consumers’ Attitudes and Behaviors,’’
Research in Social and Administrative
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Federal Register / Vol. 87, No. 184 / Friday, September 23, 2022 / Notices
Pharmacy, Vol. 11, Issue 6, pp. 891–900,
2015.
3. *PhRMA, ‘‘PhRMA Guiding Principles:
Direct to Consumer Advertisements
About Prescription Medicines,’’
Pharmaceutical Research and
Manufacturers of America, Washington,
DC, https://www.phrma.org, revised
October 2018, available at https://
phrma.org/-/media/Project/PhRMA/
PhRMA-Org/PhRMA-Org/PDF/P-R/
PhRMA_Guiding_Principles_2018.pdf
(accessed May 18, 2022).
4. *Schouten, A. P., L. Janssen, and M.
Verspaget, ‘‘Celebrity vs. Influencer
Endorsements in Advertising: The
Role of Identification, Credibility,
and Product-Endorser Fit,’’
International Journal of
Advertising, Vol. 39, Issue 2, pp.
258–281, 2020, https://doi.org/
10.1080/02650487.2019.1634898.
5. *Bulik, B.S., ‘‘Merck Adds Real
Patient to ‘TRU’ Keytruda TV Ad,’’
Fierce Pharma, September 27, 2017,
available at https://
www.fiercepharma.com/marketing/
new-merck-tv-ad-for-keytrudacontinues-tru-theme-but-nowfeatures-real-patient (accessed May
18, 2022).
Dated: September 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
Electronic Submissions
[FR Doc. 2022–20617 Filed 9–22–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–1847]
Exemption and Exclusion From Certain
Requirements of the Drug Supply
Chain Security Act for the Distribution
of Food and Drug AdministrationApproved Naloxone Products During
the Opioid Public Health Emergency;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Exemption and Exclusion from Certain
Requirements of the Drug Supply Chain
Security Act for the Distribution of
FDA-Approved Naloxone Products
During the Opioid Public Health
Emergency.’’ Combating the opioid
overdose epidemic is an urgent public
health priority for FDA. Naloxone
hydrochloride (‘‘naloxone’’) is a
medication that rapidly reverses the
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SUMMARY:
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effects of opioid overdose and is the
standard treatment for opioid overdose.
FDA understands that naloxone is being
made available to underserved
communities through entities such as
harm reduction programs and is aware
of concerns that harm reduction
programs are having difficulty acquiring
naloxone. FDA is issuing this guidance
to clarify the scope of the public health
emergency exclusion and exemption
under the Drug Supply Chain Security
Act as they apply to the distribution of
FDA-approved naloxone products
indicated for the emergency treatment of
opioid overdose to harm reduction
programs during the opioid public
health emergency. The guidance
document is immediately in effect, but
it remains subject to comment in
accordance with the Agency’s good
guidance practices.
DATES: The announcement of the
guidance is published in the Federal
Register on September 23, 2022.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
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
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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–
2022–D–1847 for ‘‘Exemption and
Exclusion from Certain Requirements of
the Drug Supply Chain Security Act for
the Distribution of FDA-Approved
Naloxone Products During the Opioid
Public Health Emergency.’’ Received
comments 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, 240–402–7500.
• 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
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
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]]>Agencies
[Federal Register Volume 87, Number 184 (Friday, September 23, 2022)]
[Notices]
[Pages 58099-58102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20617]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1886]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Endorser Status and Actual Use in Direct-to-Consumer
Television Ads
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
Actual Use in Direct-to-Consumer Television Ads.''
DATES: Submit either electronic or written comments on the collection
of information by November 22, 2022.
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 November 22, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 22, 2022. 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-2022-N-1886 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Endorser Status and Actual Use in
Direct-to-Consumer Television Ads.'' 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, 240-402-7500.
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
[[Page 58100]]
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 ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Regarding the collection of
information: JonnaLynn Capezzuto, Office of Operations, Food and Drug
Administration, Three White Flint North, 10A-12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301-796-3794, [email protected].
For copies of the questionnaire: Amie O'Donoghue, 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 Actual Use in Direct-to-Consumer Television Ads
OMB Control Number 0910--NEW
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA-regulated products in
carrying out the provisions of the FD&C Act.
The mission of the OPDP is to protect the public health by helping
to ensure that prescription drug promotional material 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, 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 the characteristics of the disease and product 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, advertising features.
Because we recognize that the strength of data and the confidence
in the robust nature of the findings are 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 home page at
https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research. The website includes
links to the latest Federal Register notices and peer-reviewed
publications produced by our office.
The objective of the present research is to conduct experimental
studies to examine issues related to endorsers in DTC prescription drug
promotion. This study complements one that is currently in progress
(FDA-2019-N-5900, OMB control number 0910-0894, Expiration Date:
February 29, 2024). As that study examined a number of different
endorser types in print or internet settings and focused on examining
how various disclosures of the payment status of the endorser
influenced audience reactions, this proposed research extends the prior
research by examining actual-use disclosures and a different medium,
television ads. Prior research has shown 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 (Refs. 1 and 2).
For healthcare providers (HCPs) endorsing a prescription drug
product, guiding industry principles advise that advertisements should
contain a disclosure that the HCP has been compensated for the
endorsement (Ref. 3). Industry guiding principles further recommend
that an advertisement disclose when an actor is being used as an HCP to
promote direct-to-consumer (DTC) prescription drugs.
Pharmaceutical firms also often use everyday people, either actual
patients or actors portraying patients, in DTC promotion, relying on
qualities of identification with the individual endorsing the product
and perceived credibility (Ref. 4). While industry guidelines recommend
that companies choosing to feature actors in the roles of HCPs in a DTC
television or print ad acknowledge in the ad that actors are being
used, the guidelines do not mention disclosures that the ``patient'' in
an ad is being portrayed by an actor (Ref. 3). Some advertisers
endeavor to gain credibility among viewers by using actual patients to
endorse the product, with a disclosure that states they are actual
users of the product (``actual-use disclosure'') (Ref. 5).
The present research will specifically examine the influence of two
independent variables--endorser type (patient, physician) and an
actual-use
[[Page 58101]]
disclosure (utilizer, actor, none)--in television advertisements.
Dependent variables will include perceptions of the risks and benefits
of the promoted prescription drug, attitudes toward and perceptions of
the endorser, attention paid to the ad, and behavioral intentions.
Because age and education level may affect perceptions of the ad, we
plan to explore whether age and education level influence these
effects.
This research will involve two studies. Studies 1 and 2 will use a
2x3 factorial design run concurrently and independently with a sample
of consumers who have been diagnosed with diabetes (Study 1) or
rheumatoid arthritis (Study 2), each watching a DTC television ad for a
fictitious drug indicated to treat the corresponding medical
conditions. The ad will be manipulated to assess the impact of two
categories of commonly used industry spokespeople: a patient and a
physician. We will test three actual-use disclosure conditions: (1) an
actual-use disclosure that indicates that the endorser either uses or
prescribes the prescription drug in real life (i.e., utilizer), (2) an
actual-use disclosure that specifies the endorser is an actor, and (3)
a control with no actual-use disclosure. The design for Studies 1 and 2
is presented in table 1.
Table 1--Study 1 and Study 2 Experimental Design
------------------------------------------------------------------------
Endorser type
Actual-use disclosure -------------------------------------
Patient Physician
------------------------------------------------------------------------
Utilizer..........................
Actor.............................
None..............................
------------------------------------------------------------------------
In both studies, participants will be randomly assigned to one of
six experimental conditions (see table 1), view their assigned
stimulus, complete a survey, and provide feedback on one of the other
ad versions. We will conduct pretests with 126 consumers who self-
identify as having been diagnosed with diabetes and 126 consumers who
self-identify as having been diagnosed with rheumatoid arthritis,
recruited from a web-based research vendor. For the main study, we will
then recruit 648 consumers who self-identify as having been diagnosed
with diabetes and 648 consumers who self-identify as having been
diagnosed with rheumatoid arthritis. Each participant will see one of
six versions of a television ad for a fictitious prescription diabetes
or rheumatoid arthritis treatment, as reflected in table 1. They will
answer a questionnaire designed to take no more than 20 minutes.
FDA estimates the burden of this collection of information as
follows:
Table 2--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response (in Total hours
respondents respondent responses hours)\ 2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Study 1 Pretest
--------------------------------------------------------------------------------------------------------------------------------------------------------
Study 1 Pretest Screener Completes........... 630 1 630 .03 (2 minutes).......................... 18.9
--------------------------------------------------------------------------------------------------------------------------------------------------------
Study 1 Pretest Questionnaire Completes...... 126 1 126 .30 (18 minutes)......................... 38
--------------------------------------------------------------------------------------------------------------------------------------------------------
Study 2 Pretest
--------------------------------------------------------------------------------------------------------------------------------------------------------
Study 2 Pretest Screener Completes........... 420 1 420 .03 (2 minutes).......................... 12.6
--------------------------------------------------------------------------------------------------------------------------------------------------------
Study 2 Pretest Questionnaire Completes...... 126 1 126 .30 (18 minutes)......................... 38
--------------------------------------------------------------------------------------------------------------------------------------------------------
Study 1 Main Study
--------------------------------------------------------------------------------------------------------------------------------------------------------
Study 1 Main Study Screener Completes........ 3,240 1 3,240 .03 (2 minutes).......................... 97.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Study 1 Main Study Questionnaire Completes... 648 1 648 .30 (18 minutes)......................... 194
--------------------------------------------------------------------------------------------------------------------------------------------------------
Study 2 Main Study
--------------------------------------------------------------------------------------------------------------------------------------------------------
Study 2 Main Study Screener Completes........ 2,160 1 2,160 .03 (2 minutes).......................... 64.8
--------------------------------------------------------------------------------------------------------------------------------------------------------
Study 2 Main Study Questionnaire Completes... 648 1 648 .30 (18 minutes)......................... 194
----------------------------------------------------------------------------------------------------------
Total.................................... .............. .............. .............. ......................................... 657.50
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of minutes per response]/60.''
References
The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 and
are available for viewing by interested persons between 9 a.m. and 4
p.m., Monday through Friday; they also are available electronically at
https://www.regulations.gov. References without asterisks are not on
public display at https://www.regulations.gov because they have
copyright restriction. Some may be available at the website address, if
listed. References without asterisks are available for viewing only at
the Dockets Management Staff. 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, ``A Study of Expert Endorsement of OTC
Pharmaceutical Products,'' Journal of Pharmaceutical Marketing &
Management, Vol. 1, Issue 2, pp. 117-128, 1986.
2. Bhutada, N.S. and B.L. Rollins, ``Disease-Specific Direct-to-
Consumer Advertising of Pharmaceuticals: An Examination of Endorser
Type and Gender Effects on Consumers' Attitudes and Behaviors,''
Research in Social and Administrative
[[Page 58102]]
Pharmacy, Vol. 11, Issue 6, pp. 891-900, 2015.
3. *PhRMA, ``PhRMA Guiding Principles: Direct to Consumer
Advertisements About Prescription Medicines,'' Pharmaceutical
Research and Manufacturers of America, Washington, DC, https://www.phrma.org, revised October 2018, available at https://phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/P-R/PhRMA_Guiding_Principles_2018.pdf (accessed May 18, 2022).
4. *Schouten, A. P., L. Janssen, and M. Verspaget, ``Celebrity vs.
Influencer Endorsements in Advertising: The Role of Identification,
Credibility, and Product-Endorser Fit,'' International Journal of
Advertising, Vol. 39, Issue 2, pp. 258-281, 2020, https://doi.org/10.1080/02650487.2019.1634898.
5. *Bulik, B.S., ``Merck Adds Real Patient to `TRU' Keytruda TV Ad,''
Fierce Pharma, September 27, 2017, available at https://www.fiercepharma.com/marketing/new-merck-tv-ad-for-keytruda-continues-tru-theme-but-now-features-real-patient (accessed May 18, 2022).
Dated: September 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20617 Filed 9-22-22; 8:45 am]
BILLING CODE 4164-01-P
