Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Endorser Status and Actual Use in Direct-to-Consumer Television Ads, 26316-26318 [2023-08965]
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Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices
respondent to include transitional foster
care programs (in addition to long-term
foster care programs).
• Update instructions on which fields
are completed for initial placements and
which are completed for transfers
within the community-based care
program.
• Added citation to related policies in
the instructions.
• Reword some fields and
instructions for clarity.
• Add field to capture the facility
name for children placed in an out-ofnetwork community-based care
program.
• Separate fields that capture contact
information for the foster family or
group home into separate subsections
and expand the fields to capture
additional contact information (e.g.,
phone or email) in addition to name and
address.
For information about all currently
approved forms under this OMB
number, see: https://www.reginfo.gov/
public/do/PRAViewICR?ref_
nbr=202210-0970-008.
Respondents: ORR grantee and
contractor staff; UC; and other Federal
agencies.
Annual Burden Estimates
Note: These burden estimates include
burden related to the revisions described
above and currently approved forms for
which we are not proposing any changes.
ESTIMATED BURDEN HOURS FOR RESPONDENTS
Annual
number of
respondents
Information collection title
Average
burden hours
per response
Annual total
burden hours
Placement Authorization (Form P–1) ..............................................................
Authorization for Medical, Dental, and Mental Health Care (Form P–2) ........
Notice of Placement in a Restrictive Setting (Form P–4) ...............................
Community-Based Care Placement Memo (Form P–5) ..................................
UC Referral (Form P–7) ..................................................................................
Care Provider Checklist for Transfers to Influx Care Facilities (Form P–8) ...
Medical Checklist for Transfers (Form P–9A) .................................................
Medical Checklist for Influx Transfers (Form P–9B) .......................................
Transfer Request (Form P–10A) .....................................................................
Transfer Request (Form P–10A) .....................................................................
Influx Transfer Request (Form P–10B) ...........................................................
Transfer Summary and Tracking (Form P–11) ...............................................
Program Entity (Form P–12) ............................................................................
UC Profile (Form P–13) ...................................................................................
ORR Transfer Notification—ORR Notification to Immigration and Customs
Enforcement Chief Counsel of Transfer of UC and Request to Change
Address/Venue (Form P–14) .......................................................................
Family Group Entity (Form P–15) ....................................................................
Influx Transfer Manifest (Form P–16) ..............................................................
Influx Transfer Manual and Prescreen Criteria Review (Form P–17) .............
Notice of Administrative Review (Form P–18) ................................................
262
262
15
110
25
262
262
262
262
275
262
262
262
262
536
536
114
337
4,909
19
49
96
67
67
96
67
12
468
0.08
0.08
0.33
0.25
1.00
0.25
0.08
0.17
0.42
0.33
0.42
0.17
0.50
0.75
11,235
11,235
564
9,268
122,725
1,245
1,027
4,276
7,373
6,080
10,564
2,984
1,572
91,962
262
25
3
262
200
67
120
12
56,213
1
0.17
0.08
0.33
0.50
0.83
2,984
240
12
7,363,903
166
Estimated Annual Burden Hours Total .....................................................
........................
........................
........................
7,649,415
Authority: 6 U.S.C. 279; 8 U.S.C.
1232; Flores v. Reno Settlement
Agreement, No. CV85–4544–RJK (C.D.
Cal. 1996); 45 CFR part 411; Lucas R. et
al. v. Azar et al. (Case No. CV 18–5741–
DMG (PLAx)) Preliminary Injunction.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–09048 Filed 4–27–23; 8:45 am]
BILLING CODE 4184–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–1886]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Endorser Status
and Actual Use in Direct-to-Consumer
Television Ads
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
ddrumheller on DSK120RN23PROD with NOTICES1
Annual
number of
responses per
respondent
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
SUMMARY:
VerDate Sep<11>2014
18:44 Apr 27, 2023
Jkt 259001
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
collection of information by May 30,
2023.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The title
of this information collection is
‘‘Endorser Status and Actual Use in
Direct-to-Consumer Television Ads.’’
Also include the FDA docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: PRA
Staff, 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.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
E:\FR\FM\28APN1.SGM
28APN1
26317
Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices
has submitted the following proposed
collection of information to OMB for
review and clearance.
ddrumheller on DSK120RN23PROD with NOTICES1
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 (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 Office of
Prescription Drug Promotion (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/
VerDate Sep<11>2014
18:44 Apr 27, 2023
Jkt 259001
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
direct-to-consumer (DTC) prescription
drug promotion. This study
complements one that has recently been
completed (FDA–2019–N–5900, OMB
control number 0910–0894, Expiration
Date: March 31, 2023). 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 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
disclosure (utilizer, actor, none)—in
television advertisements. Dependent
variables will include perceptions of the
risks and benefits of the promoted
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
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
Actual-use
disclosure
Endorser type
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.
In the Federal Register of September
23, 2022 (87 FR 58099), FDA published
E:\FR\FM\28APN1.SGM
28APN1
26318
Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices
a 60-day notice requesting public
comment on the proposed collection of
information. FDA received no
comments.
FDA estimates the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Study 1
Study 1 Pretest Screener Completes ..........................
Study 1 Pretest Questionnaire Completes ..................
Number of
responses per
respondent
Study 2 Pretest Screener Completes ..........................
Study 2 Pretest Questionnaire Completes ..................
Study 1 Main Study Screener Completes ...................
Study 1 Main Study Questionnaire Completes ...........
630
126
.03 (2 minutes) ......
.30 (18 minutes) .....
18.9
38
1
1
420
126
.03 (2 minutes) ......
.30 (18 minutes) .....
12.6
38
1
1
3,240
648
.03 (2 minutes) .......
.30 (18 minutes) .....
97.2
194
Main Study
3,240
648
Study 2
1
1
Pretest
420
126
Study 1
Total hours
Pretest
630
126
Study 2
Average burden
per response
(in hours) 2
Total annual
responses
Main Study
Study 2 Main Study Screener Completes ...................
Study 2 Main Study Questionnaire Completes ...........
2,160
648
1
1
2,160
648
.03 (2 minutes) .......
.30 (18 minutes) .....
64.8
194
Total ......................................................................
........................
........................
........................
................................
657.50
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60.’’
2 Burden
ddrumheller on DSK120RN23PROD with NOTICES1
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, ‘‘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
Pharmacy, Vol. 11, Issue 6, pp. 891–900,
2015.
3. *Pharmaceutical Research and
Manufacturers of America (PhRMA),
‘‘PhRMA Guiding Principles: Direct to
VerDate Sep<11>2014
18:44 Apr 27, 2023
Jkt 259001
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/newmerck-tv-ad-for-keytruda-continues-trutheme-but-now-features-real-patient
(accessed May 18, 2022).
Dated: April 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–08965 Filed 4–27–23; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–3208]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Records and
Reports Concerning Experiences With
Approved New Animal Drugs: Adverse
Event Reports
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by May 30,
2023.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
SUMMARY:
E:\FR\FM\28APN1.SGM
28APN1
]]>Agencies
[Federal Register Volume 88, Number 82 (Friday, April 28, 2023)]
[Notices]
[Pages 26316-26318]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08965]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1886]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by May 30, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The title of this
information collection is ``Endorser Status and Actual Use in Direct-
to-Consumer Television Ads.'' Also include the FDA docket number found
in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: PRA Staff, 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].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA
[[Page 26317]]
has submitted the following proposed collection of information to OMB
for review and clearance.
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 (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 Office of Prescription Drug Promotion (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 direct-to-consumer
(DTC) prescription drug promotion. This study complements one that has
recently been completed (FDA-2019-N-5900, OMB control number 0910-0894,
Expiration Date: March 31, 2023). 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 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 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 x 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
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.
In the Federal Register of September 23, 2022 (87 FR 58099), FDA
published
[[Page 26318]]
a 60-day notice requesting public comment on the proposed collection of
information. FDA received no comments.
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 hours) Total hours
respondents respondent responses \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 Pharmacy, Vol. 11, Issue 6,
pp. 891-900, 2015.
3. *Pharmaceutical Research and Manufacturers of America (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: April 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08965 Filed 4-27-23; 8:45 am]
BILLING CODE 4164-01-P
