Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Study of Oncology Indications in Direct-to-Consumer Television Advertising, 5213-5217 [2020-01555]
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Federal Register / Vol. 85, No. 19 / Wednesday, January 29, 2020 / Notices
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Comments regarding each of these
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than February 28, 2020.
A. Federal Reserve Bank of Dallas
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1. Dry Lake Financial, LLC, Spur,
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2. Independent Bank Group, Inc.,
McKinney, Texas; to merge with Texas
Capital Bancshares, Inc., and thereby
indirectly acquire Texas Capital Bank,
National Association, both of Dallas,
Texas.
Board of Governors of the Federal Reserve
System, January 24, 2020.
Ann E. Misback,
Secretary of the Board.
[FR Doc. 2020–01565 Filed 1–28–20; 8:45 am]
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A. Federal Reserve Bank of Chicago
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Babcock Hollowed Trust, Anne Babcock
Hollowed, trustee, both of Mercer
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Catherine Babcock, trustee, both of
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Board of Governors of the Federal Reserve
System, January 24, 2020.
Ann E. Misback,
Secretary of the Board.
[FR Doc. 2020–01566 Filed 1–28–20; 8:45 am]
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5213
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–2313]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Study of Oncology
Indications in Direct-to-Consumer
Television Advertising
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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: Fax written comments on the
collection of information by February
28, 2020.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Study of Oncology Indications in
Direct-to-Consumer Television
Advertising. ’’ Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
In compliance with 44 U.S.C. 3507,
FDA has submitted the following
proposed collection of information to
OMB for review and clearance.
Study of Oncology Indications in
Direct-to-Consumer Television
Advertising
(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
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Federal Register / Vol. 85, No. 19 / Wednesday, January 29, 2020 / Notices
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 we believe 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 falls under the topic
of advertising features (content and
format).
Oncology products are increasingly
being promoted to consumers via directto-consumer (DTC) television
advertising. Oncology indications are
often complicated and supported by
different clinical endpoints such as
overall survival, overall response rate,
and progression-free survival (Ref. 1)
that are referenced in the DTC TV ads.
The first objective of this project is to
determine whether disclosing
information about the nature of the
endpoints that support the indications
for oncology products helps consumers
understand the drug’s efficacy. This
objective complements OPDP’s research
examining disclosing information about
FDA’s accelerated approval pathway to
consumers (May 8, 2019, 84 FR 20148)
and OPDP’s research on disclosing
oncology information to healthcare
professionals (OMB control number
0910–0864—Disclosures of Descriptive
Presentations in Professional Oncology
Prescription Drug Promotion). Although
these studies all contribute to our
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knowledge of the communication of
cancer treatment information, the
current study specifically examines
particular endpoints that are wellknown to the professional oncology
community and are now used in DTC
advertising.
Because of the length of some
indications, sponsors sometimes convey
some of the indication in superimposed
text rather than in the audio in the TV
ads. The second objective is to test
whether consumers adequately
comprehend indication statements
when portions of the indication are
presented only in the superimposed text
of television ads while other
information is conveyed in the audio.
This objective extends OPDP’s previous
research on the use of dual-modality
risk presentations (presenting the
information in two modes at the same
time; OMB control numbers 0910–
0634—Experimental Evaluation of the
Impact of Distraction, 0910–0652—
Experimental Study: Toll-Free Number
for Consumer Reporting of Drug Product
Side Effects in Direct-to-Consumer
Television Advertisements for
Prescription Drugs, and 0910–0772—
Eye Tracking Study of Direct-toConsumer Prescription Drug
Advertisement Viewing) to the context
of indication statements. This previous
research supports the use of dual
modality to increase consumers’
understanding of risk information
(January 27, 2012, 77 FR 4273) (Refs. 2
and 3).
We plan to conduct two rounds (one
for each objective) of nine 1-hour inperson cognitive interviews of adults 18
years of age or older to refine the
questionnaires and stimuli (18
participants total). We plan to conduct
two pretests (one for each objective) not
longer than 20 minutes, administered
via internet panel, to test the
experimental manipulations and pilot
the main study procedures.
We plan to conduct two main studies
(one for each objective) not longer than
20 minutes, administered via internet
panel. For Study 1, we will create two
television ads for fictitious oncology
prescription drugs to increase the
generalizability of the results (one solid
tumor indication and one hematology
indication). The ads will include audio
claims about overall survival, overall
response rate with and without a
disclosure, or progression-free survival
with and without a disclosure (see table
1 for the Study 1 design).
Some current television ads for
oncology products include disclosures
that are intended to help consumers
differentiate surrogate endpoints like
progression-free survival and overall
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response rate from overall survival.
Examples include ‘‘At the time of
analysis, overall survival comparison
was not yet available’’ and ‘‘Clinical
trials are ongoing to determine if there
is an overall survival benefit.’’ The
disclosure we use in the study will be
based on disclosures currently in use
and will be informed by consumer
feedback elicited in focus groups
conducted prior to the cognitive testing
(approved under OMB control number
0910–0695). For example, the study
disclosure may include language such
as ‘‘We currently do not know if Drug
X helps people live longer.’’
Participants will be randomly
assigned to view one prescription drug
television ad and then complete a
questionnaire that assesses whether
participants noticed the disclosure, their
interpretations of the disclosure, their
retention of the endpoint, and their
perceptions of the drug’s benefits and
risks. We will also measure covariates
such as demographics, cancer history,
and literacy. Without a disclosure, we
hypothesize that participants will not
differentiate between overall survival,
overall response rate, and progressionfree survival. We hypothesize that a
disclosure will help participants
understand the surrogate endpoints (i.e.,
overall response rate and progressionfree survival) and thus will lead to
greater understanding of the drug’s
efficacy compared with conditions
without the disclosure. We will explore
unintended effects of the disclosure,
such as whether the disclosure lowers
perceived efficacy compared with the
overall survival condition.
For the second objective, in Study 2
we will vary the presentation of the
products’ indication, such that material
information related to the indication
will appear in superimposed text only,
in the audio only, in both superimposed
text and audio, or in neither (the control
condition; see tables 2 and 3 for the
Study 2 design). Participants will be
randomly assigned to view a
prescription drug television ad and then
complete a questionnaire that assesses
their retention and comprehension of
the information. Following previous
research on dual-modality
presentations, we hypothesize that
participants who view an ad with the
material information in the audio and
text will have greater retention of that
information than participants in any
other condition. We also hypothesize
that participants who view an ad with
the material information in the audio
only will have greater retention of that
information than participants in the
superimposed text condition and the
control condition. To test Study 1 and
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2 hypotheses, we will conduct
inferential statistical tests such as
logistic regression and analysis of
variance.
The questionnaires are available upon
request from DTCresearch@fda.hhs.gov.
For all phases of this research, we will
recruit a general population sample of
adult volunteers 18 years of age or older.
We will exclude individuals who work
for the Department of Health and
Human Services or work in the
healthcare, marketing, or
pharmaceutical industries. We will use
literacy quotas to ensure that our sample
includes participants with a range of
5215
literacy skills. We will also exclude
pretest participants from the main
studies, and participants will not be
able to participate in both Studies 1 and
2. With the sample sizes described
below, we will have sufficient power to
detect small-sized effects in Studies 1
and 2 (table 4).
TABLE 1—STUDY 1 DESIGN
Indication
Overall
survival
Overall
response rate
Overall
response rate
with disclosure
Progressionfree survival
Progressionfree survival
with
disclosure
Solid Tumor ..........................................................................
Hematology ..........................................................................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
Note: The solid tumor condition will be non-small cell lung cancer. The hematology condition will be multiple myeloma. Claims and disclosures
are TBD, based on focus group feedback. Overall survival and progression-free survival claims will be the same for both indications. Study 1 will
use the control ad from Study 2.
TABLE 2—STUDY 2 DESIGN: SOLID TUMOR
Material information in superimposed text only
Material information in audio only
Material information in superimposed text + audio
Material information not in superimposed text or audio (control)
Indication presentation
Audio: Drug X is for adults with advanced non-small cell lung cancer.
Superimposed text: Drug X is for
adults with advanced non-small
cell lung cancer previously treated with platinum-based chemotherapy, who have a certain type
of ALK gene.
Audio: Drug X is for adults with
advanced non-small cell lung
cancer previously treated with
platinum-based chemotherapy,
who have a certain type of ALK
gene.
Superimposed text: Drug X is for
adults with advanced non-small
cell lung cancer.
Audio: Drug X is for adults with
advanced non-small cell lung
cancer previously treated with
platinum-based chemotherapy,
who have a certain type of ALK
gene.
Superimposed text: Drug X is for
adults with advanced non-small
cell lung cancer previously
treated with platinum-based
chemotherapy, who have a certain type of ALK gene.
Audio: Drug X is for adults with
advanced non-small cell lung
cancer.
Superimposed text: Drug X is for
adults with advanced non-small
cell lung cancer.
Note: Study 2 will use the overall survival ad from Study 1.
TABLE 3—STUDY 2 DESIGN: HEMATOLOGY
Material information in superimposed text only
Material information in audio only
Material information in superimposed text + audio
Material information not in superimposed text or audio (control)
Indication presentation
Audio: Drug Y is used to treat multiple myeloma.
Superimposed text: Drug Y is used
to treat multiple myeloma in
combination with dexamethasone, in people who have received at least three prior medicines to treat multiple myeloma.
Audio: Drug Y is used to treat
multiple myeloma in combination with dexamethasone, in
people who have received at
least three prior medicines to
treat multiple myeloma.
Superimposed text: Drug Y is
used to treat multiple myeloma.
Audio: Drug Y is used to treat
multiple myeloma in combination with dexamethasone, in
people who have received at
least three prior medicines to
treat multiple myeloma.
Superimposed text: Drug Y is
used to treat multiple myeloma
in combination with dexamethasone, in people who have received at least three prior medicines to treat multiple myeloma.
Audio: Drug Y is used to treat
multiple myeloma.
Superimposed text: Drug Y is
used to treat multiple myeloma.
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Note: Study 2 will use the overall survival ad from Study 1.
In the Federal Register of June 21,
2019 (84 FR 29213), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received four
submissions that were PRA-related.
Within those submissions, FDA
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received multiple comments, which the
Agency has addressed below.
(Comment 1) One comment voiced
support for the current study and
recommended future research to
examine how DTC advertising addresses
value-based care.
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(Response 1) We thank the commenter
for their support for this study and will
consider their recommendations for
future research.
(Comment 2) Two comments
suggested limiting study recruitment to
patients already diagnosed with and/or
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Federal Register / Vol. 85, No. 19 / Wednesday, January 29, 2020 / Notices
treated for cancer and their caregivers
and family members. The comments
suggested that patients who have
already been diagnosed and/or treated
are likely to have a higher level of
disease comprehension than the general
population and that this would make
the results more reflective of the
population seeking cancer treatment
information.
(Response 2) We chose a general
population sample for the first study on
this topic because of concerns about
being able to recruit a sufficient number
of participants if we selected a cancerspecific sample. However, we agree that
in the future, a small, carefully-designed
replication study with cancer patients
and their caretakers and family
members would be valuable. Prior to
this study, we conducted both generalpopulation focus groups and cancersurvivor focus groups. We will use the
information gleaned from these focus
groups to consider the ways in which
these groups do and do not differ when
discussing the limitations of the study’s
general-population sample. We will also
ask participants if they have been
diagnosed with cancer and whether they
are a caregiver for someone with cancer.
(Comment 3) One comment suggested
that the duration of the study ads be
consistent with the duration of real-life
ads.
(Response 3) The duration of the
study ads will be consistent with the
duration of real-life ads.
(Comment 4) One comment suggested
adding screening questions to assess
whether participants watch television,
whether they watch ads, and how they
are most likely to view DTC television
ads.
(Response 4) We added questions
about television viewing to the end of
the questionnaire.
(Comment 5) One comment agreed
with the hypothesis that consumers who
view an ad with material information in
both audio and text will have greater
retention of that information. However,
they do not believe there is enough time
in a television ad to include the full
indication in the audio, and they do not
believe it is necessary because they
believe the primary objective of ads is
to raise product awareness so that
consumers can seek additional
information about the drug from health
care providers or adequate provision
sources.
(Response 5) The duration of the ads
used in this study will be consistent
with those currently airing on television
and that duration will be sufficient to
include all material information (Ref. 4)
in the audio and text. While consumers
may be able to find this information
through other sources, the intent of this
study is to determine what effect, if any,
the material information has when
delivered as an integrated part of the
DTC advertisement.
(Comment 6) One comment notes that
the Study 1 results would not be
generalizable to an ad for a drug that has
overall survival data but advertises with
claims about overall response rate or
progression-free survival.
(Response 6) We agree that our results
would not generalize to this situation.
(Comment 7) One comment suggested
wording changes for the claims in Study
1, including deleting ‘‘decrease the
number of detectable cancer cells in the
body’’ from the multiple myeloma
overall response rate, describing
progression-free survival as ‘‘delayed
disease progression or live longer
without cancer getting worse,’’ and
using the disclosure statement ‘‘clinical
trials are still ongoing to determine if
there is an overall survival benefit with
Drug X.’’
(Response 7) We thank the commenter
for these suggestions and will consider
them, along with the feedback from our
focus group participants, when we
finalize the language for the main study.
(Comment 8) One comment suggested
changes to the Study 1 questionnaire,
including rewording Q2 to make it
clearer, adding a ‘‘don’t know’’ response
to Q4, removing Q5 because it is
speculative, and rewording Q7 from
‘‘any side effects it may have’’ to ‘‘side
effects described in the ad.’’
(Response 8) We revised Q2 to ask
what the drug can do for people, added
a ‘‘don’t know’’ response to Q4, and
edited Q7 as suggested. Q5 will only be
asked of participants who already report
that the drug will help people live
longer; its purpose is to gauge their
perception of how much longer people
will live. We plan to keep this item, but
we will cognitively test and pretest it to
determine whether it should be revised
or deleted.
(Comment 9) One comment suggested
changes to the Study 2 questionnaire,
including changing Q2 to ask about
what disease the drug treats rather than
who it is for, so it is less similar to Q4,
adding Q10 from the Study 1
questionnaire to measure behavioral
intentions, and revising Q7–Q12
because they are too detailed and
require the respondent to recall a lot of
information from the ad.
(Response 9) We agree that Questions
2 and 4 are similar; they are both
designed to elicit responses related to
the material information, not just the
disease the drug is indicated to treat.
However, Question 4 will only be asked
of participants who respond ‘‘no’’ to
Question 3. We believe this will provide
context for those participants, but we
will ask whether this series of questions
is too repetitive or confusing in
cognitive interviews, and we will
review participants’ responses in a
pretest. We will add Q10a and Q10b to
the Study 2 questionnaire. Questions 7
through 12 are designed to measure
participants’ retention and
understanding of the material
information. We will cognitively test
and pretest the items to determine
whether they should be revised or
deleted.
FDA estimates the burden of this
collection of information as follows:
TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
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Activity
Number of
responses per
respondent
Average
burden
per response
Total annual
responses
Total hours
Cognitive Interview screener .......................................
Cognitive Interviews ....................................................
Pretests 1 and 2 screener ...........................................
Pretests 1 and 2 ..........................................................
Study 1 screener .........................................................
Study 1 ........................................................................
Study 2 screener .........................................................
Study 2 ........................................................................
30
18
200
120
1,167
700
867
520
1
1
1
1
1
1
1
1
30
18
200
120
1,167
700
867
520
0.08 (5 minutes) .....
1 (60 minutes) .......
0.08 (5 minutes) .....
0.33 (20 minutes) ..
0.08 (5 minutes) .....
0.33 (20 minutes) ...
0.08 (5 minutes) .....
0.33 (20 minutes) ...
2.4
18
16
39.6
93.36
231
69.36
171.6
Total ......................................................................
........................
........................
........................
................................
641.32
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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II. 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. Kim, J., J. Gao, L. Amiri-Kordestani, et
al., ‘‘Patient-Friendly Language to Facilitate
Treatment Choice for Patients with Cancer.’’
The Oncologist, 10.1634/theoncologist.2018–
0761, 2019. Available from: https://
www.ncbi.nlm.nih.gov/pmc/articles/
PMC6693727/.
2. Aikin, K.J., A.C. O’Donoghue, C.M.
Squire, et al., ‘‘An Empirical Examination of
the FDAAA-Mandated Toll-Free Statement
for Consumer Reporting of Side Effects in
Direct-to-Consumer Television
Advertisements.’’ Journal of Public Policy &
Marketing, 35(1):108–123, 2016.
3. Sullivan, H.W., V. Boudewyns, A.C.
O’Donoghue, et al., ‘‘Attention to and
Distraction from Risk Information in
Prescription Drug Advertising: An EyeTracking Study.’’ Journal of Public Policy &
Marketing, 36(2):236–245, 2017.
4. 21 U.S.C. 321(n).
Dated: January 23, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–01555 Filed 1–28–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–new]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
lotter on DSKBCFDHB2PROD with NOTICES
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before February 28, 2020.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
0990-New-30D and project title for
reference.
SUMMARY:
Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Health
Evaluation of Pregnancy Prevention
Program Replications for High Risk and
Hard to Reach Youth.
Type of Collection: OMB No. 0990–
NEW.
Abstract: The Office of the Assistant
Secretary for Health (OASH), U.S.
Department of Health and Human
Services (HHS), is requesting approval
by OMB of a new information collection
request. OASH seeks to collect
information to understand whether
previously proven adolescent pregnancy
programs have similar effects on
knowledge, attitudes, beliefs, intentions,
and behaviors related to sexual activity
and health among different youth in
different locations, especially among
understudied and hard-to-reach youth.
We propose to collect both qualitative
and quantitative information in a quasiexperimental design with a matched
SUPPLEMENTARY INFORMATION:
Max number
of respondents
Respondents
Form name
Youth Program Participants ............................
Baseline survey and youth assent .................
First follow-up survey .....................................
3-month follow-up survey ...............................
Focus group assent .......................................
VerDate Sep<11>2014
17:27 Jan 28, 2020
Jkt 250001
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
comparison group. Eight organizations
implementing a broad range of
previously proven-effective pregnancy
prevention programs (including sexual
health education, sexual risk avoidance,
and youth development programs) will
recruit hard to reach or high-risk youth.
Youth will complete surveys at baseline,
immediately following the intervention,
and at three months follow-up, yielding
quantitative data about youth
knowledge, attitudes, beliefs, intentions,
and behaviors related to sexual health.
Surveys will last for about 50 minutes.
Focus groups yielding qualitative data
about youth perspectives about
adolescent pregnancy prevention
programs will occur after the
interventions are complete and will last
for approximately 90 minutes.
Need and Proposed Use of the
Information: Rates of pregnancy among
hard-to-reach, high-risk, vulnerable, or
understudied youth are significantly
higher than the general population.
However, there have been few
evaluations assessing whether programs
that have been previously proven
successful can be delivered successfully
to these youth. Hence, this evaluation is
intended to help fill the evidence gap
about the efficacy and effectiveness of
existing pregnancy prevention programs
among high-risk, vulnerable, or
understudied youth. To enhance the
rigor of the evaluation, a matched
comparison group will be identified
from select implementing organizations
and their communities. OASH plans to
use the findings of this evaluation to
inform guidance to HHS grantees and
prospective grantees on approaches for
replication of pregnancy prevention
programs for hard-to-reach and
underserved youth.
Likely respondents: Respondents will
include youth aged 12–16 years old, and
their parents/guardians. Respondents
will also include youth in a matched
comparison group (‘‘comparison
youth’’).
Burden: Exhibit 1 summarizes the
total annual burden hours estimated for
this ICR. This hour-burden estimate
includes time spent by program youth,
comparison group youth, and parents/
guardians of both groups to complete
data collection for the ICR.
E:\FR\FM\29JAN1.SGM
1,216
730
438
474
29JAN1
Average
burden
per response
(hours)
1.00
0.83
0.83
0.25
Total max
burden
(hours)
1,216
608
365
119
]]>Agencies
[Federal Register Volume 85, Number 19 (Wednesday, January 29, 2020)]
[Notices]
[Pages 5213-5217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01555]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-2313]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Study of Oncology
Indications in Direct-to-Consumer Television Advertising
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: Fax written comments on the collection of information by
February 28, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-NEW and
title ``Study of Oncology Indications in Direct-to-Consumer Television
Advertising. '' Also include the FDA docket number found in brackets in
the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In compliance with 44 U.S.C. 3507, FDA has submitted the following
proposed collection of information to OMB for review and clearance.
Study of Oncology Indications in Direct-to-Consumer Television
Advertising
(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
[[Page 5214]]
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 we believe 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 falls under
the topic of advertising features (content and format).
Oncology products are increasingly being promoted to consumers via
direct-to-consumer (DTC) television advertising. Oncology indications
are often complicated and supported by different clinical endpoints
such as overall survival, overall response rate, and progression-free
survival (Ref. 1) that are referenced in the DTC TV ads. The first
objective of this project is to determine whether disclosing
information about the nature of the endpoints that support the
indications for oncology products helps consumers understand the drug's
efficacy. This objective complements OPDP's research examining
disclosing information about FDA's accelerated approval pathway to
consumers (May 8, 2019, 84 FR 20148) and OPDP's research on disclosing
oncology information to healthcare professionals (OMB control number
0910-0864--Disclosures of Descriptive Presentations in Professional
Oncology Prescription Drug Promotion). Although these studies all
contribute to our knowledge of the communication of cancer treatment
information, the current study specifically examines particular
endpoints that are well-known to the professional oncology community
and are now used in DTC advertising.
Because of the length of some indications, sponsors sometimes
convey some of the indication in superimposed text rather than in the
audio in the TV ads. The second objective is to test whether consumers
adequately comprehend indication statements when portions of the
indication are presented only in the superimposed text of television
ads while other information is conveyed in the audio. This objective
extends OPDP's previous research on the use of dual-modality risk
presentations (presenting the information in two modes at the same
time; OMB control numbers 0910-0634--Experimental Evaluation of the
Impact of Distraction, 0910-0652--Experimental Study: Toll-Free Number
for Consumer Reporting of Drug Product Side Effects in Direct-to-
Consumer Television Advertisements for Prescription Drugs, and 0910-
0772--Eye Tracking Study of Direct-to-Consumer Prescription Drug
Advertisement Viewing) to the context of indication statements. This
previous research supports the use of dual modality to increase
consumers' understanding of risk information (January 27, 2012, 77 FR
4273) (Refs. 2 and 3).
We plan to conduct two rounds (one for each objective) of nine 1-
hour in-person cognitive interviews of adults 18 years of age or older
to refine the questionnaires and stimuli (18 participants total). We
plan to conduct two pretests (one for each objective) not longer than
20 minutes, administered via internet panel, to test the experimental
manipulations and pilot the main study procedures.
We plan to conduct two main studies (one for each objective) not
longer than 20 minutes, administered via internet panel. For Study 1,
we will create two television ads for fictitious oncology prescription
drugs to increase the generalizability of the results (one solid tumor
indication and one hematology indication). The ads will include audio
claims about overall survival, overall response rate with and without a
disclosure, or progression-free survival with and without a disclosure
(see table 1 for the Study 1 design).
Some current television ads for oncology products include
disclosures that are intended to help consumers differentiate surrogate
endpoints like progression-free survival and overall response rate from
overall survival. Examples include ``At the time of analysis, overall
survival comparison was not yet available'' and ``Clinical trials are
ongoing to determine if there is an overall survival benefit.'' The
disclosure we use in the study will be based on disclosures currently
in use and will be informed by consumer feedback elicited in focus
groups conducted prior to the cognitive testing (approved under OMB
control number 0910-0695). For example, the study disclosure may
include language such as ``We currently do not know if Drug X helps
people live longer.''
Participants will be randomly assigned to view one prescription
drug television ad and then complete a questionnaire that assesses
whether participants noticed the disclosure, their interpretations of
the disclosure, their retention of the endpoint, and their perceptions
of the drug's benefits and risks. We will also measure covariates such
as demographics, cancer history, and literacy. Without a disclosure, we
hypothesize that participants will not differentiate between overall
survival, overall response rate, and progression-free survival. We
hypothesize that a disclosure will help participants understand the
surrogate endpoints (i.e., overall response rate and progression-free
survival) and thus will lead to greater understanding of the drug's
efficacy compared with conditions without the disclosure. We will
explore unintended effects of the disclosure, such as whether the
disclosure lowers perceived efficacy compared with the overall survival
condition.
For the second objective, in Study 2 we will vary the presentation
of the products' indication, such that material information related to
the indication will appear in superimposed text only, in the audio
only, in both superimposed text and audio, or in neither (the control
condition; see tables 2 and 3 for the Study 2 design). Participants
will be randomly assigned to view a prescription drug television ad and
then complete a questionnaire that assesses their retention and
comprehension of the information. Following previous research on dual-
modality presentations, we hypothesize that participants who view an ad
with the material information in the audio and text will have greater
retention of that information than participants in any other condition.
We also hypothesize that participants who view an ad with the material
information in the audio only will have greater retention of that
information than participants in the superimposed text condition and
the control condition. To test Study 1 and
[[Page 5215]]
2 hypotheses, we will conduct inferential statistical tests such as
logistic regression and analysis of variance.
The questionnaires are available upon request from
[email protected].
For all phases of this research, we will recruit a general
population sample of adult volunteers 18 years of age or older. We will
exclude individuals who work for the Department of Health and Human
Services or work in the healthcare, marketing, or pharmaceutical
industries. We will use literacy quotas to ensure that our sample
includes participants with a range of literacy skills. We will also
exclude pretest participants from the main studies, and participants
will not be able to participate in both Studies 1 and 2. With the
sample sizes described below, we will have sufficient power to detect
small-sized effects in Studies 1 and 2 (table 4).
Table 1--Study 1 Design
----------------------------------------------------------------------------------------------------------------
Overall Progression-
Overall Overall response rate Progression- free survival
Indication survival response rate with free survival with
disclosure disclosure
----------------------------------------------------------------------------------------------------------------
Solid Tumor..................... .............. .............. .............. .............. ..............
Hematology...................... .............. .............. .............. .............. ..............
----------------------------------------------------------------------------------------------------------------
Note: The solid tumor condition will be non-small cell lung cancer. The hematology condition will be multiple
myeloma. Claims and disclosures are TBD, based on focus group feedback. Overall survival and progression-free
survival claims will be the same for both indications. Study 1 will use the control ad from Study 2.
Table 2--Study 2 Design: Solid Tumor
----------------------------------------------------------------------------------------------------------------
Material information in Material information
Material information in superimposed Material information in superimposed text + not in superimposed
text only audio only audio text or audio (control)
----------------------------------------------------------------------------------------------------------------
Indication presentation
----------------------------------------------------------------------------------------------------------------
Audio: Drug X is for adults with Audio: Drug X is for Audio: Drug X is for Audio: Drug X is for
advanced non-small cell lung cancer. adults with advanced adults with advanced adults with advanced
Superimposed text: Drug X is for non-small cell lung non-small cell lung non-small cell lung
adults with advanced non-small cell cancer previously cancer previously cancer.
lung cancer previously treated with treated with platinum- treated with platinum- Superimposed text: Drug
platinum-based chemotherapy, who based chemotherapy, based chemotherapy, X is for adults with
have a certain type of ALK gene.. who have a certain who have a certain advanced non-small
type of ALK gene. type of ALK gene. cell lung cancer.
Superimposed text: Drug Superimposed text: Drug
X is for adults with X is for adults with
advanced non-small advanced non-small
cell lung cancer.. cell lung cancer
previously treated
with platinum-based
chemotherapy, who have
a certain type of ALK
gene..
----------------------------------------------------------------------------------------------------------------
Note: Study 2 will use the overall survival ad from Study 1.
Table 3--Study 2 Design: Hematology
----------------------------------------------------------------------------------------------------------------
Material information in Material information
Material information in superimposed Material information in superimposed text + not in superimposed
text only audio only audio text or audio (control)
----------------------------------------------------------------------------------------------------------------
Indication presentation
----------------------------------------------------------------------------------------------------------------
Audio: Drug Y is used to treat Audio: Drug Y is used Audio: Drug Y is used Audio: Drug Y is used
multiple myeloma. to treat multiple to treat multiple to treat multiple
Superimposed text: Drug Y is used to myeloma in combination myeloma in combination myeloma.
treat multiple myeloma in with dexamethasone, in with dexamethasone, in Superimposed text: Drug
combination with dexamethasone, in people who have people who have Y is used to treat
people who have received at least received at least received at least multiple myeloma.
three prior medicines to treat three prior medicines three prior medicines
multiple myeloma.. to treat multiple to treat multiple
myeloma. myeloma.
Superimposed text: Drug Superimposed text: Drug
Y is used to treat Y is used to treat
multiple myeloma.. multiple myeloma in
combination with
dexamethasone, in
people who have
received at least
three prior medicines
to treat multiple
myeloma..
----------------------------------------------------------------------------------------------------------------
Note: Study 2 will use the overall survival ad from Study 1.
In the Federal Register of June 21, 2019 (84 FR 29213), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received four submissions that were PRA-
related. Within those submissions, FDA received multiple comments,
which the Agency has addressed below.
(Comment 1) One comment voiced support for the current study and
recommended future research to examine how DTC advertising addresses
value-based care.
(Response 1) We thank the commenter for their support for this
study and will consider their recommendations for future research.
(Comment 2) Two comments suggested limiting study recruitment to
patients already diagnosed with and/or
[[Page 5216]]
treated for cancer and their caregivers and family members. The
comments suggested that patients who have already been diagnosed and/or
treated are likely to have a higher level of disease comprehension than
the general population and that this would make the results more
reflective of the population seeking cancer treatment information.
(Response 2) We chose a general population sample for the first
study on this topic because of concerns about being able to recruit a
sufficient number of participants if we selected a cancer-specific
sample. However, we agree that in the future, a small, carefully-
designed replication study with cancer patients and their caretakers
and family members would be valuable. Prior to this study, we conducted
both general-population focus groups and cancer-survivor focus groups.
We will use the information gleaned from these focus groups to consider
the ways in which these groups do and do not differ when discussing the
limitations of the study's general-population sample. We will also ask
participants if they have been diagnosed with cancer and whether they
are a caregiver for someone with cancer.
(Comment 3) One comment suggested that the duration of the study
ads be consistent with the duration of real-life ads.
(Response 3) The duration of the study ads will be consistent with
the duration of real-life ads.
(Comment 4) One comment suggested adding screening questions to
assess whether participants watch television, whether they watch ads,
and how they are most likely to view DTC television ads.
(Response 4) We added questions about television viewing to the end
of the questionnaire.
(Comment 5) One comment agreed with the hypothesis that consumers
who view an ad with material information in both audio and text will
have greater retention of that information. However, they do not
believe there is enough time in a television ad to include the full
indication in the audio, and they do not believe it is necessary
because they believe the primary objective of ads is to raise product
awareness so that consumers can seek additional information about the
drug from health care providers or adequate provision sources.
(Response 5) The duration of the ads used in this study will be
consistent with those currently airing on television and that duration
will be sufficient to include all material information (Ref. 4) in the
audio and text. While consumers may be able to find this information
through other sources, the intent of this study is to determine what
effect, if any, the material information has when delivered as an
integrated part of the DTC advertisement.
(Comment 6) One comment notes that the Study 1 results would not be
generalizable to an ad for a drug that has overall survival data but
advertises with claims about overall response rate or progression-free
survival.
(Response 6) We agree that our results would not generalize to this
situation.
(Comment 7) One comment suggested wording changes for the claims in
Study 1, including deleting ``decrease the number of detectable cancer
cells in the body'' from the multiple myeloma overall response rate,
describing progression-free survival as ``delayed disease progression
or live longer without cancer getting worse,'' and using the disclosure
statement ``clinical trials are still ongoing to determine if there is
an overall survival benefit with Drug X.''
(Response 7) We thank the commenter for these suggestions and will
consider them, along with the feedback from our focus group
participants, when we finalize the language for the main study.
(Comment 8) One comment suggested changes to the Study 1
questionnaire, including rewording Q2 to make it clearer, adding a
``don't know'' response to Q4, removing Q5 because it is speculative,
and rewording Q7 from ``any side effects it may have'' to ``side
effects described in the ad.''
(Response 8) We revised Q2 to ask what the drug can do for people,
added a ``don't know'' response to Q4, and edited Q7 as suggested. Q5
will only be asked of participants who already report that the drug
will help people live longer; its purpose is to gauge their perception
of how much longer people will live. We plan to keep this item, but we
will cognitively test and pretest it to determine whether it should be
revised or deleted.
(Comment 9) One comment suggested changes to the Study 2
questionnaire, including changing Q2 to ask about what disease the drug
treats rather than who it is for, so it is less similar to Q4, adding
Q10 from the Study 1 questionnaire to measure behavioral intentions,
and revising Q7-Q12 because they are too detailed and require the
respondent to recall a lot of information from the ad.
(Response 9) We agree that Questions 2 and 4 are similar; they are
both designed to elicit responses related to the material information,
not just the disease the drug is indicated to treat. However, Question
4 will only be asked of participants who respond ``no'' to Question 3.
We believe this will provide context for those participants, but we
will ask whether this series of questions is too repetitive or
confusing in cognitive interviews, and we will review participants'
responses in a pretest. We will add Q10a and Q10b to the Study 2
questionnaire. Questions 7 through 12 are designed to measure
participants' retention and understanding of the material information.
We will cognitively test and pretest the items to determine whether
they should be revised or deleted.
FDA estimates the burden of this collection of information as
follows:
Table 4--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cognitive Interview screener................. 30 1 30 0.08 (5 minutes)......................... 2.4
Cognitive Interviews......................... 18 1 18 1 (60 minutes)........................... 18
Pretests 1 and 2 screener.................... 200 1 200 0.08 (5 minutes)......................... 16
Pretests 1 and 2............................. 120 1 120 0.33 (20 minutes)........................ 39.6
Study 1 screener............................. 1,167 1 1,167 0.08 (5 minutes)......................... 93.36
Study 1...................................... 700 1 700 0.33 (20 minutes)........................ 231
Study 2 screener............................. 867 1 867 0.08 (5 minutes)......................... 69.36
Study 2...................................... 520 1 520 0.33 (20 minutes)........................ 171.6
----------------------------------------------------------------------------------------------------------
Total.................................... .............. .............. .............. ......................................... 641.32
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 5217]]
II. 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. Kim, J., J. Gao, L. Amiri-Kordestani, et al., ``Patient-
Friendly Language to Facilitate Treatment Choice for Patients with
Cancer.'' The Oncologist, 10.1634/theoncologist.2018-0761, 2019.
Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6693727/.
2. Aikin, K.J., A.C. O'Donoghue, C.M. Squire, et al., ``An
Empirical Examination of the FDAAA-Mandated Toll-Free Statement for
Consumer Reporting of Side Effects in Direct-to-Consumer Television
Advertisements.'' Journal of Public Policy & Marketing, 35(1):108-
123, 2016.
3. Sullivan, H.W., V. Boudewyns, A.C. O'Donoghue, et al.,
``Attention to and Distraction from Risk Information in Prescription
Drug Advertising: An Eye-Tracking Study.'' Journal of Public Policy
& Marketing, 36(2):236-245, 2017.
4. 21 U.S.C. 321(n).
Dated: January 23, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01555 Filed 1-28-20; 8:45 am]
BILLING CODE 4164-01-P
