Agency Information Collection Activities; Proposed Collection; Comment Request; Examination of Implied Claims in Direct-to-Consumer Prescription Drug Promotion, 88398-88401 [2023-28093]
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Federal Register / Vol. 88, No. 244 / Thursday, December 21, 2023 / Notices
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review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product, LYBALVI
(olanzapine and samidorphan), which is
indicated for the treatment of:
• Schizophrenia in adults
• Bipolar I disorder in adults
Æ Acute treatment of manic or mixed
episodes as monotherapy and as
adjunct to lithium or valproate
Æ Maintenance monotherapy treatment
Subsequent to this approval, the
USPTO received patent term restoration
applications for LYBALVI (U.S. Patent
Nos. 7,262,298; 9,119,848; 9,126,977;
10,300,054; and 10,716,785) from
Alkermes Inc. and the USPTO requested
FDA’s assistance in determining the
patents’ eligibility for patent term
restoration. In a letter dated September
28, 2022, FDA advised the USPTO that
this human drug product had undergone
a regulatory review period and that the
approval of LYBALVI represented the
first permitted commercial marketing or
use of the product. Thereafter, the
USPTO requested that FDA determine
the product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
LYBALVI is 4,564 days. Of this time,
4,003 days occurred during the testing
phase of the regulatory review period,
while 561 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(i)) became effective: November 30,
2008. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on November 30, 2008.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: November 15, 2019.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
LYBALVI (NDA 213378) was initially
submitted on November 15, 2019.
3. The date the application was
approved: May 28, 2021. FDA has
verified the applicant’s claim that NDA
213378 was approved on May 28, 2021.
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This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 311 days, 646 days,
1,325 days, 1,328 days, or 5 years of
patent term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: December 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–28094 Filed 12–20–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–4201]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Examination of
Implied Claims in Direct-to-Consumer
Prescription Drug Promotion
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
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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 ‘‘Examination of Implied
Claims in Direct-to-Consumer
Prescription Drug Promotion.’’
DATES: Either electronic or written
comments on the collection of
information must be submitted by
February 20, 2024.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
February 20, 2024. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
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
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Federal Register / Vol. 88, No. 244 / Thursday, December 21, 2023 / Notices
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–
2023–N–4201 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Examination of Implied Claims in
Direct-to-Consumer Prescription Drug
Promotion.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 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
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‘‘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:
Jonna 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. The draft survey
instrument is available upon request
from 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
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.
Examination of Implied Claims in
Direct-to-Consumer Prescription Drug
Promotion
OMB Control Number 0910–NEW
I. Background
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct
research relating to health information.
Section 1003(d)(2)(C) of the Federal
Food, Drug, and Cosmetic Act (FD&C
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88399
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
promotion is truthful, balanced, and
accurately communicated, so that
patients and healthcare providers can
make informed decisions about
treatment options. OPDP’s research
program provides scientific evidence to
help ensure that our policies related to
prescription drug promotion will have
the greatest benefit to public health.
Toward that end, we have consistently
conducted research to evaluate the
aspects of prescription drug promotion
that are most central to our mission,
focusing in particular on three main
topic areas: advertising features,
including content and format; target
populations; and research quality.
Through the evaluation of advertising
features, we assess how elements such
as graphics, format, and 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. Our focus on research quality
aims at maximizing the quality of our
research data through analytical
methodology development and
investigation of sampling and response
issues. This study will inform the first
topic area, advertising features.
Because we recognize that the
strength of data and the confidence in
the robust nature of the findings 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
homepage at https://www.fda.gov/
about-fda/center-drug-evaluation-andresearch-cder/office-prescription-drugpromotion-opdp-research, which
includes links to the latest Federal
Register notices and peer-reviewed
publications produced by our office.
Direct-to-consumer (DTC)
prescription drug promotion may
include truthful and non-misleading
claims about the product. A particular
claim may be direct (explicit) or indirect
(implied or implicit). Some prior
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research has shown that implied claims
are misremembered as explicit claims
(Ref. 1). Other research has shown that
claims can result in a misleading
impression of the product through
implication, rather than literal
interpretation (Ref. 2). Understanding
how consumers who self-report having
been diagnosed with a target condition
interpret implied claims in DTC
prescription drug promotion—and how
their perceptions differ from those of
consumers who have not been
diagnosed with the target condition—
will provide valuable insight into the
relevance and impact of various product
attributes and promotional claims on
treatment decisions.
The current project will test the
impact of several implied claims in DTC
prescription drug advertising on
consumer perceptions. The project has
two phases: experimental and conjoint
analysis. In the experimental phase,
participants will view one version of a
DTC television ad containing both
explicit and one of four implicit product
claims of interest or a control ad
containing only explicit claims, and be
asked their impressions of the product’s
risks, benefits, and other attributes. In
the conjoint analysis phase, we will
conduct a best-worst scaling (BWS)
experiment to elicit the relative
importance of various characteristics of
immunotherapies indicated to treat
patients with advanced melanoma,
including several implied claims. For
this study, we will use an object case
design, which does not require us to
manipulate different levels of the
characteristics included in the design.
Participants will be shown a series of
choice tasks that are each made up of
different subsets of an experiment-wide
list of characteristics. Each participant
will complete several tasks, and will be
asked to first select which one they
would care about the most if they were
considering an immunotherapy,
followed by the characteristic they
would care about the least.
We are proposing to include 13
characteristics in our BWS experiment.
Each task will include only four of those
characteristics, the combination of
which will be drawn from a balanced
incomplete block design (BIBD; see Ref.
3). A BIBD ensures that (1) each task
contains the same number of
characteristics; (2) each characteristic
occurs the same number of times across
tasks; and (3) each pair of characteristics
is shown to participants the same
number of times over the entire
experiment. These three properties are
desirable for meeting estimation
assumptions (e.g., balance and
orthogonality). An additional (and
unique) favorable property of including
13 characteristics in the experiment is
that BIBDs exist that yield 13 tasks with
4 characteristics per task. Thirteen is a
manageable number of tasks for a single
participant to complete, and as a result,
the full experimental design will be
replicated by each participant.
We estimate that participation in the
study will take approximately 20
minutes. Adult voluntary participants
aged 18 years or older will be recruited
by email through an internet panel, and
participant eligibility will be
determined with a screener at the
beginning of the online survey. We will
exclude individuals who work in
healthcare settings, employees of the
Department of Health and Human
Services, or individuals who work in
the marketing, advertising, or
pharmaceutical industries. Half the
sample will consist of individuals who
self-identify as cancer survivors,
excluding survivors of certain
nonmelanoma skin cancers.
The target sample size for the
experimental phase is 1,030 adults and
the target sample size for the conjoint
analysis phase is 800 adults. Prior to
conducting the main study for both the
experimental phase and conjoint
analysis phase, we will conduct at least
one wave of pretests for each study
phase: one before the experimental
phase and one before the conjoint
analysis phase. If the first pretest wave
reveals that changes to the measurement
instruments, stimuli, or procedures are
required, a second pretest wave (for
either the experimental phase, conjoint
phase, or both) will be conducted with
revised materials. The target sample size
for each wave of pretests is 120 adults,
split evenly between the experimental
and conjoint analysis phases.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average burden
per response 2
Total hours
Experimental phase Pretest 1 Screener 3 .......................
Experimental Phase Pretest 1 .........................................
Conjoint Analysis Phase Pretest 1 Screener 3 ................
Conjoint Analysis Phase Pretest 1 ..................................
Experimental Phase Pretest 2 Screener 3 4 ....................
Experimental Phase Pretest 2 4 ......................................
Conjoint Analysis Phase Pretest 2 Screener 3 4 ..............
Conjoint Analysis Phase Pretest 2 4 ................................
Experimental Phase Screener 3 ......................................
Experimental Phase Main Study .....................................
Conjoint Analysis Phase Screener 3 ................................
Conjoint Analysis Phase Main Study ..............................
132
66
132
66
132
66
132
66
2,266
1,133
1,760
880
1
1
1
1
1
1
1
1
1
1
1
1
132
66
132
66
132
66
132
66
2,266
1,133
1,760
880
0.08
0.33
0.08
0.33
0.08
0.33
0.08
0.33
0.08
0.33
0.08
0.33
(5 minutes)
(20 minutes)
(5 minutes)
(20 minutes)
(5 minutes)
(20 minutes)
(5 minutes)
(20 minutes)
(5 minutes)
(20 minutes)
(5 minutes)
(20 minutes)
11
22
11
22
11
22
11
22
181
374
141
290
Total ..........................................................................
........................
........................
6,831
............................
1,118
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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 decimal format.
of screener respondents assumes a 50 percent eligibility rate with targeted recruitment.
4 Pretest 2 will be conducted only if changes to study materials for the respective study phase are made in response to the findings of Pretest
1 for that phase.
2 Burden
3 Number
As with most online and mail
surveys, it is always possible that some
participants are in the process of
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completing the survey when the target
number is reached and that those
surveys will be completed and received
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before the survey is closed out. To
account for this, we have estimated
approximately 10 percent overage for
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samples in the pretest and main study
of the experimental phase and conjoint
analysis phase.
II. References
The following references are on
display with the Dockets Management
Staff (see ADDRESSES) and are available
for viewing by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday; these are not available
electronically at https://
www.regulations.gov as these references
are copyright protected. Some may be
available at the website address, if
listed. FDA has verified the website
addresses, as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
1. Harris, R.J., M.L. Trusty, J.I. Bechtold, et
al. ‘‘Memory for Implied Versus Directly
Stated Advertising Claims,’’ Psychology
& Marketing, vol. 6, issue 2, pp. 87–96,
1989, https://doi.org/10.1002/
mar.4220060202.
2. Burke, R.R., W.S. DeSarbo, R.L. Oliver, et
al. ‘‘Deception By Implication: An
Experimental Investigation,’’ Journal of
Consumer Research, vol. 14, issue 4, pp.
483–494, 1988, https://doi.org/10.1086/
209130.
3. Louviere, J.J., T.N. Flynn, and A.A.J.
Marley, Best-Worst Scaling: Theory,
Methods, and Applications. Cambridge:
Cambridge University Press, 2015.
Dated: December 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–28093 Filed 12–20–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–1136]
Development of Monoclonal Antibody
Products Targeting SARS–CoV–2 for
Emergency Use Authorization;
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
‘‘Development of Monoclonal Antibody
Products Targeting SARS–CoV–2 for
Emergency Use Authorization.’’ This
guidance provides recommendations to
sponsors on the development of
monoclonal antibody products targeting
SARS–CoV–2 intended for the
prevention or treatment of COVID–19,
including addressing the impact of
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SUMMARY:
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emerging variants. The
recommendations focus on the data and
information that may be used to support
a request for emergency use
authorization (EUA) under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act). This guidance supersedes the
guidance entitled ‘‘Development of
Monoclonal Antibody Products
Targeting SARS–CoV–2, Including
Addressing the Impact of Emerging
Variants, During the COVID–19 Public
Health Emergency’’ issued on February
22, 2021.
DATES: The announcement of the
guidance is published in the Federal
Register on December 21, 2023.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
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.’’
PO 00000
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88401
Instructions: All submissions received
must include the Docket No. FDA–
2020–D–1136 for ‘‘Development of
Monoclonal Antibody Products
Targeting SARS–CoV–2 for Emergency
Use Authorization.’’ 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
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see § 10.115(g)(5)
(21 CFR 10.115(g)(5))).
Submit written requests for single
copies of the guidance to the Division of
Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
E:\FR\FM\21DEN1.SGM
21DEN1
]]>Agencies
[Federal Register Volume 88, Number 244 (Thursday, December 21, 2023)]
[Notices]
[Pages 88398-88401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-28093]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-4201]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Examination of Implied Claims in Direct-to-Consumer
Prescription Drug Promotion
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 ``Examination of Implied
Claims in Direct-to-Consumer Prescription Drug Promotion.''
DATES: Either electronic or written comments on the collection of
information must be submitted by February 20, 2024.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 20, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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
[[Page 88399]]
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-2023-N-4201 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Examination of Implied Claims in
Direct-to-Consumer Prescription Drug Promotion.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 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-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: Jonna 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]. The draft survey instrument is available upon
request from [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.
Examination of Implied Claims in Direct-to-Consumer Prescription Drug
Promotion
OMB Control Number 0910-NEW
I. Background
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA-regulated products in
carrying out the provisions of the FD&C Act.
The mission of the Office of Prescription Drug Promotion (OPDP) is
to protect the public health by helping to ensure that prescription
drug promotion is truthful, balanced, and accurately communicated, so
that patients and healthcare providers can make informed decisions
about treatment options. OPDP's research program provides scientific
evidence to help ensure that our policies related to prescription drug
promotion will have the greatest benefit to public health. Toward that
end, we have consistently conducted research to evaluate the aspects of
prescription drug promotion that are most central to our mission,
focusing in particular on three main topic areas: advertising features,
including content and format; target populations; and research quality.
Through the evaluation of advertising features, we assess how elements
such as graphics, format, and 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. Our focus on research quality aims at
maximizing the quality of our research data through analytical
methodology development and investigation of sampling and response
issues. This study will inform the first topic area, advertising
features.
Because we recognize that the strength of data and the confidence
in the robust nature of the findings 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 homepage at
https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research, which includes links
to the latest Federal Register notices and peer-reviewed publications
produced by our office.
Direct-to-consumer (DTC) prescription drug promotion may include
truthful and non-misleading claims about the product. A particular
claim may be direct (explicit) or indirect (implied or implicit). Some
prior
[[Page 88400]]
research has shown that implied claims are misremembered as explicit
claims (Ref. 1). Other research has shown that claims can result in a
misleading impression of the product through implication, rather than
literal interpretation (Ref. 2). Understanding how consumers who self-
report having been diagnosed with a target condition interpret implied
claims in DTC prescription drug promotion--and how their perceptions
differ from those of consumers who have not been diagnosed with the
target condition--will provide valuable insight into the relevance and
impact of various product attributes and promotional claims on
treatment decisions.
The current project will test the impact of several implied claims
in DTC prescription drug advertising on consumer perceptions. The
project has two phases: experimental and conjoint analysis. In the
experimental phase, participants will view one version of a DTC
television ad containing both explicit and one of four implicit product
claims of interest or a control ad containing only explicit claims, and
be asked their impressions of the product's risks, benefits, and other
attributes. In the conjoint analysis phase, we will conduct a best-
worst scaling (BWS) experiment to elicit the relative importance of
various characteristics of immunotherapies indicated to treat patients
with advanced melanoma, including several implied claims. For this
study, we will use an object case design, which does not require us to
manipulate different levels of the characteristics included in the
design. Participants will be shown a series of choice tasks that are
each made up of different subsets of an experiment-wide list of
characteristics. Each participant will complete several tasks, and will
be asked to first select which one they would care about the most if
they were considering an immunotherapy, followed by the characteristic
they would care about the least.
We are proposing to include 13 characteristics in our BWS
experiment. Each task will include only four of those characteristics,
the combination of which will be drawn from a balanced incomplete block
design (BIBD; see Ref. 3). A BIBD ensures that (1) each task contains
the same number of characteristics; (2) each characteristic occurs the
same number of times across tasks; and (3) each pair of characteristics
is shown to participants the same number of times over the entire
experiment. These three properties are desirable for meeting estimation
assumptions (e.g., balance and orthogonality). An additional (and
unique) favorable property of including 13 characteristics in the
experiment is that BIBDs exist that yield 13 tasks with 4
characteristics per task. Thirteen is a manageable number of tasks for
a single participant to complete, and as a result, the full
experimental design will be replicated by each participant.
We estimate that participation in the study will take approximately
20 minutes. Adult voluntary participants aged 18 years or older will be
recruited by email through an internet panel, and participant
eligibility will be determined with a screener at the beginning of the
online survey. We will exclude individuals who work in healthcare
settings, employees of the Department of Health and Human Services, or
individuals who work in the marketing, advertising, or pharmaceutical
industries. Half the sample will consist of individuals who self-
identify as cancer survivors, excluding survivors of certain
nonmelanoma skin cancers.
The target sample size for the experimental phase is 1,030 adults
and the target sample size for the conjoint analysis phase is 800
adults. Prior to conducting the main study for both the experimental
phase and conjoint analysis phase, we will conduct at least one wave of
pretests for each study phase: one before the experimental phase and
one before the conjoint analysis phase. If the first pretest wave
reveals that changes to the measurement instruments, stimuli, or
procedures are required, a second pretest wave (for either the
experimental phase, conjoint phase, or both) will be conducted with
revised materials. The target sample size for each wave of pretests is
120 adults, split evenly between the experimental and conjoint analysis
phases.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden per response \2\ Total hours
respondents respondent responses
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Experimental phase Pretest 1 Screener \3\...... 132 1 132 0.08 (5 minutes)....................... 11
Experimental Phase Pretest 1................... 66 1 66 0.33 (20 minutes)...................... 22
Conjoint Analysis Phase Pretest 1 Screener \3\. 132 1 132 0.08 (5 minutes)....................... 11
Conjoint Analysis Phase Pretest 1.............. 66 1 66 0.33 (20 minutes)...................... 22
Experimental Phase Pretest 2 Screener 3 4...... 132 1 132 0.08 (5 minutes)....................... 11
Experimental Phase Pretest 2 \4\............... 66 1 66 0.33 (20 minutes)...................... 22
Conjoint Analysis Phase Pretest 2 Screener 3 4. 132 1 132 0.08 (5 minutes)....................... 11
Conjoint Analysis Phase Pretest 2 \4\.......... 66 1 66 0.33 (20 minutes)...................... 22
Experimental Phase Screener \3\................ 2,266 1 2,266 0.08 (5 minutes)....................... 181
Experimental Phase Main Study.................. 1,133 1 1,133 0.33 (20 minutes)...................... 374
Conjoint Analysis Phase Screener \3\........... 1,760 1 1,760 0.08 (5 minutes)....................... 141
Conjoint Analysis Phase Main Study............. 880 1 880 0.33 (20 minutes)...................... 290
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Total...................................... .............. .............. 6,831 ....................................... 1,118
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\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 decimal format.
\3\ Number of screener respondents assumes a 50 percent eligibility rate with targeted recruitment.
\4\ Pretest 2 will be conducted only if changes to study materials for the respective study phase are made in response to the findings of Pretest 1 for
that phase.
As with most online and mail surveys, it is always possible that
some participants are in the process of completing the survey when the
target number is reached and that those surveys will be completed and
received before the survey is closed out. To account for this, we have
estimated approximately 10 percent overage for
[[Page 88401]]
samples in the pretest and main study of the experimental phase and
conjoint analysis phase.
II. References
The following references are on display with the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; these are not
available electronically at https://www.regulations.gov as these
references are copyright protected. Some may be available at the
website address, if listed. FDA has verified the website addresses, as
of the date this document publishes in the Federal Register, but
websites are subject to change over time.
1. Harris, R.J., M.L. Trusty, J.I. Bechtold, et al. ``Memory for
Implied Versus Directly Stated Advertising Claims,'' Psychology &
Marketing, vol. 6, issue 2, pp. 87-96, 1989, https://doi.org/10.1002/mar.4220060202.
2. Burke, R.R., W.S. DeSarbo, R.L. Oliver, et al. ``Deception By
Implication: An Experimental Investigation,'' Journal of Consumer
Research, vol. 14, issue 4, pp. 483-494, 1988, https://doi.org/10.1086/209130.
3. Louviere, J.J., T.N. Flynn, and A.A.J. Marley, Best-Worst
Scaling: Theory, Methods, and Applications. Cambridge: Cambridge
University Press, 2015.
Dated: December 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28093 Filed 12-20-23; 8:45 am]
BILLING CODE 4164-01-P
