Notice2021-23507
Agency Information Collection Activities; Proposed Collection; Comment Request; Targeted Mechanism of Action Presentations in Prescription Drug Promotion
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Published
October 28, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) 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 ``Targeted Mechanism of Action Presentations in Prescription Drug Promotion.''
Full Text
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<title>Federal Register, Volume 86 Issue 206 (Thursday, October 28, 2021)</title>
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[Federal Register Volume 86, Number 206 (Thursday, October 28, 2021)]
[Notices]
[Pages 59735-59738]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-23507]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1050]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Targeted Mechanism of Action Presentations in
Prescription Drug Promotion
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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
[[Page 59736]]
solicits comments on a proposed study entitled ``Targeted Mechanism of
Action Presentations in Prescription Drug Promotion.''
DATES: Submit either electronic or written comments on the collection
of information by December 27, 2021.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 27, 2021. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 27, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2021-N-1050 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Targeted Mechanism of Action
Presentations in 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m.,
11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
<a href="/cdn-cgi/l/email-protection#500002110324313636103634317e3838237e373f26"><span class="__cf_email__" data-cfemail="d383819280a7b2b5b593b5b7b2fdbbbba0fdb4bca5">[email protected]</span></a>.
For copies of the questionnaire: Office of Prescription Drug
Promotion (OPDP) Research Team, <a href="/cdn-cgi/l/email-protection#fbbfafb8a99e889e9a899893bb9d9f9ad5939388d59c948d"><span class="__cf_email__" data-cfemail="16524255447365737764757e56707277387e7e6538717960">[email protected]</span></a>.
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.
Targeted Mechanism of Action Presentations in Prescription Drug
Promotion
OMB Control Number 0910--NEW
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA regulated products in
carrying out the provisions of the FD&C Act.
The Office of Prescription Drug Promotion's (OPDP) mission is to
[[Page 59737]]
protect the public health by helping to ensure that prescription drug
promotion is truthful, balanced, and accurately communicated. OPDP's
research program provides scientific evidence to help ensure that our
policies related to prescription drug promotion will have the greatest
benefit to public health. Toward that end, we have consistently
conducted research to evaluate the aspects of prescription drug
promotion that are most central to our mission. Our research focuses in
particular on three main topic areas: Advertising features, including
content and format; target populations; and research quality. Through
the evaluation of advertising features, we assess how elements such as
graphics, format, and disease and product characteristics impact the
communication and understanding of prescription drug risks and
benefits. Focusing on target populations allows us to evaluate how
understanding of prescription drug risks and benefits may vary as a
function of audience, and our focus on research quality aims at
maximizing the quality of research data through analytical methodology
development and investigation of sampling and response issues. This
study will inform the first two topic areas, advertising features and
target populations.
Because we recognize 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 scientific sources,
and this larger body of knowledge collectively informs our policies as
well as our research program. Our research is documented on our home
page, which can be found at: <a href="https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research">https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research</a>. The website includes links to the latest Federal Register
notices and peer-reviewed publications produced by our office.
In 2014, OPDP conducted focus groups designed to provide insights
on how consumers and healthcare providers (HCP), including physicians,
nurse practitioners, and physician assistants, interpret the term
``targeted'' in prescription drug promotional materials. Although
diverse views were voiced, there appeared to be some tendency toward
the impression that products with promotional materials using this term
would be safer and more effective than other similar treatments. OPDP
is also now conducting a nationally representative survey regarding the
ways in which consumers and primary care physicians (PCPs) interpret
terms and phrases commonly used in prescription drug promotional
materials, including assessment of impressions of the terms
``targeted'' and ``targeted mechanism of action'' (targeted MoA) (May
10, 2021, 86 FR 24867). Building upon this line of research, the
proposed study will investigate the influence of targeted MoA claims,
graphics, and disclosures that provide context about a drug's targeted
MoA, utilizing an experimental design with both consumer and HCP
samples. The experimental approach described here is intended to
complement and augment the prior research by facilitating assessment of
causality. Specifically, the proposed study will explore how varied
targeted MoA presentations affect consumer and HCP understanding of the
MoA of a drug, perception of drug benefits and risks, attention to risk
information, and interest in the drug.
Table 1 depicts the study design. Participants will be randomly
assigned to 1 of 12 experimental conditions in which the presence
versus absence of: (1) A targeted MoA claim, (2) a graphic depicting a
targeted MoA, and (3) a disclosure that provides context about the
targeted MoA of the drug are varied in a branded website for a
fictitious prescription drug indicated to treat bladder cancer and
cancers of the urinary tract (renal pelvis, ureter, or urethra) that
have spread or cannot be removed by surgery. We selected cancer as the
medical condition for study given the prevalence of targeted MoA
presentations in promotional materials for prescription drugs indicated
to treat various forms of cancer. Notably, there will be three
variations related to the targeted MoA graphic: (1) No graphic, (2) an
inaccurate graphic (graphic 1) showing only the effect of the drug on
cancerous cells but not on healthy cells, and (3) an accurate graphic
(graphic 2) that will show the effect of the drug on both cancerous and
healthy cells. The design will be replicated in both the consumer and
HCP samples with stimuli specifically created for each audience. Draft
stimuli were informed by, but not identical to, actual targeted MoA
presentations from a marketplace evaluation conducted under FDA
guidance. Draft stimuli were also informed by an FDA subject matter
expert's review. Following exposure to the stimuli, the participants
will complete a questionnaire designed to assess relevant outcome
measures. A copy of the questionnaire is available upon request. All
aspects of this study will be completed online. Participation is
estimated to take approximately 20 minutes, excluding the screener's
time.
Table 1--Study Design
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Targeted MoA graphic \1\
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Sample Disclosure Targeted MoA claim Present Present
(graphic 1-- (graphic 2-- Absent
inaccurate) accurate)
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HCP...................................... Present..................... Present..................... [ssquf] [ssquf] [ssquf]
Absent...................... [ssquf] [ssquf] [ssquf]
Absent...................... Present..................... [ssquf] [ssquf] [ssquf]
Absent...................... [ssquf] [ssquf] [ssquf]
Consumer................................. Present..................... Present..................... [ssquf] [ssquf] [ssquf]
Absent...................... [ssquf] [ssquf] [ssquf]
Absent...................... Present..................... [ssquf] [ssquf] [ssquf]
Absent...................... [ssquf] [ssquf] [ssquf]
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\1\ Each [ssquf] symbol represents an experimental condition.
For the HCP sample, we will recruit oncologists, PCPs with oncology
experience, and nurse practitioners and physician assistants who
specialize in oncology. We will also recruit a general population
sample of adult volunteers 18 years or older for the consumer sample. A
general population, rather than a diagnosed consumer sample, was
[[Page 59738]]
selected because of concerns about being able to recruit a sufficient
number of participants for this particular study if we selected a
cancer-specific sample.
We will ask consumers to consider a hypothetical scenario in which
they have recently been diagnosed with cancer and are actively looking
for available treatments. HCPs will be asked to consider a scenario in
which they are actively looking for available treatments for a patient
who has been diagnosed with cancer. We will also ask consumers if they
have ever been diagnosed with cancer. HCP participants will be drawn
from online HCP panels and general population consumer participants
will be drawn from online consumer panels. Informed by power analyses,
we will recruit a sample of 540 HCPs and 540 consumers for the main
study.
FDA estimates the burden of this collection of information as
follows:
Table 2--Estimated Annual Reporting Burden \1\
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Number of Number of Average burden
Activity respondents responses per Total annual per response Total hours
\2\ respondent responses \3\
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Pretest
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General population: Pretest 528 1 528 0.08 (5 42.2
screener completes (assumes 75% minutes)
eligible)......................
General population: Number of 396 1 396 0.33 (20 130.7
completes, pretest............. minutes)
HCP: Pretest screener completes 660 1 660 0.08 (5 52.8
(assumes 60% eligible)......... minutes)
HCP: Number of completes, 396 1 396 0.33 (20 130.7
pretest........................ minutes)
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Main Study
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General population: Number of 792 1 792 0.08 (5 63.4
main study screener completes minutes)
(assumes 75% eligible).........
General population: Number of 594 1 594 0.33 (20 196.0
completes, main study.......... minutes)
HCP: Number of main study 990 1 990 0.08 (5 79.2
screener completes (assumes 60% minutes)
eligible)......................
HCP: Number of completes, main 594 1 594 0.33 (20 196.0
study.......................... minutes)
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Total....................... .............. .............. .............. .............. 891
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ 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
both samples in the study.
\3\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.
Dated: October 22, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23507 Filed 10-27-21; 8:45 am]
BILLING CODE 4164-01-P
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