[Federal Register Volume 86, Number 206 (Thursday, October 28, 2021)]
[Notices]
[Pages 59735-59738]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-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 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: 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, 
[email protected].
    For copies of the questionnaire: Office of Prescription Drug 
Promotion (OPDP) Research Team, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research. The website includes links to the latest Federal Register 
notices and peer-reviewed publications produced by our office.
    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\
                                                                                                      --------------------------------------------------
                  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)
                                 -------------------------------------------------------------------------------
    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