[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
                                                --------------------------------------------------------------------------------------------------------
    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