[Federal Register Volume 89, Number 191 (Wednesday, October 2, 2024)]
[Notices]
[Pages 80252-80255]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22575]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-3653]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Promotion of Prescription Drugs Within a Talk Show 
Format

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 solicits comments on information collection associated with a 
proposed study entitled ``Promotion of Prescription Drugs Within a Talk 
Show Format.''

DATES: Either electronic or written comments on the collection of 
information must be submitted by December 2, 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 December 2, 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:
    <bullet> 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.
    <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

[[Page 80253]]

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-2024-N-3653 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Promotion of Prescription Drugs 
Within a Talk Show Format.'' 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.
    <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 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: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
<a href="/cdn-cgi/l/email-protection#38686a794b4c595e5e785e5c591650504b165f574e"><span class="__cf_email__" data-cfemail="b6e6e4f7c5c2d7d0d0f6d0d2d798dedec598d1d9c0">[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.

Promotion of Prescription Drugs Within a Talk Show Format

(OMB Control Number 0910--NEW)

    This information collection request supports Agency research 
authorized by section 1701(a)(4) of the Public Health Service Act (42 
U.S.C. 300u(a)(4)) and section 1003(d)(2)(C) of the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)).
    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 research data through analytical methodology 
development and investigation of sampling and response issues. This 
study will inform the first topic area, advertising features, by 
examining a form of advertising known as native advertising.
    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 home page 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.
    The objective of this present research is to conduct experimental 
studies to examine issues related to endorsers in direct-to-consumer 
prescription drug promotion that occurs within a talk show format. This 
study complements and builds upon two prior FDA studies on endorsement 
issues (OMB control numbers 0910-0894 and 0910-0918). The first study 
examined a number of different endorser types in print or internet 
settings and focused on examining how various disclosures of the 
payment status of the endorser influenced audience reactions. The 
second study extended the prior research by examining, among other

[[Page 80254]]

things, audience reactions to actual-use disclosures (e.g., ``actor 
portrayal'' versus ``actual patient'') in a different medium, 
television ads. The currently proposed study will focus on endorsers in 
a native advertising format (i.e., talk show).
    Native advertising is a form of advertisement where marketers 
present paid content in a format designed to look and feel like the 
surrounding media format and content in which it appears (Refs. 1 and 
2). Native advertisements have become an increasingly popular form of 
advertising. In 2023, advertisers in the United States were expected to 
spend $97.46 billion on native display advertising in all product 
categories (showing a product in a combination of image, text, and 
graphics), accounting for 59.7 percent of total display advertising 
spending (Ref. 2). The intent of native advertising is to minimize the 
disruption in the consumer's regular media intake experience (Ref. 3). 
Recently, FDA has issued compliance letters to pharmaceutical firms for 
misleading promotion of prescription drug products within talk show 
formats (Refs. 11 and 12).
    Research on the native advertising format extends the theoretical 
understanding of persuasion knowledge (Refs. 4 to 6) and advertisement 
recognition (Ref. 7) and has evaluated policy implications around 
deceptive advertising across different media platforms (Refs. 8 and 9). 
However, there has been less study of perceptions and attitudes 
resulting from native advertising, such as the impact on viewer 
perceptions toward the product, the advertisement, the endorser, or the 
interaction of these factors (Ref. 10). Moreover, the majority of 
research on native advertising appears to focus on advertorials in 
print or product placement (Refs. 1 to 7). In the literature, we did 
not find peer-reviewed studies examining attitudes and perceptions in 
reaction to native advertising in a talk show format.
    In the research described here, we will investigate a native 
advertisement for a fictitious prescription drug for type 2 diabetes 
embedded in a health-themed television talk show. This examination will 
help close the gap in the literature. We will examine the impacts of 
three independent variables--(1) sponsorship prominence (none, once, 
periodic, constant); (2) endorser type (the guest on the talk show: 
patient, physician); and (3) risk prominence (lower, higher)--on the 
recall and comprehension of risks and benefits depicted in the 
advertisement, perceptions of endorser characteristics, perceptions of 
drug qualities, and behavioral intentions. The four sponsorship 
prominence conditions will be: (1) no disclosure; (2) disclosure once 
at the beginning of the segment ([GUEST NAME] is a paid spokesperson 
for DRUG X); (3) periodic disclosure at the beginning, middle, and end 
of the segment (A reminder that [GUEST NAME] is a paid spokesperson for 
DRUG X); and (4) constant disclosure in text at the bottom of the 
screen through the entire segment ([GUEST NAME] is a paid spokesperson 
for DRUG X). The two endorser type conditions will vary by type of talk 
show guest: a patient or a physician. Studying sponsorship prominence 
and endorser type allows us to extend our prior research on endorsers 
in print and online promotion (OMB control numbers 0910-0894 and 0910-
0918) to native advertisements in a talk show format. Another factor 
that could affect whether viewers perceive a native advertisement for a 
prescription drug in a talk show format as advertising is the 
prominence of the risk disclosure. The two risk prominence conditions 
will vary by lower or higher prominence: (1) discussed in question-and-
answer format during the interview or (2) text scroll with voiceover 
after the interview has concluded.
    To ensure that the study is operating as planned, we will conduct a 
pretest prior to launching the main study. Both the pretest and main 
study will use a 2 x 4 x 2 factorial design (table 1). Through the use 
of an online survey, each respondent will view 1 of 16 experimental 
variations of a fictitious health-themed television show. This base 
program will be consistent across experimental conditions and will 
feature content that blends health, wellness, and lifestyle topics. The 
target native advertisement segment will be embedded between the base 
program segments, varying across the three independent variables.
    Respondents will be recruited from web panels and include those who 
have been diagnosed with type 2 diabetes, live in the United States, 
and are fluent in English. Participation in the study is voluntary. We 
will not select respondents who work for the U.S. Department of Health 
and Human Services or a pharmaceutical, advertising, or market research 
company.

                                       Table 1--Study Experimental Design
----------------------------------------------------------------------------------------------------------------
                                                                Endorser type and risk prominence
                                                ----------------------------------------------------------------
                                                          Patient guest                   Physician guest
             Sponsorship prominence             ----------------------------------------------------------------
                                                   Higher risk      Lower risk      Higher risk     Lower risk
                                                   prominence       prominence      prominence      prominence
----------------------------------------------------------------------------------------------------------------
None.
Once.
Periodic.
Constant.
----------------------------------------------------------------------------------------------------------------

    Following the video, respondents will be asked questions pertaining 
to their recall and comprehension of risks and benefits depicted in the 
advertisement, perceptions of endorser characteristics, perceptions of 
drug qualities, and behavioral intentions.
    We estimate the burden of this collection of information as 
follows:

[[Page 80255]]



                                                     Table 2--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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         Pretest
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest Screener Completes...................              400                1             400  0.03 (2 minutes).........................            12
Pretest Questionnaire Completes..............               80                1              80  0.30 (18 minutes)........................            24
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       Main Study
--------------------------------------------------------------------------------------------------------------------------------------------------------
Main Study Screener Completes................            3,200                1           3,200  0.03 (2 minutes).........................            96
Main Study Questionnaire Completes...........              640                1             640  0.30 (18 minutes)........................           192
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ...............  ...............  ..............  .........................................           324
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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.

References

    The following references marked with an asterisk (*) are on display 
at 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; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only at the 
Dockets Management Staff. Although FDA verified the website addresses 
in this document, please note that websites are subject to change over 
time.

1. Wojdynski, B.W. and G.J. Golan, ``Native Advertising and the 
Future of Mass Communication,'' American Behavioral Scientist, vol. 
60, pp. 1403-1407, 2016, https://doi.org/10.1177/0002764216660134.
2. King, J., ``Native Advertising: What It Is and How It Benefits 
Advertisers and Publishers,'' EMARKETER, October 11, 2023. Available 
at: https://www.emarketer.com/insights/native-ad-spending. Accessed 
on June 12, 2024.
3. Campbell, C. and L.J. Marks, ``Good Native Advertising Isn't a 
Secret,'' Business Horizons, vol. 58, pp. 599-606, 2015, https://doi.org/10.1016/j.bushor.2015.06.003.
4. Campbell, C. and P.E. Grimm, ``The Challenges Native Advertising 
Poses: Exploring Potential Federal Trade Commission Responses and 
Identifying Research Needs,'' Journal of Public Policy & Marketing, 
vol. 38, pp. 110-123, 2019, https://doi.org/10.1177/0743915618818576.
5. Campbell, M.C. and A. Kirmani, ``Consumers' Use of Persuasion 
Knowledge: The Effects of Accessibility and Cognitive Capacity on 
Perceptions of an Influence Agent,'' Journal of Consumer Research, 
vol. 27, pp. 69-83, 2000, https://doi.org/10.1086/314309.
6. Wei, M.-L., E. Fischer, and K.J. Main, ``An Examination of the 
Effects of Activating Persuasion Knowledge on Consumer Response to 
Brands Engaging in Covert Marketing,'' Journal of Public Policy & 
Marketing, vol. 27, pp. 34-44, 2008, https://doi.org/10.1509/jppm.27.1.34.
7. Pierre, L., ``The Effect of Covert Advertising Recognition on 
Consumer Attitudes: A Systematic Review,'' Journal of Marketing 
Communications, pp. 1-22, 2023, https://doi.org/10.1080/13527266.2023.2184851.
8. Hastak, M. and M.B. Mazis, ``Deception by Implication: A Typology 
of Truthful but Misleading Advertising and Labeling Claims,'' 
Journal of Public Policy & Marketing, vol. 30, pp. 157-167, 2011, 
http://www.jstor.org/stable/23209271.
9. Cain, R.M., ``Embedded Advertising on Television: Disclosure, 
Deception, and Free Speech Rights,'' Journal of Public Policy & 
Marketing, vol. 30, pp. 226-238, 2011, https://doi.org/10.1509/jppm.30.2.226.
10. Lee, S.S., H. Chen, and Y.-H. Lee, ``How Endorser-Product 
Congruity and Self-Expressiveness Affect Instagram Micro-
Celebrities' Native Advertising Effectiveness,'' Journal of Product 
& Brand Management, vol. 31, pp. 149-162, 2022, https://www.emerald.com/insight/content/doi/10.1108/JPBM-02-2020-2757/full/html.
*11. Untitled Letter to Aclaris Therapeutics, Inc. (June 14, 2019). 
Available at: https://www.fda.gov/media/128151/download?attachment.
*12. Untitled Letter to Biohaven Pharmaceuticals (March 8, 2021). 
Available at: https://www.fda.gov/media/146528/download?attachment.

    Dated: September 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-22575 Filed 10-1-24; 8:45 am]
BILLING CODE 4164-01-P


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