[Federal Register Volume 85, Number 129 (Monday, July 6, 2020)]
[Notices]
[Pages 40296-40299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14375]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA 2020-N-1228]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Study of Multiple Indications in Direct-to-Consumer 
Television Advertisements

AGENCY: Food and Drug Administration, Health and Human Services (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 ``Study of Multiple 
Indications in Direct-to-Consumer Television Advertisements.''

DATES: Submit either electronic or written comments on the collection 
of information by September 4, 2020.

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 September 4, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of September 4, 2020. 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

[[Page 40297]]

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 2020-N-1228 for ``Study of Multiple Indications in Direct-to-
Consumer Television Advertisements.'' 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.
     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.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
Ila.Mizrachi@fda.hhs.gov. The questionnaire is available upon request 
from DTCResearch@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    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.

Study of Multiple Indications in Direct-to-Consumer Television 
Advertisements--OMB Control Number 0910-NEW

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 
300u(a)(4)) authorizes the FDA to conduct research relating to health 
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and 
Cosmetic Act (the 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 
protect the public health, in part, by helping to ensure that 
prescription drug promotional material is truthful, balanced, and 
accurately communicated, so that patients and health care 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 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 topic area, advertising features, including content and 
format.
    Because we recognize the strength of data and the confidence in the 
robust nature of the findings is 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

[[Page 40298]]

homepage, 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. 
The website maintains information on studies we have conducted, dating 
back to a direct-to-consumer (DTC) survey conducted in 1999.
    A number of prescription drugs are approved for multiple 
indications. These indications can be similar in certain respects 
(e.g., diabetic peripheral neuropathy and fibromyalgia, which are both 
conditions that manifest in pain) or very different from one another 
(e.g., diabetic peripheral neuropathy and general anxiety disorder). If 
a drug is approved for multiple indications, sponsors choose whether to 
promote only one of those indications in DTC television advertising, or 
multiple indications in the same television ad. We are unaware of any 
quantitative research that addresses how presenting multiple 
indications in one ad affects consumers' processing of drug 
information. Some research suggests that presenting more than one 
indication in a television ad, regardless of the similarity of the 
indications, may increase the cognitive load on consumers, thus 
decreasing their understanding of the drug's indications (Refs. 1 
and3).
    When more than one indication is presented, the similarity or 
dissimilarity of the indications may affect participants' ability to 
remember and understand the indications. If this is the case, it is not 
clear whether similarity would have a positive or negative effect in 
the multimodal context of a television ad (e.g., Refs. 4 and 5).
    This study will provide preliminary information on whether 
consumers face challenges when multiple indications are promoted in a 
single television ad. The study also will explore whether similarity of 
the indications affects participants' likelihood to recall and 
understand the indications, and whether its effect would be positive or 
negative.
    We propose to test three types of fictional DTC television ads--one 
that promotes a single indication, one that promotes an indication plus 
a similar indication, and one that promotes an indication plus a 
dissimilar indication--in two different medical conditions (Table 1).

              Table 1--Study Design--1 x 3 Factorial Experiment Repeated in Two Medical Conditions
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                                                                  Indication 1 plus a      Indication 1 plus a
                                             Indication 1         similar  indication     dissimilar  indication
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Study 1: Diabetic peripheral           DPN....................  DPN + fibromyalgia.....  DPN + general anxiety
 neuropathy (DPN).                                                                        disorder.
Study 2: Rheumatoid arthritis (RA)...  RA.....................  RA + psoriatic           RA + leukemia.
                                                                 arthritis.
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    We plan to conduct two pretests (one for each main study) and two 
main studies not longer than 20 minutes, administered via internet 
panel, to test the experimental manipulations and pilot the main study 
procedures. Participants will be randomly assigned to view one study ad 
and then complete a questionnaire that assesses recall and 
comprehension of the drug's benefits and risks, benefit and risk 
perceptions, attitudes, and behavioral intentions. We will also measure 
covariates such as demographics and health literacy. Taking into 
account prior research, it is our hypothesis that participants will be 
more likely to correctly recall and understand the first indication 
when it is presented alone, compared with when it is presented with a 
second (similar or dissimilar) indication. We will explore whether 
similarity of the indications affects participants' likelihood to 
recall and understand the indications. We will also explore the effects 
of the indication presentation on benefit and risk perceptions, 
attitudes toward the drug and the indication information, and 
intentions to look for more information and ask a doctor about the 
drug.
    For all phases of this research, we will recruit adult volunteers 
18 years of age or older. For Pretest 1 and Study 1, we will recruit 
participants who self-report being diagnosed with diabetes (N = 60 in 
Pretest 1 and N = 402 in Study 1). For Pretest 2 and Study 2, we will 
recruit participants who self-report being diagnosed with rheumatoid 
arthritis (N = 60 in Pretest 2 and N = 402 in Study 2). We will exclude 
individuals who work for the Department of Health and Human Services or 
work in the healthcare, marketing, or pharmaceutical industries. We 
will also exclude pretest participants from the main studies, and 
participants will not be able to participate in both Studies 1 and 2. 
With these sample sizes, we will have sufficient power to detect small-
sized effects in Studies 1 and 2. For the burden estimate, we include 
an additional 10% over our target number of valid completes to account 
for some overage. FDA estimates the burden of this collection of 
information as follows:

                                 Table 2--Estimated Annual Reporting Burden \1\
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                                                   Number of
           Activity                Number of     responses per   Total annual    Average  burden    Total hours
                                  respondents     respondent      respondents     per  response
----------------------------------------------------------------------------------------------------------------
Pretest 1 & 2 screener........             264               1             264  .083 (5 min)....              22
Pretest 1 & 2.................             132               1             132  .333 (20 min)...              44
Main Study 1 & 2 screener.....           1,770               1           1,770  .083 (5 min)....             147
Main Study 1 & 2..............             885               1             885  .333 (20 min)...             295
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................             508
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

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

[[Page 40299]]

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. Mayer, R.E., & Moreno, R. (2003), Nine Ways to Reduce Cognitive 
Load in Multimedia Learning. Educational Psychologist, 38(1), 43-52.
     2. Mutlu-Bayraktar, D., Cosgun, V., & Altan, T. (2019), 
Cognitive Load in Multimedia Learning Environments: A Systematic 
Review. Computers & Education, 141, 103618.
3. Betts, K. R., Boudewyns, V., Aikin, K. J., Squire, C., Dolina, 
S., Hayes, J. J., & Southwell, B. G. (2018), Serious and Actionable 
Risks, Plus Disclosure: Investigating an Alternative Approach for 
Presenting Risk Information in Prescription Drug Television 
Advertisements. Research in Social and Administrative Pharmacy, 
14(10), 951-963.
4. Jiang, Y. V., Lee, H. J., Asaad, A., & Remington, R. (2016), 
Similarity Effects in Visual Working Memory, Psychonomic Bulletin & 
Review, 23(2), 476-482.
5. Oberauer, K., & Lange, E. B. (2008), Interference in Verbal 
Working Memory: Distinguishing Similarity-based Confusion, Feature 
Overwriting, and Feature Migration, Journal of Memory and Language, 
58(3), 730-745.

    Dated: June 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14375 Filed 7-2-20; 8:45 am]
BILLING CODE 4164-01-P


