[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,
[email protected]. The questionnaire is available upon request
from [email protected].
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
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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
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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