Agency Information Collection Activities; Proposed Collection; Comment Request; Study of Multiple Indications in Direct-to-Consumer Television Advertisements, 40296-40299 [2020-14375]
Download as PDF
<![CDATA[
40296
Federal Register / Vol. 85, No. 129 / Monday, July 6, 2020 / Notices
the revised questionnaire) asks level-ofagreement questions very similar to the
type of question the commenter
proposes (e.g., ‘‘I counsel my patients
differently when prescribing a product
with a boxed warning.’’). The revised
questionnaire, however, excludes the
open-ended Q30 in the revised
questionnaire, in an effort to streamline
the survey and reduce respondent
burden.
(Comment 3p): [We] recommend
adding an option ‘‘I’m not sure/I don’t
know/I’m not familiar’’ to Questions 2,
3, 4, 7, 8, 12, 14, 15, 23, 24, 25, 28, 29.
(Response 3p): FDA reviewed the
survey and added an Unsure/Don’t
know option where we deemed
appropriate: Qs 2, 3, 4, 28, 29. Questions
8 and 25 were removed. Q23 has an
‘‘Other (specify)’’ option where
participants can elaborate if they are
unable to choose an answer. For certain
key questions that elicits respondents’
opinions (Qs 7, 12, 14, 15, 24), we did
not add Unsure/Don’t know in order to
encourage them to thoughtfully pick an
answer. However, participants can
proceed through the questions without
providing an answer, if they wish.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Total annual
responses
Pretest Screener ..................................................
Pretest Informed Consent ....................................
Pretest Survey Completes ...................................
Main Survey Screener .........................................
Main Survey Informed Consent ...........................
Main Survey Completes .......................................
84
50
50
1,927
1,156
1,156
1
1
1
1
1
1
84
50
50
1,927
1,156
1,156
Total ..............................................................
4,423
........................
........................
1
Average burden
per response
0.05
0.05
0.28
0.05
0.05
0.28
Total hours
(3 minutes) ............
(3 minutes) ............
(17 minutes) ..........
(3 minutes) ............
(3 minutes) ............
(17 minutes) ..........
4
2
14
96
58
324
.......................................
498
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
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, and are
available for viewing by interested
persons between 9 a.m. and 4 p.m.,
Monday through Friday; they are not
available electronically at https://
www.regulations.gov as these references
are copyright protected.
1. Dusetzina, S.B., A.S. Higashi, E.R. Dorsey,
et al., ‘‘Impact of FDA Drug Risk
Communications on Health Care
Utilization and Health Behaviors: A
Systematic Review.’’ Medical Care,
50(6):466–478, 2012.
2. Briesacher, B.A., S.B. Soumerai, F. Zhang,
et al., ‘‘A Critical Review of Methods to
Evaluate the Impact of FDA Regulatory
Actions.’’ Pharmacoepidemiology Drug
and Safety, 22(9):986–994, 2013.
3. Morgan, M.G., et al., Risk Communication:
A Mental Models Approach. Cambridge
University Press, 2002.
Dated: June 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
khammond on DSKJM1Z7X2PROD with NOTICES
Number of responses
per respondent
[FR Doc. 2020–14377 Filed 7–2–20; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
04:41 Jul 03, 2020
Jkt 250001
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
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
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.’’
SUMMARY:
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,
DATES:
PO 00000
Frm 00113
Fmt 4703
Sfmt 4703
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
E:\FR\FM\06JYN1.SGM
06JYN1
Federal Register / Vol. 85, No. 129 / Monday, July 6, 2020 / Notices
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
khammond on DSKJM1Z7X2PROD with NOTICES
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-201509-18/pdf/2015-23389.pdf.
VerDate Sep<11>2014
04:41 Jul 03, 2020
Jkt 250001
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.
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.
FOR FURTHER INFORMATION CONTACT:
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.
PO 00000
Frm 00114
Fmt 4703
Sfmt 4703
40297
Study of Multiple Indications in Directto-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
E:\FR\FM\06JYN1.SGM
06JYN1
40298
Federal Register / Vol. 85, No. 129 / Monday, July 6, 2020 / Notices
homepage, which can be found at:
https://www.fda.gov/about-fda/centerdrug-evaluation-and-research-cder/
office-prescription-drug-promotionopdp-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 directto-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 × 3 FACTORIAL EXPERIMENT REPEATED IN TWO MEDICAL CONDITIONS
Study 1: Diabetic peripheral neuropathy (DPN) ........
Study 2: Rheumatoid arthritis (RA) ...........................
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
Indication 1
Indication 1 plus a similar
indication
DPN ...................
RA .....................
DPN + fibromyalgia ......................
RA + psoriatic arthritis ..................
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
Indication 1 plus a dissimilar
indication
DPN + general anxiety disorder.
RA + leukemia.
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 smallsized 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
Number of
respondents
Activity
khammond on DSKJM1Z7X2PROD with NOTICES
Pretest 1 &
Pretest 1 &
Main Study
Main Study
1
2
2
1
1
Number of
responses per
respondent
Average
burden per
response
Total annual
respondents
screener .........................................
........................................................
& 2 screener ..................................
& 2 .................................................
264
132
1,770
885
1
1
1
1
264
132
1,770
885
Total ..............................................................
........................
........................
........................
.083
.333
.083
.333
Total hours
(5 min) ...................
(20 min) .................
(5 min) ...................
(20 min) .................
22
44
147
295
.......................................
508
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
VerDate Sep<11>2014
04:41 Jul 03, 2020
Jkt 250001
Staff (see ADDRESSES) and are available
for viewing by interested persons
between 9 a.m. and 4 p.m., Monday
PO 00000
Frm 00115
Fmt 4703
Sfmt 4703
through Friday; these are not available
electronically at https://
www.regulations.gov as these references
E:\FR\FM\06JYN1.SGM
06JYN1
Federal Register / Vol. 85, No. 129 / Monday, July 6, 2020 / Notices
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
Submit written comments
(including recommendations) on the
collection of information by August 5,
2020.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The title
of this information collection is
‘‘Generic Clearance for Qualitative Data
to Support Social and Behavioral
Research for Food, Dietary
Supplements, Cosmetics, and Animal
Food and Feed.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
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, PRAStaff@
fda.hhs.gov.
ADDRESSES:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Generic Clearance for Qualitative Data
to Support Social and Behavioral
Research for Food, Dietary
Supplements, Cosmetics, and Animal
Food and Feed
OMB Control Number 0910–NEW
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–5841]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Generic Clearance
for Qualitative Data To Support Social
and Behavioral Research for Food,
Dietary Supplements, Cosmetics, and
Animal Food and Feed
AGENCY:
Food and Drug Administration,
HHS.
khammond on DSKJM1Z7X2PROD with NOTICES
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(PRA).
SUMMARY:
VerDate Sep<11>2014
04:41 Jul 03, 2020
Jkt 250001
This notice announces the FDA
information collection request from the
OMB for a generic clearance that will
allow FDA to use qualitative social/
behavioral science data collection
techniques (i.e., individual in-depth
interviews, small group discussions,
focus groups, and observations) to
understand stakeholders’ perceptions,
attitudes, motivations, and behaviors
better regarding various issues
associated with food and cosmetic
products, dietary supplements, and
animal food and feed. Understanding
consumers’, manufacturers’, and
producers’ perceptions, attitudes,
motivations, and behaviors plays an
important role in improving FDA’s
communications impacting these
various stakeholders and in assisting in
the development of quantitative study
proposals, complementing other
important research efforts in the
Agency.
FDA will only submit a collection for
approval under this generic clearance if
it meets the following conditions:
PO 00000
Frm 00116
Fmt 4703
Sfmt 4703
40299
• The collections are voluntary;
• the collections are low burden for
participants (based on considerations of
total burden hours, total number of
participants, or burden hours per
participant) and are low cost for both
the participants and the Federal
Government;
• the collections are
noncontroversial;
• personally identifiable information
(PII) is collected only to the extent
necessary 1 and is not retained;
• information gathered will not be
used for the purpose of substantially
informing influential policy decisions; 2
and.
• information gathered will yield
qualitative information; the collections
will not be designed or expected to
yield statistical data or used as though
the results are generalizable to the
population of study.
If these conditions are not met, FDA
will submit an information collection
request to OMB for approval through the
normal PRA process.
To obtain approval for a collection
that meets the conditions of this generic
clearance, an abbreviated supporting
statement will be submitted to OMB
along with supporting documentation
(e.g., a copy of the interview or
moderator guide, screening
questionnaire).
FDA will submit individual
qualitative collections under this
generic clearance to the OMB.
Individual qualitative collections will
also undergo review by FDA’s
institutional review board, senior
leadership in the Center for Food Safety
and Applied Nutrition, and PRA
specialists.
Description of Participants:
Participants in this collection of
information may include a wide range
of consumers and other FDA
stakeholders such as producers and
manufacturers who are regulated under
FDA-regulated food and cosmetic
products, dietary supplements, and
animal food and feed.
In the Federal Register of February
10, 2020 (85 FR 7564), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. Although five comments
1 For example, collections that collect PII to
provide remuneration for participants of focus
groups and cognitive laboratory studies will be
submitted under this request. All Privacy Act
requirements will be met.
2 As defined in OMB and Agency Information
Quality Guidelines, ‘‘influential’’ means that ‘‘an
agency can reasonably determine that
dissemination of the information will have or does
have a clear and substantial impact on important
public policies or important private sector
decisions.’’
E:\FR\FM\06JYN1.SGM
06JYN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Indication 1 plus a Indication 1 plus a
Indication 1 similar indication dissimilar indication
----------------------------------------------------------------------------------------------------------------
Study 1: Diabetic peripheral DPN.................... DPN + fibromyalgia..... DPN + general anxiety
neuropathy (DPN). disorder.
Study 2: Rheumatoid arthritis (RA)... RA..................... RA + psoriatic RA + leukemia.
arthritis.
----------------------------------------------------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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
