Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Study of Multiple Indications in Direct-to-Consumer Television Advertisements, 12692-12696 [2021-04472]
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Federal Register / Vol. 86, No. 41 / Thursday, March 4, 2021 / Notices
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
21 CFR section; activity
Number of
respondents
Number of
disclosures per
respondent
Total annual
disclosures
Average
burden per
disclosure
501.22(k); labeling of color additive or lake of color additive; labeling of color additives not subject to certification.
3,120
0.8292
2,587
0.25 .............
(15 minutes).
1 There
Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–04461 Filed 3–3–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2019–N–3077]
[FR Doc. 2021–04470 Filed 3–3–21; 8:45 am]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Obtaining Information To Understand
and Challenges and Opportunities
Encountered by Compounding
Outsourcing Facilities
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing that a collection of
information entitled ‘‘Obtaining
Information to Understand and
Challenges and Opportunities
Encountered by Compounding
Outsourcing Facilities’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
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.
SUMMARY:
On
December 18, 2020, the Agency
submitted a proposed collection of
information entitled ‘‘Obtaining
Information to Understand and
Challenges and Opportunities
Encountered by Compounding
Outsourcing Facilities’’ to OMB for
review and clearance under 44 U.S.C.
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SUPPLEMENTARY INFORMATION:
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3507. An Agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
control number. OMB has now
approved the information collection and
has assigned OMB control number
0910–0883. The approval expires on
January 31, 2022. A copy of the
supporting statement for this
information collection is available on
the internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
Food and Drug Administration
ACTION:
647
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
AGENCY:
Total hours
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1228]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Study of Multiple
Indications in Direct-to-Consumer
Television Advertisements
AGENCY:
Food and Drug Administration,
HHS.
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.
DATES: Submit written comments
(including recommendations) on the
collection of information by April 5,
2021.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
ADDRESSES:
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by using the search function. The title
of this information collection is ‘‘Study
of Multiple Indications in Direct-toConsumer Television Advertisements.’’
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.
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:
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
(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 by helping to
ensure that prescription drug promotion
is truthful, balanced, and accurately
communicated. 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: (1) Advertising
features, including content and format;
(2) target populations; and (3) 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
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Federal Register / Vol. 86, No. 41 / Thursday, March 4, 2021 / Notices
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
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
generalized 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
advertisement. We are unaware of any
quantitative research that addresses how
presenting multiple indications in one
advertisement affects consumers’
processing of drug information. Some
research suggests that presenting more
than one indication in a television
advertisement, regardless of the
similarity of the indications, may
increase the cognitive load on
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consumers, thus decreasing their
understanding of the drug’s indications
(Refs. 1–3).
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 advertisement (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
advertisement. 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
advertisements—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).
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TABLE 1—STUDY DESIGN: 1 × 3 FACTORIAL EXPERIMENT REPEATED IN TWO MEDICAL CONDITIONS
Indication 1
Indication 1 plus a similar indication
Study 1: Diabetic peripheral neuropathy (DPN)
Study 2: Rheumatoid arthritis (RA) ..................
DPN ...............
RA ..................
DPN + fibromyalgia .............................
RA + psoriatic 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 advertisement 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 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.
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Indication 1 plus a dissimilar
indication
DPN + generalized anxiety disorder.
RA + ulcerative colitis.
In the Federal Register of July 6, 2020
(85 FR 40296), FDA published a 60-day
notice requesting public comment on
the proposed collection of information.
FDA received four comments that were
PRA-related.
Within the four submissions, FDA
received multiple comments that the
Agency has addressed below. For
brevity, some public comments are
paraphrased and therefore may not
reflect the exact language used by the
commenter. We assure commenters that
the entirety of their comments was
considered even if not fully captured by
our paraphrasing in this document.
(Comment) One comment suggested
several ideas for other study designs,
including: (1) Studying consumer
reactions to actual advertisement
campaigns; (2) studying consumer
reactions to watching a DTC television
advertisement and then viewing a
related website; and (3) studying
advertisements for multiple indications
with different risk profiles. Another
comment suggested another study idea:
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Federal Register / Vol. 86, No. 41 / Thursday, March 4, 2021 / Notices
Studying a drug with multiple
indications for the same disease.
(Response) We appreciate these
alternate study ideas. As this is the first
study on this topic, we acknowledge our
study cannot answer every research
question. We believe these alternate
study ideas could be candidates for
future research, and we encourage
stakeholders to conduct research in this
area.
(Comment) One comment
recommended using Crohn’s or
ulcerative colitis rather than leukemia
as the dissimilar indication in Study 2
to avoid confusion with adverse effects
of common RA medications.
(Response) Based on this comment,
we plan to use ulcerative colitis rather
than leukemia as the dissimilar
indication in Study 2.
(Comment) Three comments noted
that care should be taken to reduce
confounding variables in the study
stimuli in terms of length, order and
presentation of indications, background
and actor profiles, advertisement
quality, and audio and visual effects.
(Response) We can confirm that care
has been taken to ensure that we do not
have any unintentional confounds
across the study conditions. The
advertisements use the same actors,
scenes, audio and visual effects and all
other design and content features to
ensure that all elements are consistent
across experimental conditions. We also
used the same setting, actors, and
advertisement concept across Study 1
and Study 2 to minimize differences
across the two studies. The only aspect
that will change is the manipulated
content (i.e., script and superimposed
text relaying the indications).
(Comment) One comment requested
that we clarify how we are defining
similar versus dissimilar indications.
(Response) The similar indications
have similar clinical manifestations: In
Study 1, nerve-related pain for diabetic
peripheral neuropathy and fibromyalgia,
and in Study 2, joint pain for
rheumatoid arthritis and psoriatic
arthritis. The dissimilar indications
have dissimilar clinical manifestations:
In Study 1, nerve-related pain for
diabetic peripheral neuropathy and
anxiety for generalized anxiety disorder,
and in Study 2, joint pain for
rheumatoid arthritis and abdominal
pain and diarrhea for ulcerative colitis.
(Comment) One comment
recommended stratification across
conditions for demographics and several
health characteristics.
(Response) Typically, stratified
randomization is used if there are
prognostic variables that correlate with
outcome measures and researchers are
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concerned about such factors not being
evenly distributed across groups (Ref.
6). We have no reason to expect that the
aforementioned factors would have a
strong association with the outcome
measures, nor do we have reason to
believe that we will not achieve
adequate balance of prognostic variables
given the large sample size proposed for
this study (Ref. 6). Random assignment
will help to produce groups which are,
on average, probabilistically similar to
each other. Because randomization
eliminates most other sources of
systematic variation, we can be
reasonably confident that any effect that
is found is the result of the intervention
and not some preexisting differences
between the groups (Ref. 7). However,
we have included questions about
demographics and health
characteristics, which will enable us to
assess their association with our
outcomes and statistically control for
them if necessary.
(Comment) One comment noted that
the sample size per cell should be at
least 75 participants.
(Response) We conducted power
analyses to determine sample size. We
plan to have 134 participants per cell in
each study, for a total of 402
participants per study.
(Comment) One comment noted that
recruiting participants with only the
primary indication could bias results
because participants will be more
familiar with their own medical
condition. Instead, it suggested that for
each study condition we recruit a
sample that matches that study
condition (e.g., recruiting participants
with diabetic peripheral neuropathy or
fibromyalgia for the second study
condition in Study 1).
(Response) We agree that participants
may know more about their own
medical condition than the other
medical conditions advertised.
However, we believe the alternate
design offered in the comment would
make results difficult to interpret as it
would be unclear whether differences
were due to the advertisement
manipulations or to the different
samples. Instead, we plan to keep the
original design. We do not plan to
compare participants’ recall,
recognition, or comprehension of the
primary indication to the second
indication (which may lead to the bias
noted in the comment). Rather, we plan
to compare understanding across the
experimental conditions. For instance,
we are testing the hypothesis that
participants (with diabetes in Study 1
and rheumatoid arthritis in Study 2)
who see the first indication alone will
be more likely to recall, recognize, and
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comprehend the first indication
compared with participants (with
diabetes in Study 1 and rheumatoid
arthritis in Study 2) who see the first
indication and a second (similar or
dissimilar) indication. As another
example, we would expect that recall,
recognition, and comprehension of the
second indication would be higher
when the second indication is
mentioned in the advertisement
compared with when it is not (e.g.,
participants are more likely to know the
drug is also indicated for fibromyalgia
when the advertisement mentions the
fibromyalgia indication). We will
measure participants’ familiarity with
treatments for each medical condition
and assess whether they have been
diagnosed with each medical condition.
We can use these variables to explore
differences among participants. A future
study could examine how individuals
suffering from fibromyalgia or
generalized anxiety, or from psoriatic
arthritis or ulcerative colitis (which are
secondary indications in the current
study) may interpret these
advertisements.
(Comment) One comment suggested
recruiting participants with diabetic
peripheral neuropathy specifically
rather than diabetes in Study 1, while
another comment noted that diabetic
peripheral neuropathy is
underdiagnosed and therefore may
present recruitment challenges.
(Response) We plan to retain the
diabetes sample for Study 1 to aid
recruitment. We will ask participants if
they experience diabetes-related pain
and whether they have been diagnosed
with diabetic peripheral neuropathy.
(Comment) One comment noted
concern about the chosen indications
because medical conditions can differ
from one another in several ways (e.g.,
prevalence, treatment options) and
suggested considering public awareness
of the medical conditions.
(Response) We agree that medical
conditions vary; this is unavoidable in
a study of this kind. To account for this,
we plan to conduct two studies using
different medical conditions to
determine whether the effects replicate
across studies. We will measure
participants’ familiarity with treatments
for the medical conditions in each
study.
(Comment) One comment suggested
asking participants if they were familiar
with the fictitious drug and terminating
participants who say yes.
(Response) It is unlikely that many
participants will claim to be familiar
with the fictional brand name. However,
past research has noted the human
tendency to falsely recognize content
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(Ref. 8). While theoretically interesting,
the fact that people may falsely
recognize our brand should not threaten
the internal validity of the current
study. Random assignment should
guard against systematic differences
among groups in terms of false
recognition tendency. Nonetheless, we
appreciate this concern and in response,
we have added a question to the survey
to measure familiarity with the brand,
which we can then explore in auxiliary
analyses, but we do not think
participants with false brand familiarity
should be removed from the study. Our
study sample includes those with
rheumatoid arthritis for one of the
studies (a condition with lower
prevalence in the United States, about
0.6 percent of the population).
Excluding those with false recognition
would impose additional burden on
recruitment.
(Comment) One comment suggested
that the questionnaire should include
the statement ‘‘Based on the ad you just
saw . . .’’ before each question.
(Response) We include this statement
and similar language throughout the
questionnaire.
(Comment) One comment suggested
we measure unaided awareness of the
indications, aided awareness of the
indications, likelihood to go to the
branded drug website to learn more
about the drug, and likelihood to ask
their doctor about the drug.
(Response) We measure unaided
awareness of the indications (benefit
recall) in Question 2, aided awareness of
the indications (benefit recognition) in
Question 3, and likelihood to look for
more information about the drug and
ask their doctor about the drug in
Questions 16 and 17.
(Comment) One comment suggested
deleting Questions 2 and 13 in favor of
Questions 3 and 14 because these openended questions may be difficult for
respondents to answer.
(Response) Questions 2 and 13
measure unaided recall of drug benefits
and risks whereas Questions 3 and 14
measure recognition of drug benefits
and risks. We agree that recall is more
difficult than recognition. We plan to
retain Questions 2 and 13 but will
assess their utility in cognitive
interviews and pretesting.
(Comment) One comment suggested
using consistent scales on the
questionnaire.
(Response) Most questionnaire items
have true/false/don’t know or yes/no/
don’t know response options. Some
items are validated measures with
Likert-type scales; for these, we have
used the response options from the
validated measures.
(Comment) Two comments suggested
removing or revising questions 7–10
because participants do not have the
medical expertise to say whether
someone is a good candidate for a drug.
Instead, the comments suggested asking
whether the drug is appropriate for
them.
(Response) These questions are
intended to measure participants’
comprehension of the indications as
communicated in the advertisements.
DTC advertisements can drive
consumers to ask their doctors about a
drug, so it is important to know whether
the drug indication is accurately
communicated to consumers. We used
similar questions about being a ‘‘good
candidate’’ in another study (OMB
control number 0910–0885). In
cognitive interviews, participants were
able to answer the questions and they
understood that the questions were
asking about the drug information in the
advertisement. We also tested language,
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such as whether it would be appropriate
for the person to ask their doctor about
the drug, but participants found this
language to be wordy and unnecessary.
We do not plan to change these
questions at this time, but we will assess
participants’ ability to answer these
questions in cognitive interviews and
pretesting.
(Comment) Two comments suggested
deleting or revising several items
(Questions 16, 17, 21–24, 26, 27 in one
comment, Questions 18–27 in the other)
because responses to these items may be
influenced by the particular stimuli
used and by factors other than those
being studied.
(Response) These items measure
intentions, attitudes, and perceptions.
We agree that several factors can
influence these outcomes. However,
random assignment to conditions allows
us to determine whether the
experimental manipulation is
responsible for differences in these
outcomes across conditions. We will
retain these items and assess their
utility in cognitive interviews and
pretesting.
(Comment) One comment suggested
combining Questions 30 through 33 into
one item and asking it at the beginning
of the questionnaire.
(Response) We combined questions
Q31 and Q32 into one item and moved
the item to the screener.
(Comment) One comment suggested
we ask participants if they have been
diagnosed with the indicated medical
conditions (diabetic neuropathy,
fibromyalgia, etc.).
(Response) These questions are
included on the questionnaire.
FDA estimates the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Total annual
respondents
Pretest 1 and 2 screener .........................................
Pretest 1 and 2 ........................................................
Main Study 1 and 2 screener ..................................
Main Study 1 and 2 .................................................
264
132
1,770
885
1
1
1
1
264
132
1,770
885
Total ..................................................................
........................
........................
........................
1 There
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Number of
responses per
respondent
Average burden per
response
0.083
0.333
0.083
0.333
Total hours
(5 minutes) ......
(20 minutes) ....
(5 minutes) ......
(20 minutes) ....
22
44
147
295
....................................
508
are no capital costs or operating and maintenance costs associated with this collection of information.
References
The following references 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
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Friday; these are not available
electronically at https://
www.regulations.gov as these references
are copyright protected. Some may be
available at the website address, if
listed. FDA has verified the website
addresses, as of the date this document
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publishes in the Federal Register, but
websites are subject to change over time.
1. Mayer, R.E. and R. Moreno (2003), ‘‘Nine
Ways to Reduce Cognitive Load in
Multimedia Learning.’’ Educational
Psychologist, 38(1), 43–52.
2. Mutlu-Bayraktar, D., V. Cosgun, and T.
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Federal Register / Vol. 86, No. 41 / Thursday, March 4, 2021 / Notices
Altan (2019), ‘‘Cognitive Load in
Multimedia Learning Environments: A
Systematic Review.’’ Computers &
Education, 141, 103618.
3. Betts, K.R., V. Boudewyns, K.J. Aikin, C.
Squire, et al. (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., H.J. Lee, A. Asaad, and R.
Remington (2016), ‘‘Similarity Effects in
Visual Working Memory.’’ Psychonomic
Bulletin & Review, 23(2), 476–482.
5. Oberauer, K. and E.B. Lange (2008),
‘‘Interference in Verbal Working
Memory: Distinguishing SimilarityBased Confusion, Feature Overwriting,
and Feature Migration.’’ Journal of
Memory and Language, 58(3), 730–745.
6. Friedman, L.M., C.D. Furberg, and D.L.
DeMets (1998), Fundamentals of Clinical
Trials. New York, NY: Spring ScienceBusiness Media, LLC.
7. Fisher, R.A. (1937), The Design of
Experiments. Edinburgh, United
Kingdom: Oliver and Boyd.
8. Southwell, B.G. and R. Langteau (2008),
‘‘Age, Memory Changes, and the Varying
Utility of Recognition as a Media Effects
Pathway’’. Communication Methods and
Measures, 2, 100–114.
Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–04472 Filed 3–3–21; 8:45 am]
BILLING CODE 4164–01–P
nonvoting industry representative.
Nominations will be accepted for an
upcoming vacancy effective with this
notice.
Any industry organizations
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
FDA by April 5, 2021 (see sections I and
III of this document for further details).
Concurrently, nomination materials for
prospective candidates should be sent to
FDA by April 5, 2021.
ADDRESSES: All statements of interest
from industry organizations interested
in participating in the selection process
of nonvoting industry representative
nominations should be sent to Margaret
Ames (see FOR FURTHER INFORMATION
CONTACT). All nominations for
nonvoting industry representatives
should be submitted electronically by
accessing FDA’s Advisory Committee
Membership Nomination Portal at
https://www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member of an FDA advisory
committee can also be obtained by
visiting FDA’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
DATES:
FOR FURTHER INFORMATION CONTACT:
Margaret Ames, Office of Management,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 5213, Silver Spring, MD 20993–
0002, 301–796–5960, margaret.ames@
fda.hhs.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–2430]
Request for Nominations on Device
Good Manufacturing Practice Advisory
Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
requesting that any industry
organization interested in participating
in the selection of a nonvoting industry
representative to serve on the Device
Good Manufacturing Practice Advisory
Committee (DGMPAC) in the Center for
Devices and Radiological Health notify
FDA in writing. FDA is also requesting
nominations for a nonvoting industry
representative to fill an upcoming
vacancy on DGMPAC. A nominee may
either be self-nominated or nominated
by an organization to serve as a
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:27 Mar 03, 2021
Jkt 253001
Section
520 of the Federal Food, Drug and
Cosmetic Act (21 U.S.C. 360j), as
amended, provides that DGMPAC shall
be composed of two representatives of
interests of the device manufacturing
industry. The Agency is requesting
nominations for a nonvoting industry
representative to fill an upcoming
vacancy on DGMPAC. FDA is
publishing a separate document
announcing the request for notification
for voting members on DGMPAC.
SUPPLEMENTARY INFORMATION:
I. Function of DGMPAC
DGMPAC reviews proposed
regulations issuance regarding good
manufacturing practices governing the
methods used in, and the facilities and
controls used for, the manufacture,
packaging, storage, installation, and
servicing of devices, and makes
PO 00000
Frm 00104
Fmt 4703
Sfmt 4703
recommendations regarding the
feasibility and reasonableness of those
proposed regulations. The committee
also reviews and makes
recommendations on proposed
guidelines developed to assist the
medical device industry in meeting the
good manufacturing practice
requirements and provides advice with
regard to any petition submitted by a
manufacturer for an exemption or
variance from good manufacturing
practice regulations.
II. Qualifications
Persons nominated for DGMPAC
should possess appropriate
qualifications to understand and
contribute to the committee’s work as
described in the committee’s function.
III. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within
the subsequent 30 days, FDA will send
a letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations,
and a list of all nominees along with
their current resumes. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
nonvoting member to represent industry
interests for the committee. The
interested organizations are not bound
by the list of nominees in selecting a
candidate. However, if no individual is
selected within the 60 days, the
Commissioner will select the nonvoting
member to represent industry interests.
IV. Application Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Nominations
must include a current, complete
re´sume´ or curriculum vitae for each
nominee, including current business
address, telephone number, email
address if available, and a signed copy
of the Acknowledgement and Consent
form available at the FDA Advisory
Committee Membership Nomination
Portal (see ADDRESSES) within 30 days of
publication of this document (see
DATES). Nominations must also specify
the advisory committee for which the
nominee is recommended. Nominations
must also acknowledge that the
E:\FR\FM\04MRN1.SGM
04MRN1
]]>Agencies
[Federal Register Volume 86, Number 41 (Thursday, March 4, 2021)]
[Notices]
[Pages 12692-12696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04472]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1228]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Study of Multiple
Indications in Direct-to-Consumer Television Advertisements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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.
DATES: Submit written comments (including recommendations) on the
collection of information by April 5, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to 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 ``Study of Multiple Indications in Direct-to-
Consumer Television Advertisements.'' 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,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 (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 by helping to ensure that prescription drug
promotion is truthful, balanced, and accurately communicated. 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: (1) Advertising features, including content and format; (2)
target populations; and (3) 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
[[Page 12693]]
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 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 generalized 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
advertisement. We are unaware of any quantitative research that
addresses how presenting multiple indications in one advertisement
affects consumers' processing of drug information. Some research
suggests that presenting more than one indication in a television
advertisement, regardless of the similarity of the indications, may
increase the cognitive load on consumers, thus decreasing their
understanding of the drug's indications (Refs. 1-3).
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 advertisement (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 advertisement. 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
advertisements--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 + generalized
neuropathy (DPN). anxiety disorder.
Study 2: Rheumatoid arthritis (RA).. RA........................ RA + psoriatic RA + ulcerative
arthritis. colitis.
----------------------------------------------------------------------------------------------------------------
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
advertisement 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.
In the Federal Register of July 6, 2020 (85 FR 40296), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received four comments that were PRA-
related.
Within the four submissions, FDA received multiple comments that
the Agency has addressed below. For brevity, some public comments are
paraphrased and therefore may not reflect the exact language used by
the commenter. We assure commenters that the entirety of their comments
was considered even if not fully captured by our paraphrasing in this
document.
(Comment) One comment suggested several ideas for other study
designs, including: (1) Studying consumer reactions to actual
advertisement campaigns; (2) studying consumer reactions to watching a
DTC television advertisement and then viewing a related website; and
(3) studying advertisements for multiple indications with different
risk profiles. Another comment suggested another study idea:
[[Page 12694]]
Studying a drug with multiple indications for the same disease.
(Response) We appreciate these alternate study ideas. As this is
the first study on this topic, we acknowledge our study cannot answer
every research question. We believe these alternate study ideas could
be candidates for future research, and we encourage stakeholders to
conduct research in this area.
(Comment) One comment recommended using Crohn's or ulcerative
colitis rather than leukemia as the dissimilar indication in Study 2 to
avoid confusion with adverse effects of common RA medications.
(Response) Based on this comment, we plan to use ulcerative colitis
rather than leukemia as the dissimilar indication in Study 2.
(Comment) Three comments noted that care should be taken to reduce
confounding variables in the study stimuli in terms of length, order
and presentation of indications, background and actor profiles,
advertisement quality, and audio and visual effects.
(Response) We can confirm that care has been taken to ensure that
we do not have any unintentional confounds across the study conditions.
The advertisements use the same actors, scenes, audio and visual
effects and all other design and content features to ensure that all
elements are consistent across experimental conditions. We also used
the same setting, actors, and advertisement concept across Study 1 and
Study 2 to minimize differences across the two studies. The only aspect
that will change is the manipulated content (i.e., script and
superimposed text relaying the indications).
(Comment) One comment requested that we clarify how we are defining
similar versus dissimilar indications.
(Response) The similar indications have similar clinical
manifestations: In Study 1, nerve-related pain for diabetic peripheral
neuropathy and fibromyalgia, and in Study 2, joint pain for rheumatoid
arthritis and psoriatic arthritis. The dissimilar indications have
dissimilar clinical manifestations: In Study 1, nerve-related pain for
diabetic peripheral neuropathy and anxiety for generalized anxiety
disorder, and in Study 2, joint pain for rheumatoid arthritis and
abdominal pain and diarrhea for ulcerative colitis.
(Comment) One comment recommended stratification across conditions
for demographics and several health characteristics.
(Response) Typically, stratified randomization is used if there are
prognostic variables that correlate with outcome measures and
researchers are concerned about such factors not being evenly
distributed across groups (Ref. 6). We have no reason to expect that
the aforementioned factors would have a strong association with the
outcome measures, nor do we have reason to believe that we will not
achieve adequate balance of prognostic variables given the large sample
size proposed for this study (Ref. 6). Random assignment will help to
produce groups which are, on average, probabilistically similar to each
other. Because randomization eliminates most other sources of
systematic variation, we can be reasonably confident that any effect
that is found is the result of the intervention and not some
preexisting differences between the groups (Ref. 7). However, we have
included questions about demographics and health characteristics, which
will enable us to assess their association with our outcomes and
statistically control for them if necessary.
(Comment) One comment noted that the sample size per cell should be
at least 75 participants.
(Response) We conducted power analyses to determine sample size. We
plan to have 134 participants per cell in each study, for a total of
402 participants per study.
(Comment) One comment noted that recruiting participants with only
the primary indication could bias results because participants will be
more familiar with their own medical condition. Instead, it suggested
that for each study condition we recruit a sample that matches that
study condition (e.g., recruiting participants with diabetic peripheral
neuropathy or fibromyalgia for the second study condition in Study 1).
(Response) We agree that participants may know more about their own
medical condition than the other medical conditions advertised.
However, we believe the alternate design offered in the comment would
make results difficult to interpret as it would be unclear whether
differences were due to the advertisement manipulations or to the
different samples. Instead, we plan to keep the original design. We do
not plan to compare participants' recall, recognition, or comprehension
of the primary indication to the second indication (which may lead to
the bias noted in the comment). Rather, we plan to compare
understanding across the experimental conditions. For instance, we are
testing the hypothesis that participants (with diabetes in Study 1 and
rheumatoid arthritis in Study 2) who see the first indication alone
will be more likely to recall, recognize, and comprehend the first
indication compared with participants (with diabetes in Study 1 and
rheumatoid arthritis in Study 2) who see the first indication and a
second (similar or dissimilar) indication. As another example, we would
expect that recall, recognition, and comprehension of the second
indication would be higher when the second indication is mentioned in
the advertisement compared with when it is not (e.g., participants are
more likely to know the drug is also indicated for fibromyalgia when
the advertisement mentions the fibromyalgia indication). We will
measure participants' familiarity with treatments for each medical
condition and assess whether they have been diagnosed with each medical
condition. We can use these variables to explore differences among
participants. A future study could examine how individuals suffering
from fibromyalgia or generalized anxiety, or from psoriatic arthritis
or ulcerative colitis (which are secondary indications in the current
study) may interpret these advertisements.
(Comment) One comment suggested recruiting participants with
diabetic peripheral neuropathy specifically rather than diabetes in
Study 1, while another comment noted that diabetic peripheral
neuropathy is underdiagnosed and therefore may present recruitment
challenges.
(Response) We plan to retain the diabetes sample for Study 1 to aid
recruitment. We will ask participants if they experience diabetes-
related pain and whether they have been diagnosed with diabetic
peripheral neuropathy.
(Comment) One comment noted concern about the chosen indications
because medical conditions can differ from one another in several ways
(e.g., prevalence, treatment options) and suggested considering public
awareness of the medical conditions.
(Response) We agree that medical conditions vary; this is
unavoidable in a study of this kind. To account for this, we plan to
conduct two studies using different medical conditions to determine
whether the effects replicate across studies. We will measure
participants' familiarity with treatments for the medical conditions in
each study.
(Comment) One comment suggested asking participants if they were
familiar with the fictitious drug and terminating participants who say
yes.
(Response) It is unlikely that many participants will claim to be
familiar with the fictional brand name. However, past research has
noted the human tendency to falsely recognize content
[[Page 12695]]
(Ref. 8). While theoretically interesting, the fact that people may
falsely recognize our brand should not threaten the internal validity
of the current study. Random assignment should guard against systematic
differences among groups in terms of false recognition tendency.
Nonetheless, we appreciate this concern and in response, we have added
a question to the survey to measure familiarity with the brand, which
we can then explore in auxiliary analyses, but we do not think
participants with false brand familiarity should be removed from the
study. Our study sample includes those with rheumatoid arthritis for
one of the studies (a condition with lower prevalence in the United
States, about 0.6 percent of the population). Excluding those with
false recognition would impose additional burden on recruitment.
(Comment) One comment suggested that the questionnaire should
include the statement ``Based on the ad you just saw . . .'' before
each question.
(Response) We include this statement and similar language
throughout the questionnaire.
(Comment) One comment suggested we measure unaided awareness of the
indications, aided awareness of the indications, likelihood to go to
the branded drug website to learn more about the drug, and likelihood
to ask their doctor about the drug.
(Response) We measure unaided awareness of the indications (benefit
recall) in Question 2, aided awareness of the indications (benefit
recognition) in Question 3, and likelihood to look for more information
about the drug and ask their doctor about the drug in Questions 16 and
17.
(Comment) One comment suggested deleting Questions 2 and 13 in
favor of Questions 3 and 14 because these open-ended questions may be
difficult for respondents to answer.
(Response) Questions 2 and 13 measure unaided recall of drug
benefits and risks whereas Questions 3 and 14 measure recognition of
drug benefits and risks. We agree that recall is more difficult than
recognition. We plan to retain Questions 2 and 13 but will assess their
utility in cognitive interviews and pretesting.
(Comment) One comment suggested using consistent scales on the
questionnaire.
(Response) Most questionnaire items have true/false/don't know or
yes/no/don't know response options. Some items are validated measures
with Likert-type scales; for these, we have used the response options
from the validated measures.
(Comment) Two comments suggested removing or revising questions 7-
10 because participants do not have the medical expertise to say
whether someone is a good candidate for a drug. Instead, the comments
suggested asking whether the drug is appropriate for them.
(Response) These questions are intended to measure participants'
comprehension of the indications as communicated in the advertisements.
DTC advertisements can drive consumers to ask their doctors about a
drug, so it is important to know whether the drug indication is
accurately communicated to consumers. We used similar questions about
being a ``good candidate'' in another study (OMB control number 0910-
0885). In cognitive interviews, participants were able to answer the
questions and they understood that the questions were asking about the
drug information in the advertisement. We also tested language, such as
whether it would be appropriate for the person to ask their doctor
about the drug, but participants found this language to be wordy and
unnecessary. We do not plan to change these questions at this time, but
we will assess participants' ability to answer these questions in
cognitive interviews and pretesting.
(Comment) Two comments suggested deleting or revising several items
(Questions 16, 17, 21-24, 26, 27 in one comment, Questions 18-27 in the
other) because responses to these items may be influenced by the
particular stimuli used and by factors other than those being studied.
(Response) These items measure intentions, attitudes, and
perceptions. We agree that several factors can influence these
outcomes. However, random assignment to conditions allows us to
determine whether the experimental manipulation is responsible for
differences in these outcomes across conditions. We will retain these
items and assess their utility in cognitive interviews and pretesting.
(Comment) One comment suggested combining Questions 30 through 33
into one item and asking it at the beginning of the questionnaire.
(Response) We combined questions Q31 and Q32 into one item and
moved the item to the screener.
(Comment) One comment suggested we ask participants if they have
been diagnosed with the indicated medical conditions (diabetic
neuropathy, fibromyalgia, etc.).
(Response) These questions are included on the questionnaire.
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 per response Total hours
respondents respondent respondents
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest 1 and 2 screener.................... 264 1 264 0.083 (5 minutes)......................... 22
Pretest 1 and 2............................. 132 1 132 0.333 (20 minutes)........................ 44
Main Study 1 and 2 screener................. 1,770 1 1,770 0.083 (5 minutes)......................... 147
Main Study 1 and 2.......................... 885 1 885 0.333 (20 minutes)........................ 295
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 508
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
References
The following references 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; these are not
available electronically at https://www.regulations.gov as these
references are copyright protected. Some may be available at the
website address, if listed. FDA has verified the website addresses, as
of the date this document publishes in the Federal Register, but
websites are subject to change over time.
1. Mayer, R.E. and R. Moreno (2003), ``Nine Ways to Reduce Cognitive
Load in Multimedia Learning.'' Educational Psychologist, 38(1), 43-
52.
2. Mutlu-Bayraktar, D., V. Cosgun, and T.
[[Page 12696]]
Altan (2019), ``Cognitive Load in Multimedia Learning Environments:
A Systematic Review.'' Computers & Education, 141, 103618.
3. Betts, K.R., V. Boudewyns, K.J. Aikin, C. Squire, et al. (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., H.J. Lee, A. Asaad, and R. Remington (2016),
``Similarity Effects in Visual Working Memory.'' Psychonomic
Bulletin & Review, 23(2), 476-482.
5. Oberauer, K. and E.B. Lange (2008), ``Interference in Verbal
Working Memory: Distinguishing Similarity-Based Confusion, Feature
Overwriting, and Feature Migration.'' Journal of Memory and
Language, 58(3), 730-745.
6. Friedman, L.M., C.D. Furberg, and D.L. DeMets (1998),
Fundamentals of Clinical Trials. New York, NY: Spring Science-
Business Media, LLC.
7. Fisher, R.A. (1937), The Design of Experiments. Edinburgh, United
Kingdom: Oliver and Boyd.
8. Southwell, B.G. and R. Langteau (2008), ``Age, Memory Changes,
and the Varying Utility of Recognition as a Media Effects Pathway''.
Communication Methods and Measures, 2, 100-114.
Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04472 Filed 3-3-21; 8:45 am]
BILLING CODE 4164-01-P
