Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigation of Consumer Perceptions of Expressed Modified Risk Claims, 54356-54359 [2018-23523]
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Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Notices
Withdrawal of approval of an
application or abbreviated application
Application No.
Drug
Applicant
NDA 009165 ..........
Delatestryl (testosterone enanthate) Injection, 200 milligrams (mg)/milliliter (mL).
Xylocaine (lidocaine hydrochloride (HCl)) 4% Topical Solution/Sterile Injection.
Xylocaine (1.5% lidocaine HCl with dextrose 7.5%) Spinal
Injection, 2 mL ampules.
Norinyl 1+80 (mestranol and norethindrone) 21-Day Tablets,
0.08 mg/1 mg.
Norinyl 1+80 (mestranol and norethindrone) 28-Day Tablets,
0.08 mg/1 mg.
Sodium Chloride 0.9% Injection USP in Plastic Container, 9
mg/mL.
Dextrose 5% Injection USP in Plastic Container, 50 mg/mL
Testosterone Gel, 2.5 mg/1.25 grams (g), 25 mg/2.5 g, 50
mg/5 g.
Xartemis XR (oxycodone HCl and acetaminophen) Extended-Release Tablets, 7.5 mg/325 mg.
Targiniq ER (naloxone HCl and oxycodone HCl) ExtendedRelease Tablets, 5 mg/10 mg, 10 mg/20 mg, and 20 mg/
40 mg.
Endo Pharmaceuticals, Inc., 1400 Atwater Dr., Malvern, PA
19355.
Fresenius Kabi, USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047.
Do.
NDA 010417 ..........
NDA 016297 ..........
NDA 016724 ..........
NDA 016725 ..........
NDA 019217 ..........
NDA 019222 ..........
NDA 203098 ..........
NDA 204031 ..........
NDA 205777 ..........
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of November 28,
2018. Introduction or delivery for
introduction into interstate commerce of
products without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
that are in inventory on November 28,
2018 may continue to be dispensed
until the inventories have been depleted
or the drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: October 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–23528 Filed 10–26–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0821]
amozie on DSK3GDR082PROD with NOTICES1
under § 314.150(c) is without prejudice
to refiling.
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Investigation of
Consumer Perceptions of Expressed
Modified Risk Claims
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
GD Searle LLC, a subsidiary of Pfizer Inc., 235 East 42nd
St., New York, NY 10017.
Do.
ICU Medical, Inc., 600 N. Field Dr., Lake Forest, IL 60045.
Do.
Perrigo Co., U.S. Agent for Perrigo Israel Pharmaceuticals
Ltd., 3490 Quebec Ave. North, Minneapolis, MN 55427.
Mallinckrodt Inc., 675 McDonnell Blvd., Hazelwood, MO
63042.
Purdue Pharma, LP, One Stamford Forum, Stamford, CT
06901–3431.
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: Fax written comments on the
collection of information by November
28, 2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Investigation of Consumer
Perceptions of Expressed Modified Risk
Claims.’’ Also include the FDA docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
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.
Investigation of Consumer Perceptions
of Expressed Modified Risk Claims
OMB Control Number 0910—NEW
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
SUMMARY:
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I. Background
FDA’s Center for Tobacco Products
proposes to conduct a study to develop
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generalizable scientific knowledge to
help inform its implementation of
section 911 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
387k), wherein FDA will be evaluating
information submitted to the Agency
about how consumers understand and
perceive modified risk tobacco products
(MRTPs). Section 911 of the FD&C Act
authorizes FDA to grant orders to
persons to allow the marketing of
MRTPs. The term ‘‘modified risk
tobacco product’’ means any tobacco
product that is sold or distributed for
use to reduce harm or the risk of
tobacco-related disease associated with
commercially marketed tobacco
products. FDA can issue a risk
modification order under section
911(g)(1) of the FD&C Act authorizing
the marketing of an MRTP only if the
Agency determines that the product, as
it is used by consumers, will
significantly reduce harm and the risk of
tobacco-related disease to individual
tobacco users and benefit the health of
the population as a whole, taking into
account both users of tobacco products
and persons who do not currently use
tobacco products (section 911(g)(1) of
the FD&C Act). Alternatively, with
respect to tobacco products that may not
be commercially marketed under
section 911(g)(1) of the FD&C Act, FDA
may issue an exposure modification
order under section 911(g)(2) of the
FD&C Act authorizing the marketing of
an MRTP if the Agency determines that
the standard in section 911(g)(2) of the
FD&C Act is met, including, among
other requirements, that: Any aspect of
the label, labeling, or advertising that
would cause the product to be an MRTP
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is limited to an explicit or implicit
representation that the tobacco product
or its smoke does not contain or is free
of a substance or contains a reduced
level of a substance, or presents a
reduced exposure to a substance in
tobacco smoke; the order would be
appropriate to promote the public
health; the issuance of the order is
expected to benefit the population as a
whole, taking into account both users
and nonusers of tobacco products; and
the existing evidence demonstrates that
a measurable and substantial reduction
in morbidity and mortality among
individual tobacco users is reasonably
likely to be shown in subsequent studies
(section 911(g)(2) of the FD&C Act). In
addition, section 911 of the FD&C Act
requires that any advertising or labeling
concerning modified risk products
enable the public to comprehend the
information concerning modified risk
and to understand the relative
significance of such information in the
context of total health and in relation to
all the diseases and health-related
conditions associated with the use of
tobacco products (section 911(h)(1) of
the FD&C Act). The proposed research
will inform the Agency’s efforts to
implement the provisions of the FD&C
Act related to MRTPs.
FDA proposes conducting a study to
assist in determining appropriate
methods for gathering information about
how consumers perceive and
understand modified risk information.
The study would develop and validate
measures of consumer perceptions of
health risk from using tobacco products.
Moreover, the study would test how
participants’ responses on these
measures are affected by viewing
modified risk labeling or advertising,
participants’ characteristics such as
prior beliefs about the harmfulness of
tobacco products, current use of tobacco
products, and sociodemographic
characteristics. Finally, the study would
examine factors that may influence the
effectiveness of debriefing at the end of
a consumer perception study to ensure
that people read and recall key
information about the study. This
research is significant because it will
validate methods that can be used in
studies of the impact of labels, labeling,
and advertising on consumer
perceptions and understanding of the
risks of product use.
Measures of consumer health risk
perception will be developed and
validated by conducting a study on two
product types: Moist snuff smokeless
tobacco products and electronic
cigarette (e-cigarette) products. For each
product type, we will assess individuallevel factors that may moderate the
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impact of modified risk information on
consumer responses. Potential
moderating factors under study include:
Beliefs (prior to viewing the modified
risk information) about the harmfulness
of tobacco products, and the strength
with which those beliefs are held;
current tobacco use behaviors; and
sociodemographic characteristics
including age and educational
attainment. For each product type,
participants will be randomized to view
one of two conditions: Tobacco product
labeling and advertising that either does
or does not contain modified risk claims
about a product. The labeling will
consist of a product package. The
advertising will consist of a print
advertisement. The study will assess
participants’ perceptions of various
health risks from using the product, as
well as their perceptions of health risk
from using the product compared to
smoking cigarettes, using nicotine
replacement therapies, and quitting all
tobacco and nicotine products. The
study will also assess participants’
intentions to use the product and their
level of doubt about whether tobacco
products are harmful to users’ health.
Measures of intentions and doubt will
be used to help assess the validity of the
measures of health risk perception.
In the Federal Register of May 21,
2018 (83 FR 23464), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received four
comments that were PRA related.
Within those submissions, FDA
received multiple comments which the
Agency has addressed.
(Comment) Three of the comments
were supportive of the usefulness and
importance of the proposed data
collection. These comments stated that
validated measures of consumers’ health
risk perceptions could be useful for
FDA, researchers in the field, and
industry—in particular, sponsors of
modified risk tobacco product
applications (MRTPAs). One of these
comments expressed hope that the
proposed study would be part of a more
general effort by FDA to establish
methods and standards for evaluating
other aspects of MRTPAs.
(Response) FDA agrees with these
comments to the extent they relate to
this study.
(Comment) One of the comments was
unsupportive of the proposed data
collection, stating that it should not be
undertaken for two reasons. The
comment stated that the data are
unneeded because U.S. consumers
already understand the negative health
effects of tobacco use and will not use
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54357
a tobacco product if they are concerned
about their health.
(Response) The proposed data
collection focuses on consumer
perceptions of modified risk tobacco
products, which are products that are
sold or distributed for use to reduce
harm or the risk of tobacco-related
diseases associated with commercially
marketed tobacco products.
(Comment) A comment stated that the
proposed data collection should not be
undertaken because it would waste
taxpayers’ money.
(Response) FDA believes this study
will provide information important to
its implementation of The Family
Smoking Prevention and Tobacco
Control Act. FDA also notes that the
study is not funded by taxpayers’
money, but rather by industry user fees
paid by regulated tobacco companies.
(Comment) One comment suggested
that the proposed data collection should
be guided by a theoretical approach.
(Response) The main objective of the
data collection—developing and
validating measures of consumer
perceptions of tobacco health risks—is
intentionally atheoretical. We intend for
this aspect of the research to be datadriven rather than theory-driven. To
accomplish this, we have created a large
pool of risk perception items by
aggregating items from all of the multiitem measures we could find in the
published tobacco literature, putting
them into the main categories of tobacco
health effects that have been identified
in prior health reviews, changing the
wording of the items to put them in a
common format, eliminating redundant
or poorly worded items by consulting
expert colleagues in medicine,
epidemiology, and social science, and
adding items to fill remaining gaps in
terms of the main categories of tobacco
health effects. When analyzing data
from this proposed data collection, we
plan to use factor analysis to identify
the main dimensions underlying how
U.S. consumers perceive tobacco
product risks. Thus, overall, the goal of
the proposed measurement
development research is to
comprehensively assess risk perceptions
without overlaying our own
preconceptions about how people may
perceive these risks.
(Comment) One comment stated that
the findings from our proposed analyses
of moderation effects—in particular, the
moderating effects of prior beliefs and
the certainty with which those beliefs
are held—should be considered
exploratory, given that these effects are
not well established in prior literature.
Relatedly, another comment pointed out
that the findings from these moderation
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analyses may only apply to moist snuff
smokeless tobacco and e-cigarette
products, given that these are the
product types under study in this
proposed data collection.
(Response) FDA agrees that the
findings of these analyses will be novel
in the tobacco literature, and we plan to
encourage others to replicate and extend
our findings. However, we also note that
the measures used in this part of the
study were adapted from measures
developed and used previously in the
attitude certainty literature, and the
hypotheses about the potential
moderating effects of belief certainty
were developed based on prior studies
of attitude certainty (Refs. 1 and 2).
Thus, there is related literature that will
help us interpret our findings on this
topic.
(Comment) A comment encouraged
FDA to consider how to account for
participants’ prior beliefs when the
tobacco product under study has not
been previously marketed in the United
States and is therefore unknown to U.S.
consumers.
(Response) Our hypothesis would be
that consumers may tend to be less
certain about their beliefs about such
unknown products, and therefore their
beliefs about such products may be
more susceptible to influence by
modified risk information—but this is a
hypothesis that has not been empirically
tested. We agree that our findings from
the proposed analyses of the moderating
effects of prior beliefs will benefit from
replication and extension by others.
(Comment) One comment suggested
that we should consider making four
changes to the proposed data collection
methodology. First, this comment
suggested modifying the study design to
change it from a between-subjects
design (i.e., in which participants are
randomized to conditions and complete
a posttest) to a mixed factorial design
(i.e., in which participants complete a
pretest, are randomized to conditions,
and then complete a posttest). The
comment stated that this modified
design, described as a pretest-posttestcontrol-group design, would allow us to
control for pretest scores, which would
‘‘explicitly minimize the potential threat
to internal validity, namely, selection
bias.’’
(Response) There are advantages and
disadvantages to this alternative design
type. Whereas the pretest-posttestcontrol-group design may help
determine whether there is anything
unusual about the sample that would
reduce its representativeness of the
target population (i.e., caused by biased
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selection), using this design would
require participants to respond to the
key measures twice within a short
period of time. This would significantly
lengthen the study, which is currently
estimated to take approximately 20
minutes, and may influence how
participants respond on the posttest
(e.g., because of boredom or frustration
with repetitive items, testing effects, or
demand characteristics). Instead, we
propose to use the original, betweensubjects design and to conduct analyses
to examine the sociodemographic and
other characteristics of the sample to
understand its representativeness of the
U.S. population and to test the success
of the randomization procedure.
(Comment) A comment suggested that
we should consider using a newly
developed measure of participants’
intentions to use tobacco products
rather than the currently proposed
intention items. The comment noted
that the currently proposed items are
based on prior research but stated that
the new measure was developed and
validated following procedures in FDA’s
(2009) guidance on patient-reported
outcome measures.
(Response) We appreciate this
comment and support the continued
development and validation of intention
measures. However, at this time, we
cannot use this newly developed
measure because the research
supporting its use has not yet been
published in a peer-reviewed journal.
(Comment) A comment suggested that
this proposed data collection should
assess many more of participants’ preexisting beliefs and attitudes. As
examples, the comment suggested
assessing participants’ skepticism and
perceived truthfulness of modified risk
claims, stating that this would allow us
to more fully capture the key constructs
that explain why some people are more
likely than others to recall and
comprehend the claims.
(Response) As with the
recommendations above, we appreciate
this suggestion but propose not to assess
these additional constructs in this data
collection because of concerns about
participant burden. The proposed data
collection is not intended to
comprehensively assess influences on
consumer responses to modified risk
claims. Rather, it is intended to achieve
several specific goals such as
developing measures and testing novel
potential moderators of the effects of
modified risk information. The
constructs proposed in this comment
have been studied in prior research, as
have additional constructs such as
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brand loyalty (November 19, 2014 (79
FR 68888)). Assessing such constructs
may be informative but is not required
to achieve the goals of the current
proposed data collection.
(Comment) To assist with this
project’s measurement validation aims,
this comment recommended that the
study should collect two types of
evidence discussed in an FDA guidance
on patient-reported outcome measures
(FDA, 2009): Evidence of the measures’
content validity, such as open-ended
input from appropriate populations, and
evidence of reliability, other aspects of
validity, and sensitivity to detect
change.
(Response) The proposed data
collection is consistent with both these
recommendations. As described above,
to achieve content validity, we
developed our initial pool of items to be
as comprehensive as possible,
consulting multi-item measures used
previously in the tobacco literature,
literature on the objective health effects
of tobacco use, and expert colleagues.
Additionally, we cognitively tested our
pool of items in individual, qualitative
interviews with tobacco users and nonusers to evaluate their understanding of
the items and beliefs about product
risks. These interviews included openended questions, as recommended.
Moreover, the proposed data collection
is designed to test the performance of
our measures on the criteria discussed
in the comment, including internal
consistency reliability, other aspects of
validity (e.g., known groups,
convergent, and discriminant validity),
and sensitivity to detect changes (i.e.,
based on responsiveness to viewing
advertisements with vs. without
modified risk information). Other
performance measures such as testretest reliability must await further
study.
(Comment) Lastly, one comment
requested that we clarify how the
proposed data collection will assist in
measuring consumers’ understanding of
modified risk information, in addition
to their perceptions of health risk.
(Response) In our conceptualization,
risk perceptions are a component of
consumer understanding, which also
includes other components. The goal of
the present study is to develop and
validate measures of understanding
insofar as this construct includes
people’s perceptions of absolute and
relative health risks of using tobacco
products.
FDA estimates the burden of this
collection of information as follows:
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Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Notices
54359
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Average
burden per
response
Total annual
responses
Total hours
Invitation: Young Adults (Ages 18–25) ...............
Invitation: Adults (Ages 26+) ...............................
Consent and Screener: Young Adults (Ages 18–
25).
Consent and Screener: Adults (Ages 26+) .........
Study: Young Adults (Ages 18–25) .....................
29,000
29,000
11,000
1
1
1
29,000
29,000
11,000
0.02 (1 minute) ..............
0.02 (1 minute) ..............
0.10 (6 minutes) .............
580
580
1,100
16,500
3,300
1
1
16,500
3,300
0.10 (6 minutes) .............
0.33 (20 minutes) ...........
1,650
1,089
Study: Adults (Ages 26+) ....................................
Total .............................................................
3,300
........................
1
........................
3,300
........................
0.33 (20 minutes) ...........
........................................
1,089
6,088
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s burden estimate is based on
prior experience with research that is
similar to this proposed study.
Approximately 58,000 people will
receive a study invitation, estimated to
take 1 minute to read (approximately
0.02 hour), for a total of 1,160 hours for
invitations. Approximately 27,500
people will complete the informed
consent and screener to determine
eligibility for participation in the study,
estimated to take 6 minutes (0.10 hour),
for a total of 2,750 hours for informed
consent and screening activities.
Approximately 6,600 people will
complete the full study, estimated to
take 20 minutes (approximately 0.33
hour), for a total of 2,178 hours for study
completion activities. The estimated
total hour burden of the collection of
information is 6,088 hours.
The following references marked with
an asterisk (*) are on display at the
Dockets Management Staff (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 also
are available electronically at https://
www.regulations.gov. References
without asterisks are not on public
display at https://www.regulations.gov
because they have copyright restriction.
Some may be available at the website
address, if listed. References without
asterisks are available for viewing only
at the Dockets Management Staff. 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. Tormala, Z.L. and D.D. Rucker, ‘‘Attitude
Certainty: A Review of Past Findings and
Emerging Perspectives.’’ Social and
Personality Psychology Compass, 1:469–
492, 2007. doi:10.1111/j.1751–
9004.2007.00025.x.
2. Tormala, Z.L. and D.D. Rucker, ‘‘Attitude
Certainty: Antecedents, Consequences,
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and New Directions.’’ Consumer
Psychology Review, 1:72–89, 2018.
doi:10.1002/arcp.1004.*
Dated: October 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–23523 Filed 10–26–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1726]
Circulatory System Devices Panel of
the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
II. References
amozie on DSK3GDR082PROD with NOTICES1
Number of
responses per
respondent
Jkt 247001
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Circulatory System
Devices Panel of the Medical Devices
Advisory Committee. The general
function of the committee is to provide
advice and recommendations to the
Agency on FDA’s regulatory issues. The
meeting will be open to the public.
DATES: The meeting will be held on
December 4 and 5, 2018, from 8 a.m. to
6 p.m.
ADDRESSES: Hilton Washington DC
North/Gaithersburg, Salons A, B, C, and
D, 620 Perry Pkwy., Gaithersburg, MD
20877. The hotel telephone number is
301–977–8900; additional information
available online at: https://
www3.hilton.com/en/hotels/maryland/
hilton-washington-dc-northgaithersburg-GAIGHHF/.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
SUMMARY:
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AdvisoryCommittees/AboutAdvisory
Committees/ucm408555.htm.
FOR FURTHER INFORMATION CONTACT:
Patricio Garcia, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G610, Silver Spring,
MD 20993–0002, patricio.garcia@
fda.hhs.gov, 301–796–6875, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
SUPPLEMENTARY INFORMATION:
Agenda: On December 4, 2018, the
committee will discuss, make
recommendations, and vote on
information regarding the premarket
application (PMA) for the OPTIMIZER
SMART Implantable Pulse Generator
device, sponsored by Impulse Dynamics
(USA), Inc. This first-of-a-kind device is
indicated to provide cardiac
contractility modulation for class III
heart failure patients who are not
responding to optimal medical therapy.
On December 5, 2018, the committee
will discuss and make
recommendations regarding issues
relating to the emergence of medical
devices, which aim to treat
hypertension. Currently, clinical studies
to evaluate the safety and effectiveness
of these devices are progressing. FDA
requests panel input regarding the
potential indications and labeling for
devices intended to treat hypertension
and optimal study designs needed to
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]]>Agencies
[Federal Register Volume 83, Number 209 (Monday, October 29, 2018)]
[Notices]
[Pages 54356-54359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23523]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0821]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Investigation of
Consumer Perceptions of Expressed Modified Risk Claims
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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: Fax written comments on the collection of information by
November 28, 2018.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-NEW and
title ``Investigation of Consumer Perceptions of Expressed Modified
Risk Claims.'' Also include the FDA docket number found in brackets in
the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[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.
Investigation of Consumer Perceptions of Expressed Modified Risk Claims
OMB Control Number 0910--NEW
I. Background
FDA's Center for Tobacco Products proposes to conduct a study to
develop generalizable scientific knowledge to help inform its
implementation of section 911 of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 387k), wherein FDA will be evaluating
information submitted to the Agency about how consumers understand and
perceive modified risk tobacco products (MRTPs). Section 911 of the
FD&C Act authorizes FDA to grant orders to persons to allow the
marketing of MRTPs. The term ``modified risk tobacco product'' means
any tobacco product that is sold or distributed for use to reduce harm
or the risk of tobacco-related disease associated with commercially
marketed tobacco products. FDA can issue a risk modification order
under section 911(g)(1) of the FD&C Act authorizing the marketing of an
MRTP only if the Agency determines that the product, as it is used by
consumers, will significantly reduce harm and the risk of tobacco-
related disease to individual tobacco users and benefit the health of
the population as a whole, taking into account both users of tobacco
products and persons who do not currently use tobacco products (section
911(g)(1) of the FD&C Act). Alternatively, with respect to tobacco
products that may not be commercially marketed under section 911(g)(1)
of the FD&C Act, FDA may issue an exposure modification order under
section 911(g)(2) of the FD&C Act authorizing the marketing of an MRTP
if the Agency determines that the standard in section 911(g)(2) of the
FD&C Act is met, including, among other requirements, that: Any aspect
of the label, labeling, or advertising that would cause the product to
be an MRTP
[[Page 54357]]
is limited to an explicit or implicit representation that the tobacco
product or its smoke does not contain or is free of a substance or
contains a reduced level of a substance, or presents a reduced exposure
to a substance in tobacco smoke; the order would be appropriate to
promote the public health; the issuance of the order is expected to
benefit the population as a whole, taking into account both users and
nonusers of tobacco products; and the existing evidence demonstrates
that a measurable and substantial reduction in morbidity and mortality
among individual tobacco users is reasonably likely to be shown in
subsequent studies (section 911(g)(2) of the FD&C Act). In addition,
section 911 of the FD&C Act requires that any advertising or labeling
concerning modified risk products enable the public to comprehend the
information concerning modified risk and to understand the relative
significance of such information in the context of total health and in
relation to all the diseases and health-related conditions associated
with the use of tobacco products (section 911(h)(1) of the FD&C Act).
The proposed research will inform the Agency's efforts to implement the
provisions of the FD&C Act related to MRTPs.
FDA proposes conducting a study to assist in determining
appropriate methods for gathering information about how consumers
perceive and understand modified risk information. The study would
develop and validate measures of consumer perceptions of health risk
from using tobacco products. Moreover, the study would test how
participants' responses on these measures are affected by viewing
modified risk labeling or advertising, participants' characteristics
such as prior beliefs about the harmfulness of tobacco products,
current use of tobacco products, and sociodemographic characteristics.
Finally, the study would examine factors that may influence the
effectiveness of debriefing at the end of a consumer perception study
to ensure that people read and recall key information about the study.
This research is significant because it will validate methods that can
be used in studies of the impact of labels, labeling, and advertising
on consumer perceptions and understanding of the risks of product use.
Measures of consumer health risk perception will be developed and
validated by conducting a study on two product types: Moist snuff
smokeless tobacco products and electronic cigarette (e-cigarette)
products. For each product type, we will assess individual-level
factors that may moderate the impact of modified risk information on
consumer responses. Potential moderating factors under study include:
Beliefs (prior to viewing the modified risk information) about the
harmfulness of tobacco products, and the strength with which those
beliefs are held; current tobacco use behaviors; and sociodemographic
characteristics including age and educational attainment. For each
product type, participants will be randomized to view one of two
conditions: Tobacco product labeling and advertising that either does
or does not contain modified risk claims about a product. The labeling
will consist of a product package. The advertising will consist of a
print advertisement. The study will assess participants' perceptions of
various health risks from using the product, as well as their
perceptions of health risk from using the product compared to smoking
cigarettes, using nicotine replacement therapies, and quitting all
tobacco and nicotine products. The study will also assess participants'
intentions to use the product and their level of doubt about whether
tobacco products are harmful to users' health. Measures of intentions
and doubt will be used to help assess the validity of the measures of
health risk perception.
In the Federal Register of May 21, 2018 (83 FR 23464), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received four comments that were PRA
related. Within those submissions, FDA received multiple comments which
the Agency has addressed.
(Comment) Three of the comments were supportive of the usefulness
and importance of the proposed data collection. These comments stated
that validated measures of consumers' health risk perceptions could be
useful for FDA, researchers in the field, and industry--in particular,
sponsors of modified risk tobacco product applications (MRTPAs). One of
these comments expressed hope that the proposed study would be part of
a more general effort by FDA to establish methods and standards for
evaluating other aspects of MRTPAs.
(Response) FDA agrees with these comments to the extent they relate
to this study.
(Comment) One of the comments was unsupportive of the proposed data
collection, stating that it should not be undertaken for two reasons.
The comment stated that the data are unneeded because U.S. consumers
already understand the negative health effects of tobacco use and will
not use a tobacco product if they are concerned about their health.
(Response) The proposed data collection focuses on consumer
perceptions of modified risk tobacco products, which are products that
are sold or distributed for use to reduce harm or the risk of tobacco-
related diseases associated with commercially marketed tobacco
products.
(Comment) A comment stated that the proposed data collection should
not be undertaken because it would waste taxpayers' money.
(Response) FDA believes this study will provide information
important to its implementation of The Family Smoking Prevention and
Tobacco Control Act. FDA also notes that the study is not funded by
taxpayers' money, but rather by industry user fees paid by regulated
tobacco companies.
(Comment) One comment suggested that the proposed data collection
should be guided by a theoretical approach.
(Response) The main objective of the data collection--developing
and validating measures of consumer perceptions of tobacco health
risks--is intentionally atheoretical. We intend for this aspect of the
research to be data-driven rather than theory-driven. To accomplish
this, we have created a large pool of risk perception items by
aggregating items from all of the multi-item measures we could find in
the published tobacco literature, putting them into the main categories
of tobacco health effects that have been identified in prior health
reviews, changing the wording of the items to put them in a common
format, eliminating redundant or poorly worded items by consulting
expert colleagues in medicine, epidemiology, and social science, and
adding items to fill remaining gaps in terms of the main categories of
tobacco health effects. When analyzing data from this proposed data
collection, we plan to use factor analysis to identify the main
dimensions underlying how U.S. consumers perceive tobacco product
risks. Thus, overall, the goal of the proposed measurement development
research is to comprehensively assess risk perceptions without
overlaying our own preconceptions about how people may perceive these
risks.
(Comment) One comment stated that the findings from our proposed
analyses of moderation effects--in particular, the moderating effects
of prior beliefs and the certainty with which those beliefs are held--
should be considered exploratory, given that these effects are not well
established in prior literature. Relatedly, another comment pointed out
that the findings from these moderation
[[Page 54358]]
analyses may only apply to moist snuff smokeless tobacco and e-
cigarette products, given that these are the product types under study
in this proposed data collection.
(Response) FDA agrees that the findings of these analyses will be
novel in the tobacco literature, and we plan to encourage others to
replicate and extend our findings. However, we also note that the
measures used in this part of the study were adapted from measures
developed and used previously in the attitude certainty literature, and
the hypotheses about the potential moderating effects of belief
certainty were developed based on prior studies of attitude certainty
(Refs. 1 and 2). Thus, there is related literature that will help us
interpret our findings on this topic.
(Comment) A comment encouraged FDA to consider how to account for
participants' prior beliefs when the tobacco product under study has
not been previously marketed in the United States and is therefore
unknown to U.S. consumers.
(Response) Our hypothesis would be that consumers may tend to be
less certain about their beliefs about such unknown products, and
therefore their beliefs about such products may be more susceptible to
influence by modified risk information--but this is a hypothesis that
has not been empirically tested. We agree that our findings from the
proposed analyses of the moderating effects of prior beliefs will
benefit from replication and extension by others.
(Comment) One comment suggested that we should consider making four
changes to the proposed data collection methodology. First, this
comment suggested modifying the study design to change it from a
between-subjects design (i.e., in which participants are randomized to
conditions and complete a posttest) to a mixed factorial design (i.e.,
in which participants complete a pretest, are randomized to conditions,
and then complete a posttest). The comment stated that this modified
design, described as a pretest-posttest-control-group design, would
allow us to control for pretest scores, which would ``explicitly
minimize the potential threat to internal validity, namely, selection
bias.''
(Response) There are advantages and disadvantages to this
alternative design type. Whereas the pretest-posttest-control-group
design may help determine whether there is anything unusual about the
sample that would reduce its representativeness of the target
population (i.e., caused by biased selection), using this design would
require participants to respond to the key measures twice within a
short period of time. This would significantly lengthen the study,
which is currently estimated to take approximately 20 minutes, and may
influence how participants respond on the posttest (e.g., because of
boredom or frustration with repetitive items, testing effects, or
demand characteristics). Instead, we propose to use the original,
between-subjects design and to conduct analyses to examine the
sociodemographic and other characteristics of the sample to understand
its representativeness of the U.S. population and to test the success
of the randomization procedure.
(Comment) A comment suggested that we should consider using a newly
developed measure of participants' intentions to use tobacco products
rather than the currently proposed intention items. The comment noted
that the currently proposed items are based on prior research but
stated that the new measure was developed and validated following
procedures in FDA's (2009) guidance on patient-reported outcome
measures.
(Response) We appreciate this comment and support the continued
development and validation of intention measures. However, at this
time, we cannot use this newly developed measure because the research
supporting its use has not yet been published in a peer-reviewed
journal.
(Comment) A comment suggested that this proposed data collection
should assess many more of participants' pre-existing beliefs and
attitudes. As examples, the comment suggested assessing participants'
skepticism and perceived truthfulness of modified risk claims, stating
that this would allow us to more fully capture the key constructs that
explain why some people are more likely than others to recall and
comprehend the claims.
(Response) As with the recommendations above, we appreciate this
suggestion but propose not to assess these additional constructs in
this data collection because of concerns about participant burden. The
proposed data collection is not intended to comprehensively assess
influences on consumer responses to modified risk claims. Rather, it is
intended to achieve several specific goals such as developing measures
and testing novel potential moderators of the effects of modified risk
information. The constructs proposed in this comment have been studied
in prior research, as have additional constructs such as brand loyalty
(November 19, 2014 (79 FR 68888)). Assessing such constructs may be
informative but is not required to achieve the goals of the current
proposed data collection.
(Comment) To assist with this project's measurement validation
aims, this comment recommended that the study should collect two types
of evidence discussed in an FDA guidance on patient-reported outcome
measures (FDA, 2009): Evidence of the measures' content validity, such
as open-ended input from appropriate populations, and evidence of
reliability, other aspects of validity, and sensitivity to detect
change.
(Response) The proposed data collection is consistent with both
these recommendations. As described above, to achieve content validity,
we developed our initial pool of items to be as comprehensive as
possible, consulting multi-item measures used previously in the tobacco
literature, literature on the objective health effects of tobacco use,
and expert colleagues. Additionally, we cognitively tested our pool of
items in individual, qualitative interviews with tobacco users and non-
users to evaluate their understanding of the items and beliefs about
product risks. These interviews included open-ended questions, as
recommended. Moreover, the proposed data collection is designed to test
the performance of our measures on the criteria discussed in the
comment, including internal consistency reliability, other aspects of
validity (e.g., known groups, convergent, and discriminant validity),
and sensitivity to detect changes (i.e., based on responsiveness to
viewing advertisements with vs. without modified risk information).
Other performance measures such as test-retest reliability must await
further study.
(Comment) Lastly, one comment requested that we clarify how the
proposed data collection will assist in measuring consumers'
understanding of modified risk information, in addition to their
perceptions of health risk.
(Response) In our conceptualization, risk perceptions are a
component of consumer understanding, which also includes other
components. The goal of the present study is to develop and validate
measures of understanding insofar as this construct includes people's
perceptions of absolute and relative health risks of using tobacco
products.
FDA estimates the burden of this collection of information as
follows:
[[Page 54359]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Invitation: Young Adults (Ages 18-25)..... 29,000 1 29,000 0.02 (1 minute)............................. 580
Invitation: Adults (Ages 26+)............. 29,000 1 29,000 0.02 (1 minute)............................. 580
Consent and Screener: Young Adults (Ages 11,000 1 11,000 0.10 (6 minutes)............................ 1,100
18-25).
Consent and Screener: Adults (Ages 26+)... 16,500 1 16,500 0.10 (6 minutes)............................ 1,650
Study: Young Adults (Ages 18-25).......... 3,300 1 3,300 0.33 (20 minutes)........................... 1,089
-------------------------------------------------------------------------------------------------------------
Study: Adults (Ages 26+).................. 3,300 1 3,300 0.33 (20 minutes)........................... 1,089
Total................................. .............. .............. .............. ............................................ 6,088
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA's burden estimate is based on prior experience with research
that is similar to this proposed study. Approximately 58,000 people
will receive a study invitation, estimated to take 1 minute to read
(approximately 0.02 hour), for a total of 1,160 hours for invitations.
Approximately 27,500 people will complete the informed consent and
screener to determine eligibility for participation in the study,
estimated to take 6 minutes (0.10 hour), for a total of 2,750 hours for
informed consent and screening activities. Approximately 6,600 people
will complete the full study, estimated to take 20 minutes
(approximately 0.33 hour), for a total of 2,178 hours for study
completion activities. The estimated total hour burden of the
collection of information is 6,088 hours.
II. References
The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (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 also are available electronically at
https://www.regulations.gov. References without asterisks are not on
public display at https://www.regulations.gov because they have
copyright restriction. Some may be available at the website address, if
listed. References without asterisks are available for viewing only at
the Dockets Management Staff. 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. Tormala, Z.L. and D.D. Rucker, ``Attitude Certainty: A Review of
Past Findings and Emerging Perspectives.'' Social and Personality
Psychology Compass, 1:469-492, 2007. doi:10.1111/j.1751-
9004.2007.00025.x.
2. Tormala, Z.L. and D.D. Rucker, ``Attitude Certainty: Antecedents,
Consequences, and New Directions.'' Consumer Psychology Review,
1:72-89, 2018. doi:10.1002/arcp.1004.*
Dated: October 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23523 Filed 10-26-18; 8:45 am]
BILLING CODE 4164-01-P
