Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study on Warning Statements for Cigarette Graphic Health Warnings, 43764-43767 [2017-19901]
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manufacturer/processor to gather the
information needed to be placed on a
list or update its information is based on
FDA’s experience with manufacturers/
processors submitting similar requests.
FDA believes that the information to be
submitted will be readily available to
manufacturers/processors. We estimate
that a firm will require 1 hour to read
the guidance, gather the information
needed, and prepare a communication
to FDA that contains the information
needed to request that the
manufacturer/processor be placed on a
list.
To be placed on a list, manufacturers/
processors should provide FDA with
evidence that they have obtained thirdparty certification from a CNCAacknowledged certifier that the
manufacturer/processor complies with
the standards, laws, and regulations of
China according to relevant
requirements specified in AQSIQ Decree
145. Based on our experience with other
certification programs, FDA estimates
that it will take each new manufacturer/
processor about 21 hours to complete
the third-party certification process for
a total of 7,770 burden hours (370
manufacturers/processors × 21 hours).
Under the guidance, every 2 years
each manufacturer/processor on the lists
must provide updated information in
order to remain on the lists. FDA
estimates that each year approximately
half of the manufacturers/processors on
the lists, or 555 manufacturers/
processors (1,110 manufacturers/
processors × 0.5 = 555), will resubmit
the information to remain on the lists.
We estimate that a manufacturer/
processor already on the lists will
require 1 hour to biennially update and
resubmit the information to FDA,
including time reviewing the
information and corresponding with
FDA, for a total of 555 hours.
During the biennial update,
manufacturers/processors also need to
be recertified by a third-party certifier to
remain on the lists. FDA estimates that
each year approximately half of the
manufacturers/processors on the lists,
555 manufacturers/processors (1,110
manufacturers/processors × 0.5 = 555),
will get recertified. We estimate that it
will take each manufacturer/processor
about 21 hours to complete the
certification process for a total of 11,655
burden hours (555 manufacturers/
processors × 21 hours).
FDA expects that, each year,
approximately 100 manufacturers/
processors will need to submit an
occasional update and each
manufacturer/processor will require 0.5
hours to prepare a communication to
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FDA reporting the change, for a total of
50 hours.
Dated: September 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–19890 Filed 9–18–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0932]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Experimental
Study on Warning Statements for
Cigarette Graphic Health Warnings
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.
SUMMARY:
Fax written comments on the
collection of information by October 19,
2017.
DATES:
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 ‘‘Experimental Study on Warning
Statements for Cigarette Graphic Health
Warnings.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Jonalynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A63, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, 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:
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Experimental Study on Warning
Statements for Cigarette Graphic Health
Warnings
OMB Control Number 0910–NEW
The health risks associated with the
use of cigarettes can be significant and
far-reaching. In 2009, Congress enacted
the Tobacco Control Act (TCA) (Pub. L.
111–31), which amends the Federal
Food, Drug, and Cosmetic Act to grant
FDA authority to regulate the
manufacture, marketing, and
distribution of tobacco products to
protect the public health and to reduce
tobacco use by minors. Section 201 of
the Tobacco Control Act amends section
4 of the Federal Cigarette Labeling and
Advertising Act (FCLAA) (15 U.S.C.
1333) to require FDA to issue
‘‘regulations that require color graphics
depicting the negative health
consequences of smoking to accompany
the label statements specified in
subsection (a)(1).’’ Section 202(b) of the
Tobacco Control Act further amends
section 4 of the FCLAA by adding that
the Secretary, through notice and
comment rulemaking, may adjust the
‘‘text of any of the label requirements
. . . . if the Secretary finds that such a
change would promote greater public
understanding of the risks associated
with the use of tobacco products.’’
In the Federal Register of June 22,
2011 (76 FR 36628), FDA issued a final
rule entitled ‘‘Required Warnings for
Cigarette Packages and
Advertisements,’’ which specified nine
images to accompany new textual
warning statements for cigarettes.
Although the rule was scheduled to
become effective 15 months after it
issued, a panel of the U.S. Court of
Appeals of the District of Columbia
held, on August 24, 2012, that the rule
in its current form violated the First
Amendment. In a letter to Congress on
March 15, 2013, the Attorney General
reported FDA’s intention to undertake
research to support a new rulemaking
consistent with the Tobacco Control
Act. Preliminary research has been
underway since 2013. Informed by the
previous court decisions on this matter,
including on the First Amendment, the
next phase of the research includes the
study proposed here, which is an effort
by FDA to collect data concerning
revised textual warning statements for
use with new images as part of cigarette
graphic health warnings, and their
potential impact on public
understanding of the risks associated
with the use of cigarettes.
As currently proposed, this
Experimental Study on Warning
Statements for Cigarette Graphic Health
Warnings is a voluntary online
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experiment conducted with consumers.
The purpose of the proposed study is to
assess whether potential textual
warnings statements, which have been
revised from those enumerated in
section 4 of FCLAA, promote greater
public understanding of the negative
health consequences of cigarette
smoking. The study will collect data
from various groups of consumers,
including adolescent (under age 18)
current cigarette smokers, adolescents
who are susceptible to initiation of
cigarette smoking, young adult (ages 18
to 24) current cigarette smokers, and
older adult (age 25 and above) current
cigarette smokers. The results will
inform the Agency’s development of
cigarette graphic health warnings to be
tested in future studies with the goal of
implementing the mandatory graphic
warning label statement consistent with
section 4(d) of FCLAA and the First
Amendment.
Proposed Study Overview: In this
study, adolescent current cigarette
smokers, adolescents who are
susceptible to initiation of cigarette
smoking, young adult current cigarette
smokers, and older adult current
smokers will be recruited from an
Internet panel of more than 1.2 million
people and screened for inclusion into
the study. Participants who meet the
inclusion criteria will be randomized
into 1 of 17 conditions in a betweensubjects design. In each condition,
participants will be exposed to a series
of nine warning statements, presented
sequentially. Participants randomized to
the control condition will view all nine
of the warning statements listed in
section 4(a)(1) of FCLAA:
• WARNING: Cigarettes are addictive.
• WARNING: Tobacco smoke can
harm your children.
• WARNING: Cigarettes cause fatal
lung disease.
• WARNING: Cigarettes cause cancer.
• WARNING: Cigarettes cause strokes
and heart disease.
• WARNING: Smoking during
pregnancy can harm your baby.
• WARNING: Smoking can kill you.
• WARNING: Tobacco smoke causes
fatal lung disease in nonsmokers.
• WARNING: Quitting smoking now
greatly reduces serious risks to your
health.
Participants randomized to 1 of the 16
experimental conditions will view 8 of
the warning statements listed in section
4(a)(1) of FCLAA (first bulleted list in
this document) plus 1 revised warning
statement. The revised warning
statements being tested in this proposed
study are:
• WARNING: Smoking causes mouth
and throat cancer.
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• WARNING: Smoking causes head
and neck cancer.
• WARNING: Smoking causes
bladder cancer, which can lead to
bloody urine.
• WARNING: Smoking during
pregnancy causes premature birth.
• WARNING: Smoking during
pregnancy stunts fetal growth.
• WARNING: Smoking during
pregnancy causes premature birth and
low birth weight.
• WARNING: Secondhand smoke
causes respiratory illnesses in children,
like pneumonia.
• WARNING: Smoking can cause
heart disease and strokes by clogging
arteries.
• WARNING: Smoking causes COPD,
a lung disease that can be fatal.
• WARNING: Smoking causes serious
lung diseases like emphysema and
chronic bronchitis.
• WARNING: Smoking reduces blood
flow, which can cause erectile
dysfunction.
• WARNING: Smoking reduces blood
flow to the limbs, which can require
amputation.
• WARNING: Smoking causes type 2
diabetes, which raises blood sugar.
• WARNING: Smoking causes agerelated macular degeneration, which
can lead to blindness.
• WARNING: Smoking causes
cataracts, which can lead to blindness.
In all conditions, after viewing each
statement, participants will respond to a
small number of questions about that
specific statement (Section A in the
questionnaire). After viewing the nine
statements per their condition,
participants will respond to a larger set
of questions (Section B in the
questionnaire). Next, participants in the
experimental conditions will view an
additional nine revised warning
statements, drawn from the revised
statements listed in this document, and
respond to an additional set of questions
(Section C in the questionnaire).
Primary study outcomes include
knowledge of the negative health
consequences of cigarette smoking. Prior
to the main data collection, 2 pretests,
each with 50 participants, will take
place to ensure correct programming
and to identify any issues with the
proposed study design and
implementation.
In the Federal Register of March 28,
2017 (82 FR 15359), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received 13 comment
submissions. Eight submissions were
PRA related, and some included
multiple comments.
(Comment) Three comments
suggested that the textual warning
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statements should be evaluated together
with accompanying images because the
impact of the final cigarette graphic
warning labels will be a combination of
the effects of both the text and images.
(Response) FDA declines to make this
change at this time. This current phase
of the research, which includes the
study proposed here, is an effort by FDA
to collect data concerning revised
textual warning statements that may
later be used with new images as part
of cigarette graphic health warnings. In
the future, FDA will conduct research
pairing warning statements with images.
(Comment) One comment suggested
using a longitudinal study design to
understand the long-term effects of the
warning statements.
(Response) FDA declines to make this
change. A longitudinal study, while
providing useful data, is beyond the
scope of the research questions being
addressed in the present study.
(Comment) One comment
recommended FDA use a baseline
assessment of understanding of risks
associated with cigarette smoking in the
form of a pre-exposure assessment of
current awareness of negative health
outcomes associated with cigarette
smoking to evaluate respondents’
baseline knowledge.
(Response) FDA declines to make this
change. The measurement of baseline
level of understanding of risk should be
evenly distributed throughout the
conditions due to the randomized
nature of the experiment.
(Comment) One comment suggested
that FDA implement prescreening
measures and collect information about
the study respondents.
(Response) Prior to randomization to
condition, FDA will implement a
screener to collect information about
potential study participants to confirm
eligibility. A copy of the screener is part
of the overall package submitted to
OMB for review through the public Web
site https://www.reginfo.gov. Participant
demographics will be assessed in the
questionnaire and additional
demographics will be provided by the
Internet panel for all participants.
(Comment) Two comments suggested
that FDA change the control group of
warning statements to which the revised
textual warning statements would be
compared in this study.
(Response) FDA declines to make this
change. The purpose of the proposed
study is to test if the revised textual
warning statements promote greater
public understanding of the negative
health consequences of cigarette
smoking compared to the warnings
enumerated in the TCA. Therefore, the
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TCA warning statements are the
appropriate comparison group.
(Comment) One comment questioned
whether the use of an Internet panel is
the most appropriate method for
obtaining the desired information in this
study, as compared to in-person
interviews.
(Response) With respect to the
sample, the large heterogeneous sample
that can be obtained through the
Internet panel will allow FDA to test
outcomes across a range of individuals,
thus strengthening the conclusions and
generalizability of the study.
(Comment) Two comments suggested
that the timing of the administration of
Section B of the questionnaire
(administered after viewing eight TCA
warnings with one revised warning, but
before viewing a second set of nine
revised warnings) could introduce bias.
One of those comments also suggested
FDA remove Section B.
(Response) FDA declines to make
such a change at this time. Section B
includes the primary outcome measures
necessary to assess participants’
understanding of the negative health
consequences of cigarette smoking as
described in the revised warning
statements compared to the TCA
statements. Further, knowledge gained
from exposure to questions in Section B
is expected to be minimal and
consistent across conditions. Therefore,
any such knowledge gained from
exposure to Section B would suggest
that any differences found between
conditions are robust.
(Comment) One comment
recommended that FDA conduct a
power analysis to ensure the sample
size is adequate for detecting the
expected effect size.
(Response) FDA agrees that it is
important to conduct a power analysis;
the Agency did conduct a power
analysis to ensure the sample size is
appropriate for the proposed study.
(Comment) One comment expressed a
desire to see the questionnaire to be
used in the study as well as an
explanation of the study design.
(Response) FDA notes that the
questionnaire and supporting
statements outlining the study design
and methods were available as
supporting documents in the docket for
public review during the public
comment period. Additionally, the
study is described in detail as part of the
overall package submitted to OMB for
review through the public Web site
https://www.reginfo.gov, and copies of
the instrument used to collect this
information are also included in that
package.
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(Comment) Many comments focused
on the content of the revised textual
warning statements in the proposed
study, and provided suggestions for
changes to the wording of the warning
statements and additional topics on
which they should focus.
(Response) The topics being tested in
this proposed study include a wide
range of health conditions caused by
cigarette smoking and are presented
with as much information as
practicable. The revised warning
statements were developed based on
opportunities to promote greater public
understanding about the negative health
consequences of cigarette smoking. In
addition, prior to the proposed study,
the warning statements have been tested
with consumers; vetted by medical and
other scientific experts; and revised to
ensure that they clearly and
understandably convey factual
information about the negative health
consequences associated with the use of
cigarettes. Based on comments about the
content of the revised textual warning
statements and FDA’s ongoing
preparation for the proposed study, FDA
is changing the warning statement
‘‘WARNING: Smoking raises blood
sugar, which can cause type 2 diabetes’’
to ‘‘WARNING: Smoking causes type 2
diabetes, which raises blood sugar.’’
This change was made to better reflect
the causal link between cigarette
smoking and diabetes and to clarify that
higher blood sugar is a result, not a
cause, of diabetes. FDA has updated the
questionnaire accordingly.
(Comment) One comment suggested
that FDA conduct a ‘‘meaningful
pretest’’ for the questionnaire.
(Response) As explained in the draft
supporting statements included in the
docket, the purpose of the pretests is to
help ensure understandability of the
questionnaire, to reduce participant
burden, and to enhance interview
administration. The questionnaire uses
slightly modified versions of scales and
instruments that have already been
thoroughly tested and used in previous
research.
(Comment) Many comments
suggested changes to or addition of
specific constructs as study outcomes or
suggested how FDA should use the
outcomes already included in the study.
Measures suggested for FDA
consideration included the following:
How much the warning statements
attract attention; how novel they are;
personal identification with the
statements; levels of emotion evoked/
emotional appeal or emotional reaction;
perceived risk or likelihood of the
outcome occurring; and perceived
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effectiveness of the revised warning
statements.
(Response) FDA declines to make
such changes to the outcome measures,
although FDA notes that the
questionnaire already includes items
assessing perceived effectiveness of the
warnings. The purpose of this study is
to assess whether potential textual
warning statements, which have been
revised from those enumerated in
section 4 of FCLAA, promote greater
understanding of the negative health
consequences of cigarette smoking, and
the proposed outcome measures focus
on just such an evaluation. Therefore,
the suggested outcome measures do not
contribute to the evaluation of whether
the revised warning statements improve
public understanding of the negative
health consequences of cigarette
smoking.
(Comment) One comment noted that
the study does not include information
that would assist in the design of the
graphic images.
(Response) FDA agrees that the
proposed study does not include these
outcomes, and the Agency declines to
make such a change. The focus of this
study is on the textual warning
statements only to assess whether they
promote greater understanding of the
negative health consequences of
cigarette smoking and not the design of
the graphic images.
(Comment) Two comments stated that
FDA was including measures of risk
perception and suggested that FDA
include additional risk perception
measures, such as likelihood of the
outcome; measures of absolute and
comparative perceived risk; and
perceptions of these risks over and
above any ‘‘background’’ risk and other
similar outcomes.
(Response) FDA declines to make
such changes because this study does
not aim to measure risk perceptions.
The measures included in this proposed
study assess knowledge and
understanding of a negative health
outcome caused by cigarette smoking.
The goal of these measures is not to
assess the absolute or relative level of
perception of such risks, but rather to
investigate the effect that viewing the
warning statements has on increasing
the understanding of the negative health
consequences of cigarette smoking.
(Comment) Two comments suggested
that, in order to minimize the burden of
the proposed collection, FDA should
use best practice methods for survey
and focus group research, including
developing a statistical analysis plan
and involving a private consultant with
experience in conducting such research
efficiently.
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(Response) As stated in the
supporting statements included in the
docket, FDA is working with a skilled
and experienced research contractor to
conduct the proposed study. In
addition, FDA scientific experts possess
skill and expertise in conducting such
research. Survey and focus group best
practices will be used, including
avoiding bias in questions due to
wording and question order and
developing a statistical analysis plan.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Portion of study
Number of
responses per
respondent
Total annual
responses
Screening for pretest ..............................................
Pretest ....................................................................
Screening for main data collection ........................
Main data collection ...............................................
762
100
19,082
2,500
1
1
1
1
762
100
19,082
2,500
Total ................................................................
........................
........................
........................
asabaliauskas on DSKBBXCHB2PROD with NOTICES
1 There
Average
burden per
response
0.033 (2
0.25 (15
0.033 (2
0.25 (15
minutes)
minutes)
minutes)
minutes)
Total hours
........
........
........
........
25
25
630
625
.....................................
1,305
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.
Screening potential participants for the
2 pretests will occur with 762
respondents (487 adults and 275
adolescents) identified and recruited
through the Internet panel. This brief
screening will take an average of 2
minutes (0.033 hours) per respondent.
Each of the 2 pretests will consist of 50
respondents (34 adults and 16
adolescents) conducted during a single
session and take an average of 15
minutes (0.25 hours) per respondent.
Screening potential participants for the
main data collection will occur with
19,082 respondents (11,925 adults and
7,157 adolescents) identified and
recruited through the same Internet
panel as used for the pretests. This brief
screening will take an average of 2
minutes (0.033 hours) per respondent.
Recent national estimates of the
numbers of adolescent current cigarette
smokers, adolescents who are
susceptible to initiation of cigarette
smoking, young adult current cigarette
smokers, and older adult current
cigarette smokers informed the
estimates of 13.9 percent qualification
rate for adults and 11.6 percent
qualification rate for adolescents.
Applying these estimates and other
assumptions from previous experience
conducting similar studies to the
number of adolescents and adults to be
screened results in the desired sample
size for the main data collection of 2,500
participants, of which 1,667 will be
adults and 833 will be adolescents. The
main data collection will occur with
those 2,500 respondents during a single
session. The main data collection will
take an average of 15 minutes (0.25
hours) per respondent. The total
estimated burden is 1,305 hours (25
hours + 25 hours + 630 hours + 625
hours).
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Dated: September 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–19901 Filed 9–18–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–3615]
Administering the Hatch-Waxman
Amendments: Ensuring a Balance
Between Innovation and Access;
Public Meeting; Request for
Comments; Extension of Comment
Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments; extension of
comment period.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
extending the comment period for the
public meeting on ‘‘Administering the
Hatch-Waxman Amendments: Ensuring
a Balance Between Innovation and
Access’’ for which the notice of public
meeting appeared in the Federal
Register of June 22, 2017. In the notice
of public meeting, FDA requested
comments concerning administration of
the Hatch-Waxman Amendments to the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) to help ensure that the
intended balance between encouraging
innovation in drug development and
accelerating the availability to the
public of lower cost alternatives to
innovator drugs is maintained. The
Agency is taking this action in response
to a request for an extension to allow
SUMMARY:
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interested persons additional time to
submit comments.
DATES: FDA is extending the comment
period on the notice of public meeting
published June 22, 2017 (82 FR 28493).
Submit either electronic or written
comments by November 17, 2017.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before November 17,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of November 17, 2017.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
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]]>Agencies
[Federal Register Volume 82, Number 180 (Tuesday, September 19, 2017)]
[Notices]
[Pages 43764-43767]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19901]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0932]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Experimental Study on
Warning Statements for Cigarette Graphic Health Warnings
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: Fax written comments on the collection of information by October
19, 2017.
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 ``Experimental Study on Warning Statements for Cigarette Graphic
Health Warnings.'' Also include the FDA docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Jonalynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North,
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
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.
Experimental Study on Warning Statements for Cigarette Graphic Health
Warnings
OMB Control Number 0910-NEW
The health risks associated with the use of cigarettes can be
significant and far-reaching. In 2009, Congress enacted the Tobacco
Control Act (TCA) (Pub. L. 111-31), which amends the Federal Food,
Drug, and Cosmetic Act to grant FDA authority to regulate the
manufacture, marketing, and distribution of tobacco products to protect
the public health and to reduce tobacco use by minors. Section 201 of
the Tobacco Control Act amends section 4 of the Federal Cigarette
Labeling and Advertising Act (FCLAA) (15 U.S.C. 1333) to require FDA to
issue ``regulations that require color graphics depicting the negative
health consequences of smoking to accompany the label statements
specified in subsection (a)(1).'' Section 202(b) of the Tobacco Control
Act further amends section 4 of the FCLAA by adding that the Secretary,
through notice and comment rulemaking, may adjust the ``text of any of
the label requirements . . . . if the Secretary finds that such a
change would promote greater public understanding of the risks
associated with the use of tobacco products.''
In the Federal Register of June 22, 2011 (76 FR 36628), FDA issued
a final rule entitled ``Required Warnings for Cigarette Packages and
Advertisements,'' which specified nine images to accompany new textual
warning statements for cigarettes. Although the rule was scheduled to
become effective 15 months after it issued, a panel of the U.S. Court
of Appeals of the District of Columbia held, on August 24, 2012, that
the rule in its current form violated the First Amendment. In a letter
to Congress on March 15, 2013, the Attorney General reported FDA's
intention to undertake research to support a new rulemaking consistent
with the Tobacco Control Act. Preliminary research has been underway
since 2013. Informed by the previous court decisions on this matter,
including on the First Amendment, the next phase of the research
includes the study proposed here, which is an effort by FDA to collect
data concerning revised textual warning statements for use with new
images as part of cigarette graphic health warnings, and their
potential impact on public understanding of the risks associated with
the use of cigarettes.
As currently proposed, this Experimental Study on Warning
Statements for Cigarette Graphic Health Warnings is a voluntary online
[[Page 43765]]
experiment conducted with consumers. The purpose of the proposed study
is to assess whether potential textual warnings statements, which have
been revised from those enumerated in section 4 of FCLAA, promote
greater public understanding of the negative health consequences of
cigarette smoking. The study will collect data from various groups of
consumers, including adolescent (under age 18) current cigarette
smokers, adolescents who are susceptible to initiation of cigarette
smoking, young adult (ages 18 to 24) current cigarette smokers, and
older adult (age 25 and above) current cigarette smokers. The results
will inform the Agency's development of cigarette graphic health
warnings to be tested in future studies with the goal of implementing
the mandatory graphic warning label statement consistent with section
4(d) of FCLAA and the First Amendment.
Proposed Study Overview: In this study, adolescent current
cigarette smokers, adolescents who are susceptible to initiation of
cigarette smoking, young adult current cigarette smokers, and older
adult current smokers will be recruited from an Internet panel of more
than 1.2 million people and screened for inclusion into the study.
Participants who meet the inclusion criteria will be randomized into 1
of 17 conditions in a between-subjects design. In each condition,
participants will be exposed to a series of nine warning statements,
presented sequentially. Participants randomized to the control
condition will view all nine of the warning statements listed in
section 4(a)(1) of FCLAA:
WARNING: Cigarettes are addictive.
WARNING: Tobacco smoke can harm your children.
WARNING: Cigarettes cause fatal lung disease.
WARNING: Cigarettes cause cancer.
WARNING: Cigarettes cause strokes and heart disease.
WARNING: Smoking during pregnancy can harm your baby.
WARNING: Smoking can kill you.
WARNING: Tobacco smoke causes fatal lung disease in
nonsmokers.
WARNING: Quitting smoking now greatly reduces serious
risks to your health.
Participants randomized to 1 of the 16 experimental conditions will
view 8 of the warning statements listed in section 4(a)(1) of FCLAA
(first bulleted list in this document) plus 1 revised warning
statement. The revised warning statements being tested in this proposed
study are:
WARNING: Smoking causes mouth and throat cancer.
WARNING: Smoking causes head and neck cancer.
WARNING: Smoking causes bladder cancer, which can lead to
bloody urine.
WARNING: Smoking during pregnancy causes premature birth.
WARNING: Smoking during pregnancy stunts fetal growth.
WARNING: Smoking during pregnancy causes premature birth
and low birth weight.
WARNING: Secondhand smoke causes respiratory illnesses in
children, like pneumonia.
WARNING: Smoking can cause heart disease and strokes by
clogging arteries.
WARNING: Smoking causes COPD, a lung disease that can be
fatal.
WARNING: Smoking causes serious lung diseases like
emphysema and chronic bronchitis.
WARNING: Smoking reduces blood flow, which can cause
erectile dysfunction.
WARNING: Smoking reduces blood flow to the limbs, which
can require amputation.
WARNING: Smoking causes type 2 diabetes, which raises
blood sugar.
WARNING: Smoking causes age-related macular degeneration,
which can lead to blindness.
WARNING: Smoking causes cataracts, which can lead to
blindness.
In all conditions, after viewing each statement, participants will
respond to a small number of questions about that specific statement
(Section A in the questionnaire). After viewing the nine statements per
their condition, participants will respond to a larger set of questions
(Section B in the questionnaire). Next, participants in the
experimental conditions will view an additional nine revised warning
statements, drawn from the revised statements listed in this document,
and respond to an additional set of questions (Section C in the
questionnaire). Primary study outcomes include knowledge of the
negative health consequences of cigarette smoking. Prior to the main
data collection, 2 pretests, each with 50 participants, will take place
to ensure correct programming and to identify any issues with the
proposed study design and implementation.
In the Federal Register of March 28, 2017 (82 FR 15359), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received 13 comment submissions. Eight
submissions were PRA related, and some included multiple comments.
(Comment) Three comments suggested that the textual warning
statements should be evaluated together with accompanying images
because the impact of the final cigarette graphic warning labels will
be a combination of the effects of both the text and images.
(Response) FDA declines to make this change at this time. This
current phase of the research, which includes the study proposed here,
is an effort by FDA to collect data concerning revised textual warning
statements that may later be used with new images as part of cigarette
graphic health warnings. In the future, FDA will conduct research
pairing warning statements with images.
(Comment) One comment suggested using a longitudinal study design
to understand the long-term effects of the warning statements.
(Response) FDA declines to make this change. A longitudinal study,
while providing useful data, is beyond the scope of the research
questions being addressed in the present study.
(Comment) One comment recommended FDA use a baseline assessment of
understanding of risks associated with cigarette smoking in the form of
a pre-exposure assessment of current awareness of negative health
outcomes associated with cigarette smoking to evaluate respondents'
baseline knowledge.
(Response) FDA declines to make this change. The measurement of
baseline level of understanding of risk should be evenly distributed
throughout the conditions due to the randomized nature of the
experiment.
(Comment) One comment suggested that FDA implement prescreening
measures and collect information about the study respondents.
(Response) Prior to randomization to condition, FDA will implement
a screener to collect information about potential study participants to
confirm eligibility. A copy of the screener is part of the overall
package submitted to OMB for review through the public Web site https://www.reginfo.gov. Participant demographics will be assessed in the
questionnaire and additional demographics will be provided by the
Internet panel for all participants.
(Comment) Two comments suggested that FDA change the control group
of warning statements to which the revised textual warning statements
would be compared in this study.
(Response) FDA declines to make this change. The purpose of the
proposed study is to test if the revised textual warning statements
promote greater public understanding of the negative health
consequences of cigarette smoking compared to the warnings enumerated
in the TCA. Therefore, the
[[Page 43766]]
TCA warning statements are the appropriate comparison group.
(Comment) One comment questioned whether the use of an Internet
panel is the most appropriate method for obtaining the desired
information in this study, as compared to in-person interviews.
(Response) With respect to the sample, the large heterogeneous
sample that can be obtained through the Internet panel will allow FDA
to test outcomes across a range of individuals, thus strengthening the
conclusions and generalizability of the study.
(Comment) Two comments suggested that the timing of the
administration of Section B of the questionnaire (administered after
viewing eight TCA warnings with one revised warning, but before viewing
a second set of nine revised warnings) could introduce bias. One of
those comments also suggested FDA remove Section B.
(Response) FDA declines to make such a change at this time. Section
B includes the primary outcome measures necessary to assess
participants' understanding of the negative health consequences of
cigarette smoking as described in the revised warning statements
compared to the TCA statements. Further, knowledge gained from exposure
to questions in Section B is expected to be minimal and consistent
across conditions. Therefore, any such knowledge gained from exposure
to Section B would suggest that any differences found between
conditions are robust.
(Comment) One comment recommended that FDA conduct a power analysis
to ensure the sample size is adequate for detecting the expected effect
size.
(Response) FDA agrees that it is important to conduct a power
analysis; the Agency did conduct a power analysis to ensure the sample
size is appropriate for the proposed study.
(Comment) One comment expressed a desire to see the questionnaire
to be used in the study as well as an explanation of the study design.
(Response) FDA notes that the questionnaire and supporting
statements outlining the study design and methods were available as
supporting documents in the docket for public review during the public
comment period. Additionally, the study is described in detail as part
of the overall package submitted to OMB for review through the public
Web site https://www.reginfo.gov, and copies of the instrument used to
collect this information are also included in that package.
(Comment) Many comments focused on the content of the revised
textual warning statements in the proposed study, and provided
suggestions for changes to the wording of the warning statements and
additional topics on which they should focus.
(Response) The topics being tested in this proposed study include a
wide range of health conditions caused by cigarette smoking and are
presented with as much information as practicable. The revised warning
statements were developed based on opportunities to promote greater
public understanding about the negative health consequences of
cigarette smoking. In addition, prior to the proposed study, the
warning statements have been tested with consumers; vetted by medical
and other scientific experts; and revised to ensure that they clearly
and understandably convey factual information about the negative health
consequences associated with the use of cigarettes. Based on comments
about the content of the revised textual warning statements and FDA's
ongoing preparation for the proposed study, FDA is changing the warning
statement ``WARNING: Smoking raises blood sugar, which can cause type 2
diabetes'' to ``WARNING: Smoking causes type 2 diabetes, which raises
blood sugar.'' This change was made to better reflect the causal link
between cigarette smoking and diabetes and to clarify that higher blood
sugar is a result, not a cause, of diabetes. FDA has updated the
questionnaire accordingly.
(Comment) One comment suggested that FDA conduct a ``meaningful
pretest'' for the questionnaire.
(Response) As explained in the draft supporting statements included
in the docket, the purpose of the pretests is to help ensure
understandability of the questionnaire, to reduce participant burden,
and to enhance interview administration. The questionnaire uses
slightly modified versions of scales and instruments that have already
been thoroughly tested and used in previous research.
(Comment) Many comments suggested changes to or addition of
specific constructs as study outcomes or suggested how FDA should use
the outcomes already included in the study. Measures suggested for FDA
consideration included the following: How much the warning statements
attract attention; how novel they are; personal identification with the
statements; levels of emotion evoked/emotional appeal or emotional
reaction; perceived risk or likelihood of the outcome occurring; and
perceived effectiveness of the revised warning statements.
(Response) FDA declines to make such changes to the outcome
measures, although FDA notes that the questionnaire already includes
items assessing perceived effectiveness of the warnings. The purpose of
this study is to assess whether potential textual warning statements,
which have been revised from those enumerated in section 4 of FCLAA,
promote greater understanding of the negative health consequences of
cigarette smoking, and the proposed outcome measures focus on just such
an evaluation. Therefore, the suggested outcome measures do not
contribute to the evaluation of whether the revised warning statements
improve public understanding of the negative health consequences of
cigarette smoking.
(Comment) One comment noted that the study does not include
information that would assist in the design of the graphic images.
(Response) FDA agrees that the proposed study does not include
these outcomes, and the Agency declines to make such a change. The
focus of this study is on the textual warning statements only to assess
whether they promote greater understanding of the negative health
consequences of cigarette smoking and not the design of the graphic
images.
(Comment) Two comments stated that FDA was including measures of
risk perception and suggested that FDA include additional risk
perception measures, such as likelihood of the outcome; measures of
absolute and comparative perceived risk; and perceptions of these risks
over and above any ``background'' risk and other similar outcomes.
(Response) FDA declines to make such changes because this study
does not aim to measure risk perceptions. The measures included in this
proposed study assess knowledge and understanding of a negative health
outcome caused by cigarette smoking. The goal of these measures is not
to assess the absolute or relative level of perception of such risks,
but rather to investigate the effect that viewing the warning
statements has on increasing the understanding of the negative health
consequences of cigarette smoking.
(Comment) Two comments suggested that, in order to minimize the
burden of the proposed collection, FDA should use best practice methods
for survey and focus group research, including developing a statistical
analysis plan and involving a private consultant with experience in
conducting such research efficiently.
[[Page 43767]]
(Response) As stated in the supporting statements included in the
docket, FDA is working with a skilled and experienced research
contractor to conduct the proposed study. In addition, FDA scientific
experts possess skill and expertise in conducting such research. Survey
and focus group best practices will be used, including avoiding bias in
questions due to wording and question order and developing a
statistical analysis plan.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Portion of study Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screening for pretest...................... 762 1 762 0.033 (2 minutes).......................... 25
Pretest.................................... 100 1 100 0.25 (15 minutes).......................... 25
Screening for main data collection......... 19,082 1 19,082 0.033 (2 minutes).......................... 630
Main data collection....................... 2,500 1 2,500 0.25 (15 minutes).......................... 625
------------------------------------------------ ---------------
Total.................................. .............. .............. .............. ........................................... 1,305
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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. Screening potential
participants for the 2 pretests will occur with 762 respondents (487
adults and 275 adolescents) identified and recruited through the
Internet panel. This brief screening will take an average of 2 minutes
(0.033 hours) per respondent. Each of the 2 pretests will consist of 50
respondents (34 adults and 16 adolescents) conducted during a single
session and take an average of 15 minutes (0.25 hours) per respondent.
Screening potential participants for the main data collection will
occur with 19,082 respondents (11,925 adults and 7,157 adolescents)
identified and recruited through the same Internet panel as used for
the pretests. This brief screening will take an average of 2 minutes
(0.033 hours) per respondent. Recent national estimates of the numbers
of adolescent current cigarette smokers, adolescents who are
susceptible to initiation of cigarette smoking, young adult current
cigarette smokers, and older adult current cigarette smokers informed
the estimates of 13.9 percent qualification rate for adults and 11.6
percent qualification rate for adolescents. Applying these estimates
and other assumptions from previous experience conducting similar
studies to the number of adolescents and adults to be screened results
in the desired sample size for the main data collection of 2,500
participants, of which 1,667 will be adults and 833 will be
adolescents. The main data collection will occur with those 2,500
respondents during a single session. The main data collection will take
an average of 15 minutes (0.25 hours) per respondent. The total
estimated burden is 1,305 hours (25 hours + 25 hours + 630 hours + 625
hours).
Dated: September 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19901 Filed 9-18-17; 8:45 am]
BILLING CODE 4164-01-P
