Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study on Warning Statements for Cigarette Graphic Health Warnings, 15359-15361 [2017-06078]
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Federal Register / Vol. 82, No. 58 / Tuesday, March 28, 2017 / Notices
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0932]
Agency Information Collection
Activities; Proposed Collection;
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 an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the Experimental Study on Warning
Statements for Cigarette Graphic Health
Warnings that is being conducted in
support of the graphic label statement
provision of the Family Smoking
Prevention and Tobacco Control Act
(the Tobacco Control Act).
DATES: Submit either electronic or
written comments on the collection of
information by May 30, 2017.
ADDRESSES: You may submit comments
as follows:
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
VerDate Sep<11>2014
17:14 Mar 27, 2017
Jkt 241001
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–N–0932 for ‘‘Agency Information
Collection Activities, Proposed
Collection; Comment Request;
Experimental Study on Warning
Statements for Cigarette Graphic Health
Warnings.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
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15359
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A63, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794.
Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\28MRN1.SGM
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Federal Register / Vol. 82, No. 58 / Tuesday, March 28, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
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 (Pub. L. 111–
31), which amends the Federal Food,
Drug, and Cosmetic Act (the FD&C 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 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 the 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
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17:14 Mar 27, 2017
Jkt 241001
Statements for Cigarette Graphic Health
Warnings is a voluntary online
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 18to 24) current cigarette smokers, and
older adult (ages 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 one 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 (above) plus 1
statement that is a revised version of a
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statutory text warning. 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 raises blood
sugar, which can cause type 2
diabetes.
• 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. Following viewing
all nine statements, participants will
respond to a larger set of questions.
Next, participants will view an
additional nine revised warning
statements, drawn from the revised
statements listed above, and respond to
an additional set of questions. Primary
study outcomes include beliefs and
knowledge of the negative health
consequences of cigarette smoking. Prior
to the main data collection, two pretests,
each with 50 participants, will take
place to ensure correct programming
and to identify any issues with the
proposed study design and
implementation.
Estimated Burden: FDA estimates the
burden of this collection of information
as follows:
E:\FR\FM\28MRN1.SGM
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Federal Register / Vol. 82, No. 58 / Tuesday, March 28, 2017 / Notices
15361
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 .......................................................
........................
........................
........................
sradovich on DSK3GMQ082PROD with NOTICES
1 There
Average
burden per
response
.033 (2
.25 (15
.033 (2
.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).
VerDate Sep<11>2014
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Dated: March 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–06078 Filed 3–27–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Announcement of Meeting of the
Secretary’s Advisory Committee on
National Health Promotion and Disease
Prevention Objectives for 2030
Office of Disease Prevention
and Health Promotion, Office of the
Assistant Secretary for Health, Office of
the Secretary, Department of Health and
Human Services.
AGENCY:
ACTION:
Notice.
The U.S. Department of
Health and Human Services (HHS)
announces the next federal advisory
committee meeting regarding the
development of national health
promotion and disease prevention
objectives for 2030. This meeting will be
held online via webinar and is open to
the public. The Committee will discuss
the nation’s health promotion and
disease prevention objectives and will
provide recommendations to improve
health status and reduce health risks for
the nation by the year 2030. The
Committee will advise the Secretary on
the Healthy People 2030 mission,
vision, framework, and organizational
structure. The Committee will provide
advice regarding criteria for identifying
a more focused set of measurable,
nationally representative objectives. The
Committee’s advice must assist the
Secretary in reducing the number of
objectives while ensuring that the
selection criteria identifies the most
critical public health issues that are
high-impact priorities supported by
current national data.
SUMMARY:
The Committee will meet on
April 27, 2017, from 12:00 p.m. to 2:00
p.m. Eastern Time (ET).
DATES:
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
The meeting will be held
online via webinar. To register to attend
the meeting, please visit the Healthy
People Web site at https://
www.healthypeople.gov.
FOR FURTHER INFORMATION CONTACT:
Emmeline Ochiai, Designated Federal
Officer, Secretary’s Advisory Committee
on National Health Promotion and
Disease Prevention Objectives for 2030,
U.S. Department of Health and Human
Services, Office of the Assistant
Secretary for Health, Office of Disease
Prevention and Health Promotion, 1101
Wootton Parkway, Room LL–100,
Rockville, MD 20852, (240) 453–8280
(telephone), (240) 453–8281 (fax).
Additional information is available on
the Healthy People Web site at https://
www.healthypeople.gov.
SUPPLEMENTARY INFORMATION: The
names and biographies of the
Committee members are available at
https://www.healthypeople.gov/2020/
about/history-development/healthypeople-2030-advisory-committee.
Purpose of Meeting: Through the
Healthy People initiative, HHS leverages
scientific insights and lessons from the
past decade, along with new knowledge
of current data, trends, and innovations,
to develop the next iteration of national
health promotion and disease
prevention objectives. Healthy People
provides science-based, 10-year national
objectives for promoting health and
preventing disease. Since 1979, Healthy
People has set and monitored national
health objectives that meet a broad
range of health needs, encourage
collaboration across sectors, guide
individuals toward making informed
health decisions, and measure the
impact of our prevention and health
promotion activities. Healthy People
2030 health objectives will reflect
assessments of major risks to health and
wellness, changing public health
priorities, and emerging technologies
related to our nation’s health
preparedness and prevention.
Public Participation at Meeting:
Members of the public are invited to
ADDRESSES:
E:\FR\FM\28MRN1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 58 (Tuesday, March 28, 2017)]
[Notices]
[Pages 15359-15361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-06078]
[[Page 15359]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0932]
Agency Information Collection Activities; Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the Experimental Study on Warning
Statements for Cigarette Graphic Health Warnings that is being
conducted in support of the graphic label statement provision of the
Family Smoking Prevention and Tobacco Control Act (the Tobacco Control
Act).
DATES: Submit either electronic or written comments on the collection
of information by May 30, 2017.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2017-N-0932 for ``Agency Information Collection Activities,
Proposed Collection; Comment Request; Experimental Study on Warning
Statements for Cigarette Graphic Health Warnings.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North,
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
[[Page 15360]]
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 (Pub. L. 111-31), which amends the Federal Food, Drug, and
Cosmetic Act (the FD&C 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 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 the 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
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 (ages 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
one 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
(above) plus 1 statement that is a revised version of a statutory text
warning. 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 raises blood sugar, which can cause type 2
diabetes.
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.
Following viewing all nine statements, participants will respond to a
larger set of questions. Next, participants will view an additional
nine revised warning statements, drawn from the revised statements
listed above, and respond to an additional set of questions. Primary
study outcomes include beliefs and knowledge of the negative health
consequences of cigarette smoking. Prior to the main data collection,
two pretests, each with 50 participants, will take place to ensure
correct programming and to identify any issues with the proposed study
design and implementation.
Estimated Burden: FDA estimates the burden of this collection of
information as follows:
[[Page 15361]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Portion of study Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Screening for pretest......... 762 1 762 .033 (2 minutes) 25
Pretest....................... 100 1 100 .25 (15 minutes) 25
Screening for main data 19,082 1 19,082 .033 (2 minutes) 630
collection.
Main data collection.......... 2,500 1 2,500 .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: March 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-06078 Filed 3-27-17; 8:45 am]
BILLING CODE 4164-01-P
