Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Cigarette Warnings, 48625-48628 [2018-20913]
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after the December 2018 billing.
Dated: September 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–20911 Filed 9–25–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3552]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Experimental
Study of Cigarette Warnings
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on an experimental
study of cigarette 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 November 26, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
SUMMARY:
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be submitted on or before November 26,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of November 26, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–N–3552 for ‘‘Experimental Study
of Cigarette Warnings.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
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Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
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: 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
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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.
Experimental Study of Cigarette
Warnings
OMB Control Number 0910—NEW
I. Background
The Tobacco Control Act (Pub. L.
111–31) 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 4(a)(1) of the
FCLAA. Section 202(b) of the Tobacco
Control Act further amends section 4 of
the FCLAA by adding that the Secretary
of Health and Human Services
(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
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images to accompany new textual
warning statements for cigarettes.
Although the rule was scheduled to
become effective 15 months after it was
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. Various phases of research have
been underway since 2013. The next
phase of the research includes the study
proposed here, which is an effort by
FDA to collect data concerning
responses to cigarette warnings placed
on cigarette packages and
advertisements for cigarettes.
The health risks associated with the
use of cigarettes are significant and farreaching. Cigarette smoking is the
leading cause of preventable disease and
death in the United States and is
responsible for more than 480,000
deaths per year. Smoking causes more
deaths each year than human
immunodeficiency virus, illegal drug
use, alcohol use, motor vehicle injuries,
and firearm-related incidents combined
(Ref. 1). In addition to lung cancer, heart
disease, and chronic obstructive
pulmonary disease, smoking also causes
numerous other serious health
conditions including several types of
cancer, premature birth, low birth
weight, respiratory illnesses, clogged
arteries, reduced blood flow, diabetes,
and vision conditions such as agerelated macular degeneration and
cataracts (Ref. 2).
Approximately 37.8 million U.S.
adults smoke cigarettes (Ref. 3) and 8.6
million Americans have at least one
serious illness caused by smoking
cigarettes (Ref. 4). Results from the 2016
National Survey on Drug Use and
Health demonstrate that, each day in the
United States, more than 2,300 youth
under age 18 smoke their first cigarette,
and nearly 400 youth become daily
cigarette smokers (Ref. 5). If the current
trajectory of smoking rates continues,
5.6 million children alive today will die
prematurely as a result of smoking (Ref.
2). Providing the public with accurate
information regarding the health
consequences of cigarette use is critical
in achieving FDA’s mission to protect
the public health.
This Experimental Study of Cigarette
Warnings is a voluntary online
experiment. The purpose of the study is
to assess whether new cigarette
warnings increase public understanding
of the negative health consequences of
cigarette smoking. The study will collect
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data from various groups of consumers,
including adolescent current cigarette
smokers aged 13 to 17 years, adolescent
non-smokers who are susceptible to
initiation of cigarette smoking aged 13
to 17 years, young adult current
cigarette smokers and non-smokers aged
18 to 24 years, and older adult current
cigarette smokers and non-smokers aged
25 years and older. The results will
inform the Agency’s efforts to
implement the mandatory graphic
warning label statements as required by
section 4(d) of FCLAA.
Study Overview: In this study,
adolescent current cigarette smokers,
adolescent non-smokers who are
susceptible to initiation of cigarette
smoking, young adult current cigarette
smokers and non-smokers, and older
adult current cigarette smokers and nonsmokers will be recruited from an
existing 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
each condition, respondents will view
one cigarette warning. In the 16
treatment conditions, participants will
view 1 graphic health warning,
containing a warning statement
accompanied by a concordant color
graphic depicting the negative health
consequences of smoking described in
the statement. In the control condition,
participants will be randomized to view
one of the four current Surgeon
General’s warnings, representing the
current state of cigarette warnings in the
United States. In all conditions,
participants will view their assigned
warnings both on a mock cigarette
package and a mock cigarette
advertisement, presented in a
randomized order.
There will be three sessions. During
Session 1, participants will complete a
baseline assessment about their beliefs
about the negative health consequences
of cigarette smoking. Next, they will be
exposed to the stimuli (i.e., the warning
based on condition assignment) and
complete a set of items assessing (a) if
the information presented in the
warning was new; (b) self-reported
learning from the warning; (c) if the
warning was easy to understand; (d) if
the warning was perceived to be a fact
or an opinion; (e) if the warning was
informative; (f) if the warning grabbed
their attention; and (g) if the warning
made them think about the health risks
of cigarette smoking. During Session 2
(1 to 2 days after Session 1), participants
will be exposed to the same stimuli
48627
again (i.e., the warning based on
condition assignment from Session 1),
and complete a set of items assessing
beliefs about the negative health
consequences caused by cigarette
smoking. During Session 3
(approximately 14 days after Session 2),
participants will complete a delayed
post-test on beliefs about the negative
health consequences caused by cigarette
smoking and items assessing recall of
the warning.
Prior to the main data collection, 2
sequential pretests, each with 50
participants, will take place to ensure
correct programming of Session 1 and to
identify any issues with the study
design and implementation.
Study outcomes include comparisons
to assess the extent to which exposure
to the graphic health warnings, relative
to the text-only Surgeon General’s
warnings, provide new information,
increase self-reported learning, change
beliefs about the negative health
consequences of cigarette smoking,
increase thinking about the risks of
smoking, as well as the extent to which
the warnings are informative, easy to
understand, factual, attention grabbing,
and recalled.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity
Total annual
responses
Average burden per response 2
Total hours
Adult—Screener for pretest ..............
Adult—Pretest ...................................
Adult—Screener for main data collection.
Adult—Main data collection (3 sessions).
456
68
51,054
1
1
1
456
68
51,054
0.03 hours (2 minutes) .....................
0.20 hours (12 minutes) ...................
0.03 hours (2 minutes) .....................
14
14
1,532
7,460
1
7,460
0.42 hours (25 minutes) ...................
3,133
Total Adult Hours ..............................
Adolescent—Screener for pretest .....
Adolescent—Pretest .........................
Adolescent—Screener for main data
collection.
Adolescent—Main data collection (3
sessions).
........................
410
32
29,487
........................
1
1
1
........................
410
32
29,487
...........................................................
0.03 hours (2 minutes) .....................
0.20 hours (12 minutes) ...................
0.03 hours (2 minutes) .....................
4,693
12
6
885
2,300
1
2,300
0.42 hours (25 minutes) ...................
966
Total Adolescent Hours ....................
........................
........................
........................
...........................................................
1,869
Total Burden Hours ...................
........................
........................
........................
...........................................................
6,562
1 There
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are no capital costs or operating and maintenance costs associated with this collection of information.
2 The hours per response are rounded to two decimal places.
FDA’s burden estimate is based on
prior experience with research that is
similar to this proposed study (OMB
control number 0910–0848). Screening
potential participants for the 2 pretests
will occur with 866 respondents (456
adults and 410 adolescents) identified
and recruited through the internet
panel. Participants will complete the
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screening questionnaire through an
email invitation. This brief screening
will take an average of 2 minutes (0.03
hours) per respondent. If, based on this
screening, participants qualify for the
study, they will be automatically
directed to begin the pretest. As
previously mentioned, each of the 2
pretests conducted will consist of 50
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respondents (34 adults and 16
adolescents in each) (100 total) during a
single session and, we estimate an
average of 12 minutes (0.20 hours) per
respondent.
Screening potential participants for
the main data collection will occur with
80,541 respondents (51,054 adults and
29,487 adolescents) identified and
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Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices
recruited through the same internet
panel as used for the pretests.
Participants will complete the screener
questionnaire through an email
invitation. This brief screening will take
an average of 2 minutes (0.03 hours) per
respondent. If, based on this screening,
participants qualify for the study, they
will be directed to begin Session 1.
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 14.6 percent qualification
rate for adults and 7.8 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 9,760
participants, of which 7,460 will be
adults and 2,300 will be adolescents.
The three sessions of the main data
collection will take an average of 12
minutes (0.20 hours) for Session 1, 8
minutes (0.13 hours) for Session 2, and
5 minutes (0.08 hours) for Session 3, for
a total of an estimated 25 minutes (0.42
hours) per respondent. The total
estimated burden for the data collection
is 6,561 hours (4,692 hours for adults +
1,869 hours for adolescents).
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II. References
The following references are on
display at the Dockets Management Staff
(see ADDRESSES) and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; they are also available
electronically at https://
www.regulations.gov.
1. Murphy, S.L., J. Xu, K.D. Kochanek.
‘‘Deaths: Final Data for 2010’’. National
Vital Statistics Reports, 61(4):37–41,
2013.
2. U.S. Department of Health and Human
Services. ‘‘The Health Consequences of
Smoking: 50 Years of Progress. A Report
of the Surgeon General.’’ Atlanta, GA:
U.S. Department of Health and Human
Services, Centers for Disease Control and
Prevention, National Center for Chronic
Disease Prevention and Health
Promotion, Office on Smoking and
Health; 2014.
3. Jamal, A., E. Phillips, A.S. Gentzke, et al.
‘‘Current Cigarette Smoking Among
Adults—United States, 2016’’. MMWR
Morbidity and Mortality Weekly Report,
67:53–59, 2018.
4. Centers for Disease Control and
Prevention. ‘‘Cigarette SmokingAttributable Morbidity—United States,
2000’’. MMWR Morbidity and Mortality
Weekly Report, 52(35):842–844, 2003
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5. Substance Abuse and Mental Health
Services Administration (SAMHSA). See
Table 4.10A in ’’ 2016 National Survey
on Drug Use and Health: Detailed
Tables.’’ Rockville, MD: U.S. Department
of Health and Human Services,
SAMHSA, Center for Behavioral Health
Statistics and Quality; 2017.
Dated: September 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–20913 Filed 9–25–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3504]
Tobacco Product Application Review;
Public Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public meeting entitled ‘‘Tobacco
Product Application Review.’’ This
meeting is intended to improve public
understanding and provide FDA
feedback on the policies and processes
for submitting and reviewing tobacco
product marketing applications,
including the general scientific
principles relevant to various
application pathways, to assist those
considering submitting marketing
applications for tobacco products under
the Federal Food, Drug, and Cosmetic
Act (FD&C Act).
DATES: The 2-day public meeting will be
held on October 22, 2018, from 8:30
a.m. to 4:30 p.m. and on October 23,
2018, from 8:30 a.m. to 3 p.m. Submit
either electronic or written comments
on this public meeting by December 7,
2018. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public meeting will be
held at the Hilton Washington DC/
Rockville Hotel & Executive Meeting
Center, 1750 Rockville Pike, Rockville,
MD 20852, https://www3.hilton.com/en/
hotels/maryland/hilton-washington-dcrockville-hotel-and-executive-meetingctr-IADMRHF/.
You may submit comments as
follows. Please note that late, untimely
filed comments may not be considered.
The https://www.regulations.gov
electronic filing system will accept
electronic comments until 11:59 p.m.
Eastern Time on December 7, 2018.
SUMMARY:
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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 December 7, 2018.
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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–N–3504 for ‘‘Tobacco Product
Application Review.’’ Received
comments, filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
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]]>Agencies
[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)]
[Notices]
[Pages 48625-48628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20913]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3552]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Experimental Study of Cigarette Warnings
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on an experimental study of cigarette 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 November 26, 2018.
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 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 26, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-N-3552 for ``Experimental Study of Cigarette Warnings.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the
[[Page 48626]]
Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: 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: 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.
Experimental Study of Cigarette Warnings
OMB Control Number 0910--NEW
I. Background
The Tobacco Control Act (Pub. L. 111-31) 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 4(a)(1) of the FCLAA. Section 202(b) of the
Tobacco Control Act further amends section 4 of the FCLAA by adding
that the Secretary of Health and Human Services (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 was 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. Various phases of research
have been underway since 2013. The next phase of the research includes
the study proposed here, which is an effort by FDA to collect data
concerning responses to cigarette warnings placed on cigarette packages
and advertisements for cigarettes.
The health risks associated with the use of cigarettes are
significant and far-reaching. Cigarette smoking is the leading cause of
preventable disease and death in the United States and is responsible
for more than 480,000 deaths per year. Smoking causes more deaths each
year than human immunodeficiency virus, illegal drug use, alcohol use,
motor vehicle injuries, and firearm-related incidents combined (Ref.
1). In addition to lung cancer, heart disease, and chronic obstructive
pulmonary disease, smoking also causes numerous other serious health
conditions including several types of cancer, premature birth, low
birth weight, respiratory illnesses, clogged arteries, reduced blood
flow, diabetes, and vision conditions such as age-related macular
degeneration and cataracts (Ref. 2).
Approximately 37.8 million U.S. adults smoke cigarettes (Ref. 3)
and 8.6 million Americans have at least one serious illness caused by
smoking cigarettes (Ref. 4). Results from the 2016 National Survey on
Drug Use and Health demonstrate that, each day in the United States,
more than 2,300 youth under age 18 smoke their first cigarette, and
nearly 400 youth become daily cigarette smokers (Ref. 5). If the
current trajectory of smoking rates continues, 5.6 million children
alive today will die prematurely as a result of smoking (Ref. 2).
Providing the public with accurate information regarding the health
consequences of cigarette use is critical in achieving FDA's mission to
protect the public health.
This Experimental Study of Cigarette Warnings is a voluntary online
experiment. The purpose of the study is to assess whether new cigarette
warnings increase public understanding of the negative health
consequences of cigarette smoking. The study will collect
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data from various groups of consumers, including adolescent current
cigarette smokers aged 13 to 17 years, adolescent non-smokers who are
susceptible to initiation of cigarette smoking aged 13 to 17 years,
young adult current cigarette smokers and non-smokers aged 18 to 24
years, and older adult current cigarette smokers and non-smokers aged
25 years and older. The results will inform the Agency's efforts to
implement the mandatory graphic warning label statements as required by
section 4(d) of FCLAA.
Study Overview: In this study, adolescent current cigarette
smokers, adolescent non-smokers who are susceptible to initiation of
cigarette smoking, young adult current cigarette smokers and non-
smokers, and older adult current cigarette smokers and non-smokers will
be recruited from an existing 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
each condition, respondents will view one cigarette warning. In the 16
treatment conditions, participants will view 1 graphic health warning,
containing a warning statement accompanied by a concordant color
graphic depicting the negative health consequences of smoking described
in the statement. In the control condition, participants will be
randomized to view one of the four current Surgeon General's warnings,
representing the current state of cigarette warnings in the United
States. In all conditions, participants will view their assigned
warnings both on a mock cigarette package and a mock cigarette
advertisement, presented in a randomized order.
There will be three sessions. During Session 1, participants will
complete a baseline assessment about their beliefs about the negative
health consequences of cigarette smoking. Next, they will be exposed to
the stimuli (i.e., the warning based on condition assignment) and
complete a set of items assessing (a) if the information presented in
the warning was new; (b) self-reported learning from the warning; (c)
if the warning was easy to understand; (d) if the warning was perceived
to be a fact or an opinion; (e) if the warning was informative; (f) if
the warning grabbed their attention; and (g) if the warning made them
think about the health risks of cigarette smoking. During Session 2 (1
to 2 days after Session 1), participants will be exposed to the same
stimuli again (i.e., the warning based on condition assignment from
Session 1), and complete a set of items assessing beliefs about the
negative health consequences caused by cigarette smoking. During
Session 3 (approximately 14 days after Session 2), participants will
complete a delayed post-test on beliefs about the negative health
consequences caused by cigarette smoking and items assessing recall of
the warning.
Prior to the main data collection, 2 sequential pretests, each with
50 participants, will take place to ensure correct programming of
Session 1 and to identify any issues with the study design and
implementation.
Study outcomes include comparisons to assess the extent to which
exposure to the graphic health warnings, relative to the text-only
Surgeon General's warnings, provide new information, increase self-
reported learning, change beliefs about the negative health
consequences of cigarette smoking, increase thinking about the risks of
smoking, as well as the extent to which the warnings are informative,
easy to understand, factual, attention grabbing, and recalled.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response \2\
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Adult--Screener for pretest... 456 1 456 0.03 hours (2 14
minutes).
Adult--Pretest................ 68 1 68 0.20 hours (12 14
minutes).
Adult--Screener for main data 51,054 1 51,054 0.03 hours (2 1,532
collection. minutes).
Adult--Main data collection (3 7,460 1 7,460 0.42 hours (25 3,133
sessions). minutes).
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total Adult Hours............. .............. .............. .............. ................ 4,693
Adolescent--Screener for 410 1 410 0.03 hours (2 12
pretest. minutes).
Adolescent--Pretest........... 32 1 32 0.20 hours (12 6
minutes).
Adolescent--Screener for main 29,487 1 29,487 0.03 hours (2 885
data collection. minutes).
Adolescent--Main data 2,300 1 2,300 0.42 hours (25 966
collection (3 sessions). minutes).
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total Adolescent Hours........ .............. .............. .............. ................ 1,869
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total Burden Hours........ .............. .............. .............. ................ 6,562
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ The hours per response are rounded to two decimal places.
FDA's burden estimate is based on prior experience with research
that is similar to this proposed study (OMB control number 0910-0848).
Screening potential participants for the 2 pretests will occur with 866
respondents (456 adults and 410 adolescents) identified and recruited
through the internet panel. Participants will complete the screening
questionnaire through an email invitation. This brief screening will
take an average of 2 minutes (0.03 hours) per respondent. If, based on
this screening, participants qualify for the study, they will be
automatically directed to begin the pretest. As previously mentioned,
each of the 2 pretests conducted will consist of 50 respondents (34
adults and 16 adolescents in each) (100 total) during a single session
and, we estimate an average of 12 minutes (0.20 hours) per respondent.
Screening potential participants for the main data collection will
occur with 80,541 respondents (51,054 adults and 29,487 adolescents)
identified and
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recruited through the same internet panel as used for the pretests.
Participants will complete the screener questionnaire through an email
invitation. This brief screening will take an average of 2 minutes
(0.03 hours) per respondent. If, based on this screening, participants
qualify for the study, they will be directed to begin Session 1. 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 14.6 percent qualification
rate for adults and 7.8 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 9,760 participants, of which 7,460 will be adults and
2,300 will be adolescents. The three sessions of the main data
collection will take an average of 12 minutes (0.20 hours) for Session
1, 8 minutes (0.13 hours) for Session 2, and 5 minutes (0.08 hours) for
Session 3, for a total of an estimated 25 minutes (0.42 hours) per
respondent. The total estimated burden for the data collection is 6,561
hours (4,692 hours for adults + 1,869 hours for adolescents).
II. References
The following references are on display at the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov.
1. Murphy, S.L., J. Xu, K.D. Kochanek. ``Deaths: Final Data for
2010''. National Vital Statistics Reports, 61(4):37-41, 2013.
2. U.S. Department of Health and Human Services. ``The Health
Consequences of Smoking: 50 Years of Progress. A Report of the
Surgeon General.'' Atlanta, GA: U.S. Department of Health and Human
Services, Centers for Disease Control and Prevention, National
Center for Chronic Disease Prevention and Health Promotion, Office
on Smoking and Health; 2014.
3. Jamal, A., E. Phillips, A.S. Gentzke, et al. ``Current Cigarette
Smoking Among Adults--United States, 2016''. MMWR Morbidity and
Mortality Weekly Report, 67:53-59, 2018.
4. Centers for Disease Control and Prevention. ``Cigarette Smoking-
Attributable Morbidity--United States, 2000''. MMWR Morbidity and
Mortality Weekly Report, 52(35):842-844, 2003
5. Substance Abuse and Mental Health Services Administration
(SAMHSA). See Table 4.10A in '' 2016 National Survey on Drug Use and
Health: Detailed Tables.'' Rockville, MD: U.S. Department of Health
and Human Services, SAMHSA, Center for Behavioral Health Statistics
and Quality; 2017.
Dated: September 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20913 Filed 9-25-18; 8:45 am]
BILLING CODE 4164-01-P
