
[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]


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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.

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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\
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                                                                Number of
              Portion of study                  Number of     responses per   Total annual           Average burden per response            Total hours
                                               respondents     respondent       responses
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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
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\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


