[Federal Register Volume 83, Number 245 (Friday, December 21, 2018)]
[Notices]
[Pages 65685-65689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27658]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3552]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) 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 January 
22, 2019.

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 <a href="/cdn-cgi/l/email-protection#fc93958e9da38f899e91958f8f959392bc93919ed299938cd29b938a"><span class="__cf_email__" data-cfemail="2c43455e4d735f594e41455f5f4543426c43414e0249435c024b435a">[email protected]</span></a>. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Experimental Study of Cigarette Warnings.'' Also include the 
FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
<a href="/cdn-cgi/l/email-protection#79292b382a0d181f1f391f1d185711110a571e160f"><span class="__cf_email__" data-cfemail="217173607255404747614745400f4949520f464e57">[email protected]</span></a>.

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 of Cigarette Warnings

OMB Control Number 0910-NEW

    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 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 health 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 
health warnings increase public understanding of the negative health 
consequences of cigarette smoking. The study will collect 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 color graphics to accompany health warning label statements 
as required by section 4 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 cigarette health 
warning, containing a textual warning statement

[[Page 65686]]

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 in 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 new cigarette 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, and the extent to which the warnings are informative, easy to 
understand, factual, attention grabbing, and recalled.
    In the Federal Register of September 26, 2018 (83 FR 48625), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received six unique comment submissions. 
Four submissions were PRA related, and some included multiple comments.
    (Comment) One commenter stated that it's important to educate and 
reinforce the facts surrounding the dangers of smoking.
    (Response) FDA agrees that it is important to provide the public 
with accurate information about the risks associated with the use of 
tobacco products. The purpose of this study is to assess whether new 
cigarette warnings increase public understanding of the negative health 
consequences of smoking.
    (Comment) One comment urged FDA to move forward to complete the 
proposed consumer research study as soon as possible to facilitate the 
prompt promulgation of a rule to require new warnings on cigarette 
packages and in cigarette advertisements. The comment also stated that 
FDA must take every available opportunity to minimize delays that may 
be attributable to the Paperwork Reduction Act.
    (Response) FDA agrees that it is important to complete this study 
and promulgate a rule in accordance with the statutory mandate laid out 
by Congress. FDA is following the requirements of the Paperwork 
Reduction Act and its associated timelines.
    (Comment) One comment stated that, as designed, the proposed study 
does not help FDA satisfy the requirements of the First Amendment 
because FDA has failed to consider less-burdensome alternatives and 
because FDA has not identified a ``substantial'' interest that this 
current iteration of a cigarette health warnings rule serves.
    (Response) As stated previously, the purpose of the proposed study 
is to assess whether new cigarette health warnings increase public 
understanding of the negative health consequences of smoking. FDA 
further notes that this notice is respecting a proposed study, the 
results of which, if used in a future rulemaking, would be provided 
along with other evidence in a future notice of proposed rulemaking and 
subject to public comment at that time.
    (Comment) FDA received two comments that asked FDA to provide more 
detail about the design of the proposed study to allow for meaningful 
public comments. One commenter also stated that FDA must provide 
additional information for public comment, including details of the 
protocol, inclusion criteria for screening study participants, 
questionnaire, and the text and color graphics the agency proposes to 
test.
    (Response) FDA notes in response to this comment that the proposed 
study and copies of the instruments used to collect this information 
are described in detail as part of the overall information collection 
request submitted to OMB for review.
    (Comment) One comment provided a published scientific study and 
suggested that focusing on the presence of certain features of the 
warnings might provide more robust evidence about the effectiveness of 
warning labels rather than a comparison of a single pictorial message 
to a text-only message.
    (Response) FDA appreciates the submission of the published study; 
however, it focuses on outcomes not relevant to the study FDA proposes 
here. The proposed study examines how new cigarette health warnings 
provide new information, increase self-reported learning, change 
beliefs about the negative health consequences of cigarette smoking, 
and increase thinking about the risks of smoking.
    (Comment) One comment stated that the cigarette health warnings 
should be compared relative to the new text-only warning statements 
rather than the current, familiar text-only Surgeon General's warnings.
    (Response) FDA disagrees. First, Section 201 of the Tobacco Control 
Act amends section 4 of FCLAA to require FDA to issue regulations that 
require color graphics depicting the negative health consequences of 
smoking to accompany the textual label statements. Second, FDA believes 
that the comparison to the current Surgeon General's warnings is the 
most appropriate comparison for the purposes of this proposed study. 
This comparison will allow for investigation of the potential effect of 
implementing new cigarette health warnings compared to the current 
state of warnings for cigarette packages and advertisements, which the 
commenter recognizes are ``familiar.''
    (Comment) One comment recommended that certain demographic (e.g., 
age, socioeconomic status) and other (e.g., nicotine dependence among 
smokers) factors should be evaluated during the course of this study.
    (Response) FDA disagrees. The purpose of this proposed study is to 
assess whether new cigarette health warnings increase public 
understanding of the negative health consequences of smoking, not the 
mechanisms for such changes. Some basic sub-group analyses will be 
performed by age group; however, the primary analyses will focus on 
whether new cigarette health warnings increase public understanding

[[Page 65687]]

of the negative health consequences of smoking in the sample overall.
    (Comment) One comment urged FDA to consider previous research that 
has shown that use of ``graphical'' warnings can produce an opposite 
effect to the desired outcome.
    (Response) In our research to develop, test, and revise the content 
of new cigarette health warnings, we considered communication best 
practices, including minimizing unintended consequences and potential 
reactance to the warnings. Additionally, given the purpose and design 
of the proposed study, unintended consequences would be evident if the 
control warnings showed greater gains on outcomes compared to the 
warnings in the treatment conditions.
    (Comment) One comment recommended that the study design include 
pre/post measures of risk perceptions to evaluate whether the cigarette 
health warnings meaningfully increase likely pre-existing high levels 
of incoming risk perceptions.
    (Response) FDA declines to make such a change. The purpose of this 
proposed study is to assess whether new cigarette warnings increase 
public understanding of the negative health consequences of smoking, 
not whether such warnings increase risk perceptions. The focus of the 
study is on the specific health conditions that are the focus of the 
warning statements and their accompanying color graphics depicting the 
negative health consequences of smoking, not on the perception of 
overall risks of smoking.
    (Comment) One comment indicated that the sample size for each 
condition appears to be small.
    (Response) FDA disagrees. The sample size for this study was 
determined by a comprehensive statistical power analysis, taking into 
account the study design, planned analyses to be conducted, and 
potential study attrition. Based on its statistical power analysis, FDA 
is confident that the study will have sufficient sample sizes to detect 
meaningful effects.
    (Comment) One comment stated that the proposed study's methodology 
suffers from selection bias. Specifically, the commenter stated that 
the proposed study is a voluntary online experiment, uses sampling 
methodology that may limit generalizability of outcomes to the broader 
U.S. population, and appears to lack corrective measures such as the 
ability to identify factors that contribute to participant drop out.
    (Response) Although the large sample for this study is not truly 
nationally representative, FDA has made efforts to ensure that the 
demographics of participants in the study population closely mirror 
those of national estimates to ensure a better representation. 
Additionally, the sample size calculation and study analysis account 
for the potential of attrition over the multiple time points (i.e., 
study sessions).
    (Comment) One comment asserted that the study questions create a 
serious risk of bias. Specifically, the commenter stated that FDA's 
broad description of the questions to be asked in the study suggests 
that they are deliberately crafted to support a ``pre-ordained'' 
result, namely, that the warnings would increase public understanding 
of the negative health consequences of cigarette smoking.
    (Response) FDA disagrees. There is no pre-ordained result. The 
questions used in this study were selected from prior studies on 
similar topics, including cigarette warnings. Some questions have been 
slightly edited to fit the specific content of the warnings to be 
tested, but the question instructions and question stems have not 
changed. The study questions are face valid (i.e., it is clear they 
measure what they are intended to measure). Additionally, the study 
questions have previously been shown to produce a range of responses, 
indicating that they do not produce demand characteristics (i.e., study 
participants do not respond to the items with what they think the 
researchers want to hear).
    (Comment) One comment stated that FDA will need to avoid question-
order bias.
    (Response) FDA agrees that it is important to avoid question-order 
bias in this proposed study. In many sections of the study instrument, 
the order of questions is randomized specifically to avoid question-
order bias. In other sections of the study instrument, the order was 
determined by starting with more general and then moving on to more 
specific items to avoid bias. In designing the survey, FDA ensured that 
the item order follows established models of information processing and 
attention.
    (Comment) One comment raised a number of concerns that the study 
protocols do not appear to adequately mimic real-world conditions 
because cigarette smokers would not be exposed to only a single warning 
(but rather they would be exposed to all of them over time); the study 
asks participants to specifically focus on the warnings, which will 
likely overestimate their effects; in the real world, consumers would 
rarely view both cigarette packaging and advertisements at the same 
time; the study does not measure whether consumers would get used to 
the warnings after viewing them repeatedly over a long period of time; 
and the study's 14-day gap between Sessions 2 and 3 gives participants 
time to do their own research about the risks of cigarettes, which 
could overstate any effects that cigarette health warnings might have.
    (Response) FDA disagrees with these assertions. The procedures 
proposed for the current study provide a greater number of exposures 
(and thus closer to real-world conditions) and use a longer follow-up 
time than many similar studies (Ref. 6).
    The Tobacco Control Act requires that the cigarette health warning 
label statements with accompanying color graphics be displayed both on 
cigarette packages and in cigarette advertisements; therefore, exposure 
to the warnings on both formats provides an appropriate assessment of 
the impact of the warnings.
    Finally, if warnings in certain conditions prompt study 
participants to seek health information in the 14-day follow-up period, 
thus resulting in greater understanding of the negative health 
consequences of cigarette smoking, such an effect would only strengthen 
findings that the warnings are working as intended and provide further 
evidence that the study mimics real world conditions in which consumers 
could seek additional information about the negative health 
consequences of smoking. Participants' health beliefs will be assessed 
at all three study sessions, thus allowing for comparison of the effect 
both immediately after exposure as well as after a delay.
    (Comment) One comment recommended that FDA consider assessing 
comprehension of the new warnings objectively (i.e., evaluating recall 
of specific content, evaluating comprehension of disease risk) rather 
than participants indicating only that they learned (i.e., ``self-
reported learning from the warning'').
    (Response) FDA agrees that it is important to assess comprehension 
of the new warnings objectively. The proposed study contains these 
items, in addition to other measures.
    (Comment) One comment stated that FDA should prioritize measuring 
the impact of the warnings on behavior (e.g., quit intentions among 
cigarette smokers, initiation intentions among non-users) over concepts 
such as whether the warning is informative or grabs attention.
    (Response) The purpose of the proposed study is to assess whether 
new cigarette health warnings increase

[[Page 65688]]

public understanding of the negative health consequences of cigarette 
smoking. The study does not focus on behavior.
    (Comment) One comment stated that the study does not appear to 
include meaningful pretesting.
    (Response) FDA disagrees with this assertion. As explained 
previously, the items in this proposed study were selected from prior 
studies on similar topics, including cigarette warnings. Additionally, 
the specific language used in the warning statements has been 
extensively tested in multiple qualitative studies and a large 
quantitative study conducted by FDA. The findings from those studies 
informed the development of warning statements, revisions to those 
statements, and the questions used to assess participant reactions 
(e.g., beliefs) about the warnings.

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses    per response \2\
----------------------------------------------------------------------------------------------------------------
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).
                               ---------------------------------------------------------------------------------
    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......               6
                                                                                (12 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.                                                                     minutes).
(3 sessions)..................
Total Adolescent Hours........  ..............  ..............  ..............  ................           1,869
                               ---------------------------------------------------------------------------------
    Total Burden Hours........  ..............  ..............  ..............  ................           6,562
----------------------------------------------------------------------------------------------------------------
\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 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).

I. 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. FDA has 
verified the website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.

    1. 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.''

[[Page 65689]]

Rockville, MD: U.S. Department of Health and Human Services, SAMHSA, 
Center for Behavioral Health Statistics and Quality; 2017.
    6. Noar, S.M., Hall, M.G., Francis, D.B., et al. ``Pictorial 
Cigarette Pack Warnings: A Meta-Analysis of Experimental Studies''. 
Tobacco Control, 25:341-354, 2016.


    Dated: December 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-27658 Filed 12-20-18; 8:45 am]
 BILLING CODE 4164-01-P


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