[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]


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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

[[Page 48627]]

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\
----------------------------------------------------------------------------------------------------------------
                                                   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).
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
----------------------------------------------------------------------------------------------------------------
\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

[[Page 48628]]

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