Document ID: FDA-2017-N-0932-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study on Warning Statements for Cigarette Graphic Health Warnings
Posted Date: 2017-03-28T04:00Z

[Federal Register Volume 82, Number 58 (Tuesday, March 28, 2017)]
[Notices]
[Pages 15359-15361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-06078]

[[Page 15359]]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0932]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Experimental Study on Warning Statements for Cigarette 
Graphic Health Warnings

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the Experimental Study on Warning 
Statements for Cigarette Graphic Health Warnings that is being 
conducted in support of the graphic label statement provision of the 
Family Smoking Prevention and Tobacco Control Act (the Tobacco Control 
Act).

DATES: Submit either electronic or written comments on the collection 
of information by May 30, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-N-0932 for ``Agency Information Collection Activities, 
Proposed Collection; Comment Request; Experimental Study on Warning 
Statements for Cigarette Graphic Health Warnings.'' Received comments 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

[[Page 15360]]

Experimental Study on Warning Statements for Cigarette Graphic Health 
Warnings

OMB Control Number--0910-New

    The health risks associated with the use of cigarettes can be 
significant and far-reaching. In 2009, Congress enacted the Tobacco 
Control Act (Pub. L. 111-31), which amends the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) to grant FDA authority to regulate the 
manufacture, marketing, and distribution of tobacco products to protect 
the public health and to reduce tobacco use by minors. Section 201 of 
the Tobacco Control Act amends section 4 of the Federal Cigarette 
Labeling and Advertising Act (FCLAA) (15 U.S.C. 1333) to require FDA to 
issue ``regulations that require color graphics depicting the negative 
health consequences of smoking to accompany the label statements 
specified in subsection (a)(1).'' Section 202(b) of the Tobacco Control 
Act further amends section 4 the FCLAA by adding that the Secretary, 
through notice and comment rulemaking, may adjust the ``text of any of 
the label requirements . . . if the Secretary finds that such a change 
would promote greater public understanding of the risks associated with 
the use of tobacco products.''
    In the Federal Register of June 22, 2011 (76 FR 36628), FDA issued 
a final rule entitled ``Required Warnings for Cigarette Packages and 
Advertisements,'' which specified nine images to accompany the new 
textual warning statements for cigarettes. Although the rule was 
scheduled to become effective 15 months after it issued, a panel of the 
U.S. Court of Appeals of the District of Columbia held, on August 24, 
2012, that the rule in its current form violated the First Amendment. 
In a letter to Congress on March 15, 2013, the Attorney General 
reported FDA's intention to undertake research to support a new 
rulemaking consistent with the Tobacco Control Act. Preliminary 
research has been underway since 2013. Informed by the previous court 
decisions on this matter, including on the First Amendment, the next 
phase of the research includes the study proposed here, which is an 
effort by FDA to collect data concerning revised textual warning 
statements for use with new images as part of cigarette graphic health 
warnings, and their potential impact on public understanding of the 
risks associated with the use of cigarettes.
    As currently proposed, this Experimental Study on Warning 
Statements for Cigarette Graphic Health Warnings is a voluntary online 
experiment conducted with consumers. The purpose of the proposed study 
is to assess whether potential textual warnings statements, which have 
been revised from those enumerated in section 4 of FCLAA, promote 
greater public understanding of the negative health consequences of 
cigarette smoking. The study will collect data from various groups of 
consumers, including adolescent (under age 18) current cigarette 
smokers, adolescents who are susceptible to initiation of cigarette 
smoking, young adult (ages 18- to 24) current cigarette smokers, and 
older adult (ages 25 and above) current cigarette smokers. The results 
will inform the Agency's development of cigarette graphic health 
warnings to be tested in future studies with the goal of implementing 
the mandatory graphic warning label statement consistent with section 
4(d) of FCLAA and the First Amendment.
    Proposed Study Overview: In this study, adolescent current 
cigarette smokers, adolescents who are susceptible to initiation of 
cigarette smoking, young adult current cigarette smokers, and older 
adult current smokers will be recruited from an Internet panel of more 
than 1.2 million people and screened for inclusion into the study. 
Participants who meet the inclusion criteria will be randomized into 
one of 17 conditions in a between-subjects design. In each condition, 
participants will be exposed to a series of nine warning statements, 
presented sequentially. Participants randomized to the control 
condition will view all nine of the warning statements listed in 
section 4(a)(1) of FCLAA:

 WARNING: Cigarettes are addictive.
 WARNING: Tobacco smoke can harm your children.
 WARNING: Cigarettes cause fatal lung disease.
 WARNING: Cigarettes cause cancer.
 WARNING: Cigarettes cause strokes and heart disease.
 WARNING: Smoking during pregnancy can harm your baby.
 WARNING: Smoking can kill you.
 WARNING: Tobacco smoke causes fatal lung disease in 
nonsmokers.
 WARNING: Quitting smoking now greatly reduces serious risks to 
your health.

    Participants randomized to 1 of the 16 experimental conditions will 
view 8 of the warning statements listed in section 4(a)(1) of FCLAA 
(above) plus 1 statement that is a revised version of a statutory text 
warning. The revised warning statements being tested in this proposed 
study are:

 WARNING: Smoking causes mouth and throat cancer.
 WARNING: Smoking causes head and neck cancer.
 WARNING: Smoking causes bladder cancer, which can lead to 
bloody urine.
 WARNING: Smoking during pregnancy causes premature birth.
 WARNING: Smoking during pregnancy stunts fetal growth.
 WARNING: Smoking during pregnancy causes premature birth and 
low birth weight.
 WARNING: Secondhand smoke causes respiratory illnesses in 
children, like pneumonia.
 WARNING: Smoking can cause heart disease and strokes by 
clogging arteries.
 WARNING: Smoking causes COPD, a lung disease that can be 
fatal.
 WARNING: Smoking causes serious lung diseases like emphysema 
and chronic bronchitis.
 WARNING: Smoking reduces blood flow, which can cause erectile 
dysfunction.
 WARNING: Smoking reduces blood flow to the limbs, which can 
require amputation.
 WARNING: Smoking raises blood sugar, which can cause type 2 
diabetes.
 WARNING: Smoking causes age-related macular degeneration, 
which can lead to blindness.
 WARNING: Smoking causes cataracts, which can lead to 
blindness.

    In all conditions, after viewing each statement, participants will 
respond to a small number of questions about that specific statement. 
Following viewing all nine statements, participants will respond to a 
larger set of questions. Next, participants will view an additional 
nine revised warning statements, drawn from the revised statements 
listed above, and respond to an additional set of questions. Primary 
study outcomes include beliefs and knowledge of the negative health 
consequences of cigarette smoking. Prior to the main data collection, 
two pretests, each with 50 participants, will take place to ensure 
correct programming and to identify any issues with the proposed study 
design and implementation.
    Estimated Burden: FDA estimates the burden of this collection of 
information as follows:

[[Page 15361]]

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
       Portion of study            Number of    responses  per   Total  annual   Average  burden    Total hours
                                  respondents      respondent      responses      per  response
----------------------------------------------------------------------------------------------------------------
Screening for pretest.........             762               1             762  .033 (2 minutes)              25
Pretest.......................             100               1             100  .25 (15 minutes)              25
Screening for main data                 19,082               1          19,082  .033 (2 minutes)             630
 collection.
Main data collection..........           2,500               1           2,500  .25 (15 minutes)             625
                               ------------------------------------------------                  ---------------
    Total.....................  ..............  ..............  ..............  ................           1,305
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA's burden estimate is based on prior experience with research 
that is similar to this proposed study. Screening potential 
participants for the 2 pretests will occur with 762 respondents (487 
adults and 275 adolescents) identified and recruited through the 
Internet panel. This brief screening will take an average of 2 minutes 
(0.033 hours) per respondent. Each of the 2 pretests will consist of 50 
respondents (34 adults and 16 adolescents) conducted during a single 
session and take an average of 15 minutes (0.25 hours) per respondent. 
Screening potential participants for the main data collection will 
occur with 19,082 respondents (11,925 adults and 7,157 adolescents) 
identified and recruited through the same Internet panel as used for 
the pretests. This brief screening will take an average of 2 minutes 
(0.033 hours) per respondent. Recent national estimates of the numbers 
of adolescent current cigarette smokers, adolescents who are 
susceptible to initiation of cigarette smoking, young adult current 
cigarette smokers, and older adult current cigarette smokers informed 
the estimates of 13.9 percent qualification rate for adults and 11.6 
percent qualification rate for adolescents. Applying these estimates 
and other assumptions from previous experience conducting similar 
studies to the number of adolescents and adults to be screened results 
in the desired sample size for the main data collection of 2,500 
participants, of which 1,667 will be adults and 833 will be 
adolescents. The main data collection will occur with those 2,500 
respondents during a single session. The main data collection will take 
an average of 15 minutes (0.25 hours) per respondent. The total 
estimated burden is 1,305 hours (25 hours + 25 hours + 630 hours + 625 
hours).

    Dated: March 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-06078 Filed 3-27-17; 8:45 am]
 BILLING CODE 4164-01-P