[Federal Register Volume 75, Number 164 (Wednesday, August 25, 2010)]
[Notices]
[Pages 52352-52355]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21123]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0079]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Experimental Study of 
Graphic Cigarette Warning Labels

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 
September 24, 2010.

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 [email protected]. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Experimental Study of Graphic Cigarette Warning Labels.'' Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT:  Jonna Capezzuto, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3794, 
[email protected].

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 Graphic Cigarette Warning Labels--(OMB Control 
Number 0910-NEW)

    Tobacco products are responsible for more than 440,000 deaths each 
year. The Centers for Disease Control and Prevention report that 
approximately 46 million U.S. adults smoke cigarettes in the United 
States, even though this behavior will result in death or disability 
for half of all regular users. Paralleling this enormous health burden 
is the economic burden of tobacco use, which is estimated to total $193 
billion annually in medical expenditures and lost productivity. Curbing 
the significant adverse consequences of tobacco use is one of the most 
important public health goals of our time. One way to do this is 
through health warnings that describe and graphically depict the harm 
caused by cigarette use.
    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 
111-31) into law. The Tobacco Control Act granted FDA important new 
authority to regulate the manufacture, marketing, and distribution of 
tobacco products to protect the public health generally and to reduce 
tobacco use by minors. Section 201 of the Tobacco Control Act, which 
amends section 4 of the Federal Cigarette Labeling and Advertising Act 
(15 U.S.C. 1333), requires 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).'' FDA 
conducts research relating to tobacco products under its statutory 
authority in section

[[Page 52353]]

1103(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act, as amended 
by the Tobacco Control Act, to conduct research ``relating to foods, 
drugs, cosmetics, devices, and tobacco products in carrying out the 
act.'' The study proposed here is an effort by FDA to collect data 
concerning graphic warnings on cigarette packages and their impact on 
consumer perceptions, attitudes, and behavior with respect to smoking.
    The study, the Experimental Study of Graphic Cigarette Warning 
Labels, is a voluntary experimental survey of consumers. The purpose of 
the study is to assess the effectiveness of various graphic warnings on 
cigarette packs for achieving three communication goals: (1) Conveying 
information about various health risks of smoking, (2) encouraging 
cessation of smoking among current smokers, and (3) discouraging 
initiation of smoking among youth and former smokers. The study will 
collect data from various groups of consumers, including current 
smokers aged 13 years and older, former smokers aged 13 years and 
older, and non-smokers aged between 13 and 25 years who may be 
susceptible to initiation of smoking. The study goals are to: (1) 
Measure consumer attitudes, beliefs, and intended behaviors related to 
cigarette smoking in response to graphic warning labels; (2) determine 
whether consumer responses to graphic warning labels differ across 
various groups based on smoking status, age, or other demographic 
variables; and (3) evaluate the relative effectiveness of various 
graphic images associated with each of the nine warning statements 
specified in the Tobacco Control Act for achieving each of the 
communication goals. The information collected from the study is 
necessary to inform the agency's efforts to implement the mandatory 
graphic warnings required by the Tobacco Control Act.
    The experimental study data will be collected from participants of 
an Internet panel. Participation in the experimental study is 
voluntary.
    In the Federal Register of February 22, 2010 (75 FR 7604), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received five comments in response to 
the notice.
    All five comments supported FDA's proposal to sponsor consumer 
research to provide a scientific basis for regulations requiring color 
graphics to accompany the new statutory health warnings set forth in 
the Federal Cigarette Labeling and Advertising Act, as amended by the 
Tobacco Control Act.
    One comment recommended that the FDA consider conducting followup 
assessments to determine whether the warnings are having their intended 
effects and, if not, to determine what revisions are needed.
    FDA agrees that appropriate surveillance is important, and that the 
comment makes an excellent suggestion for future research.
    Two comments recommended that FDA include information about 
cessation resources in the tested graphic warnings.
    FDA will be testing a variety of different graphics that will vary 
in style and intensity. Some of the tested images will include 
information about cessation resources. Decisions about whether to 
include specific graphics containing cessation information in final 
regulations will be made after the results of the experimental study 
are available and these data will be a primary factor in the selection 
of images for final regulations.
    One comment recommended that FDA use images that are medically 
accurate to avert claims that the graphics are deceptive to consumers 
and ensure that smokers are confident in the accuracy of the health 
information provided.
    FDA agrees that it is important to ensure that the graphic health 
warnings convey accurate information about smoking risks to consumers. 
The data collected from the proposed research will provide important 
information to ensure that the graphic health warnings being tested do 
not elicit unintended responses from consumers.
    One comment urged that FDA ensure that the questionnaire ask 
questions in an objective and unbiased manner.
    FDA agrees with this recommendation and has designed a survey 
instrument that includes validated measures used in other research. 
Thus the questions are objective, unbiased, and reliably understood by 
respondents. In addition, FDA plans to conduct cognitive interviews 
prior to the experimental survey. These interviews will help identify 
any unanticipated problems consumers may have in understanding or 
responding to the questions in the survey.
    One comment questioned the basic premise of requiring graphic 
health warnings, stating that international experience shows that 
graphic health warnings have not reduced smoking rates.
    The purpose of this study is not to determine whether FDA should 
require graphic health warnings. Congress has already made that 
determination. Similarly, the purpose of this study is not to determine 
the absolute effectiveness of graphic health warnings in terms of 
changing smoking behavior. Instead, the purpose of this study is to 
determine the relative efficacy of various graphic health warnings for 
conveying risk information to consumers and provide a scientific basis 
for FDA's regulations for graphic health warnings as required by the 
Federal Cigarette Labeling and Advertising Act, as amended by the 
Tobacco Control Act.
    One comment sought assurance that FDA will obtain appropriate 
parental consent and Institutional Review Board (IRB) approvals, 
especially with respect to the collection of information from 
adolescents.
    FDA strongly agrees that appropriate parental consent and IRB 
approval is important and necessary. Such consent and approval will be 
obtained as part of the standard regulatory research process and before 
any collection of information.
    One comment questioned FDA's decision to use an Internet survey, 
especially with respect to the collection of information from 
adolescents, and recommended that FDA sponsor an in-person survey 
instead.
    As indicated previously in this document, the purpose of this study 
is to assess the relative efficacy of various graphic health warnings. 
The use of an Internet-based panel to collect our experimental data is 
appropriate for this purpose. FDA believes that the Internet-based 
panel will provide the most efficient and practical methodology for 
collecting the data.
    One comment also indicated that an Internet-based survey is not 
well-suited to analyzing health warnings because the health warnings 
under real world conditions appear on three-dimensional packages rather 
than on two-dimensional images on a computer screen. The comment 
recommended that FDA consider a prior mailing of realistic mockups of 
cigarette packages, which the participants could examine while taking 
the survey.
    FDA agrees that it is important that survey participants view 
realistic images of the tested graphic health warnings on product 
packaging. The study is designed so that participants will view a 
three-dimensional animation of mockups of various graphic warnings on 
product packaging. Participants will be able to manipulate the 
animation during the survey to see the front, back, and sides of the 
package. We believe that this animation is sufficient to ensure that 
study participants view the tested graphic warnings under realistic 
conditions.

[[Page 52354]]

    One comment recommended that FDA include a meaningful pretesting of 
the survey instrument, including the use of cognitive interviews.
    FDA agrees that meaningful pretesting of the survey instrument is 
important, and plans both cognitive interviews and pretests. The 
cognitive interviews will help FDA evaluate and refine the draft 
questionnaire, and help to identify areas where the instrument is 
ambiguous, burdensome, or confusing. FDA will also conduct pretests of 
the algorithms and programs for respondent sampling, survey 
administration, and data collection.
    One comment raised a number of individual concerns that the planned 
cross-sectional design of the proposed survey is not capable of 
providing information from which causal conclusions about the 
relationship between exposure to the graphic images and smoking 
behavior can be based. The comment also raised the concern that 
questions regarding intended actions about smoking cessation or smoking 
initiation are inadequate to demonstrate actual behavioral changes. To 
address these concerns, the comment recommended the use of a 
longitudinal design that monitors actual behavior over time.
    The purpose of this study is not to determine the absolute 
effectiveness of graphic health warnings in terms of changing smoking 
behavior. Instead, as indicated previously in this document, the 
purpose of the study is to determine the relative efficacy of various 
graphic health warnings for purposes of providing a scientific basis 
for FDA's regulations for graphic health warnings as required by the 
Federal Cigarette Labeling and Advertising Act, as amended by the 
Tobacco Control Act. A cross-sectional design is appropriate for this 
purpose.
    In addition, FDA disagrees that questions concerning intentions to 
quit smoking or to not begin smoking are inappropriate. The more recent 
scientific literature shows that statements by smokers concerning their 
intentions to quit smoking are predictive of their making subsequent 
quit attempts (Ref. 1). Similarly, the scientific literature 
demonstrates that statements by children and adolescents concerning 
their intentions to smoke or not smoke are reliable predictors of 
subsequent smoking and precedes smoking initiation (Ref. 2).
    One comment noted that it is important that the study be conducted 
in a manner that avoids question order bias.
    FDA agrees that efforts must be taken to avoid any potential bias, 
and is confident that the study will be conducted in a manner that 
yields objective and reliable results. The planned cognitive interviews 
and pretests should help identify potential problems with question 
order and allow FDA to address those concerns prior to the experimental 
survey.
    One comment recommended that FDA use a research design that tests 
across subjects, rather than within subjects. The comment states that 
failure to use an across-subjects design will lead to an overestimate 
of the effects of bolder warnings.
    FDA's proposed study employs a between-subjects design that will 
test across subjects.
    One comment recommends that care be taken to avoid information 
overload, given the number of warning statements and images.
    FDA agrees with the comment. The between-subjects design of the 
study will reduce the potential for information overload. Each 
treatment group of respondents will view and respond to one graphic 
warning label.
    One comment also included comments on a separate Federal Register 
notice that sought public comment on a proposed FDA collection of 
information concerning the pretesting of tobacco communications, Docket 
No. FDA-2010-N-0084. That notice is not related to the information 
collection concerning graphic health warnings. Accordingly, those 
comments are not addressed in this document.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                          No. of         Annual Frequency       Total Annual
                 Portion of Study                      Respondents         per Response          Responses       Hours per  Response      Total Hours
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Pre-test                                                           60                     1                 60                  0.25                  15
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Screener                                                       36,000                     1             36,000                  0.016                600
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Experimental Survey                                            23,400                     1             23,400                  0.25               5,850
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Total                                                                                                                                              6,465
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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 Internet 
panel experiments similar to the study proposed here. Sixty panel 
members will take part in a pre-test of the study, estimated to last 15 
minutes (0.25 hours), for a total of 15 hours. Approximately 36,000 
respondents will complete a screener to determine eligibility for 
participation in the study, estimated to take 1 minute (0.016 hours), 
for a total of 600 hours. Eighteen thousand (18,000) respondents will 
complete the full study, estimated to last 15 minutes (0.25 hours) and 
approximately 5,400 of those respondents will complete an additional 
survey 1 to 2 weeks following the original survey, estimated to last 15 
minutes (0.25 hours), for a total of 5,850 hours. The total estimated 
burden is 6,465 hours. Burden hours exceed FDA's previous estimates 
published in the 60-day notice of this study. Additional hours are the 
result of an increase in respondent sample size. A larger sample size 
is required to ensure sufficient statistical power for analysis of the 
data.

References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES), and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Zhou, X et al. ``Attempts to quit smoking and relapse: 
Factors associated with success or failure from the ATTEMPT cohort 
study,'' Addictive Behaviors, 2009; 34: 365-373; Hyland A et al. 
(2006), ``Individual-level predictors of cessation behaviours among 
participants in the International Tobacco Control (ITC) Four Country 
Survey,'' Tobacco Control, 15: iii83-iii94.
    2. Hampson SE et al., ``Predictors of the Development of 
Elementary-School Children's Intentions to Smoke Cigarettes: 
Hostility, Prototypes, and Subjective Norms,'' Nicotine and Tobacco 
Research, 2007 July; 9(7): 751-760; Wakefield, M. et al., ``The role

[[Page 52355]]

of smoking intentions in predicting future smoking among youth: 
findings from the Monitoring the Future data,'' Addiction 2004 Jul; 
99(7): 914-22; Pierce J, et al., ``Validation of susceptibility as a 
predictor of which adolescents take up smoking in the United 
States,'' Health Psychology, 1996(Sept): 355-61.

    Dated: August 20, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-21123 Filed 8-24-10; 8:45 am]
BILLING CODE 4160-01-S