Document ID: FDA-2010-N-0079-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Experimental Study of Graphic Cigarette Warning Labels
Posted Date: 2010-02-22T05:00Z

[Federal Register: February 22, 2010 (Volume 75, Number 34)]
[Notices]               
[Page 7604-7606]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22fe10-61]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Agency Information Collection Activities; Proposed Collection; 
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 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 of Graphic Cigarette 
Warning Labels 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 written or electronic comments on the collection of 
information by April 23, 2010.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://

[[Page 7605]]

www.regulations.gov. Submit written comments on the collection of 
information to the Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 
All comments should be identified with the docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information 
Management (HFA-710), Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3794, 
JonnaLynn.Capezzuto@fda.hhs.gov.

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 Graphic Cigarette Warning Labels

    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 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 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 of approximately 43,000 people. Participation in the 
experimental study is voluntary.
    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                  0.5                   30
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Screener                                                       15,000                     1             15,000                  0.016                240
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Experimental Survey                                             5,400                     1              5,400                  0.5                2,700
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Total                                               .................                     1             15,460  .....................              2,970
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 7606]]

    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 30 
minutes (0.5 hours), for a total of 30 hours. Approximately 15,000 
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 125 hours. Fifty-four hundred (5,400) respondents will 
complete the full study, estimated to last 30 minutes (0.5 hours), for 
a total of 2,700 hours. The total estimated burden is 2,970 hours.

    Dated: February 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3320 Filed 2-19-10; 8:45 am]
BILLING CODE 4160-01-S