[Federal Register Volume 70, Number 235 (Thursday, December 8, 2005)]
[Notices]
[Pages 73008-73009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-7040]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-06-05BF)


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
the CDC Reports Clearance Officer at (404) 639-4766 or send an e-mail 
to [email protected]. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC or by fax to (202) 395-6974. 
Written comments should be received within 30 days of this notice.

Proposed Project

    Human Smoking Behavior--New--National Center for Chronic Disease 
and Public Health Promotion (NCDDPHP), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    CDC, National Center for Chronic Disease Prevention and Health 
Promotion (NCCDPHP), in a joint venture with the National Center for 
Environmental Health (NCEH), proposes to conduct a 2-year laboratory-
based study of human smoking behavior among established current smokers 
of the major styles and varieties of cigarettes consumed in the United 
States. This study will compare how different categories of cigarettes 
deliver toxic chemicals to smokers in order to further investigate the 
link between tobacco use and disease.
    The major objective of this study is to better understand how human 
and cigarette variables influence the delivered dose of harmful 
chemicals in smoke to identify risk factors that result in adverse 
health effects from smoking. The smoking behavior and biomarkers of 360 
smokers will be ascertained. Participants will attend two sessions on 
consecutive days. Solanesol levels in cigarette filter butts; carbon 
monoxide boost in breath; carcinogens and nicotine and its metabolites 
in urine; cotinine in saliva; vent-blocking (as measured by filter 
stain pattern and visualization of lip and finger placement on the rod 
using fluorescent markers); smoking topography; and breathing patterns 
(inhalation and exhalation volume, breath velocity and duration prior 
to smoking, during smoking and after smoking) will be used to measure 
dose based on the number of cigarettes smoked, amount of each cigarette 
smoked, filter vent blocking behavior, smoking behavior and puff 
characteristics.
    Another objective of this study is to define average or 
``composite'' smoking patterns across several of the most popular 
cigarette categories (ultralight, light, full-flavored menthol and 
full-flavored non-menthol) from the quantitative and observational 
data. All current smoking machine methodologies are ``one size fits 
all'' approaches to generating cigarette smoke. The composite 
conditions can be used to establish human behavior-based smoking 
machine methods for laboratory studies that require cigarette smoke for 
chemical or toxicological testing. Currently, laboratory scientists 
rely on automated smoking machines to generate cigarette smoke for 
chemical and toxicological testing.
    Funding for this study will come from both NCCDPHP and NCEH. The 
Centers will share responsibilities, with administrative and technical 
assistance coming from NCCDPHP and laboratory support coming from NCEH.
    This is a two-year study, and an estimated 500 respondents will be 
screened by telephone to yield 360 eligible respondents who complete 
both visits over the two-year study period. The total burden for each 
respondent who completes screening, visit 1 and visit 2 will be two 
hours and five minutes. The CATI screening will take five minutes. 
Visit 1 will take one hour, which includes a short screening item, the 
informed consent process, biologic sample collection (urine, saliva, 
and breath carbon monoxide), smoking topography, ventilation hole 
blocking procedure and breath measurements. Visit 2 will also take 
approximately one hour, which includes compensation, discussion of quit 
opportunities if requested, collection of cigarette butts, biologic 
sample collection (urine, saliva, and breath carbon monoxide), smoking 
topography, ventilation hole blocking procedure and breath 
measurements.
    The following table summarizes burden on an annualized basis for 
500 telephone interviews and 180 eligible respondents (one-half of the 
total respondents). The 180 eligible respondents estimated to complete 
visit 2 are the same respondents estimated to complete visit 1.
    There are no costs to the respondents other than their time. The 
total estimated annualized burden hours are 402.

                                        Estimated Annualized Burden Table
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                                                                                                      Average
                                                                     Number of       Number of      burden per
              Respondents                       Procedure           respondents    responses per   response  (in
                                                                                    respondent        hours)
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Smokers...............................  CATI Screening..........             500               1              42
Eligible Smokers......................  Visit 1, (Day 1)........             180               1             180
Eligible Smokers......................  Visit 2, (Day 2)........             180               1             180
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[[Page 73009]]

    Dated: December 1, 2005.
Joan Karr,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. E5-7040 Filed 12-7-05; 8:45 am]
BILLING CODE 4163-18-P