[Federal Register: December 8, 2005 (Volume 70, Number 235)]
[Notices]
[Page 73008-73009]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08de05-66]
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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 omb@cdc.gov. 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