E6-18825. Agency Forms Undergoing Paperwork Reduction Act Review

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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 Hours

Respondents	Procedure	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
Smokers	CATI Screening	500	1	5/60
Eligible Smokers	Visit 1 (Day 1)	180	1	1
Eligible Smokers	Visit 2 (Day 2)	180	1	1

Dated: November 1, 2006.

Catina J. Conner,

Acting Assistant Reports Clearance Officer, Centers for Disease Control and Prevention.