05-2487. Proposed Data Collections Submitted for Public Comment and Recommendations

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-371-5976 or send comments to Sandi Gambescia, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to [e-mail].

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice.

Proposed Project

Human Smoking Behavior Study—New—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background

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 study to better understand patterns of human smoking behavior across several of the most popular cigarette categories (ultralight, light, full flavored menthol and full-flavored non-menthol) and to determine the level of exposure to smoke toxins delivered by these cigarette categories. This is important because the current method of measuring constituents that smoke is via the Federal Trade Commission's machine smoking method, which does not accurately reflect human smoking patterns. Although there is ample evidence of the inadequacies and biases inherent in machine-smoking protocols, they serve the purpose of ranking cigarettes smoked under standardized conditions. Comparison of cigarette smoke emissions using machine-smoking methods will persevere until something superior is developed. Therefore, machine-smoking must be adequately informed to yield results that better reflect human smoking behavior. 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 laboratory-based descriptive study of smoking behavior and analysis of biomarkers of exposure for current adult smokers of a range of cigarette categories that are representative of the most commonly smoked U.S. cigarettes. The goals of this project are to characterize the range of human smoking behavior for a variety of cigarette categories and machine-smoked yields, and to estimate the levels of biomarkers of exposure with the various cigarette styles. This study will assess known indicators of smoking behavior (ventilation pore-blocking behavior, puff volume, puff duration, puff velocity and inter-puff interval) to determine typical patterns of smoking behavior.

Measures of exposure will include expired-air carbon monoxide boost, assessment of carcinogens, nicotine and its metabolites in urine, cotinine in saliva and solanesol in cigarette butts as an indicator of total smoke exposure. There are no direct respondent costs associated with the information collection for the study. The smoking behavior and biomarkers of 360 smokers will be ascertained.

Annualized Burden

Respondents	No. of respondents	No. of responses per respondent	Average burden per response (in hours)	Total burden (in hours)
Screening	500	1	6/60	50
Clinic Visit 1	360	1	1.1	198
Clinic Visit 2	360	1	1.0	180
Total				428

Dated: February 1, 2005.

Betsey Dunaway,

Acting Reports Clearance Officer, Office of the Chief Science Officer, Centers for Disease Control and Prevention.