2010-21723. 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 [phone] or send an e-mail to [e-mail]. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to [phone]. Written comments should be received within 30 days of this notice.

Proposed Project

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

Background and Brief Description

Cigarettes have been ranked as full-flavor, light or ultralight on the basis of machine-measured levels of smoke toxins (yield categories). The machine-based methods approximate human smoking patterns under controlled conditions but may not accurately reflect conditions of actual use, moreover, public health data have not consistently shown differences in health outcomes among smokers of cigarettes of different machine-smoked yield categories.

In 2007, the Centers for Disease Control and Prevention (CDC) received OMB approval for a research study designed to elucidate patterns of human smoking behavior, quantify biomarkers of exposure to smoke toxins under conditions of actual use, and assess how smoking behavior modifies the relationship between cigarette yield category, biomarkers of exposure, and measures of cardiovascular reactivity (OMB No. 0920-0736, exp. 3/31/2010). The study was initiated collaboratively by the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) and the National Center for Environmental Health (NCEH). Information was collected from adult smokers of full-flavor, light and ultralight cigarettes, however, the target number of respondents was not achieved during the initial project period.

CDC requests OMB approval to reinstate the information collection in order to meet recruitment goals and complete the data analysis as planned. Changes include a reduction in the number of respondents and a corresponding reduction in the total estimated burden hours. In addition, minor changes will be made to account for changes in cigarette labels, which no longer use descriptors such as full-flavor, light or ultralight. There are no changes to the data collection instruments or the estimated burden per response.

Respondents will be asked to participate in a descriptive study of smoking behavior that involves two laboratory visits. Established smokers who are interested in participating will be screened for eligibility during a brief five-minute computer-assisted telephone interview (CATI). We estimate screening approximately 150 individuals annually to yield complete data collection on the annualized goal of 61 respondents. After completing the CATI, individuals who express continued interest in study participation will undergo five additional minutes of eligibility screening at the first laboratory visit.

Each respondent who enrolls in the study will make two one-hour visits to an assessment laboratory. The visits will occur on two consecutive days: Visit 1 will be scheduled in the morning of the first day, and Visit 2 will be scheduled in the afternoon of the second day. Samples, measurements, and behavioral information will be collected at each visit. Visit 1 will include biologic sample collection (urine, saliva, breath carbon monoxide), smoking behavior of smoking one cigarette, ventilation hole blocking procedure and breath measurements. Visit 2 will include discussion of quit opportunities if requested, biologic sample collection (urine, saliva, breath carbon monoxide), smoking behavior of smoking one cigarette, ventilation hole blocking procedure and breath measurements. In addition, at Visit 2, each respondent will submit the cigarette butts of all cigarettes smoked since Visit 1 and a completed Smoking Diary Form. The estimated burden for the Smoking Diary Form is ten minutes.

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.

OMB approval is requested for two years. Participation in the study is voluntary. There are no costs to respondents other than their time. The total estimated burden hours are 151.

Estimated Annualized Burden Hours

Type of respondent	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
Adult Smokers	CATI Screener	150	1	5/60
	Visit 1 Screener	70	1	5/60
	Smoking Diary	61	1	10/60
	Laboratory Visit	61	2	1

Dated: August 23, 2010.

Maryam I. Daneshvar,

Reports Clearance Officer, Centers for Disease Control and Prevention.