[Federal Register Volume 75, Number 168 (Tuesday, August 31, 2010)]
[Notices]
[Pages 53311-53312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21723]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30-Day-10-0736]


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) 639-5960 or send an e-mail 
to <a href="/cdn-cgi/l/email-protection#e18e8c83a1828582cf868e97"><span class="__cf_email__" data-cfemail="3e51535c7e5d5a5d10595148">[email protected]</span></a>. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC or by fax to (202) 395-5806. 
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

[[Page 53312]]

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
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondent                    Form name            Number of     responses per   per response
                                                                    respondents     respondent      (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
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    Dated: August 23, 2010.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2010-21723 Filed 8-30-10; 8:45 am]
BILLING CODE 4163-18-P


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