[Federal Register Volume 68, Number 169 (Tuesday, September 2, 2003)]
[Notices]
[Pages 52213-52214]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-22255]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-68-03]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    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) 498-1210. Send written 
comments to CDC, Desk Officer, Human Resources and Housing Branch, New 
Executive Office Building, Room 10235, Washington, DC 20503 or by fax 
to (202) 395-6974. Written comments should be received within 30 days 
of this notice.

Proposed Project

    Menthol Crossover Study--New--National Center for Environmental 
Health (NCEH), Centers for Disease Control and Prevention (CDC). CDC 
proposes a study to measure differences in African-American and 
Caucasian smokers in the dose and metabolism of chemicals in smoke from 
menthol and non-menthol cigarettes.
    African-American smokers are more likely than Caucasian smokers to 
develop some forms of cancer and to have shorter long-term survival 
after diagnosis. More than 65% of African American smokers smoke 
menthol cigarettes, compared with about 23% of white smokers. Smoking 
menthol cigarettes has been associated with higher blood-cotinine 
levels. Cotinine is a product of the metabolism of nicotine, and the 
higher cotinine levels suggest that menthol may enable a smoker to 
obtain more nicotine from each cigarette. In addition, people who smoke 
menthol cigarettes also have higher levels of carbon monoxide in their 
breath than do people who smoke non-menthol cigarettes, and an elevated 
carbon monoxide level is a risk factor for cardiovascular disease. 
Additionally, the presence of menthol in cigarettes may change the way 
people smoke cigarettes.
    All previous studies have compared people who smoke menthol 
cigarettes with those who smoke non-menthol cigarettes; and it is not 
known whether increased cotinine and carbon monoxide levels in people 
who smoke menthol cigarettes are attributable to racial or ethnic 
differences, or a combination of multiple factors. In addition, no 
previous study has examined the differences between urinary levels of 
cancer-causing chemicals in people who smoke menthol or non-menthol 
cigarettes and correlated these findings with smoke exposure intake 
estimates using salivary cotinine and filter solanesol.
    For this two-part crossover study, we will recruit African-American 
and Caucasian smokers of both sexes who smoke either menthol or non-
menthol cigarettes as study subjects. We will determine smoking history 
then randomly assign each participant to smoking either menthol or non-
menthol cigarettes for an initial 2-week period. Study participants 
then will switch to the opposite type of cigarette for the next 2 
weeks. At baseline, and after each 2-week period, we will measure the 
way the participants smoke the test cigarettes to determine smoking 
topography. Saliva, urine, and breath samples will be collected to 
measure by-products of smoking, and participants will complete a brief 
smoking-history questionnaire. There is no cost to respondents.

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                                                                                            Average
                                                                No. of         No. of       burden/      Total
                           Forms                              respondents    responses/    response    burden in
                                                                             respondent   (in hours)     hours
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Response to Flyer: Screening Interview Form...............             200             1        5/60          17
Site Visits: Check in, Study Information, Visit 1, 2, 3...              71             3       15/60          53
Consent Form, Questionnaire, Visit 1, 2, 3................              71             3       15/60          53
Urine Sample and Saliva Sample, Visit 1, 2, 3.............              71             3       15/60          53
Breath Carbon monoxide (CO) Sample: Test Smoke 1, Breath                71             3       45/60         160
 CO Sample; Test Smoke 2, Breath CO Sample; Visit 1, 2, 3.
Sample Test Cigarettes, Distribute Baggies & Cigarettes,                71             2       15/60          36
 Visit 1 and 2............................................
Instructions and Check out, Visit 1 and 2.................              71             2       15/60          36
Smoking Cessation Advice, Visit 3 only....................              71             1       15/60          18

[[Page 52214]]

 
Final Check Out, Visit 3 only.............................              71             1          15          18
                                                           -----------------
      Total...............................................  ..............  ............  ..........         444
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    Dated: August 25, 2003.
Nancy E. Cheal,
Acting Associate Director for Policy, Planning, and Evaluation, Centers 
for Disease Control and Prevention.
[FR Doc. 03-22255 Filed 8-29-03; 8:45 am]
BILLING CODE 4163-18-P