[Federal Register Volume 68, Number 9 (Tuesday, January 14, 2003)]
[Notices]
[Pages 1853-1854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-674]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day 03-35]


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 the CDC Reports 
Clearance Officer on (404) 498-1210.
    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. Send comments to Seleda Perryman , CDC 
Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D24, 
Atlanta, GA 30333. Written comments should be received within 60 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

[[Page 1854]]

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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                                                                      No. of      Average burden/
                      Forms                           No. of        responses/     response (in    Total burden
                                                    respondents     respondent        hours)         in hours
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Response to Flyer: Screening Interview Form.....             200               1               5              17
Site Visits: Check in Study Information--Visit                71               3              15              53
 1, 2, 3........................................
Consent Form Questionnaire--Visit 1, 2, 3.......              71               3              15              53
Urine Sample and Saliva Sample--Visit 1, 2, 3...              71               3              15              53
Breath Carbon monoxide (CO) Sample--Test Smoke                71               3              45             160
 1, Breath CO Sample, Breath CO Sample, Test
 Smoke 2, Breath CO Sample--Visit 1, 2, 3.......
Sample Test--Cigarettes Distribute Baggies &                  71               2              15              36
 Cigarettes--Visit 1, and 2.....................
Instructions and Check out--Visit 1 and 2.......              71               2              15              36
Smoking Cessation Advice--Visit 3 only..........              71               1              15              18
Final Check Out--Visit 3 only...................              71               1              15              18
                                                 -----------------
        Total...................................  ..............  ..............  ..............             444
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    Dated: January 8, 2003.
Thomas Bartenfeld,
Acting Associate Director for Policy, Planning, and Evaluation Centers 
for Disease Control and Prevention.
[FR Doc. 03-674 Filed 1-13-03; 8:45 am]
BILLING CODE 4163-18-P