[Federal Register Volume 67, Number 217 (Friday, November 8, 2002)]
[Notices]
[Pages 68136-68137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-28454]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60 Day-03-11]


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: Case-Control Study of Environmental Exposures and 
Genetic Susceptibility in Individuals with Multiple Sclerosis in Three 
Geographic Areas--New--The Agency for Toxic Substances and Disease 
Registry (ATSDR) is mandated pursuant to the 1980 Comprehensive 
Environmental Response, Compensation, and Liability Act (CERCLA) and 
its 1986 Amendments, the Superfund Amendments and Re-authorization Act 
(SARA), to serve the public by using the best science, taking 
responsive public health actions, and providing trusted health 
information to prevent harmful exposures and disease related to toxic 
substances. This legislation was, in part, in response to the lack of 
scientific information about potential adverse health effects resulting 
from exposure of a general population to hazardous substances.
    Citizens across the nation living near hazardous waste sites have 
expressed concern about a perceived increase of multiple sclerosis (MS) 
in their communities and many believe this occurrence is directly 
linked to exposure to hazardous substances. Evidence indicates that 
multiple sclerosis is a complex disease with a multifactorial etiology 
determined by both environmental factors and genetic susceptibility. 
Although the specific biological mechanism of MS is unknown, one 
possibility is that an environmental exposure triggers an inappropriate 
type of immune response where the T-lymphocytes become sensitized to 
myelin which slows or blocks signals transmitted to the central nervous 
system. Unfortunately, basic epidemiologic data does not exist 
regarding the number of people affected with this disease, but 
estimates range from 250,000 to 400,000 people in the Unites States. MS 
differentially affects women, people in the 30 to 60 year-old age 
group, and Caucasians.
    Recently, ATSDR collaborated with researchers from the Texas 
Department of Health, the Ohio Department of Health, and the Jackson 
County Missouri Health Department to conduct a prevalence study in 
order to respond to community concerns of multiple sclerosis and 
possible associations with hazardous waste sites. This research was 
conducted to establish methodologies for estimating MS prevalence and 
to determine the prevalence rates for this disease in three geographic 
areas near source(s) of hazardous waste: Lorain County, Ohio; the 
cities of Independence and Sugar Creek, Missouri; and a 19-county area 
surrounding Lubbock, Texas. Medical records of individuals from 
neurologists' offices were used to ascertain cases and a consulting 
neurologist for each geographic area reviewed the clinical and 
laboratory data available in the patient's medical record to verify 
diagnosis. No patients were contacted in this study.
    ATSDR is currently proposing a case-control study that will examine 
specific environmental exposures that affect the immune system as well 
as specific genes that are associated with an immune response. Cases 
will include individuals who have been diagnosed with MS and were 
identified through the prevalence study conducted in Ohio, Missouri and 
Texas. Controls will be selected from patients who attended the same 
neurologists' office from which the cases arose and who meet 
eligibility requirements. Study participants will be asked to complete 
a questionnaire to ascertain exposure to heavy metals and other toxic 
chemicals either through occupational exposures, hobbies or lifestyle 
activities, or due to residential proximity to industry or hazardous 
waste sites. Participants will also be asked to provide a blood sample 
to test for exposure to possible infectious agents and to evaluate 
specific candidate genes as potential risk factors of disease.
    To reduce the amount of time required by the respondents, Computer 
Assisted Telephone Interviews (CATI) will be conducted. Following 
completion of all respondent interviews, the data will be tabulated and 
analyzed, comparing high versus low exposed participants. The 
information collected in this proposed study will provide information 
on the potential role of environmental exposures and genetic factors in 
the development of multiple sclerosis.
    There is no cost to respondents other than their time to 
participate in the study.

[[Page 68137]]



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                                                                     Number of    Average burden/
                   Respondents                       Number of      responses/     response  (in   Total burden
                                                    respondents     respondents       hours)        (in hours)
----------------------------------------------------------------------------------------------------------------
Cases...........................................             500               1               1             500
Controls........................................           1,000               1               1           1,000
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    Dated: October 30, 2002.
Kathy Cahill,
Associate Director for Policy, Planning and Evaluation, Centers for 
Disease Control and Prevention.
[FR Doc. 02-28454 Filed 11-7-02; 8:45 am]
BILLING CODE 4163-18-P