[Federal Register: November 8, 2002 (Volume 67, Number 217)]
[Notices]
[Page 68136-68137]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08no02-90]
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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)
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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