02-28454. 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 [phone].

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.

Respondents	Number of respondents	Number of responses/respondents	Average burden/response (in hours)	Total burden (in hours)
Cases	500	1	1	500
Controls	1,000	1	1	1,000
Total				1,500

Dated: October 30, 2002.

Kathy Cahill,

Associate Director for Policy, Planning and Evaluation, Centers for Disease Control and Prevention.