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: Hemostatic Disorders in Families—New—National Center for Infectious Diseases (NCID), Centers for Diseases Control and Prevention (CDC). Disorders of hemostasis are primarily due to alteration in the balance of the normal hemostatic mechanism, which provides for the appropriate formation and breakdown of the clot. Disruption in this balance causes bleeding disorders and thrombotic disorders, both of which are multifactorial, resulting from the interaction of genetic and environmental risk factors. Disorders that are transmitted in families, such as hemophilia and protein S deficiency, are due to specific mutations, but many different mutations are known to cause each disease. Since different mutations may cause variation in severity and clinical course of the disease, population studies capture a heterogeneous group. Modification of the primary gene defect by acquired factors and by action of other genes to produce further variability in clinical expression of the disease may be less apparent in populations. Study of family members allows for control of one significant parameter, gene defect, in order for the effects of other variables to be examined.
Diagnosis of a hemostatic disorder through measurement of coagulation factors or genetic testing is not always predictive of clinical disease, yet Start Printed Page 39569individuals given such a diagnosis may undergo prospective treatment for surgical procedures or even lifelong anticoagulation. The reasons that some individuals with a particular gene defect experience symptoms while others with the same defect do not is poorly understood. An understanding of additional risk factors involved would result in more appropriate targeting of therapy and reduce unnecessary treatment with blood products or drugs with significant side effects.
The primary objective of this study is to identify risk factors related to intra-familial differences in manifestations of hemostatic diseases, including bleeding disorders, such as von Willebrand disease and platelet storage pool disease, and thrombotic disorders, such as protein C deficiency and protein S deficiency.
This is a descriptive study of families with bleeding or thrombotic disorders. The goal is to identify families with 5-10 members affected with a bleeding or thrombotic disorder. Family members who have the same abnormal gene will be compared as to their clinical symptoms or lack thereof and differences in physiologic and genetic markers which may be related to the disorder under study. Data will be collected for at least five years for descriptive and hypothesis generating purposes.
Ten families a year will qualify for this study; up to 100 members will be enrolled. Participants will be asked to be interviewed by a trained interviewer with questions on demographics, medical history, behavioral and lifestyle factors, and family history; have 35 milliliters (about 2.5 tablespoons) of blood drawn from a vein in the arm. The blood will undergo testing of appropriate coagulation parameters and physiologic variables such as blood groups. The tests chosen will depend upon the disorder present in the family. Participants will also be asked to give study staff access to previous laboratory results collected at other institutions or at CDC, provide contact information for family members thought to have symptoms of bleeding or clotting, and allow his or her diagnosis to be disclosed to family members. There is no cost to the respondents.
|Respondents||No. of respondents||No. of responses per respondent||Average burden per response (in hours)||Total burden (in hours)|
Thomas A. Bartenfeld,
Acting Associate Director for Policy, Planning and Evaluation, Centers for Disease Control and Prevention.
[FR Doc. 03-16676 Filed 7-1-03; 8:45 am]
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