[Federal Register Volume 68, Number 127 (Wednesday, July 2, 2003)]
[Notices]
[Pages 39568-39569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-16676]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60 Day-03-88]


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: 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

[[Page 39569]]

individuals 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.

----------------------------------------------------------------------------------------------------------------
                                                                           No. of        Average
                                                             No. of       responses    burden per   Total burden
                       Respondents                         respondents       per        response     (in hours)
                                                                         respondent    (in hours)
----------------------------------------------------------------------------------------------------------------
Male....................................................           50             2         30/60            50
Female..................................................           50             2         30/60            50
      Total.............................................  ............  ............  ............          100
----------------------------------------------------------------------------------------------------------------


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]
BILLING CODE 4163-18-P