[Federal Register Volume 69, Number 22 (Tuesday, February 3, 2004)]
[Notices]
[Pages 5158-5159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-2101]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-04-24]


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-E11, 
Atlanta, GA 30333. Written comments should be received within 60 days 
of this notice.
    Proposed Project: Evaluation of a Family History Tool for Health 
Promotion and Disease Prevention--New--Office of Genomics and Disease 
Prevention (OGDP), Centers for Disease Control and Prevention (CDC).

Background

     Although family history is a risk factor for most chronic diseases 
of public health significance, it is underutilized in the practice of 
preventive medicine and public health for assessing disease risk and 
influencing early detection and prevention strategies. It has been 
known for years that people that have close relatives with certain 
diseases like, heart disease, diabetes, and cancers, are more likely to 
develop those diseases themselves. Geneticists have long recognized the 
value of family history for discovering inherited disorders, usually 
the result of single gene mutations. Although single gene disorders are 
typically associated with a large magnitude of risk, they account for a 
small proportion of individuals with a genetic risk for common, chronic 
diseases. Most of the genetic susceptibility to these disorders is the 
result of multiple genes interacting with multiple environmental 
factors. Family history is more than genetics; it reflects the 
consequences of inherited genetic susceptibilities, shared environment, 
shared cultures and common behaviors. All of these factors are 
important when estimating disease risk. In early 2002, the CDC Office 
of Genomics and Disease Prevention (OGDP) in collaboration with several 
CDC programs and NIH institutes began an initiative to develop a family 
history tool for identifying apparently healthy people who may be at 
increased risk for a number of common diseases. The major activities of 
this initiative have included: (1) Reviews of the literature for 
approximately 25 diseases; (2) assessments of family history tools 
currently in use or under development; (3) a meeting of experts to 
provide input into the process; (4) development of criteria for 
determining which diseases to include in the tool; (5) development of a 
framework for evaluating a family history tool and the development of a 
tool.
    As a result of this initiative, a PC-based familial risk assessment 
tool was developed to be used as a public health strategy to improve 
health and prevent disease. The assessment tool is called, ``Family 
Healthware.'' This tool will be used to collect information about the 
disease history of a person's first- and second-degree relatives 
(mother, father, children, siblings, grandparents, aunts, and uncles), 
use family history information to assess risk for common diseases of 
adulthood, and influence early detection and prevention strategies. The 
current version of the tool focuses on six diseases--heart disease, 
stroke, diabetes, and colorectal, breast, and ovarian cancer.
    The proposed project is a study to evaluate the clinical utility of 
the ``Family Healthware'' tool by determining whether family history 
risk assessment, stratification, and personalized prevention messages 
have any impact on health behaviors, and use of medical services. In 
2003, CDC awarded funding to three research centers to collaborate on a 
study set in primary care clinics to assess the clinical utility of the 
family history tool. The primary care clinics will be randomized into 
two groups. In group 1, patients attending the primary care clinics 
will be asked to complete the

[[Page 5159]]

family history tool and a questionnaire that includes an assessment of 
risk factors, preventive behaviors, use of medical services, and 
perception of risk. The patients will be provided with an assessment of 
their familial risk (average, above average, much above average) for 
each of the six diseases and information about preventive measures 
(e.g., diet, exercise, screening tests) that is tailored to their level 
of familial risk for each of the six diseases. After 6 months, the 
patients will be asked to complete a questionnaire that assess their 
risk factors, use of medical services, interest in modifying health 
behaviors, and changes in risk perception. In group 2, patients will 
complete the questionnaire only (not the family history tool) and will 
be given standard public health messages about preventing the six 
diseases of interest (messages will not be tailored to risk level). 
After 6 months, the patients in group 2 will also complete the same 
post intervention questionnaire and will also complete the family 
history tool.
    The purpose of having patients in group 2 complete the family 
history tool post intervention is so that the analysis can be 
stratified by familial risk level in both patient groups. The 
hypothesis to be tested in this study is that patients who are provided 
with personalized prevention messages based on an assessment of their 
family history of disease will be more motivated to make behavior 
changes and use preventive health services. There is no cost to 
respondents participating in this study.

----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
                   Respondents                       Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
 Group 1--healthy persons between the ages of 35           3,750            \1\2           45/60           5,625
 and 65.........................................
 Group 2--healthy persons between the ages of 35           3,750            \1\2           45/60           5,625
 and 65.........................................
                                                 -----------------
       Total....................................  ..............  ..............  ..............         11,250
----------------------------------------------------------------------------------------------------------------
\1\ Pre-test and post-test.


    Dated: January 26, 2004.
Alvin Hall,
 Director, Management Analysis and Services Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-2101 Filed 2-2-04; 8:45 am]
BILLING CODE 4163-18-P