[Federal Register Volume 70, Number 47 (Friday, March 11, 2005)]
[Notices]
[Pages 12219-12220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-4803]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-05-0424X]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
the CDC Reports Clearance Officer at (404) 371-5976 or send an e-mail 
to [email protected]. Send written comments to CDC Desk Officer, Human 
Resources and Housing Branch by fax to (202) 395-6974. Written comments 
should be received within 30 days of this notice.

Proposed Project

    Evaluating Tools 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 who have close relatives with certain 
diseases (such as 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 personal computer-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 cancers.
    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. Eligibility for the study will be determined by a 
brief screening test completed by patients from the primary care 
clinic. It is anticipated that only a small number will be ineligible 
to continue since the majority of patients will be pre-screened for 
eligibility based on a medical record review prior to the screening 
test.
    The primary care clinics affiliated with the three research centers 
will be randomized into two groups. Patients participating in the study 
will all complete the pre-test, post-test and family history tool, 
however, the order in which they do so is dependent upon the group to 
which they are randomized. In the intervention group, patients 
attending the primary care clinics will be asked to complete the family 
history tool and a pre-test 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 post-test that assesses their risk factors, use of 
medical services, interest in modifying health behaviors, and changes 
in risk perception. In the control group, patients will initially 
complete the pre-test 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 the control group will also complete the post-
test and the family history tool. Physicians will complete a post-visit 
assessment if they have a visit with a participating patient during the 
course of the study.
    The purpose of having patients in the control group 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

[[Page 12220]]

study other than their time. The estimated annualized burden is 5,922 
hours.

                                             Annualized Burden Table
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                                                                                                   Average time
          Type of respondents              Number of        Type of response       Frequency of    per response
                                          respondents                                response        (in hrs)
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Patients..............................            4180  Screening...............               1            2/60
                                        ..............  Questionnaire (pre-test                2           30/60
                                                         and post-test).
                                        ..............  Family HealthwareTM Tool               1           20/60
Physicians............................             140  Post Visit Assessment...              30            3/60
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    Dated: March 7, 2005.
Betsey Dunaway,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. 05-4803 Filed 3-10-05; 8:45 am]
BILLING CODE 4163-18-P