[Federal Register: March 15, 2004 (Volume 69, Number 50)]
[Notices]
[Page 12156-12157]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15mr04-64]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-04-34]
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: Understanding Family-based Detection as a
Strategy for Early Diagnosis of Hemochromotosis--New--National Center
for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers
for Disease Control and Prevention (CDC).
Hemochromatosis is a disease that occurs as a result of excess iron
accumulation in the tissues and organs. The majority of hemochromatosis
cases are due to HFE gene mutations. Early hemochromatosis symptoms are
nonspecific and are often overlooked by physicians or mistaken for
other conditions. Fortunately, hemochromatosis can be detected with
simple blood tests. When treatment by therapeutic phlebotomy is
instituted early in the course of the disease, the many severe
complications associated with hemochromatosis (e.g., cirrhosis of the
liver, liver cancer, cardiomyopathy, and heart failure) can be
effectively prevented.
Hemochromatosis is a genetic disease, and blood relatives of
hemochromatosis patients are at increased risk. The public health
strategy for early detection of hereditary hemochromatosis is making
patient family members aware of their increased risk and encouraging
them to seek voluntary diagnostic testing (``family-based detection'').
CDC wants to evaluate family-based detection as a strategy to identify
people with hemochromatosis. The proposed research project will examine
the effectiveness of and barriers to the use of family-based detection
as a public health strategy to reduce morbidity and mortality from
genetic diseases, and in particular, hemochromatosis.
To understand the effectiveness of family-based detection for
hemochromatosis the following will be evaluated:
Barriers and motivators to family-based
detection as a strategy for early diagnosis of hemochromatosis. (Early
detection facilitates early treatment to slow the course of disease.)
How physicians communicate with patients about
the importance of family-based detection and the need for patients to
encourage biological siblings to seek testing.
Factors that foster good communication among
biological siblings about the importance of seeking medical testing by
those at increased risk of hemochromatosis.
Factors that affect the willingness of
biological siblings to take action to seek out and receive testing for
hemochromatosis.
Information and key messages that motivate
patients to advise their biological siblings about their increased risk
for hemochromatosis and need for diagnostic testing.
How physicians use medical histories to identify
people who should be tested because they have a relative with
hemochromatosis.
The proposed research to be undertaken by CDC will incorporate
several types of qualitative data collection: structured one-on-one
interviews, triads (small focus groups) and traditional focus groups.
Subjects will include hemochromatosis patients, biological siblings of
patients, and physicians. Topics to be explored with each of the three
subject groups include the knowledge, attitudes, perceptions, and
behaviors related to family-based detection.
Patients will be recruited in Boston and Chicago from the following
places (where hemochromatosis patients often undergo treatment by
therapeutic phlebotomy):
Blood banks
Hospital laboratories
Other health care provider facilities
Siblings will be recruited either through the patients or by self-
referral. Health care providers will be recruited through publicly
available lists of physicians, or recommendations from project staff,
patients, biological siblings, blood banks, hospital laboratories,
hemochromatosis organizations, and health care providers knowledgeable
about hemochromatosis. Information about the study will be available on
the CDC Web site. Hemochromatosis organizations will be invited to
notify their members about this research. There are no costs to
respondents.
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Average
Number of Number of response per Total burden
Respondents respondents responses per respondent (in hours)
respondent (in hours)
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Individual Interviews with Patients and Siblings 15 1 2 30
Individual Interviews with Health Care Providers 18 1 2 36
Triads.......................................... 30 1 2 60
Focus Groups.................................... 80 1 2 160
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Total....................................... .............. .............. .............. 286
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[[Page 12157]]
Dated: March 8, 2004.
Alvin Hall,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 04-5738 Filed 3-12-04; 8:45 am]
BILLING CODE 4163-18-P