[Federal Register: July 26, 2004 (Volume 69, Number 142)]
[Notices]
[Page 44536-44537]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jy04-55]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-04-CC]
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 this request, call the
CDC Reports Clearance Officer at (404) 498-1210 or send an e-mail to
omb@cdc.gov. Send written comments to CDC Desk Officer, Human Resources
and Housing Branch, New Executive Office Building, Room 10235,
Washington, DC 20503 or by fax to (202) 395-6974. Written comments
should be received within 30 days of this notice.
Proposed Project
Understanding Family-based Detection as a Strategy for Early
Diagnosis of Hemochromatosis--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
[[Page 44537]]
organizations will be invited to notify their members about this
research. There are no costs to respondents. Of the 250 individuals
screened through a telephone interview, 15 will be selected for
individual interviews, 30 will be selected for triads and 80 will be
selected for participation in focus groups. The estimated annualized
burden is 311 hours.
Annualized Burden Table:
----------------------------------------------------------------------------------------------------------------
Number of Average
Respondents Number of responses per response per
respondents respondent respondent
----------------------------------------------------------------------------------------------------------------
Telephone call screener......................................... 250 1 6/60
Individual interviews (Physicians).............................. 18 1 2
Individual interviews (Patients and siblings)................... 15 1 \1\ 2
Triads.......................................................... 30 1 \2\ 2
Focus Groups.................................................... 80 1 \3\ 2
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\1\ Includes interview and exit survey.
\2\ Includes triad and exit survey.
\3\ Includes focus group and exit survey.
Dated: July 19, 2004.
Alvin Hall,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 04-16910 Filed 7-23-04; 8:45 am]
BILLING CODE 4163-18-P