[Federal Register Volume 69, Number 50 (Monday, March 15, 2004)]
[Notices]
[Pages 12156-12157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-5738]


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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
                                                 -----------------
    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