[Federal Register Volume 69, Number 142 (Monday, July 26, 2004)]
[Notices]
[Pages 44536-44537]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16910]


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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 
[email protected]. 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:

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                                                                                     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