[Federal Register Volume 73, Number 121 (Monday, June 23, 2008)]
[Notices]
[Pages 35392-35393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-14154]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-08-08BE]


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 404-639-5960 
and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance 
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail 
to [email protected].
    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. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Chronic Hepatitis Cohort Study (CHeCS)--New--National Center for 
HIV, Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    Approximately 3.2 million Americans are chronically infected with 
hepatitis C virus and 1.25 million Americans are

[[Page 35393]]

chronically infected with hepatitis B virus. Each year, there are 
approximately 8,000-10,000 hepatitis C virus infection related deaths 
and 3,000-5,000 hepatitis B virus infection related deaths.
    Current surveillance activities are not designed to monitor long-
term outcomes and merely report diagnosed cases of hepatitis B and 
hepatitis C virus infections. In order to investigate long-term effects 
of new therapies for chronic viral hepatitis B and C infections, we 
need longitudinal observational cohorts of persons chronically infected 
with hepatitis B and/or C virus. Information from longitudinal cohorts 
of patients with chronic hepatitis B and C virus infection will provide 
an understanding of the spectrum and natural history and, the public 
health impact of chronic hepatitis disease.
    The proposed project will establish a longitudinal observational 
cohort of patients with chronic viral hepatitis in one or more clinical 
centers. A patient behavior questionnaire will be included with the 
clinical information that physicians routinely collect when evaluating 
and examining a patient (i.e. during physician-patient interactions). 
The information linking behaviors with the clinical information from 
this longitudinal study will enable better care and management of 
persons with chronic hepatitis B and C virus infections and reduce 
hepatitis-related mortality.
    The total annual burden for this project is expected to be 500 
hours. The information to be collected in the patient behavior 
questionnaire includes demographic data, alcohol or drug use, access to 
care, quality of life, and adherence to prescribed therapy, which is 
essential in order to be able to correctly interpret clinical outcomes 
data. These data will be used to describe the spectrum and natural 
history of disease associated with chronic hepatitis B and C virus 
infection, to determine the extent of health burden and mortality 
related to chronic viral hepatitis, describe the characteristics of 
persons in care for chronic viral hepatitis infection, describe access 
to and effectiveness of recommended preventive and therapeutic 
interventions, and evaluate ongoing risk behaviors and their impact on 
health outcomes.
    Participation in this data collection is voluntary and there is no 
cost to respondents other than their time.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
                   Respondents                       Number of     responses per   per  response   Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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Patients with chronic hepatitis B or C virus                1000               1           30/60             500
 infection......................................
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    Dated: June 13, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
 [FR Doc. E8-14154 Filed 6-20-08; 8:45 am]
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