E8-14154. 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 [e-mail].

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 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

Respondents	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden (in hours)
Patients with chronic hepatitis B or C virus infection	1000	1	30/60	500

Dated: June 13, 2008.

Maryam I. Daneshvar,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.