[Federal Register Volume 72, Number 148 (Thursday, August 2, 2007)]
[Notices]
[Pages 42413-42414]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15020]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day-07-07BN]


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

    Pilot Project to Estimate the Incidence of Hepatitis C Virus (HCV) 
Infection Among Young Injection Drug Users (IDUs) Using Serial Cross-
Sectional Seroprevalence Surveys--New--National Center for HIV, 
Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    Hepatitis C is the most prevalent bloodborne infection in the 
United States; approximately 3.2 million persons are chronically 
infected with HCV. National recommendations for prevention and control 
of HCV infection emphasize primary prevention activities to reduce the 
risk of HCV transmission. Identifying and reaching persons at risk for 
HCV infection to provide risk-reduction counseling is thus critical to 
prevent infection. Currently the Centers for Disease Control and 
Prevention (CDC) monitors the national incidence of acute hepatitis C 
through passive surveillance of acute, symptomatic cases of laboratory 
confirmed hepatitis C. However, only a minority of people with acute 
infection have symptoms at all (<25%) and passive surveillance only 
captures a small fraction of acutely infected people, i.e., those who 
have symptoms and receive medical attention and appropriate laboratory 
testing during the acute phase of the disease. Injection drug users 
(IDUs), who are the primary risk group for acute hepatitis C (70% of 
identified acute cases), have additional barriers to health care access 
and/or utilization resulting in the potential for a further 
underestimation of overall incidence. Thus, it is necessary to consider 
strategies other than passive surveillance for incidence monitoring. 
One such strategy is to conduct Serial Cross-Sectional Seroprevalence 
Surveys (SCSS) among populations at increased risk of infection such as 
IDUs.
    For the proposed pilot project, funding will be awarded to selected 
U.S. sites that will develop and test different methods to recruit a 
sample of young IDUs that is most representative of the population of 
young IDUs at risk for HCV infection. These sampling methods will be 
compared and contrasted to identify a methodology to be used in ongoing 
SCSSs among young IDUs. Better methods of identification of persons at 
risk will enhance current surveillance efforts to monitor the incidence 
of HCV infection which in turn are the best means to direct and assess 
primary prevention strategies, determine new transmission patterns, and 
identify and control outbreaks. Moreover, methods developed in this 
study can be used in other areas to gather representative data on 
incidence of acute disease and the burden of disease caused by HCV 
infection.
    In addition, instruments for collecting behavioral/risk factor data 
from IDUs will be developed and pilot tested. It is estimated that data 
will be collected over 15 months from a total of 2000

[[Page 42414]]

respondents. The total annual burden for this project is expected to be 
1600 hours. The information to be collected includes demographic data, 
risk factors for HCV infection, missed opportunities for prevention 
(including hepatitis A and B vaccination), access to medical care, and 
knowledge, attitudes, and beliefs about HCV infection. The utility of 
using HCV nucleic acid testing (NAT), antigen-antibody testing and 
other testing modalities to identify sero-incident (window period) 
infections will also be assessed. Knowledge of factors associated with 
acquiring hepatitis C virus infection is essential to guide the 
development of prevention and control strategies.
    Participation in the data collection is voluntary and there is no 
cost to respondents to participate in the survey 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)
----------------------------------------------------------------------------------------------------------------
Young injection drug users..................            1600                1                1             1600
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    Dated: July 27, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. E7-15020 Filed 8-1-07; 8:45 am]
BILLING CODE 4163-18-P