[Federal Register: August 2, 2007 (Volume 72, Number 148)]
[Notices]
[Page 42413-42414]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02au07-95]
-----------------------------------------------------------------------
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 omb@cdc.gov.
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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