[Federal Register Volume 81, Number 9 (Thursday, January 14, 2016)]
[Notices]
[Pages 1951-1952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00561]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-16-15ARG]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted
the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (a)
Evaluate whether the proposed collection of information is necessary
for the proper performance of the functions of the agency, including
whether the information will have practical utility; (b) Evaluate the
accuracy of the agencies estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (c) Enhance the quality, utility, and clarity of
the information to be collected; (d) Minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to [email protected]. Direct written comments
and/or suggestions regarding the items contained in this notice to the
Attention: CDC Desk Officer, Office of Management and Budget,
Washington, DC 20503 or by fax to (202) 395-5806. Written comments
should be received within 30 days of this notice.
Proposed Project
Prevent Hepatitis Transmission among Persons Who Inject Drugs--
New--National Center for HIV/AIDS, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Hepatitis C virus (HCV) infection is the most common chronic blood
borne infection in the United States; approximately three million
persons are chronically infected. Identifying and reaching persons at
risk for HCV infection is critical to prevent transmission and treat
and cure if infected. CDC monitors the national incidence of acute
hepatitis C through passive surveillance of acute, symptomatic cases of
laboratory confirmed hepatitis C cases. Since 2006, surveillance data
have shown a trend toward reemergence of HCV infection mainly among
young persons who inject drugs (PWID) in nonurban counties. Of the
cases reported in 2013 with information on risk factors 62% indicated
injection drug use as the primary risk for acute hepatitis C. The
prevention of HCV infection among PWIDs requires an integrated approach
including harm reduction interventions, substance abuse treatment, and
prevention of other blood borne infections, and care and treatment of
HCV infection.
The purpose of the proposed study is to address the high prevalence
of HCV infection by developing and implementing an integrated approach
for detection, prevention, care and treatment of infection among
persons aged 18-30 years who reside in non-urban counties. Awardees
will develop and implement a comprehensive strategy to enroll young
non-urban PWID, collect epidemiological information, test for viral
hepatitis and HIV infection and provide linkage to primary care
services, prevention interventions, and treatment for substance abuse
and HCV infection. In addition to providing HCV testing, participants
will be offered testing for the presence of co-infections with
hepatitis B virus (HBV) and HIV. Adherence to prevention services and
retention in care will be assessed through follow up interviews.
Furthermore, re-infection with HCV will be evaluated through follow-up
blood tests.
The project will recruit an estimated total of 995 young PWIDs to
enroll 895 PWIDs. The participants will be recruited from settings
where young PWIDs obtain access to care and treatment services.
Recruitment will be direct and in-person by partnering with local harm
reduction sites. Recruiters will enroll subjects across recruitment
sites primarily through drug treatment programs and syringe exchange
programs, as well as persons referred to these sites as a result of
referral from other programs and respondent driven sampling. Those who
consent to participate will be administered an eligibility interview
questionnaire by trained field staff. If found eligible, the
participant will take an interviewer-administered survey that includes
information on initiation of drug use, injection practices, HCV, HBV
and HIV infection status, access to prevention and medical care, desire
to receive and barriers to receiving HCV treatment, and missed
opportunities for hepatitis prevention. Participants will receive
counselling regarding adherence to medical and/or drug treatment
services and prevention services. Participants will be interviewed for
a maximum of 5 times within any 12-month interval during the course of
the study: consent and interview at enrollment/baseline for an
estimated 60 minutes, and 30-minute follow-up interviews every 3 months
thereafter. Participants will be interviewed throughout the study
during the 3-year project. However, most of the recruitment will be
spread over first two years to allow for one year follow up period of
the later recruits.
Participation in interviews and responses to all study questions
are totally voluntary and there is no cost to respondents other than
their time. The annualized burden to participants is 974 hours.
[[Page 1952]]
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
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Young PWIDs........................... Screener................ 332 1 10/60
Eligible young PWIDs.................. Initial Survey.......... 298 1 60/60
Eligible young PWIDs.................. Follow-up survey........ 298 4 30/60
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Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2016-00561 Filed 1-13-16; 8:45 am]
BILLING CODE 4163-18-P