[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