[Federal Register Volume 81, Number 214 (Friday, November 4, 2016)]
[Notices]
[Pages 76944-76945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26667]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-16-16JD]
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]. Written comments and/or
suggestions regarding the items contained in this notice should be
directed 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
Cohort Study of HIV, STIs and Preventive Interventions among Young
MSM in Thailand--New--National Center for HIV/AIDS, Viral Hepatitis,
STD, and TB Prevention (NCHHSTP), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
CDC requests OMB approval for a new three-year information
collection.
In Thailand, there is a very high HIV incidence in men who have sex
with men (MSM) and transgender women (TGW). It is estimated that over
50% of all new HIV infections are occurring in MSM and TGW. At Silom
Community Clinic @Tropical Medicine (SCC @TropMed), there is a reported
average HIV prevalence of 28% and HIV incidence of 8 per 100 person-
years in young men (YMSM).
Areas with gaps of understanding regarding the HIV epidemic in
Thailand, as well as globally, are the epidemiology, risk factors, and
HIV beliefs and knowledge of gay identified and transgender youth. In
2013, the Joint United Nations Programme on HIV and AIDS reported that
95% of new HIV infections were in low- and middle-income countries,
where more than one third of new infections were among young people
(<18 years) who were unaware of their HIV status. Adolescents living
with HIV are more likely to die from AIDS, and there is little tracking
of the HIV epidemic and outcomes in adolescents.
We propose a study of males aged 15-29 years at risk for HIV. This
study includes a longitudinal assessment (cohort) to assess HIV and
sexually transmitted infection incidence and prevalence. This study
will also generate critical data on HIV and STD incidence and
prevalence in young men and adolescent males.
This is the first study of its kind in Bangkok to collect data on
HIV and STI incidence, access to HIV prevention, and attitudes about
HIV prevention in adolescents ages 15-17 years. In addition to the
cohort activities in which young persons are followed over three years,
this study will collect needed qualitative data in the form of focus
group discussions (FGD), and key informant interviews (KII) from teens
and those that serve these teens in the community on HIV prevention,
access to testing, pre-exposure prophylaxis or PrEP and other issues
relevant to HIV prevention. The qualitative component will assess
adolescent and key leaders' HIV prevention knowledge and practices.
This study is a five-year study in total, with active follow-up over
three years, and a two-year enrollment period.
A study of young men at risk in Thailand is urgently needed to
provide necessary data to assess and implement prevention strategies
and inform policies for HIV prevention in Thailand, as well as
globally. There is no cost to participants other than their time.
The total estimated annualized burden hours are 814.
[[Page 76945]]
Estimated Annualized Burden Hours
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Average
Number of Number burden per
Type of respondent Form name respondents responses/ response (in
respondent hours)
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Community members..................... FGD Consent Assent...... 10 1 30/60
FGD..................... 10 1 2
KII Consent Assent...... 4 1 30/60
KII..................... 4 1 2
Screening checklist..... 300 1 15/60
Potential Participant................. Screening consent Assent 300 1 30/60
Potential Participant................. Screening CASI.......... 300 1 15/60
HIV-positive at screening............. HIV CASI................ 60 1 2/60
Participants.......................... Enrollment Consent 167 1 30/60
Assent.
Participants.......................... Follow-up CASI.......... 167 4 15/60
Participants.......................... YMSM Clinical Form...... 167 4 20/60
HIV-positive Participants............. HIV CASI Cohort......... 46 4 1/60
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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. 2016-26667 Filed 11-3-16; 8:45 am]
BILLING CODE 4163-18-P