[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]


=======================================================================
-----------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of        Number        burden per
          Type of respondent                    Form name           respondents     responses/     response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------


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