Agency Forms Undergoing Paperwork Reduction Act Review

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

omb@cdc.gov.

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.

Estimated Annualized Burden Hours

Type of respondent

Form name

Number of

respondents

Number

responses/

respondent

Average

burden per

response

(in 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 Assent

167

1

30/60

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