81 FR 1952 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 81, Issue 9 (January 14, 2016)

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed information collection entitled ``Young Men who have Sex with Men (YMSM) Study Thailand''. CDC is requesting a three-year approval for this new project.

[Federal Register Volume 81, Number 9 (Thursday, January 14, 2016)]
[Notices]
[Pages 1952-1953]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-00564]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-16JD; Docket No. CDC-2016-0004]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on the proposed 
information collection entitled ``Young Men who have Sex with Men 
(YMSM) Study Thailand''. CDC is requesting a three-year approval for 
this new project.

DATES: Written comments must be received on or before March 14, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0004 by any of the following methods:
     Federal eRulemaking Portal: Regulation.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE., MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

    Please note:  All public comment should be submitted through the 
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the 
address listed above.


FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

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

    This is a new information collection request for 3 years of data 
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.
    An area with gaps of understanding regarding the HIV epidemic in 
Thailand, as well as globally, is the epidemiology, risk factors, and 
HIV beliefs and knowledge of gay identified and transgender youth. In 
2013, UNAIDS reported that 95% of new HIV infections were in low- and 
middle-income countries, where more than one third were in young people 
(<18 years) who were unaware of their HIV status. Adolescents living 
with HIV are more

[[Page 1953]]

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. The 
SCC @TropMed, the clinical site of the activity, is a Clinical Research 
Site (CRS) and that conducts HIV prevention research in network 
clinical trials supported by National Institute of Health (NIH). The 
data will be collected from young MSM and TGW in Bangkok, Thailand 
through the CRS that serves MSM and transgender women (TGW). Although 
there are other MSM and TGW clinic settings in Bangkok, there is no 
cohort data providing information on incidence and risk factors for HIV 
incidence in the young. Therefore, this study also includes a 
longitudinal assessment (cohort) to assess HIV and sexually transmitted 
infection incidence and prevalence. This study also includes a 
qualitative component to assess adolescent and key leaders HIV 
prevention knowledge and practices. A study of young men at risk in 
Thailand is urgently needed to provide needed 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
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                                                                                                                          Average burden
               Type of respondent                               Form name                    Number of        Number       per response    Total burden
                                                                                            respondents      responses      (in hours)         hours
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Community members..............................  FGD Consent Assent.....................              10               1           30/60               5
Community members..............................  FGD....................................              10               1               2              20
Community members..............................  KII Consent Assent.....................               4               1           30/60               2
Community members..............................  KII....................................               4               1               2               8
Community members..............................  Screening checklist....................             300               1           15/60              75
Potential Participant..........................  Screening Consent Assent...............             300               1           30/60             150
Potential Participant..........................  Screening CASI.........................             300               1           15/60              75
HIV-positive at screening......................  HIV CASI...............................              60               1            2/60               2
Participants...................................  Enrollment Consent Assent..............             167               1           30/60              84
Participants...................................  Follow-up CASI.........................             167               4           15/60             167
Participants...................................  YMSM Clinical Form.....................             167               4           20/60             223
HIV-positive Participants......................  HIV CASI Cohort........................              46               4            1/60               3
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............             814
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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. 2016-00564 Filed 1-13-16; 8:45 am]
 BILLING CODE 4163-18-P