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)

Page Range		1952-1953
FR Document		2016-00564

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 Issue 9 (Thursday, January 14, 2016)

[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: omb@cdc.gov.

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

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

Federal Register / Vol. 81, No. 9 / Thursday, January 14, 2016 / Notices 1953

likely to die from AIDS, and there is Thailand through the CRS that serves assess adolescent and key leaders HIV
little tracking of the HIV epidemic and MSM and transgender women (TGW). prevention knowledge and practices. A
outcomes in adolescents. Although there are other MSM and study of young men at risk in Thailand
We propose a study of males aged 15– TGW clinic settings in Bangkok, there is is urgently needed to provide needed
29 years at risk for HIV. The SCC no cohort data providing information on data to assess and implement
@TropMed, the clinical site of the incidence and risk factors for HIV prevention strategies and inform
activity, is a Clinical Research Site incidence in the young. Therefore, this policies for HIV prevention in Thailand,
(CRS) and that conducts HIV prevention study also includes a longitudinal as well as globally. There is no cost to
research in network clinical trials assessment (cohort) to assess HIV and participants other than their time.
supported by National Institute of sexually transmitted infection incidence
Health (NIH). The data will be collected and prevalence. This study also The total estimated annualized
from young MSM and TGW in Bangkok, includes a qualitative component to burden hours are 814.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of Number burden per Total burden
Type of respondent Form name respondents responses response hours
(in hours)

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

Leroy A. Richardson, following: (a) Evaluate whether the comments should be received within 30
Chief, Information Collection Review Office, proposed collection of information is days of this notice.
Office of Scientific Integrity, Office of the necessary for the proper performance of
Associate Director for Science, Office of the Proposed Project
the functions of the agency, including
Director, Centers for Disease Control and
whether the information will have Prevention Research Centers Program
Prevention.
practical utility; (b) Evaluate the National Evaluation Reporting System
[FR Doc. 2016–00564 Filed 1–13–16; 8:45 am]
accuracy of the agencies estimate of the (OMB No. 0920–0650, exp. 5/31/2016)—
BILLING CODE 4163–18–P
burden of the proposed collection of Revision—National Center for Chronic
information, including the validity of Disease Prevention and Health
the methodology and assumptions used; Promotion (NCCDPHP), Centers for
DEPARTMENT OF HEALTH AND
(c) Enhance the quality, utility, and Disease Control and Prevention (CDC).
HUMAN SERVICES
clarity of the information to be Background and Brief Description
Centers for Disease Control and collected; (d) Minimize the burden of
Prevention the collection of information on those In 1984, Congress passed Public Law
who are to respond, including through 98–551 directing the Department of
[30Day–16–0650] Health and Human Services (DHHS) to
the use of appropriate automated,
electronic, mechanical, or other establish Centers for Research and
Agency Forms Undergoing Paperwork Development of Health Promotion and
Reduction Act Review technological collection techniques or
other forms of information technology, Disease Prevention. In 1986, the CDC
The Centers for Disease Control and received lead responsibility for this
e.g., permitting electronic submission of
Prevention (CDC) has submitted the program, referred to as the Prevention
responses; and (e) Assess information
following information collection request Research Centers (PRC) Program. PRC
collection costs. Program awardees are managed as a
to the Office of Management and Budget
(OMB) for review and approval in To request additional information on CDC cooperative agreement with awards
accordance with the Paperwork the proposed project or to obtain a copy made for five years.
Reduction Act of 1995. The notice for of the information collection plan and In 2013, the CDC published program
instruments, call (404) 639–7570 or
mstockstill on DSK4VPTVN1PROD with NOTICES

the proposed information collection is announcement DP14–001 for the current
published to obtain comments from the send an email to omb@cdc.gov. Written PRC Program funding cycle (September
public and affected agencies. comments and/or suggestions regarding 30, 2014–September 29, 2019). Twenty-
Written comments and suggestions the items contained in this notice six PRCs were selected through a
from the public and affected agencies should be directed to the Attention: competitive, external, peer-review
concerning the proposed collection of CDC Desk Officer, Office of Management process; the program is currently in its
information are encouraged. Your and Budget, Washington, DC 20503 or second year of the five year funding
comments should address any of the by fax to (202) 395–5806. Written cycle.

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Document Created: 2016-01-14 02:51:11
Document Modified: 2016-01-14 02:51:11

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice with comment period.
Dates		Written comments must be received on or before March 14, 2016.
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]
FR Citation		81 FR 1952

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

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

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

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