60d Federal Register Notice

Att 2 60 Day FRN.pdf

"Cohort Study of HIV, STIs and Preventive Interventions among Young MSM in Thailand

60d Federal Register Notice

OMB: 0920-1191

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1952

Federal Register / Vol. 81, No. 9 / Thursday, January 14, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Young PWIDs .................................................
Eligible young PWIDs .....................................
Eligible young PWIDs .....................................

Screener .........................................................
Initial Survey ...................................................
Follow-up survey ............................................

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. 2016–00561 Filed 1–13–16; 8:45 am]
BILLING CODE 4163–18–P

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

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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 threeyear 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

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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
FOR FURTHER INFORMATION CONTACT:

Centers for Disease Control and
Prevention

SUMMARY:

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.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

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Number of
respondents

Type of respondents

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332
298
298

Number of
responses per
respondent
1
1
4

Average
burden per
response
(in hours)
10/60
60/60
30/60

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

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1953

Federal Register / Vol. 81, No. 9 / Thursday, January 14, 2016 / Notices
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 per
response
(in hours)

Number
responses

Total burden
hours

Form name

Community members ........................
Community members ........................
Community members ........................
Community members ........................
Community members ........................
Potential Participant ..........................
Potential Participant ..........................
HIV-positive at screening ..................
Participants ........................................
Participants ........................................
Participants ........................................
HIV-positive Participants ...................

FGD Consent Assent .......................
FGD .................................................
KII Consent Assent ..........................
KII .....................................................
Screening checklist ..........................
Screening Consent Assent ..............
Screening CASI ...............................
HIV CASI .........................................
Enrollment Consent Assent .............
Follow-up CASI ................................
YMSM Clinical Form ........................
HIV CASI Cohort .............................

10
10
4
4
300
300
300
60
167
167
167
46

1
1
1
1
1
1
1
1
1
4
4
4

30/60
2
30/60
2
15/60
30/60
15/60
2/60
30/60
15/60
20/60
1/60

5
20
2
8
75
150
75
2
84
167
223
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

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–16–0650]

Agency Forms Undergoing Paperwork
Reduction Act Review

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Number of
respondents

Type of respondent

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

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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

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comments should be received within 30
days of this notice.
Proposed Project
Prevention Research Centers Program
National Evaluation Reporting System
(OMB No. 0920–0650, exp. 5/31/2016)—
Revision—National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
In 1984, Congress passed Public Law
98–551 directing the Department of
Health and Human Services (DHHS) to
establish Centers for Research and
Development of Health Promotion and
Disease Prevention. In 1986, the CDC
received lead responsibility for this
program, referred to as the Prevention
Research Centers (PRC) Program. PRC
Program awardees are managed as a
CDC cooperative agreement with awards
made for five years.
In 2013, the CDC published program
announcement DP14–001 for the current
PRC Program funding cycle (September
30, 2014–September 29, 2019). Twentysix PRCs were selected through a
competitive, external, peer-review
process; the program is currently in its
second year of the five year funding
cycle.

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