Agency Forms Undergoing Paperwork Reduction Act Review, 1951-1952 [2016-00561]
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Federal Register / Vol. 81, No. 9 / Thursday, January 14, 2016 / Notices
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. 2016–00562 Filed 1–13–16; 8:45 am]
BILLING CODE 4163–18–P
Proposed Project
Prevent Hepatitis Transmission
among Persons Who Inject Drugs—
New—National Center for HIV/AIDS,
Viral Hepatitis, STD, and TB Prevention
(NCHHSTP), Centers for Disease Control
and Prevention (CDC).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–16–15ARG]
mstockstill on DSK4VPTVN1PROD with NOTICES
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
VerDate Sep<11>2014
16:39 Jan 13, 2016
Jkt 238001
send an email to omb@cdc.gov. Direct
written comments and/or suggestions
regarding the items contained in this
notice 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.
Background and Brief Description
Hepatitis C virus (HCV) infection is
the most common chronic blood borne
infection in the United States;
approximately three million persons are
chronically infected. Identifying and
reaching persons at risk for HCV
infection is critical to prevent
transmission and treat and cure if
infected. CDC monitors the national
incidence of acute hepatitis C through
passive surveillance of acute,
symptomatic cases of laboratory
confirmed hepatitis C cases. Since 2006,
surveillance data have shown a trend
toward reemergence of HCV infection
mainly among young persons who inject
drugs (PWID) in nonurban counties. Of
the cases reported in 2013 with
information on risk factors 62%
indicated injection drug use as the
primary risk for acute hepatitis C. The
prevention of HCV infection among
PWIDs requires an integrated approach
including harm reduction interventions,
substance abuse treatment, and
prevention of other blood borne
infections, and care and treatment of
HCV infection.
The purpose of the proposed study is
to address the high prevalence of HCV
infection by developing and
implementing an integrated approach
for detection, prevention, care and
treatment of infection among persons
aged 18–30 years who reside in nonurban counties. Awardees will develop
and implement a comprehensive
strategy to enroll young non-urban
PWID, collect epidemiological
information, test for viral hepatitis and
HIV infection and provide linkage to
primary care services, prevention
PO 00000
Frm 00015
Fmt 4703
Sfmt 4703
1951
interventions, and treatment for
substance abuse and HCV infection. In
addition to providing HCV testing,
participants will be offered testing for
the presence of co-infections with
hepatitis B virus (HBV) and HIV.
Adherence to prevention services and
retention in care will be assessed
through follow up interviews.
Furthermore, re-infection with HCV will
be evaluated through follow-up blood
tests.
The project will recruit an estimated
total of 995 young PWIDs to enroll 895
PWIDs. The participants will be
recruited from settings where young
PWIDs obtain access to care and
treatment services. Recruitment will be
direct and in-person by partnering with
local harm reduction sites. Recruiters
will enroll subjects across recruitment
sites primarily through drug treatment
programs and syringe exchange
programs, as well as persons referred to
these sites as a result of referral from
other programs and respondent driven
sampling. Those who consent to
participate will be administered an
eligibility interview questionnaire by
trained field staff. If found eligible, the
participant will take an intervieweradministered survey that includes
information on initiation of drug use,
injection practices, HCV, HBV and HIV
infection status, access to prevention
and medical care, desire to receive and
barriers to receiving HCV treatment, and
missed opportunities for hepatitis
prevention. Participants will receive
counselling regarding adherence to
medical and/or drug treatment services
and prevention services. Participants
will be interviewed for a maximum of
5 times within any 12-month interval
during the course of the study: consent
and interview at enrollment/baseline for
an estimated 60 minutes, and 30-minute
follow-up interviews every 3 months
thereafter. Participants will be
interviewed throughout the study
during the 3-year project. However,
most of the recruitment will be spread
over first two years to allow for one year
follow up period of the later recruits.
Participation in interviews and
responses to all study questions are
totally voluntary and there is no cost to
respondents other than their time. The
annualized burden to participants is 974
hours.
E:\FR\FM\14JAN1.SGM
14JAN1
1952
Federal Register / Vol. 81, No. 9 / Thursday, January 14, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
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
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
[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
mstockstill on DSK4VPTVN1PROD with NOTICES
VerDate Sep<11>2014
16:39 Jan 13, 2016
Jkt 238001
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
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.
PO 00000
Frm 00016
Fmt 4703
Sfmt 4703
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
E:\FR\FM\14JAN1.SGM
14JAN1
Agencies
[Federal Register Volume 81, Number 9 (Thursday, January 14, 2016)]
[Notices]
[Pages 1951-1952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00561]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-16-15ARG]
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. Direct written comments
and/or suggestions regarding the items contained in this notice 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
Prevent Hepatitis Transmission among Persons Who Inject Drugs--
New--National Center for HIV/AIDS, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Hepatitis C virus (HCV) infection is the most common chronic blood
borne infection in the United States; approximately three million
persons are chronically infected. Identifying and reaching persons at
risk for HCV infection is critical to prevent transmission and treat
and cure if infected. CDC monitors the national incidence of acute
hepatitis C through passive surveillance of acute, symptomatic cases of
laboratory confirmed hepatitis C cases. Since 2006, surveillance data
have shown a trend toward reemergence of HCV infection mainly among
young persons who inject drugs (PWID) in nonurban counties. Of the
cases reported in 2013 with information on risk factors 62% indicated
injection drug use as the primary risk for acute hepatitis C. The
prevention of HCV infection among PWIDs requires an integrated approach
including harm reduction interventions, substance abuse treatment, and
prevention of other blood borne infections, and care and treatment of
HCV infection.
The purpose of the proposed study is to address the high prevalence
of HCV infection by developing and implementing an integrated approach
for detection, prevention, care and treatment of infection among
persons aged 18-30 years who reside in non-urban counties. Awardees
will develop and implement a comprehensive strategy to enroll young
non-urban PWID, collect epidemiological information, test for viral
hepatitis and HIV infection and provide linkage to primary care
services, prevention interventions, and treatment for substance abuse
and HCV infection. In addition to providing HCV testing, participants
will be offered testing for the presence of co-infections with
hepatitis B virus (HBV) and HIV. Adherence to prevention services and
retention in care will be assessed through follow up interviews.
Furthermore, re-infection with HCV will be evaluated through follow-up
blood tests.
The project will recruit an estimated total of 995 young PWIDs to
enroll 895 PWIDs. The participants will be recruited from settings
where young PWIDs obtain access to care and treatment services.
Recruitment will be direct and in-person by partnering with local harm
reduction sites. Recruiters will enroll subjects across recruitment
sites primarily through drug treatment programs and syringe exchange
programs, as well as persons referred to these sites as a result of
referral from other programs and respondent driven sampling. Those who
consent to participate will be administered an eligibility interview
questionnaire by trained field staff. If found eligible, the
participant will take an interviewer-administered survey that includes
information on initiation of drug use, injection practices, HCV, HBV
and HIV infection status, access to prevention and medical care, desire
to receive and barriers to receiving HCV treatment, and missed
opportunities for hepatitis prevention. Participants will receive
counselling regarding adherence to medical and/or drug treatment
services and prevention services. Participants will be interviewed for
a maximum of 5 times within any 12-month interval during the course of
the study: consent and interview at enrollment/baseline for an
estimated 60 minutes, and 30-minute follow-up interviews every 3 months
thereafter. Participants will be interviewed throughout the study
during the 3-year project. However, most of the recruitment will be
spread over first two years to allow for one year follow up period of
the later recruits.
Participation in interviews and responses to all study questions
are totally voluntary and there is no cost to respondents other than
their time. The annualized burden to participants is 974 hours.
[[Page 1952]]
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Young PWIDs........................... Screener................ 332 1 10/60
Eligible young PWIDs.................. Initial Survey.......... 298 1 60/60
Eligible young PWIDs.................. Follow-up survey........ 298 4 30/60
----------------------------------------------------------------------------------------------------------------
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. 2016-00561 Filed 1-13-16; 8:45 am]
BILLING CODE 4163-18-P