Agency Forms Undergoing Paperwork Reduction Act Review, 45451-45452 [2018-19379]
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45451
Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
responses per
respondent
Average
burden
per response
(in hours)
Total burden
hours
Regulatory provision or form name
Importers ................................
Importer ..................................
Importer ..................................
Importer ..................................
42 CFR 71.55 Dead Bodies, 42 CFR 71.32—Death certificates
42 CFR 71.56 (a)(2) African Rodents—Request for exemption ..
42 CFR 71.56(a)(iii) Appeal .........................................................
42 CFR 71.32 Statements or documentation of non-infectiousness.
20
25
2
2,000
1
1
1
1
1
1
1
5/60
20
25
2
167
Total ................................
.......................................................................................................
........................
........................
........................
268,493
Jeffrey M. Zirger,
Acting 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. 2018–19381 Filed 9–6–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–18–18CI]
Agency Forms Undergoing Paperwork
Reduction Act Review
daltland on DSKBBV9HB2PROD with NOTICES
Number of
respondents
Type of respondent
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘Evaluation of
TransLife Center (TLC): A LocallyDeveloped Combination Prevention
Intervention for Transgender Women at
High Risk of HIV Infection’’ to the Office
of Management and Budget (OMB) for
review and approval. CDC previously
published a ‘‘Proposed Data Collection
Submitted for Public Comment and
Recommendations’’ notice on January
30, 2018 to obtain comments from the
public and affected agencies. CDC
received one (1) comment related to the
previous notice. This notice serves to
allow an additional 30 days for public
and affected agency comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(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;
VerDate Sep<11>2014
17:55 Sep 06, 2018
Jkt 244001
(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, 725 17th Street NW,
Washington, DC 20503 or by fax to (202)
395–5806. Provide written comments
within 30 days of notice publication.
Proposed Project
Evaluation of TransLife Center (TLC):
A Locally-Developed Combination
Prevention Intervention for Transgender
Women at High Risk of HIV Infection—
New—National Center for HIV/AIDS,
Viral Hepatitis, STD and TB Prevention
(NCHHSTP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The National Center for HIV/AIDS,
Viral Hepatitis, STD and TB Prevention
is requesting approval for 24 months of
data collection entitled, ‘‘Evaluation of
TransLife Center (TLC): A LocallyDeveloped Combination Prevention
Intervention for Transgender Women at
High Risk for HIV Infection.’’ The
purpose of this study is to evaluate the
efficacy of TLC, which provides
combination (biomedical, behavioral
and social/structural) HIV prevention
and care services to adult transgender
women at high risk for HIV infection, in
a culturally specific and accessible
environment. The information collected
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
through this study will be used to
evaluate whether the TLC intervention
is an effective HIV-prevention strategy
by assessing whether exposure to TLC
services results in improvements in
participants’ health and HIV prevention
behaviors. The trial will assess whether
intervention participants’ behaviors
significantly change from baseline to 4and 8-month follow-up periods.
This study will be carried out in
Chicago, Illinois, where the TLC
program is located. The study
population will include 150 HIVnegative adult transgender women
living in the Chicago metropolitan area.
Participants will be at least 18 years of
age; self-identify as transgender,
transsexual, women and/or female who
was assigned male sex at birth; and have
a self-reported history of sex with men
in the past four months. The study
population will also include 10 TLC
staff members. Staff members will be
adults, involved in the delivery of TLC
intervention services. Participation in
this study is voluntary.
We anticipate enrollment of a diverse
sample of transgender women
comprised mainly of racial/ethnic
minority participants under 35 years of
age, consistent with the current TLC
program and the epidemiology of HIV
infection among transgender women.
Intervention participants will be
recruited to the study through a
combination of approaches, including
traditional print advertisement, referral,
in-person outreach, and through word of
mouth. TLC staff members will be
randomly selected to participate in the
evaluation.
A computer-assisted quantitative
assessment will be used to collect
information for this study, which will
be delivered at the time of study
enrollment and again at 4-month and 8month follow-ups. The assessment will
be used to measure changes in sexual
risk behavior including condom use and
pre-exposure prophylaxis (PrEP) care
engagement. Intervention mediators,
including gender affirmation, collective
self-esteem and social support, and
intervention satisfaction will also be
E:\FR\FM\07SEN1.SGM
07SEN1
45452
Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices
measured. Participants will complete
the assessment at baseline and again at
4- and 8-month follow-ups after joining
the TLC program.
We will also examine intervention
experiences through semi-structured
interview with 20 of the 150 TLC
participants and 10 TLC staff members
involved in the delivery of services
through the TLC intervention. The
audio-recorded interviews will capture
participants and staff views about the
TLC implementation process, the
process through which the TLC
intervention influences HIV risk
behavior, and the role of the
intervention in addressing social
determinates of health (housing,
employment, legal issues, health care
access).
It is expected that 50% of transgender
women screened will meet study
eligibility. We expect the initial
screening to take approximately four
minutes to complete and that providing
contact information will take four
minutes. The assessment will take 60
minutes (one hour) to complete and will
be administered to 150 participants a
total of three times. The interview will
take 60 minutes (one hour) to complete
and will be administered to 30
participants (20 intervention
participants and 10 TLC staff) one time.
There are no costs to the respondents
other than their time. The total
estimated annualized burden hours are
255.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
General Public-Adults .....................................
Eligibility Screener ..........................................
Contact Information ........................................
Baseline Assessment .....................................
Follow Up Assessment ..................................
Participant Interview .......................................
Staff Interview ................................................
Jeffrey M. Zirger,
Acting 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. 2018–19379 Filed 9–6–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–18–18MY]
Agency Forms Undergoing Paperwork
Reduction Act Review
daltland on DSKBBV9HB2PROD with NOTICES
Number of
respondents
Type of respondent
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled Network
Epidemiology of Syphilis Transmission
(NEST) to the Office of Management and
Budget (OMB) for review and approval.
CDC previously published a ‘‘Proposed
Data Collection Submitted for Public
Comment and Recommendations’’
notice on 03/05/2018 to obtain
comments from the public and affected
agencies. CDC received 1 (one) comment
related to the previous notice. This
notice serves to allow an additional 30
days for public and affected agency
comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
VerDate Sep<11>2014
17:55 Sep 06, 2018
Jkt 244001
is particularly interested in comments
that:
(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, 725 17th Street NW,
Washington, DC 20503 or by fax to (202)
395–5806. Provide written comments
within 30 days of notice publication.
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
150
75
75
75
10
5
Number of
responses per
respondent
1
1
1
2
1
1
Average
burden per
response
(in hours)
4/60
4/60
1
1
1
1
Proposed Project
Network Epidemiology of Syphilis
Transmission (NEST)—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, Division of STD Prevention
(DSTDP), requests a 3-year approval for
a new data collection entitled, Network
Epidemiology of Syphilis Transmission
(NEST). Study participants’
sociodemographic, risk behavior, and
insurance coverage information will be
collected as part of study enrollment.
This study is funded by a cooperative
agreement between CDC and three study
grantees, two universities (Ohio State
University and University of Illinois at
Chicago) and one local health
department (Baltimore City Health
Department) in collaboration with a
university (Johns Hopkins School of
Medicine). The recruitment of study
participants as well as the data
collection activities will be carried out
at university-affiliated sites including
local health departments, community
LGBT organizations, local STD clinics
and HIV/AIDS care facilities.
The overall objective of NEST is to
support the establishment of cohorts of
MSM at high risk for syphilis and to
prospectively collect behavioral, social,
and sexual network data, and biological
specimens. Study participants will
attend study visits every three months
for a period of up to 24 months. NEST
is a multi-site study, with a target
E:\FR\FM\07SEN1.SGM
07SEN1
]]>Agencies
[Federal Register Volume 83, Number 174 (Friday, September 7, 2018)]
[Notices]
[Pages 45451-45452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19379]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-18-18CI]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled ``Evaluation of TransLife Center (TLC): A
Locally-Developed Combination Prevention Intervention for Transgender
Women at High Risk of HIV Infection'' to the Office of Management and
Budget (OMB) for review and approval. CDC previously published a
``Proposed Data Collection Submitted for Public Comment and
Recommendations'' notice on January 30, 2018 to obtain comments from
the public and affected agencies. CDC received one (1) comment related
to the previous notice. This notice serves to allow an additional 30
days for public and affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(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]. Direct written comments
and/or suggestions regarding the items contained in this notice to the
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide
written comments within 30 days of notice publication.
Proposed Project
Evaluation of TransLife Center (TLC): A Locally-Developed
Combination Prevention Intervention for Transgender Women at High Risk
of HIV Infection--New--National Center for HIV/AIDS, Viral Hepatitis,
STD and TB Prevention (NCHHSTP), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The National Center for HIV/AIDS, Viral Hepatitis, STD and TB
Prevention is requesting approval for 24 months of data collection
entitled, ``Evaluation of TransLife Center (TLC): A Locally-Developed
Combination Prevention Intervention for Transgender Women at High Risk
for HIV Infection.'' The purpose of this study is to evaluate the
efficacy of TLC, which provides combination (biomedical, behavioral and
social/structural) HIV prevention and care services to adult
transgender women at high risk for HIV infection, in a culturally
specific and accessible environment. The information collected through
this study will be used to evaluate whether the TLC intervention is an
effective HIV-prevention strategy by assessing whether exposure to TLC
services results in improvements in participants' health and HIV
prevention behaviors. The trial will assess whether intervention
participants' behaviors significantly change from baseline to 4- and 8-
month follow-up periods.
This study will be carried out in Chicago, Illinois, where the TLC
program is located. The study population will include 150 HIV-negative
adult transgender women living in the Chicago metropolitan area.
Participants will be at least 18 years of age; self-identify as
transgender, transsexual, women and/or female who was assigned male sex
at birth; and have a self-reported history of sex with men in the past
four months. The study population will also include 10 TLC staff
members. Staff members will be adults, involved in the delivery of TLC
intervention services. Participation in this study is voluntary.
We anticipate enrollment of a diverse sample of transgender women
comprised mainly of racial/ethnic minority participants under 35 years
of age, consistent with the current TLC program and the epidemiology of
HIV infection among transgender women. Intervention participants will
be recruited to the study through a combination of approaches,
including traditional print advertisement, referral, in-person
outreach, and through word of mouth. TLC staff members will be randomly
selected to participate in the evaluation.
A computer-assisted quantitative assessment will be used to collect
information for this study, which will be delivered at the time of
study enrollment and again at 4-month and 8-month follow-ups. The
assessment will be used to measure changes in sexual risk behavior
including condom use and pre-exposure prophylaxis (PrEP) care
engagement. Intervention mediators, including gender affirmation,
collective self-esteem and social support, and intervention
satisfaction will also be
[[Page 45452]]
measured. Participants will complete the assessment at baseline and
again at 4- and 8-month follow-ups after joining the TLC program.
We will also examine intervention experiences through semi-
structured interview with 20 of the 150 TLC participants and 10 TLC
staff members involved in the delivery of services through the TLC
intervention. The audio-recorded interviews will capture participants
and staff views about the TLC implementation process, the process
through which the TLC intervention influences HIV risk behavior, and
the role of the intervention in addressing social determinates of
health (housing, employment, legal issues, health care access).
It is expected that 50% of transgender women screened will meet
study eligibility. We expect the initial screening to take
approximately four minutes to complete and that providing contact
information will take four minutes. The assessment will take 60 minutes
(one hour) to complete and will be administered to 150 participants a
total of three times. The interview will take 60 minutes (one hour) to
complete and will be administered to 30 participants (20 intervention
participants and 10 TLC staff) one time.
There are no costs to the respondents other than their time. The
total estimated annualized burden hours are 255.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
General Public-Adults................. Eligibility Screener.... 150 1 4/60
Contact Information..... 75 1 4/60
Baseline Assessment..... 75 1 1
Follow Up Assessment.... 75 2 1
Participant Interview... 10 1 1
Staff Interview......... 5 1 1
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Acting 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. 2018-19379 Filed 9-6-18; 8:45 am]
BILLING CODE 4163-18-P
