Agency Forms Undergoing Paperwork Reduction Act Review, 45452-45453 [2018-19380]
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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
45453
Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices
address some of the knowledge gaps in
the transmission dynamics and
epidemiology of syphilis among MSM
in the United States and point towards
effective public health interventions to
slow the spread of syphilis.
The goal of NEST is to pilot the use
of survey instruments to collect
complex longitudinal sexual network
data among MSM at high risk for
syphilis in the United States. The
feasibility of data collection on basic
information about recent partners of
persons diagnosed with syphilis is clear
and is routinely performed by public
health officials. However, the feasibility
and optimal approaches for serial
collection of complex sexual network
data among populations that may have
dynamic networks are not at all clear.
Specifically, it is not clear what the
optimal recruitment strategies are to
recruit and enroll MSM at high risk for
syphilis. The optimal approaches for
retaining men as study participants for
follow-up visits over a defined study
period have not been well defined.
Furthermore the best survey format for
our proposed data collection activities
has not been established. For example,
it is not known whether study
participants would prefer a survey that
is completely self-administered and
whether data collected using a selfadministered survey will result in
complete and valid data being collected
or whether a survey administered by
study staff would be a better format.
CDC is not engaged in research, and
therefore not involved in data collection
activities. The grantees are responsible
for implementing the testing and
collecting data and specimens from the
participants.
Before starting any data collection
activities a short eligibility screener
(Attachment 4) will be administered to
prospective study participants and if
enrollment of approximately 720 MSM
aged 18 years and older from three
geographic areas of the United States:
(1) Chicago, Illinois, (2) Baltimore,
Maryland, and (3) Columbus, Ohio.
At each study visit, study participants
will be interviewed and biological
specimens (blood and urine) will be
collected to facilitate testing for
syphilis, gonorrhea, chlamydia, and
HIV, which are part of the routine
clinical care at participating sites. All
data will be collected using Form 1—
Questionnaire and Data Elements
(Attachment 3) and submitted
electronically directly to the CDC NEST
data manager. All personal identifying
information (e.g., name, address)
collected on individual patients will be
retained by the local NEST site, will not
be collected on NEST data collection
forms, and will not be transmitted to
CDC.
The United States is currently
experiencing an ongoing syphilis
epidemic. MSM are disproportionately
impacted by syphilis and the majority of
incident syphilis cases in the United
States occur among MSM. However,
factors influencing syphilis
transmission within this population,
such as social and sexual network
characteristics, sexual behaviors, and
healthcare access and utilization, are
poorly understood. In order to address
these knowledge gaps, both individuallevel and network-level data needs to be
collected among this population. As
such, we need to develop a better
understanding of the feasibility of
collecting complex sexual network data
among this population. The collection
of complex sexual network data—in
addition to more traditional individuallevel data, such as demographics and
individual-level sexual and social
behaviors—will help to collectively
determined to be eligible consent from
the participant will be obtained. Once
consent is obtained data collection will
begin and will include a baseline visit
and follow-up visits every three months
for a total follow-up period of 24
months. At each visit participants will
provide biological specimens (blood and
urine) to facilitate testing for syphilis,
gonorrhea, chlamydia, and HIV. In
addition to providing biological
specimens, participants will complete a
standardized survey which will be
delivered electronically on a tablet or
computer and will collect information
on the participants’ sexual network,
individual behaviors, healthcare access
and demographics (Attachment 3). The
survey consists of 13 questionnaire
modules with a range of 5 to 15
questions per module (Attachment 3). A
small subset of sexual behavior
questions will be delivered to the
participant closer to real time using an
open survey format and a weekly format
(Attachment 5). The open survey format
is a brief survey that participants can
respond to at any to record a sexual
encounter or other event. The weekly
format will be sent on Sunday nights
with a reminder on Monday evening, to
address sexual behavior in the last
week. These brief surveys will be
delivered electronically to participants
and each survey is expected to take 2
minutes or less. Data collected on
electronic devices will be stored on a
secure web-accessible local server at
each site which will only be accessible
with a user name and password. Study
site investigators provided input (based
on knowledge of relevant local
communities) into development of the
survey.
The total estimated annualized hourly
burden anticipated for this study is
6,828 hours.
daltland on DSKBBV9HB2PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Form name
Potential participants .......................................................
Site data manager ...........................................................
Study participant ..............................................................
Study participant ..............................................................
Screener .........................................................................
Form 1—Questionnaire ..................................................
Form 1—Questionnaire ..................................................
Smartphone survey .........................................................
900
3
720
720
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. 2018–19380 Filed 9–6–18; 8:45 am]
BILLING CODE 4163–18–P
VerDate Sep<11>2014
17:55 Sep 06, 2018
Jkt 244001
PO 00000
Frm 00043
Fmt 4703
Sfmt 9990
E:\FR\FM\07SEN1.SGM
07SEN1
Number of
responses per
respondent
1
5
5
52
Average
burden per
response
(in hours)
2/60
10
1.5
2/60
]]>Agencies
[Federal Register Volume 83, Number 174 (Friday, September 7, 2018)]
[Notices]
[Pages 45452-45453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19380]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-18-18MY]
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 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 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
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
[[Page 45453]]
enrollment of approximately 720 MSM aged 18 years and older from three
geographic areas of the United States: (1) Chicago, Illinois, (2)
Baltimore, Maryland, and (3) Columbus, Ohio.
At each study visit, study participants will be interviewed and
biological specimens (blood and urine) will be collected to facilitate
testing for syphilis, gonorrhea, chlamydia, and HIV, which are part of
the routine clinical care at participating sites. All data will be
collected using Form 1--Questionnaire and Data Elements (Attachment 3)
and submitted electronically directly to the CDC NEST data manager. All
personal identifying information (e.g., name, address) collected on
individual patients will be retained by the local NEST site, will not
be collected on NEST data collection forms, and will not be transmitted
to CDC.
The United States is currently experiencing an ongoing syphilis
epidemic. MSM are disproportionately impacted by syphilis and the
majority of incident syphilis cases in the United States occur among
MSM. However, factors influencing syphilis transmission within this
population, such as social and sexual network characteristics, sexual
behaviors, and healthcare access and utilization, are poorly
understood. In order to address these knowledge gaps, both individual-
level and network-level data needs to be collected among this
population. As such, we need to develop a better understanding of the
feasibility of collecting complex sexual network data among this
population. The collection of complex sexual network data--in addition
to more traditional individual-level data, such as demographics and
individual-level sexual and social behaviors--will help to collectively
address some of the knowledge gaps in the transmission dynamics and
epidemiology of syphilis among MSM in the United States and point
towards effective public health interventions to slow the spread of
syphilis.
The goal of NEST is to pilot the use of survey instruments to
collect complex longitudinal sexual network data among MSM at high risk
for syphilis in the United States. The feasibility of data collection
on basic information about recent partners of persons diagnosed with
syphilis is clear and is routinely performed by public health
officials. However, the feasibility and optimal approaches for serial
collection of complex sexual network data among populations that may
have dynamic networks are not at all clear. Specifically, it is not
clear what the optimal recruitment strategies are to recruit and enroll
MSM at high risk for syphilis. The optimal approaches for retaining men
as study participants for follow-up visits over a defined study period
have not been well defined. Furthermore the best survey format for our
proposed data collection activities has not been established. For
example, it is not known whether study participants would prefer a
survey that is completely self-administered and whether data collected
using a self-administered survey will result in complete and valid data
being collected or whether a survey administered by study staff would
be a better format.
CDC is not engaged in research, and therefore not involved in data
collection activities. The grantees are responsible for implementing
the testing and collecting data and specimens from the participants.
Before starting any data collection activities a short eligibility
screener (Attachment 4) will be administered to prospective study
participants and if determined to be eligible consent from the
participant will be obtained. Once consent is obtained data collection
will begin and will include a baseline visit and follow-up visits every
three months for a total follow-up period of 24 months. At each visit
participants will provide biological specimens (blood and urine) to
facilitate testing for syphilis, gonorrhea, chlamydia, and HIV. In
addition to providing biological specimens, participants will complete
a standardized survey which will be delivered electronically on a
tablet or computer and will collect information on the participants'
sexual network, individual behaviors, healthcare access and
demographics (Attachment 3). The survey consists of 13 questionnaire
modules with a range of 5 to 15 questions per module (Attachment 3). A
small subset of sexual behavior questions will be delivered to the
participant closer to real time using an open survey format and a
weekly format (Attachment 5). The open survey format is a brief survey
that participants can respond to at any to record a sexual encounter or
other event. The weekly format will be sent on Sunday nights with a
reminder on Monday evening, to address sexual behavior in the last
week. These brief surveys will be delivered electronically to
participants and each survey is expected to take 2 minutes or less.
Data collected on electronic devices will be stored on a secure web-
accessible local server at each site which will only be accessible with
a user name and password. Study site investigators provided input
(based on knowledge of relevant local communities) into development of
the survey.
The total estimated annualized hourly burden anticipated for this
study is 6,828 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Potential participants................ Screener................ 900 1 2/60
Site data manager..................... Form 1--Questionnaire... 3 5 10
Study participant..................... Form 1--Questionnaire... 720 5 1.5
Study participant..................... Smartphone survey....... 720 52 2/60
----------------------------------------------------------------------------------------------------------------
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. 2018-19380 Filed 9-6-18; 8:45 am]
BILLING CODE 4163-18-P
