Proposed Data Collection Submitted for Public Comment and Recommendations, 9318-9320 [2018-04329]
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sradovich on DSK3GMQ082PROD with NOTICES
9318
Federal Register / Vol. 83, No. 43 / Monday, March 5, 2018 / Notices
confidentiality, and integrity of
customer information.
The proposed order contains
injunctive provisions addressing the
alleged deceptive conduct and Rule
violations in connection with PayPal’s
operation of a payment and social
networking service. Part I of the
proposed order prohibits PayPal from
making misrepresentations regarding
material restrictions, limitations, or
conditions to use any payment and
social networking service. It also
prohibits misrepresentations about data
security and privacy, including
misrepresentations regarding the extent
of control provided by any privacy
settings and the extent to which PayPal
implements or adheres to a particular
level of security.
Part II of the proposed order requires
PayPal, when making any
representations through any payment
and social networking service about the
availability of funds to be transferred or
withdrawn to a bank account, to provide
clear and conspicuous disclosures that
transactions are subject to review and, if
true, that funds could be frozen or
removed as a result of transaction
reviews. Part II also requires PayPal to
issue a one-time notice informing
current Venmo users that when they
attempt to transfer or withdraw funds to
a bank account, Venmo will perform
transaction reviews and based on such
review, may block or delay the transfer
or withdrawal, and/or reverse a
payment transaction.
Part III of the proposed order requires
PayPal to provide clear and conspicuous
disclosures to users related to how any
payment and social networking service
shares transaction information with
other users and how a consumer can
limit the visibility or sharing of
transaction information through privacy
settings.
Part IV of the agreement prohibits
violations of the GLB Privacy and
Safeguards Rules.
Part V requires PayPal to obtain
biennial data security assessments for
ten years.
Parts VI through IX of the proposed
order are reporting and compliance
provisions, which include
recordkeeping requirements and
provisions requiring PayPal to provide
information or documents necessary for
the Commission to monitor compliance.
Part X states that the proposed order
will remain in effect for 20 years, with
certain exceptions.
The purpose of this analysis is to aid
public comment on the proposed order.
It is not intended to constitute an
official interpretation of the complaint
VerDate Sep<11>2014
19:25 Mar 02, 2018
Jkt 244001
or proposed order, or to modify in any
way the proposed order’s terms.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2018–04331 Filed 3–2–18; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–18–18MY; Docket No. CDC–2018–
0018]
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 effort 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 ‘‘Network Epidemiology of
Syphilis Transmission (NEST)’’. The
purpose of the NEST study is to address
knowledge gaps in the transmission of
syphilis among men who have sex with
men (MSM) in the United States by
exploring the role of sexual and social
networks. Specifically, 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.
DATES: Written comments must be
received on or before May 4, 2018.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2018–
0018 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.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
SUMMARY:
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
access to the docket to read background
documents or comments received, go to
Regulations.gov.
Please note: Submit all Federal
comments 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 Leroy A.
Richardson, 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.
The OMB is particularly interested in
comments that will help:
1. 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;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected; and
4. 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 submissions
of responses.
5. Assess information collection costs.
Proposed Project
Network Epidemiology of Syphilis
Transmission (NEST)—New—National
E:\FR\FM\05MRN1.SGM
05MRN1
9319
Federal Register / Vol. 83, No. 43 / Monday, March 5, 2018 / Notices
Center for HIV/AIDS, Viral Hepatitis,
STD, and TB Prevention (NCHHSTP),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
sradovich on DSK3GMQ082PROD with NOTICES
CDC’s Division of STD Prevention
(DSTDP) requests a three-year approval
for a new data collection entitled,
Network Epidemiology of Syphilis
Transmission (NEST). CDC intends to
collect study participants’
sociodemographic, risk behavior, and
insurance coverage information as part
of study enrollment.
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), make this
study possible. 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
lesbian, gay, bisexual, and transgender
(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,
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
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, researchers will
interview participants and collect
biological specimens (blood and urine)
to facilitate testing for syphilis,
gonorrhea, chlamydia, and HIV, which
are part of the routine clinical care at
participating sites. Researchers will
collect data using Form 1—
Questionnaire and Data Elements and
directly submit the data electronically to
the CDC NEST data manager.
Researchers will not retain or collect
individual patient personal identifying
information (e.g., name, address) on
NEST data collection forms nor will
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 involved in data collection
activities. The grantees will implement
the testing and collect data and
specimens from the participants.
Before starting any data collection
activities, researchers will administer a
short eligibility screener to prospective
study participants. If deemed eligible,
researchers will obtain participant
consent. Upon consent, researchers will
begin data collection, which 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 that researchers
will deliver electronically on a tablet or
computer and will collect information
on the participants’ sexual network,
individual behaviors, healthcare access
and demographics.
The survey consists of 13
questionnaire modules with a range of
5 to 15 questions per module.
Researchers will deliver a small subset
of sexual behavior questions to the
participant closer to real time using an
open survey format and a weekly
format. The open survey format is a
brief survey that participants can
respond to at any to record a sexual
encounter or other event. Researchers
will send the weekly format on Sunday
nights, with a reminder on Monday
evening, to address sexual behavior in
the last week. Researchers will deliver
these brief surveys electronically to
participants and each survey is expected
to take two minutes or less. Study site
investigators provided input (based on
knowledge of relevant local
communities) into development of the
survey.
Researchers will store data collected
on electronic devices on a secure webaccessible local server at each site,
which will only be accessible with a
user name and password.
The total estimated annualized hourly
burden anticipated for this study is
6,828 hours.
they transmit personal identifying
information 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, researchers must
collect both individual-level and
network-level data 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 and traditional individuallevel 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. Researchers have yet to define
the optimal approaches for retaining
men as study participants for follow-up
visits over a defined study period.
Furthermore, our proposed data
collection activities survey format 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
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Form name
Potential participants .........................
Screener ...........................................
VerDate Sep<11>2014
19:25 Mar 02, 2018
Jkt 244001
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
900
E:\FR\FM\05MRN1.SGM
1
05MRN1
Average
burden per
response
(in hours)
2/60
Total
burden
hours
30
9320
Federal Register / Vol. 83, No. 43 / Monday, March 5, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
burden per
response
(in hours)
Number of
responses per
respondent
Number of
respondents
Total
burden
hours
Type of respondent
Form name
Site data manager ............................
Study participant ...............................
Study participant ...............................
Form 1—Questionnaire ....................
Form 1—Questionnaire ....................
Smartphone survey ..........................
3
720
720
5
5
52
10
1.5
2/60
150
5,400
1,248
Total ...........................................
...........................................................
........................
........................
........................
6,828
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. 2018–04329 Filed 3–2–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Leroy A.
Richardson, 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.
FOR FURTHER INFORMATION CONTACT:
Centers for Disease Control and
Prevention
[60Day–18–0571; Docket No. CDC–2018–
0017]
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 effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled ‘‘Minimum Data Elements (MDEs)
for the National Breast and Cervical
Cancer Early Detection Program
(NBCCEDP).’’
DATES: CDC must receive written
comments on or before May 4, 2018.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2018–
0017 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.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.
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:25 Mar 02, 2018
Jkt 244001
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
Regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.
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 the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. 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;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
3. Enhance the quality, utility, and
clarity of the information to be
collected; and
4. 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 submissions
of responses.
5. Assess information collection costs.
Proposed Project
Minimum Data Elements (MDEs) for
the National Breast and Cervical Cancer
Early Detection Program (NBCCEDP)—
(OMB Control Number 0920–0571, exp.
12/31/2018)—Revision—National
Center for Chronic Disease Prevention
and Health Promotion (NCCDPHP),
Centers for Disease Control and
Prevention (CDC)
Background and Brief Description
CDC seeks to request a three-year
OMB approval to revise the information
collection project approved under OMB
Control number 0920–0571. Based on
feedback from grantees and internal
subject matter experts, CDC proposes
use of revised minimum data elements
(MDEs), which decrease the estimated
annualized time burden.
Both breast and cervical cancers are
prevalent among U.S. women. In 2014,
more than 236,000 women were
diagnosed with breast cancer, and more
than 12,000 women were diagnosed
with cervical cancer. Evidence shows
that deaths from both breast and
cervical cancers can be avoided by
increasing women screening services
(mammography and Pap tests).
However, women who are under- or
uninsured, have no regular source of
healthcare, and/or have recently
immigrated to the U.S. typically
underutilize screening services.
Congress passed the Breast and
Cervical Cancer Mortality Prevention
Act of 1990, which directed CDC to
establish the National Breast and
Cervical Cancer Early Detection
Program (NBCCEDP). The purpose of
E:\FR\FM\05MRN1.SGM
05MRN1
]]>Agencies
[Federal Register Volume 83, Number 43 (Monday, March 5, 2018)]
[Notices]
[Pages 9318-9320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04329]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-18-18MY; Docket No. CDC-2018-0018]
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.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing effort 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 ``Network
Epidemiology of Syphilis Transmission (NEST)''. The purpose of the NEST
study is to address knowledge gaps in the transmission of syphilis
among men who have sex with men (MSM) in the United States by exploring
the role of sexual and social networks. Specifically, 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.
DATES: Written comments must be received on or before May 4, 2018.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0018 by any of the following methods:
Federal eRulemaking Portal: Regulations.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: Submit all Federal comments 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 Leroy A. Richardson, 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.
The OMB is particularly interested in comments that will help:
1. 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;
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected; and
4. 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
submissions of responses.
5. Assess information collection costs.
Proposed Project
Network Epidemiology of Syphilis Transmission (NEST)--New--National
[[Page 9319]]
Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
CDC's Division of STD Prevention (DSTDP) requests a three-year
approval for a new data collection entitled, Network Epidemiology of
Syphilis Transmission (NEST). CDC intends to collect study
participants' sociodemographic, risk behavior, and insurance coverage
information as part of study enrollment.
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), make this study possible. 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 lesbian, gay, bisexual, and transgender (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, 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
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, researchers will interview participants and
collect biological specimens (blood and urine) to facilitate testing
for syphilis, gonorrhea, chlamydia, and HIV, which are part of the
routine clinical care at participating sites. Researchers will collect
data using Form 1--Questionnaire and Data Elements and directly submit
the data electronically to the CDC NEST data manager. Researchers will
not retain or collect individual patient personal identifying
information (e.g., name, address) on NEST data collection forms nor
will they transmit personal identifying information 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, researchers must
collect both individual-level and network-level data 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 and
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. Researchers have yet to define the
optimal approaches for retaining men as study participants for follow-
up visits over a defined study period. Furthermore, our proposed data
collection activities survey format 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 involved in data collection activities. The grantees
will implement the testing and collect data and specimens from the
participants.
Before starting any data collection activities, researchers will
administer a short eligibility screener to prospective study
participants. If deemed eligible, researchers will obtain participant
consent. Upon consent, researchers will begin data collection, which
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 that researchers will deliver electronically on a
tablet or computer and will collect information on the participants'
sexual network, individual behaviors, healthcare access and
demographics.
The survey consists of 13 questionnaire modules with a range of 5
to 15 questions per module. Researchers will deliver a small subset of
sexual behavior questions to the participant closer to real time using
an open survey format and a weekly format. The open survey format is a
brief survey that participants can respond to at any to record a sexual
encounter or other event. Researchers will send the weekly format on
Sunday nights, with a reminder on Monday evening, to address sexual
behavior in the last week. Researchers will deliver these brief surveys
electronically to participants and each survey is expected to take two
minutes or less. Study site investigators provided input (based on
knowledge of relevant local communities) into development of the
survey.
Researchers will store data collected on electronic devices on a
secure web-accessible local server at each site, which will only be
accessible with a user name and password.
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 Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Potential participants........ Screener........ 900 1 2/60 30
[[Page 9320]]
Site data manager............. Form 1-- 3 5 10 150
Questionnaire.
Study participant............. Form 1-- 720 5 1.5 5,400
Questionnaire.
Study participant............. Smartphone 720 52 2/60 1,248
survey.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 6,828
----------------------------------------------------------------------------------------------------------------
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. 2018-04329 Filed 3-2-18; 8:45 am]
BILLING CODE 4163-18-P
