[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]


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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.

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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
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                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
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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
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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