83 FR 45452 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 83, Issue 174 (September 7, 2018)

[Federal Register Volume 83, Number 174 (Friday, September 7, 2018)]
[Notices]
[Pages 45452-45453]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-19380]


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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
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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