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

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(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] 

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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 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 

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 


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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 

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 

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

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(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] 

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