Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices 45451 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondent Regulatory provision or form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

per response 

(in hours) 

Total burden 

hours 

Importers ................................ 42 CFR 71.55 Dead Bodies, 42 CFR 71.32—Death certificates 20 1 1 20 

Importer .................................. 42 CFR 71.56 (a)(2) African Rodents—Request for exemption .. 25 1 1 25 

Importer .................................. 42 CFR 71.56(a)(iii) Appeal ......................................................... 2 1 1 2 

Importer .................................. 42 CFR 71.32 Statements or documentation of non-infectiousness.2,000 1 5/60 167 

Total ................................ ....................................................................................................... ........................ ........................ ........................ 268,493 

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. 2018–19381 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–18–18CI] 

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 ‘‘Evaluation of 

TransLife Center (TLC): A LocallyDeveloped Combination Prevention 

Intervention for Transgender Women at 

High Risk of HIV Infection’’ 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 January 

30, 2018 to obtain comments from the 

public and affected agencies. CDC 

received one (1) 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 

Evaluation of TransLife Center (TLC): 

A Locally-Developed Combination 

Prevention Intervention for Transgender 

Women at High Risk of HIV Infection— 

New—National Center for HIV/AIDS, 

Viral Hepatitis, STD and TB Prevention 

(NCHHSTP), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

The National Center for HIV/AIDS, 

Viral Hepatitis, STD and TB Prevention 

is requesting approval for 24 months of 

data collection entitled, ‘‘Evaluation of 

TransLife Center (TLC): A LocallyDeveloped Combination Prevention 

Intervention for Transgender Women at 

High Risk for HIV Infection.’’ The 

purpose of this study is to evaluate the 

efficacy of TLC, which provides 

combination (biomedical, behavioral 

and social/structural) HIV prevention 

and care services to adult transgender 

women at high risk for HIV infection, in 

a culturally specific and accessible 

environment. The information collected 

through this study will be used to 

evaluate whether the TLC intervention 

is an effective HIV-prevention strategy 

by assessing whether exposure to TLC 

services results in improvements in 

participants’ health and HIV prevention 

behaviors. The trial will assess whether 

intervention participants’ behaviors 

significantly change from baseline to 4- 

and 8-month follow-up periods. 

This study will be carried out in 

Chicago, Illinois, where the TLC 

program is located. The study 

population will include 150 HIVnegative adult transgender women 

living in the Chicago metropolitan area. 

Participants will be at least 18 years of 

age; self-identify as transgender, 

transsexual, women and/or female who 

was assigned male sex at birth; and have 

a self-reported history of sex with men 

in the past four months. The study 

population will also include 10 TLC 

staff members. Staff members will be 

adults, involved in the delivery of TLC 

intervention services. Participation in 

this study is voluntary. 

We anticipate enrollment of a diverse 

sample of transgender women 

comprised mainly of racial/ethnic 

minority participants under 35 years of 

age, consistent with the current TLC 

program and the epidemiology of HIV 

infection among transgender women. 

Intervention participants will be 

recruited to the study through a 

combination of approaches, including 

traditional print advertisement, referral, 

in-person outreach, and through word of 

mouth. TLC staff members will be 

randomly selected to participate in the 

evaluation. 

A computer-assisted quantitative 

assessment will be used to collect 

information for this study, which will 

be delivered at the time of study 

enrollment and again at 4-month and 8- 

month follow-ups. The assessment will 

be used to measure changes in sexual 

risk behavior including condom use and 

pre-exposure prophylaxis (PrEP) care 

engagement. Intervention mediators, 

including gender affirmation, collective 

self-esteem and social support, and 

intervention satisfaction will also be 


daltland on DSKBBV9HB2PROD with NOTICES
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] 

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 

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 


daltland on DSKBBV9HB2PROD with NOTICES