Federal Register / Vol. 83, No. 162 / Tuesday, August 21, 2018 / Notices 42301 

traffic, the requested burden is 

approximately 23 hours. This total is 

estimated from 200 respondents 

submitting domestic reports of death or 

communicable disease a year, with an 

average burden of seven minutes per 

report. This totals 23 burden hours 

annually. There is no burden to 

respondents other than the time 

required to make the report of illness or 

death. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of 

respondent Form name Number of respondents 

Number of 

responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Pilot in command.42 CFR 70.11 Report of death or illness onboard aircraft 

operated by airline.

190 1 7/60 22 

Master of vessel or person in 

charge of 

conveyance.

42 CFR 70.4 Report by the master of a vessel or person 

in charge of conveyance of the incidence of a communicable disease occurring while in interstate travel.

10 1 7/60 1 

Total ....... .............................................................................................. ........................ ........................ ........................ 23 

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. 2018–17979 Filed 8–20–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60-Day–18–1100; Docket No. CDC–2018– 

0070] 

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 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 Identification of Behavioral and 

Clinical Predictors of Early HIV 

Infection (Project DETECT), which 

collects information from people testing 

for HIV in order to compare the 

performance characteristics of new 

point of care HIV tests for detection of 

early HIV infection and to identify 

behavioral and clinical predictors of 

early HIV infection. 

DATES: CDC must receive written 

comments on or before October 22, 

2018. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2018– 

0070 by any of the following methods: 

• Federal eRulemaking Portal: 

Regulations.gov. Follow the instructions 

for submitting comments. 

• Mail: Jeffrey M. Zirger, 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. 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. 

FOR FURTHER INFORMATION: To request 

more information on the proposed 

project or to obtain a copy of the 

information collection plan and 

instruments, contact Jeffery M. Zirger, 

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 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; 

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 

Identification of Behavioral and 

Clinical Predictors of Early HIV 

Infection (Project DETECT)—(OMB No. 

0920–1100 Exp: 2/29/2019)— 

Extension—National Center for HIV/ 

AIDS, Viral Hepatitis, STD, and TB 

Prevention (NCHHSTP), Centers for 

Disease Control and Prevention (CDC). 


sradovich on DSK3GMQ082PROD with NOTICES
42302 Federal Register / Vol. 83, No. 162 / Tuesday, August 21, 2018 / Notices 

Background and Brief Description 

CDC provides guidelines for HIV 

testing and diagnosis for the United 

States, as well as technical guidance for 

its grantees. The purpose of this project 

is to assess characteristics of HIV testing 

technologies to update these guidance 

documents to reflect the latest available 

testing technologies, their performance 

characteristics, and considerations 

regarding their use. Specifically, CDC 

will describe behavioral and clinical 

characteristics of persons with early 

infection to help HIV test providers 

(including CDC grantees) choose which 

HIV tests to use, and target tests 

appropriately to persons at different 

levels of risk. This information will be 

disseminated primarily through 

guidance documents and articles in 

peer-reviewed journals. 

The primary study population will be 

persons at high risk for or diagnosed 

with HIV infection, many of whom will 

be men who have sex with men (MSM) 

because the majority of new HIV 

infections occur each year among this 

population. The goals of the project are 

to: (1) Characterize the performance of 

new HIV tests for detecting established 

and early HIV infection at the point of 

care, relative to each other and to 

currently used gold standard, non-POC 

tests, and (2) identify behavioral and 

clinical predictors of early HIV 

infection. 

Project DETECT will enroll 1,667 

persons annually at the primary study 

site clinic in Seattle, and an additional 

200 persons will be enrolled from other 

clinics in the greater Seattle area. The 

study will be conducted in two phases. 

Phase 1: After a clinic client consents 

to participate, he/she will be assigned a 

unique participant ID and will then 

undergo testing with the seven new HIV 

tests under study. While awaiting test 

results, participants will undergo 

additional specimen collections and 

complete the Phase 1 Enrollment 

Survey. 

Phase 2: All Phase 1 participants 

whose results on the seven tests under 

investigation are not in agreement with 

one another (‘‘discordant’’) will be 

considered to have a potential early HIV 

infection. Nucleic amplification testing 

that detects viral nucleic acids will be 

conducted to confirm an HIV diagnosis 

and rule out false positives. Study 

investigators expect that each year, 50 

participants with discordant test results 

will be invited to participate in serial 

follow-up specimen collections to assess 

the time point at which all HIV test 

results resolve and become concordant 

positive (indicating enrollment during 

early infection) or concordant negative 

(indicating one or more false-positive 

test results in Phase 1). 

The follow-up schedule will consist 

of up to nine visits scheduled at regular 

intervals over a 70-day period. At each 

follow-up visit, participants will be 

tested with the new HIV tests and 

additional oral fluid and blood 

specimens will also be collected for 

storage and use in future HIV test 

evaluations at CDC. Participants will be 

followed up only to the point at which 

all their test results become concordant. 

At each time point, participants will be 

asked to complete the Phase 2 HIV 

Symptom and Care survey that collects 

information on symptoms associated 

with early HIV infection as well as 

access to HIV care and treatment since 

the last Phase 2 visit. When all tests 

become concordant (i.e., at the last 

Phase 2 visit) participants will complete 

the Phase 2 behavioral survey to 

identify any behavioral changes during 

follow-up. Of the 50 Phase 2 

participants; it is estimated that no more 

than 26, annually, will have early HIV 

infection. 

All data for the proposed information 

collection will be collected via an 

electronic Computer Assisted SelfInterview (CASI) survey. Participants 

will complete the surveys on an 

encrypted computer, with the exception 

of the Phase 2 Symptom and Care 

survey, which will be administered by 

a research assistant and then 

electronically entered into the CASI 

system. Data to be collected via CASI 

include questions on sociodemographic 

characteristics, medical care, HIV 

testing, pre-exposure prophylaxis, 

antiretroviral treatment, sexually 

transmitted diseases (STD) history, 

symptoms of early HIV infection, 

substance use and sexual behavior. 

Data from the surveys will be merged 

with HIV test results and relevant 

clinical data using the unique 

identification (ID) number. Data will be 

stored on a secure server managed by 

the University of Washington 

Department of Medicine Information 

Technology (IT) Services. 

The participation of respondents is 

voluntary. There is no cost to the 

respondents other than their time. The 

total estimated annual burden hours for 

the proposed project are 2,110 hours. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Persons eligible for study .................. Phase 1 Consent ............................. 2,334 1 15/60 584 

Enrolled participants .......................... Phase 1 Enrollment Survey A ......... 1,667 1 45/60 1,250 

Phase 1 Enrollment Survey B ......... 200 1 60/60 200 

Phase 2 Consent ............................. 50 1 15/60 13 

Phase 2 HIV Symptom and Care 

survey.

50 9 5/60 38 

Phase 2 Behavioral Survey ............. 50 1 30/60 25 

Total ........................................... .......................................................... ........................ ........................ ........................ 2,110 

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. 2018–17980 Filed 8–20–18; 8:45 am] 

BILLING CODE 4163–18–P 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 162 / Tuesday, August 21, 2018 / Notices 42303 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket No. CDC–2017–0059] 

Notice of Availability of Record of 

Decision for Site Acquisition and 

Campus Consolidation for the Centers 

for Disease Control and Prevention/ 

National Institute for Occupational 

Safety and Health (CDC/NIOSH), 

Cincinnati, Ohio 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC) within 

the Department of Health and Human 

Services (HHS), in cooperation with the 

U.S. General Services Administration 

(GSA), announces the availability of the 

Record of Decision (ROD) for the 

acquisition of a site in Cincinnati, Ohio, 

and development of this site into a new, 

consolidated CDC/National Institute for 

Occupational Safety and Health 

(NIOSH) campus (Proposed Action). 

The site to be acquired is bounded by 

Martin Luther King Drive East to the 

south, Harvey Avenue to the west, 

Ridgeway Avenue to the north, and 

Reading Road to the east. 

CDC published a Final Environmental 

Impact Statement (EIS) for this action on 

July 20, 2018 pursuant to the 

requirements of the National 

Environmental Policy Act (NEPA) of 

1969 as implemented by the Council on 

Environmental Quality (CEQ) 

Regulations (40 CFR parts 1500–1508). 

CDC carefully considered the findings of 

the Final EIS when making its decision. 

ADDRESSES: The ROD is available for 

viewing on the Federal eRulemaking 

Portal: http://www.regulations.gov 

(reference Docket No. CDC–2017–0059). 

A limited number of printed copies are 

available upon request to cdccincinnati-eis@cdc.gov or Harry Marsh, 

Architect, Office of Safety, Security and 

Asset Management (OSSAM), Centers 

for Disease Control and Prevention, 

1600 Clifton Road NE, MS–K80, Atlanta, 

Georgia 30329–4027. All U.S. Mail 

communications must include the 

agency name and Docket Number. 

FOR FURTHER INFORMATION CONTACT: 

Harry Marsh, Architect, Office of Safety, 

Security and Asset Management 

(OSSAM), Centers for Disease Control 

and Prevention, 1600 Clifton Road NE, 

MS–K80, Atlanta, Georgia 30329–4027, 

phone: (770) 488–8170, or email: cdccincinnati-eis@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

Background: CDC is dedicated to 

protecting health and promoting quality 

of life through the prevention and 

control of disease, injury, and disability. 

NIOSH, one of CDC’s Centers, Institutes, 

and Offices, was established by the 

Occupational Safety and Health Act of 

1970. NIOSH plans, directs, and 

coordinates a national program to 

develop and establish recommended 

occupational safety and health 

standards; conduct research and 

training; provide technical assistance; 

and perform related activities to assure 

safe and healthful working conditions 

for every working person in the United 

States. 

Currently, three NIOSH research 

facilities—the Robert A. Taft Campus, 

Taft North Campus, and the Alice 

Hamilton Laboratory Campus—are 

located in Cincinnati, Ohio. These 

facilities no longer meet the research 

needs required to support occupational 

safety and health in the modern 

workplace. The facilities’ deficiencies 

adversely affect NIOSH’s ability to 

conduct occupational safety and health 

research in Cincinnati. It is not possible 

to renovate the facilities located on the 

three campuses to meet current 

standards and requirements. 

Additionally, the current distribution of 

NIOSH activities across separate 

campuses in Cincinnati results in 

inefficiencies in scientific collaboration 

and the duplication of operational 

support activities. To address these 

issues, CDC proposed to relocate and 

consolidate its Cincinnati-based 

functions and personnel (approximately 

550 employees) currently housed at the 

three existing campuses to a new, 

consolidated campus in Cincinnati. 

Potential locations for the new 

campus were identified through a 

comprehensive site selection process 

conducted by GSA on behalf of CDC. In 

June 2016, GSA issued a Request for 

Expressions of Interest (REOI) seeking 

potential sites capable of 

accommodating the proposed new 

campus. In response to the REOI, GSA 

received seven expressions of interest. 

Following an assessment of each site, 

GSA found that only one site qualified 

for further consideration (the Site). The 

Site encompasses all land between 

Martin Luther King Drive East to the 

south, Harvey Avenue to the west, 

Ridgeway Avenue to the north, and 

Reading Road to the east in Cincinnati, 

Ohio. 

Under NEPA, as implemented by CEQ 

Regulations (40 CFR parts 1500–1508), 

Federal agencies are required to 

evaluate the environmental effects of 

their proposed actions and a range of 

reasonable alternatives to the proposed 

action before making a decision. In 

compliance with NEPA, CDC published 

a Draft EIS for the proposed site 

acquisition and campus consolidation 

on February 9, 2018 and a Final EIS on 

July 20, 2018. The Draft EIS was 

available for public review and 

comment for 45 days. All comments 

received were considered when 

preparing the Final EIS. The Draft and 

Final EIS analyzed two alternatives: the 

Proposed Action Alternative 

(acquisition of the Site and construction 

of a new, consolidated CDC/NIOSH 

campus) and the No Action Alternative 

(continued use of the existing campuses 

for the foreseeable future). The Final EIS 

identified the Proposed Action 

Alternative as CDC’s Preferred 

Alternative. 

After carefully considering the Final 

EIS and all comments received, CDC has 

made the decision to implement the 

Proposed Action Alternative. CDC’s 

rationale for this decision is detailed in 

the ROD. The ROD incorporates all the 

mitigation and minimization measures 

described in the Final EIS. 

Dated: August 13, 2018. 

Sandra Cashman, 

Executive Secretary, Centers for Disease 

Control and Prevention. 

[FR Doc. 2018–17707 Filed 8–20–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket Number CDC–2018–0059; NIOSH– 

315] 

Request for Information About 

Inorganic Lead (CAS No. 7439–92–1) 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH) of the Centers for Disease 

Control and Prevention (CDC), 

Department of Health and Human 

Services (HHS). 

ACTION: Request for information. 

SUMMARY: The National Institute for 

Occupational Safety and Health 

(NIOSH) of the Centers for Disease 

Control and Prevention (CDC) intends to 

evaluate the scientific data on inorganic 

lead, to develop updated 

recommendations on the potential 

health risks, medical surveillance, 

recommended measures for safe 

handling, and to establish an updated 

Recommended Exposure Limit (REL). 

DATES: Electronic or written comments 

must be received by October 22, 2018. 


sradovich on DSK3GMQ082PROD with NOTICES