60-day Federal Register Notice

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Federal Register / Vol. 83, No. 162 / Tuesday, August 21, 2018 / Notices
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
Number of
respondents

Average
burden per
response
(in hours)

Form name

Pilot in command.
Master of vessel or person in
charge of
conveyance.

42 CFR 70.11 Report of death or illness onboard aircraft
operated by airline.
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.

190

1

7/60

22

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.

behavioral and clinical predictors of
early HIV infection.
DATES: CDC must receive written
comments on or before October 22,
2018.

[FR Doc. 2018–17979 Filed 8–20–18; 8:45 am]

ADDRESSES:

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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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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

SUMMARY:

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Number of
responses
per
respondent

Type of
respondent

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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

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Total burden
(in hours)

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).

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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.

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.

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

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ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

Type of respondents

Form name

Persons eligible for study ..................
Enrolled participants ..........................

Phase 1 Consent .............................
Phase 1 Enrollment Survey A .........
Phase 1 Enrollment Survey B .........
Phase 2 Consent .............................
Phase 2 HIV Symptom and Care
survey.
Phase 2 Behavioral Survey .............

2,334
1,667
200
50
50
50

1

30/60

25

Total ...........................................

..........................................................

........................

........................

........................

2,110

1
1
1
1
9

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]
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45/60
60/60
15/60
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584
1,250
200
13
38

Federal Register / Vol. 83, No. 162 / Tuesday, August 21, 2018 / Notices
SUPPLEMENTARY INFORMATION:

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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:

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.

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SUMMARY:

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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

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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)
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.
AGENCY:

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.
SUMMARY:

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