Record of Decision; Acquisition of Site for Development of a Replacement Underground Safety Research Program Facility for the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH) in Mace, West Virginia, 59391-59392 [2021-23341]
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Federal Register / Vol. 86, No. 205 / Wednesday, October 27, 2021 / Notices
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[FR Doc. 2021–23428 Filed 10–26–21; 8:45 am]
BILLING CODE P
GENERAL SERVICES
ADMINISTRATION
[Notice-MA–2021–05; Docket No. 2021–
0002; Sequence No. 27]
Federal Travel Regulation (FTR);
Applicability of the Federal Travel
Regulation Part 301–13 to Employees
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Office of Government-wide
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ACTION: Notice of GSA Bulletin FTR 22–
03, Applicability of the Federal Travel
Regulation Part 301–13 to Employees
who are Nursing.
AGENCY:
GSA Bulletin FTR 22–03
provides guidance to agencies subject to
the Federal Travel Regulation (FTR) to
clarify that ‘‘special needs’’ travel may
include reasonable accommodations for
employees who breastfeed.
DATES: Applicability Date: This notice is
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Jill Denning, Office of Government-wide
Policy, Office of Asset and
Transportation Management, at
travelpolicy@gsa.gov. Please cite Notice
of GSA Bulletin FTR 22–03.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
Background
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Clearly visible and discernible; or (b)
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In recent years, agencies and
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VerDate Sep<11>2014
16:47 Oct 26, 2021
Jkt 256001
special need that agencies may
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Employees who breastfeed and go on
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GSA Bulletin FTR 22–03 can be
viewed in its entirety at https://
www.gsa.gov/ftrbulletins.
Krystal J. Brumfield,
Associate Administrator, Office of
Government-wide Policy.
[FR Doc. 2021–23397 Filed 10–26–21; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2018–0057]
Record of Decision; Acquisition of Site
for Development of a Replacement
Underground Safety Research
Program Facility for the Centers for
Disease Control and Prevention/
National Institute for Occupational
Safety and Health (CDC/NIOSH) in
Mace, West Virginia
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of availability.
AGENCY:
The Centers for Disease
Control and Prevention (CDC) within
the Department of Health and Human
Services (HHS), in cooperation with the
General Services Administration (GSA),
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
59391
announces the availability of the Record
of Decision (ROD) for the acquisition of
a Site in Mace, West Virginia, and the
development of this Site into a
replacement for the National Institute
for Occupational Safety and Health
(NIOSH) Underground Safety Research
Program facility (Proposed Action). The
acquisition and development will
replace the former Lake Lynn
Experimental Mine in Fayette County,
Pennsylvania, and will support research
programs focused on miner health and
safety issues. The site to be acquired
and developed includes 461.35 acres
located off U.S. Route 219 in Randolph
and Pocahontas Counties near Mace,
West Virginia (Site).
ADDRESSES: The ROD is available for
viewing on the Federal eRulemaking
Portal: https://www.regulations.gov
(reference Docket No. CDC–2018–0057).
FOR FURTHER INFORMATION CONTACT: Sam
Tarr, Office of Safety, Security, and
Asset Management (OSSAM), Centers
for Disease Control and Prevention,
1600 Clifton Road NE, H20–4, Atlanta,
Georgia 30329–4027, phone: (770) 488–
8170, or email: cdc-macewv-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 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 ensure
safe and healthful working conditions
for every working person in the United
States.
In 1997, when the mine safety and
health function was transferred from the
Bureau of Mines (BOM) to NIOSH,
NIOSH took over the lease for a facility
referred to as the Lake Lynn
Experimental Mine (LLEM). The BOM
had leased the LLEM facility since 1982.
The LLEM is located 60 miles south of
Pittsburgh, Pennsylvania. The LLEM
and its aboveground fire testing facility
were primarily used for studies and
research on mine explosions, mine
seals, mine rescue, ventilation, diesel
exhaust, new health and safety
technologies, ground control, and fire
suppression. After December 2012, the
property was no longer available for
long-term leasing. CDC attempted to
purchase the underlying property on
which LLEM is located, but NIOSH
vacated the LLEM after market-based
E:\FR\FM\27OCN1.SGM
27OCN1
lotter on DSK11XQN23PROD with NOTICES1
59392
Federal Register / Vol. 86, No. 205 / Wednesday, October 27, 2021 / Notices
purchase offers were rejected by the
property owners.
In 2013, CDC completed a Project
Development Study to outline a design
solution to replace the LLEM. The study
presented the facility and site
requirements and design concepts for
the replacement facilities. In 2016, to
identify potentially available locations
that could accommodate the space
requirements defined in the 2013 study,
GSA issued (on behalf of CDC) two
separate Requests for Expressions of
Interest (REOI) for a site, developed or
undeveloped, that could be used for the
new underground safety research
facility. The first REOI, advertised in
June 2016, contained a limited
delineated area within a 200-mile radius
of the LLEM. The REOI set forth criteria
that would be used to evaluate the
suitability of the submitted sites. One
expression of interest that had the
potential to meet the minimum criteria
was received. After further evaluation,
however, the site was found to be nonviable.
The second REOI was issued in
October 2016 and expanded the
delineated area to the entire contiguous
United States. Three expressions of
interest were received for sites in
Kentucky, Missouri, and West Virginia.
The Kentucky site did not meet the
minimum criteria, and the Missouri site
expression of interest did not contain all
necessary information to evaluate. The
offeror of the Missouri site did not
respond to subsequent GSA inquiries.
The potential Site in West Virginia
met the minimum criteria and was
determined to be a viable site. The Site
is located near Mace, West Virginia, and
straddles the Randolph and Pocahontas
County lines.
Under the National Environmental
Policy Act (NEPA), as implemented by
the Council on Environmental Quality
(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 Environmental Impact Statement
(EIS) for the acquisition of the Site and
construction of a new underground
safety research facility on February 14,
2019 and a Final EIS on July 16, 2021.
The Draft EIS was available for public
review and comment for 51 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 underground safety research
facility) and the No Action Alternative.
VerDate Sep<11>2014
16:47 Oct 26, 2021
Jkt 256001
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: October 21, 2021.
Angela K. Oliver,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2021–23341 Filed 10–26–21; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–E–1843; FDA–
2020–E–1840; and FDA–2020–E–1839]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; XENLETA Tablets New
Drug Application 211672
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for XENLETA tablets and is publishing
this notice of that determination as
required by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
SUMMARY:
Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by December 27, 2021.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
April 25, 2022. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before December 27,
2021. The https://www.regulations.gov
DATES:
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electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 27, 2021.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket Nos. FDA–
2020–E–1839, FDA–2020–E–1840, and
FDA–2020–E–1843 for ‘‘Determination
of Regulatory Review Period for
Purposes of Patent Extension; XENLETA
TABLETS NDA 211672.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
E:\FR\FM\27OCN1.SGM
27OCN1
]]>Agencies
[Federal Register Volume 86, Number 205 (Wednesday, October 27, 2021)]
[Notices]
[Pages 59391-59392]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23341]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2018-0057]
Record of Decision; Acquisition of Site for Development of a
Replacement Underground Safety Research Program Facility for the
Centers for Disease Control and Prevention/National Institute for
Occupational Safety and Health (CDC/NIOSH) in Mace, West Virginia
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC) within
the Department of Health and Human Services (HHS), in cooperation with
the General Services Administration (GSA), announces the availability
of the Record of Decision (ROD) for the acquisition of a Site in Mace,
West Virginia, and the development of this Site into a replacement for
the National Institute for Occupational Safety and Health (NIOSH)
Underground Safety Research Program facility (Proposed Action). The
acquisition and development will replace the former Lake Lynn
Experimental Mine in Fayette County, Pennsylvania, and will support
research programs focused on miner health and safety issues. The site
to be acquired and developed includes 461.35 acres located off U.S.
Route 219 in Randolph and Pocahontas Counties near Mace, West Virginia
(Site).
ADDRESSES: The ROD is available for viewing on the Federal eRulemaking
Portal: https://www.regulations.gov (reference Docket No. CDC-2018-
0057).
FOR FURTHER INFORMATION CONTACT: Sam Tarr, Office of Safety, Security,
and Asset Management (OSSAM), Centers for Disease Control and
Prevention, 1600 Clifton Road NE, H20-4, Atlanta, Georgia 30329-4027,
phone: (770) 488-8170, or email: [email protected].
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 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 ensure safe and healthful
working conditions for every working person in the United States.
In 1997, when the mine safety and health function was transferred
from the Bureau of Mines (BOM) to NIOSH, NIOSH took over the lease for
a facility referred to as the Lake Lynn Experimental Mine (LLEM). The
BOM had leased the LLEM facility since 1982. The LLEM is located 60
miles south of Pittsburgh, Pennsylvania. The LLEM and its aboveground
fire testing facility were primarily used for studies and research on
mine explosions, mine seals, mine rescue, ventilation, diesel exhaust,
new health and safety technologies, ground control, and fire
suppression. After December 2012, the property was no longer available
for long-term leasing. CDC attempted to purchase the underlying
property on which LLEM is located, but NIOSH vacated the LLEM after
market-based
[[Page 59392]]
purchase offers were rejected by the property owners.
In 2013, CDC completed a Project Development Study to outline a
design solution to replace the LLEM. The study presented the facility
and site requirements and design concepts for the replacement
facilities. In 2016, to identify potentially available locations that
could accommodate the space requirements defined in the 2013 study, GSA
issued (on behalf of CDC) two separate Requests for Expressions of
Interest (REOI) for a site, developed or undeveloped, that could be
used for the new underground safety research facility. The first REOI,
advertised in June 2016, contained a limited delineated area within a
200-mile radius of the LLEM. The REOI set forth criteria that would be
used to evaluate the suitability of the submitted sites. One expression
of interest that had the potential to meet the minimum criteria was
received. After further evaluation, however, the site was found to be
non-viable.
The second REOI was issued in October 2016 and expanded the
delineated area to the entire contiguous United States. Three
expressions of interest were received for sites in Kentucky, Missouri,
and West Virginia. The Kentucky site did not meet the minimum criteria,
and the Missouri site expression of interest did not contain all
necessary information to evaluate. The offeror of the Missouri site did
not respond to subsequent GSA inquiries.
The potential Site in West Virginia met the minimum criteria and
was determined to be a viable site. The Site is located near Mace, West
Virginia, and straddles the Randolph and Pocahontas County lines.
Under the National Environmental Policy Act (NEPA), as implemented
by the Council on Environmental Quality (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 Environmental Impact
Statement (EIS) for the acquisition of the Site and construction of a
new underground safety research facility on February 14, 2019 and a
Final EIS on July 16, 2021. The Draft EIS was available for public
review and comment for 51 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 underground safety research facility) and the
No Action Alternative. 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: October 21, 2021.
Angela K. Oliver,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2021-23341 Filed 10-26-21; 8:45 am]
BILLING CODE 4163-18-P
