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]

Download as PDF Federal Register / Vol. 86, No. 205 / Wednesday, October 27, 2021 / Notices government debt instruments. The Board requests comment on all aspects of the review. The Board specifically requests comment on the respects in which U.S. companies are accorded, or are not accorded, the same competitive opportunities in the underwriting and distribution of Spanish government debt instruments as Spain accords to Spanish companies. All comments received will be considered in the context of the review of this market. By order of the Board of Governors of the Federal Reserve System. Ann E. Misback, Secretary of the Board. [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 Who Are Nursing Office of Government-wide Policy (OGP), General Services Administration (GSA). 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 effective upon date of publication. FOR FURTHER INFORMATION CONTACT: Ms. 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: lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: Background Federal agencies can accommodate an employee’s special needs while on temporary duty travel pursuant to the FTR, Part 301–13. Per § 301–13.2, an agency can pay for additional travel expenses to accommodate a special physical need which is either: (a) Clearly visible and discernible; or (b) substantiated in writing by a competent medical authority. In recent years, agencies and employees have asked whether employees who breastfeed have a VerDate Sep<11>2014 16:47 Oct 26, 2021 Jkt 256001 special need that agencies may accommodate while the employee is on temporary duty travel (TDY). Employees who breastfeed and go on official travel orders face a physical challenge that other employees who are not breastfeeding do not. Travel away from home usually requires the employee to be away from the child. While milk can be expressed beforehand and left for a caregiver, sometimes there is not enough to last the duration of the trip and milk must be safely stored and shipped back home. In order to not force employees to make a choice between nursing or fulfilling work duties, Federal agencies may recognize that a nursing employee on official travel has a special need, as verified per regulatory requirements. Agencies may determine that the special need means that a spouse, nanny, or other attendant can accompany the employee on the trip at Government expense in order to watch the child in between the employee’s reasonable break periods to breastfeed while working at the temporary duty station. If no attendant is necessary, an employee on official travel may still need to use services for storage and shipment of breast milk to the child. 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 Frm 00032 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: http://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: PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 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

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[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]


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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: http://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