83 FR 56088 - Notice of Intent To Prepare an Environmental Impact Statement and Notice of Scoping Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 218 (November 9, 2018)

Page Range		56088-56089
FR Document		2018-24557

In accordance with the National Environmental Policy Act, the National Institutes of Health (NIH) is issuing this notice to advise the public that an environmental impact statement will be prepared for the Surgery, Radiology and Lab Medicine Building with associated Utility Vault and Patient Parking Garage project located on the National Institutes of Health, Bethesda Campus, Bethesda, Maryland.

Federal Register, Volume 83 Issue 218 (Friday, November 9, 2018)

[Federal Register Volume 83, Number 218 (Friday, November 9, 2018)]
[Notices]
[Pages 56088-56089]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-24557]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Notice of Intent To Prepare an Environmental Impact Statement and 
Notice of Scoping Meeting

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: In accordance with the National Environmental Policy Act, the 
National Institutes of Health (NIH) is issuing this notice to advise 
the public that an environmental impact statement will be prepared for 
the Surgery, Radiology and Lab Medicine Building with associated 
Utility Vault and Patient Parking Garage project located on the 
National Institutes of Health, Bethesda Campus, Bethesda, Maryland.

DATES: The Scoping Meeting is planned for November 28, 2018, from 6 
p.m.-9 p.m., with the formal presentation to begin at 7 p.m. Scoping 
comments must be postmarked no later than December 29, 2018, to ensure 
they are considered.

ADDRESSES: The Scoping Meeting will be held at 6001 Executive 
Boulevard, Rockville, MD 20852. All comments and questions on the 
Scoping Meeting and the Environmental Impact Statement should be 
directed to Valerie Nottingham, Deputy Director, Division of 
Environmental Protection, Office of Research Facilities, NIH, B13/2S11, 
9000 Rockville Pike, Bethesda, Maryland 20892, telephone 301-496-7775; 
fax 301-480-0204; or email: [email protected].

FOR FURTHER INFORMATION CONTACT: Valerie Nottingham, Deputy Director, 
Division of Environmental Protection, Office of Research Facilities, 
NIH, B13/2S11, 9000 Rockville Pike, Bethesda, Maryland 20892, telephone 
301-496-7775; fax 301-480-0204; or email: [email protected]. For the 
purpose of National Institutes of Health (NIH) and its National 
Environmental Policy Act (NEPA) procedures, the delegation of authority 
to administer, interpret and oversee the applicable environmental laws, 
Executive Orders and regulations for the NIH including the authority to 
oversee and manage the NIH NEPA program for assessing environmental 
impacts and publish final decisions has been given to the Director, 
Office of Research Facilities Development and Operation, Mr. Daniel G. 
Wheeland.

SUPPLEMENTARY INFORMATION: The NIH's mission is to seek fundamental 
knowledge about the nature and behavior of living systems and the 
application of that knowledge to enhance health, lengthen life, and 
reduce illness and disability. In order to fulfill and uphold this 
mission the infrastructure of the NIH Bethesda Campus must be able to 
support the NIH's biomedical research programs.
    The proposed Surgery, Radiology and Lab Medicine Building with 
associated Utility Vault and Patient Parking Garage project is to house 
General Radiology and Imaging Services (RADIS), the Department of 
Perioperative Medicine (DPM), the Department of Laboratory Medicine 
(DLM) and the relocated functions for the National Cancer Institute 
(NCI) in a state-of-the-art, safe, functionally efficient, flexible and 
cost-effective facility. During the study period, NIH expanded the 
building program to also include space for the National Heart, Lung & 
Blood Institute's (NHLBI) Cardiovascular Intervention Program (Cath 
Lab) and for the Interventional Radiology (IR) Program.
    The proposed project consists of nine (9) levels above grade 
(including interstitial floors and a roof penthouse) and two (2) levels 
below grade. The proposed 505,200 building gross square feet (BGSF) of 
new construction will be linked to the west lab wing of the existing 
CRC (Building 10), which will include an additional 82,960 BGSF of 
interior renovation. The proposed new building addition foot print of 
53,270 BGSF will be positioned between the CRC and Convent Drive.
    The proposed project scope also includes the relocation of a 
portion of the existing campus utility tunnel, reconstruction of the 
displaced children's playground and connection to the new Pedestrian 
Tunnel that will be constructed with the proposed Patient Parking 
Garage across Convent Drive. Additionally, the project will include the 
installation of supporting infrastructure, such as emergency generators 
and medical gas storage, in the new Utility Vault and Utility Yard that 
will be constructed across Convent Drive as part of a separate, 
enabling project.
    In accordance with 40 CFR 1500-1508 and Health and Human Services 
(HHS) environmental procedures, NIH will prepare an Environmental 
Impact Statement (EIS) for the proposed project. The EIS will evaluate 
the impacts of the alternatives should development occur as proposed. 
Among the items the EIS will examine are the implications of the 
project on community infrastructure, including, but not limited to, 
utilities, storm water management, traffic and transportation, and 
other public services.
    To ensure that the public is afforded the greatest opportunity to 
participate in

[[Page 56089]]

the planning and environmental review process, NIH is inviting oral and 
written comments on the proposed project and related environmental 
issues.
    The NIH will be sponsoring a public Scoping Meeting to provide 
individuals an opportunity to share their ideas, including recommended 
alternatives and environmental issues the EIS should consider. All 
interested parties are encouraged to attend. NIH has established a 30-
day public comment period for the scoping process.

    Dated: October 29, 2018.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2018-24557 Filed 11-8-18; 8:45 am]
 BILLING CODE 4140-01-P

56088 Federal Register / Vol. 83, No. 218 / Friday, November 9, 2018 / Notices

2018 (Docket No. FDA–2018–P–2506), DEPARTMENT OF HEALTH AND enhance health, lengthen life, and
under 21 CFR 10.25 and 21 CFR 10.30, HUMAN SERVICES reduce illness and disability. In order to
requesting that the Agency determine fulfill and uphold this mission the
whether AXIRON (testosterone) National Institutes of Health infrastructure of the NIH Bethesda
transdermal metered solution, 30 mg/1.5 Campus must be able to support the
Notice of Intent To Prepare an NIH’s biomedical research programs.
mL actuation, was withdrawn from sale Environmental Impact Statement and
for reasons of safety or effectiveness. The proposed Surgery, Radiology and
Notice of Scoping Meeting Lab Medicine Building with associated
After considering the citizen petition Utility Vault and Patient Parking Garage
AGENCY: National Institutes of Health,
and reviewing Agency records and project is to house General Radiology
HHS.
based on the information we have at this and Imaging Services (RADIS), the
time, FDA has determined under ACTION: Notice.
Department of Perioperative Medicine
§ 314.161 that AXIRON (testosterone) SUMMARY: In accordance with the (DPM), the Department of Laboratory
transdermal metered solution, 30 mg/1.5 National Environmental Policy Act, the Medicine (DLM) and the relocated
mL actuation, was not withdrawn for National Institutes of Health (NIH) is functions for the National Cancer
reasons of safety or effectiveness. The issuing this notice to advise the public Institute (NCI) in a state-of-the-art, safe,
petitioner has identified no data or other that an environmental impact statement functionally efficient, flexible and cost-
information suggesting that AXIRON will be prepared for the Surgery, effective facility. During the study
(testosterone) transdermal metered Radiology and Lab Medicine Building period, NIH expanded the building
solution, 30 mg/1.5 mL actuation, was with associated Utility Vault and Patient program to also include space for the
withdrawn for reasons of safety or Parking Garage project located on the National Heart, Lung & Blood Institute’s
effectiveness. We have carefully National Institutes of Health, Bethesda (NHLBI) Cardiovascular Intervention
reviewed our files for records Campus, Bethesda, Maryland. Program (Cath Lab) and for the
DATES: The Scoping Meeting is planned Interventional Radiology (IR) Program.
concerning the withdrawal of AXIRON
for November 28, 2018, from 6 p.m.-9 The proposed project consists of nine
(testosterone) transdermal metered (9) levels above grade (including
solution, 30 mg/1.5 mL actuation, from p.m., with the formal presentation to
begin at 7 p.m. Scoping comments must interstitial floors and a roof penthouse)
sale. We have also independently and two (2) levels below grade. The
be postmarked no later than December
evaluated relevant literature and data proposed 505,200 building gross square
29, 2018, to ensure they are considered.
for possible postmarketing adverse feet (BGSF) of new construction will be
ADDRESSES: The Scoping Meeting will
events. We have found no information linked to the west lab wing of the
be held at 6001 Executive Boulevard,
that would indicate that this drug existing CRC (Building 10), which will
Rockville, MD 20852. All comments and
product was withdrawn from sale for include an additional 82,960 BGSF of
questions on the Scoping Meeting and
reasons of safety or effectiveness. the Environmental Impact Statement interior renovation. The proposed new
Accordingly, the Agency will should be directed to Valerie building addition foot print of 53,270
continue to list AXIRON (testosterone) BGSF will be positioned between the
Nottingham, Deputy Director, Division
transdermal metered solution, 30 mg/1.5 CRC and Convent Drive.
of Environmental Protection, Office of
The proposed project scope also
mL actuation, in the ‘‘Discontinued Research Facilities, NIH, B13/2S11, includes the relocation of a portion of
Drug Product List’’ section of the Orange 9000 Rockville Pike, Bethesda, the existing campus utility tunnel,
Book. The ‘‘Discontinued Drug Product Maryland 20892, telephone 301–496– reconstruction of the displaced
List’’ delineates, among other items, 7775; fax 301–480–0204; or email: children’s playground and connection
drug products that have been nihnepa@mail.nih.gov. to the new Pedestrian Tunnel that will
discontinued from marketing for reasons FOR FURTHER INFORMATION CONTACT: be constructed with the proposed
other than safety or effectiveness. FDA Valerie Nottingham, Deputy Director, Patient Parking Garage across Convent
will not begin procedures to withdraw Division of Environmental Protection, Drive. Additionally, the project will
approval of approved ANDAs that refer Office of Research Facilities, NIH, B13/ include the installation of supporting
to this drug product. Additional ANDAs 2S11, 9000 Rockville Pike, Bethesda, infrastructure, such as emergency
that refer to this drug product may also Maryland 20892, telephone 301–496– generators and medical gas storage, in
be approved by the Agency as long as 7775; fax 301–480–0204; or email: the new Utility Vault and Utility Yard
they meet all other legal and regulatory nihnepa@mail.nih.gov. For the purpose that will be constructed across Convent
requirements for the approval of of National Institutes of Health (NIH) Drive as part of a separate, enabling
and its National Environmental Policy project.
ANDAs. If FDA determines that labeling
Act (NEPA) procedures, the delegation In accordance with 40 CFR 1500–1508
for this drug product should be revised
of authority to administer, interpret and and Health and Human Services (HHS)
to meet current standards, the Agency
oversee the applicable environmental environmental procedures, NIH will
will advise ANDA applicants to submit laws, Executive Orders and regulations
such labeling. prepare an Environmental Impact
for the NIH including the authority to Statement (EIS) for the proposed project.
Dated: November 5, 2018. oversee and manage the NIH NEPA The EIS will evaluate the impacts of the
Leslie Kux, program for assessing environmental alternatives should development occur
Associate Commissioner for Policy. impacts and publish final decisions has as proposed. Among the items the EIS
been given to the Director, Office of
khammond on DSK30JT082PROD with NOTICES

[FR Doc. 2018–24604 Filed 11–8–18; 8:45 am] will examine are the implications of the
Research Facilities Development and project on community infrastructure,
BILLING CODE 4164–01–P
Operation, Mr. Daniel G. Wheeland. including, but not limited to, utilities,
SUPPLEMENTARY INFORMATION: The NIH’s storm water management, traffic and
mission is to seek fundamental transportation, and other public
knowledge about the nature and services.
behavior of living systems and the To ensure that the public is afforded
application of that knowledge to the greatest opportunity to participate in

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Document Created: 2018-11-09 03:34:37
Document Modified: 2018-11-09 03:34:37

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		The Scoping Meeting is planned for November 28, 2018, from 6 p.m.-9 p.m., with the formal presentation to begin at 7 p.m. Scoping comments must be postmarked no later than December 29, 2018, to ensure they are considered.
Contact		Valerie Nottingham, Deputy Director, Division of Environmental Protection, Office of Research Facilities, NIH, B13/2S11, 9000 Rockville Pike, Bethesda, Maryland 20892, telephone 301-496-7775; fax 301-480-0204; or email: [email protected] For the purpose of National Institutes of Health (NIH) and its National Environmental Policy Act (NEPA) procedures, the delegation of authority to administer, interpret and oversee the applicable environmental laws, Executive Orders and regulations for the NIH including the authority to oversee and manage the NIH NEPA program for assessing environmental impacts and publish final decisions has been given to the Director, Office of Research Facilities Development and Operation, Mr. Daniel G. Wheeland.
FR Citation		83 FR 56088

83 FR 56088 - Notice of Intent To Prepare an Environmental Impact Statement and Notice of Scoping Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 218 (November 9, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health