NIH Bethesda Surgery, Radiology and Laboratory Medicine Record of Decision, 53386-53390 [2020-18926]
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Federal Register / Vol. 85, No. 168 / Friday, August 28, 2020 / Notices
Secretary for Health, Office of Disease
Prevention and Health Promotion, 1101
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MD 20852. Phone: (240) 453–8826.
Email: OHQ@hhs.gov.
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governed by provisions of the Federal
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Law 92–463, as amended (5 U.S.C.,
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App.) which sets forth standards for the
formation and use of federal advisory
committees.
Dated: August 24, 2020.
Paul Reed,
Deputy Assistant Secretary for Health, Acting
Director, Office of Disease Prevention and
Health Promotion, Office of the Assistant
Secretary for Health.
[FR Doc. 2020–18917 Filed 8–27–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
NIH Bethesda Surgery, Radiology and
Laboratory Medicine Record of
Decision
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The Department of Health and
Human Services, the National Institutes
of Health (NIH), has decided, after
completion of a Final Environmental
Impact Statement (FEIS) and a thorough
consideration of the public comments
on the Draft EIS, to implement the
Proposed Action, referred to as the
Proposed Action in the Final EIS. The
Surgery, Radiology and Laboratory
Medicine (SRLM) action is for
construction of an additional 527,100
gross square feet (gsf) to the exiting
Building 10. In addition to 527,100 gsf
of space in the new building, the
Proposed Action will include
renovation of 102,600 gsf of existing
space within the West Laboratory Wing
of the Clinical Research Center. The
footprint of the SRLM will occupy
55,500 gsf. A proposed patient parking
garage is also included in the proposed
action. The proposed garage will be a
multi-level, self-park garage,
accommodating approximately 780 cars.
FOR FURTHER INFORMATION CONTACT:
Valerie Nottingham, Deputy Director,
DEP, ORF, NIH, Building 13, Room
2S11, 9000 Rockville Pike, Bethesda,
MD 20892, Phone 301–496–7775,
nihnepa@mail.nih.gov. RESPONSIBLE
OFFICIAL: Daniel G. Wheeland,
Director, Office of Research Facilities
(ORF) Development and Operations,
NIH.
SUPPLEMENTARY INFORMATION:
SUMMARY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Leadership in
Alzheimer’s disease.
Date: October 15, 2020.
Time: 11:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892 (Video Meeting).
Contact Person: Greg Bissonette, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Institute on Aging, National
Institutes of Health, 7201 Wisconsin Avenue,
Gateway Building, Suite 2W200, Bethesda,
MD 20892, (301) 402–1622, bissonettegb@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: August 24, 2020
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–18927 Filed 8–27–20; 8:45 am]
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Decision
After careful review of the
environmental consequences in the
Final Environmental Impact Statement
for the SRLM, National Institutes of
Health Bethesda Campus, and
consideration of public comment
throughout the National Environmental
Policy Act of 1969 (NEPA) process, NIH
has decided to implement the Proposed
Action described below as the Selected
Alternative.
Selected Alternative
The Selected Alternative is intended
to further the NIH mission: To seek
fundamental knowledge about the
nature and behavior of living systems
and the application of that knowledge to
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enhance health, lengthen life, and
reduce illness and disability.
The Selected Alternative will meet
the purpose and need of the project in
several ways. First, the spatial
deficiencies would be addressed by
moving the current operations to
surgical, radiological, laboratory, and
office spaces that consolidate and
organize activities in an efficient
manner. Next, the SRLM Building will
be designed with the flexibility to
address future growth and change,
including floor-to-ceiling heights and
other features capable of
accommodating equipment associated
with newer technologies. The SRLM
Building will also incorporate upgraded,
up-to-date infrastructure systems which
will be more reliable, and will ensure
the ability to control temperature and
humidity. The SRLM Building will
address unacceptable vibration levels by
using more robust construction
materials and methods. The Selected
Alternative will be constructed to meet
progressive collapse requirements and
blast criteria.
Security and safety issues associated
with the current Building 10 parking
garage will be addressed by eliminating
exposure to deteriorated and spalling
concrete in the existing garage. The
Utility Vault portion of the project will
enable NIH to replace critical electrical
equipment that is beyond its service life.
Alternatives Considered
The Proposed Action Alternative and
No Action Alternative were the two
alternatives analyzed in the Final EIS.
Other alternatives were considered but
not carried forward due to their inability
to meet the purpose and need of the
project.
Factors Involved in the Decision
Several factors were involved during
the decision-making process; these
include spatial deficiencies, inability to
house new technologies, security and
safety, and an aging switching station.
Spatial deficiencies severely impact
the operating rooms, radiology suite and
clinical laboratory. Both patients and
staff lack sufficient support space as
they undergo care and conduct
treatment protocols. The distribution
systems for electrical, duct work, and
piping are degrading and require
replacement, but this work cannot be
done while the space is occupied. The
building’s floor-to-floor heights are
deficient by today’s utility requirements
and cannot contain the necessary utility
distribution systems. A lack of utility
capacity and control results in work
environments that suffer from poor
temperature and humidity control.
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These environmental factors can also
negatively impact the patient samples
that are being processed and tested.
Since the clinical research facility
opened more than 34 years ago,
biomedical research and its supporting
clinical programs have rapidly evolved
influencing the criteria for space and
infrastructure systems. The rapid
evolution of equipment (changing every
three to five years) has had a direct
impact on both space requirements and
utility systems that support them.
Hospital surgical suites are typically
replaced every 20 years to keep up with
the latest technological advancements,
operating room equipment, and
techniques. The existing facility has not
kept pace with modern surgical,
imaging, and clinical laboratory facility
requirements, and cannot accommodate
evolving requirements.
Currently, patient, visitor, and staff
parking is partially accommodated in an
underground parking garage located
below the Ambulatory Care Research
Facility tower. More specifically,
existing parking is located directly
below surgery, radiology, and laboratory
areas of the complex, which makes
repairs to the garage expensive, due to
patient occupancy on floors above. The
current garage has serious structural
deficiencies due to corrosion of the
concrete and underlying (exposed)
rebar, despite on-going maintenance.
The concrete and rebar corrosion is from
years of salt and chemicals brought into
the garage by the vehicle traffic. This
condition poses a safety threat to users
of the facility, and a liability threat to
the government, due to the potential for
falling pieces of concrete.
The equipment in Buildings 59 and
59A is aging and will soon need
replacement due to space constraints,
the inability to acquire replacement
parts, and failure of the current system
to meet requirements of the Life Safety
Code (National Fire Protection
Association 101) and Environment of
Care standards of the Joint Commission.
Resources Impacted
The Final EIS describes potential
environmental effects of the Selected
Alternative. These potential effects are
documented in Chapter 3 of the Final
EIS. Any potential adverse
environmental effects will be avoided or
mitigated through design elements,
procedures, and compliance with
regulatory and NIH requirements.
Potential impacts on air quality are all
within government standards (federal,
state, and local). NIH does not expect
significant negative effects on the
environment or on the citizens of
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Bethesda from construction and
operation at NIH.
Summary of Impacts
The following is a summary of
potential impacts resulting from the
Selected Alternative that NIH
considered when making its decision.
No adverse cumulative effects have been
identified during the NEPA process.
Likewise, no unavoidable or adverse
impacts from implementation of the
Selected Alternative have been
identified. The Selected Alternative will
be beneficial to the long-term
productivity of the national and
international biomedical research
communities. As a result of the Selected
Alternative, biomedical research
conducted at the NIH facilities on the
campus will experience an enhanced
potential of advance techniques in
disease prevention and cures,
development of infectious disease
vaccinations, and preparation of
defenses against naturally emerging and
re-emerging diseases and against
bioweapons. Additionally, the local
community will benefit from increased
employment, housing, and investment
Housing
Under the Selected Alternative, the
action will result in temporary minor
impacts on the population and the
availability of housing, due to
construction workers who might
temporarily relocate to the area. The
Proposed Action will result in no
permanent impacts to these resources as
there is no projected change in staff.
Temporary impacts on population and
housing associated with construction
activities are expected to be minor as
Bethesda is a densely populated urban
area and therefore the small temporary
increase in population would be very
small on a percentage basis.
Education
The Selected Alternative does not
involve any projected change in staff or
campus census. If any new employees
are hired, the numbers will be modest,
and the current public school capacity
in Bethesda or Montgomery County and
surrounding school districts is adequate
to accommodate the expected minimal
growth caused by the Selected
Alternative.
Transportation
Implementation of the Selected
Alternative will result in minor
temporary impacts to off-Campus roads,
transit, and traffic due to construction
activities. This will include additional
traffic due to construction vehicles, as
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well as shifts in employee and patient
traffic patterns.
Construction vehicles, estimated at
well less than 100 vehicles per day will
be screened at the Commercial Vehicle
Inspection Station (CVIF) on Rockville
Pike, and then enter via Wilson Drive.
As reported in the 2015 Chilled Water
EIS, peak morning traffic at Rockville
Pike and Wilson Drive, which is just
south of the CVIF, is 2,800 cars
southbound on Rockville Pike and 1,100
cars northbound on Rockville Pike. It is
assumed peak traffic on those roads is
similar to or higher than was reported
in 2015. Therefore, the overall impact to
off-Campus roads will be minor as the
number of construction vehicles would
be minimal (<100 vehicles per day)
relative to existing traffic counts.
Security
The Selected Alternative will not be
expected to have adverse impacts on
security on the NIH Campus. No new
security measures are proposed in the
Selected Alternative.
Employment
The Selected Alternative does not
involve any projected change in staff.
Environmental Justice
The Selected Alternative will not be
expected to have disproportionately
high or adverse impacts on low income
or minority populations of the affected
area.
Visual Quality
During construction of the Surgery
Radiology and Laboratory Medicine
(SRLM), Patient Parking Garage (PPG)
and Utility Vault (UV), direct visual
impacts will occur on Campus. Large
construction equipment will be
deployed in the project area for the
duration of activities. It is anticipated
that cranes, earth-moving equipment,
concrete trucks and other heavy
machinery will be in use for
approximately 6 years. Due to the
phased approach, the construction
duration is extended, and this will
represent a moderate, direct impact to
visual resources at the project location.
Off-Campus observers may also be
directly impacted as some of the trees
currently screening the Building 10
Complex from external views would be
removed during construction. This
impact will be considered minor,
however, as the distance from the
property line would reduce the scale of
the equipment. Additional minor
impacts are anticipated due to the
partial closure of Center Drive and
redirection of traffic during
construction.
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Noise
Implementation of the Selected
Alternative will result in direct,
temporary, minor noise impacts due to
construction activities as well as direct,
long-term, moderate noise impacts due
to operational changes at the SRLM,
PPG, and UV.
Construction activities associated
with the Selected Alternative will
temporarily increase environmental
noise levels in the vicinity of the project
site, primarily due to the use of heavy
equipment. Equipment that may be used
includes backhoes, bulldozers, and
excavators. Construction equipment
noise emission levels generally range
between 74 to 101 dBA 50 feet from the
source, depending on the type of
equipment (U.S. DOT FHWA, 2014).
Residents at the Convent will likely
experience elevated noise levels during
construction activities. NIH will
mitigate the impact of this construction
noise by limiting most construction
activity to between the hours of 7 a.m.
and 5 p.m. NIH will ensure that noise
levels from construction activities will
not exceed 75 dBA at neighboring
properties or 85 dBA if a noise
suppression plan is approved by the
Montgomery County Department of
Environmental Protection. Most of the
construction noise will be temporary
and will dissipate as the distance from
the source increases. It is expected that
residents in surrounding neighborhoods
will not experience noise louder than
the applicable noise limit.
Construction personnel will take the
necessary precautions (e.g., hearing
protection) to ensure that they will not
be exposed to noise louder than the
Occupational Safety and Health
Administration standard of 90 dBA for
8 hours. Because the construction of the
SRLM, PPG, and UV will result in the
temporary loss of some parking spaces
at surface parking lot 10E and the
Building 10 garage, some vehicular
traffic will be redirected to other
parking areas at the Campus. While
these other destinations may see an
increase in vehicular traffic, the
increases are expected to be minor and
will not be expected to substantially
alter the noise levels anywhere at the
Campus. Any added traffic noise will
blend with ambient noise.
The Selected Alternative will include
installation of new equipment,
including pumps and generators at the
UV. NIH will mitigate operational noise
from this equipment by enclosing the
equipment inside utility buildings and
providing sound-attenuating measures
such as mufflers for the emergency
generators. Due to this mitigation,
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operational noise from all elements of
the Selected Alternative will be
expected to be below regulatory
thresholds.
The Selected Alternative may change
traffic patterns during the operations
phase, as more services will be
consolidated at the SRLM complex and
as parking shifts from Building 10 to the
PPG. However, an overall increase in
traffic is not anticipated. General
operations will continue to meet the
Montgomery County nighttime noise
ordinance of 55 dBA at the property
lines. If necessary, NIH would utilize
noise suppression techniques in order to
meet that requirement.
Overall, construction impacts will be
minimal and temporary, and operational
impacts will be minor.
Air Quality
In order to demonstrate that the
Selected Alternative will result in minor
increases in emissions, NIH
conservatively performed a General
Conformity Rule (GCR) and air emission
calculations. This analysis
conservatively estimates the emissions
of nonattainment criteria pollutants
during construction of the proposed
facilities for the entire 6-year
construction period. The conservative
results, even assuming that the total
emissions over approximately six
construction years will occur only
within a single year, show no
exceedance of the applicable de
minimis criteria of 100 tons per year
(tpy) for NOX, 50 tpy of VOC, and 100
tpy of CO and PM2.5. Therefore, the
Selected Alternative will have minimal
air quality impacts and will not require
a formal conformity determination.
These incremental emissions will also
be well below the Prevention of
Significant Deterioration (PSD) major
source threshold of 250 tpy. The PSD
program is applicable to the attainment
area. Therefore, it is anticipated that the
attainment pollutant emissions under
construction of the Selected Alternative
will be minimal resulting in no
significant air quality impacts.
NIH will work with the Maryland
Department of the Environment (MDE)
to determine regulatory applicability of
the New Source Performance Standards
(NSPS) and National Emission
Standards for Hazardous Air Pollutants
(NESHAP) to the new generators, as
necessary. However, the Selected
Alternative does not include any change
in operations for any of the departments
affected except relocation and
consolidation, which will result in more
efficient operations. There will be no
associated change in the numbers of
employees or patients, and therefore no
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impact to traffic levels or need for
parking. There will be no change in the
need for or amounts of utilities provided
to support operations. The new
generators will replace the current
generators, so will not result in an
increase in air emissions. Therefore, the
need to update the current facility air
permits, such as the Campus Title V
permit, is not anticipated. Thresholds
specified in Code of Maryland
Regulation (COMAR) 26.11.02.10 are
not expected to be exceeded;
operational emissions are not expected
to exceed New Source Review or
Prevention of Significant Deterioration
levels. The air quality effects of criteria
pollutants at the Campus would be
insignificant under operations of the
Selected Alternative and will not
interfere with regional efforts to meet
the National Ambient Air Quality
Standards.
Water Resources
NIH will implement appropriate
pollution prevention measures to avoid
spills and exposure of groundwater to
contamination. These measures could
include using booms or pigs during fuel
transfer, protecting excavations during
fuel transfer and use, and
implementation of stormwater
management controls during
construction.
Implementation of the Selected
Alternative could result in minor
indirect impacts to the NIH Stream due
to runoff from construction sites, which
could enter stormwater sewer drains
that lead to that stream. Impacts to
surface waters resulting from the
construction projects are likely to be
minor due to compliance with state and
federal regulations and mitigation
measures. Mitigation measures include
development of and adherence to
sediment and erosion control plans,
stormwater management plans, and
implementation of pollution prevention
measures to ensure that sediments,
petroleum products and other
contaminants do not migrate to the
storm drains during construction.
Implementation of the Proposed
Action will result in minor temporary
impacts to stormwater quantity and
quality due to earth disturbances during
construction activities. The Limits of
Disturbance (LOD) for the Proposed
Action, will be approximately 378,972
SF (8.7 acres) of earth during
construction activities.
Potential erosion and sediment runoff
impacts will be mitigated through
implementation of stormwater
management practices, including the
development of an erosion and
sediment control plan that is approved
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by MDE. The construction of the SRLM,
PPG, and UV will disturb more than one
acre and therefore will obtain coverage
under the MDE 2014 General Permit for
Stormwater Associated with
Construction Activity (MDE, 2014). As a
result, construction activities under the
Selected Alternative will have a minor
impact on stormwater quality.
Additionally, some of the existing
stormwater drainage systems will have
to be modified or moved as they are
currently within the LOD. NIH will
design and construct replacement
systems so as not to impact existing
drainage characteristics.
Implementation of the Selected
Alterative will result in minor long-term
stormwater management impacts. The
project area covers a total of 8.7 acres.
The Selected Alternative will increase
impervious surface at the Campus by
approximately 125,196 SF (2.9 acres),
which will increase runoff within the
Rock Creek Watershed relative to
baseline conditions. The construction of
the SRLM, PPG, and UV will each
disturb greater than 5,000 SF, and
therefore site design will be required to
meet EISA 2007 Section 438
requirements to restore each site to
predevelopment conditions. This
requirement will minimize hydrologic
impacts resulting from increased
stormwater runoff volumes, such as
damage to storm sewer infrastructure,
increased likelihood of flooding, and
increased erosion.
The Selected Alternative will require
permanent site stormwater management
to control runoff and provide water
quality treatment per federal and
Maryland stormwater regulations. Longterm stormwater management facilities
will be designed and installed per an
MDE approved stormwater management
plan. Construction of the SRLM, PPG,
and UV will incorporate bioretention
areas including stormwater planter
boxes. These vegetated areas will
infiltrate runoff from impervious
surfaces at the sites, reducing the
quantity of stormwater runoff and
improving the water quality. NIH will
incorporate appropriate and feasible
Environmental Site Design (ESD)
practices into the project designs to
restore the predevelopment hydrology
to the maximum extent technically
feasible. Overall, these practices will
reduce runoff volume and rate, disperse
flow, remove pollutants, and provide for
groundwater recharge by facilitating
infiltration into the soil. These measures
will have the potential to benefit the
ability of NIH to meet the Campus’ Total
Maximum Daily Load (TMDL) nutrient
and sediment load reduction
requirements, and thus comply with the
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Campus’ Municipal Separate Storm
Sewer System (MS4) TMDL.
Historic Resources
Pursuant to Section 106 of the
National Historic Preservation Act, NIH
initiated consultation with the
Maryland State Historic Preservation
Officer (MD SHPO) to obtain their
concurrence with this finding. The MD
SHPO requested additional information
regarding the project on 29 May 2019.
NIH provided the additional
information to the MD SHPO and on
July 21, 2020, a representative from the
Maryland Historical trust concurred
with NIH on their findings of no adverse
effect associated with the Selected
Alternative.
Practicable Means To Avoid or
Minimize Potential Environmental
Harm From the Selected Alternative
All practicable means to avoid or
minimize adverse environmental effects
from the Selected Action have been
identified and incorporated into the
action. The proposed construction will
be subject to the existing NIH pollution
prevention, waste management, and
safety, security, and emergency
response policies and procedures as
well as existing environmental permits.
Best management practices, spill
prevention and control, and stormwater
management plans will be followed to
appropriately address the construction
and operation envisioned in the
Selected Alternative and comply with
applicable regulatory and NIH
requirements. No additional mitigation
measures have been identified.
Pollution Prevention
Air quality permit standards will be
met, as will all federal, state, and local
requirements to protect the environment
and public health.
Conclusion
Based upon review and careful
consideration, NIH has decided to
implement the Selected Alternative for
the construction of the SRLM, Patient
Parking garage, and associated Utility
Vault on the Bethesda NIH Campus
located in Bethesda, Maryland. The
decision accounts for the need of NIH to
further the fundamental mission of
clinical research by providing facilities
that support the NIH mission. The
decision was based upon review and
careful consideration of the impacts
identified in the Final EIS and public
comments received throughout the
NEPA process.
Separate NEPA reviews, when
required, will be done on projects that
may come about during the planning
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and design process. Proper NEPA
documentation will be completed based
on the outcome of that review.
Dated: August 22, 2020.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2020–18926 Filed 8–27–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Cell Biology
Integrated Review Group Cellular Signaling
and Regulatory Systems Study Section.
Date: September 24–25, 2020.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health
Rockledge II 6701 Rockledge Drive Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: David Balasundaram,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5189,
MSC 7840, Bethesda, MD 20892, 301–435–
1022, balasundaramd@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: August 24, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–18955 Filed 8–27–20; 8:45 am]
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HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Cancer Institute; Notice of
Meeting
Prospective Grant of an Exclusive
Patent License: Anti-CD56 as an
Antibody-Drug Conjugate (‘‘ADC’’) or
Non-ADC To Target Glioblastoma
Either Alone or in Combination With
Other Potential Immuno-Oncology
Drugs.
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Cancer Institute
Clinical Trials and Translational
Research Advisory Committee.
The meeting will be held as a virtual
meeting and is open to the public.
Individuals who plan to view the virtual
meeting and need special assistance or
other reasonable accommodations to
view the meeting, should notify the
Contact Person listed below in advance
of the meeting. The meeting will be
videocast and can be accessed from the
NIH Videocasting and Podcasting
website (https://videocast.nih.gov).
Name of Committee: National Cancer
Institute Clinical Trials and Translational
Research Advisory Committee.
Date: November 4, 2020.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: Strategic Discussion of NCI’s
Clinical and Translational Research
Programs.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Rockville,
MD 20850 (Virtual Meeting).
Contact Person: Sheila A. Prindiville, M.D.,
MPH Director, Coordinating Center for
Clinical Trials, National Institutes of Health,
National Cancer Institute, Coordinating
Center for Clinical Trials, 9609 Medical
Center Drive, Room 6W136, Rockville, MD
20850, 240–276–6173, prindivs@
mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page: https://
deainfo.nci.nih.gov/advisory/ctac/ctac.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: August 25, 2020.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–18986 Filed 8–27–20; 8:45 am]
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National Institutes of Health,
Health and Human Services. (HHS).
ACTION: Notice.
AGENCY:
The National Cancer Institute,
an institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Patent License to
practice the inventions embodied in the
Patents and Patent Applications listed
in the Supplementary Information
section of this notice to Connectyx
Technologies Holdings Group
(‘‘Connectyx’’) located in Boca Raton,
FL.
SUMMARY:
Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before September 14, 2020 will be
considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
an Exclusive Patent License should be
directed to: Jasmine Yang, Ph.D., Senior
Licensing and Patenting Manager at
Telephone: (240)-276–5530 or at Email:
jasmine.yang@nih.gov.
SUPPLEMENTARY INFORMATION:
DATES:
Intellectual Property
(1) U.S. Provisional Patent Application
No. 62/119,707 filed July 31, 2015.
HHS Ref No. E–221–2015–0–US–01
(2) PCT Application No. PCT/US2016/
044777 filed 07/29/2016. HHS Ref.
No. E–221–2015–0–PCT–02
(3) U.S. Patent No. 10,548,987 issued
February 02, 2020 (Patent Application
No. 15/747,620 filed January 25,
2018). HHS Ref. No. E–221–2015–0–
US–03.
The patent rights in these inventions
have been assigned and/or exclusively
licensed to the government of the
United States of America.
The prospective exclusive license
territory may be worldwide and the
field of use may be limited to the use
of Licensed Patent Rights for the
following: Anti-CD56 as an antibodydrug conjugate (‘‘ADC’’) to target and
treat glioblastoma either alone or in
E:\FR\FM\28AUN1.SGM
28AUN1
Agencies
[Federal Register Volume 85, Number 168 (Friday, August 28, 2020)]
[Notices]
[Pages 53386-53390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18926]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
NIH Bethesda Surgery, Radiology and Laboratory Medicine Record of
Decision
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services, the National
Institutes of Health (NIH), has decided, after completion of a Final
Environmental Impact Statement (FEIS) and a thorough consideration of
the public comments on the Draft EIS, to implement the Proposed Action,
referred to as the Proposed Action in the Final EIS. The Surgery,
Radiology and Laboratory Medicine (SRLM) action is for construction of
an additional 527,100 gross square feet (gsf) to the exiting Building
10. In addition to 527,100 gsf of space in the new building, the
Proposed Action will include renovation of 102,600 gsf of existing
space within the West Laboratory Wing of the Clinical Research Center.
The footprint of the SRLM will occupy 55,500 gsf. A proposed patient
parking garage is also included in the proposed action. The proposed
garage will be a multi-level, self-park garage, accommodating
approximately 780 cars.
FOR FURTHER INFORMATION CONTACT: Valerie Nottingham, Deputy Director,
DEP, ORF, NIH, Building 13, Room 2S11, 9000 Rockville Pike, Bethesda,
MD 20892, Phone 301-496-7775, [email protected]. RESPONSIBLE
OFFICIAL: Daniel G. Wheeland, Director, Office of Research Facilities
(ORF) Development and Operations, NIH.
SUPPLEMENTARY INFORMATION:
Decision
After careful review of the environmental consequences in the Final
Environmental Impact Statement for the SRLM, National Institutes of
Health Bethesda Campus, and consideration of public comment throughout
the National Environmental Policy Act of 1969 (NEPA) process, NIH has
decided to implement the Proposed Action described below as the
Selected Alternative.
Selected Alternative
The Selected Alternative is intended to further the NIH mission: To
seek fundamental knowledge about the nature and behavior of living
systems and the application of that knowledge to
[[Page 53387]]
enhance health, lengthen life, and reduce illness and disability.
The Selected Alternative will meet the purpose and need of the
project in several ways. First, the spatial deficiencies would be
addressed by moving the current operations to surgical, radiological,
laboratory, and office spaces that consolidate and organize activities
in an efficient manner. Next, the SRLM Building will be designed with
the flexibility to address future growth and change, including floor-
to-ceiling heights and other features capable of accommodating
equipment associated with newer technologies. The SRLM Building will
also incorporate upgraded, up-to-date infrastructure systems which will
be more reliable, and will ensure the ability to control temperature
and humidity. The SRLM Building will address unacceptable vibration
levels by using more robust construction materials and methods. The
Selected Alternative will be constructed to meet progressive collapse
requirements and blast criteria.
Security and safety issues associated with the current Building 10
parking garage will be addressed by eliminating exposure to
deteriorated and spalling concrete in the existing garage. The Utility
Vault portion of the project will enable NIH to replace critical
electrical equipment that is beyond its service life.
Alternatives Considered
The Proposed Action Alternative and No Action Alternative were the
two alternatives analyzed in the Final EIS. Other alternatives were
considered but not carried forward due to their inability to meet the
purpose and need of the project.
Factors Involved in the Decision
Several factors were involved during the decision-making process;
these include spatial deficiencies, inability to house new
technologies, security and safety, and an aging switching station.
Spatial deficiencies severely impact the operating rooms, radiology
suite and clinical laboratory. Both patients and staff lack sufficient
support space as they undergo care and conduct treatment protocols. The
distribution systems for electrical, duct work, and piping are
degrading and require replacement, but this work cannot be done while
the space is occupied. The building's floor-to-floor heights are
deficient by today's utility requirements and cannot contain the
necessary utility distribution systems. A lack of utility capacity and
control results in work environments that suffer from poor temperature
and humidity control. These environmental factors can also negatively
impact the patient samples that are being processed and tested.
Since the clinical research facility opened more than 34 years ago,
biomedical research and its supporting clinical programs have rapidly
evolved influencing the criteria for space and infrastructure systems.
The rapid evolution of equipment (changing every three to five years)
has had a direct impact on both space requirements and utility systems
that support them. Hospital surgical suites are typically replaced
every 20 years to keep up with the latest technological advancements,
operating room equipment, and techniques. The existing facility has not
kept pace with modern surgical, imaging, and clinical laboratory
facility requirements, and cannot accommodate evolving requirements.
Currently, patient, visitor, and staff parking is partially
accommodated in an underground parking garage located below the
Ambulatory Care Research Facility tower. More specifically, existing
parking is located directly below surgery, radiology, and laboratory
areas of the complex, which makes repairs to the garage expensive, due
to patient occupancy on floors above. The current garage has serious
structural deficiencies due to corrosion of the concrete and underlying
(exposed) rebar, despite on-going maintenance. The concrete and rebar
corrosion is from years of salt and chemicals brought into the garage
by the vehicle traffic. This condition poses a safety threat to users
of the facility, and a liability threat to the government, due to the
potential for falling pieces of concrete.
The equipment in Buildings 59 and 59A is aging and will soon need
replacement due to space constraints, the inability to acquire
replacement parts, and failure of the current system to meet
requirements of the Life Safety Code (National Fire Protection
Association 101) and Environment of Care standards of the Joint
Commission.
Resources Impacted
The Final EIS describes potential environmental effects of the
Selected Alternative. These potential effects are documented in Chapter
3 of the Final EIS. Any potential adverse environmental effects will be
avoided or mitigated through design elements, procedures, and
compliance with regulatory and NIH requirements. Potential impacts on
air quality are all within government standards (federal, state, and
local). NIH does not expect significant negative effects on the
environment or on the citizens of Bethesda from construction and
operation at NIH.
Summary of Impacts
The following is a summary of potential impacts resulting from the
Selected Alternative that NIH considered when making its decision. No
adverse cumulative effects have been identified during the NEPA
process. Likewise, no unavoidable or adverse impacts from
implementation of the Selected Alternative have been identified. The
Selected Alternative will be beneficial to the long-term productivity
of the national and international biomedical research communities. As a
result of the Selected Alternative, biomedical research conducted at
the NIH facilities on the campus will experience an enhanced potential
of advance techniques in disease prevention and cures, development of
infectious disease vaccinations, and preparation of defenses against
naturally emerging and re-emerging diseases and against bioweapons.
Additionally, the local community will benefit from increased
employment, housing, and investment
Housing
Under the Selected Alternative, the action will result in temporary
minor impacts on the population and the availability of housing, due to
construction workers who might temporarily relocate to the area. The
Proposed Action will result in no permanent impacts to these resources
as there is no projected change in staff. Temporary impacts on
population and housing associated with construction activities are
expected to be minor as Bethesda is a densely populated urban area and
therefore the small temporary increase in population would be very
small on a percentage basis.
Education
The Selected Alternative does not involve any projected change in
staff or campus census. If any new employees are hired, the numbers
will be modest, and the current public school capacity in Bethesda or
Montgomery County and surrounding school districts is adequate to
accommodate the expected minimal growth caused by the Selected
Alternative.
Transportation
Implementation of the Selected Alternative will result in minor
temporary impacts to off-Campus roads, transit, and traffic due to
construction activities. This will include additional traffic due to
construction vehicles, as
[[Page 53388]]
well as shifts in employee and patient traffic patterns.
Construction vehicles, estimated at well less than 100 vehicles per
day will be screened at the Commercial Vehicle Inspection Station
(CVIF) on Rockville Pike, and then enter via Wilson Drive. As reported
in the 2015 Chilled Water EIS, peak morning traffic at Rockville Pike
and Wilson Drive, which is just south of the CVIF, is 2,800 cars
southbound on Rockville Pike and 1,100 cars northbound on Rockville
Pike. It is assumed peak traffic on those roads is similar to or higher
than was reported in 2015. Therefore, the overall impact to off-Campus
roads will be minor as the number of construction vehicles would be
minimal (<100 vehicles per day) relative to existing traffic counts.
Security
The Selected Alternative will not be expected to have adverse
impacts on security on the NIH Campus. No new security measures are
proposed in the Selected Alternative.
Employment
The Selected Alternative does not involve any projected change in
staff.
Environmental Justice
The Selected Alternative will not be expected to have
disproportionately high or adverse impacts on low income or minority
populations of the affected area.
Visual Quality
During construction of the Surgery Radiology and Laboratory
Medicine (SRLM), Patient Parking Garage (PPG) and Utility Vault (UV),
direct visual impacts will occur on Campus. Large construction
equipment will be deployed in the project area for the duration of
activities. It is anticipated that cranes, earth-moving equipment,
concrete trucks and other heavy machinery will be in use for
approximately 6 years. Due to the phased approach, the construction
duration is extended, and this will represent a moderate, direct impact
to visual resources at the project location. Off-Campus observers may
also be directly impacted as some of the trees currently screening the
Building 10 Complex from external views would be removed during
construction. This impact will be considered minor, however, as the
distance from the property line would reduce the scale of the
equipment. Additional minor impacts are anticipated due to the partial
closure of Center Drive and redirection of traffic during construction.
Noise
Implementation of the Selected Alternative will result in direct,
temporary, minor noise impacts due to construction activities as well
as direct, long-term, moderate noise impacts due to operational changes
at the SRLM, PPG, and UV.
Construction activities associated with the Selected Alternative
will temporarily increase environmental noise levels in the vicinity of
the project site, primarily due to the use of heavy equipment.
Equipment that may be used includes backhoes, bulldozers, and
excavators. Construction equipment noise emission levels generally
range between 74 to 101 dBA 50 feet from the source, depending on the
type of equipment (U.S. DOT FHWA, 2014). Residents at the Convent will
likely experience elevated noise levels during construction activities.
NIH will mitigate the impact of this construction noise by limiting
most construction activity to between the hours of 7 a.m. and 5 p.m.
NIH will ensure that noise levels from construction activities will not
exceed 75 dBA at neighboring properties or 85 dBA if a noise
suppression plan is approved by the Montgomery County Department of
Environmental Protection. Most of the construction noise will be
temporary and will dissipate as the distance from the source increases.
It is expected that residents in surrounding neighborhoods will not
experience noise louder than the applicable noise limit.
Construction personnel will take the necessary precautions (e.g.,
hearing protection) to ensure that they will not be exposed to noise
louder than the Occupational Safety and Health Administration standard
of 90 dBA for 8 hours. Because the construction of the SRLM, PPG, and
UV will result in the temporary loss of some parking spaces at surface
parking lot 10E and the Building 10 garage, some vehicular traffic will
be redirected to other parking areas at the Campus. While these other
destinations may see an increase in vehicular traffic, the increases
are expected to be minor and will not be expected to substantially
alter the noise levels anywhere at the Campus. Any added traffic noise
will blend with ambient noise.
The Selected Alternative will include installation of new
equipment, including pumps and generators at the UV. NIH will mitigate
operational noise from this equipment by enclosing the equipment inside
utility buildings and providing sound-attenuating measures such as
mufflers for the emergency generators. Due to this mitigation,
operational noise from all elements of the Selected Alternative will be
expected to be below regulatory thresholds.
The Selected Alternative may change traffic patterns during the
operations phase, as more services will be consolidated at the SRLM
complex and as parking shifts from Building 10 to the PPG. However, an
overall increase in traffic is not anticipated. General operations will
continue to meet the Montgomery County nighttime noise ordinance of 55
dBA at the property lines. If necessary, NIH would utilize noise
suppression techniques in order to meet that requirement.
Overall, construction impacts will be minimal and temporary, and
operational impacts will be minor.
Air Quality
In order to demonstrate that the Selected Alternative will result
in minor increases in emissions, NIH conservatively performed a General
Conformity Rule (GCR) and air emission calculations. This analysis
conservatively estimates the emissions of nonattainment criteria
pollutants during construction of the proposed facilities for the
entire 6-year construction period. The conservative results, even
assuming that the total emissions over approximately six construction
years will occur only within a single year, show no exceedance of the
applicable de minimis criteria of 100 tons per year (tpy) for
NOX, 50 tpy of VOC, and 100 tpy of CO and PM2.5.
Therefore, the Selected Alternative will have minimal air quality
impacts and will not require a formal conformity determination. These
incremental emissions will also be well below the Prevention of
Significant Deterioration (PSD) major source threshold of 250 tpy. The
PSD program is applicable to the attainment area. Therefore, it is
anticipated that the attainment pollutant emissions under construction
of the Selected Alternative will be minimal resulting in no significant
air quality impacts.
NIH will work with the Maryland Department of the Environment (MDE)
to determine regulatory applicability of the New Source Performance
Standards (NSPS) and National Emission Standards for Hazardous Air
Pollutants (NESHAP) to the new generators, as necessary. However, the
Selected Alternative does not include any change in operations for any
of the departments affected except relocation and consolidation, which
will result in more efficient operations. There will be no associated
change in the numbers of employees or patients, and therefore no
[[Page 53389]]
impact to traffic levels or need for parking. There will be no change
in the need for or amounts of utilities provided to support operations.
The new generators will replace the current generators, so will not
result in an increase in air emissions. Therefore, the need to update
the current facility air permits, such as the Campus Title V permit, is
not anticipated. Thresholds specified in Code of Maryland Regulation
(COMAR) 26.11.02.10 are not expected to be exceeded; operational
emissions are not expected to exceed New Source Review or Prevention of
Significant Deterioration levels. The air quality effects of criteria
pollutants at the Campus would be insignificant under operations of the
Selected Alternative and will not interfere with regional efforts to
meet the National Ambient Air Quality Standards.
Water Resources
NIH will implement appropriate pollution prevention measures to
avoid spills and exposure of groundwater to contamination. These
measures could include using booms or pigs during fuel transfer,
protecting excavations during fuel transfer and use, and implementation
of stormwater management controls during construction.
Implementation of the Selected Alternative could result in minor
indirect impacts to the NIH Stream due to runoff from construction
sites, which could enter stormwater sewer drains that lead to that
stream. Impacts to surface waters resulting from the construction
projects are likely to be minor due to compliance with state and
federal regulations and mitigation measures. Mitigation measures
include development of and adherence to sediment and erosion control
plans, stormwater management plans, and implementation of pollution
prevention measures to ensure that sediments, petroleum products and
other contaminants do not migrate to the storm drains during
construction.
Implementation of the Proposed Action will result in minor
temporary impacts to stormwater quantity and quality due to earth
disturbances during construction activities. The Limits of Disturbance
(LOD) for the Proposed Action, will be approximately 378,972 SF (8.7
acres) of earth during construction activities.
Potential erosion and sediment runoff impacts will be mitigated
through implementation of stormwater management practices, including
the development of an erosion and sediment control plan that is
approved by MDE. The construction of the SRLM, PPG, and UV will disturb
more than one acre and therefore will obtain coverage under the MDE
2014 General Permit for Stormwater Associated with Construction
Activity (MDE, 2014). As a result, construction activities under the
Selected Alternative will have a minor impact on stormwater quality.
Additionally, some of the existing stormwater drainage systems will
have to be modified or moved as they are currently within the LOD. NIH
will design and construct replacement systems so as not to impact
existing drainage characteristics.
Implementation of the Selected Alterative will result in minor
long-term stormwater management impacts. The project area covers a
total of 8.7 acres. The Selected Alternative will increase impervious
surface at the Campus by approximately 125,196 SF (2.9 acres), which
will increase runoff within the Rock Creek Watershed relative to
baseline conditions. The construction of the SRLM, PPG, and UV will
each disturb greater than 5,000 SF, and therefore site design will be
required to meet EISA 2007 Section 438 requirements to restore each
site to predevelopment conditions. This requirement will minimize
hydrologic impacts resulting from increased stormwater runoff volumes,
such as damage to storm sewer infrastructure, increased likelihood of
flooding, and increased erosion.
The Selected Alternative will require permanent site stormwater
management to control runoff and provide water quality treatment per
federal and Maryland stormwater regulations. Long-term stormwater
management facilities will be designed and installed per an MDE
approved stormwater management plan. Construction of the SRLM, PPG, and
UV will incorporate bioretention areas including stormwater planter
boxes. These vegetated areas will infiltrate runoff from impervious
surfaces at the sites, reducing the quantity of stormwater runoff and
improving the water quality. NIH will incorporate appropriate and
feasible Environmental Site Design (ESD) practices into the project
designs to restore the predevelopment hydrology to the maximum extent
technically feasible. Overall, these practices will reduce runoff
volume and rate, disperse flow, remove pollutants, and provide for
groundwater recharge by facilitating infiltration into the soil. These
measures will have the potential to benefit the ability of NIH to meet
the Campus' Total Maximum Daily Load (TMDL) nutrient and sediment load
reduction requirements, and thus comply with the Campus' Municipal
Separate Storm Sewer System (MS4) TMDL.
Historic Resources
Pursuant to Section 106 of the National Historic Preservation Act,
NIH initiated consultation with the Maryland State Historic
Preservation Officer (MD SHPO) to obtain their concurrence with this
finding. The MD SHPO requested additional information regarding the
project on 29 May 2019.
NIH provided the additional information to the MD SHPO and on July
21, 2020, a representative from the Maryland Historical trust concurred
with NIH on their findings of no adverse effect associated with the
Selected Alternative.
Practicable Means To Avoid or Minimize Potential Environmental Harm
From the Selected Alternative
All practicable means to avoid or minimize adverse environmental
effects from the Selected Action have been identified and incorporated
into the action. The proposed construction will be subject to the
existing NIH pollution prevention, waste management, and safety,
security, and emergency response policies and procedures as well as
existing environmental permits. Best management practices, spill
prevention and control, and stormwater management plans will be
followed to appropriately address the construction and operation
envisioned in the Selected Alternative and comply with applicable
regulatory and NIH requirements. No additional mitigation measures have
been identified.
Pollution Prevention
Air quality permit standards will be met, as will all federal,
state, and local requirements to protect the environment and public
health.
Conclusion
Based upon review and careful consideration, NIH has decided to
implement the Selected Alternative for the construction of the SRLM,
Patient Parking garage, and associated Utility Vault on the Bethesda
NIH Campus located in Bethesda, Maryland. The decision accounts for the
need of NIH to further the fundamental mission of clinical research by
providing facilities that support the NIH mission. The decision was
based upon review and careful consideration of the impacts identified
in the Final EIS and public comments received throughout the NEPA
process.
Separate NEPA reviews, when required, will be done on projects that
may come about during the planning
[[Page 53390]]
and design process. Proper NEPA documentation will be completed based
on the outcome of that review.
Dated: August 22, 2020.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2020-18926 Filed 8-27-20; 8:45 am]
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