NIH Bethesda Surgery, Radiology and Laboratory Medicine Record of Decision, 53386-53390 [2020-18926]

Download as PDF 53386 Federal Register / Vol. 85, No. 168 / Friday, August 28, 2020 / Notices Secretary for Health, Office of Disease Prevention and Health Promotion, 1101 Wootton Parkway, Suite 420, Rockville, MD 20852. Phone: (240) 453–8826. Email: OHQ@hhs.gov. SUPPLEMENTARY INFORMATION: The National Clinical Care Commission Act (Pub. L. 115–80) requires the HHS Secretary to establish the National Clinical Care Commission. The Commission consists of representatives of specific federal agencies and nonfederal individuals and entities who represent diverse disciplines and views. The Commission will evaluate and make recommendations to the HHS Secretary and Congress regarding improvements to the coordination and leveraging of federal programs related to diabetes and its complications. The eighth meeting will be held virtually, and will consist of updates from the Commission’s three subcommittees and a discussion of public comments and outreach to stakeholder organizations. Additionally, the first round of potential ‘‘action plans’’ from the subcommittee (i.e., recommendations) to be discussed by Commission. The final meeting agenda will be available prior to the meeting at https://health.gov/our-work/health-carequality/national-clinical-carecommission/meetings. Public Participation at Meeting: The Commission invites public comment on issues related to the Commission’s charge. There will be an opportunity for limited oral comments (each no more than 3 minutes in length) at this virtual meeting. Virtual attendees who plan to provide oral comments at the Commission meeting during a designated time must register prior to the meeting at https:// kauffmaninc.adobeconnect.com/nccc_ sept2020/event/event_info.html. Written comments are welcome throughout the entire development process of the Commission’s work and may be emailed to OHQ@hhs.gov. Written comments should not exceed three pages in length. Individuals who need special assistance, such as sign language interpretation or other reasonable accommodations, should indicate the special accommodation when registering online or by notifying Jennifer Gillissen at jennifer.gillissen@ kauffmaninc.com by August 27, 2020. Authority: The National Clinical Care Commission is required under the National Clinical Care Commission Act (Pub. L. 115–80). The Commission is governed by provisions of the Federal Advisory Committee Act (FACA), Public Law 92–463, as amended (5 U.S.C., VerDate Sep<11>2014 17:16 Aug 27, 2020 Jkt 250001 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] BILLING CODE 4150–32–P 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] BILLING CODE 4140–01–P PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 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 E:\FR\FM\28AUN1.SGM 28AUN1 Federal Register / Vol. 85, No. 168 / Friday, August 28, 2020 / Notices 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. VerDate Sep<11>2014 17:16 Aug 27, 2020 Jkt 250001 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 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 53387 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 E:\FR\FM\28AUN1.SGM 28AUN1 53388 Federal Register / Vol. 85, No. 168 / Friday, August 28, 2020 / Notices 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. VerDate Sep<11>2014 17:16 Aug 27, 2020 Jkt 250001 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, PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 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 E:\FR\FM\28AUN1.SGM 28AUN1 Federal Register / Vol. 85, No. 168 / Friday, August 28, 2020 / Notices 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 VerDate Sep<11>2014 17:16 Aug 27, 2020 Jkt 250001 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 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 53389 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 E:\FR\FM\28AUN1.SGM 28AUN1 53390 Federal Register / Vol. 85, No. 168 / Friday, August 28, 2020 / Notices 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] BILLING CODE 4140–01–P 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] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND 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] BILLING CODE 4140–01–P VerDate Sep<11>2014 17:16 Aug 27, 2020 Jkt 250001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 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]
BILLING CODE 4140-01-P


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