8094 Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices 

the meeting. Background material is 

available at http://www.fda.gov/

AdvisoryCommittees/Calendar/

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: On April 9, 2015, from 

8:30 a.m. to 4 p.m. and on April 10, 

2015, from 8 a.m. to 5 p.m., the meeting 

is open to the public. Interested persons 

may present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before March 20, 2015. 

Oral presentations from the public will 

be scheduled between approximately 11 

a.m. and 12 p.m. on April 10, 2015. 

Those individuals interested in making 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before March 12, 2015. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by March 13, 2015. 

Closed Committee Deliberations: On 

April 9, 2015, between 4 p.m. and 5 

p.m., the meeting will be closed to 

permit discussion and review of trade 

secret and/or confidential commercial 

information (see 5 U.S.C. 552b(c)(3) and 

(c)(4)). This portion of the meeting will 

be closed because the Committee will be 

discussing trade secret and/or 

confidential data provided by Swedish 

Match North America Inc. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Caryn Cohen 

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meeting. 

FDA is committed to the orderly 

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AboutAdvisoryCommittees/

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: February 9, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03000 Filed 2–12–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Bethesda Campus Master Plan Record 

of Decision 

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. This 

action is for a long-range physical 

Master Plan for National Institutes of 

Health Bethesda Campus (NIH) located 

in Bethesda, Maryland. This alternative 

accounts for potential growth in NIH 

personnel, new construction, additions, 

renovations, demolitions, and upgrades 

in site utilities. 

Responsible Official: Daniel G. 

Wheeland, Director, Office of Research 

Facilities (ORF) Development and 

Operations, NIH. 

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. 

SUPPLEMENTARY INFORMATION: 

Decision 

After careful review of the 

environmental consequences in the 

Final Environmental Impact Statement 

for the Master Plan, National Institutes 

of Health Bethesda Campus, and 

consideration of public comment 

throughout the NEPA process, the NIH 

has decided to implement the Proposed 

Action described below as the Selected 

Alternative. 

Selected Alternative 

The Selected Alternative is intended 

to be a strategic tool for the efficient 

allocation of campus resources, the 

orderly accommodation of future 

growth, and the creation of an 

environment that is both functionally 

and aesthetically conducive to 

accomplishing the NIH mission. The 

Selected Alternative will provide a 

guide for the reasoned and orderly 

development of the NIH campus, one 

that values and builds on existing 

resources, corrects current deficiencies 

and meets changing needs through new 

construction or renovation. The plan 

sets forth implementation priorities and 

a logical sequencing of planned 

development. 

The Selected Alternative is for a longrange physical Master Plan for NIH. 

This alternative covers a 20-year 

planning period, with reviews every 5 

years to ensure that the plan continues 

to address issues affecting the campus. 

The alternative addresses the future 

development of the NIH site, including 

placement of future construction; 

vehicular and pedestrian circulation on 

and off-campus; parking within the 

property boundaries; open space in and 

around the campus; required setbacks; 

historic properties; natural and scenic 

resources; noise; and lighting. This 

alternative accounts for potential growth 

in NIH personnel, and consequent 

construction of space over the planning 

period. Future construction on the site 

could include such facilities as new 

animal holding, research laboratories, 

and support facilities. 

NIH will continue to develop the 

Bethesda campus to accommodate NIH’s 

research needs and required 

programmatic needs consistent with the 

commitment to maintain the ‘‘campus’’ 

character of the site. The Selected 

Alternative advances this objective by 

programming and locating future NIH 

growth so that new development would 

tie into the existing utility services and 

utilities are available to support growth, 

and establishing development 

guidelines for future changes to the site 

that ensure that as the campus grows 

new development would be responsive 

to the context of adjacent neighborhoods 

or developments. Under the Selected 

Alternative, the total NIH population on 

the campus is anticipated to grow in the 

next twenty years to a total of 

approximately 23,594, which is an 

increase of approximately 3,000 

employees. The primary growth at the 

campus would be in intramural research 

personnel and the administrative and 

facility staff to support them. The 

majority, if not all, of the employees 

would be coming from off-site facilities 

and are already employees, or 

contractors, of NIH. 

Alternatives Considered 

The Proposed Action Alternative, the 

Redevelopment Alternative and No 

Action Alternative were the three 

alternatives analyzed in the Final EIS. 


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Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices 8095 

The Master Plan covers a 20-year 

planning period, but will be reviewed 

every 5 years to ensure that the plan 

continues to remain current and 

relevant to the key issues affecting the 

campus. The alternatives addressed the 

future development of the NIH site, 

including placement of future 

construction; vehicular and pedestrian 

circulation on and off-campus; parking 

within the property boundaries; open 

space in and around the campus; 

required setbacks; historic properties; 

natural and scenic resources; noise; and 

lighting. The alternatives account for 

potential growth in NIH personnel, and 

consequent construction of space over 

the planning period. Future 

construction on the site could include 

such facilities as new animal holding, 

research laboratories, and support 

facilities. 

Factors Involved in the Decision 

The Department of Health and Human 

Services (HHS) requires that NIH 

facilities have a Master Plan and, the 

previous Master Plan for the NIH 

campus was outdated. In addition, 

factors such as the aging of facilities that 

were designed only to accommodate 

temporary use, animal housing facilities 

that do not provide adequate space for 

projected increases in animal 

populations, and research support 

facilities not being adequate to sustain 

current and projected programs. The 

Master Plan contains information, 

analysis, and recommendations to guide 

development of individual projects. It 

also serves as a means of informing city 

and county officials and utilities of 

future NIH development plans so they 

can anticipate and plan for the potential 

effects of NIH proposals on their 

systems. 

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 the 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 world 

health communities. Biomedical 

research conducted at the NIH facilities 

on the campus will have the potential 

to advance techniques in disease 

prevention and cures, develop disease 

immunizations, and prepare defenses 

against naturally emerging and reemerging diseases and against 

bioweapons. Additionally, the local 

community will benefit from increased 

employment, income and, government 

and public finance. 

Housing 

Under the Selected Alternative, the 

building program would improve 

existing laboratory and office spaces. 

This would allow NIH to attract wellqualified personnel to the campus. The 

campus building program would be 

expanded with nominal population 

increases. These added employees 

would continue to seek regional housing 

options and use local community 

services. This modest expansion would 

have a modest beneficial economic 

impact with modest increased demand 

for housing and community services. 

Education 

The expected increases of employees 

on the NIH campus are from employees 

already working in the Bethesda area in 

the agency’s off campus, leased 

facilities. If any new employees were 

hired, the current public school capacity 

in Bethesda or Montgomery County and 

surrounding school districts would be 

adequate to accommodate the expected 

minimal growth caused by the Selected 

Alternative. 

Transportation 

The potential increase in vehicular 

traffic generated by the additional 

facilities and employees envisioned in 

the Master Plan would only minimally 

contribute to the amount of traffic on 

the roadways in the vicinity of the 

campus. If the campus houses 3,000 

additional staff, the impact on morning 

and evening rushes is estimated to be 

approximately 12 percent more NIH 

vehicles. When taking into account that 

NIH’s contribution to local traffic 

constitutes only approximately 25% of 

the traffic, the impact on the community 

is estimated to be 3%. Furthermore, by 

the time the capital improvements 

contemplated under the Selected 

Alternative are in place, mass transit 

developments such as the Purple Line 

and Bus Rapid Transit might well be in 

place, thereby offsetting the 3% 

congestion. The Selected Alternative 

includes 3,000 additional employees, 

and would generate approximately an 

additional 432 a.m. and 439 p.m. trips. 

The seven proposed Base Realignment 

and Closure (BRAC) improvements, 

discussed in the EIS, several of which 

were facilitated through NIH easements, 

would result in mitigating this slight 

increase AM and PM peak traffic, and 

also help keep the congestion standard 

below 1,600 Calculated Load Value 

(CLV). Stated differently, the modest 

increase in traffic would not change the 

intersection ratings. Lastly, if NIH 

increases the campus population, it will 

increase parking at the ration of 1 

parking spot per 3 additional staff. 

Security 

The Selected Alternative would not 

be expected to have adverse impacts on 

security on the NIH Campus. No new 

security measures are proposed in the 

Master Plan. 

Employment 

If the Selected Alternative is fully 

implemented, an increase of up to 3,000 

employees and contractors would 

increase the current total of 20,594 up 

to approximately 23,594. The increase 

draws from employees that are already 

working in the Bethesda/Montgomery 

County area. 

Environmental Justice 

The Selected Alternative would not 

be expected to have disproportionately 

high or adverse impacts on low income 

or minority populations of the affected 

area. 

Visual Quality 

The Master Plan’s land use plan 

provides a framework to help organize 

future development at NIH so that 

similar land use types are consolidated 

while open space and natural features 

are preserved. NIH would exhibit the 

same basic types of land use as it does 

currently, but in a slightly different 

configuration. The Master Plan does not 

propose any land use changes outside 

NIH. Therefore, the NIH campus is 

anticipated to remain consistent with 

the county plan and zoning regulations. 

Noise 

To limit impacts to nearby residences, 

NIH would limit construction activities 

to normal daytime working hours. 

Under the Master Plan, the ambient 

noise levels at NIH would remain 

within Maryland and Montgomery 


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8096 Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices 

County noise thresholds. Furthermore, 

any minor change in noise levels is not 

expected to affect the character of the 

site. 

Air Quality 

Traffic is expected to be the primary 

mobile source of air emissions at or near 

the campus. Mobile air emissions for the 

campus at this time are expected to 

originate from vehicles associated with 

visitors, commuter transportation, 

employee parking, commercial delivery, 

and construction vehicles. Future traffic 

generated carbon monoxide (CO) 

concentrations were predicted to be less 

than 2003 concentrations in the 

Selected Alternative due to projected 

vehicle emission rate reductions. Based 

on predicted values, the one and eighthour average National Ambient Air 

Quality Standards (NAAQS) CO 

concentrations would not be exceeded 

and no impacts are expected for any of 

the proposed Alternatives. 

Wastewater/Water Supply 

The Selected Alternative would 

increase the amount of wastewater 

generated on campus with the proposal 

of additional development. To facilitate 

the construction of the improvements 

under this proposed alternative, the 

existing wastewater distribution system 

would need to be relocated and 

upgraded as necessary. With the 

increase in demand, NIH will consult 

with the Washington Suburban Sanitary 

Commission (WSSC) to ensure adequate 

sewer capacity is available for the 

campus. This consultation would also 

assist WSSC in determining if and when 

any of the public lines surrounding the 

campus need to be upgraded. All 

sanitary sewer design would be in 

accordance with the NIH Facilities 

Development Manual, ‘‘Section 8–6: 

Drainage Systems’’ of the 2008 National 

Institutes of Health Design 

Requirements for Biomedical 

Laboratories and Animal Research 

Facilities and the WSSC requirements. 

No significant impacts are expected for 

wastewater or the NIH campus water 

supply. 

Historic Resources 

NIH would comply with National 

Historic Preservation Act (NHPA) 

Section 106 by consulting with 

Maryland Historical Trust (MHT) on the 

need for particular archeological studies 

as individual Master Plan project 

elements are funded, designed, and 

executed. In the event that eligible 

prehistoric resources are identified and 

adverse effects are anticipated, NIH 

would continue Section 106 

consultation with the appropriate 

consulting parties (which would 

include MHT and may also include 

Advisory Council on Historic 

Preservation (ACHP) and Native 

American tribes) to establish a 

Memorandum of Agreement (MOA) to 

resolve adverse effects. Mitigation 

measures identified through this 

consultation could include in-place 

preservation through site avoidance, 

protection, or easement acquisition; 

development and implementation of a 

data recovery plan to retrieve and 

analyze the site’s resources 

implementation of innovative, 

alternative mitigation measures or a 

combination of these measures. 

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 Master Plan 

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 [or 

‘‘described in’’—the Master Plan itself 

will not be constructed and operated] of 

the new Master Plan 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, the NIH has decided to 

implement the Selected Alternative for 

a long-range physical Master Plan for 

NIH Bethesda Campus located in 

Bethesda, Maryland. The decision 

accounts for potential growth of NIH 

personnel, and consequent construction 

of space over the planning period. 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 

discussed in the Master Plan. Proper 

NEPA documentation will be completed 

based on the outcome of that review. 

Dated: February 5, 2015. 

Daniel G. Wheeland, P.E. 

Director, Office of Research Facilities 

Development and Operations, National 

Institutes of Health. 

[FR Doc. 2015–02993 Filed 2–12–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Announcement of a Draft NIH Policy on 

Dissemination of NIH-Funded Clinical 

Trial Information 

SUMMARY: On November 19, 2014, the 

National Institutes of Health (NIH) 

published a request for public 

comments in the NIH Guide for Grants 

and Contracts on a draft policy to 

promote broad and responsible 

dissemination of information on clinical 

trials funded by the NIH through 

registration and submission of summary 

results information to ClinicalTrials.gov. 

See Guide notice NOT–OD–15–019 at 

http://grants.nih.gov/grants/guide/

notice-files/NOT-OD-15-019.html. NIH 

is publishing this notice in order to 

inform readers of the Federal Register 

about the draft policy and the 

opportunity to comment. 

DATES: The deadline for receiving 

comments on the draft policy is no later 

than 5:00 p.m. on March 23, 2015. 

ADDRESSES: Comments may be 

submitted by any of the following 

methods: 

• Email: 

clinicaltrials.disseminationpolicy@

mail.nih.gov. 

• Fax: 301–496–9839. 

• Mail/Hand delivery/Courier: Office 

of Clinical Research and Bioethics 

Policy, Office of Science Policy, 

National Institutes of Health, 6705 

Rockledge Drive, Suite 750, Bethesda, 

MD 20892. 

FOR FURTHER INFORMATION CONTACT: 

Office of Clinical Research and 

Bioethics Policy, Office of Science 

Policy, National Institutes of Health, 

6705 Rockledge Drive, Suite 750, 

Bethesda, MD 20892, 301–496–9838, 

OCRBP-OSP@od.nih.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

The National Institutes of Health 

(NIH) is dedicated to improving the 

health of Americans by conducting and 

funding biomedical and behavioral 


tkelley on DSK3SPTVN1PROD with NOTICES