NOTICE OF INTENT:  REGIONAL BIOCONTAINMENT LABORATORIES (RBL)

Release Date:  July 19, 2002

NOTICE: NOT-AI-02-038

National Institute of Allergy and Infectious Diseases (NIAID)
 (http://www.niaid.nih.gov/)

REQUEST FOR COMMENTS - Receipt Date: July 29, 2002   Comments 
concerning the proposed requirements should be sent electronically to 
Barbara Shadrick at bs92y@nih.gov.  This is a notice of intent to issue 
a Request for Proposals (RFP).  Proposals are not being solicited at 
this time.  Authorizing legislation and appropriations for this effort 
are pending.  At this time we are only soliciting comments concerning 
the design, construction, certification, and operations of the 
facilities.  

INTERESTED PARTIES PLEASE NOTE:  NIAID will host a public briefing on 
the proposed Request for Proposals (RFP) to establish Regional 
Biocontainment Laboratories, on August 8, 2002, at the Gaithersburg 
Marriott Washingtonian Center, 9751 Washingtonian Boulevard, 
Gaithersburg, Maryland  20878 (telephone:  1-301-590-0044).  The 
briefing for the RCEs will begin at 9:00 a.m. and the RBLs will begin 
at 1:00 p.m.  Registration will be provided at the meeting.
 
The NIAID also intends to issue a Request for Applications (RFA) for 
the establishment of a network of Regional Centers of Excellence for 
Biodefense and Emerging Infectious Diseases Research (RCEs)   RFA-AI-
02-031.  Offerors for the RBLs will be required to be associated with 
an institution or consortium also applying for the RCEs.  It is 
estimated that this RFA will be available on or about August 8, 2002.

RFP FOR THE REGIONAL BIOCONTAINMENT LABORATORIES (RBLs)

1) Types of Regional Biocontainment Laboratories.  Only two types of 
RBLs will be considered for support with construction funds:

a) Comprehensive Regional Biocontainment Laboratory.  Facility or group 
of cooperating regional facilities that has the full range of 
biocontainment capabilities needed, if called upon, to:

i) safely and securely transport, receive, work with, and store or 
house all CDC Category A, B, and C agents and other emerging infectious 
agents and animals and humans exposed to and/or infected with any of 
such agent, and,

ii) perform research directed at the prevention, detection, diagnosis 
and treatment of diseases caused by all CDC Category A, B, and C agents 
and other emerging infectious diseases

b) Specialized Regional Biocontainment Laboratory.  Facility or group 
of cooperating regional facilities that has biocontainment capabilities 
with limited or no BSL4 containment space needed to:

i) safely and securely transport, receive, work with, and store or 
house most CDC Category A, B, and C agents and other emerging 
infectious agents and animals and humans exposed to and/or infected 
with any of such agent, and,

ii) perform research directed at the prevention, detection, diagnosis 
and treatment of diseases caused by most CDC Category A, B, and C 
agents and other emerging infectious diseases

2) Eligibility

a) The RBL contractors must be associated with an institution or 
consortium that is applying for one or more NIAID Regional Centers of 
Excellence in Biodefense and Emerging Infectious Diseases Research 
(RCE) awards.  Please note: RBL contractors, regardless of 
independently-planned linkages to RCEs may be required to link to one 
or more additional RCEs post-award as determined by NIAID staff to meet 
program goals.

b) The RBL contractors must be U.S. public or non-profit organizations.  
The RBL contractors must seek opportunities for collaboration with the 
public and private sectors when such collaborations promise advances in 
prevention, detection, diagnosis, and treatment of illnesses caused by 
CDC Category A, B, and C agents.  

c) The RBL contractors must demonstrate the capacity and capability to 
meet regional (multi-state, multi-institutional) research needs.  
Consortia are encouraged. 

CONSIDERATIONS IN AWARDEE SELECTION 

1) Laboratory Type.  Establishing Comprehensive RBLs quickly is more 
important than establishing Specialized RBLs.  Offerors for 
Comprehensive RBLs will have a competitive advantage.

2) Net Cost to NIAID.  In meeting the requirements for support as an 
RBL, offerors may propose Comprehensive or Specialized RBLs that 
combine existing facilities, planned facilities to be funded from other 
sources, and facilities to be designed, constructed, and certified with 
funds from contracts awarded under this solicitation.  Net cost to the 
NIAID will be a consideration in selecting awardees.

3) Early Availability of Biocontainment Laboratories.  Offerors whose 
plans include currently available facilities, facilities ready for or 
under construction, and proposals for expedited completion of planned 
facilities will have a competitive advantage.  

REQUIRED CAPABILITIES

Contractors must be in compliance with U.S. laws and regulations and 
DHHS and NIH policies in effect at the time of contract award and with 
any changes in law, regulation or policy that are implemented during 
the period of performance.

NIAID expects fast track schedules in which planning, design, and 
construction cycles overlap followed by final commissioning of the 
facility.  Offerors who are awarded RBL Construction contracts will be 
selected based on state of the art designs, technical design and 
feasibility of the plans, scientific and technical merit, Project 
Plans, linkages to institutions that will use the RBL, ability to meet 
National, regional, state, local, institutional needs, and geographic 
area served.  Plans should also describe:
 
o  High Containment Laboratory Facilities. BSL4 (for Comprehensive 
RBLs), BSL3, BSL3-AG laboratories for research including tissue 
culture and antigen production and in other in vitro studies. 
Insectary space for work with vector borne diseases. Cell biology 
and molecular biology labs are required.

o  High Containment Animal Facilities. BSL4 (for Comprehensive 
RBLs), BSL3-AG, BSL3 space for conducting research on disease 
pathogenesis and host response in multiple species of animals. 
Procedures rooms and pathology laboratory space. Housing for many 
types of animals ranging from rodents to primates. Aerosol challenge 
and response assessment facilities for drug and vaccine studies in 
animals. Individual animal studies could involve 20 or more animals.
 
o  High Containment Clinical Facilities. Isolation units for 
research on and treatment of patients, and human trials of virus-
based vaccines.

o  Support Staff and Systems for All High Containment Facilities. 
Safety and security systems that are redundant. All necessary 
environmental controls. Space for core medical, scientific, 
technical, safety, and maintenance personnel for performance of core 
services. Biosafety requirements found in Biosafety in 
Microbiological and Biomedical Laboratories at 
http://bmbl.od.nih.gov must be met. 

It is anticipated that offerors will be required to submit the 
following items with their construction proposals (not intended as an 
all inclusive list):

o  Small-scale layout drawing showing possible arrangement of space, 
conceptual designs, and schematic designs.

o  One set of existing record drawings, for existing space, if 
applicable.

o Topographic data (including seismic data or other pertinent 
information) as available.

o  Existing utilities information, as available.

o Project Milestones/Schedule

o  Project Plan including: Description of Project, Project 
Implementation Strategy, Quality Assurance and Quality Surveillance 
Plans, Environmental Control Plan, Occupancy Plan, Community 
Relations Plan, and Commissioning Plan

o  Preliminary Project Team.  A&E and Construction contractors 
should have recent and relevant biocontainment experience.  
References will be required.

o  Construction cost estimate.  

o  Plans for rapidly accommodating research needs and objectives in 
case of a national emergency.

o  Any other information that would assist the Project Officer and 
the peer review committee in determining the extent to which the 
offeror meets the requirement.

Awards will be based on an initial proposal identifying scientific 
qualifications, organizational commitment, current or planned 
biocontainment facilities, initial facility design that is state of the 
art and operationally safe and effective, design/construction team 
members, milestone schedule, Preliminary Project Plan, regional 
relationships, and cost.

REGIONAL BIOCONTAINMENT LABORATORY OPERATIONS

It is also the intent of NIAID to issue an RFP for the long-term 
operations of the RBL facility.  The contractor will operate, maintain, 
and upgrade the RBL to meet institutional, regional, and national 
needs.  The Contractor will provide all equipment, furnishings and 
supporting paraphernalia for the facilities.  At a minimum, the 
operations contractor shall provide the staff needed for the following 
core services:

o  Management and administration of the facility, staff and 
contractors

o  Safety and security - safely and securely transport, receive, 
work with, and store or house CDC Category A, B, and C agents and 
other emerging infectious agents and animals and humans exposed to 
and/or infected with any of such agent.  Safety and security staff 
will also be responsible for safety and security training for all 
persons who enter the biocontainment facilities

o  Veterinary and animal care staff

o  Maintenance services to ensure the operability and physical 
integrity of the facilities

o  Scientific and technical staff to run the core laboratories and 
train students and new and visiting personnel in appropriate 
laboratory techniques in biocontainment facilities.

If feasible, RBL Operations contracts will be awarded simultaneously 
with RBL Construction contracts in an effort to involve the scientists 
and other staff who will use and maintain the facility.  Staff for core 
operations (safety, maintenance, animal care, etc.) will be supported 
via the RBL Operations contract, as will upgrades of facilities and 
equipment as technology changes.  

RFP FOR THE DEVELOPMENT AND INTEGRATION CONTRACTOR

The NIAID also seeks to award a contract to provide the Institute with 
advice on project management, program management and other services 
consistent with the Institute"s responsibilities in the oversight of 
the construction of the Biocontainment Research Laboratories.  The 
Contractor will also assist the Government by providing advise or 
services required to ensure design excellence, operational flexibility, 
cost efficiency, and safety, and in coordinating construction efforts 
ensuring that any conflicts that may arise are quickly and efficiently 
resolved.  

NUMBER OF AWARDS AND ESTIMATED BUDGET

In Fiscal Years 2003 and 2004, NIAID anticipates awarding: 

1) RBL Construction Awards (5 to 7 awards). 

2) RBL Operations Awards (5 to 7 awards).  Awards could be for 10 
years, renewable based on performance.

3) Development and Integration Contractor (1 award).  

Funds available for these projects are estimated at $150 Million for 
FY03 and $300 Million for FY04.  Authorizing legislation and 
appropriations for these efforts are pending.  

This Notice of Intent does not commit the Government to solicit or 
award any of the above-described contracts. This notice is provided for 
informational purposes only. 

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