and Human Services (HHS)
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 [email protected]. 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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