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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