Catalyzed by the 2001 Amerithrax attacks, the United States Government recognized the need for a laboratory facility dedicated to microbial forensics and to scientific investigation of potential biological threat agents and biodefense countermeasures. In November 2002, Congress passed the Homeland Security Act, in part to coordinate and advance homeland security research and development activities across the federal government. President Bush issued government-wide directives on biodefense research and development in April 2004 that led to the creation of NBACC.
Groundbreaking and construction of the 160,000 sq ft NBACC facility began in 2006, and on December 20, 2006, DHS selected Battelle National Biodefense Institute, LLC (BNBI) to manage and operate the facility and scientific programs as a Federally Funded Research and Development Contractor (FFRDC).
The FFRDC Management and Operating (M&O) contract is structured to provide a stable, non-Federal, scientific and support workforce available to be a partner with DHS to address its strategic and evolving needs. The Federal Acquisition Regulations (FAR) defines FFRDCs as “federally-funded, privately-operated facilities established to meet a special long-term R&D need of the federal government which cannot be met effectively by existing in-house or contractor resources. FFRDCs are managed, operated, and/or administered by a university, other nonprofit organization, or an industrial firm.” The work performed under M&O contracts is closely related to the sponsoring agency’s mission and is of a long-term and continuing nature; as a result, M&O contracts are characterized by their special purpose and the close relationship they create between the sponsoring agency and the contractors. FAR 2.101 states that FFRDCs are formed when: 1) A long-term relationship is contemplated; 2) Most or all of the facilities are owned or funded by the Government; and 3) The FFRDC has access to Government and supplier data, employees, and facilities beyond that common in a normal contractual relationship.
Since being established as an FFRDC in December 2006, BNBI has successfully transitioned NBACC’s existing programs without loss of operations, stood up infrastructure, and transitioned operations to its new state-of-the-art laboratory, while earning commendations from multiple, independent accreditation organizations. BNBI assumed operational control and management of the NBACC Laboratory facility on January 13, 2010. An “endurance testing” program was immediately implemented to demonstrate the functionality of the building, adequacy of operating procedures/protocols, and readiness of facility staff. The BSL-2 labs were activated in May 2010. Activation of the high containment laboratories was accomplished when an innovative NBACC BSL-4 with “swing 3” capabilities was registered by the CDC and USDA on September 21, 2011. An amendment to the CDC/USDA BSAT registration for activation of the BSL-3 laboratories was received in December 2012.