HDTRA01-07-R-0004Amendment01BTRICUkrainePhase2SOORev122Aug07.doc

HDTRA1-07-R-0004

ATTACHMENT 2

AMENDMENT 01

BIOLOGICAL THREAT REDUCTION INTEGRATING CONTRACT (BTRIC)

SPECIFIC REQUIREMENTS FOR UKRAINE

STATEMENT OF OBJECTIVES

1.0 BACKGROUND. The U.S. Department of Defense (DoD) and the Ukraine Ministry of Health (MOH) signed the Biological Threat Reduction Implementing Agreement (BTRIA) on August 29, 2005. The BTRIA establishes the Biological Threat Reduction Program (BTRP)—part of the Cooperative Threat Reduction Program under the Defense Threat Reduction Agency—in Ukraine. Ukraine’s Ministry of the Economy approved and registered Phase 1 work of the BTRP in March 2007, with a period of performance of December 1, 2006, to March 1, 2009. BTRP assumes that follow-on registration will take place for future work.

The overarching purpose of BTRP in Ukraine is to establish (1) a nationwide surveillance and reporting system based on an integrated disease surveillance and reporting hardware and software system (provided as Government Furnished Equipment), (2) a nationwide network of diagnostic laboratories that deal with especially dangerous pathogens (EDPs), (3) a secure repository for EDPs, and (4) Cooperative Biological Research (CBR) projects to promote use of the disease surveillance system and diagnostic laboratories, consolidation of pathogens and development of enhanced diagnostics. BTRP wants to have this epidemiological surveillance system—collectively known as the Threat Agent Detection and Response (TADR) system—fully operational in Ukraine by 2014.

The TADR system requires the renovation of suitable biological facilities at as many as 35 sites throughout Ukraine, phased primarily on a regional basis. The TADR system also requires provision for and training on Western-standard laboratory practices and methods at these engaged biological facilities, the carrying out of CBR projects, training of personnel at all engaged biological facilities to U.S. standards of biological safety, and provision and training at select facilities on biological security to DoD standards. Training will be provided by the integrating contractor as well as by U.S. Government specialists from such entities as the Centers for Disease Control and Prevention (CDC) in Atlanta and the U.S. Army.

Once the Government of Ukraine accepts each engaged facility for operations, the DoD plans to sustain the operation of the facility, minus utilities, over the course of three years, diminishing support each year after the first by one-third. After the third year, sustainment of that facility becomes the sole responsibility of the Government of Ukraine.

2.0 OVERALL PROGRAM OBJECTIVES. The overarching purpose of this task order is to integrate all BTRP projects in Ukraine, including projects already under way and those to be established and completed via separate contracting actions. Efforts include upgrades of existing laboratories to Epidemiological Monitoring Stations (EMSs)/Biological Safety Level 2 (BSL-2) diagnostic laboratories and possible construction of one permanent Central Reference Laboratory (CRL) (at BSL-2 and -3) for human EDP work, conducting and coordinating of BTRP training, and support and administration of research projects. The training and logistics support will be a parallel effort to support the physical and equipment upgrades and will commence with technical direction from the DoD. Specific objectives are to:

2.1 Bring Ukraine’s existing disease surveillance, reporting, and response systems up to international diagnostic and reporting standards for robust, integrated tracking and epidemiological evaluation capability. Integrate BTRP efforts in the area of CBR projects, as many as five per year. Accommodate the efforts of designated (and separately contracted) training entities.

2.2 Meet requirements for biological safety and biological security (BS&S), counter both outsider and insider threats, reduce the risk of accidental release of pathogens, and consolidate pathogen collections at well-protected sites.

2.3 Deploy modern molecular diagnostics to eliminate or minimize the need for multiple reference pathogen collections and provide dedicated transport for samples and pathogen consolidation.

2.4 Enhance existing mobile disease response units/national response teams—to be based locations determined by the recipient state government—to bring them into line with corresponding units (or plans for such units) in other BTRP recipient states.

2.5 Encourage higher standards of openness, ethics, and conduct, to integrate former biological weapons scientists and institutes into the Western scientific community via CBR projects, transfer pathogen strains, and send reports to the United States.

3.0 CONTRACT OBJECTIVES. The contract objective of the BTRP in Ukraine is to provide for the integration, planning, organizing, management, reporting, maintenance, logistics, training, construction, technical expertise, and sustainment support resources necessary to accomplish the goals of the program. Specific objectives are to:

3.1 Integrate and synchronize all BTRP country-level efforts to accomplish BTRP program objectives in an effective and efficient manner. This includes the seamless integration of efforts of designated U.S. Government partners, other contractor efforts, and Government of Ukraine efforts. In addition, EMSs/diagnostic labs shall be available and prepared to assist Ukrainian national, oblast, and rayon-level public health efforts in the event of an EDP outbreak or bioterrorism emergency. Coordinate and assist scientific collaborators in the development of research proposals. Conduct administrative management of projects from conception through closeout, establish and distribute grant payments, procure equipment necessary to complete projects at each site, and maximize use of the BTRP-renovated facilities to the extent possible.

3.2 Conduct site analyses at potential locations of EMSs to evaluate their suitability and report on current structural integrity, utilities, laboratory equipment onsite, staff capability, and security systems. Provide analysis, recommendations, and conceptual designs to DTRA. Use a systems engineering process for renovating or constructing laboratories that are capable of achieving BSL-2 for EMSs and BSL-3 for future permanent CRL (s).

3.3 Establish a cost-efficient integrated logistics system that allows operational, albeit diminishing, sustainment of fielded systems through the stand-up period and for three years after commissioning of each engaged facility. All sustainment requirements associated with BTRP projects in Ukraine must be ready to transition fully and seamlessly to the Government of Ukraine after that three-year period.

4.0 MANAGEMENT OBJECTIVES: The operating environment of Ukraine is mercurial; therefore, the Contractor is expected to take initiative to deal with changing circumstances. Specific objectives are to:

4.1 Adjust program schedule, performance, warranties, subcontracts, and data to support the objectives of the BTRP as well as the risks and mitigation strategies that the Offeror sees in Ukraine.

4.2 Secure the cooperation and coordination necessary with the recipient state governments (at all levels), ensure compliance with regulations, and consider established recipient state procedures and organizational structure.

4.3 Maintain clear visibility for the U.S. Government into all aspects of the BTRP in Ukraine.

5.0 Constraints: The following constraints apply:

5.1 All BS&S/TADR projects (i.e., EMS) should be planned to be complete within five years of contract award with the exception of the CRL option.

5.2 Individual CBR projects should be planned for a duration of three years or fewer, not including the project development phase. As many as five projects can be ongoing at any one time, but this number reflects projects that are undergoing startup as well as closeout.

5.3 Sustainment must commence at the achievement of commissioning/acceptance by the Government of Ukraine for operations of each engaged facility and remain in place for a period of three years, with year one at 100 percent of (“full”) sustainment, year two at 66 percent of sustainment, and year three at 33 percent of sustainment or until completion of the period of performance, whichever comes first.

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July 31, 2007

Rev 1 22AUG07