Biosurveillance: Observations on BioWatch Generation-3 and Other Federal Efforts
Published: 2012-09-13T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: A catastrophic biological event could have devastating consequences. The U.S. government has efforts to provide early detection and warning of biological threats. DHSs BioWatch, which aims to detect certain pathogens in the air, is one such program. DHS has been pursuing a third generation of BioWatch technology (Gen-3) to further enhance detection. GAO has published a series of reports on national biosurveillance efforts, including a report released today on DHSs efforts to acquire Gen-3. This statement discusses (1) prior biosurveillance work and related federal efforts, (2) todays report on the Gen-3 acquisition, and (3) prior strategy recommendations and the White Houses July 2012 National Strategy for Biosurveillance. This statement is based on GAO reports published from December 2009 to September 2012 and GAOs review of the National Strategy for Biosurveillance in relation to prior GAO recommendations for a national biosurveillance strategy.
section_title: What GAO Found
paragraphs: The Department of Homeland Security (DHS) and the White House have acted to strengthen biosurveillance consistent with prior GAO recommendations made from December 2009 through October 2011.In August 2012, DHS issued a strategic plan for its National Biosurveillance Integration Center (NBIC) that officials say was written in coordination with federal partners and designed to respond to GAOs December 2009 findings that NBIC did not have key resources to carry out its mission, in part due to collaboration issues it faced. In July 2012, the White House released the National Strategy for Biosurveillance, which describes guiding principles, core functions, and enablers for strengthening biosurveillance. In June 2010, GAO recommended a national biosurveillance strategy to provide a unifying framework for building and maintaining a national biosurveillance capability. In October 2011, GAO also recommended the strategy account for the need to leverage resources and respond to challenges while partnering with nonfederal entities. The July 2012 strategy partially responds to the issues GAO called for such a strategy to address, but does not fully address them, as discussed below. A strategic implementation plan is to be published within 120 days of strategy issuance (October 2012), and may align the strategy more fully with the array of issues GAO identified.
DHS approved the Generation-3 (Gen-3) acquisition in October 2009, but it did not fully engage its acquisition framework to ensure that the acquisition was grounded in a justified mission need and that it pursued an optimal solution. The performance, schedule, and cost expectations presented in required documents when DHS approved the acquisition were not developed in accordance with DHS guidance and good acquisition practiceslike accounting for risk in schedule and cost estimates. Since October 2009, the estimated date for full deployment has been delayed from fiscal year 2016 to fiscal year 2022. The 2009 life-cycle cost estimatea point estimate unadjusted for riskwas $2.1 billion. In June 2011, DHS provided a risk-adjusted estimate at the 80 percent confidence level of $5.8 billion. Several steps remain before DHS can fully deploy Gen-3 including additional performance testing, operational testing, and developing location specific deployment plans.
The White Houses National Strategy for Biosurveillance serves as a foundation for enterprisewide efforts and begins to define mission, goals, and objectives, as we called for in making the June 2010 strategy recommendation; however, the strategy does not yet offer the mechanism GAO recommended to identify resource and investment needs, including investment priorities. Accordingly, the biosurveillance enterprise remains without a framework to guide the systematic identification of risk, assessment of resources needed to address those risks, and the prioritization and allocation of investment across the entire enterprise. In recommending a national strategy, GAO recognized the challenges individual federal programs and agencies face prioritizing resources to help ensure a coherent effort across the dispersed biosurveillance enterprise. Todays report on Gen-3 offers a timely and concrete example of this challengeto assess the extent to which Gen-3 warrants the investment of scarce resources when the incremental value of the environmental monitoring Gen-3 offers is considered as part of a layered biosurveillance strategy.
section_title: What GAO Recommends
paragraphs: In prior reports, GAO made biosurveillance recommendations to DHS and the White House Homeland Security Council. DHS concurred with prior recommendations. The White House did not comment. In todays report, GAO recommended that before continuing the Gen-3 acquisition, DHS reevaluate the mission need and alternatives and update associated performance, schedule, and cost information. DHS concurred but stated it plans to reevaluate the acquisition and pursue performance testing concurrently. We believe DHS should first develop the critical information we recommended.

section_title: Letter
paragraphs: Chairmen Bilirakis and Lungren and members of the Subcommittees:  I am pleased to have the opportunity to be here today to discuss our  biosurveillance work, with particular focus on the Department of  Homeland Security’s (DHS) BioWatch Generation-3 (Gen-3) program. A  catastrophic biological event, such as a terrorist attack with a weapon of  mass destruction or a naturally occurring pandemic, could cause  thousands of casualties or more, weaken the economy, damage public  morale and confidence, and threaten national security. In recent years,  there has been an increasing awareness of the potential for biological  agents to be used as weapons of mass destruction and of the threat of  catastrophic effects arising from emerging strains of infectious disease.  For example, events like the 2001 Amerithrax incident, which killed 5  people and sickened 17, and the global pandemic resulting from  emergence of a novel strain of influenza in 2009, have brought increased  attention to intentional and naturally occurring biological threats.
The U.S. government has a long history of employing disease  surveillance activities to help limit malady, loss of life, and economic  impact. Traditional disease surveillance activities involve trained  professionals engaged in monitoring, investigating, confirming, and  reporting in an effort to further various missions including, but not limited  to, detecting signs of pathogens in humans, animals, plants, food, and the  environment. However, in recent years, experts and practitioners,  reacting to an increasing awareness of the speed and intensity with which  a biological weapon of mass destruction or highly pathogenic strain of  emerging infectious disease could affect the nation, have sought to  augment traditional surveillance activities with biosurveillance programs  and systems. DHS’s BioWatch program is an example of such an effort. It  aims to reduce the time required to recognize and characterize potentially  catastrophic aerosolized attacks by detecting the presence of five  biological agents—considered to be at a high risk for weaponized  attack—in the air.
The currently deployed BioWatch technology—Generation-2 (Gen-2)— can take 12 to 36 hours to confirm the presence of pathogens. DHS has  been pursuing Gen-3 with the goal of implementing a system that will  perform automated testing, potentially generating a result in under 6  hours and eliminating certain labor costs. Expressing questions about  whether DHS had undertaken a rigorous effort to help guide its Gen-3  decision making, two subcommittees of this committee asked us to  examine issues related to the Gen-3 acquisition. Today, we released a  report that evaluates the acquisition decision-making process for Gen-3.  In addition, since December 2009, we have published three other reports  about efforts across the federal government and with nonfederal partners  to enhance the nation’s biosurveillance capabilities. This statement (1)  describes recent federal efforts that align with our biosurveillance work  published from December 2009 through October 2011, (2) discusses our  Gen-3 acquisition findings, and (3) makes observations about our prior  strategy recommendations and the White House’s recently released  National Strategy for Biosurveillance.
To describe recent federal efforts that align with our work published from  December 2009 through October 2011, we reviewed the National  Biosurveillance Integration Center Strategic Plan and the National  Strategy for Biosurveillance, and obtained information from DHS officials.  To develop findings in the report released today about Gen-3, which this  statement is largely based on, we reviewed DHS’s acquisition guidance,  including Acquisition Management Directive 102-01. Additionally, we  reviewed acquisition documentation and interviewed agency officials from  the BioWatch program and other DHS offices with development, policy,  and acquisition responsibilities. We then compared the information  developed from our documentation review and interviews against the  guidance. More detailed information on our scope and methodology  appears in our published work .To make observations about the National  Strategy for Biosurveillance, we analyzed the strategy and assessed its  alignment with findings and recommendations about a the need for a  national biosurveillance strategy in prior work. We conducted this work  from August 2012 to September 2012 in accordance with generally  accepted government auditing standards. Those standards require that  we plan and perform the audit to obtain sufficient, appropriate evidence to  provide a reasonable basis for our findings and conclusions based on our  audit objectives. We believe that the evidence obtained provides a  reasonable basis for our findings and conclusions based on our audit  objectives.
subsections: section_title: DHS and the White House Have Taken Action to Enhance Biosurveillance
paragraphs: In December 2009, we published a report assessing DHS’s efforts to  establish the National Biosurveillance Integration Center (NBIC). We  reported that NBIC was not fully equipped to carry out its mission  because it lacked key resources—data and personnel—from its partner  agencies, a situation that could be at least partially attributed to  collaboration challenges NBIC faced. We recommended that NBIC work  with its federal partners to develop a strategy to enhance collaboration— including sharing data, personnel, and other resources—and to establish  effectiveness measures for that collaboration. DHS generally concurred  with our findings and recommendations and stated that NBIC would work  with its partners to develop a collaboration strategy to clarify both the  mission space and roles and responsibilities for all partners. In August  2012, DHS issued the National Biosurveillance Integration Center  Strategic Plan. According to DHS officials, the plan articulates a clear  approach with a series of measurable steps and initiatives to enhance the  nation’s biosurveillance capability. In late August 2012, when providing us  with a copy of the strategy, officials stated that they believe it satisfies the  intent of our recommendations. Officials said the plan was written in  coordination with NBIC’s federal partners and is the result of a  deliberative process examining NBIC’s current capabilities and capability  gaps. We are currently assessing the extent to which the plan fully  responds to the recommendations.
In June 2010, we reported on federal efforts that support a national  biosurveillance capability and the extent to which mechanisms were in  place to guide the development of a national biosurveillance capability.  We reported that a national biosurveillance capability would largely rely  on an interagency effort because the activities and accompanying  resources that support the capability—personnel, training, equipment,  and systems—are dispersed across a number of federal agencies.
However, we found that the federal government did not have a unifying  framework and structure for integrating dispersed capabilities and  responsibilities and no federal agency had authority to guide and oversee  the development and implementation of a national effort that  encompassed all stakeholders with biosurveillance responsibilities. We  concluded that without such a framework and an entity with the authority,  resources, time, and responsibility for guiding its implementation, it would  be very difficult to create an integrated approach to building and  sustaining a national biosurveillance capability. We recommended that  the Homeland Security Council within the White House direct the National  Security Staff to identify, in consultation with relevant federal agencies, a  focal point to lead the development of such a strategy.
Our June 2010 report also noted that a national biosurveillance capability  depends upon participation from state, local, and tribal governments,  because few of the resources required to support the capability are wholly  owned by the federal government. In October 2011, we reported on how  the federal government worked with its nonfederal partners to support  biosurveillance, activities those partners identified as essential to their  biosurveillance efforts, and particular challenges those partners faced.  We recommended that the strategy we called for in June 2010  incorporate a means to leverage existing efforts that support nonfederal  biosurveillance capabilities, consider challenges that nonfederal  jurisdictions face, and include a framework to develop a baseline and gap  assessment of nonfederal jurisdictions’ biosurveillance capabilities. The  White House did not comment on these recommendations.
In July 2012, the White House released the National Strategy for  Biosurveillance to describe the U.S. government’s approach to  strengthening biosurveillance. The strategy describes guiding principles,  core functions, and enablers for strengthening biosurveillance. The  strategy states that its approach emphasized teamwork between and  within federal departments, across all layers of government, and with  private sector partners. A strategic implementation plan is to be  completed within 120 days of the strategy issuance. The strategy does  not fully meet the intent of our June 2010 and October 2011  recommendations, as discussed later in this statement, but it is possible  that it will when the implementation plan is complete.
section_title: DHS Did Not Develop Critical Knowledge before Proceeding with the Gen-3 Acquisition
subsections: section_title: DHS Proceeded with the Gen-3 Acquisition before Establishing a Mission Need
paragraphs: DHS approved the Gen-3 acquisition in October 2009 without fully  developing critical knowledge that would help ensure sound investment  decision making, pursuit of optimal solutions, and reliable performance,  cost, and schedule information. Specifically, DHS did not engage the  initial phase of its Acquisition Life-cycle Framework, which is designed to  help ensure that the mission need driving the acquisition warrants  investment of limited resources. In the Acquisition Life Cycle Framework  design, it is not the purpose of the Mission Needs Statement to specify a  technical solution. Rather it is to serve as a touchstone for subsequent  acquisition efforts by focusing on the capability gap to help articulate and  build consensus around the goals and objectives for a program.
However, DHS began to pursue a specific autonomous detection solution  well before completing a Mission Needs Statement. Specifically, DHS’s  Integrated Planning Guidance (IPG) for fiscal years 2010-2014, which  was finalized in March 2008, included specific goals for the next  generation of BioWatch—to deploy in all major cities an autonomous  BioWatch detection device reducing the operating cost per site by more  than 50 percent and warning time to less than 6 hours. The purpose of  DHS’s IPG is to communicate the Secretary’s policy and planning goals  to component-level decision makers to inform their programming,  budgeting, and execution activities. As such, this specific set of goals for  BioWatch Gen-3 demonstrates that DHS leadership had established a  course for the acquisition by March 2008, in advance of efforts to define  the mission need through the Mission Needs Statement process, which  was finalized more than a year and a half later.
DHS officials in multiple departments described a climate, in the wake of  the September 11, 2001, terrorist attacks and the subsequent Amerithrax  attacks, in which the highest levels of the administration expressed  interest in quickly deploying the early generation BioWatch detectors and  improving their functionality—as quickly as possible—to allow for faster  detection and an indoor capability. BioWatch officials stated that they  were aware that the Mission Needs Statement prepared in October 2009  did not reflect a systematic effort to justify a capability need, but stated  that the department directed them to proceed because there was already  departmental consensus around the solution. Accordingly, the utility of the  Mission Needs Statement as a foundation for subsequent acquisition  efforts was limited.
section_title: DHS Did Not Systematically Analyze Alternatives
paragraphs: Additionally, DHS did not use the processes established by its Acquisition  Life-cycle Framework to systematically ensure that it was pursuing the  optimal solution—based on cost, benefit, and risk—to mitigate the  capability gap identified in the Mission Needs Statement. The DHS  Acquisition Life-cycle Framework calls for the program office to develop  an Analysis of Alternatives that systematically identifies possible  alternative solutions that could satisfy the identified need, considers cost- benefit and risk information for each alternative, and finally selects the  best option from among the alternatives.
However, the Analysis of Alternatives prepared for the Gen-3 acquisition  did not reflect a systematic decision-making process. For example, in  addition to—or perhaps reflecting—its origin in the predetermined solution  from the Mission Needs Statement, the Analysis of Alternatives did not  fully explore costs or consider benefits and risk information as part of the  analysis. Instead, the Analysis of Alternatives focused on just one cost  metric that justified the decision to pursue autonomous detection—cost  per detection cycle—to the exclusion of other cost and benefit  considerations that might have informed decision makers.the Analysis of Alternatives examined only two alternatives, though the   Additionally,  guidance calls for at least three. The first alternative was the currently  deployed Gen-2 technology with a modified operational model (which by  definition was unable to meet the established goals). The second  alternative was the complete replacement of the deployed Gen-2 program  with an autonomous detection technology and expanded deployment.
BioWatch program officials acknowledged that other options—including  but not limited to deploying some combination of both technologies,  based on risk and logistical considerations—may be more cost-effective.  As with the Mission Needs Statement, program officials told us that they  were advised that a comprehensive Analysis of Alternatives would not be  necessary because there was already departmental consensus that  autonomous detection was the optimal solution.
Because the Gen-3 Analysis of Alternatives did not evaluate a complete  solution set, did not consider complete cost information, did not consider  benefits, and did not include a cost-benefit analysis, it does not provide  information on which to base trade-off decisions. For example, it does not  provide information about the extent to which various aspects of the  solution—such as the number of participating jurisdictions—results in a  reduction of risk and at what cost. Given the uncertainty related to Gen- 3’s costs, benefits, and risk mitigation potential, DHS does not have  reasonable assurance that the strategy of expanding and completely  replacing the existing Gen-2 program with autonomous detection  technology is the most cost-effective solution.
section_title: DHS Did Not Fully Develop Performance, Cost, and Schedule Information
paragraphs: In October 2009, DHS approved the Gen-3 acquisition at Acquisition  Decision Event (ADE) 2A—one of the key formal decision points in DHS’s  Acquisition Life-cycle Framework—based on information contained in  acquisition documents provided by the BioWatch program. One critical  purpose of the ADE-2A documentation set required by DHS’s acquisition  guidance is to describe the expected performance, cost, and schedule  parameters for an acquisition. However, the ADE-2A Acquisition Decision  Memorandum stated that significant data necessary for the proper  adjudication of an ADE-2A decision were missing. Further, we reported  that some performance, cost, and schedule expectations presented at  ADE-2A were not developed in accordance with DHS guidance and good  acquisition practices—like accounting for risk in schedule and cost  estimates.
On the basis of the Gen-3 documentation submitted at ADE-2A, DHS  expected to acquire a system that would cost $2.1 billion, be fully  deployed by fiscal year 2016, and meet certain performance  requirements. However, the performance, cost, and schedule parameters  for the Gen-3 acquisition have changed. Specifically, certain performance  requirements have been revised, the estimated date for full deployment  has been delayed from fiscal year 2016 to fiscal year 2022, and the  expected life cycle cost has changed from the $2.1 billion point estimate  prepared for ADE-2A to a risk-adjusted $5.8 billion estimate, calculated at  the 80 percent confidence level.
BioWatch program officials told us that they had to prepare ADE-2A  documentation quickly because ADE-2A had been accelerated by more  than a year. Additionally, DHS officials from multiple offices described a  climate around the time of ADE-2A in which the department’s business  processes—including acquisition practices—were maturing and thus were  less rigorous in their adherence to best practices for cost and schedule  estimating. However, in the absence of complete and reliable information,  DHS had limited assurance that the acquisition would successfully deliver  the intended capability within cost and on schedule. Comprehensive and  systematic information developed using good practices for cost and  schedule estimating could help ensure that more reliable performance,  cost, and schedule information is available for future acquisition decision  making.
We recommended that before continuing the acquisition, DHS reevaluate  the mission need and alternatives and develop performance, cost, and  schedule information in accordance with guidance and good acquisition  practices. DHS concurred with the recommendations but plans to proceed  with the next step in the acquisition—performance testing—while  implementing them. We are pleased that DHS plans to implement the  recommendation but are concerned by DHS’s intention to continue the  acquisition efforts before ensuring that it has fully developed the critical  knowledge a comprehensive Acquisition Life-cycle Framework effort is  designed to provide.
section_title: Several Steps Remain before Gen-3 Is Ready for Deployment
paragraphs: The BioWatch program completed initial testing and evaluation on a Gen- 3 prototype technology in June 2011, but several steps remain before   For example, the BioWatch  Gen-3 can be deployed and operational.program must complete additional testing. The characterization testing  conducted in 2010 and 2011 was intended to assess the state of  available technology. This testing sought to demonstrate the performance  of available candidate Gen-3 technologies against the requirements  established by the BioWatch program, and consisted primarily of  laboratory testing of individual system components. This testing did not  demonstrate the performance of the full system in detecting live  pathogens in the operational environment. It also did not test the  information technology network that will transmit results for public health  officials. Now the program plans to conduct the next phase of testing— performance testing in three independent laboratories and operational  test and evaluation in four BioWatch jurisdictions. On the basis of the  June 2011 Life-cycle Cost Estimate, the BioWatch program estimates this  testing will take approximately 3 years and cost approximately $89 million  (risk adjusted at the 80 percent confidence level).
The Deputy Secretary of Homeland Security and other senior officials met  on August 16, 2012 for an Acquisition Review Board, during which the  BioWatch program was seeking approval to initiate the next phase of the  acquisition. DHS did not make a final decision, but authorized release of a  solicitation for performance testing under the next testing phase. In  response to the recommendations we made in the Gen-3 report, DHS  officials stated that before awarding a performance testing contract— which would allow the program to acquire a small number of test units— the program office is directed to return to the Acquisition Review Board  for approval.
Before undertaking the remaining steps in the acquisition, the program  office is directed to return for Acquisition Decision Event-2B (ADE-2B)— the next formal decision point in DHS’s Acquisition Life-cycle  Framework—with updated information, including an Analysis of  Alternatives and Concept of Operations, as we recommended. No  timeframe for completing these actions has been specified, but according  to DHS officials, it may take up to 1 year to update the Analysis of  Alternatives. In preparation for the August 16, 2012, meeting, the  BioWatch program had updated key acquisition documents—including  the Life-cycle Cost Estimate and Acquisition Program Baseline—as  required by the Acquisition Decision Authority in a February 2012 memo.  However, in order to inform the ADE-2B decision, these documents must  accurately reflect changes to Gen-3 performance requirements and  updated cost and schedule estimates for the acquisition and therefore  may require further revisions.
If approved at ADE-2B, the BioWatch program plans to conduct  operational testing of Gen-3 units in four BioWatch jurisdictions. Following  operational testing, DHS intends to decide whether to authorize the  production and deployment of Gen-3. If Gen-3 is approved, the BioWatch  program plans to prepare for deployment by working with BioWatch  jurisdictions to develop location-specific plans to guide Gen-3 operations.  DHS estimates based on the June 2011 Life-cycle Cost estimate show  that about $5.7 billion of the $5.8 billion life-cycle cost (risk adjusted at the  80 percent confidence level) remains to be spent to test, produce, deploy,  and operate Gen-3 through fiscal year 2028.
section_title: Observations about Prior Strategy Recommendations and the July 2012 National Strategy for Biosurveillance
paragraphs: In the report on Gen-3 released today, we noted that beyond the  uncertainty related to the costs and benefits of the planned Gen-3  approach, there is additional uncertainty about the incremental benefit of  this kind of environmental monitoring as a risk mitigation activity because  of its relatively limited scope. As the study committee for a 2011 National  Academies evaluation of BioWatch noted, there is considerable  uncertainty about the likelihood and magnitude of a biological attack, and  how the risk of a release of an aerosolized pathogen compares with risks  from other potential forms of terrorism or from natural diseases. The  National Academies report also notes that while the BioWatch program is  designed to detect certain biological agents (currently five agents) that  could be intentionally released in aerosolized form, detecting a  bioterrorism event involving other pathogens or routes of exposure  requires other approaches.
In the report we released today, we stated that given the total estimated  operating cost for the Gen-3 program, it is important, especially in an  increasingly resource-constrained environment, to consider the benefit— in terms of its ability to mitigate the consequences of a potentially  catastrophic biological attack—that the investment provides. We noted  that the scope limitations of this kind of environmental monitoring provide  context in both the consideration of mission need and in analyzing cost  effectiveness.
However, it was not within the scope of our BioWatch Gen-3 study nor  was it our intention to reach a firm conclusion about the value of this kind  of activity as part of a layered biosurveillance strategy. Rather, we believe  the need to consider value within the larger biosurveillance enterprise as  part of an effort to define mission need for a single federal program like  Gen-3 provides a timely and concrete illustration of the kind of issues we  sought to address with our June 2010 recommendation. The  recommendation for the Homeland Security Council to direct the National  Security Staff to identify a focal point to lead the development of a  national biosurveillance strategy was grounded in previous work on  desirable strategy characteristics for complex homeland security  missions. We recognized the difficulty that decision makers and program  managers in individual federal agencies face prioritizing resources to help  ensure a coherent effort across a vast and dispersed interagency,  intergovernmental, and intersectoral network. Therefore, we called for a  strategy that would, among other things, (1) define the scope and  purpose of a national capability; (2) provide goals, objectives and  activities, priorities, milestones, and performance measures; and (3)  assess the costs and benefits and identify resource and investment  needs, including investment priorities.
We stated that one of the aims of a national biosurveillance strategy  should be to help prioritize where resources and investments should be  targeted and guide agencies to allocate resources accordingly. Further,  we reported that a national strategy could begin to address the difficult  but critical issues of who pays and how funding for biosurveillance will be  sustained in the future. Finally, we noted that in an environment with  competing priorities, a strategy could help address situations where  investments must be carefully weighed and sound judgments made about  the most cost-effective approaches, but doing so would require  information about the cost, benefits, and risks associated with the whole  biosurveillance enterprise.
The National Strategy for Biosurveillance includes four guiding principles  that are designed to serve as a foundation for enterprisewide efforts, four  core functions that are designed to promote a deliberate and shared  approach, and four enabling capabilities that are designed to represent  areas for ongoing focus. These planks of the strategy align with our call  for a strategy that would help to clarify the scope and purpose of a  national biosurveillance capability and the goals of that capability. Our  June 2010 report described several categories of federal efforts to  improve the personnel, training, and systems and equipment that support  a national capability. These included responding to workforce needs,  facilitating information sharing, and applying technologies to enhance  surveillance. Among the planks of the National Strategy for  Biosurveillance, it is possible to discern support for each these  categories. For example, the enabling capability called build capacity,  discusses both workforce and information sharing issues. The four  guiding principles that serve as the strategy’s foundation encourage  broad-based and cross-cutting actions to leverage constrained resources,  responding, in part, to our call for the strategy to help identify the  resources currently being used, additional resources that may be needed,  and opportunities for leveraging resources.
However, the strategy does not yet offer a mechanism to identify resource  and investment needs, including investment priorities among these  various efforts. Accordingly, the enterprise is still without a framework to  guide the systematic identification of risk, assessment of resources  needed to address those risks, and the prioritization and allocation of  investment across the entire biosurveillance enterprise, as we  recommended in June 2010. For example, in the case of the broader  contextual information needed to inform the BioWatch Gen-3 mission  need, the strategy has language indicating that advances in science and  technology are a priority. In fact, the capability enabler called fostering  innovation specifically calls for science and technology capabilities,  including new detection approaches. However, the strategy does not  facilitate analysis or provide tools to assess the risks to be addressed—in  the context of enterprisewide goals—by such science and technology  approaches or the value they should offer the enterprise relative to their  costs. Without such a framework and tool set, it remains difficult for  decision makers—in both the executive and legislative branches—to help  ensure that their resource allocation decisions contribute to a coherent  enterprisewide approach.
We are encouraged by the National Strategy for Biosurveillance and the  work the White House has done to date to provide a platform for  achieving a well-integrated national biosurveillance enterprise. We are  hopeful that the forthcoming strategic implementation plan which  promises to include specific actions and activity scope, designated roles  and responsibilities, and a mechanism for evaluating progress will help to  address the ongoing need for mechanisms to help prioritize resource  allocation.
Chairmen Bilirakis and Lungren, this concludes my prepared statement.  I  would be happy to respond to any questions you or the other committee  members may have.
section_title: Contact Information
paragraphs: For further information on this testimony, please contact Bill Jenkins,  (202) 512-8757 or by e-mail at jenkinswo@gao.gov. Contact points for  our Offices of Congressional Relations and Public Affairs may be found  on the last page of this statement. Other contributors include; Hal Brumm,  Nirmal Chaudhary, Michelle Cooper, Edward George, Kathryn Godfrey,  Allyson Goldstein, Tracey King, Amanda Miller, Jan Montgomery, Katy  Trenholme, and Katherine Trimble.
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