We conducted this performance audit from February 2008 through November 2009, 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. Biosurveillance is the process of gathering, analyzing, and interpreting data in order to achieve early detection and warning and overall situational awareness of biological events with the potential to have catastrophic human and economic consequences. In August 2007, the 9/11 Commission Act established NBIC to contribute to the nation’s biosurveillance capability by enhancing the ability of the federal government to rapidly identify, characterize, localize, and track biological events of national concern through integration and analysis of data relating to human health, animal, plant, food, and environmental monitoring systems (both national and international). Once a potential event is detected, NBIC is to disseminate alerts to enable response to a biological event of national concern. To achieve these objectives, NBIC is to coordinate with federal and other stakeholders that have information that can be used to enhance the safety and security of the United States against potential biological events of national significance. This community of federal stakeholders is known as the NBIS. The NBIS community predated the enactment of the 9/11 Commission Act. Beginning in 2004, DHS managed the NBIS and developed an IT system to manage other agencies’ biosurveillance information, an effort that was moved among several DHS Directorates, including DHS’s Science and Technology Directorate and the Preparedness Directorate. In 2007, DHS created the Office of Health Affairs, headed by the DHS Chief Medical Officer, to lead DHS’s biodefense activities and provide timely incident- specific management guidance for the medical consequences of disasters. At that time, DHS placed NBIS in the Office of Health Affairs. Shortly after that, the 9/11 Commission Act created NBIC and gave it responsibility for managing the NBIS, which has remained in the Office of Health Affairs. Since fiscal year 2008, NBIC has operated with an annual budget of $8 million dollars. Biosurveillance activities at NBIC are carried out by its Operations Division, which is headed by the Deputy Director and Chief Scientist and supported by 10 contract employees that serve as the analytic core for NBIC’s daily operations. These staff members have various backgrounds related to biodefense, including public health, veterinary, environmental, and intelligence training. As shown in table 1, the 9/11 Commission Act outlines certain requirements for NBIC and NBIS member agencies, and most of these relate to how NBIC is to coordinate NBIS member agency data and information management resources. Generally, there are four elements that are critical for NBIC to achieve its early detection and situational awareness missions established in the 9/11 Commission Act: (1) acquire data from NBIS partners that can be analyzed for indications of new or ongoing biological events, (2) leverage scientific and event-specific expertise from across the NBIS, (3) obtain strategic and operational guidance from NBIS partners, and (4) develop and maintain information technologies to support data collection, analysis, and communication. Although the act does not specify any member agency that must participate in the NBIS, it defines a member agency as any agency that signifies agreement to participate by signing a memorandum of understanding (MOU) and establishes for them specific requirements— generally related to sharing information and human assets. For example, as shown in table 1, the act provides that each member agency shall use its best efforts to integrate biosurveillance information into the NBIC, with the goal of promoting information sharing between federal, state, local, and tribal governments to detect biological events of national concern. NBIC has identified 11 NBIS partners at the federal level—the Departments of Health and Human Services (HHS), Agriculture (USDA), Commerce, Defense, Interior, Justice, State, Transportation, and Veterans Affairs, as well as the Environmental Protection Agency and the United States Postal Service. In some departments, more than one component has been identified for participation. Some of these departments, such as HHS and USDA, have major mission responsibilities for collecting health data that may indicate an outbreak of a disease or other biological event. Other departments may collect data or have subject matter expertise that may be used during the course of a biological event. For example, the National Oceanic and Atmospheric Agency within the Department of Commerce collects meteorological data that may be used by NBIC to help inform the progression of an outbreak based on weather patterns. Around the same time as the enactment of the 9/11 Commission Act, the President issued Homeland Security Presidential Directive-21 (HSPD-21), as a high-level biodefense strategy. HSPD-21 is built on the principles of earlier directives—HSPD-9 and HSPD-10—which collectively describe the role of the federal government in building a national capability to detect a biological event. For example, HSPD-21 lays out goals for addressing each of four biodefense elements for human health, one of which is surveillance. In this respect, HSPD-21 calls for the United States to develop a nationwide, robust, and integrated biosurveillance capability to provide early warning and ongoing characterization of disease outbreaks in near real-time. Consistent with this goal, HSPD-21 directs the Secretary of Health and Human Services to establish a national epidemiologic surveillance system for human health, in part, to integrate federal, state, and local data into a national biosurveillance common operating picture. Although HSPD-21 does not specify a role for DHS in biosurveillance, the earlier directives did, and creation and maintenance of an electronic biosurveillance common operating picture has been an NBIS goal since its inception. The data needed to detect an infectious disease outbreak or bioterrorism may come from a variety of sources, and aggregating and integrating data across multiple sources is intended to help recognize the nature of a disease event or understand its scope. Combining and comparing data streams from different sectors to detect or interpret indications of a potential health emergency is called biosurveillance integration. Both HSPD-21 and the 9/11 Commission Act seek enhanced integration of disparate systems and programs that collect data with the aim of providing early warning and ongoing characterization of biological events. HSPD-21 and the 9/11 Commission Act each also seek to enhance the situational awareness for the detection of and response to biological events. Much of the information gathered for these biosurveillance purposes is generated at the state government level. For example, state health departments collect and analyze data on notifiable diseases submitted by health care providers and others. In addition, state-run laboratories conduct testing of samples for clinical diagnosis and participate in special clinical or epidemiologic studies. Finally, state public health departments verify cases of notifiable diseases, monitor disease incidence, and identify possible outbreaks within their states. At the federal level, agencies and departments generally collect and analyze surveillance data gathered from the states and from international sources, although some federal agencies and departments also support their own national surveillance systems and laboratory networks. When an issue crosses federal agency lines, as biosurveillance integration does, the agencies involved must collaborate to deliver results more efficiently and effectively. Due to NBIC’s role as an integrator of information across the biosurveillance community, it is important for NBIC to ensure that it effectively collaborates with the NBIS to obtain the cooperation of this interagency community. One reason that it is important that NBIC effectively collaborate with federal partners is that agencies are not required by law to support NBIC or participate in the NBIS community. We have previously reported that for collaborating agencies to enhance and sustain collaboration, they need to, among other things, (1) have a clear and compelling rationale for working together; (2) establish joint strategies, policies, and procedures for aligning core processes and resources; (3) identify resources needed to initiate or sustain their collaborative effort; (4) work together to define and agree on their respective roles and responsibilities; and (5) develop accountability mechanisms to help implement and monitor their efforts to achieve collaborative results. NBIC has made some efforts to put mission-critical elements in place, such as requesting data from other federal partners, initiating relationship- building activities among NBIC analysts and subject matter experts at other agencies, and establishing governance bodies to oversee and guide the NBIS. However, NBIC currently relies on publicly available data because it receives limited data from NBIS partners and generally lacks assignments of personnel from other agencies to leverage analytical expertise from across the NBIS partners. NBIC’s ability to acquire and consolidate data from NBIS partners as well as from nonfederal sources is central to achieving its mission. Current and initial drafts of the NBIS Concept of Operations reinforce this notion, noting that the identification of relevant and timely data sources, which act in combination to provide actionable information for decisionmaking, is essential to accomplishing early detection. NBIC has taken some action to acquire these types of data from NBIS partners, for instance, by requesting that NBIS partners identify the types of data they collect or generate that might aid in NBIC’s early detection mission. However, as of October 2009, NBIC was generally not receiving the types of data best suited to early detection of biological events of national concern. NBIC officials acknowledge that they lack key data, and NBIC and other NBIS member officials described numerous challenges to sharing such information, including but not limited to scant availability of such data throughout the federal government and concerns about trust and control over sensitive information before it is vetted and verified.