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Policy and Global Affairs Office for Central Europe and Eurasia

500 Fifth Street, NW Washington, DC 20001 Phone: 202 334 2644 Fax:

August 24, 2006

Mr. Scott Levac

Defense Threat Reduction Agency

8725 John J. Kingman Boulevard, Stop 6201 Fort Belvoir, VA 22060-6201

Dear Mr. Levac:

This letter responds to your request for our views concerning the development of the data system to support the Threat Agent Detection and Response (TADR) network. During the briefings that you have arranged and in the documents you have provided, the Defense Threat Reduction Agency (DTRA) has described the objectives of this disease surveillance network, which is currently being implemented in Georgia, Azerbaijan, Kazakhstan, and Uzbekistan, with potential for deployment in other countries as well, as follows:

“Strengthen the capability of existing human and veterinary infectious disease surveillance networks by improving diagnostic laboratories; create republic-level central reference laboratories using state-of-the-art diagnostic capabilities, modern communications, and information technology backbones; deploy mobile response teams to permit rapid effective response to potential threat agent incidents; consolidate all especially dangerous pathogen collections and research at the central reference laboratories; and transfer new pathogen strains to U.S. government laboratories for prophylactic, protective, and other peaceful purposes, including cooperative research with host nation scientists.”

We have addressed the two specific issues that you have set forth for our consideration, namely:

  • Which U.S. government organization or organizations should be considered as a future location or locations for the General Data Repository (GDR) of the Electronic Integrated Disease Surveillance System (EIDSS), taking into account that EIDSS will provide the communications and information technology backbones of the TADR network?

  • Should the U.S. Government consider providing EIDSS information to one or more international bodies such as the World Health Organization (WHO), the Food and Agriculture Organization (FAO), and/or the World Organization for Animal Health (OIE)?

As requested, we have considered alternative approaches in responding to these two questions.



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Letter Report on the Threat Agent Detection Response System Database Policy and Global Affairs Office for Central Europe and Eurasia 500 Fifth Street, NW Washington, DC 20001 Phone: 202 334 2644 Fax: August 24, 2006 Mr. Scott Levac Defense Threat Reduction Agency 8725 John J. Kingman Boulevard, Stop 6201 Fort Belvoir, VA 22060-6201 Dear Mr. Levac: This letter responds to your request for our views concerning the development of the data system to support the Threat Agent Detection and Response (TADR) network. During the briefings that you have arranged and in the documents you have provided, the Defense Threat Reduction Agency (DTRA) has described the objectives of this disease surveillance network, which is currently being implemented in Georgia, Azerbaijan, Kazakhstan, and Uzbekistan, with potential for deployment in other countries as well, as follows: “Strengthen the capability of existing human and veterinary infectious disease surveillance networks by improving diagnostic laboratories; create republic-level central reference laboratories using state-of-the-art diagnostic capabilities, modern communications, and information technology backbones; deploy mobile response teams to permit rapid effective response to potential threat agent incidents; consolidate all especially dangerous pathogen collections and research at the central reference laboratories; and transfer new pathogen strains to U.S. government laboratories for prophylactic, protective, and other peaceful purposes, including cooperative research with host nation scientists.” We have addressed the two specific issues that you have set forth for our consideration, namely: Which U.S. government organization or organizations should be considered as a future location or locations for the General Data Repository (GDR) of the Electronic Integrated Disease Surveillance System (EIDSS), taking into account that EIDSS will provide the communications and information technology backbones of the TADR network? Should the U.S. Government consider providing EIDSS information to one or more international bodies such as the World Health Organization (WHO), the Food and Agriculture Organization (FAO), and/or the World Organization for Animal Health (OIE)? As requested, we have considered alternative approaches in responding to these two questions.

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Letter Report on the Threat Agent Detection Response System Database We have taken into account the following information you have provided concerning the data that are to be transmitted to the GDR, recognizing that DTRA is currently considering many details regarding this issue: In summary, the data that are transmitted to the GDR will consist of (a) periodic reports that aggregate and analyze individual data points, (b) laboratory data that are particularly relevant to outbreaks and trends, (c) medical findings with regard to patients of particular concern, keeping in mind the importance of protecting privacy information, and (d) animal sampling information that is relevant to human health concerns. Data that are transmitted will include all positive findings for the 16 agents, classes of agents, and diseases of interest to DOD/DTRA, which are as follows: anthrax (human and animal); brucellosis (human and animal); plague; tularemia; smallpox virus; Crimean-Congo hemorrhagic fever; tick-borne encephalitis; fevers of unknown origin requiring hospitalization; flu-like symptoms requiring hospitalization; foot and mouth disease; rinderpest; sheep, goat, and camel pox; highly pathogenic Newcastle disease; highly pathogenic avian influenza; glanders; and classical swine fever. Positive findings should be accompanied by information concerning the sources of illnesses. In some cases, DTRA should be more specific as to whether animal and/or human data are of interest for the diseases. Also, the committee is particularly concerned about the omission of pneumonia, which could be associated with tularemia and plague. Data on other pathogens or diseases will be transmitted if host countries decide to transmit such data. There is no DTRA requirement in this regard, although EIDSS is capable of handling data concerning other pathogens and diseases. Flow of data to the GDR will be nearly real-time as data flow into EIDSS in host countries. However, one host country will not have direct access to data from another host country via EIDSS, and access via the GDR is yet to be determined. In the case of an outbreak, cross-country data sharing is presumably anticipated. Epidemiological data sheets will be prepared and transmitted as appropriate; they should indicate the significance of information of particular interest, including the results of tests involving patients. DTRA will limit dissemination of data by the GDR to U.S. government departments and agencies (although this current position is under review). It is anticipated that at a future date, DTRA will define the extent of this limitation. Also, we note that specialists from the Centers for Disease Control and Prevention (CDC) have already provided you on an informal basis with preliminary comments on many of the details of EIDSS, and particularly the types of information that should be included and the formatting of information. I am sure you recognize that greater definition of the information content throughout the TADR network is required; therefore, this letter report addresses only general aspects of EIDSS and the GDR within the broader context of the overall TADR network.

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Letter Report on the Threat Agent Detection Response System Database Importance of the TADR Network At the outset, we commend the Department of Defense (DOD), and particularly DTRA, for launching the TADR network. This initiative has considerable potential for enhancing DOD’s nonproliferation objectives while improving disease surveillance in Central Asia and the Caucasus, and indeed in other regions of the world as well. Disease surveillance capabilities of the countries where DTRA is concentrating its efforts have declined considerably since the fragmentation of the Soviet Union. At the same time, the capabilities of the scientific personnel for working with dangerous pathogens are significant, and directing these capabilities toward public health and animal health challenges is important. Meanwhile, the threats of endemic and emerging diseases in the regions of interest remain substantial. The spread of diseases of regional and/or global significance such as Severe Acute Respiratory Syndrome (SARS) and avian influenza increases the importance of effective national surveillance networks linked to global surveillance systems. In this regard, the TADR network can play a critical role in many technical areas, such as upgrading laboratory and epidemiological capabilities, improving awareness and understanding of animal-to-human transmission of diseases, and providing important incidence data and analyses of trends in the region. Of course, if the potential of the network is to be realized, the disease agents of interest must also include many agents that are of significant public health and animal health concern within the countries where the network is implemented. One pathogen of great concern is multi-drug resistant tuberculosis. Strains of tuberculosis that are resistant to all known drugs have been found in Kazakhstan. In addition, the network should have the capability to detect syndromes that might not be easily associated with specific pathogens but could lead to investigations that uncover pathogens of concern. An Interim Step in Addressing the TADR Network We appreciate the opportunity to contribute to the further development of the TADR network by focusing our attention on data system components of the network. We consider this letter report an important interim step in our continuing efforts to assist in upgrading disease surveillance capabilities in countries of the former Soviet Union. We are prepared to provide additional views on the TADR network and on related research issues in response to future requests from DTRA. In addition to the focus on the GDR, a few observations on development of the overall network are offered. Only if the network provides information that is of considerable interest to U.S. government organizations and American specialists will the GDR be persuasive in seeking resources for investment in the program over the long term. This report suggests several steps to help ensure that the information that is obtained will indeed be of interest. Furthermore, we have not examined the cost aspects of the TADR network in general or the data system in particular. We recognize the difficulty in balancing financial investments in public and veterinary health infrastructures with payoffs measured in terms of prevention of diseases in humans or livestock, pathogen containment, achievement of nonproliferation

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Letter Report on the Threat Agent Detection Response System Database objectives, and other positive outcomes from the investments discussed below. These aspects are very difficult to quantify. Nevertheless, we urge DTRA to address the topic of cost-effectiveness jointly with the host governments that are participating in the program to help ensure that major investments are appropriate and well targeted and that the network is sustainable over the long term. Inclusion of agents important to public health in addition to the agents already specified should help ensure sustainability. Value of the TADR Network to the Host Countries and the World As already suggested, the key U.S. government departments and the ministries of the host governments, along with their specialists, must be convinced that their investments in the TADR network will provide tangible improvements in their efforts to contain diseases and to identify and respond to disease outbreaks if they are to support the network now and in the future. The types, reliability, and timeliness of the data that are processed through the system will be key determinants in this regard. Currently, DTRA is providing crucial financial and technical means to establish and maintain the network. But according to DTRA’s plans, within five years after installation of the system the host countries must assume responsibility for all financial and technical aspects of the network. The value of the TADR network to the host countries should be quite significant in improving their overall approaches to public health. With regard to the host countries: Broader, better, and more timely surveillance data regarding agents prevalent in the countries can provide early warning of emerging public health problems while helping to provide the regional context for addressing local outbreaks of diseases through cross-country sharing of data. Improved technology capabilities for field investigations, including GIS systems, and laboratory resources will not only be welcomed by the scientific workforces but should also enable upgraded field and laboratory teams to be more competitive in their search for international funding to support related research and other activities. In addition, the elevation of the level of scientific sophistication within the workforces should help attract talented young scientists to the field of infectious diseases. The laboratory control aspect of the TADR network can improve the security of strains of dangerous pathogens and other significant collections. This aspect is particularly important in protecting strains that are more virulent than strains circulating in the environment and drug-resistant strains. As discussed below, the TADR network can provide integrated system capabilities for responding to the requirements and requests of international organizations for reports on the prevalence of diseases, thereby enhancing the quality of such reports while reducing the time required to prepare them. The value of the data generated by the TADR network to the United States could also be significant. For example: Bilateral cooperation through TADR activities will enhance U.S. insights as to endemic and epidemic trends in the region.

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Letter Report on the Threat Agent Detection Response System Database Early warning of geolocated disease outbreaks is important both in responding to regional and global problems and in taking measures to protect American personnel deployed in the geographical areas covered by the TADR network. Comprehensive and timely data concerning diseases in lands distant from the United States and access to field isolates of special interest pathogens can sometimes provide the basis for establishing test areas for new vaccines and drugs that are of interest both to the United States and to local authorities. Cooperation can engage scientists in the host countries who have dual-use capabilities to direct their efforts to peaceful endeavors and can encourage transparency of activities at many local institutions, thereby contributing directly to the nonproliferation efforts of DOD. Data from the system might be used as a template for natural disease outbreaks that can be compared with events that suggest bioterrorism activities. Globally, the TADR network can have important impacts, particularly through the outreach efforts of international organizations. Also, while providing new insights about diseases in countries that have been handicapped by shortcomings in their data collection and reporting capabilities, some aspects of the TADR network can serve as models for replication by others. Governments that participate in the network can take pride in being among the technological pacesetters for many areas of the world. The Challenges in Installing the TADR Network At the same time, the problems in installing and maintaining an effective TADR network in general, and effective data systems in particular, are numerous. For example: 1) The data collection and processing technology is complex. This technology will challenge many clinicians and other specialists in the host countries who have only a limited degree of computer literacy and a long history of relying on paper records. While DTRA claims considerable success in training local specialists to use the technology and plans to support Western specialists who will modify and improve the technology as required, upgrading the field and laboratory capabilities of local specialists who have limited familiarity with the types of technology being introduced will be a continuing challenge. Two systems (the existing paper-based system and the new digitized approach) presumably will operate in parallel in a transition period until the modern system is tested, fully operational, and trustworthy. 2) Three sets of reporting requirements should be integrated into a single system. These requirements are: DTRA requirements for reporting on the 16 agents, classes of agents, and illnesses noted above. This list could change, however, with SARS or other diseases becoming of interest to DOD. Host government requirements for reporting on other agents and diseases of public health significance that will vary from country to country. Inclusion of these agents and diseases is critical in demonstrating the value to the host governments. Requirements for host governments to respond to interests of international organizations that may have other lists of agents and diseases of concern.

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Letter Report on the Threat Agent Detection Response System Database 3) Stable funding will be difficult to ensure. Funding for the system over the long term requires prompt attention. DTRA plans to finance initial installation of the data system components and cover some operational costs, but there will surely be many local employees who are receiving meager salaries for their efforts even though they are key participants in the system. Once the TADR network is installed, DTRA plans to maintain all aspects of the network in working order for five years. But will adjustments in local salaries be required to operate the components once installed? When DTRA’s five-year “warranties” expire, will the host countries or external assistance organizations be prepared to assume all costs for maintenance as well as operation, or will some aspects of the system deteriorate due to financial shortfalls? Demonstration of the value and cost-effectiveness of the system will be required if desirable long-term outcomes are to be achieved. The only foreseeable sources of funding for operating the TADR network will be government sources—ideally the host governments, supported if necessary by external assistance organizations of other governments. In some countries, such as Azerbaijan and Kazakhstan, the financial outlook from oil revenues is sufficiently bright to anticipate that if the TADR network operates as expected, the government will probably finance its indefinite continuation. However, in countries with fewer financial resources, local support to cover the costs of operating and maintaining all aspects of the TADR network seems problematic. In these cases, early consideration of long-term funding realities and options is imperative. 4) Recruitment, training, and retention of personnel capable of operating the TADR network will be a constant concern. As specialists increase their computer skills, internal and external brain drain may well become serious. Also, host government requirements to retain older personnel who are not ready to retire, even though they may have inadequate computer skills, will possibly limit entry of young, computer-literate specialists into the field. 5) Governments are already apprehensive over the possibility of U.S. control of all data. DTRA has signed agreements with each of the governments participating in the TADR network. These agreements require the host governments to share with DOD data gathered through the network, and DOD plans to designate a GDR or GDRs in the United States to receive the data. According to DTRA, one government ministry of a host country has raised concerns over the “security” implications of providing data directly to a repository in the United States selected by DOD. Such a requirement has apparently suggested that the information might be used by the U.S. government in ways that are not in the best interests of the host countries. Such a perception can raise questions over the motivations of the United States in financing the TADR network in the first place, and the U.S. government should be prepared to address this concern throughout the lifetime of the program. Unless incorrect perceptions of possible DOD misuse of data are put to rest throughout the process of establishing and then operating the network, the likelihood of long-term sustainability of a network that should be built on mutual trust and widespread benefits will be significantly diminished. In short, any use of these data by the U.S. government must be transparent and seen to be so from the very start by the Ministries of Health in the host countries. We point out that in the United States, CDC publishes weekly an open report on nearly 50

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Letter Report on the Threat Agent Detection Response System Database illnesses by state and selected cities (Morbidity and Mortality Weekly Report, posted on the Internet at http://www.cdc.gov/mmwr/). 6) Full compliance in providing “all” required data to the GDR will be difficult. Difficulties will inevitably arise in operating the systems after they are installed, particularly in the early days. Some problems in sending data to the GDR may be easily explained (for example, equipment or personnel shortcomings). In other instances, missing data may raise concerns over reluctance of host country participants in the network to provide all data that are expected. Thus, personal relations among scientists that are already being developed through the TADR program will remain very important in confidence building. 7) The selection of a location or locations for the GDR in the United States is critical. The location or locations must be fully acceptable to all participants in the network. The facility or facilities must be of adequate scientific stature. Each facility must have a strong track record in the field in order to elicit the respect of the host governments and scientists. At the same time, the leaders of the facility or facilities must be sufficiently interested in the data so that they will provide the financial and human resources to manage the GDR. Each facility should have strong linkages and an internationally recognized tradition for sharing public and animal health data broadly. Additional comments on this issue are offered below. 8) Review of large quantities of raw data transmitted to the GDR in the United States—starting from the initial report of a disease occurrence by a clinician through laboratory analyses of both suspected pathogens and human and animal tissue samples— would probably result in many false alarms. Thus, transmission of all raw data may not be the best approach. It may be preferable to rely on partnerships between the GDR and the Ministries of Health in the host countries to jointly learn about outbreaks without the necessity of an automatic system for transmitting all data to the GDR. The respective Ministries of Health could make decisions as to data transmitted to the GDR. Periodic reviews by specialists of the GDR of the total data holdings of the host countries could ascertain whether the coverage provided in this manner is adequate. Given the current DTRA commitment to automatic transmission of all data, an efficient approach might be to begin with automatic transmission of a portion of the raw data with the intention of having the system evolve into more selective transmission of data coupled with the partnerships mentioned above. 9) Effective integration of human and animal disease surveillance, reference diagnostics, and reporting activities will be difficult, both in the host countries and in the United States. There have long been sharp divisions between the activities of human health and animal health organizations throughout the world. With different social cultures, constituencies, and relationships to governments and international agencies, these organizations have often been intransigent in diffusing their responsibilities; and concerns over bioterrorism have had little impact on this entrenched division of responsibilities. When disease agents with little relevance to bioterrorism are considered, the mutuality of interests is even harder to detect. Therefore, there is the need for the surveillance data to be of near-term value and have other benefits for those collecting them. It is hoped that this project will help overcome the bureaucratic and personal barriers of the past and contribute to greater interest in outreach and sharing of data by all concerned. To this end, there should be a clear plan from the outset as to how data will be used and with whom it will be shared.

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Letter Report on the Threat Agent Detection Response System Database Significant Conclusions Given the foregoing observations, we offer the following conclusions on three key aspects of the TADR network prior to turning to specific recommendations. 1) The TADR network is well designed to support the U.S. government’s strategy for strengthening Biological Weapons Convention (BWC) compliance while also supporting DOD’s mission more broadly. The continuous focus on disease surveillance and investigations of outbreaks of diseases is an important dimension of the effort to support and strengthen the Convention through Article X. Also, TADR will provide important health-related information that will improve protection of DOD personnel stationed in strategically important countries while enhancing transparency of host country involvement in pathogen-related activities. Such transparency can provide an important backdrop for other measures that might be used to ensure BWC compliance. In addition, it will enable DOD to participate more broadly in national and international efforts to contain diseases that could threaten the United States such as avian influenza. 2) Sustainability of the TADR network after DTRA completes its participation in the program is critical. Sustainability is one of the most important and most difficult issues confronting DTRA. A feasible plan with near-term benefits to those immediately responsible for disease control while providing for long-term sustainability is clearly needed. The plan should be prepared by DTRA jointly with full participation by the host governments. In the absence of a plan with substantial buy-in from all governments, questions will continually arise as to the long-term cost-benefit aspects of DTRA’s investments. DTRA should be flexible in its implementation of the TADR network. If changes are proposed that are technically sound, are affordable, and can result in greater buy-in from host country specialists and agencies, they should be adopted. As one approach to enhance the likelihood of sustainability, consideration should be given to having a DOD medical research unit, such as the Naval Medical Research Unit (NAMRU) in Cairo, which is already actively engaged in disease surveillance activities in the countries where TADR is being installed, become a well recognized and active partner in the TADR system from the outset. The expectation would be that the unit would continue its active engagement with the participating institutions in the TADR network in the long term, after DTRA completes its involvement. Such continuing engagement that might also provide new training and exchange opportunities would demonstrate the U.S. commitment to long-term scientific partnerships in combating diseases of global significance while encouraging the host governments to continue to build their programs for the indefinite future on the foundation established through DTRA investments. 3) An essential element of sustainability is the broadening of the focus of the network from the 16 agents, classes of agents, and diseases of primary interest to DOD for proliferation reasons. The agents are primarily low-incidence agents. A much wider focus that encompasses high-incidence agents and diseases that are of great interest to the host governments is essential. Indeed, without such a broadening of the agents and diseases of interest, it is doubtful that TADR will command scarce local financial resources. Also, newly

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Letter Report on the Threat Agent Detection Response System Database emerging infectious agents may be on the horizon, and we should be prepared to understand their prevalence trends and their infection rates. According to DTRA, an unlimited number of agents and diseases can be easily encompassed within EIDSS. Therefore, broadening the focus from the outset should be feasible and would greatly improve the likelihood of sustainability. Recommendations 1) Given the foregoing considerations, we recommend that a single GDR should be located at CDC and that data from the TADR network flow directly from the host countries to CDC. CDC capabilities are well known and the institution is widely respected in the United States and internationally. It is the premier institution in the United States for responding to disease outbreaks; and with representatives stationed abroad in a number of countries, it has long experience in international disease surveillance. Also, it routinely publishes many reports, bulletins, and notifications about disease trends and incidents throughout the world. Current DTRA policy should be modified in consultation with host countries to permit data that are received at CDC to become available to credible research organizations and researchers in the United States and abroad, assuming that the issues of privacy and security-sensitivity have been resolved. Also, the issue of false alarms should be resolved jointly by host countries and CDC before releasing information that raises unwarranted concerns. Clearly, the types of data that are to be transmitted to the GDR require much more discussion with host governments and consultations between DTRA and CDC. Data that are sensitive from the point of view of privacy should probably be screened out or sanitized within the host country and not sent to CDC. In the unlikely event that data that are transmitted are security-sensitive, they should be handled appropriately by CDC. To help ensure that important data are widely and promptly available, CDC should incorporate the data into relevant reports and assign staff to monitor the data flow in order to identify data that should receive immediate attention and dissemination to appropriate organizations depending on the types of incidents. Since DOD specialists are already resident at CDC, they could be tasked by DOD to ensure that interested DOD organizations and partners promptly receive from CDC data relevant to their missions. At the same time, it seems unreasonable to expect CDC to be a repository for all TADR-generated data for the indefinite future. There simply are too many countries where disease outbreaks are important to take on the burden of serving as national data banks for foreign countries with no end in sight for this responsibility. Further clouding such a responsibility is the uncertainty as to the host countries’ interests in transmitting data after DTRA funding terminates. However, if measures are implemented to limit the data transmitted to the GDR in order to reduce false alarms to an acceptable level, as suggested above, then long-term retention of a limited amount of TADR data may be reasonable. Such a limitation runs contrary to current DTRA planning, and considerable discussion will be necessary to resolve the issue. Of course, another central issue that must be resolved is the long-term funding responsibility for the GDR, whether located at CDC or elsewhere. Since DTRA does not intend to remain involved in the TADR network indefinitely, funding the GDR would presumably become the responsibility of CDC if host countries are prepared to continue to transmit data to

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Letter Report on the Threat Agent Detection Response System Database the GDR. Therefore, CDC must be convinced of an adequate return on its investment if it is to accept the responsibility. The financial issues relate directly to the content of the data that are to be transmitted to CDC. The intertwined issues of data content and financing can only be resolved through direct discussions between DTRA and CDC involving both policy and operational personnel. Also related to the funding issue is the current overload of responsibilities at CDC due to new programs of the Department of Homeland Security (DHS). It is highly unlikely that the TADR program will command the priority attached to DHS programs, and this reality needs to be addressed before designating CDC as the GDR. Of critical importance is the amount of time that experienced CDC employees will be willing to devote to GDR responsibilities in competition with other responsibilities. If there is new external funding, the issue will be easier to resolve than if there is not. For example, if DTRA-funded contractors could be located at CDC under CDC management, the issue of government personnel limitations might be less of a problem for CDC. 2) An important recipient of data from CDC should be the Centers for Epidemiology and Animal Health of the Veterinary Services of the Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) in Fort Collins, Colorado. At this facility, the Center for Emerging Issues (Office for Emerging Diseases, Tracking, Analyses, and Forecasting) has responsibility for tracking relevant animal diseases worldwide. However, the Center currently receives only reports and not raw data. Thus, it may be necessary to upgrade the digital capabilities of the Center, and the financial arrangements will have to be worked out with DTRA. We considered having a second GDR located in Fort Collins, but this approach seems unnecessary and could raise additional administrative and financial issues. The need for host countries to send data to two locations in the United States might raise unnecessary concerns within these countries as their specialists are subjected to two sets of instructions and inquiries concerning their activities on a continuing basis. Also, two parallel reporting channels would perpetuate rather than reduce the separation of veterinary and human health cultures. APHIS should work out directly with CDC the types of data that would be helpful in pursuing its mission and make arrangements to receive those data from CDC. APHIS has a specialist resident at CDC, and this specialist could assist in ensuring that useful data are sent to Fort Collins. But again, the funding issue must be resolved through direct discussions involving DTRA, CDC, and APHIS. We considered other possible locations for the GDR. Several Department of Energy (DOE) laboratories certainly have the information technology capability to serve as the GDR, but they lack the breadth of health-related expertise that is available at CDC. Also, the DOE laboratories with the best developed expertise (i.e., Lawrence Livermore and Los Alamos national laboratories) have strong associations with weapons programs, which could raise concerns in the host countries. Other components of the Department of Health and Human Services were also considered (for example, the Fogarty Center of the National Institutes of Health and the National Institute of Allergy and Infectious Diseases). But the direct interest of CDC in ensuring the flow of the data and CDC’s capability to relate the data to other relevant sources of information are greater than other organizations.

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Letter Report on the Threat Agent Detection Response System Database Finally, a number of DOD facilities, such as the U.S. Army Medical Research Institute of Infectious Diseases and the Walter Reed Army Institute of Research, could probably develop the capability to handle the responsibilities of the GDR. However, a direct data pipeline to DOD would certainly raise concerns in the participating countries. This approach might discourage some governments from participating in the program in the long term. At the same time, none of the DOD facilities, even those associated with NAMRU, have relevant capabilities that rival CDC’s capabilities. 3) A U.S. government organization should not be the primary entity for sending information from the TADR network to international organizations. The U.S. Government should not play the role of gate-keeper with primary responsibility for distributing EIDSS data to interested international organizations. Rather, such distribution is the responsibility of the host governments that initially collect and process the data. DTRA should encourage these governments to share their data directly with the WHO, FAO, and OIE to the extent that these international organizations are interested in having the data. Also, DTRA should encourage the governments to authorize CDC to release any data that may be of interest to international organizations, and CDC should take the initiative to ensure that international organizations are receiving data that should be of interest to them. In the distant future, building on the TADR experience, it might be advisable for the host countries to have WHO-designated collaborating centers for infectious diseases. Such centers add prestige to local activities and strengthen linkages with the international community. Such designations in the near term are unrealistic since the centers must establish strong track records of successful activities before they could qualify through the WHO’s merit-based selection process. As discussed earlier, the capability to prepare data in a format required by the international organizations should be built into the EIDSS from the outset. In some cases, reports will be required to comply with new International Health Regulations and long-standing International Agriculture Regulations. In other cases, the international organizations may be interested in receiving additional information, but in yet other cases they may not have an interest in data that they cannot use. In any event, the software to be used for the TADR network should be designed to facilitate preparation of reports that are required or desired by the international organizations. Several additional suggestions are offered to facilitate the establishment of an effective data system that can have worldwide impact. 4) Although the TADR network is currently being installed in several countries, DTRA should select one country as a site for evaluation of a country-wide network as soon as possible. Georgia appears to be a good candidate for testing all components of the TADR network, including the data-related components. Kazakhstan might be an alternate choice. The testing would extend from quality control over input of data by individual physicians and by clinics through expeditious processing of the data in the country and dispatch of the data to the GDR. It would emphasize examination of the use of the data locally, by specialists at the GDR, and potentially by international organizations. It would address the issue of false alarms. A key

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Letter Report on the Threat Agent Detection Response System Database question is whether the information that flows through the system is more useful (and if so, how much more useful) than data that are obtained, distributed, and used with current approaches. Closely coupled to this testing of the system should be a plan for evaluation of the likely impact of data. Will tools be in place and hypotheses tested in the field to ensure that the data are accurate, complete, and timely and that they are used in a way that demonstrably improves the public health services of host countries? Will data generated by the system be integrated with other relevant data available to the GDR and the entire data sets be made available to host countries? Will there be plans to carry out studies of local epidemics and interventions that demonstrate the value of the systems? How will the data be used regionally and/or globally? How can the network be improved regarding efficiency and how can it provide better and more useful data? In short, will the investment in TADR pay off in the long term, and how can the payoff be maximized? Can a set of metrics be developed to demonstrate the value and cost-effectiveness of the TADR network? 5) A feasible mechanism for addressing these questions would be a conference to be held 12 to 18 months from now, when the TADR network should be sufficiently well established in at least one country to permit evaluation. At the conference, specialists from Georgia or another test-bed country, from the GDR, and from international organizations would come together to review how the data flow has changed and whether and how it is leading to improved public health services. The conference would stress the importance of quality control and would highlight best practices in operating the network. DTRA should request an organization with no vested interests in documenting the success or weaknesses of the network to take the lead in developing the program and the report of the conference. Of course, specialists from all host countries would be in attendance, along with independent specialists able to stand back and constructively assess the approach, the challenges, and the solutions. We hope that you find these comments useful in your efforts to move forward with the TADR network. Please do not hesitate to contact us if we can be helpful in elaborating on the foregoing views of our committee members. Sincerely, David R. Franz Chair, Committee to Review Research Proposals from Former Soviet Biological Weapons Institutes

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Letter Report on the Threat Agent Detection Response System Database Declaration of Technical Data Conformity The Contractor, the National Academies, hereby declares that, to the best of its knowledge and belief, the technical data delivered herewith under Contract No. DTRA01-02-D-003 are complete, accurate, and comply with all requirements of the contract. Date: August 24, 2006 Authorized Official: Glenn Schweitzer, Director, Office for Central Europe and Eurasia