DEPARTMENT OF HEALTH AND HUMAN SERVICES

HHS Plan to Combat Bioterrorism and Other Public Health Emergencies

AUTHORS: HHS BIOTERRORISM COUNCIL
DATE: SUMMER 2005

SECTION 1. BACKGROUND

In January 2003, Secretary Thompson created the HHS Bioterrorism Council to foster a “One-Department” approach to combating bioterrorism and other public health threats and emergencies. Further, he directed the Council to prepare and keep up-to-date a Department-wide strategic plan to explicate HHS priorities in this area and to guide relevant activities by HHS Operating and Staff Divisions.

In keeping with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the Plan emphasizes bioterrorism for the following reasons:

Unlike other weapons of mass destruction, weaponized pathogens are easy to conceal and easy to release; and, depending on the objectives of the terrorist, only a small quantity of material (e.g., a few kilograms) may be sufficient to cause mass casualties and disrupt society throughout a broad geographic region.
The effects of a bioweapon may not be evident for days or weeks, depending upon the distribution of incubation periods across the exposed population. During this latent period, members of the exposed population will have dispersed widely – some to other parts of the nation or to other countries.
Regardless of whether an event is a known or surreptitious bioterrorism attack, health care personnel are much more likely to encounter real or potential victims than are the traditional first responders to evident emergencies (e.g. firefighters, emergency medical personnel, hazardous materials specialists, and police).
Those health care professionals who are the first to encounter the consequences of a surreptitious bioterrorist attack may not recognize anything untoward. Several of the most fearsome bioterrorist agents (i.e., the organisms that cause anthrax, plague, and tularemia, respectively) are encountered only rarely in ordinary health care situations and, to make matters worse, often provoke symptoms similar to some of those associated with the common cold or influenza. The longer the terrorist-induced epidemic goes unrecognized and undiagnosed, the longer the delay in initiating treatment, prophylaxis, or other elements of the medical and public health response and, thus, the greater the adverse consequences for those exposed.
If the pathogen is one that produces a contagious disease such as smallpox or pneumonic plague, then secondary transmission could spread the disease well beyond the initial exposed cohort – afflicting potentially thousands of people.
If the pathogen is a smallpox virus or some other organism against which the vast majority of the U.S. population has little or no protective immunity and for which no effective treatment exists, then the consequences might be as devastating as those produced by a nuclear weapon.
In addition to producing mass casualties in sufficient numbers to overwhelm patient care resources (as also could be the case with nuclear or chemical weapons or conventional explosives), bioterrorism is likely to produce significant psychological, behavioral, and societal consequences. The prospect of serious illness or death arriving silently and invisibly would likely create tremendous anxiety and somatic distress and could precipitate maladaptive fear-generated behaviors. Such damage to human infrastructure can be far more devastating and longer lasting than damage to physical infrastructure. While civil unrest and social disruption are possible, effective consequence management and timely, accurate and informative communication with the public reduce these undesirable outcomes.
A bioterrorist attack on livestock, crops, or feed for food-producing animals could trigger a significant public health crisis. Some animal pathogens, such as Rift Valley Fever virus, also cause life-threatening illness in humans. A bioterrorist attack against the U.S. food supply could wreak economic havoc.

At the same time and also in accord with the Act, the Plan recognizes that public health threats and emergencies can ensue from myriad other causes – natural epidemics of infectious disease; terrorist acts involving conventional explosives, toxic chemicals, or radiological or nuclear devices; industrial or transportation accidents; and climatological catastrophes. HHS and its public and private partners therefore must prepare for and respond to all manner of mass casualty incidents as effectively and efficiently as possible. This militates adopting a unitary approach to the extent practicable and enriching it with threat-specific modalities as necessary. As a consequence, bioterrorism preparedness and response is not an insular activity for HHS but rather an integral critical component within an all-hazards readiness paradigm.

Building on the accomplishments already achieved, the United States Government, as directed by the President, conducted a comprehensive evaluation of the U.S.’s biological defense capabilities to identify future priorities and actions to support them. The results of that study provide a blueprint for our future biodefense program, Biodefense for the 21st Century, fully integrates the sustained efforts of the national and homeland security, medical, public health, intelligence, diplomatic, and law enforcement communities. The essential pillars of U.S.’s national biodefense program are: Threat Awareness, Prevention and Protection, Surveillance and Detection, and Response and Recovery

In view of the foregoing considerations, the HHS Bioterrorism Council has identified the following five Strategic Foci:

Preventing Bioterrorism
Enhancing State, Local, and Tribal Preparedness for Bioterrorism and Other Public Health Threats and Emergencies
Enhancing HHS Preparedness for Bioterrorism and Other Public Health Threats and Emergencies
Acquiring New Knowledge Relevant to Bioterrorism and Other Public Health Threats and Emergencies
Acquiring and Deploying Needed Biodefense Countermeasures

Taken together, these Strategic Foci are the conceptual framework for HHS efforts to achieve public health emergency preparedness.

To operationalize this framework, the Council has articulated goals associated with each Strategic Focus; these goals are presented in Section 2. Further, for each goal, the Council has identified pertinent activities of the Operating Divisions and Staff Divisions; these activities are presented in Section 3. Sections 2 and 3 thus are the same plan expressed at two different levels of resolution. Still higher levels of granularity are available should they be needed to facilitate HHS program management.

The Council envisions multiple uses for the Strategic Plan. First, the Plan will facilitate communications regarding HHS efforts toward ensuring public health emergency preparedness. The summary version of the Plan (i.e., Section 2) is a ready description of the HHS program, the specific responsibilities of Operating and Staff Divisions, and the relationships among their roles. This description should be useful for preparing speeches, testimony, and public information materials as well as for responding to broad inquiries from elsewhere within the Executive Branch, the Congress, and the public. More detailed versions of the Plan (e.g., Section 3) can serve as a reference source when preparing documents focused on only selected parts of the HHS program.

Second, the Plan will facilitate the preparation of progress reports required by the Executive Office of the President or the Congress. The Strategic Foci – with or without their associated goals – generally will be the default outline for the organization of materials regarding accomplishments, ongoing work, and proposed activities.

Third, the Plan will be an instrument for promoting results-oriented management and for appraising contributions toward ensuring public health emergency preparedness. For example, in conjunction with various milestones of the appropriations cycle (e.g., budget requests or operating plans), the Council will call upon the Operating Divisions and Staff Divisions to articulate the expected outcomes, quantified wherever possible, for each preparedness or response activity for which they are responsible. Also, as the Council routinely oversees the ongoing activities and achievements of HHS entities, it will use the Plan as the template that guides its assessments.

The Council recognizes that this Strategic Plan must be a dynamic document – changing both in the wake of progress and in the face of emergent national needs. To that end, the Council will update the Plan in concert with the pertinent HHS Operating and Staff Divisions.

SECTION 2: HHS GOALS FOR COMBATTING BIOTERRORISM AND OTHER PUBLIC HEALTH THREATS AND EMERGENCIES

STRATEGIC FOCUS I: PREVENTING BIOTERRORISM

GOAL IA: Safe and Secure Handling of Potential Bioterrorism Agents

GOAL IB: Safe and Secure Laboratories for Research and Testing Involving Potential Terrorism Agents

GOAL IC: Food Secure from Potential Terrorism Agents

GOAL ID: Medical Products Secure from Potential Terrorism Agents

GOAL IE: Effective Collaboration with Counter-Terrorism Initiatives of Other Agencies

GOAL IF: Productive Partnerships with the Private Sector in Combating Bioterrorism and Other Public Health Threats and Emergencies

GOAL IG: Productive Partnerships with other Nations and International Organizations in Combating Bioterrorism and Other Public Health Threats and Emergencies

GOAL IH: Promote Biosecurity in Life Science Research

STRATEGIC FOCUS II: ENHANCING STATE, LOCAL, AND TRIBAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH THREATS AND EMERGENCIES

GOAL IIA: Emergency-Ready Public Health Infrastructure

GOAL IIB: Emergency-Ready Healthcare Infrastructure

GOAL IIC: Emergency-Ready-Cities

GOAL IID: Secure Information Technology and Physical Infrastructure for Health Care Delivery

STRATEGIC FOCUS III: ENHANCING HHS PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH THREATS AND EMERGENCIES

GOAL IIIA: Premier National Capability for Infectious Disease Surveillance and Response

GOAL IIIB: Premier National Capability for Analysis of Potential Chemical Terrorism Agents in Clinical and Food Samples

GOAL IIIC: Effective and Efficient HHS-Wide Response to All Manner of Public Health Threats and Emergencies

GOAL IIID: Properly Trained and Equipped HHS Response Assets

GOAL IIIE: Seamless Integration of HHS Assets with Incident Management Efforts at Local, State, and National Levels

GOAL IIIF: Clear, Balanced, Accurate, and Timely Communication with the Public Regarding Public Health Threats and Emergencies

GOAL IIIG: HHS Program Regularly and Thoroughly Evaluated

STRATEGIC FOCUS IV: ACQUIRING NEW KNOWLEDGE RELEVANT TO BIOTERRORISM AND OTHER PUBLIC HEALTH THREATS AND EMERGENCIES

GOAL IVA: Extensive Knowledge Base about Potential Terrorism Agents and Medical and Behavioral Countermeasures

GOAL IVB: Comprehensive Suite of Validated Healthcare System Approaches to Combating Terrorist Events

GOAL IVC: Extensive Knowledge Base about Terrorism Consequences

STRATEGIC FOCUS V: ACQUIRING AND DEPLOYING MEDICAL COUNTERMEASURES FOR MAJOR POTENTIAL BIOTERRORISM AGENTS

GOAL VA: Research and Development of Licensable and Approvable Medical Countermeasures

GOAL VB: Licensed and Approved Medical Countermeasures

GOAL VC: A Strategic National Stockpile of Medical Countermeasures in Quantities Sufficient to Cover the Populations at Risk

GOAL VD: Ready Availability and Accessibility of Stockpiled Medical Countermeasures

GOAL VE. Protection of Security and Safety Workers

SECTION 3. HHS ACTIVITIES FOR COMBATTING BIOTERRORISM AND OTHER PUBLIC HEALTH THREATS AND EMERGENCIES

STRATEGIC FOCUS I: PREVENTING TERRORISM AND OTHER PUBLIC HEALTH EMERGENCIES

GOAL IA: Safe and Secure Handling of Potential Bioterrorism Agents

Activity IA1. (CDC) Administer the HHS Select Agent Rule

Activity IA2. (CDC) Collaborate with USDA in regulating those Select Agents that can produce illness in both humans and animals

Activity IA3. (CDC) Collaborate with DOJ and USDA in applying the pertinent parts of the USA PATRIOT Act of 2001 to the administration of the HHS and USDA Select Agent Rules

Activity IA4. (NIH/CDC) Maintain policies and procedures to help ensure that intramural laboratories and extramural institutions conducting research with Select Agents comply with relevant biosecurity and biosafety regulations and policies

GOAL IB: Safe and Secure Laboratories for Research and Testing Involving Potential Terrorism Agents

Activity IB1. (CDC/NIH) Maintain and update the “Biosafety in Microbiology and Biomedical Laboratories.

Activity IB2. (CDC/NIH) Foster compliance with regulations and policies to protect the public and laboratory workers by disseminating pertinent information in collaboration with other government agencies, academic and private sector research organizations, and relevant scientific professional societies

Activity IB3. (NIH/CDC/FDA) Continue construction and renovation efforts to achieve and maintain state-of-the-art infectious-agent safety and containment levels in intramural laboratories

Activity IB4. (NIH) Continue sponsoring construction and renovation efforts to achieve and maintain state-of-the-art infectious-agent safety and containment levels in extramural laboratories

Activity IB5. (CDC) Conduct workshops with international partners to validate diagnostic testing of infectious disease agents

Activity IB6. (CDC) Sponsor the safe and efficient transport of influenza diagnostic samples for rapid confirmation as well as biosafety training for safe handling and prevention of disease transmission

Activity IB7. (CDC) Coordinate the domestic and international enhancement of the laboratory response network to ensure standardization of methods and materials

Activity IB8. (HRSA) Foster enhanced hospital laboratory capacity to refer clinical samples and associated information to state laboratories

Activity 1B9. (FDA) Continue improving the physical security of select agent laboratories

GOAL IC: Food Secure from Potential Terrorism Agents

Activity IC1. (FDA) Increase inspections of establishments that manufacture, produce, or import foods that may be at risk of tampering, contamination or counterfeiting -- using risk-based approaches as the basis for inspection and sampling

Activity IC2. (FDA) Develop, publish, distribute, and promote industry implementation of Food Security Guidance Documents

Activity IC3. (FDA) Improve information systems to enhance regulation of food safety

GOAL ID: Medical Products Secure from Potential Terrorism Agents

Activity ID1. (FDA) Increase inspections of establishments that manufacture, produce, or import medical products or other commodities that may be at risk of tampering, contamination or counterfeiting -- using risk-based approaches as the basis for inspection and sampling

Activity ID2. (FDA) Coordinate with industry to promote the development and implementation of measures to protect the security of medical products and other regulated commodities

Activity ID3. (FDA) Improve information systems to enhance regulation of medical products and other regulated commodities

GOAL IE: Effective Collaboration with Counter-Terrorism Initiatives of Other Agencies

Activity IE1. (OPHEP) Maintain regular liaison with intelligence agencies, the Department of Homeland Security, the Department of Justice, the United States Department of Agriculture, the Environmental Protection Agency, the National Security Council, the Department of Defense and other relevant agencies; involve other HHS entities as appropriate

Activity IE2. (CDC/HRSA) Coordinate and provide training with and for other agencies and their constituents

Activity IE3. (OPHEP) Assist other agencies, upon request and as resources allow, in fulfilling their counter-terrorism missions; involve other HHS entities as appropriate

GOAL IF: Productive Partnerships with the Private Sector in Combating Bioterrorism and Other Public Health Threats and Emergencies

Activity IF1. (OPHEP), Engage representatives of the private sector in discussions regarding terrorism threats and means to combat them through the Secretary’s Advisory Council for Public Health Preparedness and other fora

Activity IF2. (FDA) Conduct and review vulnerability assessments to identify security concerns associated with FDA-regulated commodities; work with industry to promote the development and implementation of prevention strategies to eliminate or reduce these vulnerabilities

Activity IF3. (FDA) Encourage FDA-regulated entities to assist FDA in identifying risks to the safety of FDA-regulated commodities

Activity IF4. (CDC) Collaborate with State Health Departments to conduct a smallpox vaccination campaign for public health, emergency medical, and other emergency response professionals

Activity IF5 (HRSA) Collaborate with State Health Departments, to work with local health care systems to enhance health care preparedness

Activity IF6 (HRSA) Administer the Smallpox Vaccine Injury Compensation Program for eligible members of emergency response teams and individuals who suffer a medical injury from vaccine contact with a vaccinated response team member

GOAL IG: Productive Partnerships with other Nations and International Organizations in Combating Bioterrorism and Other Public Health Threats and Emergencies

Activity IG1. (OPHEP) Establish bilateral and multi-national international partnerships to develop early warning surveillance capability for infectious disease outbreaks involving potential bioterrorism agents as well as training to develop related skills; involve other HHS entities as appropriate

Activity IG2. (CDC/NIH) Continue infectious-disease collaborations with foreign institutions and investigators in ways that complement and reinforce development of international early warning surveillance capability

Activity IG3. (FDA) Expand collaborations with foreign government institutions and investigators in ways that complement and reinforce efforts to prevent the use of food, medical products, and other regulated commodities as vehicles for terrorism

Activity IG4 (HRSA) Assist in hospital preparedness efforts through international partnerships as appropriate

GOAL IH: Promote Biosecurity in Life Science Research

Activity IH1. (OPHEP) The National Science Advisory Board on Biosecurity (NSABB) has been established to provide advice to federal departments and agencies on ways to minimize the possibility that knowledge and technologies emanating from vitally important biological research will be misused to threaten public health or national security.

Activity IH2. (OPHEP) Development of a system of institutional review with Federal oversight of Federally funded research that allows for fulfillment of important research objectives while addressing national security concerns

STRATEGIC FOCUS II: ENHANCING STATE, LOCAL, AND TRIBAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH THREATS AND EMERGENCIES

GOAL IIA: Emergency-Ready Public Health Infrastructure

Activity IIA1. (CDC) Award cooperative agreements to States and other entities to enhance emergency readiness of public health departments, with emphasis on

Preparedness Planning and Readiness Assessment
Surveillance and Epidemiology Capacity
Laboratory Capacity – Biological Agents (clinical and food samples)
Laboratory Capacity – Chemical Agents (clinical and food samples)
Health Alert Network / Communications and Information Technology
Communicating Health Risks and Health Information Dissemination
Education and Training

Activity IIA2. (CDC) Provide training and support for training for public health professionals in all major aspects of public health emergency preparedness and response

Activity IIA3. (SAMHSA) Assist toward ensuring that the CDC-sponsored cooperative agreements result in State and local health departments prepared to respond effectively to the mental health impacts of bioterrorism and other public health threats and emergencies

Activity IIA4. (SAMHSA) Continue funding State Capacity grants for the development of State mental health and substance abuse plans to address disaster preparedness, and facilitate the completion of State plans; disseminate a new SAMHSA publication, Mental Health All Hazards Disaster Planning

Activity IIA5. (FDA) In collaboration with CDC, provide guidance to State and local health departments regarding proper use of medical countermeasures and reporting of adverse events

Activity IIA6. (IHS) Assist toward ensuring that the CDC-sponsored cooperative agreements address the terrorism-related public health needs of Indian tribes within each awardee’s jurisdiction

Activity IIA7. (FDA) In collaboration with CDC and HRSA, provide assistance to cooperative agreement partners regarding the development of laboratory capabilities for testing food specimens for pathogens and chemicals that might be agents of terrorism

Activity IIA8. (CDC/FDA) Through continued development of FoodNet, enable active surveillance of diseases caused by food-borne pathogens; collaborate with USDA

Activity IIA9. (CDC) Expand the number of public health laboratories participating in PulseNet with a view to achieving early detection of and catalyzing response to outbreaks of illness caused by food borne pathogens

Activity IIA10. (FDA) In collaboration with USDA continue development of eLEXNET and the national laboratory Food Emergency Response Network with a view to facilitating detection of and response to incidents of food contamination.

Activity IIA11. (HRSA/CDC) Support the national network of Poison Control Centers and strengthen their linkage to public health departments, emphasizing the special needs of newborns, infants, children, and adolescents

Activity IIA12. (CDC) Develop the National Chemical Poisoning and Radiological Illness Monitoring Center

Activity IIA13. (CDC/ NIH) In the wake of public health emergencies, conduct follow up studies of physical and psychological health and establish registries of affected individuals to facilitate consequence management

Activity IIA14. (CDC/HRSA) Provide training through Preparedness and Public Health Training Programs to health care professional in all aspects of public health emergency preparedness and response

Activity IIA15. (CDC) Operate the specialized information network Epi-X with a view to fostering rapid communication among epidemiologists about infectious disease outbreaks

Activity IIA16. (CDC) Operate ArboNet, a computer-based system for rapid collection of information regarding the incidence of infectious disease outbreaks caused by arthropod-borne pathogens such as the viruses that, respectively, cause West Nile encephalitis and eastern equine encephalitis.

Activity IIA17. (CDC) Operate the Health Alert Network with a view to broadcasting public health alerts and other information throughout the public health community

Activity IIA18. (CDC) Continue to foster State and local legal preparedness initiatives to develop statutes and regulations that allow for necessary and appropriate responses to public health emergencies – e.g., the Model State Emergency Health Powers Act

Activity IIA19. (CDC) Sponsor curriculum development and other educational activities, complementary to those carried out by its cooperative agreement partners and those funded by HRSA, to help ensure a well-trained public health workforce to counter bioterrorism and other public health threats and emergencies

Activity IIA20. (OPHEP) Prepare for the timely delivery of medicines and medical supplies during a large-scale public health emergency, and efficient and effective use of the resources available for emergency response and preparedness

Activity IIA21. (HRSA) Provide training for community-based health professions workforce nationally to respond to bioterrorism and other public health emergencies

Activity IIA22. (SAMHSA) Distill best practices for the development and integration of mental health and substances abuse into the state infrastructure by reviewing the State Capacity grantees’ activities. Develop a mechanism to disseminate this information to all states

GOAL IIB: Emergency-Ready Healthcare Infrastructure

Activity IIB1. (HRSA) Award cooperative agreements to States and other entities to enhance emergency readiness of hospitals and other healthcare entities, with emphasis on

Regional Surge Capacity Plan for Adult and Pediatric Victims of Terrorism, including focus on

Hospital Beds
Isolation
Health Care Personnel
Pharmaceutical Caches
Personal Protection and Decontamination
Behavioral Health
Communications and Information Technology

Emergency Medical Services
Linkages to Public Health Departments

Hospital Laboratories
Surveillance and Patient Tracking

Education and Preparedness Training
Terrorism Preparedness Exercises

Activity IIB2. (SAMHSA/HRSA) Ensure hospitals, other health entities and providers are prepared to respond effectively to the mental health impacts of bioterrorism and other public health emergencies

Activity IIB3. (SAMHSA) Provide technical assistance and guidance to foster the development of emergency all-hazard preparedness and response plans that fully integrate mental health and substance abuse; disseminate recent SAMHSA publications, Mental Health All Hazards Disaster Planning Guide and Developing Cultural Competence in Disaster Mental Health Programs

Activity IIB4. (HRSA/IHS) Assist toward ensuring that, consistent with applicable statutes, the HRSA-sponsored cooperative agreements enhance the emergency response capabilities of Indian tribal health care facilities within each awardee’s jurisdiction

Activity IIB5. (FDA) In collaboration with HRSA, provide guidance to hospitals and other health care entities regarding proper use of medical countermeasures and reporting of adverse events

Activity IIB6. (HRSA): Assist in the development of a national system of state-based Emergency System for Advance Registration of Volunteer Health Professionals (ESAR-VHP) through:

1) the development of ESAR-VHP Technical and Policy Guidelines, Standards and Definitions;

2) technical assistance in the implementation of the Guidelines and development of the state-based ESAR-VHPs; and

3) supplemental funding to National Bioterrorism Hospital Preparedness Program grantees to assist with development of their state-based ESAR-VHPs

Activity IIB7. (HRSA) Sponsor competency-based continuing education for practicing health care professionals and curriculum development for health professions students as well as other educational activities through the Bioterrorism Training and Curriculum Development Program, complementary to those carried out by its cooperative agreement partners and those funded by CDC, to help ensure a well-trained healthcare workforce for public health threats and emergencies

Activity IIB8. (HRSA) Promote efforts to improve the readiness of Federally-supported Health Centers to participate in State and local planning for emergency preparedness and response; and provide a network of primary care that is integrated into the local emergency response network

Activity IIB9. (OPHS) Sponsor Medical Reserve Corps units in municipalities to enhance local response capability

Activity IIB10. (OPHEP) Conduct an end-to-end analysis of the continuum of surge capacity and develop measures to address identified gaps

Activity IIB11. (OPHEP) Create at the level of the Office of the Secretary a central coordinating and directing capability for chemical and radionuclear preparedness, in addition to the existing biological threat expertise

Activity IIB12. (FDA) Provide preparedness information to the public regarding home use of life-saving/life-sustaining medical devices when resources to operate the equipment may not be available during terrorist activities and national disasters.

Activity IIB13 (HRSA) Establish guidance to states for the establishment of competency based training systems for the preparation of practicing health care personnel

Activity IIB14. (FDA) Provide guidance to State and local officials on the compounding of medical countermeasures during acute shortage situations.

Activity IIB15. (FDA) Participate in Federal interagency workgroups to address consequence management following a radiological terrorist attack.

GOAL IIC: Emergency-Ready Cities

Activity IIC1. (CDC/OPHEP) Provide direct assistance to the Cities Readiness Initiative Pilot.

Activity IIC2. (CDC) Enhance the capacity of the nation’s 21 most populous urban centers to provide antibiotics in the wake of a large-scale catastrophic event for which such medical countermeasure are appropriate

Activity IIC3. (CDC) Augment the antibiotic distribution capabilities of the 21 cities by engaging the United States Postal Service for direct residential delivery of antibiotics if necessary.

Activity IIC4. (CDC) Expand CDC’s quarantine station capacity beyond the current 8 installations

Activity IIC5. (CDC) Expand the scope of the BioSence surveillance initiative to include new medical and public health data sources

Activity IIC6. (CDC/OPHEP) Integrate plans from all levels of government (federal, state and local) to ensure a consistent, effective and timely response in the event of a large-scale public health emergency

Activity IIC7. (CDC/OPHEP) Develop the “best practices,” tools and information will be shared with all American cities and regions

GOAL IID: Secure Information Technology and Physical Infrastructure for Health Care Delivery

Activity IID1. (OPHEP) Serve as Sector Liaison, per Homeland Security Presidential Directive 7, to the Health Care and Public Health Sector regarding cybersecurity and protection of critical infrastructure

Activity IID2. (OPHEP) Implement the Health Care and Public Health Information Sharing and Analysis Center and related activities, including linkage to the Secretary’s Operation Center

Activity IID3. (OPHEP) Create the linkage with private sector partners such as the network of blood centers and the occupational medicine community to foster the development of information sharing and analysis activities

Activity IID4. (OPHEP) In conjunction with DHS, foster the development of the Government Coordinating Council

STRATEGIC FOCUS III: ENHANCING HHS PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH THREATS AND EMERGENCIES

GOAL IIIA: Premier National Capability for Infectious Disease Surveillance and Response

Activity IIIA1. (CDC) Enhance the Epidemic Intelligence Service by increasing the number, skills, and geographic distribution of infectious-disease detection and investigation professionals

Activity IIIA2. (CDC) Expand the scope and capacity of the CDC reference diagnostic laboratory in support of the national Laboratory Response Network

Activity IIIA3. (CDC/HRSA) Promulgate information technology standards with a view toward fostering the development of interoperable information systems throughout the public health and health care communities

Activity IIIA4. (CDC) Collaborate with the DHS and the EPA in monitoring ambient air for potential bioterrorism agents (Project BioWatch)

Activity IIIA5. (CDC/AHRQ) In collaboration with partner organizations throughout the nation, explore the feasibility and utility of syndromic surveillance as a means to early detection of possible disease outbreaks and progressive characterization of affected and at-risk populations throughout the course of the outbreak (Project BioSense)

Activity IIIA6. (FDA/CDC) Continue development of rapid and confirmatory laboratory methods to detect potential bioterrorism agents in food; provide analyses in support of State and local response activities as appropriate

Activity IIIA7. (FDA) Enhance monitoring and testing for blood-borne and tissue-borne pathogens with a view toward ensuring a safe blood and tissue supply

Activity IIIA8. (CDC) In collaboration with the DHS, continue to develop and operate the Strategic National Stockpile; provide training, education, and demonstration packages to help State and local partners prepare to receive and manage Stockpile deployments and, during deployments, provide Technical Advisory Response Units

Activity IIIA9. (CDC) Develop standard case definitions to facilitate coordinated local, State, and national responses to public health emergencies

GOAL IIIB: Premier National Capability for Analysis of Potential Chemical Terrorism Agents in Clinical and Food Samples

Activity IIIB1. (CDC) Continue development of the Rapid Toxic Screen for potential chemical terrorism agents in clinical samples

Activity IIIB2. (CDC) Operate the Toxic Response Laboratory, providing analyses in support of State and local response activities as appropriate

Activity IIIB3. (CDC) Operate the Radionuclide Response Laboratory, providing analyses in support of State and local response activities as appropriate

Activity IIIB4. (FDA) Continue development of rapid and confirmatory laboratory methods to detect potential chemical terrorism agents in food; provide analyses in support of State and local response activities as appropriate

GOAL IIIC: Effective and Efficient HHS-Wide Response to All Manner of Public Health Threats and Emergencies

Activity IIIC1. (OPHEP) Through the Secretary’s Operation Center, maintain continuous vigilance for possible public health threats and emergencies and direct and coordinate whatever HHS response(s) may be indicated

Activity IIIC2. (OPHEP/CDC/FDA) Ensure full interoperability among the Secretary’s Operation Center, the Emergency Operations Centers of CDC and FDA, and the emergency response capabilities of HRSA, SAMHSA, and other HHS agencies

Activity IIIC3. (OPHEP) Direct and coordinate the activities of HHS components during activations of the Federal Response Plan and the Federal Radiological Emergency Response Plan

Activity IIIC4. (OPHS) Increase the percent of Commissioned Corps officers who meet the basic readiness standards to 100% by the end of FY 2005 for deployment

Activity IIIC5. (OPHS/OPHEP) Maintain readiness of the Public Health Service Disaster Medical Assistance Team (PHS-1 DMAT)

Activity IIIC6. (CDC) Maintain a CDC/ATSDR Emergency Response Team for deployment as directed by the Secretary

Activity IIIC7. (OPHS/OPHEP) Promulgate, revise, and update as necessary a process for deploying PHS Commissioned Officers in support of HHS emergency responses

Activity IIIC8. (SAMHSA) Following declaration of a national disaster, provide crisis-counseling services to victims and others impacted by the events, as well as providing training to providers through the SAMHSA/FEMA Crisis Counseling and Training Assistance Program.

Activity IIIC9. (OPHEP) Activate, as needed, Secretary’s Emergency Response Teams to coordinate the deployment and disposition of HHS assets at the scene of a public health emergency

Activity IIIC10. (FDA) In collaboration with USDA, direct and coordinate the eLEXNET and the laboratory Food Emergency Response Network in addressing potential chemical terrorism agents;

Activity IIIC11. (HHS/FDA) Development of a web-based national incident management system for all FDA offices (which will include headquarters, centers, and field offices) through which accurate real-time information about incidents involving FDA regulated products can be shared, discussed and coordinated within FDA and with HHS and other federal, state, and local jurisdictions.

Activity IIIC12. (OPHEP) Develop an effective system for management of HHS assets deployed to the field during an emergency response.

Goal IIID: Properly Trained HHS Response Assets

Activity IIID1. (CDC) Provide training to CDC and ATSDR staff rostered for possible deployment for biological, chemical, radiological, or nuclear incidents

Activity IIID2. (OPHS) Improve the training and capabilities of all PHS Commissioned Corps officers in all-hazards preparedness, deployment and response; conduct periodic exercises of their capabilities

GOAL IIIE: Seamless Integration of HHS Assets with Incident Management Efforts at Local, State, and National Levels

Activity IIIE1. (OPHEP) Ensure full interoperability and regular interactions between the Secretary’s Operation Center and the Emergency Operations Center of the Department of Homeland Security

Activity IIIE2. (OPHEP) On an incident-specific basis, establish communications links between the Secretary’s Operation Center and other pertinent parties – such as State and local public health officials, the network of blood centers, and distributors of medical material

Activity IIIE3. (OPHEP) Upon request from the Secretary of Homeland Security and in accord with the National Response Plan, direct and coordinate the deployment and disposition of federal government assets to address the medical and public health aspects of a national emergency (Emergency Support Function #8)

Activity IIIE4. (OPHS) Through the Regional Health Administrators, collaborate with state and local departments of public health and emergency medical services toward the seamless utilization of HHS response assets during a disaster

GOAL IIIF: Clear, Balanced, Accurate, and Timely Communication with the Public Regarding Terrorism Risks

Activity IIIF1. (OPHEP/OASPA/HRSA) Develop risk communication capabilities and protocols in collaboration with CDC, FDA, HRSA, SAMHSA, NIH, other HHS components, and the National Public Health Information Coalition

Activity IIIF2. (OPHEP/OASPA) In preparation for public health threats and emergencies and in collaboration with CDC, FDA, SAMHSA, NIH, and OIGA, provide risk information to the public in concert with state and local initiatives undertaken through the CDC-sponsored cooperative agreements – according special attention to the needs of newborns, infants, children, and adolescents

Activity IIIF3. (OPHEP/OASPA) In response to public health threats and emergencies, provide risk information to the public health and medical communities and the public in concert with CDC, FDA, HRSA and OIGA; the Department of Homeland Security and the National Security Council; and other partners

GOAL IIIG: HHS Program Regularly and Thoroughly Evaluated

Activity IIIG1. (OPHEP/AHRQ) Provide leadership for designing and conducting HHS assessments and evaluations of its emergency preparedness and responses, including those initiated by the Department of Homeland Security or other non-HHS agencies

Activity IIIG2. (OPHEP) Conduct after-action reviews, prepare assessments of all emergency deployments of PHS Commissioned Corps assets and recommend improvements in force management

Activity IIIG3. (OPHEP) Assess the effectiveness of this strategic plan in meeting HHS responsibilities for combating bioterrorism and responding to other public health threats and emergencies, and based on the assessment, providing leadership for making changes to this plan

STRATEGIC FOCUS IV: ACQUIRING NEW KNOWLEDGE RELEVANT TO BIOTERRORISM AND OTHER PUBLIC HEALTH THREATS AND EMERGENCIES

GOAL IVA: Extensive Knowledge Base about Potential Terrorism Agents and Medical and Behavioral Countermeasures

Activity IVA1. (NIH/CDC/FDA) Expand basic research relevant to potential biological terrorism agents – including pathogen/host interactions, disease pathogenesis, microbial ecology, and molecular toxicology and chemical terrorism agents (including the mechanisms, pathophysiology, and natural progression of agent-induced injury)

Activity IVA2. (NIH/CDC/FDA) Expand targeted research involving microbial genomics, proteomics, and bioinformatics

Activity IVA3. (NIH) Enhance the national research infrastructure by expanding the number of Regional Centers of Excellence featuring advanced research capabilities for biodefense studies

Activity IVA4. (NIH) Expand the number of BioSafety Level 3 and 4 laboratories in the United States

Activity IVA5. (NIH) Establish national research resources such as specialized collections of reagents and pathogens to enhance collaboration and increase the productivity of HHS-funded basic and targeted research related to bioterrorism

Activity IVA6. (NIH/CDC/FDA) Expand efforts to develop and demonstrate proof of principle of new and improved countermeasures (vaccines, therapies, and diagnostics)]

Activity IVA7. (FDA/CDC) Increase research relevant to developing new or improved rapid and confirmatory laboratory methods to analyze suspect foods for select agents or chemicals

Activity IVA8. (FDA) Increase research relevant to ensuring the safety of medical products and other regulated commodities

Activity IVA9. (FDA) Develop a risk-based approach for targeting regulatory pathways for critical medical countermeasures.

Activity IVA10. (FDA) Identify promising medical countermeasures (new products and new indications) and advise CDC, NIH, and other agencies, as well as private entities requesting or intending to request an emergency use authorization, licensure, or approval.

Activity IVA11. (FDA) Review data and other information on known and potential risks and benefits of unapproved medical countermeasures, including investigational products currently in the SNS, for possible deployment under an emergency use authorization.

Activity IVA12. (FDA) Collaborate with state and local agencies through participation in professional organizations (Conference of Radiation Control Program Directors /Health Physics Society) to address radiation exposure emergencies

Activity IVA13 (NIH) Support research examining ways to promote the public’s resistance to maladaptive responses to terrorist threats and attacks

GOAL IVB: Comprehensive Suite of Validated Health Care System Approaches to Combating Terrorist Events

Activity IVB1. (AHRQ) Develop and assess alternative approaches to ensuring health care surge capacity for mass casualty events – including needs of ambulatory care, long term care, pediatric care, and other health services

Activity IVB2. (AHRQ) Develop and assess alternative uses of information technology and electronic communication networks in enhancing the preparedness of the health care systems to deal with public health threats and emergencies

Activity IVB3. (AHRQ) Develop and assess protocols and technologies to enhance interoperability among the health care system, the public health system, and the other organizational participants that constitute the emergency response network

Activity IVB4. (AHRQ) In collaboration with HRSA, develop and assess models that address the training and information needs of health care providers related to enhanced emergency preparedness

Activity IVB5. (CDC) Operate the National Protective Technology Laboratory

Activity IVB6. (CDC) Develop standards for, test, and certify respiratory protection devices

Activity IVB7. (SAMHSA) Develop and assess approaches to ensuring mental health care surge capacity for mass casualty events - including needs for psychological first aid, acute hospitalization, long term care, pediatric mental health, and other mental health services

GOAL IVC: Extensive Knowledge Base about Terrorism Consequences

Activity IVC1. (SAMHSA) Through contractual agreements with technical assistance centers, continue to develop a database of best practices for anticipating and addressing the psychosocial needs of individuals and communities; continue to collaborate with other HHS agencies to examine the need for psychological triage instruments and other concerns

Activity IVC2. (CDC/SAMSHA) Incorporate mental health questions into routine physical health surveys that could serve as a baseline against which to measure changes following terrorist threats or attacks.

STRATEGIC FOCUS V: ACQUIRING AND DEPLOYING MEDICAL COUNTERMEASURES FOR MAJOR POTENTIAL BIOTERRORISM AGENTS

GOAL VA: Research and Development of Licensable and Approvable Medical Countermeasures

Activity VA1. (OPHEP/NIH/CDC/FDA) Coordinate R&D programs to support Project BioShield requirements and acquisition needs

Activity VA2. (NIH) Expedite peer review and award processes for grants, cooperative agreements, and contracts related to medical countermeasure R&D activities associated with Project BioShield

Activity VA3. (NIH/CDC/FDA) Use funding mechanisms to expand and accelerate research (including clinical trials) on medical countermeasures

Activity VA4. (CDC) Complete clinical trials and related studies of the current anthrax vaccine to enable more effective and efficient use

Activity VA5. (NIH) In collaboration with industry and the FDA, perform pre-clinical and clinical development of next generation anthrax vaccine

Activity VA6. (CDC) Continue efforts to acquire botulinum antitoxin for the Strategic National Stockpile

Activity VA7. (CDC) Continue efforts to acquire anthrax immunoglobulin for the Strategic National Stockpile

Activity VA8. (NIH) In collaboration with industry and the FDA, complete pre-clinical development of next generation smallpox vaccine for potential procurement by Project BioShield

Activity VA9. (NIH) Perform pre-clinical screening of selected antibiotic, antiviral, and immunotherapeutic drugs for activity against potential bioterrorism agents; collaborate with DoD, USDA, DHS, FDA, CDC, industry and academia

Activity VA10. (NIH/CDC/FDA) Develop and validate, in collaboration with DoD and other research organizations as appropriate, animal models of human diseases caused by potential bioterrorism agents so as to qualify these models for use under the animal efficacy rule

Activity VA11. (NIH/FDA/CDC) Collaborate with DoD and other agencies, industry, and academia to enhance the availability of adequate animal model resources and research facilities to conduct appropriate studies related to developing medical countermeasures

Activity VA12. (NIH/CDC/FDA) Develop new methods, reagents, and standards to facilitate the development and evaluation of biodefense medical countermeasures; provide these methods and reagents to industry and academia as appropriate

Activity VA13. (NIH/CDC/FDA) Conduct scientific workshops in collaboration with industry to present and discuss innovative new approaches for the detection, prevention and treatment of diseases caused by potential bioterrorism agents

Activity VA14. (FDA) Issue regulatory guidance on the development of antibiotic and antiviral drugs, vaccines, immunotherapeutics, radioprotectants, devices, and other medical products as bioterrorism medical countermeasures

GOAL VB: Licensed and Approved Medical Countermeasures

Activity VB1. (OPHEP) Efficiently coordinate and manage Project BioShield initiative with a view toward ensuring timely acquisition of critical medical countermeasures; collaborate with DoD and DHS

Activity VB2. (OPHEP) Establish acquisition requirements for critical medical countermeasures in collaboration with DoD and DHS

Activity VB3. (HHS/CDC) Award acquisition contracts for the next generation anthrax and smallpox vaccines and for botulinum antitoxins

Activity VB4. (NIH/CDC/FDA) Expedite the testing and review of currently approved drugs and biologics for use as potential new or improved medical countermeasures for biodefense

Activity VB5. (FDA) As part of Project BioShield, establish a bioterrorism preparedness priority review program and expedite the review of drug, biological, and device related countermeasures; provide for pre-submission meetings and guidance for manufacturers interested in developing drugs, biologics, and devices for bioterrorism countermeasures

Activity VB6. (FDA) Establish a program to provide technical assistance and Good Manufacturing Practices compliance guidance to manufacturers actively involved in developing medical countermeasures

GOAL VC: A Strategic National Stockpile of Medical Countermeasures in Quantities Sufficient to Cover the Populations at Risk

Activity VC1 (CDC) With the assistance of FDA, collaborate with DHS to maintain and upgrade supplies and facilities of the Strategic National Stockpile with a view toward ensuring adequate and efficient inventory control, storage, shipping, and deployment of Stockpile components

Activity VC2. (CDC) With the assistance of FDA, collaborate with DHS to establish a Quality Assurance program with a view toward ensuring compliance with Good Manufacturing Practice (GMP) regulations and other applicable quality standards and certification requirements

Activity VC3. (FDA) Provide for regular inspection of the Stockpile facilities for proper monitoring and storage of products according to product labeling.

Activity VC4. (FDA) Continue the implementation of the Shelf-life Extension Program for the components of the Stockpile

Activity VC5. (FDA/NIH) Evaluate whether any psychotropics or other medications targeted at reducing physiological arousal and promoting restful sleep are indicated.

Activity VC6. (CDC): Validate readiness plans with a view toward ensuring readiness of Stockpile components for deployment

GOAL VD: Ready Availability and Accessibility of Stockpiled Medical Countermeasures

Activity VD1. (CDC) Provide guidance and training of State and local officials to facilitate receipt, storage, and distribution of deployed Stockpile materials

Activity VD2. (FDA/OPHS) Provide guidance to clarify the exception from the general requirement for informed consent in life-threatening situations necessitating the use of a test article and explain how the regulations would apply during emergencies, including a response to biological or chemical terrorism, requiring the use of investigational products regulated by the FDA

Activity VD3. (FDA/OPHS) Collaborate to harmonize informed consent requirements and expedite Institutional Review Board processes to make investigational products available expeditiously in emergency situations

Activity VD4. (FDA) With assistance from CDC and NIH, develop and publish guidance on the unlabeled indication use of currently approved or licensed medical countermeasure products for further countermeasure uses, as appropriate

Activity VD5. (FDA) Publish guidance on the development and approval of medical countermeasures to enhance the elimination of internal radioisotope contaminants.

Activity VD6. (FDA/OPHEP) Implement a program to assess and monitor manufacturing production surge capacities and facilitate availability and security of non-stockpiled products with a view toward ensuring that adequate medical countermeasures are available to respond to a terrorist event

Activity VD7. (CDC) Provide for bioterrorism risk analysis, risk assessment, and risk management and model logistics strategies for emergency deployment of medical countermeasures

Activity VD8. (FDA) In collaboration with CDC, develop and implement interagency procedures for post-event adverse event reporting and collection of efficacy and clinical outcome data for appropriate medical countermeasures

GOAL VE: Protection of Security and Safety Workers

Activity VE1. (FDA) Advise agencies about radiation safety, risk, justification, and optimization from new and existing products and technologies.

Activity VE2. (FDA) Regulate and advise manufacturers to assure that products can be used safely without discouraging innovative new products.

Activity VE3. (FDA) Partner with other agencies such as NIOSH, DOT, and FAA to assure worker safety.