SUMMARY OF DHHS ANTI-BIOTERRORISM INITIATIVE FOR FY 2000

The President has requested $230 million in FY 2000 for the initiative by the Department of Health and Human Services (DHHS) against bioterrorism._ DHHS will work closely with state and local health agencies as well as with law enforcement and emergency response agencies at the local, state, and national levels to effect this initiative.

The DHHS initiative features activities in five distinct but related areas:

Deterrence of biological terrorism

Surveillance for unusual outbreaks of illness

Medical and public health response

Development of a national pharmaceutical stockpile

Research and development

Highlights for each area follow.

Deterrence of biological terrorism ($1 million) - The Centers for Disease Control and Prevention (CDC) will work to ensure that laboratories throughout the nation are in compliance with requirements governing shipment of highly infectious organisms and dangerous toxins. CDC also will work to ensure safe design and secure operation of laboratories that handle the most dangerous organisms.

Surveillance for unusual outbreaks of illness ($85 million) - CDC will intensify its efforts to upgrade public health capability to counter bioterrorism through complementary, simultaneous improvements in bioterrorism-related expertise, facilities, and procedures at local, state, and national levels. The emphasis areas are (a) preparedness planning by state and local health departments; (b) prompt detection of outbreaks of illness that might have been caused by terrorists; (c) epidemiological analysis of outbreaks to identify the source and mode of transmission; (d) laboratory identification and characterization of the agents causing the outbreaks; and (e) electronic communications among public health officials regarding occurrences of outbreaks and responses to them.

Medical and public health response ($24.6 million) - Municipal leaders, with support from state and federal agencies, must be prepared to provide protective and responsive measures for the affected populations including mass patient care, mass immunization or prophylactic drug treatment, mass fatality management, and decontamination of the environment. The Office of Emergency Preparedness (OEP) will expand its efforts to develop complementary medical response capabilities at local and national levels. In particular, it will increase the number of Metropolitan Medical Response Systems and, for both existing and new Systems, help them upgrade their capabilities for providing mass patient care and dealing with other consequences of biological terrorism. Also, OEP will strengthen the National Disaster Medical System in these same areas so that it can augment local capabilities as needed and will continue to work closely with the Department of Justice, the Federal Emergency Management Agency, the Department of

Defense, and other agencies toward ensuring that plans for managing the medical consequences of terrorist acts are well integrated with other emergency response systems.

Development of a national pharmaceutical stockpile ($52 million) - A national stockpile is ersential because no state or municipality will have ready access to the volume and range of pharmaceuticals that could be needed to respond to a bioterrorist attack. The primary initial focus will be on acquiring antibiotics useful in treating anthrax, plague, and tularemia; enhancing the utility of the existing supply of smallpox vaccine; and developing a cache of drugs and equipment for countering chemical attacks. Once research and development has yielded improved vaccines against anthrax and smallpox and new antiviral drugs effective against smallpox, they will he included in the stockpile.

CDC has responsibility for developing the stockpile. The Surgeon General of the U. S. Public Health Service in consultation with pertinent national, state, and local officials - will determine whether a particular incident warrants distribution of drugs and vaccines from the stockpile. OEP will direct the deployment of stockpile materials through the National Disaster Medical System in accord with the Surgeon General's guidance.

Research and development ($67.7 million) - DHHS will expand research on likely bioterrorism agents. The National Institutes of Health will focus on techniques for rapid, accurate detection and identification of organisms used in a bioterrorist attack, new and improved vaccines (especially vaccines against anthrax and smallpox), and new and improved drugs to treat anthrax, plague, tularemia, and smallpox. An ares of special emphasis will be the generation of genome sequence information on potential bioterrorism agents to speed such medical and technological advances.

In related work, the Food and Drug Administration will increase its research on detection and characterization of toxins that might be used by terrorists and will expedite its review of new or improved diagnostics, therapeutics, and vaccines against potential terrorism agents

DHHS OPERATING PLAN FOR ANTI-BIOTERRORISM INITIATIVE

Fiscal Year 1999

The DHHS initiative against bioterrorism features activities in four distinct but related areas:

deterrence of biological terrorism;

surveillance for unusual outbreaks of illness;

medical and public health response; and

research and development.

This paper describes current plans in each area. Attached are a cross-walk table relating the sections of this paper to the items identified in the Appropriations Conference Report (Appendix 1) and copies of the relevant appropriations reports (Appendix 2).

DETERRENCE (S1,000,000)

DHHS, through its Centers for Disease Control and Prevention (CDC), has the responsibility mandated by the Antiterrorism and Effective Death Penalty Act of 1996 to regulate shipment of certain hazardous biological organisms and toxins (hereinafter called "select agents"). Two examples are the bacteria that cause anthrax and plague, respectively. Organizations such as research universities, pharmaceutical manufacturers, and microbiological archives often have occasion, as part of their routine work, to send or receive samples of select agents. DHHS regulations (42 CFR 72.6) require that all facilities sending or receiving shipments of select agents register with CDC, maintain records of such transfers, and otherwise document their compliance.

CDC will expand its efforts toward ensuring that all pertinent laboratories are registered and otherwise in compliance with the select agent rule. CDC will continue to cooperate with intelligence and law-enforcement agencies to help ensure that the select agent rule is an effective part of the multi-agency effort, led by the Department of Justice, to deter terrorism in all its forms.

CDC also will expand its efforts toward ensuring safe design and secure operation of laboratories rated as high quality Biosafety Level (BSL) 3 - the biosafety safety level required for handling the most dangerous organisms. This will involve consultation with laboratory officials to help ensure that new, renovated, or proposed facilities are appropriate for the infectious organisms that will be handled there, development of guidelines and training materials for use by laboratory personnel, and provision of technical assistance to states regarding their inspection programs for BSL 3 facilities.

SURVEILLANCE (S68,000,000)

Terrorist use of biological weapons (and certain chemical agents) against the civilian population is likely to be surreptitious. Absent an explosion, other immediate evidence of an attack, or notification of authorities by a perpetrator that an attack has been made (i.e., people have been exposed), the first responders will be health-care workers rather than fire or police personnel (as

would be expected for a conventional emergency response scenario). The first indication that a silent attack has occurred probably will be an outbreak of some uncommon illness or an abrupt, significant increase in the incidence of commonly observed symptoms. How quickly the outbreak is detected, analyzed, understood, and addressed will determine the timeliness and effectiveness of the medical and public health response and hence the extent and severity of the impact upon the health and well-being of the affected community. For example, a silent release of a biological agent capable of producing a highly communicable disease could afflict hundreds, even thousands, of individuals over a wide geographic area during a period of several weeks before a full medical and public health response could be designed and mounted.

Overall Planning ($1,000,000)

DHHS, through CDC., will lead an effort to upgrade national public health capability to counter bioterrorism. Through national and regional meetings with representatives of stakeholder groups, CDC will seek broad-based consensus regarding strategy for effecting complementary and coordinated improvements in bioterrorism-related expertise, facilities, and procedures at local, state, and national levels. This effort will result in the development of a CDC counter terrorism response plan in FY 1999. The meetings will focus on five areas:

preparedness of state and local health departments to deal with bioterrorism;

detection of outbreaks of illness that might have been caused by terrorists;

epidemiological analysis of outbreaks to identify the source(s) and mode(s) of
transmission;

laboratory identification and characterization of causal agents for outbreaks; and

electronic communications among public health officials regarding occurrences of
outbreaks and responses to them.

Whereas research and product development are primarily the role of the federal government, surveillance, epidemiologic capabilities, and medical response systems are activities for which the federal government works in partnership with states. In countering bioterrorism, the federal government is providing leadership and principal funding in the early years of a multi-year effort. DHHS will explore with the states how they might assume a larger share of the partnership expenses over time.

The following paragraphs describe the framework of roles and relationships among local, state, and federal government that will be the starting point for this joint effort.

Upgrading State and Local Capabilities ($55,000,000)

CDC will award cooperative agreements to state health departments to help upgrade state and local surveillance capabilities. To provide the states with the most flexibility and to make the application process more efficient, CDC plans to fund the various activities with a single award instrument, a cooperative agreement, featuring separate program components focused on the activities listed below (e.g., preparedness planning). Thus, based on eligibility criteria published in the Program Announcement, states will have the opportunity to apply for funding for one, all, or any of the program components. The following table indicates the expected ranges in the number of states to be funded and the amount of funds to be awarded for each activity.

CDC expects to solicit cooperative agreement applications during the second quarter of FY 1999, review them during the third quarter, and make the awards during the fourth quarter.

Preparedness ($2,000,000). Most state and local health departments lack plans for
responding to biological or chemical terrorism. Moreover, public health activities
generally are not well integrated with those of other government agencies that are
responsible for responding to emergencies of all sorts.

CDC will address this deficiency in three ways: a) by collaborating with other agencies of the federal government and with state and local health departments in developing model