Fact Sheet

FOR IMMEDIATE RELEASE
Jan 13, 2006

Contact: HHS Press Office
(202) 690-6343

HHS ACCOMPLISHMENT IN BIODEFENSE PREPAREDNESS

Overview: President Bush has made strengthening the nation's defenses against biological weapons a critical national priority. While significant progress has been made, the President instructed federal departments and agencies to review their efforts and find new and better ways to secure America from bioattacks. The result of this review was "Biodefense for the 21st Century," a Presidential directive that provides a comprehensive framework for our nation's biodefense. Released in an unclassified version on April 28, "Biodefense for the 21st Century" builds on past accomplishments, specifies roles and responsibilities, and integrates the programs and efforts of various communities -- national security, medical, public health, intelligence, diplomatic, agricultural and law enforcement -- into a sustained and focused national effort against biological weapons threats. "Biodefense for the 21st Century" outlines the essential pillars of our biodefense program and provides specific directives to further strengthen the significant gains put in place during the past three years. At HHS, in cooperation with the Department of Homeland Security, preparations have included the following highlights:

Federal investment in Biodefense is times greater than in years past and the President has proposed another significant increase for next year.

Combined HHS and DHS Biodefense preparedness spending:

FY 2001 -- $294 million [HHS budget]
FY 2002 -- $3 billion [HHS budget]
FY 2003 -- $4.4 billion [combined HHS and DHS budgets for Biodefense]
FY 2004 -- $5.2 billion [combined HHS/DHS - incl. BioShield proposal]

An unprecedented partnership effort with states and hospitals was launched quickly.

A total of $3.6 billion has been made available for state, local and hospital preparedness since 2001.
Funds go through state public health agencies, but 75 percent will ultimately go for direct or indirect support of local public health departments and hospitals.
States are drawing these funds as quickly as they are able to ramp up their preparedness efforts and invest the money productively.

Public health systems are already much stronger and better prepared for bioterrorism and other mass casualty incidents.

All 50 states have bioterrorism response plans in place.
Ninety-eight percent of states have individuals assigned to receive and evaluate urgent disease reports 24 hours a day, 7 days a week, 365 days a year (24/7/365) and all states have protocols in place to activate the public health emergency response system 24/7/365.
All states have plans in place for receiving and distributing assets from the Strategic National Stockpile and are implementing those plans.
Twenty-one pilot cities, plus 15 new cities, are receiving funding through CDC's Cities Readiness Initiative (CRI) to develop plans for dispensing mass prophylaxis to their entire population within 48 hours.
States are updating their laws for dealing with public health emergencies, using the draft model legislation on emergency health powers that was prepared at CDC's request. As of June 2005, 37 states and the District of Columbia have passed bills or resolutions related to the draft model legislation.

More workers and expertise have been directed at public health emergency preparedness.

CDC awards fund over 3,500 state and local public health staff working full or part time on emergency preparedness activities.
HHS staff dedicated to public health emergency preparedness is now 1,700, up from 212 in FY 2001. Next year, the number will rise again, to over 2,000.
CDC will complete training in emergency preparedness and response for approximately 400 existing staff assigned to state and local public health agencies by 2006.
CDC continues to provide expert assistance, especially through its "disease detectives," the Epidemic Intelligence Service (EIS). This two-year program has 149 EIS officers available to respond to biodefense and other public health emergencies.

America's public health laboratory capacity, a crucial element in detecting and understanding any disease outbreak, is greatly expanding.

The Laboratory Response Network, connecting labs of many kinds that can help in an emergency, has been expanded to 142 member labs in all 50 states and several international sites, up from 91 labs in 2001.
CDC has trained more than 8,800 clinical laboratorians to play a role in the detection, diagnostics, and reporting of public health emergencies.
Fifteen new high-level biocontainment research laboratories are being funded by NIH primarily for extramural research purposes, but they would also be available to assist in public health response to bioterrorism or infectious disease emergencies.

Communications capacity within the public health structure has been expanded and improved.

CDC's Public Health Information Network Partner Communication capacity can reach 1 million recipients quickly, including 86 percent of all state public health agencies.
BioSense, a component of CDC's Public Health Information Network, advances the nation's capabilities for early event detection by providing real-time data from hospitals and other facilities, has been made available to 34 city jurisdictions and 50 states, and supports over 330 users in all states and major metropolitan areas.
CDC's EPI-X system also connects more than 3,600 public health officials nationwide for immediate sharing of emergent public health data, compared with 200 in 2001.
These improvements will help make public communications clearer and faster in an emergency.

Hospital preparedness efforts have resulted in new state- and region-wide coordination, with coherent plans for investment and response.

A new nationwide program, developed after the Sept. 11, 2001, terrorist attacks, has initiated planning processes in all states and territories to bolster the capacity of hospitals to deliver coordinated and effective care to victims of terrorism and other public health emergencies.
Through HRSA's National Bioterrorism Hospital Preparedness Program, funded at $491 million (FY 2005), hospitals and supporting healthcare systems receive funds to augment the number of hospital beds that can be used in a large-scale public health emergency; increase and expand hospital and regional isolation capacity; enhance hospital-based pharmaceutical stocks, and plan for community-wide disease prevention efforts.
Program funds also are used to identify additional health care personnel who would be called on in a mass casualty incident, which may include terrorism, accidents or naturally occurring disease, and to increase behavioral health training and triage for all health care personnel.
All states have developed plans with their hospitals for dealing with mass casualty incidents, including terrorism, accidents or naturally-occurring diseases.

Nationwide training for health care professionals is being implemented, and scientific expertise is growing.

Almost 174,000 health professionals have been trained in FY 2003 and 2004 through HRSA's Bioterrorism Training and Curriculum Development program, with 19 grants for continuing education aimed at the diverse health care workforce, and 13 grants to health professions schools to develop curricula.
NIH's new Regional Centers of Excellence (RCEs) for Biodefense and Emerging Infectious Diseases will build a strong intellectual infrastructure for research and development while also developing our base of scientific expertise by training a new generation of science professionals to perform Biodefense research.
CDC's Centers for Public Health Preparedness (CPHPs) help prepare frontline health workers at the local level. There are now 41 CPHPs in 46 states, comprised of schools of public health, schools of medicine and other local institutions. The CPHP has delivered over 380 preparedness education activities, reaching over 250,000 learners nationwide.

Federal emergency resources have been expanded to back-up local resources when they become overwhelmed.

The Strategic National Stockpile now includes twelve 50-ton "12-hour Push Packages," up from eight in 2001. The amount and variety of stockpile contents has also grown. It now contains increased amounts of antibiotic prophylactic regimens for anthrax and the inventory goal has risen from 12 million in 2003 to 50 million in 2005.
The National Disaster Medical System has 33 percent more personnel for its emergency response teams - 8,000 personnel today, up from 6,000 in 2001.
HHS has quadrupled the Readiness Force in the U.S. Public Health Service Commissioned Corps, from 600 in 2001 to almost 2,300 today.

FDA is implementing the most fundamental enhancements of its food safety activities in many years.

FDA has more than doubled its presence at ports of entry, from 40 ports in 2001 to 90 ports today.
This year, FDA is performing 60,000 inspections of imported foods, five times more than in 2001. In FY 2005, FDA proposes to conduct 97,000 inspections, eight times higher than 2001.
FDA is implementing its new authority for registration of food facilities (some 425,000 are expected to register); for prior notification of food import shipment (some 20,000 notices per day expected); for record-keeping to identify the immediate previous sources and immediate subsequent recipients of food; and for administrative detention of suspected foods.
FDA has created a Food Emergency Response Network, with 63 labs representing 34 states - no such network existed in 2001.
FDA is expanding its eLEXNET communications network for immediate exchange of critical food testing data. At present, there are 108 laboratories representing 49 states and the District of Columbia. They are capable of dealing with more than 3,700 analytes. In 2000, there were eight labs, capable of tracking a sole analyte.

The Biodefense research initiative is the largest single increase in resources for any initiative in the history of NIH.

Biodefense research funding at NIH has increased from $53 million in FY 2001 to $1.6 billion in FY 2004.
The increased effort is guided by strategic plans and research agendas developed with the guidance of panels of scientific experts.
More than 50 biodefense initiatives have been developed to address research and development priorities in therapeutics, vaccines, diagnostics, and basic research including genomics, proteomics and bioinformatics.
NIH has invested more than $800 million for the construction of 15 extramural labs and three intramural labs, and physical security. These are critical to developing countermeasures against agents of bioterror.
NIH will emphasize product development and cooperative enterprises with private industry and academia, in addition to its traditional role of supporting basic scientific research.

Progress in Biodefense research has been swift and substantial.

New and improved vaccines against smallpox, anthrax, and other potential bioterror agents are being developed and evaluated and will soon enter the national stockpile through Project BioShield.

NIH rapidly developed a fast-acting Ebola virus vaccine and showed its efficacy in monkeys; it is now being tested in human volunteers.
NIH-supported scientists have identified antivirals that may play a role in treating smallpox or the complications of smallpox vaccination, as well as new antibiotics and antitoxins against other major bioterror threats.
NIH has established ten Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research (RCE). This nationwide group of multidisciplinary centers is a key element in the HHS strategic plan for biodefense research.
NIH has supported the genomic sequencing of all bacteria (including the anthrax bacterium) considered to be bioterror threats, as well as the sequencing of genomes for at least one strain of every potential viral and protozoan bioterror pathogen.

Capacity is being expanded to produce medical countermeasures to protect Americans from bioterrorism attacks.

The supply of smallpox vaccine has increased from 15.4 million doses available in 2001, to more than 300 million full doses today, enough to vaccinate every American, if necessary.
TThe President has launched the BioShield initiative, to create a more stable and assured source of funding to purchase new vaccines or treatments. BioShield will provide $5.6 billion over the next 10 years for new products. FDA has approved new medical countermeasures, including therapies for anthrax, radiation exposure and antidotes to nerve agent poisoning. FDA has also implemented programs to facilitate development of new products.
TIn the past four years, FDA finalized the "animal rule," which provides for using animals to test the safety and efficacy of products where human tests would be unfeasible. This rule can be important in the development of many Biodefense countermeasures.

Federal coordination and capacity has been expanded.

The Department of Homeland Security creates a focal point for federal leadership.
HHS has created a top-level Office of Public Health Emergency Preparedness to coordinate Department-wide efforts.
HHS operating divisions work closely with states, providing specific performance measures and benchmarks, with semi-annual review of progress. HHS' Office of Inspector General is also increasing its activities to ensure proper accounting and expenditure of federal support.
In collaboration with the Department of Justice, CDC launched the "Forensic Epidemiology" course to train frontline public health, public safety and law enforcement professionals to conduct effective joint investigations.

Mental Health and Substance Abuse Preparedness has been enhanced at the State and Local level.

SAMHSA developed cooperative agreements with 35 States to enhance State-level capacity for a coordinated response to large-scale emergencies. These 2-year planning grants for about $100,000 annually are helping States with substance abuse and mental health preparedness, planning, training, technical assistance, and coordination. States are currently finalizing their plans for submission to SAMHSA.
In 2003, SAMHSA sponsored Creating a Roadmap for Disaster Preparedness: Strengthening State Capacity for Disaster Mental Health and Substance Abuse. Representatives of over 50 States and territories attended this meeting, which was followed by a series of six regional planning meetings for State and community-level agencies.
In October 2002, SAMHSA hosted a multi-State meeting, Forum for 9/11 State Disaster Relief Grantees. State teams could include mental health, substance abuse, emergency response, and community representatives. The meeting aimed to share State experiences and lessons learned, review programmatic findings and make recommendations.
In June 2003, SAMHSA released the comprehensive Mental Health All-Hazards Disaster Planning Guidance for use by States and local communities. In 2004, SAMHSA collaborated with the Office for Victims of Crime in the U.S. Department of Justice to produce Mental Health Response to Mass Violence and Terrorism: A Training Manual.

Other efforts.

CDC developed and issued performance standards for four classes of respirators for use in chemical, biological, radiological, and nuclear events, including one for self-contained breathing apparatus (SBA) respirators and one for full-face piece air-purifying (FFAP) respirators for occupational use by emergency responders.
Since 2002, CDC's Select Agent Program has registered over 400 entities that possess, use, or transfer select biological agents and toxins - agents that have the potential to pose a serious threat to public health and safety.

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Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.

Last Revised: February 21, 2006

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