HHS PUBLIC HEALTH EMERGENCY MEDICAL 

COUNTERMEASURE ENTERPRISE 

IMPLEMENTATION PLAN 

FOR CHEMICAL, BIOLOGICAL, 

RADIOLOGICAL AND NUCLEAR THREATS

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

OFFICE OF THE ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE

OFFICE OF PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES

APRIL 2007
DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Office of the Assistant Secretary for Preparedness and Response 

HHS PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES 

ENTERPRISE IMPLEMENTATION PLAN FOR CHEMICAL, BIOLOGICAL, 

RADIOLOGICAL AND NUCLEAR THREATS 

SUMMARY: 

The United States faces serious public health threats from the deliberate use of weapons of mass 

destruction (WMD) —chemical, biological, radiological, or nuclear (CBRN) —by hostile States 

or terrorists, and from naturally emerging infectious diseases that have a potential to cause illness 

on a scale that could adversely impact national security. Effective strategies to prevent, mitigate, 

and treat the consequences of CBRN threats is an integral component of our national security 

strategy. To that end, the United States must be able to rapidly develop, stockpile, and deploy 

effective medical countermeasures to protect the American people. The HHS Public Health 

Emergency Medical Countermeasures Enterprise (PHEMCE) has taken a holistic, end-to-end 

approach that considers multiple aspects of the medical countermeasures mission including 

research, development, acquisition, storage, maintenance, deployment, and guidance for 

utilization. Phase one of this approach established the HHS PHEMCE Strategy for Chemical 

Biological, Radiological and Nuclear Threats (HHS PHEMCE Strategy). The HHS PHEMCE 

Strategy, published in the Federal Register on March 20, 2007, described a framework of 

strategic policy goals and objectives for identifying medical countermeasure requirements and 

establishing priorities for medical countermeasure evaluation, development and acquisition. 

These strategic policy goals and objectives were used to establish the Four Pillars upon which 

this HHS Public Health Emergency Medical Countermeasures Enterprise Implementation Plan 

(HHS PHEMCE Implementation Plan) is based. The HHS PHEMCE Implementation Plan 

considers the full spectrum of medical countermeasures-related activities, including research, 

development, acquisition, storage/maintenance, deployment, and utilization. The HHS 

PHEMCE Implementation Plan is consistent with the President’s Biodefense for the 21st Century

and is aligned with the National Strategy for Medical Countermeasures against Weapons 

of Mass Destruction. 

FOR FURTHER INFORMATION CONTACT: 

Dr. Susan Coller, Policy Analyst, Office of Public Health Emergency Medical Countermeasures, 

Office of the Assistant Secretary for Preparedness and Response at 330 Independence Ave., SW., 

Room G640 Washington, DC 20201 or by phone: 202–260–1200. 

HHS PHEMCE APPROACH TO MEDICAL COUNTERMEASURES: 

The United States faces serious public health threats from the deliberate use of chemical, 

biological, radiological, or nuclear (CBRN) threat agents by hostile states or terrorists, and from 

naturally emerging infectious diseases that have the potential to cause illness on a scale that 

would impact national security. Within the Federal government, the mission of the Department 

of Health and Human Services (HHS) is to protect the civilian population by providing 

leadership in research, development, acquisition, deployment, and guidance for effective use of 

medical countermeasures for mitigation of CBRN events. This key role was identified in the 
National Strategy to Combat Weapons of Mass Destruction,1 Biodefense for the 21st Century,2

and the National Strategy for Medical Countermeasures against Weapons of Mass Destruction, 3

which together comprise the national blueprint for addressing CBRN defense. 

The HHS Public Health Emergency Medical Countermeasures Enterprise (HHS PHEMCE) leads 

the mission to develop and acquire medical countermeasures that will improve public health 

emergency preparedness as well as prevent and mitigate the adverse health consequences 

associated with CBRN and naturally occurring threats. HHS PHEMCE is a coordinated, intraagency effort led by the Office of the Assistant Secretary for Preparedness and Response (ASPR) 

and includes three HHS internal agencies: the Centers for Disease Control and Prevention 

(CDC), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH). 

Additionally, HHS PHEMCE collaborates with its ex officio members: the Department of 

Defense (DOD), the Department of Homeland Security (DHS), the Department of Veterans 

Affairs (VA) and other interagency stakeholders as appropriate. 

The HHS PHEMCE Implementation Plan for CBRN Threats addresses twelve biological threat 

agents, a class of chemical threats (volatile nerve agents) and radiological and nuclear threats. 

The medical countermeasure programs described will involve the full range of activities from 

research through advanced development, acquisition, storage, maintenance, deployment and 

utilization and will include all of the PHEMCE. However, the detailed focus of this Plan will be 

on the acquisition phase using the remaining funds available under Project BioShield, 

recognizing that significant efforts both upstream and downstream of the acquisition will be 

required to ensure the successful development, maintenance and utilization of these critical 

response assets, that may be needed in the event of a public health emergency. 

The HHS PHEMCE Implementation Plan for CBRN Threats excludes pandemic influenza, 

which is addressed in the HHS Pandemic Influenza Plan. The HHS Pandemic Influenza Plan

includes an overview of the threat of pandemic influenza, a description of the relationship of the 

HHS Pandemic Influenza Plan to other Federal plans, and an outline of key roles and 

responsibilities during a pandemic. It is aligned with the National Strategy for Pandemic 

Influenza, issued by President George W. Bush on November 1, 2005, and the Implementation 

Plan for the National Strategy for Pandemic Influenza, which guides the Nation's preparedness 

and response to an influenza pandemic. Significant progress has been made in the development 

and acquisition of medical countermeasures for pandemic influenza. Additional detailed 

information is available at www.pandemicflu.gov. 

CURRENT STATE OF MEDICAL COUNTERMEASURE PREPAREDNESS 

To date, HHS has significantly expanded national medical countermeasure preparedness utilizing 

significant investments from throughout the HHS PHEMCE, including NIH research and 

development; CDC Division of the Strategic National Stockpile (DSNS) acquisition, storage, and 

maintenance of medical countermeasures; and substantive technical and regulatory support 

provided by FDA to product developers. Funding support by the NIH for basic research, product 

development, and clinical research of CBRN medical countermeasures has increased 

 

1

 www.whitehouse.gov/news/releases/2002/12/WMDStrategy.pdf 

2

 www.whitehouse.gov/homeland/20040430.html 

3

 www.whitehouse.gov/news/releases/2007/02/20070207-2.html 

2
dramatically between Fiscal Year 2001 (FY 2001) to FY 2006. Funding for the DSNS has 

increased more than ten-fold in that same period, providing for the acquisition and stockpiling of 

medical countermeasures and supplies to protect the American public. Furthermore, the Project 

BioShield Act of 2004 (P.L. 108-276)4

 (Project BioShield) was enacted to accelerate the 

acquisition and availability of safe and effective medical countermeasures to protect the United 

States from CBRN threats. Project BioShield created a $5.6 billion Special Reserve Fund (SRF) 

for use over 10 years (FY 2004 – FY 2013) to acquire appropriate medical countermeasures for 

DSNS. 

During its first two years of implementation, Project BioShield acquisitions were guided by 

requirements derived from interagency deliberations in 2003 that involved Cabinet-level 

Departments and the Executive Office of the President. Under this initial strategy, HHS pursued 

acquisitions for those highest priority threats for which there were candidate products at 

relatively advanced stages of development and for which there were opportunities to have a 

significant impact on improving preparedness. These products included medical 

countermeasures for anthrax, smallpox, botulinum toxins, and radiological/nuclear agents - the 

four threat agents initially determined by DHS to pose a material threat to national security.5

 

Acquisitions under Project BioShield to date include the currently licensed anthrax vaccine, 

anthrax therapeutics (monoclonal and human immune globulin), a pediatric formulation of 

potassium iodide to protect against absorption of radioactive iodine, calcium and zinc 

diethylenetriaminepentaacetate (DTPA), chelating agents to treat ingestion of certain radiological 

particles, and botulinum antitoxin. 

Additional acquisitions of medical countermeasures for the DSNS have also provided a 

substantial preparedness level for a number of material threats. Specifically, DSNS inventory 

includes smallpox vaccine to immunize every American and Vaccinia Immune Globulin to treat 

complications that may arise from smallpox vaccination; anthrax therapeutics and a substantial 

level of antibiotics to provide treatment (thousands of doses) or prophylaxis (millions of doses) 

for bacterial threat agents anthrax, plague and tularemia; thousands of treatment courses of the 

chelating agent Prussian Blue (which mitigates internal absorption of cesium-137, a component 

of dirty bombs); enough potassium iodide tablets (which protects against radioactive iodine) for 

over one million people; thousands of courses of growth factors that could be useful for 

addressing the hematopoietic effects of acute radiation syndrome (ARS); CHEMPACKs (prepositioned antidotes for volatile nerve agent exposure) distributed throughout the country; and 

general supplies that will be required to treat the complex array of medical problems following a 

nuclear attack, including antibiotics, anti-nausea drugs, and large quantities of supplies to treat 

burn and blast injuries. Some of these stockpiled products are licensed, approved, or cleared by 

FDA for use as medical countermeasures. Others are investigational and would need to be used 

under an Investigational New Drug application or an Emergency Use Authorization6

. In 2002, 

DSNS began participating in the Shelf Life Extension Program (SLEP) with FDA. SLEP allows 

the extension of the expiration date of certain drugs in DSNS where adequate supporting data 

 

4

 http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=108_cong_public_laws&docid=f:publ276.108.pdf 5 The Project BioShield Annual Report to Congress July 2004 – July 2006 is available at 

http://www.hhs.gov/aspr/ophemc/bioshield/bioshieldreport/index.html 

6

 See http://www.FDA.gov for further information regarding the Investigational New Drug application and the 

Emergency Use Authorization 

3
exist, so that critical medical countermeasures that are still safe and effective can continue to be 

used. 

HHS has also acted to improve and strengthen the underlying national response capacity and 

distribution efficiency that is required to take full advantage of these stockpiled medical 

countermeasures. HHS has specifically worked to prepare public health systems for bioterrorism 

and other mass casualty incidents; expand America’s public health laboratory capacity, a crucial 

element in detecting and understanding any disease outbreak; expand and improve 

communications capacity within the public health structure to make public communications 

clearer and faster in an emergency; enhance food defense and safety activities at the FDA; 

expand the biodefense research program at NIH; and address response capacity for at-risk 

populations including children, pregnant women, senior citizens and other individuals who have 

special needs in the event of a public health emergency, as determined by the Secretary.7

DEVELOPMENT OF THE HHS PHEMCE IMPLEMENTATION PLAN FOR 

CHEMICAL, BIOLOGICAL, RADIOLOGICAL AND NUCLEAR THREATS 

HHS approached the development of the HHS PHEMCE Implementation Plan recognizing that 

the past investments outlined above have resulted in an armamentarium of medical 

countermeasures in DSNS that provides a substantial preparedness level for a number of CBRN 

threats. HHS recognizes that while it was important to achieve the current level of preparedness, 

it is equally as important to maintain and improve this capability. 

HHS PHEMCE has taken a holistic, end-to-end approach that considers multiple aspects of the 

medical countermeasures mission including research, development, acquisition, storage, 

maintenance, deployment, and guidance for utilization. Phase One of this approach established 

the HHS Public Health Emergency Medical Countermeasures Enterprise Strategy for Chemical 

Biological, Radiological and Nuclear Threats (HHS PHEMCE Strategy).8 The September 2006 

BioShield Stakeholders Workshop brought together stakeholders from all aspects of the mission 

to discuss the framework and approach for the HHS PHEMCE Strategy. The valuable input 

solicited from stakeholders at the Workshop, combined with the responses received to the 

medical countermeasures Request for Information issued in October 20069

 and through the 

Federal Register, was incorporated into the HHS PHEMCE Strategy.

The HHS PHEMCE Strategy, published in the Federal Register on March 20, 2007, described a 

framework of strategic policy goals and objectives for identifying medical countermeasure 

requirements and establishing priorities for medical countermeasure evaluation, development and 

acquisition. These strategic policy goals and objectives were used to establish the Four Pillars 

upon which this HHS PHEMCE Implementation Plan is based. 

 

7

 As defined in the Pandemic and All-Hazards Preparedness Act (P.L.109-417), which is available at 

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_cong_public_laws&docid=f:publ417.109.pdf 8

 Available at http://frwebgate.access.gpo.gov/cgibin/getdoc.cgi?dbname=2007_register&docid=%5bDOCID:fr20mr07-65 

9

 http://www.fbo.gov/servlet/Documents/R/589030 

4
Pillar One: Identify and assess CBRN threats. 

DHS leads the Federal response to National Response Plan incidents, conducts integrated 

assessments of the risks posed by CBRN agents, and issues Material Threat Determinations 

(MTDs) as to which CBRN pose a material threat sufficient to affect U.S. national security.10 

The Secretary of Homeland Security has issued MTDs for threat agents (Table 1) and has 

conducted Population Threat Assessments (PTA) to estimate the number of individuals who 

might be exposed to each of these threats in plausible, high-consequence scenarios. A 

Population Threat Assessment has been conducted for volatile nerve agents. 

In the future, additional MTDs may be issued if technology advances or if our understanding of 

the potential threats changes. The PHEMCE strategy is to have specific medical 

countermeasures that address each of the threats for which an MTD has been issued while also 

providing broad spectrum medical countermeasures to address as many as is practicable of those 

threats that did not rise to the level of an MTD. 

Table 1. Material Threat Determinations (MTDs) and Population Threat Assessment (PTAs) 

issued to date by the Department of Homeland Security 

Bacillus anthracis (ANTHRAX) Marburg virus (HEMORRHAGIC FEVER) 

Botulinum toxins (BOTULISM) Multi-drug resistant Bacillus anthracis (MDR ANTHRAX) 

Burkholderia mallei (GLANDERS) Radiological/Nuclear agents 

Burkholderia pseudomallei (MELIODOSIS) Rickettsia prowazekii (TYPHUS) 

Ebola virus (HEMORRHAGIC FEVER) Variola virus (SMALLPOX) 

Franciscella tularensis (TULAREMIA) Volatile nerve agents [PTA only] 

Junin virus (HEMORRHAGIC FEVER) Yersinia pestis (PLAGUE)

Pillar Two: Assess medical/public health consequences. 

The information supporting the MTDs and PTAs regarding population exposures from high 

consequence scenarios provided by DHS is used by HHS to inform subsequent medical and 

public health consequence assessments using multiple sources of information, including 

modeling. HHS uses modeling to help to explore potential outcomes when medical 

countermeasures are employed in operationally realistic timelines. The HHS assessments 

provide public health impact estimates for a given threat scenario and use of medical 

countermeasures for each threat agent. 

 

10 Material Threat Determinations are authorized under section 319 F-2(c)(2) of the Public Health Service Act, as 

added by section 3 of the Project BioShield Act and are a legally required precursor to procurements under that 

authority 

5
Pillar Three: Establish medical countermeasure requirements that incorporate 

assessments of current levels of preparedness, concepts of utilization, and 

product specifications. 

Our current state of preparedness and medical countermeasure requirements have been assessed 

for these fourteen CBRN threats. To establish medical countermeasure requirements for the top 

priority threat agents, HHS combines the threat prioritization and medical and public health 

consequence assessments, along with subject matter expert evaluations, domestic and 

international intelligence information, and information on current State, local and tribal response 

capabilities. 

Pillar Four: Identify and prioritize near-, mid-, and long-term development and 

acquisition programs, informed by assessment of the maturity of the 

product development pipeline and estimated costs. 

The mission to develop and acquire agent-specific medical countermeasures for the entire U.S. 

population for all fourteen threats and broad spectrum medical countermeasures against the 

remaining current and future threats encompasses a vast range of activities and dictates prioritysetting. The process for setting the priorities for the portfolio of investments ultimately outlined 

in this plan required careful consideration and deliberation. Specifically, HHS PHEMCE 

evaluated three possible approaches during the priority setting process. The first option was to 

focus only on a single, highest priority threat. In line with this, all available acquisition dollars 

would be spent trying to fully address the requirements for this one agent with the aim of 

eliminating it as a material threat to national security. The second option was to divide the 

available resources equally among the known fourteen threats. The third option, and the 

approach that the PHEMCE ultimately pursued, was to prioritize strategic policy decisions, 

framed by the HHS PHEMCE Strategy, which will most effectively improve overall public 

health preparedness. This decision-making process to set priorities included extensive discussion 

with Federal government subject matter experts11 and was guided by the principles of the 

National Strategy for Medical Countermeasures against Weapons of Mass Destruction. As a 

result, HHS has prioritized the medical countermeasures programs - including, research, 

development, and acquisition in the near-term, mid-term and long-term - that were determined to 

provide the greatest opportunities to improve public health emergency preparedness across the 

threat spectrum. 

The key elements that established the foundation for the priority-setting decisions were as 

follows: 

 

11 Including subject matter experts from HHS (CDC, FDA, and NIH), DOD, DHS, VA, and the respective HHS 

PHEMCE Chemical, Biologics, Radiological and Nuclear Working Groups. 

6
Prevention versus Mitigation and Treatment 

HHS has generally adopted a strategy of developing and acquiring medical countermeasures for 

post-event response to CBRN threats. Preventive measures are appropriate only for threats of 

such potential catastrophic consequence that a pre-event strategy will be examined in order to 

reduce vulnerability and mitigate post-event consequences. Therapeutics and diagnostics or the 

use of post-event prophylaxis will be the preferred strategy for all other threats. Priority will be 

placed on medical countermeasures that focus on post-event prophylaxis or post-exposure 

treatment.

Concept of Operations 

In alignment with the National Strategy for Medical Countermeasures against Weapons of Mass 

Destruction, HHS will prioritize the development and acquisition of medical countermeasures 

that are associated with an effective concept of operations (CONOPs). These CONOPs include a 

deployment strategy and utilization policy that is supportable by the present and future 

programmed distribution capabilities of Federal, State, local, and tribal public health emergency 

responders to rapidly ship and distribute critical items following a CBRN event. Within HHS, 

ASPR coordinates with the CDC Coordinating Office for Terrorism Preparedness and 

Emergency Response (COPTER) in determining processes, procedures, tactics, and techniques 

for how DSNS deploys countermeasures12 and the utilization strategies for those materials and 

medical countermeasures. ASPR’s Office of Preparedness and Emergency Operations (OPEO) 

works with its response partners, using event and response modeling, to outline how the current 

DSNS inventory will be used. These approaches are exercised with interagency partners to 

ensure that the plans are based on realistic and achievable timelines. 

The CONOPs for a particular threat scenario and medical countermeasure are a crucial 

component in setting specific product requirements and contribute directly to the acquisition 

strategy. While there is much in common in medical countermeasure development for civilian 

and military medical countermeasures, CONOPs for HHS and DOD, respectively, have 

differences which must be considered in the requirements and acquisitions processes. HHS is 

committed to continuing to work with all its emergency responder partners to improve public 

health response capabilities. 

Broad Spectrum Medical Countermeasures and Platform Technologies 

A fixed defense13 or “one-bug, one-drug” approach for medical countermeasure development is 

determined to be effective and viable for some of the highest priority threats such as smallpox 

and anthrax. As the list of material threats increases, and technology advances, HHS will be 

focusing its medical countermeasure research, development and acquisition efforts on broad 

spectrum and platform approaches. 

 

12 The authority of the Secretary of HHS to deploy the SNS is codified at 42 U.S.C. § 247d-6b. 13 Relman DA. Bioterrorism – Preparing to Fight the Next War, NEJM, 2006, 354(2):113-115. In the context of 

defense against biological threats, a fixed defense is a medical countermeasure intended for use against a specific 

organism and not useful in scenarios that employ a different organism. 

7
Preparing for New Threats 

In order to address emerging, enhanced, and advanced threats14, HHS will be investing in 

research and development on innovative approaches and platform technologies15. These 

technologies will facilitate rapid identification and characterization of novel threat agents, 

thereby creating the capability to rapidly produce relevant medical countermeasures. This policy 

is aligned with the National Strategy for Medical Countermeasures against Weapons of Mass 

Destruction which targets the use of existing, proven approaches for developing medical 

countermeasures to address challenges posed by traditional CBRN agents while calling for a 

flexible capability to develop new medical countermeasures. These latter activities emphasize 

the need to capitalize upon the development of innovative and future technologies that will 

enhance our ability to respond swiftly and effectively to potential, emerging, and future unknown 

CBRN threats. This will require targeted, balanced, and sustained investments to support 

fundamental basic research to discover new technologies and update platforms as well as applied 

research for technology development to deliver new medical capabilities and countermeasures. 

TOP PRIORITY MEDICAL COUNTERMEASURE RESEARCH, DEVELOPMENT, 

AND ACQUISITION PROGRAMS TO INCREASE PUBLIC HEALTH EMERGENCY 

PREPAREDNESS 

Following the principles and processes described above, HHS has assessed the top priority 

CBRN threats from a medical countermeasure perspective and has developed medical 

countermeasure acquisition priorities for the near-term (FY 2007 – FY 2008), the mid-term (FY 

2009 – FY 2013), and, in less detail, the long-term (beyond FY 2013)16. This prioritization 

spans the CBRN threat spectrum and best utilizes available resources in addressing the highest 

priority threats to maximize risk mitigation. Table 2 arrays the top priority medical 

countermeasure programs against the specific threat agents addressed by the program. The broad 

spectrum antibiotic, broad spectrum antiviral, and diagnostics programs address multiple threat 

agents, while other programs are, of necessity, agent-specific. 

Medical countermeasure requirements are based primarily on the number of persons exposed to 

clinically significant levels of a threat agent in a single-event, plausible, high- consequence 

scenario. In setting appropriate targets for an acquisition program, a number of factors in 

addition to the single event, exposure-based medical countermeasure requirement could be 

considered, including: 

• Multiple events 

 

14 As defined in the National Strategy for Medical Countermeasures against Weapons of Mass Destruction: 

Enhanced Agents are traditional agents that have been modified or selected to enhance their ability to harm human 

populations or circumvent current countermeasures, such as a bacterium that has been modified to resist antibiotic 

treatment; Emerging Agents are previously unrecognized pathogens that might be naturally occurring and present a 

serious risk to human populations, such as the virus responsible for Severe Acute Respiratory Syndrome (SARS); 

and Advanced Agents are novel pathogens or other materials of biological nature that have been artificially 

engineered in the laboratory to bypass traditional countermeasures or produce a more severe or otherwise enhanced 

spectrum of disease. 

15 Examples of platform technologies include strategies that permit rapid commercial scale production of threatspecific countermeasures or expression systems that permit rapid production of new vaccines. 16 SRF that supports Project BioShield released $3.4 billion for use between FY 2004-2008 and the remaining $2.2 

billion will be available for use between FY 2009-2013. 

8
• Citizens concerned about exposure17

• The lack of availability of rapid, point-of-care diagnostics 

• Potential nationwide demand after a single large-scale event 

• Pre-positioning of individual medical countermeasures to meet specific response time 

requirements 

• Economies of scale for production18

• Providing a target acquisition size sufficient to drive industrial development of the 

medical countermeasure. 

HHS will continue to coordinate medical countermeasure development and acquisition efforts 

with DOD; however, separate development and acquisition programs may be necessary in 

situations where military requirements differ from civilian requirements, including with regard to 

concepts of use of particular countermeasures. Consistent with the National Strategy for Medical 

Countermeasures against Weapons of Mass Destruction, the Secretary of Health and Human 

Services is tasked with civilian medical countermeasure preparedness, and it is National policy 

that “the Secretary of Defense shall retain the exclusive responsibility for research, development 

and acquisition of medical countermeasures to prevent or mitigate the health effects of WMD 

threats [...] to the Armed Forces.19 

 

17 Non-exposed population seeking medical care for non-specific symptoms or concerns about exposure. 

18 A production process in which an increase in the number of units produced causes a decrease in the average cost

of each unit. 

19 www.whitehouse.gov/news/releases/2007/02/20070207-2.html 

9
Table 2. CBRN Threats and Projected Future Top Priority Medical Countermeasure Programs 

PROJECTED FUTURE TOP PRIORITY

MEDICAL COUNTERMEASURE (MCM) PROGRAMS

Anthrax antitoxin(s) Anthrax vaccine ARS/DEARE MCM(s) Biodosimetry, Bioassay Broad spectrum antibiotic(s) Broad spectrum antiviral(s) Diagnostics Enterprise CHEMPACKs Filovirus MCM(s) Radionuclidespecific agent(s) Smallpox antiviral(s) Smallpox vaccine Volatile nerve agent single antidote 

Bacillus anthracis 

ANTHRAX

Multi-drug resistant 

Bacillus anthracis 

MDR ANTHRAX

   

Botulinum toxins 

BOTULISM 

Burkholderia mallei GLANDERS 

Burkholderia 

pseudomallei 

MELIOIDOSIS

 

Filoviruses 

(Ebola and Marburg) 

HEMORRHAGIC FEVER

  

Francisella tularensis TULAREMIA  

Junin virus 

ARGENTINE HEMORRHAGIC 

FEVER

 

Radiological/nuclear 

agents   

Rickettsia prowazekii TYPHUS  

Variola virus 

SMALLPOX    

Volatile nerve agents  

TOP PRIORITY CBRN THREATS (LISTED ALPHABETICALLY)

Yersinia pestis 

PLAGUE  

 

10
STRATEGIES FOR ADDRESSING HIGH PRIORITY MEDICAL 

COUNTERMEASURES 

Research and Development 

NIH is the lead agency within the Federal Government for conducting and supporting biomedical 

research relating to causes, diagnosis, treatment, control, and prevention of diseases. NIH will 

align research and development efforts with the PHEMCE priority medical countermeasure 

programs. In addition, NIH will support Research and Development for next-generation 

products to replace currently-held medical countermeasures in DSNS, as needed. These next 

generation products include medical countermeasures with broad spectrum activity against a 

wide variety of threat agents; broad spectrum technologies that enhance effectiveness of multiple 

classes of medical countermeasures; and broad spectrum platforms that permit more rapid 

generation of required medical countermeasures. Continued research and development efforts 

will ensure a sustainable, continuous stream of promising medical countermeasures in the 

pipeline that are aligned with top priority HHS PHEMCE requirements for future acquisitions 

and/or replacement of DSNS inventory. NIH’s long-term focus is on platform technologies and 

broad spectrum medical countermeasures that will allow for the rapid introduction of additional 

response capabilities for emerging infectious agents. 

Advanced Development20

The use of advanced development efforts that support multiple candidates for each medical 

countermeasure need is a key element to mitigating risk in the Project BioShield acquisition 

phase of the product development pathway. The Pandemic and All-Hazards Preparedness Act 

(P.L. 109-417) established the Biomedical Advanced Research and Development Authority 

(BARDA). Utilizing those tools, HHS plans to promote innovation, reduce risk to both medical 

countermeasure developers and the Government, and invest in medical countermeasure advanced 

development that will carry products through the crucial middle phase21 of drug development 

between basic research and acquisition of final products. HHS anticipates that available funding 

through these authorities, in FY 2007 and beyond, will be aligned with the highest priority 

medical countermeasure development programs. Finally, Advanced Development activities will 

depend on congressional approval of the President's FY 2008 budget request of $189 million. 

The future funding levels for BARDA remain to be determined. 

PROJECTED ACQUISITIONS 

The HHS PHEMCE will consider opportunities for acquiring medical countermeasures using 

both DSNS appropriations as well as SRF monies under Project BioShield. Acquisitions under 

DSNS will be limited to commercially available products. Current funding levels were 

considered in projecting acquisition forecasts. While BARDA funding has been established to 

support the advanced development of medical countermeasures, Project BioShield acquisition 

 

20 The Pandemic and All-Hazards Preparedness Act (P.L.109-417) definition of advanced research and 

development: “with respect to a product that is or may become a qualified countermeasure or a qualified pandemic 

or epidemic product, activities that predominantly are conducted after basic research and preclinical development of 

the product; and are related to manufacturing the product on a commercial scale and in a form that satisfies the 

regulatory requirements under the Federal Food, Drug, and Cosmetic Act or under section 351 of this Act.” 21 Often referred to as the “Valley of Death.” 

11
contracts may still include late-stage development costs for scale-up manufacturing, clinical 

trials, and pivotal animal efficacy studies, in addition to final production and delivery. 

The near-term is defined as FY 2007 – FY 2008, which is the time frame of allocation of 

approximately half of the Project BioShield SRF. The mid-term is defined as FY 2009 – FY 

2013, which is the remainder of the ten year duration of the Special Reserve Fund. Medical 

countermeasures will be procured in the near-term and mid-term using both the SRF as well as 

from the DSNS appropriations. During the near-term, HHS also will pursue acquiring a number 

of medical countermeasures for which utilization of the Project BioShield Special Reserve Fund 

has been approved, but for which funds have not yet been fully obligated. 

Table 3 summarizes the proposed near-term and mid-term acquisitions for the priority medical 

countermeasures. In some cases, the estimated funding ranges indicated are based on identified 

potential medical countermeasure candidates currently under development; whereas in other 

cases the estimated ranges are based on industry standard information for vaccine and drug 

development costs. Descriptions of the acquisitions for priority medical countermeasures follow 

Table 3. 

12
Table 3. Proposed Near-Term and Mid-Term Acquisitions for High Priority Medical 

Countermeasures to Address CBRN Threat Agents 

Near-Term 

(FY 2007-08)

Mid-Term 

BIOLOGICAL THREATS (FY 2009-13)

Funding 

Source 

Funding 

Level1

Funding 

Source 

Funding 

Level1, 2

Diagnostics SRF X

Broad spectrum antibiotic(s) DSNS X DSNS, 

SRF X, XX

Anthrax antitoxin(s) SRF XX

Anthrax vaccine(s) SRF XX

Medical Countermeasure(s) for Filoviruses SRF XX

Smallpox antiviral(s) SRF X

Smallpox vaccine SRF XX

Near-Term 

(FY 2007-08)

Mid-Term RADIOLOGICAL and NUCLEAR (FY 2009-13)

THREATS Funding 

Source 

Funding 

Level1

Funding 

Source 

Funding 

Level1,2

Medical Countermeasure(s) for ARS/DEARE SRF XX SRF XX

Biodosimetry, Bioassay SRF‡ X

Radionuclide-specific agent(s) SRF X

Near-Term 

(FY 2007-08)

Mid-Term 

CHEMICAL THREATS (FY 2009-13)

Funding 

Source 

Funding 

Level1

Funding 

Source 

Funding 

Level1,2

Enterprise CHEMPACKs DSNS XX

KEY 

DSNS Anticipated to be funded through the CDC Division of the Strategic National Stockpile budget, 

 pending availability of funds. 

SRF Anticipated Project BioShield Special Reserve Fund acquisition with remaining available funds.

SRF‡ While the diagnostics portion of this requirement may be funded through the Project BioShield 

Special Reserve Fund, appropriate funding to establish the network of biodosimetry and 

radionuclide bioassay laboratories is yet to be determined.

X Currently estimated to be less than or equal to $100 million3 

XX Currently estimated to be greater than $100 million3 

1 Funding is cumulative within the time period indicated. 

2

 Uncertainties in funding support throughout the pipeline in the mid-term preclude making more 

 definitive projections. 

3

 These estimates are not final. Funding levels are subject to change. 

13
 

PROJECTED NEAR-TERM 

(FY 2007 – FY 2008) 

Medical Countermeasure Development and Acquisition Programs 

to Enhance Preparedness 

PROGRAMS FOR BIOLOGICAL THREATS 

Broad Spectrum Antibiotic(s)

MTD: BACILLUS ANTHRACIS AND MULTI-DRUG RESISTANT BACILLUS ANTHRACIS, BURKHOLDERIA MALLEI,

BURKHOLDERIA PSEUDOMALLEI, FRANCISCELLA TULARENSIS, RICKETTSIA PROWAZEKII, YERSINIA PESTIS.

Many of MTDs address bacterial species that can be treated using antibiotics. Broad spectrum 

antibiotics, therefore, will continue to be a critical component of strategy HHS will take to 

maintain and improve public health preparedness. For each biological threat agent or class of 

agents, however, there is a limited array of antibiotics with demonstrated efficacy. In the nearterm, HHS will continually evaluate the antibiotics in the DSNS and, as needed, will acquire 

commercially available antibiotics using DSNS appropriations. 

Anthrax Vaccine(s) 

MTD: BACILLUS ANTHRACIS, MULTI-DRUG RESISTANT BACILLUS ANTHRACIS.

Antibiotics represent the first line of defense to protect the nation following an anthrax attack. 

However, anthrax vaccines are also an essential element of our national preparedness. Vaccines 

may be given as post-exposure prophylaxis in combination with antibiotics to potentially provide 

longer-term protection; this combination may also allow for a reduction in the duration of the 

antibiotic regimen. Vaccines can also provide pre-event protection to the relatively small 

population that is at high risk of frequent occupational exposure to Bacillus anthracis. 

 

In December 2006, a contract for the development and acquisition of a recombinant Protective 

Antigen (rPA) anthrax vaccine was terminated by HHS; however, the Department remains 

committed to acquiring next-generation anthrax vaccines that will be part of a balanced and 

diversified portfolio of medical countermeasures. HHS has developed a comprehensive strategy 

for advanced development and acquisition of current and next generation anthrax vaccines and 

anticipates that these activities will be pursued in the near-term. 

Smallpox Vaccine(s) 

MTD: VARIOLA VIRUS.

HHS has made significant progress in providing smallpox vaccine to the DSNS. In addition, a 

requirement has been established for a smallpox vaccine to protect immunocompromised persons 

for whom use of the existing smallpox vaccines is medically contraindicated in the absence of 

smallpox exposure. 

One candidate next-generation smallpox vaccine, modified vaccinia Ankara (MVA), is based on 

a strain of the vaccinia virus that, in contrast to current smallpox vaccines such as Dryvax, does 

not replicate effectively in human cells and, therefore, may cause fewer side effects. The MVA 

development programs were supported by the National Institute of Allergy and Infectious 

Diseases (NIAID) with milestone-driven contract awards in 2003 and 2004. HHS is welladvanced in the pre-award stage of an MVA vaccine acquisition program. 

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PROGRAMS FOR RADIOLOGICAL and NUCLEAR THREATS 

ARS/Hematopoietic Syndrome Medical Countermeasure(s) 

MTD: RADIOLOGICAL/NUCLEAR AGENTS.

HHS regards radiological and nuclear agents as a significant threat to national security and is 

committed to purchasing safe and efficacious medical countermeasures to treat Acute Radiation 

Syndrome (ARS). In March 2007, HHS withdrew the ARS RFP because it was determined, after 

extensive scientific and technical expert evaluation, that no competing offeror had a product that 

met USG requirements for a Project BioShield acquisition. HHS will continue to pursue an 

initial acquisition of a safe and effective medical countermeasure to treat ARS. In moving 

forward to meet this goal, HHS will make use of scientific developments that have occurred 

since the previous RFP closed, as well as new authorities provided by the Pandemic and AllHazards Preparedness Act that could accelerate the advanced development of promising 

countermeasures. 

 

HHS supports further development of the radiological and nuclear medical countermeasure 

pipeline. The NIAID’s Radiation Countermeasures Research Program has funded numerous 

projects, including: ARS medical countermeasure screening programs in cell-based and rodent 

models at multiple institutions around the country; development of three Good Laboratory 

Practices (GLP) animal testing facilities to evaluate the efficacy of medical countermeasures 

against ARS; eight Centers for Medical Countermeasures against Radiation at academic 

institutions around the country; and intramural research programs at the DOD Armed Forces 

Radiobiology Research Institute (AFRRI) and the National Cancer Institute. 

PROJECTED MID-TERM 

(FY 2009 – FY 2013) 

Medical Countermeasure Development and Acquisition Programs 

to Enhance Preparedness 

HHS will pursue the following medical countermeasure acquisitions in the mid-term using the 

remaining SRF and pending availability of other funding for those acquisitions that do not use 

the SRF. These anticipated acquisitions are also predicated on the availability of products at the 

appropriate developmental stage that meet U.S. Government civilian requirements. 

PROGRAMS FOR BIOLOGICAL THREATS 

The ideal medical countermeasures for biological agents will be highly effective for postexposure prophylaxis as well as early symptomatic treatment, will display an excellent safety 

profile and could be easily self-administered.

Broad Spectrum Antibiotic(s) 

MTD: BACILLUS ANTHRACIS, MULTI-DRUG RESISTANT BACILLUS ANTHRACIS. BURKHOLDERIA MALLEI,

BURKHOLDERIA PSEUDOMALLEI, FRANCISELLA TULARENSIS, RICKETTSIA PROWAZEKII, YERSINIA PESTIS. 

In addition to the near-term strategy for acquisition of commercially available antibiotics, HHS 

anticipates maintaining a robust basic research and development program along with advanced 

development for broad spectrum antimicrobials that will specifically provide support for 

15
regulatory approval for clinical indications that address bacterial agent MTDs. In order to better 

balance antimicrobial DSNS holdings in light of newer MTDs, HHS will pursue a potential 

acquisition of additional broad spectrum antimicrobials in the mid-term. 

Diagnostics (Point-of-Care) 

MTD: ALL BIOLOGICAL THREAT AGENTS.

Following a terrorist event, clinical diagnostic assays (in vitro diagnostics, IVDs) are critical 

tools for distinguishing infected (symptomatic) individuals needing treatment from potentially 

exposed but asymptomatic individuals needing post-exposure prophylaxis. Overall, the 

requirements for diagnostic assays to facilitate a response to a bioterrorism event will focus on 

rapid, point-of-care assays. Rapid triaging of the symptomatic patients will be required to 

provide, as necessary, treatment, isolation and implementation of universal precautions for 

infectious diseases and may also be useful in the allocation of limited critical therapeutic 

materials to only those patients in need. Multiplexed, adaptive platforms that confer flexibility, 

offer alternative commercial opportunities, and allow for the rapid introduction of additional 

tests for emerging infectious agents are highly desired. 

These IVDs used for clinical purposes are distinguished from detection assays used for 

environmental samples (air, water, food, surface swabs) in that they are required to be approved 

or cleared by the FDA. To date, limited incentives have been available to sustain commercial 

market production of IVDs; however, once specific requirements in this area are developed and 

prioritized, HHS will pursue a potential mid-term acquisition of biological agent diagnostics to 

enhance public health preparedness capability. 

Anthrax Antitoxin 

MTD: BACILLUS ANTHRACIS, MULTI-DRUG RESISTANT BACILLUS ANTHRACIS.

The primary mortality and morbidity of anthrax disease is mediated through toxins produced by 

the bacteria, B. anthracis. Antibiotics (currently within DSNS) target the B. anthracis bacteria 

itself; while vaccines (discussed under Near-Term Acquisitions) provide long-term protection 

from disease. Antitoxins are required to neutralize the effects of the toxins and may contribute to 

a more successful therapeutic outcome. Given the current status of anthrax antitoxins and animal 

model development, HHS will continue its phased acquisition program and will pursue a midterm acquisition of additional anthrax antitoxin to allow HHS to more fully meet medical 

countermeasure requirements, including to address the threat from MDR anthrax. 

Filovirus Medical Countermeasure(s)

MTD: EBOLA VIRUS, MARBURG VIRUS.

Infection with filoviruses produces an aggressive disease that is highly lethal. Currently, no 

FDA-approved filovirus-specific medical countermeasures exist. An antiviral is preferred to 

treat infected patients and to provide pre-exposure prophylaxis to health care workers and 

personal contacts. A vaccine will be useful for civilian populations if it provides rapid onset of 

protective immunity. HHS will continue to invest in research and development and will pursue 

an acquisition for filovirus medical countermeasures in the mid-term. 

16
Smallpox Antiviral 

MTD: VARIOLA VIRUS.

Currently there is no treatment available for smallpox disease once the symptoms manifest. An 

effective antiviral treatment could mitigate the effects of smallpox disease. It is likely that such 

an antiviral may also be effective against other pox viruses. Given the current status of the most 

advanced products as well as the status of animal model development, HHS will pursue a midterm acquisition of a smallpox antiviral for the treatment of smallpox. The ideal antiviral will be 

highly effective post-exposure as well as an effective treatment early in the symptomatic phase 

of the disease. 

PROGRAMS FOR RADIOLOGICAL and NUCLEAR THREATS 

ARS/DEARE Medical Countermeasure(s) 

MTD: RADIOLOGICAL/NUCLEAR AGENTS.

Acute Radiation Syndrome (ARS) often called radiation sickness, results when humans are 

exposed to a large dose of ionizing radiation. ARS develops in the timeframe of hours to weeks, 

and the Delayed Effects of Acute Radiation Exposure (DEARE) injury in weeks to months 

following radiation exposure. HHS will pursue one or more ARS/DEARE medical 

countermeasure acquisition(s) in the mid-term to continue the phased acquisition strategy 

launched in the near-term. 

Biodosimetry and Bioassay 

MTD: RADIOLOGICAL/NUCLEAR AGENTS.

Biodosimetry and radionuclide bioassay capabilities are essential for medical management of 

ARS/DEARE following acute radiation exposure and are integral to triage and management 

processes. HHS anticipates that rapid biodosimetry assays for on-scene triage should be 

available for acquisition in the mid-term. A system of biodosimetry and radionuclide bioassay 

laboratories is also proposed to increase overall national capacity. While the diagnostics portion 

of this requirement may be funded through the Project BioShield SRF, appropriate funding to 

establish this laboratory network is yet to be determined. 

Radionuclide-Specific Medical Countermeasure(s) 

MTD: RADIOLOGICAL/NUCLEAR AGENTS.

Radionuclide-specific medical countermeasures are a key component to managing the medical 

consequences of radiation dispersal device (RDD) events, both explosive and non-explosive, as 

well as nuclear power plant events. In the near term, HHS will continue to fund the development 

of improved formulations of diethylenetriaminepentaacetate (DTPA) and other novel 

decorporating agents that remove radioactive particles from the body. If continued progress is 

made on the radionuclide-specific countermeasures currently under development, it is 

conceivable that oral formulations of DTPA (which would considerably ease the logistical 

requirements for rapid delivery of this medical countermeasure) and/or other novel decorporating 

agents could be available for acquisition in the mid-term. 

17
PROGRAMS FOR CHEMICAL THREATS 

Enterprise CHEMPACKs 

PTA: VOLATILE NERVE AGENTS.

The CHEMPACK program is an ongoing initiative of the DSNS, begun in 2003, that provides 

antidotes (three countermeasures used concomitantly) to volatile nerve agents for pre-positioning 

by State, local, and/or tribal officials throughout the U.S. In its current form, the program will 

receive continued funding in the near-term for procurement and fielding of additional 

CHEMPACKs, replacement of expired product, and administrative support. The proposed 

Enterprise CHEMPACK program would build upon the existing system, improving it by adding 

an education, training and exercise component and by optimizing the pre-positioning of 

antidotes. In the near- term, HHS will begin performing the operations analysis that is 

prerequisite to such improvements. It is anticipated that acquisition of some next-generation 

replacement products and the implementation of changes to improve the program could occur in 

the mid-term, pending availability of DSNS funds.

PROJECTED LONG-TERM 

(Beyond FY 2013) 

Medical Countermeasure Development and Acquisition Programs 

to Enhance Preparedness 

PROGRAM FOR BIOLOGICAL THREATS 

Broad Spectrum Antiviral(s) 

MTD: EBOLA VIRUS, JUNIN VIRUS, MARBURG VIRUS, VARIOLA VIRUS. 

Three families of viruses are represented among the existing MTDs: Poxviridae (variola virus), 

Filoviridae (Ebola and Marburg viruses), and Arenaviridae (Junin virus). These different viral 

families have diverse biological and pathological characteristics and cause unique diseases in 

humans. All of these viruses can be disseminated via aerosolization, a feature which enhances 

their potential use as bioterrorism agents. There are no approved antiviral drugs available for 

either post-exposure prophylaxis or for therapeutic use for any of these viral diseases. Overall, 

the development of broad spectrum medical countermeasures that can address several threat 

agents would maximize the efficiency and flexibility of the DSNS, thereby reducing storage and 

maintenance costs. HHS will prioritize research and development funding in this area in the 

near- and mid-terms. Due to its relative immaturity in the development pipeline, it is unlikely 

that a broad spectrum antiviral will be acquisition-ready until after FY 2013. 

PROGRAM FOR CHEMICAL THREATS 

Volatile Nerve Agent Single Antidote 

PTA: VOLATILE NERVE AGENTS. 

The optimal medical defense against volatile nerve agents would be a single, rapidly effective 

countermeasure that could be used, for example, via intranasal or inhaled routes and by untrained 

persons at risk or by first responders dealing with large numbers of exposed individuals. HHS 

will continue research and development funding in this area in the near- and mid-terms. Given 

18
the current immature status of the development pipeline, a single antidote for volatile nerve 

agents would likely not be available for acquisition until the long-term timeframe. 

CONCLUSION: 

This HHS PHEMCE Implementation Plan identifies top priorities for medical countermeasure 

research, development and acquisition programs that HHS has determined, in collaboration with 

interagency partners, to have the greatest potential to improve public health emergency 

preparedness. It is anticipated that this plan will be reviewed at least biennially to encompass 

potential changes in assessments of the threat, consequences (particularly with regard to the 

evolution of CONOPs), and maturity of the medical countermeasure development pipeline. 

The prioritization of medical countermeasure programs described in this HHS PHEMCE 

Implementation Plan represents the current thinking of HHS informed by material threat 

determinations, population threat assessments, or the assessments of medical and public health 

consequences. DHS is conducting an integrated CBRN threat assessment, to be completed in 

June 2008 that will further inform the next version of the HHS PHEMCE Implementation Plan. 

Additionally, future versions are anticipated to incorporate more detailed assessments of 

potential multipliers of medical countermeasure requirements, based on the potential for 

enhanced, emerging, or advanced biological agents, multiple and simultaneous CBRN events and 

other factors informed by scientific and threat analysis. As State, local, and tribal medical 

countermeasure delivery capabilities and event response planning evolve, they will also open 

new flexibilities with respect to the types of medical countermeasures that can be incorporated 

into Federal planning efforts, and will influence HHS assessments of potential medical and 

public health consequences following CBRN events. 

The development and acquisition strategies to most effectively improve preparedness resulted 

from critical evaluation of the status of medical countermeasure development pipelines. HHS 

recognizes that developing, acquiring, and utilizing medical countermeasures to prepare for and 

respond to CBRN events requires significant resources and unprecedented cooperation among 

many stakeholders, including Federal counterparts outside HHS; private industry (domestic and 

international); State, local and tribal governments; first responders and healthcare workers; 

academia; and the public. HHS will build upon its 2006 RFI for medical countermeasures 

against CBRN threats, including the technology readiness levels (TRLs) defined in that RFI, to 

continue to explore new, more efficient ways to reach out to the academic and medical 

countermeasure development communities to ensure that future versions of the HHS PHEMCE 

Implementation Plan are informed by the latest breakthroughs in the field. 

In addition, while this HHS PHEMCE Implementation Plan focuses on the further enhancement 

of public health emergency preparedness, HHS is simultaneously evaluating the costs and 

benefits associated with the mid- and long-term maintenance of existing and projected stockpiles 

of medical countermeasures. HHS anticipates that such an evaluation will be detailed in a future 

version of the HHS PHEMCE Implementation Plan. 

Finally, Advanced Development activities will depend upon congressional approval of the 

President's FY 2008 budget request and will increase the chance of programmatic success. 

Through the Pandemic and All-Hazards Preparedness Act, HHS now has the authority to 

19
promote innovation, increase the potential for success for both medical countermeasure 

developers and the Government, and invest in medical countermeasure advanced development 

that will carry products across the so-called “Valley of Death” to meet medical countermeasure 

requirements. It is anticipated that future versions of the HHS PHEMCE Implementation Plan

will more fully incorporate implementation of these authorities and funding levels that may be 

appropriated in support of the robust advanced development programs that are critical to mission 

success. 

The prioritization of medical countermeasures to improve public health preparedness reflected in 

this HHS PHEMCE Implementation Plan was an interagency process led by HHS and involving 

significant collaboration with DHS, DOD, VA, and others. The HHS PHEMCE Implementation 

Plan has also benefited tremendously from the information provided by Stakeholders, 

particularly at the BioShield Stakeholders Workshop held in September 2006, and from the many 

formal comments received in response to the Federal Register notice of the draft HHS PHEMCE 

Strategy. Notice of the issuance of this HHS PHEMCE Implementation Plan will be posted in 

the Federal Register and HHS welcomes comments from stakeholders. 

The HHS PHEMCE Implementation Plan will be a feature of the upcoming HHS Public Health 

Emergency Medical Countermeasures Enterprise Stakeholders Workshop to be held in 

Washington, DC, July 31 – August 2, 2007. HHS is committed to improving transparency and 

continuing to find the most appropriate venues to work with stakeholders who are likewise 

committed to meeting the goals of this critical mission of preparing the nation for the adverse 

health consequences of public health emergencies. 

Improving preparedness will be an ongoing process as science advances, innovations mature, and 

the threat scope changes. HHS resources beyond the SRF, when it ends in FY 2013, will 

continue to be strategically invested in programs throughout the medical countermeasure 

development and acquisition pipeline to achieve this goal. It is anticipated that targets for the 

timeframe beyond FY 2013 will be articulated with increasing clarity and granularity with each 

successive revision of the HHS PHEMCE Implementation Plan. 

Finally, to successfully execute the program objectives outlined in the HHS PHEMCE 

Implementation Plan for Chemical, Biological, Radiological and Nuclear Threats, ASPR will 

strengthen and build upon its achievements to develop, recruit, and support a world-class 

workforce. To realize this goal, ASPR will intensify its efforts to attract and expedite hiring of 

qualified candidates; focus and align training, education, and career development; recognize staff 

accomplishments; and foster learning and growth with improved knowledge management. 

_______________________________ 

Gerald Parker, DVM, Ph.D., MS 

Principal Deputy Assistant Secretary 

Office of the Assistant Secretary for Preparedness and Response 

Department of Health and Human Services 

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