[Federal Register Volume 71, Number 174 (Friday, September 8, 2006)]
[Notices]
[Pages 53097-53102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14908]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Office of Public Health Emergency Preparedness; Draft HHS Public 
Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy 
for Chemical, Biological, Radiological and Nuclear (CBRN) Threats \1\
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    \1\ This Strategy excludes pandemic influenza which is addressed 
in the HHS Pandemic Influenza Plan, a blueprint for pandemic 
influenza preparation and response. It provides guidance to 
national, state, and local policy makers and health departments. The 
HHS Pandemic Influenza Plan includes an overview of the threat of 
pandemic influenza, a description of the relationship of this 
document 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 Bush November 
1, 2005, and the Implementation Plan for the National Strategy for 
Pandemic Influenza which guide our nation's preparedness and 
response to an influenza pandemic.
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AGENCY: Office of Public Health Emergency Preparedness.

ACTION: Draft HHS Public Health Emergency Medical Countermeasures 
Enterprise (PHEMCE) Strategy for Chemical, Biological, Radiological and 
Nuclear (CBRN) Threats.

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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 ultimate goal of 
this HHS Public Health Emergency Medical Countermeasures Enterprise 
Strategy (PHEMCE Strategy) is to establish the foundational elements 
and guiding principles that will support medical countermeasure 
availability and utilization for the highest priority CBRN threats 
facing our nation.

DATES: The public is invited to submit comments on the draft HHS PHEMCE 
Strategy up to thirty days from the date of publication in the Federal 
Register. After consideration of the comments submitted, HHS will issue 
a final PHEMCE Strategy.
    Comments: Address all comments to Dr. Susan Coller at 
[email protected].

FOR FURTHER INFORMATION CONTACT: Dr. Susan Coller, Policy Analyst, 
Office of Public Health Emergency Medical Countermeasures, Office of 
Public Health Emergency Preparedness at 330 Independence Ave., SW., 
Room G640 Washington, DC 20201, or by phone at 202-260-1200.

Overview

    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. A failure to anticipate these threats, or the lack 
of a capacity to effectively respond to them could leave an untold 
number of Americans dead or permanently disabled. Thus, effective 
strategies to prevent, mitigate, and treat the consequences of CBRN 
threats are 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 (MCM) to protect the 
American people.
    The key role for development and acquisition of effective medical 
countermeasures for WMD was previously identified in the National 
Strategy to Combat Weapons of Mass Destruction and Biodefense for the 
21st Century, the President's blueprint for addressing the nation's 
biodefense programs. Research and early development support of CBRN MCM 
by the National Institutes of Health has grown from $53 million in 
Fiscal Year (FY) 2001 to $1.8 billion in FY 2006. Funding for the 
Strategic National Stockpile similarly has grown from $52 million in 
FY01 to $530 million in FY06. Furthermore, on July 21, 2004, President 
George W. Bush signed into law the Project BioShield Act of 2004 
(Project BioShield) to accelerate the research, development, 
acquisition, and availability of effective medical countermeasures to 
protect our citizens against CBRN threats. Project BioShield provided 
$5.6 billion over 10 years to acquire these medical countermeasures.
    During its first two years of implementation, Project BioShield 
acquisitions were guided by a policy and requirements document derived 
from interagency deliberations in 2003 that involved Cabinet-level 
Departments and the Executive Office of the President. This document 
served as the initial strategic plan for acquisition under Project 
BioShield. Under this strategy, the Department of Health and Human 
Services (HHS) pursued acquisitions for those highest priority threats 
for which there were candidate products at relatively advanced stages 
of development. These products included medical countermeasures for 
anthrax, smallpox, botulinum toxins and radiological/nuclear agents, 
the four threat agents deemed by the Department of Homeland Security 
(DHS) to pose a ``material threat'' to national security. The 
relatively advanced nature of the products pursued resulted from years 
of investment, made in large part by the Department of Defense in 
advance of the BioShield program, as well as aggressive development 
programs launched by the National Institutes of Health soon after the 
anthrax attacks in 2001.
    Despite these achievements, more can and must be done. HHS will 
continue to shape and execute a comprehensive, focused MCM program to 
protect our citizens against CBRN threats today and into the future. On 
behalf of the Secretary, the Office of Public Health Emergency 
Preparedness is dedicated to the mission of preventing and mitigating 
the adverse public health consequences of disasters resulting from 
these threats. This mission encompasses the breadth of activities 
required to accomplish the goal including: threat agent and disease 
surveillance and detection; and research, development, acquisition, 
storage, deployment and utilization of medical countermeasures.
    A focused medical countermeasure program will reflect threat 
priorities, threat agent characteristics, medical/public health 
consequence assessments, and the likelihood that effective medical and 
public health intervention will prevent and mitigate adverse health 
consequences. Given the expense and time required to develop each 
countermeasure, and the wide range of pathogens and compounds that 
potentially could be used in an attack, we must develop a strategy that 
prioritizes investment in a manner that optimizes our ability to 
mitigate the public health impact of current and future threats.
    The type and magnitude of both CBRN and natural threats are 
evolving. New diseases emerge and existing diseases change. World-wide 
travel is

[[Page 53098]]

commonplace and more rapid. Advances in biotechnology support the 
development of new treatments, but make those same tools more widely 
available to adversaries who might use them to intentionally inflict 
harm. Nuclear technologies proliferate despite international efforts to 
contain them, and chemical exposures can result from accidents or 
deliberate releases. We must, therefore, focus our efforts to meet the 
evolving nature of these threats by relying on cutting-edge 
technologies to expand and improve national capacity and capabilities 
to protect public health in a dynamic environment. This will require 
unprecedented cooperation among all levels of Government, private 
industry, academia, international partners and the public.

Approach and Guiding Principles

    HHS is undertaking a two-staged approach to develop a Public Health 
Emergency Medical Countermeasures Enterprise Strategy that will lead to 
an Implementation Plan for the Public Health Emergency Medical 
Countermeasures Enterprise (PHEMCE). The PHEMCE Implementation Plan 
will be a prioritized plan with near-, mid- and long-term goals for 
research, development and acquisition of medical countermeasures that 
is consistent with the guiding principles and priority-setting criteria 
defined in this PHEMCE Strategy.
    HHS created the Public Health Emergency Medical Countermeasures 
Enterprise (PHEMCE) in July 2006 [ref: Office of Public Health 
Emergency Preparedness: Statement of Organization, Functions and 
Delegations of Authority, 71 FR 38403 (July 6, 2006)]. The PHEMCE is a 
coordinated interagency effort led by HHS and charged with the 
responsibility to: (1) Define and prioritize requirements for public 
health medical emergency countermeasures; (2) coordinate research, 
early- and advanced product development and procurement activities to 
address the requirements; and (3) set deployment and use strategies for 
medical countermeasures held in the Strategic National Stockpile.
    The PHEMCE Strategy defines the principles and objectives that will 
guide our Implementation Plan for the entire PHEMCE-surveillance/
detection of threats; research, development, acquisition, storage/
maintenance, deployment and utilization of medical countermeasures. The 
ultimate goal of the PHEMCE Strategy is to establish the foundational 
elements and guiding principles that will support medical 
countermeasure availability and utilization for the highest priority 
CBRN threats facing our nation.
    The PHEMCE Strategy will provide a framework for future U.S. 
Government planning efforts that is consistent with the President's 
Biodefense for the 21st Century, the National Security Strategy and the 
National Strategy for Homeland Security. It recognizes that preparing 
for and responding to CBRN events is not strictly a Federal 
responsibility, but relies significantly on multiple key stakeholders, 
including both domestic and international industrial, academic and 
governmental biomedical research and development communities, Federal, 
State and local Governments, public health authorities, first 
responders, and the public.
    To address the challenges presented by the diverse CBRN threat 
spectrum, mitigate the risks associated with MCM development and ensure 
that our development and acquisition of MCM significantly enhances our 
response and recovery capabilities, we must utilize the following 
overarching principles to guide decisions on the development and 
acquisition of medical countermeasures:
     We must focus our preparations on countering the threat 
agents that have the highest potential to cause catastrophic public 
health consequences.
     We must direct investments where medical intervention 
presents the greatest opportunity to prevent, mitigate, and treat those 
public health consequences.
     Under HHS leadership, we must align and synchronize 
efforts on the part of all key stakeholders involved in the PHEMCE 
towards defending the United States of America against CBRN weapons of 
mass destruction.
     We must adapt our plans and programs to changes in 
intelligence, threat assessments, and assessments of medical and public 
heath consequences including our public health emergency response 
capabilities, and the progress that is made in the development and 
availability of candidate medical countermeasures.
    To implement programs that most effectively acquire medical 
countermeasures, including those under Project BioShield, the PHEMCE 
Strategy addresses the full spectrum of events required from the 
identification of priority threats, to setting medical countermeasure 
requirements for those threats, to the ultimate acquisition and 
effective use of those medical countermeasures. The PHEMCE Strategy 
builds upon the following four pillars:
    1. Threat Identification and Prioritization:
    [cir] HHS will consider the best available intelligence and 
scientific information to identify and prioritize CBRN threats. HHS' 
public health consequences assessments and corresponding MCM priorities 
and requirements will be informed by the DHS Material Threat 
Determinations which, as defined in the Project BioShield Act, present 
a material threat sufficient to affect national security.
    2. Medical/Public Health Consequence Assessment:
    [cir] HHS will utilize modeling, where available, to complement the 
subject matter experts' evaluation of the effectiveness of various 
medical countermeasure strategies and response capabilities.
    3. Establishment and Prioritization of Medical Countermeasures 
Requirements:
    [cir] HHS will establish baseline requirements based on unmitigated 
consequence assessments.
    [cir] HHS will assess the status of medical countermeasures 
available and in development including:
    [squf] Holdings of the SNS
    [squf] Relevant commercial products potentially 
accessible to the USG
    [squf] Candidate medical countermeasures in the 
developmental pipeline (USG and Industry)
    [cir] HHS will establish Concept of Operations including 
maintenance, utilization policies and deployment plans for each MCM in 
the context of all available consequence mitigation strategies.
    [cir] Gap analysis: HHS will assess medical countermeasure 
requirements vs. candidate and available medical and non-medical 
countermeasures
    [cir] HHS will define specific medical countermeasure requirements, 
including product specifications consistent with USG storage plans and 
operational capabilities for deployment and utilizations by federal, 
state and local authorities.
    4. Establish and Prioritize Near-Term (FY07-08), Mid-Term (FY09-
13), and Long-Term (FY14-23) Development, Acquisition, Stockpiling and 
Maintenance Strategies:
    [cir] HHS will establish a research and development portfolio to 
address MCM gaps and to meet future acquisition targets (align 
requirements with priorities).
    [cir] HHS will identify and support critical infrastructure that 
enables medical countermeasure development such as biocontainment 
facilities, animal models, workforce training, production, etc.
    [cir] HHS will establish short-, mid-, and long-term acquisition 
strategies that

[[Page 53099]]

incorporate all relevant cost elements for acquisition, storage, 
maintenance, deployment and utilization of the medical countermeasure.
    After publishing a final PHEMCE Strategy, HHS will develop and 
publish an Implementation Plan for this strategy. Several critical 
policy issues will guide creation of the Implementation Plan. These 
policies will address both the development and acquisition of MCM to 
threat agents. These ten strategic policies include:

1. Relative Hierarchy of CBRN Threat Classes (Biological versus 
Chemical versus Radiological/Nuclear)

    The PHEMCE Implementation Plan will address the relative value of 
medical countermeasures across all classes of threat agents. There is 
general consensus that the greatest potential for medical mitigation 
exists for biological threat agents. However, HHS also envisions 
identifying significant, though more limited, opportunities for MCM for 
radiological, nuclear and chemical threats.

2. Addressing Top Priority versus All Threats

    While our primary goal is to prevent the health effects of an 
attack with WMD, we recognize that despite our best efforts we will not 
be able to develop and acquire medical countermeasures to prevent and 
reduce adverse health effects against all threats in all places at all 
times for all people. Consequently, the PHEMCE Implementation Plan will 
consider all CBRN threats weighing costs, risks, and benefits such as 
their relative priority, feasibility of use in an event, and cost to 
mitigate with MCM and non-MCM to develop the best strategy. Recognizing 
the scope of the threats and the limited resources, the investments 
will focus on the top priorities for medical mitigation. Where 
possible, HHS will aim to develop and acquire medical countermeasures 
that have the potential to address multiple threats, particularly for 
lower priority threat agents.

3. Traditional, Enhanced, Emerging, and Advanced Threats

    There are four classes of biological threat agents: traditional, 
enhanced, emerging, and advanced (or engineered) threats. These are 
defined, briefly as:
     Traditional Agents: naturally occurring microorganisms or 
toxin products with the potential to be weaponized and disseminated to 
cause mass casualties (e.g. anthrax, smallpox, etc.).
     Enhanced Agents: traditional agents that have been 
modified or selected to circumvent current countermeasures. For 
example, an enhanced agent could be a bacterial pathogen that is 
modified to confer resistance to an antibiotic.
     Emerging Agents: naturally occurring organisms that are 
newly recognized or anticipated to present a public health threat. 
Recent examples of emerging agents include Severe Acute Respiratory 
Syndrome (SARS) and West Nile Virus.
     Advanced Agents: novel organisms that have been engineered 
or newly generated in the laboratory. Ongoing advances in biotechnology 
are believed to enable the engineering of novel organisms that could be 
targeted to completely bypass our countermeasures and might even be 
mistaken as naturally occurring emerging agents.
    The PHEMCE Implementation Plan will address traditional, enhanced, 
emerging, and advanced (engineered) threats and develop the best 
strategy to mitigate risk within time and cost constraints. HHS will 
continue to support a robust basic research program that will aim to 
develop broad-spectrum solutions using technologies that enable more 
flexible next generation interventional concepts and to consider 
approaches and technologies derived from the commercial drug 
development sector to support the biodefense mission. However, it is 
anticipated that near- and mid-term acquisition programs will continue 
to focus on addressing specific high priority threats with specific 
medical countermeasures. We will work closely with the intelligence 
community to ensure that our priorities are consistent with 
intelligence assessment of the threats most likely to be faced by our 
nation.

4. Medical Versus Non-Medical Countermeasures

    HHS will work closely with interagency partners and in concert with 
national strategies and directives to guide and coordinate our medical 
countermeasure efforts with the other aspects of our homeland security 
strategies and missions to maximize synergies and minimize any gaps in 
our national defenses. Specifically, the PHEMCE Implementation Plan 
will take into consideration the use of non-medical countermeasures 
when establishing priorities to complement the use of medical 
countermeasures.

5. Specific Versus Broad Spectrum or Fixed Versus Flexible Defenses

    As is true in the broader biodefense context, a key challenge to 
the Implementation Plan will be to define the optimal balance between 
fixed and flexible defenses.\2\ While static defenses and the so-called 
``one bug-one drug'' approach can be justified for top priority threat 
agents such as anthrax, with well-recognized potential for catastrophic 
medical and economic consequences, the uncertainties associated with 
the CBRN threat environment require that the PHEMCE Strategy also be as 
flexible as possible, to allow for the best approach for protection of 
our nation's citizens. Therefore, HHS will support the development of 
flexible MCM while recognizing that, at least for the immediate future, 
some agents will require agent-specific MCM.
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    \2\ ``Bioterrorism--Preparing to Fight the Next War'', David A. 
Relman, New England Journal of Medicine, Vol 354(2):113-115, 2006. 
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.
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6. Prevention/Mitigation Versus Treatment

    The PHEMCE Implementation Plan will address both medical prevention 
and treatment alternatives and develop the best strategy considering 
both costs and benefits. The term ``cost'' in this case goes beyond 
simple immediate expenditure of funds to also include weighing future 
opportunity costs. For example, if the United States government 
purchases a medical countermeasure in the short term it may then miss 
the opportunity to buy a more effective medical countermeasure in the 
future due to budgetary constraints. In addition, a medical 
countermeasure that has a more expensive cost upfront, may be more 
valuable in the long term if it meets the criteria in utilization 
during a crisis, that is, easily self administered, no cold-chain 
storage, or broad spectrum with respect to threat mitigation. As with 
the definition of costs, benefits also go beyond the simple definition 
of ``curing disease'' and include concepts such as overall lifecycle of 
the medical countermeasure including storage, utilization and 
deployment.
    For civilian populations, it is anticipated that, aside from some 
of the top priority threats, a post-event strategy will be adopted. 
Pre-event MCM (e.g. vaccines) are appropriate for high priority threats 
and when pre-event MCM are justified. Therapeutics/diagnostics or the 
use of post-exposure prophylaxis following an event will be the 
preferred strategy for all other threats. From this perspective, 
vaccines that provide post-exposure efficacy will be of interest.

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7. Acute Versus Chronic Effects

    The PHEMCE Implementation Plan will give priority to addressing the 
acute (immediate to weeks time frame) medical/public health outcomes 
resulting from CBRN threat agents.

8. First Available Versus Next Generation

    The PHEMCE Implementation Plan will address both currently 
available and next generation medical countermeasures and will 
regularly evaluate on a case-by-case basis strategies for long-term 
maintenance and/or replacement of medical countermeasures in the SNS. 
Currently available medical countermeasures will be considered for 
acquisition if they meet immediate, critical needs and may be 
effectively deployed under current preparedness plans. Investment to 
meet particular threats will not however be a singular event, but 
rather an ongoing process that synchronizes the lifecycle requirements 
of currently stockpiled medical countermeasures with on-going research 
and development efforts. This synchronization should ensure that, as 
current stockpiles age and decline, more appropriate, next generation 
products will be available for acquisition consideration.

9. General Versus Special Populations

    The PHEMCE Implementation Plan will address the needs of both 
general and special populations such as children, the elderly, pregnant 
women, persons with immunocompromised conditions and persons with 
disabilities that may impact the efficacy of, or the ability to access, 
MCM. Given limited available resources, priority will be given to those 
medical countermeasures that will prevent and treat adverse health 
effects to the greatest number of individuals. However, efforts will 
continue to be made to find creative solutions for providing treatment 
and mitigation of high priority threats to all populations.

10. Domestic Versus International

    The PHEMCE Implementation Plan will focus on the domestic medical 
countermeasure needed to protect the homeland, while recognizing that 
in a global emergency these resources may be utilized by the USG to 
meet critical international needs and the need to protect the homeland, 
to the extent feasible, under the framework of the International Health 
Regulations (2005) that will go into force in June 2007. Additionally, 
the Implementation Plan will call out and address those instances in 
which domestic manufacturing capacity is critical to national security.

PHEMCE Strategic Objectives

    To achieve the goal of acquiring critical, targeted MCM, HHS will 
act on the following strategic objectives:
    1. Identify and prioritize current and future MCM objectives;
    2. Build balanced, effective programs across all phases of the 
PHEMCE;
    3. Increase transparency and predictability in the Nation's 
civilian MCM priorities;
    4. Develop, Recruit, and Support A World-Class Workforce

1. Identify and Prioritize Current and Future MCM Objectives

    HHS has made substantial progress toward protecting the Nation from 
several of the most worrisome bioterrorist threats.\3\ Biological 
threats have significant potential to have a catastrophic impact on 
public health by causing tens of thousands to millions of casualties in 
single, multiple, or sequential attacks. There are fewer technical 
barriers to the acquisition, production and dissemination of biological 
agents to a large number of people relative to those posed by other 
CBRN threat classes. In addition, biological threats are unique in that 
some agents are contagious and have the potential to continue 
inflicting casualties beyond their original area of release. Therefore, 
the acquisition of medical countermeasures for priority biological 
agents presents the greatest opportunity to prevent and mitigate health 
effects of public health emergencies. When addressing radiological/
nuclear and chemical threats emphasis should be on well-defined 
diagnostics and therapeutic interventions, since the mitigation of the 
threat will be after the catastrophic event has occurred.
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    \3\ In 2000 the Centers for Disease Control and Prevention 
issued a ranked list of bioterrorism agents. The highest priority, 
Category A, was assigned to agents that can be easily disseminated 
or transmitted person-to-person, cause high mortality and major 
public health impact, might cause public panic and social 
disruption, and require special action for public health 
preparedness. The Category A agents (and the diseases they cause) 
are variola major (smallpox), Bacillus anthracis (anthrax), Yersinia 
pestis (plague), Clostridium botulinum toxin (botulism), Francisella 
tularensis (tularemia), and two categories of hemorrhagic fever 
viruses: filoviruses, (Ebola and Marburg) and arenaviruses (Lassa 
fever, Junin [Argentine hemorrhagic fever] and related viruses). 
Many other organizations have done rankings of bioterrorism threats 
and the principle results have roughly been the same. An integrated 
all WMD hazards risk assessment is necessary for the creation of an 
overarching guide for setting prioritize across the range of CBRN 
agents. The Department of Homeland Security will complete and 
deliver to the Homeland Security Council by January 2008 the results 
of an all-WMD assessment that builds upon their bioterrorism risk 
assessment and will integrate chemical, radiological and nuclear 
threats.
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    HHS has major stockpiles of antibiotics for use against anthrax, 
plague, and tularemia, as well as a significant stockpile of smallpox 
vaccines. These medical countermeasures can be used to protect our 
citizens from adverse health effects following exposure to these 
pathogens. The timelines for effective use after a large number of 
people are exposed are however very demanding and HHS is working with 
States and localities to enhance our ability to distribute these MCM 
swiftly enough to be effective in a crisis. HHS also has invested in a 
growing stockpile of the current anthrax vaccine which is licensed for 
pre-exposure immunization, as well as the acquisition of a new anthrax 
vaccine targeted for licensure for both pre-exposure and post-exposure 
use. Additionally, HHS has contracted for anthrax treatments including 
polyclonal and monoclonal antibodies. In addition, HHS will include in 
its overall MCM acquisition strategy the threat of naturally occurring, 
emerging or re-emerging infectious diseases of which SARS or West Nile 
Virus represent two examples. Analysis of the threat potential will 
influence resource allocation towards targeted versus flexible MCM 
investments. At the same time, long term investments towards the 
development of broad spectrum platform technologies are expected to 
enhance the overall threat detection, diagnosis, and disease mitigation 
capabilities.
    In its strategy for future priority setting for acquisition of MCM, 
HHS recognizes it must focus MCM investments across two separate 
dimensions.
    One dimension is across potential CBRN threat agents. MCM 
investments must be appropriately targeted across the full range of 
CBRN agents, informed by the potential gravity of a threat agent, as 
well as by the probability that such an event might occur. Broad 
assessments from DHS and the intelligence and scientific community, 
including both domestic and international perspectives will inform 
these judgments. Protection against threats must be broad enough to 
mitigate the impact of major biological, radiological, nuclear and 
chemical threats and enhance overall security.
    A second dimension to consider is the near, mid and long-term MCM 
needs across time. As we move into the future, both the sophistication 
of the threat and the sophistication of potential medical 
countermeasures are expected to increase. The need for and the benefits

[[Page 53101]]

of purchasing large quantities of a currently available MCM must be 
weighed against the risks and benefits of waiting for a new MCM that 
could be more effective but will not be available for years. HHS must 
balance between the risk of an event in the immediate future and the 
opportunity of a fully refined, advanced MCM in the longer term.
    The balancing of these two dimensions will require some difficult 
tradeoffs. HHS cannot acquire all of the countermeasures that might be 
available to counter all potential threat agents in each of the near, 
mid and long-term time frames. Using a more cost-effective and 
efficient approach, HHS might choose to fund fully the development of a 
needed MCM, take it through clinical trials, and then purchase only a 
small stockpile and principally rely on a finely honed, well-planned 
and exercised surge production capability to swiftly produce enough 
doses in a national crisis.
    For the near-term, HHS will continue to identify MCM opportunities 
for currently licensed medical treatments and candidate medical 
treatments already in advanced development that fill near-term 
vulnerabilities. These will focus on the most worrisome agents, in 
terms of adverse public health and medical outcomes. We will seek 
greater robustness in our anthrax and smallpox responses, for example, 
by using different classes of antibiotics against a bacterial pathogen 
or focusing on MCM with different mechanisms of action such as 
vaccines, antimicrobials, and antitoxins which use newer rather than 
legacy technologies.
    For the mid-term, HHS will monitor advances in medical 
countermeasure technology and seek to provide the needed incentive to 
pull promising candidate MCM out of the laboratory and turn them into 
greatly improved medical countermeasures through a more tightly focused 
advanced development effort. A high priority, for example, will be 
development of point-of-care assays and diagnostics that can rapidly 
differentiate microbial pathogens, specific radionuclides, or toxic 
chemicals that would lead to timely and appropriate medical decisions. 
Such assays are critical in rapidly separating those who have been 
exposed and require intervention from the unexposed but ``worried 
well.'' HHS also will support new MCM manufacturing methods. Just as it 
has been promoting the development of cell-based production of 
influenza vaccines to supplement egg-based vaccine preparation methods, 
the Department will seek other opportunities to promote faster 
production methods that lend themselves to surge production in a 
crisis. Furthermore, HHS will support the development of MCM with 
produce specifications that will facilitate a rapid public health 
response such as needle-less delivery systems and single dose solutions 
over multidose strategies.
    For the long-term, HHS will strive to develop broad-spectrum 
countermeasures as well as other new MCM approaches. We, for example, 
hope to see, over time, improved methods for treating the acute effects 
of radiation exposure. Replacement of legacy technologies, such as 
equine heptavalent botulinum antitoxin, may also be needed upon 
expiration of the current generation products currently being 
stockpiled.
Prioritizing MCM Based on Product Characteristics
    HHS also will select candidate medical countermeasures based on 
desired product characteristics are most compatible with the concept of 
operations for public health emergency response. For example, HHS will 
favor medical countermeasures that people can self-administer, such as 
oral antibiotics, over those that require a health care worker (doctor 
or nurse) to administer. Among those that require a health care worker, 
HHS will favor easily administered medications, such as a simple 
injection, over those needing longer interventions such as slow-
infusion intravenous drugs or multiple interventions. Ideal medical 
countermeasures will have a low risk of adverse side effects so that 
their benefits clearly outweigh their risks. Finally, ideal medical 
countermeasures will include products that can be stored at room 
temperature and be appropriate for use by the vast majority of 
citizens. Their use will require little or no screening to identify 
those patients who cannot use them and hence will most readily 
facilitate their rapid and broad distribution in a public health 
emergency.

2. Build Balanced, Effective Programs Across All Phases of the PHEMCE

    HHS will assure a balanced, effective program across the PHEMCE and 
will pursue the broad priorities across the spectrum of research and 
early development, advanced development, and procurement to ensure a 
comprehensive, mutually-supportive program.
    A strong biodefense research and early development program is 
currently underway under the leadership of the National Institute of 
Allergy and Infectious Diseases at the NIH. To supplement this effort, 
over the next year, and pending the availability of funds, HHS intends 
to expand its advanced development program. The Department plans to 
fund and staff this new function to enhance its ability to pursue an 
aggressive and strategic advanced development program as part of the 
comprehensive PHEMCE.
    HHS is similarly committed to strengthening its execution of MCM 
procurements. It is expanding the size of procurement staff and is 
working with DHS to streamline the approval process for use of the 
Special Reserve Fund authorized in the Project BioShield Act of 2004.
    In July 2006, HHS created a strategic planning function in the 
Office of Public Health Emergency Preparedness. This office will be 
responsible for carrying out a PHEMCE Strategic Plan that balances 
investment across CBRN agents and timelines. It also will produce 
threat-specific plans for the most worrisome bioterrorism agents, 
identify all the potential junctures for medical intervention post-
exposure and present procurement options for the HHS Secretary's 
decision.

3. Increase Transparency and Predictability in The Nation's Civilian 
MCM Priorities

    HHS will clearly and publicly articulate MCM priorities, the types 
of MCM it will seek to acquire and the general timelines for 
acquisition. The development of new medical countermeasures requires 
effective interactions among Government, the private sector and 
academia. Private research organizations, pharmaceutical manufacturers, 
biotechnology companies, and clinical research organizations already 
have many of the resources and the expertise needed to develop MCM but 
have been reluctant to make substantial investments in research and 
development because of market uncertainties.
    HHS will promote appropriate discussion of these priorities with 
all stakeholders, public and private, by convening meetings and 
workshops with representatives from relevant industries, academia, 
other Federal departments and agencies, international agencies as 
appropriate, and other interested persons. In addition, HHS will launch 
a stakeholder Web portal to enhance industry's access to and 
communication with the relevant HHS agencies regarding MCM product 
development.
    HHS will work to streamline the regulatory process for medical 
countermeasures. HHS will facilitate private investment of time, energy 
and

[[Page 53102]]

resources in MCM development by removing or lowering obstacles whenever 
appropriate, including the application of liability protections where 
appropriate. HHS will conduct its selection and acquisition process 
with full transparency while respecting requirements for 
confidentiality.

4. Develop, Recruit, and Support a World-Class Workforce

    A successful PHEMCE will need a highly qualified and accomplished 
workforce with appropriate technical training, scientific skills, and 
business experience. HHS is committed to staffing the PHEMCE with 
outstanding professionals and to creating a supportive work 
environment.
    The Department will recruit outstanding professionals from both the 
public and private sectors, to build a model program for advanced 
product development and procurement program that will provide needed 
products as efficiently and effectively as possible. HHS will recruit 
career Federal employees for their experience, skills and expertise in 
research, development, and the regulatory aspects of product 
development programs as well as management of such government programs. 
Highly qualified researchers and managers from academia and private 
industry will compliment their expertise. HHS will facilitate the 
appointment of these individuals through existing general and senior 
service programs.
    HHS also will develop programs to provide opportunities for 
information regarding scientific and product development by using such 
mechanisms as fellowship, sabbatical, internship and exchange programs. 
This effort will allow private sector individuals to bring new skills 
and fresh ideas to the program from the biotechnology and 
pharmaceutical industries. The Department also will create appropriate 
career paths to assure staff who are working in the PHEMCE have 
opportunities to continue to grow professionally and assure that 
excellence remains the hallmark.
    HHS will use current Federal hiring practices to offer compensation 
that attracts the best human capital to meet its mission and 
challenges. HHS also will accept service from qualified individuals 
with special expertise who are willing to contribute their skills to 
advisory boards or committees that the Secretary determines would 
contribute to the overall program.

Conclusion

    This HHS PHEMCE Strategy reflects the new HHS approach to develop 
and acquire medical countermeasures against CBRN events. It provides 
strategic direction to the Department, signals the Department's intent 
and priorities to its Governmental and private partners and will serve 
to guide development of the PHEMCE Implementation Plan. Consistent with 
its stated commitment to transparency, predictability, and wide-ranging 
solicitation of expertise, the Department will engage those partners as 
it develops specific strategic initiatives to meet its goals and 
objectives in MCM advanced development, procurement, and delivery. The 
HHS PHEMCE Strategy underscores the recognition of HHS's top leadership 
that the President is relying on the Department to craft and execute a 
program that responsibly protects our fellow citizens from CBRN 
threats.

    Dated: September 5, 2006.
Gerald Parker,
Principal Deputy Assistant Secretary, Office of Public Health Emergency 
Preparedness.
[FR Doc. E6-14908 Filed 9-7-06; 8:45 am]
BILLING CODE 4150-37-P