[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
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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
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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
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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
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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]
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