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21 March 2007
[Federal Register: March 20, 2007 (Volume 72, Number 53)]
[Notices]
[Page 13109-13114]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20mr07-65]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Assistant Secretary for Preparedness and Response;
HHS Public Health Emergency Medical Countermeasures Enterprise Strategy
for Chemical, Biological, Radiological and Nuclear Threats
AGENCY: Office of the Assistant Secretary for Preparedness and
Response, Department of Health and Human Services.
ACTION: Notice.
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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. This HHS Public Health
Emergency Medical Countermeasures Enterprise Strategy (HHS PHEMCE
Strategy) establishes the goals and objectives that HHS will employ to
ensure that medical countermeasures are available for effective use
against the highest priority CBRN threats facing the Nation. The HHS
PHEMCE Strategy considers the full spectrum of medical countermeasures-
related activities, including research, development, acquisition,
storage/maintenance, deployment, and utilization. The HHS PHEMCE
Strategy is consistent with the President's Biodefense for the 21st
Century and aligned with the National Strategy for Medical
Countermeasures against Weapons of Mass Destruction.
DATES: This notice is effective as of March 14, 2007.
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.
Introduction
The United States faces serious public health threats from the
deliberate use of chemical, biological, radiological, or nuclear (CBRN)
weapons of mass destruction (WMD) by hostile states or terrorists, and
from naturally emerging infectious diseases that have the potential to
cause illness on a scale that could adversely impact national security.
The type and magnitude of both CBRN and naturally-occurring threats are
evolving. Chemical exposures can result from accidents as well as
deliberate releases. Advances in biotechnology support the development
of new medical treatments, but also make those same tools more widely
available to adversaries who might use them to modify biological
organisms with the intention to inflict harm. New diseases, like Severe
Acute Respiratory Syndrome (SARS), emerge; and regionally endemic
diseases, like West Nile Fever and Rift Valley Fever, are introduced
into susceptible populations. Nuclear technologies may proliferate
despite international efforts to contain them.
A failure to anticipate these threats or the lack of a capacity to
effectively prevent them could leave an untold number of Americans dead
or permanently disabled. The United States must be able to effectively
develop, stockpile, and rapidly deploy critical medical countermeasures
to prevent, mitigate, and treat the adverse health consequences of
threats both natural and manmade. Given the diverse and dynamic nature
of these threats, and the expense and time required to develop threat
agent-specific medical countermeasures, a strategy must be developed
that prioritizes investment and optimizes the ability to protect the
Nation.
The Role of the Department of Health and Human Services in Public
Health Preparedness
Within the Federal government, the Department of Health and Human
Services (HHS) leads the research, development, acquisition,
deployment, and use of effective medical countermeasures to protect the
civilian population from WMD. 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
are the President's blueprint for addressing the Nation's CBRN defense
programs.
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\1\ http://www.whitehouse.gov/news /releases/2002/12/
WMDStrategy.pdf.
\2\ http://www.whitehouse.gov/homeland/20040430.html \3\ http://www.whitehouse.gov/news/. releases/2007/02/20070207-
70207-
2.html.
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Within HHS, multiple operating and staff divisions work together to
develop and implement strategies to prevent and control disease,
injury, illness, and disability from terrorist threats and naturally-
occurring diseases capable of negatively impacting Government and
social systems. In July 2006, HHS created the Public Health Emergency
Medical Countermeasures Enterprise (PHEMCE).\4\ The PHEMCE is a
coordinated, intra-agency effort led by the Office of the Assistant
Secretary for Preparedness and Response \5\ (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). The mission of the PHEMCE is to: (1) Define
and prioritize requirements for public health emergency medical
countermeasures; (2) integrate and coordinate research, early and late
stage product development, and procurement activities addressing the
requirements; and (3) set deployment and use
[[Page 13110]]
strategies for medical countermeasures held in the Strategic National
Stockpile (SNS).
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\4\ Federal Register, Vol. 71, No. 129, Thursday, July 6, 2006,
Notices.
\5\ Formerly the Office of Public Health Emergency Preparedness;
changed to reflect the Pandemic and All-Hazards Preparedness Act
enacted on December 19, 2006 (P.L. 109-417).
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Many resources throughout HHS have already been coordinated in
support of medical countermeasure preparedness. Funding support by the
NIH for basic research, product development, and clinical research of
CBRN medical countermeasures has grown from $53 million in Fiscal Year
2001 (FY01) to $1.8 billion in FY06. Funding for the SNS 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).\6\ The purpose of Project
BioShield is to accelerate the research, development, acquisition, and
availability--including through use of the Emergency Use Authorization
(EUA)--of safe and effective medical countermeasures to protect the
United States from CBRN threats. Project BioShield created a $5.6
billion special reserve fund for use over 10 years (FY04--FY13) to
acquire these medical countermeasures.
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\6\ http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=108_
cong--public--laws&docid=f:publ090.108.pdf.
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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.
These products included medical countermeasures for anthrax, smallpox,
botulinum toxins, and radiological/nuclear agents \7\--the four threat
agents initially determined by the Department of Homeland Security
(DHS) to pose a material threat to national security.\8\ The relatively
advanced nature of the products pursued resulted from years of earlier
investment made in large part by NIH and the Department of Defense
(DOD).
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\7\ To date, contracts have been awarded using the Project
BioShield special reserve fund for the purchase of anthrax
therapeutics, anthrax vaccines, botulism antitoxin, a pediatric
formulation of potassium iodide (a drug that blocks absorption of
radioactive iodide in the thyroid gland), and Calcium- and Zinc-DTPA
(two forms of a decorporation agent to remove transuranic
radionuclides from the body). The SNS also contains enough smallpox
vaccine to protect every American, antibiotics for anthrax, adult
(tablet) formulations of potassium iodide, the decorporation agent
Prussian Blue, and additional supplies for treating the burn and
blast injuries that could be associated with a nuclear event.
\8\ The Project BioShield Act of 2004 requires the Secretary of
Homeland Security, in consultation with the Secretary of Health and
Human Services and the heads of other agencies, as appropriate, to
determine which current and emerging CBRN threats present a material
threat against the United States population sufficient to affect
national security.
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In addition to the achievements made to date, more can and must be
done. The National Strategy for Medical Countermeasures against Weapons
of Mass Destruction provides guiding principles to align United States
Government (USG) programs and funding mechanisms that support the
research, development, acquisition, deployment, and utilization of
medical countermeasures for current and future CBRN threats. In
accordance with the National Strategy, HHS will continue its commitment
to shape and execute a focused medical countermeasures program to
protect the Nation's citizens against high priority CBRN threats where
medical countermeasures can have the greatest impact. The NIH will
continue its existing research and development efforts to identify
medical countermeasures for known as well as emerging diseases. HHS
will use the Biomedical Advanced Research and Development Authority
(BARDA) in the Pandemic and All-Hazards Preparedness Act (Pub. L. 109-
417) to provide direct investment in medical countermeasure advanced
research and development. Finally, HHS will use the Project BioShield
special reserve fund and the Strategic National Stockpile resources to
acquire, store, maintain and deploy top priority medical
countermeasures.
Medical Countermeasure Preparedness For CBRN Threats: A Two-Stage
Approach
To fulfill the mission of the ASPR to lead the Nation in
preventing, preparing for, and responding to the adverse health effects
of public health emergencies and disasters, HHS through the PHEMCE is
undertaking a two-stage approach to planning that aims to solicit
stakeholder input and to efficiently integrate the requirements for,
and the advanced development and acquisition of, medical
countermeasures for priority CBRN threat agents.
Stage One
The first stage is development of this Public Health Emergency
Medical Countermeasures Enterprise Strategy 9 10 (HHS PHEMCE
Strategy). The HHS PHEMCE Strategy establishes the goals and objectives
that HHS will employ to ensure that the most appropriate medical
countermeasures are developed and acquired for use against the highest
priority CBRN threats facing the Nation. This HHS PHEMCE Strategy
considers the full spectrum of medical countermeasures-related
activities, including research, development, acquisition, storage/
maintenance, deployment, and utilization.
---------------------------------------------------------------------------
\9\ A draft of this HHS PHEMCE Strategy was published in the
Federal Register on September 8, 2006, for public comment and was
presented and discussed at the 2006 BioShield Stakeholders Workshop
on September 25-26, 2006. The HHS PHEMCE Strategy reflects input
received from the stakeholders representing industry, academia,
other non-governmental organizations, and State, local, and Federal
governments. Additional information on the Workshop is available at
http://www.hhs.gov/aspr/ophemc/bioshield/workshop.html.
\10\ This HHS PHEMCE Strategy excludes pandemic influenza, which
is addressed in the HHS Pandemic Influenza Plan, a blueprint for
pandemic influenza preparation and response that provides guidance
to Federal, 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 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.[0]
Additional information is available at http://www.pandemicflu.gov.
---------------------------------------------------------------------------
Stage Two
The second stage in this process is the development of the HHS
PHEMCE Implementation Plan. This document, to be published in early
2007, will outline the medical countermeasure programs that 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. The HHS PHEMCE Implementation Plan will incorporate
valuable lessons learned from the initial implementation of Project
BioShield; consider new authorities made available in the Pandemic and
All-Hazards Preparedness Act; and outline HHS near-, mid- and long-term
goals for research, development, and acquisition of medical
countermeasures, consistent with the goals defined in this HHS PHEMCE
Strategy. The HHS Implementation Plan will be reviewed at least
biennially and revised to reflect changes in the threat scope and the
availability of new or improved countermeasures.
While ASPR leads the execution of the HHS PHEMCE Implementation
Plan, HHS recognizes that developing, acquiring, and utilizing medical
countermeasures to prepare for and respond to CBRN events will require
significant resources and unprecedented
[[Page 13111]]
cooperation among many stakeholders, including Federal counterparts
outside HHS,\11\ private industry (domestic and international), State
and local governments, frontline first responders and healthcare
workers, academia, and the public.
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\11\ Partners include Department of Defense (DOD), Department of
Homeland Security (DHS), Department of Labor (DOL), Department of
Transportation (DOT), Department of State (DOS), Department of
Veterans Affairs (DVA), Department of Energy (DOE), and Department
of Agriculture (USDA).
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Four Strategic Goals
To address the challenges presented by the diverse CBRN threat
spectrum, to mitigate the financial and programmatic risks associated
with medical countermeasure development and acquisition, and to ensure
that the development and acquisition of medical countermeasures
significantly enhances the Nation's response and recovery capabilities,
the following four strategic goals and underlying objectives will guide
critical funding allocation decisions.
Goal 1. Identify and Prioritize Programs for the Development and
Acquisition of Medical Countermeasures
While a primary goal of HHS is to prepare the Nation to prevent and
respond to the health effects of natural and manmade disasters,
constraints of both time and financial resources do not allow for the
development and acquisition of medical countermeasures to prevent and
mitigate all threats, in all places, at all times, and for all people.
Consequently, several factors must be considered when developing the
most appropriate strategies for high priority CBRN threats. The
prioritization of medical countermeasure development and acquisition
programs that will be delineated in the HHS PHEMCE Implementation Plan
will be informed by the following three objectives.
Objective 1. Establish the Relative Hierarchy of the Chemical,
Biological, Radiological, and Nuclear Threat Classes
In the process of determining the most effective ways to mitigate
and treat the effects of the CBRN threats, it is essential to
understand that the three threat classes (i.e., chemical, biological,
and radiological/nuclear) are distinct in their feasibility of use and
in their potential public health consequences. HHS recognizes that the
overall strategy for protection against these threats must be broad
enough to effectively mitigate the public health impact of a major
chemical, biological, radiological, or nuclear event, while focusing
preparations on developing and acquiring medical countermeasures to
protect against the threat agents that have the greatest potential to
cause catastrophic public health consequences and for which medical
intervention will be effective, feasible, and pragmatic. Threat
identification and prioritization to inform medical countermeasure
development and acquisition is a collaborative effort between HHS and
DHS. DHS has the lead in considering the best available intelligence
and scientific information to identify and prioritize CBRN threats. DHS
uses this as the basis for issuing determinations about which agents
present a material threat sufficient to affect national security. DHS
then provides HHS with estimates of the numbers of potentially exposed
individuals using plausible, high-consequence scenarios for each
threat. To inform subsequent medical and public health consequence
assessments, HHS combines this data with medical consequence modeling,
subject matter expert evaluations, domestic and international
intelligence information, and information on current State and local
response capabilities. The HHS PHEMCE Implementation Plan will consider
all of these inputs when establishing the HHS medical countermeasure
priorities and requirements.
Objective 2. Prioritize Gaps in the Research, Development, and
Acquisition of Medical Countermeasures
HHS is committed to investing in research and development of
medical countermeasures that will provide the most benefit for
preventing or treating the effects of exposure to CBRN threats. HHS
will apply the following specific guidelines and principles when
evaluating potential investments.
Medical \12\ versus Non-Medical \13\ Countermeasures. HHS will
address the relative value of medical countermeasures and non-medical
countermeasures, both within each class of threat agent and across all
classes of threat agents. The HHS PHEMCE Implementation Plan will be
developed with the overall goal of creating--through investments in
research, development, and acquisitions--a portfolio that optimizes
public health preparedness using the best combined strategies to
prevent, mitigate, and treat the effects of a catastrophic CBRN event.
---------------------------------------------------------------------------
\12\ Includes both pharmaceutical medical countermeasures (e.g.,
vaccines, antibiotics, antitoxins) and non-pharmaceutical medical
countermeasures (e.g., ventilators, devices, personal protective
equipment such as face masks and gloves).
\13\ Includes elements such as contact and transmission
interventions, social distancing, and community shielding.
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Prevention and Mitigation versus Treatment. HHS will address both
medical prevention and medical treatment alternatives for public health
preparedness. Given cost/benefit and implementation considerations,
post-event diagnostics, prophylaxis, and/or treatment are likely to be
the preferred strategies for most threats; however, pre-event medical
countermeasures (such as vaccines) may still be appropriate for some
high priority threats.
Acute versus Chronic. Many CBRN agents have the potential to cause
acute health consequences. In addition to relieving these acute
consequences, early mitigation and treatment may prevent subsequent
chronic health effects. The HHS PHEMCE Implementation Plan, therefore,
will give priority to addressing the acute (immediate to weeks
timeframe) medical and/or public health outcomes resulting from CBRN
threat agents, while acknowledging that some threats, despite early
interventions, may cause long-term health consequences.
Specific versus Broad-spectrum. The USG must be capable of
responding to a wide variety of potential challenges, including
traditional as well as novel biological agents that are highly
communicable, associated with a high rate of morbidity or mortality,
and potentially without known countermeasure at the time of discovery.
Identified in the National Strategy for Medical Countermeasures against
Weapons of Mass Destruction is the spectrum of potential biological
threat agents that pose such risks. These include threats that are
traditional (i.e., naturally occurring microorganisms or toxin products
with the potential to be disseminated to cause mass casualties, such as
anthrax and plague); enhanced (i.e., a traditional agent that has been
modified or selected to circumvent current countermeasures, such as an
engineered, antibiotic-resistant, bacterial pathogen[0]); emerging
(i.e., a[0] naturally occurring organism that is newly recognized or
anticipated to present a public health threat, such as Severe Acute
Respiratory Syndrome-associated coronavirus [SARS-CoV][0][0]); or
advanced (i.e., a novel organism that has been engineered or newly
generated in the laboratory and that could be targeted to bypass
traditional countermeasures or produce a more severe or otherwise
enhanced spectrum of disease).
Medical countermeasure acquisitions planned in the near-term will
continue
[[Page 13112]]
to focus on addressing specific, high-priority threats with specific
medical countermeasures. Where available, HHS will pursue development
and acquisition of medical countermeasures that address multiple
threats, as is the case with the current stockpile of antibiotics that
are effective against multiple bacterial threat agents. A key challenge
for the HHS PHEMCE Implementation Plan, however, will be to define the
optimal balance between fixed and flexible defenses \14\ to best
prepare for the future.
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\14\ 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.
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Fixed defenses (the so-called ``one bug--one drug'' approach) for
medical counter-measure development can be time-consuming and
expensive. To date, however, this has been the preeminent path for
addressing current threats. This approach has been successful in part
because it presents industry with clearly defined targets for product
development. At the same time, however, the uncertainties associated
with the CBRN threat environment require that the HHS PHEMCE
Implementation Plan support the development of flexible defenses to
allow for innovations in medical countermeasure design that may result
in enhanced products. For example, the benefit of broad-spectrum
pharmaceuticals and platform technologies \15\ will extend beyond their
ability to counter current biological threat agents and will allow for
rapid response to future threats. In addition, development of broad-
spectrum medical countermeasures and platform technologies may also
contribute to the mitigation and treatment of the health effects
associated with chemical and radiological/nuclear threats. Therefore,
HHS will support the development of flexible medical countermeasures
including broad-spectrum pharmaceuticals and diagnostics, while
recognizing that, at least for the immediate future, some threats will
require agent-specific medical countermeasures.
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\15\ Platform technologies are methods for developing and
producing medical countermeasures that are rapidly adaptable to
multiple threats.
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The NIH will continue its existing research and development efforts
to identify medical countermeasures for known as well as emerging
diseases. HHS will use the Biomedical Advanced Research and Development
Authority (BARDA) in the Pandemic and All-Hazards Preparedness Act to
provide direct investment in medical countermeasure advanced research
and development. Finally, HHS will use the Project BioShield special
reserve fund and the Strategic National Stockpile resources to acquire,
store, maintain, and deploy top priority medical countermeasures. HHS
will work to ensure that its internal agencies, including ASPR, NIH,
FDA, and CDC, continue to present industry with clear and comprehensive
guidelines for HHS expectations regarding the development, approval,
and utilization policies for fixed and flexible defenses.
General versus Special Populations. The HHS PHEMCE Implementation
Plan will address the medical countermeasure needs of both the general
population and those special populations (e.g., children, the elderly,
pregnant women, immunocompromised individuals, and persons with
disabilities) for whom efficacy or dosing have not been determined, to
whom FDA licensure has not been extended, or for whom the use of a
countermeasure is medically contraindicated. Given the limited
availability of resources, priority will be given to those medical
countermeasures that will prevent and treat adverse health effects for
the greatest number of individuals. Meanwhile, HHS will continue its
dedication to finding treatment and mitigation solutions for high
priority threats to all populations.
Concept of Operations. HHS will develop, and select for
acquisition, candidate medical countermeasures based on desired product
characteristics that are most compatible with the current Concept of
Operations (CONOPs) for public health emergency response at the
Federal, State, and local levels. For each medical countermeasure, HHS
will establish civilian CONOPs, including maintenance, utilization
policies, and deployment plans in the context of available consequence
mitigation strategies. When feasible, HHS will identify and integrate
existing CONOPs developed by its Federal partners.\16\ Consistent with
previously issued material threat determinations, HHS will define
specific medical countermeasure requirements, including product
specifications consistent with USG storage plans and operational
capabilities for deployment \17\ and utilization by Federal, State, and
local authorities. For example, HHS will favor medical countermeasures
that people can self-administer (e.g., oral antibiotics) over those
that require administration by a health care worker. For those medical
countermeasures that do require a health care worker, HHS will favor
easily administered medications (e.g., a simple single injection) over
medications that require intravenous administration, continuous medical
monitoring, or prolonged courses. Preferred medical countermeasures
will include products that can be stored at room temperature, have a
minimum 5-year shelf-life, and are appropriate for use by the vast
majority of the at-risk population.
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\16\ DOD will separately develop its medical countermeasure
CONOPs for military populations and will work to integrate DOD
medical countermeasure requirements and product development plans
with HHS strategies for addressing civilian requirements.
\17\ Deployment includes the transportation and distribution
system (both vehicular equipment and human capital) needed to
distribute the medicines and supplies.
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Domestic versus International. The HHS PHEMCE Implementation Plan
will focus on medical countermeasures needed to protect the domestic
civilian population. In a global emergency, however, the USG may
utilize these resources, as feasible and as appropriate, to meet
critical international needs.
Objective 3. Establish and Prioritize Near-Term, Mid-Term, and Long-
Term Development and Acquisition Programs
HHS will achieve the optimal state of public health preparedness by
synchronizing its near-term, mid-term, and long-term investments in the
research, development, and acquisition of existing as well as novel
medical countermeasures to effectively prevent, mitigate, and treat the
dynamic nature of the threat scope. The HHS PHEMCE Implementation Plan
will address both existing and next generation medical countermeasures.
HHS will regularly evaluate, on a case-by-case basis, investment
strategies for long-term maintenance and/or replacement of medical
countermeasures in the SNS. HHS will establish a research and
development portfolio that will meet future top priority countermeasure
gaps.
Building on the existing USG infrastructure, HHS will identify and
support the critical framework necessary to enable medical
countermeasure development, including biocontainment facilities, animal
models, workforce training and education, and product manufacturing.
HHS will establish strategies that consider the total life-cycle costs
\18\ of
[[Page 13113]]
each medical countermeasure and will employ the following guidelines
and principles to evaluate potential investments in the near-term, the
mid-term, and the long-term.
---------------------------------------------------------------------------
\18\ Relevant cost elements including development, acquisition,
storage, maintenance, deployment, utilization, industrial warm-base,
and disposal of expired items.
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Near-term Strategies (FY07-08). Recognizing the broad spectrum of
CBRN threats and the limited resources available, all investments will
focus on those threats with the highest possibility for medical
mitigation. Currently available medical countermeasures will be
considered for acquisition if they meet immediate, critical needs and
if they can be deployed effectively under current preparedness plans.
HHS will continue to invest in research and development activities to
identify additional indications for currently approved \19\ products.
Furthermore, HHS will continue to support candidate medical
countermeasures already in advanced development that have the potential
to address current vulnerabilities. These efforts will focus on the
highest priority gaps in terms of adverse public health and medical
outcomes.
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\19\ The term ``approved'' is used broadly in this report to
refer to products and uses that FDA has approved, licensed, or
cleared under sections 505, 510(k), and 515 of the Federal Food,
Drug, and Cosmetic Act or that FDA has licensed under section 351 of
the Public Health Service Act.
---------------------------------------------------------------------------
Mid-term Strategies (FY09-13). HHS will monitor advances in medical
countermeasure technology and will provide, through a narrowly focused
advanced development effort, the support needed to pull promising
candidate medical countermeasures through the development pipeline. It
will be accepted that some of these candidate countermeasures and
platforms may not be deemed suitable for further investment as
additional data become available; however, this approach is expected to
result in a net expansion of the pool of medical countermeasure
candidates. HHS also will work with the private sector to support new
technologies for medical countermeasure manufacturing that may be
utilized for both CBRN and commercial interests. Furthermore, HHS will
support the development of point-of-care assays and diagnostics, and
other medical countermeasure products that facilitate a rapid public
health response, such as those with needle-less delivery systems or
single dose solutions.
Long-term Strategies (FY14-23). HHS will maintain its commitment to
providing appropriate resources to address those threat agents deemed
by DHS to pose the greatest risks to national security. In addition to
these known dangers, HHS will continue to work to protect the Nation
from unknown threats. HHS will also continue its support of the
development of novel, broad-spectrum medical countermeasures as well as
innovative approaches to countermeasure deployment logistics, including
manufacturing processes, delivery systems, storage requirements, and
distribution tactics. Maintenance in the SNS of products made with
existing technologies will be evaluated in the context of availability
of next generation products and of products made with modernized
manufacturing technologies. Existing technologies will continue to be
evaluated for applicability to producing novel medical countermeasures.
Goal 2. Build Balanced, Effective Programs Across the HHS Public Health
Emergency Medical Countermeasures Enterprise
The HHS PHEMCE will build and maintain a balanced and effective
medical countermeasure research, development, and acquisition program.
Currently, a robust research and early development program exists under
the leadership of the NIH. In the coming years, HHS will expand on this
foundation to enhance its ability to pursue an aggressive, integrated,
and strategic advanced development program using authorities provided
in the Pandemic and All-Hazards Preparedness Act. The prioritization of
threat-specific medical countermeasures will be reflected in
corresponding changes in the NIH's research and development funding
allocations. Furthermore, HHS will enhance its ability to pursue an
aggressive and strategic advanced development program as part of the
comprehensive PHEMCE. ASPR will coordinate biodefense research and
development at NIH, CDC, and FDA; synchronize funding streams for
advanced development; and utilize scientific capital and technological
capability from all Federal government agencies to ensure that the
necessary medical countermeasure solutions are available to respond to
and minimize critical public health needs.
Similarly, HHS will strengthen its execution of medical
countermeasure procurements. It is expanding its acquisition staff and
has worked with DHS to streamline the approval process for use of the
special reserve fund authorized in the Project BioShield Act of 2004.
For current and future medical countermeasures, HHS will continue to
establish, in partnership with State and local authorities, CONOPs that
include maintenance, utilization policies, and deployment plans in the
context of available consequence mitigation strategies.
Goal 3. Increase Transparency and More Actively Engage the Private
Sector
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 medical
countermeasures; however, they have been reluctant to make substantial
investments in research and development because of market
uncertainties. HHS will clearly and publicly articulate its medical
countermeasure development and acquisition priorities, as well as the
general timelines associated with addressing these priorities.
HHS will enhance communication between the Federal government and
external stakeholders through several mechanisms, including this HHS
PHEMCE Strategy, the soon-to-be-released HHS PHEMCE Implementation
Plan, the PHEMCE Stakeholder Workshops, and a dedicated Web site,
MedicalCountermeasures.gov. HHS's annual Stakeholder Workshops will
educate the public and promote appropriate discussion of these
priorities with public and private stakeholders. As needed, HHS will
also convene other meetings and workshops with representatives from
relevant industries, academia, and other Federal departments and
agencies (including the Government and Sector Coordinating Councils
involved in the development of the National Infrastructure Protection
Plan), international agencies as appropriate, and other interested
persons.
In 2007, HHS will launch MedicalCountermeasures.gov, a secure Web
site designed to enhance industry's access to and rapid communication
with the relevant USG agencies regarding medical countermeasure
development. MedicalCountermeasures.gov will provide frequent updates
on Federal medical countermeasure activities, and will feature upcoming
events, pre-solicitation notices, key Federal resources, announcements,
and links to related USG Web sites. Conversely, stakeholders will be
able to use MedicalCountermeasures.gov to submit information on their
products in development as well as to request meetings with USG
departments or agencies.
[[Page 13114]]
As required by the Pandemic and All-Hazards Preparedness Act, HHS
will establish the National Biodefense Science Board (NBSB) to provide
expert advice and guidance to the HHS Secretary on scientific,
technical, and other matters of special interest to HHS regarding
current and future CBRN agents, whether naturally occurring,
accidental, or deliberate. The membership of the NBSB will be comprised
of the Nation's preeminent scientific, public health, and medical
experts; Federal officials as the Secretary may determine are necessary
to support the functions of the Board; individuals representing the
pharmaceutical, biotechnology, and device industries; individuals
representing academia; and other members as determined appropriate by
the Secretary, including a practicing healthcare professional and a
representative from a healthcare consumer organization.
With diligent respect for confidentiality concerns and Federal
regulations, HHS will increase the transparency and public visibility
of processes by which it selects and acquires medical countermeasures.
Acknowledging industry's risky investments of time, energy, and
resources, HHS will foster medical countermeasure development by
removing or lowering obstacles whenever appropriate, including through
the application of liability protections under the Public Readiness and
Emergency Preparedness Act (PREP Act) \20\ and, as appropriate and
necessary, more flexible contracting procedures. In addition to
granting the HHS Secretary limited antitrust exemption authorities
regarding medical countermeasure research and development, the Pandemic
and All-Hazards Preparedness Act allows the Secretary to make
milestone-based awards and payments to biotechnology companies and
pharmaceutical manufacturers.
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\20\ On December 30, 2005, President George W. Bush signed into
law the Public Readiness and Emergency Preparedness Act (PREP Act)
as part of the 2006 Defense Appropriations Act.
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Goal 4. Develop, Recruit, and Support a World-Class Workforce
A successful PHEMCE relies on a highly qualified and accomplished
workforce with appropriate technical training, scientific skills, and
business management experience--both within the public and the private
sectors. HHS is committed, as is each of its Federal partners in this
endeavor, to continued staffing of the PHEMCE with outstanding
professionals and to maintaining a work environment conducive to high
performance. The Department will continue to recruit outstanding
professionals from both the public and private sectors to build a model
program for advanced product development, procurement, and delivery
that will provide needed products as efficiently and effectively as
possible. HHS will recruit Federal employees (civil service and the
U.S. Public Health Service) 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, clinicians, and managers from
academia and private industry will complement their expertise. HHS will
facilitate the appointment of these individuals through existing
general and senior service programs.
HHS also will develop programs to train professionals at all career
stages in the foundations of the PHEMCE, utilizing mechanisms such as
fellowships, sabbaticals, internships, 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
provide PHEMCE staff with opportunities to continue to grow
professionally, to retain outstanding staff, and to ensure that
excellence remains a PHEMCE hallmark.
HHS will use all available Federal hiring practices and all
Pandemic and All-Hazards Preparedness Act authorities to offer
compensation that attracts the best human capital to meet its mission
and challenges. HHS also will identify qualified individuals with
special expertise who are willing to serve on 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 the
development, acquisition, and use of medical countermeasures against
CBRN threats. It provides strategic direction to the Department,
signals the Department's intents and priorities to its Governmental and
private partners, and guides the development of the HHS PHEMCE
Implementation Plan. Consistent with its stated commitment to
transparency, predictability, and wide-ranging solicitation of
expertise, the Department will continue to engage stakeholders as it
develops specific strategic initiatives to meet its goals and
objectives for the advanced development, procurement, and delivery of
medical countermeasures. The HHS PHEMCE Strategy underscores the
commitment by the top leadership of HHS to achieve the vision
articulated in the President's National Strategy for Medical
Countermeasures against Weapons of Mass Destruction. It seeks to craft
and execute a robust, integrated, and end-to-end Public Health
Emergency Medical Countermeasure Enterprise that provides the Nation
with an ``all hazards'' capability to protect against, respond to, and
enable recovery from chemical, biological, radiological, or nuclear
attacks upon the public health.
Dated: March 15, 2007.
Gerald Parker,
Principal Deputy Assistant Secretary, Office of the Assistant Secretary
for Preparedness and Response, Department of Health and Human Services.
[FR Doc. E7-5066 Filed 3-19-07; 8:45 am]
BILLING CODE 4150-37-P