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Skriven 2007-02-07 23:31:16 av Whitehouse Press (1:3634/12.0)
Ärende: Press Release (0702072) for Wed, 2007 Feb 7
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Homeland Security Presidential Directive/HSPD-18
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For Immediate Release
Office of the Press Secretary
February 7, 2007

Homeland Security Presidential Directive/HSPD-18



January 31, 2007

Subject:ÿ Medical Countermeasures against Weapons of MassÿDestruction

BACKGROUND

(1)ÿ Weapons of Mass Destruction (WMD) -- chemical, biological,
radiological, and nuclear agents (CBRN) -- in the possession ofÿhostile
states or terrorists represent one of the greatest security challenges
facing the UnitedÿStates.ÿ An attack utilizing WMD potentially could cause
mass casualties, compromise critical infrastructure, adversely affect our
economy, and inflict social and psychological damage that could negatively
affect the American way of life.

(2)ÿ Our National Strategy to Combat Weapons of Mass Destruction (December
2002) and Biodefense for the 21stÿCentury (April 2004) identify response
and recovery as key components of our Nation's ability to manage the
consequences of a WMD attack.ÿ Our primary goal is to prevent such an
attack, but we must be fully prepared toÿrespond to and recover from an
attack if one occurs.ÿ Accordðingly, we have made significant investments
in our WMD consequence management capabilities in order to mitigate impacts
to the public's health, the economy, and our critical infrastructure.ÿ
Theÿdevelopment and acquisition of effective medical counterðmeasures to
mitigate illness, suffering, and death resulting from CBRN agents is
central to our consequence management efforts.

(3)ÿ It is not presently feasible to develop and stockpile medical
countermeasures against every possible threat.ÿ The development of vaccines
and drugs to prevent or mitigate adverse health effects caused by exposure
to biological agents, chemicals, or radiation isÿa time-consuming and
costly process.ÿ This directive builds uponÿthe vision and objectives
articulated in our National Strategy toÿCombat Weapons of Mass Destruction
and Biodefense for the 21stÿCentury to ensure that our Nation's medical
countermeasure research, development, and acquisition efforts:

(a)ÿ Target threats that have potential for catastrophic impact on our
public health and are subject to medical mitigation;

(b)ÿ Yield a rapidly deployable and flexible capability toÿaddress both
existing and evolving threats;

(c)ÿ Are part of an integrated WMD consequence management approach informed
by current risk assessments of threats, vulnerabilities, and capabilities;
and

(d)ÿ Include the development of effective, feasible, and pragmatic concepts
of operation for responding to andÿ recovering from an attack.

(4)ÿ In order to address the challenges presented by the diverseÿCBRN
threat spectrum, optimize the investments necessary for medical
countermeasures development, and ensure that our activities significantly
enhance our domestic and international response and recovery capabilities,
our decisions as to the research, development, and acquisition of medical
countermeasures will be guided by three overarching principles:

(a)ÿ Our preparations will focus on countering current andÿanticipated
threat agents that have the greatest potentialÿfor use by state and
non-state actors to causeÿcatastrophic public health consequences to the
Americanÿpeople.

(b)ÿ We will invest in medical countermeasures and public health
interventions that have the greatest potential toÿprevent, treat, and
mitigate the consequences of WMD threats.

(c)ÿ We will link acquisition of medical countermeasures toÿthe existence
of effective deployment strategies that areÿsupportable by the present and
foreseeable operational andÿlogistic capabilities of Federal, State, and
local assetsÿfollowing a WMD attack or otherÿevent that presents
aÿcatastrophic public healthÿimpact.

(5)ÿ Mitigating illness and preventing death are the principal goals of our
medical countermeasure efforts.ÿ As a class, bioðlogical agents offer the
greatest opportunity for such medical mitigation, and this directive
prioritizes our countermeasure efforts accordingly.ÿ This directive also
provides for tailoring our Nation's ongoing research and acquisition
efforts to continueÿto yield new countermeasures against CBRN agents and
forÿincorporating such new discoveries into our domestic and international
response and recovery planning efforts.

Biological Threats

(6)ÿ The biological threat spectrum can be framed in four
distinctÿcategories, each of which presents unique challenges and
significant opportunities for developing medical countermeasures:

(a)ÿTraditional Agents:ÿ Traditional agents are naturally occurring
microorganisms or toxin products with the potential to be disseminated to
cause mass casualties.ÿ Examples of traditional agents include Bacillus
anthracisÿ(anthrax) and Yersinia pestis (plague).

(b)ÿEnhanced Agents:ÿ Enhanced agents are traditional agentsÿthat have been
modified or selected to enhance their ability to harm human populations or
circumvent current countermeasures, such as a bacterium that has been
modified toÿresist antibiotic treatment.

(c)ÿEmerging Agents:ÿ Emerging agents are previously unrecognized pathogens
that might be naturally occurring andÿpresent a serious risk to human
populations, such as theÿvirus responsible for Severe Acute Respiratory
Syndrome (SARS).ÿ Tools to detect and treat these agents might not exist or
might not be widely available.

(d)ÿAdvanced Agents:ÿ Advanced agents are novel pathogens orÿother
materials of biological nature that have been artificially engineered in
the laboratory to bypass traditional countermeasures or produce a more
severe or otherwise enhanced spectrum of disease.

Nuclear and Radiological Threats

(7)ÿ Threats posed by fissile and other radiological material will
persist.ÿ Our Nation must improve its biodosimetry capabilities
andÿcontinue to develop medical countermeasures as appropriate toÿmitigate
the health effects of radiation exposure from the following threats:

(a)ÿImprovised Nuclear Devices:ÿ Improvised nuclear devices incorporate
radioactive materials designed to result in the formation of a
nuclear-yield reaction. ÿSuch devices can be wholly fabricated or can be
created by modifying aÿnuclear weapon.

(b)ÿRadiological Dispersal Devices:ÿ Radiological Dispersal Devices (RDDs)
are devices, other than a nuclear explosive device, designed to disseminate
radioactive material to cause destruction, damage, or injury.

(c)ÿIntentional Damage or Destruction of a Nuclear Power Plant:ÿ Deliberate
acts that cause damage to a reactor core and destruction of the containment
facility of a nuclear reactor could contaminate a wide geographic area with
radioactive material.

Chemical Threats

(8)ÿ Existing and new types of chemicals present a range of threats.ÿ
Development of targeted medical countermeasures might beÿwarranted for
materials in the following categories:

(a)ÿToxic Industrial Materials and Chemicals:ÿ Toxic Industrial Materials
and Chemicals are toxic substances inÿsolid, liquid, or gaseous form that
are used or stored forÿuseÿfor military or commercial purposes.

(b)ÿTraditional Chemical Warfare Agents:ÿ Traditional chemical warfare
agents encompass the range of blood, blister,ÿchoking, and nerve agents
historically developed forÿwarfighter use.

(c)ÿNon-traditional Agents:ÿ Non-traditional agents (NTAs) are novel
chemical threat agents or toxicants requiring adapted countermeasures.

(9)ÿ Creating defenses against a finite number of known or anticipated
agents is a sound approach for mitigating the most catastrophic CBRN
threats; however, we also must simultaneously employ a broad-spectrum
"flexible" approach to address other current and future threats.ÿ We must
be capable of responding toÿaÿwide variety of potential challenges,
including a novel biological agent that is highly communicable, associated
withÿaÿhigh rate of morbidity or mortality, and without known
countermeasure at the time of its discovery.ÿ Although significant
technological, organizational, and procedural challenges will have to be
overcome, such a balanced strategic approach would mitigate current and
future CBRN threats and benefit public health.

POLICY

(10) ÿIt is the policy of the UnitedÿStates to draw upon the considerable
potential of the scientific community in the publicÿand private sectors to
address our medical countermeasure requirements relating to CBRN threats.ÿ
Our Nation will use a two tiered approach for development and acquisition
of medical countermeasures, which will balance the immediate need to
provide aÿcapability to mitigate the most catastrophic of the current
CBRNÿthreats with long-term requirements to develop more flexible, broader
spectrum countermeasures to address future threats.ÿ Our approach also will
support regulatory decisions and will permit us to address the broadest
range of current and future CBRN threats.

Tier I:ÿ Focused Development of Agent-Specific Medical Countermeasures

(11)ÿ The first tier uses existing, proven approaches for developing
medical countermeasures to address challenges posed by select current and
anticipated threats, such as traditional CBRN agents.ÿ Recognizing that as
threats change our counterðmeasures might become less effective, we will
invest in an integrated andÿmulti-layered defense.ÿ Department-level
strategiesÿand implementation plans will reflect the followingÿthree
guiding principles and objectives:

(a)ÿ Evaluate and clearly define investments in near- andÿmid term
defenses:ÿ We will develop and use risk assessment processes that integrate
data and threat assessments from the life science, consequence management,
public health, law enforcement, and intelligence communities to guide
investment priorities for current and anticipated threats.ÿ We will openly
identify the high-risk threats thatÿhold potential for catastrophic
consequences to civilianÿpopulations and warrant development of targeted
countermeasures.

(b)ÿ Target medical countermeasure strategies to satisfy practical
operational requirements:ÿ We will model the potential impact of high-risk
threats and develop scenario-based concepts of operations for medical
consequence management and public health mitigation and treatment of
aÿlarge-scale attack on our population.ÿ These concepts ofÿoperations will
guide complementary decisions regarding medical countermeasure development
and acquisition.

(c)ÿ Take advantage of opportunities to buttress U.S. defenses:ÿ We will
coordinate interagency efforts to identifyÿand evaluate vulnerabilities in
our currentÿarsenal of countermeasures to protect the U.S.ÿpopulation.ÿ
Where appropriate, we will target theÿdevelopment of alternate or
supplementary medical countermeasures to ensure that a multi-layered
defense against the most significant high-impact CBRN threats is
established.

Tier II:ÿ Development of a Flexible Capability for New Medical
Countermeasures

(12)ÿ Second tier activities will emphasize the need to capitalize upon the
development of emerging and future technologies that will enhance our
ability to respond flexibly to anticipated, emerging, and future CBRN
threats.ÿ Importantly, this end-state will foster innovations in medical
technologies that will provide broad public health benefit.ÿ
Department-level strategic and implementation plans willÿreflect the
following guiding principles and objectives:

(a)ÿ Integrate fundamental discovery and medical developmentÿto realize
novel medical countermeasure capabilities:ÿ Weÿwill target some investments
to support theÿdevelopðment of broad spectrum approaches toÿsurveillance,
diagnostics, prophylactics, and therapeutics that utilize platform
technologies.ÿ Thisÿwill require targeted, balanced, and sustained
investments between fundamental research to discover newÿtechnologies and
applied research for technology development to deliver new medical
capabilities and counterðmeasures.ÿ Although by no means all-inclusive,
ourÿgoals couldÿincludeidentification and use of early markers for
exposure, greater understanding of host responses to target therapeutics,
and development of integrated technologies for rapid production of new
countermeasures.

(b)ÿ Establish a favorable environment for evaluating newÿapproaches:ÿ We
must ensure that our investments leadÿtoÿproducts that expand the
scientific data base, increase the efficiency with which safety and
efficacy can beÿevaluated, and improve the rate at which products under
Investigational New Drug or Investigational Device Exemption status
progress through the regulatory or approval process.ÿ In addition, we must
continue to use new tools to evaluate andÿutilize promising candiðdates in
a time of crisis.ÿ Examples of such tools include the "Animal Rule" for
testing the efficacy of medical countermeasures against threat agents when
human trials are not ethically feasible and the Emergency Use
Authorization.ÿ Although by no means all-inclusive, our desired end-state
could includethe use of novel approaches for improved evaluation tools,
streamlined clinical trials that meet safety and regulatory needs, and the
development andÿuse of novel approaches to manufacturing.

(c)ÿ Integrate the products of new and traditional approaches: We must
address the challenges that will arise from inteðgrating these new
approaches with existing processes.ÿ We must incorporate the use of
non-pharmacological interðventions in our response planning.ÿ This
integration will forge a flexible biodefense capability that aligns our
national requirements for medical countermeasures with the concepts of
operation that are used in conjunction with other strategies for mitigating
the public health impacts of WMD attacks.

(13)ÿ In order to achieve our Tier I and II objectives, it
willÿbeÿnecessary to facilitate the development of products
andÿtechnologies that show promise but are not yet eligible for procurement
through BioShield or the Strategic National Stockpile.

We will support the advanced development of these products through targeted
investments across a broad portfolio, with the underðstanding that some of
these products may be deemed unsuitable for further investment as
additional data becomes available, but the expectation that others will
become candidates for procurement.

POLICY ACTIONS

(14)ÿ We will employ an integrated approach to WMD medical countermeasure
development that draws upon the expertise of theÿpublic health, life
science, defense, homeland security, intelligence, first responder, and law
enforcement communities, asÿwell as the private sector, to promote a
seamless integration throughout the product development life cycle.

(a)ÿ The Secretary of Health and Human Services (Secretary) will
leadÿFederal Government efforts to research, develop, evaluate, and acquire
public health emergency medical countermeasures to prevent or mitigate the
health effects ofÿCBRN threats facing the U.S. civilian population.ÿ The
Department of Health and Human Services (HHS) will lead the interagency
process and strategic planning and will manage programs supporting medical
countermeasures development and acquisition for domestic preparedness.

(i)ÿStewardship.ÿ Not later than 60ÿdays after the date of this directive,
the Secretary shall establish an interagency committee to provide advice in
setting medical countermeasure requirements and coordinate HHS research,
development, and procurement activities.ÿ Theÿcommittee will include
representatives desigðnated byÿthe Secretaries of Defense and Homeland
Security andÿthe heads of other appropriate executive departments and
agencies.ÿ This committee will serve as the primary conduit for
communication among entities involved in medical countermeasure
development.ÿ The chair of theÿcommittee shall keep the joint Homeland
Security Council/National Security Council Biodefense Policy Coordination
Committee apprised of HHS efforts toÿintegrate investment strategies and
the Federal Government's progress in the development and acquisitionÿof
medical countermeasures.

(ii)ÿStrategic Planning.ÿNot later than 60ÿdays after the date of this
directive, the Secretary shall establish a dedicated strategic planning
activity to integrate risk-based requireðments across the threat spectrum
and over the full range of research, early-, mid-, and late-stage
development, acquisition, deployment, and life-cycleÿmanagement of medical
countermeasures.ÿ The Secretary shall align all relevant HHS programs and
functions to support this strategic planning.

(iii)ÿExecution.ÿ The Secretary shall ensure that the efforts of component
agencies, centers and institutes are coordinated andÿtargeted to facilitate
both development of near-termÿmedical countermeasures and transformation of
our capability to address future challenges.ÿ The Secretary shall also
establish an advanced development portfolio that targets investments in
promising countermeasures and technologies that are beyond
earlyÿdevelopment, but not yet ready for acquisition consideration. ÿIn
order to realize the full potential for broad partnership with academia and
industry, the Secretary shall ensure that HHSÿcoordinates strategies and
implementation plans in a manner that conveys integrated priorities,
activities, and objectives acrossÿthe spectrum ofÿrelevant Federal
participants.

(iv)ÿEngaging the Private Sector and Nongovernmental Entities.ÿ The
Secretary shall develop and implement aÿstrategy to engage the unique
expertise and capabilities of the private sector in developing
medicalÿcountermeasures to combat WMD, andÿshall provide clear and timely
communication of HHSÿpriorities and objectives.ÿ The Secretary shall
consider creating an advisory committee composed of leading experts from
academia and the biotech and pharmaceutical industries to provide insight
on barriers to progress and help identify promising innovations and
solutions to problems such as life-cycle management of medical
countermeasures.ÿ The Secretary shall designate one office within HHS as
the principal liaison for nongovernmental entities who wish to bring new
technologies, approaches, or potential medical countermeasures to the
attention of the Federal Government.

(b)ÿ The Secretary of Defense shall retain exclusive responsibility for
research, development, acquisition, and deployment of medical
countermeasures to prevent or mitigate the health effects of WMD threats
and naturally occurring threats to the Armed Forces and shall continue to
direct strategic planning for and oversight of programs to support medical
countermeasures development and acquisition for our Armed Forces
personnel.ÿ The Secretaries of Health and Human Services and Defense shall
ensure that the efforts of the Department of Defense (DOD) and HHS are
coordinated to promote synergy, minimize redundancy, and, to the extent
feasible, useÿcommon requirements for medical countermeasure developðment.ÿ
The Secretary of Defense shall ensure that DOD continues to draw upon its
longstanding investment and experience in WMD medical countermeasure
research, developðment, acquisition, and deployment to ensure protection of
the Armed Forces, but also to accelerate and improve the overall national
effort, consistent with Departmental authorities and responsibilities, and
shall ensure that DOD continues to place a special focus on medical
countermeasure development for CBRNÿthreat agents because of the unique
facilities, testing capabilities, and trained and experienced personnel
within theÿDepartment.ÿ These efforts will constitute the basis for
interagency partnership and combined investment to safeguard the American
people.

(c)ÿ The Secretary of Homeland Security shall develop aÿstrategic,
integrated all-CBRN risk assessment that integratesÿthe findings ofÿthe
intelligence and law enforcement communiðties with input from the
scientific, medical, and public health communities.ÿ Not later than Juneÿ1,
2008, the Secretary of Homeland Security shall submitÿa report to the
President through the Assistant to theÿPresident for Homeland Security and
Counterterrorism, which shall summarize the key findings of this
assessment, andÿshall update those findings when appropriate, but not
lessÿfrequently than every 2ÿyears.ÿ TheÿDepartment of Homeland Security
shall continue to issue Material Threat

Determinations for those CBRN agents that poseÿa material threat to
national security.

(d)ÿ The Secretaries of Health and Human Services, Defense, andÿHomeland
Security shall ensure the availability of theÿinfrastructure required to
test and evaluate medical countermeasures for CBRN threat agents.

(i)ÿ The Secretaries of Health and Human Services, Defense, and Veterans
Affairs shall leverage their partnership to identify and accelerate
research, development, testing, and evaluation programs for the acquisition
of medical countermeasures for CBRN threats.

(ii)ÿ The Secretary of Health and Human Services and the Secretary of
Homeland Security shall develop effective and streamlined processes,
including mutually agreed-upon timelines, to assist the respective
Secretaries in jointly recommending that the Special Reserve Fund (SRF) be
used for the acquisition of specified security countermeasures.

(iii)ÿ The Director of National Intelligence shall facilitate coordination
across the intelligence community and, in coordination with the Attorney
General, engage the law enforcement community to provide all relevant
andÿappropriate WMD-related intelligence information toÿDHS for the
development of the integrated CBRN risk assessment that is used in
prioritizing the development, acquisition, and maintenance of medical
countermeasures.

GENERAL

(15)ÿ This directive:

(a)ÿ shall be implemented consistent with applicable law and the
authorities of executive departments and agencies, or heads of such
departments and agencies, vested by law, and subject to the availability of
appropriations;

(b)ÿ shall not be construed to impair or otherwise affect theÿfunctions of
the Director of the Office of Management and Budget relating to budget,
administrative, and legislative proposals; and

(c)ÿ is not intended to, and does not, create any rights or benefits,
substantive or procedural, enforceable at law or inÿequity by a party
against the UnitedÿStates, its agencies, instrumentalities, or entities,
its officers, employees, or agents, or any other person.

GEORGE W. BUSH

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