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ATIONAL BIODEFENSE STRATEGY
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NATIONAL
BIODEFENSE
STRATEGY AND
IMPLEMENTATION
PLAN
FOR COUNTERING BIOLOGICAL THREATS, ENHAN CING
PANDEMIC PREPAREDNES S, AND ACHIEVING GLOBAL
HEALTH SECURITY
OCTOBER 2022

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FOREWORD
It is a vital interest of the United States to manage the risk of biological incidents, whether naturally
occurring, accidental, or deliberate. This National Biodefense Strategy and Implementation Plan for
Countering Biological Threats, Enhancing Pandemic Preparedness, and Achieving Global Health
Security updates the 2018 National Biodefense Strategy and serves as a foundational component of the
President’s vision to create a world free from catastrophic biological incidents, laying out a set of
objectives to effectively counter the spectrum of biological threats. It defines biodefense as actions to
counter biological threats, reduce biological risks, and prepare for, respond to, and recover from
biological incidents, whether naturally occurring, accidental, or deliberate in origin and whether
impacting human, animal, plant, or environmental health. It is broader than a Federal Government
strategy; it is a call to action for state, local, tribal, and territorial (SLTT) entities, practitioners,
physicians, scientists, educators, industry, and the international community to work together to elevate
biological preparedness and response.
Biological threats can impact human, animal (domestic and wildlife), plant, and environmental health.
They require an integrated approach that ensures the United States will address not only deliberate
biological incidents as top national security priorities, but also epidemic and pandemic preparedness and
global health security. The inclusion of naturally occurring and accidental biological threats underscores
that our understanding of biodefense must be broader than only the threats posed by terrorist groups or
adversaries seeking to use biological weapons. In today’s interconnected world, biological incidents
anywhere can potentially have profound effects on physical and mental health and well-being in the
United States and globally, cause significant morbidity and mortality, and disrupt livelihoods and
economies, including domestic and international trade and travel. Throughout the Coronavirus Disease
2019 (COVID-19) pandemic, every individual, community, and nation has experienced firsthand the
health, social, and economic crises biological incidents can cause and the severe impact they can have on
lives and livelihoods. The COVID -19 response has illuminated both longstanding and newly discovered
limitations in local, national, and international biodefense capabilities. It has also resulted in the
unparalleled mobilization of citizens, nations, and diverse sectors, and galvanized innovation to address a
global biological threat. The pandemic has demonstrated the urgent need for sustained investment and
coordination across the U.S. Government, private and nonprofit sectors, SLTT entities, our international
partners and organizations, and our communities to assess, prevent, prepare for, respond to, and recover
from future biological incidents.
Biological threats—whether naturally occurring, accidental, or deliberate in origin—are among the most
serious threats facing the United States and the international community. As we have seen with the
COVID-19 pandemic, biological incidents can cause extreme harm to the United States, including death,
hospitalizations, disabilities, psychological trauma, and economic and social disruption on a massive
scale. Biological incidents, whether naturally occurring, accidental, or deliberate, can originate in one
country and spread to many others, with potentially far-reaching international consequences.
Advances in life sciences and biotechnology promise better and faster cures, economic advances, a
cleaner environment, and improved quality of life, but they also bring new security risks that must be
managed. In this rapidly changing landscape, the United States must be prepared to manage the risks
posed by natural outbreaks of disease, accidents with high- consequence pathogens, or adversaries who
wish to do harm with biological agents.

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The health, prosperity, and security of the American people depend on our ability to stop infectious
disease outbreaks at their source and rapidly and effectively contain biological incidents wherever they
occur. The significant viral, bacterial, fungal, and other infectious disease outbreaks and toxin- related
illnesses of recent decades impacting human, animal, and agricultural health, including COVID-19,
continue to reveal that the financing cycle of panic and neglect must end. There is significant and urgent
need to achieve sustained investments and transformative improvements in the ability of both the U.S.
Government and the international community to assess, prevent, prepare for, respond to, and recover from
the next biological incident. Our capabilities must address the range of biological threats: emerging and
reemerging infectious diseases affecting humans, animals, plants, and the environment; risk of intentional
misuse of advances in biotechnology; accidental release of biological agents; and threats posed by
terrorist groups or adversaries seeking to use biological weapons.

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Table of C ontents
FOREWORD .................................................................................................................................. 2
VISION ........................................................................................................................................... 5
PURPOSE ....................................................................................................................................... 5
THREATS AND CONSEQUENCES ............................................................................................ 6
BIOLOGICAL RISK MANAGEMENT ........................................................................................ 7
ASSUMPTIONS ............................................................................................................................. 8
GOALS AND OBJECTIVES ....................................................................................................... 10
GOAL 1: Enable risk awareness and detection to inform decision- making across the
biodefense enterprise. ................................................................................................................ 10

GOAL 2: Ensure biodefense enterprise capabilities to prevent bioincidents. ........................... 10
GOAL 3: Ensure biodefense enterprise preparedness to reduce the impacts of bioincidents. .. 11
GOAL 4: Rapidly respond to limit the impacts of bioincidents. .............................................. 12
GOAL 5: Facilitate recovery to restore the community, the economy, and the environment
after a bioincident. ..................................................................................................................... 12

CONCLUSION ............................................................................................................................. 13
ANNEX I: DEFINITIONS ........................................................................................................... 14
ANNEX II: IMPLEMENTATION PLAN ....................................................................................... i
ANNEX III: LIST OF ACRONYMS .......................................................................................... xxi
ANNEX IV: LEGAL AND POLICY AUTHORITIES .............................................................. xxii

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VISION
The United States actively and effectively assesses, prevents, prepares for, responds to, and
recovers from naturally occurring, accidental, and deliberate biological threats impacting
humans, animals, plants, and the environment and creates a world free from catastrophic
biological incidents.
PURPOSE
This National Biodefense Strategy and Imple mentation Plan for Countering Biological Threats,
Enhancing Pandemic Preparedness, and Achieving Global Health Security (Strategy) brings
together a single coordinated effort to orchestrate the full range of activity that is carried out
across the U.S. Government to protect the American people and its global interests from
biological threats, regardless of origin. With National Security Memorandum -15 (NSM-15), this
Strategy explains how the U.S. Government will manage its activities to more effectively assess,
prevent, prepare for, respond to, and recover from biological threats, coordinating its biodefense
efforts with those of SLTT entities, international partners, industry, academia, nongovernmental
entities, and the private sector.
The mission of the Federal Government during a biological incident is to save lives; reduce
human and animal suffering; protect property and the environment; control the spread of disease;
support community efforts to overcome the physical, emotional, environmental, and economic
impact of the incident; and determine the cause and source of the incident. This federal mission
is contingent upon coordination with and the response of SLTT entities, international partners,
industry, academia, nongovernmental entities, and the private sector. This Strategy describes the
goals and objectives that will guide the United States in assessing biological risks and developing
risk-mitigation measures, as well as assessing, preventing, preparing for, responding to, and
recovering from a biological incident, consistent with its international obligations, including
those identified in the World Health Organization’s International Health Regulations (2005).
Enhancing the national biodefense enterprise will help protect the United States and its partners
abroad from biological incidents, whether naturally occurring, accidental, or deliberate in origin.
It will simultaneously build the U.S. innovation base for cutting-edge countermeasures,
biosensors, diagnostics, and biosurveillance information technologies, and advance the
biomedical and agricultural industries’ biodefense capabilities.

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THREATS AND CONSEQUENCES
Naturally Occurring Biological Threats. Biological threats can affect humans, animals, plants,
and the environment, resulting in significant health, economic, social, and national security
impacts. It is therefore important to address biological threats using a One Health approach that
recognizes the interconnections among people, animals (domestic and wildlife), plants, and the
environment. Infectious disease threats do not respect borders. Urbanization, climate change,
habitat encroachment, economic interdependence, and increased travel, coupled with weak
health systems, increase the ability of infectious diseases to spread rapidly across the globe.
Novel infectious diseases, the resurgence and spread of once geographically limited infectious
diseases, zoonotic diseases, and antimicrobial resistance can overwhelm response capacities and
make outbreaks harder to control. As we have seen with the COVID 19 pandemic, an infectious
disease outbreak—even in the most remote places of the world—could spread rapidly across
oceans and continents, directly affecting the U.S. population and its health, security, and
prosperity.
Accidental Biological Threats. The risk of laboratory accidents may be increasing with the rise
in the number of laboratories around the world conducting high- risk life sciences research and
research with potential pandemic pathogens without appropriate oversight. While this research
is important for developing countermeasures and understanding and predicting future outbreaks,
laboratories with insufficient biocontainment or biosafety protocols and practices exacerbate the
risk of an outbreak through laboratory-acquired infections or accidental release of a pathogen
into the environment. Even with state-of-the-art equipment and standard biosafety protocols,
laboratory accidents are possible due to human error or mechanical failures.
Deliberate Biological Threats. The use of biological weapons or their proliferation by state or
nonstate actors presents a significant challenge to our national security, our people, our
agriculture, and the environment. Multiple nations have pursued clandestine biological weapons
programs, and a number of terrorist groups have sought to acquire biological weapons. In
addition, advances in biotechnology, including synthetic biology, are making it easier to develop
and use biological agents as weapons. In many countries around the world, pathogens are stored
in laboratories that lack appropriate biosecurity measures and could be diverted by actors who
wish to do harm. Further, thousands of clinical samples generated during an epidemic can pose a
biosecurity vulnerability if handled without appropriate security considerations, potentially
facilitating access to materials and information that could be used in the development of a
biological weapon.

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BIOLOGICAL RISK MANAGEMENT
Biological risk management requires understanding and assessing biological risks and taking
steps to mitigate those risks, regardless of whether they originate in the United States or abroad.
It also requires shared international recognition that the risk is global to empower effective,
collective mitigation. The COVID-19 pandemic reminds us that the issue is not if, but when, the
next biological incident will occur.
As the biological threat landscape continues to evolve, so must our biodefense capabilities. If all
countries could assess, prevent, prepare for, respond to, and recover from biological incidents at
the local level, we could minimize the risk of nationally or internationally significant biological
incidents, saving both lives and resources. Preventing acquisition of dangerous pathogens,
equipment, and expertise for nefarious purposes, and maintaining the capability to rapidly
control outbreaks in the event of a biological attack, are strategic interests of the United States.
These must be strategic interests for our partners around the world as well. The United States
cannot carry the burden alone, as an outbreak anywhere in the world can pose a threat to all.
Finally, as we reap the benefits from biotechnologies and state-of-the-art research, we must also
understand and consider the risks they pose. Accordingly, the United States will support an
efficient and coordinated biodefense enterprise to protect the American people and its global
interests.
Domestic action alone is insufficient to protect America’s health and security. The rapid
globalization of science and technology and the increased interconnectedness through travel and
trade necessitate a strong biodefense enterprise that has global reach to effectively assess,
prevent, prepare for, respond to, and recover from biological incidents. The U.S. Government
works domestically and globally to ensure that the United States and its partners are protected
from naturally occurring, accidental, or deliberate biological threats. While the desired outcomes
domestically and globally are the same, the conditions and avenues available to achieve these
outcomes can be very different. Internationally, our efforts to protect the United States and our
partners include direct investment in sustainable, context-appropriate capacity building, and
continued performance assessment and improvement, with the goal of achieving effective,
country-led, and financed health security systems. We will work with multilateral organizations,
partner nations, private donors, and civil society to prevent and control biological threats at their
source by supporting the development and implementation of transparent biodefense and health
security capabilities, policies, and standards.
The United States has long been an innovation leader. To meet the biodefense goals in this
Strategy requires significant advances at the convergence of multiple disciplines, including
biological, chemical, physical, and computational sciences. Whether augmenting our ability to
provide healthcare and safeguard the environment or expanding our capacity for energy and
agricultural production toward global sustainability, continued research and development is
essential for a brighter future for the American people. To ensure that the United States is poised
to meet the evolving biological risk landscape, at a time when unparalleled advancement and
innovation in the life sciences and technology globally continue to transform our way of life, we
are committed to promoting innovation throughout the national biodefense enterprise. We will
promote innovative technologies and systems; encourage technology communities and industry
leaders to meet our targeted biodefense and health capacity needs; link stakeholders with new

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ideas, tools, and products; enhance biosafety and biosecurity practices to minimize the risk of
accidental or deliberate misuse of biological research and biotechnologies; and pursue innovative
approaches and partnerships to achieve, domestically and globally, the goals articulated in
Strategy.
Through the Strategy, the United States will use all appropriate means to assess, prevent, prepare
for, respond to, and recover from biological incidents—whatever their origin—that threaten
health and national or economic security. The Strategy recognizes that a collaborative,
multisectoral, and transdisciplinary One Health approach to the national biodefense enterprise is
necessary to counter biological threats effectively and efficiently.
ASSUMPTIONS
The evolving biological threat landscape requires a comprehensive approach, and the United
States recognizes the following principles:
• Biological Threats Are Persistent. Pathogens have emerged and spread throughout
history, and the risk from these pathogens grows more acute as the world becomes more
urbanized, travel increases, and climate and habitat s change. Separately, nation-states
and terrorist groups have found value in pursuing biological weapons, and there can be
no confidence that will change in the future. Advances in the life sciences will both
reduce the technological hurdles to acquiring such weapons and expand the number of
individuals with relevant skills to effectuate threats.
• Biological Threats Originate from Multiple Sources. Within the scope of biodefense,
the United States includes countering both deliberate biological threats and threats that
stem from naturally occurring and accidental outbreaks. This approach allows the U.S.
Government to fully utilize, integrate, and coordinate the biodefense enterprise and
ensure the most efficient use of all biodefense assets.
• Infectious Diseases Do Not Respect Borders. An interconnected world increases the
opportunity for pathogens to emerge, reemerge, and spread such that a disease threat
anywhere is a disease threat everywhere. Infectious diseases cross borders
indiscriminately, whether via the movement of humans, animals, plants, or through the
environment. The U.S. Government will mitigate biological incidents domestically and
globally by working with our partners abroad, because the United States cannot counter
biological threats domestically without addressing them globally. We will also seek to
improve our ability to prevent the spread of infectious diseases to the United States—
including those that affect humans, animals, plants, and the environment —through
inbound travelers and goods. The ongoing COVID-19 pandemic, African Swine Fever
and Ug99 Stem Rust outbreaks, and the 2014, 2018, and 2021 Ebola outbreaks
demonstrate that the U.S. Government must be prepared to act swiftly when outbreaks
occur. A swift response necessitates engaging at the local, national, and international
levels to galvanize support for and implement context-relevant interventions for the
duration of the response. Furthermore, the United States must continue to exhibit
catalytic global leadership by working with multilateral institutions, foreign governments,
public and private sector partners, and communities for coordinated, whole-of-society
action to strengthen health security systems throughout the world.

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• Biological Incidents Impact Critical Infrastructure and Supply Chains. COVID 19
has demonstrated the severe impact biological incidents can have on critical
infrastructure and supply chains. Depending on the biological incident, a wide array of
sectors may be vulnerable to disruption. The U.S. Government must work across sectors
to improve the resiliency of critical infrastructure and supply chains, especially those
most needed to mount an effective response.
• Multisectoral and Multilateral Cooperation Is Critical for Effective Biodefense.
This Strategy calls for whole-of-government and whole-of-society engagement in
biodefense, domestically and globally. Assessment, prevention, preparedness, response,
and recovery involves diverse sectors, including medical; human, animal, and plant
health; emergency response; scientific and technical; law enforcement; industrial;
academic; diplomatic; defense and security; intelligence; social and behavioral sciences;
strategic risk communications; transportation; travel and tourism; and nonproliferation
and counterproliferation sectors, among others. Engagement with SLTT entities,
international organizations, nongovernmental organizations, communities, the private
sector, and the general public is critical to prevent a biological event and respond to the
next one. Transparency in communications, data sharing, surveillance, and response
efforts by and with domestic and international partners is vital for success.
• A One Health Approach Reduces the Occurrence and Impact of Bioincidents. The
health of people, animals, plants, and the environment are linked. One Health is a
collaborative, multisectoral, and transdisciplinary approach at the local, regional,
national, and global levels, with the goal of achieving optimal health outcomes
recognizing the interconnection between people, animals (domestic and wildlife), plants,
and our environment. Approximately 75 percent of new or emerging infectious disease
threats to human health are of animal origin. Biological threats affecting humans,
animals, or plants can cause physical harm to health and well-being and economic and
supply chain disruption. Implementing a coordinated One Health approach is a best
practice for understanding, communicating, and mitigating biological threats swiftly and
efficiently. Such an approach is necessary to rapidly and effectively assess, prevent,
prepare for, respond to, and recover from biothreats, mitigating potential nationally or
internationally significant biological incidents.
• Science and Technology Will Continue to Advance Globally. The ongoing revolution
in the life sciences and biotechnology will continue at an ever-increasing rate, offering
solutions to many of the challenges of ensuring the health, prosperity, and security of a
growing global population. No longer confined to sophisticated research laboratories,
these technologies are being developed and utilized all over the world, and the necessary
expertise, materials, and equipment are widely available. Advances in science and
technology bring revolutionary cures and progress, but they also have the potential for
intentional misuse. The United States has a responsibility to ensure our technology,
development, and assistance programs do not exacerbate this risk unintentionally.

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GOALS AND OBJECTIVES
The Strategy has five goals with associated objectives for strengthening the biodefense
enterprise, establishing a layered risk management approach to countering biological threats and
incidents.
GOAL 1: Enable risk awareness and detection to inform
decision-making across the biodefense enterprise.
The United States will build risk awareness at the strategic level through analyses and
coordinated research efforts to characterize naturally occurring, accidental, and deliberate
biological risks; and at the operational level through One Health surveillance and detection
activities to detect and identify biological threats and anticipate biological incidents.
Objectives:
1. Ensure decision- making is informed by intelligence, forecasting, and risk assessment.
2. Ensure that domestic and global biothreat detection, biosurveillance, and information
systems are coordinated, integrated, and capable of enabling timely bioincident
prevention, detection, reporting, assessment, response, and recovery.
GOAL 2: Ensure biodefense enterprise capabilities to
prevent bioincidents.
The United States will work to prevent the outbreak and spread of naturally occurring infectious
diseases and minimize the risk of laboratory accidents both domestically and globally. The
United States will also strengthen biosecurity to prevent both state and non-state actors from
obtaining or using biological material, equipment, and expertise for nefarious purposes,
consistent with the U.S. Government’s approach to countering weapons of mass destruction.
Implementing Goal 2 will ensure we have the capabilities necessary to disrupt plots, degrade
technical capabilities, and deter support for state and non- state actors seeking to use biological
weapons. This goal also recognizes the dual-use nature of the life sciences and biotechnology, in
which the same science and technology base that improves health, promotes innovation, and
protects the environment can also be misused for harmful purposes. Domestically and
internationally, the United States seeks to prevent the misuse of science and technology while
promoting and enhancing its legitimate use and innovation.
Objectives:
1. Promote measures to prevent or reduce the spread of infectious diseases.
2. Strengthen global health security capacities internationally to prevent local bioincidents
from becoming epidemics.

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3. Deter, detect, degrade, disrupt, deny, or otherwise prevent nation- state and non- state
actors’ attempts to pursue, acquire, or use biological weapons, related materials, or their
means of delivery.
4. Strengthen biosafety and biosecurity practices and oversight to prevent bioincidents and
reduce biological risks associated with life sciences research and development and
advances in biotechnology.
GOAL 3: Ensure biodefense enterprise preparedness to
reduce the impacts of bioincidents.
The United States will take measures to reduce the impacts of bioincidents, including
maintaining a vibrant national science and technology base to support biodefense; promoting a
strong domestic and international public, veterinary, and plant health infrastructure; developing,
updating, and exercising response and recovery capabilities; establishing risk communications;
developing and effectively distributing and dispensing countermeasures; and collaborating across
the country and internationally to support biodefense.
Objectives:
1. Promote a vibrant, safe, and secure domestic and international science and technology
base, including in biotechnology and biomanufacturing, to support biodefense.
2. Ensure a strong public, veterinary, and plant health infrastructure.
3. Develop, exercise, and update prevention, response, and recovery plans and capabilities,
including efforts to secure critical supply chains.
4. Develop, exercise, and update risk communication plans and promote consistent, plain
language messaging to inform key audiences, expedite desired response actions, and
address public uncertainty and fear.
5. Enhance preparedness to save lives through development, testing, evaluation,
manufacturing, regulatory approval, distribution, and administration of countermea sures.
6. Enhance preparedness to limit the spread of disease through community mitigation
measures.
7. Enhance preparedness to support decontamination, waste management, environmental
controls, and other methods of suppressing pathogens during a biological event.
8. Strengthen preparedness to operate and collaborate across the United States, including the
U.S. territories.
9. Strengthen international preparedness to support international response and recovery
capabilities.

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GOAL 4: Rapidly respond to limit the impacts of
bioincidents.
The United States will respond rapidly to limit the impacts of bioincidents through information
sharing and networking; evidence-driven, coordinated response operations and investigations;
effective public messaging; and research.
Objectives:
1. Compile and share biothreat, bioincident, and response information to enable appropriate
decision-making and response operations across all levels of government and with
nongovernmental, private sector, and international entities, as appropriate.
2. Conduct evidence-driven federal response operations and activities and implement a
federal research agenda in coordination with relevant nongovernmental, private sector,
and international partners where appropriate to contain, control, and rapidly mitigate
impacts of biothreats or bioincidents.
3. Conduct operations and investigations, and use all available tools to hold perpetrators
accountable.
4. Execute risk-informed, accurate, timely, and actionable science- driven risk
communications and community engagement.

GOAL 5: Facilitate recovery to restore the community, the
economy, and the environment after a bioincident.
The United States will take actions to restore critical infrastructure services and capability;
coordinate recovery activities; provide recovery support and long- term mitigation; and minimize
cascading effects elsewhere in the world.
Objectives:
1. Promote restoration of critical infrastructure capability and capacity to enable the
resumption of vital U.S. activities.
2. Ensure coordination of recovery activities across all levels of government and with
nongovernmental, private sector, and international entities, as appropriate, to enable
effective and efficient recovery operations.
3. Provide recovery support and conduct long-term mitigation actions to promote resilience.
4. Reduce the cascading effects of international biological incidents on the global economy,
health, and security.

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CONCLUSION
COVID-19 has demonstrated the enormous dangers posed by biological threats, impacting
virtually every community in the world. Mitigating these risks remains an urgent domestic and
global imperative. Decisive action is required to build on the investments made for, and the
lessons learned from, the COVID-19 response to protect the Nation and our partners from the
full range of biological threats to humans, plants, animals, and the environment. Through this
Strategy, the U.S. Government will optimize its own efforts and harness the work of essential
partners—inside and outside government, domestically and internationally – to assess, prevent,
prepare for, respond to, and recover from biological events, whether naturally occurring,
accidental, or deliberate, that can harm the American people and the global community.

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ANNEX I: DEFINITIONS
The terminology used throughout the Strategy is consistent with the following definitions:
Biodefense: Actions to counter biological threats, reduce biological risks, and prepare for,
respond to, and recover from bioincidents, whether naturally occurring, accidental, or deliberate
in origin and whether impacting human, animal, plant, or environmental health.
Biodefense enterprise: Stakeholders with a role in the prevention, preparedness, detection,
response, and recovery from bioincidents (e.g., Federal and SLTT governments,
nongovernmental and private sector entities, and international partners).
Biological hazard (biohazard): A biological agent or biologically active substance—excluding
toxic chemical substances that are considered solely as chemical weapons agents, regardless of
origin (e.g., naturally occurring or bioengineered)—that represents an actual or potential danger
to humans, animals, plants, or the environment.
Biological incident (bioincident):
• Any natural or accidental occurrence in which a biothreat harms humans, animals, plants,
or the environment consistent with the scope of this Strategy ;
• A crime involving a biothreat consistent with the scope of this Strategy ; or
• Any act of biological warfare or terrorism.
Biological threat (biothreat): An entity involved with, or a situation involving, a biohazard that
can potentially cause a bioincident.
Biosurveillance: The process of gathering, integrating, interpreting, and communicating
essential information and indications related to all- hazard threats or disease activity affecting
human, animal, plant, and environmental health to achieve early detection and provide early
warning, contribute to overall situational awareness of the health aspects of the incident, and
enable better decision-making at all levels.
Community Mitigation Measures: Behaviors or actions that people and communities can take
to help slow the spread of a biological threat, to include threat-appropriate travel and border
health measures, contact tracing, isolation, quarantine, social distancing, handwashing, use of
personal protective equipment (PPE), and other non- pharmaceutical interventions.
Countermeasures: Medical countermeasures, veterinary, or plant health pharmaceutical
products, such as vaccines, antimicrobials, and antitoxins, as well as non-pharmaceutical
products, such as ventilators, diagnostic tests, PPE, and patient decontamination materials, that
may be used to prevent, mitigate, or treat the adverse health effects from a bioincident.
Dual use: Intended for legitimate purposes but having the potential for both benevolent and
malevolent applications.
One Health: A collaborative, multisectoral, and transdisciplinary approach working at the local,
regional, national, and global levels, with the goal of achieving optimal health outcomes
recognizing the interconnection between people, animals, plants, and the environment.

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Nationally or Internationally Significant Biological Incident: A biological threat or incident
with present or potential scale, timing, severity, complexity, or unpredictability to: cause harm to
the United States or across international borders; overwhelm existing resources,
countermeasures, and personnel; and threaten U.S. or global health, national, economic, or food
security.

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ANNEX II: IMPLEMENTATION PLAN
FOR THE NATIONAL BIODEFENSE
STRATEGY

OVERVIEW
Coronavirus D isease 2019 (COVID-19) continues to take a tremendous toll on lives and
livelihoods around the world, disrupting national and global security and affecting the national,
health, and economic security of every nation. The United States must now chart a new vision
for biodefense. The COVID -19 pandemic illuminated both longstanding and newly discovered
limitations in local, national, and international biodefense capabilities, starkly demonstrating that
continual investment in, and innovations toward, a biodefense enterprise must be a top priority
for the United States. The United States will take actions to achieve and sustain epidemic and
pandemic preparedness, counter biological weapons, and improve health security and global
health in collaboration with our international partners.
The Biden-Harris Administration is setting our Nation on a course that is designed to provide all
Americans a safe place to live and prosper. Through this implementation plan, we are setting
forth a new moonshot, a set of bold outcomes for biodefense, which prioritize transformational
technical and measurable targets. Achieving this vision will require not only the technical
advancements but also necessitate sociological achievements, such as enhancing trust in science
and overcoming a growing hesitancy towards safe and effective medical countermeasures.
Domestic action alone is insufficient; achieving this vision necessitates working with multilateral
organizations, partner nations, the private sector, and civil society to support and strengthen
capacity to prevent and effectively control biological threats at their source.
The outcomes prioritized in this implementation plan include the integration of the critical
needed capabilities described in this Administration’s American Pandemic Preparedness:
Transforming Our Capabilities. Departments and agencies will implement these efforts,
commensurate with available resources and subject to the availability of appropriations, in
support of the National Biodefense Strat egy for Countering Biological Threats, Enhancing
Pandemic Preparedness, and Achieving Global Health Security (Strategy). The prioritized bold
outcomes found here, mapped to the overarching Strategy, are intended to realize the unified
vision across U.S. departments and agencies that the United States must actively and effectively
detect, prevent, prepare for, respond to, and recover from naturally occurring, accidental, and
deliberate biological threats impacting humans, domestic and wildlife animals, plants, and the
environment to create a world free from catastrophic biological incidents.

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IMPLEMENTING THE STRATEGY
To fulfill its vision for biodefense, the Administration identified the following transformational
bold outcomes for countering biological threats, enhancing pandemic preparedness, and
achieving global health security. Under each Goal of the Strategy, the following actions will be
implemented to achieve these priorities and advance the Strategy. Some activities may contribute
to multiple Goals but are listed only under one for simplicity. The conditions and avenues to
achieve the international elements of these priorities differ from those available for U.S.
domestic capacities; they rely on direct and catalytic engagement through partnership with
multilateral organizations, partner nations, the private sector, and civil society to encourage
prioritization of biodefense. Implementation of this plan is subject to the annual President’s
Budget process and the availability of appropriations. Nothing in this Implementation Plan shall
be construed to impair or otherwise affect the functions of the Director of the Office of
Management and Budget relating to budgetary, administrative, or legislative proposals.
The U.S. Government will lead and drive towards the historic goals laid out within this
Implementation P lan. The U.S. Government can advance many of the actions described below,
but we cannot do everything on our own. We will seek to advance these goals in partnership and
collaboration with international organizations, foreign governments, and state, local, tribal, and
territorial authorities—as well as other private sector, academic, and civil society stakeholders—
that in many cases have primary responsibility and/or legal authority.
For each priority (#.#.), a set of targets (#.#.#.), and corresponding actions (I ) have been
identified. The priorities and selected targets and actions listed below provide direction as well as
a concrete method for tracking and measuring progress towards the achievement of the outcome,
with lead and supporting departments and agencies listed for each target. Implementation of this
plan is a priority for the Administration and progress on implementation will be tracked
internally through the regular updates to the Global Health Security and Biodefense Directorate
of the National Security Council as tasked in National Security Memorandum-15 (NSM-15).
In addition to the activities laid out in this section, agencies will implement all of the Strategy
through existing policies, plans, and frameworks and consistent with existing statutory
authorities. A demonstrative list of policies, plans, frameworks, and statutory authorities can be
found in Annex IV.

N
ATIONAL BIODEFENSE STRATEGY
iii
GOAL 1. Enable Risk Awareness and
Detection to Inform Decision-Making across
the Biodefense Enterprise
The United States will build risk awareness at the strategic level through analyses and
coordinated research efforts to characterize naturally occurring, accidental, and deliberate
biological risks; and at the operational level through One Health surveillance and detection
activities to detect and identify biological threats and anticipate biological incidents.
1.1. Early Warning
Develop the ability to rapidly detect, characterize, report, forecast, and share relevant
information (including genetic sequence data), as appropriate, on pathogens that pose a
biological threat of national or international significance soon after they emerge in humans,
animals

, and plants. Early warning will inform and enable (a) early assessment and
identification of the origin of biological incidents and (b) effective decision- making and
interventions at local, national, and international levels.
1.1.1. Detection and Reporting of Biological Threats
Develop domestic, and support the development of global, capacities and capabilities to detect
and report disease outbreaks in humans, animals†, and plants anywhere in the world and collect
and rapidly share information, data, and samples including internationally and across sectors,
with appropriate safety and security controls, to prevent or limit nationally or internationally
significant biological incidents.
I. Work domestically and with international partner countries to support and implement the
development and integration of international systems and operating procedures to rapidly,
safely, and securely share technical and analytical information, data, and samples
supporting surveillance and mitigation to prevent or limit nationally or internationally
significant biological incidents including a Public Health Emergency of International
Concern. (Lead: United States Department of State (DOS), United States Department of
Health and Human Services (HHS); Support: United States Department of Defense
(DoD), United States Department of the Interior (DOI), United States Department of
Agriculture (USDA), United States Department of Commerce (DOC), United States
Department of Energy (DOE), United States Department of Homeland Security (DHS),
United States Agency for International Development (USAID), National Institutes of
Health (NIH), Federal Bureau of Investigation (FBI), Centers for Disease Control and
Prevention (CDC))
II. Demonstrate the sustained domestic and international capacity of surveillance and
monitoring systems, including syndromic, pathogen, and events-based systems, needed to
detect and regularly report known and new infectious diseases threats in humans, plants,


Including wildlife and domestic

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NATIONAL BIODEFENSE STRATEGY iv
and animals†. (Lead: DOS, USAID, CDC; Support: DoD, DOI, USDA, HHS, DOE,
DHS, United States Environmental Protection Agency (EPA), NIH, FBI)
III. Accelerate domestic and international basic and applied research and innovation across
disciplines to implement advanced biosurveillance and biodetection capabilities for
clinical and environmental early warning and enable large- scale, affordable, and routine
biological hazard agnostic and/or specific biosurveillance and biodetection, for animal,
human

, plant, and environmental surveillance. (Lead: USDA, DHS, EPA, CDC;
Support: DOS, DoD, DOI, DOC, HHS, DOE, USAID, FBI)
1.1.2. Biological Threat Sequencing and Analytical Data Sharing
After acquiring a suitable sample, generate and disseminate domestically, and internationally
consistent with international norms and standards and in accordance with applicable laws and
policies, pathogen genome sequence data and other analytical information, with appropriate
safety and security controls, to support the surveillance and mitigation of nationally or
internationally significant biological incidents.
I. Develop domestically, and support internationally, the capacities, policies, and
capabilities needed to perform and share rapid genomic sequencing and analysis. (Lead:
HHS; Support: DOS, DOI, USDA, DOC, DOE, United States Department of Veterans
Affairs (VA), DHS, NIH, FBI, CDC)
1.1.3. Data Integration for Early Warning
After receiving relevant information and data, share domestically and internationally, with
appropriate safety and security controls, through identifying, integrating, and improving existing
effective global early warning systems, across all sectors, that are tightly integrated with existing
state, local, tribal, and t erritorial ( SLTT), national, and international surveillance and monitoring
systems for public health, animal health†, plant health, and water infrastructure.
I. Develop a U.S. Government early warning joint capabilities plan to: 1) advance early
warning technologies and capabilities for more rapid identification of pathogens; and 2)
rapidly and securely aggregate and share surveillance, biological threat information, and
additional information needed for early warning and containment of any pathogen with
pandemic potential among the federal government, SLTT governments, health providers,
international partners, and other key stakeholders. This joint capabilities plan will focus
on areas including, but not limited to, data platforms and sharing, real-world evidence
based infectious disease modeling, reportable disease lists, improved integration of
laboratory response, and wastewater and environmental surveillance, as well as insights
gleaned from outreach and partnerships described herein. (Lead: United Sta tes National
Security Council (NSC), Office of Science and Technology Policy (OSTP); Support:
DOS, DoD, DOI, USDA, DOC, HHS, United States Department of Transportation
(DOT), DOE, VA, DHS, EPA, USAID, NIH, FBI, CDC, IC)
II. Enhance capacity for rapid analysis, modeling, baselining, forecasting, and reporting to
monitor and evaluate the health threat landscape, through a One Health lens, and improve
early warning capabilities. (Lead: DHS, CDC; Support: DoD, USDA, HHS, DOT, DOE,
FBI)


Including clinical and wastewater


NATIONAL BIODEFENSE STRATEGY v
III. Establish multi- sectoral groups of federal, SLTT, and private sector partners, and with
international partners, to address policy issues that may limit the interchange of
biosurveillance data by addressing issues, such as data provenance; privacy; information
security, including but not limited to classification or status as controlled unclassified
information, conditions of disclosure, and other applicable safeguarding measures;
standard data use agreements and memoranda of understanding; civil liberties; and civil
rights. (Lead: DOI, USDA, HHS, DHS; Support: DOS, DoD, DOT, DOE, EPA, USAID,
NIH, CDC)
1.1.4. Biological Threat Assessment and Characterization Capabilities
Develop enhanced capabilities and capacities, with appropriate safety and security controls, to
initially assess and characterize biological threats to humans, animals, and plants within one
week of acquiring a suitable sample, including by developing characterization capabilities for
novel pathogens; timely and effective biological material characterization to support
investigations, origin determination, and attribution; and functional characterization to support
response and recovery decisions.
I. Develop and implement a domestic characterization research and development agenda for
collaboration between the federal government, academia, and the private sector and work
with foreign partner countries and international organizations to develop internationally
recognized standards for safe and secure characterization of novel pathogens to support
response and recovery decisions, meeting high standards for biosecurity and biosafety.
(Lead: DOI, USDA, DHS, NIH, FBI; Support: DOS, DoD, DOC, HHS, DOE, EPA,
CDC)
II. In collaboration with diverse stakeholders and partners, continue existing efforts to
leverage strategic risk assessment capabilities to provide data-driven risk-based decision
support for resource allocation to measures that protect the United States from a range of
biological attacks as required by Homeland Security Presidential Directive- 18. (Lead:
DHS; Support: USDA, HHS, EPA, NSC, FBI, IC)
III. Enhance and sustain U.S. Government characterization capabilities for forensics and
attribution, serving the U.S. human, animal, plant, and environmental health and national
security communities. (Lead: HHS, FBI; Support: DOI, USDA, DOE, DHS, EPA, CDC,
IC)
1.2. Additional Actions
I. Revise, implement, and exercise operational plans for early warning to enable rapid
response, including clarifying roles and responsibilities for integrating biosurveillance
information; managing early warning across federal government and participating
international partners; and institutionalizing and exercising the Biological Incident
Notification and Assessment (BINA) Protocol. (Lead: NSC; Support: DOS, DoD, DOI,
USDA, HHS, DOT, DOE, VA, DHS, EPA, USAID, FBI, CDC, IC)
II. Maintain and enhance an enduring domestic all-hazards hospital
§
data collection
capability, including data reporting and management systems, governance processes, and

§
Including other appropriate healthcare facilities and systems


NATIONAL BIODEFENSE STRATEGY vi
user guidance, to enable comprehensive data reporting for biosurveillance, situational
awareness, and emergency response operations at the federal and SLTT levels. (Lead:
CDC; Support: DoD, HHS, VA, DHS)
III. Support the capacity of the United Nations system to investigate outbreaks of unknown
origin. (Lead: DOS, HHS)

N
ATIONAL BIODEFENSE STRATEGY
vii
GOAL 2. Ensure Biodefense Enterprise
Capabilities to Prevent Bioincidents
The United States will work to prevent the outbreak and spread of naturally occurring
infectious diseases and minimize the risk of laboratory accidents both domestically and
globally. The United States will also strengthen biosecurity to prevent both state and non-
state actors from obtaining or using biological material, equipment, and expertise for
nefarious purposes, consistent with the U.S. Government’s approach to countering
weapons of mass destruction.
2.1. Global Health Security
Advance the development, enhancement, and maintenance of effective global health security
capacities through sustained political, financial, and technical support, leveraging catalytic U.S.
leadership and support, including in support of the multilateral Global Health Security Agenda
(GHSA).
2.1.1. Strengthen Country Capacities
Provide direct support to at least 50 countries and use catalytic leadership to work with key
donors and partners to support at least 50 additional countries, to achieve “Demonstrated
Capacity” or comparable level (depending on country context) in at least five technical areas
critical to the country, by 2025, as measured by relevant health security assessments, such as
those conducted within the World Health Organization (WHO) IHR Monitoring and Evaluation
Framework, such as the JEE, SPAR, and/or other relevant health security assessments.

I. Review and revise recommendations for the annual expansion of global health security
partner countries, considering factors listed in the Global Health Security Strategy, status
of country progress towards the GHSA 2024 targets, foreign policy priorities, and
existing footprints of departments and agencies, building on U.S. Government COVID -
19 response activities. (Lead: NSC)
II. Work with country governments and other partners in United States Government-
supported countries to address identified gaps and improve capacities in key technical
areas for global health security. (Lead: DOS, USDA, HHS, DOT, USAID; Support: DoD,
DHS)
III. In addition to providing direct support to partners, encourage countries to prioritize their
domestic health security capabilities and invest in building and sustaining these
capacities, including through domestic resource mobilization, and work with donor
countries, international financial institutions, and regional organizations to coordinate
plans and generate new commitments. (Lead: DOS, HHS)
IV. Catalyze political leadership and attention for biological crisis in order to act more
quickly in future emergencies, including at the leaders’ level. (Lead: DOS, HHS)

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NATIONAL BIODEFENSE STRATEGY viii
2.1.2. Establish and Maintain Sustainable Global Financing for Health Security and
Pandemic Preparedness
Support and help lead the establishment of a reliably financed international mechanism to
catalyze and provide sustainable financing for global health security, pandemic preparedness,
and response capabilities.
I. Work with international partners, including the members of the Group of 7 (G7 ) and the
Group of 20 (G20), to develop and establish a Financial Intermediary Fund at the World
Bank for global health security and pandemic preparedness. (Lead: DOS, United States
Department of Treasury (Treasury), HHS, USAID)
2.2. Prevention
Prevent nationally or internationally significant biological incidents by (a) minimizing the
chances of laboratory accidents; (b) reducing the likelihood of deliberate use or accidental
misuse; (c) ensuring effective biosafety and biosecurity practices and oversight; (d) promoting
responsible research and innovation; and (e) reducing the likelihood of animal to human
spillover of zoonotic pathogens.
2.2.1. Promote Safe and Secure Biological Laboratories and Practices
Ensure all facilities in the United States or funded by the U.S. Government that conduct life
sciences research, development, manufacturing, or diagnostic activities with especially
dangerous biological materials—or which conduct work reasonably anticipated to result in such
materials—are implementing and maintaining effective, transparent, rigorous, and
comprehensive oversight, training, and monitoring programs for biosafety, biosecurity, and
responsible and ethical conduct in science. Ensure the workforce at these facilities is trained to
recognize, respond to, and report unsafe practices and threats.
I. Complete an interagency review and provide recommendations for U.S. policy, guidance,
and practices to improve laboratory biosafety and biosecurity policy. (Lead: NSC, OSTP;
Support: DOS, Treasury, DoD, DOI, USDA, DOC, United States Department of Labor
(DOL), HHS, DOT, DOE, VA, DHS, EPA, National Science Foundation (NSF), USAID,
NIH, FBI, United States Food and Drug Administration (FDA), CDC, IC)
II. Support the development of a domestic and international cohort of biosafety and
biosecurity experts to champion responsible research and cultivate measurably improved
biosafety and biosecurity practices globally. (Lead: DOS, USDA, HHS, FBI; Support:
NIH, CDC)
III. Strengthen the scientific evidence base of laboratory biological risk management. (Lead:
DOS, USDA, NIH; Support: DoD, HHS, DHS, EPA, FBI, CDC)
IV. Strengthen partner countries’ ability to have in place a whole-of-government national
biosafety and biosecurity system, including at sub-national levels, helping to ensure that
especially dangerous biological materials are identified, held, secured, cultured,
processed, transferred, and monitored in a minimal number of facilities according to best
practices and regulations to prevent proliferation risks. (Lead: DOS, HHS; Support: DoD,
USAID, FBI, CDC)
V. Galvanize support for multilateral biosafety and biosecurity commitments and the
establishment of regional and global mechanisms to raise the global bar for biosafety and


NATIONAL BIODEFENSE STRATEGY ix
biosecurity norms and practices, including through effective partnerships with the private
sector and existing international organizations and other international forums. (Lead:
DOS; Support: DoD, HHS, DHS, EPA, FBI, CDC)
2.2.2. Strengthen Responsible Conduct for Biological Research
Establish or identify domestic or international forums, mechanisms, or entities to focus on
supporting efforts to develop and provide guidance for implementable, effective, and rigorous
life sciences research biosafety and biosecurity norms and oversight and monitoring programs in
all sectors worldwide.
I. Complete an interagency review of efforts to strengthen responsible conduct for
biological research and develop and operationalize interagency plans. (Lead: NSC,
OSTP; Support: DOS, Treasury, DoD, DOI, USDA, DOC, DOL, HHS, DOT, DOE, VA,
DHS, EPA, NSF, USAID, NIH, FBI, CDC)
II. Enhance screening of domestic biotechnology research, nucleic acid and biologics
synthesis orders, and systems for identification and reporting suspicious orders, in
consultation with relevant private sector partners. (Lead: USDA, DOC, HHS, EPA,
OSTP; Support: DOS, DOE, DHS, NIH, FBI, FDA, CDC)
III. Support domestic forums and mechanisms to encourage routine peer-to-peer sharing
regarding best practices in responsible conduct of biological sciences research. (Lead:
USDA, HHS; Support: EPA, NIH, FBI, CDC)
IV. Work with foreign partners to strengthen responsible research best practices, promote
research security, and support the development of systems for research oversight. (Lead:
DOS, HHS; Support: USDA, DOE, FBI, CDC)
2.2.3. Accelerate biosafety and biosecurity innovation
Accelerate laboratory biosafety and biosecurity innovation by supporting efforts to identify and
address the research gaps needed to improve evidence-based laboratory biological risk
management, both in the United States and globally, and share with international partners.
I. Develop a U.S. Government joint capabilities plan to accelerate biosafety and biosecurity
innovation. (Lead: NSC, OSTP; Support: DOS , DoD, USDA, HHS, DOT, DOE, VA,
DHS, EPA, USAID, NIH, CDC)
2.2.4. Deter Biological Weapons
Strengthen (1) the international norms against biological weapons (BW) and (2) the mechanisms
and tools needed to hold state and non- state actors accountable for BW development,
proliferation, use, or the deliberate misuse of biological research, technologies, and knowledge.
I. Work with foreign partners to strengthen the international security communities’
capabilities to recognize, interdict, disable, and destroy biological weapons and weapons-
related equipment, material, means of delivery, and facilities, as well as to attribute
responsibility for their use. (Lead: DOS, DoD; Support: DHS, FBI)
II. Strengthen the implementation of the Biological Weapons Convention and United
Nations Security Council Resolution 1540 in order to prevent nation- state or non-state
development, acquisition, or use of biological weapons, related materials, or means of
delivery. (Lead: DOS, DoD; Support: DOT, DOE, FBI)

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NATIONAL BIODEFENSE STRATEGY x
III. Strengthen the capability of the UN Secretary -General's Mechanism for Investigation of
Alleged Use of Chemical and Biological Weapons (UNSGM) to determine the facts,
including attribution, regarding the alleged use of biological or toxin weapons. (Lead:
DOS, DoD, FBI)
2.2.5. Reduc e Zoonotic Pathogen Spillover
Use a One Health approach to understand the greatest drivers of risk for pathogen spillover, with
appropriate safety and security controls, and implement sustainable, evidence-based, infectious
disease prevention, detection, identification, control, mitigation interventions, and risk reduction
activities at the local, community, tribal, national, and regional levels, and support
implementation internationally.
I. Enable a common U.S. federal operating picture of spillover events. (Lead: DOI, USDA,
DHS, EPA, CDC; Support: DOS, HHS, DOT, USAID, NIH, FBI)
II. Work with domestic public health, animal and plant health, and environmental health
stakeholders to increase agricultural biosafety, biosecurity, and bio- surveillance for
activities associated with pathogen spillover, and reduce activities found to be drivers of
pathogen spillover. (Lead: DOI, USDA, DHS, CDC; Support: HHS, EPA, NIH, FBI)
III. Support partner countries to develop, implement, and scale-up evidence-informed
interventions at the community level to reduce zoonotic pathogen spillover informed by
risk assessment and other critical information (i.e., understanding of viral and ecological
factors), engagement of traditional and non- traditional partners, and targeted research to
prioritize, implement, and validate interventions. (Lead: DOS, USDA, USAID, CDC;
Support: HHS, NIH, FBI)

N
ATIONAL BIODEFENSE STRATEGY
xi
GOAL 3. Ensure Biodefense Enterprise
Preparedness to Reduce the Impacts of
Bioincidents
The United States will take measures to reduce the impacts of bioincidents, including
maintaining a vibrant national science and technology base to support biodefense;
promoting a strong domestic and international public, veterinary, and plant health
infrastructure; developing, updating, and exercising response and recovery capabilities;
establishing risk communications; developing and effectively distributing and dispensing
countermeasures; and collaborating across the country and internationally to support
biodefense.
3.1 Domestic Health Capacity
Enhance U.S. ability to respond swiftly to biological incidents by modernizing and expanding
the footprint of domestic health infrastructure and by restoring public trust in health, science, and
medicine, in part by countering misinformation and disinformation.
3.1.1. Invest in Domestic Public Health Capacities
Ensure all levels of government, including SLTTs, the largest population centers, and rural and
frontier jurisdictions, are operationally ready to assess, prevent, prepare for, respond to, and
recover from nationally or internationally significant biological incidents affecting public health.
I. Update federal SLTT operational plans and upgrade national and SLTT capabilities for
contact tracing, including digital technologies to facilitate contact tracing, and exposure
notification to enable containment of infectious pathogens during future biological
incidents. (Lead: CDC; Support: DHS)
II. Develop SLTT capability to preserve healthcare and public health delivery capacity
during public health outbreaks and emergencies to enhance and preserve timeliness and
continuity and quality of care. (Lead: CDC)
III. Recruit, train, and sustain a robust, flexible, permanent cadre of essential critical health
infrastructure workers, public health laboratory scientists, technicians, and data quality
managers to support surveillance and response testing and reporting and support the
recruitment of One Health experts and dedicated animal disease epidemiologists, who are
critical frontline workers for animal disease control at relevant state and territorial
agencies and departments, in all 50 states. (Lead: USDA, CDC)
IV. Provide technical assistance on border health security to support domestic capacity to
detect, report, and respond to diseases affecting travelers and mobile populations arriving
in, transitioning through, and departing from the United States. (Lead: CDC; Support:
DOT, DHS)

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NATIONAL BIODEFENSE STRATEGY xii
3.1.2. Strengthen Capacities to Combat Emerging and Zoonotic Disease
Ensure governments at all levels, federal and SLTT, can implement, using a One Health
approach, enhanced emerging and zoonotic surveillance, prevention, and control programs,
including for vector-borne diseases.
I. Enhance and expand domestic capacity to advance a One Health approach for the
surveillance, prevention, and control of emerging and zoonotic infectious diseases in
animals, human populations, and the environment with all SLTT health departments
using a data- driven approach in decision making around both vector control and
surveillance efforts. (Lead: DOI, USDA, EPA, CDC; Support: DOE, DHS, FBI)
II. Increase domestic surveillance and sampling of potential sources of zoonotic spillover of
existing and emerging diseases. (Lead: DOI, USDA, HHS; Support: DHS, EPA, NIH,
FBI, CDC)
3.1.3. Promote Evidence- Based Health Communication to the Public
Increase (1) vaccine uptake rates for all recommended vaccines to over 85% of American
population and (2) public information campaigns reaching 80% of American population related
to health, science, innovation, medicine, and biodefense by empowering the public and SLTT
officials to keep themselves and their communities safe from biological incidents through
evidence-based public messaging and education campaigns, while also countering and mitigating
the spread of disinformation and misinformation.
I. Improve federal messaging coordination for biothreats and bioincidents by developing a
government-wide strategy that creates an enabling environment for coordination of
information, institutionalizes the use of risk communication principles, and provides
clear, consistent, and coordinated information. (Lead: HHS; Support: USDA, DOT, DHS,
NSC, OSTP, United States Domestic Policy Council (DPC), NIH, FBI, CDC)
II. Enhance messaging partnerships in advance of a bioincident. (Lead: USDA, HHS;
Support: DOT, NSC, OSTP, DPC, CDC)
III. Create evidence-based public information campaigns to prepare the public for potential
adverse events, handle messaging during response, and prepare, educate, and inform the
public of appropriate steps to take. This work would incorporate learning from past
responses, in particular COVID-19. (Lead: USDA, HHS; Support: DHS, NSC, OSTP,
DPC, NIH, CDC)
3.1.4. Strengthen Healthcare- Associated Infections (HAI) and Antibiotic Resistant (AR)
Pathogens Capacities
Ensure states, localities, tribes, and territories can implement comprehensive programs to detect,
respond to , and prevent the transmission of healthcare-associated infections (HAI) and antibiotic
resistant (AR) pathogens .
I. Through E.O. 13676 and the National Action Plan for Combating Antibiotic Resistant
Bacteria (CARB), 2020-2025, strengthen U.S. federal and SLTT capacity to slow the
emergence of resistant bacteria, prevent the spread of resistant infections, promote the
responsible use of antibiotics, and conduct surveillance of antibiotic resistant pathogens.
(Lead: DoD, USDA, HHS, VA; Support: CARB Task Force agencies as identified in the
CARB National Action Plan)

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NATIONAL BIODEFENSE STRATEGY xiii
3.2. Rapidly and Widely Available Diagnostics
Develop, validate, manufacture, authorize, and deploy widely available, affordable, and highly
sensitive and both specific and broadly reactive tests domestically for biological hazards assayed
from any human- , animal-, agriculturally-, or environmentally derived specimen, at timescales
and sensitivities necessary to respond, contain, and control a potential nationally or
internationally significant biological incident.
Targets 3.2.1 through 3.2.3 will be covered in a diagnostics joint capabilities plan, described
below.
3.2.1. Pathogen Agnostic Tests
Enable the capability and capacity, including pre - and post-analytical capabilities and capacities,
to deploy and utilize, including clinical utilization, at least one authorized pathogen agnostic test,
such as sequencing, for use in epidemiologically relevant locations, or for deployment within
twelve hours, for thousands of samples on the first day, and tens of thousands of samples per day
within seven days, after determination of a potential nationally or internationally significant
biological incident, to support response, containment, and control.
3.2.2. Pathogen Specific Tests
Develop, validate, and produce authorized pathogen- specific tests, for human-, animal-,
agriculturally-, or environmentally derived specimens, that can be deployed rapidly within thirty
days of determination of a potential nationally or internationally significant biological incident,
in sufficient quantities domestically to support the response to, and containment and control of, a
potential nationally or internationally significant biological incident.
3.2.3. Rapid, Low Cost, Point-of-Need Tests
Develop, validate, and produce affordable authorized pathogen-specific tests, for human, animal,
agriculturally, or environmentally derived specimens, with necessary sensitivity and specificity
for wider clinical and non- clinical use domestically, such as point-of-need testing (i.e., near-
patient use, field use, or pen- side use), including low-resource settings, with a test run time
between five and thirty minutes within ninety days of determination of a potential nationally or
internationally significant biological incident.
I. Develop a U.S. Government diagnostics joint capabilities plan. (Lead: NSC, OSTP ;
Support: DOS, DoD, USDA, DOC, HHS, DOE, DOT, VA, DHS, EPA, NIH, FDA,
CDC)
3.3. Resilient and Scalable Supply of Personal Protective Equipment (PPE)
Establish resilient and scalable supply and manufacturing capabilities for PPE in the United
States that can: (a) enable a containment response for; and (b) meet U.S. peak projected demand
for healthcare and other essential critical infrastructure workers during a nationally or
internationally significant biological incident.
3.3.1. PPE Capacity
Maintain a sustainable and continuously improving federal stockpile of PPE systems and
enhance capacities and capabilities that, including through the implementation of Executive
Order 14017 of February 24, 2021 (America’s Supply Chains): (1) provides a domestic

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NATIONAL BIODEFENSE STRATEGY xiv
minimum ninety-day surge capability; (2) can accommodate commercial distribution channels as
well as replenish federal, state, and local PPE stockpiles and provides (a) steady -state market
supply, (b) manufacturing surge capacity, and (c) storage and inventory capacity, including
monitoring of PPE stockpiles and user inventories; and (3) contributes domestically to the
response to, and containment and control of, a potential nationally or internationally significant
biological incident.
I. Conduct an analysis to determine the quantities of PPE needed to protect the healthcare
and other essential critical infrastructure workforce in any catastrophic biological incident
or pandemic, to set requirements for the Strategic National Stockpile and domestic surge
manufacturing capacity. Analysis will cover equipment needed in the event of highly
virulent and transmissible pathogens or other biological hazards, including N95 masks,
gowns, gloves, reusable respirators (half-face and full-face), reusable full body suits,
fully encapsulated Occupational Safety and Health (OSHA) Level A or B boots, Powered
Air Purifying Respirators, and sterilization chemicals. Analysis will also assess PPE
capacity needs to cover vulnerable populations and a diversity of body types, including
children. (Lead: HHS; Support: DOT, VA, DHS, EPA, CDC)
II. Safeguard PPE supply chain diversity for public and animal health through policy,
incentives, regulation, and other tools to reduce dependence on a single region, source, or
product. Diversity in this context includes a diverse set of products (e.g., N95 filtering
facepiece respirators and elastomeric half mask respirators) and domestic
sources/suppliers (e.g., components and end products) for these products. (Lead: USDA,
HHS; Support: DOS, DoD, DOL, DOT, VA, DHS, FBI, CDC)
III. Reinforce PPE supply chain agility to ensure that supply chain partners can better
respond to supply chain disruptions and increased demand. (Lead: HHS; Support: DOS,
USDA, DOL, DOT, CDC)
IV. Enhance the PPE supply chain at the SLTT level through partnership, policy,
procurement, guidance, and regulation. (Lead: DOL, HHS; Support: DOT, CDC)
3.3.2. PPE Innovation
Invest in and incentivize innovations in PPE design, novel material development, advanced
manufacturing, and reusable technology capabilities that result in steady state and surge
capacities for domestic production of PPE with resilient supply chains and enhanced
effectiveness, usability, comfort, affordability, reusability, and fit capabilities to protect against
various routes of pathogen transmission, including for use by the general population.
I. Develop a U.S. Government PPE joint capabilities plan. (Lead: NSC, OSTP; Support:
DOS, DoD, USDA, DOL, HHS, DOT, DOE, DHS, EPA, FDA, CDC)
3.4. Vaccines
Rapidly make and equitably deploy safe and effective vaccines against any pathogen family, at
timescales and quantities necessary to contain and control a potential nationally or internationally
significant biological incident.
Targets 3.4.1 through 3.4.4 will be covered in a vaccines joint capabilities plan, described below.

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NATIONAL BIODEFENSE STRATEGY xv
3.4.1. Vaccine Design, Testing, and Authorization
Establish and maintain domestic, and catalyze international, capacity and capabilities in vaccine
design, testing, and review of safe and effective vaccines against (1) any human or animal viral
threat for which a candidate vaccine has been developed within one hundred days after
determination of a potential nationally or internationally significant biological incident, and (2)
any other human or animal pathogen threat.
3.4.2. Vaccine Production
Establish and maintain domestic capability and capacity to produce sufficient quantities of
regimens of safe and effective vaccines to vaccinate the United States population or for impacted
animal species to control a nationally or internationally significant biological incident, within
one hundred thirty days of the determination of a potential nationally or internationally
significant biological incident, and work with international partners to catalyze international
capability to produce sufficient quantities to vaccinate high-risk populations within two hundred
days.
3.4.3. Vaccine Distribution
Support capabilities and capacities to distribute vaccines rapidly and equitably to anywhere in
the world, by eliminating challenging requirements for transportation and storage, and
supporting distributed manufacturing.
3.4.4. Vaccine Administration and Allocation
Establish and maintain the domestic capability and capacity, and support international
capabilities and capacities, to safely, securely, and equitably allocate and flexibly administer to
at-risk human and impacted animal populations the necessary vaccine quantities to control a
nationally or internationally significant biological incident, within one hundred days following
authorization or approval.
I. Develop a U.S. Government vaccines joint capabilities plan. (Lead: NSC, OSTP;
Support: DOS, DoD, USDA, DOL, HHS, DOT, VA, DHS, USAID, NIH, FDA, CDC)
3.5. Agile Therapeutics Development and Production
Establish innovative and agile domestic therapeutic research, development, manufacturing, and
delivery capabilities that yield a range of safe and effective therapeutics, available before or
readily created during a nationally or internationally significant biological incident.
Targets 3.5.1 through 3.5.3 will be covered in a therapeutics joint capabilities plan, described
below.
3.5.1. Therapeuti c Development and Manufacturing
Create and maintain the domestic capability to identify, develop, test, authorize, manufacture,
and deploy new and repurposed therapeutics that reduce mortality, morbidity, or transmission by
at least fifty percent within ninety days (for repurposed therapeutics) and six months (for new
therapeutics) of determination of a potential nationally or internationally significant biological
incident.

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NATIONAL BIODEFENSE STRATEGY xvi
3.5.2. Antiviral Development and Manufacturing
Develop antivirals with fifty percent reduction in mortality, morbidity, or transmission, focusing
pre-emptive efforts on outbreak- prone virus families, and achieve FDA approval for at least two
novel antivirals that will be ready for domestic stockpiling within five years.
3.5.3. Controlling Counterproductive Responses to Infection
Develop pathogen agnostic therapeutics for the treatment of severe disease and achieve
regulatory approval of at least two therapeutics that will be ready for domestic stockpiling within
five years.
I. Develop a U.S. Government therapeutics joint capabilities plan. (Lead: NSC, OSTP;
Support: DOS, DoD, USDA, HHS, DOE, VA, NIH, FDA, CDC)
3.6. Additional Actions
I. Conduct a whole-of-government approach to assessing vulnerabilities in, and
strengthening the resilience of, critical supply chains and implement through Executive
Order 14017. The White House issued Executive Order on America's Supply Chains (EO
14017) in February of 2021. EO 14017 requires the Secretary of Health and Human
Services to develop a report outlining considerations and recommendations for improving
the public health industrial base supply chain, describing the current state of the supply
chain for each of the following domains: raw materials, PPE, testing and diagnostics,
pharmaceuticals and active pharmaceutical ingredients, therapeutics, and vaccines; risks
and vulnerabilities for each of the six domains above; how to mitigate those risks and
vulnerabilities in each domain; and recommendations for future actions. (Lead: HHS;
Support: DOS, FBI)
II. Implement the National Strategy for a Resilient Public Health Supply Chain (the
Strategy), which was developed in response to the Executive Order (EO) 14001 on a
Sustainable Public Health Supply Chain. The implementation plan supports the nation’s
efforts to prepare for and respond to a public health emergency by designing, building,
and sustaining a long-term capability in the United States to manufacture supplies for
future pandemics and biological threats. To achieve the goals outlined in the Strategy, the
implementation plan provides a clear pathway to meet those goals and support objectives
articulated within EO 14001 and EO 14017. (Lead: HHS, NSC; Support: DOS, DoD,
DHS)
III. Strengthen federal capabilities to effectively mitigate the impact of, and recover from,
future bioincidents. (Lead: HHS, DHS; Support: DOT, EPA)
IV. Analyze the effectiveness of community mitigation measures and related public health
policies domestically and internationally, based on evidence from the COVID-19
pandemic and other responses; determine gaps in community mitigation preparedness and
response to address emerging and deliberate threats; and develop guidelines for updated
community mitigation plans for future biological incident response. (Lead: CDC;
Support: DOS, HHS, DOT, USAID)
V. Fund basic research, innovation, and the development of tools and technology for
suppressing pathogen transmission in the built environment, including antimicrobial and
antiviral structures and surfaces, ventilation, filtration, sterilization, and decontamination


NATIONAL BIODEFENSE STRATEGY xvii
technologies. Increase the adoption of these technologies in federal buildings and work
with external stakeholders to encourage and incentivize adoption of these technologies in
public spaces, public transport, and laboratories. (Lead: HHS, EPA; Sup port: DoD, DOL,
DOT, DOE, DHS, General Services Administration (GSA))
VI. Develop a national environmental countermeasures capability to enable rapid
containment and remediation of environmental contamination. (Lead: EPA; Support:
DOT, DHS, FBI)
VII. Develop a unified, regional approach to improve national health care readiness and
medical surge capacity by better integrating preparedness within the already-existing
health care delivery infrastructure and by strengthening public-private partnerships.
(Lead: HHS; Support: DOT, DHS)
VIII. Enhance pre- existing capabilities for treatment, biocontainment, and movement of
patients infected with high consequence pathogens. (Lead: HHS; Support: DOS, DOT)

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GOAL 4. Rapidly Respond to Limit the
Impacts of Bioincidents
The United States will respond rapidly to limit the impacts of bioincidents through
information sharing and networking; evidence-driven, coordinated response operations
and investigations; effective public messaging; and research.
4.1. Whole-of-Society Response
Establish both (a) a unity of effort across governments (federal, SLTT) and local communities
and (b) a national environmental countermeasures capability; to limit health, economic, social,
and national security impacts and consequences of nationally or internationally significant
biological incidents, whether naturally occurring, accidental, or deliberate.
4.1.1. Effective Response to Mitigate Biological Incidents
Develop the capability to, within seven days of the determination of a potential nationally or
internationally significant biological incident, (1) trigger and coordinate a domestic One Health
evidence-informed response and (2) support an appropriate collaborative One Health evidence-
informed international response, to contain and mitigate any significant domestic biological
incident.
I. Promptly activate and appropriately scale interagency response coordination
mechanisms, centers, and strategic groups described in Presidential policies and federal
planning documents (e.g., Homeland Security Presidential Directive 5, as amended;
National Prevention and Response Frameworks; Biological Incident Annex), and adapt to
the biothreat or bioincident, after notification of a credible biothreat or bioincident.
(Lead: (Non-Stafford Human Health Impact) HHS, (Non- Stafford Animal, Plant, or
Agricultural Health Impact) DOI, USDA, (International Response C o-Lead) DOS,
(Stafford) HHS and DHS; Support: (Non-Stafford Human Health Impact) DOS, DoD,
DOI, USDA, DOC, DOL, HHS, DOT, DOE, VA, DHS, EPA, USAID, FBI, Appalachian
Regional Commission, GSA, United States Postal Service, (Non-Stafford Animal, Plant,
or Agricultural Health Impact) Same as above and Emergency Support Function- 13
supporting agencies and organizations)
4.1.2. Limit Environmental Impacts of Biological Incidents
Develop the domestic capability to detect, sample, analyze, and evaluate the extent of
environmental contamination of affected areas by a biological hazard to inform and
operationalize mitigation, response, remediation, and recovery efforts, within seven days of the
determination of a nationally or internationally significant biological incident.
I. Specific to the incident, develop and publish decontamination and waste management
plans to address the proper handling, collection, and disposal of waste streams
contaminated with a biological hazard(s) as well as to inform re-occupancy after
decontamination and established clearance levels achieved. (Lead: EPA)

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NATIONAL BIODEFENSE STRATEGY xix
4.1.3. Coordinate Real-Time Research for Response
Develop and implement an integrated, adaptive, and flexible federal One Health research agenda
that coordinates real-time federal and public and private sector research to support rapid
domestic response and mitigation, within fourteen days of the determination of a nationally or
internationally significant biological incident.
I. Develop an approved plan and clear processes that allow for developing and
implementing a coordinated, transparent, United States Government research response
agenda for nationally or internationally significant biological incidents within fourteen
days, subject to revision as new evidence becomes available. (Lead: DOI, USDA, HHS,
DHS, EPA; Support: VA, NIH, FDA, CDC)
4.1.4. Innovative
Clinical- Trial Infrastructure
Maintain and build upon the clinical -trials infrastructure, inclusive of U.S. rural hospitals, and
international sites as appropriate, ready to administer candidate countermeasures to participants
within 14 days after the identification of a viable countermeasure to expedite the evaluation of
safe and effective vaccines, therapeutics, and diagnostics for all segments of the population
during a nationally or internationally significant biological incident.
I. Develop a U.S. Government clinical trials infrastructure joint capabilities plan. (Lead:
NSC, OSTP; Support: DOS, HHS, VA, NIH)

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GOAL 5. Facilitate Recovery to Restore the
Community, the Economy, and the
Environment after a Bioincident
The United States Will Take Actions to Restore Critical Infrastructure Services and
Capability; Coordinate Recovery Activities; Provide Recovery Support and Long- Term
Mitigation; and Minimize Cascading Effects Elsewhere i n the World.
5.1. Whole-of-Society Recovery
Establish both (a) a unity of effort across governments (federal, SLTT) and local communities
and (b) a national environmental countermeasures capability; to limit health, economic, social,
and national security impacts and consequences of nationally or internationally significant
biological incidents, whether naturally occurring, accidental, or deliberate.
5.1.1. Recovery Planning and Implementation
Develop and initiate a domestic recovery strategy and long-term federal strategic and equitable
recovery plan, within seven days of the determination of a potential nationally or internationally
significant biological incident.
I. Ensure recovery actions are described in a crisis action plan (CAP), consistent with the
Biological Incident Annex and specific to an identified large-scale biological incident,
and update the CAP as additional information and science of the large- scale biological
incident occurs. (Lead: (Non -Stafford Human Health Impact) HHS, (Non- Stafford
Animal, Plant, or Agricultural Health Impact) DOI, USDA, (Stafford) DHS; Support:
DOS, DOC, United States Department of Housing and Urban Development, DOT, DOE,
EPA, USAID)
II. Update and/or develop additional policy, guidance and practices as necessary to improve
future recovery efforts. (Lead: NSC)

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ANNEX III: List of Acronyms

AR Antibiotic Resistance
CDC Centers for Disease Control and Prevention
COVID-19 Coronavirus Disease—2019
DHS United States Department of Homeland Security
DOC United States Department of Commerce
DoD United States Department of Defense
DOE United States Department of Energy
DOI United States Department of the Interior
DOL United States Department of Labor
DOS United States Department of State
DOT United States Department of Transportation
DPC United States Domestic Policy Council
EPA United States Environmental Protection Agency
FAO Food and Agriculture Organization
FBI Federal Bureau of Investigation
FDA United States Food and Drug Administration
FEMA Federal Emergency Management Agency
GHSA Global Health Security Agenda
GSA General Services Administration
HAI Healthcare-Associated Infections
HHS United States Department of Health and Human Services
IC Intelligence Community
IHR International Health Regulations
JEE Joint External Evaluation
NHSN National Health Safety Network
NIH National Institutes of Health
NSC United States National Security Council
NSF National Science Foundation
OSHA Occupational Safety and Health
OSTP Office of Science and Technology Policy
PPE Personal Protective Equipment
PPT Personal Protective Technology
S&T Science and Technology
SLTT State, Local, Tribal, and Territorial
SPAR State Party Self-Assessment Annual Report (SPAR)
Treasury United States Department of the Treasury
USAID United States Agency for International Development
USDA United States Department of Agriculture
VA United States Department of Veterans Affairs
WHO World Health Organization

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NATIONAL BIODEFENSE STRATEGY xxii
ANNEX IV: Legal and Policy Authorities
Departments and Agencies will support the broader implementation of the entirety of the
National Biodefense Strategy and Implementation Plan for Countering Biological Threats,
Enhancing Pandemic Preparedness, and Achieving Global Health Security through existing
policies, plans, and frameworks and consistent with relevant legal authorities. The policies,
plans, frameworks, and legal authorities listed below are examples of many, but not all, of the
authorities and guidance documents that the United States Federal Government relies upon to
fulfill the United States Federal Government’s vision for biodefense, including many important
activities not included in the prioritized goals. These relevant policies, plans, frameworks, and
legal authorities may change over time and, depending on the circumstances or nature of the
biological threat, the United States Federal Government may rely upon other authorities not
included herein to enable an appropriate and effective response.
GOAL 1. Enable Risk Awareness and Detection to Inform Decision-Making
Across the Biodefense Enterprise
The United States will build risk awareness at the strategic level through analyses and
coordinated research efforts to characterize naturally occurring, accidental, and deliberate
biological risks; and at the operational level through One Health surveillance and detection
activities to detect and identify biological threats and anticipate biological incidents.
Objective 1.1: Ensure Decision-Making is Informed by Intelligence, Forecasting, and Risk
Assessment
Agencies will implement Objective 1.1 through existing policies, plans, and frameworks and
consistent with existing legal authorities , including:
• 6 USC §§ 104, 195b, 321q, 591 et seq.
• 7 USC §§ 391, 5921, 5939, 7701 et seq., 8301 et seq., 8401, 8411, 8901, 8912
• 18 USC §§ 175- 178
• 22 USC §§ 2151b, 2151b- 2, 2151b- 3, 2151b- 4, 2292
• 42 USC §§ 247d- 4, 7139, 7251, 7256
• 50 USC §§ 2370, 2401, 3057
• HSPD-9
• HSPD-18
• HSPD-21
• PPD-21
• NSM-1
• EO 12333
• EO 13676
• EO 13747

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NATIONAL BIODEFENSE STRATEGY xxiii
• EO 13987
• Global Health Security Strategy
• 2019-2022 National Health Security Strategy Implementation Plan
• National Strategy for Biosurveillance
• National Biosurveillance S&T Roadmap
• National Strategy for Pandemic Influenza
• National Strategy for Combating Antibiotic Resistant Bacteria
• National Action Plan for Combating Antibiotic Resistant Bacteria 2020-25
• National Action Plan for Multidrug Resistant Tuberculosis
• United States President’s Emergency Plan for AIDS Relief
• U.S. President’s Malaria Initiative Strategy
Objective 1.2: Ensure that domestic and global biothreat detection, biosurveillance, and
information systems are coordinated, integrated, and capable of enabling timely
bioincident prevention, detection, reporting, assessment, response, and recovery.
Agencies will implement Objective 1.2 through existing policies, plans, and frameworks and
consistent with existing legal authorities , including:
• 6 USC §§ 104, 195b, 321q, 591 et seq.
• 7 USC §§ 391, 5921, 5939, 7701 et seq., 8301 et seq., 8401, 8411, 8901, 8912
• 18 USC §§ 175- 178
• 22 USC §§ 2151b, 2151b- 2, 2151b- 3, 2151b- 4, 2292
• 42 USC §§ 247d- 4, 300hh- 1 as amended (PL 107- 296), 300hh- 10b, 300jj-17, 300jj-51,
7139, 7251, 7256, 17903
• 50 USC §§ 402- 1a-c, 402a, 2370, 2401
• Global Health Security Strategy
• 2019-2022 National Health Security Strategy Implementation Plan
• HSPD-9
• HSPD-21
• PPD-21
• NSM-1
• EO 12333
• EO 13676
• EO 13747
• EO 13987

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NATIONAL BIODEFENSE STRATEGY xxiv
• National Strategy for Biosurveillance
• National Biosurveillance S&T Roadmap
• National Strategy for the COVID-19 Response and Pandemic Preparedness
• National Strategy for Pandemic Influenza
• National Strategy for Combating Antibiotic Resistant Bacteria
• National Action Plan for Combating Antibiotic Resistant Bacteria 2020-25
• National Action Plan for Multidrug Resistant Tuberculosis
• U.S. President’s Malaria Initiative Strategy
• U.S. President’s Emergency Plan for AIDS Relief
• U.S. COVID- 19 Global Response and Recovery Framework
GOAL 2. Ensure Biodefe nse Enterprise Capabilities to Prevent Bioincidents
The United States will work to prevent the outbreak and spread of naturally occurring
infectious diseases and minimize the risk of laboratory accidents both domestically and
globally. The United States will also strengthen biosecurity to prevent both state and nonstate
actors from obtaining or using biological material, equipment, and expertise for nefarious
purposes, consistent with the U.S. Government’s approach to countering weapons of mass
destruction. Implementing Goal 2 will ensure we have the capabilities necessary to disrupt
plots, degrade technical capabilities, and deter support for state and nonstate actors seeking to
use biological weapons. This goal also recognizes the dual-use nature of the life sciences and
biotechnology, in which the same science and technology base that improves health, promotes
innovation, and protects the environment can also be misused for harmful purposes.
Domestically and internationally, the United States seeks to prevent the misuse of science and
technology while promoting and enhancing its legitimate use and innovation.
Objective 2.1: Promote measures to prevent or reduce the spread of infectious diseases
Agencies will implement Objective 2.1 through existing policies, plans, and frameworks and
consistent with existing legal authorities, including:
• 6 USC § 104
• 7 USC §§391, 396, 398, 499n, 5921, 5939, 7701 et seq., 8301 et seq., 8401, 8411
• 22 USC §§ 2151b, 2151b- 2, 2151b- 3, 2151b- 4, 2292
• 42 USC §§ 201 et seq.
• HSPD-9
• NSM-1
• EO 13676
• EO 13747
• EO 13987

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NATIONAL BIODEFENSE STRATEGY xxv
• 2019-2022 NHSS-IP
• National Action Plan for Combating Antibiotic Resistant Bacteria, 2020-2025 (CARB)
• National Framework for the Prevention and Control of Vector-Borne Diseases in Humans
• National Strategy for Pandemic Influenza
• National Strategy for the COVID-19 Response and Pandemic Preparedness
• Countering Terrorism and Targeted Violence (PAP and IP)
• National Prevention Framework (FEMA)
• National Strategy for Combating Antibiotic Resistant Bacteria;
• National Action Plan for Multidrug Resistant Tuberculosis
• U.S. President's Malaria Initiative Strategy
• U.S. Global Water Strategy 2022- 2027
• U.S. COVID- 19 Global Response and Recovery Framework
• USAID Water and Development Plan
• Global Health Security Strategy
Objective 2.2: Strengthen Global Health Security Capacities Internationally to Prevent
Local Bioincidents from Becoming Epidemics
Agencies will implement Objective 2.2 through existing policies, plans, and frameworks and
consistent with existing legal authorities, including:
• 6 USC § 104
• 7 USC §§ 391, 396, 398, 499n, 5921, 5939, 7701 et seq., 8301 et seq., 8401, 8411
• 22 USC §§ 2151b, 2151b- 3
• 42 USC § 300hh–1 as amended (PL 107- 296)
• HSPD-21
• PPD-21
• NSM-1
• EO 13747
• EO 13987
• Global Health Security Agenda
• Global Health Security Strategy
• National Strategy for the COVID-19 Response and Pandemic Preparedness
• U.S. COVID- 19 Global Response and Recovery Framework

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NATIONAL BIODEFENSE STRATEGY xxvi
• Promoting Global Health Security: Guidance and Principles for U.S. Government
Departments and Agencies to Strengthen IHR Core Capacities Internationally (2011)
Objective 2.3: Deter, Detect, Degrade, Disrupt, Deny, or Otherwise Prevent Nation-State
and Nonstate Actors’ Attempts to Pursue, Acquire, or Use Biological Weapons, Related
Materials, or Their Means of Delivery
Agencies will implement Objective 2.3 through existing policies, plans, and frameworks and
consistent with existing legal authorities, including:
• 6 USC § 104
• 7 USC §§ 391, 396, 398, 499n, 5921, 7701 et seq., 8301 et seq., 8401, 8411
• 18 USC §§ 175- 178
• 22 USC §§ 2349bb- 1
• 42 USC §§ 300hh–1 as amended (PL 107- 296)
• PL 109- 347
• HSPD-9
• PPD-21
• Countering Terrorism and Targeted Violence (PAP and IP)
• National Protection Framework (FEMA)
Objective 2.4: Strengthen biosafety and biosecurity practices and oversight to prevent
bioincidents and reduce biological risks associated with life sciences research and
development and advances in biotechnology
Agencies will implement Objective 2.4 through existing policies, plans, and frameworks and
consistent with existing legal authorities, including:
• 6 USC § 104
• 7 USC §§ 391, 396, 398, 499n, 3351, 3354, 5921, 5939, 7701 et seq., 8301 et seq., 8401,
8411
• 22 USC §§ 2151a, 2151b
• 42 USC §§ 201 et seq., 300hh–1 as amended (PL 107- 296)
• 29 CFR §§ 1910, 1926
• NSM-1
• EO 13747
• EO 13987
• EO 14081
• 2019-2022 NHSS-IP
• Global Health Security Strategy

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NATIONAL BIODEFENSE STRATEGY xxvii
GOAL 3. Ensure Biodefense Enterprise Preparedness to Reduce the Impacts
of Bioincidents
The United States will take measures to reduce the impacts of bioincidents, including
maintaining a vibrant national science and technology base to support biodefense; promoting
a strong domestic and international public, veterinary, and plant health infrastructure;
developing, updating, and exercising response and recovery capabilities; establishing risk
communications; developing and effectively distributing and dispensing countermeasures;
and collaborating across the country and internationally to support biodefense.
Objective 3.1: Promote a Vibrant, Safe, and Secure Domestic and International Science
and Technology Base, Including i n Biotechnology and Biomanufacturing, t o Support
Biodefense
Agencies will implement Objective 3.1 through existing policies, plans, and frameworks and
consistent with existing legal authorities, including:
• 6 USC §§ 104, 195b, 321q, 591 et seq.
• 7 USC §§ 391, 398, 5841, 5939, 7701 et seq., 8301 et seq., 8901, 8912
• 21 USC §§ 151- 158
• 22 USC §§ 2151a, 2151b
• 42 USC §§ 241, 243, 247d- 6a, 247d- 6b, 247d- 7e, 247d- 7f, 289c, 289g-4, 300hh- 10,
300hh- 31, 7139, 7251, 7256
• 50 USC § 2401
• PAHPAIA, Title VI: Advancing Technologies for Medical Countermeasures, Section
605: Review of the Benefits of Genomic Engineering Technologies and Their Potential
Role in National Security
• 29 CFR §§ 1910, 1926
• HSPD-9
• HSPD-18
• NSM-1
• EO 13747
• EO 13987
• EO 14081
• PHEMCE SIP
• 2019-2022 NHSS-IP
• Global Health Security Strategy
Objective 3.2: Ensure a Strong Public, Veterinary, and Plant Health Infrastructure
Agencies will implement Objective 3.2 through existing policies, plans, and frameworks and
consistent with existing legal authorities, including:

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NATIONAL BIODEFENSE STRATEGY xxviii
• 6 USC §§ 104, 195b, 321q, 591 et seq.
• 7 USC §§ 391, 398, 5841, 5939, 7701 et seq., 8301 et seq., 8901, 8912
• 21 USC §§ 511- 518
• 22 USC §§ 2151a, 2151b
• 42 USC §§ 204, 204a, 243, 247b- 21, 247d- 3b, 247d- 4, 247d- 6, 247d- 7b, 264- 272, 280g-
16, 289g-4, 300hh-1, 300hh- 10, 300hh- 11, 300hh- 15, 300hh- 17, 300hh- 2, 300hh- 31,
2391, 2391- 2
• 18 USC §§ 175- 178
• 29 CFR §§ 1910, 1936
• PL 115- 43
• PL 115- 387
• HSPD-9
• HSPD-21
• NSM 1
• EO 13747
• EO 13987
• 2019-2022 NHSS-IP
• Global Health Security Strategy
• National Influenza Vaccine Modernization Strategy
Objective 3.3: Develop, Exercise, and Update Prevention, Response, and Recovery Plans
and Capabilities, Including Efforts to Secure Critical Supply Chains
Agencies will implement Objective 3.3 through existing policies, plans, and frameworks and
consistent with existing legal authorities, including:
• 6 USC §§ 104, 591 et seq.
• 7 USC §§ 391, 5841, 5939, 7701 et seq., 8301 et seq., 8901, 8912
• 18 USC §§ 175- 178
• 21 USC §§ 151- 158
• 22 USC §§ 2292 as extended to include “international disaster rehabilitation and
reconstruction” by annual appropriations (e.g., PL 116- 260 for FY21)
• 42 USC §§ 204, 204a, 234, 239, 241, 243, 247d, 247d- 3a, 247d- 3b, 247d- 3c, 247d- 4,
247d-6, 247d- 6a, 247d- 6b, 247d- 6d, 247d- 6e, 247d- 7b, 247d- 7e, 247d- 7f, 247d- 91, 280g-
16, 281, 282, 289c, 289g- 4, 300ff-131, 300hh-1, 300hh- 10, 300hh- 10a, 300hh- 11, 300hh-
15, 300hh- 16, 300hh- 17, 300hh- 2, 300hh- 31, 2391, 2391- 2, 7139, 7251, 7256


NATIONAL BIODEFENSE STRATEGY xxix
• PAHPAIA, Improving Preparedness and Response, Section 210 42 USC 300hh- 11 42
USC 300hh- 1042 USC 247d- 4b
• 50 USC § 2401
• PPD-21
• PPD-40
• HSPD-9
• HSPD-18
• HSPD-21
• PPD-21
• PPD-40
• NSM-1
• EO 12656
• EO 13961
• EO 14001
• EO 14017
• EO 13257
• EO 13747
• EO 13987
• National Prevention Framework
• National Mitigation Framework
• National Response Framework
• National Disaster Recovery Framework
• ESF-11
• Federal Continuity Directive 1 (FCD-1)
• Federal Continuity Directive 2 (FCD-2)
• National Continuity Policy Implementation Plan
• National Strategy for the COVID-19 Response and Pandemic Preparedness
• U.S. COVID- 19 Global Response and Recovery Framework
• National Infrastructure Protection Plan
• Global Health Security Strategy
• Annual updates to DOL/OSHA emergency plans

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NATIONAL BIODEFENSE STRATEGY xxx
Objective 3.4: Develop, Exercise, and Update Risk Communication Plans and Promote
Consistent, Plain Language Messaging to Inform Key Audiences, Expedite Desired
Response Actions, and Address Public Uncertainty and Fear
Agencies will impleme nt Objective 3.4 through existing policies, plans, and frameworks and
consistent with existing legal authorities, including:
• 6 USC §§ 104, 591 et seq.
• 7 USC §§ 398, 5841, 5939, 7701 et seq., 8901, 8912
• 21 USC §§ 151- 158
• 22 USC §§ 2151b, 2292
• 42 USC §§ 247d- 4, 289c, 300hh- 1, 300hh- 10
• PPD-40
• HSPD-9
• HSPD-21
• EO 12656
• EO 13961
• Federal Continuity Directive 1 (FCD-1)
• Federal Continuity Directive 2 (FCD-2)
• National Continuity Policy Implementation Plan
• National Response Framework
• National Infrastructure Protection Plan
• National Disaster Recovery Framework
• Annual updates to DOL/OSHA emergency plans; provide information to DOL/OSHA
Office of Communications on internal and external messages for response and recovery
actions
Objective 3.5: Enhance Preparedness to Save Lives through Development, Testing,
Evaluation, Manufacturing, Regulatory Approval, Distribution, and Administration of
Countermeasures
Agencies will implement Objective 3.5 through existing policies, plans, and frameworks and
consistent with existing legal authorities, including:
• 6 USC §§ 104, 195b, 591 et seq.
• 7 USC §§ 391, 398, 5841, 5939, 7701 et seq., 8301 et seq., 8901, 8912
• 21 USC §§ 151- 158
• 22 USC § 2151b

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NATIONAL BIODEFENSE STRATEGY xxxi
• 42 USC §§ 241, 247d- 4, 247d- 6, 247d- 6a, 247d- 6b, 247d- 6d, 247d- 7e, 280g-16, 281,
289c, 300hh- 1 as amended (PL 107- 296), 300hh- 10, 300hh- 10b, 300hh- 13, 300hh- 31,
360bbb- 4b, 7139, 7251, 7256
• 50 USC § 2401
• PAHPAIA, Title VI: Advancing Technologies for Medical Countermeasures, Section
606: Report on the Development of Vaccines to Prevent Future Epidemics
• HSPD-9
• HSPD-18
• HSPD-21
• 2019-2022 NHSS-IP
• PHEMCE SIP
• National Action Plan for Combating Antibiotic Resistant Bacteria, 2020-2025 (CARB)
• National Response Framework
Objective 3.6: Enhance Preparedness to Limit the Spread of Disease through Community
Mitigation Measures
Agencies will implement Objective 3.6 through existing policies, plans, and frameworks and
consistent with existing legal authorities, including:
• 6 USC §§ 104, 921, 945, 1003
• 7 USC §§ 391, 5841, 5939, 7701 et seq., 8301 et seq., 8901, 8912
• 21 USC §§ 151- 158
• 22 USC §§ 2292, 9808b
• 42 USC §§ 264- 71, 300hh- 1, 300hh- 10
• 29 CFR §§ 1910, 1926
• 42 CFR §§ 70, 71
• PL 109- 347
• HSPD-9
• 2019-2022 NHSS-IP
Objective 3.7: Enhance Preparedness to Support Decontamination, Waste Management,
Environmental Controls, and Other Methods of Suppressing Pathogens during a Biological
Event
Agencies will implement Objective 3.7 through existing policies, plans, and frameworks and
consistent with existing legal authorities, including:
• 6 USC §§ 104, 921, 945, 1003
• 7 USC §§ 391, 5939, 7701 et seq., 8301 et seq., 8901, 8912

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NATIONAL BIODEFENSE STRATEGY xxxii
• 21 USC §§ 151- 158
• 22 USC §§ 2151a
• 42 USC §§ 241, 243, 247d- 6, 247d- 6a, 247d- 6b, 247d- 7e, 281, 289c, 300hh-1, 300hh- 10,
300hh- 13, 7139, 7251, 7256
• 50 USC § 2401
• PL 109- 347
• 29 CFR §§ 1910, 1926
• HSPD-9
• 2019-2022 NHSS-IP
Objective 3.8: Strengthen Preparedness to Operate and Collaborate Across the United
States, Including the U.S. Territories
Agencies will implement Objective 3.8 through existing policies, plans, and frameworks and
consistent with existing legal authorities, including:
• 6 USC §§ 104, 591 et seq.
• 7 USC §§ 391, 398, 5841, 5939, 7701 et seq., 8301 et seq., 8901, 8912
• 21 USC §§ 151- 158
• 42 USC §§ 204, 243, 282, 247d- 3c, 247d- 4, 247d- 7b, 247d- 7e, 280g-16, 300hh- 1, 300hh-
10, 300hh- 11, 300hh- 15, 300hh- 17, 300hh- 2, 300hh- 31, 300hh- 21
• PAHPAIA, Title VI: Advancing Technologies for Medical Countermeasures, Section
606: Report on the Development of Vaccines to Prevent Future Epidemics
• HSPD-9
• HSPD-21
• PPD-21
• PPD-40
• EO 12656
• EO 13961
• 2019-2022 NHSS-IP
• Federal Continuity Directive 1 (FCD-1)
• Federal Continuity Directive 2 (FCD-2)
• National Continuity Policy Implementation Plan
• National Response Framework
• National Infrastructure Protection Plan
• National Disaster Recovery Framework

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NATIONAL BIODEFENSE STRATEGY xxxiii
Objective 3.9: Strengthen International Preparedness to Support International Response
and Recovery Capabilities
Agencies will implement Objective 3.9 through existing policies, plans, and frameworks and
consistent with existing legal authorities , including:
• 6 USC § 104
• 7 USC §§ 391, 5841, 5939, 7701 et seq., 8301 et seq.
• 18 USC §§ 175- 178
• 21 USC §§ 151- 158
• 22 USC §§ 2151b, 2292 as extended to include “international disaster rehabilitation and
reconstruction” by annual appropriations (e.g., PL 116- 260 for FY21), 9808b
• 42 USC §§ 281, 243, 247d- 4, 242l, 300hh- 10
• PAHPAIA, Title VI: Advancing Technologies for Medical Countermeasures, Section
606: Report on the Development of Vaccines to Prevent Future Epidemics
• HSPD-9
• HSPD-21
• NSM-1
• EO 13747
• EO 13987
• Global Health Security Agenda
• Global Health Security Strategy
• Building Resilience to Recurrent Crisis—USAID Policy and Program Guidance
• National Strategy for the COVID-19 Response and Pandemic Preparedness
• U.S. COVID- 19 Global Response and Recovery Framework
• U.S. Government Global Food Security Strategy (GFSS); Global Food Security Strategy
“Refresh” (GFSS-R)
• U.S. Government Global Nutrition Coordination Plan
• U.S. Government Global Water Strategy 2022- 2027 and USAID Water and Development
Plan
GOAL 4. Rapidly Respond to Limit the Impacts of Bioincidents
The United States will respond rapidly to limit the impacts of bioincidents through information
sharing and networking; evidence-driven, coordinated response operations and investigations;
effective public messaging; and research.

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NATIONAL BIODEFENSE STRATEGY xxxiv
Objective 4.1: Compile and Share Biothreat, Bioincident, and Response Information to
Enable Appropriate Decision-Making and Response Operations across All Levels of
Government and With Nongovernmental, Private Sector, and International Entities, as
Appropriate
Agencies will implement Objective 4.1 through existing policies, plans, and frameworks and
consistent with existing legal authorities, including:
• 6 USC §§ 104, 195b, 467 321g, 591, 592, 596, 597,
• 7 USC §§ 499n, 7701 et seq., 8301 et seq.
• 22 USC §§ 2151b, 2292, 9808b
• 42 USC §§ 103, 247d, 247d- 4, 280g- 16, 300ff-138, 300hh- 1 as amended (PL 107- 296),
300hh- 10, 300hh- 11, 7545c-4c(ii)
• 50 USC § 4501
• 54 USC §§ 100101 et seq.
• HSPD-9
• PPD-8
• PPD-21
• NSM-1
• 2019-2022 NHSS-IP
• National Response Framework
• Response Federal Interagency Operational Plan (Response FIOP)
• Biological Incident Annex (BIA)
• National Disaster Recovery Framework
Objective 4.2: Conduct Evidence- Driven Federal Response Operations and Activities and
Implement a Federal Research Agenda in Coordination with Relevant Nongovernmental,
Private Sector, and International Partners Where Appropriate to Contain, Control, and
Rapidly Mitigate Impacts of Biothreats or Bioincidents
Agencies will implement Objective 4.2 through existing policies, plans, and frameworks and
consistent with existing legal authorities, including:
• 6 USC §§ 104, 195b, 591 et seq., 592, 596, 7545c-4c(ii)
• 7 USC §§ 499n, 3351, 3354, 7701 et seq., 8301 et seq., 8401
• 22 USC §§ 2151b, 2292, 9808b
• 42 USC §§ 103, 204, 204a, 243, 247d, 247d- 4, 247d- 4b, 247d- 6d, 247d- 6e, 247d- 7b,
280g-16, 300hh, 300hh-1 as amended (PL 107-296), 300hh- 10, 300hh- 10a, 300hh- 11,
300hh- 15, 300hh- 16, 300ff-131, 7139, 7251, 7256
• PAHPAIA, Title VI: Advancing Technologies for Medical Countermeasures, Section
606: Report on the Development of Vaccines to Prevent Future Epidemics

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NATIONAL BIODEFENSE STRATEGY xxxv
• 50 USC §§ 2401, 4501 et seq.
• 54 USC §§ 100101 et seq.
• HSPD-9
• PPD-8
• PPD-21
• 2019-2022 NHSS-IP
• National Response Framework
• Response Federal Interagency Operational Plan (Response FIOP)
• Biological Incident Annex (BIA)
• National Disaster Recovery Framework
Objective 4.3: Conduct Operations and Investigations, and Use All Available Tools to Hold
Perpetrators Accountable
Agencies will implement Objective 4.3 through existing policies, plans, and frameworks and
consistent with existing legal authorities, including:
• 6 USC §§ 104, 195b, 591, 592, 596, 597
• 7 USC §§ 499n, 8401
• 18 USC §§ 175- 178, 2332a, 2332b(f)
• 42 USC §§ 103, 247d, 280g -16, 300hh-1 as amended (PL 107-296), 300hh- 11, 7545c-
4c(ii)
• 50 USC §§ 4501 et seq.
• 54 USC §§ 100101 et seq.
• 28 CFR § 0.85(1)
• 42 CFR § 73
• HSPD-5
• HSPD-9
• PPD-8
• PPD-21
• 2019-2022 NHSS-IP
• National Response Framework
• National Prevention Framework
• Prevention Federal Interagency Operational Plan (Prevention FIOP)
• Response Federal Interagency Operational Plan (Response FIOP)

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NATIONAL BIODEFENSE STRATEGY xxxvi
• Biological Incident Annex (BIA)
Objective 4.4: Execute Risk-Informed, Accurate, Timely, and Actionable Science- Driven
Risk Communications and Community Engagement
Agencies will implement Objective 4.4 through existing policies, plans, and frameworks and
consistent with existing legal authorities, including:
• 6 USC §§ 104, 195b, 591, 592, 596, 597
• 7 USC §§ 499n, 7701 et seq., 8301 et seq., 8401
• 42 USC §§ 103, 247d- 6e, 300hh- 1 as amended (PL 107- 296), 300hh- 11, 300hh- 16,
7545c-4c(ii)
• 50 USC §§ 4501 et seq.
• 54 USC §§ 100101 et seq.
• HSPD-5
• HSPD-9
• PPD-8
• PPD-21
• 2019-2022 NHSS-IP
• National Response Framework
• Response Federal Interagency Operational Plan (Response FIOP)
• Biological Incident Annex (BIA)
• National Disaster Recovery Framework
GOAL 5. Facilitate Recovery to Restore the Community, the Economy, and
the Environment after a Bioincident.
The United States will take actions to restore critical infrastructure services and capability;
coordinate recovery activities; provide recovery support and long-term mitigation; and
minimize cascading effects elsewhere in the world.
Objective 5.1: Promote Restoration of Critical Infrastructure Capability and Capacity to
Enable the Resumption of Vital U.S. Activities
Agencies will implement Objective 5.1 through existing policies, plans, and frameworks and
consistent with existing legal authorities, including:
• 6 USC §§ 104, 195b, 591, 592, 296, 597
• 22 USC §§ 2292 as extended to include “international disaster rehabilitation and
reconstruction” by annual appropriations (e.g., PL 116- 260 for FY21), 9808b
• 42 USC §§ 300h- 1 as amended (PL 107- 296), 300hh- 11, 7545c-4c(ii)
• 50 USC §§ 4501 et seq.

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NATIONAL BIODEFENSE STRATEGY xxxvii
• 54 USC §§ 100101 et seq.
• HSPD-9
• PPD-21
• NSM-1
• EO 13987
• 2019-2022 NHSS-IP
• National Response Framework
• National Disaster Recovery Framework
• National Strategy for the COVID-19 Response and Pandemic Preparedness
• U.S. COVID- 19 Global Response and Recovery Framework
Objective 5.2: Ensure Coordination of Recovery Activities across All Levels of Government
and With Nongovernmental, Private Sector, and International Entities, As Appropriate, to
Enable Effective and Efficient Recovery Operations
Agencies will implement Objective 5.2 through existing policies, plans, and frameworks and
consistent with existing legal authorities, including:
• 6 USC §§ 104, 195b, 591, 592, 596, 597
• 22 USC §§ 2292 as extended to include “international disaster rehabilitation and
reconstruction” by annual appropriations (e.g., PL 116- 260 for FY21), 9808b
• 42 USC §§ 300hh- 1 as amended (PL 107- 296), 7545c-4c(ii)
• HSPD-9
• PPD-21
• NSM-1
• EO 13987
• National Disaster Recovery Framework
• National Strategy for the COVID-19 Response and Pandemic Preparedness
• U.S. COVID- 19 Global Response and Recovery Framework
Objective 5.3: Provide Recovery Support and Conduct Long- Term Mitigation Actions to
Promote Resilience
Agencies will implement Objective 5.3 through existing policies, plans, and frameworks and
consistent with existing legal authorities, including:
• 42 USC §§ 247d- 6d, 300hh- 11, 300hh- 16
• HSPD-9
• PPD-21

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NATIONAL BIODEFENSE STRATEGY xxxviii
• Biological Incident Annex
• Response and Recovery Federal Interagency Operational Plans
• 2016 National Mitigation Framework
• U.S. Government Global Water Strategy 2022- 2027
• National Disaster Recovery Framework
Objective 5.4: Reduce the Cascading Effects of International Biological Incidents on the
Global Economy, Health, and Security
Agencies will implement Objective 5.4 through existing policies, plans, and frameworks and
consistent with existing legal authorities, including:
• 22 USC §§ 2151a, 2292, 9808b
• PPD-21
• NSM-1
• EO 13987
• Building Resilience to Recurrent Crisis—USAID Policy and Program Guidance,
• U.S. Government Global Food Security Strategy (GFSS); Global Food Security Strategy
“Refresh” (GFSS-R)
• U.S. Government Global Nutrition Coordination Plan
• U.S. Government Global Water Strategy 2022- 2027
• National Response Framework
• National Disaster Recovery Framework
• National Strategy for the COVID-19 Response and Pandemic Preparedness
• U.S. COVID- 19 Global Response and Recovery Framework
• National Mitigation Framework