SUBJECT: Countering Biological Threats, Enhancing
Pandemic Preparedness, and Achieving Global
Health Security
It is a vital interest of the United States to prepare for, prevent, detect, respond to, and recover from biological threats at home and abroad. The coronavirus disease 2019 (COVID-19) has highlighted that the United States and the world are vulnerable to biological threats, whether naturally occurring, accidental, or deliberate. COVID-19 has cost millions of lives and has resulted in trillions of dollars in economic loss and major setbacks in health and economic development globally. No sector of the United States economy or society is immune to the effects of a major biological incident. Moreover, few other national security threats are capable of producing catastrophic and potentially existential global consequences at the scale and speed of biological threats. Therefore, countering biological threats, advancing pandemic preparedness, and achieving global health security are top national and international security priorities for the United States. Nearly all executive departments and agencies (agencies) contribute to the biodefense mission of the United States Government. Moving forward, the United States must fundamentally transform its capabilities to protect our Nation from biological threats and advance pandemic preparedness and health security more broadly for the world.
Section 1. Policy. It is the policy of the United States to preserve our health, economic, social, and national security by protecting the Nation from biological threats and promoting pandemic preparedness and global health security. The United States Government will undertake actions at home and with partners globally to reduce the risk of naturally occurring, accidental, and deliberate biological events with the potential to significantly impact humans, animals (domestic and wildlife), plants, and the environment, and to negatively affect health, the economy, society, and security.
The foundational policies for the United States Government's role in biodefense include: the National Biodefense Strategy for Countering Biological Threats, Enhancing Pandemic Preparedness, and Achieving Global Health Security (Biodefense Strategy) and its associated Implementation Plan, American Pandemic Preparedness: Transforming Our Capabilities, and the U.S. Global Health Security Strategy. Agency activities in support of the Biodefense Strategy and its Implementation Plan shall be conducted consistent with the Biodefense Strategy. Activities undertaken to implement existing Executive Orders and Presidential Directives, including but not limited to those listed in Annex IV of the Biodefense Strategy, shall be conducted consistent with the Biodefense Strategy. Further, implementation of this memorandum shall ensure consistent integration with Presidential Directives regarding domestic response.
Sec. 2. Coordination and Governance of United States Biodefense Efforts. The policy set forth in section 1 of this memorandum shall be implemented, to the extent permitted by law and available appropriations and subject to the internal programmatic and budgetary processes of relevant agencies, as follows:
(a) The Assistant to the President for National Security Affairs (APNSA) shall serve as the lead for policy coordination and review, acting through the process described in National Security Memorandum 2 (NSM-2) of February 4, 2021 (Renewing the National Security Council System), to provide strategic input and facilitate policy integration for Federal biodefense efforts.
(b) In accordance with Executive Order 13987 of January 20, 2021 (Organizing and Mobilizing the United States Government to Provide a Unified and Effective Response to Combat COVID-19 and to Provide United States Leadership on Global Health and Security), and National Security Memorandum 1 of January 21, 2021 (United States Global Leadership to Strengthen the International COVID-19 Response and to Advance Global Health Security and Biological Preparedness), the APNSA shall coordinate the Federal Government's efforts to prepare for, prevent, detect, respond to, and recover from biological threats and to advance global health security, international pandemic preparedness, and global health resilience. This subsection does not apply to Federal law enforcement activities, criminal investigations, or intelligence activities related to domestic incidents involving suspected terrorist threats, terrorist attacks, significant cyber incidents or other acts within the criminal jurisdiction of the United States.
(c) The heads of agencies shall:
(i) implement the Biodefense Strategy, as well as related strategies such as the U.S. Global Health Security Strategy, and include biodefense-related activities, including resourcing and achieving the goals of the Biodefense Strategy and the priorities, targets, and actions of its Implementation Plan, within their strategic planning and budgetary processes;
(ii) in the event of the determination of a nationally or internationally significant biological incident, implement Federal response efforts in accordance with Homeland Security Presidential Directive 5 of February 28, 2003 (Management of Domestic Incidents), Presidential Policy Directive 8 of March 30, 2011 (National Preparedness), Presidential Policy Directive 44 of November 7, 2016 (Enhancing Domestic Incident Response), and Federal Government response and recovery frameworks and operational plans;
(iii) coordinate their biodefense policies with other agencies that have responsibilities or capabilities pertaining to biodefense, as well as with appropriate non-Federal entities;
(iv) share information and coordinate decision-making related to the biodefense enterprise; and
(v) monitor, evaluate, and hold their respective agencies accountable for the implementation of section 3(a) of this memorandum.
(d) Heads of agencies are not required to share information on counterproliferation activities, military plans or operations, intelligence activities, or specific law enforcement activities and criminal investigations.
Sec. 3. Implementation. (a) At least once every 3 years, in alignment with the annual budget cycle, the APNSA and the Assistant to the President and Homeland Security Advisor (APHSA), in coordination with the heads of relevant agencies, shall review and update, as necessary, biodefense priorities under the Biodefense Strategy's Implementation Plan. These updates shall be submitted to the President through the APNSA and, to the extent permitted by and consistent with applicable law and policy, released to the public.
(b) Within 1 year of the date of this memorandum and annually thereafter, the APNSA or the APHSA, in coordination with the Director of the Office of Science and Technology Policy and the Assistant to the President for Domestic Policy, shall chair a Principals Committee Senior Officials Exercise (SOE) on a biopreparedness health emergency in coordination with the heads of relevant agencies. The SOE shall include a detailed summary of conclusions, which shall inform the review listed in subsection (a) of this section. The heads of relevant agencies shall, on an annual basis, submit all related SOE After Action Reports to the APNSA and the APHSA to inform the review listed in subsection (a) of this section; the Administrator of the Federal Emergency Management Agency to inform the National Exercise Program; and the heads of relevant agencies to inform biopreparedness.
(c) Within 1 year of the date of this memorandum, and annually thereafter in alignment with the annual budget cycle:
(i) the heads of relevant agencies shall include in their annual budget requests to the Office of Management and Budget (OMB) information on those activities, programs, and projects that are planned, programmed, or have been executed that advance or are expected to advance the Biodefense Strategy and its Implementation Plan; ensure that these new and existing activities are prioritized in their annual budget requests; quantify resources allocated to biodefense within their annual budget requests; make a determination on whether their budget requests are sufficient to meet priorities established in the Biodefense Strategy's Implementation Plan; and meet annually with National Security Council (NSC) staff to review their annual budget requests;
(ii) as part of the annual budget process, the Director of OMB, in consultation with the APNSA, shall conduct an analysis of Federal biodefense and pandemic preparedness programs to assess whether resources are sufficient to meet the objectives of the Biodefense Strategy's Implementation Plan; and
(iii) the APNSA, through the process described in NSM-2 and in coordination with the Director of OMB, shall convene relevant agencies to ensure that interagency budgets for programs that contribute directly to the implementation of this memorandum and additional relevant resource requests are directed to meet the objectives of the Biodefense Strategy's Implementation Plan.
(d) To facilitate effective implementation of the Biodefense Strategy, within 90 days of the date of this memorandum and at least quarterly thereafter, the NSC staff Directorate for Global Health Security and Biodefense shall convene lead agencies identified in the Biodefense Strategy's Implementation Plan at the Assistant Secretary level. These agencies shall brief the NSC staff on progress towards key milestones and timelines, as well as on critical gaps and barriers to progress. The NSC staff Directorate for Global Health Security and Biodefense shall provide updates quarterly to the APNSA based off of these briefs, summarizing progress towards the implementation of the Biodefense Strategy by highlighting the extent to which the goals and objectives are being met, outlining major gaps and impediments to timely and effective implementation, and presenting options for overcoming these gaps. The APNSA shall provide to the President, on an annual basis, a memorandum summarizing these updates.
(e) Within 180 days of the date of this memorandum and annually thereafter, or more frequently as warranted, the Director of National Intelligence, in coordination with the Secretaries of Defense and Homeland Security, the Attorney General, and the heads of relevant agencies, shall provide to the APNSA and the heads of relevant agencies a threat assessment on potential actors and threats, delivery systems, and methods that could be directed against or affect the national biodefense enterprise or that could negatively affect global health security, prioritizing high consequence or potentially catastrophic biological threats. These threat assessments shall be used to inform the review listed in subsection (a) of this section.
(f) Within 1 year of the date of this memorandum, the APNSA shall, in coordination with relevant agencies pursuant to Executive Order 13747 of November 4, 2016 (Advancing the Global Health Security Agenda to Achieve a World Safe and Secure from Infectious Disease Threats), recommend to the President updated goals and objectives for inclusion in the United States Government Global Health Security Strategy of 2019. These recommendations shall incorporate lessons from the COVID-19 pandemic and shall guide the Federal Government in protecting the United States at home and abroad from health security threats; describe the health security capacities needed in partner countries to prevent, detect, and respond to infectious disease threats, whether naturally occurring, accidental, or deliberate; and outline the United States' international support for the global health security architecture.
Sec. 4. General Provisions. (a) This memorandum rescinds and replaces National Security Presidential Memorandum 14 of September 18, 2018 (Support for National Biodefense).
(b) Nothing in this memorandum shall be construed to impair or otherwise affect:
(i) the authority granted by law to an executive department or agency, or the head thereof; or
(ii) the functions of the Director of OMB relating to budgetary, administrative, or legislative proposals.
(c) This memorandum shall be implemented consistent with applicable law and subject to the availability of appropriations.
(d) This memorandum is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
JOSEPH R. BIDEN JR.
