Recommendation Implementation Status

The President should place the Vice President in charge of national biodefense. The Vice President should take necessary action to ensure adequate biodefense for the United States, address relevant international issues and requirements, and coordinate the U.S. biodefense enterprise. The President should also provide the Vice President with jurisdiction within, and authority to coordinate among, the various relevant councils in the White House.

Action Item a. Empower the Vice President with jurisdiction and authority: Crisis action.

Prior to the spread of COVID-19 to the United States, neither President Obama nor President Trump made the Vice President responsible for federal biodefense as recommended by the Commission. When confronted with the 2014 Ebola crisis, President Obama appointed Ron Klain to serve as the coordinator within the White House to address this biological threat.25 Through National Security Presidential Memorandum
14, President Trump assigned primary responsibility for implementation of the National Biodefense Strategy to the National Security Advisor. While President Trump eventually put Vice President Pence in charge of the COVID-19 response, this authority did not extend to biodefense more broadly. President Biden has also chosen to locate the biodefense portfolio within the NSC, instead of with Vice President Harris.

The President must give the Vice President authority to review and advise on all agency biodefense budgets to achieve national security goals for biodefense
at any point during the budget development and submission process. This authority should extend to directing the budget submissions of departments and agencies in collaboration with the Director of the Office of Management and Budget.

Action Item b. Empower the Vice President with budget authority: Crisis action.

As recommended in A National Blueprint for Biodefense, neither President Obama nor President Trump directed their Vice Presidents to review and advise on federal biodefense budget submissions, work with OMB to direct these submissions, or make decisions about the biodefense budget. Instead, as usual, the NSC coordinated with OMB to set biodefense priorities in the President’s Budget Request. Empowering the Vice President or another individual within the White House with budget authority over biodefense is critical to ensuring adequate federal funding of the Nation’s biodefense.

The Vice President should direct all departments and agencies that address biodefense (in keeping with the National Biodefense Strategy of the United States of America per Recommendation 3) to hold a seat on the Biodefense Coordination Council. The designees should be at the Deputy Secretary level.

Action Item a. Require broad federal participation: Crisis Action.

Instead of a Biodefense Coordination Council, National Security Presidential Memorandum 14 established the Biodefense Steering Committee to oversee the implementation of the National Biodefense Strategy. The Biodefense Steering Committee is a policy-focused principals committee which must seek assistance from other federal departments and agencies as needed to carry out its duties. Chaired by the Secretary of Health and Human Services, the Biodefense Steering Committee is composed of the Secretary of State, Secretary of Agriculture, Secretary of Defense, Secretary of Homeland Security, Secretary of Veterans Affairs, Attorney General, and Administrator of the Environmental Protection Agency. The Secretary of Energy, Secretary of the Treasury, Administrator of the United States Agency for International Development, and Director of the Federal Bureau of Investigation are listed as Covered Officials in National Security Presidential Memorandum 14 and are Biodefense Steering Committee members by invitation of the Secretary of Health and Human Services.

Although the Biodefense Steering Committee includes many key federal agencies, not all federal departments, agencies, and institutions with biodefense responsibilities are required to participate, and National Security Presidential Memorandum 14 does not ensure that their interests are represented by other members. Additionally, the White House decision to place the Secretary of Health and Human Services in charge of the Biodefense Steering Committee, rather than the National Security Advisor or another official within the White House itself—means the Biodefense Steering Committee must reach decisions by consensus, with the White House resolving problems as needed.

The Vice President should lead the primary designees and the members as a coalition that will prioritize needed activities, designate responsibilities, and ensure accountability. Each federal department and agency with a seat on the Council should be charged, through the National Biodefense Strategy, with deliverables that the Council will develop and periodically evaluate.

Action Item b. Structure the Council for consensus and accountability. Partial Action.

National Security Presidential Memorandum 14 describes tasks and responsibilities for both the Biodefense Steering Committee and the Biodefense Coordination Team. It requires those federal departments and agencies addressed by the National Security Presidential Memorandum to compile and submit biodefense programmatic and spending data to the Committee and OMB. This information is meant to be assessed by the NSC and OMB and factored into the President’s Budget Request.

National Security Presidential Memorandum 14 requires the Biodefense Steering Committee to submit an annual Biodefense Assessment to the National Security Advisor and the Director of Office of Management and Budget that identifies shortfalls and redundancies, describes challenges to implementation of the National Biodefense Strategy, and recommends updates to the National Biodefense Strategy. National Security Presidential Memorandum 14 required the initial Biodefense Assessment to be completed and submitted to the NSC and OMB within 180 days after the establishment of the Biodefense Coordination Team. The Team completed and finalized the FY 2019 Biodefense Assessment well after the required deadline of June 15, 2019. The 2019 Biodefense Assessment was ultimately submitted to the National Security Advisor and the Director of Office of Management and Budget in December 2020. The Fiscal Year 2020 Biodefense Assessment is currently under development.

A publicly available summary of the 2019 Biodefense Assessment—required by National Security Presidential Memorandum 14—was released in September 2020 by the Biodefense Steering Committee. The report discussed the biological threat environment and steps taken to address the five goals of the National Biodefense Strategy, but the document failed to specify the roles and responsibilities federal departments and agencies have in addressing those goals, with one exception. Though not required by National Security Presidential Memorandum 14, roles, responsibilities, and other requirements are essential to developing successful accountability structures for implementing the National Biodefense Strategy.

In addition to the primary designees, the Vice President should include a state governor, a mayor, a territorial governor/administrator, a tribal leader, and private sector leaders representing critical infrastructure sectors that are vital to the success and continuity of biodefense.

Action Item c. Invite broad non-federal stakeholder participation. Partial Action.

The Biodefense Steering Committee does not include non-federal stakeholders. While the Biodefense Steering Committee is empowered to “establish appropriate consultative or advisory mechanisms” to obtain input from non-federal partners, it is not obligated to do so.

As the chair of the Biodefense Coordination Team, the Department of Health and Human Services Assistant Secretary for Preparedness and Response hosted a summit with non-federal stakeholders in April 2019 to receive verbal input regarding implementation of the National Biodefense Strategy and issued a call for written public comments thereafter. While this was helpful, it fell far short of incorporating state, local, tribal, and territorial government, and private sector perspectives into the Biodefense Steering Committee.

The NSC should collate all extant biodefense policies, laws, and treaties that promulgate defense responsibilities against intentionally introduced, accidentally released, and naturally occurring biological threats.

Action Item a. Collate the whole of biodefense policy: Partial Action

The National Defense Authorization Act of Fiscal Year 2017 (P.L. 114-328) required DOD, HHS, DHS, the Department of Agriculture (USDA), and other departments and agencies with biodefense responsibilities to develop the National Biodefense Strategy. The law mandated that this Strategy include a review and assessment of biodefense policies, practices, programs, and initiatives. Accordingly, as part of the Strategy’s development, the NSC obtained input from 17 federal departments and agencies that implement biodefense policies and programs. Having not obtained input from all governmental agencies with biodefense responsibilities, it is unlikely that the Trump NSC collated all biodefense policy, but it came much further in doing so than previous Administrations.

Based on the body of policy documents identified in action item 3a, the NSC and other relevant offices in the White House should catalog responsibilities and delineated requirements in all biodefense-related laws, directives, and other policy documents. Other relevant White House offices and councils beyond the NSC should further examine requirements in keeping with their areas of expertise and responsibility.

Action Item b. Identify requirements within all extant policies: Partial Action

The NSC’s work developing the National Biodefense Strategy included the identification of biodefense requirements across several federal policies. However, the White House has not yet described and assigned specific roles, responsibilities, and requirements to each goal in the Strategy. Some of these details should be captured by the implementation and periodic update process required by National Security Presidential Memorandum 14.

Additionally, National Security Presidential Memorandum 14 establishes an annual process to collect data across federal agencies to develop a Biodefense
Assessment. This Assessment must identify any gaps, shortfalls, and redundancies; describe any challenges to the implementation and execution of the Strategy; and recommend any necessary updates or changes to the National Biodefense Strategy. To gather this data, the Secretary of Health and Human Services issued an initial request for information to numerous federal agencies to determine how programs and activities governed by their agencies contribute to the objectives of the National Biodefense Strategy.

The Director of the Office of Management and Budget should identify how much funding has been budgeted and appropriated for each requirement identified in action item 3b. OMB should audit performance and determine if requirements are still appropriate, and if not, provide options for refining, moving, or eliminating them.

Action Item c. Assess spending history and value: Partial Action

Prior to the release of the National Biodefense Strategy, OMB started an analysis of biodefense program spending. This appears to be a function of the order in which the Trump Administration initiated the development of the National Biodefense Strategy. Policy identification and alignment occurred first. If the federal government executes National Security Presidential Memorandum 14 as directed, the implementation process should capture budgetary analysis and alignment, and the annual Biodefense Assessment should also include an analysis of the extent to which allocated resources support the Strategy’s goals and objectives.

The Vice President (using the information collected from action items 3a, 3b, and 3c) should develop a comprehensive national biodefense strategy and implementation plan. Departments and agencies must be held accountable for the elements of the plan for which they have been made responsible. A progress report should be provided to Congress annually.

Action Item d. Produce the National Biodefense Strategy of the United States of America and its Implementation Plan: Partial action

The Trump Administration released the National Biodefense Strategy in September 2018. The Strategy provided vision and mission statements, as well as specific goals and broad objectives. President Trump concurrently signed National Security Presidential Memorandum 14, which described some of the structures and processes needed for implementation of the Strategy. The National Biodefense Strategy also included an implementation plan, but it lacked sufficient detail. The implementation plan described the goals of the Strategy, but it did not assign responsibilities, roles, timelines, or milestones—key elements of any effective implementation plan.

National Security Presidential Memorandum 14 also describes the way in which the Strategy is to be implemented, beginning with the establishment of the Biodefense Steering Committee. This Committee is responsible for monitoring and coordinating the implementation of the Strategy and is supported by the Biodefense Coordination Team as led by a designated senior official in, or detailed to, HHS. Presently, this official is the Department of Health and Human Services Assistant Secretary for Preparedness and Response. National Security Presidential Memorandum 14 also requires the Biodefense Coordination Team to develop a proposal that would address the accountability structures and action items needed for implementation of the National Biodefense Strategy. Though originally scheduled for finalization and release in late 2019, the proposal was never released by the Trump Administration.

The National Defense Authorization Act for Fiscal Year 2021 (P.L. 116-283) requires the Secretary of Health and Human Services, the Secretary of Defense, the Secretary of Agriculture, the Secretary of Homeland Security, the
Secretary of State, and other federal departments and agencies with biodefense responsibilities, to update the implementation plan for the National Biodefense Strategy. These updates include adding processes, roles, and responsibilities for executing the Strategy, as well as short, medium, and long term goals. The law instructs these departments and agencies to work with the National Security Advisor and the Director of the Office of Management and Budget to update the implementation plan.

Congress should direct the Government Accountability Office (GAO) to analyze gaps in resources mapped against the requirements of the National Biodefense Strategy and estimate resource requirements for small-, medium-, and large-scale events.

Action Item e. Develop a gap analysis based on this comprehensive strategy: Partial Action.

In 2019, the Secretary of Health and Human Services issued a request for information to federal departments and agencies to assess how their programs align with the National Biodefense Strategy. The deadline for responding to the request for information was May 2019. The Biodefense Coordination Team collected the information from federal departments and agencies with biodefense responsibilities to inform the Biodefense Assessment and the following budget cycle. The Biodefense Steering Committee transmitted the Fiscal Year 2019 Biodefense Assessment to the National Security Advisor and the Director of the Office of Management and Budget in December 2020. The Department of Health and Human Services Assistant Secretary for Preparedness and Response released a public-facing 2019 Biodefense Public Report in September 2020, based on the 2019 Biodefense Assessment. Future assessments should assist with periodically refreshing the National Biodefense Strategy.

Additionally, the National Defense Authorization Act of Fiscal Year 2017 (P.L. 114-328) required the GAO to analyze gaps in resources mapped against the requirements of the National Biodefense Strategy and other existing biodefense policies. GAO released this report on February 19, 2020. This report concluded that the structure of the National Biodefense Strategy and National Security Presidential Memorandum 14 showed promise but identified several obstacles to implementation, including a lack of centralized authority to influence policy and make budget decisions for federal departments and agencies with biodefense responsibilities. Although the statute required GAO to assess resource gaps regarding the goals set forth in the National Biodefense Strategy, GAO did not address this matter in its final report.

At the direction of Congress and under the management of the Vice President, the NSC should conduct a major quadrennial biodefense review of all relevant departments and agencies, with a report and updated National Biodefense Strategy submitted on behalf of the Executive Branch to Congress by the Vice President.

Action Item f. Institute a major quadrennial biodefense review: Inaction.

Congress has not passed legislation requiring a quadrennial biodefense review, and the Executive Branch has not indicated interest in such an effort. A long-range review of federal departments and agencies with biodefense responsibilities should follow implementation of the National Biodefense Strategy and corresponding review and unification of existing federal biodefense spending. In turn, the review should inform the next iteration of the Strategy.

The President and congressional appropriators should require the Director of the Office of Management and Budget to conduct this data call, coordinated by the Vice President. Each department and agency should catalogue all of their biodefense programs and indicate which support specific biodefense requirements in the National Biodefense Strategy, and which do not. The submissions should include historical annual expenditures for each program and predicted future needs

Action Item a. Develop and execute a mandatory annual biodefense call for data: Completed.

National Security Presidential Memorandum 14 tasks the Secretary of Health and Human Services with issuing an annual request for information to identify federal programs and activities that contribute to the objectives of the National Biodefense Strategy. Each federal department and agency develops an annual Biodefense Memorandum in response to the request for information that the Biodefense Coordination Team uses to prepare an annual Biodefense Assessment to identify gaps, shortfalls, and redundancies; describe challenges to the implementation and execution of the Strategy; and recommend any necessary updates or changes to the Strategy. Based on the Biodefense Assessment, the NSC and OMB are tasked with working together to align biodefense policy priorities with program budgets. OMB and agency budget personnel should help formulate the reporting criteria to enable this assessment.

Using the information collected in the data call, the Vice President and the Director of the Office of Management and Budget should identify gaps and overlaps in and among federal programs. This analysis should be used to inform OMB budgetary guidance sent to departments and agencies for the coming fiscal year.

Action Item b. Conduct a cross-cutting biodefense budget analysis: Partial Action.

In February 2019, Congress included a requirement that OMB conduct a cross- cutting biodefense budget analysis in the conference report for the Consolidated Appropriations Act of 2019 (P.L. 116-6). Congress again included such a requirement in the conference report for the Consolidated Appropriations Act of 2020 (P.L. 116- 93). Congress further emphasized their interest in oversight of federal biodefense by including in the National Defense Authorization Act of 2021 (P.L. 116-283) a permanent standing requirement to conduct a biodefense budget analysis and submit an annual biodefense budget to Congress. However, OMB has yet to finalize and release the analysis required by the two previous conference reports. As Congress and the federal government continue COVID-19 response activities and begin work to reassess the funding and organization of the Nation’s biodefense efforts, a cross- cutting analysis would serve as a useful tool for the development of future policy recommendations.

The Director of the Office of Management and Budget should require that all annual budget request submissions pertaining to biodefense adhere to the guidance from OMB, based on the National Biodefense Strategy and the budget crosscut.

Action Item c. Align budget items to the National Biodefense Strategy of the United States of America: Partial Action.

National Security Presidential Memorandum 14 requires departments and agencies to describe to the Secretary of Health and Human Services how existing programs and resources could be better utilized or allocated to align with the National Biodefense Strategy and how additional resources could be applied to support the goals of the Strategy. National Security Presidential Memorandum 14 further requires departments and agencies to submit budgets for biodefense-related programs that are based on policy guidance derived from the National Biodefense Strategy and informed by the annual Biodefense Assessment. Departments and agencies are required to justify spending relative to the goals of the National Biodefense Strategy. National Security Presidential Memorandum 14 also requires submission of annual budget requests to conform with budget guidance issued by OMB and detail how they align with the National Biodefense Strategy.

The results of the process required by National Security Presidential Memorandum 14 were partially reflected in the FY 2021 budget, most explicitly in the budget for the Office of the Department of Health and Human Services Assistant Secretary for Preparedness and Response. However, other legacy biodefense programs saw little budgetary change from one fiscal year to the next and lacked references to the National Biodefense Strategy.

The President should request funding for all biodefense activities in the annual budget request, including multi-year requests for those programs that the Vice President and Director of the Office of Management and Budget determine would benefit from such forward funding. Additionally, departments and agencies should provide multi-year grants, contracts, and/or cooperative agreements wherever possible.

Action Item d. Provide predictable and multi-year funding for all biodefense programs: Inaction.

With limited exceptions, the White House has not requested, and Congress has not appropriated, multi-year funding for biodefense programs. Instead, biodefense programs have received funding through the annual appropriations process. In recent years, Congress has struggled to finalize government funding prior to the start of each fiscal year, leaving key biodefense programs subject to continuing resolutions and government shutdowns. This presents challenges to federal departments and agencies seeking to make long-term investments in biodefense.

Lack of predictable multi-year funding also makes it more difficult for federal departments and agencies to incentivize private sector entities to develop medical countermeasures, where the federal government is the only purchaser. The medical countermeasure development process is long and risky and relies on continued governmental engagement with industry. Multi-year funding would allow for more efficient utilization of available resources and provide market certainty to private sector partners who may be hesitant to invest in the biodefense enterprise.

Notably, some discrete activities do have multi-year budgets. The Public Health Emergency Medical Countermeasures Enterprise annually issues a five-year budget covering HHS entities involved in medical countermeasure development and procurement: the Food and Drug Administration (FDA), the National Institutes of Health (NIH), BARDA, and Strategic National Stockpile. This multi-year budgeting approach should be mirrored across the biodefense enterprise. Moreover, OMB and Congress should consider these multi-year budgets as part of the budgeting and appropriations processes, respectively.

Compounding the challenges of dependency on the annual appropriations process, chronic federal underfunding of biodefense programs has necessitated significant emergency spending when crises occur. Responses to all recent infectious disease public health emergencies (i.e., H1N1 influenza, Ebola, Zika, COVID-19) were funded through emergency supplemental appropriations, an approach that dramatically reduces certainty and consistency in preventing, deterring, preparing for, detecting, responding to, attributing, recovering from, and mitigating biological events.

The nature of supplemental funding can also have significant implications for the success of the programs it is designed to support. The uncertain nature of emergency funding prevents non-federal partners from conducting long-term
biodefense planning. State, local, tribal, and territorial governments that depend on federal assistance to support their biodefense programs can better apply resources over a multi-year timeframe. Moreover, because this emergency funding is provided outside the normal appropriations process, it usually disappears after the immediate crisis has abated. In many cases, this means that valuable response capacity and capability are lost when funding dwindles, leaving the public and private sectors to start afresh with each new crisis.

At the start of each congressional session, Senate and House leadership should direct each committee with biodefense jurisdiction, in accordance with House and Senate rules, to convene for an in-depth classified biological threat briefing. Leadership should ensure that all identified committees include pressing biodefense topics in their oversight agendas. These agendas should include joint committee and joint chamber hearings and other oversight activities.

Action Item a. Develop joint congressional oversight agendas: Crisis Action.

Thirty-one Congressional committees have jurisdiction over aspects of the Nation’s biodefense enterprise. Despite this overlapping jurisdiction and the importance of adequate oversight, Congressional leadership has yet to develop joint congressional oversight agendas, and Congress has not held joint committee and joint chamber hearings. House and Senate committees did hold 17 biodefense-related oversight hearings in the 115th Congress, and 50 biodefense-related hearings—the vast majority of which addressed the response to COVID-19—in the 116th Congress. These hearings varied substantially in scope and aim. Additionally, in April 2020, Speaker of the House Nancy Pelosi created the Select Subcommittee on the Coronavirus Crisis within the House Committee on Oversight and Reform to investigate the federal response to the crisis and monitor the spending of federal emergency appropriations to address the pandemic. Though the Committee’s focus is on the immediate threat posed by COVID-19, its oversight activities could address overall federal biodefense capabilities.

In 2018, we recommended that House and Senate leadership establish a bicameral, bipartisan Congressional Biodefense Working Group. Through this forum, representatives from all relevant committees with authorization and appropriation responsibilities for biodefense would convene regularly. Discussion would address oversight objectives for Congressional authorization and appropriations, and potential government reform.

In addition to oversight hearings, COVID-19 drove substantial congressional activity. Numerous pieces of legislation were introduced in the 116th Congress, addressing various aspects of the Nation’s ability to prevent, deter, prepare for, detect, respond to, attribute, recover from, and mitigate biological events, although few made it past committee consideration. Additionally, Congress passed several large emergency legislative packages to fund public and private sector response efforts.

The Director of National Intelligence should create a National Intelligence Manager for Biological Threats and ensure that this National Intelligence Manager interacts appropriately with other National Intelligence Managers who address some aspect of the biological threat. The Director of National Intelligence should make this new National Intelligence Manager the executive agent for distributing certain funds for biological intelligence activities, transferring responsibility from the Central Intelligence Agency.

Action Item a. Create a National Intelligence Manager for Biological Threats: Partial Action.

Former Director of National Intelligence Coats chose not to establish a separate National Intelligence Manager for Biological Threats. Instead, he assigned primary responsibility for biological threats to the National Intelligence Manager for Weapons of Mass Destruction, who is also the Director of the National Counterproliferation Center. The National Intelligence Manager for Weapons of Mass Destruction already had a portfolio that included biological weapons of mass destruction and the Director of National Intelligence believed that a separate National Intelligence Manager was, therefore, unnecessary.

In January 2021, President Biden issued a National Security Memorandum to address federal COVID-19 response efforts and biological preparedness, including biological intelligence. The Memorandum instructs the Director of National Intelligence to review Intelligence Community activities related to pandemics and high consequence- biological threats, and develop a plan to strengthen biodefense intelligence capabilities. The Memorandum suggests the creation of National Intelligence Manager and National Intelligence Officer positions focused on biological threats as solutions for further prioritizing the biological threat.

Meanwhile, the National Counterterrorism Center and other National Intelligence Managers continue their own activities addressing the biological threat. Military intelligence efforts—especially those supporting and resulting from U.S. Special Operations Command (that assumed responsibilities for addressing weapons of mass destruction from U.S. Strategic Command)—have continued as well.

The Director of National Intelligence should ensure that the Intelligence Community assigns priorities to countries and non-state actors as they relate to biological weapons programs and activities. The Intelligence Community should broaden focus to address classes of biological agents, as opposed to individual diseases. The Intelligence Community should also collaborate with the private sector when conducting this analysis and ensure that scientific and other expertise residents within the Community are sufficient to develop biological threat futures.

Action Item b. Make biological weapons programs and related activities a discrete intelligence topic: Partial Action.

The Intelligence Community continues to determine how best to assign priorities to the biological weapons programs and activities of countries and non-state actors, as well as to classes of biological agents.

The Director of National Intelligence should ensure that the Intelligence Community develops intelligence collection strategies that address bystanders, who may be able to provide useful information.

Action Item c. Address Bystanders: Partial Action.

In 2019, the Director of National Intelligence released the National Intelligence Strategy that aligns intelligence objectives with national strategies and communicates these objectives to the Intelligence Community workforce, partners, oversight, customers, and citizens. Bystanders are not addressed by the Strategy. However, the Intelligence Community addresses bystanders as part of regular intelligence activities.

The Director of National Intelligence should ensure that the Intelligence Community dedicates sufficient intelligence and scientific resources to collection and analysis to produce and distribute comprehensive biological threat assessments to all members of the biodefense enterprise.

Action Item d. Distribute assessments: Partial Action.

According to the 2019 National Intelligence Strategy, the Intelligence Community will provide in-depth assessments, context, and expertise about the strategic environment, including capabilities, activities, and intentions of key state and non-state entities to inform U.S. national security policy and strategy development. While the Intelligence Community does develop some biological threat-related products, it does not produce and distribute comprehensive biological threat assessments to the entire biodefense enterprise.

The White House should lead all relevant agencies to a new level of understanding, planning, and operating with respect to biodefense that includes an animal health and, more broadly, a One Health mindset. The Vice President should direct the NSC to review all strategic biodefense documents to ensure that animal health and environmental health agencies are identified and assigned responsibility, and that their activities are fully aligned and coordinated with other biodefense activities and are current with respect to new science and evidence.

Action Item a. Institutionalize One Health: Partial Action.

The federal approach to biodefense is still largely geared toward human health, instead of an approach that also factors in animal and environmental health.
COVID-19 demonstrates this disparity. Though SARS-CoV-2 is the third zoonotic coronavirus in recent years, related federal animal health and human health programs and policies are not integrated. Two of these three viruses originated in wildlife, also indicating the need for expertise from agencies such as the Department of the Interior (DOI). The federal government continues to prioritize human health above that of animal or environmental health, with little coordination across responsible federal agencies.

Limited steps have been taken to embed the One Health approach in federal biodefense strategies and activities. One recent development is the One Health Federal Interagency Network. Run by the Centers for Disease Control and Prevention (CDC) One Health Office, the Network is developing a five-year strategic plan built on multisectoral collaboration for One Health. CDC, DOI, and USDA co-lead this effort, working to find multisectoral ways to desegregate public health security-related activity while taking human, animal, and environmental health into consideration. The onset of the COVID-19 pandemic delayed development of this plan.

Complete response and recovery plans for zoonotic diseases do not yet exist. However, the January 2017 update of the Biological Incident Annex to the Response and Recovery Federal Interagency Operational Plans took the human-animal interface into account. The Annex reinforced the need for animal surveillance and infection control, medical countermeasure development, and other activities in the event of a zoonotic outbreak. It contains some elements of a zoonotic disease emergency response plan. The 2019 Pandemic and All-Hazards Preparedness and Advancing Innovation Act (P.L. 116-22), also required the National Health Security Strategy to specifically address zoonoses.

The Administrator of the Department of Agriculture’s Animal and Plant Health Inspection Service, working with the Director of the Department of the Interior’s U.S. Fish and Wildlife Service and other partners as appropriate, should develop a nationally notifiable animal disease list and implement a reporting system for states, localities, tribes, territories, and other owners of disease information. USDA should afford the DHS, the HHS, and other agencies engaged in biodefense access to the data in this system.

Action Item b. Develop a nationally notifiable animal disease system: Partial Action.

In an important step toward a national animal disease system, USDA published a draft framework for public comment in 2016 that would make reporting of notifiable diseases mandatory by veterinary practitioners, producers, diagnostic laboratory personnel, and others with knowledge of confirmed or suspected occurrences. For the first time, private laboratories and entities would be required to report both notifiable and monitored diseases. The framework would rely on collaboration among federal, state, tribal, and territorial officials, and the private sector to determine the specific data needs for each disease on the monitored list. The framework underwent a prolonged review period and a proposed rule for the National List of Animal Diseases was issued on April 2, 2020 for public comment. After the end of that initial comment period, USDA again invited public comments for the proposed rule in August 2020. USDA has not yet finalized the rule.

The Secretary of Health and Human Services, in coordination with the Secretary of Agriculture and Secretary of Defense, should prioritize emerging infectious disease threats. They should consider using a multi-criteria decision analysis tool and transparent methodology to develop these determinations. They should address pathogens and pathogen families with the potential to cause a catastrophic public health emergency sufficient to affect national security, including agents known to infect wildlife and domestic animals. The list should drive funding in surveillance, response planning, medical countermeasure development, and any activities revealed as gaps per action item 3e.

Action Item c. Prioritize emerging and reemerging infectious diseases: Inaction.

HHS and USDA leadership have not convened to systematically determine the most pressing emerging infectious disease threats and inform funding decisions. Before we issued our recommendation in A National Blueprint for Biodefense, the CDC developed a zoonotic disease prioritization tool and began utilizing it in several countries. In December 2017, the CDC applied this tool to the United States partially addressing this recommendation.

Cabinet-level leadership must drive any threat identification and prioritization process. Absent this effort, it will remain difficult to determine how best to budget finite resources for defense against emerging and reemerging infectious diseases.

The Vice President should ensure that Public Health Emergency Medical Countermeasures Enterprise priorities, as well as those agents that have been determined to be material threats, guide NIH biodefense research investments and ensure delivery of medical countermeasure candidates that address Public Health Emergency Medical Countermeasures Enterprise medical countermeasure priorities.

Action Item a. Ensure NIH research supports civilian medical countermeasure priorities: Partial Action.

The NIH, through NIAID, is heavily involved in the basic research needed to support the development of effective medical countermeasure candidates for subsequent advanced development. NIAID grants also support the early development of promising medical countermeasure candidates before transitioning products to BARDA for continued development assistance. The relationship between NIH and BARDA has matured, and there are now stronger connections between BARDA requirements and NIH basic research to support those requirements. Additionally, NIAID is a member of the Public Health Emergency Medical Countermeasures Enterprise. Recent reorganization of the Public Health Emergency Medical Countermeasures Enterprise by the Department of Health and Human Services Assistant Secretary for Preparedness and Response and the codification of Public Health Emergency Medical Countermeasures Enterprise structures and requirements in the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (P.L. 116- 22) should also help drive further progress.

Despite these positive developments, systematic prioritization of emerging infectious diseases remains necessary to provide NIH with additional information in support of medical countermeasures for emerging infectious diseases. A NIAID spend plan is also still needed.

The Vice President should assess whether the level of funding allocated for biological agents that have received a material threat determination, and the proportion of funding allocated for early research and development of medical countermeasure candidates versus advanced research and development, is appropriate for maximizing opportunity to achieve overall success. The unified budget per Recommendation 4 provides a mechanism to achieve this harmonization. If the funding level for BARDA needs to be increased, that must be requested.

Action Item b. Ensure funding allocations are appropriate to meet the need: Inaction.

Neither the White House nor the federal departments and agencies that develop medical countermeasures has issued a publicly available assessment of the funding levels that would address national medical countermeasure requirements based
on material threat determinations and ascertain whether the balance of basic and advanced research is yielding needed results. Historically, the nation’s medical countermeasure enterprise has lacked the necessary funding to develop and stockpile medical countermeasures for all material biological threats, let alone for emerging and reemerging infectious diseases.

DHS determined that Ebola virus was a material threat a decade prior to the West Africa Ebola outbreak seven years ago, but medical countermeasures were nonexistent when the need arose in 2014 because early basic research candidates had long since been abandoned. Whereas the Defense Advanced Research and Projects Agency is permitted to take risks (it is effectively their mandate to do so), BARDA is not. BARDA is expected to succeed with every contract it awards, and to do so at a much lower price than the regular drug development process entails. The Public Health Emergency Medical Countermeasures Enterprise Multiyear Budget includes two projected out-years of funding, but when the time comes to request the funding for those out-years, the agencies involved provide different justification for the requested resources than the explanation given in the original multiyear budget.

Pursuant to action items 8a and 8b, and concurrent with the annual President’s Budget Request, the Director of the National Institute of Allergy and Infectious Diseases should annually submit a plan to Congress that describes in detail the goals for the NIAID medical countermeasure research investments, including transition to advanced research, development, and procurement planning at BARDA. The Director of the National Institute of Allergy and Infectious Diseases should base this plan on the development of medical countermeasure candidates targeted against agents that have received an material threat determination, as well as to priorities identified on the emerging infectious disease list developed per action item 7c. The Director of the National Institute of Allergy and Infectious Diseases should include ways to strengthen the bridge between the NIAID and BARDA so that products can more easily transition from early-stage development to advanced research and development.

Action Item c. Require a biodefense spend plan from the NIAID: Inaction.

NIAID does not submit an annual plan to Congress that describes its goals for research investments to meet BARDA requirements. The Public Health Emergency Medical Countermeasures Enterprise does submit a five-year budget plan, and the 21st Century Cures Act (P.L. 114-255) requires submission of this plan no later than March 1st of each year. Although the submission does break down the multi- year budget by agency, including for NIAID, this plan does not capture the NIAID spending plan in detail. The plan also frequently differs dramatically from the President’s Budget Request and is subject to change when the Administration requests funding from Congress for the out-years of the five-year budget plan. The plan consists primarily of a high-level, three-page narrative that explains NIAID’s past accomplishments. It does not describe how NIAID intends to map its funding to a specific list of BARDA requirements for medical countermeasures.

The major disconnect between NIAID and BARDA regarding the development of Ebola medical countermeasures became problematic when the disease reemerged in 2014 and no product candidates were available. Congress and BARDA must understand the ways that NIAID investments specifically address BARDA medical countermeasure requirements. The existing five-year Public Health Emergency Medical Countermeasures Enterprise plan does not fulfill this requirement.

The Vice President should direct the Secretary of State, Secretary of Defense, Secretary of Homeland Security, the Attorney General, and the Director of National Intelligence to establish and formalize this apparatus. They should inform this apparatus with 1) standards/burdens of proof in the U.S. criminal justice system; 2) evidence, information, and intelligence regarding the source; 3) accuracy, reliability, timeliness, credibility and defensibility of that evidence, information, and intelligence; and 4) national security considerations. This apparatus should be exercised to inform decisions and to ensure that these decisions are defensible.

Action Item a. Establish a national biological attribution decision-making apparatus: Inaction.

There is currently no framework in place for the White House, departments, and agencies to inform decisions in the aftermath of a biological event. Various federal departments and agencies contributed to attribution efforts related to COVID-19 and found no evidence that the SARS-CoV-2 strain that caused the disease was genetically engineered. The federal government should assess the attribution process undertaken to reach that conclusion and use it as a foundation to develop a national apparatus for future biological threats requiring attribution activities.

The FBI is the primary customer of the National Biodefense Analysis and Countermeasures Center and has the needed credibility and influence to allow the Center to fulfill its role in biological forensics and attribution. Congress should amend The Act to Enact Title 5 of the U.S. Code, “Government Organization and Employees,” and make the FBI responsible for the National Bioforensics Analysis Center, its administration, and its activities, including interagency support and coordination. Congress should reallocate appropriations accordingly. Congress should also increase its oversight over National Bioforensics Analysis Center activities.

Action Item b. Place the FBI in charge of the National Bioforensics Analysis Center: Partial Action.

The National Bioforensics Analysis Center provides dedicated biological attribution capability. The federal government, foremost the FBI, uses the facility to help determine the origin and characteristics of biological specimens. The President’s Budget Request for FY 2018 sought to close the National Biodefense Analysis and Countermeasures Center, the home of the National Bioforensics Analysis Center. Thankfully, Congress did not agree. Language contained in the National Defense Authorization Act for Fiscal Year 2018 (P.L. 115-91) required the Secretary of Homeland Security and the Secretary of Defense to submit a report to Congress on the functions, mission, and end users of the National Biodefense Analysis and Countermeasures Center, as well as a transition plan in the event of the facility’s closure.

At the direction of OMB, and as reflected in the President’s Budget Request for FY 2019, DHS and the FBI entered into a Memorandum of Agreement in September 2018 about National Bioforensics Analysis Center funding and operational responsibilities. Under the Memorandum of Agreement, the FBI and DHS share the costs of operating the National Bioforensics Analysis Center. The FBI is responsible for daily operations of the National Bioforensics Analysis Center while DHS operates and maintains the building. The President’s Budget Requests for FY 2020 and FY 2021 reflect this new status quo.

Congress should transfer responsibility for the National Bioforensics Analysis Center to the FBI. Additionally, Congress should provide additional funding to the FBI to support the agency’s new responsibilities with regard to the National Bioforensics Analysis Center.

The Vice President should ensure that FEMA is included in interagency efforts led by the Office of Science and Technology Policy (OSTP) and other federal efforts to study and determine policy regarding remediation after biological attacks.

Action Item a. Include FEMA in efforts to address remediation: Inaction.

There is no indication that FEMA has been included in any federal effort to study and develop policy for environmental remediation following a biological event. Under the 2017 Biological Incident Annex to the Response and Recovery Federal Interagency Operational Plans, FEMA is primarily responsible for managing coordinating centers, funding sources, and non-medical supply resourcing, and supporting the Emergency Support Functions and Recovery Support Functions for biological incidents. However, leadership and policy with regard to remediation activities has not been clearly established.

Congress should amend the National Environmental Policy Act of 1969 to place the Administrator of the Environmental Protection Agency in charge of environmental decontamination and remediation after accidental releases and biological attacks. The EPA should assume operational responsibility and coordinate with other agencies, non-federal governments, academia, and private sector organizations for environmental decontamination and remediation after accidental releases and biological attacks.

Action Item b. Assign responsibility to the EPA for environmental decontamination and remediation: Partial Action.

Congress has not amended the National Environmental Policy Act of 1969 (P.L. 91-190) to place the Administrator of the Environmental Protection Agency in charge of environmental decontamination and remediation after accidental releases and biological attacks. However, under the 2017 Biological Incident Annex to the Response and Recovery Federal Interagency Operational Plans, EPA is the lead agency for environmental cleanup and remediation in the inland zone. In the event of environmental contamination due to a biological incident, HHS is supposed to collaborate with EPA to develop and implement strategies for sampling and sharing testing results. Additionally, EPA conducts response activities under the Comprehensive Environmental Response Compensation and Liability Act (42 U.S.C. §9601 et seq.), or an Emergency Support Function 10 mission assignment in the event of a declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act (Public Law 93-288, as amended, 42 U.S.C. 5121 et seq). The National Biodefense Strategy superseded HSPD-10 but did not make the EPA the lead agency responsible for decontamination.

Real world events have not tested these plans and responsibilities. FEMA should work with EPA and HHS to exercise the Biological Incident Annex to the Response and Recovery Federal Interagency Operational Plans regarding environmental remediation and include DOI to address issues related to preventing or controlling the establishment of new wildlife reservoirs of disease agents introduced into the United States.

The Vice President and Congress should require the Secretary of Defense, Secretary of Agriculture, Secretary of Health and Human Services, Secretary of Homeland Security, Secretary of the Interior, Secretary of Veterans Affairs, and the Attorney General to monitor those that come under their purview when they have or could have been exposed during or as a result of accidental releases, natural occurrences, and biological attacks. The Vice President and Congress should require the Secretary of Health and Human Services to conduct cross-sectional studies of those exposed to anthrax on Capitol Hill and elsewhere during the events of 2001.

Action Item c. Conduct studies of those exposed to disease-causing agents: Inaction.

The Vice President and Congress have not required the Secretary of Agriculture, Secretary of Defense, Secretary of Health and Human Services, Secretary of the Interior, and Secretary of Veteran’s Affairs to monitor those under their purview for ill effects from exposure to naturally occurring, accidentally released, or intentionally introduced diseases (including those due to biological terrorism and warfare).

Under the direction of the Vice President, NSC staff should finalize and release the implementation plan for this strategy. The plan must describe roles and responsibilities for specific departments and agencies and provide metrics and goals for the individuals responsible. The plan must identify information required by decision makers (federal, state, local, tribal, territorial, and private sector) to manage a biological event. These requirements should then be used to determine needed data sources, technology, and operational processes to achieve situational awareness and response capabilities. The plan should encourage and incentivize private sector input.

Action Item a. Implement the National Strategy for Biosurveillance: Partial Action.

The federal government implemented some of the elements of the 2012 National Strategy for Biosurveillance. However, the release of the National Biodefense Strategy effectively supplanted the National Strategy for Biosurveillance.

The National Biodefense Strategy includes objectives related to national biosurveillance. Goal 1.2 of the National Biodefense Strategy emphasized the importance of coordinated domestic and international information-sharing systems that are capable of timely prevention, detection, assessment, response, and recovery from biological incidents, and specified the need to enhance integration of biosurveillance systems and improve information-sharing and reporting. Goal 4.1 calls for the sharing of biological threat and incident information with appropriate stakeholders to support multi-sectoral decision-making.

In July 2019, DHS completed a Strategy for Integrated Biosurveillance to govern the Department’s biosurveillance activities, as required by the Joint Explanatory Statement accompanying the Consolidated Appropriations Act of 2018 (P.L. 115-141). A corresponding implementation plan is in development but has not yet been released. The federal government continues to face problems in assisting state, local, tribal, territorial, and private sector biosurveillance efforts. The lack of integrated COVID-19 biosurveillance data at the federal level illustrates this capability gap.

The Secretary of Homeland Security should make this committee the nexus for active collaboration with non-federal government and non-governmental partners. This group will clarify and coordinate the response and recovery goals, objectives, and activities of federal, state, local, tribal, and territorial agencies and non-governmental organizations following the determination that a biological event has occurred.

Action Item a. Create an interagency biosurveillance planning committee: Partial action.

An interagency biosurveillance planning committee as envisioned by A National Blueprint for Biodefense does not currently exist, and current organizational structures fall short of what is needed to ensure timely collaboration among federal and non- federal stakeholders.

The National Biodefense Strategy requires the Biodefense Steering Committee to “establish appropriate consultative or advisory mechanisms” to obtain input from non- federal partners. However, the Biodefense Steering Committee is not obligated to do so, and existing mechanisms for stakeholder input have been limited.

Additionally, there is no standing advisory board on which state, local, tribal, and territorial officials can support the National Biosurveillance Integration System. According to the DHS Countering Weapons of Mass Destruction Office, resource limitations have impacted its ability to stand up an advisory board. This is especially troubling because stakeholder input is critical for the successful execution of the National Biosurveillance Integration System’s activities, particularly considering the DHS Strategy for Integrated Biosurveillance.

The Pandemic and All-Hazards Preparedness and Advancing Innovation Act (P.L. 116-22) also included provisions related to biosurveillance. The statute requires the Secretary of Health and Human Services to establish technical and reporting standards for biosurveillance, and to convene a public meeting to gather input from federal departments and agencies with biosurveillance responsibilities; state, local, tribal, and territorial representatives; and non-governmental experts. The Pandemic and All-Hazards Preparedness and Advancing Innovation Act mandates that this public meeting inform a strategy and implementation plan that include a review and assessment of existing capabilities and measures of progress. The law required the strategy and implementation plan to be submitted no later than December 2020.

As directed by the Vice President, the NSC should immediately examine the System to determine whether expenditures have yielded sufficient amounts of useful information to decision makers beyond the DHS. A serious effort at planning and prioritization on the part of the White House is the only means to achieve success in this complicated interagency endeavor. If it cannot be achieved, the current effort should be discontinued.

Action Item a. Assess the viability of the National Biosurveillance Integration System as the prime integrator of biosurveillance information: Inaction.

A 2016 independent appraisal of the Nation’s readiness to prevent, detect, and respond to biological threats concluded that different purposes and funding streams resulted in parallel biosurveillance systems with poor interoperability and electronic linkages. The National Biosurveillance Integration System would have solved many of these problems through integrated analysis of human and animal data.

The response of the Department of Health and Human Services Assistant Secretary for Preparedness and Response to this independent appraisal contained several action items targeted for calendar years 2018 and 2019, including the development of “a plan for increasing interagency liaison activity between the National Biosurveillance Integration System and 14 federal departments and agencies” and provision of “an information technology system designed to integrate and exchange surveillance information between departments and agencies as part of a national targeting capability.” Additionally, DOD is working with the National Biosurveillance Integration System on a joint venture to further collaboration and data analysis. This system, the Biosurveillance Ecosystem, is a technological platform that will allow for controlled and secure collaboration across users, customized data analytics, and advanced machine learning.

Neither the White House nor DHS has assessed the viability of the National Biosurveillance Integration System as the primary hub for federal biosurveillance information aggregation, analysis, and dissemination. The White House and DHS also have not offered corrective actions or alternative approaches to Congress for how to resolve existing challenges for the National Biosurveillance Integration System to fulfill its statutory requirements.

The NSC should convene data owners and other stakeholders to evaluate incentive options and determine which are most viable for data and information sharing. These incentives should then be built into the National Biosurveillance Integration System, or a different construct as determined by the NSC and Congress.

Action Item b. Incentivize data sharing: Partial Action.

A lack of data and information-sharing—not technology platforms—is the primary barrier to effective biosurveillance. Incentives for interagency and non-federal entities to share biosurveillance data and information would help resolve these issues. The NSC can play a vital role by convening data owners and other stakeholders to evaluate and implement options that could incentivize data and information-sharing.

In the absence of this national coordination, some organizations are finding ways to facilitate information-sharing on their own. For instance, the Biosurveillance Ecosystem platform includes organization-specific spaces that are firewalled and controlled by the tenant of that space, allowing the tenant to control who sees their data and the extent to which their data may be integrated with that of others. As another example, a joint effort by the National Biosurveillance Integration System and the National Wildlife Health Center to enable federal, state, tribal, and territorial partners to rapidly report wildlife mortality events is working to enable export to, and interoperability with, other systems. The National Biosurveillance Integration System has also worked with interagency platforms and emergency medical service providers to develop an early warning and situational awareness tool using state and local data. The program accomplishes this by providing a no-cost platform that allows biosurveillance and analysis of events in users’ own and surrounding communities.

The Secretary of Homeland Security, via the National Biosurveillance Integration System, should further DHS collaborations with federal, state, local, tribal, territorial and private sector entities that collect animal health data. Establishing partnerships with these stakeholders for data and information sharing will require incentives.

Action Item a. Increase opportunities for animal health data collection: Partial action.

The 2018 Farm Bill (P.L. 115-334) required USDA to establish a National Animal Disease Preparedness and Response Program that would address the risk of the introduction and spread of animal pests and diseases that affect livestock and related industries. Congress authorized this program to work through cooperative or other legal agreements with state departments of agriculture, academic institutions, producers, veterinary organizations, and others to enhance animal disease analysis and surveillance. and electronic sharing of health data and risk analysis. The authorities and funding mechanisms are discretionary, so USDA leadership and the White House must still prioritize animal health data collection. In FY 2019, USDA awarded $5.2 million in funding for the program to support animal disease preparedness projects in 29 states.

USDA has continued its data collection activities in two primary populations: wild birds (with regard to avian influenza) and feral swine (with regard to pseudorabies and brucellosis). The USDA National Institute for Food and Agriculture (NIFA) has instituted a competitive program, the Food and Agriculture Cyberinformatics and Tools Initiative, designed to catalyze innovative ideas for harnessing big data and to synthesize new knowledge in agriculture.

At DHS, the National Biosurveillance Integration System disseminates animal disease outbreak information through various channels to its federal and other partners. The National Biosurveillance Integration System has a long-standing liaison with USDA APHIS and more recently with the DOI National Wildlife Health Center. The National Biosurveillance Integration System has also partnered with the National Wildlife Health Center to modernize the latter’s wildlife mortality reporting system, such that state, local, tribal, and territorial officials can digitally transmit mortality data to DHS in real time.

The national response to the COVID-19 pandemic demonstrated the value of a One Health approach to disease tracking. For example, the Bronx Zoo in New York City diagnosed COVID-19 in several of its tigers. Previously, the Zoo also discovered West Nile Virus in wild birds and several of its captive birds before the disease was found in New York’s human population.

The Administration should request, and Congress should fund, the National Animal Health Laboratory Network at its authorized levels.

Action Item b. Fund the National Animal Health Laboratory Network at a level that allows it to achieve success: Completed.

In FY 2019, the National Animal Health Laboratory Network received approximately $16.8 million in discretionary funding through APHIS and NIFA. The 2018 Farm Bill (P.L. 115-334) increased the Network’s authorized funding level to $30 million and made available $40 million a year from the Commodity Credit Corporation through FY 2022 for agricultural security programs, including the National Animal Health Laboratory Network. This funding is separate from annual discretionary appropriations for the Network. APHIS veterinary diagnostics programs, including the National Animal Health Laboratory Network, received only $7 million in additional discretionary funding in FY 2020 relative to FY 2019 appropriations. Additionally, the President’s Budget Request for FY 2021 included a $5.1 million cut in funding to the Network for infrastructure needs. If enacted, these cuts would impact the Network’s ability to provide real-time animal health surveillance.

The Director of the Centers for Disease Control and Prevention, Administrator of the Federal Emergency and Management Agency and Administrator of the Animal and Plant Health Inspection Service, in collaboration with non-federal
stakeholders, should develop guidance for states, localities, tribes, and territories to handle companion animal infections in the event of a major zoonotic disease outbreak. States, localities, tribes, and territories can then base their own planning requirements on this guidance. Congress should amend the Robert T. Stafford Disaster Relief and Emergency Assistance Act (Public Law 93-288, as amended, 42 U.S.C. 5121 et seq) to require the Administrator of the Federal Emergency Management Agency to ensure that state, local, tribal, and territorial emergency preparedness and response plans address the handling of zoonoses in companion animals and wildlife.

Action Item c. Develop guidance for the serious implications of companion animal and wildlife zoonoses: Partial Action.

Specific guidance for state, local, tribal, and territorial partners, and the private sector on how to handle high consequence emergent zoonotic diseases in companion animals and wildlife has not yet been developed. A comprehensive One Health approach has not materialized.

In December 2017, DOI, USDA, and CDC convened a One Health workshop with the goal of prioritizing endemic, existing, and zoonotic diseases of greatest national concern. The One Health Federal Interagency Network has been developing a national One Health five-year strategic plan aimed at enabling multisectoral collaboration (e.g., linking surveillance systems across sectors). However, the COVID-19 pandemic has impeded their ability to finalize the Network’s strategic plan. The zoonotic nature of COVID-19, as well as its spillback from humans into animals, including both farmed and wild mink in the United States, underscores the dire need for this strategy.

CDC is also working with the National Association of State Public Health Veterinarians to develop recommendations to prevent diseases related to animals in public settings. A variety of programs already exist that can foster needed progress. DOI, USDA, and CDC, for example, collaborate on several programs for the surveillance and control of diseases like rabies, brucellosis, bovine tuberculosis, and swine and avian influenza. The USDA also detailed a liaison to the CDC who could become part of zoonotic emergency response and incident command there. Additionally, CDC holds monthly webinars on zoonotic threats.

FEMA published an updated Biological Incident Annex to the Response and Recovery Federal Interagency Operational Plans in 2017. This policy document falls under the National Response Framework and governs federal response activities to biological threats. The Annex points out that the primary Emergency Support Function for animal issues during a biological incident is ESF #8, Public Health and Medical Services (coordinated by HHS).

The Secretary of Homeland Security must ensure that the DHS pilot program to provide emergency service providers with anthrax vaccines is implemented. The Secretary should make doing so an immediate priority. If successful, the Secretary should formalize the program and extend it to meet other threats.

Action Item a. Provide vaccines to responders who request them: Partial Action.

In 2016, the First Responder Anthrax Preparedness Act (P.L. 114-268) authorized DHS, in coordination with CDC, to distribute and administer anthrax vaccine stored in the Strategic National Stockpile that is nearing its labeled usage date for administration to emergency response providers who choose to participate.

The legislation required participation of two to five cities. Implementation was delayed in 2017 and 2018, due in part to the reorganization that produced the DHS Countering Weapons of Mass Destruction Office. DHS began implementing the two-year First Responder Vaccine Initiative Pilot Program in 2019, with Mississippi and Missouri participating through a cooperative agreement. As of September 2020, the program has trained nearly 2,000 emergency responders, and has administered 2,300 doses of anthrax vaccine from the Strategic National Stockpile to more than 1,000 first responder volunteers. The COVID-19 pandemic has limited the total number of volunteers participating in the pilot, but the Countering Weapons of Mass Destruction Office anticipates completion of the trial by the end of FY 2021. Furthermore, the Countering Weapons of Mass Destruction Office is assessing both the impact of the pandemic on the program, as well as opportunities for the program to enhance COVID-19 vaccine distribution efforts. Congress and federal agencies should build on this initiative to ensure first responders have access to other vaccines in the Strategic National Stockpile for material threats, such as smallpox.

The Director of the Centers for Disease Control and Prevention, Commissioner of the Food and Drug Administration, and Department of Health and Human Services Assistant Secretary for Preparedness and Response should finalize plans for prepositioning medkits with emergency service providers and their families, and request annual funding to implement the program.

Action Item b. Provide medkits to emergency service providers and their families: Inaction.

CDC has not prepositioned medkits with emergency services providers and their families and has no plans to do so. The agency evaluated the idea but declined to pursue it, citing issues such as program sustainability, the potential for antimicrobial resistance, and the lack of measures to prevent access by children and pets. Instead, CDC personnel engaged in discussions with federal and other stakeholders to address the last mile question of getting supplies and medicines to first responders. Proposals under discussion include pre-positioning medkit components at pharmacies and residential delivery by the private sector.

The Secretary of Health and Human Services should commission the Institute of Medicine to examine current personal protective equipment research and
requirements in light of potential biological threats. The Institute of Medicine should conduct this assessment in conjunction with the National Institute for Occupational Safety and Health, Occupational Safety and Health Administration (OSHA), and representatives from all of the major emergency service associations.

Action Item c. Establish reasonable personal protective equipment guidelines and requirements in advance of a biological event: Partial Action.

Not later than June 2021, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (P.L. 116-22) requires HHS to establish guidelines addressing the safety and personal protection of healthcare workers. Additionally, the Department of Health and Human Services Assistant Secretary for Preparedness and Response has taken steps since 2015 to increase personal protective equipment training through the development of the Regional Ebola Treatment Network (now the National Special Pathogen System), which seeks to improve infection control practices at participating healthcare institutions.

The Director of National Intelligence should improve upon the partnerships (with first responders and other non-federal personnel) that are critical to the effective performance of the Director of National Intelligence-hosted JCAT. The Director of National Intelligence should solicit their feedback on how the JCAT can function in a way that allows these stakeholders to participate more fully and provides more value to them. The Director of National Intelligence should use this feedback to improve the program.

Action Item a. Strengthen the JCAT: Inaction.

The JCAT is housed within the National Counterterrorism Center and staffed by employees from the National Counterterrorism Center, DHS, and FBI, as well as non-federal public safety officers (including law enforcement, fire service, emergency medical services, and emergency management). The JCAT identifies, produces, and disseminates counterterrorism intelligence to state, local, tribal, and territorial consumers. For example, in response to the COVID-19 pandemic, JCAT developed and issued guidance to state, local, tribal, and territorial agencies regarding the potential for terrorists to take advantage of the national crisis. Prior to dissemination, the National Counterterrorism Center, DHS, and FBI review the intelligence.

The Attorney General and the Director of National Intelligence should share analytic methods relevant to these units to assist in the development of more robust and effective biological threat analysis.

Action Item b. Strengthen the ability of local police intelligence units to address the biological threat: Partial Action.

Limited progress has been made to strengthen this capability locally. In September 2017, the Director of National Intelligence created the First Responder Toolbox, an ad hoc, unclassified, For Official Use Only reference to promote coordination among federal and state, local, tribal, and territorial government authorities (including law enforcement) in deterring, preventing, disrupting, and responding to terrorist attacks. However, while progress has been made in increasing the number of information sharing platforms, the Attorney General and Director of National Intelligence have not shared analytic methods with local police intelligence units regarding the biological threat.

The Administrator of the Federal Emergency Management Agency and Department of Homeland Security Under Secretary for Intelligence and Analysis should provide technical assistance to fusion centers to enable them to obtain needed biological information and intelligence from all relevant federal, non-federal governmental, and private sector partners.

Action Item c. Enable fusion centers to address the biological threat: Inaction.

FEMA and DHS I&A provide technical assistance to fusion centers. DHS manages the Fusion Center Performance Program and conducts a regular assessment to measure the performance of individual fusion centers and those in the national network. The 2017 assessment found that the number of major events or incidents (e.g., special security events, disasters, active shooters) supported by fusion centers was increasing. The report recommended that FEMA identify opportunities to further information sharing, intelligence, and prevention-focused use of grant funds, with specific emphasis on fusions centers’ ability to address current and emerging threats associated with terrorism, drugs, gangs, active shooters, transnational organized crime, and cybersecurity. Congress has also expressed interest in increased dissemination of biological risk information to federal and state, local, tribal, and territorial agencies.

Congress authorized $685 million per year from FY 2019–2023 for this program. Congress should at a minimum meet the President’s Budget Request for FY 2021, which at $675 million is level funding relative to the amounts appropriated in FY 2019 and FY 2020.94 More importantly, the Administration and Congress should increase funding for this vital program to support the activities of public health departments, benefiting their own populations and the entire country.

Action Item a. Appropriate Public Health Emergency Preparedness funding to authorized levels or the President’s Budget Request, whichever is higher: Partial Action.

The President’s Budget Request for FY 2021 would have maintained Public Health Emergency Preparedness cooperative agreement program funding at $675 million. Such an amount would have kept the funding at the same level as that of FY 2020. The Pandemic and All-Hazards Preparedness and Advancing Innovation Act (P.L. 116-22) authorized the program at $685 million for FY 2019 to FY 2023, or $10 million above FY 2020 funding levels and the FY 2021 request. Congress ultimately appropriated $695 million for Public Health Emergency Preparedness cooperative agreements as part of the FY 2021 omnibus funding package, $20 million more than FY 2020 appropriations, and $10 million more than authorized levels. We applaud Congress for establishing a multi-year budget for the Public Health Emergency Preparedness cooperative agreement, and we urge Congress to continue to appropriate funding to at least authorized levels to help strengthen state, local, tribal, and territorial preparedness and response capabilities.

Congress should direct the Secretary of Health and Human Services and the Secretary of Labor to implement a process (involving experts throughout the federal government and the private sector) to develop clinical guidelines for treatment, infection control, use of personal protective equipment, waste management, and other activities needed in the hospital setting. The Secretary of Health and Human Services and the Secretary of Labor should direct the CDC and OSHA, respectively, to identify specific steps within this process and make the description of that process readily and publicly available in advance of a biological event.

Action Item a. Standardize the development of clinical infection control guidelines before biological events occur: Partial Action.

Contrary to the recommendation in A National Blueprint for Biodefense, Congress and the federal government have not taken action to standardize the development of clinical infection control guidelines. Rather, HHS and DOL continue to address individual outbreaks (e.g., Ebola, Zika, COVID-19) as they occur.

The National Biodefense Strategy placed further emphasis on the need to address clinical infection control. Goal 3 concentrates on developing plans that implement or support surge capabilities and should include clinical guidance to assist with appropriate triage and medical management of illnesses. The Pandemic and All-Hazards Preparedness and Advancing Innovation Act (P.L. 116-22) also requires the creation of guidelines for disease containment as part of a larger regional healthcare emergency response system.

During events occurring in the United States, the Vice President should direct the Secretary of Health and Human Services and the Secretary of Labor to convene a standing group of experts (including those from outside of the federal government) that reviews feedback from federal, state, local, tribal, territorial, and private healthcare facilities, and meets at least weekly to evaluate, update, and reissue clinical guidance.

Action Item b. Institute a process for obtaining and incorporating feedback regarding clinical infection control guidelines during biological events: Partial Action.

During the U.S. response to Zika, OSHA and the National Institute for Occupational Health and Safety solicited input from private sector experts and state, local, tribal, and territorial officials on Zika guidelines. HHS established the Healthcare Infection Control Practices Advisory Committee in 1991 to provide external perspective to CDC and the Secretary of Health and Human Services. CDC has leveraged this entity to obtain and incorporate feedback during the response to the COVID-19 pandemic from healthcare providers, advocacy organizations, health departments, and other stakeholders. However, outside of Healthcare Infection Control Practices Advisory Committee, it is unclear what formalized processes exist to facilitate discussion and sharing of infection control practices with the DOL or with HHS.

The Secretary of Health and Human Services and the Secretary of Labor should regularly provide training for end users in the implementation of the guidelines.

Action Item c. Require training based on these guidelines: Partial action.

Limited steps have been taken to make infection control training available. CDC has developed training and educational resources to help healthcare providers understand the principles of infection control and how to produce risk assessments. CDC has also developed training for Ebola and Zika. In response to COVID-19, CDC developed Project Firstline, a national training collaborative for infection control practices, and is working with state health departments to develop infection control training courses.

Additionally, the Department of Health and Human Services Assistant Secretary for Preparedness and Response funded the National Emerging Special Pathogen Training and Education Center that provides education and training for public health and healthcare providers to manage individuals with suspected and confirmed highly infectious diseases. The National Emerging Special Pathogen Training and Education Center is now one of four components of the National Special Pathogen System which builds on the Regional Ebola Treatment Network. The System was originally created
to support the preparedness and response needs of hospitals, health systems, and healthcare providers to help prepare them to identify, isolate, assess, transport, and treat patients with COVID-19 or other special pathogens, or persons under investigation for such illnesses. As of December 2020, the National Emerging Special Pathogen Training and Education Center had conducted 119 virtual consultations, created 430 COVID-19 related resources, and established 1 phone line for emergency consultation with federal partners and healthcare facilities requiring assistance with patients suspected of or proven to be infected by special pathogens.

Congress should amend the Public Health Service Act to require that no less than 97 percent of appropriated Hospital Preparedness Program funds go directly to grantees.

Action Item a. Cap Hospital Preparedness Program management and administration costs at three percent: Partial action.

The FY 2021 HHS Budget Justification requested $257,555 million, a decrease of $18 million from FY 2020. Of the $257,555 million, $26.1 million (10.1 percent) was set aside for Hospital Preparedness Program administration, performance evaluation, and oversight. This left slightly under 90 percent of funding for grants. In FY 2020, slightly above 84 percent of Hospital Preparedness Program funding went to the awardees, though the actual dollar amount for grants was the same in FY 2020 appropriations and the President’s Budget Request for FY 2021.

This evaluation should address, at a minimum: (1) the extent to which the goals of the Hospital Preparedness Program are being met; (2) how Hospital Preparedness Program funds should be allocated (e.g., based on risk); and (3) whether funding for the Hospital Preparedness Program is sufficient. The Department of Health and Human Services Assistant Secretary for Preparedness and Response and Congress should then use the results of the evaluation to determine reforms and funding needed to optimize the program.

Action Item b. Assess the impact of the Hospital Preparedness Program: Partial action.

In 2017, Congress tasked GAO with conducting an analysis of the Hospital Preparedness Program and other key preparedness and capacity-building programs. GAO found that funding for the Hospital Preparedness Program decreased by about 54 percent from FY 2002 to FY 2017. Additionally, GAO reviewed Hospital Preparedness Program performance measures for personal protection, focusing on Hospital Preparedness Program Ebola awards from supplemental appropriations. For each of the five measures in the area of protection, the majority (ranging from 61–97 percent) of Hospital Preparedness Program awardees met each target.

Additionally, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (P.L. 116-22) contains a requirement for the Secretary of Health and Human Services to conduct a study examining healthcare preparedness and response capabilities and medical surge capacities of hospitals, long-term care facilities, and other healthcare facilities with respect to public health emergencies. The study should capture, at least in part, the impact Hospital Preparedness Program has had on hospital preparedness. HHS is developing this assessment.

Public health departments administer Hospital Preparedness Program funding, even though the recipients are healthcare institutions. The Department of Health and Human Services Assistant Secretary for Preparedness and Response found that Hospital Preparedness Program awardees are spending approximately 21 percent of Hospital Preparedness Program funds on administrative costs, with roughly 40 percent going to healthcare institutions. In 2019, the Assistant Secretary for Preparedness and Response included a clause in Hospital Preparedness Program cooperative agreements prohibiting awardees from utilizing more than 18 percent of the award amount for administrative costs. In 2020, allowable administrative costs decreased to 15 percent.

The Administrator of the Centers for Medicare and Medicaid Services, in conjunction with the Department of Health and Human Services Assistant Secretary for Preparedness and Response, should seek the endorsement of the National Quality Forum and adopt, as part of its health delivery reform efforts, a disaster preparedness portfolio that includes: Conditions of Participation, Interpretive Guidance, measures of development for inclusion within value-based purchasing, and innovation projects. Preparedness measures should be included in the evolving Merit-Based Incentive Payment System program and link community, supplier, and provider resilience efforts to reimbursement and incentives.

Action Item a. Adopt a disaster preparedness portfolio: Partial Action.

In 2016, CMS issued Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers (commonly referred to as the Emergency Preparedness Rule), to ensure adequate planning for naturally occurring and human-generated disasters, and to promote coordination among federal and state, local, tribal, and territorial emergency preparedness programs. The rule ties reimbursement to certain preparedness activities.

Congress should authorize CMS to provide funding to those hospitals that meet these new accreditation standards for bioterrorism preparedness and preparedness for other highly infectious disease events.

Action Item b. Link CMS incentives and reimbursement to new accreditation standards. Partial Action.

While there is reimbursement for infection control, there is currently nothing in place that links reimbursement to an officially or unofficially stratified hospital system to which new accreditation standards would be associated. However, CMS did eventually issue clear guidance regarding reimbursement for COVID-19 treatment.

The Secretary of Health and Human Services should establish a stratified system of hospitals with increasing levels of capability to treat patients affected by bioterrorism and other events involving highly pathogenic infectious diseases. A categorical rather than disease-specific approach should be used. Where possible, the Secretary should add biodefense responsibilities to Accountable Care Organizations, trauma centers, and hospital coalitions to expand their capabilities.

Action Item a. Stratify hospitals: Partial Action.

In 2018, the Department of Health and Human Services Assistant Secretary for Preparedness and Response announced his intent to develop a Regional Disaster Health Response System, leveraging the Hospital Preparedness Program, the National Disaster Medical System, and the Regional Treatment Network for Ebola and Other Special Pathogens. The Regional Disaster Health Response System “aims to establish a network of state-level clinical response assets as well as regional assets to create a more coherent, comprehensive, and capable healthcare disaster response system.” The Regional Disaster Health Response System is not intended to impact day-to-day patient referral patterns, but instead to define care delivery during catastrophic events.

In 2019, the Assistant Secretary for Preparedness and Response awarded two grants for Regional Disaster Health Response System pilot projects to
Massachusetts General Hospital and Nebraska Medicine to address healthcare preparedness, improve disaster readiness for healthcare delivery, and demonstrate the effectiveness and viability of a Regional Disaster Health Response System. The Assistant Secretary for Preparedness and Response established a third pilot project at Denver Health and Hospital Authority in late 2020 and tasked all three pilot participants to assist in developing guidelines for an eventual stratified hospital system.

The Administrator of the Centers for Medicare and Medicaid Services should develop accreditation standards with the Joint Commission, Det Norske Veritas, Health Facilities Accreditation Program, and Center for Improvement in Healthcare Quality, as well as certification and licensure associated with each level.

Action Item b. Develop accreditation standards for each stratum: Partial Action.

CMS is responsible for the certification of hospitals after they meet established standards to receive reimbursement from Medicare or Medicaid. Deeming entities (i.e., Joint Commission, Det Norske Veritas, Health Facilities Accreditation Program, Center for Improvement in Healthcare Quality) establish elements of performance based on CMS standards and use survey processes to ensure hospitals meet or exceed federal requirements. With the adoption of the Emergency Preparedness Rule, the Joint Commission updated its emergency management standards to include the following: continuity of operations and succession plans; documented collaboration with federal, state, local, tribal, and territorial emergency management officials; contact information of volunteers and tribal groups; annual training of all new and existing staff, contractors, and volunteers; and integrated healthcare systems. There is an additional emergency and standby power system requirement for hospitals (including critical access hospitals). Hospitals also have a requirement for transplant services. However, stratified biodefense hospital certification does not currently exist.

The Administrator of the Centers for Medicare and Medicaid Services should associate hospital funding with the ability to meet these accreditation standards for each stratum.

Action Item c. Associate Centers for Medicare and Medicaid Services funding: Inaction.

CMS has not associated hospital funding with meeting biodefense accreditation standards. In 2019, CMS, in partnership with the National Academies of Science, conducted a workshop with private sector stakeholders to create a matrixed incentive structure that could help CMS develop a system to provide funding to hospitals as a condition of participation. Considering CMS actions taken to reimburse telehealth and COVID-19 specific treatments during the response to the COVID-19 pandemic, the agency should offer financial incentives to hospitals.

Together with non-federal partners, the Department of Health and Human Services Assistant Secretary for Preparedness and Response, the Director of the Centers for Disease Control and Prevention, and the Administrator of the Federal Emergency Management Agency should identify requirements and capacities needed to achieve successful distribution and dispensing of medical countermeasures from the Strategic National Stockpile, as well as from local caches. The framework they develop must address unresolved issues. It should be a progressive and innovative approach that pushes the envelope beyond what a given agency might devise and the bureaucratic impediments associated with a federal-only distribution system. If implementation would exceed funding available through current grant allocations, additional funding must be requested.

Action Item a. Produce a comprehensive framework to guide medical countermeasure distribution and dispensing planning: Partial Action.

Federal agencies have not yet produced a comprehensive medical countermeasure response framework. Oversight of the Strategic National Stockpile was transferred from CDC to the Assistant Secretary for Preparedness and Response in October 2018 and the Assistant Secretary for Preparedness and Response has made organizational changes to enable a more strategic end-to-end process from development through stockpiling of medical countermeasures. The Assistant Secretary for Preparedness and Response has identified the terminal distribution and dispensing of medical countermeasures (“The Last Mile”) as a key priority, and developed the following: (1) pilots in seven jurisdictions (Los Angeles, San Francisco, Chicago, Denver, Kansas City, MO, New York City, and Washington, D.C.) that could support federal points of distribution and alleviate pressure on local distribution resources; (2) a pilot with mail-order pharmacy groups to augment national delivery in an emergency; (3) public-private partnerships with groups like hoteliers, retailers, and pharmacies that can reach large segments of a population experiencing crisis; (4) a projection of the cost of purchase, deployment, maintenance, and replacement of prepositioned medical countermeasures with states and localities; and (5) creating agreements with federal departments and agencies to support emergencies, such as by leveraging federally qualified health centers to staff points of distribution. The Assistant Secretary for Preparedness and Response developed a Medical Countermeasure Operations Program to support the implementation of these courses of action.

Additionally, the Assistant Secretary for Preparedness and Response is evaluating coordination between the Strategic National Stockpile and the National Disaster Medical System, including cost efficiencies and ways to make response more effective.

The Department of Health and Human Services Assistant Secretary for Preparedness and Response should determine the necessary assessment, logistical, and funding requirements to forward deploy Strategic National Stockpile assets.

Action Item a. Determine logistics and funding needs: Partial Action.

As part of its effort to address challenges related to terminal distribution and dispensing of medical countermeasures, the Assistant Secretary for Preparedness and Response has developed The Last Mile Project. The Last Mile Project tests various distribution and delivery efforts in seven major U.S. cities (Los Angeles, San Francisco, Chicago, Denver, Kansas City, MO, New York City, and Washington, D.C.), with a focus on oral antibiotics. One potential course of action under review is the limited prepositioning of medical countermeasures at the state and local (not tribal or territorial) levels. The Office of the Assistant Secretary for Preparedness and Response is reviewing the cost of this pre-positioning, including medical countermeasure purchase and replacement costs related to deployment.

Once the requirements are established, the President should request funding in the next budget cycle to support forward deployments to cities that have demonstrated readiness. Deployments of reasonable quantities should go toward to high-threat, high-density urban areas that have demonstrated an ability to stand up points of distribution faster than Strategic National Stockpile medications can be delivered to these jurisdictions and subsequently distributed to points of distribution. The Assistant Secretary for Preparedness and Response should actively encourage leaders of other major urban areas to plan for, and demonstrate ability to, stand up points of distribution faster than Strategic National Stockpile contents can currently be delivered.

Action Item b. Implement forward deployments: Partial Action.

When oversight of the Strategic National Stockpile was held by CDC, the Strategic National Stockpile program worked with one city to forward deploy small quantities of Stockpile assets. However, that jurisdiction only received antibiotics as part of that agreement, which are of no use against viral threats like COVID-19. Control of the Strategic National Stockpile transitioned from CDC to the Office of the Assistant Secretary for Preparedness and Response in 2019. Through The Last Mile Project, the Assistant Secretary for Preparedness and Response is addressing pre-positioning and identifying additional options for rapid deployment of medical countermeasures at the state and local levels.

The Vice President must ensure that the security of pathogen information is addressed by national U.S. cybersecurity strategy and policy, incorporating such deterrent and enforcement measures as oversight and inspection. Any policies promulgated pursuant to the strategy should set forth clear consequences for individuals or countries that undertake such actions. The measures developed should not imperil the legitimate sharing of scientific data and information.

Action Item a. Develop and implement a security strategy for stored pathogen data: Inaction.

The Pandemic and All-Hazards Preparedness and Advancing Innovation Act (P.L. 116-22) requires HHS to develop a national strategy for public health preparedness and response to address cybersecurity threats that present a threat to national public health security. This strategy must also address the cyber threat to, and vulnerabilities of, unprotected sensitive pathogen data. Additionally, the Trump Administration took some steps to address the broad threat posed by cyberattacks, including the release of the National Cyber Strategy in September 2018. The Strategy notes that the United States will seek to build a cyber deterrence initiative. However, the Strategy does not directly address the need to better secure pathogen data and does not articulate consequences for cyberattacks. Warnings from DHS and the FBI regarding hacking activities targeting research organizations focused on COVID-19 reinforce the need to develop a national pathogen data security strategy immediately.

Federal departments and agencies should include federally supported pathogen research projects in the revised procurement model under development. They should develop and establish voluntary standards in partnership with the members of the research community. The Secretary of Agriculture and the Secretary of Health and Human Services should incorporate these standards into any new Select Agent Program regulations promulgated per Recommendation 32.

Action Item b. Provide the research community with tools and incentives to secure its data: Partial Action.

HHS has not yet developed voluntary cybersecurity standards for the research community. A Healthcare Cybersecurity Coordination Center located in the HHS Office of the Chief Information Officer helps prepare some outside partners for potential cyber events, but it primarily supports the Department’s agencies and offices. The Department plans to incorporate and address the role of academia when it refreshes its critical infrastructure plan. Additionally, recent regulatory changes to the Federal Select Agent Program failed to address cybersecurity.

The Vice President should elevate the priority of addressing cyber threats to these communities, including both virtual and physical infrastructure. The Secretary of Homeland Security, working with existing privately led Information Sharing and Analysis Centers, should also address cyber threats to these communities. The Director of Immigration and Customs Enforcement should direct the Intellectual Property Rights Center and Immigration and Customs (ICE) Cyber Crimes Center to specifically address cyber threats to and vulnerabilities of the data possessed by these communities and prevent intellectual property loss in this regard. The Vice President should also direct the Secretary of Health and Human Services to establish a formal pathogen and biotechnology subsector within the Healthcare and Public Health Critical Infrastructure Sector.

Action Item c. Develop cyber-threat information-sharing mechanisms for the pathogen and advanced biotechnology communities: Partial Action.

In December 2015, President Obama signed into law the Cybersecurity Act of 2015 as part of omnibus spending legislation (P.L. 114-113). This statute aimed to foster the sharing of cybersecurity information between the federal government and the private sector by providing liability protections and clarifying the process by which information can be transferred through privately led Information Sharing and Analysis Centers. However, it is unclear to what extent the owners of pathogen data have been made aware of, and are leveraging, this mechanism.

The Director of ICE did not direct the Intellectual Property Rights Center or the ICE Cyber Crimes Center to take action. The Secretary of Health and Human Services did not establish a formal pathogen and biotechnology subsector.

The Secretary of State should lead U.S. efforts to revitalize the Biological and Toxin Weapons Convention by addressing topics such as universalization of the Convention; calls for national laws and regulations concerning use, storage, and transport; and submission of complete annual reports by all member State Parties. All U.S. federal agencies should press these issues in meetings with foreign counterparts.

Action Item a. Continue to strengthen implementation of the Biological and Toxin Weapons Convention where U.S. support is unequivocal: Partial Action.

The United States has continued to financially support and participate in the Biological and Toxin Weapons Convention but has not revitalized the Convention as recommended by the Commission. In general, the meetings of State Parties have been less productive than the technical meetings of experts.

The United States partnered with Parliamentarians for Global Action, a non- governmental organization that works to drive agreements to international treaties, including the Biological and Toxin Weapons Convention. Overall, the United States has elected to use the Biological and Toxin Weapons Convention platform in ways that differ from the original intent. The United States has focused on routine country inspection, worked to promote public health security in developing countries, and garnered commitments from member states to provide voluntary response assistance in the event of a deliberate biological attack. Additionally, the United States continues to press for new national initiatives and ways to measure implementation, and worked to build relationships among implementers.

The Vice President should direct the NSC to use the period leading up to the December 2016 Biological and Toxin Weapons Convention review conference to determine desired outcomes. The Secretary of State should employ a high-level emissary to press these issues with other parties to the treaty in advance of the next review conference.

Action Item b. Set U.S. goals for the Biological and Toxin Weapons Convention and determine the conditions necessary to achieve them: Partial Action.

The DOS entered the Eighth Biological and Toxin Weapons Convention Review Conference with some clear goals, including support to create a more transparent process. The U.S. has worked between sessions to help promote common understanding of the Biological and Toxin Weapons Convention and verification actions. The process enabled progress on some specific issues, such as laboratory pathogen security.

Unfortunately, the Conference was not able to agree upon the five-year work-plan that the United States and some other parties to the treaty supported. In the absence of a work- plan, the United States continued to strengthen the international nonproliferation regime.

The next Review Conference should occur in 2021. The United States should reexamine its stance with regard to the Convention and reinvigorate efforts to ensure the viability and practicability of the Convention.

Prior to the next Biological and Toxin Weapons Convention Review Conference, the Vice President and the Secretary of State should convene a series of meetings with representatives from all Cabinet and independent agencies with responsibilities for biological defense, as well as industry and academia, to discuss verification and compliance with the Biological and Toxin Weapons Convention. The result of this meeting should be the development of three recommendations for a verification protocol that would meet U.S national security needs as well as state-level compliance.

Action Item c. Develop three actionable recommendations for Biological and Toxin Weapons Convention verification: Partial Action.

The DOS Biological Policy Office most recently held a Biological and Toxin Weapons Convention Engagement Workshop in November 2020 with 70 non-governmental entities. Participants from academia, industry, think tanks, laboratories, and other non- governmental organizations gathered to consider the major challenges facing the Biological and Toxin Weapons Convention and to discuss their role in the upcoming Ninth Review Conference and issues to consider at the meeting. A series of follow up roundtables to further discuss the matter are planned for 2021. The DOS has not convened meetings with all departments and agencies with biodefense responsibilities to further discuss verification of, and compliance with, the Biological and Toxin Weapons Convention, and to develop recommendations.

Congress should amend the Biological Weapons Anti-Terrorism Act of 1989 (Public Law 101-298) and the USA PATRIOT Act (Public Law 107-56) to include more specific sentencing guidelines and consideration for the real and growing possibility that biological weapons will be used in the United States.

Action Item d. Establish better biological weapons sentencing guidelines in statute: Partial Action.

In July 2019, President Trump signed into law the Effective Prosecution of Possession of Biological Toxins and Agents Act (P.L. 116-31). This law clearly made it illegal for any individual to knowingly obtain select agents without proper registration, strengthening penalties for the procurement of these deadly pathogens.

The Secretary of Defense should conduct a review of previous and current efforts to collaborate with civilian counterparts and partners, including on biodefense. The Secretary of Defense should identify best practices from other efforts that could be applied to collaboration on biodefense, constraints that could prevent collaboration, potential solutions for removing these constraints, and recommendations for creating, implementing, and institutionalizing a formal program for ongoing military-civilian interaction and collaboration for biodefense. DOD should report the results of this review to the Vice President and the House and Senate Committees on the Armed Services.

Action Item a. Conduct a review of military-civilian collaborative efforts: Partial action.

DOD has not conducted a comprehensive review of existing efforts to collaborate with civilian counterparts on biodefense. The National Biodefense Strategy and National Security Presidential Memorandum 14 require federal departments and agencies to conduct internal assessments of current biodefense activities and provide this information to the Biodefense Coordination Team for its annual Biodefense Assessment. Ideally, the Assessment will identify areas in which DOD can further collaborate with its civilian counterparts. DOD has indicated that in the interim it is evaluating areas of overlap with other departments and agencies, such as with medical countermeasure development, where military resources could be used more efficiently to accomplish joint goals.

Congress should mandate military-civilian collaboration on biodefense, including research regarding force protection. Congress should include this requirement for ongoing collaboration in the National Defense Authorization Act and add it to the oversight agendas of the House and Senate Committees on the Armed Services.

Action Item b. Establish military-civilian biodefense collaboration: Partial action.

As directed by the National Defense Authorization Act of Fiscal Year 2017 (P.L. 114-328), DOD participated in the development process for the National Biodefense Strategy. The Strategy and National Security Presidential Memorandum 14 require relevant departments and agencies, including DOD, to participate in the Biodefense Steering Committee that will coordinate implementation of the Strategy.

The Secretary of Defense should clarify existing military doctrine to provide this support. The Vice President should develop clear policies addressing the integration of military assets when called upon to respond to a domestic biological attack. The Vice President should also direct the NSC to determine in what specific circumstances decision-making may need to be delegated to DOD leaders and the National Command Authority in the event of a biological attack.

Action Item c. Clarify parameters for military support to civilian authorities in response to a domestic biological attack: Partial action.

Since the publication of A National Blueprint for Biodefense, DOD updated some of its policies for Defense Support to Civil Authorities, including Joint Public 3-11, Operations in Chemical, Biological, Radiological, and Nuclear Environments, and Joint Publication 3-28, Defense Support of Civil Authorities. Additionally, the development and release of the Biological Incident Annex to the Response and Recovery Federal Interagency Operational Plans further details the role of DOD in an interagency response to a large-scale biological event. During the federal response to COVID-19, the military assumed many logistical duties traditionally associated with their civilian counterparts. It is unclear how much of this activity was governed by existing policies and procedures.

DOD must produce technically feasible and politically acceptable doctrine for biodefense activities if it is to fulfill its primary responsibilities for force protection and projection. The Secretary of Defense should be held accountable by the Vice President and Congress for ensuring that this doctrine has been developed and/or refreshed with the input and full concurrence of the Joint Chiefs of Staff. DOD should base scientific research and development, training, and other activities necessary for biodefense on this doctrine.

Action Item d. Update and implement military biodefense doctrine: Partial action.

DOD did update some military biodefense doctrine. The White House updated the National Defense Strategy and the National Strategy for Countering Weapons of Mass Destruction Terrorism in 2018. Further, the DOD functional contingency plan for Pandemic Influenza and Infectious Disease is currently under review. Additionally, DOD updated several other policies and programs addressing biological threats.

Congress has proposed establishing an NIH Innovation Fund at $2 billion annually. Ten percent of this fund, if appropriated, should be dedicated to innovation at NIH in biodefense and emerging infectious disease medical countermeasure tied to BARDA requirements. The Director of the Biomedical Advanced Research and Development Authority should devote no less than ten percent of BARDA’s annual budget to funding innovative technologies that can achieve progress across a broad spectrum of biological threats. Working groups should be established at all these agencies to secondarily review proposals rejected as being too risky.

Action Item a. Prioritize innovation in medical countermeasure at agencies with biodefense responsibilities: Partial action.

Limited steps have been taken to further innovation in medical countermeasure development. The 21st Century Cures Act (P.L. 114-255) authorized BARDA to establish a Division of Research, Innovation, and Ventures to accelerate transformative technological solutions for, and approaches to, public health security. Initial Division of Research, Innovation, and Ventures programs have focused on detecting, prognosticating outcomes, and enabling early interventions; solving the problem of sepsis; developing alternative vaccine technologies to make immunizations easier
to administer and more widely available; repurposing therapeutics as medical countermeasures in the event of a chemical emergency; and deploying technologies to fight COVID-19. However, BARDA continues to utilize inflexible contracting processes that are not aligned with private sector business models. Established by BARDA in 2018, the Division of Research, Innovation, and Ventures could solve some of these contracting problems with (1) an accelerator network of scouts seeking innovative solutions across the country; (2) a quicker and less cumbersome contracts and grants process (known as an easy Broad Agency Agreement); and (3) venture capital. BARDA issued a solicitation for non-profit third-party partner to bring new ideas and private equity funding to the table, which could help address existing gaps.

Innovation in advanced development and manufacturing is as important as innovation in novel biotechnology discoveries. Unfortunately, the Centers for Innovation and Advanced Development and Manufacturing, established by the Department of Health and Human Services Assistant Secretary for Preparedness and Response during the Obama Administration, failed to provide rapid, U.S.-based manufacturing capability as intended and were not prepared for the COVID-19 pandemic.

BARDA has reviewed the Centers for Innovation and Advanced Development and Manufacturing program and intends to make major adjustments, provided funding is available. BARDA officials have expressed interest in identifying other solutions for domestic development and manufacturing, including ways to reduce the number of animals and humans needed for clinical trials, modernizing drug production, and simplifying emergency response drug formulations to decrease dependency on international ingredients. Congress encouraged the use of contractual vehicles to promote “platform technologies, technologies to administer countermeasures, and technologies to improve storage, transportation, and distribution of countermeasures,’’ but has not appropriated funding to this end.

The Commission also recommended the use of an NIH Innovation Fund as a tool to dedicate funding to innovation at NIH in biodefense and emerging infectious disease medical countermeasures tied to BARDA requirements. While the 21st Century Cures Act authorized multi-year funding for an NIH Innovation Fund, expenditures were restricted to areas unrelated to medical countermeasure development.

The Director of the National Institute of Allergy and Infectious Diseases, the Director of the Biomedical Advanced Research and Development Authority, and the Deputy Assistant Secretary of Defense for Chemical and Biological Defense should coordinate to identify at least five promising novel technologies (including platform technologies) that could ultimately be applied to medical countermeasure development for material threats. The most promising candidates (with sufficient safety and efficacy data to meet FDA standards) that enable use of multiple antigens on an existing platform should be developed. If needed, FDA should develop a new approval pathway for these technologies.

Action Item b. Exploit existing innovation: Crisis Action.

Despite broad support from policymakers and external stakeholders, platform technology did not advance substantially until the COVID-19 pandemic. The pandemic drove the government and industry to leverage existing scientific advancements in new and rapid ways, but this effort has been the exception to the rule. In 2018, the Commission stressed in a letter to Congress that the acceleration of platform technology development must be a priority. With targeted investment, these technologies (especially for vaccines and diagnostics) could come to fruition within three to four years.

While DOD, NIAID and BARDA have invested in novel technologies (including platforms) to various extents, the contracting reforms required to accommodate these innovations have not materialized. BARDA should also consider the role of the agricultural sector in providing needed technological advancements.