Fast Facts

Biological threats range from naturally occurring diseases to deliberately created biological weapons. The National Biodefense Strategy, issued in 2018 along with guidance on how to implement it, spells out the nation’s plan to address these threats. Among other things, it calls for a joint effort by multiple agencies as well as private sector partners.

We reviewed how well the strategy has worked so far. We found there are no clear processes, roles, or responsibilities for joint decision making. We made 4 recommendations, including that Health and Human Services (the lead agency for the strategy) clearly document these factors.

Container marked as biohazard

Container marked as biohazard

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Highlights

What GAO Found

Issued in September 2018, the National Biodefense Strategy (Strategy) and implementation plan, along with National Security Presidential Memorandum-14 (NSPM-14), are designed to enhance national biodefense capabilities. NSPM-14 established a governance structure composed of relevant federal agencies and chaired by the Secretary of Health and Human Services (HHS) to guide implementation. It also required federal agencies with biodefense responsibilities to collect and assess data on their biodefense activities to, among other things, identify gaps. The Strategy defined the scope of the biodefense enterprise (which includes partners at all levels of government and the private sector) and brought all of the biological threats—intentional, accidental, and naturally-occurring—together, establishing an overarching vision, goals, and objectives.

Membership of the Biodefense Steering Committee

Membership of the Biodefense Steering Committee

There are a number of challenges, however, that could limit long-term implementation success. Among other things, there was no documented methodology or guidance for how data are to be analyzed to help the enterprise identify gaps and opportunities to leverage resources, including no guidance on how nonfederal capabilities are to be accounted for in the analysis. Many of the resources that compose national capbilities are not federal, so enterprise-wide assessment efforts should account for nonfederal capabilities.

Agency officials were also unsure how decisions would be made, especially if addressing gaps or opportunties to leverage resources involved redirecting resources across agency boundaries. Although HHS officials pointed to existing processes and directives for interagency decision making, GAO found there are no clear, detailed processes, roles, and responsibilities for joint decision-making, including how agencies will identify opportunities to leverage resources or who will make and enforce those decisions. As a result, questions remain about how this first-year effort to catalogue all existing activities will result in a decision-making approach that involves jointly defining and managing risk at the enterprise level. Without clearly documented methods, guidance, processes, and roles and responsibilities for enterprise-wide decision-making, the effort runs the risk of failing to move away from traditional mission stovepipes toward a strategic enterprise-wide approach that meaningfuly enhances national capabilities.

Why GAO Did This Study

GAO has reported on the inherent fragmented nature of the federal and nonfederal resources needed to protect the nation from potentially catastrophic biological threats. GAO called for a strategic approach to help the federal government better leverage resources and manage risk The White House issued the National Biodefense Strategy and the Presidential Memorandum on the Support for National Biodefense to promote a more efficient and coordinated biodefense enterprise.

The National Defense Authorization Act for Fiscal Year 2017 included a provision that GAO review the strategy. This report addresses the extent to which the Strategy and implementation efforts are designed to enhance national biodefense capabilities and any implementation challenges that exist.

GAO analyzed the Strategy, plans, and NSPM-14, and compared them to selected characteristics of GAO's work on effective national strategies, enterprise risk management, organizational transformation, and interagency coordination. GAO interviewed officials from the eight federal agencies that comprised the Biodefense Steering Committee to learn about early implementation.

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Recommendations

GAO is making four recommendations to the Secretary of HHS, including working with other agencies to document methods for analysis and the processes, roles, and responsibilities for enterprise-wide decision making. HHS concurred with all the recommendations and described steps to implement them.

Recommendations for Executive Action

Agency Affected Recommendation Status
Office of the Secretary
Priority Rec.
This is a priority recommendation.
The Secretary of HHS should direct the Biodefense Coordination Team to establish a plan that includes change management practices—such as strategies for feedback, communication, and education—to reinforce collaborative behaviors and enterprise-wide approaches and to help prevent early implementation challenges from becoming institutionalized. (Recommendation 1)
Open
HHS agreed with our recommendation and, in April 2021, described actions it has taken to implement it, but did not provide supporting documentation that would allow GAO to assess the extent to which these actions respond to the report findings and meet the intent of the recommendation. To fully implement the recommendation, HHS will need to provide evidence of the communication strategy and plan it created and that evidence will need to demonstrate that the actions respond effectively to the change-management related report findings. HHS will also need to provide evidence of the feedback mechanisms it is using, such as tools used to conduct annual after action reviews of the data collection process and demonstrate how corrective actions based on that feedback have been implemented to help manage change.
Office of the Secretary
Priority Rec.
This is a priority recommendation.
The Secretary of HHS should direct the Biodefense Coordination Team to clearly document guidance and methods for analyzing the data collected from the agencies, including ensuring that nonfederal resources and capabilities are accounted for in the analysis. (Recommendation 2)
Open
HHS agreed with our recommendation and, in April 2021, described actions it has taken to implement it, but did not provide supporting documentation that would allow GAO to assess the extent to which these actions respond to the report findings and meet the intent of the recommendation. For example, HHS described that standard operating procedures are in development to further codify the annual assessment process. To fully implement this recommendation, HHS will need to provide evidence of these standard operating procedures-and the procedures must outline how the Biodefense Coordination Team plans to account for nonfederal capabilities in its annual assessment. HHS also needs to provide other guidance documents established for the annual assessment that clearly articulate the methods to be used.
Office of the Secretary
Priority Rec.
This is a priority recommendation.
The Secretary of HHS should direct the Biodefense Coordination Team to establish a resource plan to staff, support, and sustain its ongoing efforts. (Recommendation 3)
Open
HHS agreed with our recommendation and, in April 2021, described actions it has taken to implement it, but did not provide supporting documentation that would allow GAO to assess the extent to which these actions respond to the report findings and meet the intent of the recommendation. For example, HHS submitted a budget request for $5 million to support implementation of the National Biodefense Strategy. To fully implement this recommendation, HHS will need to provide a detailed plan on how such budget requests will be used to staff, support, and sustain ongoing implementation efforts. This is particularly important because the Biodefense Coordination Team is comprised of over a dozen member departments and agencies, and the budget request made by HHS does not detail specific resources that may be required of other members.
Office of the Secretary
Priority Rec.
This is a priority recommendation.
The Secretary of HHS should direct the Biodefense Coordination Team to clearly document agreed upon processes, roles, and responsibilities for making and enforcing enterprise-wide decisions. (Recommendation 4)
Open
HHS agreed with our recommendation and, in April 2021, described actions it has taken to implement it, but did not provide supporting documentation that would allow GAO to assess the extent to which these actions respond to the report findings and meet the intent of the recommendation. To fully implement this recommendation, HHS will need to provide supporting evidence of the governance documents, including charters and processes developed for enterprise-wide decisions that address the deficiencies identified in our report.

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