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National Biodefense Strategy: Opportunities and Challenges with Early Implementation

GAO-20-483T Published: Mar 11, 2020. Publicly Released: Mar 11, 2020.
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Fast Facts

Biological threats can be manmade biological weapons, naturally occurring diseases such as novel coronavirus COVID-19, and more.

The National Biodefense Strategy, issued in 2018 along with implementation guidance, spells out the nation’s plan to address these threats. It calls for a joint effort by multiple agencies and private sector partners.

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

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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.

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.

Agency officials were also unsure how decisions would be made, especially if addressing gaps or opportunities 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 meaningfully 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 testimony highlights key findings from our February 2020 report, which analyzed the extent to which the Strategy and related implementation efforts are designed to allow an enterprise-wide approach.


In the February 2020 report, GAO made 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.

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