National Biodefense Strategy:

Additional Efforts Would Enhance Likelihood of Effective Implementation

GAO-20-273: Published: Feb 19, 2020. Publicly Released: Feb 19, 2020.

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Contact:

Chris Currie
(404) 679-1875
curriec@gao.gov

 

Mary Denigan-Macauley
(202) 512-7114
deniganmacauleym@gao.gov

 

Office of Public Affairs
(202) 512-4800
youngc1@gao.gov

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

Multimedia:

Additional Materials:

Contact:

Chris Currie
(404) 679-1875
curriec@gao.gov

 

Mary Denigan-Macauley
(202) 512-7114
deniganmacauleym@gao.gov

 

Office of Public Affairs
(202) 512-4800
youngc1@gao.gov

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.

What GAO Recommends

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.

For more information, contact Chris Currie at (404) 679-1875 or CurrieC@gao.gov or Mary Denigan-Macauley at (202) 512-7114 or DeniganMacauleyM@gao.gov.

Recommendations for Executive Action

  1. Status: Open

    Priority recommendation

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    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)

    Agency Affected: Department of Health and Human Services: Office of the Secretary

  2. Status: Open

    Priority recommendation

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    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)

    Agency Affected: Department of Health and Human Services: Office of the Secretary

  3. Status: Open

    Priority recommendation

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    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)

    Agency Affected: Department of Health and Human Services: Office of the Secretary

  4. Status: Open

    Priority recommendation

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    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)

    Agency Affected: Department of Health and Human Services: Office of the Secretary

 

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