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    Subject Term: "Medical countermeasures"

    2 publications with a total of 3 open recommendations
    Director: Marcia Crosse
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: In order to improve FDA's strategic planning for regulatory science efforts, the Secretary of Health and Human Services should direct the Commissioner of FDA to develop and document measurable goals, such as targets and time frames, for its regulatory science efforts so it can consistently assess and report on the agency's progress in regulatory science efforts.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: On 9/6/16, FDA provided an update on its actions to address this recommendation. FDA concurred with the recommendation and reiterated that it plans to identify opportunities for setting measurable goals related to regulatory science. The agency indicated that it would provide an update by 3/6/17.
    Recommendation: In order to improve FDA's strategic planning for regulatory science efforts, the Secretary of Health and Human Services should direct the Commissioner of FDA to systematically track funding of regulatory science projects across each of its priority areas.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: On 9/6/16, FDA provided an update on its actions to address this recommendation. FDA concurred with the recommendation and reiterated that it is identifying mechanisms to improve its tracking of funding across the priority areas. The agency indicated that it would provide an update by 3/6/17.
    Director: Joseph Kirschbaum
    Phone: (202) 512-9971

    1 open recommendations
    Recommendation: To help ensure that DOD's investments are being applied toward developing medical countermeasures to respond to the most serious and likely biological threat agents, the Secretary of Defense should direct the appropriate DOD officials to develop and implement a process to update and validate DOD's list of biological threats, as required by DOD Directives 5160.05E and 6205.3, or implement a process that aligns with the department's current policies, practices, and priorities as reflected in the 2001 and 2010 Quadrennial Defense Reviews .

    Agency: Department of Defense
    Status: Open

    Comments: DOD concurred with the recommendation. DOD has been reviewing directives addressing biological warfare threats and is in the process of revising DOD Directive 5160.05E to ensure that the directive appropriately captures and institutionalizes the use of risk assessments to support research, development, and acquisition of chemical and biological defense capabilities. The Chemical and Biological Defense Program (CBDP) piloted the risk assessment process in 2014 and will continue to conduct annual risk assessments to support portfolio planning and guidance. In addition to this revision, the CBDP continues to improve stakeholder awareness and discussions on threats through the utilization of an annual threat day review and on-going Joint Service discussions on chemical and biological threats and capabilities to address those threats. Alignment of the threat information and medical countermeasure capabilities are discussed through the CBDP Medical Prime/Non-Prime Working Group, which was established in February 2015 to ensure the CBDP medical portfolio is addressing the highest priority threats considering available candidates and resources. The group meets quarterly to address key programmatic changes, discuss program strategic guidance, and to address information presented and discussed at the annual threat review sessions. In total, these efforts have improved the Department's ability to ensure biological threats are aligned and considered through holistic, threat-informed, risk-based assessments. DOD is also taking actions to improve the development of medical countermeasures against priority threats through a number of actions such as developing a process guide, holding threat days, and performing in-depth analyses on medical science and technology solutions. Once DOD completes and issues Directive 5160.05E, we will assess the extent to which DOD's combined actions address the recommendation.