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    Subject Term: "Biological research"

    5 publications with a total of 17 open recommendations
    Director: Timothy M. Persons
    Phone: (202) 512-6412

    11 open recommendations
    Recommendation: To improve independence, the Administrator of APHIS should formally document the reporting structure for the APHIS component of the Select Agent Program from the APHIS director of the program to the Administrator of APHIS. (Recommendation 1)

    Agency: Department of Agriculture: Animal and Plant Health Inspection Service
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To improve independence, the CDC director of the Select Agent Program should work with APHIS to establish control activities to help ensure that each component of the program carries out its inspection responsibilities as outlined in the program's memorandum of understanding. (Recommendation 2)

    Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To improve independence, the APHIS director of the Select Agent Program should work with CDC to establish control activities to help ensure that each component of the program carries out its inspection responsibilities as outlined in the program's memorandum of understanding. (Recommendation 3)

    Agency: Department of Agriculture: Animal and Plant Health Inspection Service
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To improve independence, the CDC director of the Select Agent Program should regularly assess the potential risks posed by the program's structure and the effectiveness of its mechanisms to address those risks, such as by commissioning external reviews, and take actions as necessary to ensure that any identified risks are addressed so that impairments to independence do not affect its ability to achieve its objectives. (Recommendation 4)

    Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To improve independence, the APHIS director of the Select Agent Program should regularly assess the potential risks posed by the program's structure and the effectiveness of its mechanisms to address those risks, such as by commissioning external reviews, and take actions as necessary to ensure any identified risks are addressed so that impairments to independence do not affect its ability to achieve its objectives. (Recommendation 5)

    Agency: Department of Agriculture: Animal and Plant Health Inspection Service
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To improve the ability to perform reviews, the CDC director of the Select Agent Program should work with APHIS to develop and implement a plan to identify which laboratory activities carry the highest biological safety and security risks and to respond to those risks by aligning inspections and other oversight efforts to target those activities. (Recommendation 6)

    Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To improve the ability to perform reviews, the APHIS director of the Select Agent Program should work with CDC to develop and implement a plan to identify which laboratory activities carry the highest biological safety and security risks and to respond to those risks by aligning inspections and other oversight efforts to target those activities. (Recommendation 7)

    Agency: Department of Agriculture: Animal and Plant Health Inspection Service
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To improve transparency, the CDC director of the Select Agent Program should work with APHIS to determine what additional information about laboratories' use of select agents, incidents, and violations of the select agent regulations is appropriate for the program to share with registered laboratories. (Recommendation 8)

    Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To improve transparency, the APHIS director of the Select Agent Program should work with CDC to determine what additional information about laboratories' use of select agents, incidents, and violations of the select agent regulations is appropriate for the program to share with registered laboratories. (Recommendation 9)

    Agency: Department of Agriculture: Animal and Plant Health Inspection Service
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To improve technical expertise and overcome fragmentation, the CDC director of the Select Agent Program should work with APHIS to develop a joint workforce plan that assesses workforce and training needs for the program as a whole. This assessment should be done in conjunction with the development of the strategic plan. (Recommendation 10)

    Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To improve technical expertise and overcome fragmentation, the APHIS director of the Select Agent Program should work with CDC to develop a joint workforce plan that assesses workforce and training needs for the program as a whole. This assessment should be done in conjunction with the development of the strategic plan. (Recommendation 11)

    Agency: Department of Agriculture: Animal and Plant Health Inspection Service
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Tim Persons
    Phone: (202) 512-6412

    1 open recommendations
    Recommendation: The Secretary of Homeland Security--in consultation with the Federal Bureau of Investigation--should conduct a formal bioforensics capability gap analysis to identify scientific and technical gaps and needs in bioforensics capabilities to help guide current and future bioforensics investments and update its analysis periodically.

    Agency: Department of Homeland Security
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Joseph Kirschbaum
    Phone: (202) 512-9971

    3 open recommendations
    Recommendation: To improve the identification, alignment, and management of DOD's chemical and biological defense infrastructure and to fully institutionalize the use of risk assessments to support future investment decisions, the Secretary of Defense should direct the Under Secretary of Defense for Acquisition, Technology and Logistics to update the roles and responsibilities guidance in DOD Directive 5160.05E to identify which organizations are responsible for conducting and participating in CBDP Enterprise risk assessments.

    Agency: Department of Defense
    Status: Open

    Comments: DOD concurred with this recommendation but has not yet completed actions to implement it. As of August 2017, DOD was still waiting to release the final version of DOO Directive 5160.05E.
    Recommendation: To improve the identification, alignment, and management of DOD's chemical and biological defense infrastructure and to fully institutionalize the use of risk assessments to support future investment decisions, the Secretary of Defense should direct the Under Secretary of Defense for Acquisition, Technology and Logistics to update the CBDP Enterprise's portfolio planning process, to include when risk assessments will be conducted.

    Agency: Department of Defense
    Status: Open

    Comments: DOD concurred with this recommendation but has not yet completed actions to implement it. On 6/8/16, DOD reported that the risk assessment process was initially piloted in 2014 to determine its utility for informing CBDP Enterprise portfolio planning and guidance. Moving forward, the CBDP Enterprise plans to conduct risk assessments annually to support portfolio planning and guidance. As of August 2017, DOD reported that the department was beginning an approximately 12-month process to revise the CBDP Business Plan, which would likely be published as a DOD Instruction. This plan should address the risk assessment recommendation.
    Recommendation: To improve the identification, alignment, and management of DOD's chemical and biological defense infrastructure and to enhance PAIO's ongoing analysis of potential infrastructure duplication in the CBDP Enterprise and gain potential efficiencies, the Secretary of Defense should direct the Under Secretary of Defense for Acquisition, Technology and Logistics to identify, request, and consider any information from existing infrastructure studies from other federal agencies with chemical and biological research and development and test and evaluation infrastructure.

    Agency: Department of Defense
    Status: Open

    Comments: DOD concurred with this recommendation but has not yet completed actions to implement it. As of July 2017, DOD has requested, but not received, such studies from other federal agencies. However, DOD is currently engaged in phase two of a three-phase effort regarding its chemical and biological defense infrastructure program (CBDP), which includes a review of the department's interagency roles and responsibilities for its chemical and biological defense Infrastructure Manager. Targeted completion for this phase is December 2017, at which time, DOD may have obtained relevant information from other federal agencies.
    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.
    Director: Mccool, Thomas J
    Phone: (202)512-8678

    1 open recommendations
    Recommendation: In developing legislation for a national reporting system for the biological laboratory community, Congress may wish to consider provisions for the agency it designates as responsible for the system to take into account the following in design and implementation: (1) including stakeholders in setting system goals; (2) assessing labs' organizational culture to guide design and implementation decisions; (3) making reporting voluntary, with open-reporting formats that allow workers to report events in their own words and that can be submitted by all workers in a variety of modes (Web or postal), with the option to report to either an internal or external entity; (4) incorporating strong reporter protections, data deidentification measures, and other incentives for reporting; (5) developing feedback mechanisms and an industry-level entity for disseminating safety data and safety recommendations across the lab community; and (6) ensuring ongoing monitoring and evaluation of the safety reporting system and safety culture.

    Agency: Congress
    Status: Open

    Comments: Congress has not taken action on this recommendation.