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    Subject Term: Epidemics

    4 publications with a total of 11 open recommendations
    Director: Persons, Timothy M
    Phone: (202) 512-6412

    5 open recommendations
    Recommendation: The Secretary of Health and Human Services should direct the Commissioner of the Food and Drug Administration to consolidate information from individual diagnostic test labels and make this information available in a form that enables users to more readily compare information across tests.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In August 2017, officials from the Department of Health and Human Services told us that the Food and Drug Administration is working to consolidate and make available on its website information for Zika virus diagnostic tests that have emergency use authorization.
    Recommendation: The Secretary of Health and Human Services should direct the Commissioner of the Food and Drug Administration to require manufacturers to list the identity of comparator assays on their diagnostic test labels.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In August 2017, officials from the Department of Health and Human Services told us that the Food and Drug Administration plans to recommend to sponsors of Zika virus diagnostic tests that they provide a description of the comparator assay.
    Recommendation: The Secretary of Health and Human Services should direct the Director of Centers for Disease Control and Prevention to establish a transparent process to provide CDC diagnostic tests, upon request, to manufacturers that are in the final stages of diagnostic test authorization.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In August 2017, officials from the Department of Health and Human Services told us that the Centers for Disease Control and Prevention (CDC) Technology Transfer Office is working to establish a transparent process that ensures CDC diagnostic tests can be provided to manufacturers.
    Recommendation: The Secretary of Health and Human Services should direct the Director of Centers for Disease Control and Prevention to include information on CDC-developed tests distributed to or shared with public health laboratories on CDC's website, including laboratory developed tests.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In August 2017, officials from the Department of Health and Human Services told us the Centers for Disease Control and Prevention (CDC) provides information on CDC-developed diagnostic tests on the Food and Drug Administration?s (FDA) website. CDC stated that their website will feature a direct link to FDA information on CDC-developed tests. CDC will continue to explore additional outlets for publication of information on CDC-developed diagnostic tests.
    Recommendation: The Secretary of Health and Human Services should direct the Director of Centers for Disease Control and Prevention to provide details such as collection records, dates, and data limitations on posted and disseminated mosquito distribution maps to better inform mosquito control experts and the general public.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In June 2016, the Centers for Disease Control and Prevention (CDC) published a report on the distribution of the mosquitos that can transmit Zika virus and other viruses in the United States. This report included new county collection records, collection dates, and summary maps for each species of mosquitos. In August 2017, officials from the Department of Health and Human Services told us the CDC is planning to update the mosquito distribution information on their website by the end of 2017, and it will include the underlying model predictions and country collection records.
    Director: David B. Gootnick
    Phone: (202) 512-3149

    4 open recommendations
    Recommendation: To ensure that USAID reimburses funds in accordance with section 9002 of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2015, the Administrator of USAID should reverse reimbursements that were not made to the same appropriation account as the account from which USAID obligated the funds.

    Agency: United States Agency for International Development
    Status: Open

    Comments: USAID concurred with the recommendation. In written comments on a draft of this report, USAID noted that it is examining whether sufficient appropriate resources exist to support all of the obligations against the accounts that were improperly reimbursed. As of September 2017, USAID is in the process of reversing the improper reimbursements. We will continue to monitor USAID's efforts to implement our recommendation.
    Recommendation: To ensure that USAID reimburses funds in accordance with section 9002 of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2015, the Administrator of USAID should reverse reimbursements for which there is no documentary evidence that the obligation was incurred to prevent, prepare for, and respond to the Ebola outbreak.

    Agency: United States Agency for International Development
    Status: Open

    Comments: USAID concurred with the recommendation. In written comments on a draft of this report, USAID stated that it would reverse reimbursements for which the documentation was lacking that the obligation was incurred to prevent, prepare for, and respond to the Ebola outbreak. As of September 2017, USAID is in the process of reversing the reimbursements. We will continue to monitor USAID's efforts to implement our recommendation.
    Recommendation: To ensure that USAID reimburses funds in accordance with section 9002 of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2015, the Administrator of USAID should determine whether reversing any of these reimbursements results in the obligation of funds in excess of appropriations in violation of the Antideficiency Act and, if so, report any violations in accordance with law.

    Agency: United States Agency for International Development
    Status: Open

    Comments: USAID concurred with the recommendation. In written comments on a draft of this report, USAID noted that USAID's Office of the Chief Financial Officer has been notified of a potential funds control violation and that USAID's ongoing review will determine whether an Antideficiency Act violation occurred. USAID further noted that, in the event it finds an Antideficiency Act violation, the agency would notify the violation in accordance with the law. In September 2017, USAID told GAO that it is finalizing the determination regarding the potential Antideficiency Act violation. We will continue to monitor USAID's efforts to implement our recommendation.
    Recommendation: To help ensure that USAID complies with reimbursement provisions that may arise in future appropriations laws, the Administrator of USAID should develop written policies and procedures for the agency's reimbursement process.

    Agency: United States Agency for International Development
    Status: Open

    Comments: USAID concurred with the recommendation. In written comments on a draft of this report, USAID noted that the agency will develop written policies and procedures that adequately address reimbursement provisions of applicable appropriations laws. In September 2017, USAID told GAO that it is in the process of finalizing the written policies and procedures for the agency's reimbursement process. We will continue to monitor USAID's efforts to implement our recommendation.
    Director: Gerald Dillingham, Ph.D
    Phone: (202) 512-2834

    1 open recommendations
    Recommendation: To help improve the U.S. aviation sector's preparedness for future communicable disease threats from abroad, the Secretary of Transportation should work with relevant stakeholders, such as the Department of Health and Human Services, to develop a national aviation-preparedness plan for communicable disease outbreaks. Such a plan could establish a mechanism for coordination between the aviation and public health sectors and provides clear and transparent planning assumptions for a variety of types and levels of communicable disease threats.

    Agency: Department of Transportation
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Currie, Christopher
    Phone: (404)679-3000

    1 open recommendations
    Recommendation: In order to help build and maintain a national biosurveillance capability---an inherently interagency enterprise---the Homeland Security Council should direct the National Security Staff to, in coordination with relevant federal agencies, charge this focal point with the responsibility for developing, in conjunction with relevant federal agencies, a national biosurveillance strategy that: 1) defines the scope and purpose of a national capability; 2) provides goals, objectives and activities, priorities, milestones, and performance measures; 3) assesses the costs and benefits associated with supporting and building the capability and identifies the resource and investment needs, including investment priorities; 4) clarifies roles and responsibilities of leading, partnering, and supporting a national capability; and 5) articulates how the strategy is integrated with and supports other related strategies' goals, objectives, and activities.

    Agency: Executive Office of the President: Homeland Security Council
    Status: Open

    Comments: In July 2012, the White House released the National Strategy for Biosurveillance to describe the U.S. government's approach to strengthening biosurveillance. A strategic implementation plan was to be completed within 120 days of the strategy issuance. As we testified in September 2012, the strategy did not fully meet the intent of our recommendation; however, when the implementation plan is complete, it may meet our recommendation. Specifically, the strategy did not provide the mechanism GAO recommended to identify resource and investment needs, including investment priorities. As of September 2015, GAO has not received a copy of the implementation plan for review and has not been able to confirm that it has been finalized and is considered operational by the White House and the key interagency partners.