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    Subject Term: "Public health"

    28 publications with a total of 62 open recommendations including 9 priority recommendations
    Director: Valerie C. Melvin
    Phone: (202) 512-6304

    3 open recommendations
    Recommendation: To ensure progress is made toward the implementation of any IT enhancements needed to establish electronic public health situational awareness network capabilities mandated by PAHPRA, the Secretary of HHS should direct the Assistant Secretary for Preparedness and Response to task an integrated project team, made up of an IT project manager and business owner, with including specific actions in the Public Health and Medical Situational Awareness Strategy Implementation Plan for conducting all activities required to establish and operate the network.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To ensure progress is made toward the implementation of any IT enhancements needed to establish electronic public health situational awareness network capabilities mandated by PAHPRA, the Secretary of HHS should direct the Assistant Secretary for Preparedness and Response to task the integrated project team with developing a project management plan that includes measurable steps--including a timeline of tasks, resource requirements, estimates of costs, and performance metrics--that can be used to guide and monitor HHS's actions to establish the network defined in the plans.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To ensure progress is made toward the implementation of any IT enhancements needed to establish electronic public health situational awareness network capabilities mandated by PAHPRA, the Secretary of HHS should direct the Assistant Secretary for Preparedness and Response to conduct all IT management and oversight processes related to the establishment of the network in accordance with Enterprise Performance Life Cycle Framework guidance, under the leadership of the HHS CIO.

    Agency: Department of Health and Human Services
    Status: Open

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

    3 open recommendations
    Recommendation: As DOD plans to respond to a pandemic, the Secretary of Defense should direct the Under Secretary of Defense for Policy and other DOD officials, as appropriate, to use DOD's existing coordination mechanisms with HHS and the Federal Emergency Management Agency (FEMA) to explore opportunities to improve their preparedness and response to a pandemic if DOD's capabilities are limited.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: As HHS plans to respond to a pandemic, the Secretary of Health and Human Services should direct the Assistant Secretary for Preparedness and Response to use HHS's existing coordination mechanisms with DOD and FEMA to explore opportunities to improve their preparedness and response to a pandemic if DOD's capabilities are limited.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: As DHS, through FEMA, plans to respond to a pandemic, the Secretary of Homeland Security should direct the Administrator of FEMA to use FEMA's existing coordination mechanisms with DOD and HHS to explore opportunities to improve their preparedness and response to a pandemic if DOD's capabilities are limited.

    Agency: Department of Homeland Security: Directorate of Emergency Preparedness and Response: Federal Emergency Management Agency
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Elizabeth H. Curda
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: To help ensure that HHS agencies and offices fully understand the requirements and processes for the temporary reassignment authority, their responsibilities under the authority, and that ASPR is adequately and comprehensively assessing the effect of the authority on public health emergency response and medical surge, the Secretary of HHS should direct ASPR to conduct outreach to HHS agencies and offices that administer programs eligible for the reassignment authority to inform them of their responsibilities and ASPR's expected time frames for reviewing and approving states' and tribes' requests for personnel reassignments, and inform them of their responsibilities and ASPR's expectations for reviewing states' and tribes' after-action reports.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To help ensure that HHS agencies and offices fully understand the requirements and processes for the temporary reassignment authority, their responsibilities under the authority, and that ASPR is adequately and comprehensively assessing the effect of the authority on public health emergency response and medical surge, the Secretary of HHS should direct ASPR to develop a plan to evaluate states' and tribes' after-action reports to assess the impact of the reassignment authority on states' public health emergency response and medical surge and to provide technical assistance as necessary.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Gregory C. Wilshusen
    Phone: (202) 512-6244

    3 open recommendations
    Recommendation: To effectively implement key elements of the FDA's information security program, the Secretary of Health and Human Services should direct the Commissioner of FDA to update security plans to ensure the plans fully and accurately document the controls selected and intended for protecting each of the six systems.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: FDA concurred with the recommendation but has not yet provided sufficient evidence that it has implemented the recommendation.
    Recommendation: To effectively implement key elements of the FDA's information security program, the Secretary of Health and Human Services should direct the Commissioner of FDA to implement a process to effectively monitor and track training for personnel with significant security roles and responsibilities.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: FDA concurred with the recommendation but has not yet provided sufficient evidence that it has implemented the recommendation.
    Recommendation: To effectively implement key elements of the FDA's information security program, the Secretary of Health and Human Services should direct the Commissioner of FDA to ensure that personnel with significant security responsibilities receive role-based training.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: FDA concurred with the recommendation but has not yet provided sufficient evidence that it has implemented the recommendation.
    Director: Steve Morris
    Phone: (202) 512-3841

    1 open recommendations
    Recommendation: To further enhance FDA's PREDICT tool and its ability to ensure the safety of imported food, the Secretary of Health and Human Services should direct the Commissioner of FDA to document the process for identifying the type of open source data to collect, obtaining such data, and determining how PREDICT is to use the data.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of February 2017, GAO was awaiting action by the agency to implement this 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: J. Alfredo Gómez
    Phone: (202) 512-3841

    1 open recommendations
    Recommendation: To enhance HHS's ability to protect public health from the impacts of climate change, the Secretary of HHS should direct CDC to develop a plan describing when it will be able to issue climate change communication guidance to state and local health departments, to better position relevant officials to effectively communicate about the risks that climate change poses to public health and address requirements of the Climate Ready States and Cities Initiative.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of December 2016, CDC has taken steps to start developing a communications strategy, and expects this process to include the development of guidance for public health officials to help them more effectively communicate about the health effects of climate change. CDC expects the strategy to be completed by the fall of 2017.
    Director: Brenda S. Farrell
    Phone: (202) 512-3604

    3 open recommendations
    including 3 priority recommendations
    Recommendation: To provide decision makers with appropriate and more complete information on the continuing implementation, management, and oversight of the DHA, the Secretary of Defense should direct the Assistant Secretary of Defense (Health Affairs) to develop a comprehensive requirements assessment process that accounts for needed future skills through the consideration of potential organizational changes and helps ensure appropriate consideration of workforce composition through the determination of the final status of military personnel within the DHA.

    Agency: Department of Defense
    Status: Open
    Priority recommendation

    Comments: As of April 2017, DOD has taken some steps to implement this action. According to an April 2017 letter from the Acting Principal Deputy Assistant Secretary of Defense (Health Affairs), DOD has established processes and procedures to create an overall personnel management process which are documented in a draft Administrative Instruction estimated to be finalized and published by July 31, 2017.
    Recommendation: To provide decision makers with appropriate and more complete information on the continuing implementation, management, and oversight of the DHA, the Secretary of Defense should direct the Assistant Secretary of Defense (Health Affairs) to develop a plan for reassessing and revalidating personnel requirements as the missions and needs of the DHA evolve over time.

    Agency: Department of Defense
    Status: Open
    Priority recommendation

    Comments: As of April 2017, DOD has taken some steps to implement this action. According to an April 2017 letter from the Acting Principal Deputy Assistant Secretary of Defense (Health Affairs), DOD has established processes and procedures to create an overall personnel management process which are documented in a draft Administrative Instruction estimated to be finalized and published by July 31, 2017.
    Recommendation: To provide decision makers with appropriate and more complete information on the continuing implementation, management, and oversight of the DHA, the Secretary of Defense should direct the Assistant Secretary of Defense (Health Affairs) to determine the future of the Public Health and Medical Education and Training shared services by either identifying common functions to consolidate to achieve cost savings or by developing a justification for the transfer of these functions from the military services to the DHA that is not premised on cost savings.

    Agency: Department of Defense
    Status: Open
    Priority recommendation

    Comments: As of April 2017, DOD has taken some steps to implement this action. According to an April 2017 letter from the Acting Principal Deputy Assistant Secretary of Defense (Health Affairs), DOD has changed the designation of its Public Health function from a shared service to a division. This change recognizes the distinction that we previously highlighted between a shared service, or the consolidation of functions previously performed by the military services, and a transfer of functions from the military services to the DHA. The letter states that DOD is in the process of assessing business case analyses for various efficiency efforts, with one proposal estimated to save $613 million over three years. DOD has not taken similar action with regard to its Medical Education and Training shared service. As we previously reported in our prior update, while DOD cites future cost savings in its modeling and simulation and online learning product lines, we reported in 2014 that these initiatives overlap with the DHA's Contracting and Procurement and Information Technology shared services. For example, while cost savings for Modeling and Simulation are allocated to the Medical Education and Training Directorate, implementation costs are to be incurred by the Contracting and Procurement shared service. This recommendation will remain open until DOD either identifies common functions to consolidate within Medical Education and Training to achieve cost savings or develops a justification for the transfer of these functions from the military services to the DHA that is not premised on cost savings.
    Director: J. Alfredo Gómez
    Phone: (202) 512-3841

    2 open recommendations
    Recommendation: To better ensure compliance with ERDDAA when handling congressional requests for scientific advice from EPA's SAB, the EPA Administrator should document procedures for reviewing congressional committee requests to determine which questions should be taken up by the SAB and criteria for evaluating such requests.

    Agency: Environmental Protection Agency
    Status: Open

    Comments: In September 2016, EPA finalized procedures for reviewing congressional committee requests for advice from the Science Advisory Board (SAB). According to EPA officials, the agency will also make modifications to the SAB charter to be consistent with the process. When the charter is updated, we will review it to determine whether clarifying language included meets the intent of this recommendation.
    Recommendation: To better ensure compliance with ERDDAA when handling congressional requests for scientific advice from EPA's SAB, the EPA Administrator should clarify in policy documents when it is and when it is not appropriate for the EPA Administrator to forward advice to the requesting committee.

    Agency: Environmental Protection Agency
    Status: Open

    Comments: In September 2016, EPA finalized procedures for reviewing congressional committee requests for advice from the Science Advisory Board (SAB) to determine which questions should be taken up by the SAB. These procedures, however, do not ensure compliance with ERDDAA because they fail to recognize that under ERDDAA, the SAB is required to provide requested scientific advice to select committees. The procedures lay out a process and criteria for reviewing congressional requests for SAB advice which include: 1) the scope of EPA's legal authorities; 2) whether the requested advice is related to the science and technical aspect of the environmental issue, rather than a question of public policy; and 3) EPA priorities and strategic plan. The relevant criterion for determining whether the SAB should take up a question, however, is whether it is scientific in nature. The other criteria may be relevant to EPA's prioritization of requests to the SAB in light of the SAB's limited resources.
    Director: Debra A. Draper
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: To eliminate the fragmentation and duplication in the storage of unclassified OEHS data, the Secretary of Defense should determine which IT system--DOEHRS or MESL--should be used to store specific types of unclassified OEHS data, clarify the department's policy accordingly, and require all other departmental and military-service-specific policies to be likewise amended and implemented to ensure consistency.

    Agency: Department of Defense
    Status: Open

    Comments: In November 2016, officials told us that draft versions of the revised DoDI 6490.03, Deployment Health, and the new Defense Health Agency Procedural Instruction (DHA PI) 6490.03, Deployment Health, are still under review with DOD components. These revised and updated documents will address the recommendation on OEHS data storage. Additionally, DoDI 6055.05, Occupational and Environmental Health (OEH), and Military Service and Combatant Command policy and guidance documents are still being revised to be consistent with DoDI 6490.03 and DHA PI 6490.03 after they are published. These revisions will ensure the consistency among policies. As of November 2016, the entire process is expected to be complete within 10 to 14 months.
    Recommendation: To ensure the reliability of OEHS data, the Secretary of Defense should establish clear policies and procedures for performing quality assurance reviews of the OEHS data collected during deployment, to include verifying the completeness and the reasonableness of these data, and require that all other related military-service-specific policies be amended and implemented to ensure consistency.

    Agency: Department of Defense
    Status: Open

    Comments: In August 2016, officials told us that draft versions of the revised DoDI 6490.03, Deployment Health, and the new Defense Health Agency Procedural Instruction (DHA PI) 6490.03, Deployment Health, are in review among the DOD Components. Further, DoDI 6055.05, Occupational and Environmental Health (OEH) and Military Service and Combatant Command policy and guidance documents will be revised to be consistent with DoDI 6490.03 and DHA PI 6490.03 after they are published. In addition, DOD is exploring improvement to the data quality assurance functionality within the Defense Occupational and Environmental Health Readiness System Industrial Hygiene (DOEHRS-IH). A new DOEHRS-IH version (2.0.18.1) was released on August 19, 2016 that contained several system enhancements and defect corrections to improve overall data quality in the system. DOD anticipates additional releases in FY 2017 that will further improve DOEHRS-IH data quality. The revised policies and the new DOEHRS-IH functionality will appropriately address the recommendation on quality assurance of OEHS data.
    Recommendation: To ensure that potential occupational and environmental health risks are mitigated for servicemembers deployed to Iraq and Afghanistan, the Secretary of Defense should require CENTCOM to revise its policy to ensure that base commanders' decisions on whether to implement risk mitigation recommendations identified in OEHSAs are adequately documented and consistently monitored by the appropriate command.

    Agency: Department of Defense
    Status: Open

    Comments: In August 2016, officials told us that the current DoDI 6055.01, DoD Safety and Occupational Health Program, requires DoD components to establish procedures that document, archive, and reevaluate risk management decisions on a recurring basis. Draft versions of the revised DoDI 6490.03, Deployment Health, and the new Defense Health Agency Procedural Instruction (DHA PI) 6490.03, Deployment Health, include language that is consistent with DoDI 6055.01. Additionally, U.S. Central Command Regulation 40-2 (CCR 40-2), which was updated as of March 8, 2016, references the requirement to establish procedures to assure risk management decisions are documented, archived, and reevaluated on a recurring basis. The DOD is also exploring a risk management decision and monitoring functionality in DOEHRS-IH. It has identified and approved the necessary system change requests required to improve risk management decisions and monitoring functionality. These functionalities are primarily focused around the Occupational & Environmental Health Site Assessment (OEHSA) and associated exposure pathways, sampling plans, and assessments. Subject to the availability of FY 2017 funding, DOD will implement the system change requests, and achieve the required enhancements to DOEHRS-IH. These policies once published and the new DOEHRS-IH functionality will appropriately address the recommendation on documenting and monitoring risk management decisions.
    Director: John Neumann
    Phone: (202) 512-3841

    2 open recommendations
    Recommendation: To improve internal control and promote transparency and to ensure consistency with OMB's guidance for internal control assessment, DNFSB should clearly document each step of its control assessment activities; maintain that documentation to provide evidence that assessment and control activities are being performed; and ensure that key responsibilities, such as reviewing control assessments, should be segregated among different people to help ensure that control activities are being accurately performed.

    Agency: Defense Nuclear Facilities Safety Board
    Status: Open

    Comments: According to DNFSB officials, DNFSB has updated its policies to maintain paper and electronic documentation of its internal control activities and ensure that key responsibilities, such as reviewing internal control assessments, are segregated among different staff. In addition, DNFSB has contracted for an independent evaluation of its internal control policies. We will continue to monitor actions to address this recommendation.
    Recommendation: To improve internal control and promote transparency and to promote public transparency and openness, DNFSB should clearly distinguish in Federal Register notices and during the proceedings between (1) public hearings held pursuant to DNFSB's statutory authority and (2) meetings as defined by the Sunshine Act, required to be open to the public.

    Agency: Defense Nuclear Facilities Safety Board
    Status: Open

    Comments: According to DNFSB officials, as of October 2016, the agency has taken no action in response to this recommendation. We will continue to monitor actions to address this recommendation.
    Director: Morris, Steve D
    Phone: (202) 512-3841

    3 open recommendations
    including 1 priority recommendation
    Recommendation: To help ensure that their food safety goals are complementary and strategies are mutually reinforcing, the Secretary of Agriculture and the Secretary of Health and Human Services should continue to build upon their efforts to implement GPRAMA requirements to address crosscutting food safety efforts, including by more fully describing in their strategic and performance planning documents how they are working with other agencies to achieve their food safety-related goals and objectives.

    Agency: Department of Agriculture
    Status: Open
    Priority recommendation

    Comments: USDA and HHS agreed with our recommendation that they continue to build upon their efforts to implement GPRAMA requirements to address crosscutting food safety efforts. In response to the recommendation, HHS took steps to update its strategic and performance planning documents to better address crosscutting food safety efforts. For example, in February 2015, HHS updated its strategic plan to more fully describe how it is working with other agencies to achieve its food safety-related goals and objectives. As a result, we closed the recommendation to HHS as implemented. In its written comments on our report, USDA said that the Department was working to achieve the GPRAMA requirement for interagency collaboration and continues to work with HHS to align its strategic and performance planning to achieve their mutual food safety goals and efforts. As of March 2017, USDA had not fully implemented our recommendation, although the Department's Food Safety and Inspection Service (FSIS) had taken some steps that could contribute toward full implementation. For example, FSIS included more information on crosscutting food safety efforts in its fiscal year 2017-2021 strategic plan and in its draft fiscal year 2017 annual plan than it did in its prior strategic and annual plans. Such information could be included in USDA's next strategic plan. According to USDA officials, the Department plans to include more information on interagency collaboration in its next strategic plan, to be issued in February 2018. As USDA and its component agencies work to develop the Department's new strategic plan, attention should be given to fully addressing crosscutting food safety efforts in it and in USDA's associated performance planning documents. Once USDA's new strategic plan has been released, we will evaluate whether the recommendation has been implemented. We continue to believe that implementing the recommendation is an important step toward addressing fragmentation in federal oversight of food safety.
    Recommendation: Because challenges associated with the fragmented federal food safety system are long-standing, decision makers do not have an integrated perspective on federal food safety performance, and centralized mechanisms for broad-based collaboration have not been sustained, Congress should consider directing OMB to develop a government-wide performance plan for food safety that includes results oriented goals and performance measures and a discussion of strategies and resources.

    Agency: Congress
    Status: Open

    Comments: As of March 2017, Congress had not acted on this matter.
    Recommendation: Because challenges associated with the fragmented federal food safety system are long-standing, decision makers do not have an integrated perspective on federal food safety performance, and centralized mechanisms for broad-based collaboration have not been sustained, Congress should consider formalizing the FSWG through statute to help ensure sustained leadership across food safety agencies over time.

    Agency: Congress
    Status: Open

    Comments: As of March 2017, Congress had not acted on this matter.
    Director: J. Alfredo Gómez
    Phone: (202) 512-3841

    1 open recommendations
    Recommendation: To help ensure that FSIS efforts protect human health by reducing Salmonella and Campylobacter contamination in FSIS-regulated poultry products, in future revisions of the compliance guidelines on controlling Salmonella and Campylobacter, the Secretary of Agriculture should direct the Administrator of FSIS to ensure the inclusion of information on the effectiveness of each recommended farm practice to reduce these pathogens in live poultry.

    Agency: Department of Agriculture
    Status: Open

    Comments: In December 2015, USDA's Food Safety and Inspection Service released the draft revised compliance guideline to assist poultry establishments in controlling Salmonella and Campylobacter in raw poultry. The draft guideline included information on the effectiveness of each recommended farm practice to reduce Salmonella and Campylobacter in live poultry. FSIS announced the availability of and requested comment on the revised compliance guideline in a December 2015 Federal Register Notice. FSIS officials told us that they anticipate finalizing the draft guideline in fiscal year 2017 and the guideline states that while the document is draft, establishments are encouraged to incorporate information in the guideline in their decision-making process. As of April 2017, FSIS had not finalized the guideline.
    Director: Stephen Caldwell
    Phone: (202) 512-8777

    4 open recommendations
    Recommendation: Within DHS, to promote efficiency and harmonize the various assessments to advance security and resilience across the spectrum of CI in a manner consistent with the Homeland Security Act of 2002, PPD-21, and the NIPP, the Secretary of Homeland Security should direct the Under Secretary for the National Protection and Programs Directorate work with other DHS offices and components to develop and implement ways that DHS can facilitate data sharing and coordination of vulnerability assessments to minimize the risk of potential duplication or gaps in coverage.

    Agency: Department of Homeland Security
    Status: Open

    Comments: DHS has taken action in response to GAO's September 2014 recommendation to develop a department-wide process to facilitate data sharing and coordination among the various DHS components that conduct or require vulnerability assessments, but has not fully implemented the recommendation. DHS first reported to GAO in August 2015 that its Office of Infrastructure Protection (IP) and the Sector Outreach and Programs Division Innovation Center had formed a vulnerability assessment working group comprised of a variety of federal stakeholders, both within and outside DHS, to enhance overall integration and coordination of vulnerability assessment efforts. In December 2015, DHS stated that IP was conducting pilot projects to expand access to its IPGateway portal--IP's system that houses infrastructure data and identifies facilities that have been assessed by IP. In a July 2016 update, DHS reported that IP had reached agreement with DHS components to expand access to its IP Gateway portal to those partners as a means to share IP's vulnerability assessment information and help coordinate assessment visits and related activities. DHS also noted in its update that IP had begun providing access to IP Gateway to components within DHS but did not provide a date as to when that step would be complete. These are positive steps toward implementing a systematic and integrated approach for facilitating data sharing and coordination of vulnerability assessments throughout the department. However, developing a department-wide process to facilitate data sharing and coordination among the DHS offices and components that conduct or require vulnerability assessments would better enable DHS to minimize the risk of potential duplication and gaps by its offices and components in the vulnerability assessments they conduct. Because DHS is still in the process of completing these steps, the recommendation has not yet been fully implemented.
    Recommendation: Regarding SSAs and other federal departments or agencies external to DHS with CI security-related responsibilities that offer or conduct vulnerability assessment tools and methods and building on our recommendation that DHS review its own vulnerability assessments, the Secretary of Homeland Security should direct the Under Secretary for the National Protection and Programs Directorate to work with SSAs and other federal agencies that have CI security responsibilities to identify key CI security-related assessment tools and methods used or offered by SSAs and other federal agencies.

    Agency: Department of Homeland Security
    Status: Open

    Comments: As of September 2016, DHS has established a Cross-Sector Integration and Innovation Center in conjunction with the Office of Infrastructure Protection, and has designed, created, and launched a Cross-Agency Vulnerability Assessment Working Group portal on the Homeland Security Information Network-Critical Infrastructure (HSIN-CI). The Working Group, consisting of members from multiple departments and agencies, is collaborating to enhance the integration and coordination of vulnerability assessment efforts. This working group is intended to serve as an interagency forum to address several recommendations from GAO Report 14-507. However, the effort is ongoing and it is too early to determine if it will successfully address the recommendation.
    Recommendation: Regarding SSAs and other federal departments or agencies external to DHS with CI security-related responsibilities that offer or conduct vulnerability assessment tools and methods and building on our recommendation that DHS review its own vulnerability assessments, the Secretary of Homeland Security should direct the Under Secretary for the National Protection and Programs Directorate to work with SSAs and other federal agencies that have CI security responsibilities to analyze the key CI security-related assessment tools and methods offered by sector-specific agencies (SSA) and other federal agencies to determine the areas they capture.

    Agency: Department of Homeland Security
    Status: Open

    Comments: As of September 2016, DHS has established a Cross-Sector Integration and Innovation Center in conjunction with the Office of Infrastructure Protection, and has designed, created, and launched a Cross-Agency Vulnerability Assessment Working Group portal on the Homeland Security Information Network-Critical Infrastructure (HSIN-CI). The Working Group, consisting of members from multiple departments and agencies, is collaborating to enhance the integration and coordination of vulnerability assessment efforts. This working group is intended to serve as an interagency forum to address several recommendations from GAO Report 14-507. However, the effort is ongoing and it is too early to determine if it will successfully address the recommendation.
    Recommendation: Regarding SSAs and other federal departments or agencies external to DHS with CI security-related responsibilities that offer or conduct vulnerability assessment tools and methods and building on our recommendation that DHS review its own vulnerability assessments, the Secretary of Homeland Security should direct the Under Secretary for the National Protection and Programs Directorate to work with SSAs and other federal agencies that have CI security responsibilities to develop and provide guidance for what areas should be included in vulnerability assessments of CI that can be used by DHS, SSAs, and other CI partners in an integrated and coordinated manner, among and across sectors, where appropriate.

    Agency: Department of Homeland Security
    Status: Open

    Comments: As of September 2016, DHS has established a Cross-Sector Integration and Innovation Center in conjunction with the Office of Infrastructure Protection, and has designed, created, and launched a Cross-Agency Vulnerability Assessment Working Group portal on the Homeland Security Information Network-Critical Infrastructure (HSIN-CI). The Working Group, consisting of members from multiple departments and agencies, is collaborating to enhance the integration and coordination of vulnerability assessment efforts. This working group is intended to serve as an interagency forum to address several recommendations from GAO Report 14-507. However, the effort is ongoing and it is too early to determine if it will successfully address the recommendation.
    Director: Marcia Crosse
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To enhance its oversight of drug shortages, particularly as the agency fine-tunes the manner in which it gathers data on shortages and transitions from its database to a more robust system, the Commissioner of FDA should conduct periodic analyses using the existing drug shortages database (and, eventually, the new drug shortages information system) to routinely and systematically assess drug shortage information, and use this information proactively to identify risk factors for potential drug shortages early, thereby potentially helping FDA to recognize trends, clarify causes, and resolve problems before drugs go into short supply.

    Agency: Department of Health and Human Services: Food and Drug Administration
    Status: Open

    Comments: In August 2017, FDA reported that it had not conducted any rigorous analysis of predictors of drug shortages nor have new drug risk factors been identified. Although FDA adopted a new, commercially developed data system, the "Shortage Tracker" to track drug shortages in March 2016, it is used to help the Drug Shortage Staff manage their workload. FDA reported that this system has now been fully operational for over a year. However, no trend analysis relating to drug shortages has been conducted and the agency has no plans to conduct such analyses at this time.
    Director: Gomez, Jose A
    Phone: (202) 512-3841

    2 open recommendations
    Recommendation: To take advantage of opportunities to collect UCMR data on additional unregulated contaminants, Congress should consider amending SDWA to give EPA the flexibility to select more than 30 contaminants for monitoring under the UCMR program if high-priority contaminants, such as those on the Contaminant Candidate List (CCL) or contaminants of emerging concern, can be included at minimal cost, with minimal additional burden on public water systems, and while using analytical methods that EPA is already employing.

    Agency: Congress
    Status: Open

    Comments: As of December 2016, Congress has not taken action to address this matter; we will continue to monitor actions and provide updated information when it becomes available.
    Recommendation: To optimize the ability of the UCMR data to support regulatory determinations, Congress should consider adjusting the statutory time frames for the UCMR and regulatory determinations cycles so that EPA can use the UCMR data to support regulatory determinations in the same cycle.

    Agency: Congress
    Status: Open

    Comments: As of December 2016, Congress has not taken action to address this matter; we will continue to monitor actions and provide updated information when it becomes available.
    Director: Crosse, Marcia G
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: To improve the usefulness of IACC data and enhance its efforts to coordinate HHS autism activities and monitor all federally funded autism activities, the Secretary of Health and Human Services should direct the IACC and NIH, in support of the IACC, to provide consistent guidance to federal agencies when collecting data for the portfolio analysis and web tool so that information can be more easily and accurately compared over multiple years.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS continues to disagree with this recommendation. In the spring of 2016 NIH released fiscal years 2011 and 2012 data, and in the spring of 2017, it released fiscal year 2013 data and made these data available through the IACC Web Tool. GAO continues to believe that the issuance of consistent guidance could enhance coordination and monitoring and that implementing this recommendation would be beneficial.
    Recommendation: To improve the usefulness of IACC data and enhance its efforts to coordinate HHS autism activities and monitor all federally funded autism activities, the Secretary of Health and Human Services should direct the IACC and NIH, in support of the IACC, to create a document or database that provides information on non-research autism-related activities funded by the federal government and make this document or database publicly available.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS continues to disagree with this recommendation. However, GAO believes that having a document or database that contains current information on these non-research activities is an important aspect of fulfilling the IACC's responsibility to monitor all federal autism activities, not just research. In May 2016, we issued another report on federal autism activities (GAO-16-446). During our work for this engagement, we found that HHS and the IACC have recently taken actions required by the Autism CARES Act that could help coordinate federal non-research autism activities and implement our November 2013 recommendation. First, as directed by the act, in April 2016, the Secretary of Health and Human Services designated an official to serve as the Autism Coordinator to oversee national autism research, services, and support activities and ensure that autism activities funded by HHS and other federal agencies are not unnecessarily duplicative. Secondly, the Act required the development of a strategic plan for autism research, including for services and supports as practicable, for individuals with autism and the families of such individuals. The plan is to include recommendations to ensure that autism research, and services and support activities to the extent practicable, of HHS and other federal departments and agencies are not unnecessarily duplicative. During IACC meetings in 2016, NIH staff and IACC members discussed updating the strategic plan to include services and supports. This plan is expected to be published in calendar year 2017. We acknowledge the steps taken by HHS and the IACC in response to the Autism CARES Act; however, we believe continued action is needed to develop these initial steps into methods for identifying and monitoring non-research autism-related activities funded by the federal government. We believe that continued fulfillment of provisions in the Autism CARES Act could help the department implement GAO's 2013 recommendation.
    Recommendation: To improve the usefulness of IACC data and enhance its efforts to coordinate HHS autism activities and monitor all federally funded autism activities, the Secretary of Health and Human Services should direct the IACC and NIH, in support of the IACC, to identify projects through its monitoring of federal autism activities--including Office of Autism Research Coordination's annual collection of data for the portfolio analysis and the IACC's annual process to update the strategic plan--that may result in unnecessary duplication and thus may be candidates for consolidation or elimination, and identify potential coordination opportunities among agencies.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS continues to disagree with this recommendation. However, GAO questions the purpose and value of devoting federal resources to collecting these data, if they are not then used to ensure federal funds are used appropriately. In May 2016, we issued another report on federal autism activities (GAO-16-446), which among other topics, examined the steps HHS and other federal agencies have taken to improve coordination and help avoid unnecessary duplication in autism research. We reported that HHS has recently taken actions required by the Autism CARES Act that could help coordinate federal autism research and implement our November 2013 recommendation. First, as directed by the act, in April 2016 the Secretary of Health and Human Services designated an official to serve as the Autism Coordinator to oversee national autism research, services, and support activities and ensure that autism activities funded by HHS and other federal agencies are not unnecessarily duplicative. Second, the Autism Cares Act requires that the IACC's strategic plan include recommendations to ensure that autism research funded by HHS and other federal agencies is not unnecessarily duplicative. During IACC meetings in 2016, NIH staff and IACC members discussed updating the strategic plan, including the aforementioned requirement. This plan is expected to be published in calendar year 2017. We acknowledge the steps taken by HHS and the IACC in response to the Autism CARES Act; however, until the designated Autism Coordinator takes steps to meet the act's requirements and the forthcoming strategic plan is published, there is a risk that opportunities to coordinate and create efficiencies and avoid unnecessary duplication in federal autism research will not be seized. We believe that continued fulfillment of provisions in the Autism CARES Act could help the department implement GAO's 2013 recommendation.
    Director: Crosse, Marcia G
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: To improve CTP's ability to operate efficiently, achieve effective results, and plan appropriately, the Secretary of Health and Human Services should direct the Commissioner of FDA to establish performance measures that include time frames for making final decisions on SE submissions and Exemption from SE submissions.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: FDA has established performance measures that include time frames for reviewing and acting on some of its new tobacco product submissions, including regular Substantial Equivalence (SE) submissions and Exemption from SE submissions, received in fiscal years 2015 through 2018. However, as of September, 2017, FDA has not developed performance measures for provisional SE submissions, the type of SE submissions that represent new tobacco products that may continue to be marketed unless and until FDA's Center for Tobacco Products finds that they are not substantially equivalent. We are keeping this recommendation open until the agency establishes performance measures, including time frames for making final decisions, for provisional SE submissions.
    Recommendation: To improve CTP's ability to operate efficiently, achieve effective results, and plan appropriately, the Secretary of Health and Human Services should direct the Commissioner of FDA to monitor FDA's performance relative to those time frames, such as evaluating whether staff are performing reviews of these submissions efficiently and effectively.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: FDA has established and monitors performance measures that include time frames for reviewing and acting on regular SE submissions, Exemption from SE requests, and Modified Risk Tobacco Product applications for fiscal years 2015 through 2018. However, because the agency has not yet reported establishing and monitoring performance measures for provisional SE submissions, we are leaving this recommendation open as of August 2017.
    Director: Crosse, Marcia G
    Phone: (202)512-3407

    2 open recommendations
    Recommendation: To help ensure that HHS is adequately and comprehensively assessing HPP and PHEP awardees' performance and progress in meeting the medical and public health preparedness goals of the cooperative agreements, the Secretary of Health and Human Services should direct ASPR and CDC to develop objective and quantifiable performance targets and incremental milestones that correspond to the new HPP and PHEP performance measures, against which HHS can gauge progress toward the medical and public health preparedness goals of the cooperative agreements and direct technical assistance, as needed.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: Since we examined the HPP and PHEP cooperative agreements in 2012, ASPR had developed few targets for the HPP program measures or their corresponding indicators that were contained in the HPP performance measurement guidance documents issued for Budget Periods (BP) 2-5, ending June 30, 2017. Additionally, the new HPP performance measure implementation guidance for the 5-year project cycle from 2017-2022 introduces 28 performance measures, with few having targets?the guidance notes that corresponding goals or targets may be set at a later date after data from the first budget period of this new project cycle has been reviewed. Regarding PHEP, CDC had developed performance targets for about half of the performance measures as of the PHEP BP5 performance measurement guidance (BP5 ended June 30, 2017). These performance measures generally remain the same, with existing targets, for BP1 (July 1, 2017-June 30, 2018) of the new 5-year budget cycle. GAO recognizes that it may not be appropriate to develop performance targets for every performance measure depending on the desired process or outcome; however, both agencies still have work to do in this area.
    Recommendation: To help ensure that HHS is adequately and comprehensively assessing HPP and PHEP awardees' performance and progress in meeting the medical and public health preparedness goals of the cooperative agreements, the Secretary of Health and Human Services should ensure that performance measures and targets remain consistent across the 5-year project cycle and that any future measures be comparable to determine whether awardees are making progress toward meeting short- and long-term medical and public health preparedness goals of the cooperative agreements.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: Since we first examined the HPP and PHEP cooperative agreements in 2012, ASPR and CDC had made efforts to maintain consistency in their performance measures, particularly in the last 3 years of the prior project cycle which ended June 30, 2017. However, because part of the recommendation includes consistency of performance measures into future project cycles, we also examined whether both cooperative agreements continued to use basically the same performance measures into the current 5-year cycle, which began July 1, 2017. ASPR's HPP has made a significant change in its performance measures, introducing a new set of 28 performance measures for this new 5-year cycle. CDC's PHEP performance measures generally remained consistent in the last two budget periods of the prior 5-year cycle, and remained generally the same for the first year of the new 5-year cycle (some measures were "retired," though key components from a measure may continue to be used by CDC in other types of reviews). As a result of the change to HPP's measures, GAO anticipates keeping this recommendation open at least for the next few budget periods, in order to determine whether HPP maintains consistency with its new performance measures during the new project cycle.
    Director: Cackley, Alicia P
    Phone: (202) 512-8678

    1 open recommendations
    Recommendation: To better enable CPSC to target unsafe consumer products, Congress may wish to amend section 29(f) of CPSA to allow CPSC greater ability to enter into information-sharing agreements with its foreign counterparts that permit reciprocal terms on disclosure of nonpublic information.

    Agency: Congress
    Status: Open

    Comments: As of July 31, 2017, Section 29 of CPSA had not been amended since 2008. In 2013, a bill was introduced (S.1887) but not passed. That bill would have allowed "the Commission, when sharing information under the federal-state cooperation program with a foreign government agency for official law enforcement or consumer protection purposes, to authorize a foreign government agency to make that information available to another agency of the same foreign government (including a political subdivision of that foreign government that is located within the same territory or administrative area as the agency disclosing the information) if an appropriate official of the foreign government agency disclosing the information certifies (by prior agreement, memorandum of understanding with the CPSC, or other written certification) that it will establish and apply specified confidentiality restrictions under the Consumer Product Safety Act."
    Director: Trimble, David C
    Phone: 202-512-9338

    5 open recommendations
    including 4 priority recommendations
    Recommendation: To better ensure the credibility of IRIS assessments by enhancing their timeliness and certainty, the EPA Administrator should require the Office of Research and Development to assess the feasibility and appropriateness of the established time frames for each step in the IRIS assessment process and determine whether different time frames should be established, based on complexity or other criteria, for different types of IRIS assessments.

    Agency: Environmental Protection Agency
    Status: Open
    Priority recommendation

    Comments: In October 2016 we reviewed information provided by EPA related to this recommendation. While in July 2013, the EPA issued "enhancements" to the IRIS process and throughout 2016, EPA provided us with details on its online chemical information. EPA stated that the Program introduced the idea that different timelines are needed for different types of assessments based on criteria such as complexity (i.e., large database, many endpoints, complex questions about dose-response, multiple science issues, and novel approaches), potential public health impact, and the amount of new research that needs to be considered. Consequently, two sets of timelines for the IRIS assessment process were developed, one set for "standard" assessments and one set for "complex" assessments. GAO believes that this is important progress but that EPA needs to continue to determine whether different time frames should be established.
    Recommendation: To better ensure the credibility of IRIS assessments by enhancing their timeliness and certainty, the EPA Administrator should require the Office of Research and Development, should different time frames be necessary, to establish a written policy that clearly describes the applicability of the time frames for each type of IRIS assessment and ensures that the time frames are realistic and provide greater predictability to stakeholders.

    Agency: Environmental Protection Agency
    Status: Open
    Priority recommendation

    Comments: In October 2016 we reviewed information provided by EPA related to this recommendation. While in July 2013, EPA issued "enhancements" to the IRIS process and provided us with details on the online information available for each chemical, a written policy that is publicly available is still needed. EPA stated that the Program introduced the idea that different timelines are needed for different types of assessments based on criteria such as complexity (i.e., large database, many endpoints, complex questions about dose-response, multiple science issues, and novel approaches), potential public health impact, and the amount of new research that needs to be considered. Consequently, two sets of timelines for the IRIS assessment process were developed, one set for "standard" assessments and one set for "complex" assessments. GAO believes that EPA has made progress and we will continue to review information provided by EPA as they work to ensure that the time frames are realistic and provide greater predictability to stakeholders.
    Recommendation: To ensure that current and accurate information on chemicals that EPA plans to assess through IRIS is available to IRIS users--including stakeholders such as EPA program and regional offices, other federal agencies, and the public--the EPA Administrator should direct the Office of Research and Development to annually publish the IRIS agenda in the Federal Register each fiscal year.

    Agency: Environmental Protection Agency
    Status: Open

    Comments: In October 2016, EPA provided an update to GAO and said they believe they have met the intent of this GAO recommendation by publishing an IRIS Multi-Year Agenda in December 2015. According to EPA, the Multi-Year Agenda provides detailed information on near-term agency priorities including IRIS assessments that are ongoing and those that will be initiated over the next few years. EPA also told GAO that they are working to update the information provided on the status of each ongoing IRIS assessment. As this important work continues, GAO will monitor EPA's progress and determine if the information provides IRIS users with transparent information about assessments.
    Recommendation: To ensure that current and accurate information on chemicals that EPA plans to assess through IRIS is available to IRIS users--including stakeholders such as EPA program and regional offices, other federal agencies, and the public--the EPA Administrator should direct the Office of Research and Development to indicate in published IRIS agendas which chemicals EPA is actively assessing and when EPA plans to start assessments of the other listed chemicals.

    Agency: Environmental Protection Agency
    Status: Open
    Priority recommendation

    Comments: In October 2016, EPA provided an update to GAO and said they believe they have met the intent of this GAO recommendation by publishing an IRIS Multi-Year Agenda in December 2015. According to EPA, the Multi-Year Agenda provides detailed information on near-term agency priorities including IRIS assessments that are ongoing and those that will be initiated over the next few years. GAO still believes that annually providing current and accurate information on chemicals that EPA plans to assess through the IRIS program is critical for IRIS users and specifically which chemicals EPA is actively assessing and when EPA plans to start assessments of the other listed chemicals.
    Recommendation: To ensure that current and accurate information on chemicals that EPA plans to assess through IRIS is available to IRIS users--including stakeholders such as EPA program and regional offices, other federal agencies, and the public--the EPA Administrator should direct the Office of Research and Development to update the IRIS Substance Assessment Tracking System (IRISTrack) to display all current information on the status of assessments of chemicals on the IRIS agenda, including projected and actual start dates, and projected and actual dates for completion of steps in the IRIS process, and keep this information current.

    Agency: Environmental Protection Agency
    Status: Open
    Priority recommendation

    Comments: In October 2016, EPA provided an update to GAO and said they believe they have met the intent of this GAO recommendation by publishing an IRIS Multi-Year Agenda in December 2015. According to EPA, the Multi-Year Agenda provides detailed information on near-term agency priorities including IRIS assessments that are ongoing and those that will be initiated over the next few years. GAO still believes that annually providing current and accurate information on chemicals that EPA plans to assess through the IRIS program is critical for IRIS users. In addition, The Agenda does not identify projected start dates for new assessments, and therefore is not ensuring that current and accurate information on chemicals that EPA plans to assess through IRIS is available to IRIS users.
    Director: Trimble, David C
    Phone: (202)512-9338

    4 open recommendations
    Recommendation: To increase EPA's consistency, transparency, and clarity in implementing the Safe Drinking Water Act in a way that better assures the public of safe drinking water, and to systematically implement the statutory requirement to consider for regulation the contaminants that present the greatest public health concern, the EPA Administrator should require that the Office of Water to develop a coordinated process for obtaining both the occurrence and health effects data that may be needed for the agency to make informed regulatory determinations on these priority contaminants.

    Agency: Environmental Protection Agency
    Status: Open

    Comments: EPA has not demonstrated that it has developed a coordinated process for obtaining both occurrence and health effects data to make informed determinations on priority contaminants. EPA's response to this recommendation is that it will continue the status quo of obtaining occurrence data through UCMRs and work with the Office of Research and Development. As we reported, the approach EPA currently uses does not provide the agency with all of the data it needs in a timely manner to support determinations for some priority contaminants.
    Recommendation: To increase EPA's consistency, transparency, and clarity in implementing the Safe Drinking Water Act in a way that better assures the public of safe drinking water, and to support the development of regulatory determinations that are transparent, clear, and consistent and that follow applicable agency policy, the EPA Administrator should require the Office of Water to expeditiously develop, and make available to the public, policies or guidance that clearly articulates the agency's interpretation of the act's broad statutory criteria for making regulatory determinations and provides a protocol for making such determinations. In particular, the guidance should establish a process to ensure that the presentation of health effects and occurrence information in regulatory determination notices and support documents is comprehensive, consistent, informative, and understandable and that it includes clear explanations of key information, such as any exceptions to existing guidance reflected in the agency's support for its regulatory determinations.

    Agency: Environmental Protection Agency
    Status: Open

    Comments: EPA's Preliminary Regulatory Determinations for Contaminants on the Third Drinking Water Contaminant Candidate List (Reg Det 3) did not appear to include any cases in which EPA made an exception to existing guidance, negating the need for an explanation. EPA has not developed policies or guidance that establishes a process to ensure that the presentation of health effects and occurrence information in regulatory determination notices and support documents is comprehensive, consistent, informative, and understandable, and that it includes clear explanations of key information and the Protocol for Regulatory Determinations 3 does not appear to address this circumstance. Without policies or guidance establishing a process to ensure the comprehensive, consistent, informative, and understandable presentation of its regulatory determinations, there is no guarantee at this time that EPA would include this information in future regulatory determinations.
    Recommendation: To increase EPA's consistency, transparency, and clarity in implementing the Safe Drinking Water Act in a way that better assures the public of safe drinking water, and to support the development of regulatory determinations that are transparent, clear, and consistent and that follow applicable agency policy, the EPA Administrator should require the Office of Water to expeditiously develop, and make available to the public, policies or guidance that clearly articulates the agency's interpretation of the act's broad statutory criteria for making regulatory determinations and provides a protocol for making such determinations. In particular, the guidance should specify that appropriate stakeholders--that is, EPA offices with relevant expertise such as the Office of Children's Health Protection and regional offices that have known or likely occurrence of the contaminants being evaluated in public water systems within their areas of jurisdiction--be encouraged and have the opportunity to participate in the regulatory determination work groups.

    Agency: Environmental Protection Agency
    Status: Open

    Comments: EPA's response to this recommendation reflects the practice that was in place at the time we issued our report including this recommendation. As a result, it does not appear that EPA has taken any additional action to satisfy this recommendation at this time.
    Recommendation: In light of EPA's decisions to issue health advisories in conjunction with determinations to not regulate certain contaminants that have been detected in some public water systems at levels of public health concern, the EPA Administrator should (1) determine whether the Office of Water's use of health advisories provides sufficient information on these unregulated contaminants to support timely and effective actions by states, localities, public water systems, and the public to ensure the safety of public drinking water, and (2) if not, direct the Office of Water to develop a plan to more effectively communicate such information to these entities.

    Agency: Environmental Protection Agency
    Status: Open

    Comments: EPA indicated that it has begun a process of developing concise updates to carry forward into its health advisory table and that the process will be completed gradually over the next year, with updates continuing in the future, but has not yet published any updates for non-microbial contaminants. In addition, EPA has not addressed the call in the recommendation for the documentation of the process to update the advisories. The agency did indicate its plan to update the Drinking Water Standards and Health Advisory table in the fall of 2016, so we will leave this recommendation open and continue to monitor for future actions.
    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.
    Director: Gomez, Jose A
    Phone: (202)512-2649

    1 open recommendations
    Recommendation: To enhance FDA's oversight of dietary supplements and foods with added dietary ingredients, and to better enable FDA to meet its responsibility to regulate dietary supplements that contain new dietary ingredients, the Secretary of the Department of Health and Human Services should direct the Commissioner of FDA to issue guidance to clarify when an ingredient is considered a new dietary ingredient, the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing ingredient identity.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In July 2011, FDA published draft guidance for industry on new dietary ingredient notifications and related issues. This draft guidance includes information on when a dietary ingredient is considered new, evidence of safety, and methods for ingredient identity. We are waiting for the draft guidance to become final to close the recommendation.
    Director: Crosse, Marcia G
    Phone: (202)512-3407

    1 open recommendations
    Recommendation: The Secretary of Health and Human Services should direct the FDA Commissioner to expeditiously take steps to issue regulations for each class III device type currently allowed to enter the market through the 510(k) process. These steps should include issuing regulations to (1) reclassify each device type into class I or class II, or requiring it to remain in class III, and (2) for those device types remaining in class III, require approval for marketing through the PMA process.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: FDA has taken steps to respond to this recommendation; however we are leaving the recommendation open because the agency has not yet taken final steps to reclassify or require premarket approval (PMA) for two class III device types allowed to enter the market through the less stringent 510(k) process. In 2009, FDA began a 5-step process to reclassify or to require PMAs for 26 class III device types. This process was modified by the Food and Drug Administration Safety and Innovation Act (FDASIA)--instead of issuing regulations as the final step, FDA issues an administrative order to reclassify or require PMAs for the device types. In 2014, the agency reported it had set a goal to have all remaining devices finalized by the second quarter of 2015; however, as of August 2017, FDA had not finished the process of reclassifying or requiring PMAs for 2 of 26 devices types. The agency reported completing the process for 24 device types, and provided new planned milestones to complete the process for the remaining device types by the middle of 2018. We will leave this recommendation open until FDA makes progress in reclassifying or requiring PMAs for the remaining device types.
    Director: Trimble, David C
    Phone: (202)512-6225

    1 open recommendations
    including 1 priority recommendation
    Recommendation: To develop timely chemical risk information that EPA needs to effectively conduct its mission, the Administrator, EPA, should require the Office of Research and Development to re-evaluate its draft proposed changes to the IRIS assessment process in light of the issues raised in this report and ensure that any revised process periodically assesses the level of resources that should be dedicated to this significant program to meet user needs and maintain a viable IRIS database.

    Agency: Environmental Protection Agency
    Status: Open
    Priority recommendation

    Comments: In October 2016 we reviewed information provided by EPA related to this recommendation. The issuance of the Integrated Risk Information System (IRIS) Program Multi-Year Agenda in December 2015 demonstrated progress in responding to this recommendation. While we are currently reviewing additional documentation on how the agenda development process assessed the level of resources needed to meet user demand and to maintain a viable IRIS database, we will reevaluate how EPA continues to document the level of resources dedicated to this program to determine whether updates are occurring periodically.
    Director: Trimble, David C
    Phone: (202)512-6225

    1 open recommendations
    Recommendation: To better enable EPA and its partner agencies to minimize the environmental risks resulting from future disasters, the EPA Administrator should work with potentially affected federal land management agencies, the Coast Guard, DHS, and FEMA to determine what actions are needed to ensure that environmental contamination on federal lands, such as national wildlife refuges, can be expeditiously and efficiently addressed in future disasters. Potential actions include the development of protocols or memorandums of understanding or amendments to the Stafford Act if the agencies determine that amendments are needed to achieve the timely availability of such funding when responding to disasters involving federal lands.

    Agency: Environmental Protection Agency
    Status: Open

    Comments: In July 2016, EPA reported that the National Response Team considered this issue but decided that it was addressed by the Major Disasters, Section 405 of the Stafford Act and that no further action was needed. We will update the status of this recommendation when we complete our review of Section 405 and determine whether additional actions by EPA are needed to respond to disasters involving federal lands.