Recommendation: The Secretary of Health and Human Services in coordination with the Administrator of the Federal Emergency Management Agency—who head agencies leading the COVID-19 response through the Unified Coordination Group—should immediately document roles and responsibilities for supply chain management functions transitioning to the Department of Health and Human Services, including continued support from other federal partners, to ensure sufficient resources exist to sustain and make the necessary progress in stabilizing the supply chain, and address emergent supply issues for the duration of the COVID-19 pandemic. (Recommendation 1)

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: The Secretary of Health and Human Services in coordination with the Administrator of the Federal Emergency Management Agency—who head agencies leading the COVID-19 response through the Unified Coordination Group—should further develop and communicate to stakeholders plans outlining specific actions the federal government will take to help mitigate remaining medical supply gaps necessary to respond to the remainder of the pandemic, including through the use of Defense Production Act authorities. (Recommendation 2)

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: The Secretary of Health and Human Services—who heads one of the agencies leading the COVID-19 response through the Unified Coordination Group—consistent with their roles and responsibilities, should work with relevant federal, state, territorial, and tribal stakeholders to devise interim solutions, such as systems and guidance and dissemination of best practices, to help states enhance their ability to track the status of supply requests and plan for supply needs for the remainder of the COVID-19 pandemic response. (Recommendation 3)

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: The Administrator of the Federal Emergency Management Agency—who heads one of the agencies leading the COVID-19 response through the Unified Coordination Group—consistent with their roles and responsibilities, should work with relevant federal, state, territorial, and tribal stakeholders to devise interim solutions, such as systems and guidance and dissemination of best practices, to help states enhance their ability to track the status of supply requests and plan for supply needs for the remainder of the COVID-19 pandemic response. (Recommendation 4)

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.

Recommendation: The Secretary of Health and Human Services, with support from the Secretary of Defense, should establish a time frame for documenting and sharing a national plan for distributing and administering COVID-19 vaccine, and in developing such a plan ensure that it is consistent with best practices for project planning and scheduling and outlines an approach for how efforts will be coordinated across federal agencies and nonfederal entities. (Recommendation 5)

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 the Centers for Disease Control and Prevention (CDC) implements its COVID-19 Response Health Equity Strategy, the Director of the Centers for Disease Control and Prevention should determine whether having the authority to require states and jurisdictions to report race and ethnicity information for COVID-19 cases, hospitalizations, and deaths is necessary for ensuring more complete data, and if so, seek such authority from Congress. (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: As CDC implements its COVID-19 Response Health Equity Strategy, the Director of the Centers for Disease Control and Prevention should involve key stakeholders to help ensure the complete and consistent collection of demographic data. (Recommendation 7)

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: As CDC implements its COVID-19 Response Health Equity Strategy, the Director of the Centers for Disease Control and Prevention should take steps to help ensure CDC's ability to comprehensively assess the long-term health outcomes of persons with COVID-19, including by race and ethnicity. (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: The Secretary of the Treasury, in coordination with the Commissioner of Internal Revenue, should update and refine the estimate of eligible recipients who have yet to file for an economic impact payment to help target outreach and communications efforts. (Recommendation 9)

Agency: Department of the Treasury
Status: Open

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

Recommendation: The Secretary of the Treasury, in coordination with the Commissioner of Internal Revenue, should make estimates of eligible recipients who have yet to file for an economic impact payment, and other relevant information, available to outreach partners to raise awareness about how and when to file for economic impact payments. (Recommendation 10)

Agency: Department of the Treasury
Status: Open

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

Recommendation: The Director of the Office of Management and Budget, in consultation with the Department of the Treasury, should issue the addendum to the 2020 Compliance Supplement as soon as possible to provide the necessary audit guidance. (Recommendation 11)

Agency: Executive Office of the President: Office of Management and Budget
Status: Open

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

Recommendation: The Director of the Centers for Disease Control and Prevention should ensure that, as it makes updates to its federal guidance related to reassessing schools' operating status, the guidance is cogent, clear, and internally consistent. (Recommendation 12)

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: The Secretary of Homeland Security, in coordination with the Secretary of Defense, should (1) revise the criteria in the 2019 National Interest Action code memorandum of agreement to clearly identify steps they will take to obtain input from key federal agencies prior to extending or closing a National Interest Action code, (2) establish timelines for evaluating the need to extend a National Interest Action code, and (3) define what constitutes a consistent decrease in contract actions and routine contract activity to ensure the criteria for extending or closing the National Interest Action code reflect government-wide needs for tracking contract actions in longer term emergencies, such as a pandemic. (Recommendation 13)

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.

Recommendation: The Secretary of Defense, in coordination with the Secretary of Homeland Security, should (1) revise the criteria in the 2019 National Interest Action code memorandum of agreement to clearly identify steps they will take to obtain input from key federal agencies prior to extending or closing a National Interest Action code, (2) establish timelines for evaluating the need to extend a National Interest Action code, and (3) define what constitutes a consistent decrease in contract actions and routine contract activity to ensure the criteria for extending or closing the National Interest Action code reflect government-wide needs for tracking contract actions in longer term emergencies, such as a pandemic. (Recommendation 14)

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: The Secretary of Health and Human Services, in consultation with the Centers for Medicare & Medicaid Services and CDC, should develop a strategy to capture more complete data on confirmed COVID-19 cases and deaths in nursing homes retroactively back to January 1, 2020, and to clarify the extent to which nursing homes have reported data before May 8, 2020. To the extent feasible, this strategy to capture more complete data should incorporate information nursing homes previously reported to CDC or to state or local public health offices. (Recommendation 15)

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: Based on the imminent cybersecurity threats, the Secretary of Health and Human Services should expedite implementation of our prior recommendations regarding cybersecurity weaknesses at its component agencies. (Recommendation 16)

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: The Secretary of Labor should, in consultation with the Small Business Administration and the Department of the Treasury, immediately provide information to state unemployment agencies that specifically addresses the Small Business Administration's Paycheck Protection Program loans, and the risk of improper payments associated with these loans. (Recommendation 1)

Agency: Department of Labor
Status: Open

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

Recommendation: The Commissioner of Internal Revenue should consider cost-effective options for notifying ineligible recipients on how to return payments. (Recommendation 2)

Agency: Department of the Treasury: Internal Revenue Service
Status: Open

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

Recommendation: The Administrator of the Small Business Administration should develop and implement plans to identify and respond to risks in the Paycheck Protection Program to ensure program integrity, achieve program effectiveness, and address potential fraud, including in loans of $2 million or less. (Recommendation 3)

Agency: Small Business Administration
Status: Open

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

Recommendation: In the absence of efforts to develop a plan, we urge Congress to take legislative action to require the Secretary of Transportation to work with relevant agencies and stakeholders, such as the Departments of Health and Human Services and Homeland Security, and members of the aviation and public health sectors, to develop a national aviationpreparedness plan to ensure safeguards are in place to limit the spread of communicable disease threats from abroad while at the same time minimizing any unnecessary interference with travel and trade. (Matter for Consideration 1)

Agency: Congress
Status: Open

Comments: When we determine what steps the Congress has taken, we will provide updated information.

Recommendation: To provide agencies access to Social Security Administration's more complete set of death data, we urge Congress to provide the Department of the Treasury with access to the Social Security Administration's full set of death records, and to require that the Department of the Treasury consistently use it. (Matter for Consideration 2)

Agency: Congress
Status: Open

Comments: When we determine what steps the Congress has taken, we will provide updated information.

Recommendation: To help ensure that federal funding is targeted and timely, we urge Congress to use GAO's Federal Medical Assistance Percentage formula for any future changes to the Federal Medical Assistance Percentage during the current or any future economic downturn. (Matter for Consideration 3)

Agency: Congress
Status: Open

Comments: When we determine what steps the Congress has taken, we will provide updated information.

Recommendation: The Secretary of HHS should develop and implement a plan to improve data collected on the prevalence of brain injuries resulting from intimate partner violence and use these data to inform HHS's allocation of resources to address the issue. (Recommendation 1)

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: The Assistant Secretary for Employment and Training should clarify DOL's expectations of the role of state workforce agencies in addressing the employment and training needs of those affected by SUD and how non-targeted WIOA funding can be used to assist job seekers and employers. (Recommendation 1)

Agency: Department of Labor
Status: Open

Comments: DOL agreed with this recommendation. ETA anticipates providing information and technical assistance to help workforce system grantees understand how they can address the impacts of SUD on the workforce. The agency also plans to issue guidance by the end of 2020 to share promising practices and describe how WIOA funds can be used to support job seekers in recovery and employers.

Recommendation: The Assistant Secretary for Employment and Training should share information from targeted grantees with all state workforce agencies, tribal governments, and outlying areas regarding lessons learned and promising practices in addressing the needs of job seekers affected by SUD and potential employers. (Recommendation 2)

Agency: Department of Labor
Status: Open

Comments: DOL agreed with this recommendation, noting that ETA has created resources that are available to all states based on its experience administering some of the targeted grants. ETA officials cited the recently published literature review and companion resource guide, and said they also plan to share the evaluation of the Phase 1 grants widely when it is available, including any resources or tools developed by states that were awarded Phase 1 grants. In addition, ETA plans to host at least one webinar to share additional promising practices from the targeted grants that could be useful to local workforce boards around the country.

Recommendation: The Secretary of Health and Human Services should develop a mechanism to routinely monitor, evaluate, and report on coordination efforts for infectious disease modeling across multiple agencies. (Recommendation 1)

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services concurred with this recommendation and stated that it is developing a process whereby it will coordinate its efforts in infectious disease modeling across its components, including efforts to monitor, evaluate and report on its coordination. When we confirm what actions the agency has taken in response to the recommendation, we will provide updated information.

Recommendation: The Secretary of Health and Human Services should direct CDC to establish guidelines that ensure full reproducibility of CDC's research by sharing with the public all permissible and appropriate information needed to reproduce research results, including, but not limited to, model code. (Recommendation 2)

Agency: Department of Health and Human Services
Status: Open

Comments: The Centers for Disease Control and Prevention concurred with this recommendation. When we confirm what actions the agency has taken in response to the recommendation, we will provide updated information.

Recommendation: The U.S. Commissioner of the IBWC should work with the Mexican Commissioner to formalize a binational rapid response team to address sewage infrastructure failures along the U.S.-Mexico border, including the Nogales and South Bay wastewater treatment plants. (Recommendation 1)

Agency: International Boundary and Water Commission, United States and Mexico
Status: Open

Comments: In July 2020, USIBWC stated that two teams have been established with members, one in the Nogales, Arizona and Nogales, Sonora region and one in the San Diego and Tijuana region. IBWC continues to take actions to formalize the binational rapid response teams. We will review the final documents for each team when they are completed and available.

Recommendation: The U.S. Commissioner of the IBWC should direct USIBWC staff to conduct long-term capital planning for the Santa Cruz River Basin and Tijuana River Valley watersheds, following the principles in OMB Circular A-11. (Recommendation 2)

Agency: International Boundary and Water Commission, United States and Mexico
Status: Open

Comments: In July 2020, the U.S. Commissioner of the IBWC stated that it had conducted long-term capital planning for the facilities for which it is responsible. They noted the 5-year plan that USIBWC had developed for the South Bay plant and the 10-year plan that it had developed for the Nogales plant. We noted these plans in our original report and stated that they needed to be broadened to identify needs in the Santa Cruz River Basin and Tijuana River Valley watersheds. The agency only partially concurred with our recommendation in the report and noted that to the extent our report envisions USIBWC undertaking long-term capital planning for (1) nonfederal infrastructure; (2) infrastructure that does not yet exist; and/or (3) infrastructure that the USIBWC is not yet authorized to construct or maintain, it does not concur. The agency is a key player in managing water quality on the border and has the infrastructure and organization that will be part of the solution. Without the information that USIBWC would generate by comprehensively assessing its long-term needs, such as through long-term capital planning efforts, Congress cannot authorize specific work that needs to be done. We recommended that the agency conduct long-term planning, including for infrastructure that does not exist and for infrastructure that is not yet authorized specifically to address this problem. We continue to believe that USIBWC should recognize its role along the border and start planning for it, including by undertaking long-term capital planning for existing and potential future infrastructure and identifying alternatives to address the long-standing water quality problems.

Recommendation: The PHMSA Administrator should analyze the factors affecting states' participation in underground natural gas storage inspections and analyze its workforce needs on an ongoing basis to guide its budget requests. (Recommendation 1)

Agency: Department of Transportation: Pipeline and Hazardous Materials Safety Administration
Status: Open

Comments: As of February 2020, the Department of Transportation (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) is collaborating with an organization of state government oil and gas oversight officials to assess the factors affecting their participation in its underground natural gas storage inspections, according to DOT. PHMSA plans to use this information by December 2020 to assess whether additional measures can be undertaken to increase state participation for its use starting in Fiscal Year 2022.

Recommendation: ASPR should develop a response personnel strategy to ensure, at a minimum, a lead ASPR liaison officer is consistently at the local emergency operations center(s) during an emergency support functions (ESF) #8 response and another liaison, if not more, is at strategic location(s) in the area. (Recommendation 1)

Agency: Department of Health and Human Services: Office of the Assistant Secretary for Preparedness and Response
Status: Open

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

Recommendation: As ASPR finalizes its federal patient movement framework, the agency should exercise the framework with its National Disaster Medical System (NDMS) partners to ensure that patients evacuated through NDMS will be consistently tracked from the start of their evacuation. (Recommendation 2)

Agency: Department of Health and Human Services: Office of the Assistant Secretary for Preparedness and Response
Status: Open

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

Recommendation: ASPR should put controls in place to ensure data on all NDMS evacuated patients are complete and accurate. (Recommendation 3)

Agency: Department of Health and Human Services: Office of the Assistant Secretary for Preparedness and Response
Status: Open

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

Recommendation: ASPR Region II should revise its Incident Response Plans for the territories to include strategies for providing chronic and primary care in isolated communities. These strategies could include the incorporation of Federally Qualified Health Centers and other local health clinics as part of a response. (Recommendation 4)

Agency: Department of Health and Human Services: Office of the Assistant Secretary for Preparedness and Response
Status: Open

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

Recommendation: ASPR should work with support agencies to develop and finalize memorandums of agreement that include information on the capabilities and limitations of these agencies to meet ESF#8 core capabilities. (Recommendation 5)

Agency: Department of Health and Human Services: Office of the Assistant Secretary for Preparedness and Response
Status: Open

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

Recommendation: ASPR should develop a strategy demonstrating how it ESF#8 core capabilities can be provided through HHS and ESF#8 support agencies if DOD's capacity to respond is limited. (Recommendation 6)

Agency: Department of Health and Human Services: Office of the Assistant Secretary for Preparedness and Response
Status: Open

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

Recommendation: ASPR should take steps to ensure the perspectives of key external parties are incorporated in the development of HHS's after-action reviews, following future ESF#8 activations. (Recommendation 7)

Agency: Department of Health and Human Services: Office of the Assistant Secretary for Preparedness and Response
Status: Open

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

Recommendation: The Administrator of APHIS should develop a timeline for (1) defining birds that are not bred for research and that are covered by the Animal Welfare Act, and (2) requiring that research facilities report to APHIS their use of birds covered by the act. (Recommendation 1)

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

Comments: According to APHIS officials, the agency developed a timeline and a work plan for an Advance Notice of Proposed Rule Making (ANPRM) to define "bred for use in research" as it applies to birds (as well as to rats and mice) under the Animal Welfare Act and submitted it to USDA officials on July 18, 2019. However, as of October 2019, USDA had not established a date to publish the ANPRM and had instead placed it on the department's long-term regulatory agenda. We will continue to monitor USDA's efforts and provide updated information when it becomes available.

Recommendation: The Administrator of APHIS should instruct federal agencies to report their use of animals covered by the Animal Welfare Act in federal facilities located outside of the United States. (Recommendation 2)

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

Comments: USDA disagreed with this recommendation for several reasons. For example, USDA stated that the absence of an exclusion to the requirements of the Animal Welfare Act or its regulations for federal research located outside of the United States does not create a requirement to collect information about such facilities' use of animals. In October 2019, APHIS officials said the agency continues to disagree with the recommendation. However, we have no reason to believe that such facilities should be excluded under the Act, and we continue to believe that the Administrator of APHIS should instruct federal agencies to report their use of animals in activities covered by the Animal Welfare Act in federal facilities located outside of the United States. We will continue to monitor any actions taken by APHIS to address this recommendation and provide updated information when it becomes available.

Recommendation: In developing the definition of field studies, the Administrator of APHIS should provide research facilities with clear criteria for identifying field studies that are covered by the Animal Welfare Act's regulations and that facilities should report to APHIS as well as field studies that facilities should not report. (Recommendation 3)

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

Comments: In its comments on our draft report, USDA stated that APHIS agreed to issue a guidance document by December 31, 2018. According to APHIS officials, the agency prepared a draft guidance document entitled "Research Involving Free-Living Wild Species" for departmental review in April 2019. As of October 2019, APHIS was in the process of reviewing comments from the department. We will continue to monitor APHIS and USDA's actions to implement the recommendation.

Recommendation: The Director of ONDCP, in collaboration with law enforcement and public health counterparts, should lead a review on ways to improve the timeliness, accuracy, and accessibility of fatal and non-fatal overdose data from law enforcement and public health sources that provide critical information to understand and respond to the opioid epidemic. Such a review should expand on and leverage the findings from previous federal studies. It should also assess the benefits and scalability of ongoing efforts to leverage data systems, such as the Washington-Baltimore High-Intensity Drug Trafficking Areas' (HIDTA) OD MAP program, and examine ways in which laws that restrict access to public health data to protect patient privacy have exemptions for law enforcement entities that could be more widely leveraged while protecting patient privacy. (Recommendation 2)

Agency: Executive Office of the President: Office of National Drug Control Policy
Status: Open

Comments: In the 60-day letter, dated June 28, 2018, ONDCP officials noted a number of federal initiatives underway to evaluate the timeliness, accuracy, and accessibility of overdose data. For example, ONDCP discussed its participation in a new Interagency Working Group led by the National Security Council to consider the implementation of overdose tracking and analytic capability, such as the expansion of ODMAP, as well as evaluating the appropriate federal role to engage in this initiative. In March 2019, ONDCP reported that it had suspended its ODMAP working group in the summer of 2018, after determining that this effort would be more effective for the Department of Justice's Bureau of Justice Assistance (BJA) and the Centers for Disease Control and Prevention (CDC) to work together through the Comprehensive Opioid Abuse Program Initiative. Nevertheless, as of April 2019, ONDCP officials reported that they continue to provide grant funding and training and technical assistance towards the expansion and use of ODMAP by state and local jurisdictions. Further, ONDCP reported supporting other federal data initiatives, such as providing funding to develop software for the CDC's National Center for Health Statistics Mortality Data that could better read narrative fields in death certificates to improve the timeliness and accuracy of the data. While ONDCP's efforts are directed towards supporting and improving existing data sources, the recommendation asks ONDCP to lead a review which it has not done. Further, ONDCP's initiatives to date have not addressed issues raised in our report related to balancing law enforcement's access to restricted health data while protecting patient privacy. We will continue to monitor ONDCP's efforts towards implementing this recommendation.

Recommendation: The Director of ONDCP should work with the HIDTAs participating in the Heroin Response Strategy to establish outcome-oriented performance measures for the four main goals set out in the strategy. (Recommendation 3)

Agency: Executive Office of the President: Office of National Drug Control Policy
Status: Open

Comments: In the 60-day letter, dated June 28, 2018, ONDCP officials stated that they had engaged with leaders from HIDTA participating in the Heroin Response Strategy to develop performance measures. According to ONDCP, as of early May 2018, eleven performance measures had been established--nine mandatory measures and two optional measures--and four of these measures constitute outcome-oriented measures. The June letter also noted that the HIDTA Performance Management Process database was being updated to reflect the new measures and ONDCP expected the system to be fully operational by the end of September 2018. In March 2019, ONDCP reported that, throughout the summer of 2018, it had revisited the performance measures it had developed and settled on ten revised performance measures (eight mandatory measures and two optional measures) for the newly branded Opioid Response Strategy (formerly known as the Heroin Response Strategy). According to ONDCP, these measures were implemented in HIDTA's Performance Management Process as of February 1, 2019. We will continue to coordinate with ONDCP to obtain documentation of these new measures. Once we obtain them, we will review and work toward closing the recommendation, as appropriate.

Recommendation: The Executive Director of Organized Crime Drug Enforcement Task Forces should work with the National Heroin Initiative Coordinator to establish outcome-oriented performance measures for the goals set out for National Heroin Initiative. (Recommendation 4)

Agency: Department of Justice: Organized Crime Drug Enforcement Task Forces
Status: Open
Priority recommendation

Comments: In its 60 Day-letter, dated June 26, 2018, officials from the Organized Crime Drug Enforcement Task Force (OCDETF) noted the output metrics and statistics that OCDETF is tracking as part of its National Heroin Initiative. For example, the letter states that OCDETF will track statistics on opioid overdose deaths, however it is unclear how this tracking effort is being incorporated into the National Heroin Initiative. While our report noted that statistics on overdose deaths have been used as outcome-oriented measures by agencies like the Office of National Drug Control Policy to assess its efforts, it is unclear how OCDETF is using these statistics to assess its performance and inform its efforts under the National Heroin Initiative. In October 2018, OCDETFs National Heroin Initiative Coordinator told us that the OCDETF Regional Directors were in the process of establishing and tracking region-specific metrics, such as local data on drug overdoses. In January 2020, we reached out to OCEDTF officials for an update, and they did not have any further information to provide. In August 2020, OCDETF officials told us that the National Heroin Initiative had evolved and they are no longer positioned to collect and report on drug overdoses as a performance measure for the initiative. However, officials stated that the initiative is measuring the number of OCDETF cases that are produced that result in the disruption or dismantlement of criminal networks involved in heroin and opioid trafficking. We asked OCDETF to provide documentation of the current state of the initiative and its related goals and performance measures. Once received, we will review and follow-up with OCDETF, if needed, to work towards the closure of the recommendation as implemented.

Recommendation: The Attorney General should, in consultation with its relevant components such as the Drug Enforcement Administration (DEA) and Executive Office for United States Attorneys (EOUSA), establish goals and outcome oriented performance measures for its Strategy to Combat the Opioid Epidemic. (Recommendation 5)

Agency: Department of Justice
Status: Open
Priority recommendation

Comments: In its 60 Day-letter, dated June 26, 2018, DOJ officials reported a number of output measures, such as conviction rates, that they will use to assess the effectiveness of the department's efforts to respond to the opioid epidemic. However, it is unclear how, if all, these measures have been incorporated into the department-wide strategy or if additional outcome-oriented metrics are being developed. In October 2018, DOJ officials reported that while they have not updated the strategy, then-Attorney General Sessions had issued a memo to the U.S. Attorneys that communicated some goals for their efforts, such as reductions in overdose deaths, and called for the U.S. Attorneys Office's Regional Opioid Coordinators to develop metrics specific to their regions. In October 2019, DOJ officials reported that the department is currently working on finalizing its Annual Priority Goals and related performance measures with respect to opioids, however they could not provide additional details nor a timeline for when these efforts are to be completed. We reached out in January 2020 to receive additional details and the Department did not have any further information to provide. We will continue to coordinate with DOJ to learn more about these efforts and when officials expect them to be implemented.

Recommendation: The DEA Administrator should establish goals and outcome-oriented performance measures for the enforcement and diversion control activities within the 360 Strategy and establish outcome-oriented performance measures for the community engagement activities within the 360 Strategy. (Recommendation 6)

Agency: Department of Justice: Drug Enforcement Administration
Status: Open
Priority recommendation

Comments: In its 60-Day Letter, dated June 26, 2018, DEA officials noted the steps they had taken to develop performance metrics for its enforcement and diversion control activities under the 360 Strategy and reported that DEA had implemented outcome-oriented performance metrics for the 360 Strategy's community engagement activities for fiscal year 2019. Further, DEA officials noted applying DEA's Threat Enforcement Planning Process (TEPP) specifically to the 360 Strategy to develop outcome-oriented metrics. Further, according to DEA officials, the TEPP includes an impact report that assesses the outcomes of the activities undertaken under 360. In October 2018, DEA told us that TEPP was still in development and they did not give a date for projected completion. In January 2020, we reached out to DEA officials for an update, and they did not have any further information to provide. We will continue to follow up with DEA officials on their progress.

Recommendation: The Secretary of Agriculture, in cooperation with the Secretary of Health and Human Services, should take steps to consult with respective sector partner(s), such as the sector coordinating council (SCC), Department of Homeland Security (DHS) and NIST, as appropriate, to develop methods for determining the level and type of framework adoption by entities across their respective sector. (Recommendation 1)

Agency: Department of Agriculture
Status: Open
Priority recommendation

Comments: In written comments, United States Department of Agriculture (USDA) neither agreed nor disagreed with the recommendation in our report, but stated that it would attempt to develop a measurement mechanism as part of its annual data calls to the Food and Agriculture Sector. Specifically, officials stated that the diversity of the sector makes it difficult to develop a method for determining the level and type of framework adoption across the sector that would apply to all members. USDA officials added, however, that the sector coordinating council frequently invites the Department of Homeland Security to semi-annual meetings to present on both the threat to cybersecurity and resources available to support the needs of the sector. However, as of January 2020, USDA officials had yet to develop methods to determine the level and type of framework adoption. Implementing our recommendations to gain a more comprehensive understanding of the framework's use by critical infrastructure sectors is essential to the success of protection efforts.

Recommendation: The Secretary of Energy should take steps to consult with respective sector partner(s), such as the SCC, DHS and NIST, as appropriate, to develop methods for determining the level and type of framework adoption by entities across their respective sector. (Recommendation 3)

Agency: Department of Energy
Status: Open
Priority recommendation

Comments: The Department of Energy (DOE) stated that it worked with stakeholders to better align the Cybersecurity Capability Maturity Model (C2M2) with the updated NIST Cybersecurity Framework but did not provide specific information regarding the adoption or use of the framework. To fully address the recommendation, DOE should have a more comprehensive understanding of the framework's use by sector entities if DOE, along with other entities, want to ensure that its facilitation efforts are successful and determine whether organizations are realizing positive results by adopting the framework. We will continue to monitor DOE actions in response to this recommendation.

Recommendation: The Administrator of the Environmental Protection Agency should take steps to consult with respective sector partner(s), such as the SCC, DHS and NIST, as appropriate, to develop methods for determining the level and type of framework adoption by entities across their respective sector. (Recommendation 4)

Agency: Environmental Protection Agency
Status: Open
Priority recommendation

Comments: In written comments, EPA did not explicitly state whether it agreed or disagreed with our recommendation, but said that several factors constrain the agency from implementing the recommendation. EPA also said it agrees that a comprehensive assessment of framework adoption within the water sector would assist with evaluating and tailoring efforts to promote its use. Further, the agency stated that it will continue to work with the Water Sector Coordinating Council and sector partners to promote and facilitate adoption of the cybersecurity framework. The agency also suggested options related to developing cross-sector metrics and survey methods and stated that it will collect available data that may be characterized as cybersecurity framework "awareness," such as downloads of guidance materials and participation in classroom trainings and webinars. However, as of February 2020, EPA had yet to develop methods to determine the level and type of framework adoption. Officials identified steps the department is taking to facilitate framework use. Specifically, EPA officials told us that the agency will coordinate with its Sector Coordinating Council to identify appropriate means to collect and report information, including a survey, to determine the level and type of framework adoption. They explained that, in the past, the water sector expressed concerns with sharing sensitive cybersecurity information and in developing metrics to evaluate cybersecurity practices. . However, EPA officials stated that they have conducted training, webcasts, and outreach related to cybersecurity, including using the framework and tailoring its efforts to sector needs. According to EPA officials, the agency's goal in doing so was to ensure that sector organizations understood the importance of the framework. While the agency has some ongoing initiatives, implementing our recommendation to gain a more comprehensive understanding of the framework's use by its critical infrastructure sector is essential to the success of protection efforts.

Recommendation: The Secretary of Health and Human Services, in cooperation with the Secretary of Agriculture, should take steps to consult with respective sector partner(s), such as the SCC, DHS and NIST, as appropriate, to develop methods for determining the level and type of framework adoption by entities across their respective sector. (Recommendation 6)

Agency: Department of Health and Human Services
Status: Open
Priority recommendation

Comments: In written comments, the Department of Health and Human Services (HHS) concurred with the recommendation in our report and stated that it would work with appropriate entities to assist in sector adoption. HHS officials, in collaboration with NIST and a joint Cybersecurity Working Group, developed 10 best practices in May 2017 (Health Industry Cybersecurity Practices) for the Healthcare and Public Health Services sector based on the framework. These practices allowed stakeholders to identify how to use the framework with existing sector resources by raising awareness and providing vetted cybersecurity practices to enable the organizations to mitigate cybersecurity threats to the sector. In addition, officials from HHS's Assistant Secretary for Preparedness and Response (ASPR) stated that the working group discussed the challenges associated with measuring the use and impact of the NIST framework, and approved the establishment of a task group to further investigate the issue. ASPR officials added that some of the ideas discussed included the use of surveys and identification of a set of voluntary reporting indicators. In its fiscal year 2021 budget justification, HHS noted that it participated in a Health Care SCC Cybersecurity Working Group survey that was sent to group members in June 2019. However, while the survey included a question on the extent a working group member used the framework, SCC officials stated that the survey results were not statistically meaningful. While the department has ongoing initiatives, it had yet to develop methods to determine the level and type of framework adoption. Implementing our recommendations to gain a more comprehensive understanding of the framework's use by critical infrastructure sectors is essential to the success of protection efforts.

Recommendation: The Secretary of Homeland Security, in cooperation with the co-SSAs as necessary, should take steps to consult with respective sector partner(s), such as the SCC, and NIST, as appropriate, to develop methods for determining the level and type of framework adoption by entities across their respective sectors. (Recommendation 7)

Agency: Department of Homeland Security
Status: Open
Priority recommendation

Comments: In written comments, the Department of Homeland Security (DHS) concurred with the recommendation in our report and stated that its National Protection and Programs Directorate, as the sector-specific agency for 9 of the 16 critical infrastructure sectors, will continue to work closely with its private sector partners to ensure framework adoption is a priority. Additionally, the department stated that the directorate will work closely with its private sector partners to better understand the extent of framework adoption and barriers to adoption by entities across their respective sectors. As of January 2020, the department had begun taking steps to develop methods to determine the level and type of framework adoption in the respective sectors. Specifically, in October 2019, DHS, in coordination with its Information Technology (IT) sector partner, administered a survey to all small and midsized IT sector organizations to gather information on, among other things, framework use and plans to report on the results in 2020. DHS officials stated that any small or mid-sized business across all critical infrastructure sectors could complete the survey and that the department had promoted the survey to all sectors.

Recommendation: The Secretary of Transportation, in cooperation with the Secretary of Homeland Security, should take steps to consult with respective sector partner(s), such as the SCC, DHS and NIST, as appropriate, to develop methods for determining the level and type of framework adoption by entities across their respective sector. (Recommendation 8)

Agency: Department of Transportation
Status: Open
Priority recommendation

Comments: As of January 2020, the department had begun taking steps to develop methods to determine the level and type of framework adoption in the respective sectors. Specifically, officials in the Department of Transportation's (DOT) Office of Intelligence, Security, and Emergency Response, in coordination with the Department of Homeland Security (DHS), told us that they planned to develop and distribute a survey to the Transportation Systems sector to determine the level and type of framework adoption. DOT officials stated that the draft survey was undergoing DHS legal review and that the completion of the review and subsequent Office of Management and Budget review would determine when the survey is approved for distribution.

Recommendation: The Secretary of Treasury should take steps to consult with respective sector partner(s), such as the SCC, DHS and NIST, as appropriate, to develop methods for determining the level and type of framework adoption by entities across their respective sector. (Recommendation 9)

Agency: Department of the Treasury
Status: Open
Priority recommendation

Comments: The Department of the Treasury neither agreed nor disagreed with the recommendation in our report. The department stated that it will assess using the identified initiatives and their viability for collecting and reporting sector-wide improvements from use of the framework with input from the sector coordinating council (SCC) and financial regulators. However, as of January 2020, the department had yet to develop methods to determine the level and type of framework adoption. Treasury officials stated that the department, in coordination with the Financial and Banking Information Infrastructure Committee, and in consultation with NIST, developed the Cybersecurity Lexicon in March 2018. The lexicon addressed, among other things, common terminology for cyber terms used in the framework. Additionally, the Financial Services sector, in consultation with NIST, created the Financial Service Sector Cybersecurity Profile (profile) in October 2018, which mapped the framework core to existing regulations and guidance, such as the Commodity Futures Trading Commission System Safeguards Testing Requirements. Officials stated that these efforts will facilitate the use of the framework. However, while the department has ongoing initiatives, implementing our recommendations to gain a more comprehensive understanding of the framework's use by critical infrastructure sectors is essential to the success of protection efforts.

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: Officials have previously acknowledged that a public health situational awareness network capability is important for identifying, processing, and comprehending data in real-time and stated that such a capability requires coordination and participation from numerous federal entities, including numerous HHS's operating divisions. However, as of January 2020, GAO has not received any information demonstrating progress made to implement our recommendation. Further, HHS has not provided us with a plan of action describing how they would implement the recommendation. Until steps are taken to implement our recommendation, HHS may not make the progress needed to establish an electronic public health situational awareness network capability mandated by PAHPRA in 2013 and the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019.

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: Officials have previously acknowledged that a public health situational awareness network capability is important for identifying, processing, and comprehending data in real-time and stated that such a capability requires coordination and participation from numerous federal entities, including numerous HHS's operating divisions. However, as of February 2020 agency officials have not indicated whether or not they concur with the recommendation, nor have they taken any action or provided a plan of action describing how they would implement the recommendation. Until steps are taken to implement our recommendation, HHS may not make progress toward establishing an electronic public health situational awareness network capability mandated by PAHPRA in 2013 and in the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 .

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
Priority recommendation

Comments: In HHS' Public Health and Social Services Emergency Fund's fiscal year 2021 budget justification-which includes the Office of the Assistant Secretary for Preparedness and Response-the agency stated it "concurred" with this recommendation. However, as of February 2020, GAO has not received any information demonstrating progress made to implement our recommendation. Until then, HHS may continue to lack the necessary progress needed in order to establish an electronic public health situational awareness network capability mandated by PAHPRA. To address this recommendation, HHS needs to 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.

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. 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 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: HHS provided us with information on its efforts to share information about the temporary reassignment authority throughout the department. However, it is not clear that HHS has routed the temporary reassignment standard operation procedures, which provides instructions on how to request use of the authority and documentation and reporting requirements, with the HHS agencies that are likely to be primarily affected.

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
Priority recommendation

Comments: The Department of Transportation (DOT) has not developed a national aviation-preparedness plan to respond to communicable disease threats from abroad. In June 2020, we urged Congress to take legislative action to require the Secretary of Transportation to work with relevant agencies and stakeholders to develop a national aviation-preparedness plan to limit the spread of communicable disease threats, and minimize travel and trade impacts (see GAO-20-625). GAO's periodic updates on the CARES Act of 2020 provide information about actions taken by Congress to address this matter. DOT partially concurs with our recommendation and agrees that an aviation preparedness plan is needed, but continues to suggest that the Department of Health and Human Services (HHS) and the Department of Homeland Security (DHS) have responsibility for communicable disease response and preparedness planning, respectively, and that these departments should lead any efforts to address planning for communicable disease outbreaks, including for transportation. In the absence of a national aviation-preparedness plan, DOT officials point to ongoing efforts to engage with interagency partners at DHS and HHS, as well as industry stakeholders, to better collaborate on communicable disease response and preparedness as they relate to civil aviation. For example, in July 2020, DOT, HHS, and DHS issued guidance to airports and airlines for implementing measures to mitigate public health risks associated with COVID-19. While this guidance is a positive step, DOT has not yet taken action to develop an aviation preparedness plan for future communicable disease threats that incorporate such things as protocols for responding to the threat and coordination among stakeholders.

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: DOD concurred with our recommendation. In August 2016, DOD officials told us that a new DOEHRS version was released that contained several system enhancements and defect corrections to improve overall data quality in the system. However, as of July 2020, DOD had not provided specific information on these system enhancements, which would allow us to determine whether our recommendation has been fully addressed.

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 2020, Congress had not acted on this matter. OMB informed GAO in January 2020 that they had no plans to develop a government-wide performance plan for food safety. We continue to believe that such a plan is necessary for effective 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 formalizing the FSWG through statute to help ensure sustained leadership across food safety agencies over time.

Agency: Congress
Status: Open

Comments: As of March 2020, Congress had not acted on this matter.

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 September 2018, FDA told us that it was using its drug shortage data system, the "Shortage Tracker," to summarize information reported by manufacturers as the reasons for existing shortages. The agency indicated that it was developing a model that would factor in drug shortage data, warning signs identified through social media, and other factors to help identify early indicators that may predict future shortages. In July 2019, the agency indicated it could conduct periodic analyses of the causes of drug shortages. However, FDA had not yet proactively conducted any rigorous analyses of predictors of drug shortages to help recognize trends, clarify causes, and resolve problems before drugs go into short supply. In an August 2020 written response, FDA reported that it was undertaking modeling efforts to explore the feasibility of predicting future drug shortages using machine learning approaches. FDA planned to complete the initial modeling by fall 2020, at which time it would identify next steps. The agency indicated that the recommendation should remain open, and GAO will continue to monitor the implementation of this recommendation.

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 July 2020, 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 July 2020, 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 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. In November 2017, both ASPR and CDC officials noted that they could not commit to setting consistent targets with incremental milestones over a budget cycle and therefore could not implement the recommendation. As of August 2018, there was no change from the agencies' position that they do not have plans to fully implement the recommendation at this time.

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). Additionally, in November 2017, both CDC and ASPR officials noted that they may need to continue to adjust the performance measures during the new 5-year cycle. As of August 2018, as a result of the change to HPP's measures and the agency statements in November 2017, GAO anticipates keeping this recommendation open at least for the next few budget periods, in order to determine whether the agencies maintain consistency with the performance measures during the new project cycle.

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 May 15, 2020, 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."

Recommendation: Disparities in tax rates on smoking tobacco products have negative revenue implications because they create incentives for manufacturers and consumers to substitute higher-taxed products with lower-taxed products. In light of that fact, as Congress continues its oversight of CHIPRA and Tobacco Control Act implementation, it may wish to consider modifying tobacco tax rates to eliminate significant tax differentials between similar products. Specifically, Congress may wish to consider equalizing tax rates on roll-your-own and pipe tobacco and, in consultation with Treasury, also consider options for reducing tax avoidance due to tax differentials between small and large cigars.

Agency: Congress
Status: Open

Comments: As of March 2020, Congress has not passed legislation to eliminate tax differentials between roll-your-own and pipe tobacco or between small and large cigars. In the 116th Congress, five bills have been introduced to create tax equity between roll-your-own and pipe tobacco, as GAO suggested in its April 2012 report. However, these bills have not been enacted. In addition, the 116th Congress has not passed legislation to address tax differentials between small and large cigars. Modifying tax rates to eliminate the tax differentials between similar tobacco products could address potential future revenue losses stemming from the substitution of higher-taxed products with lower-taxed products.

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: As of March 2020, we have not seen a formal written memo from the IRIS program laying out this information - in detail - publicly, or how timelines for assessments are influenced by various criteria. While IRIS program staff have discussed this issue, no written guidance has been created. Such communication from the IRIS Program, as well as more frequent updates of the timelines for chemicals currently in assessment and projected starting dates for every chemical listed as "under assessment" is needed.

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: As of March 2020, EPA's Integrated Risk Information System (IRIS) Program has established the priority chemicals it is working on, and has published some timelines via the IRIS Program Outlook document. However, this information has not been published as an agenda in the Federal Register.

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: As of February 2020, EPA officials indicated that the IRIS Program had almost completed internal review of a "Handbook for Developing IRIS Assessments," intended to guide staff through the sequential stages of the IRIS assessment process and ensure consistency across assessments. The Handbook, when finalized and used by staff, codifies the agency's effort to reevaluate their assessment process, but doesn't address the resources that should be dedicated to the IRIS Program. A workforce plan that includes both staff and budget resources consistent with user needs is necessary. As we reported in March 2019, the program has made strides utilizing project management software and project management techniques that enable the IRIS Program to better plan assessment schedules and utilize staff. However, we also reported in March 2019 that the President's budget requests since fiscal year 2018 have repeatedly cut the budget by as much as 40 percent for the Health and Environmental Risk Assessment (HERA) area, of which IRIS is a part. While these cuts were not enacted by Congress, the President's fiscal year 2021 budget request again cuts the HERA program by 34 percent, or approximately $12.7 million dollars. These cuts could have an impact on the IRIS program's ability to meet EPA program and regional office needs, if enacted by Congress.