January 20, 2022

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Assistant Attorney General Kristen Clarke Gives Remarks at the National Association of Attorneys General Capital Forum

9 min read
<div>Good morning and thank you for having me. It is a pleasure to be here with you all, in person, and not just inside a screen.</div>
Good morning and thank you for having me. It is a pleasure to be here with you all, in person, and not just inside a screen.

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    GAO began 42 new audits that involved the Department of Defense (DOD) in the third quarter of fiscal year 2020. Of the 42 requested entrance conferences (i.e., initial meetings between agency officials and GAO staff) for those audits, DOD scheduled 41 within 14 days of notification and held all 42 entrance conferences within 30 days of notification. Scheduling was delayed for one entrance conference, which was scheduled 21 days after notification, because DOD and GAO were working to reach agreement on the primary action officer, which is the appropriate office or component within the department that coordinates DOD's response to the audit. The entrance conference was held 8 days after it was scheduled. Entrance conferences allow GAO to communicate its audit objectives and enable agencies to assign key personnel to support the audit work. GAO's agency protocols govern GAO's relationships with audited agencies. These protocols assist GAO in scheduling entrance conferences with key agency officials within 14 days of receiving notice of a new audit. The ability of the Congress to conduct effective oversight of federal agencies is enhanced through the timely completion of GAO audits. In past years, DOD experienced difficulty meeting the protocol target for the timely facilitation of entrance conferences. In Senate Report 116-48 accompanying a bill for the National Defense Authorization Act for Fiscal Year 2020, the Senate Armed Services Committee included a provision for GAO to review DOD's scheduling and holding of entrance conferences. In this report, GAO's agency protocols govern GAO's relationships with audited agencies. These protocols assist GAO in scheduling entrance conferences with key agency officials within 14 days of receiving notice of a new audit. The ability of the Congress to conduct effective oversight of federal agencies is enhanced through the timely completion of GAO audits. In past years, DOD experienced difficulty meeting the protocol target for the timely facilitation of entrance conferences. In Senate Report 116-48 accompanying a bill for the National Defense Authorization Act for Fiscal Year 2020, the Senate Armed Services Committee included a provision for GAO to review DOD's scheduling and holding of entrance conferences. In this report, GAO evaluates the extent to which DOD scheduled entrance conferences within 14 days of receiving notice of a new audit, consistent with GAO's agency protocols, and held those conferences within 30 days. This is the third of four quarterly reports that GAO will produce on this topic for fiscal year 2020. In the first two quarterly reports, GAO found that DOD had improved its ability to meet the protocol target. GAO analyzed data on GAO audits involving DOD and initiated in the third quarter of fiscal year 2020 (April 1, 2020, through June 30, 2020). Specifically, GAO identified the number of notification letters requesting entrance conferences that were sent to DOD during that time period. GAO determined the number of days between when DOD received the notification letter for each new audit and when DOD scheduled the entrance conference and assessed whether DOD scheduled entrance conferences within 14 days of notification, which is the time frame identified in GAO's agency protocols. GAO also determined the date that each requested entrance conference was held by collecting this information from the relevant GAO team for each audit and assessed whether DOD held entrance conferences for new audits within 30 days of notification, which was the time frame identified in the mandate for this review For more information, contact Elizabeth Field at (202) 512-2775 or Fielde1@gao.gov.
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  • Public Health Preparedness: Information on the Use of Medical Reserve Corps Volunteers during Emergencies
    In U.S GAO News
    Almost all states have a network of health care volunteers—the Medical Reserve Corps—who can augment federal, state, and local capabilities in response to public health emergencies, such as those arising from wildfires and hurricanes, and infectious disease outbreaks. Having sufficient, trained personnel, such as these volunteers, is critical to a state's capability to respond and recover from public health emergencies. According to federal data, 48 states and the District of Columbia reported 102,767 health care volunteers in 838 Medical Reserve Corps units as of September 2019, with nurses making up 43 percent. Number of Medical Reserve Corps Volunteers by Type, as of September 2019 Note: These data illustrate 90 percent of total health care volunteers. The remaining five types volunteers each make up less than 5 percent of the total. Other Public Health Medical volunteers may include cardiovascular technicians, sonographers, and phlebotomists. Medical Reserve Corps volunteers in states included in GAO's review—Alabama, California, North Carolina, and New Mexico—were deployed in response to natural disasters in 2018 and 2019, migrants at the southern border in 2019, and COVID-19 in 2020. Department of Health and Human Services (HHS) documentation shows these volunteers performed a variety of health care activities, such as providing medical services, setting up and providing support at shelters, and distributing medical supplies. Volunteers from these four states and others also participated in the response to COVID-19 by supporting testing sites, collecting specimens, and performing administrative tasks, such as data entry. For example, one unit deployed four volunteers a day for 3 days to work alongside nurses at a drive-through testing site. In addition to responding to public health emergencies, volunteers participated in preparedness activities, such as an initiative to train the public on how to respond to emergencies. HHS oversees the Medical Reserve Corps program and has assisted units in developing their volunteer capabilities. For example, HHS funded the development of a checklist of activities that should occur during volunteer deployment such as re-verifying medical credentials; provided training to new unit leaders on developing, managing, and sustaining Medical Reserve Corps units; and issued generally accepted practices, such as periodically re-evaluating volunteer recruitment procedures. The Medical Reserve Corps consists of health care volunteers—medical and public health professionals—who donate their time to help strengthen a response to public health emergencies and build community resilience. These volunteers prepare for and respond to public health emergencies, which may include natural disasters—such as hurricanes and wildfires—as well as disease outbreaks, whether intentional or natural. The Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 included a provision for GAO to review states' use of health care volunteers during public health emergencies. This report describes (1) the number and type of Medical Reserve Corps volunteers; (2) the types of public health emergencies volunteers have participated in; and (3) how HHS has assisted in developing volunteer capabilities. To conduct this work, GAO analyzed data reported to HHS as of September 2019; reviewed HHS documentation on four states' use of volunteers, which GAO selected based on population, number of volunteers, and event; and interviewed officials from HHS who oversee the Medical Reserve Corps program. GAO plans to further examine how states have used health care volunteers to respond to public health emergencies, including COVID-19, and any associated challenges to doing so in a future report. GAO provided a draft of this report to HHS. In response, HHS provided technical comments, which were incorporated as appropriate. For more information, contact Mary Denigan-Macauley at (202) 512-7114 or deniganmacauleym@gao.gov.
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  • Vaccine Development: Capabilities and Challenges for Addressing Infectious Diseases
    In U.S GAO News
    What GAO Found Vaccines protect people from disease by preparing the body to respond to an infection. Vaccinations are a key part of individual and community health, but vaccine development remains complex and costly. Innovative technologies and approaches, such as those identified in this report, may enhance the nation’s ability to respond to infectious disease. For example, reverse vaccinology and next-generation platforms—combined with existing research—helped researchers develop some COVID-19 vaccines more quickly and effectively. However, key challenges may hinder the adoption of these innovative technologies and approaches. Some promising technologies face issues and challenges such as inherent technical limitations and high cost. For example, organ chips may facilitate testing, but they are not yet able to replicate many of the complex functions of the human immune system. Similarly, single-use systems may increase the flexibility of vaccine manufacturing facilities, but may require extensive testing to ensure that they do not negatively affect the resulting vaccine. Further, economic challenges may hinder vaccine development. Experts attribute underinvestment in vaccines to market failures (i.e. market interactions that fall short of what would have been socially beneficial). For example, vaccines benefit those who are vaccinated, and, to some degree, those who are not. This additional benefit is not captured in the price, which reduces return on vaccine investment. GAO identified 9 policy options that may help address challenges hindering the adoption of vaccine development technologies and approaches or economic challenges. These policy options involve possible new actions by policymakers, who may include Congress, federal agencies, state and local governments, academic and research institutions, and industry. See below for details for some of the policy options and relevant opportunities and considerations. Selected Policy Options to Address Challenges in Vaccine Development   Opportunities Considerations Prioritize infectious disease pathogens (report page 21) Policymakers could collaborate across sectors (e.g., government, academia, researchers, industry, and nonprofit organizations) to prioritize infectious disease pathogens with pandemic potential for vaccine R&D. For example, policymakers could develop a working group to prioritize pathogens with pandemic potential and work more closely with international organizations to prioritize vaccine development as well as develop monoclonal antibodies. Prioritizing pathogens with pandemic potential could improve strategic vaccine R&D decision-making and help focus resources on developing and adopting key technologies and approaches that most effectively address those pathogens. Appropriately matching the technologies and approaches to the prioritized potential pandemic pathogens then leveraging technologies may help address certain technical limitations and cost. With greater leadership and strategic partnerships, policymakers could more quickly address threats to the U.S. population. As new threats are identified, priorities may change, which may cause uncertainty for vaccine developers. Policymakers may have different priorities based on their respective missions. There may be disagreements as to which key technologies should be prioritized and used, resulting in the need for policymakers to weigh the potential advantages and disadvantages associated with various options. Improve preparedness (report page 21) Policymakers could provide support for public-private partnerships to strategically address potential pandemic pathogens identified as priorities. These partnerships could, for example, develop and test vaccine candidates that may provide protection from pathogens with pandemic potential. This early development could provide a coordinated foundation that can be mobilized in an emergency. Such an approach could speed vaccine development as well as potentially reduce risk for vaccine researchers and developers concerning questions of safety, efficacy, and manufacturability. The lack of certainty of the commercial market and government funding for vaccines against pathogens with pandemic potential may be too risky for the private sector to undertake. Further support development of data standards (report page 32) Policymakers could further support coordinated efforts to obtain the views of all stakeholders and to develop standards for health data and their use in clinical trials. Integrating researchers’ needs into the standards development process could better ensure the necessary data are available. Access to high-quality data in a standardized format may allow streamlined patient recruitment for clinical trials. Expanding access to patient heath data requires attention to ensure privacy. Developing and implementing standardized data formats and IT infrastructure is time-consuming and costly. Improve preparedness (report page 41) Policymakers could provide support for public/private partnerships to strategically develop manufacturing capacity to respond to surge requirements. To maintain this capacity, partnerships could manufacture prototype vaccine candidates against high-priority pathogens. Manufacturing, testing, and stockpiling vaccines could be mobilized in an emergency and more rapidly mitigate future pandemics. By leveraging strategic partnerships, policymakers could take steps to increase the availability of vaccines to more quickly address threats to the U.S. population. May require new resources or reallocation of resources from other efforts. There may be a risk that the vaccines manufactured, tested, and stockpiled against prioritized pathogen classes miss certain pandemic pathogens.  The stockpiled vaccines would need to be regularly replenished prior to expiration. Evaluate factors that inhibit vaccine investment and mechanisms to increase it (report page 54) Policymakers could collaborate across sectors, such as government, academia, and industry, to conduct a systematic evaluation of factors that inhibit developers from investing in new vaccines. A clear understanding of the range of factors discouraging vaccine investment would provide the basis for effectively addressing those factors. Collaboration between policymakers and other stakeholders to obtain all relevant viewpoints can be time-consuming and it may be hard to reach a consensus. Source: GAO. | GAO-22-104371 Why GAO Did This Study The CARES Act included a provision for GAO to report on its ongoing monitoring and oversight efforts related to the COVID-19 pandemic. This report discusses technologies, approaches, and associated challenges for vaccine (1) research and development, (2) testing, and (3) manufacturing, as well as (4) the economic factors that affect vaccine investment. GAO conducted literature searches including scholarly articles and government reports relevant to these four areas. GAO interviewed stakeholders and experts with a diverse set of perspectives on the science, administration, and economics of vaccine development. GAO also convened a 3-day meeting of 22 experts with expertise in at least one area related to our four objectives with assistance from the National Academies of Sciences, Engineering, and Medicine. GAO received technical comments on a draft of this report from 1 federal agency and 9 participants at its expert meeting, which it incorporated as appropriate. GAO is identifying policy options in this report. For more information, contact Karen L. Howard at (202) 512-6888 or howardk@gao.gov.
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  • COVID-19: HHS Should Clarify Agency Roles for Emergency Return of U.S. Citizens during a Pandemic
    In U.S GAO News
    What GAO Found At the beginning of the COVID-19 pandemic, the U.S. returned, or repatriated, about 1,100 U.S. citizens from abroad and quarantined them domestically to prevent the spread of COVID-19. The Department of Health and Human Services (HHS) experienced coordination and safety issues that put repatriates, HHS personnel, and nearby communities at risk. This occurred because HHS component agencies—the Administration for Children and Families, the Office of the Assistant Secretary for Preparedness and Response, and the Centers for Disease Control and Prevention—did not follow plans or guidance delineating their roles and responsibilities for repatriating individuals during a pandemic—an event these agencies had never experienced. While they had general repatriation plans, there was disagreement as to whether the effort was in fact a repatriation. This led to fundamental problems for HHS agencies and their federal partners, including at the March Air Reserve Base quarantine facility in California where the first repatriated individuals were quarantined prior to widespread transmission of COVID-19 in the U.S. These problems included the following: Lack of clarity as to which agency was in charge when the first repatriation flight from Wuhan, China, arrived at the quarantine facility, which caused confusion among the HHS component agencies. Coordination issues among HHS component agencies resulted in component agencies operating independently of each other, and led to frustration and complications. HHS's delay in issuing its federal quarantine order, during which time a repatriate tried to leave the quarantine facility. HHS personnel's inconsistent use of personal protective equipment (PPE), and HHS officials' disagreement on which agency was responsible for managing infection prevention and control. An HHS official also directed personnel to remove their PPE as it created “bad optics,” according to an HHS report that examined the repatriation effort. The National Response Framework, a guide to how the U.S. responds to disasters and emergencies, instructs agencies to understand their respective roles and responsibilities, know what plans apply, and develop appropriate guidance for emergency responses. Until HHS revises or develops new plans that clarify agency roles and responsibilities during a repatriation in response to a pandemic, it will be unable to prevent the coordination and health and safety issues it experienced during the COVID-19 repatriation response in future pandemic emergencies. HHS also did not include repatriation in its pandemic planning exercises. As a result, agencies lacked experience deploying together to test repatriation plans during a pandemic, which contributed to serious coordination issues. GAO has previously reported that exercises play an important role in preparing for an incident by providing opportunities to test response plans and assess the clarity of roles and responsibilities. Until HHS conducts such exercises, it will be unable to test its repatriation plans during a pandemic and identify areas for improvement. Why GAO Did This Study HHS provides temporary assistance to U.S. citizens repatriated by the Department of State (State) from a foreign country because of destitution, illness, threat of war, or similar crises through the U.S. Repatriation Program. In January and February 2020, HHS assisted State in repatriating individuals from Wuhan, China, and the Diamond Princess cruise ship in Yokohama, Japan, to the U.S. HHS quarantined repatriates at five Department of Defense (DOD) installations to ensure they did not infect others with COVID-19. GAO was asked to examine HHS's COVID-19 repatriation efforts to ensure the health and safety of those involved in the response. This report examines HHS's coordination and management of its COVID-19 repatriation response. GAO reviewed relevant documentation from HHS, State, and DOD related to repatriation planning, including documentation on pandemic planning exercises. GAO also interviewed officials from HHS, State, and DOD.
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  • Overseas Real Property: Prioritizing Key Assets and Developing a Plan Could Help State Manage Its Estimated $3 Billion Maintenance Backlog
    In U.S GAO News
    What GAO Found The Department of State's portfolio of overseas assets and expenditures to operate them have grown, but State-allocated funding for maintenance has stayed nearly the same. For fiscal years 2015 through 2019, both the number and square footage of State's assets increased 11 percent and operations expenditures grew 24 percent. However, maintenance and repair funding has remained nearly unchanged. For example, State's allocation for Maintenance Cost Sharing—for projects collectively funded by State and tenant agencies overseas—was $399 million in fiscal year 2016 and $400 million in 2020. GAO found that more than one-quarter of State's overseas assets are in poor condition according to State's condition standard. Further, 20 percent (almost 400) of assets that State identifies as critical to its mission are in poor condition. Federal accounting standards recognize that what constitutes acceptable asset condition may vary by the importance of specific assets to agencies' missions. However, State set a single acceptable condition standard of “fair” for all assets and did not consider whether some assets, like chancery office buildings, were more critical to State's mission when estimating its $3 billion deferred maintenance backlog. Had State set a higher condition standard for critical assets, its backlog would be higher. By reassessing its condition standard, State could determine whether to adopt an approach that considers asset importance and that could help guide maintenance funding to key assets. Condition of U.S. Embassy Manila, Philippines – Left: Chancery Office Building; Right: Chancery Courtyard Showing Maintenance Issues, Including Mold and Water Damage State follows most, but not all, leading practices for managing deferred maintenance backlogs. Of the nine leading practices, GAO found that State followed five, partially followed three, and did not follow one. For example, State has goals, baselines, and measures for its facility management performance. However, State did not specifically request funding to address the backlog in its congressional budget requests. Officials said they had not found it necessary to specifically request such funding because they only determined that the backlog had substantially increased from $96 million in fiscal year 2019 to $3 billion in fiscal year 2020 after using a new methodology for estimating deferred maintenance and repair. In addition, State does not have a plan to address the backlog, but officials estimated it could take 30 to 40 years to eliminate the backlog with current funding levels. Developing such a plan with specific information on the funding and time frames needed to reduce the backlog would help decision makers better understand how funding levels affect backlog reduction. Why GAO Did This Study State's Bureau of Overseas Buildings Operations operates and maintains over 8,500 owned and leased real property assets, including both buildings and structures. According to State, at least 60 percent of a building's total lifecycle cost stems from operations and maintenance costs. GAO has reported that deferring maintenance and repairs can lead to higher costs in the long term and pose risks to agencies' missions. GAO was asked to review State's efforts to manage its operations and maintenance needs. This report examines (1) how operations and maintenance funding for overseas assets changed from fiscal years 2016 through 2020, (2) the condition and maintenance needs of State's overseas assets, and (3) the extent to which State has followed leading practices to address its deferred maintenance backlog. GAO analyzed State data on operations and maintenance funding and asset condition, as well as documentation related to leading facility management practices. GAO also met with State officials in headquarters and in seven embassies.
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