January 23, 2022

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Department Renews Charter of Overseas Schools Advisory Council

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Office of the Spokesperson

On March 26, 2021, the Department of State renewed the charter of the Overseas Schools Advisory Council (OSAC) to provide a formal channel for consultation and advice from U.S. corporations and foundations regarding American-sponsored overseas schools. The Under Secretary for Management has determined that renewal of the advisory committee charter is necessary and in the public interest.

The Assistant Secretary for Administration will appoint the members of the committee. The committee will follow the procedures prescribed by the Federal Advisory Committee Act (FACA). Meetings will be open to the public unless a determination is made in accordance with the FACA Section 10(d) and 5 U.S.C. 552b(c) that a meeting or a portion of the meeting should be closed to the public. Notice of each meeting will be provided in the Federal Register at least 30 days prior to the meeting date.

For further information, contact Mr. Thomas Shearer, Executive Secretary of the Committee at (202) 261-8200 or OverseasSchools@state.gov.

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  • COVID-19: Continued Attention Needed to Enhance Federal Preparedness, Response, Service Delivery, and Program Integrity
    In U.S GAO News
    What GAO Found The nation is concurrently responding to, and recovering from, the COVID-19 pandemic, as the number of cases, hospitalizations, and deaths have declined in recent months. Among the factors that have contributed to the decline in these metrics, the development and administration of multiple vaccines across the nation have been key. About 53.1 percent of the U.S. population 12 years and older—almost 150.7 million individuals—had been fully vaccinated as of June 23, 2021, according to the Centers for Disease Control and Prevention (CDC). Continuing to deliver “shots in arms” will be a priority for the federal government, as individuals yet to be vaccinated remain at risk from COVID-19 and as new variants of the virus continue to emerge. A successful vaccination program is seen as essential to further stabilizing the economy and safely returning to prepandemic activities, such as in-person learning for students in the 2021–22 school year. The economic and public health recovery from the pandemic and its effects remains fragile. Data from the Department of Labor show that labor market conditions improved in March, April, May, and June 2021 but remained worse relative to the prepandemic period. Additionally, new reported COVID-19 cases from June 5 to June 18, 2021, averaged about 13,000 per day—less than a tenth of the peak reported in January 2021 (see figure). Reported COVID-19 Cases per Day in the U.S., Mar. 1, 2020–June 18, 2021 Since GAO began reporting on the federal response to the pandemic in June 2020, it has made 72 recommendations. The agencies generally agreed with 57 of these recommendations and are in the process of implementing a majority of them; 16 of these recommendations have been fully implemented. GAO also made four matters for congressional consideration, three of which remain open. In this report, GAO is making 15 new recommendations in the areas of federal preparedness and response, delivery of benefits and services, and program integrity. GAO’s recommendations, if effectively implemented, can help improve the government’s ongoing response and recovery efforts as well as help it to prepare for future public health emergencies. GAO’s new recommendations are discussed below. COVID-19 Testing CDC has opportunities to improve collaboration and communication with stakeholders. Prior to the COVID-19 response, CDC had not developed a plan for enhancing laboratory testing capacity that identifies objectives and outlines agency and stakeholder roles and responsibilities for achieving these objectives within defined time frames. Doing so would be consistent with the stated goal of its own memorandum of understanding with public health and private laboratory partners and would also be consistent with other leading principles on sound planning that GAO has identified in its prior work. GAO recommends that CDC work with appropriate stakeholders to develop a plan to enhance surge capacity for laboratory testing. CDC agreed with this recommendation. CDC initially developed a flawed COVID-19 diagnostic test, which caused challenges for the rollout of testing nationwide. CDC has taken steps to improve its process for developing tests, but additional actions could help strengthen CDC’s preparedness and enhance the nation’s testing capacity during a future infectious disease outbreak. For example, establishing contracts with test kit manufacturers prior to a public health emergency could allow CDC to supplement the supply produced by CDC and aid in the rapid manufacturing and deployment of test kits during a future public health emergency. GAO recommends that CDC assess the agency’s needs for goods and services for the manufacturing and deployment of diagnostic test kits in public health emergencies, including the potential role of establishing contracts in advance of an emergency. CDC agreed with this recommendation. Strategic National Stockpile The Strategic National Stockpile (SNS) contains a multibillion dollar inventory of medical countermeasures—drugs, vaccines, supplies, and other materials—to respond to a broad range of public health emergencies. The SNS can be used as a short-term stopgap buffer when the supply of materials may not be immediately available in affected areas during a public health emergency. The Department of Health and Humans Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) oversees the SNS. The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), an interagency group of experts, advises the Secretary of Health and Human Services in prioritizing, developing, procuring, deploying, and effectively using medical supplies and other countermeasures for the SNS. In the years before the COVID-19 pandemic, ASPR began restructuring the PHEMCE. This led to concerns from interagency partners regarding the effectiveness of interagency collaboration and transparency, such as a lack of clarity on how ASPR makes decisions about medical countermeasure issues, including for the SNS inventory. In addition, while the PHEMCE was being restructured, ASPR did not conduct SNS annual reviews from 2017 through 2019; these reviews result in recommendations to HHS regarding SNS procurement and are provided to Congress. According to the former Assistant Secretary who initiated the restructure, although PHEMCE was successful in advancing the development of medical countermeasures, its consensus-driven process did not reflect the urgency needed and PHEMCE proceedings created security vulnerabilities. ASPR officials acknowledged that the changes ASPR made to the PHEMCE from 2018 to 2020 did not fully achieve the desired aims and created other challenges. The office is in the process of reassessing and reestablishing new organizational processes for the PHEMCE, but it has not yet finalized planning documents, including an organizational charter and implementation plan, to guide those efforts. GAO recommends that ASPR develop and document its plans for restructuring the PHEMCE. The plans should describe how ASPR will ensure a transparent and deliberative process that engages interagency partners in PHEMCE responsibilities outlined in the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, including those related to SNS annual reviews. These plans should also incorporate GAO’s leading practices to foster more effective collaboration, while ensuring that sensitive information is appropriately protected. HHS—which includes ASPR—agreed with this recommendation. PHEMCE interagency partners raised concerns about the transparency of PHEMCE activities and deliberations, and ASPR lacked documentation of PHEMCE activities and deliberations after 2017. ASPR was unable to provide documentation to GAO regarding PHEMCE decisions or recommendations made from 2018 to 2020; the rationale for the changes to the PHEMCE; or PHEMCE meeting agendas and minutes from 2018 to 2020. Not maintaining such documentation is inconsistent with HHS’s policy for records management and leaves Congress and key stakeholders without assurance that steps taken are advancing national preparedness for natural, accidental, and intentional threats. GAO recommends that ASPR implement records management practices that include developing, maintaining, and securing documentation related to PHEMCE activities and deliberations, including those related to the SNS. HHS, including ASPR, agreed with this recommendation. The nationwide need for supplies to respond to COVID-19 quickly exceeded the quantity of supplies contained in the SNS. Thus, ASPR used procurement processes in addition to its standard process, including direct shipment of supplies from vendors. Through this direct shipment process, supplies purchased by ASPR were not used to replenish the SNS but instead were primarily distributed from vendors directly to state, local, territorial, and tribal governments. Although ASPR has documented policies and procedures for its standard procurement process, ASPR did not have documented policies and procedures, including related control and monitoring activities, to address payment integrity risks for its direct shipment procurement process. Without written policies and procedures documenting how ASPR tracks the direct shipment and receipt of supplies before issuing payments, there is an increased risk that ASPR may make improper payments to vendors for incorrect supplies or quantities or for supplies that the intended recipients did not receive. In addition, it is difficult for management to assess the adequacy of controls over the direct shipment procurement process, and ASPR lacks assurance that its staff fully understand the process and properly and consistently perform their duties. GAO recommends that, to strengthen the current procedures for the SNS, HHS update its policies and procedures for the SNS, including related control and monitoring activities, to document the direct shipment procurement process and address payment integrity risks. Although HHS, including ASPR, did not agree with GAO regarding the need to address payment integrity risks, it stated that HHS will update its policies and procedures, including related control and monitoring activities to document the direct shipment procurement process. Domestic Medical Supply Manufacturing Before the pandemic, the U.S. generally depended on foreign suppliers for certain types of personal protective equipment (PPE), including nitrile gloves and surgical gowns. Multiple stakeholders representing manufacturers, distributors, and other purchasers noted that meaningful, transparent federal engagement with industry could enhance the resilience of domestic manufacturing and the supply chain. According to some stakeholders, such engagement with the private sector could help ramp up private investment in domestic PPE manufacturing, among other things. In January 2021, GAO reported that HHS had not developed a process for engaging with key nonfederal stakeholders and Congress for development of a supply chain strategy for pandemic preparedness, including the role of the SNS. GAO recommended that HHS do so, and the department generally agreed with GAO’s recommendation. However, as of May 2021, HHS had not implemented this recommendation. GAO continues to underscore that engaging with key nonfederal stakeholders—in meaningful, proactive ways to obtain their business and industry expertise—and with Congress is critical for developing strategies to build a sustainable domestic medical supply manufacturing base. HHS COVID-19 Funding As of May 31, 2021, Congress had appropriated to HHS approximately $484 billion in COVID-19 funds in six relief laws. The majority of HHS’s appropriations from the first five relief laws had been obligated and about half had been expended. Specifically, as of May 31, 2021, the department reported the following (see figure): Of the $324 billion appropriated in the first five COVID-19 relief laws, about $253 billion had been obligated (about 78 percent) and about $168 billion had been expended (about 52 percent). Of the $160 billion appropriated in the sixth law, the American Rescue Plan Act of 2021 (ARPA), about $75 billion had been obligated (about 47 percent) and about $3 billion had been expended (about 2 percent). HHS’s Reported COVID-19 Relief Appropriations, Obligations, and Expenditures from COVID-19 Relief Laws, as of May 31, 2021 The percentage of obligations and expenditures varied across selected COVID-19 response activities for a variety of reasons, including the nature of the activities, their planned uses, and the timing of the funds provided through the six COVID-19 relief laws. HHS uses spend plans to communicate information about its COVID-19 spending. The first five COVID-19 relief laws generally require the department to develop, update, and provide these spend plans to Congress every 60 days. The sixth relief law, ARPA, does not require a spend plan, but according to HHS officials, the department is preparing a consolidated plan that captures the first five relief laws and a separate spend plan for funding provided through ARPA. The consolidated spend plan is under internal review at HHS and the ARPA spend plan is still being finalized. As of May 2021, GAO had received and reviewed a total of 15 spend plans—the original spend plans and subsequent updates—provided by HHS. GAO found that the most current spend plans generally do not include time frames for obligating the remaining funds, which is useful information for oversight and informing future funding decisions by Congress. Guidance from the Office of Management and Budget to federal agencies, including HHS, noted the importance of spending transparency and regular reporting to help safeguard taxpayer dollars. GAO recommends that HHS communicate information about, and facilitate oversight of, the department’s use of COVID-19 relief funds by providing projected time frames for its planned spending in the spend plans it submits to Congress. HHS partially concurred with the recommendation and stated that the department would aim to incorporate some time frames on planned spending where that information may be available such as time frames for select grants to states. Higher Education Grants The Department of Education (Education) has faced inherent challenges that increase the risk of improper payments for its Higher Education Emergency Relief Fund (HEERF) grants to institutions of higher education to prevent, prepare for, and respond to COVID-19. For example, funding needed to be processed and distributed expeditiously because of health and economic threats to institutions of higher education posed by the COVID-19 pandemic. GAO tested Education’s procedures for approving and processing HEERF grants through a sample of obligations and found that the department had not effectively designed and implemented procedures needed to identify erroneous obligations after awarding the grants. GAO estimated that for 5.5 percent of schools receiving HEERF grants (about 262 of 4,764 schools in GAO’s sample), Education awarded grants that exceeded the amounts allocated—including three instances in GAO’s sample for which Education obligated $20 million more than was allocated. Officials from Education’s Office of Postsecondary Education stated that because of time and staffing constraints and the high volume of grants administered, they did not regularly perform quality assurance reviews after obligation to identify and correct erroneous obligations. GAO recommends Education design and implement procedures for regularly conducting quality assurance reviews of obligated amounts for higher education grants, including HEERF, to help identify and correct erroneous obligations in a timely manner. Education agreed with this recommendation. Coronavirus State and Local Relief and Recovery Funds COVID-19 relief laws appropriated $500 billion to the Department of the Treasury (Treasury) to provide direct funding to states, localities, tribal governments, the District of Columbia, and U.S. territories to help them respond to, and recover from, the COVID-19 pandemic. This amount includes $150 billion that the CARES Act appropriated to Treasury for the Coronavirus Relief Fund (CRF) in March 2020 as well as $350 billion that ARPA appropriated to Treasury for the Coronavirus State and Local Fiscal Recovery Funds (CSLFRF) in March 2021. Recipients can use CRF payments to offset costs related to either the pandemic’s direct effects (e.g., public health needs) or its indirect effects (e.g., harm to individuals or businesses as a result of COVID-19-related closures). The CSLFRF provides payments to these recipients to cover a broader range of costs stemming from the fiscal effects of the COVID-19 pandemic. The Single Audit Act establishes requirements for states, localities, Indian tribes, the District of Columbia, U.S. territories, and nonprofit organizations that receive federal awards to undergo single audits of those awards annually when their expenditures meet a certain dollar threshold. Single audits are critical to the federal government’s ability to help safeguard the use of the billions of dollars distributed through the CRF and CSLFRF. Auditors who conduct single audits follow guidance in the Single Audit Act’s Compliance Supplement, which provides guidelines and policy for performing single audits. After consultation with federal agencies, OMB annually updates and issues the supplement. Auditors have reported that the timing of the supplement is critical in allowing them to effectively plan their work. The timely issuance of single audit guidance is critical to ensuring timely completion and reporting of single audits to inform the federal government about actions needed to help safeguard the use of the billions of dollars distributed through the CRF and CSLFRF. GAO recommends that OMB, in consultation with Treasury, issue timely and sufficient single audit guidance for auditing recipients’ uses of payments from the CSLFRF. OMB neither agreed nor disagreed with this recommendation. Economic Impact Payments The CARES Act, the Consolidated Appropriations Act, 2021, and ARPA authorized Treasury and the Internal Revenue Service (IRS) to issue three rounds of economic impact payments (EIP) as direct payments to help individuals alleviate financial stress due to the pandemic. (See figure.) To publicize information about how to file a tax return with the IRS to receive an EIP, IRS partners with organizations that work with communities that may not traditionally interact with IRS, such as lower-income families, senior citizens, veterans, tribal communities, and families with mixed-immigration status. According to officials from IRS partner organizations, ensuring eligible nonfilers receive their payments continues to be a challenge. Partners also told GAO their outreach efforts to nonfilers could be more effective if the partners had current data that could help identify specific communities of nonfilers who may need assistance. Total Number and Amount of Economic Impact Payments (EIP) Disbursed, Rounds 1, 2, and 3, as of May 28, 2021 In January 2021, Treasury began analyzing nearly 9 million notices it had sent to nonfilers who may be eligible for the first round of EIP payments. However, Treasury does not plan to complete this analysis until fall 2021, more than 6 months after the third round of EIP payments began to be issued. This timing would limit the findings’ usefulness for informing EIP outreach efforts. By waiting to complete the analysis, Treasury and IRS are missing an opportunity to identify communities that may have a higher number of nonfilers and to use that information to inform their outreach efforts as well as the efforts of their outreach partners.GAO recommends that Treasury, in coordination with IRS, release interim findings on the effectiveness of the notices it sent in September 2020 to potentially EIP-eligiblenonfilers; incorporate that analysis into IRS outreach efforts as appropriate; and then, if necessary, release an update based on new analysis after the 2021 filing season. Treasury neither agreed nor disagreed with this recommendation. Tax Relief for Businesses To provide liquidity to businesses during the COVID-19 pandemic, the CARES Act and other COVID-19 relief laws included tax measures to reduce certain tax obligations, including measures related to net operating loss carryback claims. In some cases, these reductions of obligations led to cash refunds. The Internal Revenue Code and the CARES Act generally require IRS to issue certain refunds within 90 days from the date when a complete application for a tentative carryback adjustment is filed or 90 days from the last day of the month in which the return is due, whichever is later. IRS data show that the agency is not meeting the statutory refund requirement for these relief measures and that as of May 1, 2021, the average processing time for refunds was 154 days, excluding additional time for final processing and distribution. IRS officials said it is taking longer to process returns because IRS facilities that process paper returns continue to operate at reduced capacity to accommodate social distancing. In the meantime, transparent communication about these issues could help taxpayers know when to expect their refunds. Specifically, an explanation on IRS’s website that processing times for tentative refunds may exceed the expected 90 days because of service disruptions would provide taxpayers with more accurate information and expectations for receiving a refund. GAO recommends that IRS clearly communicate on its website that there are delays beyond the statutory 90-day timeline in processing tentative refunds. IRS neither agreed nor disagreed with this recommendation. 2021 Tax Filing Season IRS is experiencing delays in processing certain returns received in 2021, resulting in extended time frames for processing returns for some taxpayers. IRS reported that it is taking longer than usual to manually review some of these returns. Specifically, as of the end of the 2021 filing season, IRS had about 25.5 million unprocessed individual and business returns, including about 1.2 million returns from its 2020 backlog, and 13.7 million returns that it had suspended because of errors. IRS staff must manually review these returns with errors. IRS typically has unprocessed returns in its inventory at the end of the filing season, but not to this extent. For example, at the end of the 2019 filing season, IRS had 8.3 million unprocessed individual and business returns, including 2.7 million returns suspended for errors. IRS’s annual tax filing activities include processing more than 150 million individual and business tax returns electronically or on paper. With significantly more returns currently being held for manual review than in prior years, more taxpayers are trying to get information about the status of their returns and refunds. However, taxpayers have had difficulty obtaining status updates on their refunds from IRS, either by phone or online. IRS’s website does not contain all of the relevant information regarding delays in processing 2021 returns and issuing taxpayers’ refunds. Additionally, IRS’s automated message on its toll-free telephone line for individual taxpayers has not been updated to explain refund delays or to include any other alerts associated with the 2021 filing season.GAO recommends that IRS update relevant pages of its website and, if feasible, add alerts to its toll-free telephone lines to more clearly and prominently explain the nature and extent of individual refund delays occurring for returns that taxpayers filed in 2021. IRS neither agreed nor disagreed with this recommendation. This report contains additional recommendations related to disseminating information related to leave benefits for employees. Why GAO Did This Study As of mid-June 2021, the U.S. had about 33.4 million reported cases of COVID-19 and about 593,000 reported deaths, according to CDC. The country also continues to experience serious economic repercussions from the pandemic. Six relief laws, including the CARES Act, had been enacted as of May 31, 2021, to address the public health and economic threats posed by COVID-19. As of May 31, 2021, of the $4.7 trillion appropriated by these six laws for COVID-19 relief—including about $1.6 trillion appropriated by ARPA, which was enacted in March 2021—the federal government had obligated a total of $3.5 trillion and had expended $3.0 trillion, as reported by federal agencies. The CARES Act includes a provision for GAO to report on its ongoing monitoring and oversight efforts related to the COVID-19 pandemic. This report examines the federal government’s continued efforts to respond to, and recover from, the COVID-19 pandemic. GAO reviewed data, documents, and guidance from federal agencies about their activities. 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    U.S. agencies primarily use Leahy vetting as the enforcement mechanism to prevent U.S. funding for combating wildlife trafficking from supporting human rights abuses. Statutory provisions commonly referred to as "Leahy Laws" prohibit the U.S. government from using certain funds to assist units of foreign security forces where there is credible information they have committed a gross violation of human rights. The Department of State (State) and the U.S. Agency for International Development (USAID) generally consider park rangers to be foreign security forces that are authorized to search, detain, arrest, or use force against people, and thus subject to Leahy vetting, according to agency officials. State or USAID may provide funding to the Department of the Interior's Fish and Wildlife Service (FWS) that it then uses to support park ranger activities. In those instances, FWS submits the candidates' applications to State for Leahy vetting. According to a State official, Leahy approval of a security force unit is good for 1 year, and State must vet individuals again if their unit continues to receive support from State or USAID funding sources. Both U.S. agencies and implementing partners took a variety of steps in response to recent allegations of human rights abuses by overseas park rangers. For example, a State official in the Central Africa region told GAO that while the Democratic Republic of the Congo embassy's vetting program has very strict control mechanisms, the International Narcotics and Law Enforcement Affairs Bureau requested quarterly reports to facilitate a review of all assistance to park rangers to ensure that any reported activities were vetted according to Leahy Laws. USAID officials told GAO that in addition to continuing Leahy vetting, the agency's response included strengthening human rights training and conducting a site visit to a park in the DRC where human rights abuses had allegedly occurred. According to officials, the visit involved speaking with beneficiaries to further understand the allegations and efforts to assess root causes, mitigate impacts, and stop future occurrences, including making referrals to appropriate law enforcement authorities if warranted. FWS officials also stated that they take seriously allegations that U.S implementing partners have supported park rangers who have committed human rights abuses. Since June 2019, the Department of the Interior has approved no new awards to the World Wildlife Fund (WWF)—one of the implementing partners which has supported park rangers alleged to have committed human rights abuses. Moreover, the International Affairs program within FWS has put all new funding on hold since September 2019, pending a departmental review. Agencies are also implementing various changes in response to congressional directives on safeguarding human rights. For example, State officials told GAO that they have added language to all notices for countering wildlife trafficking awards that requires implementing partners to include social safeguards plans in their projects. The plans will articulate an understanding of how their work could negatively affect local communities. USAID officials stated that USAID has included provisions in new agreements with FWS that require adherence to the congressional directives. FWS officials also confirmed that they are cooperating with USAID in these efforts. Implementing partners—WWF, the Wildlife Conservation Society (WCS), and African Parks (AP)—have all conducted investigations to address allegations of human rights abuses by park rangers, according to officials from these organizations. They have also developed grievance mechanisms to report human rights abuses. For example, WWF has received 50 complaints in roughly the past year related to its project work, according to WWF representatives. WWF has responded to complaints of human rights abuses through this mechanism by reporting the allegations to relevant authorities and meeting with community representatives. U.S. agencies provide training and equipment for park rangers overseas to combat wildlife trafficking. From fiscal years 2014 through 2020, the U.S. government provided approximately $554 million to undertake a range of activities through federal agencies and in cooperation with implementing partner organizations in the field. Multiple non-governmental organization and media reports, however, have alleged that organizations that have received U.S. funds have supported park rangers engaged in combating wildfire trafficking who have committed human rights violations since the mid-2000s. GAO was asked to review human rights protection mechanisms related to U.S. efforts to combat wildlife trafficking. This report examines 1) what enforcement mechanisms agencies have to prevent U.S. funded efforts to combat wildlife trafficking from supporting human rights abuses and how they implement them, and 2) how agencies and implementing partners address allegations of human rights abuses. GAO spoke with agency officials and implementing partner representatives locally in person and overseas by phone, and collected and analyzed information related to program implementation. For more information, contact Kimberly Gianopoulos at (202) 512-8612 or gianopoulosk@gao.gov.
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Vaccine Platform Technologies Supported by Operation Warp Speed, as of January 2021 As of January 30, 2021, five of the six OWS vaccine candidates have entered phase 3 clinical trials, two of which—Moderna's and Pfizer/BioNTech's vaccines—have received an emergency use authorization (EUA) from the Food and Drug Administration (FDA). For vaccines that received EUA, additional data on vaccine effectiveness will be generated from further follow-up of participants in clinical trials already underway before the EUA was issued. Technology readiness. GAO's analysis of the OWS vaccine candidates' technology readiness levels (TRL)—an indicator of technology maturity— showed that COVID-19 vaccine development under OWS generally followed traditional practices, with some adaptations. FDA issued specific guidance that identified ways that vaccine development may be accelerated during the pandemic. Vaccine companies told GAO that the primary difference from a non-pandemic environment was the compressed timelines. To meet OWS timelines, some vaccine companies relied on data from other vaccines using the same platforms, where available, or conducted certain animal studies at the same time as clinical trials. However, as is done in a non-pandemic environment, all vaccine companies gathered initial safety and antibody response data with a small number of participants before proceeding into large-scale human studies (e.g., phase 3 clinical trials). The two EUAs issued in December 2020 were based on analyses of clinical trial participants and showed about 95 percent efficacy for each vaccine. These analyses included assessments of efficacy after individuals were given two doses of vaccine and after they were monitored for about 2 months for adverse events. Manufacturing. As of January 2021, five of the six OWS vaccine companies had started commercial scale manufacturing. OWS officials reported that as of January 31, 2021, companies had released 63.7 million doses—about 32 percent of the 200 million doses that, according to OWS, companies with EUAs have been contracted to provide by March 31, 2021. Vaccine companies face a number of challenges in scaling up manufacturing to produce hundreds of millions of doses under OWS's accelerated timelines. DOD and HHS are working with vaccine companies to help mitigate manufacturing challenges, including: Limited manufacturing capacity: A shortage of facilities with capacity to handle the vaccine manufacturing needs can lead to production bottlenecks. Vaccine companies are working in partnership with OWS to expand production capacity. For example, one vaccine company told GAO that HHS's Biomedical Advanced Research and Development Authority helped them identify an additional manufacturing partner to increase production. Additionally, the U.S. Army Corps of Engineers is overseeing construction projects to expand capacity at vaccine manufacturing facilities. Disruptions to manufacturing supply chains: Vaccine manufacturing supply chains have been strained by the global demand for certain goods and workforce disruptions caused by the global pandemic. For example, representatives from one facility manufacturing COVID-19 vaccines stated that they experienced challenges obtaining materials, including reagents and certain chemicals. They also said that due to global demand, they waited 4 to 12 weeks for items that before the pandemic were typically available for shipment within one week. Vaccine companies and DOD and HHS officials told GAO they have undertaken several efforts to address possible manufacturing disruptions and mitigate supply chain challenges. These efforts include federal assistance to (1) expedite procurement and delivery of critical manufacturing equipment, (2) develop a list of critical supplies that are common across the six OWS vaccine candidates, and (3) expedite the delivery of necessary equipment and goods coming into the United States. Additionally, DOD and HHS officials said that as of December 2020 they had placed prioritized ratings on 18 supply contracts for vaccine companies under the Defense Production Act, which allows federal agencies with delegated authority to require contractors to prioritize those contracts for supplies needed for vaccine production. Gaps in the available workforce: Hiring and training personnel with the specialized skills needed to run vaccine manufacturing processes can be challenging. OWS officials stated that they have worked with the Department of State to expedite visa approval for key technical personnel, including technicians and engineers to assist with installing, testing, and certifying critical equipment manufactured overseas. OWS officials also stated that they requested that 16 DOD personnel be detailed to serve as quality control staff at two vaccine manufacturing sites until the organizations can hire the required personnel. As of February 5, 2021, the U.S. had over 26 million cumulative reported cases of COVID-19 and about 449,020 reported deaths, according to the Centers for Disease Control and Prevention. The country also continues to experience serious economic repercussions, with the unemployment rate and number of unemployed in January 2021 at nearly twice their pre-pandemic levels in February 2020. In May 2020, OWS was launched and included a goal of producing 300 million doses of safe and effective COVID-19 vaccines with initial doses available by January 2021. Although FDA has authorized two vaccines for emergency use, OWS has not yet met its production goal. Such vaccines are crucial to mitigate the public health and economic impacts of the pandemic. GAO was asked to review OWS vaccine development efforts. This report examines: (1) the characteristics and status of the OWS vaccines, (2) how developmental processes have been adapted to meet OWS timelines, and (3) the challenges that companies have faced with scaling up manufacturing and the steps they are taking to address those challenges. GAO administered a questionnaire based on HHS's medical countermeasures TRL criteria to the six OWS vaccine companies to evaluate the COVID-19 vaccine development processes. GAO also collected and reviewed supporting documentation on vaccine development and conducted interviews with representatives from each of the companies on vaccine development and manufacturing. For more information, contact Karen L. Howard and Candice N. Wright at (202) 512-6888 or howardk@gao.gov or wrightc@gao.gov.
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  • Afghanistan: Key Oversight Issues for USAID Development Efforts
    In U.S GAO News
    What GAO Found In 2010, the United States pledged to provide at least 50 percent of its development aid directly through the Afghan government budget within 2 years. This direct assistance is intended to help develop the capacity of Afghan government ministries to manage programs and funds. Using bilateral agreements and multilateral trust funds, the United States more than tripled its direct assistance awards to Afghanistan in the first year of the pledge, going from over $470 million in fiscal year 2009 to over $1.4 billion in fiscal year 2010. The U.S. Agency for International Development's (USAID) most current reporting shows that for fiscal year 2012 the agency provided over $800 million in mission funds through direct assistance. In 2013, GAO reported that while USAID had established and generally complied with various financial and other controls in its direct assistance agreements, it had not always assessed the risks in providing direct assistance before awarding funds. USAID has taken steps in response to GAO's recommendations to help ensure the accountability of direct assistance funds provided to the Afghan government. Recently, the Special Inspector General for Afghanistan Reconstruction (SIGAR) reported that USAID determined that seven ministries were unable to manage direct assistance funds without a risk mitigation strategy in place. However, SIGAR reported that USAID approved assistance for the ministries, but did not mitigate for all identified risks. GAO has previously reported on systemic weaknesses in USAID's monitoring and evaluation of programs carried out by its implementing partners in Afghanistan. For example, although USAID collected progress reports from implementing partners for agriculture and water projects, it did not always analyze and interpret data to, among other things, inform future decisions. USAID has undertaken some efforts to improve its monitoring and evaluation of the billions of dollars invested towards development projects in Afghanistan. GAO and other oversight agencies, however, have highlighted gaps that show USAID continued to inconsistently apply performance management procedures, falls short in maintaining institutional knowledge, and needs to improve oversight of contractors. USAID's ability to conduct its mission and the challenges it has faced in providing oversight and monitoring of its development projects in Afghanistan are likely to be exacerbated by the planned withdrawal of U.S. and coalition combat troops from Afghanistan at the end of 2014. The United States is currently transitioning from counterinsurgency and stability operations toward more traditional diplomatic and development activities. As U.S. combat troops withdraw from Afghanistan, provincial reconstruction teams will continue to decline in number, thus challenging USAID's opportunities to directly monitor and evaluate programs in certain parts of Afghanistan. To prepare for the possible lack of USAID personnel in the field, USAID has undertaken various planning efforts to mitigate against potential challenges. For example, USAID is planning to implement a remote monitoring program that will use contractors to verify activities that implementing partners have completed. As the United States plans for the withdrawal of its combat troops and the transition from an integrated civilian and military effort to a civilian-led presence, GAO believes it is important to have safeguards in place to help ensure sustainment of the gains made by U.S. and coalition investments. Why GAO Did This Study The U.S. government has been engaged in efforts in Afghanistan since declaring a global war on terrorism that targeted al Qaeda, its affiliates, and other violent extremists. The U.S. effort has involved a whole of government approach to disrupt, dismantle, and defeat al Qaeda and its affiliates and strengthen Afghanistan so that it can never again be a haven for terrorists. This approach includes USAID's development assistance and reconstruction efforts, which to date have invested over $15 billion in Afghanistan since 2002. To assist Congress in its oversight, GAO has issued over 50 products in the past 5 years focusing on U.S. efforts in Afghanistan. This testimony summarizes the findings from those products related to USAID efforts in Afghanistan and discusses: (1) levels of U.S. direct assistance and need for continued oversight, (2) the importance of routine monitoring and evaluation of USAID projects in Afghanistan, and (3) the need for mitigation planning for how USAID will continue to operate in Afghanistan after the withdrawal of U.S. combat troops.
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  • Justice Department Settles Retaliation Claim Against Florida Electrician Company
    In Crime News
    The Justice Department today announced that it reached a settlement agreement with Service Minds Inc., dba Mister Sparky (Service Minds), a company that provides contract electrical services to residential customers in Florida and Alabama. The settlement resolves a claim that the company retaliated against a work-authorized job applicant, in violation of the anti-discrimination provision of the Immigration and Nationality Act (INA), when he and his wife challenged a U.S. citizens-only hiring rule that a recruiter had wrongly claimed was the company’s policy.
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  • Puerto Rico Electricity: FEMA and HUD Have Not Approved Long-Term Projects and Need to Implement Recommendations to Address Uncertainties and Enhance Resilience
    In U.S GAO News
    As of October 2020, 3 years since the hurricanes destroyed much of Puerto Rico's electricity grid, neither the Federal Emergency Management Agency (FEMA) nor the Department of Housing and Urban Development (HUD) had approved long-term grid recovery projects in Puerto Rico. In 2019, GAO made four recommendations to FEMA and HUD to address identified challenges in rebuilding the electricity grid in Puerto Rico. As of October 2020, FEMA had fully implemented one recommendation and partially implemented two others, while HUD had not implemented its recommendation. Specifically, FEMA established an interagency agreement with the Department of Energy (DOE) to clarify how the agencies would consult on recovery efforts. FEMA had taken actions to partially implement recommendations on improving coordination among federal and local agencies and providing information on industry standards. However, further steps are needed, including finalizing guidance on FEMA's process for approving funding for projects. Regarding HUD, it has not addressed GAO's recommendation to establish time frames and requirements for available funding. Damaged Power Lines in Puerto Rico in November 2017 after Hurricane Maria Until HUD and FEMA implement GAO's recommendations, uncertainty will linger about how and when federal funding for long-term grid recovery will proceed. In particular, it is uncertain how available funding sources will support measures to enhance grid resilience to hurricanes, such as smart grid technology. FEMA officials told GAO that additional funding sources could be used for resilience measures but that this would not be determined until specific projects are submitted to FEMA for approval. Moreover, although FEMA finalized a $10 billion cost estimate for grid repairs in September 2020, several steps remain before FEMA approves funding for projects—a process officials said they were drafting. HUD funding could supplement FEMA funding but, as discussed above, HUD has yet to establish conditions for using these funds and has not established time frames and a plan for issuing this information. According to HUD officials, they plan to publish requirements in the first quarter of fiscal year 2021, but this depends on other factors, such as input from other federal agencies. Further delays in publishing the conditions could contribute to delays in Puerto Rico's ability to initiate grid recovery projects. In 2017, Hurricanes Irma and Maria damaged Puerto Rico's electricity grid, causing the longest blackout in U.S. history. It took roughly 11 months after the hurricanes for power to be restored to all of the customers with structures deemed safe for power restoration. Since electricity service has been restored, local entities have undertaken the longer-term task of more fully repairing and rebuilding the grid. GAO reported in 2019 on challenges hindering progress in rebuilding the grid and recommended that FEMA and HUD take actions to address these challenges. This report examines the status of efforts to support long-term grid recovery in Puerto Rico, including actions taken by FEMA and HUD to implement GAO's 2019 recommendations. For this report, GAO assessed agency actions; reviewed relevant reports, regulations, policies, and documents; and interviewed federal and local officials. GAO previously made three recommendations to FEMA and one to HUD to provide needed information and improve coordination to support grid recovery. Both agencies disagreed with GAO's characterization of their progress made addressing these prior recommendations. GAO continues to believe additional actions are needed to fully implement these recommendations. For more information, contact Frank Rusco at (202) 512-3841 or ruscof@gao.gov.
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  • Canadian National Pleads Guilty to Human Smuggling Conspiracy
    In Crime News
    A Canadian national pleaded guilty today to conspiracy to bring aliens to the United States for private financial gain in connection with his role in a scheme to smuggle aliens from Sri Lanka through the Caribbean and into the United States.
    [Read More…]

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