Justice Department Settles with North Carolina School District to Provide Equal Opportunities to English Learner Students

The Justice Department announced today a settlement agreement with the Rowan-Salisbury Board of Education to resolve the department’s investigation into the Rowan-Salisbury School System’s (District) programs for its English learner students. The department’s investigation found system-wide failures to provide these students with the instruction and support they need to learn English and fully participate in school. The department conducted its investigation under the Equal Educational Opportunities Act of 1974.

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    Operation Warp Speed (OWS)—a partnership between the Departments of Health and Human Services (HHS) and Defense (DOD)—aimed to help accelerate the development of a COVID-19 vaccine. GAO found that OWS and vaccine companies adopted several strategies to accelerate vaccine development and mitigate risk. For example, OWS selected vaccine candidates that use different mechanisms to stimulate an immune response (i.e., platform technologies; see figure). Vaccine companies also took steps, such as starting large-scale manufacturing during clinical trials and combining clinical trial phases or running them concurrently. Clinical trials gather data on safety and efficacy, with more participants in each successive phase (e.g., phase 3 has more participants than phase 2). 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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    In U.S GAO News
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    In U.S GAO News
    The Department of Veterans Affairs (VA) has received one real property donation through a partnership pilot program authorized by the Communities Helping Invest through Property and Improvements Needed for Veterans Act of 2016 (CHIP-IN Act) and is planning for a second. This Act authorized VA to accept donated real property—such as buildings or facility construction or improvements—and to contribute certain appropriated funds to donors that are entering into donation agreements with VA. Under VA's interpretation, its ability to contribute to such funds is limited to major construction projects (over $20 million). The first CHIP-IN project—an ambulatory care center in Omaha, Nebraska—opened in August 2020. Pending requested appropriations for a second CHIP-IN project, VA intends to partner with another donor group to construct an inpatient medical center in Tulsa, Oklahoma. (See figure.) Other potential donors have approached VA about opportunities that could potentially fit the CHIP-IN pilot, but these project ideas have not proceeded for various reasons, including the large donations required. VA officials told us they have developed a draft legislative proposal that seeks to address a challenge in finding CHIP-IN partnerships. For example, officials anticipate that a modification allowing VA to make funding contributions to smaller projects of $20 million and under would attract additional donors. Completed Department of Veterans Affairs' (VA) Ambulatory Care Center in Omaha, NE, and Rendering of Proposed Inpatient Facility in Tulsa, OK VA has discussed and documented some lessons learned from the Omaha project. For example, VA officials and the Omaha donor group identified and documented the benefits of a design review software that helped shorten timeframes and reduce costs compared to VA's typical review process. However, VA has not consistently followed a lessons-learned process, and as a result, other lessons, such as the decision-making that went into developing the Omaha project's donation agreement, have not been documented. Failure to document and disseminate lessons learned puts VA at risk of losing valuable insights from the CHIP-IN pilot that could inform future CHIP-IN projects or other VA construction efforts. VA has pressing infrastructure demands and a backlog of real property projects. VA can accept up to five real property donations through the CHIP-IN pilot program, which is authorized through 2021. GAO previously reported on the CHIP-IN pilot program in 2018. The CHIP-IN Act includes a provision for GAO to report on donation agreements entered into under the pilot program. This report examines: (1) the status of VA's efforts to execute CHIP-IN partnerships and identify additional potential partners and (2) the extent to which VA has collected lessons learned from the pilot, among other objectives. GAO reviewed VA documents, including project plans and budget information, and interviewed VA officials, donor groups for projects in Omaha and Tulsa, and selected non-profits with experience in fundraising. GAO compared VA's efforts to collect lessons learned with key practices for an overall lessons-learned process. GAO is making two recommendations to VA to implement a lessons-learned process. Recommendations include documenting and disseminating lessons learned from CHIP-IN pilot projects. VA concurred with GAO's recommendations. For more information, contact Andrew Von Ah at (202) 512-2834 or vonaha@gao.gov.
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  • Southwest Border: Information on Federal Agencies’ Process for Acquiring Private Land for Barriers
    In U.S GAO News
    The interagency process for acquiring private land for border barrier construction along the southwest border involves the Department of Homeland Security's U.S. Border Patrol and the Department of Defense's U.S. Army Corps of Engineers (USACE) as well as the Department of Justice. The key acquisition steps are (1) identifying the landowners affected by planned barriers, (2) contacting landowners to obtain access to their property for surveying and other due diligence activities, (3) negotiating with landowners, and (4) concluding the acquisition preferably through negotiated purchase or via condemnation. The government may acquire temporary access to or permanent ownership of property by initiating a condemnation proceeding in federal district court. In this judicial process, the government articulates the public use necessitating the acquisition and the estimated compensation for the landowner, among other things. Border Barrier Construction in South Texas GAO's analysis of USACE data shows that, as of July 2020, the federal government acquired 135 private tracts, or sections, of land and is working to acquire 991 additional tracts. The privately owned land the government acquired or is working to acquire totals about 5,275 acres or 8.2 square miles, and most of it—1,090 of 1,126 tracts—is in south Texas. The Border Patrol planned for private land acquisition in south Texas to take 21 to 30 months compared with 12 months for comparable land acquisitions in other regions. Border Patrol estimated private land acquisition in south Texas would take more time due to factors unique to south Texas, including: Barrier placement in south Texas. Additional time is needed for the government to work with landowners to ensure that they have access to and are justly compensated for any negative impact on the value of remaining property between the border barrier and the Rio Grande River, according to Border Patrol officials. Missing or incomplete land records. Border Patrol officials said that it often takes time to identify parties with interest in a tract of land due to missing or incomplete land records. In cases where the government is unable to identify interested parties, the government has to use the condemnation process to resolve title issues and acquire ownership. In January 2017, the President issued Executive Order 13767, which directed the Secretary of Homeland Security to immediately plan, design, and construct a wall or other physical barriers along the southwest border. These new barriers would add to or replace 654 miles of primary pedestrian and vehicular barriers constructed as of fiscal year 2015. Of the nearly 2,000-mile southwest border, roughly 30 percent is federal land. Private, tribal, and state-owned land constitutes the remaining 70 percent of the border. GAO was asked to review the U.S. government's efforts to acquire privately owned land along the southwest border for barrier construction. GAO's review focused on the government's acquisition of private land and did not address acquisition of federal, state, or tribal property. This report examines (1) federal agencies' process for acquiring private land identified for the construction of border barriers and (2) the status of federal acquisition of private land for the barrier construction. GAO reviewed key documents; interviewed Border Patrol, USACE, and Department of Justice officials; and interviewed stakeholder organizations and landowners. GAO also analyzed data on the status of private land acquisition and conducted a site visit to areas in south Texas. For more information, contact Rebecca Gambler at (202) 512-8777 or GamblerR@gao.gov.
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    In U.S GAO News
    This is the French language highlights associated with GAO-21-359. Constats du GAO Au 31 mars 2020, l’Agence des États-Unis pour le développement international (USAID) et les Centres des États-Unis pour le contrôle et la prévention des maladies (CDC) ensemble avaient alloué un total de plus de 1,2 milliard de dollars et avaient décaissé environ 1 milliard pour financer des activités de sécurité sanitaire mondiale (global health security - GHS), sur des fonds affectés durant les années fiscales 2015 à 2019. L’USAID et les CDC ont soutenu des activités de renforcement des capacités des pays dans 11 domaines techniques en rapport avec la lutte contre les maladies infectieuses. Les fonds engagés ont soutenu des activités de GHS dans pas moins de 34 pays, dont 25 étaient partenaires du Programme d’action pour la sécurité sanitaire mondiale (Global Health Security Agenda - GHSA). Activités soutenues par les États-Unis en Éthiopie pour renforcer la sécurité sanitaire mondiale Les évaluations de responsables officiels des États-Unis portant sur les capacités de 17 pays partenaires du GHSA à faire face aux menaces des maladies infectieuses révèlent qu’à la fin de l’année fiscale 2019, la plupart de ces pays avaient des capacités dans chacun des 11 domaines techniques retenus mais connaissaient diverses difficultés. Les équipes-pays interinstitutionnelles américaines réalisent des évaluations de capacités bisannuelles dont le personnel du siège de l’USAID et des CDC se sert pour assurer un suivi des progrès des pays. Selon les évaluations de l’année fiscale 2019, 14 pays avaient développé ou démontré des capacités dans la plupart des domaines techniques. Les rapports ont démontré par ailleurs que la plupart des capacités de ces pays étaient restées stables ou avaient augmenté par rapport à 2016 et 2017. C’est dans le domaine technique de la résistance aux antimicrobiens qu’ont été enregistrées les plus fortes augmentations de capacités, par exemple dans la mise en place de systèmes de surveillance. Dans son analyse des rapports, le GAO a constaté que les difficultés les plus fréquentes en matière de renforcement des capacités de GHS étaient les faiblesses des institutions de l’État et le manque de ressources et de capital humain. Selon des responsables officiels, certaines de ces difficultés peuvent être résolues par plus de financement, d’assistance technique ou d’efforts diplomatiques des États-Unis, mais beaucoup d’autres restent en dehors du control du gouvernement des États-Unis. Ceci est une version publique d’un rapport confidentiel émis par le GAO en février 2021; les informations jugées sensibles par l’USAID et les CDC en ont été omises. Pourquoi cette étude du GAO La survenue de la maladie à coronavirus (COVID-19) en décembre 2019 a démontré que les maladies infectieuses peuvent causer des pertes de vie catastrophiques et infliger des dommages durables à l’économie mondiale. L’USAID et les CDC dirigent les efforts déployés par les États-Unis pour renforcer la sécurité sanitaire mondiale, à savoir la capacité mondiale à se préparer à lutter contre les maladies infectieuses, à les détecter et à y riposter, ainsi qu’à réduire ou à prévenir leur propagation sur le plan international. Ces efforts comprennent des activités liées au GHSA, qui vise à accélérer l’obtention de progrès en matière de respect des règlements et autres accords mondiaux relatifs à la santé. Le rapport 114-693 de la Chambre des représentants prévoyait un examen, par le Government Accountability Office (GAO), de l’emploi des fonds de GHS. Dans ce rapport, le GAO examine, pour les 5 années fiscales précédant le début de la pandémie de COVID-19 : 1) l’état des financements et des activités de l’USAID et des CDC relatifs à la GHS et 2) des évaluations d’organismes des États -Unis, réalisées à la fin de l’année fiscale 2019, portant sur les capacités des pays partenaires du GHSA à faire face aux menaces des maladies infectieuses et sur les difficultés que ces pays ont dû relever pour renforcer leurs capacités. Le GAO a analysé des documents d’organismes des États-Unis et d’organismes internationaux. Le GAO a aussi interviewé des responsables officiels à Washington et à Atlanta (Géorgie) ainsi qu’en Ethiopie, en Indonésie, au Sénégal et au Viet Nam. Le GAO a choisi ces pays sur la base de critères tels que la présence de personnel de multiples organismes des États-Unis. Le GAO a également analysé des évaluations interinstitutionnelles des capacités des pays à faire face aux menaces des maladies infectieuses durant l’année fiscale 2019 et les a comparées aux données de référence de 2016 et 2017. Pour plus d’informations, s’adresser à David Gootnick au (202) 512-3149 ou à gootnickd@gao.gov.
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