Jury Convicts Former Delaware Doctor of Unlawful Drug Distribution and Maintaining a Drug Premises

A federal jury convicted a former Delaware doctor Wednesday for unlawfully distributing and dispensing controlled substances and for maintaining a drug-involved premises.

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    What GAO Found GAO found that the Housing Choice Voucher program had 1.1 million voucher holders living in units built before 1978, the year the U.S. banned lead paint in housing. Of these units, roughly 171,000 were occupied by approximately 229,000 young children (under age 6)––putting these children at an increased risk of lead exposure. The voucher program requires visual assessments for identifying deteriorated paint, with no testing of paint or dust. Any change to stricter evaluation methods would need to consider that certain states have a larger portion of pre-1978 voucher units occupied by families with young children. Estimated costs for adopting stricter lead evaluation methods for the voucher program would vary substantially depending on the method used and what units were included (see figure). Estimated initial costs range from about $60 million for a less expensive method applied only to units with young children to about $880 million for a more expensive method applied to all pre-1978 units. These estimated costs range from 3 percent to 41 percent, respectively, of the fiscal year 2021 budget dedicated to public housing agencies' administrative expenses for the voucher program. Total costs would also depend on the mobility of voucher households and the frequency of any additional lead evaluations. Total Estimated Cost to Change the Lead Evaluation Methods for Housing Choice Voucher Units Would Vary by Evaluation Method Used and Units Included Note: A combination evaluation includes all components of a lead inspection and a risk assessment. Estimated costs may vary by up to plus or minus 14 percentage points at the 95 percent level of confidence. GAO analysis estimated that nearly 6,000 lead professionals can conduct lead evaluations in the U.S. While there is no indication of a national shortage of lead professionals, areas with high numbers of pre-1978 voucher units and low numbers of lead professionals may face implementation challenges. Selected cities offer observations from their implementation of a change in lead evaluation method. For example, education of landlords can help clarify new evaluation requirements and encourage landlords to continue to rent to voucher holders. Further, implementing a new method in phases could target areas with the greatest need and help landlords and the industry adapt to the new requirement and the increased demand for lead evaluations. Why GAO Did This Study Exposure to lead paint, which was used in housing built before 1978, can have serious health effects, especially for young children. The Department of Housing and Urban Development (HUD) has primary responsibility for identifying lead paint hazards in housing receiving HUD assistance, including private rental units in the voucher program. Some members of Congress have raised questions about whether the voucher program should change from visual assessments to a stricter lead evaluation method. The 2017 Consolidated Appropriations Act, Joint Explanatory Statement, includes a provision for GAO to review HUD's efforts to address lead paint hazards. This report identifies considerations for policymakers related to changing to stricter lead evaluation methods for the voucher program, specifically regarding the (1) number and characteristics of voucher housing units and their occupants, (2) costs for lead evaluations based on method used and units included, (3) availability of lead professionals, and (4) observations from selected cities that use lead evaluation methods stricter than visual assessments. GAO analyzed HUD data on the voucher program (as of year-end 2019, the most recent available) and information on lead professionals from the Environmental Protection Agency (EPA) and states. GAO also conducted a nationwide, generalizable survey of lead professionals to estimate the costs of lead evaluation methods. In addition, GAO interviewed staff from HUD, EPA, and public housing agencies, and representatives from two national organizations that represent lead professionals. For more information, contact John H. Pendleton at (202) 512-8678 or pendletonj@gao.gov.
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    In U.S GAO News
    In fiscal year 2019, the Missile Defense Agency (MDA) delivered many of the Ballistic Missile Defense System (BMDS) assets it planned and conducted key flight tests, but did not meet all of its goals for the year. For example, MDA successfully delivered interceptors for use by warfighters and conducted a salvo test (which involves launching two interceptors at an incoming target) for the Ground-based Midcourse Defense program. However, MDA did not meet all of its goals for delivering assets or testing. For example, MDA completed only two of seven planned flight tests, plus eight additional flight tests that were later added for fiscal year 2019. MDA did not fully execute its fiscal year 2019 flight testing, continuing a decade-long trend in which MDA has been unable to achieve its fiscal year flight testing as scheduled. Although MDA revised its approach to developing its annual test plan in 2009 to ensure the test plan was executable, over the past decade MDA has only been able to conduct 37 percent of its baseline fiscal year testing as originally planned due to various reasons including developmental delays, range and target availability, or changing test objectives. In addition, MDA has not conducted an assessment to determine whether its current process for developing and executing its annual test plan could be improved to help ensure its executability. Without an independent assessment, MDA will continue down the same path, increasing the risk of the same outcomes from the past decade—less testing than originally planned, resulting in less data to demonstrate and validate capabilities. Missile Defense Agency (MDA) Cumulative Flight Test Planning, Fiscal Years 2010-2019 Note: This graphic is a compilation of each individual fiscal year's flight test schedule. As such, if a flight test was planned for a particular fiscal year but then delayed to a later fiscal year, it would be counted both times. MDA is currently at a pivotal crossroads, needing to balance its ability to pursue new and advanced efforts while also maintaining its existing portfolio of BMDS elements that have not transferred to the military services as originally planned. The new and advanced efforts, such as the Next Generation Interceptor—a new interceptor for homeland defense—are research and development-intensive tasks, which carry significant technical risks and financial commitments. As MDA takes on these new efforts, it is increasingly important that the agency establish and maintain a sound and disciplined acquisition approach for these efforts to be successful and within anticipated costs and timeframes. For over half a century, the Department of Defense (DOD) has funded efforts to defend the United States from ballistic missile attacks. From 2002 through 2018, MDA has received about $152 billion to develop the BMDS and requested about $47 billion from fiscal year 2019 through fiscal year 2023. The BMDS consists of diverse and highly complex land-, sea-, and space-based systems and assets located across the globe. Congress included a provision in statute that GAO annually assess and report on MDA's progress. This, our 17th annual review, addresses for fiscal year 2019 (1) the progress MDA made in achieving delivery and testing goals; (2) the extent to which MDA's annual test plan is executable; and (3) broad challenges that could impact MDA's portfolio. GAO reviewed the planned fiscal year 2019 baselines, along with test plans since 2010, and other program documentation and assessed them against program and baseline reviews. GAO also interviewed officials from MDA and DOD agencies, including the office of the Director, Operational Test and Evaluation, Undersecretary of Defense for Research and Engineering, and the BMDS Operational Test Agency. GAO recommends that MDA ensure an independent assessment is conducted of its process for developing and executing its annual BMDS flight test plan. DOD concurred with the recommendation. For more information, contact William Russell at (202) 512-4841 or Russellw@gao.gov.
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    In U.S GAO News
    Fiscal year 2015 was the first time that the Food and Drug Administration (FDA) conducted more inspections of foreign drug manufacturers than domestic manufacturers, with the majority conducted in China and India. However, in June 2020, GAO reported that from fiscal year 2016 through fiscal year 2018, both foreign and domestic inspections decreased, in part due to staffing vacancies. While foreign inspections increased in 2019, since March 2020, FDA has largely paused foreign and domestic inspections due to the Coronavirus Disease 2019 (COVID-19) pandemic, conducting only those deemed mission critical. In January 2021, GAO reported that FDA conducted three foreign inspections in fiscal year 2020 following the pause—significantly less than in recent years. Number of FDA-Conducted Foreign Drug Manufacturing Establishment Inspections, Fiscal Years 2019–2020, by Month FDA has used alternative inspection tools to maintain some oversight of drug manufacturing quality while inspections are paused. These tools include relying on inspections conducted by foreign regulators, requesting and reviewing records and other information, and sampling and testing drugs. FDA has determined that inspections conducted by certain European regulators are equivalent to and can be substituted for an FDA inspection. Other tools provide useful information but are not equivalent. In addition, FDA was unable to complete more than 1,000 of its planned fiscal year 2020 inspections and will likely face a backlog of inspections in future years. In January 2021, GAO recommended that FDA ensure that inspection plans for future fiscal years respond to the issues presented by the backlog and that FDA fully assess the agency's alternative inspection tools. FDA concurred with both recommendations. Even before the COVID-19 pandemic, FDA faced persistent challenges conducting foreign inspections. GAO found in December 2019 that there continued to be vacancies among the investigators who conduct foreign inspections. GAO further found that FDA's practice of preannouncing foreign inspections up to 12 weeks in advance could give manufacturers the opportunity to fix problems ahead of the inspection and raised questions about their equivalence to domestic inspections. In light of COVID-19, FDA is now preannouncing both foreign and domestic inspections for the safety of its staff and manufacturers. GAO also found that language barriers can create challenges during foreign inspections as FDA generally relies on the establishment for translation services. The outbreak of COVID-19 has called greater attention to the United States' reliance on foreign drug manufacturers. FDA reports that 74 percent of establishments manufacturing active ingredients and 54 percent of establishments manufacturing finished drugs for the U.S. market were located overseas, as of May 2020. FDA is responsible for overseeing the safety and effectiveness of all drugs marketed in the United States, regardless of where they are produced, and it conducts inspections of both foreign and domestic manufacturing establishments. GAO has had long-standing concerns about FDA's ability to oversee the increasingly global pharmaceutical supply chain, an issue highlighted in GAO's High Risk Series since 2009. This statement is largely based on GAO's Drug Manufacturing Inspections enclosure in its January 2021 CARES Act report, as well as GAO's December 2019 and June 2020 testimonies. Specifically, it discusses (1) the number of FDA's foreign inspections, (2) FDA's response to the COVID-19 pandemic pause in inspections, and (3) persistent foreign inspection challenges. For that work, GAO examined FDA data from fiscal years 2012 through 2020, interviewed FDA investigators, and reviewed documents related to drug oversight during the COVID-19 pandemic, among other things. For more information, contact Mary Denigan-Macauley at (202) 512-7114 or deniganmacauleym@gao.gov.
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    GAO's analysis of Occupational Safety and Health Administration (OSHA) data showed that the number of recordkeeping violations OSHA cited fluctuated over 15 years (see fig.). An April 2012 federal court decision (that effectively limited the time period for citing these violations) and a January 2015 expansion of OSHA's rule for reporting severe injuries and illnesses coincided with, and were cited by, OSHA staff as key factors explaining these fluctuations. Number Recordkeeping Violations OSHA Cited by Fiscal Year Employers did not report any summary injury and illness data on more than one-half of their establishments that GAO estimated met the reporting requirements (see table). Estimated Compliance with Summary Injury and Illness Reporting Requirement Calendar year Estimated establishments that met summary injury and illness reporting requirements Establishments whose employers submitted summary injury and illness data     Number Percent 2016 451,000 159,000 35% 2017 454,000 189,000 42% 2018 459,000 212,000 46% Source: GAO analysis of U.S. Census Bureau County Business Patterns data and Occupational Safety and Health Administration (OSHA) summary (300A) injury and illness data. Establishments in all 50 states and the District of Columbia reported these data. Data rounded to the nearest thousand. | GAO-21-122 OSHA has limited procedures for encouraging compliance with this reporting requirement and for penalizing non-compliance. For example, OSHA officials told GAO that they identified nearly 220,000 employers in 2019 who may not have reported their data and mailed reminder postcards to about 27,000 of them. OSHA also cited 255 employers for failure to report their data from mid-December 2017 through September 2019 after OSHA conducted on-site inspections. OSHA uses the summary injury and illness data to target high-risk establishments for certain comprehensive inspections. Because OSHA has not evaluated its procedures, it does not know the extent to which its efforts may be improving injury and illness reporting or what other efforts it should undertake. Absent more complete information, OSHA is at risk for not achieving its objective of targeting inspections to establishments with the highest injury and illness rates. In 2018, about 3.5 million workers suffered job-related injuries, and illnesses and 5,250 died on the job, according to Bureau of Labor Statistics data. Employers are required to record work-related injuries and illnesses, promptly report severe injury and illness incidents to OSHA, and certain employers are required to report summary injury and illness data electronically on an annual basis. GAO was asked to review how OSHA addresses recordkeeping violations, and implements its rule for reporting summary data. This report examines: (1) how and why recordkeeping violations changed from fiscal years 2005 through 2019 and (2) the extent to which employers report summary injury and illness data and OSHA has taken steps to ensure compliance with this requirement. GAO analyzed 15 years of OSHA recordkeeping violation data and compared OSHA and Census data to estimate how many employers complied with summary reporting requirements. GAO also reviewed agency procedures and relevant federal laws and regulations and interviewed OSHA headquarters officials and staff at seven OSHA area offices, selected for geographic dispersion and varying amounts of recordkeeping violations. GAO recommends OSHA evaluate procedures for ensuring reporting of summary data and develop a plan to remediate deficiencies. OSHA generally concurred with our recommendation. For more information, contact Thomas Costa at (202) 512-4769 or costat@gao.gov.
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    In U.S GAO News
    What GAO Found Containerized shipping—performed by oceangoing vessels using standardized shipping containers—accounted for approximately 60 percent of all world seaborne trade, which was valued at approximately $12 trillion in 2017. At a port, shipping containers are placed on "intermodal chassis" (chassis), standardized trailers that carry shipping containers and attach to tractors for land transport. Multiple entities are involved in the movement of shipping containers, including intermodal equipment providers (IEP) (which own and provide chassis for a fee); ocean carriers (which transport cargo over water); and motor carriers (which transport shipping containers over land via chassis). Four distinct models are used in the U.S. to make chassis available to motor carriers (see table), each with benefits and drawbacks according to the entities GAO interviewed. While chassis are generally provided to motor carriers using one of these four models, more than one model may be available at a port. Chassis Provisioning Models Model 1: Single chassis provider An individual intermodal equipment provider (IEP) owns chassis that are directly provided to shippers or motor carriers. Model 2: Motor carrier-controlled A motor carrier owns or is responsible for a chassis that it has procured under a long-term lease. Model 3: Gray pool A single manager, often a third party, oversees the operations of a pool that is made up of chassis contributed by multiple IEPs. Model 4: Pool-of-pools Each IEP manages its respective chassis fleet, but each allow motor carriers to use any chassis among the fleets and to pick up and drop off chassis at any of the IEPs’ multiple locations. Source: GAO.  |  GAO-21-315R Entities GAO interviewed identified multiple benefits and drawbacks to each of the chassis provisioning models. Regarding benefits, for example, both the single chassis provider model and the motor carrier-controlled model allow IEPs and motor carriers to have direct control over the maintenance and repair of their chassis, something these entities potentially lose under other chassis provisioning models. Further, the gray pool and the pool-of-pools models can resolve many of the logistical concerns regarding the availability of chassis, leading to operational efficiencies for port operators and the ability of motor carriers to choose whatever chassis they wish. Regarding drawbacks, cost considerations were identified in some cases. For example, under the single chassis provider model, two IEPs told us that while an expected part of the business, repositioning chassis to ensure there is a sufficient supply of chassis where they are needed can be costly to the IEPs. The federal government provides oversight of chassis safety but has a limited economic oversight role regarding chassis. The Federal Motor Carrier Safety Administration (FMCSA) employs several inspection methods to help oversee chassis safety and compliance with regulations. For example, inspectors perform roadside inspections on commercial vehicles, including chassis, in operation. FMCSA also performs investigations of individual IEPs to oversee chassis safety. While one stakeholder GAO spoke with stated that FMCSA should consider maintaining safety ratings for IEPs—as is currently done for motor carriers—FMCSA officials told us that the current processes provide sufficient information to select IEPs for investigation. The Federal Maritime Commission (FMC) oversees ocean carriers that provide service to and from the U.S. and works to ensure a competitive and reliable ocean transportation supply system. Entities may file complaints with FMC to allege violations of the Shipping Act of 1984, as amended. One such complaint was filed in August 2020, in which the complainants allege, among other things, that although ocean carriers do not own chassis, they still control the operation of chassis pools at ports. An initial decision on this complaint is expected in August 2021. None of the entities GAO spoke with identified additional actions they would like for FMC to take regarding chassis. Why GAO Did This Study Senate Report 116-109—incorporated by reference into the explanatory statement accompanying the Further Consolidated Appropriations Act, 2020—contained a provision for GAO to study intermodal chassis. Within the U.S., some entities have expressed concerns about chassis, including limited availability of chassis in some circumstances, as well as the age and safety of chassis. This report describes selected stakeholders' views on: (1) the ways in which chassis are made available for the movement of shipping containers and the benefits and drawbacks of those models, and (2) the federal government's role in the chassis market. To address these objectives, GAO reviewed relevant reports on chassis provisioning and federal oversight. GAO interviewed representatives from FMC, FMCSA, five industry associations, and the three largest intermodal equipment providers. GAO also interviewed three ocean carriers, five port operators, and a motor carrier selected, in part, for their large number of container movements. The information obtained from these interviews provides a broad perspective of relevant issues but is not generalizable to all entities. For more information, contact Andrew Von Ah at (202) 512-2834 or vonaha@gao.gov.
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  • Data Center Optimization: Agencies Report Progress and Billions Saved, but OMB Needs to Improve Its Utilization Guidance
    In U.S GAO News
    The 24 agencies participating in the Office of Management and Budget's (OMB) Data Center Optimization Initiative (DCOI) continue to report progress toward meeting OMB's goals for closing data centers and achieving the related cost savings. According to data submitted by the 24 agencies, almost all of them met or planned to meet their closure and cost savings goals for fiscal years 2019 and 2020. As of August 2020, the agencies reported that they expected to achieve 230 data center closures, resulting in $1.1 billion in savings, over the 2-year period. Agencies expected to realize a cumulative total of $6.24 billion in cost savings and avoidances from fiscal years 2012 through 2020. However, agencies have excluded approximately 4,500 data centers from their inventories since May 2019 due to a change in the definition of a data center. Specifically, in June 2019, OMB narrowed the definition of a data center to exclude certain facilities it had previously identified as having potential cybersecurity risks. GAO reported that each such facility provided a potential access point, and that unsecured access points could aid cyber attacks. Accordingly, GAO recommended that OMB require agencies to report those facilities previously reported as data centers so that visibility of the risks of these facilities was retained. However, OMB has not taken action to address the recommendation. Overall, GAO has made 125 recommendations since 2016 to help agencies meet their DCOI goals, but agencies have not implemented 53. The 24 agencies reported varied progress against OMB's data center optimization targets for fiscal year 2020 (see figure). Agency-Reported Progress towards Meeting Office of Management and Budget (OMB) Data Center Optimization Targets, as of August 2020 Notes: Virtualization measures the number of servers and mainframes serving as a virtual host. Advanced energy metering counts data centers with metering to measure energy efficiency. A metric is not applicable if an agency does not have any agency-owned data centers or if its remaining centers are exempted from optimization by OMB. In June 2019, OMB revised the server utilization metric to direct agencies to develop their own definitions of underutilization, and then count their underutilized servers. As a result, agencies adopted widely varying definitions and were no longer required to report actual utilization, a key measure of server efficiency. In December 2014, Congress enacted federal IT acquisition reform legislation known as FITARA, which included provisions related to ongoing federal data center consolidation efforts. OMB's federal Chief Information Officer launched DCOI to build on prior data center consolidation efforts and improve federal data centers' performance. FITARA included a provision for GAO to annually review agencies' data center inventories and strategies. This report addresses (1) agencies' progress on data center closures and the related savings that have been achieved, and agencies' plans for future closures and savings; (2) agencies' progress against OMB's data center optimization targets; and (3) the effectiveness of OMB's metric for server utilization and how the agencies are implementing it. To do so, GAO reviewed the 24 DCOI agencies' data center inventories as of August 2020, their reported cost savings documentation and data center optimization strategic plans, and OMB's revised utilization metric. GAO reiterates that agencies need to address the 53 recommendations previously made to them that have not yet been implemented. GAO is making one new recommendation to OMB to revise its server utilization metric to more consistently address server efficiency. OMB had no comments on the report and the recommendation directed to the agency. Of the 24 DCOI agencies, five agreed with the information in the report, six did not state whether they agreed or disagreed, and 13 had no comments. For more information, contact Carol C. Harris at (202) 512-4456 or harriscc@gao.gov.
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  • COVID-19: Implementation and Oversight of Preparedness Strategies at Veterans Affairs Medical Centers
    In U.S GAO News
    What GAO Found Beginning in January 2020, the Veterans Health Administration (VHA) took actions to help the Department of Veterans Affairs medical centers (VAMC) prepare for COVID-19. VHA's Office of Emergency Management facilitated the development of VHA's COVID-19 Response Plan, which defined preparedness strategies for VAMCs to mitigate the effects of COVID-19. According to VHA, preparedness refers to the development of plans, resources, and capabilities to manage and recover from the effects of emergencies. Plans for the safety of staff and patients, identification of sufficient supplies and capacity, and coherent communication were among the identified strategies. VAMCs began implementing these strategies in February 2020. Officials from four selected VAMCs reported using similar approaches to implement VHA's preparedness strategies, such as developed plans for screening and testing; trained staff on personal protective equipment (PPE) use; identified the capability to expand beds in the event of a patient surge; conducted problem solving activities to identify gaps in response capabilities; counted PPE and calculated consumption rates; and communicated safety information to patients. VHA oversaw VAMCs' implementation of COVID-19 preparedness strategies by collecting data on the VAMCs' efforts and holding VHA-wide conference calls. VHA's Healthcare Operations Center (HOC) worked with Veterans Integrated Service Networks (VISN) to gather data from VAMCs on a daily basis. HOC Data Collection on COVID-19 Preparedness Strategies Implemented at VAMCs The VHA-wide conference calls included officials from VHA Central Office, VISNs, and VAMCs, among others, and focused on the data collected. Some topics discussed included the number of VAMC staff able to provide PPE training and VAMC plans to screen staff and patients for COVID-19. VHA-wide calls were also a way to discuss data collection challenges and for VAMCs and VISNs to share best practices. In addition to the preparedness issues in this report, GAO expects to continue examining VHA's actions to address COVID-19. Why GAO Did This Study VHA provides health care to more than 10 million veterans each year, offering a range of services at approximately 170 VAMCs nationwide. In January 2020, components of VHA's emergency management system began coordinating the agency's efforts to prepare for the COVID-19 pandemic so VAMCs could continue the delivery of services while maintaining the health and safety of patients and staff. 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 describes VHA efforts to prepare for COVID-19, including (1) how selected VAMCs implemented VHA's COVID-19 preparedness strategies; and (2) the steps VHA took to oversee VAMCs' implementation of preparedness strategies. GAO reviewed VHA plans, policies, and guidance related to COVID-19 preparedness, including VHA's COVID-19 Response Plan. GAO interviewed officials at four VAMCs, a nongeneralizable sample selected based on hospital complexity and geographic diversity, as well as officials from their associated VISNs. GAO also interviewed officials from VHA's Central Office, Office of Emergency Management, HOC, and other VHA offices. GAO provided a draft of this report to VA. In response, VA provided one technical comment, which was incorporated as appropriate. For more information, contact A. Nicole Clowers at (202) 512-7114 or clowersa@gao.gov.
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  • Justice Department Seeks to Shut Down Louisiana Tax Return Preparers
    In Crime News
    The United States has filed a complaint seeking to bar Louisiana tax return preparers from owning or operating a tax return preparation business and preparing tax returns for others, the Justice Department announced today. The civil complaint against Leroi Gorman Jackson and Mario Alexander, both individually and doing business as The Taxman Financial Services LLC, was filed in the U.S. District Court for the Eastern District of Louisiana.
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  • Financial Assistance: Lessons Learned from CARES Act Loan Program for Aviation and Other Eligible Businesses
    In U.S GAO News
    The CARES Act authorized up to $46 billion for the Department of the Treasury (Treasury) to make loans to aviation and other eligible businesses affected by the COVID-19 pandemic. Of the 267 applications submitted to the loan program, 35 loans providing $21.9 billion in assistance were executed. Treasury officials do not expect to make any additional loans before Treasury's authority to make loans expires. Applications and Loans for CARES Act Loan Program for Aviation and Other Eligible Businesses, by Category in Statute Type of business Number of applications submitted Assistance sought/available (billions of dollars) Number of loans executed Assistance provided (billions of dollars) Passenger air carrier, repair station operator, and ticket agent 183 35 / 25 23 21.2 Cargo air carrier 10 0.8 / 4 1 0.002 National security business 74 2.6 / 17 11 0.7 Total 267 38.3 / 46 35 21.9 Source: GAO analysis of Department of the Treasury data | GAO-21-198 Note: Pub. L. No. 116-136, § 4003(b)(1)-(3). Participation in the loan program varied across business types due to timing of decisions and other factors, according to stakeholders. Treasury prioritized applications from the largest passenger air carriers and executed loans with seven of them for nearly $20.8 billion. For other applicants, including smaller passenger air carriers and ticket agents, the amount of time Treasury took to evaluate their applications and other challenges affected the number of loans executed, according to selected industry associations. Treasury's authority to make new loans under this program is set to expire in December 2020, and the loan program offers Congress and Treasury lessons for designing and implementing programs of this type in the future. For example: Multiple programs, or multiple paths within a program, may better accommodate businesses of varied types and sizes. It is difficult to implement a program quickly for a wide range of businesses. In addition, a loan program well suited to large, financially sophisticated applicants will not likely be well suited to smaller businesses. Setting and communicating clear program goals could better align lender and borrower expectations. Treasury viewed itself as a lender of last resort but did not state this view in published documents. This omission led to some applicants being surprised by parts of the process, such as when Treasury encouraged over a third of all applicants to apply to another loan program before continuing to pursue a loan from Treasury. Communicating clear timelines for action can also help align lender and borrower expectations. The lack of a published timeline resulted in frustration among some applicants when loans were not made more quickly. The COVID-19 pandemic has resulted in catastrophic loss of life and substantial damage to the global economy, including the aviation sector. U.S. passenger air carriers have lost almost $20 billion and over 47,000 jobs in 2020, with losses forecast to continue into 2021. In March 2020, Congress passed, and the President signed into law, the CARES Act, which provides over $2 trillion in emergency assistance and health care response for individuals, families, and businesses affected by the COVID-19 pandemic, including businesses in the aviation sector. The CARES Act contained a provision for GAO to review the loans provided under the Act. This report examines, among other things, eligible businesses' participation in the loan program and lessons learned from the program for Congress and Treasury. GAO reviewed Treasury documents and data on applications received and loans executed; interviewed Treasury officials on the design and implementation of the program; and interviewed eight industry associations that represent the range of businesses eligible for loans, eight passenger air carriers, and other selected applicants to gather their views on the program. GAO will continue to monitor and report on CARES Act assistance to the aviation industry. This oversight includes the loan program and another Treasury program—the Payroll Support Program—that provided assistance to certain aviation businesses to continue paying employee wages, salaries, and benefits. For more information, contact Heather Krause at (202) 512-2834 or krauseh@gao.gov.
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  • Laboratory Safety: FDA Should Strengthen Efforts to Provide Effective Oversight
    In U.S GAO News
    The Food and Drug Administration (FDA) has taken steps intended to improve safety at its laboratories, including those that work with hazardous biological agents. Specifically, FDA created the Office of Laboratory Safety (OLS) in 2017 as a safety oversight body for all FDA laboratories. Establishment of FDA's Office of Laboratory Safety (OLS) Note: Prior to March 2019, OLS was referred to as the Office of Laboratory Science and Safety. In coordination with FDA's operating divisions—known as centers—OLS has standardized safety policies, incident reporting, inspections, and safety training. However in creating OLS, FDA did not implement key reform practices that could have helped ensure OLS's effectiveness. For example, FDA's centers and OLS did not reach a shared understanding of OLS's roles and responsibilities—a key practice for effective agency reforms. Although senior agency leaders were involved in developing OLS's strategic plan, disagreements about OLS's role raised by center directors at that time still remain. For example, center directors told GAO that OLS's mission should not include science, laboratory quality management, or inspections. Conversely, the director of OLS said OLS remains committed to its mission as envisioned in the strategic plan, which includes these areas of responsibility. FDA officials said they plan to update the plan in 2021, which presents an opportunity for FDA to address areas of disagreement. In its current form, FDA's laboratory safety program also does not meet the key elements of effective oversight identified in GAO's prior work. For example, The oversight organization should have clear authority to ensure compliance with requirements. However, as part of a 2019 reorganization, FDA placed the OLS director at a lower level than the center directors. Also, OLS does not directly manage the center safety staff responsible for ensuring the implementation of safety policies that OLS develops. As a result, OLS has limited ability to access centers' laboratories—in part because they cannot inspect them unannounced—or to ensure compliance with safety policies. The oversight organization should also be independent from program offices to avoid conflict between program objectives and safety. However, OLS depends on the centers for much of its funding and has had to negotiate with the centers annually for those funds, which can allow center directors to influence OLS priorities through the funding amounts they approve. FDA has not assessed potential independence risks from using center funds for OLS. Without taking steps to do so, FDA's laboratory safety program will continue to compete with the centers' mission objectives and priorities. In 2014, FDA discovered improperly stored boxes of smallpox virus, posing a risk to individuals who might have been exposed. This raised concerns about the oversight of FDA's laboratories that conduct research on hazardous biological agents. In 2016, GAO made five recommendations to improve FDA's laboratory safety, four of which the Department of Health and Human Services (HHS) had not fully implemented as of July 2020. GAO was asked to examine FDA's efforts to strengthen laboratory safety. This report examines FDA's efforts since GAO's 2016 report to improve safety in its laboratories that work with hazardous biological agents. To conduct this work, GAO reviewed FDA documents; assessed FDA's safety oversight practices against key reform practices and oversight elements GAO identified in prior work; and interviewed FDA officials, including staff and senior leaders at OLS and the three centers that work with hazardous biological agents. GAO is making five recommendations to FDA, including to resolve disagreements over roles and responsibilities, to provide OLS with the authority and access to facilities necessary to oversee laboratory safety, and to take steps to assess and mitigate any independence risks posed by how OLS is funded. HHS agreed with all five recommendations. For more information, contact Mary Denigan-Macauley at (202) 512-7114 or deniganmacauleym@gao.gov.
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  • 2020 Wiretap Report: Intercepts and Convictions Decrease
    In U.S Courts
    Federal and state courts reported a combined 26 percent decrease in authorized wiretaps in 2020, compared with 2019, according to the Judiciary’s 2020 Wiretap Report. Convictions in cases involving electronic surveillance also decreased.
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  • Fugitive Charged with Leading Multimillion Dollar Fraud Scheme, Falsifying Evidence, and Tax Crimes
    In Crime News
    An American citizen was charged in two indictments unsealed this week for his alleged participation in an investment fraud scheme in which he allegedly misappropriated $6.1 million in investor-funds, manufactured evidence to mislead an investigation by the Securities and Exchange Commission (SEC) and concealed the proceeds of his fraudulent scheme from the IRS.
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  • Canadian National Sentenced for Human Smuggling Conspiracy
    In Crime News
    A Canadian national was sentenced to 32 months in prison for conspiracy to bring undocumented immigrants to the United States for private financial gain in connection with his role in a scheme to smuggle undocumented immigrants from Sri Lanka through the Caribbean and into the United States.
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