December 5, 2021

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Clinical Researchers Sentenced in Connection with Scheme to Falsify Drug Trial Data

7 min read
<div>A federal judge sentenced a Florida nurse practitioner and a Florida woman to prison terms today in connection with their participation in a conspiracy to falsify data related to clinical drug trials.</div>
A federal judge sentenced a Florida nurse practitioner and a Florida woman to prison terms today in connection with their participation in a conspiracy to falsify data related to clinical drug trials.

More from: August 11, 2021

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  • Devon Energy Companies Agree to Pay $6.15 Million to Settle False Claims Act Allegations for Underpaying Royalties on Gas from Federal Lands
    In Crime News
    Devon Energy Corporation, an Oklahoma-based oil and natural gas exploration and production company, and its affiliates, Devon Energy Corp. (Oklahoma) and Devon Energy Production Company LP (collectively, “Devon”), have agreed to pay $6.15 million to resolve allegations that it violated the False Claims Act by underpaying and underreporting royalties for natural gas from federal lands in Wyoming and New Mexico.
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  • Disaster Recovery: COVID-19 Pandemic Intensifies Disaster Recovery Challenges for K-12 Schools
    In U.S GAO News
    Local education officials in natural disaster-affected areas told us the Coronavirus Disease 2019 (COVID-19) pandemic has exacerbated mental health issues and contributed to lost instructional time, staff burnout, delays in recovery projects, and financial strain in their communities. These officials explained that after the natural disaster, restoring students' mental health was a top priority. Many local education officials said that the services needed to treat trauma and other disaster-related mental health issues were not readily available in their areas, and some noted that providing mental health services has been especially difficult during the pandemic. For example, one official said that because half of her students live in poverty, they usually access mental health services through the school, and were cut off from those services during the pandemic. Some local education officials said they were also particularly worried about the effects of the pandemic on their low-income and other at-risk students, noting that these students are especially vulnerable to learning loss. The COVID-19 pandemic has also affected districts by slowing progress on some disaster recovery projects. For example, an official in a district affected by wildfire said that an effort to restore running water to damaged school buildings was delayed due the pandemic. The U.S. Department of Education (Education) supported school recovery efforts by awarding nearly $1.4 billion to assist schools in over 30 states and U.S. territories with recovery from presidentially-declared major disasters occurring between 2017 and 2019, although some local education officials reported difficulty in using these grant funds during the pandemic. Education provided this funding through the Immediate Aid to Restart School Operations (Restart) and the Project School Emergency Response to Violence grant programs, among others. Local education officials from several districts and counties said that they are using or planning to use Education disaster grants to provide mental health services to students and cover other costs associated with re-opening, such as additional transportation services, but that during the pandemic this was sometimes challenging. For example, officials in two counties said that timeframes for using Restart funds, which expire after 2 years, were too short for long-term recovery needs such as mental health services, particularly with the compounding effects of the pandemic. Education officials said that grantees may request waivers to extend the end dates of these grants and that as of October 2020, no Restart grantees who experienced a 2018 disaster had done so. With regard to oversight, Education officials said they paused on-site monitoring efforts for recent disaster grants as a result of the pandemic, but have continued to hold quarterly phone calls with Restart grantees. These grantees have noted some challenges related to the grant program but have not discussed specific technical assistance needs, according to Education officials. More than 260 presidentially-declared major disasters have occurred since 2017, affecting every state and several U.S. territories, according to the Federal Emergency Management Agency (FEMA). Many of these natural disasters have had devastating effects, including rendering K-12 school facilities unusable for lengthy periods of time. These schools are now experiencing the compounding challenge of recovering from natural disasters while managing effects of the COVID-19 pandemic. Social distancing practices and building closures are meant to keep staff and students safe, but may also complicate recovery efforts for disaster-affected districts. The Additional Supplemental Appropriations for Disaster Relief Act of 2019 provided funds for GAO to audit issues related to presidentially-declared major disasters that occurred in 2018. We reviewed (1) how the COVID-19 pandemic has affected schools recovering from recent natural disasters; and (2) support Education has provided to help school recover from recent natural disasters and how the COVID-19 pandemic has affected schools' use of these resources. We interviewed 29 local education officials representing over 50 school districts in California, Commonwealth of the Northern Mariana Islands, Florida, and Hawaii, which were selected because they were affected by a diverse set of major natural disasters in 2018 that occurred in a mix of populated and less-populated areas. In addition, through a national school superintendents association, we convened a discussion group of superintendents who have experienced natural disasters and mentor other affected districts. Finally, we reviewed federal guidance and interviewed Education officials. For more information, contact Jacqueline M. Nowicki at (617) 788-0580 or nowickij@gao.gov.
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  • Cybersecurity: Federal Agencies Need to Implement Recommendations to Manage Supply Chain Risks
    In U.S GAO News
    What GAO Found Federal agencies continue to face software supply chain threats. In December 2020, the Department of Homeland Security's Cybersecurity and Infrastructure Security Agency issued an emergency directive requiring agencies to take action regarding a threat actor that had been observed leveraging a software supply chain compromise of a widely used enterprise network management software suite—SolarWinds Orion. Subsequently, the National Security Council staff formed a Cyber Unified Coordination Group to coordinate the government response to the cyberattack. The group took a number of steps, including gathering intelligence and developing tools and guidance, to help organizations identify and remove the threat. During the same month that the SolarWinds compromise was discovered, GAO reported that none of 23 civilian agencies had fully implemented selected foundational practices for managing information and communication technology (ICT) supply chain risks—known as supply chain risk management (SCRM) (see figure). Twenty-three Civilian Agencies' Implementation of Information and Communication Technology (ICT) Supply Chain Risk Management (SCRM) Practices GAO stressed that, as a result of not fully implementing the foundational practices, the agencies were at a greater risk that malicious actors could exploit vulnerabilities in the ICT supply chain, causing disruptions to mission operations, harm to individuals, or theft of intellectual property. Accordingly, GAO recommended that each of the 23 agencies fully implement these foundational practices. In May 2021, GAO received updates from six of the 23 agencies regarding actions taken or planned to address its recommendations. However, none of the agencies had fully implemented the recommendations. Until they do so, agencies will be limited in their ability to effectively address supply chain risks across their organizations. Why GAO Did This Study Federal agencies rely extensively on ICT products and services (e.g., computing systems, software, and networks) to carry out their operations. However, agencies face numerous ICT supply chain risks, including threats posed by malicious actors who may exploit vulnerabilities in the supply chain and, thus, compromise the confidentiality, integrity, or availability of an organization's systems and the information they contain. Recent events involving a software supply chain compromise of SolarWinds Orion, a network management software suite, and the shutdown of a major U.S. fuel pipeline due to a cyberattack highlight the significance of these threats. GAO was asked to testify on federal agencies' efforts to manage ICT supply chain risks. Specifically, GAO (1) describes the federal government's actions in response to the compromise of SolarWinds and (2) summarizes its prior report on the extent to which federal agencies implemented foundational ICT supply chain risk management practices. To do so, GAO reviewed its previously published reports and related information. GAO has ongoing work examining federal agencies' responses to SolarWinds and plans to issue a report on this in fall 2021.
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  • Florida Tax Preparer Charged in Connection with $7 Million Loan Fraud Scheme
    In Crime News
    A Florida tax preparer was charged in an indictment filed in the Eastern District of Pennsylvania yesterday with scheming to fraudulently obtain more than $7 million in Paycheck Protection Program (PPP) loans, Economic Injury Disaster Loans (EIDL) and pre-pandemic Small Business Administration (SBA) loans, and to launder the proceeds of the illegal scheme.
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  • DOD Critical Technologies: Plans for Communicating, Assessing, and Overseeing Protection Efforts Should Be Completed
    In U.S GAO News
    Critical technologies—such as elements of artificial intelligence and biotechnology—are those necessary to maintain U.S. technological superiority. As such, they are frequently the target of theft, espionage, and illegal export by adversaries. The Department of Defense (DOD) has outlined a revised process (see figure) to better identify and protect its critical technologies including those associated with acquisition programs throughout their lifecycle or those early in development. Prior DOD efforts to identify these technologies were considered by some military officials to be too broad to adequately guide protection. The revised process is expected to address this by offering more specificity about what elements of an acquisition program or technology need to be protected and the protection measures DOD is expected to implement. It is also expected to support DOD's annual input to the National Strategy for Critical and Emerging Technologies, which was first published in October 2020. Overview of DOD's Revised Process to Identify and Protect Critical Acquisition Programs and Technologies DOD began implementing this process in February 2020, and officials expect to complete all steps for the first time by September 2021. DOD has focused on identifying critical acquisition programs and technologies that need to be protected and how they should be protected. It has not yet determined how it will communicate the list internally and to other agencies, which metrics it will use to assess protection measures, and which organization will oversee future protection efforts. By determining the approach for completing these tasks, DOD can better ensure its revised process will support the protection of critical acquisition programs and technologies consistently across the department. Once completed, the revised process should also inform DOD and other federal agencies' protection efforts. Military officials stated they could use the list of critical acquisition programs and technologies to better direct resources. Officials from the Departments of State, Commerce, and the Treasury stated that they could use the list, if it is effectively communicated, to better understand what is important to DOD to help ensure protection through their respective programs. The federal government spends billions annually to develop and acquire advanced technologies. It permits the sale and transfer of some of these technologies to allies to promote U.S. national security, foreign policy, and economic interests. However, the technologies can be targets for adversaries. The John S. McCain National Defense Authorization Act for Fiscal Year 2019 requires the Secretary of Defense to develop and maintain a list of acquisition programs, technologies, manufacturing capabilities, and research areas that are critical for preserving U.S. national security advantages. Ensuring effective protection of critical technologies has been included on GAO's high-risk list since 2007. This report examines (1) DOD's efforts to identify and protect its critical technologies, and (2) opportunities for these efforts to inform government protection activities. GAO analyzed DOD critical acquisition program and technologies documentation, and held interviews with senior officials at DOD and other federal agencies responsible for protecting critical technologies. GAO is recommending that DOD specify how it will communicate its critical programs and technologies list, develop metrics to assess protection measures, and select the DOD organization that will oversee protection efforts beyond 2020. DOD concurred with the first recommendation and partially concurred with the second and third. GAO maintains the importance of all recommendations in this report. For more information, contact William Russell at (202) 512-4841 or russellw@gao.gov.
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  • Puerto Rico Mayor Pleads Guilty to Accepting Bribes in Exchange for Millions in Municipal Contracts
    In Crime News
    A mayor pleaded guilty yesterday in Puerto Rico to engaging in a bribery scheme in which he received cash payments in exchange for awarding municipal contracts to a particular company (Company A). Relatedly, a Puerto Rico contractor was arrested today for allegedly paying bribes and kickbacks to the mayor.
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  • Science & Tech Spotlight: Consumer Electronics Recycling
    In U.S GAO News
    Why This Matters Consumer electronics contain critical materials whose supplies are limited, including gold, platinum, and rare earth metals. Domestic recycling of consumer electronics could extend the supply and reduce the current U.S. reliance on imports. New technologies are becoming available, but electronics recycling is complex and faces challenges, such as narrow profit margins. The Technology What is it? Recycling of consumer electronics—including smartphones, televisions, and computers—generally involves separating high-value metals from plastics and other low-value materials. Precious metals and rare earth metals are the economic driving force for consumer electronic recycling technology. These metals have high market values and limited supplies, and they can be reused across many industries, including the defense and energy sectors. Consumer electronic devices can also contain personally identifiable information (PII), including medical and financial data, which could be improperly disclosed if they are not destroyed prior to recycling. According to a study of selected consumer electronics, about 2.8 million tons were disposed of in the U.S. in 2017, of which about 36 percent was recycled. Figure 1. Selected valuable, hazardous, and digital materials contained within consumer electronics that can be recovered, disposed, or destroyed There is no federal standard requiring consumer electronics recycling. Some states have enacted electronics recycling laws requiring electronics producers to pay fees or contract with businesses to ensure electronic waste is collected for recycling. The U.S. recycles electronics domestically and also exports electronics for recycling abroad. How does it work? The high concentration of valuable material in certain consumer electronics is key to the economic viability of recycling these products. Cell phones, as one example, have more precious metal by weight than raw ore does. According to the EPA, 35,274 pounds of copper, 772 pounds of silver, and 75 pounds of gold can be recovered from a million recycled cell phones. Based on commodity market prices on August 12, 2020, these weights of metals are worth approximately $100,000, $290,000, and $2.1 million for copper, silver, and gold, respectively. In contrast, cathode ray tube (CRT) displays in older televisions and computer monitors have little recycling value, but they contain leaded glass and may be considered hazardous waste. In addition, recovery of certain valuable materials from consumer electronics is limited due to the high costs of technology and processing. Electronics recycling companies disassemble devices by shredding, which also destroys PII, or by hand. These companies then separate valuable materials for reuse (including gold, silver, platinum, and rare earth metals) from toxic materials for disposal (including brominated materials and lead). Traditional methods include burning to remove non-metal parts and separation using strong acids. New separation technologies are being used or piloted to recover precious and rare earth metals. For example, robotic disassembly uses machine learning and computer vision to more rapidly pick and sort items. Another new technology uses ultrasound to speed up the chemical removal of gold from cell phone SIM cards. Figure 2. Emerging separation technologies for recycled electronics Other technologies are emerging, like biometallurgy, which uses microorganisms to separate high-value metals from other materials, such as plastics, glass, and glue. For example, naturally occurring bacteria can oxidize gold in acidic solutions, making it soluble and thus easier to separate from other materials. Other advanced techniques, such as magnetic or electrochemical separation, are showing promise in the laboratory with existing technology. For example, in one study, researchers used ultrasound to dissolve nickel and gold within a SIM card. They then used a magnetic field to separate the dissolved nickel, which is magnetic, from the gold, which is not. Similarly, other techniques use electric fields to separate dissolved metals based on their weight and electric charge. How mature is it? Recycling technology is well established for some traditional single-stream processes, such as aluminum recycling. However, electronic devices are more complex and require disassembly and separation. At least one consumer electronics manufacturer is piloting robotic disassembly for its products. Emerging separation technologies such as ultrasound have come to market in the past decade and are being used. Manual disassembly and shredding are decades old. Biometallurgy is being tested in pilot plants, and new microorganisms are being developed in laboratories to treat electronic waste. Opportunities Increase supply and reduce imports. Recycling could increase the domestic supply of precious and rare earth metals and reduce the current U.S. reliance on overseas sources. Grow the green economy. Developing advanced recycling technologies could promote domestic business and employment. Reduce hazardous practices. A significant amount of recycling currently occurs in the developing world, where methods include open-pit burning. New technology could reduce the use of such methods, which are hazardous to the environment and human health. Lessen environmental impacts. Developing advanced recycling technologies could reduce the environmental impacts of raw ore mining and landfill disposal of hazardous materials such as lead and brominated materials. Challenges Market challenges. Markets for recovered materials may be limited, and the value of recovered materials may not be enough to cover the costs of equipment for collection, sorting, disassembly, and separation. Secure destruction of personal information. Many electronic devices contain PII. Shredding them may effectively destroy PII but may also make high-value material harder to recover. Counterfeit electronic parts. Exported used electronics may serve as a source of counterfeit electronic parts, which, as GAO previously reported, could disrupt parts of the Department of Defense supply chain and threaten the reliability of weapons systems. (See GAO-16-236, linked below.) Rapid technological development. As consumer electronics made with new materials get smaller, new technologies for separation may be needed to recycle valuable materials. Policy Context and Questions With the volume of electronic waste expected to grow, questions include: How can programs to support technological innovation, economic development, and advanced manufacturing be leveraged to promote a more robust domestic electronics recycling industry? What efforts can the federal government, states, and others make to incentivize recycling rather than disposal? What are the potential benefits and challenges of such policies? What strategies can the public and private sectors implement to address the risk that exports of used electronics will contribute to unsafe recycling practices, disclosure of PII, and counterfeit electronics? How can reductions in exports bolster job growth? For more information, contact Karen Howard at (202) 512-6888 or HowardK@gao.gov.
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  • United States Obtains $140 Million in False Claims Act Judgments Against South Carolina Pain Management Clinics, Drug Testing Laboratories and a Substance Abuse Counseling Center
    In Crime News
    On Thursday, the U.S. District Court for the District of South Carolina entered default judgments for the United States totaling $136,025,077 against Oaktree Medical Centre P.C. (Oaktree), FirstChoice Healthcare P.C. (FirstChoice), Labsource LLC (Labsource), Pain Management Associates of the Carolinas LLC (PMA of the Carolinas) and Pain Management Associates of North Carolina P.C. (PMA of North Carolina).
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    In Crime News
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  • Bankruptcy: Enhanced Authority Could Strengthen Oversight of Executive Bonuses Awarded Before a Bankruptcy Filing
    In U.S GAO News
    What GAO Found Chapter 11 bankruptcy allows a company (debtor) to restructure its debt—so that it may continue to operate—and generally retain its executives. Section 503(c) of the Bankruptcy Code (Code) restricts retention bonuses for executives and, to a lesser extent, executive and non-executive incentive bonuses during bankruptcy. For instance, to pay an executive a retention bonus, the Code requires the debtor to meet three requirements, including that the executive has another job offer at the same or greater compensation. Also, debtors must obtain court approval to pay employee bonuses during bankruptcy—a process that gives creditors an opportunity to raise objections. However, the Code generally does not govern executive retention bonuses paid before a bankruptcy filing (pre-bankruptcy bonuses). Academics and attorneys GAO interviewed largely viewed Section 503(c) as less-than-effective because debtors can work around its restrictions on executive retention bonuses both before and during bankruptcy. For example, debtors can pay retention bonuses before filing (when there are generally no restrictions), or they can pay incentive bonuses during bankruptcy (that have fewer restrictions). Some stakeholders viewed Section 503(c) as overly restrictive, but others viewed it as helping to prevent abusive bonuses. Nearly all stakeholders GAO interviewed viewed pre-bankruptcy bonuses as problematic. For example, they said that these bonuses reduce the debtor estate's value for creditors but are awarded without notice to creditors or court approval. Based on court dockets for the approximately 7,300 companies that filed for Chapter 11 bankruptcy in fiscal year 2020, GAO found the following: Less than 1 percent (70) of debtors requested court approval to pay employee bonuses, and the courts approved nearly all the requests. Debtors awarded around $571 million to more than 16,600 executive and non-executive employees through court-approved bonuses. Creditors or U.S. Trustees (who administer and monitor Chapter 11 cases) raised objections in 50 percent of all bonus requests, including 68 percent of executive incentive bonus requests, which frequently led debtors to modify their plans (for example, by lowering bonus amounts). None of the debtors requested court approval for executive retention bonuses during bankruptcy; 42 debtors awarded pre-bankruptcy retention bonuses—totaling about $165 million—from 5 months to 2 days before filing. According to some attorneys GAO interviewed, Section 503(c) makes it nearly impossible to award executives retention bonuses during bankruptcy, so debtors use pre-bankruptcy bonuses as a workaround. As noted above, GAO found that none of the 7,300 Chapter 11 debtors that filed in fiscal year 2020 requested executive retention bonuses during bankruptcy but 42 awarded such bonuses shortly before filing. This practice may undermine Section 503(c)'s restrictions and decrease the ability of creditors, U.S. Trustees, and the courts to prevent bonuses that are inconsistent with the section's requirements. Why GAO Did This Study In response to potential abuses involving executive bonuses, Congress amended the Code in 2005 to restrict debtors in Chapter 11 from paying executives retention bonuses for staying through bankruptcy and, to a lesser extent, incentive bonuses to achieve performance targets. Recently, some large companies have paid their executives considerable bonuses during bankruptcy. House Report 116-455 included a provision for GAO to review Code provisions on bonuses and a selected number and amount of court-requested and approved bonuses in fiscal year 2020. This report reviews (1) Bankruptcy Code provisions on employee bonuses, (2) selected stakeholder views on such provisions, and (3) employee bonuses awarded by companies before or after filing for bankruptcy in fiscal year 2020. GAO reviewed the Code, academic literature, and legal analyses; interviewed 12 academics, attorneys, and an organization selected for their bankruptcy expertise; and analyzed bankruptcy filings and related data using Westlaw Edge and other sources.
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