Utah Company and Its Owner Plead Guilty to Wildlife Trafficking Charges

A Utah man and his company Natur Inc. pleaded guilty yesterday in federal court in Salt Lake City to violating the Lacey and Endangered Species Acts.

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  • Justice Department Settles With Texas Based Furniture and Appliances Chain for Charging Servicemembers Excess Interest
    In Crime News
    The Justice Department reached an agreement today with Conn Credit I, LP, Conn Appliances, Inc., and Conn’s, Inc. (“Conn’s”), to resolve allegations that they violated the Servicemembers Civil Relief Act (“SCRA”) by charging at least 184 servicemembers excess interest on their purchases. 
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  • Science & Tech Spotlight: Vaccine Safety
    In U.S GAO News
    Why this Matters Safe vaccines are critical to fighting diseases, from polio to COVID-19. Research shows that the protection provided by U.S. licensed vaccines outweighs their potential risks. However, misinformation and unjustified safety concerns can cause people to delay or refuse vaccination, which may increase preventable deaths and prolong negative social and economic impacts. The Science What is it? A vaccine is generally considered safe when the benefits of protecting an individual from disease outweigh the risks from potential side effects (fig. 1). The most common side effects stem from the body's immune reaction and include swelling at the injection site, fever, and aches. Figure 1. Symptoms of polio and side effects of the polio vaccine. A vaccine is generally considered safe if its benefits (preventing disease) outweigh its risks (side effects). In rare cases, some vaccines may cause more severe side effects. For example, the vaccine for rotavirus—a childhood illness that can cause severe diarrhea, dehydration, and even death—can cause intestinal blockage in one in 100,000 recipients. However, the vaccine is still administered because this very rare side effect is outweighed by the vaccine's benefits: it saves lives and prevents an estimated 40,000 to 50,000 childhood hospitalizations in the U.S. each year. The two messenger RNA (mRNA) vaccines authorized for COVID-19—a disease that contributed to more than 415,000 American deaths between January 2020 and January 2021—can cause severe allergic reactions. However, early safety reporting found that these reactions have been extremely rare, with only about five cases per 1 million recipients, according to data from January 2021 reports by the Centers for Disease Control and Prevention. In general, side effects from vaccines are less acceptable to the public than side effects from treatments given to people who already have a disease. What is known? Vaccine developers assess safety from early research, through laboratory and animal testing, and even after the vaccine is in use (fig. 2). Researchers may rely on previous studies to inform future vaccine trials. For example, safety information from preclinical trials of mRNA flu vaccine candidates in 2017 allowed for the acceleration of mRNA COVID-19 vaccine development. Vaccine candidates shown to be safe in these preclinical trials can proceed to clinical trials in humans. In the U.S., clinical trials generally proceed through three phases of testing involving increasing numbers of volunteers: dozens in phase 1 to thousands in phase 3. Although data may be collected over years, most common side effects are identified in the first 2 months after vaccination in clinical trials. After reviewing safety and other data from vaccine studies, the Food and Drug Administration (FDA) may license a vaccine to be marketed in the U.S. There are also programs to expedite—but not bypass—development and review processes, such as a priority review designation, which shortens FDA’s goal review time from 10 to 6 months. Safety monitoring continues after licensing. For example, health officials are required to report certain adverse events—such as heart problems—following vaccination, in order to help identify potential long-term or rare side effects that were not seen in clinical trials and may or may not be associated with the vaccine. Figure 2. Vaccine safety is assessed at every stage: development through post-licensure. Following a declared emergency, FDA can also issue emergency use authorizations (EUA) to allow temporary use of unlicensed vaccines if there is evidence that known and potential benefits of the vaccine outweigh known and potential risks, among other criteria. As of January 2021, two COVID-19 vaccines had received EUAs, after their efficacy and short-term safety were assessed through large clinical trials. However, developers must continue safety monitoring and meet other requirements if they intend to apply for FDA licensure to continue distribution of these vaccines after the emergency period has ended. What are the knowledge gaps? One knowledge gap that can remain after clinical trials is whether side effects or other adverse events may occur in certain groups. For example, because clinical trials usually exclude certain populations, such as people who are pregnant or have existing medical conditions, data on potential adverse events related to specific populations may not be understood until vaccines are widely administered. In addition, it can be difficult to determine the safety of new vaccines if outbreaks end suddenly. For example, vaccine safety studies were hindered during the 2014-2015 Ebola epidemic when a large increase in the number of cases was followed by a sharp decrease. This disrupted the clinical trials of Ebola vaccine candidates, because the trials require many infected and non-infected people. Furthermore, a lack of understanding and/or misinformation about the steps taken to ensure the safety of vaccines hinders accurate public knowledge about safety concerns, which may cause people to delay or refuse vaccination. This resulting hesitancy may, in turn, increase deaths, social harm, and economic damage. Opportunities Continuing and, where necessary, improving existing vaccine safety practices offers the following opportunities to society: Herd immunity. Widespread immunity in a population, acquired in large part through safe and effective vaccines, can slow the spread of infection and protect those most vulnerable. Health care improvements. Vaccinations can reduce the burden on the health care system by reducing severe symptoms that require individuals to seek treatment. Eradication. Safe vaccination programs, such as those combatting smallpox, may eliminate diseases to the point where transmission no longer occurs. Challenges There are a number of challenges to ensuring safe vaccines: Public confidence. Vaccine hesitancy, in part due to misinformation or historic unethical human experimentation, decreases participation in clinical trials, impeding identification of side effects across individuals with different racial, ethnic, and socioeconomic backgrounds. Mutating viruses. Some viruses, such as those that cause the flu or COVID-19, may mutate rapidly and thus may require new or updated vaccines, for which ongoing safety monitoring is important. Long-term and rare effects. Exceedingly rare or long-term effects may not be identified until after vaccines have been widely administered. Further study is needed to detect any such effects and confirm they are truly associated with the vaccine. Policy Context & Questions What steps can policymakers take to improve public trust and understanding of the process of assessing vaccine safety? How can policymakers convey the social importance of vaccines to protect the general public and those who are most vulnerable? How can policymakers leverage available resources to support ongoing vaccine development and post-licensure safety monitoring? For more information, contact Karen Howard at (202) 512-6888 or HowardK@gao.gov.
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  • Former Owner of Aquarium Business Sentenced to Prison for Illicit Trafficking of Protected Reef Creatures
    In Crime News
    The Justice Department announced today that a Puerto Rico man was sentenced to a year and a day in federal prison for felony violations of the Lacey Act that involved the trafficking and false labeling of protected reef creatures as part of an effort to subvert Puerto Rican laws designed to protect coral reef organisms.
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  • Reagan National Airport: Information on Effects of Federal Statute Limiting Long-Distance Flights
    In U.S GAO News
    Airlines serving Ronald Reagan Washington National Airport (Reagan National) are subject to, among other federal operational requirements, (1) a “perimeter rule,” limiting nonstop flights to a distance of 1,250 miles unless there is an exemption, and (2) a “slot” or operating authorization requirement for each takeoff and landing. GAO found that while the 40 daily beyond-perimeter flights to or from Reagan National accounted for about 6 percent of flights and 10 percent of passengers at the airport in 2019, the additional flights may have had some limited effects, including further reducing the airport's landside capacity (e.g., ticketing and gates). GAO's analysis of the Department of Transportation's (DOT) data from 2010 through 2019 showed that airlines used larger aircraft on beyond-perimeter flights carrying, on average, about 75 more passengers than within-perimeter flights. While these larger aircraft may use more capacity, they did not contribute to a substantial increase in flight delays at Reagan National. The beyond-perimeter flights may have also had other effects, such as drawing a few flights and passengers from Washington Dulles International Airport (Dulles). 2020 Beyond-Perimeter Flight Exemptions at Ronald Reagan Washington National Airport Several factors—existing slot control rules; capacity at Reagan National; and potential effects on noise, other area airports, passengers, and airline competition—should be considered in any decision to modify Reagan National's perimeter rule, according to GAO's prior work and stakeholder interviews. GAO examined these factors under three scenarios: (1) no changes to the current perimeter rule or beyond-perimeter flights, (2) adding a small number of beyond-perimeter flights, and (3) completely lifting the perimeter rule. Many stakeholders who provided a perspective did not support changes to the perimeter rule, citing concerns about increased congestion at Reagan National or drawing passengers from other airports, primarily Dulles. Some stakeholders supported adding a small number of beyond-perimeter flights, citing increased competition if airlines added service to existing routes. No stakeholders supported lifting the perimeter rule, saying it would disadvantage airlines with a small number of flights at Reagan National. Regardless of their position on the rule, many stakeholders said airlines would add beyond-perimeter flights if allowed. Reagan National's perimeter and slot control rules were designed in part, respectively, to help increase use of Dulles and manage congestion at Reagan National by limiting the number of flights. On three occasions—2000, 2003, and 2012—federal statutes have provided exemptions to the perimeter rule, collectively allowing 40 daily beyond-perimeter flights (20 round trips) at Reagan National. Of these exemptions, 32 were new beyond-perimeter flights and eight allowed airlines to convert existing slots to beyond-perimeter flights. The Metropolitan Washington Airports Authority (MWAA) operates Reagan National and Dulles, and DOT and the Federal Aviation Administration (FAA) oversee these rules. GAO was asked to update its past work on the perimeter rule. This report describes (1) the effects of beyond-perimeter flights at Reagan National, and (2) key considerations if additional beyond-perimeter flights are allowed. GAO analyzed DOT data for the most recent 10-year period (2010 through 2019) on passengers and flights at Reagan National and Dulles, and MWAA data on airport capacity at Reagan National in 2019. GAO also reviewed relevant statutes and regulations, and interviewed DOT and FAA officials, and a non-generalizable sample of 32 stakeholders: 9 airlines, 4 airport authorities, 7 academics, 5 associations, 5 community groups, and 2 consumer advocates. Selected airlines included those that operate out of Reagan National or Dulles; other stakeholders were recommended or selected, in part, from prior GAO work and their expertise on the topic. For more information, contact Heather Krause at (202) 512-2834 or krauseh@gao.gov.
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    A Massachusetts woman pleaded guilty today to tax evasion, conspiracy to distribute marijuana, possession of marijuana with intent to distribute, and money laundering.
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  • USDA Market Facilitation Program: Information on Payments for 2019
    In U.S GAO News
    The U.S. Department of Agriculture's (USDA) Farm Service Agency (FSA) distributed about $14.4 billion in 2019 Market Facilitation Program (MFP) payments to farming operations in all 50 states and Puerto Rico. According to USDA, these payments were intended to offset the effects of trade disruptions and tariffs targeting a variety of U.S. agricultural products. FSA distributed these payments to 643,965 farming operations. The average MFP payment per farming operation for 2019 was $22,312 but varied by county, ranging from $44 to $295,299. MFP payments for 2019 also varied by type of commodity. Three types of commodities were eligible for 2019 MFP payments: (1) nonspecialty crops (including grains and oilseeds, such as corn and soybeans); (2) specialty crops (including nuts and fruits, such as pecans and cranberries); and (3) dairy and hogs. Most of the 2019 MFP payments went to farming operations that produced nonspecialty crops. Less than 10 percent went to farming operations that produced specialty crops or dairy and hogs. USDA made approximately $519 million in additional MFP payments for 2019 compared with 2018 because of increases in payment limits—the cap on payments that members of farming operations can receive. FSA distributed these additional MFP payments to about 10,000 farming operations across 39 states. The amount of additional MFP payments that FSA distributed for 2019 varied by location. Farming operations in five states—Texas, Illinois, Iowa, Missouri, and Minnesota—received almost half of all additional payments. In May 2019, USDA announced it would distribute up to $14.5 billion in direct payments to farming operations that were affected by trade disruptions, following the approximately $8.6 billion USDA announced it had distributed for 2018. USDA referred to these 2018 and 2019 payments as the MFP. In comparison with 2018, USDA changed the 2019 payment structure for the three types of commodities that were eligible for payments. For example, USDA increased the payment limit for each of these three types. GAO was asked to review the distribution of MFP payments for 2019. This report examines, among other things, MFP payments for 2019 and how they varied by location, farming operation, and type of commodity, as well as additional MFP payments for 2019 compared with 2018 that resulted from increased payment limits. To accomplish these objectives, GAO analyzed data from USDA and interviewed agency officials knowledgeable about the data. For more information, contact Steve Morris at (202) 512-3841 or morriss@gao.gov.
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  • Information Technology: Agencies Need to Develop and Implement Modernization Plans for Critical Legacy Systems
    In U.S GAO News
    What GAO Found In June 2019, GAO identified 10 critical federal information technology (IT) legacy systems that were most in need of modernization. These legacy systems provided vital support to agencies' missions. According to the agencies, these legacy systems ranged from about 8 to 51 years old and, collectively, cost about $337 million annually to operate and maintain. Several of the systems used older languages, such as Common Business Oriented Language (COBOL). GAO has previously reported that reliance on such languages has risks, such as a rise in procurement and operating costs, and a decrease in the availability of individuals with the proper skill sets. Further, several of the legacy systems were operating with known security vulnerabilities and unsupported hardware and software. Of the 10 agencies responsible for these legacy systems, GAO reported in June 2019 that seven agencies (the Departments of Defense, Homeland Security, the Interior, the Treasury; as well as the Office of Personnel Management; Small Business Administration; and Social Security Administration) had documented plans for modernizing the systems (see table). Of the seven agencies with plans, only the Departments of the Interior's and Defense's modernization plans included all of the key elements identified in best practices (milestones, a description of the work necessary to complete the modernization, and a plan for the disposition of the legacy system). The other five agencies lacked complete modernization plans. The Departments of Education, Health and Human Services, and Transportation did not have documented modernization plans. Table: Extent to Which Agencies' Had Documented Modernization Plans for Legacy Systems That Included Key Elements, as of June 2019 Agency Included milestones to complete the modernization Described work necessary to modernize system Summarized planned disposition of legacy system Department of Defense Yes Yes Yes Department of Education n/a – did not have a documented modernization plan Department of Health and Human Services n/a – did not have a documented modernization plan Department of Homeland Security No Yes No Department of the Interior Yes Yes Yes Department of the Treasury Partial Yes No Department of Transportation n/a – did not have a documented modernization plan Office of Personnel Management Partial Partial No Small Business Administration Yes No Yes Social Security Administration Partial Partial No Source: GAO analysis of agency modernization plans. | GAO-21-524T Agencies received a “partial” if the element was completed for a portion of the modernization. GAO stressed that, until the eight agencies established complete plans, their modernizations would face an increased risk of cost overruns, schedule delays, and project failure. Accordingly, GAO recommended that each of the eight develop such plans. However, to date, seven of the agencies had not done so. It is essential that agencies implement GAO's recommendations and these plans in order to meet mission needs, address security risks, and reduce operating costs. Why GAO Did This Study Each year, the federal government spends more than $100 billion on IT and cyber-related investments. Of this amount, agencies have typically spent about 80 percent on the operations and maintenance of existing IT investments, including legacy systems. However, federal legacy systems are becoming increasingly obsolete. In May 2016, GAO reported instances where agencies were using systems that had components that were at least 50 years old or the vendors were no longer providing support for hardware or software. Similarly, in June 2019 GAO reported that several of the federal government's most critical legacy systems used outdated languages, had unsupported hardware and software, and were operating with known security vulnerabilities. GAO was asked to testify on its June 2019 report on federal agencies' legacy systems. Specifically, GAO summarized (1) the critical federal legacy systems that we identified as most in need of modernization and (2) its evaluation of agencies' plans for modernizing them. GAO also provided updated information regarding agencies' implementation of its related recommendations.
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    In Crime News
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    In Crime News
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  • Science & Tech Spotlight: Air Quality Sensors
    In U.S GAO News
    Why This Matters Air quality sensors are essential to measuring and studying pollutants that can harm public health and the environment. Technological improvements have led to smaller, more affordable sensors as well as satellite-based sensors with new capabilities. However, ensuring the quality and appropriate interpretation of sensor data can be challenging. The Technology What is it? Air quality sensors monitor gases, such as ozone, and particulate matter, which can harm human health and the environment. Federal, state, and local agencies jointly manage networks of stationary air quality monitors that make use of sensors. These monitors are expensive and require supporting infrastructure. Officials use the resulting data to decide how to address pollution or for air quality alerts, including alerts during wildfires or on days with unhealthy ozone levels. However, these networks can miss pollution at smaller scales and in rural areas. They generally do not measure air toxics—more localized pollutants that may cause cancer and chronic health effects—such as ethylene oxide and toxic metals. Two advances in sensor technologies may help close these gaps. First, newer low-cost sensors can now be deployed virtually anywhere, including on fences, cars, drones, and clothing (see fig. 1). Researchers, individuals, community groups, and private companies have started to deploy these more affordable sensors to improve their understanding of a variety of environmental and public health concerns. Second, federal agencies have for decades operated satellites with sensors that monitor air quality to understand weather patterns and inform research. Recent satellite launches deployed sensors with enhanced air monitoring capabilities, which researchers have begun to use in studies of pollution over large areas. Figure 1. There are many types of air quality sensors, including government-operated ground-level and satellite-based sensors, as well as low-cost commercially available sensors that can now be used on a variety of platforms, such as bicycles, cars, trucks, and drones. How does it work? Low-cost sensors use a variety of methods to measure air quality, including lasers to estimate the number and size of particles passing through a chamber and meters to estimate the amount of a gas passing through the sensor. The sensors generally use algorithms to convert raw data into useful measurements (see fig. 2). The algorithms may also adjust for temperature, humidity and other conditions that affect sensor measurements. Higher-quality devices can have other features that improve results, such as controlling the temperature of the air in the sensors to ensure measurements are consistent over time. Sensors can measure different aspects of air quality depending on how they are deployed. For example, stationary sensors measure pollution in one location, while mobile sensors, such as wearable sensors carried by an individual, reflect exposure at multiple locations. Satellite-based sensors generally measure energy reflected or emitted from the earth and the atmosphere to identify pollutants between the satellite and the ground. Some sensors observe one location continuously, while others observe different parts of the earth over time. Multiple sensors can be deployed in a network to track the formation, movement, and variability of pollutants and to improve the reliability of measurements. Combining data from multiple sensors can increase their usefulness, but it also increases the expertise needed to interpret the measurements, especially if data come from different types of sensors. Figure 2. A low-cost sensor pulls air in to measure pollutants and stores information for further study. How mature is it? Sensors originally developed for specific applications, such as monitoring air inside a building, are now smaller and more affordable. As a result, they can now be used in many ways to close gaps in monitoring and research. For example, local governments can use them to monitor multiple sources of air pollution affecting a community, and scientists can use wearable sensors to study the exposure of research volunteers. However, low-cost sensors have limitations. They operate with fewer quality assurance measures than government-operated sensors and vary in the quality of data they produce. It is not yet clear how newer sensors should be deployed to provide the most benefit or how the data should be interpreted. Some low-cost sensors carry out calculations using artificial intelligence algorithms that the designers cannot always explain, making it difficult to interpret varying sensor performance. Further, they typically measure common pollutants, such as ozone and particulate matter. There are hundreds of air toxics for which additional monitoring using sensors could be beneficial. However, there may be technical or other challenges that make it impractical to do so. Older satellite-based sensors typically provided infrequent and less detailed data. But newer sensors offer better data for monitoring air quality, which could help with monitoring rural areas and pollution transport, among other benefits. However, satellite-based sensor data can be difficult to interpret, especially for pollution at ground level. In addition, deployed satellite-based sensor technologies currently only measure a few pollutants, including particulate matter, ozone, sulfur dioxide, nitrogen dioxide, formaldehyde, and carbon monoxide. Opportunities Improved research on health effects. The ability to track personal exposure and highly localized pollution could improve assessments of public health risks. Expanded monitoring. More dense and widespread monitoring could help identify pollution sources and hot spots, in both urban and rural areas. Enhanced air quality management. Combined measurements from stationary, mobile, and satellite-based sensors can help officials understand and mitigate major pollution issues, such as ground-level ozone and wildfire smoke. Community engagement. Lower cost sensors open up new possibilities for community engagement and citizen science, which is when the public conducts or participates in the scientific process, such as by making observations, collecting and sharing data, and conducting experiments. Challenges Performance. Low-cost sensors have highly variable performance that is not well understood, and their algorithms may not be transparent. Low-cost sensors operated by different users or across different locations may have inconsistent measurements. Interpretation. Expertise may be needed to interpret sensor data. For example, sensors produce data in real time that may be difficult to interpret without health standards for short-term exposures. Data management. Expanded monitoring will create large amounts of data with inconsistent formatting, which will have to be stored and managed. Alignment with needs. Few of the current low-cost and satellite-based sensors measure air toxics. In addition, low-income communities, which studies show are disproportionally harmed by air pollution, may still face challenges deploying low-cost sensors. Policy Context and Questions How can policymakers leverage new opportunities for widespread monitoring, such as citizen science, while also promoting appropriate use and interpretation of data? How can data from a variety of sensors be integrated to better understand air quality issues, such as environmental justice concerns, wildfires, and persistent ozone problems? How can research and development efforts be aligned to produce sensors to monitor key pollutants that are not widely monitored, such as certain air toxics? For more information, contact Karen Howard at (202) 512-6888 or HowardK@gao.gov.
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  • Organ Transplants: Changes in Allocation Policies for Donated Livers and Lungs
    In U.S GAO News
    The Organ Procurement and Transplantation Network (OPTN) develops allocation policies in the United States to determine which transplant candidates receive offers for organs, such as livers or lungs, that are donated from deceased donors. In July 2018, the Department of Health and Human Services (HHS), which oversees OPTN, directed it to change the liver allocation policy to be more consistent with federal regulations. The liver allocation policy changed in February 2020 from a system that, in general, offered donated livers first to the sickest candidates within the fixed boundaries of a donation service area or region to a system based on a candidate's level of illness and distance from the donor hospital. The current liver allocation policy offers livers first to the sickest candidates within 500 nautical miles of the donor hospital using a series of distance-based concentric circles, called acuity circles. The processes used to develop the liver and lung allocation policies had various similarities and differences. For example, while the current liver allocation policy, the 2017 liver allocation policy, and the current lung allocation policy each had public comment periods, the length of these comment periods varied—25 days for the current liver allocation policy; two separate 62-day and 64-day periods for the 2017 liver allocation policy; and 61 days (retroactive) for the current lung allocation policy. In addition, the current lung allocation policy resulted in part from a federal district court order directing HHS to initiate emergency review of the policy. However, the 2017 liver allocation policy—that was approved but never implemented—resulted from a 2012 OPTN Board directive to reduce geographic disparities in organ allocation. HHS oversight of OPTN's processes were similar for all three allocation policies and included reviewing the proposed changes to the policies to ensure compliance with federal regulations, according to HHS officials. Timeline of Selected Events Related to Three Organ Allocation Policies Organ transplantation is the leading form of treatment for patients with severe organ failure. OPTN, a nonprofit entity that was established in 1984 under the National Organ Transplant Act, manages the nation's organ allocation system. In 2019, 32,322 organs were transplanted from deceased donors in the United States. Nevertheless, as of July 2020, close to 110,000 individuals remained on waiting lists for donor organs. Previously, donated livers and lungs were generally offered first to the sickest candidates in donation service areas. However, livers and lungs are now generally offered first to the sickest candidates based on distance. GAO was asked to review the changes to the liver and lung allocation policies. This report describes (1) changes to the liver allocation policy, and (2) similarities and differences in the processes OPTN used to change the liver and lung allocation policies, and federal oversight of these processes, among other things. GAO reviewed documents, including those related to the current liver and lung allocation policies, and the 2017 liver allocation policy; interviewed HHS officials and OPTN members; reviewed the National Organ Transplant Act and its implementing regulations; and conducted a literature review of studies published from January 2017 through April 2020 in peer-reviewed and other publications. HHS and the United Network for Organ Sharing (the contractor serving as OPTN) provided technical comments on a draft of this report, which GAO incorporated as appropriate. For more information, contact James Cosgrove at (202) 512-7114 or cosgrovej@gao.gov.
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    In U.S GAO News
    Research conducted at Department of Health and Human Services (HHS) labs led to 4,446 U.S. patents owned by the agency covering a range of inventions from 1980 through 2019. During that period, the National Institutes of Health (NIH) had 93 patents—2 percent of the total—that contributed to the successful development of 34 drugs approved by the Food and Drug Administration (FDA) and brought to market, including vaccines and treatments for cancer. These 34 drugs were developed by pharmaceutical companies and were associated with 32 licenses granted to them by NIH. As shown in the figure, these licenses have generated up to $2 billion in royalty revenue for NIH since 1991, when FDA approved the first of these drugs. Three licenses generated more than $100 million each for the agency. Royalties from NIH Licenses of Inventions Associated with FDA-Approved Drugs, 1991 to February 2020 When licensing its inventions, NIH prioritizes the likelihood that the licensee can successfully develop a drug by considering such factors as technical expertise and the ability to raise capital. Consistent with federal interpretation of technology transfer statutory authorities, NIH does not consider the affordability of the resulting drug. NIH provides limited information to the public about its licensing activities. For example, the agency does not report which of its patents are licensed or release metrics that would enable the public to evaluate how licensing affects patient access to resulting drugs. Increasing the transparency of its licensing activities could improve the public’s and policymakers’ understanding of NIH’s management of its intellectual property. HHS monitors for unauthorized use of its inventions (infringement) and has taken steps to protect its rights. HHS relies primarily on inventors at its labs to monitor for potential infringement and generally encourages potential infringers to license the inventions. If cases proceed to litigation, HHS relies on the Department of Justice (DOJ) to protect its rights. Since 2009, HHS has worked with DOJ to defend its intellectual property in several cases in the U.S. and abroad and has referred one case to DOJ for litigation against an alleged infringer. HHS labs conduct research that can contribute to the development of new life-saving drugs. HHS may grant rights to its inventions by licensing the patents to pharmaceutical companies that conduct the additional development activities and testing necessary to bring drugs to market. Public health experts and patients’ rights advocates have raised concerns about the prices of drugs developed with federal support. GAO was asked to review HHS’s management of its intellectual property. This report examines (1) the extent to which HHS-owned intellectual property has contributed to the development of FDA-approved drugs, (2) what is known about the licenses associated with FDA-approved drugs, (3) factors NIH prioritizes when licensing its inventions and information about licensing it makes public, and (4) steps HHS has taken to protect its rights. GAO reviewed relevant laws and agency documents, analyzed patent and licensing data, and interviewed HHS officials, academic experts, industry representatives, and nongovernmental organizations. GAO is making two recommendations, including that NIH provide more information to the public about the licensing of its intellectual property. HHS concurred with GAO’s recommendations. For more information, contact John Neumann, (202) 512-6888, NeumannJ@gao.gov.
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    The Justice Department, along with the New York City Police Department (NYPD) and U.S. Army Counterintelligence, announced today the arrest of a private first class in the U.S. Army, on federal terrorism charges based on Bridges’ alleged efforts to assist ISIS to attack and kill U.S. soldiers in the Middle East. 
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  • GAO Audits Involving DOD: Status of Efforts to Schedule and Hold Timely Entrance Conferences
    In U.S GAO News
    GAO began 42 new audits that involved the Department of Defense (DOD) in the third quarter of fiscal year 2020. Of the 42 requested entrance conferences (i.e., initial meetings between agency officials and GAO staff) for those audits, DOD scheduled 41 within 14 days of notification and held all 42 entrance conferences within 30 days of notification. Scheduling was delayed for one entrance conference, which was scheduled 21 days after notification, because DOD and GAO were working to reach agreement on the primary action officer, which is the appropriate office or component within the department that coordinates DOD's response to the audit. The entrance conference was held 8 days after it was scheduled. Entrance conferences allow GAO to communicate its audit objectives and enable agencies to assign key personnel to support the audit work. GAO's agency protocols govern GAO's relationships with audited agencies. These protocols assist GAO in scheduling entrance conferences with key agency officials within 14 days of receiving notice of a new audit. The ability of the Congress to conduct effective oversight of federal agencies is enhanced through the timely completion of GAO audits. In past years, DOD experienced difficulty meeting the protocol target for the timely facilitation of entrance conferences. In Senate Report 116-48 accompanying a bill for the National Defense Authorization Act for Fiscal Year 2020, the Senate Armed Services Committee included a provision for GAO to review DOD's scheduling and holding of entrance conferences. In this report, GAO's agency protocols govern GAO's relationships with audited agencies. These protocols assist GAO in scheduling entrance conferences with key agency officials within 14 days of receiving notice of a new audit. The ability of the Congress to conduct effective oversight of federal agencies is enhanced through the timely completion of GAO audits. In past years, DOD experienced difficulty meeting the protocol target for the timely facilitation of entrance conferences. In Senate Report 116-48 accompanying a bill for the National Defense Authorization Act for Fiscal Year 2020, the Senate Armed Services Committee included a provision for GAO to review DOD's scheduling and holding of entrance conferences. In this report, GAO evaluates the extent to which DOD scheduled entrance conferences within 14 days of receiving notice of a new audit, consistent with GAO's agency protocols, and held those conferences within 30 days. This is the third of four quarterly reports that GAO will produce on this topic for fiscal year 2020. In the first two quarterly reports, GAO found that DOD had improved its ability to meet the protocol target. GAO analyzed data on GAO audits involving DOD and initiated in the third quarter of fiscal year 2020 (April 1, 2020, through June 30, 2020). Specifically, GAO identified the number of notification letters requesting entrance conferences that were sent to DOD during that time period. GAO determined the number of days between when DOD received the notification letter for each new audit and when DOD scheduled the entrance conference and assessed whether DOD scheduled entrance conferences within 14 days of notification, which is the time frame identified in GAO's agency protocols. GAO also determined the date that each requested entrance conference was held by collecting this information from the relevant GAO team for each audit and assessed whether DOD held entrance conferences for new audits within 30 days of notification, which was the time frame identified in the mandate for this review For more information, contact Elizabeth Field at (202) 512-2775 or Fielde1@gao.gov.
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  • Transportation Research: Additional Actions Could Improve DOT’s Internal Collaboration and Reliability of Information on Research Activities
    In U.S GAO News
    The Department of Transportation (DOT) uses a multistep, centralized process to prioritize and select research activities it will fund. DOT's modal administrations—which focus on specific modes of transportation like air, rail, and highways—conduct and manage most of DOT's research. The modal administrations GAO spoke to used a variety of methods to prioritize and select research, including soliciting stakeholders' feedback on research needs. The Office of the Assistant Secretary for Research and Technology (OST-R) is responsible for reviewing this proposed research to ensure alignment with DOT's strategic plans and to prevent duplicative research efforts, as required by statute. DOT has multiple efforts to facilitate research collaboration both externally and internally, but in guidance to promote collaboration, OST-R did not incorporate all leading practices. Specifically, OST-R established topical-research working groups on 12 multimodal subject areas in October 2018 and issued accompanying guidance. This guidance incorporated some leading collaboration practices, such as directing working groups to identify leadership roles and relevant participants. However, the guidance did not incorporate two leading practices—defining and monitoring progress toward long-term outcomes and regularly updating and monitoring written agreements. Taking steps to ensure the working groups follow these practices could provide OST-R greater assurance that the groups coordinate their efforts effectively, better plan long-term research, and better position themselves to address future transportation challenges. OST-R has taken some steps to help ensure that its public database on DOT-funded research projects (the Research Hub) contains complete and accurate information, as required by DOT's data management policy; however, data reliability issues remained. For example, as of July 2019—the latest available data at the time of GAO's analysis—36 percent of records in the database were missing research partners' contact information, hindering the research community's ability to obtain current project details. Taking additional steps, such as providing instructions to the modal administrations on how to improve the completeness and accuracy of the information they give OST-R for the Research Hub, would help ensure the database is fulfilling DOT's intended purpose that it serve as a reliable source of information on the department's research portfolio. Examples of Research Activities on Advanced Driver-Assistance Systems and Connected Vehicles Funded by the U.S. Department of Transportation DOT's research activities are critical to DOT's mission to make the nation's transportation system safer and more efficient. To meet current research needs and prepare for emerging technologies, DOT partners with public and private entities. In fiscal year 2018, DOT funded about 2,300 partners and had a research budget exceeding $1 billion. GAO was asked to review DOT's research activities. This report addresses: (1) how DOT prioritizes and selects which research activities it will undertake; (2) the extent to which DOT facilitates research collaboration with external stakeholders and across the department; and (3) the extent to which DOT ensures its Research Hub database contains complete and accurate project information. GAO reviewed documents and analyzed data from DOT; observed DOT-funded research; interviewed DOT officials from OST-R and four selected modal administrations; and used GAO's leading collaboration practices to assess the extent of collaboration. GAO also interviewed 17 DOT research partners, including universities and associations. GAO recommends that OST-R (1) take steps to ensure the topical-research working groups follow all leading collaboration practices, and (2) take additional steps to ensure the information in the Research Hub is complete and accurate. DOT concurred with GAO's recommendations. For more information, contact Elizabeth Repko at (202) 512-2834 or repkoe@gao.gov.
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