Former Owner of Aquarium Business Sentenced to Prison for Illicit Trafficking of Protected Reef Creatures

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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  • Environment and Natural Resources Division Distributes Memorandum Summarizing Enforcement Policies and Priorities
    In Crime News
    On Friday, the Environment and Natural Resources Division publicly distributed a memorandum summarizing important principles and priorities for environmental enforcement. The memorandum, issued Jan. 14 by outgoing Assistant Attorney General Jeffrey Bossert Clark, emphasizes that robust enforcement of our nation's environmental laws remains one of the division’s highest priorities. It emphasizes that, when engaged in criminal and civil enforcement, it is important that the division continue to enhance the fair and impartial application of the law.
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    In Crime News
    During a visit with law enforcement in Memphis today, Attorney General William P. Barr announced updates on Operation Legend, which was expanded to Memphis on Aug. 6, 2020.
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    In Crime News
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  • Michigan Man Charged with Hate Crimes for Attacking African-American Teenager
    In Crime News
    The Justice Department announced today that Lee Mouat, 42, has been charged by criminal complaint in federal district court with violating 18 U.S.C. § 249 by willfully causing bodily injury to an African-American teenager because of the teenager’s race.
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    In Crime News
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    In Crime News
    A Utah man and his company were charged in an indictment today with violating the Endangered Species Act and Lacey Act for their role in illegal wildlife trafficking, announced Principal Deputy Assistant Attorney General Jonathan D. Brightbill of the Justice Department’s Environment and Natural Resources Division and U.S. Attorney John W. Huber of the District of Utah.
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    In Crime News
    I want to first thank Secretary Pompeo and Special Envoy Carr for hosting this conference and for inviting me to participate. As we have heard, the Internet is just the latest outlet for the “oldest hatred.” The litany of attacks on the Jewish people has gone on through every era of history. We should not be surprised then--even though it saddens us--that it is part of our modern world. And, since that world depends on the Internet for communication, commerce, and daily life, anti-Semites can use it for their purposes as much as anyone else can use it for legitimate causes.
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    In Crime News
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    In Crime News
    The Justice Department announced today that it signed a settlement agreement with Fleetlogix Inc. (Fleetlogix) resolving claims that the company discriminated against work-authorized non-U.S. citizens by requiring them to provide specific and unnecessary work authorization documentation because of their citizenship or immigration status. Fleetlogix, based in San Diego, California, operates offices nationwide that provide cleaning and transportation services to rental car companies.
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    In Crime News
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  • Crude Oil Markets: Effects of the Repeal of the Crude Oil Export Ban
    In U.S GAO News
    GAO's analysis of U.S. Energy Information Administration (EIA) data and interviews with industry stakeholders shows that the repeal of the U.S. crude oil export ban is associated with increased crude oil exports—from less than half a million barrels per day in 2015 to almost 3 million barrels per day in 2019. The repeal of the ban expanded the market for U.S. crude oil to overseas buyers and, along with other market factors, allowed U.S. crude oil producers to charge higher prices relative to comparable foreign crude oil. Higher prices and an expanded market for U.S. crude oil further incentivized domestic crude oil production, which had been growing since the shale oil boom began around 2009 (see figure). During the period after the repeal, total U.S. imports of crude oil remained largely unchanged. Annual Production and Exports of U.S. Crude Oil, 2009-2019 GAO's analysis found limited effects associated with the repeal of the ban on the production, export, and import of domestic refined petroleum products, such as gasoline. However, profit margins—which are determined in part by the costs a refiner pays for the crude oil and the earnings a refiner receives from the sale of refined products—likely decreased as the prices refiners paid for domestic crude oil increased relative to international prices. Because gasoline prices are largely determined on the global market, U.S. refiners could not pass on to consumers the additional costs associated with the increase in crude oil prices, resulting in decreased profit margins for U.S. refiners. Finally, after the repeal of the crude oil export ban, the U.S. shipping industry experienced a decline as demand fell for U.S. tankers—known as Jones Act tankers—used to move domestic crude oil between U.S. ports. The increase in the relative price of domestic crude oils associated with the repeal of the export ban may have resulted in some U.S. refineries deciding to use more foreign crude oil. Foreign crude oil is typically transported by foreign tankers, reducing the demand for Jones Act tankers compared to what it would have been if the export ban had remained in place, according to six of the seven shipping industry stakeholders GAO interviewed. Between 1975 and the end of 2015, the Energy Policy and Conservation Act directed a ban on nearly all exports of U.S. crude oil. This ban was not considered a significant policy issue when U.S. oil production was declining and import volumes were increasing. However, U.S. crude oil production roughly doubled from 2009 to 2015, due in part to a boom in shale oil production made possible by advancements in drilling technologies. In December 2015, Congress effectively repealed the ban, allowing the free export of U.S. crude oil worldwide. GAO was asked to provide information on the effects of repealing the crude oil export ban. This report describes the effects of the repeal of the crude oil export ban on the domestic crude oil production, petroleum refining, and related sectors of the U.S. shipping industry. GAO analyzed data from EIA and other federal databases to determine the effects of repealing the export ban. GAO also interviewed a nongeneralizeable sample of economists, market analysts, and stakeholders from the oil and gas, refining, and shipping industries. GAO's analysis focused on the repeal of the crude oil export ban and any effects of the repeal on U.S. crude oil and related industries through March 2020. For more information, contact Frank Rusco at (202) 512-3841 or ruscof@gao.gov.
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  • United States Seizes 27 Additional Domain Names Used by Iran’s Islamic Revolutionary Guard Corps to Further a Global, Covert Influence Campaign
    In Crime News
    The United States has seized 27 domain names that Iran’s Islamic Revolutionary Guard Corps (IRGC) unlawfully used to further a global covert influence campaign.
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  • Justice Department Releases Report On Modernizing The Administrative Procedure Act
    In Crime News
    WASHINGTON – The Justice Department released a report today on the need for Congress to update and improve the Administrative Procedure Act (APA), the 74-year-old statute setting forth the procedures agencies must follow when regulating individuals, businesses, non-profits, and state and local government entities. The report, entitled Modernizing the Administrative Procedure Act, discusses how the administrative state has developed in ways not foreseen by the APA in 1946, how the APA might be legislatively improved, and how this Administration’s improvements to agencies’ regulatory processes could inform modernizing the APA. The Justice Department, which significantly shaped the original APA, hopes that the ideas and insights discussed in the report will encourage and inform much needed action by Congress to modernize the APA.
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  • Science & Tech Spotlight: Tracing the Source of Chemical Weapons
    In U.S GAO News
    Why This Matters Some governments are suspected of using chemical weapons despite international prohibitions under the Chemical Weapons Convention. For example, sarin and VX nerve gas have been identified in attacks. Most recently, Novichok nerve agent was used in 2020. Technologies exist to identify chemical warfare agents and possibly their sources, but challenges remain in identifying the person or entity responsible. The Technology What is it? According to the Global Public Policy Institute, there have been more than 330 chemical weapons attacks since 2012. Such attacks are prohibited under the Chemical Weapons Convention. A set of methods called forensic chemical attribution has the potential to trace the chemical agent used in such attacks to a source. A set of methods called forensic chemical attribution has the potential to trace the chemical agent used in such attacks to a source. For example, investigators could use these methods to identify the geographic sources of raw materials used to make the agent, for example, or to identify the manufacturing process Such information can aid leaders in deciding on whether or how to respond to a chemical weapons attack. Figure 1. Forensic chemical attribution process How does it work? Forensic chemical attribution is a three-step process, though the third step is being developed (see Fig. 1). First, a sample is taken from a victim or the site of an attack. Second, the sample's chemical components are analyzed and identified (see Fig. 2), either at a mobile lab or at one of 18 authorized biomedical labs worldwide. Common identification methods are: Gas chromatography, which separates chemical components of a mixture and quantifies the amount of each chemical. Mass spectrometry, which measures the mass-to-charge ratio of ions (i.e., charged particles) by converting molecules to ions and separating the ions based on their molecular weight. Nuclear magnetic resonance (NMR), which can determine the structure of a molecule by measuring the interaction between atomic nuclei placed in a magnetic field and exposing it to radio waves. NMR works on is the same principle as magnetic resonance imaging (MRI) used in medical diagnostics. In the third step—still under development—investigators use the data from the forensic chemical identification and analysis and identification methods from step two to develop a "chemical fingerprint." The fingerprint can be matched to a database of information on existing methods or known sources to identify chemical agents (i.e., Source A matching Sample 1 of Fig. 2). However, a comprehensive database containing complete, reliable data for known agents does not exist. How mature is it? Forensic chemical analysis and identification (i.e., Step 2 of Fig.1) is mature for known chemical agents. For example, investigators determined the nerve agent sarin was used in an attack on civilians in 2017. The methods can also identify new agents, as when investigators determined the chemical composition of the Novichok nerve agent after its first known use, in 2018. Forensic chemical analysis and identification methods are also mature enough to generate data that investigators could use as a "chemical fingerprint"– that is, a unique chemical signature that could be used in part to attribute a chemical weapon to a person or entity. For example, combining gas chromatography and mass spectrometry can provide reliable information about the chemical components and molecular weight of an agent. To achieve Step 3, scientists could use this these methods in a laboratory experiment to match impurities in chemical feedstocks of the weapon to potentially determine who made it. In an investigation, such impurities could indicate the geographic origin of the starting material and the process used to create the agent. Figure 2. Example of forensic chemical identification and analysis, showing a match between Sample 1 and Source A. Opportunities An effective international system for forensic chemical attribution can open up several opportunities, including: Defense. Knowing the source of a chemical agent could help nations better defend against future attacks and, when appropriate, take military action in response to an attack.  Legal response. Source attribution may provide information to help find and prosecute attackers or to impose sanctions. Deterrence. The ability to trace chemical agents to a source might deter future use of chemical weapons.  Challenges Chemical database. Creating a comprehensive international database of chemical fingerprints would require funding and international collaboration to sample chemicals from around the world. Finding perpetrators. Matching a chemical to its sources does not reveal who actually used it in an attack. Almost all investigations require additional evidence. Samples. Collecting a sufficient sample for attribution can be challenging, as can storing and transporting it using a secure chain of custody—potentially over great distance—to one of the 18 authorized biomedical labs worldwide. International cooperation. Lack of cooperation can delay investigations and may compromise sample quality.  Cooperation is also essential for creating an international database. Standardization. Attribution methods are complex and require standardized, internationally accepted protocols to ensure results are reliable and trusted. Such protocols do not yet exist for attributing a chemical weapons attack. Policy Context and Questions The following questions are relevant to building an effective, trusted system for tracing attacks using forensic chemical attribution: How can federal agencies promote and contribute to the international standardization of scientific methods for forensic chemical attribution? Which agency or agencies should lead this effort? How can the international community create and implement a framework for cooperation and trust in forensic chemical attribution? What actions could promote or incentivize creation of an internationally accepted database of unique chemical fingerprints for attributing chemical agents to their sources? What can be done to fully identify and address the scientific and technological gaps in current capabilities for attributing a chemical agent to its source? For more information, contact Karen Howard at (202) 512-6888 or HowardK@gao.gov.
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  • Justice Department Obtains $20,000 Settlement Against Tampa, Florida Towing Company for Unlawfully Selling Deployed Servicemember’s Car
    In Crime News
    The Justice Department today announced that Target Recovery Towing Inc. (Target) has agreed to enter into a court-enforceable consent order to resolve allegations that it failed to obtain a legally required court order before auctioning off a car belonging to a U.S. Marine Corps Sergeant who was deployed overseas. 
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  • Nuclear Weapons: NNSA Should Further Develop Cost, Schedule, and Risk Information for the W87-1 Warhead Program
    In U.S GAO News
    The National Nuclear Security Administration (NNSA) did not consider cost estimates in early major design decisions for the W87-1 warhead because it was not required to do so, but NNSA has since changed its guidance to require that cost be considered, according to a May 2019 NNSA review of program documentation. The design decisions that remain for features that would achieve either minimum or enhanced requirements for the W87-1 could affect cost, according to NNSA officials (see table). We found, however, that NNSA did not yet have study plans for assessing the costs and benefits of the remaining decisions consistent with best practices as detailed in NNSA's analysis of alternatives business procedure. NNSA does not require and only recommends that programs such as the W87-1 follow these best practices. By directing the W87-1 program and future weapons programs to follow best practices for design studies, or to justify and document deviations, NNSA would have better assurance that design studies apply consistent, reliable, and objective approaches. NNSA Cost Estimates for W87-1 Warhead Design Variations That Meet Minimum and Enhanced Requirements, as of December 2018 (Dollars in billions) W87-1 design variations Cost estimate rangea Design includes features that meet minimum safety and security requirements 7.7 - 13.3 Design includes enhanced safety and security features 8.6 - 14.8 Difference between the above estimate ranges 0.9 - 1.5 Source: National Nuclear Security Administration (NNSA) documentation | GAO-20-703 aThe cost ranges reflect low and high estimates for a single design variation. The ranges represent technical and production risk and uncertainty. It is not clear that NNSA will be able to produce sufficient numbers of pits—the fissile cores of the primary—to meet the W87-1 warhead's planned production schedule. Recent NNSA and independent studies have cast doubt on NNSA's ability to ready its two planned pit production facilities in time. If one facility is not ready to produce pits in the early 2030s, for example, NNSA would likely produce fewer weapons than planned, according to GAO's analysis of NNSA plans. We were unable to fully assess the extent to which the two pit production facilities will be ready to produce pits for the W87-1 because NNSA's plutonium program—which is managing the facility readiness efforts—has not yet completed an integrated schedule for the overall pit production effort. An integrated schedule is important, according to best practices, because it integrates the planned work, resources, and budget. An NNSA official stated that the program was building a schedule, but could not provide documentation that it would meet best practices. A schedule consistent with best practices would provide NNSA with better assurance that it will have adequate pits to meet planned W87-1 production. This is a public version of a classified report that GAO issued in February 2020. Information that NNSA or DOD deemed classified or sensitive has been omitted. The Department of Defense (DOD) and NNSA restarted a program in fiscal year 2019 to replace the capabilities of the aging W78 nuclear warhead with the W87-1. NNSA made key design decisions for this weapon from 2010 until the program was paused in 2014. NNSA estimated in December 2018 that the W87-1 would cost $8.6 billion to $14.8 billion, which could make it the most expensive warhead modernization program to date. NNSA plans to newly manufacture the entire warhead, including the two major nuclear components, called the primary and secondary, using facilities it is modernizing or repurposing. You asked us to examine plans for the W87-1 warhead. This report examines, among other things, the extent to which NNSA (1) considered cost estimates in prior design decisions for the W87-1 and the potential effects of remaining design decisions on program cost, and (2) will be able to produce sufficient numbers of key nuclear components to meet W87-1 production needs. GAO reviewed NNSA documentation on prior and remaining design decisions and preliminary cost estimates, reviewed warhead and component production schedules, and interviewed NNSA and DOD officials. GAO is making four recommendations, including that NNSA require programs such as the W87-1 to follow analysis of alternatives best practices when studying design options and that the plutonium program build an integrated schedule consistent with schedule best practices. NNSA generally agreed with the recommendations. For more information, contact Allison B. Bawden at (202) 512-3841 or bawdena@gao.gov.
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  • 5G Wireless: Capabilities and Challenges for an Evolving Network
    In U.S GAO News
    Fifth-generation (5G) wireless networks promise to provide significantly greater speeds and higher capacity to accommodate more devices. In addition, 5G networks are expected to be more flexible, reliable, and secure than existing cellular networks. The figure compares 4G and 5G performance goals along three of several performance measures. Note: Megabits per second (Mbps) is a measure of the rate at which data is transmitted, milliseconds (ms) is a measure of time equal to one thousandth of a second, and square kilometer (km²) is a measure of area. As with previous generations of mobile wireless technology, the full performance of 5G will be achieved gradually as networks evolve over the next decade. Deployment of 5G network technologies in the U.S. began in late 2018, and these initial 5G networks focus on enhancing mobile broadband. These deployments are dependent on the existing 4G core network and, in many areas, produced only modest performance improvements. To reach the full potential of 5G, new technologies will need to be developed. International bodies that have been involved in defining 5G network specifications will need to develop additional 5G specifications and companies will need to develop, test, and deploy these technologies. GAO identified the following challenges that can hinder the performance or usage of 5G technologies in the U.S. GAO developed six policy options in response to these challenges, including the status quo. They are presented with associated opportunities and considerations in the following table. The policy options are directed toward the challenges detailed in this report: spectrum sharing, cybersecurity, privacy, and concern over possible health effects of 5G technology. Policy options to address challenges to the performance or usage of U.S. 5G wireless networks Policy Option Opportunities Considerations Spectrum-sharing technologies (report p. 47) Policymakers could support research and development of spectrum sharing technologies. Could allow for more efficient use of the limited spectrum available for 5G and future generations of wireless networks. It may be possible to leverage existing 5G testbeds for testing the spectrum sharing technologies developed through applied research. Research and development is costly, must be coordinated and administered, and its potential benefits are uncertain. Identifying a funding source, setting up the funding mechanism, or determining which existing funding streams to reallocate will require detailed analysis. Coordinated cybersecurity monitoring (report p. 48) Policymakers could support nationwide, coordinated cybersecurity monitoring of 5G networks. A coordinated monitoring program would help ensure the entire wireless ecosystem stays knowledgeable about evolving threats, in close to real time; identify cybersecurity risks; and allow stakeholders to act rapidly in response to emerging threats or actual network attacks. Carriers may not be comfortable reporting incidents or vulnerabilities, and determinations would need to be made about what information is disclosed and how the information will be used and reported. Cybersecurity requirements (report p. 49) Policymakers could adopt cybersecurity requirements for 5G networks. Taking these steps could produce a more secure network. Without a baseline set of security requirements the implementation of network security practices is likely to be piecemeal and inconsistent. Using existing protocols or best practices may decrease the time and cost of developing and implementing requirements. Adopting network security requirements would be challenging, in part because defining and implementing the requirements would have to be done on an application-specific basis rather than as a one-size-fits-all approach. Designing a system to certify network components would be costly and would require a centralized entity, be it industry-led or government-led. Privacy practices (report p. 50) Policymakers could adopt uniform practices for 5G user data. Development and adoption of uniform privacy practices would benefit from existing privacy practices that have been implemented by states, other countries, or that have been developed by federal agencies or other organizations. Privacy practices come with costs, and policymakers would need to balance the need for privacy with the direct and indirect costs of implementing privacy requirements. Imposing requirements can be burdensome, especially for smaller entities. High-band research (report p. 51) Policymakers could promote R&D for high-band technology. Could result in improved statistical modeling of antenna characteristics and more accurately representing propagation characteristics. Could result in improved understanding of any possible health effects from long-term radio frequency exposure to high-band emissions. Research and development is costly and must be coordinated and administered, and its potential benefits are uncertain. Policymakers will need to identify a funding source or determine which existing funding streams to reallocate. Status quo (report p. 52) Some challenges described in this report may be addressed through current efforts. Some challenges described in this report may remain unresolved, be exacerbated, or take longer to resolve than with intervention. GAO was asked to assess the technologies associated with 5G and their implications. This report discusses (1) how the performance goals and expected uses are to be realized in U.S. 5G wireless networks, (2) the challenges that could affect the performance or usage of 5G wireless networks in the U.S., and (3) policy options to address these challenges. To address these objectives, GAO interviewed government officials, industry representatives, and researchers about the performance and usage of 5G wireless networks. This included officials from seven federal agencies; the four largest U.S. wireless carriers; an industry trade organization; two standards bodies; two policy organizations; nine other companies; four university research programs; the World Health Organization; the National Council on Radiation Protection and Measurements; and the chairman of the Defense Science Board's 5G task force. GAO reviewed technical studies, industry white papers, and policy papers identified through a literature review. GAO discussed the challenges to the performance or usage of 5G in the U.S. during its interviews and convened a one-and-a-half day meeting of 17 experts from academia, industry, and consumer groups with assistance from the National Academies of Sciences, Engineering, and Medicine. GAO received technical comments on a draft of this report from six federal agencies and nine participants at its expert meeting, which it incorporated as appropriate. For more information, contact Hai Tran at (202) 512-6888, tranh@gao.gov or Vijay A. D’Souza at (202) 512-6240, dsouzav@gao.gov.
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  • Department of Justice Files Statement of Interest Supporting Capitol Hill Baptist Church’s Efforts to Practice its Faith During COVID-19
    In Crime News
    The Justice Department today filed a statement of interest in federal district court in Washington, D.C., arguing the Constitution and federal law require the District of Columbia to accommodate Capitol Hill Baptist Church’s effort to hold worship services outdoors, at least to the same extent the District of Columbia allows other forms of outdoor First Amendment activity, such as peaceful protests.
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  • Former Elkhart, Indiana Resident Sentenced to Over Six Years in Prison for Financing of Terrorism
    In Crime News
    Samantha Marie Elhassani, aka Samantha Sally, 35, formerly of Elkhart, Indiana, was sentenced by U.S. District Court Judge Philip P. Simon to 78 months in prison and three years of supervised release after pleading guilty to Financing Terrorism, announced Assistant Attorney General for National Security John C. Demers, U.S. Attorney for the Northern District of Indiana Thomas L. Kirsch II, FBI Assistant Director of the Counterterrorism Division Jill Sanborn, and FBI Special Agent in Charge of the Indianapolis field office Paul Keenan.
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  • Comparative Effectiveness Research: Patient-Centered Outcomes Research Institute and HHS Continue Activities and Plan New Efforts
    In U.S GAO News
    GAO found that the Patient-Centered Outcomes Research Institute (PCORI)—a federally funded, nonprofit corporation—and the Department of Health and Human Services (HHS) have continued to perform comparative clinical effectiveness research (CER) activities required by law since our prior report issued in 2015. CER evaluates and compares health outcomes, risks, and benefits of medical treatments, services, or items. The requirements direct PCORI and HHS to, among other things, fund CER and disseminate and facilitate the implementation of CER findings. GAO's analysis of PCORI and HHS documents show that they allocated a total of about $3.6 billion for CER activities and program support during fiscal years 2010 through 2019 from the Patient Centered Outcomes Research Trust Fund (Trust Fund). Specifically, PCORI allocated about $2 billion for research awards and another $542 million for other awards, to be paid over multiple years. HHS allocated about $598 million for activities such as the dissemination and implementation of CER findings. PCORI and HHS also allocated about $470 million for program support. PCORI and HHS Allocations for Comparative Clinical Effectiveness Research (CER) Activities, Fiscal Years 2010 through 2019 aTotals may not add up due to rounding. bPCORI and HHS allocated $457 million and $13 million for program support, respectively. PCORI assessed the effectiveness of its activities using performance measures and targets. Since fiscal year 2017, when early CER projects were completed, PCORI officials reported that the institute met its performance targets, such as an increased number of research citations of its CER findings in news and online sources. HHS described accomplishments or assessed the effectiveness of its dissemination and implementation activities. PCORI and HHS officials told GAO they are planning comprehensive evaluations of their CER dissemination and implementation activities as part of their strategic plans for the next 10 years. The 2010 Patient Protection and Affordable Care Act (PPACA) authorized establishment of PCORI to conduct CER and improve its quality and relevance. PPACA also established new requirements for HHS to, among other things, disseminate findings from federally funded CER and coordinate federal programs to build data capacity for this research. To fund CER activities, PPACA established the Trust Fund, which provided a total of about $3.6 billion to PCORI and HHS for CER activities during fiscal years 2010 through 2019. The Further Consolidated Appropriations Act, 2020, added new CER requirements and extended funding at similar levels through fiscal year 2029. PPACA and the Appropriations Act 2020 included provisions that GAO review PCORI and HHS's CER activities. This report describes (1) the CER activities PCORI and HHS carried out to meet legislative requirements, (2) how PCORI and HHS allocated funding to those CER activities, and (3) PCORI and HHS efforts to evaluate the effectiveness of their CER dissemination and implementation activities, such as changes in medical practice. GAO reviewed legislative requirements and PCORI and HHS documentation and data for fiscal years 2010-2019. GAO also interviewed PCORI and HHS officials and obtained information from nine selected stakeholder groups that were familiar with PCORI's or HHS's CER activities. These groups included payer, provider, and patient organizations. GAO incorporated technical comments from PCORI and HHS as appropriate. For more information, contact John Dicken at (202) 512-7114 or dickenj@gao.gov.
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  • Missile Defense: Assessment of Testing Approach Needed as Delays and Changes Persist
    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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  • COVID-19: Federal Efforts Accelerate Vaccine and Therapeutic Development, but More Transparency Needed on Emergency Use Authorizations
    In U.S GAO News
    Through Operation Warp Speed—a partnership between the Department of Health and Human Services (HHS) and the Department of Defense (DOD)—the federal government is accelerating efforts to develop vaccines and therapeutics for COVID-19. A typical vaccine development process can take approximately 10 years or longer, but efforts under Operation Warp Speed seek to greatly accelerate this process by completing key steps simultaneously (see figure). As of October 15, 2020, Operation Warp Speed publicly announced financial support for the development or manufacturing of six COVID-19 vaccine candidates totaling more than $10 billion in obligations. It has also announced financial support for the development of therapeutics, such as a $450 million award to manufacture a monoclonal antibody treatment (a treatment that uses laboratory-made antibodies, which also may be able to serve as a prevention option). Operation Warp Speed Timeline for a Potential Vaccine Candidate Note: An Emergency Use Authorization allows for emergency use of medical products without FDA approval or licensure during a declared emergency, provided certain statutory criteria are met. The Food and Drug Administration (FDA) may temporarily allow the use of unlicensed or unapproved COVID-19 vaccines and therapeutics through emergency use authorizations (EUA), provided there is evidence that the products may be effective and that known and potential benefits outweigh known and potential risks. For vaccines, FDA issued guidance in October 2020 to provide vaccine sponsors with recommendations regarding the evidence FDA needed to support issuance of an EUA. For therapeutics, FDA has issued four EUAs as of November 9, 2020. The evidence to support FDA's COVID-19 therapeutic authorization decisions has not always been transparent, in part because FDA does not uniformly disclose its scientific review of safety and effectiveness data for EUAs, as it does for approvals for new drugs and biologics. Given the gravity of the pandemic, it is important that FDA identify ways to uniformly disclose this information to the public. By doing so, FDA could help improve the transparency of, and ensure public trust in, its EUA decisions. The U.S. had about 10.3 million cumulative reported cases of COVID-19 and about 224,000 reported deaths as of November 12, 2020. Given this catastrophic loss of life as well as the pandemic's effects on the U.S. economy, effective and safe vaccines and therapeutics are more important than ever. The CARES Act includes a provision for GAO to report on its ongoing monitoring and oversight efforts related to the COVID-19 pandemic. This report examines, (1) efforts of Operation Warp Speed to accelerate COVID-19 vaccine and therapeutic development; and (2) FDA's use of EUAs for COVID-19 therapeutics and vaccines, among other objectives. GAO reviewed federal laws and agency documents, including HHS and DOD information on vaccine and therapeutic development and EUAs as of November 2020. GAO interviewed or received written responses from HHS and DOD officials, and interviewed representatives from vaccine developers and manufacturers, as well as select public health stakeholders and provider groups covering a range of provider types. FDA should identify ways to uniformly disclose to the public the information from its scientific review of safety and effectiveness data when issuing EUAs for therapeutics and vaccines. HHS neither agreed nor disagreed with the recommendation, but said it shared GAO's goal of transparency and would explore approaches to achieve this goal. For more information, contact Mary Denigan-Macauley at (202) 512-7114 or deniganmacauleym@gao.gov, or Alyssa M. Hundrup at (202) 512-7114 or hundrupa@gao.gov.
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  • Weapon System Sustainment: Aircraft Mission Capable Rates Generally Did Not Meet Goals and Cost of Sustaining Selected Weapon Systems Varied Widely
    In U.S GAO News
    Mission Capable Rates for Selected Department of Defense Aircraft GAO examined 46 types of aircraft and found that only three met their annual mission capable goals in a majority of the years for fiscal years 2011 through 2019 and 24 did not meet their annual mission capable goals in any fiscal year as shown below. The mission capable rate—the percentage of total time when the aircraft can fly and perform at least one mission—is used to assess the health and readiness of an aircraft fleet. Number of Times Selected Aircraft Met Their Annual Mission Capable Goal, Fiscal years 2011 through 2019 aThe military departments did not provide mission capable goals for all nine years for these aircraft. Aggregating the trends at the military service level, the average annual mission capable rate for the selected Air Force, Navy, and Marine Corps aircraft decreased since fiscal year 2011, while the average annual mission capable rate for the selected Army aircraft slightly increased. While the average mission capable rate for the F-35 Lightning II Joint Strike Fighter showed an increase from fiscal year 2012 to 2019, it trended downward from fiscal year 2015 through fiscal year 2018 before improving slightly in fiscal year 2019. For fiscal year 2019, GAO found only three of the 46 types of aircraft examined met the service-established mission capable goal. Furthermore, for fiscal year 2019: six aircraft were 5 percentage points or fewer below the goal; 18 were from 15 to 6 percentage points below the goal; and 19 were more than 15 percentage points below the goal, including 11 that were 25 or more percentage points below the goal. Program officials provided various reasons for the overall decline in mission capable rates, including aging aircraft, maintenance challenges, and supply support issues as shown below. Sustainment Challenges Affecting Some of the Selected Department of Defense Aircraft aA service life extension refers to a modification to extend the service life of an aircraft beyond what was planned. bDiminishing manufacturing sources refers to a loss or impending loss of manufacturers or suppliers of items. cObsolescence refers to a lack of availability of a part due to its lack of usefulness or its no longer being current or available for production. Operating and Support Costs for Selected Department of Defense Aircraft Operating and support (O&S) costs, such as the costs of maintenance and supply support, totaled over $49 billion in fiscal year 2018 for the aircraft GAO reviewed and ranged from a low of $118.03 million for the KC-130T Hercules (Navy) to a high of $4.24 billion for the KC-135 Stratotanker (Air Force). The trends in O&S costs varied by aircraft from fiscal year 2011 to 2018. For example, total O&S costs for the F/A-18E/F Super Hornet (Navy) increased $1.13 billion due in part to extensive maintenance needs. In contrast, the F-15C/D Eagle (Air Force) costs decreased by $490 million due in part to a reduction in the size of the fleet. Maintenance-specific costs for the aircraft types we examined also varied widely. Why This Matters The Department of Defense (DOD) spends tens of billions of dollars annually to sustain its weapon systems in an effort to ensure that these systems are available to simultaneously support today's military operations and maintain the capability to meet future defense requirements. This report provides observations on mission capable rates and costs to operate and sustain 46 fixed- and rotary-wing aircraft in the Departments of the Army, Navy, and Air Force. How GAO Did This Study GAO was asked to report on the condition and costs of sustaining DOD's aircraft. GAO collected and analyzed data on mission capable rates and O&S costs from the Departments of the Army, Navy, and Air Force for fiscal years 2011 through 2019. GAO reviewed documentation and interviewed program office officials to identify reasons for the trends in mission capability rates and O&S costs as well as any challenges in sustaining the aircraft. This is a public version of a sensitive report issued in August 2020. Information on mission capable and aircraft availability rates were deemed to be sensitive and has been omitted from this report. For more information, contact Director Diana Maurer at (202) 512-9627 or maurerd@gao.gov.
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  • Covid-19: Data Quality and Considerations for Modeling and Analysis
    In U.S GAO News
    The rapid spread and magnitude of the COVID-19 pandemic have underscored the importance of having quality data, analyses, and models describing the potential trajectory of COVID-19 to help understand the effects of the disease in the U.S. The Centers for Disease Control and Prevention (CDC) is using multiple surveillance systems to collect data on COVID-19 in the U.S. in collaboration with state, local, and academic and other partners. The data from these surveillance systems can be useful for understanding the disease, but decision makers and analysts must understand their limitations in order to interpret them properly. For example, surveillance data on the number of reported COVID-19 cases are incomplete for a number of reasons, and they are an undercount the true number of cases, according to CDC and others. There are multiple approaches to analyzing COVID-19 data that yield different insights. For example, some approaches can help compare the effects of the disease across population groups. Additional analytical approaches can help to address incomplete and inconsistent reporting of COVID-19 deaths as well. For example, analysts can examine the number of deaths beyond what would normally be expected in the absence of the pandemic. Examining higher-than-expected deaths from all causes helps to address limitations in the reporting of COVID-19 deaths because the number of total deaths is likely more accurate than the numbers of deaths from specific causes. The figure below shows actual deaths from the weeks ending January 1 through June 27, 2020, based on data from CDC’s National Center for Health Statistics, compared with the expected deaths based on prior years’ data. Deaths that exceeded this threshold starting in late March are considered excess deaths that may be related to the COVID-19 pandemic. Higher-Than-Expected Weekly Mortality for 2020, as of July 14, 2020 Analysts have used several forecasting models to predict the spread of COVID-19, and understanding these models requires understanding their purpose and limitations. For example, some models attempt to predict the effects of various interventions, whereas other models attempt to forecast the number of cases based on current data. At the beginning of an outbreak, such predictions are less likely to be accurate, but accuracy can improve as the disease becomes better understood. The COVID-19 pandemic has resulted in significant loss of life and profoundly disrupted the U.S. economy and society, and the Congress has taken action to support a multifaceted federal response on an unprecedented scale. It is important for decision makers to understand the limitations of COVID-19 data, and the uses and limitations of various methods of analyzing and interpreting those data. The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) includes a provision for GAO to, in general, conduct monitoring and oversight of the authorities and funding provided to address the COVID-19 pandemic and the effect of the pandemic on the health, economy, and public and private institutions of the U.S. This technology assessment examines (1) collection methods and limitations of COVID-19 surveillance data reported by CDC, (2) approaches for analyzing COVID-19 data, and (3) uses and limitations of forecast modeling for understanding of COVID-19. In conducting this assessment, GAO obtained publicly available information from CDC and state health departments, among other sources, and reviewed relevant peer reviewed and preprint (non-peer-reviewed) literature, as well as published technical data on specific models. For more information, contact Timothy M. Persons, PhD at (202) 512-6888 or PersonsT@gao.gov, SaraAnn Moessbauer at (202) 512-4943, or MoessbauerS@gao.gov, or Mary Denigan-Macauley, PhD at (202) 512-7114 or DeniganMacauleyM@gao.gov.
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  • Survivors of Childhood Cancer: Factors Affecting Access to Follow-up Care
    In U.S GAO News
    Stakeholders GAO interviewed and studies GAO reviewed identified three factors that affect access to follow-up care for childhood cancer survivors—individuals of any age who were diagnosed with cancer from ages 0 through 19. These factors are care affordability, survivors' and health care providers' knowledge of appropriate care, and proximity to care. Childhood cancer survivors need access to follow-up care over time for serious health effects known as late effects—such as developmental problems, heart conditions, and subsequent cancers—which result from their original cancer and its treatment. Affordability: Survivors of childhood cancer may have difficulty paying for follow-up care, which can affect their access to this care. For example, one study found that survivors were significantly more likely to have difficulty paying medical bills and delay medical care due to affordability concerns when compared to individuals with no history of cancer. Knowledge: Survivors' access to appropriate follow-up care for late effects of childhood cancer can depend on both survivors' and providers' knowledge about such care, which can affect access in various ways, according to stakeholders GAO interviewed and studies GAO reviewed: Some survivors may have been treated for cancer at an early age and may have limited awareness of the need for follow- up care. Some primary or specialty care providers may not be knowledgeable about guidelines for appropriate follow-up care, which can affect whether a survivor receives recommended treatment. Follow-up care may include psychosocial care (e.g., counseling), and palliative care (e.g., pain management). Proximity: Survivors may have difficulty reaching appropriate care settings. Stakeholders GAO interviewed and studies GAO reviewed noted that childhood cancer survivors may have to travel long distances to receive follow-up care from multidisciplinary outpatient clinics—referred to as childhood cancer survivorship clinics. The lack of proximity may make it particularly difficult for survivors with limited financial resources to adhere to recommended follow-up care. The National Cancer Institute (NCI) and the Centers for Disease Control and Prevention (CDC)—agencies within the Department of Health and Human Services (HHS) that conduct activities specific to childhood cancer survivors, including research about access to care—have taken steps to implement three provisions in the Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2018 (Childhood Cancer STAR Act) relevant to access to care for survivors. For example, CDC has awarded a contract to develop software to improve the collection of information on individuals with childhood cancer, and NCI has funded three research projects focused on interventions aimed at addressing adverse outcomes among childhood cancer survivors. NCI has also funded research to study the health status and use of follow-up services of 2,000 young adult survivors. Stakeholders have raised questions about the ability of childhood cancer survivors to access needed follow-up care. According to the most recent data available, approximately 465,000 childhood cancer survivors—children, adolescents, and adults—were alive in the United States as of January 1, 2017. Although the 5-year survival rate for childhood cancer has increased from about 62 percent in the mid-1970s to about 86 percent in the mid-2010s, childhood cancer survivors may face late effects, which could require follow-up care across multiple stages of their lives. The conference report accompanying Public Law 115-245 included a provision for GAO to report on barriers to obtaining medical care for childhood cancer survivors, including psychosocial services and palliative care. This report identifies factors reported to affect access to follow-up care for this population. GAO spoke with officials from NCI and CDC and interviewed stakeholders such as providers who care for childhood cancer survivors, professional associations, and advocacy groups. Additionally, GAO reviewed peer-reviewed studies related to access to care for survivors, outcomes of treatment they may receive, and factors that may affect their access to follow-up care. To supplement this work, GAO reviewed the status of selected HHS activities to support access to care for childhood cancer survivors, including steps taken to implement selected provisions in the Childhood Cancer STAR Act. GAO provided a draft of this report to HHS for review and comment. HHS provided technical comments, which GAO incorporated as appropriate. For more information, contact Jessica Farb at (202) 512-7114 or FarbJ@gao.gov.
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  • Tax Administration: Opportunities Exist to Improve Oversight of Hospitals’ Tax-Exempt Status
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    Nonprofit hospitals must satisfy three sets of requirements to obtain and maintain a nonprofit tax exemption (see figure). Requirements for Nonprofit Hospitals to Obtain and Maintain a Tax-Exemption While PPACA established requirements to better ensure hospitals are serving their communities, the law is unclear about what community benefit activities hospitals should be engaged in to justify their tax exemption. The Internal Revenue Service (IRS) identified factors that can demonstrate community benefits, but they are not requirements. IRS does not have authority to specify activities hospitals must undertake and makes determinations based on facts and circumstances. This lack of clarity makes IRS's oversight challenging. Congress could help by adding specificity to the Internal Revenue Code (IRC). While IRS is required to review hospitals' community benefit activities at least once every 3 years, it does not have a well-documented process to ensure that those activities are being reviewed. IRS referred almost 1,000 hospitals to its audit division for potential PPACA violations from 2015 through 2019. However, IRS could not identify if any of these referrals related to community benefits. GAO's analysis of IRS data identified 30 hospitals that reported no spending on community benefits in 2016, indicating potential noncompliance with providing community benefits. A well-documented process, such as clear instructions for addressing community benefits in the PPACA reviews or risk-based methods for selecting cases, would help IRS ensure it is effectively reviewing hospitals' community benefit activities. Further, according to IRS officials, hospitals with little to no community benefit expenses would indicate potential noncompliance. However, IRS was unable to provide evidence that it conducts reviews related to hospitals' community benefits because it does not have codes to track such audits. Slightly more than half of community hospitals in the United States are private, nonprofit organizations. IRS and the Department of the Treasury have recognized the promotion of health as a charitable purpose and have specified that nonprofit hospitals are eligible for a tax exemption. IRS has further stated that these hospitals can demonstrate their charitable purpose by providing services that benefit their communities as a whole. In 2010, Congress and the President enacted PPACA, which established additional requirements for tax-exempt hospitals to meet to maintain their tax exemption. GAO was asked to review IRS's implementation of requirements for tax-exempt hospitals. This report assesses IRS's (1) oversight of how tax-exempt hospitals provide community benefits, and (2) enforcement of PPACA requirements related to tax-exempt hospitals. GAO is making one matter for congressional consideration to specify in the IRC what services and activities Congress considers sufficient community benefit. GAO is also making four recommendations to IRS, including to establish a well-documented process to ensure hospitals' community benefit activities are being reviewed, and to create codes to track audit activity related to hospitals' community benefit activities. IRS agreed with GAO's recommendations. For more information, contact Jessica Lucas-Judy at (202) 512-9110 or lucasjudyj@gao.gov.
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