Acting Associate Attorney General Matthew Colangelo Delivers Remarks at Listening Session on Environmental Crime Victims

Good Afternoon.

Kris, thank you for the kind introduction. Thank you all for joining us this afternoon for this opportunity to exchange ideas about how to better serve victims of environmental crime. We are honored to be joined by so many knowledgeable and dedicated professionals working on behalf of crime victims and the environment, federal and state law enforcement, academic experts, and representatives of organizations.

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    While the Department of Homeland Security (DHS) followed the Office of Management and Budget (OMB) guidance for announcing the 2016 Countering Violent Extremism (CVE) Grant Program and reviewing applications, DHS did not document the basis for its final award decisions. In June 2017, DHS awarded a total of $10 million in CVE grants to 26 grantees for a 2-year performance period (2017 to 2019). Consistent with OMB guidance, DHS included program priorities and eligibility requirements in its grant announcement and described the process for reviewing and selecting grant applications for award. However, after DHS announced its selection of 31 applications for awards, it ran a new process resulting in revised selections, which was based on additional selection criteria not expressly listed in the grant announcement. While DHS officials explained to GAO how these additional criteria aligned with the grant announcement, these explanations do not appear in DHS's award documentation. Without such documentation, DHS cannot clearly demonstrate that its award decisions were based on the process described in the grant announcement. Figure: Location and Number of Deaths Associated with Domestic Extremist Attacks, 2010-2019 DHS did not obtain the necessary data from grantees to evaluate the overall CVE grant program. DHS required grant organizations to develop, collect, and submit their own output and outcome-related information to help enable the department to evaluate individual grantees and the overall grant program. However, a DHS review of four grant projects concluded that the grantees did not collect the type of performance information DHS needed to determine the grants' effectiveness, such as data at various time intervals to assess change in attitudinal behavior. Taking steps to ensure grantees collect and submit appropriate performance data would enable DHS to evaluate the extent that individual grant projects and the overall grant program are achieving results. Such information would help DHS manage the program and make adjustments as warranted. From 2010 through 2019, data collected through the Extremist Crime Database show that 205 deaths resulted from 59 violent extremist attacks in the United States. DHS received funding in 2016 to establish a new CVE Grant Program to support efforts by state and local governments and nongovernmental organizations to reduce risk factors associated with violent extremism. GAO was asked to review management of the CVE Grant Program. This report examines, among other things, the extent to which DHS (1) announced, reviewed, and awarded CVE grants in accordance with OMB guidance and (2) evaluated the performance of CVE grantees and the overall program. GAO reviewed documentation of DHS's actions in announcing, reviewing and awarding CVE grants; and documentation on steps taken to assess the performance of grantees and the overall program; as compared to requirements in key documents, including the CVE grant announcement, elements of internal control, and a DHS 2017 report to Congress. GAO recommends that DHS, for future CVE-related grant programs: (1) develop policy to document the rationale for award decisions, and (2) take steps to ensure that grantees collect and submit data on project performance that enable evaluation of individual grants and the overall grant program toward intended outcomes. DHS concurred with both recommendations. For more information, contact Triana McNeil at (202) 512-8777 or mcneilt@gao.gov.
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  • Biogen Agrees To Pay $22 Million To Resolve Alleged False Claims Act Liability For Paying Kickbacks
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    Pharmaceutical company Biogen, Inc. (Biogen), based in Cambridge, Massachusetts, has agreed to pay $22 million to resolve claims that it violated the False Claims Act by illegally using  foundations as a conduit to pay the copays of Medicare patients taking Biogen’s multiple sclerosis drugs, Avonex and Tysabri, the Justice Department announced today. 
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  • Maine Man Sentenced for Federal Hate Crime Convictions
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    The Justice Department today announced the sentencing of Maurice Diggins, 36, of Biddeford, Maine, in federal court for his role in a series of racially motivated assaults against black men in Maine.
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  • Justice Department Finds Yale Illegally Discriminates Against Asians and Whites in Undergraduate Admissions in Violation of Federal Civil-Rights Laws
    In Crime News
    The Department of Justice today notified Yale University of its findings that Yale illegally discriminates against Asian American and white applicants in its undergraduate admissions process in violation of Title VI of the 1964 Civil Rights Act. The findings are the result of a two-year investigation in response to a complaint by Asian American groups concerning Yale’s conduct.   
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  • Over-The-Counter Drugs: Information on FDA’s Regulation of Most OTC Drugs
    In U.S GAO News
    The Food and Drug Administration (FDA) has regulated most over-the-counter (OTC) drugs—that is, drugs available without a prescription—through the OTC monograph process. FDA has described an OTC monograph as a "rulebook" for marketing safe and effective OTC drugs, such as aspirin, cough and cold medicine, and hand sanitizer. OTC monographs established conditions—such as active ingredients, indications for use, dosage forms, and product labeling—under which an OTC drug was generally recognized as safe and effective. According to FDA officials, before the CARES Act, which was enacted in March 2020, the agency's ability to update and finalize monographs in response to safety issues and to reflect new scientific information was limited by the rulemaking process the agency was required to follow, as well as insufficient resources. Agency officials estimated that it took at least 6 years to complete the required rulemaking process. Additionally, the agency reported it was critically under-resourced to regulate the estimated 100,000 OTC drugs marketed through the monograph process. However, the CARES Act provided for a new process to regulate these OTC drugs rather than the rulemaking process. FDA officials expect it will take less time to update and finalize requirements for OTC drugs using the new process. The CARES Act also authorized FDA to assess user fees to provide additional resources to regulate OTC drugs. Although FDA officials said this new process and user fees should improve its regulation of OTC drugs, the agency's analysis of the effect of the CARES Act is still ongoing. FDA officials told GAO that prior to the CARES Act, they used various methods to identify and respond to safety issues related to OTC drugs. For example, to identify these issues, FDA officials said they read medical literature related to safety issues and reviewed reports submitted to the agency's adverse event reporting system. To respond to these issues, FDA took steps such as issuing drug safety communications to consumers and requesting that manufacturers make changes to a drug's labeling. For example, in 2015, two FDA advisory committees recommended that cough and cold drugs with codeine be removed from the relevant OTC monograph for use in drugs in children. In 2018, FDA also issued a drug safety communication stating the risks outweighed the benefits for the use of these drugs in children. However, FDA officials said these methods were not a substitute for rulemaking because manufacturers could legally market their OTC drugs without making requested safety changes until the rulemaking process was completed. According to FDA officials, the new process for regulating OTC drugs included in the CARES Act could improve FDA's ability to address identified safety risks in a more timely and efficient manner in the future. The act established an expedited process to address safety issues that pose an imminent hazard to public health or to change a drug's labeling to mitigate a significant or unreasonable risk of a serious adverse event. OTC drugs prevent and treat a variety of conditions; for example, sunscreen is used to help prevent sunburn. FDA officials and stakeholders, such as industry representatives and patient and provider groups, have questioned whether the monograph process used to regulate most OTC drugs has been overly burdensome and has limited FDA's ability to quickly update and finalize monographs in response to potential safety issues for consumers. Enacted in March 2020, the CARES Act changed how FDA regulates OTC drugs. The Sunscreen Innovation Act included a provision for GAO to review FDA's regulation of OTC drugs. This report describes, among other issues, (1) the factors that affected FDA's ability to regulate OTC drugs and (2) how FDA identified and responded to safety issues associated with these drugs. GAO reviewed federal statutes and agency documents and interviewed FDA officials and stakeholders familiar with the monograph process. These stakeholders included representatives from the OTC drug industry, health care provider and consumer groups, and researchers. The Department of Health and Human Services provided technical comments on this report, which GAO incorporated as appropriate. For more information, contact John E. Dicken at (202) 512-7114 or dickenj@gao.gov.
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  • Justice Department Signs Antitrust Memorandum of Understanding with Korean Prosecution Service
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    Yesterday, the Department of Justice signed an antitrust Memorandum of Understanding (MOU) with the Korean Prosecution Service (KPS). The MOU is designed to promote increased cooperation and communication on criminal antitrust enforcement and policy in both countries.
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  • Venezuelan Business Executive Charged in Connection with International Bribery and Money Laundering Scheme
    In Crime News
    A dual Venezuelan-Italian citizen who controlled multiple companies via U.S. based bank accounts was charged in an indictment returned Tuesday for his role in laundering the proceeds of inflated contracts that were obtained by making bribe payments to officials at Venezuela’s state-owned and state-controlled energy company Petróleos de Venezuela S.A. (PDVSA).
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  • Missile Defense: Fiscal Year 2020 Delivery and Testing Progressed, but Annual Goals Unmet
    In U.S GAO News
    What GAO Found In fiscal year 2020, the Missile Defense Agency (MDA) made progress toward achieving its delivery and testing goals for some of the individual systems—known as elements—that combine and integrate to create the Missile Defense System (also known as the Ballistic Missile Defense System). However, MDA did not complete its overall planned deliveries or annual testing. The figure below shows MDA's progress delivering assets and conducting flight tests against its fiscal year 2020 plans. Percentage of Missile Defense Agency Planned Deliveries and Flight Tests Completed for Fiscal Year 2020 Deliveries— In fiscal year 2020, MDA delivered many assets it had planned. Specifically, MDA was able to deliver 82 missile interceptors for 3 elements. However, MDA was not able to deliver all planned interceptors, including one originally planned for 2018 for the Ground-based Midcourse Defense program, as the program experienced delays related to qualifying parts from a new supplier. Flight testing— MDA conducted two planned flight tests, but neither was successful. The issues were due to problems with non-MDA assets, but the agency was able to collect important data. In addition, COVID-19 restrictions also affected the planned schedule. However, the delays continue a trend of MDA's inability to conduct planned annual flight testing, resulting in assets and capabilities that are subsequently delayed or delivered with less data than planned. Ground testing— In fiscal year 2020, MDA continued to implement a new ground testing approach that the agency began in fiscal year 2019. In addition, MDA successfully completed three planned ground tests demonstrating defense capabilities for the U.S., U.S. forces and regional allies. However, MDA delayed two other ground tests to future fiscal years and expects disruptions in fiscal year 2021, in part due to ongoing COVID-19 disruptions. Cyber— Despite failing to meet annual operational cybersecurity assessments since 2017, MDA canceled its planned fiscal year 2020 operational assessments, instead taking steps to implement a new approach designed to improve cyber system requirements while streamlining cyber test planning. It is premature to assess whether this new approach will achieve its intended goals. Why GAO Did This Study For over half a century, the Department of Defense has funded efforts to defend the U.S. from ballistic missile attacks. This effort consists of diverse and highly complex land-, sea-, and space-based systems and assets located across the globe. From 2002 through 2019, MDA—the agency charged with developing, testing, integrating, and fielding this system of systems—received about $162.5 billion. The agency also requested about $45 billion from fiscal year 2020 through fiscal year 2024. In fiscal year 2020, MDA's mission broadened to include evolving threats beyond ballistic missiles such as defending against hypersonic missile attacks. With the inclusion of non-ballistic missile threats, the Ballistic Missile Defense System is in the process of transitioning to the Missile Defense System. Congress included a provision in statute that GAO annually assess and report on MDA's progress. This, our 18th annual review, addresses the progress MDA made in achieving fiscal year 2020 delivery and testing goals. GAO reviewed planned fiscal year 2020 baselines, along with program changes due to COVID-19 restrictions, and other program documentation and assessed them against responses to GAO detailed question sets and program and baseline reviews. GAO also interviewed officials from MDA and various Department of Defense Combatant Commands. We do not make any new recommendations in this report but continue to track the status of prior recommendations. For more information, contact John D. Sawyer at (202) 512-4841 or SawyerJ@gao.gov.
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  • New Jersey Man Indicted for Promoting Tax Fraud Scheme
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    A Pemberton, New Jersey, man appeared in court yesterday on a federal grand jury indictment charging him with conspiring to defraud the United States, assisting in the filing of false tax returns, obstructing the internal revenue laws, and failing to file a tax return, announced Acting Deputy Assistant Attorney General Stuart M. Goldberg of the Justice Department’s Tax Division. The Sept. 2, 2020 indictment was unsealed following the court appearance.
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  • Public Health Preparedness: HHS Has Taken Some Steps to Implement New Authority to Speed Medical Countermeasure Innovation
    In U.S GAO News
    The Department of Health and Human Services' (HHS) Biomedical Advanced Research and Development Authority has taken steps towards implementing an authority provided by the 21st Century Cures Act to accelerate the development of medical countermeasures. Medical countermeasures are drugs, vaccines, and devices to diagnose, treat, prevent, or mitigate potential health effects of exposure to chemical, biological, radiological, and nuclear threats. However, as of June 2020, HHS had not selected a medical countermeasures innovation partner—an independent, nonprofit entity that the 21st Century Cures Act authorizes HHS to partner with to use venture capital practices and methods to invest in companies developing medical countermeasures. Towards implementing the authority, HHS has developed a vision for the innovation partner, staffed a division to manage HHS's medical innovation partnership and determined an initial amount of funding needed, solicited and considered feedback from venture capital and other stakeholders, and developed preliminary plans for structuring and overseeing the partnership. HHS officials explained this type of partnership approach was new to the agency and required due diligence to develop. According to agency officials, the innovation partner will allow HHS to invest in potentially transformative medical countermeasures that have the potential to benefit the government. For example, the innovation partner could invest in innovative wearable technologies to help early detection of viral infections. HHS officials told GAO that the partner, which is required by law to be a nonprofit entity, will be required to reinvest BARDA's revenues generated from government investments into further investments made through the partnership. BARDA's ultimate goal will be to use these revenues to fund new investments. According to a review of stakeholder comments submitted to HHS, potential venture capital partners identified concerns regarding aspects of the agency's plans for the innovation partner, which the stakeholders indicated could hinder HHS's implementation of the authority. For example, there is a statutory limit to the annual salary that can be paid to an individual from HHS's annual appropriation, which some stakeholders indicated was too low to attract an entity to manage the innovation partner funds. HHS officials told GAO they are assessing options to mitigate some of these concerns, but that plans will not be final until they select the partner. GAO provided a draft of this correspondence to HHS and the Department of Defense for review and comment. HHS did not provide comments on this report and DOD provided technical comments that we incorporated as appropriate. The COVID-19 pandemic and other public health emergencies caused by chemical, biological, radiological, and nuclear agents or emerging infectious diseases raise concern about the nation's vulnerability to, and capacity to prevent or mitigate, potential health effects from exposure to such threats. The 21st Century Cures Act authorized HHS to partner with a private, nonprofit entity that can use venture capital practices and methods to invest in companies developing promising, innovative, medical countermeasures. The 21st Century Cures Act included a provision for GAO to review activities conducted under the innovation partner authority. This report describes the status of HHS's implementation of the authority. GAO reviewed relevant statutes and HHS documentation regarding its plans and actions taken to implement the authority, reviewed responses HHS received to the two requests for information it used to collect information from venture capital and other stakeholders, interviewed HHS officials, and interviewed officials from the Department of Defense, which has partnered with a private, nonprofit entity to make investments using venture capital practices. For more information, contact Mary Denigan-Macauley at (202) 512-7114 or DeniganMacauleyM@gao.gov.
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  • Civil Rights Division Opens Investigation into Potential Discrimination in Public Contracting
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    The Department of Justice Civil Rights Division has opened an investigation into whether the public contracting and procurement practices of Kansas City, Missouri comply with the U.S. Constitution and the Civil Rights Act of 1964.
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  • General Aviation: Stakeholders Expressed Mixed Views of FAA Policies on Private Pilot Expense Sharing
    In U.S GAO News
    The Federal Aviation Administration's (FAA) primary rationale for its policies on private pilots' sharing expenses with passengers is based on passenger expectations of safety. FAA policies allow private pilots to share the cost of certain flight expenses with passengers but prohibit these pilots from engaging in “common carriage,” which is communicating to the public a willingness to fly in exchange for compensation. These policies generally prohibit pilots from using the internet to find passengers. FAA officials said these policies are in place because they are concerned the public might expect a similar level of safety on private expense-sharing flights as commercial flights. However, the safety record of commercial aviation is better than that of private flying (general aviation). For example, according to data from the National Transportation Safety Board (NTSB), commercial carriers had a fatal accident rate around 30 times lower than general aviation in 2018. FAA officials said their goal for FAA's 2020 guidance on expense sharing was to restate and clarify existing policies. Example of an Aircraft Private Pilots Could Use for Expense-Sharing Flights Stakeholders described benefits of expense sharing but expressed mixed views on FAA's policies and guidance. For example, stakeholders cited potential economic benefits to the general aviation sector and a potential expansion of the pool of future professional pilots as benefits of expense sharing. Most (eight of 13) stakeholders said FAA's 2020 guidance on expense-sharing is clear and provides sufficient information. However, some stakeholders said the guidance could provide more definitive examples of allowed expense-sharing flights, and others disagreed with how FAA defined certain concepts such as how pilots can be compensated for flying passengers. Also, stakeholders split on whether FAA should allow pilots to use the internet to find expense-sharing passengers. Seven of 15 stakeholders, including four representatives from companies with expense-sharing applications, said FAA should allow pilots to use the internet to find these passengers by citing, for example, ongoing positive experiences in Europe. However, eight stakeholders, including six of seven professional organizations, said FAA should not. These stakeholders cited safety-related risks of expense sharing including what they characterized as FAA's limited capacity to enforce current regulations and flights using less experienced pilots. Private flying is expensive, and FAA allows private pilots to reduce their costs by carrying passengers and sharing certain flight expenses with them. However, private pilots cannot engage in common carriage. If pilots do engage in common carriage, they are subject to FAA's more stringent regulations covering commercial air carriers. Some private pilots have sought to use internet applications to find expense-sharing passengers. The FAA Reauthorization Act of 2018 directed FAA to issue advisory guidance clarifying how private pilots may share expenses. In February 2020, FAA released this guidance as an advisory circular. The Act also includes a provision for GAO to review FAA's policies on expense sharing. This report describes: (1) FAA's rationale for its policies on how private pilots may find expense-sharing passengers and (2) selected stakeholder perspectives on FAA's policies and the risks and benefits of arranging these expense-sharing flights online. GAO interviewed FAA officials on how FAA developed its policies and guidance related to expense sharing. GAO also reviewed FAA's data on enforcement actions related to expense sharing and safety data from NTSB. In addition, GAO interviewed a non-generalizable sample of 15 private-sector stakeholders, including professional organizations, such as trade groups representing general aviation pilots, companies that developed expense-sharing internet applications, and flying clubs. For more information, contact Heather Krause at (202) 512-2834 or krauseh@gao.gov.
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