Condemning the Assassination of Abdul Wase Ghafari

Michael R. Pompeo, Secretary of State

The United States condemns the assassination of Abdul Wase Ghafari, the father of Mayor Zarifa Ghafari, in Kabul. Since I awarded Mayor Ghafari the International Women of Courage Award in March 2020, she has survived two assassination attempts. We extend our deepest condolences to Mayor Ghafari, her family, and her community.

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    The procedures that GAO agreed to perform on fiscal year 2020 net excise tax distributions to the Airport and Airway Trust Fund (AATF) and the Highway Trust Fund (HTF) and the results of those procedures are described in the enclosures to this report. The sufficiency of these procedures is solely the responsibility of the Department of Transportation (DOT) Office of Inspector General (OIG). The Internal Revenue Service (IRS) is responsible for certifying quarterly net excise tax collections to be distributed to the AATF and the HTF. The Department of the Treasury's Office of Tax Analysis (OTA) is responsible for developing reasonable estimates of net excise tax collections to be distributed to the AATF and the HTF. These IRS certifications and OTA estimates are the basis of the net excise tax distributions to the AATF and the HTF. GAO was not engaged to perform, and did not perform, an examination or review. Accordingly, GAO does not express such an opinion or conclusion. The purpose of this report is solely to describe agreed-upon procedures related to information representing the basis of amounts distributed from the general fund to the AATF and the HTF during fiscal year 2020, and the report is not suitable for any other purpose. IRS agreed with the findings related to the procedures performed concerning excise tax distributions to the AATF and the HTF during the fiscal year 2020. OTA stated that it had no comments on the report. GAO performed agreed-upon procedures solely to assist the DOT OIG in ascertaining whether the net excise tax revenue distributed to the AATF and the HTF for the fiscal year ended September 30, 2020, is supported by information from the Department of the Treasury, including IRS's excise tax receipt certifications and OTA's estimates. DOT OIG is responsible for the sufficiency of these agreed-upon procedures to meet its objectives, and GAO makes no representation in that respect. The procedures that GAO agreed to perform were related to information representing the basis of amounts distributed from the General Fund to the AATF and the HTF during fiscal year 2020, including (1) IRS's quarterly AATF and HTF excise tax certifications prepared during fiscal year 2020 and (2) OTA's estimates of excise tax amounts to be distributed to the AATF and the HTF for the third and fourth quarters of fiscal year 2020. For more information, contact Cheryl E. Clark at (202) 512-3406 or clarkce@gao.gov.
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Vaccine companies told GAO that the primary difference from a non-pandemic environment was the compressed timelines. To meet OWS timelines, some vaccine companies relied on data from other vaccines using the same platforms, where available, or conducted certain animal studies at the same time as clinical trials. However, as is done in a non-pandemic environment, all vaccine companies gathered initial safety and antibody response data with a small number of participants before proceeding into large-scale human studies (e.g., phase 3 clinical trials). The two EUAs issued in December 2020 were based on analyses of clinical trial participants and showed about 95 percent efficacy for each vaccine. These analyses included assessments of efficacy after individuals were given two doses of vaccine and after they were monitored for about 2 months for adverse events. Manufacturing. As of January 2021, five of the six OWS vaccine companies had started commercial scale manufacturing. OWS officials reported that as of January 31, 2021, companies had released 63.7 million doses—about 32 percent of the 200 million doses that, according to OWS, companies with EUAs have been contracted to provide by March 31, 2021. Vaccine companies face a number of challenges in scaling up manufacturing to produce hundreds of millions of doses under OWS's accelerated timelines. DOD and HHS are working with vaccine companies to help mitigate manufacturing challenges, including: Limited manufacturing capacity: A shortage of facilities with capacity to handle the vaccine manufacturing needs can lead to production bottlenecks. Vaccine companies are working in partnership with OWS to expand production capacity. For example, one vaccine company told GAO that HHS's Biomedical Advanced Research and Development Authority helped them identify an additional manufacturing partner to increase production. Additionally, the U.S. Army Corps of Engineers is overseeing construction projects to expand capacity at vaccine manufacturing facilities. Disruptions to manufacturing supply chains: Vaccine manufacturing supply chains have been strained by the global demand for certain goods and workforce disruptions caused by the global pandemic. For example, representatives from one facility manufacturing COVID-19 vaccines stated that they experienced challenges obtaining materials, including reagents and certain chemicals. They also said that due to global demand, they waited 4 to 12 weeks for items that before the pandemic were typically available for shipment within one week. Vaccine companies and DOD and HHS officials told GAO they have undertaken several efforts to address possible manufacturing disruptions and mitigate supply chain challenges. 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OWS officials stated that they have worked with the Department of State to expedite visa approval for key technical personnel, including technicians and engineers to assist with installing, testing, and certifying critical equipment manufactured overseas. OWS officials also stated that they requested that 16 DOD personnel be detailed to serve as quality control staff at two vaccine manufacturing sites until the organizations can hire the required personnel. As of February 5, 2021, the U.S. had over 26 million cumulative reported cases of COVID-19 and about 449,020 reported deaths, according to the Centers for Disease Control and Prevention. The country also continues to experience serious economic repercussions, with the unemployment rate and number of unemployed in January 2021 at nearly twice their pre-pandemic levels in February 2020. In May 2020, OWS was launched and included a goal of producing 300 million doses of safe and effective COVID-19 vaccines with initial doses available by January 2021. Although FDA has authorized two vaccines for emergency use, OWS has not yet met its production goal. Such vaccines are crucial to mitigate the public health and economic impacts of the pandemic. GAO was asked to review OWS vaccine development efforts. This report examines: (1) the characteristics and status of the OWS vaccines, (2) how developmental processes have been adapted to meet OWS timelines, and (3) the challenges that companies have faced with scaling up manufacturing and the steps they are taking to address those challenges. GAO administered a questionnaire based on HHS's medical countermeasures TRL criteria to the six OWS vaccine companies to evaluate the COVID-19 vaccine development processes. GAO also collected and reviewed supporting documentation on vaccine development and conducted interviews with representatives from each of the companies on vaccine development and manufacturing. For more information, contact Karen L. Howard and Candice N. Wright at (202) 512-6888 or howardk@gao.gov or wrightc@gao.gov.
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    Most state Adult Protective Services (APS) agencies have been providing data on reports of abuse to the Department of Health and Human Services (HHS), including data on financial exploitation, although some faced challenges collecting and submitting these data. Since states began providing data to HHS's National Adult Maltreatment Reporting System (NAMRS) in 2017, they have been voluntarily submitting more detailed data on financial exploitation and perpetrators each year (see figure). However, some APS officials GAO interviewed in selected states said collecting data is difficult, in part, because victims are reluctant to implicate others, especially family members or other caregivers. APS officials also said submitting data to NAMRS was challenging initially because their data systems often did not align with NAMRS, and caseworkers may not have entered data in the system correctly. HHS has provided technical assistance and grant funding to help states address some of these challenges and help provide a better picture of the prevalence of the various types of financial exploitation and its perpetrators nationwide. Number of States That Provide Data on Financial Exploitation and Perpetrators to NAMRS Studies estimate some of the costs of financial exploitation to be in the billions, but comprehensive data on total costs do not exist and NAMRS does not currently collect cost data from APS agencies. The Consumer Financial Protection Bureau found actual losses and attempts at elder financial exploitation reported by financial institutions nationwide were $1.7 billion in 2017. Also, studies published from 2016 to 2020 from three states—New York, Pennsylvania, and Virginia—estimated the costs of financial exploitation could be more than $1 billion in each state alone. HHS does not currently ask states to submit cost data from APS casefiles to NAMRS, though officials said they have begun to reevaluate NAMRS with state APS agencies and other interested parties, including researchers, and may consider asking states to submit cost data moving forward. Adding cost data to NAMRS could make a valuable contribution to the national picture of the cost of financial exploitation. Recognizing the importance of these data, some APS officials GAO interviewed said their states have developed new data fields or other tools to help caseworkers collect and track cost data more systematically. HHS officials said they plan to share this information with other states to make them aware of practices that could help them collect cost data, but they have not established a timeframe for doing so. Elder financial exploitation—the fraudulent or illegal use of an older adult's funds or property—has far-reaching effects on victims and society. Understanding the scope of the problem has thus far been hindered by a lack of nationwide data. In 2013, HHS worked with states to create NAMRS, a voluntary system for collecting APS data on elder abuse, including financial exploitation. GAO was asked to study the extent to which NAMRS provides information on elder financial exploitation. This report examines (1) the status of HHS's efforts to compile nationwide data through NAMRS on the extent of financial exploitation and the challenges involved, and (2) what is known about the costs of financial exploitation to victims and others. GAO analyzed NAMRS data from fiscal year 2016 through 2019 (the most recent available); reviewed relevant federal laws; and interviewed officials from HHS, other federal agencies, elder abuse prevention organizations, and researchers. GAO also reviewed APS documents and spoke with officials in eight states, selected based on their efforts to study, collect, and report cost data; and reviewed studies on financial exploitation. GAO recommends that HHS (1) work with state APS agencies to collect and submit cost data to NAMRS, and (2) develop a timeframe to share states' tools to help collect cost data. HHS did not agree with the first recommendation, but GAO maintains that it is warranted, as discussed in the report. HHS agreed with the second recommendation. For more information, contact Kathryn A. Larin at (202) 512-7215 or larink@gao.gov.
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    In Crime News
    Three Japanese nationals, including the president and chief executive officer of Yokohama, Japan-based Kanto Kosan Co. Ltd. (Kanto Kosan) were indicted by a federal grand jury Tuesday in connection with an alleged long-running scheme to defraud the U.S. Navy and pollute Japanese waters by dumping contaminated water removed from U.S. Navy ships into the ocean.
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    In Crime News
    Darnell Fulton, 36, was charged today in a multiple count indictment with charges including forced labor, conspiracy, and transportation of a minor with the intent to engage in criminal sexual activity, announced Eric S. Dreiband, Assistant Attorney General for Civil Rights, and David C. Joseph, U.S. Attorney for the Western District of Louisiana. 
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    Assistant Attorney General for National Security John C. Demers and U.S. Attorney Erica H. MacDonald today announced the sentencing of Seyed Sajjad Shahidian, 33, to 23 months in prison for his role in conducting financial transactions in violation of U.S. sanctions against Iran. Shahidian, who pleaded guilty on June 18, 2018, was sentenced today before Judge Patrick J. Schiltz in U.S. District Court in Minneapolis, Minnesota. Shahidian, a citizen of Iran, was arrested in London, England on Nov. 11, 2018, and, on May 15, 2020, was extradited to the United States.
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  • Biomedical Research: NIH Should Publicly Report More Information about the Licensing of Its Intellectual Property
    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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  • Whistleblower Protection: Actions Needed to Strengthen Selected Intelligence Community Offices of Inspector General Programs
    In U.S GAO News
    The six Intelligence Community (IC)-element Offices of Inspectors General (OIG) that GAO reviewed collectively received 5,794 complaints from October 1, 2016, through September 30, 2018, and opened 960 investigations based on those complaints. Of the 960 investigations, IC-element OIGs had closed 873 (about 91 percent) as of August 2019, with an average case time ranging from 113 to 410 days to complete. Eighty-seven cases remained open as of August 2019, with the average open case time being 589 days. The number of investigations at each IC-element OIG varied widely based on factors such as the number of complaints received and each OIG's determination on when to convert a complaint into an investigation. An OIG may decide not to convert a complaint into an investigation if the complaint lacks credibility or sufficient detail, or may refer the complainant to IC-element management or to another OIG if the complaint involves matters that are outside the OIG's authority to investigate. Four of the IC-element OIGs—the Central Intelligence Agency (CIA) OIG, the Defense Intelligence Agency (DIA) OIG, the National Reconnaissance Office (NRO) OIG, and the National Security Agency (NSA) OIG—have a 180-days or fewer timeliness objective for their investigations. The procedures for the remaining two OIGs—the Inspector General of the Intelligence Community (ICIG) and the National Geospatial-Intelligence Agency (NGA) OIG—state that investigations should be conducted and reported in a timely manner. Other than those prescribed by statute, the ICIG and NGA OIG have not established timeliness objectives for their investigations. Establishing timeliness objectives could improve the OIGs' ability to efficiently manage investigation time frames and to inform potential whistleblowers of these time frames. All of the selected IC-element OIG investigations units have implemented some quality assurance standards and processes, such as including codes of conduct and ethical and professional standards in their guidance. However, the extent to which they have implemented processes to maintain guidance, conduct routine quality assurance reviews, and plan investigations varies (see table). Implementation of Quality Assurance Standards and Practices by Selected IC-element OIG Investigations Units   ICIG CIA OIG DIA OIG NGA OIG NRO OIG NSA OIG Regular updates of investigation guidance or procedures — — — ✓ — ✓ Internal quality assurance review routinely conducted — — ✓ — — — External quality assurance review routinely conducted — ✓ — — — — Required use of documented investigative plans ✓ ✓ ✓ ✓ — ✓ Legend: ✓ = standard or practice implemented; — = standard or practice not implemented. Source: GAO analysis of IC-element OIG investigative policies and procedures. | GAO-20-699 The Council of Inspectors General on Integrity and Efficiency's (CIGIE) Quality Standards for Investigations states that organizations should facilitate due professional care by establishing written investigative policies and procedures via handbooks, manuals, or similar mechanisms that are revised regularly according to evolving laws, regulations, and executive orders. By establishing processes to regularly update their procedures, the ICIG, CIA OIG, DIA OIG, and NRO OIG could better ensure that their policies and procedures will remain consistent with evolving laws, regulations, Executive Orders, and CIGIE standards. Additionally, CIGIE's Quality Standards for Federal Offices of Inspector General requires OIGs to establish and maintain a quality assurance program. The standards further state that internal and external quality assurance reviews are the two components of an OIG's quality assurance program, which is an evaluative effort conducted by reviewers independent of the unit being reviewed to ensure that the overall work of the OIG meets appropriate standards. Developing quality assurance programs that incorporate both types of reviews, as appropriate, could help ensure that the IC-element OIGs adhere to OIG procedures and prescribed standards, regulations, and legislation, as well as identify any areas in need of improvement. Further, CIGIE Quality Standards for Investigations states that case-specific priorities must be established and objectives developed to ensure that tasks are performed efficiently and effectively. CIGIE's standards state that this may best be achieved, in part, by preparing case-specific plans and strategies. Establishing a requirement that investigators use documented investigative plans for all investigations could facilitate NRO OIG management's oversight of investigations and help ensure that investigative steps are prioritized and performed efficiently and effectively. CIA OIG, DIA OIG, and NGA OIG have training plans or approaches that are consistent with CIGIE's quality standards for investigator training. However, while ICIG, NRO OIG, and NSA OIG have basic training requirements and tools to manage training, those OIGs have not established training requirements for their investigators that are linked to the requisite knowledge, skills, and abilities, appropriate to their career progression, and part of a documented training plan. Doing so would help the ICIG, NRO OIG, and NSA OIG ensure that their investigators collectively possess a consistent set of professional proficiencies aligned with CIGIE's quality standards throughout their entire career progression. Most of the IC-element OIGs GAO reviewed consistently met congressional reporting requirements for the investigations and semiannual reports GAO reviewed. The ICIG did not fully meet one reporting requirement in seven of the eight semiannual reports that GAO reviewed. However, its most recent report, which covers April through September 2019, met this reporting requirement by including statistics on the total number and type of investigations it conducted. Further, three of the six selected IC-element OIGs—the DIA, NGA, and NRO OIGs—did not consistently document notifications to complainants in the reprisal investigation case files GAO reviewed. Taking steps to ensure that notifications to complainants in such cases occur and are documented in the case files would provide these OIGs with greater assurance that they consistently inform complainants of the status of their investigations and their rights as whistleblowers. Whistleblowers play an important role in safeguarding the federal government against waste, fraud, and abuse. The OIGs across the government oversee investigations of whistleblower complaints, which can include protecting whistleblowers from reprisal. Whistleblowers in the IC face unique challenges due to the sensitive and classified nature of their work. GAO was asked to review whistleblower protection programs managed by selected IC-element OIGs. This report examines (1) the number and time frames of investigations into complaints that selected IC-element OIGs received in fiscal years 2017 and 2018, and the extent to which selected IC-element OIGs have established timeliness objectives for these investigations; (2) the extent to which selected IC-element OIGs have implemented quality standards and processes for their investigation programs; (3) the extent to which selected IC-element OIGs have established training requirements for investigators; and (4) the extent to which selected IC-element OIGs have met notification and reporting requirements for investigative activities. This is a public version of a sensitive report that GAO issued in June 2020. Information that the IC elements deemed sensitive has been omitted. GAO selected the ICIG and the OIGs of five of the largest IC elements for review. GAO analyzed time frames for all closed investigations of complaints received in fiscal years 2017 and 2018; reviewed OIG policies, procedures, training requirements, and semiannual reports to Congress; conducted interviews with 39 OIG investigators; and reviewed a selection of case files for senior leaders and reprisal cases from October 1, 2016, through March 31, 2018. GAO is making 23 recommendations, including that selected IC-element OIGs establish timeliness objectives for investigations, implement or enhance quality assurance programs, establish training plans, and take steps to ensure that notifications to complainants in reprisal cases occur. The selected IC-element OIGs concurred with the recommendations and discussed steps they planned to take to implement them. For more information, contact Brenda S. Farrell at (202) 512-3604, farrellb@gao.gov or Brian M. Mazanec at (202) 512-5130, mazanecb@gao.gov.
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  • Natural Disasters: Economic Effects of Hurricanes Katrina, Sandy, Harvey, and Irma
    In U.S GAO News
    Between January 1980 and July 2020, the United States experienced 273 climate and weather disasters causing more than $1 billion in damages each, according to NOAA. The total cost of damages from these disasters exceeded $1.79 trillion, with hurricanes and tropical storms accounting for over 50 percent of these damages, according to NOAA. Across the regions affected by these hurricanes over the period from 2005 to 2015, CBO estimated that federal disaster assistance covered, on average, 62 percent of the damage costs. GAO has reported that the rising number of natural disasters and reliance on federal disaster assistance is a key source of federal fiscal exposure. GAO was asked to review the costs of natural disasters and their effects on communities. This report examines (1) estimates of the costs of damages caused by hurricanes and hurricanes' effects on overall economic activity and employment in the areas they affected, and (2) actions subsequently taken in those areas to improve resilience to future natural disasters. GAO conducted case studies of Hurricanes Katrina, Sandy, Harvey, and Irma, selected for two reasons. First, they were declared a major disaster by the President under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, which establishes key programs through which the federal government provides disaster assistance, primarily through FEMA. Second, they had sizable effects on the 50 U.S. states and the District of Columbia during the period from 2004 through 2018. GAO analyzed federal agency and other data on costs, economic activity, employment, and recovery and mitigation projects in selected areas affected by these hurricanes. GAO also visited selected recovery and mitigation project sites; interviewed experts and federal, state, and local government officials; and reviewed federal, state, and local government reports and academic studies. Hurricanes Katrina, Sandy, Harvey, and Irma (selected hurricanes) caused costly damages and challenges for some populations in affected communities. In these communities, the National Oceanic and Atmospheric Administration (NOAA) estimated the cost of damages to be approximately $170 billion for Katrina, $74 billion for Sandy, $131 billion for Harvey, and $52 billion for Irma. These estimates include the value of damages to residential, commercial, and government or municipal buildings; material assets within the buildings; business interruption; vehicles and boats; offshore energy platforms; public infrastructure; and agricultural assets. These hurricanes were also costly to the federal government. For example, in 2016, the Congressional Budget Office (CBO) estimated that federal spending exceeded $110 billion in response to Katrina and $53 billion in response to Sandy. GAO analysis suggests that the selected hurricanes were associated with widely varying effects on overall economic activity and total employment in affected metropolitan areas and counties. Economic activity was lower than expected in the month of the hurricane or some of the three subsequent months in three of the affected metropolitan areas GAO analyzed. Within one year, average economic activity in these three metropolitan areas was similar to or greater than what it had been the year before the hurricane. Total employment was lower than expected in the month of the hurricane or some of the three subsequent months in 80 of the affected counties GAO analyzed. Total employment was higher than pre-hurricane employment on average in 47 of those counties within one year but remained below pre-hurricane employment on average in the other 33 counties for at least one year. Finally, state and local government officials said that the selected hurricanes had significant impacts on communities, local governments, households, and businesses with fewer resources and less expertise, and that challenges faced by households may have impacted local businesses. Communities affected by selected hurricanes have been taking actions to improve resilience, but multiple factors can affect their decisions. Actions taken after selected hurricanes include elevating, acquiring, and rehabilitating homes; flood-proofing public buildings; repairing and upgrading critical infrastructure; constructing flood barriers; and updating building codes. A community’s decision to take resilience actions can depend on the costs and benefits of those actions to the community. Multiple factors affect these costs and benefits, including the likelihood, severity, and location of future disasters, as well as the amount of federal assistance available after a disaster. Finally, vulnerabilities remain in areas affected by selected hurricanes. For example, state and local government officials indicated that many older homes in these areas do not meet current building codes. In reports to the Federal Emergency Management Agency (FEMA), states indicate they anticipate that the scope of damages via exposure to weather hazards, such as hurricanes, will likely remain high and could expand across regions affected by the selected hurricanes. In addition, some local governments have projected that population will grow in the regions affected by selected hurricanes. For more information, contact Oliver Richard at 202-512-8424 or richardo@gao.gov.
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    In Crime News
    A venture capitalist and political fundraiser was sentenced today to 144 months in federal prison for falsifying records to conceal his work as a foreign agent while lobbying high-level U.S. government officials, evading the payment of millions of dollars in taxes, making illegal campaign contributions, and obstructing a federal investigation into the source of donations to a presidential inauguration committee. Imaad Shah Zuberi, 50, of Arcadia, California, was sentenced by U.S. District Judge Virginia A. Phillips, who also ordered him to pay $15,705,080 in restitution and a criminal fine of $1.75 million.
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