January 23, 2022

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Florida Co-Owner of Clinical Trial Company Pleads Guilty to Obstructing FDA Inspection

15 min read
<div>A Florida woman pleaded guilty today to obstructing a 2017 regulatory inspection in connection with an alleged scheme to fraudulently falsify clinical drug trial data. </div>
A Florida woman pleaded guilty today to obstructing a 2017 regulatory inspection in connection with an alleged scheme to fraudulently falsify clinical drug trial data. 

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  • Assistant Attorney General Kristen Clarke Delivers Remarks Announcing a Civil Rights Investigation into Conditions in Texas Juvenile Facilities
    In Crime News
    Good afternoon.  My name is Kristen Clarke, Assistant Attorney General for Civil Rights at the U.S. Department of Justice. I am joined by Ashley Hoff, United States Attorney for the Western District of Texas; Jennifer Lowery, Acting United States Attorney for the Southern District of Texas; Nicholas Ganjei, Acting United States Attorney for the Eastern Districts of Texas; and Chad Meacham, Acting United States Attorney for the Northern District of Texas. 
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  • U.S. Special Envoy for Yemen Lenderking’s Travel to the Middle East
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  • North Carolina Man Pleads Guilty to Production of Child Pornography
    In Crime News
    A North Carolina man pleaded guilty Monday to production of child pornography. 
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  • Joint Statement: The United States and the United Kingdom are Working Together in the Fight Against Climate Change
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  • Justice Department and Federal Trade Commission Seek to Strengthen Enforcement Against Illegal Mergers
    In Crime News
    Today, the Justice Department’s Antitrust Division and Federal Trade Commission (FTC) launched a joint public inquiry aimed at strengthening enforcement against illegal mergers. Recent evidence indicates that many industries across the economy are becoming more concentrated and less competitive – imperiling choice and economic gains for consumers, workers, entrepreneurs and small businesses. These problems are likely to persist or worsen due to an ongoing merger surge that has more than doubled merger filings from 2020 to 2021. To address mounting concerns, the agencies are soliciting public input on ways to modernize federal merger guidelines to better detect and prevent illegal, anticompetitive deals in today’s modern markets.
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  • Justice Department Resolves Housing Discrimination Lawsuit Against the Town of Wolcott, Connecticut
    In Crime News
    The Justice Department announced today it has reached an agreement with the Town of Wolcott, Connecticut, to settle a lawsuit alleging that the Town violated the Fair Housing Act when it refused to allow the operation of a group home for adults with disabilities in a residential neighborhood.
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  • Federal Oil and Gas Revenue: Actions Needed to Improve BLM’s Royalty Relief Policy
    In U.S GAO News
    In reaction to falling domestic oil prices due to the COVID-19 pandemic, the Bureau of Land Management (BLM) developed a temporary policy in spring 2020 for oil and gas royalty relief. The policy aimed to prevent oil and gas wells from being shut down in way that could lead to permanent losses of recoverable oil and gas. During March through June 2020, BLM gave companies the opportunity to apply for a reduction in the royalty rates for certain oil and gas leases on federal lands. BLM approved reductions from 12.5 percent of total revenue on oil and gas sold from those leases to an average of less than 1 percent for a period of 60 days. However, BLM did not establish in advance that royalty relief was needed to keep applicants' wells operating, according to BLM officials. BLM also did not assess the extent to which the temporary policy kept oil and gas companies from shutting down their wells or the amount of royalty revenues forgone by the federal government. By evaluating the extent to which the policy met BLM's objective of preventing unrecoverable loss of oil and gas resources–and likely costs, such as forgone revenues—BLM could better inform its decisions about granting royalty relief that provides a fair return to the government, should the agency decide to consider such relief in the future. BLM officials told GAO that BLM state offices implementing the temporary policy for royalty relief made inconsistent decisions about approving applications for relief because the temporary policy did not supply sufficient detail to facilitate uniform decision-making. The officials added that their state offices did not have recent experience in processing applications for oil and gas royalty relief. Several of the officials had never received or processed royalty relief applications. In addition, GAO found that ongoing guidance for processing royalty relief decisions—within BLM's Fees, Rentals and Royalties Handbook , last revised in 1995—also does not contain sufficient instructions for approving royalty relief. For example, the handbook does not address whether to approve applications in cases where the lease would continue to be uneconomic, even after royalty relief. As a result, some companies that applied for royalty relief were treated differently, depending on how BLM officials in their state interpreted the policy and guidance. In particular, officials from two state offices told GAO they denied royalty relief to applicants because the applicants could not prove that royalty relief would enable their leases to operate profitably. However, two other state offices approved royalty relief in such cases. The fifth state office denied both of the applications it received for other reasons. BLM's existing royalty relief guidance did not address this issue, and BLM's temporary policy did not supply sufficient detail to facilitate uniform decision-making in these situations. BLM's directives manual states that BLM should provide BLM employees with authoritative instructions and information to implement BLM programs and support activities. Until BLM updates the royalty relief guidance, BLM cannot ensure that future relief decisions will be made efficiently and equitably across the states and provide a fair return to the federal government. BLM manages the federal government's onshore oil and gas program with the goals of facilitating safe and responsible energy development while providing a fair return for the American taxpayer. In April 2020, oil and gas producers faced financial challenges from a drop in demand for oil during the COVID-19 pandemic. If oil and gas prices decline, it places financial stress on oil and gas companies, thereby increasing bankruptcies and the risk of wells being shut down. BLM developed a temporary policy to provide oil and gas companies relief from royalties that they owe to the federal government when they sell oil and gas produced on federal lands. This testimony discusses (1) BLM's development of the temporary policy for royalty relief and what is known about the policy's effects, and (2) BLM's implementation of this policy across relevant states. To do this work, GAO reviewed BLM documents; analyzed royalty data; and interviewed BLM officials from headquarters and the five BLM state offices with jurisdiction over states that account for 94 percent of royalties from oil and gas production on federal lands. GAO is making two recommendations. BLM should (1) evaluate the effects of its temporary royalty relief policy and use the results to inform its ongoing royalty relief program, and (2) update its guidance to provide consistent policies for royalty relief.  For more information, contact Frank Rusco at (202) 512-3841 or ruscof@gao.gov.
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  • Man Convicted of Multiple Obscenity Crimes Involving Children
    In Crime News
    A Texas man was convicted by a federal jury today for operating a website dedicated to publishing writings that detailed the sexual abuse of children.
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  • Attorney General William P. Barr Announces Publication of Cryptocurrency Enforcement Framework
    In Crime News
    Attorney General William P. Barr announced today the release of “Cryptocurrency: An Enforcement Framework,” a publication produced by the Attorney General’s Cyber-Digital Task Force.  The Framework provides a comprehensive overview of the emerging threats and enforcement challenges associated with the increasing prevalence and use of cryptocurrency; details the important relationships that the Department of Justice has built with regulatory and enforcement partners both within the United States government and around the world; and outlines the Department’s response strategies. 
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  • COVID-19 Task Force Nets Florida Duct Cleaning Company; Settles False Claims Act Allegations Relating to Improper Paycheck Protection Program Loan
    In Crime News
    Sextant Marine Consulting LLC (Sextant), a Florida-based duct cleaning company, has agreed to pay $30,000 in damages and civil penalties to settle allegations that it violated the False Claims Act by obtaining more than one Paycheck Protection Program (PPP) loan in 2020. Sextant also repaid the duplicative PPP funds in full to its lender, relieving the U.S. Small Business Administration (SBA) of liability to the lender for the federal guaranty of approximately $170,000 on the improper loan.   
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  • Lifting Self-Imposed Restrictions on the U.S.-Taiwan Relationship
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  • Justice Department Sues Uber for Overcharging People with Disabilities
    In Crime News
    The Justice Department today filed a lawsuit against Uber Technologies Inc. (Uber) for charging “wait time” fees to passengers who, because of disability, need more time to enter a car. Uber’s policies and practices of charging wait time fees based on disability have harmed many passengers and potential passengers with disabilities throughout the country. The lawsuit, filed in the U.S. District Court for the Northern District of California, alleges that Uber violated Title III of the Americans with Disabilities Act (ADA), which prohibits discrimination by private transportation companies like Uber.
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  • Real Estate Appraisals: Most Residential Mortgages Received Appraisals, but Waiver Procedures Need to Be Better Defined
    In U.S GAO News
    What GAO Found Although Title XI permits federal regulators to exempt certain mortgages from an appraisal requirement, such exemptions likely have not increased overall risks for regulated lenders (e.g., banks and credit unions) and homebuyers. This is because GAO estimates the lenders obtained appraisals for around 85 percent of the mortgages eligible for an exemption in 2018–2019 (see figure). An appraisal of a home's market value can help lenders mitigate the risk of loss and homebuyers mitigate the risk of overpaying. Regulated lenders obtained appraisals even when not required by Title XI for various reasons. For example, Fannie Mae and Freddie Mac generally require appraisals for mortgages they purchase from lenders, so lenders obtained appraisals in order to sell mortgages to them. In addition, regulated lenders typically obtained appraisals for mortgages of $250,000 or less, although they were permitted to use an evaluation (an estimate of a home's market value not conducted by a state-approved appraiser) in place of an appraisal. Most Residential Mortgages Originated in 2018–2019 That Qualified for a Title XI Appraisal Exemption Still Had an Appraisal The Appraisal Subcommittee (ASC) followed its process in granting a waiver to North Dakota in 2019 but faced challenges in making the determination. ASC may temporarily waive the requirement that only state-approved appraisers perform Title XI appraisals if it determines a scarcity of appraisers led to a significant delay in obtaining appraisals. However, ASC's regulations and guidance for processing temporary waiver requests do not define scarcity and significant delay or establish standards to determine when these conditions exist. For North Dakota's request, the absence of such standards led different stakeholders to use different definitions and data to prove or disprove the conditions existed—creating challenges for ASC in making its determination. Defining the key terms in measurable ways and establishing standards to determine if such conditions exist would better ensure that ASC has a consistent and objective process for reviewing and granting future waiver requests. Why GAO Did This Study Congress enacted Title XI in the Financial Institutions Reform, Recovery, and Enforcement Act of 1989 to require regulated lenders to obtain appraisals for residential mortgages from state-approved appraisers, unless eligible for one of its exemptions. Title XI also created ASC to monitor Title XI-related activities and authorized it to grant waivers related to appraiser credentialing requirements. In late 2019 and early 2020, federal regulators raised the threshold under which lenders can (but do not have to) obtain an evaluation instead of an appraisal for mortgages to $400,000 or less. Also, in 2018, North Dakota requested a temporary waiver, citing delays in appraisals because of a scarcity of appraisers. GAO was asked to review Title XI exemptions. This report examines the extent to which (1) Title XI appraisal exemptions increased risks for federally regulated lenders and homebuyers, and (2) ASC followed its waiver review process or faced challenges when it granted North Dakota a temporary waiver. GAO reviewed and analyzed Title XI and related regulations, most recently available mortgage data, research on appraisals, and ASC records, and interviewed federal agencies and industry stakeholders.
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  • Compounding Pharmacy Mogul Sentenced for Multimillion-Dollar Health Care Fraud Scheme
    In Crime News
    A Mississippi businessman was sentenced today for his role in a multimillion-dollar scheme to defraud TRICARE, the health care benefit program serving U.S. military, veterans, and their respective family members, as well as private health care benefit programs.
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  • Areas with High Poverty: Changing How the 10-20-30 Funding Formula Is Applied Could Increase Impact in Persistent-Poverty Counties
    In U.S GAO News
    What GAO Found Some federal agencies have been statutorily required to use the “10-20-30 formula” when allocating funding for certain programs. That is, agencies must allocate at least 10 percent of designated funds to counties with poverty rates of at least 20 percent over the last 30 years (persistent-poverty counties). However, GAO found the formula has not always increased the proportion of funding awarded to those counties. The Department of Commerce's Economic Development Administration (EDA) and Department of the Treasury's Community Development Financial Institutions (CDFI) Fund both awarded at least 10 percent of designated funds to persistent-poverty counties in fiscal years 2017–2020, but generally had done so before 2017. Most of their programs subject to the formula already were required to target funds to economically distressed areas. The Department of Agriculture's (USDA) Rural Development awarded less than 10 percent of designated funds to persistent-poverty counties in at least one fiscal year for six out of 10 appropriations accounts. Rural Development set aside 10 percent of designated funds for use in those counties, which officials said met the statutory requirement to allocate these funds. Officials said some programs had not received a sufficient number of applications from these counties to meet the threshold because the programs are not well-suited to areas with severe poverty. For example, it may not be financially prudent for local governments in persistent-poverty counties to participate in a loan program to finance community facilities if the governments cannot service the debt. The purpose of the 10-20-30 formula—to increase the proportion of funding awarded to persistent-poverty counties—could be better achieved by focusing its application on programs that do not already target such areas and which can provide meaningful assistance to economically distressed communities. The three agencies GAO reviewed used different datasets and methodologies to identify persistent-poverty counties for the 10-20-30 formula. Appropriations laws for 2017–2020 required the agencies to use data from different years and sources, some outdated, to identify the counties. EDA also used a methodology that identified more than 100 additional persistent-poverty counties, than the other two agencies. Requiring each agency to identify persistent-poverty counties in this way is inefficient, and the inconsistency limits the ability to compare targeted funding across agencies. Using a uniform list of persistent-poverty counties, updated each year, would reduce administrative costs and facilitate assessments of the formula's impact across agencies. Such a measure also could help ensure more consistent investment in areas with current poverty rates of at least 20 percent. USDA's Economic Research Service has the technical capabilities to produce such a list and officials said that doing so each year would not be resource intensive because the agency already publishes other related work using the same data. Why GAO Did This Study Since 2009, the 10-20-30 formula has been applied to appropriations for certain federal programs and accounts. This includes programs and accounts administered by USDA's Rural Development, Treasury's CDFI Fund, and Commerce's EDA that averaged more than $10 billion in each fiscal year from 2017 to 2020. GAO was asked to review certain issues related to the 10-20-30 formula. This report examines (1) the proportion of funds subject to the 10-20-30 formula that these agencies awarded in persistent-poverty counties in 2017–2020 and the effects on funding levels to these areas, and (2) how agencies identify persistent-poverty counties. GAO analyzed agency budget and administrative data for fiscal years 2017—2020. GAO also reviewed documentation, such as program descriptions and funding notices, and interviewed agency officials.
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  • Joint Statement Calling for a Ceasefire in Nagorno-Karabakh
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  • Rebuilding Iraq: Resource, Security, Governance, Essential Services, and Oversight Issues
    In U.S GAO News
    Rebuilding Iraq is a U.S. national security and foreign policy priority. According to the President, the United States intends to help Iraq achieve democracy and freedom and has a vital national interest in the success of free institutions in Iraq. As of April 30, 2004, billions of dollars in grants, loans, assets, and revenues from various sources have been made available or pledged to the reconstruction of Iraq. The United States, along with its coalition partners and various international organizations and donors, has embarked on a significant effort to rebuild Iraq following multiple wars and decades of neglect by the former regime. The Coalition Provisional Authority (CPA), established in May 2003, was the U.N.-recognized coalition authority led by the United States and the United Kingdom that was responsible for the temporary governance of Iraq. Specifically, the CPA wasresponsible for overseeing, directing, and coordinating the reconstruction effort. On June 28, 2004, the CPA transferred power to a sovereign Iraqi interim government, and the CPA officially dissolved. To pave the way for this transfer, the CPA helped the Iraq Governing Council develop the Law of Administration for the State of Iraq for the Transitional Period in March 2004. The transitional law provides a framework for governance of Iraq while a permanent government is formed. In June 2004, U.N. Security Council Resolution 1546 provided international support to advance this process, stating that, by June 30, CPA will cease to exist and Iraq will reassert full sovereignty. Resolution 1546 also endorsed the formation of a fully sovereign Iraqi interim government; endorsed a timetable for elections and the drafting of an Iraqi constitution; and decided that the United Nations, at the Iraq government's request, would play a leading role in establishing a permanent government. Resolution 1546 further noted the presence of the multinational force in Iraq and authorized it to take all necessary measures to contribute to security and stability in Iraq, in accordance with letters annexed to the resolution. Such letters provide, in part, that the multinational force and the Iraqi government will work in partnership to reach agreement on security and olicy issues, including policy on sensitive offensive operations. Resolution 1546 stated that the Security Council will review the mandate of the multinational force in 12 months or earlier if requested by the government of Iraq and that it will terminate the mandate if requested by the government of Iraq. As part of our broad effort to monitor Iraq reconstruction, which we undertook at the request of Congress, this report provides information on the status of the issues we have been monitoring, as well as key questions that will assist Congres in its oversight responsibilities. Specifically, this report focuses on issues associated with (1) resources, (2) security, (3) governance, and (4) essential services. For the essential services issue, we focused on the Army Corps of Engineers' Restore Iraqi Electricity project, a major component of the U.S. assistance effort to rebuild the power sector.As of the end of April 2004, about $58 billion in grants, loans, assets, and revenues from various sources had been made available or pledged to the relief and reconstruction of Iraq. Resource needs are expected to continue after the transfer of power to a sovereign Iraqi interim government. Of the funds available, the United States obligated about $8 billion of the available $24 billion in U.S. funds. The CPA obligated about $15.5 billion of the nearly $21 billion in available Iraqi funds. The international community pledged nearly $14 billion. In December 2003, the CPA put into effect an Iraqi-led process to coordinate reconstruction efforts. An October 2003 U.N./World Bank assessment noted that Iraq's ability to absorb resources as the country gains sovereignty and decision-making authority will be one of the most significant challenges to reconstruction. The security situation in Iraq has deteriorated since June 2003, with significant increases in attacks against the coalition and coalition partners. The increase in attacks has had a negative impact on military operations and the work of international civilian organizations in Iraq. As part of the effort to provide stability, the coalition plans to transfer security responsibilities from the multinational force to Iraqi security forces and to dissolve Iraqi militias operating outside the central government's control. During the escalation of violence that occurred during April 2004, these security forces collapsed in several locations. However, key elements of the CPA's transition and reintegration process remain to be finalized. With U.S. and others' assistance, Iraqis have taken control of government institutions at the national and subnational levels. National ministries are providing some services to citizens as their facilities are being rebuilt, reforms are being introduced, and their staffs trained. According to the head of the now-dissolved CPA, all ministries were under Iraqi authority as of the transfer of power on June 28, 2004. However, the security situation hinders the ability of the ministries to provide needed services and maintain daily operations. To reform the rule of law, ongoing efforts have begun to establish a functioning independent judiciary, although courts are not at their pre-war capacity. However, efforts to rebuild Iraq's judicial system and restore the rule of law face multiple challenges. U.S. officials said that rehabilitating and reforming Iraq's judicial system will likely take years. The Coalition considers reconstruction of the power sector critical to reviving Iraq's economy, supporting essential infrastructure, improving daily well-being, and gaining local support for the coalition presence in Iraq. The CPA set a goal of 6,000 megawatts of generating capacity by June 30, 2004, in anticipation of the higher demand for power during the summer months. As part of the overall effort to achieve this goal, the U.S. Army Corps of Engineers (Corps) has undertaken $1.4 billion in work under the Restore Iraqi Electricity (RIE) program. As of late May, the Corps anticipated that 59 of the 66 RIE projects expected to help meet the goal would be completed by June 30. However, electrical service in the country as a whole has not shown a marked improvement over the immediate postwar levels of May 2003 and has worsened in some governorates. RIE contractors report numerous instances of project delays due to difficulties in getting employees and materials safely to project sites. Further, the security environment continues to affect the cost of rebuilding the power sector.
    [Read More…]

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