A federal grand jury in Greensboro, North Carolina, returned an indictment today, charging a North Carolina couple with federal employment tax and individual income tax violations, announced Principal Deputy Assistant Attorney General Richard E. Zuckerman of the Justice Department’s Tax Division and U.S. Attorney Matthew G.T. Martin for the Middle District of North Carolina.
As alleged in the indictment, from 1992 through the present, James Rice was an orthopedic surgeon who owned and operated an orthopedic practice that the indictment refers to as “Sandhills Orthopaedic.” The indictment further alleges that his wife, Susan Rice, worked at Sandhills Orthopaedic and handled the administrative operations, including payroll and employment tax obligations. Susan Rice also purportedly owned and operated a truffle business.
The Rices have been charged with a variety of tax offenses, including conspiring to not pay any taxes on their business and personal income and to defraud the United States by failing to pay employment taxes owed by Sandhills Orthopaedic. Between 2007 and 2014, the Rices allegedly withheld employment taxes from Sandhills Orthopaedic’s employees, but failed to pay over approximately $580,000 in social security and other tax withholdings to the IRS. The indictment also alleges that the Rices did not file individual income tax returns for the 2014 through 2016 tax years, despite earning gross income in excess of the filing threshold, and that James Rice did not file corporate tax returns for an entity over which he was president for the 2014 through 2017 tax years.
If convicted, the Rices face a statutory maximum sentence of five years in prison and a $250,000 fine for each conspiracy, tax evasion, and employment tax count. They also face one year in prison for each of the charges relating to failing to file individual and corporate tax returns. They are also subject to additional monetary penalties, supervised release, and restitution.
An indictment merely alleges that crimes have been committed. The defendants are presumed innocent until proven guilty beyond a reasonable doubt.
Principal Deputy Assistant Attorney General Zuckerman and U.S. Attorney Martin commended special agents of IRS-Criminal Investigation, who investigated the case, and Trial Attorneys Alexander Effendi and Michael Jones of the Tax Division, who are prosecuting this case.
Additional information about the Tax Division and its enforcement efforts may be found on the division’s website.
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- DHS Annual Assessment: Most Acquisition Programs Are Meeting Goals but Data Provided to Congress Lacks Context Needed For Effective OversightBy Sam NewsJanuary 19, 2021As of September 2020, 19 of the 24 Department of Homeland Security (DHS) programs GAO assessed that had DHS approved acquisition program baselines were meeting their currently established goals. However, of the 24 programs, ten had been in breach of their cost or schedule goals, or both, at some point during fiscal year 2020. A few programs experienced breaches related to external factors, such as the COVID-19 pandemic, while others breached their baseline goals because of acquisition management issues. Five of these programs rebaselined to increase costs or delay schedules, but the remaining five were still in breach status as of September 2020 (see table). Further, GAO found that some of the 19 programs that were meeting their currently established goals—including the U.S. Coast Guard's Offshore Patrol Cutter program—are at risk of future cost growth or schedule slips. DHS Major Acquisition Programs In Breach of Approved Cost or Schedule Goals (or Both) As of September 2020. Program (estimated life-cycle cost) Breach Type National Cybersecurity Protection System ($5,908 million) Schedule Homeland Advanced Recognition Technology ($3,923 million) Cost and Schedule Grants Management Modernization ($289 million) Cost and Schedule National Bio Agro-Defense Facility ($1,298 million) Schedule Medium Range Surveillance Aircraft ($15,187 million) Schedule Source: GAO analysis of Department of Homeland Security (DHS) data. | GAO-21-175 Note: The life-cycle cost information is the current acquisition program baseline cost goal as of September 2020. Programs may revise cost goals, if necessary, when the new baseline is approved. GAO found that supplemental guidance for the development of acquisition documents generally aligned with requirements in DHS's acquisition management policy. However, guidance for developing acquisition documentation in DHS's Systems Engineering Life Cycle Instruction and accompanying Guidebook does not reflect current requirements in DHS's acquisition management policy. DHS officials stated that the information related to development of acquisition documents—including the systems engineering life cycle tailoring plan—should be consistent across all of DHS's policies, instructions, and guidebooks. Inconsistent agency-wide guidance can lead to a lack of clarity on when programs should submit their program documentation. The Joint Explanatory Statement accompanying a bill to the DHS Appropriations Act, 2019, directed DHS to provide quarterly briefings on summary ratings for all major acquisition programs. While DHS is meeting this direction with summary ratings, the ratings do not include contextual information, such as programs' cost, schedule, or performance risks. This type of information would help Congress understand how the ratings relate to potential program outcomes. Determining what additional risk information is needed for DHS's major acquisition programs along with the reporting timeframes and the appropriate mechanism to provide the information, would help ensure that decision makers have needed context. DHS plans to spend more than $7 billion on its portfolio of major acquisition programs—with life-cycle costs over $300 million— in fiscal year 2021 to help execute its many critical missions. The Explanatory Statement accompanying the DHS Appropriations Act, 2015, included a provision for GAO to review DHS's major acquisitions on an ongoing basis. This report, GAO's sixth review, assesses the extent to which (1) DHS's major acquisition programs are meeting baseline goals, (2) DHS's guidance for developing acquisition documentation is consistent with DHS acquisition policy, and (3) DHS is reporting relevant information to Congress on its portfolio of major acquisition programs. GAO assessed 24 acquisition programs, including DHS's largest programs that were in the process of obtaining new capabilities as of April 2018, and programs GAO or DHS identified as at risk of poor outcomes. GAO assessed cost and schedule progress against baselines; assessed DHS's congressional reporting requirements; and interviewed DHS officials and congressional appropriations committee staff. GAO is making one recommendation for DHS to align acquisition guidance with policy, and one matter for Congress to consider determining what additional information it needs to perform oversight. DHS concurred with our recommendation. For more information, contact Marie A. Mak at (202) 512-4841 or firstname.lastname@example.org.[Read More…]
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- Veteran Suicide: VA Needs Accurate Data and Comprehensive Analyses to Better Understand On-Campus SuicidesBy Sam NewsSeptember 9, 2020The Department of Veterans Affairs' (VA) process for identifying on-campus suicides does not include a step for ensuring the accuracy of the number of suicides identified. As a result, its numbers are inaccurate. VA's Veterans Health Administration (VHA) first started tracking on-campus veteran suicides in October 2017, and uses the results to inform VA leadership and Congress. GAO reviewed the data and found errors in the 55 on-campus veteran suicides VHA identified for fiscal years 2018 and 2019, including 10 overcounts (deaths that should not have been reported but were) and four undercounts (deaths that should have been reported but were not). Examples of Errors on the Department of Veterans Affairs' (VA) List of 55 On-Campus Veteran Suicides for Fiscal Years 2018 and 2019 (as of September 2019) VA has taken some steps to address on-campus veteran suicides, such as issuing guidance and staff training. However, GAO found that the analyses informing these efforts are limited. Specifically, VHA requires root cause analyses—processes to determine what can be done to prevent recurrences of incidents—for some but not all on-campus veteran suicides. According to VHA officials, only 25 percent of on-campus suicides from October 2017 to April 2019 met the criteria for a root cause analysis. does not make use of all relevant information VA collects about these deaths, such as clinical and demographic data collected through other VA suicide prevention efforts. VHA officials said they could not link the different sources of information, but GAO found that selected medical facilities could do so. Without accurate information on the number of suicides and comprehensive analyses of the underlying causes, VA does not have a full understanding of the prevalence and nature of on-campus suicides, hindering its ability to address them. VA established suicide prevention as its highest clinical priority. In recent years, there have been reports of veterans dying by suicide on VA campuses—in locations such as inpatient settings, parking lots, and on the grounds of cemeteries. GAO was asked to review veteran deaths by suicide on VA campuses. This report examines (1) VA's process to track the number of veterans that died by suicide on VA campuses, and (2) steps VA has taken to address these types of suicides. GAO reviewed the sources of information VHA uses to identify and analyze on-campus veteran suicides, VA and VHA strategic plans and policies related to suicide prevention and reporting, and federal internal control standards. GAO also interviewed VA and VHA central office officials, and officials from three medical facilities that GAO selected because they reportedly had on-campus veteran suicides between fiscal years 2018 and 2019. GAO is making three recommendations, including that VA improve its process to accurately identify all on-campus veteran suicides and conduct more comprehensive analyses of these occurrences. VA did not concur with one of GAO's recommendations related to conducting root cause analyses. GAO continues to believe that this recommendation is valid, as discussed in the report. For more information, contact Debra A. Draper at (202) 512-7114 or email@example.com.[Read More…]
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- GAO Audits Involving DOD: Status of Efforts to Schedule and Hold Timely Entrance ConferencesBy Sam NewsNovember 20, 2020GAO began 37 new audits that involved the Department of Defense (DOD) in the fourth quarter of fiscal year 2020. Of GAO's 37 requested entrance conferences for those audits, DOD scheduled 33 within 14 days and held 34 within 30 days of GAO's notification. Entrance conferences are initial meetings between agency officials and GAO staff that allow GAO to communicate its audit objectives and enable agencies to assign key personnel to support the audit work. The four entrance conferences that were scheduled more than 14 days after notification were scheduled late due to either difficulties in identifying a primary action officer or aligning the schedules of GAO and DOD officials. The three entrance conferences that were held more than 30 days after notification were scheduled late due to difficulties in aligning the schedules of GAO and DOD officials. GAO's agency protocols govern GAO's relationships with audited agencies. These protocols assist GAO in scheduling entrance conferences with key agency officials within 14 days of their receiving notice of a new audit. The ability of the Congress to conduct effective oversight of federal agencies is enhanced through the timely completion of GAO audits. In past years, DOD experienced difficulty meeting the protocol target for the timely facilitation of entrance conferences. In Senate Report 116-48 accompanying a bill for the National Defense Authorization Act for Fiscal Year 2020, the Senate Armed Services Committee included a provision for GAO to review DOD's scheduling and holding of entrance conferences. In this report, GAO evaluates the extent to which DOD scheduled entrance conferences within 14 days of receiving notice of a new audit, consistent with GAO's agency protocols, and held those conferences within 30 days. This is the final of four quarterly reports that GAO will produce on this topic for fiscal year 2020. In the first three quarterly reports, GAO found that DOD had improved its ability to meet the protocol target. GAO analyzed data on GAO audits involving DOD and initiated in the fourth quarter of fiscal year 2020 (July 1, 2020, through September 30, 2020). Specifically, GAO identified the number of notification letters requesting entrance conferences that it sent to DOD during that time period. GAO determined the number of days between when DOD received GAO's notification letter for each new audit and when DOD scheduled the entrance conference and assessed whether DOD scheduled entrance conferences within 14 days of notification, which is the time frame identified in GAO's agency protocols. GAO also determined the date that each requested entrance conference was held by collecting this information from the GAO team conducting each audit and assessed whether DOD held entrance conferences for new audits within 30 days of notification, which was the time frame identified in the mandate for this review. For more information, contact Elizabeth Field at (202) 512-2775 or Fielde1@gao.gov.[Read More…]
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- Department of Defense: Eating Disorders in the MilitaryBy Sam NewsAugust 7, 2020The Department of Defense (DOD) screens for eating disorders for all applicants entering into the military but does not specifically screen servicemembers for eating disorders after entrance. However, after joining the military, servicemembers receive annual health screenings, and medical personnel may be able to diagnose eating disorders during in-person physical exams. Service branch behavioral health specialists told GAO that DOD medical personnel are trained to notice signs of eating disorders, such as changes in vital signs and emaciated appearance. DOD is examining ways to improve its screening of eating disorders in the military and recently expanded the available research funding for eating disorders in its Peer-Reviewed Medical Research Program (PRMRP). DOD provides health care services to approximately 9.5 million eligible beneficiaries, including services to treat those diagnosed with eating disorders, through TRICARE, DOD’s regionally structured health care system. Servicemembers can obtain these services at military treatment facilities—referred to as direct care—or receive care purchased from civilian providers—referred to as purchased care. DOD officials told us that the specialized level of care necessary to treat eating disorders is available to TRICARE beneficiaries through purchased care, rather than direct care. The Defense Health Agency (DHA), which oversees the TRICARE program, uses two contractors to develop regional provider networks. According to the two TRICARE contractors’ data for purchased care, as of spring 2020, there were 166 eating disorder facilities located in 32 states throughout the country and the District of Columbia. The facilities vary by geographic location, population served, and level of treatment provided: Geography: About half of the 166 facilities (79) are located in the following five states: California (24), Florida (18), Illinois (15), Texas (13), and Virginia (nine). Population: Of the 166 eating disorder facilities, over three-quarters provide treatment to both adult (132 facilities) and child and adolescent (132 facilities) populations. Level of Treatment: Most facilities provide inpatient hospitalization programs, which are for serious cases requiring medical stabilization (81 facilities); partial hospitalization, which are day programs providing treatment 5 to 7 days a week (133 facilities); or intensive outpatient programs, which are treatment programs providing therapy 2 to 6 days a week (107 facilities). About one-fifth of the facilities (35) provide residential treatment services, which are living accommodations providing intensive therapy and 24-hour supervision. TRICARE contractors have met with some challenges entering into contracts with eating disorder treatment facilities in certain areas of the country, according to DHA officials and both contractors. However, both contractors told GAO they consider it their responsibility to ensure beneficiaries receive the care they need regardless of the location of the facility. No access-to-care complaints related to eating disorder treatment were reported by TRICARE beneficiaries, according to the most recent DHA data for years 2018 through 2019. Eating disorders are complex conditions affecting millions of Americans and involve dangerous eating behaviors, such as the restriction of food intake. They can have a severe impact on heart, stomach, and brain functionality, and they significantly raise the risk of mortality. Many with eating disorders also experience co-occurring conditions such as depression. Research has yielded a range of estimates of the number of servicemembers with an eating disorder, due to differences in research methods. For example, a 2018 DOD study concluded that servicemembers likely experienced eating disorders at rates that are comparable to rates in the general population, while other survey-based research suggested the number of servicemembers with eating disorders may be higher than those with a medical diagnoses of such disorders. The potential effects that eating disorders can have on the health and combat readiness of servicemembers and their dependents underscores the importance of screening and treating this population. GAO was asked to provide information on eating disorders among servicemembers and their dependents. To describe how DOD screens for eating disorders among servicemembers, GAO reviewed DOD policies related to health screening and interviewed behavioral health specialists from the military branches. To understand approaches and challenges with implementing screening in a military environment, any planned or ongoing DOD-sponsored research related to this topic, and available eating disorder treatment, GAO interviewed representatives from the Eating Disorder Coalition, Uniformed Services University of Health Sciences, and the University of Kansas. To describe how DOD provides eating disorder treatment to servicemembers and their dependents, GAO interviewed DHA officials and TRICARE contractors and reviewed the TRICARE policy manual to identify the types of eating disorder diagnoses and treatments that are covered through direct and purchased care. GAO received data from the two TRICARE contractors related to the availability of eating disorder treatment services as of spring 2020. For more information, contact Sharon Silas at (202) 512-7114 or Silass@gao.gov.[Read More…]
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- Aircraft Carriers: Homeport Changes Are Primarily Determined by Maintenance RequirementsBy Sam NewsApril 22, 2021What GAO Found The Navy has a process for proposing and implementing homeport changes that considers a range of factors. The first key step in this process involves the Navy developing and updating an annual plan, known as the Strategic Laydown and Dispersal Plan, that guides the Navy's positioning of operating forces worldwide. Based on the plan, fleet commanders then identify requirements for any changes to homeports and submit requests to schedule a homeport change. Throughout the process, Navy leadership and a working group of stakeholders from across the Navy provide input and analysis. Among other things , the working group develops and assesses proposed changes among the possible aircraft carrier homeports based on their expertise and evaluates various homeport installation factors, such as maintenance dry docks (see figure) or ship power and maintenance facilities. The Navy also considers local factors including crew support and quality of life, such as schools and morale, and possible impacts to the natural and physical environment. The Navy has strengthened its process by implementing prior GAO recommendations, and has other planned actions underway to further improve and update its guidance. Recent Navy Aircraft Carrier Homeport Locations and Dry Dock at Puget Sound Naval Shipyard The Navy made 15 aircraft carrier homeport changes in fiscal years 2011 through 2020 among the five available homeports. The driving factor for all 15 changes was maintenance. For example, 10 of the 15 changes involved ships moving to or returning from shipyards in Bremerton or Norfolk for planned dry-dock maintenance or midlife refueling. In 2015 and 2019, the Navy decided to homeport aircraft carriers in Bremerton and San Diego because Everett lacked nuclear maintenance facilities, which were available at the Navy's other aircraft carrier homeport locations. Previously, carriers homeported in Everett received regularly scheduled maintenance at the shipyard in Bremerton but did not conduct an official homeport change. The Navy reported that during these maintenance periods that lasted 6 months or more, the crew commuted 3 to 4 hours daily, which negatively affected maintenance and crew morale. As a result, the Navy decided not to return an aircraft carrier to Everett. According to Navy officials, factors in addition to maintenance needs also informed the changes, including a long-held plan to homeport three aircraft carriers in San Diego. Why GAO Did This Study The Navy relies on 11 aircraft carriers homeported on the East and West Coasts and in Japan to support U.S. defense strategic objectives and operations. These nuclear-powered ships require complex infrastructure, technology, and maintenance, some of which may not be available near their homeport. Changing an aircraft carrier's homeport means moving the ship's approximately 3,200 sailors, a fluctuation of 5,000 or more people depending on the number of family members involved. In House Report 116-120, accompanying a bill for the National Defense Authorization Act for Fiscal Year 2020, the House Armed Services Committee noted that the Navy reversed previous plans to homeport an aircraft carrier at Naval Station Everett, Washington. The House Report also included a provision for GAO to review the Navy's process to assign aircraft carriers' homeports. This report examines, for Navy aircraft carriers, (1) the extent to which the Navy has a process for making homeport changes, and considers local installation and other factors in the homeporting process, and (2) homeport changes from fiscal years 2011 through 2020 and the reasons for them. GAO analyzed Navy instructions and related policies, laws, and regulations; homeport plans and maintenance schedules; and fiscal years 2011–2020 documentation of homeport changes. GAO also interviewed Navy officials, including from relevant commands and homeports. For more information, contact Diana Maurer at (202) 512-9627 or MaurerD@gao.gov.[Read More…]
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- Technology Assessment Design HandbookBy Sam NewsFebruary 18, 2021The Technology Assessment (TA) Design Handbook identifies tools and approaches GAO staff and others can consider in the design of robust and rigorous technology assessments. The handbook underscores the importance of TA design (Chapter 1), outlines the process of designing TAs (Chapter 2), and describes approaches for mitigating select TA design and implementation challenges (Chapter 3). While the primary audience of this handbook is GAO staff, other organizations may also find portions of this handbook useful as they consider or conduct TAs. This is an update to the handbook published in December 2019, based on the experiences of GAO teams and a review of relevant literature and comments submitted by external experts and the public between December 2019 and December 2020. The handbook identifies three general design stages, as shown in the figure below. The handbook also highlights seven cross-cutting considerations for designing TAs: the iterative nature of TA design, congressional and policymakers' interests, resources, independence, engaging internal and external stakeholders, potential challenges, and communication strategy. In addition, the handbook provides a high-level process for developing policy options, as a tool for analyzing and articulating a range of possible actions a policymaker could consider that may enhance the benefits or mitigate the challenges of a technology. Steps in developing policy options include, as applicable: determining the potential policy objective; gathering evidence; identifying possible policy options and the relevant dimensions along which to analyze them; analyzing policy options; and presenting the results of the analysis. Summary of Key Stages of Technology Assessment Design We found that GAO TAs can use a variety of design approaches and methods. The handbook includes TA design and methodology examples, along with example objectives commonly found in GAO TAs, such as: describe a technology, assess opportunities and challenges of a technology, and assess policy implications or options. For example, some GAO TAs include an objective related to describing the status and feasibility of a technology, which GAO teams have addressed by using methodologies such as expert panels, interviews, literature and document reviews, site visits, and determining the technology readiness level. Also included in the handbook are examples of TA design and implementation challenges, along with possible mitigation strategies. We identified four general categories of challenges: (1) ensuring that the design and implementation of TAs result in useful products for Congress and other policymakers; (2) determining the policy objective and measuring potential effects; (3) researching and communicating complicated issues; and (4) engaging relevant stakeholders. For example, allowing sufficient time for writing, review, and any needed revisions is one potential mitigation strategy that could help teams write simply and clearly about technical subjects and ensure that the design and implementation of TAs result in useful products for Congress and other policymakers. In 2019, GAO created the Science, Technology Assessment, and Analytics team to expand its work on cutting-edge science and technology issues, and to provide oversight, insight, and foresight for science and technology. TAs can be used to strengthen decision-making, enhance knowledge and awareness, and provide early insights into the potential effects of technology. Systematically designing a TA can enhance its quality, credibility, and usefulness; ensure independence of the analysis; and ensure effective use of resources. Under Comptroller General Authority, we developed this handbook by generally following the format of the 2012 GAO methodology transfer paper, Designing Evaluations. Below is a summary of the approach we used to affirm and document TA design steps and considerations for this handbook. Reviewed select GAO documents, including Designing Evaluations (GAO-12-208G), published GAO TAs, select GAO products using policy analysis approaches to present policy options, and other GAO reports Reviewed select Office of Technology Assessment reports Reviewed select Congressional Research Service reports Reviewed select English-language literature regarding TAs and related to development and analysis of policy options Consulted with external experts and performed outreach, including holding an expert meeting to gather input on TA design, soliciting comments from external experts who contributed to GAO TAs published since 2015, and soliciting comments from the public Reviewed experiences of GAO teams that have successfully assessed and incorporated policy options into GAO products and TA design, including challenges to TA design and implementation and possible solutions GAO is not making any recommendations. For more information, contact Timothy M. Persons or Karen L. Howard at (202) 512-6888 or firstname.lastname@example.org or email@example.com.[Read More…]
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- U.S. Department of State to Honor Foreign Service Officer (ret.) William S. Rowland as Hero of U.S. DiplomacyBy Sam NewsSeptember 28, 2020
- Operation Legend: Case of the DayBy Sam NewsOctober 2, 2020An Albuquerque man was charged on Sept. 29, 2020, in federal court for possessing fentanyl, heroin, and more than a kilo of methamphetamine, as well as four firearms.[Read More…]
- Farmworkers: Additional Information Needed to Better Protect Workers from Pesticide ExposureBy Sam NewsJanuary 15, 2021The U.S. Environmental Protection Agency (EPA) and states ensure compliance with the Agricultural Worker Protection Standard (WPS) primarily through inspections of farms. The states collect some information—such as the number of inspections they conduct—and provide that information to EPA as part of cooperative agreements between EPA and the states. The extent of use of the designated representative provision of the WPS, and its effect on the availability of pesticide information, are not known because EPA does not collect information on the use of the provision and does not coordinate with states to do so. EPA's guidance to states for conducting inspections encourages, but does not require, state inspectors to ask farmers and farmworkers about whether a designated representative has been used. EPA officials said that the agency has not asked states to collect information on the provision because the agency has focused on compliance with other aspects of the WPS. By coordinating with states, through the cooperative agreements or some another mechanism, to collect information on the use of the designated representative provision, EPA would be better positioned to determine whether the provision is serving its intended purpose. Some stakeholders have raised concerns about potential misuse of pesticide information, such as other farmers using the information obtained by a designated representative to gain a competitive advantage. However, EPA officials, state officials, and stakeholders told us they did not know of any instance in which a person serving as a designated representative misused the pesticide information obtained from farmers. Neither EPA's guidance nor its website explain the agency's expectations for appropriate use or describe how such information could be misused. EPA officials said that the agency has not explained what constitutes misuse. By explaining, in the agency's guidance, on its website, or through another mechanism, EPA's expectations about appropriate use of pesticide information obtained by designated representatives, including the misuse of such information, the agency could ensure designated representatives understand the importance of the information in reducing the consequences of pesticide exposure. Farmworkers Picking Strawberries at a Farm The use of pesticides contributes to U.S. agricultural productivity by protecting crops against pests or weeds, but this use may pose risks to human health. To reduce the consequences of pesticide exposure to farmworkers' health, EPA revised the WPS in 2015 to include a provision that allows a farmworker to identify a person who can request, for their benefit, certain pesticide information from their employer—this is called the designated representative provision. This report examines (1) what is known about the extent of use and effect of the designated representative provision on the availability of pesticide information and (2) what is known about any misuse of information obtained through the provision. GAO reviewed laws, regulations, and guidance, and interviewed officials from EPA and 13 selected states about how they implement and oversee compliance with the standard. GAO also interviewed stakeholders, such as farmer groups and farmworker advocacy groups. GAO is making two recommendations to EPA to (1) coordinate with states to collect information on the use of the designated representative provision and (2) take steps to explain, in guidance, on its website, or through another mechanism, the agency's expectations about appropriate use of pesticide information obtained by a designated representative and describe potential misuse of such information. EPA agreed, in part, to both recommendations. For more information, contact Steve D. Morris at (202) 512-3841 or firstname.lastname@example.org.[Read More…]
- Secretary Blinken’s Call with Portuguese Foreign Minister Santos SilvaBy Sam NewsFebruary 16, 2021
- Opioid Use Disorder: Treatment with Injectable and Implantable BuprenorphineBy Sam NewsAugust 4, 2020Of the medications used to treat opioid use disorder (OUD), only buprenorphine is both a controlled substance and available as an injection or implant. Buprenorphine is used to treat patients with OUD because it reduces or eliminates opioid withdrawal symptoms and blunts the euphoria or dangerous side effects of other opioids, such as heroin. When used to treat OUD, buprenorphine, in any form, is subject to additional laws and regulations that are overseen by the Drug Enforcement Administration (DEA), within the Department of Justice (DOJ) and the Substance Abuse and Mental Health Services Administration (SAMHSA), within the Department of Health and Human Services (HHS). To ensure patient safety when injectable and implantable buprenorphine is used, the Food and Drug Administration (FDA), within HHS has also required drug companies to establish risk evaluation and mitigation strategies to help ensure the benefits of these medications outweigh their risks. Providers and pharmacies must follow a number of specific steps based on federal requirements when providing treatment with injectable and implantable buprenorphine. Providers are responsible for prescribing, storing, and administering injectable and implantable buprenorphine, while pharmacies are responsible for dispensing these medications (see figure). Representatives GAO interviewed from provider groups and pharmacies said they did not find the steps involved in treating patients to be difficult overall. However, they stated that careful and timely coordination with each other and patients is needed at key steps of the process to ensure that the patient receives treatment. Representatives from provider groups and pharmacies reported that the risk of diversion of injectable and implantable buprenorphine is low. For example, all of the provider groups GAO spoke with said that diversion of injectable or implantable buprenorphine is unlikely, and representatives from three of the six provider groups said that the design of these formulations reduces opportunities for diversion due to how they are administered. Process for Treating Opioid Use Disorder with Injectable and Implantable Buprenorphine The use of injectable and implantable buprenorphine to treat OUD is relatively low compared to oral forms of buprenorphine. HHS has reported that about 7,250 prescriptions were issued for injectable and implantable buprenorphine in fiscal year 2019, compared to over 700,000 patients who received buprenorphine prescriptions for oral formulations to treat OUD or pain in that year. In 2018, SAMHSA estimated that about one-quarter of the estimated 2 million people with OUD had received some form of substance use treatment in the prior year. One form of treatment—medication-assisted treatment (MAT)— combines behavioral therapy with the use of certain medications. HHS has identified expanding access to treatment for OUD as an important strategy for reducing opioid morbidity and mortality, which includes increasing the number of injectable and implantable buprenorphine prescriptions. Congress included a provision in the SUPPORT Act for GAO to review access to and the potential for the diversion of controlled substances administered by injection or implantation. This report focuses on injectable and implantable controlled substances that can be used to treat OUD and specifically, describes the process for treating OUD with injectable and implantable buprenorphine and what is known about their use. GAO reviewed laws, regulations, and documentation from DEA, FDA, and SAMHSA governing the process of providing treatment with buprenorphine and interviewed officials from those agencies. GAO also interviewed representatives from stakeholder groups representing MAT providers; drug companies that manufacture injectable or implantable buprenorphine; and pharmacies that dispense these medications. HHS and DOJ reviewed a draft of this report, and GAO incorporated their technical comments, as appropriate. For more information, contact James Cosgrove at (202) 512-7114 or email@example.com.[Read More…]
- Special Representative for Afghanistan Reconciliation Zalmay Khalilzad Travels to Afghanistan, Qatar, and the RegionBy Sam NewsJune 5, 2021
- Cameroonian Operator Charged in Fraudulent Online “Puppy Scam” that Exploited the COVID-19 PandemicBy Sam NewsDecember 7, 2020A criminal complaint unsealed Friday in federal court in Pittsburgh charges Desmond Fodje Bobga for his alleged involvement in a puppy fraud scheme perpetrated against American consumers. Fodje Bobga, 27, is a citizen of Cameroon who is in Romania on a visa to attend a university there.[Read More…]
- Former Supplement Company Owner Pleads Guilty to Unlawful Distribution of Anabolic Steroids and Steroid-like DrugsBy Sam NewsJune 21, 2021A Georgia resident and his company pleaded guilty today to a felony charge relating to the distribution of anabolic steroids and steroid-like drugs in purported dietary supplements.[Read More…]
- Department of Justice Issues Positive Business Review Letter to Companies Developing Plasma Therapies for Covid-19By Sam NewsJanuary 12, 2021The Department of Justice announced today that it has no intention to challenge proposed efforts by Baxalta US Inc., Emergent BioSolutions Inc., Grifols Therapeutics LLC, and CSL Plasma Inc. (together, the “Requesting Parties”) to assist the Biomedical Advanced Research and Development Authority (BARDA) in designing quality standards for collecting COVID-19 convalescent plasma.[Read More…]