Working on the front lines of justice amid the pandemic, federal defenders are navigating uncharted territory as they work to maintain virtual access to clients in detention facilities and participate in socially distanced trials and hearings.
“There is no one size fits all approach to solving the challenges that the pandemic has created for defenders,” said Wesley P. Page, the federal public defender in the Southern District of West Virginia. “We are constantly adapting in an effort to maintain access to our clients and find new ways to keep cases moving safely through the court system.”
Through resiliency and innovation, federal defenders have continued to zealously advocate for those unable to afford an attorney, a right guaranteed by the Sixth Amendment to the Constitution and the Criminal Justice Act. Early on in the pandemic, some defenders worked with court offices to procure audio and video equipment to help bridge the physical distance with detained clients.
In the Western District of Missouri, IT staff in the defender office programmed iPads with videoconferencing software, so that attorneys could conduct private and secure virtual visits with clients in detention facilities. Working with the U.S. Attorney’s Office, defenders received permission to put discovery documents on encrypted flash drives. This enabled them to review the materials with clients virtually, a process normally done in person.
“Technology has been a saving grace for us during the pandemic, but it can’t ever replace the connection that you create with a client through an in-person visit,” said Laine Cardarella, the federal public defender in Western Missouri. “I think videoconferencing technology can complement face-to-face visits beyond the pandemic. It gives us a way to immediately update clients on their cases, rather than having to wait until we can make a sometimes several-hour round trip from the office to the detention facility.”
With the rollout of multiple coronavirus (COVID-19) vaccines, defenders across the country are hoping that they and other court personnel can move up on state and local vaccination priority lists to help make conducting court proceedings safer. However, until a larger portion of the population is vaccinated, in-person trials and hearings will continue to look much like they did last summer, with strict social distancing guidelines.
“Trials are already stressful for lawyers, clients, and jurors. The added risk of infection with a deadly virus – regardless of the safety measures – only adds to that stress,” said Marjorie A. Meyers, the federal public defender in the Southern District of Texas.
Socially distanced trials look quite different from the typical in-person trials. Participants wear masks, large plexiglass partitions separate the participants from each other, lawyers wear headsets to confer with their clients, and jurors sometimes are assigned chairs wrapping around the courtroom.
“While these safety measures are necessary in helping us move clients’ cases through the system, it makes developing relationships with clients very difficult because it looks like we’re afraid of them,” Cardarella said. “Our clients can’t see our smile as we greet them, we can’t give them a pat on the back, shake their hand, or even sit next to them at the defense table.”
Federal defenders hope to continue having productive discussions with judges, detention officials, U.S. attorney’s offices, and probation and pretrial services officers to tackle issues of fostering safe and effective interactions among the parties in courtrooms, and empaneling juries that are representative of the community.
“There is a constant tension between safety and due process as we steer our way through the pandemic, and as courts continue to manage a growing backlog of cases,” Meyers said. “We will continue to do everything in our power to make our clients’ voices heard.”
Greetings I’m Sam.
I edit, report and maintain this site. If you have any questions You can mail below me but it could be a while before I get back to you.
- Abusive Tax Schemes: Offshore Insurance Products and Associated Compliance RisksBy Sam NewsAugust 31, 2020Federal law provides certain tax benefits for transactions involving genuine insurance products, including insurance products held offshore. While taxpayers may lawfully hold offshore insurance products, they contain features that make them vulnerable for use in abusive tax schemes. For example, offshore insurance products can be highly technical and individualized, making enforcement challenging, according to Internal Revenue Service (IRS) officials. Furthermore, insurance is not defined by federal statute, potentially making a determination of what constitutes genuine insurance for federal tax purposes unclear. Offshore micro-captive insurance products, which are made by small insurance companies owned by the businesses they insure, may be abused if the corporate taxpayer improperly claims deductions for payments made to a micro-captive for federal tax purposes. Courts have applied certain considerations to determine whether these deductions can be claimed. For example, one consideration is whether the insurance legitimately distributes risk across participating entities. IRS officials said they expend significant resources reviewing these schemes because of the varied ways insurance companies may work. Offshore variable life insurance products, which are insurance policies with investment components over which the insured has certain control, may be abused if the individual taxpayer fails to meet IRS reporting requirements or pay appropriate federal income taxes. Federal regulations require that taxpayers with certain foreign life insurance accounts report this information to IRS and the Financial Crimes Enforcement Network. The structure of life insurance products may vary and taxpayers are required to pay taxes based on the underlying type of financial product the policy represents. The figure below shows how noncompliance may occur when taxpayers use life insurance and micro-captive insurance in abusive tax schemes. Abusive Use of Micro-captive and Life Insurance When structured in abusive ways, insurance products held offshore can be designed to aid in unlawful tax evasion by U.S. taxpayers. Two products that IRS has recently warned have the potential for such abuse include micro-captive insurance and variable life insurance policies. GAO was asked to review how taxpayers may abuse offshore insurance products. This report describes (1) how offshore insurance tax shelters provide opportunities for income tax abuse; (2) how offshore micro-captive insurance is used and how it is used in abusive tax schemes; and (3) how offshore variable life insurance is used and how it is used in abusive tax schemes. GAO reviewed IRS tax and information return forms, relevant U.S. case law and IRS guidance, academic and trade publications, and applicable statutes and regulations. GAO also interviewed IRS officials and professionals in the tax preparation and insurance industries. For more information, contact Jessica Lucas-Judy at (202) 512-9110 or LucasJudyJ@gao.gov.[Read More…]
- Secretary Blinken’s Meeting with the C5+1By Sam NewsApril 23, 2021
- Joint Statement on the Occasion of a Trilateral Discussion among Afghanistan, Tajikistan and the United StatesBy Sam NewsMarch 19, 2021
- Justice Department Files Sexual Harassment Lawsuit Against Massachusetts Property ManagerBy Sam NewsDecember 7, 2020The Department of Justice announced today that it has filed a lawsuit alleging that a property manager in Chicopee, Massachusetts violated the Fair Housing Act by subjecting female tenants to sexual harassment.[Read More…]
- North Korea (Democratic People’s Republic of Korea) Travel AdvisoryBy Sam NewsSeptember 26, 2020Do not travel to North [Read More…]
- Secretary Michael R. Pompeo With Bret Baier of Fox News Special ReportBy Sam NewsNovember 27, 2020Michael R. Pompeo, [Read More…]
- 12th Annual HBCU Foreign Policy ConferenceBy Sam NewsMarch 2, 2021
- Operation Legend: Case of the DayBy Sam NewsOctober 13, 2020Each weekday, the Department of Justice will highlight a case that has resulted from Operation Legend. Today’s case is out of the Northern District of Ohio. Operation Legend launched in Cleveland on July 29, 2020, in response to the city facing increased homicide and non-fatal shooting rates.[Read More…]
- The Sentencing of Russian Opposition Figure Aleksey NavalnyBy Sam NewsFebruary 2, 2021
- Secretary Antony J. Blinken Virtual Remarks to Embassy London StaffBy Sam NewsMay 4, 2021
- VA Disability Exams: Actions Needed to Improve Program ManagementBy Sam NewsMay 13, 2021What GAO Found In recent years, the Department of Veterans Affairs (VA) has significantly expanded the Veterans Benefits Administration's (VBA) use of contractors to perform disability medical exams instead of relying on Veterans Health Administration (VHA) medical centers. According to VBA officials, VA's policy is to continue using contractors for most exams. GAO previously identified sound practices agencies can use to plan for significant programmatic changes. However, VBA has not applied several of these practices to its plans for allocating workloads among its contractors and VHA medical centers. For example, VBA has not assessed potential risks to capacity and exam quality in allocating the bulk of exams to contractors. Employing such practices could help VBA identify potential risks stemming from this long-term program change and better plan for addressing future workload needs. Percent of Disability Exams Performed by VBA Contractors and by VHA Medical Centers, Fiscal Years 2017-2021 Over time, VA has also permitted contractors to complete exams for more complex disability claims—such as Gulf War Illness—according to VBA officials, but VBA does not conduct targeted reviews specifically to assess the quality of the exam reports completed for these exams. VBA data show that exam reports for selected complex claims were returned to examiners for correction or clarification at about twice the rate that exam reports were returned overall. Disability medical examiners told GAO that these types of exams can be challenging. Without specifically assessing how well contractors perform on exams for complex claims, VBA is missing an opportunity to identify actions that could help ensure veterans receive high quality exams and that exam reports are completed correctly. Why GAO Did This Study This testimony summarizes the information contained in GAO's March 2021 report, entitled VA Disability Exams: Better Planning Needed as Use of Contracted Examiners Continues to Grow (GAO-21-444T). This testimony also builds upon prior GAO reporting on VBA's contract exam program in October 2018 (GAO-19-13).[Read More…]
- Ireland Travel AdvisoryBy Sam NewsSeptember 26, 2020
- Former Union Official Sentenced for Violent ExtortionBy Sam NewsMay 3, 2021An Indiana man and former business agent of Iron Workers Local 395 was sentenced today to more than four years in prison for conspiracy to commit Hobbs Act extortion.[Read More…]
- Singapore Travel AdvisoryBy Sam NewsSeptember 26, 2020
- Reframing Disarmament DiscourseBy Sam NewsSeptember 26, 2020Dr. Christopher Ashley [Read More…]
- NASA’s Jet Propulsion Laboratory Has a Bold, New LookBy Sam NewsIn SpaceDecember 9, 2020A giant version of [Read More…]
- Suriname Travel AdvisoryBy Sam NewsSeptember 26, 2020Reconsider travel [Read More…]
- State Department Employee and Spouse Plead Guilty to Trafficking in Counterfeit Goods from U.S. EmbassyBy Sam NewsDecember 10, 2020A U.S. Department of State employee and his spouse pleaded guilty today to one count of conspiracy to traffic in counterfeit goods. The guilty pleas took place before U.S. District Judge Michael J. McShane, who has scheduled sentencing for March 18, 2021, for both defendants.[Read More…]
- Malaysia Travel AdvisoryBy Sam NewsSeptember 26, 2020
- On the Passing of Former Papua New Guinea Prime Minister Sir Michael SomareBy Sam NewsMarch 3, 2021
- Secretary Blinken’s Call with Israeli Foreign Minister AshkenaziBy Sam NewsApril 30, 2021
- Texan sentenced for attempting to smuggle over 70 people in one trailerBy Sam NewsIn Justice NewsMay 12, 2021A 24-year-old Corpus [Read More…]
- Owner of Oil Chem Inc. Sentenced for Clean Water Act ViolationBy Sam NewsMay 14, 2021The president and owner of Oil Chem Inc. was sentenced today to 12 months in prison for violating the Clean Water Act stemming from illegal discharges of landfill leachate — totaling more than 47 million gallons — into the city of Flint sanitary sewer system over an eight and a half year period.[Read More…]
- Federal Tactical Teams: Characteristics, Training, Deployments, and InventoryBy Sam NewsSeptember 10, 2020Within the executive branch, GAO identified 25 federal tactical teams, and the characteristics of these teams varied. The 25 tactical teams were across 18 agencies, such as agencies within the Departments of Homeland Security, Justice, Energy, and the Interior. The number of reported team members per team ranged from two to 1,099. More than half (16 of 25) of the teams reported that they are composed of team members working for the team on a collateral basis. Most teams (17 of 25) had multiple units across various locations. Photos of Federal Tactical Teams in Action Tactical teams generally followed a similar training process, with initial training, specialty training, and ongoing training requirements. Nearly all teams (24 of 25) reported that new team members complete an initial tactical training course, which ranged from 1 week to 10 months. For example, potential new team members of the Federal Bureau of Investigation's Hostage Rescue Team complete a 10-month initial training that includes courses on firearms; helicopter operations; and surveillance, among others. Nearly all teams (24 of 25) reported offering specialized training to some team members, such as in sniper operations and breaching. Nearly all teams (24 of 25) also reported having ongoing training requirements, ranging from 40 hours per year to over 400 hours per year. The number and types of deployments varied across the 25 tactical teams for fiscal years 2015 through 2019. The number of reported deployments per tactical team during this time period ranged from 0 to over 5,000. Teams conducted different types of deployments, but some types were common among teams, such as: supporting operations of other law enforcement entities, such as other federal, state, and local law enforcement (16 of 25); providing protection details for high-profile individuals (15 of 25); responding to or providing security at civil disturbances, such as protests (13 of 25); and serving high-risk search and arrest warrants (11 of 25). Four teams reported that they had deployed in response to the Coronavirus 2019 (COVID-19) pandemic, and 16 teams reported deployments related to nationwide civil unrest and protests in May and June 2020. Tactical teams reported having various types of firearms, tactical equipment, and tactical vehicles in their inventories. Team members generally have a standard set of firearms (e.g., a pistol, a backup pistol, and a rifle), but some may also have specialized firearms (e.g., a shotgun designed to breach doors). Tactical teams also have a variety of tactical equipment, such as night vision devices to maintain surveillance of suspects or tactical robots that can go into locations to obtain audio and video information when team members cannot safely enter those locations. Tactical teams may also have tactical vehicles, such as manned aircraft (e.g., helicopters) and armored vehicles to patrol locations. The figure below identifies the number of tactical teams that reported having such items in their inventories. Number of Federal Tactical Teams That Reported Having Firearms, Tactical Equipment, and Tactical Vehicles in Their Inventories, as of January 2020 Appendix I of the report provides details on each of the 25 tactical teams, such as each team's mission; staffing; types and frequency of training; and number and types of deployments from fiscal years 2015 through 2019. This is a public version of a sensitive report issued in August 2020. Information deemed to be sensitive by the agencies in this review, such as the quantities of firearms, tactical equipment, and tactical vehicles in team inventories, has been omitted from this report. Many federal agencies employ law enforcement officers to carry out the agency's law enforcement mission and maintain the security of federal property, employees, and the public. Some of these agencies have specialized law enforcement teams—referred to as federal tactical teams in this report—whose members are selected, trained, equipped, and assigned to prevent and resolve critical incidents involving a public safety threat that their agency's traditional law enforcement may not otherwise have the capability to resolve. This report provides information on the (1) federal tactical teams and their characteristics; (2) training team members receive; (3) deployments of such teams from fiscal years 2015 through 2019; and (4) firearms, tactical equipment, and tactical vehicles in team inventories, as of January 2020. To identify federal tactical teams, GAO contacted executive branch agencies with at least 50 federal law enforcement officers. GAO administered a standardized questionnaire and data collection instrument to the identified teams to gather information on team missions, staffing, training, deployments, and inventories. GAO reviewed team documents, such as standard operating procedures, and interviewed agency officials. GAO collected descriptive information on reported deployments as of June 2020 in response to COVID-19 and nationwide civil unrest, which were ongoing during the review. GAO incorporated agency technical comments as appropriate. For more information, contact Gretta L. Goodwin at (202) 512-8777 or email@example.com.[Read More…]
- The Justice Department’s Hate Crimes Enforcement and Prevention Initiative Announces Newly Translated Online Hate Crimes ResourcesBy Sam NewsApril 23, 2021Today, marking the 40th Anniversary of National Crime Victims’ Rights Week (NCVRW), the Justice Department’s Hate Crimes Enforcement and Prevention Initiative announced newly translated hate crimes resources in eight languages for the department’s hate crimes website, www.justice.gov/hatecrimes.[Read More…]
- Department Press Briefing – March 2, 2021By Sam NewsMarch 3, 2021
- Canadian National Pleads Guilty to Human Smuggling ConspiracyBy Sam NewsFebruary 24, 2021A Canadian national pleaded guilty today to conspiracy to bring aliens to the United States for private financial gain in connection with his role in a scheme to smuggle aliens from Sri Lanka through the Caribbean and into the United States.[Read More…]
- Small Business Innovation Research: Three Agencies Made Awards to Businesses Majority-Owned by Investment Companies and FundsBy Sam NewsJanuary 29, 2021Under the Small Business Innovation Research (SBIR) program, participating agencies can make awards to small businesses majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms (investment companies and funds). In fiscal years 2019 and 2020, four of the 11 agencies participating in the program received proposals from small businesses majority-owned by investment companies and funds (i.e., qualified small businesses), and three of the four made awards to such small businesses. Specifically, the Department of Health and Human Services' National Institutes of Health (NIH), the Department of the Navy within the Department of Defense (DOD), and the Department of Education made a combined 45 awards worth $31.6 million to qualified small businesses during this period. As in previous years, NIH made the most awards and awarded the most funds to qualified small businesses in fiscal years 2019 and 2020. The Department of Energy's Advanced Research Projects Agency-Energy opened its SBIR awards to qualified small businesses, but did not issue any awards to them during fiscal years 2019 and 2020. Since 2011, when qualified small businesses became eligible for SBIR awards, participating SBIR agencies have considered whether to allow qualified small businesses to participate in the program. Consistent with what GAO found in December 2018, in fiscal years 2019 and 2020, agencies cited several reasons for not allowing qualified small businesses to participate in their SBIR program. For example, officials at the National Aeronautics and Space Administration and the Department of Homeland Security said that they did not pursue the option because qualified small businesses have not expressed much interest in their SBIR programs. In contrast, two component agencies within DOD—the Departments of the Navy and the Air Force—decided to allow qualified small businesses to receive awards and the Department of the Army within DOD was considering doing so. For example, Air Force program officials told us they found that providing SBIR funding to qualified small businesses would expand the Air Force's investment in cutting-edge technologies with both commercial and military uses. NIH—the agency that has made the majority of awards to qualified small businesses—has continued to make awards to qualified small businesses in its SBIR program, as these businesses are subject to the same standard reporting requirements as all other SBIR award recipients. NIH officials also noted that SBIR recipients provide information on specific project impacts, such as technology transfer and commercialization activities, and NIH cited development of a long-release capsule for medication as an example of a successful outcome from an award to a qualified small business. The SBIR program enables federal agencies to support research and development (R&D) projects carried out by small businesses. Participating agencies are required to spend a certain percentage of their extramural R&D obligations on their SBIR program each year. Eleven federal agencies participate in the SBIR program. To qualify for SBIR awards, a small business must meet certain ownership and other eligibility criteria. The Small Business Act, as amended, authorizes agencies to allow participation in their SBIR programs by qualified small businesses. Upon providing a written determination to the Administrator of the Small Business Administration (SBA)—the agency that oversees the SBIR program—and specified congressional committees, agencies may make SBIR awards to qualified small businesses. The Small Business Act, as amended, includes a provision for GAO to conduct a study of the impact of requirements relating to the involvement of investment companies and funds in the SBIR program and submit a report to Congress regarding the study every 3 years. GAO's first review covered fiscal years 2013 and 2014, and in December 2018, GAO issued its second report on this issue, for fiscal years 2015 through 2018. This third report addresses (1) SBIR participating agencies' awards to small businesses that are majority-owned by multiple investment companies and funds in fiscal years 2019 and 2020 and (2) reasons participating agencies cited for allowing or not allowing the participation of qualified small businesses in the SBIR program. GAO reviewed agencies' data on the participation of qualified small businesses and conducted interviews with or obtained written answers from program managers from the 11 participating agencies and SBA. For more information, contact Candice N. Wright at (202) 512-6888 or firstname.lastname@example.org.[Read More…]
- Statement by Acting Attorney General Jeffrey A. Rosen on the Pakistani Proceedings Relating to the Abduction and Murder of Daniel PearlBy Sam NewsDecember 29, 2020Acting Attorney General Jeffrey A. Rosen has released the following statement:[Read More…]
- Venezuelan Business Executive Charged in Connection with International Bribery and Money Laundering SchemeBy Sam NewsNovember 25, 2020A dual Venezuelan-Italian citizen who controlled multiple companies via U.S. based bank accounts was charged in an indictment returned Tuesday for his role in laundering the proceeds of inflated contracts that were obtained by making bribe payments to officials at Venezuela’s state-owned and state-controlled energy company Petróleos de Venezuela S.A. (PDVSA).[Read More…]
- COVID-19: Federal Efforts Could Be Strengthened by Timely and Concerted ActionsBy Sam NewsSeptember 21, 2020In the government’s ongoing response to the COVID-19 pandemic, the Congress and the administration have taken action on multiple fronts to address challenges that have contributed to catastrophic loss of life and profound economic disruption. These actions have helped direct much-needed federal assistance to support many aspects of public life, including local public health systems and private-sector businesses. However, the nation faces continued public health risks and economic difficulties for the foreseeable future. Among other challenges, the public health system, already strained from months of responding to COVID-19 cases, will face the additional task of managing the upcoming flu season. At the same time, many of the federal, state, and local agencies responsible for responding to the ongoing public health emergency are called on to prepare for and respond to the current hurricane season. Timely and concerted federal leadership will be required in responding to these and other challenges. GAO has identified lessons learned and issues in need of continued attention by the Congress and the administration, including the need to collect reliable data that can drive decision-making; to establish mechanisms for accountability and transparency; and to protect against ongoing cyber threats to patient information, intellectual property, public health data, and intelligence. Attention to these issues can help to make federal efforts as effective as possible. GAO has also identified a number of opportunities to help the federal government prepare for the months ahead while improving the ongoing federal response: Medical Supply Chain The Department of Health and Human Services (HHS) and the Federal Emergency Management Agency (FEMA), with support from the Department of Defense (DOD), have taken numerous, significant efforts to mitigate supply shortages and expand the medical supply chain. For example, the agencies have coordinated to deliver supplies directly to nursing homes and used Defense Production Act authorities to increase the domestic production of supplies. However, shortages of certain types of personal protective equipment and testing supplies remain due to a supply chain with limited domestic production and high global demand. The Food and Drug Administration (FDA) and FEMA have both identified shortages, and officials from seven of the eight states GAO interviewed in July and August 2020 identified previous or ongoing shortages of testing supplies, including swabs, reagents, tubes, pipettes, and transport media. Testing supply shortages have contributed to delays in turnaround times for testing results. Delays in processing test results have multiple serious consequences, including delays in isolating those who test positive and tracing their contacts in a timely manner, which can in turn exacerbate outbreaks by allowing the virus to spread undetected. In addition, states and other nonfederal entities have experienced challenges tracking supply requests made through the federal government and planning for future needs. GAO is making the following recommendations: HHS, in coordination with FEMA, should immediately document roles and responsibilities for supply chain management functions transitioning to HHS, including continued support from other federal partners, to ensure sufficient resources exist to sustain and make the necessary progress in stabilizing the supply chain. HHS, in coordination with FEMA, should further develop and communicate to stakeholders plans outlining specific actions the federal government will take to help mitigate supply chain shortages for the remainder of the pandemic. HHS and FEMA—working with relevant stakeholders—should devise interim solutions, such as systems and guidance and dissemination of best practices, to help states enhance their ability to track the status of supply requests and plan for supply needs for the remainder of the COVID-19 pandemic response. HHS and the Department of Homeland Security (DHS) objected to GAO’s initial draft recommendations. GAO made revisions based on their comments. GAO maintains that implementation of its modified recommendations is both warranted and prudent. These actions could contribute to ensuring a more effective response by helping to mitigate challenges with the stability of the medical supply chain and the ability of nonfederal partners to track, plan, and budget for ongoing medical supply needs. Vaccines and Therapeutics Multiple federal agencies continue to support the development and manufacturing of vaccines and therapeutics to prevent and treat COVID-19. These efforts are aimed at accelerating the traditional timeline to create a vaccine (see figure). Traditional Timeline for Development and Creation of a Vaccine Note: See figure 5 in the report. As these efforts proceed, clarity on the federal government’s plans for distributing and administering vaccine, as well as timely, clear, and consistent communication to stakeholders and the public about those plans, is essential. DOD is supporting HHS in developing plans for nationwide distribution and administration of a vaccine. In September 2020, HHS indicated that it will soon send a report to Congress outlining a distribution plan, but did not provide a specific date for doing so. GAO recommends that HHS, with support from DOD, establish a time frame for documenting and sharing a national plan for distributing and administering COVID-19 vaccine, and in developing such a plan ensure that it is consistent with best practices for project planning and scheduling and outlines an approach for how efforts will be coordinated across federal agencies and nonfederal entities. DOD partially concurred with the recommendation, clarifying that it is supporting HHS in developing plans for nationwide distribution and administration of vaccine. HHS neither agreed nor disagreed with the recommendation, but noted factors that complicate the publication of a plan. GAO maintains that a time frame is necessary so all relevant stakeholders will be best positioned to begin their planning.On September 16, 2020, HHS and DOD released two documents outlining a strategy for any COVID-19 vaccine. GAO will evaluate these documents and report on them in future work.GAO will also continue to conduct related work, including examining federal efforts to accelerate the development and manufacturing of COVID-19 vaccines and therapeutics. COVID-19 Data Data collected by the Centers for Disease Control and Prevention (CDC) suggest a disproportionate burden of COVID-19 cases, hospitalizations, and deaths exists among racial and ethnic minority groups, but GAO identified gaps in these data. To help address these gaps, on July 22, 2020, CDC released a COVID-19 Response Health Equity Strategy. However, the strategy does not assess whether having the authority to require states and jurisdictions to report race and ethnicity information is necessary to ensure CDC can collect such data. CDC’s strategy also does not specify how it will involve key stakeholders, such as health care providers, laboratories, and state and jurisdictional health departments. GAO recommends that CDC (1) determine whether having the authority to require the reporting of race and ethnicity information for cases, hospitalizations, and deaths is necessary for ensuring more complete data, and if so, seek such authority from Congress; (2) involve key stakeholders to help ensure the complete and consistent collection of demographic data; and (3) take steps to help ensure its ability to comprehensively assess the long-term health outcomes of persons with COVID-19, including by race and ethnicity. HHS agreed with the recommendations. In addition, HHS’s data on COVID-19 in nursing homes do not capture the early months of the pandemic. HHS’s Centers for Medicare & Medicaid Services (CMS) began requiring nursing homes to report COVID-19 data to CDC by May 17, 2020, starting with information as of May 8, 2020, but made reporting prior to May 8, 2020 optional. By not requiring nursing homes to submit data from the first 4 months of 2020, HHS is limiting the usefulness of the data in helping to understand the effects of COVID-19 in nursing homes. GAO recommends that HHS, in consultation with CMS and CDC, develop a strategy to capture more complete data on COVID-19 cases and deaths in nursing homes retroactively back to January 1, 2020. HHS partially agreed with this recommendation by noting the value of having complete data, but expressed concern about the burden of collecting it. GAO maintains the importance of collecting these data to inform the government’s continued response and recovery, and HHS could ease the burden by incorporating data previously reported to CDC or to state or local public health offices. Economic Impact Payments The Department of the Treasury’s (Treasury) Internal Revenue Service (IRS) has issued economic impact payments (EIP) to all eligible individuals for whom IRS has the necessary information to do so; however, not everyone eligible was able to be initially identified. To help ensure all eligible recipients received their payments in a more timely manner, IRS took several actions to address challenges GAO reported on in June, including a policy change—reopening the Non-Filers tool registration period for federal benefit recipients and extending it through September 30—that should allow some eligible recipients to receive supplemental payments for qualifying children sooner than expected. However, Treasury and IRS lack updated information on how many eligible recipients have yet to receive these funds. The lack of such information could hinder outreach efforts and place potentially millions of individuals at risk of missing their payment. GAO recommends that Treasury, in coordination with IRS, (1) update and refine the estimate of eligible recipients who have yet to file for an EIP to help target outreach and communications efforts and (2) make estimates of eligible recipients who have yet to file for an EIP, and other relevant information, available to outreach partners to raise awareness about how and when to file for EIP. Treasury and IRS neither agreed nor disagreed with the recommendations and described actions they are taking in concert with the recommendations to notify around 9 million individuals who may be eligible for an EIP. Coronavirus Relief Fund The Coronavirus Relief Fund (CRF) is the largest program established in the four COVID-19 relief laws that provides aid to states, the District of Columbia, localities, tribal governments, and U.S. territories. Audits of entities that receive federal funds, including CRF payments, are critical to the federal government’s ability to help safeguard those funds. Auditors that conduct single audits follow guidance in the Single Audit Act’s Compliance Supplement, which the Office of Management and Budget (OMB) updates and issues annually in coordination with federal agencies. OMB issued the 2020 Compliance Supplement in August 2020, but the Compliance Supplement specified that OMB is still working with federal agencies to identify the needs for additional guidance for auditing new COVID-19-related programs, including the CRF payments, as well as existing programs with compliance requirement changes. According to OMB, an addendum on COVID-19-related programs, including the CRF payments, will be issued in the fall of 2020. Further delays in issuing this guidance could adversely affect auditors’ ability to issue consistent and timely reports. GAO recommends that OMB, in consultation with Treasury, issue the addendum to the 2020 Compliance Supplement as soon as possible to provide the necessary audit guidance, as many single audit efforts are underway. OMB neither agreed nor disagreed with the recommendation. Guidance for K-12 Schools State and local school district officials tasked with reassessing their operating status and ensuring their school buildings are safe are generally relying on guidance and recommendations from federal, state, and local public health and education officials. However, portions of CDC’s guidance on reopening K-12 schools are inconsistent, and some federal guidance appears misaligned with CDC’s risk-based approach on school operating status. Based on GAO’s review, Education has updated the information and CDC has begun to do so. GAO recommends that CDC ensure that, as it makes updates to its guidance related to schools’ operating status, the guidance is cogent, clear, and internally consistent. HHS agreed with the recommendation. Tracking Contract Obligations Federal agencies are tracking contract actions and associated obligations in response to COVID-19 using a National Interest Action (NIA) code in the Federal Procurement Data System-Next Generation. The COVID-19 NIA code was established in March 2020 and was recently extended until March 31, 2021, while a draft of this report recommending that DHS and DOD extend the code beyond September 30, 2020, was with the agencies for comment. GAO has identified inconsistencies in establishing and closing these codes following previous emergencies, and has continued concerns with the criteria that DHS and DOD rely on to determine whether to extend or close a code and whether the code meets long-term needs. GAO recommends that DHS and DOD make updates to the 2019 NIA Code Memorandum of Agreement so as to enhance visibility for federal agencies, the public, and Congress on contract actions and associated obligations related to disaster events, and to ensure the criteria for extending or closing the NIA code reflect government-wide needs for tracking contract actions in longer-term emergencies, such as a pandemic. DHS and DOD did not agree, but GAO maintains implementation of its recommendation is essential. Address Cybersecurity Weaknesses Since March 2020, malicious cyber actors have exploited COVID-19 to target organizations that make up the health care and public health critical infrastructure sector, including government entities, such as HHS. GAO has identified numerous cybersecurity weaknesses at multiple HHS component agencies, including CMS, CDC, and FDA, over the last 6 years, such as weaknesses in key safeguards to limit, prevent, and detect inappropriate access to computer resources. Additionally, GAO’s March 2019 high-risk update identified cybersecurity and safeguarding the systems supporting the nation’s critical infrastructure, such as health care, as high-risk areas. As of July 2020, CMS, FDA, and CDC had made significant progress by implementing 350 (about 81 percent) of the 434 recommendations GAO issued in previous reports to address these weaknesses. Based on the imminent cybersecurity threats, GAO recommends that HHS expedite implementation of GAO’s prior recommendations regarding cybersecurity weaknesses at its component agencies. HHS agreed with the recommendation. As of September 10, 2020, the U.S. had over 6.3 million cumulative reported cases of COVID-19 and over 177,000 reported deaths, according to federal agencies. The country also continues to experience serious economic repercussions and turmoil. Four relief laws, including the CARES Act, were enacted as of September 2020 to provide appropriations to address the public health and economic threats posed by COVID-19. As of July 31, 2020, the federal government had obligated a total of $1.6 trillion and expended $1.5 trillion of the COVID-19 relief funds as reported by federal agencies on USAspending.gov. The CARES Act includes a provision for GAO to report bimonthly on its ongoing monitoring and oversight efforts related to the COVID-19 pandemic. This third report examines key actions the federal government has taken to address the COVID-19 pandemic and evolving lessons learned relevant to the nation’s response to pandemics. GAO reviewed data, documents, and guidance from federal agencies about their activities and interviewed federal and state officials, as well as industry representatives. GAO is making 16 new recommendations for agencies that are detailed in this Highlights and in the report. For more information, contact A. Nicole Clowers at (202) 512-7114 or email@example.com.[Read More…]
- United States and Japan Hold Bilateral Security DiscussionsBy Sam NewsOctober 7, 2020
- Secretary Blinken’s Call with EU High Representative for Foreign Affairs and Security Policy BorrellBy Sam NewsMay 17, 2021
- Supporting a Healthy, Sustainable Mekong RiverBy Sam NewsFebruary 24, 2021
- U.S. Holocaust Memorial Museum Honors DOJ with Elie Wiesel AwardBy Sam NewsApril 23, 2021The U.S. Holocaust Memorial Museum last night conferred their highest honor, the Elie Wiesel Award, on the U.S. Department of Justice in recognition of the successes of its longtime enforcement program’s efforts to identify, investigate, and prosecute participants in World War II-era Nazi crimes.[Read More…]
- Secretary Michael R. Pompeo’s Call with Indian External Affairs Minister S. JaishankarBy Sam NewsSeptember 26, 2020
- The Impact of the Pandemic on Pregnancy: A Research ResponseBy Sam NewsJuly 29, 2020Maternal health and [Read More…]
- COVID-19 Loans: SBA Has Begun to Take Steps to Improve Oversight and Fraud Risk ManagementBy Sam NewsApril 20, 2021What GAO Found In April 2020, the Small Business Administration (SBA) quickly implemented the Paycheck Protection Program (PPP) and expedited the processing of Economic Injury Disaster Loans (EIDL) and a new EIDL advance program. These important programs have helped businesses survive during the COVID-19 pandemic. In an effort to move quickly on these programs, SBA initially put limited internal controls in place, leaving both susceptible to program integrity issues, improper payments, and fraud. Because of concerns about program integrity, GAO added PPP and the EIDL program onto its High-Risk List in March 2021. SBA has begun to take steps to address these initial deficiencies: PPP oversight. Because ongoing oversight is crucial, GAO recommended in June 2020 that SBA develop plans to respond to PPP risks to ensure program integrity, achieve program effectiveness, and address potential fraud. Since then, SBA has developed a loan review process and added up-front verifications before it approves new loans. Improper payments for PPP. GAO recommended in November 2020 that SBA expeditiously estimate improper payments for PPP and report estimates and error rates. SBA has now developed a plan for the testing needed to estimate improper payments. Analyzing EIDL data. Based on evidence of widespread potential fraud for EIDL, GAO recommended in January 2021 that SBA conduct portfolio-level analysis to detect potentially ineligible applications. SBA has not announced plans to implement this recommendation. EIDL oversight. GAO recommended in March 2021 that SBA implement a comprehensive oversight plan for EIDL to ensure program integrity. SBA agreed to implement such a plan. Assessment of fraud risks. SBA has not conducted a formal fraud risk assessment for PPP or the EIDL program. GAO made four recommendations in March 2021, including that SBA conduct a formal assessment and develop a strategy to manage fraud risks for each program. SBA said it would work to complete fraud risk assessments for PPP and EIDL and continually monitor fraud risks. Financial statement audit. In December 2020, SBA's independent financial statement auditor issued a disclaimer of opinion on SBA's fiscal year 2020 consolidated financial statements because SBA could not provide adequate documentation to support a significant number of transactions and account balances related to PPP and EIDL. GAO continues to review information SBA recently provided, including data on PPP loan forgiveness and details on the PPP and EIDL loan review processes. In addition, GAO has obtained additional information from a survey of PPP participating lenders, interviews with SBA's PPP contractors, and written responses to questions provided by SBA's EIDL contractor and subcontractors. Why GAO Did This Study SBA has made or guaranteed about 18.7 million loans and grants through PPP and the EIDL program, providing about $968 billion to help small businesses adversely affected by COVID-19. PPP provides potentially forgivable loans to small businesses, and EIDL provides low-interest loans of up to $2 million for operating and other expenses, as well as advances (grants). This testimony discusses the lack of controls in PPP and the EIDL program and SBA's efforts to improve its oversight of these programs. It is based largely on GAO's June 2020–March 2021 reports on the federal response, including by SBA, to the economic downturn caused by COVID-19 (GAO-20-625, GAO-20-701, GAO-21-191, GAO-21-265, GAO -21-387). For those reports, GAO reviewed SBA documentation and SBA Office of Inspector General (OIG) reports; analyzed SBA data; and interviewed officials from SBA, the SBA OIG, and the Department of the Treasury.[Read More…]
- Tuvalu Travel AdvisoryBy Sam NewsSeptember 26, 2020
- Department of Justice Issues Statement Regarding Federal Civil Rights Review Into March 2020 Police Encounter with Daniel PrudeBy Sam NewsFebruary 23, 2021Pamela Karlan, Principal Deputy Assistant Attorney General for the Civil Rights Division of the Department of Justice, James P. Kennedy Jr., U.S. Attorney for the Western District of New York, and Stephen A. Belongia, Special Agent in Charge of the FBI Buffalo Field Office, released the following statement:[Read More…]
- VA Vet Centers: Evaluations Needed of Expectations for Counselor Productivity and Centers’ StaffingBy Sam NewsSeptember 23, 2020The Veterans Health Administration's (VHA) Readjustment Counseling Service (RCS) provides counseling through 300 Vet Centers, which can be found in community settings and are separate from other VHA facilities. RCS has set expectations for counselor productivity at Vet Centers. For example, one expectation is for counselors to achieve an average of 1.5 visits for each hour they provide direct services. However, RCS officials told GAO that they have not conducted, and do not have plans to conduct, an evaluation of the expectations. VA Vet Center Productivity Expectations for Counselors Although most counselors met the productivity expectations in fiscal year 2019, counselors GAO spoke with said the expectations led them to change work practices in ways that could negatively affect client care. For example, counselors at one Vet Center told GAO that, to meet productivity expectations, they spend less time with each client to fit more clients into their schedules. Without an evaluation of its productivity expectations, RCS lacks reasonable assurance that it is identifying any unintended or potentially negative effects of the expectations on counselor practices and client care. RCS officials told GAO that by the start of fiscal year 2021 they plan to implement a staffing model to identify criteria for determining staffing needs at Vet Centers. The model incorporates data on counselors' productivity (work hours and number of visits), and total clients to determine criteria for adding or removing a counselor position from a Vet Center. However, the model does not fully address key practices in staffing model design GAO identified in previous work. For example, the model does not include the input of Vet Center counselors, or client data associated with directors, who also provide counseling. As a result, RCS is at risk of making decisions about Vet Center staffing that may not be responsive to changing client needs. Shortages of mental health staff within VHA coupled with the increasing veteran demand for mental health services highlight the critical importance of ensuring appropriate Vet Center staffing. VHA's RCS provided counseling (individual, group, marriage, and family) and outreach services through Vet Centers to more than 300,000 veterans and their families in fiscal year 2019. In 2017, RCS implemented changes to expectations that it uses to assess Vet Center counselor productivity, setting expectations for counselors' percentage of time with clients and number of client visits. GAO was asked to review Vet Center productivity expectations for counselors and staffing. Among other issues, this report examines the extent to which VHA (1) evaluates its productivity expectations; and (2) assesses Vet Centers' staffing needs. To do this work, GAO reviewed RCS documentation regarding counselors' productivity expectations and analyzed RCS data on counselor productivity expectations and staffing, for fiscal year 2019. GAO interviewed RCS leadership, including district directors, and directors and counselors from 12 Vet Centers, selected for variation in geographic location and total number of clients, among other factors. GAO is making four recommendations, including that VHA (1) evaluate Vet Center productivity expectations for counselors; and (2) develop and implement a staffing model that incorporates key practices. The Department of Veterans Affairs concurred with GAO's recommendations and identified actions VHA is taking to implement them. For more information, contact Debra A. Draper at (202) 512-7114 or firstname.lastname@example.org.[Read More…]
- Imperial Pacific International and MCC International Saipan Executives Indicted on Federal ChargesBy Sam NewsAugust 4, 2020Three executives from Imperial Pacific International (IPI) and MCC International Saipan have been indicted on federal criminal charges, including Racketeer Influenced and Corrupt Organizations Act (RICO) conspiracy, harboring illegal aliens, unlawful employment of aliens, and international promotional money laundering announced Acting Assistant Attorney General Brian C. Rabbitt of the Justice Department’s Criminal Division and U.S. Attorney Shawn N. Anderson for the Districts of Guam and the Northern Mariana Islands.[Read More…]
- Armenian Independence DayBy Sam NewsSeptember 26, 2020Michael R. Pompeo, [Read More…]
- Justice Department Reaches Agreement with Nevada to End Discriminatory Policies Against Inmates with HIV and Inmates with DisabilitiesBy Sam NewsFebruary 11, 2021The Justice Department today reached a settlement agreement with Nevada to ensure that inmates with HIV are not illegally segregated or otherwise discriminated against on the basis of HIV status and that inmates with disabilities are provided an equal opportunity to participate in and benefit from Nevada Department of Corrections (NDOC) programs.[Read More…]
- Texas Woman Charged with Fraudulently Obtaining Nearly $2 Million in COVID Relief FundsBy Sam NewsSeptember 15, 2020A Texas woman has been taken into custody on allegations she fraudulently obtained more than $1.9 million in Paycheck Protection Program (PPP) loans, announced Acting Assistant Attorney General Brian C. Rabbitt of the Justice Department’s Criminal Division and U.S. Attorney Ryan K. Patrick of the Southern District of Texas.[Read More…]
- Al Qaeda-Trained Jihadist Who Recruited Other Inmates to Join ISIS Sentenced to 300 MonthsBy Sam NewsOctober 20, 2020A 46-year-old international terrorist convicted of additional terrorist activity that he committed while an inmate of the U.S. Bureau of Prisons has been sentenced in the Eastern District of Texas, announced the Department of Justice.[Read More…]
- Justice Department Reaches Settlement with San Antonio Housing Providers for Charging Unlawful Lease Termination Fees to ServicemembersBy Sam NewsSeptember 28, 2020The Justice Department today announced that it has reached an agreement with the former owners of two apartment complexes in San Antonio, Texas, to resolve allegations that they violated the Servicemembers Civil Relief Act (SCRA) by imposing unlawful lease termination charges on 41 servicemembers and by refusing to allow four other servicemembers to terminate their leases early.[Read More…]
- Justice Department Files Lawsuit Against Two California Doctors for Discrimination Against Patient with HIVBy Sam NewsJanuary 14, 2021The Justice Department filed lawsuits today alleging that two obstetrician-gynecologist (OB/GYN) doctors in Bakersfield, California refused to provide routine medical care to a patient on the basis of her HIV status, in violation of Title III of the Americans with Disabilities Act (ADA).[Read More…]
- Justice Department Joins Computational Antitrust Project at Stanford Law SchoolBy Sam NewsJanuary 19, 2021The Department of Justice announced today that it will participate in the Computational Antitrust project, hosted by the Stanford University CodeX Center and created by Professor Thibault Schrepel. The project brings together academics from law, computer science, and economics as well as developers, policymakers, and antitrust agencies from around the world to discuss how technology and automation can improve antitrust enforcement.[Read More…]
- Immigration Enforcement: ICE Can Further Enhance Its Planning and Oversight of State and Local AgreementsBy Sam NewsFebruary 26, 2021Within the Department of Homeland Security (DHS), U.S. Immigration and Customs Enforcement (ICE) met its goal to expand the 287(g) program. However, ICE has not established performance goals that cover all program activities, such as ICE's oversight of its law enforcement agency (LEA) partners, or measures to assess the program's performance, such as the percentage of LEA partners in compliance with annual training requirements. As a result, ICE is not well-positioned to determine the extent to which the program is achieving intended results. ICE considers a number of factors, such as LEAs' capability to act as an ICE force multiplier, when reviewing their suitability to join the program; however, ICE has not assessed how to optimize the use of its resources and program benefits to guide its recruitment of future 287(g) participants. For example, ICE has two models in which LEAs can participate with varying levels of immigration enforcement responsibilities. In the Jail Enforcement Model (JEM), designated state or local officers identify and process removable foreign nationals who have been arrested and booked into the LEA's correctional facility, whereas in the Warrant Service Officer (WSO) model, the designated officers only serve warrants to such individuals. However, ICE has not assessed the mix of participants for each model that would address resource limitations, as each model has differing resource and oversight requirements. By assessing how to leverage its program resources and optimize benefits received, ICE could approach recruitment more strategically and optimize program benefits. 287(g) Participants in January 2017 and September 2020 ICE uses a number of mechanisms to oversee 287(g) JEM participants' compliance with their agreements, such as conducting inspections and reviewing reported complaints. However, at the time of GAO's review, ICE did not have an oversight mechanism for participants' in the WSO model. For example, ICE did not have clear policies on 287(g) field supervisors' oversight responsibilities or plan to conduct compliance inspections for WSO participants. An oversight mechanism could help ICE ensure that WSO participants comply with their 287(g) agreement and other relevant ICE policies and procedures. The 287(g) program authorizes ICE to enter into agreements with state and local law enforcement agencies to assist with enforcing immigration laws. The program expanded from 35 agreements in January 2017 to 150 as of September 2020. GAO was asked to review ICE's management and oversight of the program. This report examines (1) the extent to which ICE has developed performance goals and measures to assess the 287(g) program; (2) how ICE determines eligibility for 287(g) program participation and considers program resources; and (3) how ICE conducts oversight of 287(g) program participant compliance and addresses noncompliance. GAO reviewed ICE policies and documentation, and interviewed officials from ICE headquarters and field offices. GAO also interviewed 11 LEAs selected based on the type of 287(g) agreement, length of participation, and facility type (e.g. state or local).While not generalizable, information collected from the selected LEAs provided insights into 287(g) program operations and oversight of program participants. GAO analyzed data on 287(g) inspection results and complaints from fiscal years 2015 through 2020. GAO recommends that ICE (1) establish performance goals and related performance measures; (2) assess the 287(g) program's composition to help leverage its resources and optimize program benefits; and (3) develop and implement an oversight mechanism for the WSO model. DHS concurred with the recommendations. For more information, contact Rebecca Gambler at (202) 512-8777 or GamblerR@gao.gov.[Read More…]
- Operation Legend: Case of the DayBy Sam NewsSeptember 11, 2020Each weekday, the Department of Justice will highlight a case that has resulted from Operation Legend. Today’s case is out of the Eastern District of Wisconsin. Operation Legend launched in Milwaukee on July 29, 2020, in response to the city facing increased homicide and non-fatal shooting rates.[Read More…]
- NASA Announces Mini Payload Challenge WinnersBy Sam NewsIn SpaceSeptember 26, 2020The winners for the [Read More…]
- Small Business Administration: COVID-19 Loans Lack Controls and Are Susceptible to FraudBy Sam NewsOctober 1, 2020In April 2020, the Small Business Administration (SBA) moved quickly to implement the Paycheck Protection Program (PPP), which provides loans that are forgivable under certain circumstances to small businesses affected by COVID-19. Given the immediate need for these loans, SBA worked to streamline the program so that lenders could begin distributing these funds as soon as possible. For example, lenders were permitted to rely on borrowers' self-certifications for eligibility and use of loan proceeds. As a result, there may be significant risk that some fraudulent or inflated applications were approved. Since May 2020, the Department of Justice has publicly announced charges in more than 50 fraud-related cases associated with PPP funds. In April 2020, SBA announced it would review all loans of more than $2 million to confirm borrower eligibility, and SBA officials subsequently stated that they would review selected loans of less than $2 million to determine, for example, whether the borrower is entitled to loan forgiveness. However, SBA did not provide details on how it would conduct either of these reviews. As of September 2020, SBA reported it was working with the Department of the Treasury and contractors to finalize the plans for the reviews. Because SBA had limited time to implement safeguards up front for loan approval, GAO believes that planning and oversight by SBA to address risks in the PPP program is crucial moving forward. SBA's efforts to expedite processing of Economic Injury Disaster Loans (EIDL)—such as the reliance on self-certification—may have contributed to increased fraud risk in that program as well. In July 2020, SBA's Office of Inspector General (OIG) reported indicators of widespread potential fraud—including thousands of fraud complaints—and found deficiencies with SBA's internal controls. In response, SBA maintained that its internal controls for EIDL were robust, including checks to identify duplicate applications and verify account information, and that it had provided banks with additional antifraud guidance. The Department of Justice, in conjunction with other federal agencies, also has taken actions to address potential fraud. Since May 2020, the department has announced fraud investigations related to the EIDL program and charges against recipients related to EIDL fraud. SBA has made or guaranteed more than 14.5 million loans and grants through PPP and EIDL, providing about $729 billion to help small businesses adversely affected by COVID-19. However, the speed with which SBA implemented the programs may have increased their susceptibility to fraud. This testimony discusses fraud risks associated with SBA's PPP and EIDL programs. It is based largely on GAO's reports in June 2020 (GAO-20-625) and September 2020 (GAO-20-701) that addressed the federal response, including by SBA, to the economic downturn caused by COVID-19. For those reports, GAO reviewed SBA documentation and interviewed officials from SBA, the Department of the Treasury, and associations that represent lenders and small businesses. GAO also met with officials from the SBA OIG and reviewed OIG reports. In its June 2020 report, GAO recommended that SBA develop and implement plans to identify and respond to risks in PPP to ensure program integrity, achieve program effectiveness, and address potential fraud. SBA neither agreed nor disagreed, but GAO believes implementation of this recommendation is essential. For more information, contact William B. Shear at (202) 512-4325 or email@example.com.[Read More…]
- Nowruz MessageBy Sam NewsMarch 20, 2021
- Secretary Blinken’s Call with Japanese Foreign Minister MotegiBy Sam NewsFebruary 10, 2021
- Secretary Antony J. Blinken With Jake Tapper of CNN’s The Lead with Jake TapperBy Sam NewsApril 29, 2021
- Operation Warp Speed: Accelerated COVID-19 Vaccine Development Status and Efforts to Address Manufacturing ChallengesBy Sam NewsFebruary 11, 2021Operation Warp Speed (OWS)—a partnership between the Departments of Health and Human Services (HHS) and Defense (DOD)—aimed to help accelerate the development of a COVID-19 vaccine. GAO found that OWS and vaccine companies adopted several strategies to accelerate vaccine development and mitigate risk. For example, OWS selected vaccine candidates that use different mechanisms to stimulate an immune response (i.e., platform technologies; see figure). Vaccine companies also took steps, such as starting large-scale manufacturing during clinical trials and combining clinical trial phases or running them concurrently. Clinical trials gather data on safety and efficacy, with more participants in each successive phase (e.g., phase 3 has more participants than phase 2). Vaccine Platform Technologies Supported by Operation Warp Speed, as of January 2021 As of January 30, 2021, five of the six OWS vaccine candidates have entered phase 3 clinical trials, two of which—Moderna's and Pfizer/BioNTech's vaccines—have received an emergency use authorization (EUA) from the Food and Drug Administration (FDA). For vaccines that received EUA, additional data on vaccine effectiveness will be generated from further follow-up of participants in clinical trials already underway before the EUA was issued. Technology readiness. GAO's analysis of the OWS vaccine candidates' technology readiness levels (TRL)—an indicator of technology maturity— showed that COVID-19 vaccine development under OWS generally followed traditional practices, with some adaptations. FDA issued specific guidance that identified ways that vaccine development may be accelerated during the pandemic. 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. These efforts include federal assistance to (1) expedite procurement and delivery of critical manufacturing equipment, (2) develop a list of critical supplies that are common across the six OWS vaccine candidates, and (3) expedite the delivery of necessary equipment and goods coming into the United States. Additionally, DOD and HHS officials said that as of December 2020 they had placed prioritized ratings on 18 supply contracts for vaccine companies under the Defense Production Act, which allows federal agencies with delegated authority to require contractors to prioritize those contracts for supplies needed for vaccine production. Gaps in the available workforce: Hiring and training personnel with the specialized skills needed to run vaccine manufacturing processes can be challenging. 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 firstname.lastname@example.org or email@example.com.[Read More…]
- Secretary Antony J. Blinken and Jordanian Foreign Minister Ayman Safadi Before Their MeetingBy Sam NewsMay 12, 2021
- Attorney General Merrick B. Garland Delivers Remarks at Joint DOJ-EPA Event with EPA Administrator Michael S. Regan: Promoting Justice for Victims of Environmental CrimeBy Sam NewsApril 20, 2021Good afternoon and thank you so much for those kind words, Kris.[Read More…]
- Department of Justice Recognizes International Day of Zero Tolerance for Female Genital MutilationBy Sam NewsFebruary 10, 2021Female genital mutilation (FGM) has broad implications for the health and human rights of women and girls, as well as societies at large.[Read More…]