For nearly two decades, a bone marrow transplant has been the only known cure for sickle cell disease, an inherited blood disorder that can cause excruciating pain for those who have it. But very few patients have qualified for the grueling procedure. And they’re mainly children, who can better tolerate the high doses of chemotherapy needed to wipe out the bone marrow, which doctors then replace with matching donor stem cells from a sibling.
Today, researchers at the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, are on a fast track to change that bleak outlook. They are working hard to expand options that not only treat sickle cell disease, but also cure it. From new transplant approaches to new genetic therapies, the treatments, these researchers say, could be game changers in the not-so-distant future.
“It’s an exciting time because people with sickle cell disease may one day have three more curative options to choose from, not just the traditional bone marrow transplant,” said Courtney Fitzhugh, M.D., who has had recent success with bone marrow transplantation in adults.
An investigator in the Laboratory of Early Sickle Mortality Prevention, part of NHLBI’s Cellular and Molecular Therapeutics Branch, Fitzhugh’s latest transplant regimen has been recruiting adults with sickle cell disease for a clinical study since 2017, and the results so far have been encouraging. Instead of completely replacing a patient’s bone marrow with that of their donor, Fitzhugh says it’s now possible to reverse sickle cell disease using a mixture of donor and patient cells. Eligible participants only need a relative, such as a parent or child, whose stem cells only partially match the patient’s. This change—from needing a full match— increases the patient’s chances of finding a suitable donor from 10% to 90%. Further, because this approach does not include high dose chemotherapy, patients with severe organ damage may be eligible for transplant.
Before receiving donor cells, participants will need to take a combination of medications to suppress only part of their immune system and reduce the risk of graft-versus-host-disease, a serious complication that occurs when donor cells recognize the patient’s healthy cells as foreign, then attack them. Fitzhugh will follow participants three months after the transplant to make sure this complication doesn’t occur. She also wants to ensure that the donor cells aren’t rejected and the disease hasn’t returned. Patients will also be followed for many years afterwards to evaluate efficacy of the procedure and to check for any long-term effects of the transplant on their organs.
Also in the works are a number of genetic therapies aimed at correcting the abnormal beta globin gene that results in rigid, sickled red blood cells that wreak havoc on the body, especially when the blood cells are exposed to low oxygen levels. Gene addition therapy, said John Tisdale, M.D., can restore the missing function of the faulty gene by adding a new gene to bone marrow stem cells harvested from the patient. The new gene—a normal version of the faulty gene—would then produce healthy red blood cells.
“We’ve been able to reduce frequent pain that lands patients in the hospital by using this gene addition therapeutic approach in combination with a conditioning treatment that creates space in the marrow,” said Tisdale, chief of NHLBI’s Cellular and Molecular Therapeutic Branch. “The reduction in pain has been remarkable, and this approach is working. It’s really exciting.”
Another newer curative therapy is gene editing, which researchers could use to reactivate fetal hemoglobin that is typically present during fetal life. When sickle cell disease develops, a misspelled adult hemoglobin is soon replaced after birth.
Investigators don’t yet know which therapeutic approach will reach patients first, but Traci Mondoro, Ph.D., chief of NHLBI’s Translational Blood Science and Resources Branch, said the groundwork is being laid to make sure whatever emerges is effective. Mondoro helps manage NIH’s Cure Sickle Cell initiative, which supports research into promising therapies like these so that they can be safely used in clinical research in the years to come. It also adds to existing efforts being funded by NHLBI, such as basic biology and pain research.
“Therapeutic approaches, such as gene therapy and gene editing, are still in the early stages,” said Mondoro. “While these approaches are not suitable for all, we are also working with a sense of urgency to research other treatment options for older or sicker patients.”
National Sickle Cell Awareness Month Series:
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GAO found that the Department of Health and Human Services (HHS) has not issued a comprehensive and publicly available national testing strategy. HHS’s national strategy documents are not comprehensive because they only partially address the characteristics that GAO has found to be desirable in an effective national strategy. For example, testing strategy documents do not always provide consistent definitions and benchmarks to measure progress, not all documents clearly define the problem and risks, and there is limited information on the types of resources required for future needs. Furthermore, some of the documents have not been made public. While the national testing strategy is formally outlined in a publicly available document, HHS has provided only Congress with the COVID-19 Testing Strategy Reports, which detail the implementation of the testing strategy. Stakeholders who are involved in the response efforts told GAO they were unaware of the existence of a national strategy or did not have a clear understanding of the strategy. Without a comprehensive, publicly available national strategy, HHS is at risk of key stakeholders and the public lacking crucial information to support an informed and coordinated testing response. GAO is recommending that HHS develop and make publicly available a comprehensive national COVID-19 testing strategy that incorporates all six characteristics of an effective national strategy. Such a strategy could build upon existing strategy documents that HHS has produced for the public and Congress to allow for a more coordinated pandemic testing approach. HHS partially concurred with this recommendation and agreed that it should take steps to more directly incorporate some of the elements of an effective national strategy. Vaccines and Therapeutics Multiple federal agencies, through Operation Warp Speed, continue to support the development and manufacturing of vaccines and therapeutics to prevent and treat COVID-19. As of January 8, 2021, two of the six vaccines supported by Operation Warp Speed have been authorized for emergency use, and vaccine distribution and administration have begun. (See figure below). However, distribution and administration fell short of expectations set for the end of the year. As of December 30, 2020, Operation Warp Speed had distributed (shipped) about 12.4 million doses of COVID-19 vaccine and providers reported administering about 2.8 million initial doses, according to Centers for Disease Control and Prevention data. In September 2020, GAO stressed the importance of having a plan that focused on coordination and communication and recommended that HHS, with the support of the Department of Defense, establish a time frame for documenting and sharing a national plan for distributing and administering COVID-19 vaccine, and among other things, outline an approach for how efforts would be coordinated across federal agencies and nonfederal entities.To date, this recommendationhas not been fully implemented. GAO reiterates the importance of doing so. Effective coordination and communication among federal agencies, commercial partners, jurisdictions, and providers is critical to successfully deploying COVID-19 vaccines and managing public expectations, especially because the initial supply of vaccine has been limited. Status of Development of Six Operation Warp Speed COVID-19 Vaccine Candidates, as of January 8, 2021 Medical Supply Chain The pandemic has highlighted vulnerabilities in the nation’s medical supply chain, which includes personal protective equipment and other supplies necessary to treat individuals with COVID-19. The Strategic National Stockpile (SNS) is an important piece of HHS’s recently developed strategy to improve the medical supply chain to enhance pandemic response capabilities. However, the department has yet to develop a process for engaging about the strategy with key nonfederal stakeholders that have a shared role for providing supplies during a pandemic, such as state and territorial governments and the private sector. GAO’s work has noted the importance of directly and continuously involving key stakeholders, including Congress, in the development of successful agency reforms and helping to harness ideas, expertise, and resources. To improve the nation’s response and preparedness for pandemics, GAO recommends that HHS establish a process for regularly engaging with Congress and nonfederal stakeholders—including state, local, tribal, and territorial governments and private industry—as the agency refines and implements its supply chain strategy for pandemic preparedness, to include the role of the SNS. HHS generally concurred with this recommendation and noted that the department regularly engages with Congress and nonfederal stakeholders. GAO maintains that capitalizing on existing relationships to engage these critical stakeholders as HHS refines and implements a supply chain strategy, to include the role of the SNS, will improve a whole-of-government response to, and preparedness for, pandemics. In August 2020, the President issued an Executive Order directing agencies to take steps toward the goal of strengthening domestic drug manufacturing and supply chains. Federal agencies have started implementing the Executive Order, but expressed concerns about their ability to implement some of the provisions. In particular, GAO found that federal agencies do not have complete and accessible information to identify supply chain vulnerabilities and to report the manufacturing supply chains of drugs that were procured by the agency. To help it identify and mitigate vulnerabilities in the U.S. drug supply chain, GAO recommends that the Food and Drug Administration (FDA) ensure drug manufacturing data obtained are complete and accessible, including by working with manufacturers and other federal agencies, such as the Department of Defense and the Department of Veterans Affairs and, if necessary, seek authority to obtain complete and accessible information. HHS neither agreed nor disagreed with this recommendation. COVID-19 Data for Health Care Indicators The federal government does not have a process to help systematically define and ensure the collection of standardized data across the relevant federal agencies and related stakeholders to help respond to COVID-19, communicate the status of the pandemic with citizens, or prepare for future pandemics. As a result, COVID-19 information that is collected and reported by states and other entities to the federal government is often incomplete and inconsistent. The lack of complete and consistent data limits HHS’s and others’ ability to monitor trends in the burden of the pandemic across states and regions, make informed comparisons between such areas, and assess the impact of public health actions to prevent and mitigate the spread of COVID-19. Further, incomplete and inconsistent data have limited HHS’s and others’ ability to prioritize the allocation of health resources in specific geographic areas or among certain populations most affected by the pandemic. To improve the federal government’s response to COVID-19 and preparedness for future pandemics, GAO recommends that HHS immediately establish an expert committee comprised of knowledgeable health care professionals from the public and private sectors, academia, and nonprofits or use an existing one to systematically review and inform the alignment of ongoing data collection and reporting standards for key health indicators. HHS partially concurred with this recommendation and agreed that it should establish a dedicated working group or other mechanism with a focus on addressing COVID-19 data collection shortcomings. Drug Manufacturing Inspections FDA is responsible for overseeing the safety and effectiveness of all drugs marketed in the U.S., including those manufactured overseas, and typically conducts more than 1,600 inspections of foreign and domestic drug manufacturing establishments every year. In light of the COVID-19 pandemic, since March 2020, FDA has limited domestic and foreign inspections for the safety of its employees. (See figure below.) FDA has used alternative inspection tools to maintain some oversight of drug manufacturing quality while inspections are paused, including inspections conducted by foreign regulators, requesting and reviewing records and other information, and sampling and testing. Although FDA has determined that inspections conducted by certain European regulators are equivalent to an FDA inspection, other tools provide useful information but are not equivalent to an FDA inspection. As a result, FDA could be faced with a backlog of inspections, threatening the agency’s goal to maximize inspections prioritized by its risk-based site selection model each year. GAO recommends that FDA (1) ensure that inspection plans for future fiscal years identify, analyze, and respond to the issues presented by the backlog of inspections that could jeopardize its goal of risk-driven inspections, and (2) fully assess the agency’s alternative inspection tools and consider whether these tools or others could provide the information needed to supplement regular inspection activities or help meet the agency’s drug oversight objectives when inspections are not possible in the future. FDA concurred with both recommendations. Number of FDA-Conducted Domestic and Foreign Drug Manufacturing Establishment Inspections, Fiscal Years 2019–2020, by Month Federal Contracting Federal agencies are using other transaction agreements to respond to the pandemic, which are contracting mechanisms that can enable agencies to negotiate terms and conditions specific to a project. GAO found that HHS misreports its other transaction agreements related to COVID-19 as procurement contracts, including other transaction agreements with about $1.5 billion obligated for Operation Warp Speed and other medical countermeasures. HHS’s approach is inconsistent with federal acquisition regulations and limits the public’s insight into the agency’s contract spending. To ensure consistent tracking and transparency of federal contracting activity related to the pandemic, GAO recommends that HHS accurately report data in the federal procurement database system and provide information that would allow the public to distinguish between spending on other transaction agreements and procurement contracts. HHS concurred with this recommendation. Oversight of Worker Safety and Health GAO identified concerns about federal oversight of worker safety and health amid the COVID-19 pandemic. Specifically, the Occupational Safety and Health Administration (OSHA) has adapted its enforcement methods for COVID-19 to help protect agency employees from the virus and address resource constraints, such as by permitting remote inspections in place of on-site inspections of workplaces. However, gaps in OSHA’s oversight and tracking of its adapted enforcement methods prevent the agency from assessing the effectiveness of its enforcement methods during the pandemic, ensuring that its adapted enforcement methods do not miss violations, and ensuring that employers are addressing certain identified violations. To improve its oversight, GAO recommends that OSHA (1) develop a plan, with time frames, to implement the agency’s oversight processes for COVID-19-adapted enforcement methods, and (2) ensure that its data system includes comprehensive information on use of these enforcement methods to inform these processes. The agency neither agreed nor disagreed with these recommendations. Additionally, OSHA’s data do not include comprehensive information on workplace exposure to COVID-19. For example, OSHA does not receive employer reports of all work-related hospitalizations related to COVID-19, as disease symptoms do not appear within the required reporting time frames. Employers may also face challenges determining whether COVID-19 hospitalizations or fatalities are work-related because of COVID-19’s incubation period and the difficulties in tracking the source of exposure. GAO recommends that OSHA determine what additional datamay be neededfrom employers or other sources to better target the agency’s COVID-19 enforcement efforts. The agency neither agreed nor disagreed with this recommendation. Assistance for Fishery Participants The CARES Act appropriated $300 million in March 2020 to the Department of Commerce (Commerce) to assist eligible tribal, subsistence, commercial, and charter fishery participants affected by COVID-19, which may include direct relief payments. After administrative fees were assessed, $298 million of the $300 million appropriated was obligated for fishery participants.Widespread restaurant closures in the spring of 2020 led to a decrease in demand for seafood, adversely affecting the fisheries industry. As of December 4, 2020, all funds had been obligated and only about 18 percent ($53.9 million) of the CARES Act funding obligated for fishery participants had been disbursed, which is inconsistent with Office of Management and Budget guidance on the importance of agencies distributing CARES Act funds in an expedient manner. Commerce’s National Oceanic and Atmospheric Administration (NOAA) officials said they expect that the vast majority of funds will be disbursed to fisheries participants by early 2021. However, the agency does not have the needed information centralized to help ensure that funds are being disbursed expeditiously and efficiently. GAO recommends that NOAA develop a mechanism to track the progress of states, tribes, and territories in meeting established timelines to disburse funds in an expedited and efficient manner. NOAA concurred with this recommendation. Program Integrity GAO continues to identify areas to improve program integrity and reduce the risk of improper payments for programs funded by the COVID-19 relief laws now that federal agencies have obligated a total of $1.9 trillion and expended $1.7 trillion of the $2.7 trillion appropriated for response and recovery efforts as of November 30, 2020. Federal relief programs remain vulnerable to significant risk of fraudulent activities because of the need to quickly provide funds and other assistance to those affected by COVID-19 and its economic effects. In this report, GAO identifies concerns about overpayments and potential fraud in the unemployment insurance (UI) system, specifically in the federally funded Pandemic Unemployment Assistance (PUA) program, which provides UI benefits to individuals not otherwise eligible for these benefits, such as self-employed and certain gig economy workers. As of January 11, 2021, states that had submitted data to DOL reported more than $1.1 billion in PUA overpayments from March through December 2020. While DOL requires states to report data on PUA overpayments, as of the beginning of 2021, the agency was not tracking the amount of overpayments recovered, limiting insight into the effectiveness of states’ efforts to recoup federal funds. To better track the recovery of federal funds, GAO recommends that DOL collect data from states on the amount of PUA overpayments recovered. DOL concurred with this recommendation, and has taken the first step toward implementing it by issuing new guidance and updated instructions for states to report PUA overpayment recovery data. GAO also remains concerned about SBA’s management of internal controls and fraud risks in the Economic Injury Disaster Loans (EIDL) program. COVID-19 relief laws made qualifying small businesses and nonprofit organizations adversely affected by COVID-19 eligible for financial assistance from the EIDL program. Some approval requirements were also relaxed, such as requiring each applicant to demonstrate that it could not obtain credit elsewhere, through December 31, 2021. As of December 31, 2020, SBA officials said they had approved about 3.7 million applications for loans related to COVID-19, totaling about $200 billion. SBA rapidly processed loans and advances to millions of small businesses affected by COVID-19. GAO’s analysis of SBA data shows that the agency approved EIDL loans and advances for potentially ineligible businesses. For example, SBA approved at least 3,000 loans totaling about $156 million to potentially ineligible businesses in industries that SBA policies state were ineligible for the EIDL program, such as insurance and real estate development, as of September 30, 2020. GAO recommends that SBA develop and implement portfolio-level data analytics across EIDL loans and advances made in response to COVID-19 as a means to detect potentially ineligible and fraudulent applications. SBA neither agreed nor disagreed with this recommendation. As of January 15, 2021, the U.S. had about 23 million cumulative reported cases of COVID-19 and more than 387,000 reported deaths, according to the Centers for Disease Control and Prevention. The country also continues to experience serious economic repercussions. Four relief laws, including the CARES Act, were enacted as of November 2020 to provide appropriations to address the public health and economic threats posed by COVID-19. As of November 30, 2020, of the $2.7 trillion appropriated by these four laws, the federal government had obligated a total of $1.9 trillion and expended $1.7 trillion of the COVID-19 relief funds, as reported by federal agencies. In December 2020, the Consolidated Appropriations Act, 2021, provided additional federal assistance for the ongoing response and recovery. The CARES Act includes a provision for GAO to report on its ongoing monitoring and oversight efforts related to the COVID-19 pandemic. This report examines the federal government’s continued efforts to respond to and recover from the COVID-19 pandemic. GAO reviewed data, documents, and guidance from federal agencies about their activities and interviewed federal and state officials and stakeholders. GAO completed its audit work on January 15, 2021. GAO is making 13 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 firstname.lastname@example.org.[Read More…]
- Judges Focus on Diversity in Clerkship, Internship HiringBy Sam NewsIn U.S CourtsApril 29, 2021Federal judges are working to make highly sought-after law clerkships and judicial internships more accessible to a diverse pool of law students.[Read More…]
- 25th Anniversary of the Fourth World Conference on WomenBy Sam NewsOctober 1, 2020
- Eastern Kentucky Doctor Sentenced to Prison for Unlawfully Distributing Controlled SubstancesBy Sam NewsDecember 10, 2020A Kentucky doctor and his former office manager were sentenced to 60 and 32 months respectively in prison Wednesday for their roles in unlawfully distributing controlled substances during a time when the defendants did not have a legitimate medical practice.[Read More…]
- Secretary Blinken to Deliver Remarks to the Media in the Press Briefing RoomBy Sam NewsJanuary 26, 2021
- Political Scientist Author Charged With Acting As An Unregistered Agent Of The Iranian GovernmentBy Sam NewsJanuary 19, 2021A criminal complaint was unsealed today in federal court in Brooklyn charging Kaveh Lotfolah Afrasiabi, also known as “Lotfolah Kaveh Afrasiabi,” with acting and conspiring to act as an unregistered agent of the Government of the Islamic Republic of Iran, in violation of the Foreign Agents Registration Act (FARA). Afrasiabi was arrested yesterday at his home in Watertown, Massachusetts, and will make his initial appearance this morning in federal court in Boston, Massachusetts, before United States Magistrate Judge Jennifer C. Boal.[Read More…]
- Statement from Assistant Attorney General Eric Dreiband and Acting U.S. Attorney for the District of Columbia Michael Sherwin on Legal Victory Protecting Religious Worship in the Nation’s CapitalBy Sam NewsOctober 10, 2020Judge enjoins District [Read More…]
- The United States Has Repatriated 27 Americans from Syria and Iraq Including Ten Charged with Terrorism-Related Offenses for Their Support to ISISBy Sam NewsOctober 1, 2020The International [Read More…]
- Man Sentenced to 20 Years in Prison for Attempting to Provide Material Support to ISISBy Sam NewsMay 12, 2021A New York man was sentenced today to 20 years in prison for attempting to provide material support to the Islamic State of Iraq and al-Sham, aka ISIS. Zachary Clark, aka Umar Kabir, Umar Shishani and Abu Talha, 42, of Brooklyn, New York, pleaded guilty in August 2020 to one count of attempting to provide material support or resources to a designated foreign terrorist organization, namely, ISIS.[Read More…]
- Designation of Jhon Fredy Zapata Garzon Under the Foreign Narcotics Kingpin Designation ActBy Sam NewsDecember 1, 2020
- Two Former Tennessee Correctional Officers Sentenced for Civil Rights OffensesBy Sam NewsJune 17, 2021Two former Tennessee Department of Corrections (TDOC) Correctional Officers were sentenced today for assaulting an inmate in violation of a federal civil rights statute.[Read More…]
- China-Based Executive at U.S. Telecommunications Company Charged with Disrupting Video Meetings Commemorating Tiananmen Square MassacreBy Sam NewsDecember 18, 2020A complaint and arrest warrant were unsealed today in federal court in Brooklyn charging Xinjiang Jin, also known as “Julien Jin,” with conspiracy to commit interstate harassment and unlawful conspiracy to transfer a means of identification. Jin, an employee of a U.S.-based telecommunications company (Company-1) who was based in the People’s Republic of China (PRC), allegedly participated in a scheme to disrupt a series of meetings in May and June 2020 held to commemorate the June 4, 1989 Tiananmen Square massacre in the PRC. The meetings were conducted using a videoconferencing program provided by Company-1, and were organized and hosted by U.S-based individuals, including individuals residing in the Eastern District of New York. Jin is not in U.S. custody.[Read More…]
- Special Presidential Envoy for Climate John Kerry with Raj Chengappa of India TodayBy Sam NewsApril 23, 2021John Kerry, Special [Read More…]
- Remarks by Attorney General William P. Barr at the Funeral of Cleveland Police Detective and Operation Legend Officer James SkernivitzBy Sam NewsSeptember 11, 2020Good Morning. I am [Read More…]
- New Jury Instructions Strengthen Social Media CautionsBy Sam NewsIn U.S CourtsOctober 1, 2020A federal Judiciary committee has issued a new set of model jury instructions that federal judges may use to deter jurors from using social media to research or communicate about cases.[Read More…]
- U.S. Statement on the 25th Anniversary of the Fourth World Conference on WomenBy Sam NewsIn Women’s NewsOctober 2, 2020Video Remarks In the 25 [Read More…]
- Massachusetts Man Convicted of Placing Firebomb at Entrance of Jewish Nursing HomeBy Sam NewsJune 16, 2021A Massachusetts man was convicted by a federal jury yesterday in connection with placing a lit firebomb at the entrance of a Longmeadow senior health care facility in April 2020.[Read More…]
- Endeavor Executives Resign from Live Nation Board of Directors after Justice Department Expresses Antitrust ConcernsBy Sam NewsJune 21, 2021The Department of Justice announced today that two executives of Endeavor Group Holdings Inc. – Chief Executive Officer and Director Ariel Emanuel, and President Mark Shapiro – have resigned their positions on the Live Nation Entertainment Inc. Board of Directors after the department expressed concerns that their positions on the Live Nation Board created an illegal interlocking directorate. An interlocking directorate is where one person – or an agent of one person or company – serves as an officer or director of two companies. Section 8 of the Clayton Act prohibits the same person or company from serving as an officer or director of two competing companies, except under certain defined safe harbors.[Read More…]
- Justice Department Settles with New York-Based Pharmaceutical Manufacturing Company to Resolve Immigration-Related Discrimination ClaimsBy Sam NewsMay 27, 2021The Department of Justice announced yesterday that it reached a settlement with LNK International Inc. (LNK), a Hauppauge, New York-based manufacturer of over-the-counter pharmaceuticals. The settlement resolves the department’s claims that LNK violated the Immigration and Nationality Act (INA) when it discriminated against work-authorized non-U.S. citizens.[Read More…]
- Ukraine Travel AdvisoryBy Sam NewsSeptember 26, 2020
- Researcher Pleaded Guilty to Conspiring to Steal Scientific Trade Secrets from Ohio Children’s Hospital to Sell in ChinaBy Sam NewsJuly 30, 2020Former Ohio woman Li Chen, 46, pleaded guilty today via video conference in U.S. District Court today to conspiring to steal scientific trade secrets and conspiring to commit wire fraud concerning the research, identification and treatment of a range of pediatric medical conditions.[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…]
- Young Giant Planet Offers Clues to Formation of Exotic WorldsBy Sam NewsIn SpaceSeptember 26, 2020Jupiter-size planets [Read More…]
- Substance Use Disorder: Reliable Data Needed for Substance Abuse Prevention and Treatment Block Grant ProgramBy Sam NewsDecember 14, 2020According to Substance Abuse and Mental Health Services Administration (SAMHSA) data, the number of substance use disorder (SUD) treatment facilities and services increased since 2009. However, potential gaps in treatment capacity remain. For example, SAMHSA data show that, as of May 2020, most counties did not have all levels of SUD treatment available, including outpatient, residential, and hospital inpatient services; nearly one-third of counties had no levels of treatment available. Stakeholders GAO interviewed said it is important to have access to each level for treating individuals with varying SUD severity. Availability of Substance Use Disorder Treatment Levels, by County, as of May 2020 SAMHSA primarily relies on the number of individuals served to assess the effect of three of its largest grant programs on access to SUD treatment and recovery support services. However, GAO found the agency lacks two elements of reliable data—that they be consistent and relevant—for the number of individuals served under the Substance Abuse Prevention and Treatment Block Grant (SABG) program. For example, grantee reporting includes individuals served outside of the program, which limits this measure's relevance for program assessment of access. SAMHSA plans to implement data quality improvements for the SABG program starting in fiscal year 2021. However, the agency has not identified specific changes needed to improve the information it collects on individuals served. As SAMHSA moves forward with its plans, it will be important for it to identify and implement such changes. Doing so will allow SAMHSA to better assess whether the SABG program is achieving a key goal of improving access to SUD treatment and recovery services or whether changes may be needed. Treatment for SUD—the recurrent use of substances, such as illicit drugs, causing significant impairment—can help individuals reduce or stop substance use and improve their quality of life. SUDs, and in particular drug misuse, have been a persistent and long-standing public health issue in the United States. Senate Report 115-289 contains a provision for GAO to review SUD treatment capacity. This report, among other things, describes what is known about SUD treatment facilities, services, and overall capacity; and examines the information SAMHSA uses to assess the effect of three grant programs on access to SUD treatment. GAO analyzed national SAMHSA data on SUD treatment facilities and providers, and reviewed studies that assessed treatment capacity. GAO also reviewed documentation for three of SAMHSA's largest grant programs available to states, and compared the agency's grant data quality to federal internal control standards. Finally, GAO interviewed SAMHSA officials and stakeholders, including provider groups. GAO is recommending that SAMHSA identify and implement changes to the SABG program's data collection efforts to improve two elements of reliability—the consistency and relevance—of data collected on individuals served. SAMHSA concurred with this recommendation. For more information, contact Alyssa M. Hundrup at (202) 512-7114 or HundrupA@gao.gov.[Read More…]
- Owner of Japanese Fishing Vessel Pleads Guilty to Unlawful Trafficking of Shark FinsBy Sam NewsOctober 9, 2020Hamada Suisan Co. Ltd., the owner of the Japanese-flagged fishing vessel, M.V. Kyoshin Maru No. 20, pleaded guilty, pursuant to a plea agreement, to aiding and abetting the attempted export of shark fins out of Hawaii in violation of the Lacey Act, the Department of Justice announced.[Read More…]
- Missile Defense: Assessment of Testing Approach Needed as Delays and Changes PersistBy Sam NewsJuly 30, 2020In fiscal year 2019, the Missile Defense Agency (MDA) delivered many of the Ballistic Missile Defense System (BMDS) assets it planned and conducted key flight tests, but did not meet all of its goals for the year. For example, MDA successfully delivered interceptors for use by warfighters and conducted a salvo test (which involves launching two interceptors at an incoming target) for the Ground-based Midcourse Defense program. However, MDA did not meet all of its goals for delivering assets or testing. For example, MDA completed only two of seven planned flight tests, plus eight additional flight tests that were later added for fiscal year 2019. MDA did not fully execute its fiscal year 2019 flight testing, continuing a decade-long trend in which MDA has been unable to achieve its fiscal year flight testing as scheduled. Although MDA revised its approach to developing its annual test plan in 2009 to ensure the test plan was executable, over the past decade MDA has only been able to conduct 37 percent of its baseline fiscal year testing as originally planned due to various reasons including developmental delays, range and target availability, or changing test objectives. In addition, MDA has not conducted an assessment to determine whether its current process for developing and executing its annual test plan could be improved to help ensure its executability. Without an independent assessment, MDA will continue down the same path, increasing the risk of the same outcomes from the past decade—less testing than originally planned, resulting in less data to demonstrate and validate capabilities. Missile Defense Agency (MDA) Cumulative Flight Test Planning, Fiscal Years 2010-2019 Note: This graphic is a compilation of each individual fiscal year's flight test schedule. As such, if a flight test was planned for a particular fiscal year but then delayed to a later fiscal year, it would be counted both times. MDA is currently at a pivotal crossroads, needing to balance its ability to pursue new and advanced efforts while also maintaining its existing portfolio of BMDS elements that have not transferred to the military services as originally planned. The new and advanced efforts, such as the Next Generation Interceptor—a new interceptor for homeland defense—are research and development-intensive tasks, which carry significant technical risks and financial commitments. As MDA takes on these new efforts, it is increasingly important that the agency establish and maintain a sound and disciplined acquisition approach for these efforts to be successful and within anticipated costs and timeframes. For over half a century, the Department of Defense (DOD) has funded efforts to defend the United States from ballistic missile attacks. From 2002 through 2018, MDA has received about $152 billion to develop the BMDS and requested about $47 billion from fiscal year 2019 through fiscal year 2023. The BMDS consists of diverse and highly complex land-, sea-, and space-based systems and assets located across the globe. Congress included a provision in statute that GAO annually assess and report on MDA's progress. This, our 17th annual review, addresses for fiscal year 2019 (1) the progress MDA made in achieving delivery and testing goals; (2) the extent to which MDA's annual test plan is executable; and (3) broad challenges that could impact MDA's portfolio. GAO reviewed the planned fiscal year 2019 baselines, along with test plans since 2010, and other program documentation and assessed them against program and baseline reviews. GAO also interviewed officials from MDA and DOD agencies, including the office of the Director, Operational Test and Evaluation, Undersecretary of Defense for Research and Engineering, and the BMDS Operational Test Agency. GAO recommends that MDA ensure an independent assessment is conducted of its process for developing and executing its annual BMDS flight test plan. DOD concurred with the recommendation. For more information, contact William Russell at (202) 512-4841 or Russellw@gao.gov.[Read More…]
- Two sentenced after law enforcement uncovers illegal aliens in 100 degree trailerBy Sam NewsIn Justice NewsMay 13, 2021A 28-year-old Laredoan [Read More…]
- Maine Man Sentenced for Federal Hate Crime ConvictionsBy Sam NewsOctober 27, 2020The Justice Department today announced the sentencing of Maurice Diggins, 36, of Biddeford, Maine, in federal court for his role in a series of racially motivated assaults against black men in Maine.[Read More…]
- Iceland Travel AdvisoryBy Sam NewsSeptember 26, 2020
- FY 2021 State Justice Statistics Program for Statistical Analysis Centers (SJS-SAC) Technical Assistance ProgramBy Sam NewsIn Justice NewsMay 18, 2021(Solicitation)
The U.S. Department of Justice (DOJ), Office of Justice Programs (OJP), Bureau of Justice Statistics (BJS) is seeking applications for funding to administer activities under the FY 2021 State Justice Statistics Program for Statistical Analysis Centers (SJS-SAC) Technical Assistance Program. This program supports the collection, analysis, and dissemination of statistical information on crime and criminal justice at the state and local level.
Grants.gov Application Deadline: 11:59 p.m. eastern time on June 14, 2021; JustGrants Application Deadline: 11:59 p.m. eastern time on June 28, 2021 [Read More…]
- Secretary Antony J. Blinken and Iceland Foreign Minister Gudlaugur Thor Thordarson Before Their MeetingBy Sam NewsMay 18, 2021
- Statement from Assistant Attorney General Eric Dreiband Commemorating the Twentieth Anniversary of the Trafficking Victims Protection ActBy Sam NewsOctober 28, 2020Assistant Attorney General for Civil Rights Eric Dreiband issued the following statement today commemorating the twentieth anniversary of the Trafficking Victims Protection Act:[Read More…]
- Zambia Travel AdvisoryBy Sam NewsSeptember 26, 2020
- Japan Travel AdvisoryBy Sam NewsSeptember 26, 2020
- Passengers with Disabilities: Airport Accessibility Barriers and Practices and DOT’s Oversight of Airlines’ Disability-Related TrainingBy Sam NewsApril 14, 2021What GAO Found Passengers with disabilities face infrastructure, information, and customer service barriers at U.S. airports, according to representatives of selected airports, disability advocacy organizations, as well as a review of relevant literature. Infrastructure barriers can include complex terminal layouts and long distances between gates and can be difficult for some to navigate. Essential travel information is not always available in a format accessible to all. For example, a person with hearing loss could miss crucial gate information that is solely provided over a loudspeaker. A passenger might not receive appropriately sensitive service, such as wheelchair assistance, at the airport, although the service provided is required by the Air Carrier Access Act of 1986 (ACAA) regulations. According to stakeholders, while no solution meets all needs, a number of practices can help reduce or eliminate some of these barriers to equal access at airports. For example, some selected airports use external disability community and passenger groups to proactively engage in identifying barriers and develop solutions. Other airports have implemented technology-based solutions, such as mobile phone applications to make airport navigation easier. Examples of Stakeholder-Identified Features to Assist Airport Passengers with Disabilities The Office of Aviation Consumer Protection within the Department of Transportation (DOT) is responsible for oversight of airlines' compliance with the ACAA. In 2008, DOT updated its entire ACAA regulation, including adding new training requirements for airline personnel, such as requiring training to be recurrent. Following this update, DOT conducted outreach to domestic and foreign airlines on the changes and reviewed airlines' disability training sessions and materials. Agency officials said that in recent years, DOT has conducted reviews of airlines' training only when passengers' complaints indicate a possible problem, as officials' analyses have not shown training generally to be a significant cause of service violations. DOT officials and stakeholders said other factors, such as limited availability of staff to assist passengers with disabilities, at times may affect the service passengers with disabilities receive. DOT is assessing some of these factors through the statutorily mandated ACAA Advisory Committee, formed in late 2019 to make recommendations to improve accessibility to air travel. The committee met in 2020, established three subcommittees, and plans to reconvene by summer 2021. Why GAO Did This Study Approximately 43 million people in the United States have some type of disability, which may affect mobility, vision, hearing, and cognition. Without accessible airport facilities and accommodations—such as appropriate assistance from the check-in counter to the gate, or effective communication of flight information—air travel for people with disabilities can be extremely challenging. The FAA Reauthorization Act of 2018 includes provisions for GAO to review leading airport accessibility practices for passengers with disabilities, as well as required training for airline and contract service personnel who assist these passengers within the airport. This report examines, among other objectives: stakeholder-identified barriers that passengers with disabilities face when accessing airport facilities, accessibility practices to assist passengers with disabilities, as well as how DOT has overseen airlines' disability-related training. GAO reviewed relevant federal laws, regulations, DOT documents, literature, as well as information describing disability training provided by selected airlines and contractors. GAO interviewed a non-generalizable sample of stakeholders, including those at 16 U.S. airports selected based on size and geography, eight large and low-cost domestic airlines selected based on the greatest number of disability-related passenger complaints and enplanements, and six aviation service contractors working for those airlines. GAO also conducted interviews with DOT officials and 10 disability advocacy organizations, among others. For more information, contact Heather Krause at (202) 512-2834 or firstname.lastname@example.org.[Read More…]