Biomedical Research: NIH Should Publicly Report More Information about the Licensing of Its Intellectual Property

What GAO Found

Research conducted at Department of Health and Human Services (HHS) labs led to 4,446 U.S. patents owned by the agency covering a range of inventions from 1980 through 2019. During that period, the National Institutes of Health (NIH) had 93 patents—2 percent of the total—that contributed to the successful development of 34 drugs approved by the Food and Drug Administration (FDA) and brought to market, including vaccines and treatments for cancer.

These 34 drugs were developed by pharmaceutical companies and were associated with 32 licenses granted to them by NIH. As shown in the figure, these licenses have generated up to $2 billion in royalty revenue for NIH since 1991, when FDA approved the first of these drugs. Three licenses generated more than $100 million each for the agency.

Royalties from NIH Licenses of Inventions Associated with FDA-Approved Drugs, 1991 to February 2020

When licensing its inventions, NIH prioritizes the likelihood that the licensee can successfully develop a drug by considering such factors as technical expertise and the ability to raise capital. Consistent with federal interpretation of technology transfer statutory authorities, NIH does not consider the affordability of the resulting drug. NIH provides limited information to the public about its licensing activities. For example, the agency does not report which of its patents are licensed or release metrics that would enable the public to evaluate how licensing affects patient access to resulting drugs. Increasing the transparency of its licensing activities could improve the public’s and policymakers’ understanding of NIH’s management of its intellectual property.

HHS monitors for unauthorized use of its inventions (infringement) and has taken steps to protect its rights. HHS relies primarily on inventors at its labs to monitor for potential infringement and generally encourages potential infringers to license the inventions. If cases proceed to litigation, HHS relies on the Department of Justice (DOJ) to protect its rights. Since 2009, HHS has worked with DOJ to defend its intellectual property in several cases in the U.S. and abroad and has referred one case to DOJ for litigation against an alleged infringer.

Why GAO Did This Study

HHS labs conduct research that can contribute to the development of new life-saving drugs. HHS may grant rights to its inventions by licensing the patents to pharmaceutical companies that conduct the additional development activities and testing necessary to bring drugs to market. Public health experts and patients’ rights advocates have raised concerns about the prices of drugs developed with federal support.

GAO was asked to review HHS’s management of its intellectual property. This report examines (1) the extent to which HHS-owned intellectual property has contributed to the development of FDA-approved drugs, (2) what is known about the licenses associated with FDA-approved drugs, (3) factors NIH prioritizes when licensing its inventions and information about licensing it makes public, and (4) steps HHS has taken to protect its rights. GAO reviewed relevant laws and agency documents, analyzed patent and licensing data, and interviewed HHS officials, academic experts, industry representatives, and nongovernmental organizations.

What GAO Recommends

GAO is making two recommendations, including that NIH provide more information to the public about the licensing of its intellectual property. HHS concurred with GAO’s recommendations.

For more information, contact John Neumann, (202) 512-6888, NeumannJ@gao.gov.

Hits: 3

News Network

  • Indivior Solutions Sentenced To Pay $289 Million In Criminal Penalties For Unlawful Marketing Of Opioid Drug
    In Crime News
    Indivior Solutions was sentenced to pay $289 million in criminal penalties in connection with a previous guilty plea related to the marketing of the opioid-addiction-treatment drug Suboxone, the Department of Justice announced today.
    [Read More…]
  • Justice Department Brings Enforcement Action Against Centurylink
    In Crime News
    The Department of Justice announced today that CenturyLink, Inc. has agreed to settle allegations that CenturyLink violated the court-ordered Final Judgment designed to prevent anticompetitive effects arising from its acquisition of Level 3 Communications, Inc. 
    [Read More…]
  • More Achieved in 2020 to Improve Kidney Care Than in Decades
    In Human Health, Resources and Services
    Since the Department of [Read More…]
  • Former Union Official Sentenced for Violent Extortion
    In Crime News
    An 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…]
  • Albania Travel Advisory
    In Travel
    Reconsider travel to [Read More…]
  • North Carolina Man Charged with Fraudulently Seeking Over $6 Million in COVID Relief Funds
    In Crime News
    A North Carolina man was charged with fraudulently seeking over $6 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 Robert J. Higdon Jr. of the Eastern District of North Carolina.
    [Read More…]
  • Updated – Secretary Pompeo’s Travel to India, Sri Lanka, Maldives, Indonesia, and Vietnam
    In Crime Control and Security News
    Morgan Ortagus, [Read More…]
  • Imposing Sanctions on Russia for the Poisoning and Imprisonment of Aleksey Navalny
    In Crime Control and Security News
    Antony J. Blinken, [Read More…]
  • Iranian Nationals Charged with Conspiring to Evade U.S. Sanctions on Iran by Disguising $300 Million in Transactions Over Two Decades
    In Crime News
    A federal criminal complaint unsealed today charges 10 Iranian nationals with running a nearly 20-year-long scheme to evade U.S. sanctions on the Government of Iran by disguising more than $300 million worth of transactions – including the purchase of two $25 million oil tankers – on Iran’s behalf through front companies in the San Fernando Valley, Canada, Hong Kong and the United Arab Emirates.
    [Read More…]
  • Climate Change: USAID Is Taking Steps to Increase Projects’ Resilience, but Could Improve Reporting of Adaptation Funding
    In U.S GAO News
    The U.S. Agency for International Development (USAID) provided at least $810 million to directly and indirectly support climate adaptation from fiscal years 2014 through 2018—the latest available data at the time of GAO's analysis. However, USAID ended new funding for programming activities that directly address climate adaptation (i.e., direct funding) in fiscal year 2017 in part due to a shift in administration priorities, according to agency officials. However, following a congressional directive in the fiscal year 2020 appropriations act, USAID restored direct funding for adaptation programming. GAO found that USAID did not consistently report all funding data for activities that indirectly addressed climate adaptation, which does not align with expectations in foreign assistance guidance and internal controls standards. USAID's direct adaptation assistance had the primary program goal of enhancing resilience and reducing vulnerability. For example, in the Philippines, a USAID activity assisted communities in preparing for extreme weather events by developing maps of potential hazards to aid in evacuation planning. USAID attributed funding that indirectly addresses climate adaptation assistance (i.e., indirect funding) from programs with other goals such as agriculture, where priorities include supporting food production and distribution. For example, in Guatemala, a USAID agricultural activity worked with farmers to transition to crops with greater economic benefits that are also drought tolerant. However, not all missions with indirect adaptation assistance reported these funding data and reporting has varied, in part, because the agency has not clearly communicated the expectation to do so. Without addressing this issue, USAID risks providing incomplete and inconsistent data to Congress and others. A Community Leader Shows the Hazard Map Prepared as Part of a U.S. Agency for International Development Project to Help Adapt to Climate Change in the Philippines Since October 2016, USAID has generally required projects and activities to conduct climate risk management, which is the process of assessing and managing the effects of climate change. USAID requires documentation of this process and GAO's review found 95 percent compliance for USAID's priority countries for adaption funding. USAID has experienced some challenges with its initial implementation of climate risk management and is assessing these challenges and identifying improvements. For example, mission officials said that some technical staff lack expertise to do climate risk management and that their environment offices had a small number of staff to provide assistance. To help staff conduct climate risk management, USAID is building staff capacity through trainings and is in the process of evaluating implementation of the policy and whether it requires any changes, among other efforts. USAID is the primary U.S. government agency helping countries adapt to the effects of climate change. USAID has provided this assistance through activities that directly address climate adaptation as well as indirectly through activities that received funding for other purposes, such as agriculture, but which also support climate adaptation goals. GAO was asked to review issues related to U.S. foreign assistance for climate adaptation. For USAID, this report examines (1) funding the agency provided for climate adaptation assistance in fiscal years 2014 through 2018, and (2) how climate risk management is implemented. GAO analyzed funding data and documentation of agency activities and climate risk management; interviewed agency and project officials; and conducted fieldwork in three countries receiving adaptation assistance—Guatemala, the Philippines, and Uganda. GAO selected these countries based on the amount of funding they received for climate adaptation activities, geographic diversity, and variety of observed and projected climate effects, among other factors. GAO recommends that USAID communicate to its missions and bureaus that they are expected to report all data on funding that indirectly addresses climate adaptation. USAID agreed with the recommendation and outlined a number of steps the agency plans to take to improve the reporting of these data. For more information, contact David Gootnick at (202) 512-3149 or gootnickd@gao.gov.
    [Read More…]
  • Defense Management: Opportunities Exist to Improve DOD’s Reform Efforts
    In U.S GAO News
    What GAO Found The Department of Defense (DOD) has long sought to reform its enterprise business operations—such as its processes to manage contracts, finances, and supply chain— but faces challenges in improving department-wide management. DOD has taken some actions to improve its business operations data, but remains limited by the lack of reliable cost data, affecting its ability to monitor and inform its reform efforts. Having reliable data to identify baseline costs of the department's business and management functions and to measure progress has been a key challenge facing DOD, but one the department is trying to address. As GAO reported in November 2020, DOD has made progress in setting baseline costs of certain activities, such as logistics and real estate management. Further, DOD has ongoing efforts to develop baselines for all of the department's enterprise business operations that should enable it to better monitor reform progress. However, DOD needs better data about how it performs its business functions. For example, in September 2018, GAO reported that DOD's efforts to reduce inefficiencies in human resources services were hampered by inconsistent performance data across the six organizations that provide these services. DOD has ongoing efforts to address GAO's recommendations. DOD still needs clear roles, responsibilities, authorities and dedicated resources to support reform. GAO has found that demonstrating sustained leadership commitment—including through ensuring that those responsible for leading change have clearly defined and documented roles, responsibilities, and authorities—is imperative for successful business transformation. GAO has assessed many of DOD's organizational structures over the decades, including the recently eliminated Chief Management Officer (CMO) position. GAO found that, while Congress had given the CMO both significant responsibilities and authorities, DOD had not resolved unanswered questions about how those authorities would be carried out, nor communicated the CMO's roles and responsibilities department-wide. GAO also identified instances where CMO reforms were hampered by a lack of resources. As DOD moves to an organization without the CMO position, which was eliminated in 2021, clarifying the roles and responsibilities of those tasked with managing business reform remains important. DOD could also improve its efforts to reliably demonstrate progress toward meaningful reform. DOD has reported achievements from some of its department-wide efforts, such as its reported $37 billion in savings from fiscal years 2017 to 2021. However, GAO reported in November 2020 that while DOD's reported savings were largely reflected in its budget materials, the underlying analyses were not always well documented and the savings were not always consistent with the department's definitions of reform. For example, one reform initiative was based on delaying military construction projects that, according to DOD officials, allowed DOD to fund higher priorities. If a delayed project is still planned, however, the costs will likely be realized in a future year and are not a reflection of business process reform. DOD concurred with GAO's recommendations to establish a process to standardize development and documentation of such cost savings, and ensure that reported savings are consistent with the department's definitions of reform. Why GAO Did This Study DOD spends billions of dollars each year to maintain key business operations and defense-wide agencies and programs intended to support the warfighter, including systems and processes related to the management of contracts, finances, the supply chain, support infrastructure, and weapon systems acquisition. The department's approach to transforming these business operations is linked to its ability to perform its overall mission, directly affecting the readiness and capabilities of U.S. military forces. This testimony summarizes GAO's past work related to DOD's efforts to improve the management of its business operations. Specifically, this testimony discusses DOD's efforts to (1) improve data and baselines to monitor and inform reform efforts; (2) establish clear roles, responsibilities, and authorities for leading reform efforts, and dedicate resources to these efforts; and (3) reliably demonstrate progress in its reform efforts. This statement is based on GAO's body of work issued from 2017 through 2020 on DOD management and business reform issues.
    [Read More…]
  • United States and Partners Promote Accountability for Corruption and Human Rights Abuse
    In Crime Control and Security News
    Michael R. Pompeo, [Read More…]
  • Office of the Historian, Foreign Service Institute Release of Foreign Relations of the United States, 1969–1976, Volume E–15, Part 2, Documents on Western Europe, 1973–1976, Second, Revised Edition
    In Crime Control and Security News
    Office of the [Read More…]
  • Secretary Antony J. Blinken With Jake Tapper of CNN’s The Lead with Jake Tapper
    In Crime Control and Security News
    Antony J. Blinken, [Read More…]
  • High-Performance Computing: NNSA Could Improve Program Management Processes for System Acquisitions
    In U.S GAO News
    What GAO Found The National Nuclear Security Administration's (NNSA) analysis of alternatives (AOA) process for its $600 million El Capitan HPC acquisition did not fully follow agency policy that states that AOA processes should be consistent with GAO best practices, where possible, and any deviations must be justified and documented. According to GAO best practices, a reliable AOA process should meet four characteristics: it should be comprehensive, well documented, unbiased, and credible. As seen in the table, the AOA process for El Capitan partially met one of these characteristics and minimally met the other three. NNSA did not justify or document the deviations from these best practices, as required by NNSA policy. GAO also found that the AOA process was conducted by the contractor that manages the El Capitan acquisition program, contrary to agency policy and guidance stating that AOAs should be conducted by an independent entity. Without following AOA best practices where possible; justifying and documenting any deviations; and ensuring AOA processes are conducted by an independent entity, as required, NNSA cannot be assured of a reliable assessment of options for meeting critical mission needs. Extent to Which the National Nuclear Security Administration (NNSA) Met the Characteristics of a Reliable Analysis of Alternatives (AOA) Process AOA characteristic GAO assessment Example of deviation Comprehensive Partially met Cost estimates are incomplete and did not follow best practices. Well documented Minimally met The alternatives' descriptions are not detailed enough for a robust analysis. Unbiased Minimally met NNSA had a predetermined solution, acquiring an HPC system, before performing the AOA process. Credible Minimally met The selection criteria appear to have been written for the preferred alternative. Source: GAO analysis of NNSA information. | GAO-21-194 GAO found that, in the second year of the El Capitan acquisition program's 5-year acquisition life cycle, NNSA has fully implemented selected key practices related to program monitoring and control. However, NNSA has only partially implemented key practices related to requirements management. Specifically, El Capitan program officials did not update and maintain acquisition program documents to include current requirements. NNSA officials stated that once the program developed its program plan early in the program's life cycle, they did not require the program to update and maintain that program plan. However, NNSA's own program management policy requires programs to update program documents throughout the duration of the program. Without updating and maintaining El Capitan program documents to include current requirements, NNSA officials may be limited in their ability to ensure that all mission requirements are met. Why GAO Did This Study NNSA is responsible for maintaining the nation's nuclear stockpile. To analyze the performance, safety, and reliability of nuclear weapons, it acquires high-performance computing (HPC) systems to conduct simulations. The latest system, El Capitan, is expected to be fully deployed by March 2024. The committee report accompanying the Energy and Water Development and Related Agencies Appropriations Act, 2019, includes a provision for GAO to review NNSA's management of its Advanced Simulation and Computing program. This report examines, among other things, (1) the extent to which NNSA's AOA process for the El Capitan acquisition met best practices and followed agency policy and guidance and (2) the extent to which NNSA is implementing selected acquisition best practices in carrying out the El Capitan acquisition program. GAO reviewed documents and interviewed NNSA officials and laboratory representatives involved in carrying out the AOA and acquisition processes.
    [Read More…]
  • Seven Charged in Connection with a COVID-Relief Fraud Scheme Involving more than 80 Fraudulent Loan Applications Worth Approximately $16 Million
    In Crime News
    Seven individuals across two states were charged in an indictment unsealed today for their alleged participation in a scheme to obtain approximately $16 million in forgivable Paycheck Protection Program (PPP) loans guaranteed by the Small Business Administration (SBA) under the Coronavirus Aid, Relief, and Economic Security (CARES) Act.
    [Read More…]
  • Maine Man Sentenced for Federal Hate Crime Convictions
    In Crime News
    The 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…]
  • Bolivia Travel Advisory
    In Travel
    Do not travel to Bolivia [Read More…]
  • Courts Suspending Jury Trials as COVID-19 Cases Surge
    In U.S Courts
    About two dozen U.S. district courts have posted orders that suspend jury trials or grand jury proceedings, and scale back other courthouse activities in response to a sharp nationwide rise in coronavirus (COVID-19) cases. The surge in new court orders in recent weeks marks a significant pause in efforts by federal courts to resume full operations.
    [Read More…]
  • Assistant Attorney General Makan Delrahim Delivers Remarks at Georgetown Law’s Global Antitrust Enforcement Symposium
    In Crime News
    “Reflections”: Looking [Read More…]
  • Secretary Antony J. Blinken, Secretary of Defense Lloyd Austin and Republic of Korea President Moon Jae-in Before Their Meeting
    In Crime Control and Security News
    Antony J. Blinken, [Read More…]
  • Ecuador Travel Advisory
    In Travel
    Reconsider travel to [Read More…]
  • Sanctions on Russian Entity and a Vessel Engaging in the Construction of Nord Stream 2 
    In Crime Control and Security News
    Today, the United States [Read More…]
  • Remarks by Attorney General William P. Barr at the Funeral of Cleveland Police Detective and Operation Legend Officer James Skernivitz
    In Crime News
    Good Morning. I am [Read More…]
  • NASA Invites Public to Share Excitement of Mars 2020 Perseverance Rover Launch
    In Space
    A Mars photo booth, [Read More…]
  • Man Who Worked At Local Research Institute For 10 Years Pleads Guilty To Conspiring To Steal Trade Secrets, Sell Them In China
    In Crime News
    A former Dublin, Ohio, man pleaded guilty in U.S. District Court today to conspiring to steal exosome-related trade secrets concerning the research, identification and treatment of a range of pediatric medical conditions. Yu Zhou, 50, also pleaded guilty to conspiring to commit wire fraud.
    [Read More…]
  • Morocco Travel Advisory
    In Travel
    Reconsider travel to [Read More…]
  • VA Vet Centers: Evaluations Needed of Expectations for Counselor Productivity and Centers’ Staffing
    In U.S GAO News
    The 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 draperd@gao.gov.
    [Read More…]
  • Environment and Natural Resources Division Recognizes Employees for Outstanding Service at Annual Awards Ceremony
    In Crime News
    The Environment and Natural Resources Division (ENRD) held its annual awards ceremony to highlight the past year’s achievements.
    [Read More…]
  • Bankruptcy Filings Fall Sharply for Second Straight Quarter
    In U.S Courts
    Despite continued high unemployment related to the coronavirus (COVID-19) pandemic, personal and business bankruptcy filings fell 21.1 percent for the 12-month period ending Sept. 30, 2020, according to statistics released by the Administrative Office of the U.S. Courts.
    [Read More…]
  • Georgia Travel Advisory
    In Travel
    Reconsider travel to [Read More…]
  • The Department of State Breaks Ground for New U.S. Consulate General in Casablanca
    In Crime Control and Security News
    Office of the [Read More…]
  • VA Health Care: Actions Needed to Improve Oversight of Graduate Medical Education Reimbursement
    In U.S GAO News
    The Department of Veterans Affairs' (VA) Veterans Health Administration (VHA) provides training to more than 45,000 medical and dental residents annually through its Graduate Medical Education (GME) program. VHA has established policy for its GME program that details many roles and responsibilities for overseeing VA medical facilities' reimbursements to affiliated academic institutions for residents' salaries and benefits. However, this policy does not define key roles and responsibilities for VHA's central office components, its regional networks, or its medical facilities. For example, VHA's regional networks do not have defined roles and responsibilities for overseeing GME disbursements—contributing to noninvolvement or inconsistent involvement in disbursement agreement oversight. VHA officials reported that they are in the process of updating disbursement agreement policy, but did not indicate if the updates would address all identified concerns. While VHA officials said that VHA's two disbursement agreement oversight mechanisms—facility periodic audits and the Resident Disbursement Audit Process (ReDPro) checklist—are meant to have distinct but complementary purposes, GAO found that VHA policy, guidance, and the tools distributed for these oversight mechanisms did not reflect the distinct purposes officials described. VHA officials said that periodic audits are intended to be a first level of defense and to review actual payments to affiliates, whereas the ReDPro checklist is intended to be a second level of defense, aimed at reviewing the process to see if the rules related to disbursement agreements are being followed by VA medical facilities. However, the ReDPro checklist tool and VHA's recommended periodic audit tool have numerous areas of overlap, including duplicative questions. This overlap causes inefficiencies and unnecessary burden on VA medical facility staff. GAO also found additional weaknesses in the tools, guidance, and training for the two oversight mechanisms. For example, GAO found an unclear ReDPro checklist tool, along with insufficient guidance and training related to conducting the ReDPro reviews. Officials from eight of 13 facilities in GAO's review indicated that the ReDPro checklist instructions were unclear regarding appropriate supporting documents for checklist responses. These weaknesses contributed to errors and inconsistencies in ReDPro responses. the lack of a standard audit tool, and inadequate guidance and training for periodic audit teams that contributed to problematic inconsistencies in the methodologies used by the audit teams and deficiencies in some of the audits conducted. Officials from 10 of 13 facilities in GAO's review indicated that they would benefit from more tools, guidance, or training related to conducting periodic audits. These weaknesses limit the effectiveness of VHA's oversight mechanisms, and put VHA at increased risk of both not being able to identify and correct facilities' lack of adherence to disbursement agreement policy and of possible improper payments to GME affiliates. Under VHA's GME program, VA medical facilities use disbursement agreements to reimburse affiliated academic institutions for residents' salaries and benefits. VHA developed policy related to establishing and administering disbursement agreements, but audits have found that facilities have not always adhered to VHA policy—resulting in improper payments to affiliates. GAO was asked to review VHA policies and procedures related to reimbursements to affiliates for GME. This report examines (1) oversight roles and responsibilities for GME disbursement agreements and (2) VHA's mechanisms for ensuring VA medical facilities adhere to policy. GAO reviewed relevant VHA documents and federal internal control standards and interviewed VHA officials. GAO also reviewed ReDPro checklist responses and documentation from 13 VA medical facilities—selected based on factors including geographic variation, GME program size, and number of affiliates. GAO also visited four of the 13 facilities and interviewed officials at the other nine facilities. GAO is making seven recommendations to VA to define key roles in policy, reduce overlap between the ReDPro checklist and facility periodic audits, and improve the oversight mechanisms' tools, guidance, and training. VA concurred with GAO's recommendations. For more information, contact Sharon M. Silas at (202) 512-7114 or silass@gao.gov.
    [Read More…]
  • United States-Japan Extended Deterrence Dialogue
    In Crime Control and Security News
    Office of the [Read More…]
  • University of Arkansas Professor Indicted for Wire Fraud and Passport Fraud
    In Crime News
    The Department of Justice announced today that Simon Saw-Teong Ang, 63, of Fayetteville, Arkansas, was indicted by a federal grand jury in the Western District of Arkansas on 42 counts of wire fraud and two counts of passport fraud.
    [Read More…]
  • Pennsylvania Man Charged with Trafficking in Endangered and Invasive Fish
    In Crime News
    A Pennsylvania man has been indicted in the Western District of Pennsylvania for violating the Lacey Act.
    [Read More…]
  • Individual Pleads Guilty to Participating in Internet-of-Things Cyberattack in 2016
    In Crime News
    An individual, formerly a juvenile, pleaded guilty to committing acts of federal juvenile delinquency in relation to a cyberattack that caused massive disruption to the Internet in October 2016.
    [Read More…]
  • Colorado Man Pleads Guilty to Federal Hate Crime and Explosives Charges for Plotting to Blow up Synagogue
    In Crime News
    The Justice Department announced that Richard Holzer, 28, pleaded guilty today to federal hate crime and explosives charges for plotting to blow up the Temple Emanuel Synagogue in Pueblo, Colorado.
    [Read More…]
  • Alabama Salesman Sentenced to Prison for Tax Evasion
    In Crime News
    A Hoover, Alabama, salesman was sentenced to 24 months in prison yesterday for tax evasion, announced Principal Deputy Assistant Attorney General Richard E. Zuckerman of the Justice Department’s Tax Division and U.S. Attorney Prim F. Escalona for the Northern District of Alabama.
    [Read More…]
  • Libya Travel Advisory
    In Travel
    Do not travel to Libya [Read More…]
  • Sargeant Marine Inc. Pleads Guilty and Agrees to Pay $16.6 Million to Resolve Charges Related to Foreign Bribery Schemes in Brazil, Venezuela, and Ecuador
    In Crime News
    Sargeant Marine Inc., an asphalt company formerly based in Boca Raton, Florida, pleaded guilty today to conspiracy to violate the anti-bribery provisions of the Foreign Corrupt Practices Act (FCPA) and agreed to pay a criminal fine of $16.6 million to resolve charges stemming from a scheme to pay bribes to foreign officials in three South American countries.
    [Read More…]
  • Statement by Assistant Attorney General Eric Dreiband for the Civil Rights Division on Veterans Day
    In Crime News
    The Civil Rights Division of the U.S. Department of Justice and its Servicemembers and Veterans Initiative would like to wish a happy Veterans Day to our soldiers, both past and present. We owe you our thanks, but more than that, we owe you our freedom. As the head of the Civil Rights Division, I am entrusted with enforcing laws that protect the rights of the brave men and women of our nation’s armed forces, and the veterans who have served in the past. Enforcement of these very important federal civil rights laws helps ensure that these men and women can continue to safeguard our freedom. 
    [Read More…]
  • Puerto Rico Legislator Indicted for Theft, Bribery, and Fraud
    In Crime News
    A federal grand jury in the District of Puerto Rico returned a 13-count indictment against legislator María Milagros Charbonier-Laureano (Charbonier), aka “Tata,” a member of the Puerto Rico House of Representatives, as well as her husband Orlando Montes-Rivera (Montes), their son Orlando Gabriel Montes-Charbonier, and her assistant Frances Acevedo-Ceballos (Acevedo), for their alleged participation in a years-long theft, bribery, and kickback conspiracy.
    [Read More…]
  • Secretary Michael R. Pompeo and Saudi Foreign Minister Prince Faisal bin Farhan Al Saud After Their Meeting
    In Crime Control and Security News
    Michael R. Pompeo, [Read More…]
  • F-35 Sustainment: DOD Needs to Address Key Uncertainties as It Re-Designs the Aircraft’s Logistics System
    In U.S GAO News
    The Autonomic Logistics Information System (ALIS) is integral to supporting F-35 aircraft operations and maintenance. However, F-35 personnel at 5 locations GAO visited for its March 2020 report cited several challenges. For example, users at all 5 locations we visited stated that electronic records of F-35 parts in ALIS are frequently incorrect, corrupt, or missing, resulting in the system signaling that an aircraft should be grounded in cases where personnel know that parts have been correctly installed and are safe for flight. At times, F-35 squadron leaders have decided to fly an aircraft when ALIS has signaled not to, thus assuming operational risk to meet mission requirements. GAO found that DOD had not (1) developed a performance-measurement process for ALIS to define how the system should perform or (2) determined how ALIS issues were affecting overall F-35 fleet readiness, which remains below warfighter requirements. DOD recognizes that ALIS needs improvement and plans to leverage ongoing re-design efforts to eventually replace ALIS with a new logistics system. However, as DOD embarks on this effort, it faces key technical and programmatic uncertainties (see figure). Uncertainties about the Future F-35 Logistics Information System These uncertainties are complicated and will require significant planning and coordination with the F-35 program office, military services, international partners, and the prime contractor. For example, GAO reported in March 2020 that DOD had not determined the roles of DOD and the prime contractor in future system development and management. DOD had also not made decisions about the extent to which the new system will be hosted in the cloud as opposed to onsite servers at the squadron level. More broadly, DOD has experienced significant challenges sustaining a growing F-35 fleet. GAO has made over 20 recommendations to address problems associated with ALIS, spare parts shortages, limited repair capabilities, and inadequate planning. DOD has an opportunity to re-imagine the F-35's logistics system and improve operations, but it must approach this planning deliberately and thoroughly. Continued attention to these challenges will help ensure that DOD can effectively sustain the F-35 and meet warfighter requirements. The F-35 Lightning II is DOD's most ambitious and costly weapon system in history, with total acquisition and sustainment costs for the three U.S. military services who fly the aircraft estimated at over $1.6 trillion. Central to F-35 sustainment is ALIS—a complex system that supports operations, mission planning, supply-chain management, maintenance, and other processes. A fully functional ALIS is critical to the more than 3,300 F-35 aircraft that the U.S. military services and foreign nations plan to purchase. Earlier this year, DOD stated that it intends to replace ALIS with a new logistics system. This statement highlights (1) current user challenges with ALIS and (2) key technical and programmatic uncertainties facing DOD as it re-designs the F-35's logistics system. This statement is largely based on GAO's March 2020 report on ALIS ( GAO-20-316 ), as well as previous F-35 sustainment work. GAO previously recommended that DOD develop a performance-measurement process for ALIS, track how ALIS is affecting F-35 fleet readiness, and develop a strategy for re-designing the F-35's logistics system. GAO also suggested that Congress consider requiring DOD to develop a performance-measurement process for its logistics system. DOD concurred with GAO's recommendations and is taking actions to address them. For more information, contact Diana C. Maurer at (202) 512-9627 or maurerd@gao.gov.
    [Read More…]
  • Secretary Pompeo’s Meeting with French Foreign Minister Le Drian
    In Crime Control and Security News
    Office of the [Read More…]
  • Medicaid Information Technology: Effective CMS Oversight and States’ Sharing of Claims Processing and Information Retrieval Systems Can Reduce Costs
    In U.S GAO News
    The Centers for Medicare and Medicaid Services (CMS) has reimbursed billions of dollars to states for the development, operation, and maintenance of claims processing and information retrieval systems—the Medicaid Management Information Systems (MMIS) and Eligibility and Enrollment (E&E) systems. Specifically, from fiscal year 2008 through fiscal year 2018, states spent a total of $44.1 billion on their MMIS and E&E systems. CMS reimbursed the states $34.3 billion of that total amount (see figure). Money Spent by States and Reimbursed by CMS from 2008–2018 for Medicaid Management Information Systems (MMIS) and Eligibility and Enrollment (E&E) Systems For fiscal years 2016 through 2018, CMS approved 93 percent and disapproved 0.4 percent of MMIS funding requests, while for E&E it approved 81 percent and disapproved 1 percent of the requests. The remaining 6.6 percent of MMIS requests and 18 percent of E&E requests were either withdrawn by states or were pending. GAO estimates that CMS had some level of supporting evidence of its review for about 74 percent of MMIS requests and about 99 percent of E&E requests. However, GAO estimates that about 100 percent of E&E requests and 68 percent of MMIS requests lacked pertinent information that would be essential for indicating that a complete review had been performed. Among CMS requirements for system implementation funding is that states submit an alternatives analysis, feasibility study, and cost benefit analysis. However, GAO found that about 45 percent of such requests it sampled for fiscal years 2016 through 2018 did not include these required documents. The above weaknesses were due, in part, to a lack of formal, documented procedures for reviewing state funding requests. CMS also lacked a risk-based process for overseeing systems after federal funds were provided. CMS provided helpful comments and recommendations to states in selected cases, but in other instances it did not. In two states that had contractors struggling to deliver successful projects, state officials said they had not received recommendations or technical assistance from CMS. The states eventually terminated the projects after spending a combined $38.5 million in federal funds. According to CMS officials, they rely largely on states to oversee systems projects. This perspective is consistent with a 2018 Office of Management and Budget (OMB) decision that federal information technology (IT) grants totaling about $9 billion annually would no longer be tracked on OMB's public web site on IT investment performance. Accordingly, the CMS and Health and Human Services chief information officers (CIO) are not involved in overseeing MMIS or E&E projects. Similarly, 21 of 47 states responding to GAO's survey reported that their state CIO had little or no involvement in overseeing their MMISs. Such non-involvement of officials with duties that should be heavily focused on successful acquisition and operation of IT projects could be hindering states' ability to effectively implement systems. To improve oversight, CMS has begun a new outcome-based initiative that focuses the agency's review of state funding requests on the successful achievement of business outcomes. However, as of February 2020, CMS had not yet established a timeline for including MMIS and E&E systems in the new outcome-based process. CMS had various initiatives aimed at reducing duplication of Medicaid systems (see table). Description and Status of Centers for Medicare and Medicaid Services Initiatives Aimed at Reducing Duplication by Sharing, Leveraging, and Reusing Medicaid Information Technology Initiative Description Implementation status Number of surveyed states reporting use of the initiative Reuse Repository Used by states to collect and share reusable artifacts. Made available in August 2017. As of January 2020, CMS was no longer supporting this initiative. 25 of the 50 reporting states Poplin Project Was to provide free, open-source application program interfaces for states to use in developing their modular Medicaid systems. Initiative never fully implemented. As of January 2020, CMS was no longer supporting this initiative. Three of the 50 reporting states Open Source Provider Screening Module Open-source module for states to use at no charge. Made available in August 2018. As of January 2020, CMS was no longer supporting this initiative. One of the 50 states reported attempting to use the module. Medicaid Enterprise Cohort Meetings A forum where states can discuss sharing, leveraging, and/or reuse of Medicaid technologies. As of January 2020, Cohort meetings were being held on a monthly basis. 47 of the 50 states reported participating in the meetings. Source: GAO analysis of agency data. | GAO-20-179 However, as of January 2020, the agency was no longer supporting most of these initiatives because they failed to produce the desired results. CMS regulations and GAO's prior work have highlighted the importance of reducing duplication by sharing and reusing Medicaid IT. To illustrate the potential for reducing duplication, 53 percent of state Medicaid officials responding to our survey reported using the same contractor to develop their MMIS. Nevertheless, selected states are taking the initiative to share systems or modules. Further support by CMS could result in additional sharing initiatives and potential cost savings. The Medicaid program is the largest source of health care funding for America's most at-risk populations and is funded jointly by states and the federal government. GAO was asked to assess CMS's oversight of federal expenditures for MMIS and E&E systems used for Medicaid. This report examines (1) the amount of federal funds that CMS has provided to state Medicaid programs to support MMIS and E&E systems, (2) the extent to which CMS reviews and approves states' funding requests for the systems and oversees the use of these funds, and (3) CMS's and states' efforts to reduce potential duplication of Medicaid IT systems. GAO assessed information related to MMIS and E&E systems, such as state expenditure data, federal regulations, and CMS guidance to the states for submitting funding requests, states' system funding requests, and IT project management documents. GAO also evaluated a generalizable sample of approved state funding requests from fiscal years 2016 through 2018 to analyze, among other things, CMS's review and approval process and conducted interviews with agency and state Medicaid officials. GAO also reviewed relevant regulations and guidance on promoting, sharing, and reusing MMIS and E&E technologies; and surveyed 50 states and six territories (hereafter referred to as states) regarding the MMIS and E&E systems, and assessed the complete or partial responses received from 50 states. GAO is making nine recommendations to improve CMS's processes for approving and overseeing the federal funds for MMIS and E&E systems and for bolstering efforts to reduce potential duplication. Among these recommendations are that CMS should develop formal, documented procedures that include specific steps to be taken in the advanced planning document review process and instructions on how CMS will document the reviews; develop, in consultation with the HHS and CMS CIOs, a documented, comprehensive, and risk-based process for how CMS will select IT projects for technical assistance and provide recommendations to assist states that is aimed at improving the performance of the systems; encourage state Medicaid program officials to consider involving state CIOs in overseeing Medicaid IT projects; establish a timeline for implementing the outcome-based certification process for MMIS and E&E systems; and identify, prior to approving funding for systems, similar projects that other states are pursuing so that opportunities to share, leverage, or reuse systems or system modules are considered. In written comments on a draft of this report, the department concurred with eight of the nine recommendations, and described steps it had taken and/or planned to take to address them. The department did not state whether it concurred with GAO's recommendation to encourage state officials to consider involving state CIOs in Medicaid IT projects. HHS stated that it was unable to discern evidence as to whether a certain structure contributed to a specific outcome. GAO believes, consistent with federal law, that CIOs are critically important to the success of IT projects. For more information, contact Vijay D’Souza at (202) 512-6240 or dsouzav@gao.gov.
    [Read More…]
  • Framework Agreement for Israel-Lebanon Maritime Discussions
    In Crime Control and Security News
    Michael R. Pompeo, [Read More…]
  • This Week in Iran Policy
    In Crime Control and Security News
    Office of the [Read More…]
  • Justice Department Resolves Antitrust Case Against Leading Central Pennsylvania Health Care Providers
    In Crime News
    The Department of Justice announced today that it has reached a settlement with Geisinger Health (Geisinger) and Evangelical Community Hospital (Evangelical) that will resolve the department’s ongoing civil antitrust litigation challenging Geisinger’s partial acquisition of Evangelical. Among other terms, the settlement requires Geisinger to cap its ownership interest in Evangelical at a 7.5% passive interest and eliminates additional entanglements between the two competing hospitals.
    [Read More…]
  • Chinese National Sentenced for Laundering Millions for Mexican Drug Cartels
    In Crime News
    A Chinese national was sentenced today to five years in prison and ordered to forfeit more than $4.2 million for laundering drug proceeds generated by large-scale cocaine trafficking in the United States.
    [Read More…]
  • New York Fisherman and Fish Dealer Charged with Conspiracy, Fraud, and Obstruction
    In Crime News
    Today, a federal grand jury in the Eastern District of New York unsealed the indictment of one fisherman, a wholesale fish dealer, and two of its managers for conspiracy to commit mail and wire fraud and obstruction in connection with a scheme to illegally overharvest fluke and black sea bass. All four defendants are from Montauk.
    [Read More…]
  • Missile Defense: Fiscal Year 2020 Delivery and Testing Progressed, but Annual Goals Unmet
    In U.S GAO News
    What GAO Found In fiscal year 2020, the Missile Defense Agency (MDA) made progress toward achieving its delivery and testing goals for some of the individual systems—known as elements—that combine and integrate to create the Missile Defense System (also known as the Ballistic Missile Defense System). However, MDA did not complete its overall planned deliveries or annual testing. The figure below shows MDA's progress delivering assets and conducting flight tests against its fiscal year 2020 plans. Percentage of Missile Defense Agency Planned Deliveries and Flight Tests Completed for Fiscal Year 2020 Deliveries— In fiscal year 2020, MDA delivered many assets it had planned. Specifically, MDA was able to deliver 82 missile interceptors for 3 elements. However, MDA was not able to deliver all planned interceptors, including one originally planned for 2018 for the Ground-based Midcourse Defense program, as the program experienced delays related to qualifying parts from a new supplier. Flight testing— MDA conducted two planned flight tests, but neither was successful. The issues were due to problems with non-MDA assets, but the agency was able to collect important data. In addition, COVID-19 restrictions also affected the planned schedule. However, the delays continue a trend of MDA's inability to conduct planned annual flight testing, resulting in assets and capabilities that are subsequently delayed or delivered with less data than planned. Ground testing— In fiscal year 2020, MDA continued to implement a new ground testing approach that the agency began in fiscal year 2019. In addition, MDA successfully completed three planned ground tests demonstrating defense capabilities for the U.S., U.S. forces and regional allies. However, MDA delayed two other ground tests to future fiscal years and expects disruptions in fiscal year 2021, in part due to ongoing COVID-19 disruptions. Cyber— Despite failing to meet annual operational cybersecurity assessments since 2017, MDA canceled its planned fiscal year 2020 operational assessments, instead taking steps to implement a new approach designed to improve cyber system requirements while streamlining cyber test planning. It is premature to assess whether this new approach will achieve its intended goals. Why GAO Did This Study For over half a century, the Department of Defense has funded efforts to defend the U.S. from ballistic missile attacks. This effort consists of diverse and highly complex land-, sea-, and space-based systems and assets located across the globe. From 2002 through 2019, MDA—the agency charged with developing, testing, integrating, and fielding this system of systems—received about $162.5 billion. The agency also requested about $45 billion from fiscal year 2020 through fiscal year 2024. In fiscal year 2020, MDA's mission broadened to include evolving threats beyond ballistic missiles such as defending against hypersonic missile attacks. With the inclusion of non-ballistic missile threats, the Ballistic Missile Defense System is in the process of transitioning to the Missile Defense System. Congress included a provision in statute that GAO annually assess and report on MDA's progress. This, our 18th annual review, addresses the progress MDA made in achieving fiscal year 2020 delivery and testing goals. GAO reviewed planned fiscal year 2020 baselines, along with program changes due to COVID-19 restrictions, and other program documentation and assessed them against responses to GAO detailed question sets and program and baseline reviews. GAO also interviewed officials from MDA and various Department of Defense Combatant Commands. We do not make any new recommendations in this report but continue to track the status of prior recommendations. For more information, contact John D. Sawyer at (202) 512-4841 or SawyerJ@gao.gov.
    [Read More…]
  • Co-Owner of Puerto Rican Online Aquarium Business Pleads Guilty to Two Lacey Act Felonies and Export Smuggling for Illicit Trafficking of Protected Reef Creatures
    In Crime News
    A resident of San Sebastian, Puerto Rico, pleaded guilty today to export smuggling and two felony violations of the Lacey Act for collecting, purchasing, falsely labeling, and shipping protected marine invertebrate species as part of an effort to subvert Puerto Rican law designed to protect corals and other reef species, the Department of Justice announced.
    [Read More…]
  • Secretary Michael R. Pompeo With Larry O’Connor of the Larry O’Connor Show/WMAL
    In Crime Control and Security News
    Michael R. Pompeo, [Read More…]
  • Over-The-Counter Drugs: Information on FDA’s Regulation of Most OTC Drugs
    In U.S GAO News
    The Food and Drug Administration (FDA) has regulated most over-the-counter (OTC) drugs—that is, drugs available without a prescription—through the OTC monograph process. FDA has described an OTC monograph as a "rulebook" for marketing safe and effective OTC drugs, such as aspirin, cough and cold medicine, and hand sanitizer. OTC monographs established conditions—such as active ingredients, indications for use, dosage forms, and product labeling—under which an OTC drug was generally recognized as safe and effective. According to FDA officials, before the CARES Act, which was enacted in March 2020, the agency's ability to update and finalize monographs in response to safety issues and to reflect new scientific information was limited by the rulemaking process the agency was required to follow, as well as insufficient resources. Agency officials estimated that it took at least 6 years to complete the required rulemaking process. Additionally, the agency reported it was critically under-resourced to regulate the estimated 100,000 OTC drugs marketed through the monograph process. However, the CARES Act provided for a new process to regulate these OTC drugs rather than the rulemaking process. FDA officials expect it will take less time to update and finalize requirements for OTC drugs using the new process. The CARES Act also authorized FDA to assess user fees to provide additional resources to regulate OTC drugs. Although FDA officials said this new process and user fees should improve its regulation of OTC drugs, the agency's analysis of the effect of the CARES Act is still ongoing. FDA officials told GAO that prior to the CARES Act, they used various methods to identify and respond to safety issues related to OTC drugs. For example, to identify these issues, FDA officials said they read medical literature related to safety issues and reviewed reports submitted to the agency's adverse event reporting system. To respond to these issues, FDA took steps such as issuing drug safety communications to consumers and requesting that manufacturers make changes to a drug's labeling. For example, in 2015, two FDA advisory committees recommended that cough and cold drugs with codeine be removed from the relevant OTC monograph for use in drugs in children. In 2018, FDA also issued a drug safety communication stating the risks outweighed the benefits for the use of these drugs in children. However, FDA officials said these methods were not a substitute for rulemaking because manufacturers could legally market their OTC drugs without making requested safety changes until the rulemaking process was completed. According to FDA officials, the new process for regulating OTC drugs included in the CARES Act could improve FDA's ability to address identified safety risks in a more timely and efficient manner in the future. The act established an expedited process to address safety issues that pose an imminent hazard to public health or to change a drug's labeling to mitigate a significant or unreasonable risk of a serious adverse event. OTC drugs prevent and treat a variety of conditions; for example, sunscreen is used to help prevent sunburn. FDA officials and stakeholders, such as industry representatives and patient and provider groups, have questioned whether the monograph process used to regulate most OTC drugs has been overly burdensome and has limited FDA's ability to quickly update and finalize monographs in response to potential safety issues for consumers. Enacted in March 2020, the CARES Act changed how FDA regulates OTC drugs. The Sunscreen Innovation Act included a provision for GAO to review FDA's regulation of OTC drugs. This report describes, among other issues, (1) the factors that affected FDA's ability to regulate OTC drugs and (2) how FDA identified and responded to safety issues associated with these drugs. GAO reviewed federal statutes and agency documents and interviewed FDA officials and stakeholders familiar with the monograph process. These stakeholders included representatives from the OTC drug industry, health care provider and consumer groups, and researchers. The Department of Health and Human Services provided technical comments on this report, which GAO incorporated as appropriate. For more information, contact John E. Dicken at (202) 512-7114 or dickenj@gao.gov.
    [Read More…]
  • Bosnia and Herzegovina National Statehood Day
    In Crime Control and Security News
    Michael R. Pompeo, [Read More…]
  • Justice Department Settles with Florida Towing Company it Alleges Illegally Sold or Scrapped Servicemembers’ Vehicles
    In Crime News
    The Justice Department today reached an agreement with ASAP Towing & Storage Company (“ASAP”) in Jacksonville, Florida, to resolve allegations that ASAP violated a federal law, the Servicemembers Civil Relief Act (“SCRA”), by auctioning off or otherwise disposing of cars owned by protected servicemembers without first obtaining court orders. 
    [Read More…]
  • Federalism: Opportunities Exist to Improve Coordination and Consultation with State and Local Governments
    In U.S GAO News
    Federal agencies' intergovernmental affairs activities advance agency objectives that require coordination with state and local governments. Most of the 24 Chief Financial Officers (CFO) Act agencies GAO surveyed reported undertaking similar information-sharing and coordination activities, such as serving as liaisons, conducting outreach, and hosting and attending events. The agencies GAO surveyed also reported taking varied approaches to structuring their intergovernmental affairs operations to conduct these activities. Of the 20 agencies with agency-wide intergovernmental affairs offices, half focused on intergovernmental affairs as their sole function while the other half included multiple functions, such as congressional or legislative affairs. How Agencies Organized Their Intergovernmental Affairs Operations Most agencies also reported that intergovernmental affairs activities and responsibilities were dispersed across their agencies. Regional and program offices perform intergovernmental affairs functions at some agencies, while others have an agency-wide office for them. Responsibilities for consulting with state and local governments under Executive Order (E.O.) 13132 also varied. The order requires that each federal agency designate an official to implement the order. Fourteen agencies reported having such an official; 10 did not report having one. Representatives from state and local associations GAO interviewed reported interacting with federal agency intergovernmental affairs offices for outreach and information-sharing purposes. They also cited coordination and consultation challenges, such as difficulty identifying intergovernmental affairs contacts, limited federal agency knowledge of state and local government, and inconsistent consultation on proposed regulations. The Office of Management and Budget (OMB) has primary responsibility for implementing E.O. 13132 and related implementation guidance, including a requirement for the designation of a federalism official. However, OMB could not identify any oversight steps it had taken to ensure federal agencies' designation of a federalism official consistent with its guidance for implementation of the executive order. Taking steps to ensure federal agencies' designation of a federalism official could help ensure that agencies have an accountable process in place for appropriately consulting with state and local governments. Federal programs fulfilling national goals in education, health care, transportation infrastructure, and homeland security, among other issues, are implemented through a complex partnership between federal, state, and local governments. E.O. 13132, Federalism, outlines principles and criteria to guide the formulation and implementation of policies and the appropriate division of responsibilities between levels of government. GAO was asked to review intergovernmental affairs activities at executive branch agencies. This report (1) identifies intergovernmental affairs offices' key responsibilities and activities at selected federal agencies and how these offices are organized, and (2) assesses state and local government officials' interaction with intergovernmental affairs offices, including their reported strengths and challenges. GAO examined relevant policies and executive orders and surveyed officials from the 24 CFO Act agencies. GAO also interviewed a nongeneralizable sample of individuals from 10 associations representing state and local government officials. GAO is recommending that OMB ensure that federal agencies implement its guidance on agency adherence to E.O. 13132 requirements, particularly related to designating a federalism official. OMB neither agreed nor disagreed with the recommendation. For more information, contact Michelle Sager at (202) 512-6806 or sagerm@gao.gov.
    [Read More…]
  • Amateur Athletes: The U.S. Center for SafeSport’s Response and Resolution Process for Reporting Abuse
    In U.S GAO News
    The U.S. Center for SafeSport (the Center), an independent nonprofit organization, was established in response to concerns about the consistency of investigations conducted and resolutions reached by amateur sports organizations of allegations of misconduct and abuse. According to Center staff, their response to allegations of misconduct are guided by the SafeSport Code, which establishes acceptable standards of conduct for all individuals who participate in U.S. Olympic and Paralympic events and training, Standard Operating Procedures (SOPs), and other tools. The SafeSport Code defines the scope of the Center's jurisdiction, establishes the standard of proof for its decisions, identifies types of prohibited conduct, describes possible temporary measures and sanctions, and outlines the resolution process and requirements to report to law enforcement. SOPs outline intake and investigation staff roles and responsibilities and provide a step-by-step guide of processes, and a case management system is used by intake and investigation staff to document their work. The Center seeks to ensure its intake and investigation process is fair by taking steps to ensure anonymity and privacy; providing opportunities for claimants (the persons alleged to have experienced misconduct) and respondents (the individuals accused of misconduct) to participate in investigations; and providing parties with the right to consult with an advisor and to seek arbitration of sanctions or other measures imposed by the Center. The Center refers to allegations of misconduct as cases when it establishes that it has enough information to proceed with intake and investigation. From February 2018 through June 2020, the Center created and resolved 3,909 cases. Most of the Center’s cases were resolved through administrative closure or jurisdictional closure. Administrative closure may occur as a result of insufficient evidence, claimants who elect not to participate in the resolution process, or other factors. Jurisdictional closure occurs when the Center does not have jurisdiction or the Center chooses not to exercise its discretionary jurisdiction, as defined in the SafeSport Code. As of June 30, 2020, approximately 1,300 individuals were listed in the Center’s Centralized Disciplinary Database; this number includes individuals placed on temporary restriction(s) or temporary suspension, as well as individuals suspended or rendered permanently ineligible to participate. On February 14, 2018, the Protecting Young Victims from Sexual Abuse and Safe Sport Authorization Act of 2017 was enacted, which codified the Center’s jurisdiction over the U.S. Olympic and Paralympic Committee and its affiliated organizations with regard to safeguarding amateur athletes against abuse in sports. It also required the Center to develop resources and policies to prevent abuse of amateur athletes. The Center investigates and resolves allegations of sexual misconduct by coaches, trainers, managers, peers, and others that may be in violation of the Center’s policies and procedures. In addition, the Center may, at its discretion, investigate and resolve allegations of other policy violations, including non-sexual child abuse and emotional and physical misconduct. The Center plays a key role in ensuring the safety of amateur athletes, many of whom are minors, who participate in Olympic, Paralympic, and Pan-American events and training. GAO was asked to describe the process the Center uses in responding to, investigating, and resolving allegations of misconduct. This report describes (1) how the Center responds to allegations of misconduct in amateur athletics and seeks to ensure its process for investigating and resolving allegations is fair, and (2) what is known about incidents reported to the Center from February 2018 through June 2020. GAO reviewed documents relevant to Center intake and investigation policies and practices and interviewed the Center's leadership, including individuals responsible for the intake and investigation of allegations of misconduct. In addition, GAO requested summary data for the period February 2018 through June 2020—the most recent data available—including information about allegations of misconduct and abuse, and the investigation and resolution of cases. For more information, contact Kathy A. Larin at (202) 512-7215 or larink@gao.gov.
    [Read More…]