A letter report issued by the Government Accountability Office with an abstract that begins "Before approving a drug, the Food and Drug Administration (FDA) assesses a drug's effectiveness. This assessment may be based on evidence showing that a drug has a positive impact on a surrogate endpoint--a laboratory measure, such as blood pressure--instead of more direct clinical evidence, like preventing strokes. After approval, FDA often requires or requests a drug sponsor to further study the drug. Concerns have been raised about FDA's reliance on surrogate endpoints and its oversight of postmarketing studies. This report provides information on (1) all drug applications approved based on surrogate endpoints in FDA's accelerated approval process, (2) a subset of applications for potentially innovative drugs approved based on surrogate endpoints under FDA's traditional process, and (3) FDA's oversight of postmarketing studies. GAO identified drugs approved based on surrogate endpoints, obtained the status of related postmarketing studies, and reviewed FDA's oversight of a sample of 35 studies it required under its accelerated approval process, selected to include studies which were at varying levels of completion."

A letter report issued by the Government Accountability Office with an abstract that begins "What GAO Found"

A letter report issued by the Government Accountability Office with an abstract that begins "Of the more than two million total participants in the Workforce Investment Act's (WIA) Adult and Dislocated Worker Programs, about 11 percent and 16 percent, respectively, received training in program year 2011, and about two-thirds of the training participants in each program attained a credential. Little is known, however, about how many participants got jobs related to their training. From program year 2006 through program year 2011, the percentages of training participants who earned a credential declined from about 74 percent to 58 percent for the Adult Program and from about 75 percent to 63 percent for the Dislocated Worker Program, according to data from the Department of Labor (DOL). Of those training participants who attained a credential in program year 2011, about 65 percent earned occupational credentials, such as a welding certificate, followed by lower percentages who earned occupational skill licenses and associate's degrees, among others. In contrast, GAO found training-related employment data unreliable primarily because a significant portion of the data was missing."

A letter report issued by the Government Accountability Office with an abstract that begins "In the face of growing demand for veterans' health care, GAO and the Department of Veterans Affairs Office of Inspector General (OIG) have raised concerns about the Veterans Health Administration's (VHA) ability to maximize its third-party collections to supplement its medical care appropriation. GAO has testified that inadequate patient intake procedures, insufficient documentation by physicians, a shortage of qualified billing coders, and insufficient automation diminished VA's collections. In turn, the OIG reported that VA missed opportunities to bill, had billing backlogs, and did inadequate follow-up on bills. While VA has made improvements in these areas, GAO was asked to review internal control activities over third-party billings and collections at selected medical centers to assess whether they were designed and implemented effectively."

A letter report issued by the Government Accountability Office with an abstract that begins "The increasing need for warfighters for the Global War on Terrorism has meant longer and multiple deployments for soldiers. Medical readiness is essential to their performing needed duties, and an impairment that limits a soldier's capacities represents risk to the soldier, the unit, and the mission. Asked to review the Army's compliance with its guidance, GAO examined the extent to which the Army is (1) adhering to its medical and deployment requirements regarding decisions to send soldiers with medical conditions to Iraq and Afghanistan, and (2) deploying soldiers with medical conditions requiring duty limitations, and assigning them to duties suitable for their limitations. GAO reviewed Army guidance, and medical records for those preparing to deploy between April 2006 and March 2007; interviewed Army officials and commanders at Forts Benning, Stewart, and Drum, selected for their high deployment rates; and surveyed deployed soldiers with medical limitations."

A letter report issued by the Government Accountability Office with an abstract that begins "Prior GAO reports have identified problems with the Department of Defense's (DOD) management and oversight of contractors supporting deployed forces. GAO issued its first comprehensive report examining these problems in June 2003. Because of the broad congressional interest in U.S. military operations in Iraq and DOD's increasing use of contractors to support U.S. forces in Iraq, GAO initiated this follow-on review under the Comptroller General's statutory authority. Specifically, GAO's objective was to determine the extent to which DOD has improved its management and oversight of contractors supporting deployed forces since our 2003 report. GAO reviewed DOD policies and interviewed military and contractor officials both at deployed locations and in the United States."

A letter report issued by the Government Accountability Office with an abstract that begins "Pervasive and sustained computer-based attacks pose a potentially devastating impact to systems and operations and the critical infrastructures they support. Addressing these threats depends on effective partnerships between the government and private sector owners and operators of critical infrastructure. Federal policy, including the Department of Homeland Security's (DHS) National Infrastructure Protection Plan, calls for a partnership model that includes public and private councils to coordinate policy and information sharing and analysis centers to gather and disseminate information on threats to physical and cyber-related infrastructure. GAO was asked to determine (1) private sector stakeholders' expectations for cyber-related, public-private partnerships and to what extent these expectations are being met and (2) public sector stakeholders' expectations for cyber-related, public-private partnerships and to what extent these expectations are being met. To do this, GAO conducted surveys and interviews of public and private sector officials and analyzed relevant policies and other documents."

A letter report issued by the Government Accountability Office with an abstract that begins "Under PPACA, states are responsible for making a number of changes to their Medicaid programs by January 1, 2014, including expanding eligibility levels and streamlining their enrollment processes. Specifically, states must expand Medicaid eligibility to non-elderly individuals with incomes at or below 133 percent of FPL. Under the newly eligible category, states will provide Medicaid coverage to eligible low-income parents and childless adults. States must also begin determining income eligibility for Medicaid beneficiaries, including newly eligible adults, using a uniform methodology—MAGI, which is a tax-based definition of income. To implement these requirements, eligibility categories have been consolidated into four groups—adults, children, parents, and pregnant women. States may choose to expand Medicaid coverage to the newly eligible prior to January 1, 2014 (referred to as the early expansion option), but must cover lower income individuals before higher income individuals. These more uniform eligibility requirements will replace the current system where Medicaid eligibility and income rules may vary from state to state. Further, states must adopt a methodology for identifying the newly eligible in order to obtain the increased federal match. States will receive the enhanced federal match …

A letter report issued by the Government Accountability Office with an abstract that begins "The federal workforce, like the nation's workforce as a whole, is aging, and increasingly large percentages are becoming eligible to retire. Eventually baby boomers will leave the workforce and when they do, they will leave behind gaps in leadership, skills, and knowledge due to the slower-growing pool of younger workers. GAO and others have emphasized the need for federal agencies to hire and retain older workers to help address these shortages. Building upon earlier testimony, GAO was asked to examine (1) age and retirement eligibility trends of the current federal workforce and the extent to which agencies hire and retain older workers; (2) workforce challenges selected agencies face and the strategies they use to hire and retain older workers; and (3) actions taken by the Office of Personnel Management (OPM) to help agencies hire and retain experienced workers. To address these questions, GAO analyzed data from OPM's Central Personal Data File, interviewed officials at three agencies with high proportions of workers eligible to retire, and identified agencies' promising practices to hire and retain older workers. What GAO Recommends"

A letter report issued by the Government Accountability Office with an abstract that begins "To move passengers and cargo, the Department of Defense (DOD) must supplement its military aircraft with cargo and passenger aircraft from commercial carriers participating in the Civil Reserve Air Fleet (CRAF) program. Carriers participating in CRAF commit their aircraft to DOD to support a range of military operations. In the Fiscal Year 2008 National Defense Authorization Act, Congress required DOD to sponsor an assessment of CRAF and required GAO to review that assessment. GAO briefed congressional staff on its observations. As discussed with the staff, GAO further analyzed some of the issues identified in its review. This report assesses (1) the extent to which DOD has assessed potential risks to the CRAF program, and (2) the extent to which DOD's management of CRAF supports program objectives. For this engagement, GAO reviewed DOD-sponsored CRAF study reports and interviewed study leadership. GAO also interviewed over 20 of 35 CRAF participating carriers that responded to a request for a meeting, DOD officials, and industry officials."

A letter report issued by the Government Accountability Office with an abstract that begins "Surface coal mining in the mountainous areas of Appalachia--often called "mountaintop mining"--generates controversy, in part because of its scale and the post-mining appearance of the land. Yet there is limited public access to information on the size, location, and life span of these operations, or on how the land can be expected to look afterward. The Government Accountability Office (GAO) was asked to report on the characteristics of (1) surface coal mining and (2) reclaimed lands that were disturbed by surface coal mining in the mountainous, eastern part of Kentucky and in West Virginia, where most such mining occurs. Federal and state law requires mining operators to obtain permits before mining. Among other things, the permits identify the acres under open permit (the acres subject to mining associated with a permit that has not been closed) and how the land will be reclaimed--including the post-mining land use, whether the approximate original contour (AOC) of the land will be restored, and the extent to which excess earth, rock, and other materials (known as "spoil") are placed in nearby valleys. For this study, GAO relied on electronic databases …

A letter report issued by the Government Accountability Office with an abstract that begins "Since 2002, the federal government has offered long-term care insurance to its employees, retirees, and certain others through the Federal Long Term Care Insurance Program (FLTCIP). Enrollees pay the full cost of their premiums. The Office of Personnel Management (OPM) oversees the program. OPM has held two competitive processes to select contractors to insure enrollees and administer FLTCIP, although interest in and competition for these contracts has been limited. In 2009, soon after OPM's award of FLTCIP's second 7-year contract to John Hancock Life Insurance Company (John Hancock), 66 percent of enrollees were notified that their premiums would increase up to 25 percent in order to compensate for how the actuarial assumptions used to set premiums differed from the program's experience. GAO was asked to review FLTCIP. In this report, GAO describes (1) factors affecting carriers' interest in FLTCIP, (2) how the actuarial assumptions used to set FLTCIP premiums have changed since the program's inception, and (3) OPM's oversight of actuarial assumptions and experience and program communications. To do so, GAO interviewed officials from six carriers that in 2009 insured over 60 percent of all long-term …

A letter report issued by the Government Accountability Office with an abstract that begins "Federal agencies occupying facilities owned or leased by the General Services Administration (GSA) are responsible for preparing and maintaining occupant emergency plans (OEP), with assistance or guidance from the Federal Protective Service (FPS) and others, and the majority of selected federal facilities' OEPs GAO reviewed reflect federal guidance. As required by federal regulations, all 20 selected facilities had OEPs and had designated officials, who are responsible for maintaining OEPs and initiating action according to the OEP in the event of an emergency, including the evacuation of facility occupants. Consistent with federal guidance, officials at 19 of the 20 selected facilities reported that they review and update OEPs at least annually, and officials at 1 facility said they were in the process of updating their OEP. When requested, FPS provides OEP guidance, such as templates to facility officials. Officials at 14 facilities reported using FPS guidance or feedback for their OEPs, officials at 1 facility reported not using FPS guidance, and officials at 5 facilities said they used their own agency's guidance. FPS also checks OEPs during periodic facility security assessments--conducted at least every 3 to 5 …

A letter report issued by the Government Accountability Office with an abstract that begins "The tax credit for qualified research expenses provides significant subsidies to encourage business investment in research intended to foster innovation and promote long-term economic growth. Generally the credit provides a subsidy for research spending in excess of a base amount but concerns have been raised about its design and administrability. Government Accountability Office (GAO) was asked to describe the credit's use, determine whether it could be redesigned to improve the incentive to do new research, and assess whether recordkeeping and other compliance costs could be reduced. GAO analyzed alternative credit designs using a panel of corporate tax returns and assessed administrability by interviewing Internal Revenue Service (IRS) and taxpayer representatives."

A letter report issued by the General Accounting Office with an abstract that begins "Congress and the administration have established a new performance-based pay system for members of the Senior Executive Service (SES) that is designed to provide a clear and direct linkage between SES performance and pay. Also, GAO previously reported that significant opportunities exist for agencies to hold the SES accountable for improving organizational results. GAO assessed how well selected agencies are creating linkages between SES performance and organizational success by applying nine key practices GAO previously identified for effective performance management. GAO selected the Department of Education, the Department of Health and Human Services (HHS), and the National Aeronautics and Space Administration (NASA)."

A letter report issued by the General Accounting Office with an abstract that begins "In 1978, the Congress passed the Humane Methods of Slaughter Act to ensure that cattle, sheep, hogs, and other animals destined for human consumption are handled and slaughtered humanely. Within the U.S. Department of Agriculture (USDA), the Food Safety and Inspection Service (FSIS) is responsible for enforcing the act. Recently, the Congress took additional actions to improve FSIS enforcement. GAO reviewed (1) the frequency and scope of humane handling and slaughter violations, (2) actions to enforce compliance, and (3) the adequacy of existing resources to enforce the act."

A letter report issued by the Government Accountability Office with an abstract that begins "In 2002, the President and Secretary of Defense called for the creation of the United States Strategic Command (USSTRATCOM) to anticipate and counter global threats. Currently, USSTRATCOM has responsibility for seven mission areas including nuclear deterrence and integrated missile defense. GAO was asked to determine the extent to which USSTRATCOM has made progress in (1) implementing its new missions and assessing mission results and (2) defining organizational responsibilities and establishing relationships with other Department of Defense (DOD) commands and organizations. To assess progress, GAO compared USSTRATCOM's efforts with lessons learned in implementing successful organizational transformations."

A letter report issued by the Government Accountability Office with an abstract that begins "The four Department of Defense (DOD) components GAO examined have active processes for referring identified cases of contractor misconduct for appropriate action, including suspension or debarment. The components identify numerous cases of actual or alleged contractor misconduct each year from various internal and external sources. The figure below shows the process for identifying and referring cases to the suspension and debarment official for consideration."

A letter report issued by the Government Accountability Office with an abstract that begins "In accordance with 36 U.S.C. 2103, GAO is responsible for conducting audits of the agencywide financial statements of the American Battle Monuments Commission (the Commission). GAO audited the financial statements of the Commission for the fiscal years ended September 30, 2006, and 2005. The audits were done to determine whether, in all material respects, (1) the Commission's financial statements were presented fairly, and (2) Commission management maintained effective internal control over financial reporting and compliance with laws and regulations. Also, GAO tested Commission management's compliance with selected laws and regulations. The Commission was created in 1923 to commemorate the sacrifices and achievements of U.S. Armed Forces where they have served overseas since April 6, 1917, and locations within the United States as directed by Congress. The Commission designs, administers, operates, and maintains 24 American military cemeteries on foreign soil and 25 federal memorials, monuments, and markers, 22 of which are on foreign soil. The Commission was also responsible for designing and constructing the national World War II Memorial on the Capitol Mall in Washington, D.C., and for maintaining six nonfederal memorials with funds provided by those …

A letter report issued by the Government Accountability Office with an abstract that begins "Under the administration's National Energy Policy, the Department of Energy (DOE) is promoting nuclear energy to meet increased U.S. energy demand. In 2003, DOE began developing the Next Generation Nuclear Plant, an advanced nuclear reactor that seeks to improve upon the current generation of operating commercial nuclear power plants. DOE intends to demonstrate the plant's commercial application both for generating electricity and for using process heat from the reactor for the production of hydrogen, which then would be used in fuel cells for the transportation sector. The Energy Policy Act of 2005 required plant design and construction to be completed by 2021. GAO was asked to examine (1) the progress DOE has made in meeting its schedule for the Next Generation Nuclear Plant and (2) DOE's approach to ensuring the commercial viability of the project. To meet these objectives, GAO reviewed DOE's research and development (R&D) plans for the project and the reports of two independent project reviews, observed R&D activities, and interviewed DOE, Nuclear Regulatory Commission (NRC), and industry representatives."

A letter report issued by the Government Accountability Office with an abstract that begins "GAO identified 298 trade and investment commitments made by China in the U.S.-China Joint Commission on Commerce and Trade (JCCT)—184 since 2004—and the U.S.-China Strategic and Economic Dialogue (S&ED) and its predecessor—114 since 2007. The commitments range from affirmations of open trade principles to sector-specific actions. GAO identified 11 issue areas to characterize the content of each commitment. The prominence of issue areas, measured in number of commitments associated with an issue area, differs between the dialogues, reflecting differences in the dialogues' structure and focus. Intellectual property rights commitments are among those most common in the JCCT and investment commitments are among those most common in the S&ED. (For a detailed inventory of commitments and their categorization, see GAO-14-224SP .)"

A letter report issued by the Government Accountability Office with an abstract that begins "The National Oceanic and Atmospheric Administration (NOAA) accounts for about half of the Department of Commerce's (Commerce) acquisition spending, over $851 million in fiscal year 2005 alone. In recent years however, NOAA has experienced instances of poor contract management. GAO was asked to determine if NOAA is positioned to effectively carry out its acquisition function. Specifically, GAO assessed the extent to which NOAA has structured an acquisition organization that provides appropriate oversight; established policies and processes that promote, among other things, a knowledge-based acquisition process for development and production of complex systems; and planned and managed its contracting workforce to address future retirement challenges."

A letter report issued by the Government Accountability Office with an abstract that begins "DOL and OSC began the USERRA demonstration project on August 9, 2011, meeting the time frame (within 60 days of our report on the project's design) required by the VBA. From August 9, 2011, to May 9, 2012, DOL has received 87 USERRA demonstration project cases and OSC has received 123 cases. The data reported in this study cover only 9 months of the demonstration project and do not represent the overall results of the 36-month project nor are we drawing any conclusions of the relative performance at either agency. As both agencies continue to collect and track data, we will be able to provide an in-depth evaluation of relative performance. We did not report customer satisfaction survey data in this assessment due to the short amount of time the survey has been available to claimants and the low survey response rate. Also, while both agencies track time spent on cases on an ongoing basis, OSC only compiles cost data on those cases that have been closed while DOL compiles cost data on open and closed cases. Therefore, we plan to evaluate and compare the relative …

A letter report issued by the Government Accountability Office with an abstract that begins "In fiscal year 2007, the Department of Homeland Security (DHS) obligated about $12 billion for acquisitions to support homeland security missions. DHS's major investments include Coast Guard ships and aircraft; border surveillance and screening equipment; nuclear detection equipment; and systems to track finances and human resources. In part to provide insight into the cost, schedule, and performance of these acquisitions, DHS established an investment review process in 2003. However, concerns have been raised about how well the process has been implemented--particularly for large investments. GAO was asked to (1) evaluate DHS's implementation of the investment review process, and (2) assess DHS's integration of the investment review and budget processes to ensure major investments fulfill mission needs. GAO reviewed relevant documents, including those for 57 DHS major investments (investments with a value of at least $50 million)--48 of which required department-level review through the second quarter of fiscal year 2008; and interviewed DHS headquarters and component officials."