A letter report issued by the Government Accountability Office with an abstract that begins "The Food and Drug Administration (FDA) inspects domestic and foreign establishments where U.S.-marketed medical devices are manufactured to assess compliance with FDA's quality system requirements for ensuring good manufacturing practices and other applicable requirements. The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) required FDA to accredit organizations to inspect certain establishments where devices that are marketed in both the United States and other countries are manufactured. This report includes information that MDUFMA requires GAO to provide on (1) the number of organizations that sought accreditation, the number that were accredited, and reasons for denial of accreditation and (2) the number of inspections conducted by accredited organizations. It also includes information about factors that could influence manufacturers' interest in voluntarily requesting and paying for an inspection by an accredited organization. GAO examined FDA documents, interviewed FDA officials, and obtained information from FDA on the number of inspections conducted from March 11, 2004--when FDA first cleared an accredited organization to conduct independent inspections--through October 31, 2006. GAO also interviewed affected entities, including accredited organizations and medical device manufacturers."

Other written product issued by the Government Accountability Office with an abstract that begins "As the United States reviews its plans to secure, stabilize, and rebuild Iraq, GAO has enclosed a series of issue papers for Congressional consideration in developing its oversight agenda for the 110th Congress and analyzing the President's revised strategy for Iraq. These papers are based on the continuing work of the U.S. Government Accountability Office and the 67 Iraq-related reports and testimonies we have provided to the Congress since May 2003. Iraq has had three successful elections, adopted a constitution, and installed its first elected government. At the same time, since the initial ground offensive ended in 2003, the costs to secure and stabilize Iraq have grown substantially, as has the level of violence that afflicts Iraqi society. Such violence stems from an insurgency that has grown more complex and lethal over the past 3 and 1/2 years and the Sunni-Shi'a conflict, which escalated dramatically in 2006. This instability complicates meaningful political reconciliation among Iraq's religious and tribal groups, reduces the effectiveness of U.S. and Iraqi reconstruction and capacity-building efforts, and diminishes the hopes and expectations of an Iraqi people without adequate jobs, water, fuel, and …

A letter report issued by the Government Accountability Office with an abstract that begins "The expanding implementation of health information technology (IT) and electronic health information exchange networks raises concerns regarding the extent to which the privacy of individuals' electronic health information is protected. In April 2004, President Bush called for the Department of Health and Human Services (HHS) to develop and implement a strategic plan to guide the nationwide implementation of health IT. The plan is to recommend methods to ensure the privacy of electronic health information. GAO was asked to describe HHS's efforts to ensure privacy as part of its national strategy and to identify challenges associated with protecting electronic personal health information. To do this, GAO assessed relevant HHS privacy-related initiatives and analyzed information from health information organizations."

Testimony issued by the Government Accountability Office with an abstract that begins "This testimony, given by David M. Walker, Comptroller General of the United States before the Senate Committee on the Budget, addresses the nation's long-term fiscal outlook and the challenge it presents. However, the outlook is not good. Continuing down this current fiscal path would gradually erode, if not suddenly damage, out economy, our standard of living, and ultimately even our domestic tranquility and national security. The five major points of the testimony are: (1) The current fiscal condition is worse than advertised, (2) the long-term fiscal outlook is both imprudent and unsustainable, (3) improvements in information and processes are needed and can help, (4) meeting out long-term fiscal challenge will require tough choices, bi-partisan cooperation, and compromise, and lastly (5) the time for action is now."

Testimony issued by the Government Accountability Office with an abstract that begins "Rising prescription drug spending has led the United States and other countries to seek ways to negotiate lower prices with drug manufacturers. Currently, the Medicare Part D benefit, which offers outpatient prescription drug benefits to beneficiaries including elderly and certain disabled people, comprises competing prescription drug plans overseen by the Centers for Medicare & Medicaid Services. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 prohibits the Secretary of Health and Human Services from interfering with price negotiations between Part D plan sponsors and drug manufacturers and pharmacies. Some Members of Congress have proposed amending the statute to allow the Secretary of Health and Human Services to negotiate directly with drug manufacturers on behalf of Part D beneficiaries. GAO was asked to describe how prescription drug prices are negotiated. This testimony provides an overview of such efforts (1) by governments in other countries; (2) by U.S. private payers, such as employer-based health plans; and (3) by federal programs other than Medicare Part D. This testimony is based on previous GAO reports from 2002 through 2006 on federal programs that purchase or cover prescription drugs and other relevant …

Correspondence issued by the Government Accountability Office with an abstract that begins "On December 6, 2006, GAO testified before the Senate Committee on Homeland Security and Governmental Affairs on the results of our audit and investigation of hurricanes Katrina and Rita disaster relief efforts. This letter provides our response to Congress's supplemental question for the record. The testimony indicated that the Federal Emergency Management Agency (FEMA) distributed $20 million under the Individuals and Household Program to individuals who claimed damages for both Hurricane Katrina and Hurricane Rita. Congress asked whether it was our conclusion that the entire $20 million was paid improperly or was the $20 million the amount that potentially was paid improperly. Congress also asked whether we investigated each payment comprising the total $20 million."

Correspondence issued by the Government Accountability Office with an abstract that begins "This letter and its enclosure respond to the Congressional request for information on selected executive agencies' policies and practices for making responsibility determinations before awarding contracts. Congress requested this information because of its continued concern for effective pre-contract screening to reduce fraudulent activities by contractors. On the basis of discussions, GAO's objectives were to (1) identify agency policies and practices for making contractor responsibility assessments, and determine under what conditions agencies conduct criminal background checks, (2) determine how contracting officers use the Excluded Parties List System (EPLS) to make responsibility assessments and identify planned improvements to the system, if any, and (3) determine the number of fraud investigations in which the contractor or principals had a prior criminal background."

Correspondence issued by the Government Accountability Office with an abstract that begins "The U.S. Office of Special Counsel (OSC) is an independent federal investigative and prosecutorial agency. Its primary mission is to safeguard the merit system in federal employment by protecting employees and applicants for federal employment from prohibited personnel practices, especially reprisal from whistleblowing. Individuals who believe that a prohibited personnel practice, such as nepotism or obstruction of the right to compete for employment, has been committed may file complaints with OSC. In addition, the agency operates a secure channel for federal whistleblowing disclosures of violations of law, rule, or regulation; gross mismanagement; gross waste of funds; abuse of authority; and substantial and specific dangers to public health or safety. OSC's handling of cases has been publicized in the media and concerns were raised about the assignment of two cases that involved alleged violations of the Hatch Act that OSC officials appeared to handle differently from other such cases. This report responds to the request to provide information on OSC's policies and procedures for assigning incoming cases to and within its organizational units."

Testimony issued by the Government Accountability Office with an abstract that begins "The Environmental Quality Incentives Program (EQIP) and the Conservation Security Program (CSP), administered by the U.S. Department of Agriculture's (USDA) Natural Resources Conservation Service (NRCS), are designed to promote conservation goals. In recently issued reports on these programs, GAO assessed (1) NRCS's process for allocating EQIP funds to the states to optimize environmental benefits, (2) NRCS's measures to monitor EQIP's performance, and (3) the legislative and regulatory measures available to prevent duplication between CSP and other conservation programs, such as EQIP."

Testimony issued by the Government Accountability Office with an abstract that begins "The Department of Defense (DOD) is relying more and more on contractors to provide billions of dollars in services. Congress has been concerned about DOD's ability to prudently manage these funds, and this subcommittee in particular has pushed DOD to employ sound business practices when using the private sector for services. Nevertheless, DOD may not have always obtained good value while spending billions of dollars on services at a time when serious budget pressures are facing the nation. This testimony discusses DOD's (1) increasing reliance on contractors; (2) failure to consistently follow sound business practices when acquiring services; and (3) opportunities for DOD to improve its management of services. The testimony is based on GAO's work from the past decade as well as recent reports issued by the Inspectors General."

A letter report issued by the Government Accountability Office with an abstract that begins "Military operations in Iraq and Afghanistan have focused attention on the Department of Defense's (DOD) supply chain management. The supply chain can be critical to determining outcomes on the battlefield, and the investment of resources in DOD's supply chain is substantial. In 2005, with the encouragement of the Office of Management and Budget (OMB), DOD prepared an improvement plan to address some of the systemic weaknesses in supply chain management. GAO was asked to monitor implementation of the plan and DOD's progress toward improving supply chain management. GAO reviewed (1) the integration of supply chain management with broader defense business transformation and strategic logistics planning efforts; and (2) the extent DOD is able to demonstrate progress. In addition, GAO developed a baseline of prior supply chain management recommendations. GAO surveyed supply chain-related reports issued since October 2001, identified common themes, and determined the status of the recommendations."

A letter report issued by the Government Accountability Office with an abstract that begins "The Nuclear Regulatory Commission (NRC) is responsible for licensing and inspecting the nation's nuclear power plants to ensure their safety and security. By 2010, about one third of NRC's workforce with mission-critical skills will be eligible to retire. At the same time, NRC's workforce needs to expand because NRC expects to receive at least 20 applications for 29 new nuclear power reactors beginning in October 2007. GAO assessed NRC's ability to meet its workforce needs by examining the extent to which NRC (1) has aligned its human capital planning framework with its strategic mission and programmatic goals; (2) is effectively recruiting, developing, and retaining critically skilled personnel; and (3) is addressing future uncertainties that could affect its overall workforce capacity. GAO examined strategic workforce planning and implementation documents, interviewed cognizant managers on NRC's human capital framework and activities, and surveyed these managers about NRC's human capital flexibilities and measures."

A letter report issued by the Government Accountability Office with an abstract that begins "Cost-plus-award-fee contracts accounted for almost half of the National Aeronautic and Space Administration's (NASA) obligated contract dollars for fiscal years 2002-2004. Since 1990, we have identified NASA's contract management as a high-risk area--in part because of a lack of emphasis on end results. Congress asked us to examine (1) the extent NASA's guidance on award fees addresses problems previously identified with the use of award-fee contracts and (2) whether NASA follows its guidance in using award fees to achieve desired outcomes. We reviewed the top 10 dollar value award-fee contracts active from fiscal years 2002 through 2004."

A letter report issued by the Government Accountability Office with an abstract that begins "The Department of Labor's (DOL) Employee Benefits Security Administration (EBSA) enforces the Employee Retirement Income Security Act of 1974 (ERISA), which sets certain minimum standards for private sector pension plans. On the basis of GAO's prior work, the Senate Committee on Health, Education, Labor and Pensions asked GAO to review EBSA's enforcement program. Specifically, this report assesses (1) the extent to which EBSA has improved its compliance activities since 2002; (2) how EBSA's enforcement practices compare to those of other agencies; and (3) what obstacles, if any, affect ERISA enforcement. To do this, we reviewed EBSA's enforcement strategy and operations, and interviewed officials at EBSA, the Internal Revenue Service (IRS) and the Securities and Exchange Commission (SEC), among others."

Correspondence issued by the Government Accountability Office with an abstract that begins "The future of intercity passenger rail service in the United States has come to a critical juncture. The National Railroad Passenger Corporation (Amtrak) continues to rely heavily on federal subsidies--over $1 billion annually in recent years--and operating losses have remained high. In addition, Amtrak will require billions of dollars to address deferred maintenance and achieve a "state of good repair." These needs for Amtrak come at a time when the nation faces long-term fiscal challenges. As we reported in February 2005, the federal government's financial condition and long-term fiscal outlook present enormous challenges to the nation's ability to respond to emerging forces reshaping American society, the United States' place in the world, and the future role of the federal government. Addressing the projected fiscal gaps will require policy makers to examine the affordability and sustainability of all existing programs, policies, functions, and activities throughout the federal budget. Reexamining the federal role and expenditures on intercity passenger rail service will be particularly difficult because opinions differ about what this service should be. Some advocate a greatly expanded federal role and the expansion of intercity passenger rail to relieve growing …

Testimony issued by the Government Accountability Office with an abstract that begins "Oil and gas production from federal lands and waters is vital to meeting the nation's energy needs. As such, oil and gas companies lease federal lands and waters and pay royalties to the federal government based on a percentage of the oil and gas that they produce. The Minerals Management Service (MMS), an agency in the Department of the Interior, is responsible for collecting royalties from these leases. In order to promote oil and gas production, the federal government at times and in specific cases has provided "royalty relief," waiving or reducing the royalties that companies must pay. However, as production from these leases grows and oil and gas prices have risen since a major 1995 royalty relief act, questions have emerged about the financial impacts of royalty relief. Based on our work to date, GAO's statement addresses (1) the likely fiscal impacts of royalty relief on leases issued under the Outer Continental Shelf Deep Water Royalty Relief Act of 1995 and (2) other authority for granting royalty relief that could further impact future royalty revenue. To address these issues our ongoing work has included, among other things, …

Testimony issued by the Government Accountability Office with an abstract that begins "The July 2005 London subway bombings and July 2006 rail attacks in Mumbai, India dramatically revealed the vulnerability of passenger rail and other surface transportation systems worldwide to terrorist attack and demonstrated the need for increased focus on the security of these systems. This testimony, which is based primarily on GAO's September 2005 report on passenger rail security (GAO-05-851) and selected program updates obtained in January 2007 provides information on (1) how the Department of Homeland Security (DHS) has assessed the risks posed by terrorism to the U.S. passenger rail system; (2) actions TSA and other federal agencies have taken to enhance the security of U.S. rail systems; and (3) rail security practices implemented by domestic and selected foreign passenger rail operators."

Testimony issued by the Government Accountability Office with an abstract that begins "GAO provided a strategic overview of GAO's work related to securing, stabilizing, and rebuilding Iraq. In our statement today, as requested, GAO highlighted (1) GAO's scope, authority, and coordination; (2) some of the insights stemming from our work in Iraq; and (3) the rigorous quality assurance framework that GAO uses to ensure relevant, reliable, and consistent results in all of our work. This testimony is based upon extensive work spanning several years. Since 2003, we have issued 67 Iraq-related reports and testimonies. For example, GAO sent a report to the Congress last week on a range of key issues for congressional oversight of efforts to secure, stabilize, and rebuild Iraq. Although many of our sources are classified, we strive to report information to the Congress in a public format to promote greater transparency and accountability of U.S. government policies, programs, and activities. As provided for in our congressional protocols, most of our work in Iraq has been performed under my authority to conduct evaluations on my own initiative since it is a matter of broad interest to the entire Congress and numerous committees in both chambers. Our work …

A letter report issued by the Government Accountability Office with an abstract that begins "Much of the Federal Emergency Management Agency's (FEMA) funding is provided in supplemental appropriations when a disaster is declared, but funds to staff, manage, and operate other FEMA programs and underlying support functions--what GAO refers to as its day-to-day operations--compete with other Department of Homeland Security (DHS) and federal priorities for limited resources. In this environment, FEMA must strategically plan for and manage its day-to-day operations to ensure they efficiently and effectively support the agency's disaster relief mission. To analyze this issue, GAO examined resource trends and management related to FEMA's day-to-day operations from fiscal year 2001 through fiscal year 2005."

A letter report issued by the Government Accountability Office with an abstract that begins "The 2006 Quadrennial Defense Review Report states that the Department of Defense (DOD) must be prepared to respond to and mitigate the effects of weapons of mass destruction (WMD) attacks at home or overseas. Moreover, the Secretary of Defense directed the U.S. military to define the nature and potential requests for military capabilities needed to respond to 15 National Planning Scenarios issued by the Homeland Security Council. The Army's chemical units are key players in this mission. GAO was asked to evaluate the preparedness of the Army's chemical and biological units, including the extent to which (1) units tasked with providing chemical and biological defense support to combat units and commands are adequately staffed, equipped, and trained and (2) units also tasked with a homeland defense mission--especially National Guard and Reserve units--are adequately prepared for this mission. During this review, we analyzed readiness data and other preparedness indicators for 78 Army chemical units."

A letter report issued by the Government Accountability Office with an abstract that begins "For the military to operate in environments contaminated by chemical and biological warfare agents, the Department of Defense (DOD) has developed collective protection equipment to provide a protected environment for group activities. GAO previously reported persistent problems in providing collective protection for U.S. forces in high threat areas overseas. In this report, GAO examined (1) current intelligence assessments of chemical and biological threats, (2) the extent to which DOD has provided collective protection at critical overseas facilities and major expeditionary warfighting assets, and (3) DOD's framework for managing installation protection policies and prioritizing critical installations for funding. In conducting this review, GAO developed criteria to identify critical sites in the absence of a DOD priority listing of such sites in overseas high threat areas--areas at high risk of terrorist or missile attack."

A letter report issued by the Government Accountability Office with an abstract that begins "California is the nation's fourth largest producer of crude oil and has the third largest oil refining industry (behind Texas and Louisiana). Because crude oil is a globally traded commodity, natural and geopolitical events can affect its price. These fluctuations affect state revenues because a share of the royalty payments from companies that lease state or federal lands to produce crude oil are distributed to the states. Because there are many varieties and grades of crude oil, buyers and sellers often price their oil relative to another abundant, highly traded, and high quality crude oil called a benchmark. West Texas Intermediate (WTI), a light crude oil, is the most commonly used benchmark in the United States. The price difference between a crude oil and its benchmark is commonly expressed as a price differential. In fall 2004, crude oil price differentials between WTI and California's heavier, and generally lower valued, crude oil rose sharply. GAO was asked to examine (1) the extent to which crude oil price differentials in California have fluctuated over the past 20 years and (2) the factors that may explain the recent changes …

A letter report issued by the Government Accountability Office with an abstract that begins "To improve acquisition outcomes, in 1997 the District established the Office of Contracting and Procurement under the direction of a newly created chief procurement officer (CPO). Since then, the District's inspector general and auditor have identified improper contracting practices. This report examines whether the District's procurement system is based on procurement law and management and oversight practices that incorporate generally accepted key principles to protect against fraud, waste, and abuse. GAO's work is based on a review of generally accepted key principles identified by federal, state, and local procurement laws, regulations, and guidance. GAO also reviewed District audit reports and discussed issues with current and former District officials as well as select state and local officials."

A letter report issued by the Government Accountability Office with an abstract that begins "Accessing and retaining high-quality officers in the current environment of increasing deployments and armed conflict may be two of the all volunteer force's greatest challenges. The military services use three programs to access officer candidates: (1) military academies, (2) the Reserve Officers' Training Corps (ROTC), and (3) Officer Candidate Schools (OCS). In addition to accessing new officers, the services must retain enough experienced officers to meet current operational needs and the services' transformation initiatives. GAO was asked to assess the extent to which the services are accessing and retaining the officers required to meet their needs. GAO also identified steps that the Department of Defense (DOD) and the services have taken and the impediments they face in increasing officers' foreign language proficiency. For this report, GAO examined actual accession and retention rates for officers in fiscal years (FYs) 2001, 2003, and 2005 as well as projections for later years. Also, GAO reviewed documents on foreign language training and plans."