New Drug Approval: FDA Needs to Enhance Its Oversight of Drugs Approved on the Basis of Surrogate Endpoints (open access)

New Drug Approval: FDA Needs to Enhance Its Oversight of Drugs Approved on the Basis of Surrogate Endpoints

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."
Date: September 23, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
HIV/AIDS: Federal and State Efforts to Identify Infected Individuals and Connect Them to Care (open access)

HIV/AIDS: Federal and State Efforts to Identify Infected Individuals and Connect Them to Care

A letter report issued by the Government Accountability Office with an abstract that begins "Of the estimated 1.1 million Americans living with HIV, not all are aware of their HIV-positive status. Timely testing of HIV-positive individuals is important to improve health outcomes and to slow the disease's transmission. It is also important that individuals have access to HIV care after being diagnosed, but not all diagnosed individuals are receiving such care. The Centers for Disease Control and Prevention (CDC) provides grants to state and local health departments for HIV prevention and collects data on HIV. In 2006, CDC recommended routine HIV testing for all individuals ages 13-64. The Health Resources and Services Administration (HRSA) provides grants to states and localities for HIV care and services. GAO was asked to examine issues related to identifying individuals with HIV and connecting them to care. This report examines: 1) CDC and HRSA's coordination on HIV activities and steps they have taken to encourage routine HIV testing; 2) implementation of routine HIV testing by select state and local health departments; 3) available information on CDC funding for HIV testing; and 4) available data on the number of HIV-positive individuals not receiving care for HIV. …
Date: September 23, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Recovery Act: Funds Continue to Provide Fiscal Relief to States and Localities, While Accountability and Reporting Challenges Need to Be Fully Addressed (open access)

Recovery Act: Funds Continue to Provide Fiscal Relief to States and Localities, While Accountability and Reporting Challenges Need to Be Fully Addressed

A letter report issued by the Government Accountability Office with an abstract that begins "This report, the third in response to a mandate under the American Recovery and Reinvestment Act of 2009 (Recovery Act), addresses the following objectives: (1) selected states' and localities' uses of Recovery Act funds, (2) the approaches taken by the selected states and localities to ensure accountability for Recovery Act funds, and (3) states' plans to evaluate the impact of Recovery Act funds. GAO's work for the report is focused on 16 states and certain localities in those jurisdictions as well as the District of Columbia (District)-- representing about 65 percent of the U.S. population and two-thirds of the intergovernmental federal assistance available. Under the Recovery Act, GAO collected and analyzed documents and interviewed state and local officials. GAO also analyzed federal agency guidance and spoke with Office of Management and Budget (OMB) officials and with program officials at the federal agencies overseeing Recovery Act programs."
Date: September 23, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Homeland Security: Federal Protective Service Has Taken Some Initial Steps to Address Its Challenges, but Vulnerabilities Still Exist (open access)

Homeland Security: Federal Protective Service Has Taken Some Initial Steps to Address Its Challenges, but Vulnerabilities Still Exist

Testimony issued by the Government Accountability Office with an abstract that begins "To accomplish its mission of protecting federal facilities, the Federal Protective Services (FPS), within the Department of Homeland Security (DHS), currently has a budget of about $1 billion, about 1,200 full-time employees, and about 15,000 contract security guards. This testimony is based on completed and ongoing work for this Subcommittee and discusses: (1) challenges FPS faces in protecting federal facilities and (2) how FPS's actions address these challenges. To perform this work, GAO visited FPS's 11 regions, analyzed FPS data, and interviewed FPS officials, guards, and contractors. GAO also conducted covert testing at 10 judgmentally selected level IV facilities in four cities. Because of the sensitivity of some of the information, GAO cannot identify the specific locations of incidents discussed. A level IV facility has over 450 employees and a high volume of public contact."
Date: September 23, 2009
Creator: United States. Government Accountability Office.
Object Type: Text
System: The UNT Digital Library
DCAA Audits: Widespread Problems with Audit Quality Require Significant Reform (open access)

DCAA Audits: Widespread Problems with Audit Quality Require Significant Reform

A letter report issued by the Government Accountability Office with an abstract that begins "The Defense Contract Audit Agency (DCAA) under the Department of Defense (DOD) Comptroller plays a critical role in contractor oversight by providing auditing, accounting, and financial advisory services in connection with DOD and other federal agency contracts and subcontracts. Last year, GAO found numerous problems with DCAA audit quality at three locations in California, including the failure to meet professional auditing standards. This report addresses audit quality issues at DCAA offices nationwide. GAO was asked to (1) conduct a broad assessment of DCAA's management environment and audit quality assurance structure, (2) evaluate DCAA actions to date to correct previously identified problems, and (3) identify potential legislative and other actions for improving DCAA effectiveness and independence. To achieve these objectives, GAO analyzed DCAA's mission, strategic plan, audit policies, and quality assurance program; conducted interviews; reviewed selected audits at DCAA offices; and analyzed legislative and other actions."
Date: September 23, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Tax Administration: Opportunities Exist for IRS to Enhance Taxpayer Service and Enforcement for the 2010 Filing Season (open access)

Tax Administration: Opportunities Exist for IRS to Enhance Taxpayer Service and Enforcement for the 2010 Filing Season

A letter report issued by the Government Accountability Office with an abstract that begins "Preparing for the tax filing season is a significant undertaking for Internal Revenue Service (IRS). The filing season is when most individuals file their tax returns, receive refunds, and contact IRS if they have questions. As returns are received, IRS begins a series of automated compliance checks to correct errors on tax returns and ensure that refunds are justified. For example, IRS rejects electronically filed returns with basic errors requiring taxpayers to correct and resubmit them. It uses what is called "math error authority" to automatically correct obvious noncompliance such as violations of limits on deductions or credits, which allows IRS to avoid costly audits. IRS must begin preparing for each filing season months in advance and preparations include the following. (1) Revising tax forms and publications to implement tax law changes. Recent major law changes that affected the 2009 filing season include the (a) Economic Stimulus Act of 2008, which contained the recovery rebate credit allowing taxpayers who did not receive the full economic stimulus payment last year to claim some or all of the unpaid credit on their 2008 returns; (b) Housing and Economic …
Date: September 23, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Recovery Act: Funds Continue to Provide Fiscal Relief to States and Localities, While Accountability and Reporting Challenges Need to Be Fully Addressed (Appendixes), an E-supplement to GAO-09-1016 (open access)

Recovery Act: Funds Continue to Provide Fiscal Relief to States and Localities, While Accountability and Reporting Challenges Need to Be Fully Addressed (Appendixes), an E-supplement to GAO-09-1016

Other written product issued by the Government Accountability Office with an abstract that begins "This supplementary report to GAO-09-1016 provides individual state appendixes for 16 states and the District of Columbia for GAO's work on the third of its bimonthly reviews of the American Recovery and Reinvestment Act (Recovery Act). GAO's work focused on nine federal programs that are estimated to account for approximately 87 percent of federal Recovery Act outlays in fiscal year 2009 for programs administered by states and localities."
Date: September 23, 2009
Creator: United States. Government Accountability Office.
Object Type: Text
System: The UNT Digital Library
Navy Nuclear Aircraft Carrier (CVN) Homeporting at Mayport: Background and Issues for Congress (open access)

Navy Nuclear Aircraft Carrier (CVN) Homeporting at Mayport: Background and Issues for Congress

This report provides background information and issues for Congress on the Navy's proposal to homeport a nuclear-powered aircraft carrier (CVN) at Mayport, Florida. Transferring a CVN from Norfolk, Virginia, to Mayport would also shift the local economic activity associated with homeporting a CVN, which some sources estimate as being worth hundreds of millions of dollars per year.
Date: September 23, 2009
Creator: O'Rourke, Ronald
Object Type: Report
System: The UNT Digital Library
Coast Guard Polar Icebreaker Modernization: Background, Issues, and Options for Congress (open access)

Coast Guard Polar Icebreaker Modernization: Background, Issues, and Options for Congress

This report provides background information and issues for Congress on the modernization of the Coast Guard's polar icebreaker fleet, which performs a variety of missions supporting U.S. interests in polar regions.
Date: September 23, 2009
Creator: O'Rourke, Ronald
Object Type: Report
System: The UNT Digital Library
War Powers Resolution: Presidential Compliance (open access)

War Powers Resolution: Presidential Compliance

This report gives a summary of the usage of the War Powers Resolution (WPR) and various issues related to proposals to modify or repeal the resolution. The report summarizes most recent developments and background, and gives an overview of United Nations actions, and WPR activities in former Yugoslavia/Bosnia, Kosovo, Iraq (post-1991), Haiti, and Somalia. It also includes commentary on the instances formally reported under the WPR, consultation with Congress, and the current issues which Congress is considering.
Date: September 23, 2009
Creator: Grimmett, Richard F.
Object Type: Report
System: The UNT Digital Library
Long-Range Ballistic Missile Defense in Europe (open access)

Long-Range Ballistic Missile Defense in Europe

In early 2007, after several years of internal discussions and consultations with Poland and the Czech Republic, the Bush Administration formally proposed to defend against an Iranian missile threat by deploying a ground-based mid-course defense (GMD) element in Europe as part of the global U.S. BMDS (Ballistic Missile Defense System). The system would have included 10 interceptors in Poland, a radar in the Czech Republic, and another radar that would have been deployed in a country closer to Iran, to be completed by 2013 at a reported cost of at least $4 billion. This report is designed to retain background information and analysis of the Bush-proposed European BMD initiative up to the Obama Administration's decision to cancel it.
Date: September 23, 2009
Creator: Hildreth, Steven A. & Ek, Carl
Object Type: Report
System: The UNT Digital Library
Navy Ship Names: Background for Congress (open access)

Navy Ship Names: Background for Congress

This report discusses the process of naming Navy ships, which have traditionally been chosen and announced by the Secretary of the Navy. Congress in recent years has proposed, and sometimes passed, legislation regarding the naming of specific ships.
Date: September 23, 2009
Creator: O'Rourke, Ronald
Object Type: Report
System: The UNT Digital Library
DCAA Audits: Widespread Problems with Audit Quality Require Significant Reform (open access)

DCAA Audits: Widespread Problems with Audit Quality Require Significant Reform

Testimony issued by the Government Accountability Office with an abstract that begins "This testimony discusses our recent audit of the Defense Contract Audit Agency's (DCAA) overall management environment and quality assurance structure. DCAA is charged with a critical role in Department of Defense (DOD) contractor oversight by providing auditing, accounting, and financial advisory services in connection with the negotiation, administration, and settlement of contracts and subcontracts. DCAA's mission encompasses both audit and nonaudit services in support of DOD contracting and contract payment functions. DCAA audits of contractor internal controls in accounting, billing, estimating, and other key systems support decisions on pricing and contract awards. Internal control audits also impact the planning and reliability of other DCAA audits because DCAA uses the results of these audits to assess risk and plan the nature, extent, and timing of tests for other contractor audits and assignments. Last year, we reported the results of our investigation of allegations about certain DCAA audits at three locations in California, which substantiated claims that (1) audit documentation did not support the reported opinions; (2) DCAA supervisors dropped findings and changed audit opinions without adequate audit evidence for their changes; and (3) sufficient work was not performed to …
Date: September 23, 2009
Creator: United States. Government Accountability Office.
Object Type: Text
System: The UNT Digital Library
Federal Research and Development Funding: FY2010 (open access)

Federal Research and Development Funding: FY2010

This report summarizes the FY2010 budget request for research & development (R&D) funding, including comparisons to R&D funding requests in the FY2009 budget. This report breaks down in detail the various aspects of the President's FY2010 R&D funding request.
Date: September 23, 2009
Creator: Sargent, John F., Jr.
Object Type: Report
System: The UNT Digital Library
Coast Guard Deepwater Acquisition Programs: Background, Oversight Issues, and Options for Congress (open access)

Coast Guard Deepwater Acquisition Programs: Background, Oversight Issues, and Options for Congress

This report provides background information and oversight issues for Congress on the Coast Guard's Deepwater acquisition programs for replacing and modernizing the service's aging fleet of deepwater-capable ships and aircraft.
Date: September 23, 2009
Creator: O'Rourke, Ronald
Object Type: Report
System: The UNT Digital Library