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Clean Coal Technology: Status of Projects and Sales of Demonstrated Technology (open access)

Clean Coal Technology: Status of Projects and Sales of Demonstrated Technology

Correspondence issued by the General Accounting Office with an abstract that begins "Pursuant to a congressional request, GAO reviewed the Department of Energy's (DOE) Clean Coal Technology Demonstration Program, focusing on the: (1) status of 13 Clean Coal Technology projects that preliminary information indicated could have over $1 million in unspent funds; and (2) extent to which DOE's participants in completed projects have sold demonstrated Clean Coal technologies to coal users."
Date: March 9, 2000
Creator: United States. General Accounting Office.
Object Type: Text
System: The UNT Digital Library
Defense Acquisitions: Assessments of Selected Major Weapon Programs (open access)

Defense Acquisitions: Assessments of Selected Major Weapon Programs

A letter report issued by the Government Accountability Office with an abstract that begins "The Department of Defense (DOD) is embarking on a number of efforts to enhance warfighting and the way the department conducts business. Major investments are being made to develop improved weapon systems to combat various threats to U.S. security. While the weapons that DOD ultimately develops have no rival in superiority, weapon systems acquisition remains a long-standing high-risk area. GAO's reviews over the past 30 years have found consistent problems with weapon acquisitions such as cost increases, schedule delays, and performance shortfalls. In addition, DOD faces several budgetary challenges that underscore the need to deliver its new major weapon programs within estimated costs and to obtain the most from those investments. DOD can help resolve these problems by using a more knowledge-based approach for developing new weapons. This report provides congressional and DOD decision makers with an independent, knowledge-based assessment of selected defense programs that identifies potential risks and needed actions when a program's projected attainment of knowledge diverges from the best practice. It can also highlight those programs that employ practices worthy of emulation by other programs. GAO plans to update and issue this report …
Date: March 31, 2005
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Maritime Security: Vessel Tracking Systems Provide Key Information, but the Need for Duplicate Data Should Be Reviewed (open access)

Maritime Security: Vessel Tracking Systems Provide Key Information, but the Need for Duplicate Data Should Be Reviewed

A letter report issued by the Government Accountability Office with an abstract that begins "U.S. ports, waterways, and coastal approaches are part of a system handling more than $700 billion in merchandise annually. With the many possible threats--including transportation and detonation of weapons of mass destruction, suicide attacks against vessels, and others--in the maritime domain, awareness of such threats could give the Coast Guard advance notice to help detect, deter, interdict, and defeat them and protect the U.S. homeland and economy. GAO was asked to review the Coast Guard's efforts to achieve awareness about activity in the maritime domain. This report addresses: the extent to which the Coast Guard (1) has vessel tracking systems in place, (2) can use these systems to track vessels that may be threats, and (3) has coordinated the development and implementation of these systems. To answer these questions, GAO analyzed relevant statutes, regulations, and plans for vessel tracking systems, compared the roles of the planned systems, and interviewed appropriate officials."
Date: March 17, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Army Stryker Brigades: Assessment of External Logistics Support Should Be Documented for the Congressionally Mandated Review of the Army's Operational Evaluation Plan (open access)

Army Stryker Brigades: Assessment of External Logistics Support Should Be Documented for the Congressionally Mandated Review of the Army's Operational Evaluation Plan

Correspondence issued by the General Accounting Office with an abstract that begins "We are reviewing the Army's plans for deploying and sustaining Stryker brigades. We plan to complete our review and report the results in June 2003. In the meantime, the Army will be conducting an operational evaluation of the first Stryker brigade from late April through May 2003 as required by law. The purpose of this letter is to bring attention to issues concerning the adequacy of the Army's proposed operational evaluation plan. The operational evaluation is intended to facilitate an understanding of the initial brigade's overall capabilities. The evaluation was first directed by the conference report accompanying the 2001 defense authorization act. Subsequently, Congress included the requirement in Section 113 of the National Defense Authorization Act for fiscal year 2002, which provides that (1) the Secretary of the Army is to evaluate the brigade's execution of combat missions across the full spectrum of potential threats and operational scenarios, (2) the Department of Defense's Director of Operational Test and Evaluation (DOT&E) must approve the Army's operational evaluation plan before the evaluation may be conducted, and (3) the Secretary of Defense is to certify to Congress that the results of …
Date: March 25, 2003
Creator: United States. General Accounting Office.
Object Type: Text
System: The UNT Digital Library
Financial Audit: American Battle Monuments Commission's Financial Statements for Fiscal Years 2006 and 2005 (open access)

Financial Audit: American Battle Monuments Commission's Financial Statements for Fiscal Years 2006 and 2005

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 …
Date: March 1, 2007
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Catalogue of Federal Insurance Activities (open access)

Catalogue of Federal Insurance Activities

Correspondence issued by the Government Accountability Office with an abstract that begins "The federal government assumes insurance risk for a wide range of activities that are funded through numerous federal budget accounts and administered by a variety of federal organizations. For some activities, such as those funded through the National Flood Insurance account, the federal government assumes the entire insurance risk. The federal government also assumes part of the risk for insurance activities that are administered by state and local governments--for example, those funded through the Unemployment Trust Fund or that are partly underwritten by private insurers, such as those funded through the Special Workers' Compensation Expenses account. These insurance risks, whether fully or partially assumed by the federal government, are in lines of insurance that private insurers also recognize: health, life, disability, and property/casualty insurance. The federal government has generally assumed insurance risks for at least two reasons. First, the government may step in when insurance is not widely available because private insurers cannot collectively absorb or affordably price the insurance risk. For example, when private insurers were unable to offer affordable terrorism insurance in the aftermath of September 11, 2001, the federal government created a terrorism insurance program. …
Date: March 4, 2005
Creator: United States. Government Accountability Office.
Object Type: Text
System: The UNT Digital Library
Unemployment Insurance: Factors Associated with Benefit Receipt (open access)

Unemployment Insurance: Factors Associated with Benefit Receipt

A letter report issued by the Government Accountability Office with an abstract that begins "Unemployment Insurance (UI), established in 1935, is a complex system of 53 state programs that in fiscal year 2004 provided $41.3 billion in temporary cash benefits to 8.8 million eligible workers who had become unemployed through no fault of their own. Given the size of the UI program, its importance in helping workers meet their needs when they are unemployed, and the little information available on what factors lead eligible workers to receive benefits over time, GAO was asked to determine (1) the extent to which an individual worker's characteristics, including past UI benefit receipt, are associated with the likelihood of UI benefit receipt or unemployment duration, and (2) whether an unemployed worker's industry is associated with the likelihood of UI benefit receipt and unemployment duration. Using data from a nationally representative sample of workers born between 1957 and 1964 and spanning the years 1979 through 2002, and information on state UI eligibility rules, GAO used multivariate statistical techniques to identify the key factors associated with UI benefit receipt and unemployment duration. In its comments, the Department of Labor stated that while there are certain qualifications …
Date: March 7, 2006
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
National Institute of Standards and Technology: Carryover Balances for the Advanced Technology Program (open access)

National Institute of Standards and Technology: Carryover Balances for the Advanced Technology Program

Correspondence issued by the General Accounting Office with an abstract that begins "Pursuant to a congressional request, GAO provided information on the carry over balances in the Department of Commerce's Advanced Technology Program (ATP), focusing on: (1) balances in the program for fiscal years 1995 through 1999; and (2) any balances that might exist at the end of fiscal year (FY) 2000 that could be used as offsets for the National Institute of Standards and Technology (NIST) programs in the FY 2001 budget."
Date: March 2, 2000
Creator: United States. General Accounting Office.
Object Type: Text
System: The UNT Digital Library
Export-Import Bank: Changes Would Improve the Reliability of Reporting on Small Business Financing (open access)

Export-Import Bank: Changes Would Improve the Reliability of Reporting on Small Business Financing

A letter report issued by the Government Accountability Office with an abstract that begins "The Export-Import Bank (Ex-Im) provides loans, loan guarantees, and insurance to support U.S. exports. Its level of support for small business has been a long-standing issue of congressional interest. Most recently in 2002, Congress increased the proportion of financing Ex-Im must make available for small business to 20 percent. GAO examined legal and policy issues related to Ex-Im's small business financing. Specifically, GAO (1) analyzes Ex-Im's methodology for calculating its direct support of small business and the reliability of Ex-Im's data used in the methodology and (2) describes Ex-Im's legal interpretation of its obligations under the statutory 20 percent small business mandate."
Date: March 3, 2006
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Payment Processing: Documentation Procedures For Electronic Billing and Payment Under the Families First Personal Property Program (open access)

Payment Processing: Documentation Procedures For Electronic Billing and Payment Under the Families First Personal Property Program

Correspondence issued by the Government Accountability Office with an abstract that begins "This letter responds to a Department of the Army request for our views on whether certain payment procedures included in the Defense Department's (DOD) proposed Families First Personal Property Program conform with relevant criteria in GAO's Policy and Procedures Manual for Guidance of Federal Agencies. Families First is a DOD initiative to reengineer its processes for transporting household goods and personal property for its service members and civilians. Army's request is in response to a Defense Finance and Accounting Service (DFAS) recommendation that DOD seek our views specifically on whether the proposed procedures for electronic billing and payment meet the supporting documentation requirements in Title VII of GAO's Policy and Procedures Manual for Guidance of Federal Agencies. While the General Services Administration (GSA) is responsible for issuing federal regulations for transportation, including moves of household goods and personal property as well as agency prepayment and postpayment audit requirements for transportation payments, we are responsible for issuing fiscal guidance based on authorities in the U.S. Code. We considered DOD's proposed process of electronic billing and payment in light of our requirements established in Title VII for disbursements and related …
Date: March 31, 2005
Creator: United States. Government Accountability Office.
Object Type: Text
System: The UNT Digital Library
Urban Partnership Agreements: Congestion Relief Initiative Holds Promise; Some Improvements Needed in Selection Process (open access)

Urban Partnership Agreements: Congestion Relief Initiative Holds Promise; Some Improvements Needed in Selection Process

A letter report issued by the Government Accountability Office with an abstract that begins "As part of a broad congestion relief initiative, the Department of Transportation awarded about $848 million from 10 grant programs to five cities (Miami, Minneapolis, New York, San Francisco, and Seattle) in 2007 as part of the Urban Partnership Agreements (UPA) initiative. The UPA initiative is intended to demonstrate the feasibility and benefits of comprehensive, integrated, and innovative approaches to relieving congestion, including the use of tolling (congestion pricing), transit, technology, and telecommuting (4Ts). Congestion pricing involves charging drivers a fee that varies with the density of traffic. This report addresses congressional interest in (1) how well the department communicated UPA selection criteria, (2) whether it had discretion to allocate grant funds to UPA recipients and consider congestion pricing as a priority selection factor, and (3) how it is ensuring that UPA award conditions are met and results are assessed. GAO reviewed departmental documents, statutes and case law, and interviewed department officials and UPA applicants."
Date: March 25, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Railroad Safety--Responses to Posthearing Questions (open access)

Railroad Safety--Responses to Posthearing Questions

Correspondence issued by the Government Accountability Office with an abstract that begins "This letter responds to a Congressional request that we provide responses to questions related to our recent testimony before Congress on reauthorizing federal rail safety programs. Our testimony discussed how the Federal Railroad Administration (FRA) (1) focuses its efforts on the highest priority risks related to train accidents in planning its oversight, (2) identifies safety problems on railroad systems in carrying out its oversight, and (3) assesses the impact of its oversight efforts on safety. This testimony was based on our recent report on these topics."
Date: March 15, 2007
Creator: United States. Government Accountability Office.
Object Type: Text
System: The UNT Digital Library
Defense Acquisitions: Changes in E-10A Acquisition Strategy Needed before Development Starts (open access)

Defense Acquisitions: Changes in E-10A Acquisition Strategy Needed before Development Starts

A letter report issued by the Government Accountability Office with an abstract that begins "The Air Force is on the verge of making a major commitment to the multi-billion dollar E-10A Multi-sensor Command and Control Aircraft program. Due to the substantial investment needed and technological challenges in developing the aircraft, the Subcommittee on Tactical Air and Land Forces asked GAO to examine the soundness of the E-10A business case as well as the risks associated with the current acquisition strategy."
Date: March 15, 2005
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Activities of the Amtrak Inspector General (open access)

Activities of the Amtrak Inspector General

Correspondence issued by the Government Accountability Office with an abstract that begins "In a prior report we suggested that the consolidation of certain offices of inspectors general (IG) could strengthen the independence, efficiency, and effectiveness of the IGs in the federal government. Based on the potential for benefits and the similarities in their basic missions, we identified the Amtrak Office of Inspector General and the Department of Transportation (DOT) Office of Inspector General as among those Congress might consider for consolidation. We reported that by consolidating the office of the Amtrak IG with the larger DOT IG office, the resulting office would have a larger budget and more staff with which to achieve its mission. Potential benefits include an increased ability to improve the allocation of human and financial resources and to attract and retain an adequate and skilled workforce. We concluded that consolidation of smaller IG offices, if implemented properly with specific plans to mitigate potential weaknesses, is a means of achieving economies of scale and greater independence and of providing critical mass and range of skills, particularly given the ever increasing need for technical staff with specialized skills. This report responds to a Congressional request that, building on …
Date: March 4, 2005
Creator: United States. Government Accountability Office.
Object Type: Text
System: The UNT Digital Library
U.S. Commission on Civil Rights: Deficiencies Found in Financial Management and Internal Controls (open access)

U.S. Commission on Civil Rights: Deficiencies Found in Financial Management and Internal Controls

Correspondence issued by the Government Accountability Office with an abstract that begins "The United States Commission on Civil Rights (Commission) was first established in 1957 as the Commission on Civil Rights. The Commission's life was extended in 1983 and reestablished again in 1994 with its current name. The Commission's purpose is to collect and study information on discrimination or denials of equal protection of the laws because of race, color, religion, sex, age, disability, or national origin, or in the administration of justice in such areas as voting rights, enforcement of federal civil rights laws, and equal opportunity in education, employment, and housing. The Commission has been subject to long-standing congressional concerns over the adequacy of its management practices and procedures, concerns that were reinforced by several GAO reports. In July 1997, we issued a report in which we found broad management problems at the Commission, including limited awareness of how its resources were used. In more recent studies, we found that the Commission lacked good project management and transparency in its contracting procedures and needed improved strategic planning. As a result of these reports and other concerns, we conducted additional work at the Commission. Specifically, Congress asked us to …
Date: March 7, 2005
Creator: United States. Government Accountability Office.
Object Type: Text
System: The UNT Digital Library
Department of Energy: Further Actions Are Needed to Strengthen Contract Management for Major Projects (open access)

Department of Energy: Further Actions Are Needed to Strengthen Contract Management for Major Projects

A letter report issued by the Government Accountability Office with an abstract that begins "The Department of Energy (DOE) pays its contractors billions of dollars each year to implement its major projects--those costing more than $400 million each. Many major projects have experienced substantial cost and schedule overruns, largely because of contract management problems. GAO was asked to assess, for major departmental projects, (1) DOE's use of performance incentives to effectively control costs and maintain schedules, (2) the reliability of the data DOE uses to monitor and assess contractor performance, and (3) the reliability of the Project Assessment and Reporting System (PARS) data that senior managers use for project oversight."
Date: March 18, 2005
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
High Speed Passenger Rail: Future Development Will Depend on Addressing Financial and Other Challenges and Establishing a Clear Federal Role (open access)

High Speed Passenger Rail: Future Development Will Depend on Addressing Financial and Other Challenges and Establishing a Clear Federal Role

A letter report issued by the Government Accountability Office with an abstract that begins "Federal and other decision makers have had a renewed interest in how high speed rail might fit into the national transportation system and address increasing mobility constraints on highways and at airports due to congestion. GAO was asked to review (1) the factors affecting the economic viability--meaning whether total social benefits offset or justify total social costs--of high speed rail projects, including difficulties in determining the economic viability of proposed projects; (2) the challenges in developing and financing high speed rail systems; and (3) the federal role in the potential development of U.S. high speed rail systems. GAO reviewed federal legislation; interviewed federal, state, local, and private sector officials, as well as U.S. project sponsors; and reviewed high speed rail development in France, Japan, and Spain."
Date: March 19, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Port Risk Management: Additional Federal Guidance Would Aid Ports in Disaster Planning and Recovery (open access)

Port Risk Management: Additional Federal Guidance Would Aid Ports in Disaster Planning and Recovery

A letter report issued by the Government Accountability Office with an abstract that begins "U.S ports are significant to the U.S. economy, handling more than 2 billion tons of domestic and import/export cargo annually. Since Sept. 11, 2001, much of the national focus on ports' preparedness has been on preventing potential acts of terror, the 2005 hurricane season renewed focus on how to protect ports from a diversity of threats, including natural disasters. This report was prepared under the authority of the Comptroller General to examine (1) challenges port authorities have experienced as a result of recent natural disasters, (2) efforts under way to address these challenges, and (3) the manner in which port authorities plan for natural disasters. GAO reviewed documents and interviewed various port stakeholders from 17 major U.S. ports."
Date: March 28, 2007
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Defense Acquisitions: Production and Fielding of Missile Defense Components Continue with Less Testing and Validation Than Planned (open access)

Defense Acquisitions: Production and Fielding of Missile Defense Components Continue with Less Testing and Validation Than Planned

A letter report issued by the Government Accountability Office with an abstract that begins "The Missile Defense Agency (MDA) has spent about $56 billion and will spend about $50 billion more through 2013 to develop a Ballistic Missile Defense System (BMDS). GAO was directed to assess the annual progress MDA made in developing the BMDS as well as improvements in accountability and transparency in agency operations, management processes, and the new block strategy. To accomplish this, GAO reviewed contractor cost, schedule, and performance; tests completed; and the assets fielded during 2008. GAO also reviewed pertinent sections of the U.S. Code, acquisition policy, and the activities of the new Missile Defense Executive Board (MDEB). An appendix on the effect the cancellation of a Ground-based Midcourse Defense flight test had on BMDS development is also included."
Date: March 13, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Coast Guard: Replacement of HH-65 Helicopter Engine (open access)

Coast Guard: Replacement of HH-65 Helicopter Engine

A letter report issued by the General Accounting Office with an abstract that begins "Over the last several years, the Coast Guard has experienced what it considers to be serious reliability and safety problems with its workhorse HH-65 helicopter used for key missions, such as search and rescue, migrant and drug interdiction, and homeland security. Annually, the HH-65 contributes to saving 375 lives and assists on 2,065 drug interdiction cases, according to the Coast Guard. An increasing trend in the number and seriousness of safety-related HH-65 incidents in recent months, highlighted by some the Coast Guard deemed to be serious life-threatening incidents, prompted a Coast Guard decision in January 2004 to replace the existing engine and the associated engine control system in this helicopter with a different engine, which it believes will improve safety and reliability and substantially reduce incidents. In light of the Coast Guard's decision to replace the existing engine, and as part of our already ongoing work on the safety and reliability of the HH-65 helicopter, we determined (1) whether the Coast Guard's decision to replace the existing HH-65 helicopter engine was fact- and risk-based; (2) the management and efficiency implications, if any, of the Coast Guard's …
Date: March 24, 2004
Creator: United States. General Accounting Office.
Object Type: Report
System: The UNT Digital Library
Defined Benefit Plans: Proposed Plan Buyouts by Financial Firms Pose Potential Risks and Benefits (open access)

Defined Benefit Plans: Proposed Plan Buyouts by Financial Firms Pose Potential Risks and Benefits

A letter report issued by the Government Accountability Office with an abstract that begins "Some U.S. financial and pension consulting firms have recently proposed alternatives to terminating a defined benefit (DB) pension plan and contracting with insurance companies to pay promised benefits. In their proposals, a plan sponsor would typically transfer the assets and liabilities of a hard-frozen DB plan--one in which all participant benefit accruals have ceased--along with additional money, to a financial entity, which would become the new sponsor. Such buyouts would have implications for participants, plan sponsors, and the Pension Benefit Guaranty Corporation (PBGC), the federal agency that insures private DB plans. This report addresses the following questions: (1) What is the basic model of proposed sales of frozen DB plans to third-party financial firms and how does it compare with a standard plan termination? (2) What are the potential risks and benefits of plan buyouts for participants, PBGC, plan sponsors, and other stakeholders? To address these questions, GAO reviewed proposed models for plan buyouts and analyzed regulatory and statutory issues associated with terminations and buyouts. GAO also interviewed labor and pension advocacy groups, pension regulatory agencies, and pension experts."
Date: March 16, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Securing Wastewater Facilities: Costs of Vulnerability Assessments, Risk Management Plans, and Alternative Disinfection Methods Vary Widely (open access)

Securing Wastewater Facilities: Costs of Vulnerability Assessments, Risk Management Plans, and Alternative Disinfection Methods Vary Widely

A letter report issued by the Government Accountability Office with an abstract that begins "In 2006, GAO reported that many large wastewater facilities have responded to this risk by voluntarily conducting vulnerability assessments and converting from chlorine gas to other disinfection methods. The Clean Air Act requires all wastewater facilities that use threshold quantities of chlorine gas to prepare and implement risk management plans to prevent accidental releases and reduce the severity of any releases. In this study, GAO was asked to provide information on (1) the range of costs large wastewater treatment facilities incurred in preparing vulnerability assessments and risk management plans, and (2) the costs large wastewater treatment facilities incurred in converting from chlorine gas to alternative disinfection processes. To answer these questions, GAO conducted structured telephone interviews with a number of facilities surveyed for the 2006 report. The Environmental Protection Agency (EPA) agreed with the report and provided several technical changes and clarifications."
Date: March 30, 2007
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Information Technology: Observations on Department of Defense's Draft Enterprise Architecture (open access)

Information Technology: Observations on Department of Defense's Draft Enterprise Architecture

Correspondence issued by the General Accounting Office with an abstract that begins "The fiscal year 2003 Defense Authorization Act requires the Department of Defense (DOD) to develop by May 1, 2003, a financial management enterprise architecture, including a transition plan, that meets certain requirements. The act also requires that GAO submit to congressional defense committees an assessment of the architecture and transition plan within 60 days of their approval. As part of our ongoing work to satisfy this legislative requirement and at the request of Senate Subcommittee on Readiness and Management Support, Committee on Armed Services, staff, we briefed the Subcommittee on Readiness and Management Support, Senate Committee on Armed forces on March 4, 2003, on our preliminary assessment of the DOD draft architecture products dated February 7, 2003. As further requested by the staff, this letter transmits the observations we made during the briefing."
Date: March 28, 2003
Creator: United States. General Accounting Office.
Object Type: Text
System: The UNT Digital Library
Pediatric Drug Research: Studies Conducted under Best Pharmaceuticals for Children Act (open access)

Pediatric Drug Research: Studies Conducted under Best Pharmaceuticals for Children Act

A letter report issued by the Government Accountability Office with an abstract that begins "About two-thirds of drugs that are prescribed for children have not been studied and labeled for pediatric use, which places children at risk of being exposed to ineffective treatment or incorrect dosing. The Best Pharmaceuticals for Children Act (BPCA), enacted in 2002, encourages the manufacturers, or sponsors, of drugs that still have marketing exclusivity--that is, are on-patent--to conduct pediatric drug studies, as requested by the Food and Drug Administration (FDA). If they do so, FDA may extend for 6 months the period during which no equivalent generic drugs can be marketed. This is referred to as pediatric exclusivity. BPCA required that GAO assess the effect of BPCA on pediatric drug studies and labeling. As discussed with the committees of jurisdiction, GAO (1) assessed the extent to which pediatric drug studies were being conducted under BPCA for on-patent drugs, including when drug sponsors declined to conduct the studies; (2) evaluated the impact of BPCA on labeling drugs for pediatric use and the process by which the labeling was changed; and (3) illustrated the range of diseases treated by the drugs studied under BPCA. GAO examined data about …
Date: March 22, 2007
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library