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.
System: The UNT Digital Library
Social Security Reform: Greater Transparency Needed about Potential General Revenue Financing (open access)

Social Security Reform: Greater Transparency Needed about Potential General Revenue Financing

A letter report issued by the Government Accountability Office with an abstract that begins "Absent reform, Social Security's financing gap will grow until currently scheduled benefits can no longer be paid in full. Recent reform proposals often include general revenue (GR)--a major change that can have significant implications for the budget as a whole. This report addresses these issues: (1) What information is available about GR in recent proposal scorings by Social Security's Office of the Chief Actuary (OCACT)? (2) What common mechanisms, especially GR mechanisms, are used to increase program revenue? (3) What are the implications of GR for the trust fund and the federal budget? We have prepared this report under the Comptroller General's statutory authority to conduct evaluations on his own initiative as part of a continued effort to assist Congress in addressing the challenges facing Social Security."
Date: March 22, 2007
Creator: United States. Government Accountability Office.
System: The UNT Digital Library
Operation Iraqi Freedom: DOD Should Apply Lessons Learned Concerning the Need for Security over Conventional Munitions Storage Sites to Future Operations Planning (open access)

Operation Iraqi Freedom: DOD Should Apply Lessons Learned Concerning the Need for Security over Conventional Munitions Storage Sites to Future Operations Planning

A letter report issued by the Government Accountability Office with an abstract that begins "Following the invasion of Iraq in March 2003--known as Operation Iraqi Freedom (OIF)--concerns were raised about how the Department of Defense (DOD) secured Iraqi conventional munitions storage sites during and after major combat operations. Because of the broad interest in this issue, GAO conducted this work under the Comptroller General's authority to conduct evaluations. This report examines (1) the security provided by U.S. forces over Iraqi conventional munitions storage sites and (2) DOD actions to mitigate risks associated with an adversary's conventional munitions storage sites for future operations on the basis of OIF lessons learned. To address these objectives, GAO reviewed OIF war plans, joint doctrine and policy, and intelligence reports, and interviewed senior-level DOD officials."
Date: March 22, 2007
Creator: United States. Government Accountability Office.
System: The UNT Digital Library
Article 98 Agreements and Sanctions on U.S. Foreign Aid to Latin America (open access)

Article 98 Agreements and Sanctions on U.S. Foreign Aid to Latin America

This report is on Article 98 Agreements and Sanctions on U.S. Foreign Aid to Latin America.
Date: March 22, 2007
Creator: Ribando, Clare M.
System: The UNT Digital Library
Federal Employee Retirement Programs: Summary of Recent Trends (open access)

Federal Employee Retirement Programs: Summary of Recent Trends

This report describes recent trends in the number of civil service annuitants and the financial status of the Civil Service Retirement and Disability Fund.
Date: March 22, 2007
Creator: Purcell, Patrick
System: The UNT Digital Library
The Economics of Corporate Executive Pay (open access)

The Economics of Corporate Executive Pay

None
Date: March 22, 2007
Creator: Shorter, Gary & Labonte, Marc
System: The UNT Digital Library
IH-35 Expansion Options- Cost Estimates and Analysis (open access)

IH-35 Expansion Options- Cost Estimates and Analysis

Report on the costs estimates of expanding IH-35. The report is organized by geographic section of the highway and includes the estimated costs of each described project.
Date: March 22, 2007
Creator: TTC-35 Corridor Engineering Team
System: The Portal to Texas History