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
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.
Object Type: Report
System: The UNT Digital Library
Federal Aviation Administration: Key Issues in Ensuring the Efficient Development and Safe Operation of the Next Generation Air Transportation System (open access)

Federal Aviation Administration: Key Issues in Ensuring the Efficient Development and Safe Operation of the Next Generation Air Transportation System

Testimony issued by the Government Accountability Office with an abstract that begins "The Federal Aviation Administration (FAA) operates one of the safest air transportation systems in the world. It is, however, a system under strain. The skies are becoming more crowded every day, with an estimated 1 billion passengers per year expected by 2015. The current aviation system cannot be expanded to meet this growth. The reauthorization of FAA is an opportunity to examine how the agency is managing the operation and safety of the air transportation system as it leads the transition to the Next Generation Air Transportation System (NextGen)--a major redesign of the current system. GAO's testimony focuses on key issues related to FAA's reauthorization, including (1) FAA's progress in implementing initiatives that could provide a solid foundation for NextGen, (2) issues that need to be addressed to help ensure a successful transition to NextGen, and (3) safety areas that are important for the continued safe operation of the current and future system. This statement is based on recent GAO reports and ongoing work on some management and safety initiatives."
Date: March 22, 2007
Creator: United States. Government Accountability Office.
Object Type: Text
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.
Object Type: Report
System: The UNT Digital Library
Next Generation Air Transportation System: Progress and Challenges in Planning and Implementing the Transformation of the National Airspace System (open access)

Next Generation Air Transportation System: Progress and Challenges in Planning and Implementing the Transformation of the National Airspace System

Testimony issued by the Government Accountability Office with an abstract that begins "The skies over America are becoming more crowded every day. The consensus of opinion is that the current aviation system cannot be expanded to meet this projected growth. Recognizing the need for system transformation, in 2003 Congress authorized the Joint Planning and Development Office (JPDO) and requires the office to operate in conjunction with multiple federal agencies, including the Departments of Transportation, Commerce, Defense, and Homeland Security; the Federal Aviation Administration (FAA); the National Aeronautics and Space Administration (NASA); and the White House Office of Science and Technology Policy. JPDO is responsible for coordinating the related efforts of these partner agencies to plan the transformation to the Next Generation Air Transportation System (NextGen): a fundamental redesign of the national airspace system. FAA will be largely responsible for implementing the policies and systems necessary for NextGen, while safely operating the current air traffic control system. GAO's testimony focuses on (1) the progress that JPDO has made in planning NextGen and some challenges it continues to face and (2) the challenges that FAA faces transitioning to NextGen. GAO's statement is based on our recent reports as well as ongoing work, …
Date: March 22, 2007
Creator: United States. Government Accountability Office.
Object Type: Text
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

Testimony issued by the Government Accountability Office with an abstract that begins "GAO is releasing a report today on lessons learned concerning the need for security over conventional munitions storage sites which provides the basis for this testimony. 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. This testimony addresses (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, intelligence reports, and interviewed senior-level DOD officials."
Date: March 22, 2007
Creator: United States. Government Accountability Office.
Object Type: Text
System: The UNT Digital Library
Defense Acquisitions: Analysis of Costs for the Joint Strike Fighter Engine Program (open access)

Defense Acquisitions: Analysis of Costs for the Joint Strike Fighter Engine Program

Testimony issued by the Government Accountability Office with an abstract that begins "The Joint Strike Fighter (JSF) is the linchpin of future Department of Defense (DOD) tactical aircraft modernization efforts because of the sheer size of the program and its envisioned role as the replacement for hundreds of aircraft that perform a wide variety of missions in the Air Force, Navy, and Marine Corps. DOD implemented the JSF alternate engine development program in 1996 to provide competition between two engine manufacturers in an effort to achieve cost savings, improve performance, and gain other benefits. This testimony focuses on GAO's cost analysis performed in response to Section 211 of the John Warner National Defense Authorization Act for Fiscal Year 2007. We examined the following areas: (1) sole-source and competitive scenarios for development, production, and sustainment of the JSF engine, (2) results of past engine programs and their related strategies, and (3) impact on the industrial base in the event of the complete cancellation of the JSF alternate engine program. DOD did not provide comments on our findings."
Date: March 22, 2007
Creator: United States. Government Accountability Office.
Object Type: Text
System: The UNT Digital Library
Stabilizing Iraq: Preliminary Observations on Budget and Management Challenges of Iraq's Security Ministries (open access)

Stabilizing Iraq: Preliminary Observations on Budget and Management Challenges of Iraq's Security Ministries

Testimony issued by the Government Accountability Office with an abstract that begins "In November 2005, the President issued the National Strategy for Victory in Iraq. According to the strategy, victory will be achieved when Iraq is peaceful, united, stable, secure, well integrated into the international community, and a full partner in the global war on terror. To help Iraq achieve this, the U.S. is, among other efforts, helping strengthen the capabilities of the Iraq Ministries of Defense and Interior (police forces) so they can assume greater responsibility for the country's security. The United States has provided about $15.4 billion to develop Iraqi security forces and institutions. In this testimony, GAO discusses preliminary observations on (1) U.S. and Iraqi funding to develop and sustain the Iraqi security forces, and (2) key challenges the United States and Iraq face in improving the security ministries' operations and management. This statement is based on prior GAO reports, recent fieldwork in Iraq and Department of Defense, U.S. Treasury and Embassy budget documents. GAO added information to this statement in response to comments from Multinational Security Transition Command-Iraq. We completed the work in accordance with generally accepted government auditing standards."
Date: March 22, 2007
Creator: United States. Government Accountability Office.
Object Type: Text
System: The UNT Digital Library
FINAL ANALYTICAL RESULTS FROM THE EXAMINATION OF CORROSION ON SECTIONS OF CORROSION PROBE REMOVED FROM TANK 241-AN-107 ON 08/10/2006 (open access)

FINAL ANALYTICAL RESULTS FROM THE EXAMINATION OF CORROSION ON SECTIONS OF CORROSION PROBE REMOVED FROM TANK 241-AN-107 ON 08/10/2006

Tank Farms Operations removed an electrochemical noise probe from Tank 241-AN-107. In the field, the probe was cut into four sections, wrapped, and placed in a 55-gallon drum, This drum was delivered to the 222-S Laboratory. The 222 S Laboratory unpackaged the sections of the AN-107 electrochemical noise probe and examined the material for evidence of corrosion. Each of the four sections contained three C-ring and three bullet specimens. The specimens were examined for pitting corrosion, crevice corrosion, and stress corrosion cracking. No evidence of stress corrosion cracking was found in the stressed C-ring specimens. Minor pitting was evident on some surfaces. Crevice corrosion was the dominant type of corrosion observed.
Date: March 22, 2007
Creator: JB, DUNCAN & GA, COOKE
Object Type: Report
System: The UNT Digital Library
Development of a Cell-Based Fluorescence Resonance Energy Transfer Reporter for Bacillus anthracis Lethal Factor Protease (open access)

Development of a Cell-Based Fluorescence Resonance Energy Transfer Reporter for Bacillus anthracis Lethal Factor Protease

We report the construction of a cell-based fluorescent reporter for anthrax lethal factor (LF) protease activity using the principle of fluorescence resonance energy transfer (FRET). This was accomplished by engineering an Escherichia coli cell line to express a genetically encoded FRET reporter and LF protease. Both proteins were encoded in two different expression plasmids under the control of different tightly controlled inducible promoters. The FRET-based reporter was designed to contain a LF recognition sequence flanked by the FRET pair formed by CyPet and YPet fluorescent proteins. The length of the linker between both fluorescent proteins was optimized using a flexible peptide linker containing several Gly-Gly-Ser repeats. Our results indicate that this FRET-based LF reporter was readily expressed in E. coli cells showing high levels of FRET in vivo in the absence of LF. The FRET signal, however, decreased 5 times after inducing LF expression in the same cell. These results suggest that this cell-based LF FRET reporter may be used to screen genetically encoded libraries in vivo against LF.
Date: March 22, 2007
Creator: Kimura, R H; Steenblock, E R & Camarero, J A
Object Type: Article
System: The UNT Digital Library
Proposal for Extending the UPC Memory Copy Library Functions andSupporting Extensions to GASNet, Version 2.0 (open access)

Proposal for Extending the UPC Memory Copy Library Functions andSupporting Extensions to GASNet, Version 2.0

This document outlines a proposal for extending UPC'spoint-to-point memcpy library with support for explicitly non-blockingtransfers, and non-contiguous (indexed and strided) transfers. Variousportions of this proposal could stand alone as independent extensions tothe UPC library. The designs presented here are heavily influenced byanalogous functionality which exists in other parallel communicationsystems, such as MPI, ARMCI, Titanium, and network hardware API's such asQuadrics elan, Infiniband vapi, IBM LAPI and Cray X-1. Each sectioncontains proposed extensions to the libraries in the UPC LanguageSpecification (section 7) and corresponding extensions to the GASNetcommunication system API.
Date: March 22, 2007
Creator: Bonachea, Dan
Object Type: Report
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.
Object Type: Report
System: The UNT Digital Library
Medicaid Citizenship Documentation (open access)

Medicaid Citizenship Documentation

None
Date: March 22, 2007
Creator: unknown
Object Type: Report
System: The UNT Digital Library
Should Credit Unions Be Taxed? (open access)

Should Credit Unions Be Taxed?

None
Date: March 22, 2007
Creator: unknown
Object Type: Report
System: The UNT Digital Library
K Basins Groundwater Monitoring Task, K Basins Closure Project: Report for October, November, and December 2006 (open access)

K Basins Groundwater Monitoring Task, K Basins Closure Project: Report for October, November, and December 2006

This report provides information on groundwater monitoring at the K Basins during October, November, and December 2006. Conditions remained very similar to those reported in the previous quarterly report, with no evidence in monitoring results to suggest groundwater impact from current loss of basin water to the ground. The K Basins monitoring network will be modified in the coming months as a consequence of new wells having been installed near KW Basin as part of a pump-and-treat system for chromium contamination, and new wells installed between the KE Basin and the river to augment long-term monitoring in that area.
Date: March 22, 2007
Creator: Peterson, Robert E.
Object Type: Report
System: The UNT Digital Library
FULL-SCALE TREATMENT WETLANDS FOR METAL REMOVAL FROM INDUSTRIAL WASTEWATER (open access)

FULL-SCALE TREATMENT WETLANDS FOR METAL REMOVAL FROM INDUSTRIAL WASTEWATER

The A-01 NPDES outfall at the Savannah River Site receives process wastewater discharges and stormwater runoff from the Savannah River National Laboratory. Routine monitoring indicated that copper concentrations were regularly higher than discharge permit limit, and water routinely failed toxicity tests. These conditions necessitated treatment of nearly one million gallons of water per day plus storm runoff. Washington Savannah River Company personnel explored options to bring process and runoff waters into compliance with the permit conditions, including source reduction, engineering solutions, and biological solutions. A conceptual design for a constructed wetland treatment system (WTS) was developed and the full-scale system was constructed and began operation in 2000. The overall objective of our research is to better understand the mechanisms of operation of the A-01 WTS in order to provide better input to design of future systems. The system is a vegetated surface flow wetland with a hydraulic retention time of approximately 48 hours. Copper, mercury, and lead removal efficiencies are very high, all in excess of 80% removal from water passing through the wetland system. Zinc removal is 60%, and nickel is generally unaffected. Dissolved organic carbon in the water column is increased by the system and reduces toxicity of …
Date: March 22, 2007
Creator: Nelson, E & John Gladden, J
Object Type: Article
System: The UNT Digital Library
Drug Safety: FDA Needs to Further Address Shortcomings in Its Postmarket Decision-making Process (open access)

Drug Safety: FDA Needs to Further Address Shortcomings in Its Postmarket Decision-making Process

Testimony issued by the Government Accountability Office with an abstract that begins "GAO was asked to testify on the effectiveness of the Food and Drug Administration's (FDA) postmarket decision-making process. This testimony is based on Drug Safety: Improvement Needed in FDA's Postmarket Decision-making and Oversight Process, GAO-06-402 (March 31, 2006). The report focused on the complex interaction between two offices within FDA that are involved in postmarket drug safety activities: the Office of New Drugs (OND), and the Office of Drug Safety (ODS). OND's primary responsibility is to review new drug applications, but it is also involved in monitoring the safety of marketed drugs. ODS is focused primarily on postmarket drug safety issues. ODS is now called the Office of Surveillance and Epidemiology. For its report, GAO reviewed FDA policies, interviewed FDA staff, and conducted case studies of four drugs with safety issues: Arava, Baycol, Bextra, and Propulsid. To gather information on FDA's initiatives since March 2006 to improve its decision-making process for this testimony, GAO interviewed FDA officials and reviewed FDA documents in February and March 2007."
Date: March 22, 2007
Creator: United States. Government Accountability Office.
Object Type: Text
System: The UNT Digital Library
Dose, exposure time, and resolution in Serial X-ray Crystallography (open access)

Dose, exposure time, and resolution in Serial X-ray Crystallography

Using detailed simulation and analytical models, the exposure time is estimated for serial crystallography, where hydrated laser-aligned proteins are sprayed across a continuous synchrotron beam. The resolution of X-ray diffraction microscopy is limited by the maximum dose that can be delivered prior to sample damage. In the proposed Serial Crystallography method, the damage problem is addressed by distributing the total dose over many identical hydrated macromolecules running continuously in a single-file train across a continuous X-ray beam, and resolution is then limited only by the available fluxes of molecules and X-rays. Orientation of the diffracting molecules is achieved by laser alignment. We evaluate the incident X-ray fluence (energy/area) required to obtain a given resolution from (1) an analytical model, giving the count rate at the maximum scattering angle for a model protein, (2) explicit simulation of diffraction patterns for a GroEL-GroES protein complex, and (3) the frequency cut off of the transfer function following iterative solution of the phase problem, and reconstruction of a density map in the projection approximation. These calculations include counting shot noise and multiple starts of the phasing algorithm. The results indicate the number of proteins needed within the beam at any instant for a given …
Date: March 22, 2007
Creator: Starodub, D.; Rez, P.; Hembree, G.; Howells, M.; Shapiro, D.; Chapman, H. N. et al.
Object Type: Article
System: The UNT Digital Library
Tri-Laboratory Linux Capacity Cluster 2007 SOW (open access)

Tri-Laboratory Linux Capacity Cluster 2007 SOW

The Advanced Simulation and Computing (ASC) Program (formerly know as Accelerated Strategic Computing Initiative, ASCI) has led the world in capability computing for the last ten years. Capability computing is defined as a world-class platform (in the Top10 of the Top500.org list) with scientific simulations running at scale on the platform. Example systems are ASCI Red, Blue-Pacific, Blue-Mountain, White, Q, RedStorm, and Purple. ASC applications have scaled to multiple thousands of CPUs and accomplished a long list of mission milestones on these ASC capability platforms. However, the computing demands of the ASC and Stockpile Stewardship programs also include a vast number of smaller scale runs for day-to-day simulations. Indeed, every 'hero' capability run requires many hundreds to thousands of much smaller runs in preparation and post processing activities. In addition, there are many aspects of the Stockpile Stewardship Program (SSP) that can be directly accomplished with these so-called 'capacity' calculations. The need for capacity is now so great within the program that it is increasingly difficult to allocate the computer resources required by the larger capability runs. To rectify the current 'capacity' computing resource shortfall, the ASC program has allocated a large portion of the overall ASC platforms budget to …
Date: March 22, 2007
Creator: Seager, M
Object Type: Report
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
Object Type: Report
System: The UNT Digital Library
Post-Katrina Insurance Issues Surrounding Water Damage Exclusions in Homeowners’ Insurance Policies (open access)

Post-Katrina Insurance Issues Surrounding Water Damage Exclusions in Homeowners’ Insurance Policies

None
Date: March 22, 2007
Creator: unknown
Object Type: Report
System: The UNT Digital Library
Low Income Home Energy Assistance Program (LIHEAP): Estimated Allocations (open access)

Low Income Home Energy Assistance Program (LIHEAP): Estimated Allocations

None
Date: March 22, 2007
Creator: unknown
Object Type: Report
System: The UNT Digital Library
Farm Bill Proposals and Legislative Action in the 110th Congress (open access)

Farm Bill Proposals and Legislative Action in the 110th Congress

Many provisions of the current omnibus farm bill, the Farm Security and Rural Investment Act of 2002, expire in 2007. Without new legislation, notably in the area of farm commodity and income support programs, permanent statutes will take effect. Most of these statutes were enacted decades ago and are no longer compatible with current national economic objectives, global trading rules, and federal budgetary of regulatory policies. This report follows major legislation relating to existing farm bill statues introduced in the House and Senate in the 110th Congress.
Date: March 22, 2007
Creator: Johnson, Renée
Object Type: Report
System: The UNT Digital Library
Presidential Succession: An Overview with Analysis of Legislation Proposed in the 109th Congress (open access)

Presidential Succession: An Overview with Analysis of Legislation Proposed in the 109th Congress

None
Date: March 22, 2007
Creator: unknown
Object Type: Report
System: The UNT Digital Library