A letter report issued by the General Accounting Office with an abstract that begins "Ten years ago, Congress passed the Prescription Drug User Fee Act to speed up the review process used to ensure that new drugs and biological products are safe and effective. GAO found that the act has provided the Food and Drug Administration (FDA) with the funding needed to hire more drug reviewers, which has led to faster availability of new drugs to the United States. Approval times have shortened both for priority drugs--those that FDA expects to offer significant therapeutic benefits beyond drugs already on the market--and standard drugs, which are not thought to have significant therapeutic benefits beyond available drugs. Although the act has increased the funds available for FDA's drug and biological reviews, funds for other activities, such as the regulation of foods and medical devices, have shrunk as a share of FDA's overall budget. The 1997 amendments to the act, which shortened review schedules and set new performance goals to reduce overall drug development time, have increased reviewer workload at FDA. GAO found that some drug reviewers may have forgone training and professional development opportunities to ensure that the new goals were met. …

A letter report issued by the General Accounting Office with an abstract that begins "Since September 1996, the Federal Aviation Administration (FAA) has been developing the Standard Terminal Automation Replacement System (STARS) project to replace the outdated computer equipment that air traffic controllers currently use in some facilities to control air traffic within 5 to 50 nautical miles of an airport. Comparing the currently projected cost and deployment schedule for STARS with the original cost and schedule is difficult because the program presently bears little resemblance to the program envisioned in 1996. FAA has officially changed the cost, schedule, and requirements for STARS twice. In October 1999, FAA estimated the cost for its new approach at $1.4 billion, with a schedule to begin deploying STARS in 2002 at 188 facilities and complete installation at all facilities by 2008. The second change occurred in March 2002, when FAA lowered its estimate from $1.4 billion to $1.33 billion, reduced the number of facilities receiving STARS from 188 to 74, and changed the date to complete installation at all facilities from 2008 to 2005. FAA responded to the Department of Transportation Inspector General's concerns about the agency's plans for deploying STARS in Philadelphia …

Testimony issued by the General Accounting Office with an abstract that begins "Vaccine shortages began to appear in November 2000, when supplies of the tetanus and diptheria booster fell short. By October 2001, the Centers for Disease Control and Prevention (CDC) reported shortages of five vaccines that protect against eight childhood diseases. In addition to diptheria and tetanus vaccines, vaccines to protect against pertussis, invasive pneumococcal disease, measles, mumps, rubella, and varicella were in short supply. In July 2002, updated CDC data indicated supplies were returning to normal for most vaccines. However, the shortage of vaccine to protect against invasive pneumococcal disease was expected to continue through at least late 2002. Shortages have prompted federal authorities to recommend deferring some vaccinations and have caused most states to reduce or suspend immunization requirements for school and day care programs so that children who have not received all mandatory immunizations can enroll. States are concerned that failure to be vaccinated at a later date may reduce the share of the population protected and increase the potential for disease to spread; however, data are not currently available to measure these effects. Many factors, including production problems and unanticipated demand for new vaccines, contributed …

A letter report issued by the General Accounting Office with an abstract that begins "GAO reviewed efforts by the Interagency Security Committee (ISC) to protect critical federal infrastructure since the committee was created in 1995. ISC is chaired by the General Services Administration (GSA) and comprises 14 department-level agencies and other executive agencies and officials. ISC's primary responsibilities are to (1) establish policies for security in and protection of federal facilities; (2) develop and evaluate security standards for federal facilities, develop a strategy for ensuring compliance with such standards, and oversee the implementation of appropriate security measures in federal facilities; and (3) take the steps necessary to enhance the quality and effectiveness of security and protection of federal facilities. ISC has carried out some of its responsibilities, but it has made little progress on others. During the past 7 years, ISC has developed and issued security design criteria and minimum standards for building access procedures; disseminated information to member agencies, for their consideration and implementation, on entry security technology for buildings needing the highest security levels; and through its meetings and 13 working groups, provided a forum for federal agencies to discuss security issues and share information and ideas. ISC …

Testimony issued by the General Accounting Office with an abstract that begins "This testimony discusses the results of GAO's review of the Department of Housing and Urban Development's (HUD) technical assistance and capacity-building programs. Technical assistance programs can be defined as training designed to improve the performance or management of program recipients, such as teaching one-on-one procurement regulations to housing authority staff. Capacity building can be generally defined as funding to strengthen the capacity or capability of program recipients or providers--typically housing or community development organizations--thereby building the institutional knowledge within those organizations. The overall goal of both technical assistance and capacity building is to enhance the delivery of HUD's housing and community development programs. HUD administers 21 technical assistance programs through five program offices. From fiscal year 1998 through fiscal year 2002, the annual funding for HUD technical assistance ranged between $128 million and $201 million, accounting for less than 1 percent of HUD's overall budget each year. Although the general purpose of HUD's technical assistance is to help program participants carry out HUD program goals, each program office designs technical assistance specifically related to its programs. Recipients could be states and units of local government, public or Indian …

Testimony issued by the General Accounting Office with an abstract that begins "Federal recognition of an Indian tribe can dramatically affect economic and social conditions for the tribe and the surrounding communities because these tribes are eligible to participate in federal assistance programs. There are currently 562 recognized tribes with a total membership of 1.7 million, and several hundred groups are currently seeking recognition. In fiscal year 2002, Congress appropriated $5 billion for programs and funding, almost exclusively for recognized tribes. Recognition also establishes a formal government-to-government relationship between the United States and a tribe. The Indian Gaming Regulatory Act of 1988, which regulated Indian gaming operations, permits a tribe to operate casinos on land in trust if the state in which it lies allows casino-like gaming and if the tribe has entered into a compact with the state regulating its gaming businesses. In 1999, federally recognized tribes reported $10 billion in gaming revenue, surpassing the amounts that the Nevada casinos collected that year. Owing to the rights and benefits that accrue with recognition and the controversy surrounding Indian gaming, the Bureau of Indian Affairs' (BIA) regulatory process has been subject to intense scrutiny by groups seeking recognition and other …

A number basic sorbents based on CaO were synthesized, characterized with novel techniques and tested for sorption of CO{sub 2} and selected gas mixtures simulating flue gas from coal fired boilers. Our studies resulted in highly promising sorbents which demonstrated zero affinity for N{sub 2}, O{sub 2}, SO{sub 2}, and NO very low affinity for water, ultrahigh CO{sub 2} sorption capacities, and rapid sorption characteristics, CO{sub 2} sorption at a very wide temperature range, durability, and low synthesis cost. One of the 'key' characteristics of the proposed materials is the fact that we can control very accurately their basicity (optimum number of basic sites of the appropriate strength) which allows for the selective chemisorption of CO{sub 2} at a wide range of temperatures. These unique characteristics of this family of sorbents offer high promise for development of advanced industrial sorbents for the effective CO{sub 2} removal.

In this study a respirometer is tested for its ability to act as an early upset warning device and whole effluent toxicity monitor for industrial discharge. Industrial discharge water quality is commonly evaluated by comparing measured chemical concentrations to target values or regulatory limits established by governmental agencies. Unless the regulatory values are based upon empirical data, the actual effect of the discharge on aquatic systems is unknown. At the same time assessing the environmental toxicology of wastewater discharges is complicated by synergistic relationships among chemical constituents producing greater total toxicity. For example, metals may be more toxic in waters with low total hardness or more soluble at lower pH. An alternative approach that we are investigating is whole effluent toxicity testing. This study investigates the measurement of whole effluent toxicity through an on-line respirometer that measures toxicity to microorganisms comprising activated sludge. In this approach the oxygen uptake rate is monitored and used as an indicator of microbial activity or health. This study investigates the use of an online whole effluent toxicity testing system to provide early upset warning and the consistency of measured response to low pH. Repeated exposure of the microorganisms to low pH results in reduced …

These proceedings contain papers prepared for the 24th Seismic Research Review: Nuclear Explosion Monitoring: Innovation and Integration, held 17-19 September, 2002 in Ponte Vedra Beach, Florida. These papers represent the combined research related to ground-based nuclear explosion monitoring funded by the National Nuclear Security Administration (NNSA), Defense Threat Reduction Agency (DTRA), and other invited sponsors. The scientific objectives of the research are to improve the United States capability to detect, locate, and identify nuclear explosions. The purpose of the meeting is to provide the sponsoring agencies, as well as potential users, an opportunity to review research accomplished during the preceding year and to discuss areas of investigation for the coming year. For the researchers, it provides a forum for the exchange of scientific information toward achieving program goals, and an opportunity to discuss results and future plans. Paper topics include: seismic regionalization and calibration; detection and location of sources; wave propagation from source to receiver; the nature of seismic sources, including mining practices; hydroacoustic, infrasound, and radionuclide methods; on-site inspection; and data processing.

The objective of the research is to analyze pathways of reactions of hydrogen with oxides of carbon over sulfides, and to predict which characteristics of the sulfide catalyst (nature of metal, defect structure) give rise to the lowest barriers toward oxygenated hydrocarbon product. Reversal of these pathways entails the generation of hydrogen, which is also proposed for study. In this first year of study, adsorption reactions of H atoms and H{sub 2} molecules with MoS{sub 2}, both in molecular and solid form, have been modeled using high-level density functional theory. The geometries and strengths of the adsorption sites are described and the methods used in the study are described. An exposed MO{sup IV} species modeled as a bent MoS{sub 2} molecule is capable of homopolar dissociative chemisorption of H{sub 2} into a dihydride S{sub 2}MoH{sub 2}. Among the periodic edge structures of hexagonal MoS{sub 2}, the (1{bar 2}11) edge is most stable but still capable of dissociating H{sub 2}, while the basal plane (0001) is not. A challenging task of theoretically accounting for weak bonding of MoS{sub 2} sheets across the Van der Waals gap has been addressed, resulting in a weak attraction of 0.028 eV/MoS{sub 2} unit, compared to …

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A new technique for removal of elemental mercury from emissions of coal-fired utilities was investigated. The key idea is to selectively photo ionize the mercury atoms. A strong electric field gradient then drags them to the negative plate where they can be collected and removed.

This effort will provide a technical basis to assure safe and efficient system operation of the melt-dilute process and have general applicability to off-gas streams.

Criticality analysis of the proposed melt-dilute (MD) form of aluminum-based spent nuclear fuel (SNF), under geologic repository conditions, was performed following the methodology documented in the Disposal Criticality Analysis Methodology Topical Report. This methodology evaluates the potential for nuclear criticality for a waste form in a waste package. Criticality calculations show that even with waste package failure, followed by degradation of material within the waste package and potential loss of neutron absorber materials, sub-critical conditions can be readily demonstrated for the MD form of aluminum-based SNF.

Aluminum-based spent nuclear fuel from foreign and domestic research reactors is being consolidated at the Savannah River Site (SRS) for ultimate disposal in the Monitored Geologic Repository. The melt-dilute treatment technology has been developed to consolidate fuel assemblies by a melting/casting process in which depleted uranium is added to reduce enrichment below 20 percent 235-U. The melt-dilute product is essentially a binary uranium-aluminum alloy to which neutron absorber materials may be readily added.

This is a multiyear experimental research program that focuses on improving relevant material properties of high-T{sub c} superconductors (HTSs) and developing fabrication methods that can be transferred to industry for production of commercial conductors. The development of teaming relationships through agreements with industrial partners is a key element of the Argonne National Laboratory (ANL) program. The technical highlights from this quarter are that the capabilities and performance of a new pulsed laser deposition system (PLD2) are described. Using PLD2, a YBa{sub 2}Cu{sub 3}O{sub x} (YBCO) film with critical current density (J{sub c}) of 5.3 MA/cm{sup 2} was prepared on single-crystal SrTiO{sub 3} (STO). Study of a RABiTS{trademark} sample from Oak Ridge National Laboratory showed new effects of magnetic history on grain boundary transport in YBCO. The critical current (I{sub c}) of melt-textured YBCO rings was measured under pulsed current conditions.

To assess the effects of long-term, low-dose-rate neutron exposure on mechanical strength and ductility, tensile properties were measured on 12% and 20% cold-worked Type 316 stainless steel. Samples were prepared from reactor core components retrieved from the EBR-II reactor following final shutdown. Sample locations were chosen to cover a dose range of 1-56 dpa at temperatures from 371-440 C and dose rates from 0.5-5.8 x10{sup -7} dpa/s. These dose rates are approximately an order of magnitude lower than those of typical EBR-II test sample locations. The tensile tests for the 12% CW material were performed at 380 C and 430 C while those for the 20% CW samples were performed at 370 C. In each case, the tensile test temperature approximately matched the irradiation temperature. To help understand the tensile properties, microstructural samples with similar irradiation history were also examined. The strength and loss of work hardening increase the fastest as a function of irradiation dose for the 12% CW material irradiated at lower temperature. The decrease in ductility with increasing dose occurs more rapidly for the 12% CW material irradiated at lower temperature and the 20% cold-worked material. Post-tensile test fractography indicates that at higher dose, the 20% CW …

The Intense Pulse Neutron Source (IPNS) 50-MeV Drift-Tube Linac uses a single-gap, single-harmonic buncher cavity to increase transmission efficiency. However, it is also the case that the linac output beam longitudinal and transverse emittance is dependent on buncher amplitude and phase as well as with the input beam energy and emittance. The linac is the injector for a Rapid Cycling Synchrotron (RCS) that increases the beam energy to 450 MeV and shortens the pulse to the 100 ns region. The RCS is operated loss-limited, and its operating current is strongly dependent on the properties (emittance, and its variation during the pulse) of the beam from the linac. A new amplifier has been installed allowing for better amplitude and phase control of buncher rf. This new amplifier gives independent control of amplitude and phase, permitting more systematic studies of the relation between linac and RCS performance. This paper presents the results of recent studies where we characterize beam properties that lead to high efficiency operation in both linac and RCS, and compare them with simulation calculations.

The RFQ design for the Rare Isotope Accelerator (RIA) driver operates at 57.5 MHz, room temperature and is CW, Continuous Wave. This device is capable of accelerating a variety of masses as well as simultaneously accelerating multiple charge states. Therefore, the structure must operate over a wide range of RF power dissipation, from less than 1kW to about 48 kW. The physics design was developed by ANL and the preliminary engineering design by AES. Some of its principal design requirements include efficient cooling of components, mechanical stability, precise alignment and fine tuning of the resonant frequency during operation. This paper discusses RF, thermal and structural analyses that have been completed in response to these requirements. RF analysis was used to determine the heat loss distribution on the cavity surfaces. The heat loads were then transferred to a thermal model of a single segment and scaled to match total heat loss obtained from the code CST Microwave Studio. The thermal model includes the cavity vanes, walls and all coolant channels. To determine the coolant temperature rise, one-dimensional pipe flow elements were used. These elements account for fluid heat transport and heat transfer coefficients. The model was then used to minimize coolant …

Nb films containing extended arrays of holes with 45-nm diameter and 100-nm spacing have been fabricated using anodized aluminum oxide (AAO) as substrate. Pronounced matching effects in the magnetization are seen in fields up to 9 kOe. Flux pinning in the patterned samples is enhanced by two orders of magnitude as compared to unpatterned reference samples in applied fields exceeding 5 kOe. The matching effects are a dominant contribution to vortex pinning at temperatures as low as 4.2 K due to the nano-scale spacing of the holes.

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An evaluation of the impact of breached cladding of aluminum-based spent nuclear fuel (Al-SNF) has been completed. The evaluation has focused on the impact of the resulting exposed fuel core material on radioactive material containment during shipping and on the radioactive material release to basin water during wet storage.

Using magnetization, transport and single-crystal specific heat measurements we have determined the superconducting phase diagram of MgB{sub 2}. A zero-temperature in-pane coherence length of 9.4 nm is found. The superconducting anisotropy changes monotonously from a value around 2 near T{sub c} to above 4.5 near 22 K. We present strong evidence for a surface superconducting state for H{parallel}c which might account for the wide spread in reported values of the superconducting anisotropy.

The Advanced Photon Source (APS) storage ring operation at higher beam current is one of the potential enhancements to increase beam brilliance. However, this would impact the beamline components and high heat-load crotch absorbers. Thus, this analysis is conducted to better understand the impact of higher beam current on water-cooled crotch absorbers, made out of Glidcop, without introducing any heat-related problems.