Medical Devices: Status of FDA's Program for Inspections by Accredited Organizations (open access)

Medical Devices: Status of FDA's Program for Inspections by Accredited Organizations

A letter report issued by the Government Accountability Office with an abstract that begins "The Food and Drug Administration (FDA) inspects domestic and foreign establishments where U.S.-marketed medical devices are manufactured to assess compliance with FDA's quality system requirements for ensuring good manufacturing practices and other applicable requirements. The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) required FDA to accredit organizations to inspect certain establishments where devices that are marketed in both the United States and other countries are manufactured. This report includes information that MDUFMA requires GAO to provide on (1) the number of organizations that sought accreditation, the number that were accredited, and reasons for denial of accreditation and (2) the number of inspections conducted by accredited organizations. It also includes information about factors that could influence manufacturers' interest in voluntarily requesting and paying for an inspection by an accredited organization. GAO examined FDA documents, interviewed FDA officials, and obtained information from FDA on the number of inspections conducted from March 11, 2004--when FDA first cleared an accredited organization to conduct independent inspections--through October 31, 2006. GAO also interviewed affected entities, including accredited organizations and medical device manufacturers."
Date: January 5, 2007
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Pestoides F, and Atypical Yersinia pestis Strain from the Former Soviet Union (open access)

Pestoides F, and Atypical Yersinia pestis Strain from the Former Soviet Union

Unlike the classical Yersinia pestis strains, members of an atypical group of Y. pestis from Central Asia, denominated Y. pestis subspecies caucasica (also known as one of several pestoides types), are distinguished by a number of characteristics including their ability to ferment rhamnose and melibiose, their lacking the small plasmid encoding the plasminogen activator (pla) and pesticin, and their exceptionally large variants of the virulence plasmid pMT (encoding murine toxin and capsular antigen). We have obtained the entire genome sequence of Y. pestis Pestoides F, an isolate from the former Soviet Union that has enabled us to carryout a comprehensive genome-wide comparison of this organism's genomic content against the six published sequences of Y. pestis and their Y. pseudotuberculosis ancestor. Based on classical glycerol fermentation (+ve) and nitrate reduction (+ve) Y. pestis Pestoides F is an isolate that belongs to the biovar antiqua. This strain is unusual in other characteristics such as the fact that it carries a non-consensus V antigen (lcrV) sequence, and that unlike other Pla{sup -} strains, Pestoides F retains virulence by the parenteral and aerosol routes. The chromosome of Pestoides F is 4,517,345 bp in size comprising some 3,936 predicted coding sequences, while its pCD and …
Date: January 5, 2007
Creator: Garcia, E.; Worsham, P.; Bearden, S.; Malfatti, S.; Lang, D.; Larimer, F. et al.
Object Type: Book
System: The UNT Digital Library
Biological impacts and context of network theory (open access)

Biological impacts and context of network theory

Many complex systems can be represented and analyzed as networks, and examples that have benefited from this approach span the natural sciences. For instance, we now know that systems as disparate as the World-Wide Web, the Internet, scientific collaborations, food webs, protein interactions and metabolism all have common features in their organization, the most salient of which are their scale-free connectivity distributions and their small-world behavior. The recent availability of large scale datasets that span the proteome or metabolome of an organism have made it possible to elucidate some of the organizational principles and rules that govern their function, robustness and evolution. We expect that combining the currently separate layers of information from gene regulatory-, signal transduction-, protein interaction- and metabolic networks will dramatically enhance our understanding of cellular function and dynamics.
Date: January 5, 2007
Creator: Almaas, E
Object Type: Article
System: The UNT Digital Library
Russian Natural Gas: Regional Dependence (open access)

Russian Natural Gas: Regional Dependence

None
Date: January 5, 2007
Creator: unknown
Object Type: Report
System: The UNT Digital Library
Higher Education Tax Credits and Deduction: An Overview of the Benefits and Their Relationship to Traditional Student Aid (open access)

Higher Education Tax Credits and Deduction: An Overview of the Benefits and Their Relationship to Traditional Student Aid

This report is intended to provide information about the direct assistance for education expenses provided through the federal income tax system, thereby placing HEA student aid programs in a broader context.
Date: January 5, 2007
Creator: Levine, Linda & Stoll, Adam
Object Type: Report
System: The UNT Digital Library
Ballistic Missile Defense: Historical Overview (open access)

Ballistic Missile Defense: Historical Overview

For some time there has been a growing sense of urgency to develop and deploy effective missile defenses against a range of long and short range ballistic missile threats. Although many might believe this to be relative new to U.S. national security objectives, such interest has been ongoing since the 1960s, and many current technologies being investigated date their start to the early 1980s. This effort has been challenging technically and politically controversial. Some $110 billion has been spent since the mid-1980s; Congress appropriated $9.3 billion in FY2006. Many observers expect that the 110th Congress will review the current technology and BMD test program in 2007. This report provides a brief overview of U.S. efforts to date.
Date: January 5, 2007
Creator: Hildreth, Steven A.
Object Type: Report
System: The UNT Digital Library
Homosexuals and U.S. Military Policy: Current Issues (open access)

Homosexuals and U.S. Military Policy: Current Issues

This report provides an overview of the current issues on homosexuals and U.S. military policy. It also discusses about recruiting, JROTC, ROTC and campus Policies.
Date: January 5, 2007
Creator: Burrelli, David F. & Feder, Jody
Object Type: Report
System: The UNT Digital Library
Disaster Housing Assistance: A Legal Analysis of ACORN v. FEMA (open access)

Disaster Housing Assistance: A Legal Analysis of ACORN v. FEMA

None
Date: January 5, 2007
Creator: Holder, Kamilah
Object Type: Report
System: The UNT Digital Library
Measurements of CP-Violating Asymmetries in B^0 toa_1^+(1260) \pi^- Decays (open access)

Measurements of CP-Violating Asymmetries in B^0 toa_1^+(1260) \pi^- Decays

The authors present measurements of CP-violating asymmetries in the decay B{sup 0} {yields} a{sub 1}{sup {+-}}(1260){pi}{sup {-+}} with a{sub 1}{sup {+-}}(1260) {yields} {pi}{sup {-+}}{pi}{sup {+-}}{pi}{sup {+-}}. The data sample corresponds to 384 x 10{sup 6} B{bar B} pairs collected with the BABAR detector at the PEP-II asymmetric B-factory at SLAC. They measure the CP-violating asymmetry {Alpha}{sub CP}{sup a{sub 1}{pi}} = -0.07 {+-} 0.07 {+-} 0.02, the mixing-induced CP violation parameter S{sub a{sub 1}{pi}} = 0.37 {+-} 0.21 {+-} 0.07, the direct Cp violation parameter C{sub a{sub 1}{pi}} = -0.10 {+-} 0.15 {+-} 0.09, and the parameters {Delta}C{sub a{sub 1}{pi}} = 0.26 {+-} 0.15 {+-} 0.07 and {Delta}S{sub a{sub 1}{pi}} = -0.14 {+-} 0.21 {+-} 0.06. From these measured quantities they determine the angle {alpha}{sub eff} = 78.6{sup o} {+-} 7.3{sup o}.
Date: January 5, 2007
Creator: Aubert, B.
Object Type: Article
System: The UNT Digital Library
Changes in delta-Plutonium due to self-irradiation aging observed by Continuous in-situ X-ray Scattering (open access)

Changes in delta-Plutonium due to self-irradiation aging observed by Continuous in-situ X-ray Scattering

The aging in plutonium is predominantly caused by its internal self-irradiation. The self-irradiation in Pu-239 is by the decay process of transmuting the Pu atom into uranium atom and emitting an {alpha}-particle. Most of the lattice damage comes from the uranium recoil resulting in Frenkel-type defects consisting of vacancies and self-interstitial atoms, helium in-growth and defect clusters and possibly even though it is not yet observed, the generation of voids. As part of the stockpile stewardship, it is important to understand the changes in the structure and microstructures and their correlations to the physical properties. Changes in the physical properties have a direct relationship to the quality of the structure, in terms of formation of defects and defect clustering, accumulation of voids, grain boundaries, phase changes and etc. which can adversely affect the stability of the material. These changes are very difficult to monitor because of the high activity of the sample, high atomic number making x-ray and synchrotron probe into the bulk very difficult (neutron probe is not feasible) and the long life time which normally requires decades to measure. In this paper we describe the development of an in-situ in-house transmission x-ray diffraction (XRD) experimental technique used to …
Date: January 5, 2007
Creator: Saw, C K; Chung, B W & Wall, M A
Object Type: Article
System: The UNT Digital Library
Flux-induced Isometry Gauging in Heterotic Strings (open access)

Flux-induced Isometry Gauging in Heterotic Strings

We study the effect of flux-induced isometry gauging of the scalar manifold in N = 2 heterotic string compactification with gauge fluxes. We show that a vanishing theorem by Witten provides the protection mechanism. The other ungauged isometries in hyper moduli space could also be protected, depending on the gauge bundle structure. We also discuss the related issue in IIB setting.
Date: January 5, 2007
Creator: Chuang, Wu-yen & Gao, Peng
Object Type: Report
System: The UNT Digital Library
Improved Distances to Type Ia Supernovae withMulticolor Light Curve Shapes: MLCS2k2 (open access)

Improved Distances to Type Ia Supernovae withMulticolor Light Curve Shapes: MLCS2k2

We present an updated version of the Multicolor Light Curve Shape method to measure distances to type Ia supernovae (SN Ia), incorporating new procedures for K-correction and extinction corrections. We also develop a simple model to disentangle intrinsic color variations and reddening by dust, and expand the method to incorporate U-band light curves and to more easily accommodate prior constraints on any of the model parameters. We apply this method to 133 nearby SN Ia, including 95 objects in the Hubble flow (cz {ge} 2500 km s{sup -1}), which give an intrinsic dispersion of less than 7% in distance. The Hubble flow sample, which is of critical importance to all cosmological uses of SN Ia, is the largest ever presented with homogeneous distances. We find the Hubble flow supernovae with H{sub 0}d{sub SN} {ge} 7400 km s{sup -1} yield an expansion rate that is 6.5 {+-} 1.8% lower than the rate determined from supernovae within that distance, and this can have a large effect on measurements of the dark energy equation of state with SN Ia. Peculiar velocities of SN Ia host galaxies in the rest frame of the Local Group are consistent with the dipole measured in the Cosmic …
Date: January 5, 2007
Creator: Jha, Saurabh; Riess, Adam G. & Kirshner, Robert P.
Object Type: Article
System: The UNT Digital Library
Structure of the Lithosphere and Upper Mantle Across the Arabian Peninsula (open access)

Structure of the Lithosphere and Upper Mantle Across the Arabian Peninsula

Analysis of modern broadband (BB) waveform data allows for the inference of seismic velocity structure of the crust and upper mantle using a variety of techniques. This presentation will report inferences of seismic structure of the Arabian Plate using BB data from various networks. Most data were recorded by the Saudi Arabian National Digital Seismic Network (SANDSN) which consists of 38 (26 BB, 11 SP) stations, mostly located on the Arabian Shield. Additional data were taken from the 1995-7 Saudi Arabian IRIS-PASSCAL Deployment (9 BB stations) and other stations across the Peninsula. Crustal structure, inferred from teleseismic P-wave receiver functions, reveals thicker crust in the Arabian Platform (40-45 km) and the interior of the Arabian Shield (35-40 km) and thinner crust along the Red Sea coast. Lithospheric thickness inferred from teleseismic S-wave receiver functions reveals very thin lithosphere (40-80 km) along the Red Sea coast which thickens rapidly toward the interior of the Arabian Shield (100-120 km). We also observe a step of 20-40 km in lithospheric thickness across the Shield-Platform boundary. Seismic velocity structure of the upper mantle inferred from teleseismic P- and S-wave travel time tomography reveals large differences between the Shield and Platform, with the Shield being …
Date: January 5, 2007
Creator: Al-Amri, A. & Rodgers, A.
Object Type: Article
System: The UNT Digital Library
General Relativistic Radiative Transfer and GeneralRelativistic MHD Simulations of Accretion and Outflows of Black Holes (open access)

General Relativistic Radiative Transfer and GeneralRelativistic MHD Simulations of Accretion and Outflows of Black Holes

We calculate the emission from relativistic flows in black hole systems using a fully general relativistic radiative transfer formulation, with flow structures obtained by general relativistic magneto-hydrodynamic simulations. We consider thermal free-free emission and thermal synchrotron emission. Bright filament-like features protrude (visually) from the accretion disk surface, which are enhancements of synchrotron emission where the magnetic field roughly aligns with the line-of-sight in the co-moving frame. The features move back and forth as the accretion flow evolves, but their visibility and morphology are robust. We propose that variations and drifts of the features produce certain X-ray quasi-periodic oscillations (QPOs) observed in black-hole X-ray binaries.
Date: January 5, 2007
Creator: Fuerst, Steven V.; Mizuno, Yosuke; Nishikawa, Ken-Ichi & Wu, Kinwah
Object Type: Article
System: The UNT Digital Library
Relativistic many-body calculations of electric-dipole lifetimes, rates, and oscillator strengths of Delta(n) = 0 transitions between 3l^-1 4l' states in Ni-like ions (open access)

Relativistic many-body calculations of electric-dipole lifetimes, rates, and oscillator strengths of Delta(n) = 0 transitions between 3l^-1 4l' states in Ni-like ions

Transition rates, oscillator strengths, and line strengths are calculated for electric-dipole (E1) transitions between odd-parity 3s{sup 2}3p{sup 6}3d{sup 9}4{ell}{sub 2}, 3s{sup 2}3p{sup 5}3d{sup 10}4{ell}{sub 2}, and 3s3p{sup 6}3d{sup 10}4{ell}{sub 1} states and even-parity 3s{sup 2}3p{sup 6}3d{sup 9}4{ell}{sub 2}, 3s{sup 2}3p{sup 5}3d{sup 10}4{ell}{sub 1}, and 3s3p{sup 6}3d{sup 10}4{ell}{sub 2} (with 4{ell}{sub 1} = 4p; 4f and 4{ell}{sub 2} = 4s; 4d) in Ni-like ions with the nuclear charges ranging from Z = 34 to 100. Relativistic many-body perturbation theory (RMBPT), including the Breit interaction, is used to evaluate retarded E1 matrix elements in length and velocity forms. The calculations start from a 1s{sup 2}2s{sup 2}2p{sup 6}3s{sup 2}3p{sup 6}3d{sup 10} Dirac-Fock potential. First-order RMBPT is used to obtain intermediate coupling coefficients and second-order RMBPT is used to calculate transition matrix elements. Contributions from negative-energy states are included in the second-order E1 matrix elements to ensure the gauge independence of transition amplitudes. Transition energies used in the calculation of oscillator strengths and transition rates are from second-order RMBPT. Lifetimes of the 3s{sup 2}3p{sup 6}3d{sup 9}4d levels are given for Z = 34-100. Transition rates, line strengths, and oscillator strengths are compared with critically evaluated experimental values and with results from other recent calculations. …
Date: January 5, 2007
Creator: Safronova, U I; Safronova, A S & Beiersdorfer, P
Object Type: Article
System: The UNT Digital Library
CsBr Photocathode at 257nm: A Rugged High Current Density Electron Source (open access)

CsBr Photocathode at 257nm: A Rugged High Current Density Electron Source

There is a continuing need for high intensity electron sources that will operate in demountable vacuum and can be externally modulated. Materials with wide bandgap, e.g. diamond, are rugged but need photon energies exceeding the bandgap to emit efficiently and this rules out the use of CW lasers. We have found that a photocathode of CsBr is both adequately intense(>150A/cm{sup 2}) and rugged and can be excited with photons of energy of 4.8eV(257nm). This is below the energy gap of CsBr(7.3eV) but such operation can be explained by the presence of intraband states about 4eV below the conduction band minimum.
Date: January 5, 2007
Creator: Liu, Zhi; Maldonado, Juan; Sun, Yun; Pianetta, Piero; Pease, R.F.W. & /SLAC, SSRL
Object Type: Article
System: The UNT Digital Library
Measuring the Effects of Disturbance & Climate on the CO2 & Energy Exchange of Ponderosa Pine Forests in the Pacific Northwest: Integration of Eddy Flux, Plant and Soil Measurements (open access)

Measuring the Effects of Disturbance & Climate on the CO2 & Energy Exchange of Ponderosa Pine Forests in the Pacific Northwest: Integration of Eddy Flux, Plant and Soil Measurements

The goal is to quantify and understand the influence of climate and disturbance on ecosystem processes and thus net carbon uptake by forests. The objective is to combine tower and ground-based observations to quantify the effects of disturbance on processes controlling carbon storage and CO{sub 2} and energy exchange in varying climatic conditions. Specific objectives are: (1) Investigate the effects of logging and fire on carbon storage and carbon dioxide and energy exchange in chronosequences of ponderosa pine, using consistent methodology; (2) Determine key environmental factors controlling carbon storage and carbon dioxide and energy exchange in these forests through a combination of measurements and process modeling; and (3) Assess spatial variation of the concentrations and transport in complex terrain. The eddy covariance method is used for measurements of CO2, water vapor, and energy exchanges in a chronosequence of ponderosa pine forests (burned in 2002 wildfire, 10 year-old stand, 90 year-old mature stand). The mature stand has been an AmeriFlux site since 2000 (following previous flux sites in young and old stands initiated in 1996). In addition to the eddy covariance measurements, a large suite of biological processes and ecosystem properties are determined for the purpose of developing independent forest carbon …
Date: January 5, 2007
Creator: Law, Beverly E. & Mahrt, Larry
Object Type: Report
System: The UNT Digital Library
Health Care and Markets (open access)

Health Care and Markets

Health care spending is one of the most rapidly growing portions of the federal budget. Projections suggest if the rapid growth in health care costs is not curtailed, governments at all levels will face an uncomfortable choice between significant cuts in other spending priorities or major tax increases. This report examines the economic justification for government intervention and involvement in health care markets.
Date: January 5, 2007
Creator: Austin, D. Andrew
Object Type: Report
System: The UNT Digital Library
Nonproliferation and Threat Reduction Assistance: U.S. Programs in the Former Soviet Union (open access)

Nonproliferation and Threat Reduction Assistance: U.S. Programs in the Former Soviet Union

None
Date: January 5, 2007
Creator: unknown
Object Type: Report
System: The UNT Digital Library
Textile and Apparel Trade Issues (open access)

Textile and Apparel Trade Issues

None
Date: January 5, 2007
Creator: unknown
Object Type: Report
System: The UNT Digital Library
The Telephone Excise Tax: An Economic Analysis (open access)

The Telephone Excise Tax: An Economic Analysis

None
Date: January 5, 2007
Creator: unknown
Object Type: Report
System: The UNT Digital Library
Fishery, Aquaculture, and Marine Mammal Legislation in the 109th Congress (open access)

Fishery, Aquaculture, and Marine Mammal Legislation in the 109th Congress

Fish and marine mammals are important resources in open ocean and nearshore coastal areas. Many laws and regulations guide the management of these resources by federal agencies. This report contains information on commercial and sport fisheries, aquaculture, and marine mammals and issues related to the 109th Congress.
Date: January 5, 2007
Creator: Buck, Eugene H.
Object Type: Report
System: The UNT Digital Library
Mercosur: Evolution and Implications for U.S. Trade Policy (open access)

Mercosur: Evolution and Implications for U.S. Trade Policy

None
Date: January 5, 2007
Creator: unknown
Object Type: Report
System: The UNT Digital Library
Federal Drug Price Negotiation: Implications for Medicare Part D (open access)

Federal Drug Price Negotiation: Implications for Medicare Part D

None
Date: January 5, 2007
Creator: Hahn, Jim
Object Type: Report
System: The UNT Digital Library