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Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections
Testimony issued by the Government Accountability Office with an abstract that begins "As part of the Food and Drug Administration's (FDA) oversight of the safety and effectiveness of medical devices marketed in the United States, it inspects domestic and foreign establishments where these devices are manufactured. To help FDA address shortcomings in its inspection program, the Medical Device User Fee and Modernization Act of 2002 required FDA to accredit third parties to inspect certain establishments. In response, FDA has implemented two such voluntary programs. GAO previously reported on the status of one of these programs, citing concerns regarding its implementation and factors that may influence manufacturers' participation. (Medical Devices: Status of FDA's Program for Inspections by Accredited Organizations, GAO-07-157, January 2007.) This statement (1) assesses FDA's management of inspections of establishments--particularly those in foreign countries--manufacturing devices for the U.S. market, and (2) provides the status of FDA's programs for third-party inspections of medical device manufacturing establishments. GAO interviewed FDA officials; reviewed pertinent statutes, regulations, guidance, and reports; and analyzed information from FDA databases. GAO also updated its previous work on FDA's programs for inspections by accredited third parties."
Date:
January 29, 2008
Creator:
United States. Government Accountability Office.
Object Type:
Text
System:
The UNT Digital Library
Federal User Fees: A Design Guide
Other written product issued by the Government Accountability Office with an abstract that begins "The federal government will need to make the most of its resources to meet the emerging challenges of the 21st century. As new priorities emerge, policymakers have demonstrated interest in user fees as a means of financing new and existing services. User fees can be designed to reduce the burden on taxpayers to finance the portions of activities that provide benefits to identifiable users above and beyond what is normally provided to the public. By charging the costs of those programs or activities to beneficiaries, user fees can also promote economic efficiency and equity. However, to achieve these goals, user fees must be well designed. GAO was asked to study how user fee design characteristics may influence the effectiveness of user fees. Specifically, GAO examined how the four key design and implementation characteristics of user fees--how fees are set, collected, used, and reviewed--may affect the economic efficiency, equity, revenue adequacy, and administrative burden of cost-based fees. GAO reviewed economic and policy literature on federal and nonfederal user fees, including prior GAO work, and used relevant case examples to illustrate different types of design elements and the …
Date:
May 29, 2008
Creator:
United States. Government Accountability Office.
Object Type:
Text
System:
The UNT Digital Library
Environmental Protection: EPA Needs to Ensure That Best Practices and Procedures Are Followed When Making Further Changes to Its Library Network
A letter report issued by the Government Accountability Office with an abstract that begins "Established in 1971, the Environmental Protection Agency's (EPA) library network provides staff and the public with access to environmental information. Its 26 libraries contain a wide range of information and resources and are located at headquarters, regional offices, research centers, and laboratories nationwide. In 2006, EPA issued a plan to reorganize the network beginning in fiscal year 2007. The plan proposed closing libraries and dispersing, disposing of, and digitizing library materials. GAO was asked to assess (1) the status of, and plans for, the network reorganization; (2) EPA's rationale for reorganizing the network; (3) the extent to which EPA has communicated with and solicited the views of EPA staff and external stakeholders in conducting the reorganization; (4) EPA's steps to maintain the quality of library services after the reorganization; and (5) how EPA is funding the network and its reorganization. For this study, GAO reviewed pertinent EPA documents and interviewed EPA officials and staff from each of the libraries."
Date:
February 29, 2008
Creator:
United States. Government Accountability Office.
Object Type:
Report
System:
The UNT Digital Library
Human Rights: U.S. Government's Efforts to Address Alleged Abuse of Household Workers by Foreign Diplomats with Immunity Could Be Strengthened
A letter report issued by the Government Accountability Office with an abstract that begins "In 2007, the Department of State (State) reported that some foreign diplomats may be abusing the household workers they brought to the United States on A-3 or G-5 visas. GAO was asked to (1) determine the number of A-3 or G-5 visa holders who have alleged abuse by foreign diplomats with immunity since 2000, (2) review the U.S. government's process for investigating these allegations, and (3) assess how State ensures that its policies for issuing A-3 and G-5 visas are implemented correctly and consistently. GAO analyzed documents, interviewed officials, and conducted fieldwork at four consular posts that issue large numbers of A-3 or G-5 visas."
Date:
July 29, 2008
Creator:
United States. Government Accountability Office.
Object Type:
Report
System:
The UNT Digital Library
Pension Benefit Guaranty Corporation: A Fact Sheet
The Pension Benefit Guaranty Corporation (PBGC) is a federal government agency established in 1974 by the Employee Retirement Income Security Act (ERISA) (P.L. 93- 406). It was created to protect the pensions of participants and beneficiaries covered by private sector, defined benefit (DB) plans. These pension plans provide a specified monthly benefit at retirement, usually either a percent of salary or a flat dollar amount multiplied by years of service. Defined contribution plans, such as §401(k) plans, are not insured. The PBGC is chaired by the Secretary of Labor, with the Secretaries of Treasury and Commerce serving as board members.
Date:
January 29, 2008
Creator:
Topoleski, John J.
Object Type:
Report
System:
The UNT Digital Library
Sun-Climate Complexity Linking
Article discussing sun-climate complexity linking and how this property is a consequence of the phenomenon of information transfer.
Date:
February 29, 2008
Creator:
West, Bruce J. & Grigolini, Paolo
Object Type:
Article
System:
The UNT Digital Library
Solar Radiation Data Sets: Solar Resource Assessment Workshop
None
Date:
October 29, 2008
Creator:
Wilcox, S.; George, R. & Myers, D.
Object Type:
Article
System:
The UNT Digital Library
Design study of a DPIS injector for a heavy ion FFAG
A new heavy ion injector linac is proposed for providing heavy ion beams to a fixed field alternating gradient (FFAG) accelerator in Kyushu University. A combination of the new intense laser source based injector and the FFAG will be able to accelerate high current ion beams with 100 Hz of a repetition rate. The planned average current reaches 7 {micro}A with carbon 6+ beam.
Date:
September 29, 2008
Creator:
Okamura,M.; Raparia, D.; Ishibashi, K.; Yonemura, Y. & Kanesue, T.
Object Type:
Article
System:
The UNT Digital Library
Uranium Contamination in the Subsurface Beneath the 300 Area, Hanford Site, Washington
This report provides a description of uranium contamination in the subsurface at the Hanford Site's 300 Area. The principal focus is a persistence plume in groundwater, which has not attenuated as predicted by earlier remedial investigations. Included in the report are chapters on current conditions, hydrogeologic framework, groundwater flow modeling, and geochemical considerations. The report is intended to describe what is known or inferred about the uranium contamination for the purpose of making remedial action decisions.
Date:
February 29, 2008
Creator:
Peterson, Robert E.; Rockhold, Mark L.; Serne, R. Jeffrey; Thorne, Paul D. & Williams, Mark D.
Object Type:
Report
System:
The UNT Digital Library
Electric-dipole 5s - 5p Transitions in Promethiumlike Ions
The 5s-5p electric-dipole resonance transitions in highly ionized promethiumlike ions have been studied applying relativistic multi-reference Moeller-Plesset second-order perturbation theory. The transition wavelengths are determined to within 0.2 {angstrom} in the more highly charged ions, where the level degeneracies are small. For somewhat lighter ions a very large reference space was used in order to account for the many degeneracies. In order to calculate transition probabilities and lifetimes, correlation corrections have been added to the transition operator in the next order. The contributions from the higher orders of the theory, that is, frequency-dependent Breit correction, Lamb shift, and mass shifts, have been estimated. The results are used to re-assess spectroscopic data from beam-foil, electron beam ion trap, and tokamak observations.
Date:
February 29, 2008
Creator:
Vilkas, M J; Ishikawa, Y & Trabert, E
Object Type:
Article
System:
The UNT Digital Library
Recalibration of H Canyon Online Spectrophotometer at Extended Uranium Concentration
The H Canyon online spectrophotometers are calibrated for measurement of the uranium and nitric acid concentrations of several tanks in the 2nd Uranium Cycle.[1] The spectrometers, flow cells, and prediction models are currently optimized for a process in which uranium concentrations are expected to range from 0-15 g/L and nitric acid concentrations from 0.05-6 M. However, an upcoming processing campaign will involve 'Super Kukla' material, which has a lower than usual enrichment of fissionable uranium. Total uranium concentrations will be higher, spanning approximately 0-30 g/L U, with no change in the nitric acid concentrations. The new processing conditions require the installation of new flow cells with shorter path lengths. As the process solutions have a higher uranium concentration, the shorter path length is required to decrease the absorptivity to values closer to the optimal range for the instrument. Also, new uranium and nitric acid prediction models are required to span the extended uranium concentration range. The models will be developed for the 17.5 and 15.4 tanks, for which nitric acid concentrations will not exceed 1 M. The restricted acid range compared to the original models is anticipated to reduce the measurement uncertainty for both uranium and nitric acid. The online …
Date:
October 29, 2008
Creator:
Lascola, R.
Object Type:
Report
System:
The UNT Digital Library
Rh(I)-Catalyzed Direct Arylation of Pyridines and Quinolines
The pyridine and quinoline nuclei are privileged scaffolds that occupy a central role in many medicinally relevant compounds. Consequently, methods for their expeditious functionalization are of immediate interest. However, despite the immense importance of transition-metal catalyzed cross-coupling for the functionalization of aromatic scaffolds, general solutions for coupling 2-pyridyl organometallics with aryl halides have only recently been presented. Direct arylation at the ortho position of pyridine would constitute an even more efficient approach because it eliminates the need for the stoichiometric preparation and isolation of 2-pyridyl organometallics. Progress towards this goal has been achieved by activation of the pyridine nucleus for arylation via conversion to the corresponding pyridine N-oxide or N-iminopyridinium ylide. However, this approach necessitates two additional steps: activation of the pyridine or quinoline starting material, and then unmasking the arylated product. The use of pyridines directly would clearly represent the ideal situation both in terms of cost and simplicity. We now wish to document our efforts in this vein, culminating in an operationally simple Rh(I)-catalyzed direct arylation of pyridines and quinolines. We recently developed an electron-rich Rh(I) system for catalytic alkylation at the ortho position of pyridines and quinolines with alkenes. Therefore, we initially focused our attention on the …
Date:
July 29, 2008
Creator:
Berman, Ashley; Lewis, Jared; Bergman, Robert & Ellman, Jonathan
Object Type:
Article
System:
The UNT Digital Library
Remaining Sites Verification Package for the 100-F-26:14, 116-F-5 Influent Pipelines, Waste Site Reclassification Form 2007-029
The 100-F-26:14 waste site includes underground pipelines associated with the 116-F-5 Ball Washer Crib and remnants of process pipelines on the west side of the 105-F Building. In accordance with this evaluation, the verification sampling results support a reclassification of this site to Interim Closed Out. The results of verification sampling show that residual contaminant concentrations do not preclude any future uses and allow for unrestricted use of shallow zone soils. The results also demonstrate that residual contaminant concentrations are protective of groundwater and the Columbia River.
Date:
February 29, 2008
Creator:
Dittmer, L. M.
Object Type:
Report
System:
The UNT Digital Library
Annual Hanford Seismic Report for Fiscal Year 2008
The Hanford Seismic Assessment Program (HSAP) provides an uninterrupted collection of high-quality raw and processed seismic data from the Hanford Seismic Network for the U.S. Department of Energy and its contractors. The HSAP is responsible for locating and identifying sources of seismic activity and monitoring changes in the historical pattern of seismic activity at the Hanford Site. The data are compiled, archived, and published for use by the Hanford Site for waste management, natural phenomena hazards assessments, and engineering design and construction. In addition, the HSAP works with the Hanford Site Emergency Services Organization to provide assistance in the event of a significant earthquake on the Hanford Site. The Hanford Seismic Network and the Eastern Washington Regional Network consist of 44 individual sensor sites and 15 radio relay sites maintained by the Hanford Seismic Assessment Team. During fiscal year 2008, the Hanford Seismic Network recorded 1431 triggers on the seismometer system, which included 112 seismic events in the southeast Washington area and an additional 422 regional and teleseismic events. There were 74 events determined to be local earthquakes relevant to the Hanford Site. The highest-magnitude event (3.7 Mc) occurred on May 18, 2008, and was located approximately 17 km east …
Date:
December 29, 2008
Creator:
Rohay, Alan C.; Sweeney, Mark D.; Hartshorn, Donald C.; Clayton, Ray E. & Devary, Joseph L.
Object Type:
Report
System:
The UNT Digital Library
The GLAST Large Area Telescope: Design, Construction,Test and Calibration
None
Date:
February 29, 2008
Creator:
Latronico, Luca & Spandre, Gloria
Object Type:
Article
System:
The UNT Digital Library
Facilitation of the Estuary/Ocean Subgroup for Federal Research, Monitoring, and Evaluation, FY08 Annual Report
The Estuary/Ocean Subgroup (EOS) is part of the research, monitoring, and evaluation (RME) effort that the Action Agencies (Bonneville Power Administration, U.S. Army Corps of Engineers, U.S. Bureau of Reclamation) developed in response to obligations arising from the Endangered Species Act as applied to operation of the Federal Columbia River Power System (FCRPS). The goal of the EOS project is to facilitate activities of the estuary/ocean RME subgroup as it coordinates design and implementation of federal RME in the lower Columbia River and estuary. In fiscal year 2008 (FY08), EOS project accomplishments included 1) subgroup meetings; 2) participation in the estuary work group of the Pacific Northwest Aquatic Monitoring Partnership; 3) project management via the project tracking system, Pisces; 4) quarterly project status reports; and 5) a major revision to the Estuary RME document and its subsequent regional release (new version January 2008). Many of the estuary RME recommendations in this document were incorporated into the Biological Opinion on hydrosystem operations (May 2008). In summary, the FY08 EOS project resulted in expanded, substantive coordination with other regional RME forums, a new version of the federal Estuary RME program document, and implementation coordination. This annual report is a FY08 deliverable for …
Date:
September 29, 2008
Creator:
Johnson, Gary E. & Diefenderfer, Heida L.
Object Type:
Report
System:
The UNT Digital Library
Investigation of the 2p3/2-3d5/2 line emission of Au53+ -- Au69+ for diagnosing high energy density plasmas
Measurements of the L-shell emission of highly charged gold ions were made under controlled laboratory conditions using the SuperEBIT electron beam ion trap, allowing detailed spectral observations of lines from ironlike Au{sup 53+} through neonlike Au{sup 69+}. Using atomic data from the Flexible Atomic Code, we have identified strong 3d{sub 5/2} {yields} 2p{sub 3/2} emission features that can be used to diagnose the charge state distribution in high energy density plasmas, such as those found in the laser entrance hole of hot hohlraum radiation sources. We provide collisional-radiative calculations of the average ion charge <Z> as a function of temperature and density, which can be used to relate charge state distributions inferred from 3d{sub 5/2} {yields} 2p{sub 3/2} emission features to plasma conditions, and investigate the effects of plasma density on calculated L-shell Au emission spectra.
Date:
January 29, 2008
Creator:
Brown, G V; Hansen, S B; Trabert, E; Beiersdorfer, P; Widmann, K; Chen, H et al.
Object Type:
Article
System:
The UNT Digital Library
Electronic structure effects in liquid water studied by photoelectron spectroscopy and density functional theory
We present valence photoelectron emission spectra of liquid water in comparison with gas-phase water, ice close to the melting point, low temperature amorphous and crystalline ice. All aggregation states have major electronic structure changes relative to the free molecule, with rehybridization and development of bonding and anti-bonding states accompanying the hydrogen bond formation. Sensitivity to the local structural order, most prominent in the shape and splitting of the occupied 3a{sub 1} orbital, is understood from the electronic structure averaging over various geometrical structures, and reflects the local nature of the orbital interaction.
Date:
April 29, 2008
Creator:
Nordlund, Dennis; Odelius, Michael; Bluhm, Hendrik; Ogasawara, Hirohito; Pettersson, Lars G.M. & Nilsson, Anders
Object Type:
Article
System:
The UNT Digital Library
The Origins of the Rate Enhancement in LiNi0.4Co0.2-yAlyMn0.4O2 (0<y<_0.2) Cathode Materials
Recently, much research has been directed towards finding a replacement cathode material for LiCoO{sub 2} combining high performance with lower cost and toxicity. One promising candidate material is the mixed transition metal oxide LiNi{sub 0.4}Co{sub 0.2}Mn{sub 0.4}O{sub 2}, which delivers 180 mAh/g below 4.4 V versus Li/Li{sup +} (1, 2). However, in this material, there is 4% anti-site cation mixing, which hinders the mobility of lithium within the lattice, adversely affecting its rate performance in lithium batteries. Ongoing work in our lab has shown that partial or full substitution of cobalt with aluminum, LiNi{sub 0.4}Co{sub 0.2}Mn{sub 0.4}O{sub 2} (0 < y {le} 0.2), can lead to significant improvements in rate performance (3). In particular, LiNi{sub 0.4}Co{sub 0.2}Mn{sub 0.4}O{sub 2} shows greatly improved rate capability with almost no sacrifice in the overall capacity delivered at low rates between 2.0 and 4.3V (Figure 1). The smaller ionic radius of Al{sup 3+} in octahedral coordination (0.535 {angstrom}) compared to Li{sup +} (0.76 {angstrom}) creates a strong driving force for the formation of a more lamellar structure in the aluminum containing materials (4, 5). XRD experiments and subsequent Rietveld refinement (Figure 2) reveal a significant decrease in anti-site defect concentration upon aluminum substitution, dropping …
Date:
May 29, 2008
Creator:
Doeff, Marca M; Wilcox, James & Doeff, Marca M.
Object Type:
Article
System:
The UNT Digital Library
Stable Spheromaks with Profile Control
A spheromak equilibrium with zero edge current is shown to be stable to both ideal MHD and tearing modes that normally produce Taylor relaxation in gun-injected spheromaks. This stable equilibrium differs from the stable Taylor state in that the current density j falls to zero at the wall. Estimates indicate that this current profile could be sustained by non-inductive current drive at acceptable power levels. Stability is determined using the NIMROD code for linear stability analysis. Non-linear NIMROD calculations with non-inductive current drive could point the way to improved fusion reactors.
Date:
January 29, 2008
Creator:
Fowler, T K & Jayakumar, R
Object Type:
Report
System:
The UNT Digital Library
Worldlines as Wilson Lines
Gravitational theories do not admit gauge invariant local operators. We study the limits under which there exists a quasi-local description for a class of non-local gravitational observables where a sum over worldlines plays the role of the Wilson line for gauge theory observables. We study non-local corrections to the local description and circumstances where these corrections become large. We find that these operators are quasi-local in at space and AdS, but fail to be quasi-local in de Sitter space.
Date:
April 29, 2008
Creator:
Green, Daniel & /SLAC /Stanford U., Dept. Phys.
Object Type:
Article
System:
The UNT Digital Library
Dynamic molecular imaging of cardiac innervation using a dual headpinhole SPECT system
Typically 123I-MIBG is used for the study of innervation andfunction of the sympathetic nervous system in heart failure. The protocolinvolves two studies: first a planar or SPECT scan is performed tomeasure initial uptake of the tracer, followed some 3-4 hours later byanother study measuring the wash-out of the tracer from the heart. A fastwash-out is indicative of a compromised heart. In this work, a dual headpinhole SPECT system was used for imaging the distribution and kineticsof 123I-MIBG in the myocardium of spontaneous hypertensive rats (SHR) andnormotensive Wistar Kyoto (WKY) rats. The system geometry was calibratedbased on a nonlinear point projection fitting method using a three-pointsource phantom. The angle variation effect of the parameters was modeledwith a sinusoidal function. A dynamic acquisition was performed byinjecting 123I-MIBG into rats immediately after starting the dataacquisition. The detectors rotated continuously performing a 360o dataacquisition every 90 seconds. We applied the factor analysis (FA)methodand region of interest (ROI) sampling method to obtain time activitycurves (TACs)in the blood pool and myocardium and then appliedtwo-compartment modeling to estimate the kinetic parameters. Since theinitial injection bolus is too fast for obtaining a consistenttomographic data set in the first few minutes of the study, we appliedthe FA method directly …
Date:
March 29, 2008
Creator:
Hu, Jicun; Boutchko, Rostyslav; Sitek, Arkadiusz; Reutter, BryanW.; Huesman, Ronald H. & Gullberg, Grant T.
Object Type:
Report
System:
The UNT Digital Library
Center for Programming Models for Scalable Parallel Computing
Rice University's achievements as part of the Center for Programming Models for Scalable Parallel Computing include: (1) design and implemention of cafc, the first multi-platform CAF compiler for distributed and shared-memory machines, (2) performance studies of the efficiency of programs written using the CAF and UPC programming models, (3) a novel technique to analyze explicitly-parallel SPMD programs that facilitates optimization, (4) design, implementation, and evaluation of new language features for CAF, including communication topologies, multi-version variables, and distributed multithreading to simplify development of high-performance codes in CAF, and (5) a synchronization strength reduction transformation for automatically replacing barrier-based synchronization with more efficient point-to-point synchronization. The prototype Co-array Fortran compiler cafc developed in this project is available as open source software from http://www.hipersoft.rice.edu/caf.
Date:
February 29, 2008
Creator:
Mellor-Crummey, John
Object Type:
Report
System:
The UNT Digital Library
CONSTRAINT EFFECT IN FRACTURE WHAT IS IT
The meaning of the phrase 'constraint effect in fracture' has changed in the past two decades from 'contained plasticity' to a broader description of 'dependence of fracture toughness value on geometry of test specimen or structure'. This paper will first elucidate the fundamental mechanics reasons for the apparent 'constraint effects in fracture', followed by outlining a straightforward approach to overcoming this problem in both brittle (elastic) and ductile (elastic-plastic) fracture. It is concluded by discussing the major difference in constraint effect on fracture event in elastic and elastic-plastic materials.
Date:
October 29, 2008
Creator:
Lam, P & Prof. Yuh J. Chao, P
Object Type:
Article
System:
The UNT Digital Library