A flexible nonlinear diffusion acceleration method for the S N transport equations discretized with discontinuous finite elements

DOE Office of Scientific and Technical Information (OSTI.GOV)

Schunert, Sebastian; Wang, Yaqi; Gleicher, Frederick

This paper presents a flexible nonlinear diffusion acceleration (NDA) method that discretizes both the S N transport equation and the diffusion equation using the discontinuous finite element method (DFEM). The method is flexible in that the diffusion equation can be discretized on a coarser mesh with the only restriction that it is nested within the transport mesh and the FEM shape function orders of the two equations can be different. The consistency of the transport and diffusion solutions at convergence is defined by using a projection operator mapping the transport into the diffusion FEM space. The diffusion weak form ismore » based on the modified incomplete interior penalty (MIP) diffusion DFEM discretization that is extended by volumetric drift, interior face, and boundary closure terms. In contrast to commonly used coarse mesh finite difference (CMFD) methods, the presented NDA method uses a full FEM discretized diffusion equation for acceleration. Suitable projection and prolongation operators arise naturally from the FEM framework. Via Fourier analysis and numerical experiments for a one-group, fixed source problem the following properties of the NDA method are established for structured quadrilateral meshes: (1) the presented method is unconditionally stable and effective in the presence of mild material heterogeneities if the same mesh and identical shape functions either of the bilinear or biquadratic type are used, (2) the NDA method remains unconditionally stable in the presence of strong heterogeneities, (3) the NDA method with bilinear elements extends the range of effectiveness and stability by a factor of two when compared to CMFD if a coarser diffusion mesh is selected. In addition, the method is tested for solving the C5G7 multigroup, eigenvalue problem using coarse and fine mesh acceleration. Finally, while NDA does not offer an advantage over CMFD for fine mesh acceleration, it reduces the iteration count required for convergence by almost a factor of two in the case of coarse mesh acceleration.« less

A flexible nonlinear diffusion acceleration method for the S N transport equations discretized with discontinuous finite elements

DOE PAGES

Schunert, Sebastian; Wang, Yaqi; Gleicher, Frederick; ...

2017-02-21

This paper presents a flexible nonlinear diffusion acceleration (NDA) method that discretizes both the S N transport equation and the diffusion equation using the discontinuous finite element method (DFEM). The method is flexible in that the diffusion equation can be discretized on a coarser mesh with the only restriction that it is nested within the transport mesh and the FEM shape function orders of the two equations can be different. The consistency of the transport and diffusion solutions at convergence is defined by using a projection operator mapping the transport into the diffusion FEM space. The diffusion weak form ismore » based on the modified incomplete interior penalty (MIP) diffusion DFEM discretization that is extended by volumetric drift, interior face, and boundary closure terms. In contrast to commonly used coarse mesh finite difference (CMFD) methods, the presented NDA method uses a full FEM discretized diffusion equation for acceleration. Suitable projection and prolongation operators arise naturally from the FEM framework. Via Fourier analysis and numerical experiments for a one-group, fixed source problem the following properties of the NDA method are established for structured quadrilateral meshes: (1) the presented method is unconditionally stable and effective in the presence of mild material heterogeneities if the same mesh and identical shape functions either of the bilinear or biquadratic type are used, (2) the NDA method remains unconditionally stable in the presence of strong heterogeneities, (3) the NDA method with bilinear elements extends the range of effectiveness and stability by a factor of two when compared to CMFD if a coarser diffusion mesh is selected. In addition, the method is tested for solving the C5G7 multigroup, eigenvalue problem using coarse and fine mesh acceleration. Finally, while NDA does not offer an advantage over CMFD for fine mesh acceleration, it reduces the iteration count required for convergence by almost a factor of two in the case of coarse mesh acceleration.« less

DOE Office of Scientific and Technical Information (OSTI.GOV)

Benda, Gary; Hayes, David; Gorham, Ron

The NDA participated in a panel session 31B on Wednesday afternoon starting at 3:15. The NDA is a non-departmental public body, set up in April 2005 under the Energy Act 2004 to take strategic responsibility for the UK's nuclear legacy. Details of their organization and history are located on their web site at www.nda.gov.uk. Also copies of their Power Point presentations made at WM'06 are available on their web site. Their core objective is to ensure that the 20 civil public sector nuclear sites under our ownership are decommissioned and cleaned up safely, securely, cost effectively and in ways thatmore » protect the environment for this and future generations. They lead the development of a unified and coherent decommissioning strategy, working in partnership with regulators and site licensees to achieve best value, optimum impact on local communities, and the highest environmental standards. The NDA's main task is the decommissioning and clean up of civil nuclear sites. If the Government decides it is necessary, however, the Energy Act 2004 allows the NDA to take responsibility for sites currently operated by, or on behalf of, the Ministry of Defence (MoD). Resources will then be transferred from the MoD to meet the costs of clean up. The NDA made a number of presentations to allow conference delegates the opportunity to understand some of the major aspects of their work and to interact with NDA staff. These included the following topics and gave opportunity for audience discussion: - A brief presentation to update on progress by the NDA; - Outline of low level waste management and the prioritisation process; - Discussion of the competition schedule related to low level waste management and the Drigg site. The following presentations and handout were delivered in various sessions of the conference as noted below and are available on their web page including the WM'06 Plenary Session presentation by Sir Anthony Cleaver, Chairman of the NDA. During Session 31B, the following Power Point presentations were made. NDA Overview by David Hayes, Director of Special Projects National M and O Contractor Work Prioritisation Process by Mark Wareing, including topics on: - Need for prioritisation; - Development of the process; - Using the process as a measure of progress. Competition by Ron Gorham, Head of Procurement, including topics on: - The current model; - What NDA are actually competing; - The acquisition process; - NDA aspirations for competition; - NDA aspirations from the market. Low Level Waste Contracting in the UK by Adrian Simper, Expenditure and Programme Strategy Manager, including topics on: - Low Level Waste: NDA responsibilities, Definitions, Arisings; - Proposed NDA Procurement for LLW Management: Scope, Contracting approach, Timetable. The NDA responded to questions from the audience and also announced that the NDA will be holding a special Industry Day for potential contractors interested in the first NDA competition - the Low Level Waste Repository near Drigg in Cumbria. The event is scheduled on the 25-26 April 2006 with more details on their web site at www.nda.gov.uk. (authors)« less

A new facility for non-destructive assay using a 252Cf source.

PubMed

Stevanato, L; Caldogno, M; Dima, R; Fabris, D; Hao, Xin; Lunardon, M; Moretto, S; Nebbia, G; Pesente, S; Pino, F; Sajo-Bohus, L; Viesti, G

2013-03-01

A new laboratory facility for non-destructive analysis (NDA) using a time-tagged (252)Cf source is presented. The system is designed to analyze samples having maximum size of about 20 × 25 cm(2), the material recognition being obtained by measuring simultaneously total and energy dependent transmission of neutrons and gamma rays. The equipment technical characteristics and performances of the NDA system are presented, exploring also limits due to the sample thickness. Some recent applications in the field of cultural heritage are presented. Copyright © 2012 Elsevier Ltd. All rights reserved.

Sanofi Pharmaceuticals, Inc., et al.; withdrawal of approval of 21 new drug applications and 62 abbreviated new drug applications--FDA. Notice.

PubMed

1998-05-12

The Food and Drug Administration (FDA) is withdrawing approval of 21 new drug applications (NDA's) and 62 abbreviated new drug applications (ANDA's). The holders of the applications notified the agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

Creating NDA working standards through high-fidelity spent fuel modeling

DOE Office of Scientific and Technical Information (OSTI.GOV)

Skutnik, Steven E; Gauld, Ian C; Romano, Catherine E

2012-01-01

The Next Generation Safeguards Initiative (NGSI) is developing advanced non-destructive assay (NDA) techniques for spent nuclear fuel assemblies to advance the state-of-the-art in safeguards measurements. These measurements aim beyond the capabilities of existing methods to include the evaluation of plutonium and fissile material inventory, independent of operator declarations. Testing and evaluation of advanced NDA performance will require reference assemblies with well-characterized compositions to serve as working standards against which the NDA methods can be benchmarked and for uncertainty quantification. To support the development of standards for the NGSI spent fuel NDA project, high-fidelity modeling of irradiated fuel assemblies is beingmore » performed to characterize fuel compositions and radiation emission data. The assembly depletion simulations apply detailed operating history information and core simulation data as it is available to perform high fidelity axial and pin-by-pin fuel characterization for more than 1600 nuclides. The resulting pin-by-pin isotopic inventories are used to optimize the NDA measurements and provide information necessary to unfold and interpret the measurement data, e.g., passive gamma emitters, neutron emitters, neutron absorbers, and fissile content. A key requirement of this study is the analysis of uncertainties associated with the calculated compositions and signatures for the standard assemblies; uncertainties introduced by the calculation methods, nuclear data, and operating information. An integral part of this assessment involves the application of experimental data from destructive radiochemical assay to assess the uncertainty and bias in computed inventories, the impact of parameters such as assembly burnup gradients and burnable poisons, and the influence of neighboring assemblies on periphery rods. This paper will present the results of high fidelity assembly depletion modeling and uncertainty analysis from independent calculations performed using SCALE and MCNP. This work is supported by the Next Generation Safeguards Initiative, Office of Nuclear Safeguards and Security, National Nuclear Security Administration.« less

21 CFR 20.117 - New drug information.

Code of Federal Regulations, 2011 CFR

2011-04-01

... covered by such applications. (b) Other computer printouts containing IND and NDA information are... computer printouts are available for public inspection in the Food and Drug Administration's Freedom of Information Public Room: (1) A numerical listing of all new drug applications and abbreviated new drug...

Interfacial behavior of N-nitrosodiethylamine/bovine serum albumin complexes at the air-water and the chloroform-water interfaces by axisymmetric drop tensiometry.

PubMed

Juárez, J; Galaz, J G; Machi, L; Burboa, M; Gutiérrez-Millán, L E; Goycoolea, F M; Valdez, M A

2007-03-15

Interfacial properties of N-nitrosodiethylamine/bovine serum albumin (NDA/BSA) complexes were investigated at the air-water interface. The interfacial behavior at the chloroform-water interface of the interaction product of phospholipid 1,2-dipalmitoyl-sn-glycero-3-phosphocholine (DPPC), dissolved in the chloroform phase, and NDA/BSA complex, in the aqueous phase, were also analyzed by using a drop tensiometer. The secondary structure changes of BSA with different NDA concentrations were monitored by circular dichroism spectroscopy at different pH and the NDA/BSA interaction was probed by fluorescence spectroscopy. Different NDA/BSA mixtures were prepared from 0, 7.5 x 10(-5), 2.2 x 10(-4), 3.7 x 10(-4), 5 x 10(-4), 1.6 x 10(-3), and 3.1 x 10(-3) M NDA solutions in order to afford 0, 300/1, 900/1, 1 500/1, 2 000/1, 6 000/1, and 12 500/1 NDA/BSA molar ratios, respectively, in the aqueous solutions. Increments of BSA alpha-helix contents were obtained up to the 2 000/1 NDA/BSA molar ratio, but at ratios beyond this value, the alpha-helix content practically disappeared. These BSA structure changes produced an increment of the surface pressure at the air-water interface, as the alpha-helix content increased with the concentration of NDA. On the contrary, when alpha-helix content decreased, the surface pressure also appeared lower than the one obtained with pure BSA solutions. The interaction of DPPC with NDA/BSA molecules at the chloroform-water interface produced also a small, but measurable, pressure increment with the addition of NDA molecules. Dynamic light scattering measurements of the molecular sizes of NDA/BSA complex at pH 4.6, 7.1, and 8.4 indicated that the size of extended BSA molecules at pH 4.6 increased in a greater proportion with the increment in NDA concentration than at the other studied pH values. Diffusion coefficients calculated from dynamic surface tension values, using a short-term solution of the general adsorption model of Ward and Tordai, also showed differences with pH and the NDA concentration. Both, the storage and loss dilatational elastic modulus were obtained at the air-water and at the chloroform-water interfaces. The interaction of NDA/BSA with DPPC at the chloroform-water produced a less rigid monolayer than the one obtained with pure DPPC (1 x 10(-5) M), indicating a significant penetration of NDA/BSA molecules at the interface. At short times and pH 4.6, the values of the storage elastic modulus were larger and more sensible to the NDA addition than the ones at pH 7.1 and 8.4, probably due to a gel-like network formation at the air-water interface.

16 CFR 1702.3 - Substantive requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 1702.3 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT REQUIREMENTS; PETITION PROCEDURES... (IND) or a New Drug Application (NDA). ...

77 FR 59196 - Anti-Infective Drugs Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-26

... committee information line to learn about possible modifications before coming to the meeting. Agenda: The committee will discuss the safety and efficacy of new drug application (NDA) 204384, bedaquiline tablets...

77 FR 17487 - Antiviral Drugs Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-26

... line/phone line to learn about possible modifications before coming to the meeting. Agenda: The committee will discuss new drug application (NDA) 203- 100, for a fixed-dose combination tablet of...

77 FR 16038 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-19

... and call the appropriate advisory committee hot line/phone line to learn about possible modifications... application (NDA) 22-529 (lorcaserin hydrochloride) tablets, manufactured by Arena Pharmaceuticals, Inc., as...

78 FR 734 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-04

... committee link, or call the advisory committee information line to learn about possible modifications before... new drug application (NDA) 022506, gabapentin 600 milligram (mg) tablets, submitted by Depomed, Inc...

78 FR 25749 - Submission of New Drug Application/Abbreviated New Drug Application Field Alert Reports: Notice...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-02

... language)-enabled Adobe PDF form, Form FDA 3331--Automated to submit new drug application (NDA) and...-enabled Adobe PDF form, Form FDA 3331--Automated, will be available for piloting between May 1, 2013, and... modernize the FAR submission and review pathway using an XML-enabled PDF form to enable integration with...

21 CFR 312.47 - Meetings.

Code of Federal Regulations, 2010 CFR

2010-04-01

... resources permit. The general principle underlying the conduct of such meetings is that there should be free...) “End-of-Phase 2” meetings and meetings held before submission of a marketing application. At specific... meetings held near completion of Phase 3 and before submission of a marketing application (“pre-NDA...

75 FR 80061 - Abbott Laboratories, Inc.; Withdrawal of Approval of a New Drug Application for MERIDIA

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-21

... withdrawing approval of a new drug application (NDA) for MERIDIA (sibutramine hydrochloride (HCl)) oral... requested that Abbott voluntarily withdraw MERIDIA (sibutramine HCl) oral capsules from the market, based on FDA's recent analysis of clinical trial data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT...

75 FR 8970 - Guidance for Industry on Submission of Documentation in Applications for Parametric Release of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-26

... Veterinary Drug Products Terminally Sterilized by Moist Heat Processes; Availability AGENCY: Food and Drug... Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes.'' This... for sterile products terminally sterilized by moist heat when submitting a new drug application (NDA...

Simultaneous observations of solar sporadic radio emission by the radio telescopes UTR-2, URAN-2 and NDA within the frequency range 8-41MHz

NASA Astrophysics Data System (ADS)

Melnik, V. N.; Konovalenko, A. A.; Rucker, H. O.; Brazhenko, A. I.; Briand, C.; Dorovskyy, V. V.; Zarka, P.; Denis, L.; Bulatzen, V. G.; Frantzusenko, A. V.; Stanislavskyy, A. A.

2012-04-01

From 25 June till 12 August 2011 sporadic solar radio emission was observed simultaneously by three separate radio telescopes: UTR-2 (Kharkov, Ukraine), URAN-2 (Poltava, Ukraine) and NDA (Nancay, France). During these observations several type II bursts with double and triple harmonics were registered, as well as type II bursts with complex herringbone structure. The events of particular interest were type II bursts registered on 9 and 11 August 2011. These bursts had opposite sign of circular polarization at different parts of their dynamic spectra. In our opinion we registered the emissions, which came from the different parts of the shock propagating through the solar corona. We have observed also groups of type III bursts merged into one burst, type III bursts with triple harmonics and type III bursts with "split" polarization. In addition some unusual solar bursts were registered: storms of strange narrow-band (up to 500kHz) bursts with high polarization degree (about 80%), decameter spikes of extremely short durations (200-300ms), "tadpole-like" bursts with durations of 1-2s and polarization degree up to 60%.

77 FR 13612 - Anti-Infective Drugs Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-07

.../phone line to learn about possible modifications before coming to the meeting. Agenda: On April 3, 2012... supplements for LEVAQUIN (levofloxacin) tablets, injection, and oral solution (NDA 20-634, NDA 20-635, and NDA...

77 FR 24724 - Sanofi-aventis, U.S., LLC; Withdrawal of Approval of a New Drug Application for OFORTA

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-25

... withdrawing approval of a new drug application (NDA) for OFORTA (fludarabine phosphate) Tablets held by sanofi... (fludarabine phosphate) Tablets on December 18, 2008, under the Agency's accelerated approval regulations, 21..., 2011, FDA requested that sanofi-aventis voluntarily withdraw OFORTA (fludarabine phosphate) Tablets...

77 FR 24723 - AstraZeneca Pharmaceuticals LP; Withdrawal of Approval of a New Drug Application for IRESSA

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-25

... withdrawing approval of a new drug application (NDA) for IRESSA (gefitinib) Tablets held by AstraZeneca... Spring, MD 20993-0002, 301- 796-3601. SUPPLEMENTARY INFORMATION: FDA approved IRESSA (gefitinib) Tablets... voluntarily withdraw IRESSA (gefitinib) Tablets from the market, because the postmarketing studies required as...

78 FR 33426 - Eli Lilly and Co.; Withdrawal of Approval of a New Drug Application for ORAFLEX

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-04

... new drug application (NDA) for ORAFLEX (benoxaprofen) Tablets, held by Eli Lilly and Co. (Lilly.... SUPPLEMENTARY INFORMATION: On April 19, 1982, FDA approved ORAFLEX (benoxaprofen) Tablets, a nonsteroidal [[Page... voluntarily withdrew ORAFLEX (benoxaprofen) Tablets from the market because of postmarketing reports of severe...

78 FR 38053 - Determination That OPANA ER (Oxymorphone Hydrochloride) Drug Products Covered by New Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-25

...] Determination That OPANA ER (Oxymorphone Hydrochloride) Drug Products Covered by New Drug Application 21-610... (oxymorphone hydrochloride (HCl)) Extended-Release Tablet products approved under new drug application (NDA) 21... refer to these drug products, and it will allow FDA to continue to approve ANDAs for oxymorphone HCl...

Multi-objective evolutionary optimization for constructing neural networks for virtual reality visual data mining: application to geophysical prospecting.

PubMed

Valdés, Julio J; Barton, Alan J

2007-05-01

A method for the construction of virtual reality spaces for visual data mining using multi-objective optimization with genetic algorithms on nonlinear discriminant (NDA) neural networks is presented. Two neural network layers (the output and the last hidden) are used for the construction of simultaneous solutions for: (i) a supervised classification of data patterns and (ii) an unsupervised similarity structure preservation between the original data matrix and its image in the new space. A set of spaces are constructed from selected solutions along the Pareto front. This strategy represents a conceptual improvement over spaces computed by single-objective optimization. In addition, genetic programming (in particular gene expression programming) is used for finding analytic representations of the complex mappings generating the spaces (a composition of NDA and orthogonal principal components). The presented approach is domain independent and is illustrated via application to the geophysical prospecting of caves.

PWR and BWR spent fuel assembly gamma spectra measurements

NASA Astrophysics Data System (ADS)

Vaccaro, S.; Tobin, S. J.; Favalli, A.; Grogan, B.; Jansson, P.; Liljenfeldt, H.; Mozin, V.; Hu, J.; Schwalbach, P.; Sjöland, A.; Trellue, H.; Vo, D.

2016-10-01

A project to research the application of nondestructive assay (NDA) to spent fuel assemblies is underway. The research team comprises the European Atomic Energy Community (EURATOM), embodied by the European Commission, DG Energy, Directorate EURATOM Safeguards; the Swedish Nuclear Fuel and Waste Management Company (SKB); two universities; and several United States national laboratories. The Next Generation of Safeguards Initiative-Spent Fuel project team is working to achieve the following technical goals more easily and efficiently than in the past using nondestructive assay measurements of spent fuel assemblies: (1) verify the initial enrichment, burnup, and cooling time of facility declaration; (2) detect the diversion or replacement of pins, (3) estimate the plutonium mass, (4) estimate the decay heat, and (5) determine the reactivity of spent fuel assemblies. This study focuses on spectrally resolved gamma-ray measurements performed on a diverse set of 50 assemblies [25 pressurized water reactor (PWR) assemblies and 25 boiling water reactor (BWR) assemblies]; these same 50 assemblies will be measured with neutron-based NDA instruments and a full-length calorimeter. Given that encapsulation/repository and dry storage safeguards are the primarily intended applications, the analysis focused on the dominant gamma-ray lines of 137Cs, 154Eu, and 134Cs because these isotopes will be the primary gamma-ray emitters during the time frames of interest to these applications. This study addresses the impact on the measured passive gamma-ray signals due to the following factors: burnup, initial enrichment, cooling time, assembly type (eight different PWR and six different BWR fuel designs), presence of gadolinium rods, and anomalies in operating history. To compare the measured results with theory, a limited number of ORIGEN-ARP simulations were performed.

PWR and BWR spent fuel assembly gamma spectra measurements

DOE Office of Scientific and Technical Information (OSTI.GOV)

Vaccaro, S.; Tobin, Stephen J.; Favalli, Andrea

A project to research the application of nondestructive assay (NDA) to spent fuel assemblies is underway. The research team comprises the European Atomic Energy Community (EURATOM), embodied by the European Commission, DG Energy, Directorate EURATOM Safeguards; the Swedish Nuclear Fuel and Waste Management Company (SKB); two universities; and several United States national laboratories. The Next Generation of Safeguards Initiative–Spent Fuel project team is working to achieve the following technical goals more easily and efficiently than in the past using nondestructive assay measurements of spent fuel assemblies: (1) verify the initial enrichment, burnup, and cooling time of facility declaration; (2) detectmore » the diversion or replacement of pins, (3) estimate the plutonium mass, (4) estimate the decay heat, and (5) determine the reactivity of spent fuel assemblies. This study focuses on spectrally resolved gamma-ray measurements performed on a diverse set of 50 assemblies [25 pressurized water reactor (PWR) assemblies and 25 boiling water reactor (BWR) assemblies]; these same 50 assemblies will be measured with neutron-based NDA instruments and a full-length calorimeter. Given that encapsulation/repository and dry storage safeguards are the primarily intended applications, the analysis focused on the dominant gamma-ray lines of 137Cs, 154Eu, and 134Cs because these isotopes will be the primary gamma-ray emitters during the time frames of interest to these applications. This study addresses the impact on the measured passive gamma-ray signals due to the following factors: burnup, initial enrichment, cooling time, assembly type (eight different PWR and six different BWR fuel designs), presence of gadolinium rods, and anomalies in operating history. As a result, to compare the measured results with theory, a limited number of ORIGEN-ARP simulations were performed.« less

PWR and BWR spent fuel assembly gamma spectra measurements

DOE PAGES

Vaccaro, S.; Tobin, Stephen J.; Favalli, Andrea; ...

2016-07-17

A project to research the application of nondestructive assay (NDA) to spent fuel assemblies is underway. The research team comprises the European Atomic Energy Community (EURATOM), embodied by the European Commission, DG Energy, Directorate EURATOM Safeguards; the Swedish Nuclear Fuel and Waste Management Company (SKB); two universities; and several United States national laboratories. The Next Generation of Safeguards Initiative–Spent Fuel project team is working to achieve the following technical goals more easily and efficiently than in the past using nondestructive assay measurements of spent fuel assemblies: (1) verify the initial enrichment, burnup, and cooling time of facility declaration; (2) detectmore » the diversion or replacement of pins, (3) estimate the plutonium mass, (4) estimate the decay heat, and (5) determine the reactivity of spent fuel assemblies. This study focuses on spectrally resolved gamma-ray measurements performed on a diverse set of 50 assemblies [25 pressurized water reactor (PWR) assemblies and 25 boiling water reactor (BWR) assemblies]; these same 50 assemblies will be measured with neutron-based NDA instruments and a full-length calorimeter. Given that encapsulation/repository and dry storage safeguards are the primarily intended applications, the analysis focused on the dominant gamma-ray lines of 137Cs, 154Eu, and 134Cs because these isotopes will be the primary gamma-ray emitters during the time frames of interest to these applications. This study addresses the impact on the measured passive gamma-ray signals due to the following factors: burnup, initial enrichment, cooling time, assembly type (eight different PWR and six different BWR fuel designs), presence of gadolinium rods, and anomalies in operating history. As a result, to compare the measured results with theory, a limited number of ORIGEN-ARP simulations were performed.« less

Analysis of historical delta values for IAEA/LANL NDA training courses

DOE Office of Scientific and Technical Information (OSTI.GOV)

Geist, William; Santi, Peter; Swinhoe, Martyn

2009-01-01

The Los Alamos National Laboratory (LANL) supports the International Atomic Energy Agency (IAEA) by providing training for IAEA inspectors in neutron and gamma-ray Nondestructive Assay (NDA) of nuclear material. Since 1980, all new IAEA inspectors attend this two week course at LANL gaining hands-on experience in the application of NDA techniques, procedures and analysis to measure plutonium and uranium nuclear material standards with well known pedigrees. As part of the course the inspectors conduct an inventory verification exercise. This exercise provides inspectors the opportunity to test their abilities in performing verification measurements using the various NDA techniques. For an inspector,more » the verification of an item is nominally based on whether the measured assay value agrees with the declared value to within three times the historical delta value. The historical delta value represents the average difference between measured and declared values from previous measurements taken on similar material with the same measurement technology. If the measurement falls outside a limit of three times the historical delta value, the declaration is not verified. This paper uses measurement data from five years of IAEA courses to calculate a historical delta for five non-destructive assay methods: Gamma-ray Enrichment, Gamma-ray Plutonium Isotopics, Passive Neutron Coincidence Counting, Active Neutron Coincidence Counting and the Neutron Coincidence Collar. These historical deltas provide information as to the precision and accuracy of these measurement techniques under realistic conditions.« less

Environmental assessments and findings of no significant impact--FDA. Notice.

PubMed

1998-05-18

The Food and Drug Administration (FDA) is announcing that it has reviewed environmental assessments (EA's) and issued findings of no significant impact (FONSI's) relating to the 167 new drug applications (NDA's) and supplemental applications listed in this document. FDA is publishing this notice because Federal regulations require public notice of the availability of environmental documents.

76 FR 14023 - Determination that ROCEPHIN (Ceftriaxone Sodium) Injection, 250 Milligrams, 500 Milligrams, 1...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-15

...] Determination that ROCEPHIN (Ceftriaxone Sodium) Injection, 250 Milligrams, 500 Milligrams, 1 Gram, 2 Grams, and 10 Grams Base/Vial, Approved Under New Drug Application 050585, Were Not Withdrawn From Sale for... milligrams (mg), 500mg, 1 gram (g), 2g, and 10g base/vial, approved under new drug application (NDA) 050585...

77 FR 40367 - Wyeth Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for DURACT Capsules

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-09

... withdrawing approval of a new drug application (NDA) for DURACT (bromfenac sodium) Capsules, held by Wyeth... voluntarily withdrew DURACT (bromfenac sodium) Capsules from the market. DURACT (bromfenac sodium) Capsules, a... sodium) Capsules, under Sec. 314.150(d) (21 CFR 314.150(d)). In that letter, Wyeth also waived its...

DOE Office of Scientific and Technical Information (OSTI.GOV)

Keepin, G.R.

Over the years the Los Alamos safeguards program has developed, tested, and implemented a broad range of passive and active nondestructive analysis (NDA) instruments (based on gamma and x-ray detection and neutron counting) that are now widely employed in safeguarding nuclear materials of all forms. Here very briefly, the major categories of gamma ray and neutron based NDA techniques, give some representative examples of NDA instruments currently in use, and cite a few notable instances of state-of-the-art NDA technique development. Historical aspects and a broad overview of the safeguards program are also presented.

Equilibrium and heat of adsorption of diethyl phthalate on heterogeneous adsorbents.

PubMed

Zhang, Weiming; Xu, Zhengwen; Pan, Bingcai; Hong, Changhong; Jia, Kun; Jiang, Peijuan; Zhang, Qingjian; Pan, Bingjun

2008-09-01

Removal of phthalate esters from water has been of considerable concern recently. In the present study, the adsorptive removal performance of diethyl phthalate (DEP) from water was investigated with the aminated polystyrene resin (NDA-101) and oxidized polystyrene resin (NDA-702). In addition, the commercial homogeneous polystyrene resin (XAD-4) and acrylic ester resin (Amberlite XAD-7) as well as coal-based granular activated carbon (AC-750) were chosen for comparison. The corresponding equilibrium isotherms are well described by the Freundlich equation and the adsorption capacities for DEP followed the order NDA-702 > NDA-101 > AC-750 > XAD-4 > XAD-7. Analysis of adsorption mechanisms suggested that these adsorbents spontaneously adsorb DEP molecules driven mainly by enthalpy change, and the adsorption process was derived by multiple adsorbent-adsorbate interactions such as hydrogen bonding, pi-pi stacking, and micropore filling. The information related to the adsorbent surface heterogeneity and the adsorbate-adsorbate interaction was obtained by Do's model. All the results indicate that heterogeneous resins NDA-702 and NDA-101 have excellent potential as an adsorption material for the removal of DEP from the contaminated water.

Beaming Structures of Jupiter's Decametric Radiation from LWA1, NDA, and URAN2 Simultaneous Observations

NASA Astrophysics Data System (ADS)

Imai, M.; Lecacheux, A.; Higgins, C. A.; Clarke, T.; Panchenko, M.; Brazhenko, A. I.; Frantsuzenko, A. V.; Konovalenko, A. A.; Imai, K.

2015-12-01

From December 2014 to March 2015, Jupiter's decametric (DAM) radio observations were carried out by using simultaneously three powerful low-frequency radio telescopes: Long Wavelength Array One (LWA1), Socorro, USA; Nançay Decameter Array (NDA), Nançay, France; and URAN2 telescope, Poltava, Ukraine. Baselines are 10000, 8600, and 2400 kilometers for LWA1-URAN2, NDA-LWA1, and URAN2-NDA, respectively. One Io-B and two Io-A emissions were simultaneously observed. Using cross-correlation analysis of obtained spectrograms, it was found that, as a function of lag time in a pair of two stations, Io-B (mainly S-bursts) and Io-A (L-bursts) show different kinds of cross-correlation coefficients, with sharp and broad peaks, respectively. By measuring lag times between LWA1-URAN2, NDA-LWA1, and URAN2-NDA pairs, it can be tested if either flashlight- or beacon-like beaming is emanated from Jupiter. Measurements of beaming width are also analyzed. Most probable beaming scenarios for Io-B and -A events are suggested.

78 FR 63228 - Determination That Potassium Citrate, 10 Milliequivalents/Packet and 20 Milliequivalents/Packet...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-23

... approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain... mEq/packet and 20 mEq/packet, is the subject of NDA 19-647, held by Nova-K LLC, and initially...

Neural correlates of nondual awareness in meditation.

PubMed

Josipovic, Zoran

2014-01-01

Dualities such as self versus other, good versus bad, and in-group versus out-group are pervasive features of human experience, structuring the majority of cognitive and affective processes. Yet, an entirely different way of experiencing, one in which such dualities are relaxed rather than fortified, is also available. It depends on recognizing, within the stream of our consciousness, the nondual awareness (NDA)--a background awareness that precedes conceptualization and intention and that can contextualize various perceptual, affective, or cognitive contents without fragmenting the field of experience into habitual dualities. This paper introduces NDA as experienced in Tibetan Buddhist meditation and reviews the results of our study on the influence of NDA on anticorrelated intrinsic and extrinsic networks in the brain. Also discussed are preliminary data from a current study of NDA with minimized phenomenal content that points to involvement of a precuneus network in NDA. © 2013 New York Academy of Sciences.

ARIES NDA Robot operators` manual

DOE Office of Scientific and Technical Information (OSTI.GOV)

Scheer, N.L.; Nelson, D.C.

1998-05-01

The ARIES NDA Robot is an automation device for servicing the material movements for a suite of Non-destructive assay (NDA) instruments. This suite of instruments includes a calorimeter, a gamma isotopic system, a segmented gamma scanner (SGS), and a neutron coincidence counter (NCC). Objects moved by the robot include sample cans, standard cans, and instrument plugs. The robot computer has an RS-232 connection with the NDA Host computer, which coordinates robot movements and instrument measurements. The instruments are expected to perform measurements under the direction of the Host without operator intervention. This user`s manual describes system startup, using the mainmore » menu, manual operation, and error recovery.« less

Information Model for Reusability in Clinical Trial Documentation

ERIC Educational Resources Information Center

Bahl, Bhanu

2013-01-01

In clinical research, New Drug Application (NDA) to health agencies requires generation of a large number of documents throughout the clinical development life cycle, many of which are also submitted to public databases and external partners. Current processes to assemble the information, author, review and approve the clinical research documents,…

21 CFR 312.47 - Meetings.

Code of Federal Regulations, 2013 CFR

2013-04-01

... meetings held near completion of Phase 3 and before submission of a marketing application (“pre-NDA... uses under investigation. (ii) Eligibility for meeting. While the end-of-Phase 2 meeting is designed... Phase 3 tests are made. The scheduling of an end-of-Phase 2 meeting is not, however, intended to delay...

76 FR 14027 - Antiviral Drugs Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-15

..., 2011, the committee will discuss a new drug application (NDA) 201-917, telaprevir (a hepatitis C virus... treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin (two medicines approved to treat chronic hepatitis C infection) in adult patients with compensated...

76 FR 14026 - Antiviral Drugs Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-15

..., 2011, the committee will discuss a new drug application (NDA) 202-258, boceprevir (a hepatitis C virus... chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin (two medicines approved to treat chronic hepatitis C infection) in adult patients with compensated liver disease...

Calibrating and training of neutron based NSA techniques with less SNM standards

DOE Office of Scientific and Technical Information (OSTI.GOV)

Geist, William H; Swinhoe, Martyn T; Bracken, David S

2010-01-01

Accessing special nuclear material (SNM) standards for the calibration of and training on nondestructive assay (NDA) instruments has become increasingly difficult in light of enhanced safeguards and security regulations. Limited or nonexistent access to SNM has affected neutron based NDA techniques more than gamma ray techniques because the effects of multiplication require a range of masses to accurately measure the detector response. Neutron based NDA techniques can also be greatly affected by the matrix and impurity characteristics of the item. The safeguards community has been developing techniques for calibrating instrumentation and training personnel with dwindling numbers of SNM standards. Montemore » Carlo methods have become increasingly important for design and calibration of instrumentation. Monte Carlo techniques have the ability to accurately predict the detector response for passive techniques. The Monte Carlo results are usually benchmarked to neutron source measurements such as californium. For active techniques, the modeling becomes more difficult because of the interaction of the interrogation source with the detector and nuclear material; and the results cannot be simply benchmarked with neutron sources. A Monte Carlo calculated calibration curve for a training course in Indonesia of material test reactor (MTR) fuel elements assayed with an active well coincidence counter (AWCC) will be presented as an example. Performing training activities with reduced amounts of nuclear material makes it difficult to demonstrate how the multiplication and matrix properties of the item affects the detector response and limits the knowledge that can be obtained with hands-on training. A neutron pulse simulator (NPS) has been developed that can produce a pulse stream representative of a real pulse stream output from a detector measuring SNM. The NPS has been used by the International Atomic Energy Agency (IAEA) for detector testing and training applications at the Agency due to the lack of appropriate SNM standards. This paper will address the effect of reduced access to SNM for calibration and training of neutron NDA applications along with the advantages and disadvantages of some solutions that do not use standards, such as the Monte Carlo techniques and the NPS.« less

A Tale of Two Citizens: A State Attorney General and a Hematologist Facilitate Translation of Research Into US Food and Drug Administration Actions—A SONAR Report

PubMed Central

Chen, Brian; Restaino, John; Norris, LeAnn; Xirasagar, Sudha; Qureshi, Zaina P.; McKoy, June M.; Lopez, Isaac S.; Trenery, Alyssa; Murday, Alanna; Kahn, Adam; Mattison, Donald R.; Ray, Paul; Sartor, Oliver; Bennett, Charles L.

2012-01-01

Purpose: Pharmaceutical safety is a public health issue. In 2005, the Connecticut Attorney General (AG) raised concerns over adverse drug reactions in off-label settings, noting that thalidomide was approved to treat a rare illness, but more than 90% of its use was off label. A hematologist had reported thalidomide with doxorubicin or dexamethasone was associated with venous thromboembolism (VTE) rates of 25%. We review US Food and Drug Administration (FDA) and manufacturer responses to a citizen petition filed to address these thalidomide safety issues. Methods: Case study. Results: The AG petitioned the FDA requesting thalidomide-related safety actions. Coincidentally, the manufacturer submitted a supplemental New Drug Approval (sNDA), requesting approval to treat multiple myeloma with thalidomide-dexamethasone. FDA safety officers reviewed the petition and the literature and noted that VTE risks with thalidomide were not appropriately addressed in the existing package insert. In the sNDA application, the manufacturer reported thalidomide-associated toxicities for multiple myeloma were primarily somnolence and neurotoxicity, and a proposed package insert did not focus on VTE risks. In October, the FDA informed the Oncology Drug Division that VTE risks with thalidomide were poorly addressed in the existing label. After reviewing this memorandum, an Oncology Drug Division reviewer informed the manufacturer that approval of the sNDA would be delayed until several thalidomide-associated VTE safety actions, including revisions of the package insert, were implemented. The manufacturer and FDA agreed on these actions, and the sNDA was approved. Conclusion: New approaches addressing off-label safety are needed. The conditions that facilitated the successful response to this citizen petition are uncommon. PMID:23598851

A tale of two citizens: a State Attorney General and a hematologist facilitate translation of research into US Food and Drug Administration actions--a SONAR report.

PubMed

Chen, Brian; Restaino, John; Norris, LeAnn; Xirasagar, Sudha; Qureshi, Zaina P; McKoy, June M; Lopez, Isaac S; Trenery, Alyssa; Murday, Alanna; Kahn, Adam; Mattison, Donald R; Ray, Paul; Sartor, Oliver; Bennett, Charles L

2012-11-01

Pharmaceutical safety is a public health issue. In 2005, the Connecticut Attorney General (AG) raised concerns over adverse drug reactions in off-label settings, noting that thalidomide was approved to treat a rare illness, but more than 90% of its use was off label. A hematologist had reported thalidomide with doxorubicin or dexamethasone was associated with venous thromboembolism (VTE) rates of 25%. We review US Food and Drug Administration (FDA) and manufacturer responses to a citizen petition filed to address these thalidomide safety issues. Case study. The AG petitioned the FDA requesting thalidomide-related safety actions. Coincidentally, the manufacturer submitted a supplemental New Drug Approval (sNDA), requesting approval to treat multiple myeloma with thalidomide-dexamethasone. FDA safety officers reviewed the petition and the literature and noted that VTE risks with thalidomide were not appropriately addressed in the existing package insert. In the sNDA application, the manufacturer reported thalidomide-associated toxicities for multiple myeloma were primarily somnolence and neurotoxicity, and a proposed package insert did not focus on VTE risks. In October, the FDA informed the Oncology Drug Division that VTE risks with thalidomide were poorly addressed in the existing label. After reviewing this memorandum, an Oncology Drug Division reviewer informed the manufacturer that approval of the sNDA would be delayed until several thalidomide-associated VTE safety actions, including revisions of the package insert, were implemented. The manufacturer and FDA agreed on these actions, and the sNDA was approved. New approaches addressing off-label safety are needed. The conditions that facilitated the successful response to this citizen petition are uncommon.

Ferromagnetic interactions and slow magnetic relaxation behaviors of two lanthanide coordination polymers bridged by 2,6-naphthalenedicarboxylate ligand

DOE Office of Scientific and Technical Information (OSTI.GOV)

Fang, Ming; Li, Xiuhua; Cui, Ping

2015-03-15

Two lanthanide-based frameworks: (Ln(phen)(NDA){sub 1.5}(H{sub 2}O)){sub n} (Ln=Gd(1), NDA=2,6-naphthalenedicarboxylate anion, phen=1,10-phenanthroline), and ([Dy(phen)(NDA){sub 1.5}]·0.5H{sub 2}NDA){sub n} (2) were structurally and magnetically characterized. Compound 1 exhibits 2D layer structure, belonging to the triclinic system with space group P−1, while compound 2 features a 3D framework with space group P−1. The magnetic studies revealed that ferromagnetic coupling existed between adjacent lanthanide ions in 1 and 2, and frequency-dependence out-of-phase signals in the measurement of alternate-current susceptibilities were observed for 2, albeit without reaching the characteristic maxima above 2 K, implying slow magnetic relaxation behavior in 2. After the application of a dcmore » field, good peak shapes of ac signal were obtained and got the energy barrier ΔE/k{sub B}=29 K and the pre-exponential factor τ{sub 0}=4.47×10{sup −7} s at 2000 Oe field; and when the dc field was in 5000 Oe, giving ΔE/k{sub B}=40 K and τ{sub 0}=2.82×10{sup −6}. - Graphical abstract: Two novel lanthanide-based frameworks 1 and 2 were structurally and magnetically characterized. The results revealed that ferromagnetic coupling exists between adjacent lanthanide ions in 1 and 2, and 2 displayed slow magnetic relaxation behavior with the energy barrier of 29 K. - Highlights: • Two lanthanide frameworks were synthesized and magnetically characterized. • The magnetism studies indicate slow magnetic relaxation behavior in 2. • Weak ferromagnetic coupling existing between adjacent lanthanide centers.« less

Treatment of aqueous diethyl phthalate by adsorption using a functional polymer resin.

PubMed

Xu, Zhengwen; Zhang, Weiming; Pan, Bingcai; Lv, Lu; Jiang, Zhengmao

2011-01-01

To study the adsorptive separation efficiency, adsorption and desorption performances of diethyl phthalate (DEP) were investigated with a functional polymer resin (NDA-702). A macroporous polymer resin (XAD-4) and a coal-based granular activated carbon (AC-750) were chosen for comparison. The kinetic adsorption data obeyed the pseudo-second-order rate model, and the adsorption processes were limited by both film and intraparticle diffusions. Adsorption equilibrium data were well fitted by the Freundlich equation, and the larger uptake and higher selection of NDA-702 than AC-750 and XAD-4 was probably due to the microporous structure, phenyl rings and polar groups on NDA-702. Thermodynamic adsorption studies indicated that the test adsorbents spontaneously adsorbed DEP, driven mainly by enthalpy change. Continuous fixed-bed runs demonstrated that there no significant loss of the resin's adsorption capacity and there was complete regeneration of NDA-702. The results suggest that NDA-702 has excellent potential as an adsorption material for water treatment.

Nondestructive Assay Data Integration with the SKB-50 Assemblies - FY16 Update

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tobin, Stephen Joseph; Fugate, Michael Lynn; Trellue, Holly Renee

2016-10-28

A project to research the application of non-destructive assay (NDA) techniques for spent fuel assemblies is underway at the Central Interim Storage Facility for Spent Nuclear Fuel (for which the Swedish acronym is Clab) in Oskarshamn, Sweden. The research goals of this project contain both safeguards and non-safeguards interests. These nondestructive assay (NDA) technologies are designed to strengthen the technical toolkit of safeguard inspectors and others to determine the following technical goals more accurately; Verify initial enrichment, burnup, and cooling time of facility declaration for spent fuel assemblies; Detect replaced or missing pins from a given spent fuel assembly tomore » confirm its integrity; and Estimate plutonium mass and related plutonium and uranium fissile mass parameters in spent fuel assemblies. Estimate heat content, and measure reactivity (multiplication).« less

77 FR 6804 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-09

... symptoms of urge urinary incontinence, urgency, and urinary frequency. Mirabegron is a beta-3- adrenoceptor (AR) agonist and is a new molecular entity. The benefit/ risk discussion will focus on the adequacy of... benefits and risks of mirabegron (YM178), under new drug application (NDA) 202611, submitted by Astellas...

77 FR 29665 - Determination That PITRESSIN TANNATE IN OIL (Vasopressin Tannate) Injection, 5 Pressor Units...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-18

... Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION... safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications... suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines...

75 FR 14444 - Determination That DIDREX (Benzphetamine Hydrochloride) Tablets, 25 Milligrams, Were Not...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-25

... Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug... safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications... or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA...

76 FR 44012 - Determination That NUVIGIL (Armodafinil) Tablets, 100 Milligrams and 200 Milligrams, Were Not...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-22

... Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug... effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for... the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed...

NDA issues with RFETS vitrified waste forms

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hurd, J.; Veazey, G.

1998-12-31

A study was conducted at Los Alamos National Laboratory (LANL) for the purpose of determining the feasibility of using a segmented gamma scanner (SGS) to accurately perform non-destructive analysis (NDA) on certain Rocky Flats Environmental Technology Site (RFETS) vitrified waste samples. This study was performed on a full-scale vitrified ash sample prepared at LANL according to a procedure similar to that anticipated to be used at RFETS. This sample was composed of a borosilicate-based glass frit, blended with ash to produce a Pu content of {approximately}1 wt %. The glass frit was taken to a degree of melting necessary tomore » achieve a full encapsulation of the ash material. The NDA study performed on this sample showed that SGSs with either {1/2}- or 2-inch collimation can achieve an accuracy better than 6 % relative to calorimetry and {gamma}-ray isotopics. This accuracy is achievable, after application of appropriate bias corrections, for transmissions of about {1/2} % through the waste form and counting times of less than 30 minutes. These results are valid for ash material and graphite fines with the same degree of plutonium particle size, homogeneity, sample density, and sample geometry as the waste form used to obtain the results in this study. A drum-sized thermal neutron counter (TNC) was also included in the study to provide an alternative in the event the SGS failed to meet the required level of accuracy. The preliminary indications are that this method will also achieve the required accuracy with counting times of {approximately}30 minutes and appropriate application of bias corrections. The bias corrections can be avoided in all cases if the instruments are calibrated on standards matching the items.« less

Active and passive computed tomography mixed waste focus area final report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Roberson, G P

1998-08-19

The Mixed Waste Focus Area (MWFA) Characterization Development Strategy delineates an approach to resolve technology deficiencies associated with the characterization of mixed wastes. The intent of this strategy is to ensure the availability of technologies to support the Department of Energy's (DOE) mixed waste low-level or transuranic (TRU) contaminated waste characterization management needs. To this end the MWFA has defined and coordinated characterization development programs to ensure that data and test results necessary to evaluate the utility of non-destructive assay technologies are available to meet site contact handled waste management schedules. Requirements used as technology development project benchmarks are basedmore » in the National TRU Program Quality Assurance Program Plan. These requirements include the ability to determine total bias and total measurement uncertainty. These parameters must be completely evaluated for waste types to be processed through a given nondestructive waste assay system constituting the foundation of activities undertaken in technology development projects. Once development and testing activities have been completed, Innovative Technology Summary Reports are generated to provide results and conclusions to support EM-30, -40, or -60 end user/customer technology selection. The Active and Passive Computed Tomography non-destructive assay system is one of the technologies selected for development by the MWFA. Lawrence Livermore National Laboratory's (LLNL) is developing the Active and Passive Computed Tomography (A&PCT) nondestructive assay (NDA) technology to identify and accurately quantify all detectable radioisotopes in closed containers of waste. This technology will be applicable to all types of waste regardless of .their classification; low level, transuranic or provide results and conclusions to support EM-30, -40, or -60 end user/customer technology selection. The Active and Passive Computed Tomography non-destructive assay system is one of the technologies selected for development by the MWFA. Lawrence Livermore National Laboratory's (LLNL) is developing the Active and Passive Computed Tomography (A&PCT) nondestructive assay (NDA) technology to identify and accurately quantify all detectable radioisotopes in closed containers of waste. This technology will be applicable to all types of waste regardless of .their classification; low level, transuranic or mixed, which contains radioactivity and hazardous organic species. The scope of our technology is to develop a non-invasive waste-drum scanner that employs the principles of computed tomography and gamma-ray spectral analysis to identify and quantify all of the detectable radioisotopes. Once this and other applicable technologies are developed, waste drums can be non- destructively and accurately characterized to satisfy repository and regulatory guidelines prior to disposal.« less

An experimental evaluation of a new designed apparatus (NDA) for the rapid measurement of impaired motor function in rats.

PubMed

Jarrahi, M; Sedighi Moghadam, B; Torkmandi, H

2015-08-15

Assessment of the ability of rat to balance by rotarod apparatus (ROTA) is frequently used as a measure of impaired motor system function. Most of these methods have some disadvantages, such as failing to sense motor coordination rather than endurance and as the sensitivity of the method is low, more animals are needed to obtain statistically significant results. We have designed and tested a new designed apparatus (NDA) to measure motor system function in rats. Our system consists of a glass box containing 4 beams which placed with 1cm distance between them, two electrical motors for rotating the beams, and a camera to record the movements of the rats. The RPM of the beams is adjustable digitally between 0 and 50 rounds per minute. We evaluated experimentally the capability of the NDA for the rapid measurement of impaired motor function in rats. Also we demonstrated that the sensitivity of the NDA increases by faster rotation speeds and may be more sensitive than ROTA for evaluating of impaired motor system function. Compared to a previous version of this task, our NDA provides a more efficient method to test rodents for studies of motor system function after impaired motor nervous system. In summary, our NDA will allow high efficient monitoring of rat motor system function and may be more sensitive than ROTA for evaluating of impaired motor system function in rats. Copyright © 2015 Elsevier B.V. All rights reserved.

77 FR 50121 - Hospira, Inc.; Withdrawal of Approval of a New Drug Application for DEXTRAN 70

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-20

..., Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike... and Research, by the Commissioner of Food and Drugs, approval of NDA 080- 819, DEXTRAN 70 [6% Dextran... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0840...

EMR Measurements on NDA Equipment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Macdonell, Alexander Thomas; Meierbachtol, Krista Cruse; Evans, James Walter Jr.

2017-07-10

Electromagnetic radiation (EMR) emission strength measurements were performed on a suite of passive non-destructive assay (NDA) radiation detection equipment. Data were collected from 9 kHz up to 6 GHz on each of the assembled systems.

CSER-98-002: Criticality analysis for the storage of special nuclear material sources and standards in the WRAP facility

DOE Office of Scientific and Technical Information (OSTI.GOV)

GOLDBERG, H.J.

1999-05-18

The Waste Receiving and Processing (WRAP) Facility will store uranium and transuranic (TRU) sources and standards for certification that WRAP meets the requirements of the Quality Assurance Program Plan (QAPP) for the Waste Isolation Pilot Plant (WIPP). In addition, WRAP must meet internal requirements for testing and validation of measuring instruments for nondestructive assay (NDA). In order to be certified for WIPP, WRAP will participate in the NDA Performance Demonstration Program (PDP). This program is a blind test of the NDA capabilities for TRU waste. It is intended to ensure that the NDA capabilities of this facility satisfy the requirementsmore » of the quality assurance program plan for the WIPP. The PDP standards have been provided by the Los Alamos National Laboratory (LANL) for this program. These standards will be used in the WRAP facility.« less

21 CFR 201.66 - Format and content requirements for over-the-counter (OTC) drug product labeling.

Code of Federal Regulations, 2013 CFR

2013-04-01

...: “[Bullet] side effects occur. You may report side effects to FDA at 1-800-FDA-1088.” The telephone number... means any component that is intended to furnish pharmacological activity or other direct effect in the... specified activity or effect. (3) Approved drug application means a new drug (NDA) or abbreviated new drug...

21 CFR 201.66 - Format and content requirements for over-the-counter (OTC) drug product labeling.

Code of Federal Regulations, 2012 CFR

2012-04-01

...: “[Bullet] side effects occur. You may report side effects to FDA at 1-800-FDA-1088.” The telephone number... means any component that is intended to furnish pharmacological activity or other direct effect in the... specified activity or effect. (3) Approved drug application means a new drug (NDA) or abbreviated new drug...

21 CFR 310.6 - Applicability of “new drug” or safety or effectiveness findings in drug efficacy study...

Code of Federal Regulations, 2010 CFR

2010-04-01

... identical, related, and similar drug products. 310.6 Section 310.6 Food and Drugs FOOD AND DRUG... National Academy of Sciences-National Research Council (NAS-NRC), Drug Efficacy Study Group. Many products... feasible for the Food and Drug Administration to list all products which are covered by an NDA and thus...

21 CFR 310.6 - Applicability of “new drug” or safety or effectiveness findings in drug efficacy study...

Code of Federal Regulations, 2011 CFR

2011-04-01

... identical, related, and similar drug products. 310.6 Section 310.6 Food and Drugs FOOD AND DRUG... National Academy of Sciences-National Research Council (NAS-NRC), Drug Efficacy Study Group. Many products... feasible for the Food and Drug Administration to list all products which are covered by an NDA and thus...

16 CFR 1702.15 - Petitions alleging the incompatiability of child resistant packaging with the particular...

Code of Federal Regulations, 2010 CFR

2010-01-01

... is based upon the fact that package choice is limited by a new drug application filed with the FDA, the petition shall state the limitation of package choice and a description of a time schedule to revise the NDA in order to allow additional package choice. (c) If the allegation of incompatibility is...

16 CFR 1702.15 - Petitions alleging the incompatiability of child resistant packaging with the particular...

Code of Federal Regulations, 2011 CFR

2011-01-01

... is based upon the fact that package choice is limited by a new drug application filed with the FDA, the petition shall state the limitation of package choice and a description of a time schedule to revise the NDA in order to allow additional package choice. (c) If the allegation of incompatibility is...

16 CFR 1702.15 - Petitions alleging the incompatibility of child resistant packaging with the particular substance...

Code of Federal Regulations, 2012 CFR

2012-01-01

... is based upon the fact that package choice is limited by a new drug application filed with the FDA, the petition shall state the limitation of package choice and a description of a time schedule to revise the NDA in order to allow additional package choice. (c) If the allegation of incompatibility is...

16 CFR 1702.15 - Petitions alleging the incompatibility of child resistant packaging with the particular substance...

Code of Federal Regulations, 2014 CFR

2014-01-01

... is based upon the fact that package choice is limited by a new drug application filed with the FDA, the petition shall state the limitation of package choice and a description of a time schedule to revise the NDA in order to allow additional package choice. (c) If the allegation of incompatibility is...

16 CFR § 1702.15 - Petitions alleging the incompatibility of child resistant packaging with the particular substance...

Code of Federal Regulations, 2013 CFR

2013-01-01

... is based upon the fact that package choice is limited by a new drug application filed with the FDA, the petition shall state the limitation of package choice and a description of a time schedule to revise the NDA in order to allow additional package choice. (c) If the allegation of incompatibility is...

Recent drug approvals from the US FDA and EMEA: what the future holds.

PubMed

Pevarello, Paolo

2009-04-01

The decreased productivity of the pharmaceutical industry in terms of new medical entities approved by the US FDA and the European Medicines Agency (EMEA) on a yearly basis has long been debated. This review will analyze overall new drug applications (NDAs) approved by both the FDA and EMEA in 2007, with the aim of finding trends (also looking at the past) that can be used to predict what the future may be. After a general introduction to the regulatory terminology, NDA approvals in 2007 are divided into categories (new applications of old medicines, metabolites, enantiomers and prodrugs, biological products, natural products and small organic molecule new molecular entities) and discussed. General aspects of the NDA approvals, such as historical trends, the length of the drug-discovery process, geography, differences among therapeutic areas, and the relative role of biotech and pharma industries are also outlined. From this analysis, a perspective is gained on some aspects that will probably influence future drug approvals. The conclusion is that 2007 may represent an inflexion point, in terms of quality if not quantity of new approvals, and that the future may be brighter than previously forecast.

Impact of Nuclear Data Uncertainties on Calculated Spent Fuel Nuclide Inventories and Advanced NDA Instrument Response

DOE PAGES

Hu, Jianwei; Gauld, Ian C.

2014-12-01

The U.S. Department of Energy’s Next Generation Safeguards Initiative Spent Fuel (NGSI-SF) project is nearing the final phase of developing several advanced nondestructive assay (NDA) instruments designed to measure spent nuclear fuel assemblies for the purpose of improving nuclear safeguards. Current efforts are focusing on calibrating several of these instruments with spent fuel assemblies at two international spent fuel facilities. Modelling and simulation is expected to play an important role in predicting nuclide compositions, neutron and gamma source terms, and instrument responses in order to inform the instrument calibration procedures. As part of NGSI-SF project, this work was carried outmore » to assess the impacts of uncertainties in the nuclear data used in the calculations of spent fuel content, radiation emissions and instrument responses. Nuclear data is an essential part of nuclear fuel burnup and decay codes and nuclear transport codes. Such codes are routinely used for analysis of spent fuel and NDA safeguards instruments. Hence, the uncertainties existing in the nuclear data used in these codes affect the accuracies of such analysis. In addition, nuclear data uncertainties represent the limiting (smallest) uncertainties that can be expected from nuclear code predictions, and therefore define the highest attainable accuracy of the NDA instrument. This work studies the impacts of nuclear data uncertainties on calculated spent fuel nuclide inventories and the associated NDA instrument response. Recently developed methods within the SCALE code system are applied in this study. The Californium Interrogation with Prompt Neutron instrument was selected to illustrate the impact of these uncertainties on NDA instrument response.« less

Impact of Nuclear Data Uncertainties on Calculated Spent Fuel Nuclide Inventories and Advanced NDA Instrument Response

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hu, Jianwei; Gauld, Ian C.

The U.S. Department of Energy’s Next Generation Safeguards Initiative Spent Fuel (NGSI-SF) project is nearing the final phase of developing several advanced nondestructive assay (NDA) instruments designed to measure spent nuclear fuel assemblies for the purpose of improving nuclear safeguards. Current efforts are focusing on calibrating several of these instruments with spent fuel assemblies at two international spent fuel facilities. Modelling and simulation is expected to play an important role in predicting nuclide compositions, neutron and gamma source terms, and instrument responses in order to inform the instrument calibration procedures. As part of NGSI-SF project, this work was carried outmore » to assess the impacts of uncertainties in the nuclear data used in the calculations of spent fuel content, radiation emissions and instrument responses. Nuclear data is an essential part of nuclear fuel burnup and decay codes and nuclear transport codes. Such codes are routinely used for analysis of spent fuel and NDA safeguards instruments. Hence, the uncertainties existing in the nuclear data used in these codes affect the accuracies of such analysis. In addition, nuclear data uncertainties represent the limiting (smallest) uncertainties that can be expected from nuclear code predictions, and therefore define the highest attainable accuracy of the NDA instrument. This work studies the impacts of nuclear data uncertainties on calculated spent fuel nuclide inventories and the associated NDA instrument response. Recently developed methods within the SCALE code system are applied in this study. The Californium Interrogation with Prompt Neutron instrument was selected to illustrate the impact of these uncertainties on NDA instrument response.« less

Decameter Type IV Burst Associated with a Behind-the-limb CME Observed on 7 November 2013

NASA Astrophysics Data System (ADS)

Melnik, V. N.; Brazhenko, A. I.; Konovalenko, A. A.; Dorovskyy, V. V.; Rucker, H. O.; Panchenko, M.; Frantsuzenko, A. V.; Shevchuk, M. V.

2018-03-01

We report on the results of observations of a type IV burst made by the Ukrainian Radio interferometer of the Academy of Sciences (URAN-2) in the frequency range 22 - 33 MHz. The burst is associated with a coronal mass ejection (CME) initiated by a behind-the-limb active region (N05E151) and was also observed by the Nançay Decameter Array (NDA) radio telescope in the frequency band 30 - 60 MHz. The purpose of the article is the determination of the source of this type IV burst. After analysis of the observational data obtained with the URAN-2, the NDA, the Solar-Terrestrial Relations Observatory (STEREO) A and B spacecraft, and the Solar and Heliospheric Observatory (SOHO) spacecraft, we come to the conclusion that the source of the burst is the core of a behind-the-limb CME. We conclude that the radio emission can escape the center of the CME core at a frequency of 60 MHz and originates from the periphery of the core at a frequency of 30 MHz that is due to occultation by the solar corona at the corresponding frequencies. We find plasma densities in these regions assuming the plasma mechanism of radio emission. We show that the frequency drift of the start of the type IV burst is governed by an expansion of the CME core. The type III bursts that were observed against this type IV burst are shown to be generated by fast electrons propagating through the CME core plasma. A type II burst was registered at frequencies of 44 - 64 MHz and 3 - 16 MHz and was radiated by a shock with velocities of about 1000 km s^{-1} and 800 km s^{-1}, respectively.

Application of texture analysis method for classification of benign and malignant thyroid nodules in ultrasound images.

PubMed

Abbasian Ardakani, Ali; Gharbali, Akbar; Mohammadi, Afshin

2015-01-01

The aim of this study was to evaluate computer aided diagnosis (CAD) system with texture analysis (TA) to improve radiologists' accuracy in identification of thyroid nodules as malignant or benign. A total of 70 cases (26 benign and 44 malignant) were analyzed in this study. We extracted up to 270 statistical texture features as a descriptor for each selected region of interests (ROIs) in three normalization schemes (default, 3s and 1%-99%). Then features by the lowest probability of classification error and average correlation coefficients (POE+ACC), and Fisher coefficient (Fisher) eliminated to 10 best and most effective features. These features were analyzed under standard and nonstandard states. For TA of the thyroid nodules, Principle Component Analysis (PCA), Linear Discriminant Analysis (LDA) and Non-Linear Discriminant Analysis (NDA) were applied. First Nearest-Neighbour (1-NN) classifier was performed for the features resulting from PCA and LDA. NDA features were classified by artificial neural network (A-NN). Receiver operating characteristic (ROC) curve analysis was used for examining the performance of TA methods. The best results were driven in 1-99% normalization with features extracted by POE+ACC algorithm and analyzed by NDA with the area under the ROC curve ( Az) of 0.9722 which correspond to sensitivity of 94.45%, specificity of 100%, and accuracy of 97.14%. Our results indicate that TA is a reliable method, can provide useful information help radiologist in detection and classification of benign and malignant thyroid nodules.

78 FR 66748 - Smith Miller and Patch Inc. et al.; Proposal to Withdraw Approval of 14 New Drug Applications...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-06

... Ave., Glendale, CA 91201. NDA 017861 Acthar Gel Synthetic Armour (seractide acetate) Pharmaceutical Co... the Center for Drug Evaluation and Research proposes to issue an order under section 505(e) of the... reports required under Sec. 314.81. In accordance with section 505 of the FD&C Act and part 314 (21 CFR...

Cryogenic gamma detectors enable direct detection of 236U and minor actinides for non-destructive assay [Cryogenic gamma detectors enable direct detection of minor actinides for non-destructive assay

DOE Office of Scientific and Technical Information (OSTI.GOV)

Velazquez, Miguel; Dreyer, Jonathan; Drury, Owen B.

2015-09-05

Here, we demonstrate the utility of a superconducting transition edge sensor (TES) γ-ray detector with high energy resolution and low Compton background for non-destructive assay (NDA) of a uranium sample from reprocessed nuclear fuel. We show that TES γ-detectors can separate low energy actinide γ-emissions from the background and nearby lines, even from minor isotopes whose signals are often obscured in NDA with conventional Ge detectors. Superconducting γ detectors may therefore bridge the gap between high-accuracy destructive assay (DA) and easier to-use NDA.

RU 486, the FDA and free enterprise.

PubMed

Buc, N L

1992-01-01

The legal question whether RU-486 can meet the standards for US Food and Drug Administration (FDA) approval for a drug indicated for abortion can be answered in the affirmative. Under the Food, Drug, and Cosmetic Act, efficacy must be demonstrated by evidence consisting of adequate and well-controlled investigations to show that a drug is safe and effective for its intended use. The FDA will approve it if on the basis of the clinical trials it could be concluded that the drug will have the effect it purports as prescribed in the labeling, and if the drug is safe. In congressional hearings and in the newspapers the so-called import alert issued by the FDA to prevent the importing of RU-486 under certain circumstances has been publicized. The import alert is no bar to conducting clinical studies in the US under an investigational new drug application (IND) nor is the import alert a bar to the filing and the pursuit of a new drug application (NDA) to allow marketing in the US. The import alert is no bar to anything except importation without an IND or NDA. The real problem is that there is no seller of RU-486 in the US and no sponsor of an NDA offering clinical evidence of safety and efficacy as well as the ability to manufacture the drug and the necessary prostaglandins properly. In additions to abortion, other uses of RU-486 include contraception, breast cancer, and Cushing syndrome. Some limited research could be done under INDs with small supplies of the drug obtained elsewhere on the world market. There are only 2 solutions to this problem. One is that Roussel must change its mind or have its mind changed as the example of the AIDS community showed, which has managed to induce the development of drugs that were impossible 8 or 10 years ago. The other solution is to found a pharmaceutical company that could induce competition for manufacturing RU-486.

Power-Hop: A Pervasive Observation for Real Complex Networks

DTIC Science & Technology

2016-03-14

found at: https:// github.com/kpelechrinis/powerhop. The web graph used was obtained from Yahoo ! under signing NDA and hence, cannot be made available...However, Yahoo ! is making available datasets to eligible organizations/entities through application to Webscope. In particular, the dataset used in...our study can be requested through the following URL: http:// webscope.sandbox.yahoo.com/catalog.php? datatype=g (G2 - Yahoo ! AltaVista Web Page

Exubera. Inhale therapeutic systems.

PubMed

Bindra, Sanjit; Cefalu, William T

2002-05-01

Inhale, in colaboration with Pfizer and Aventis Pharma (formerly Hoechst Marion Roussel; HMR), is developing an insulin formulation utilizing its pulmonary delivery technology for macromolecules for the potential treatment of type I and II diabetes. By July 2001, the phase III program had been completed and the companies had begun to assemble data for MAA and NDA filings; however, it was already clear at this time that additional data might be required for filing. By December 2001, it had been decided that the NDA should include an increased level of controlled, long-term pulmonary safety data in diabetic patients and a major study was planned to be completed in 2002, with the NDA filed thereafter (during 2002). US-05997848 was issued to Inhale Therapeutic Systems in December 1999, and corresponds to WO-09524183, filed in February 1995. Equivalent applications have appeared to date in Australia, Brazil, Canada, China, Czech Republic, Europe, Finland, Hungary, Japan, Norway, New Zealand, Poland and South Africa. This family of applications is specific to pulmonary delivery of insulin. In February 1999, Lehman Brothers gave this inhaled insulin a 60% probability of reaching market, with a possible launch date of 2001. The analysts estimated peak sales at $3 billion in 2011. In May 2000, Aventis predicted that estimated peak sales would be in excess of $1 billion. In February 2000, Merrill Lynch expected product launch in 2002 and predicted that it would be a multibillion-dollar product. Analysts Merril Lynch predicted, in September and November 2000, that the product would be launched by 2002, with sales in that year of e75 million, rising to euro 500 million in 2004. In April 2001, Merrill Lynch predicted that filing for this drug would occur in 2001. Following the report of the potential delay in regulatory filing, issued in July 2001, Deutsche Banc Alex Brown predicted a filing would take place in the fourth quarter of 2002 and launch would take place in the first quarter of 2003. In August 2001, Lehman Brothers predicted that launch would take place in the first half of 2002 and that the product would make sales of $475 million in 2003, rising to $875 million in 2004. In the same month, Deutsche Bank predicted that there would be worldwide sales of $50 million in 2003, rising to $400 million in 2005. At this time, analysts at Credit Suisse predicted a launch of the product in 2003, with sales of $70 million in that year, rising to $550 million in 2005. By October 2001, Deutsche Bank predicted sales of $50 million in 2004 and $250 million in 2005. In September 2001, Morgan Stanley predicted sales of $500 million in 2002, rising to $1250 million in 2006.

Shared activity patterns arising at genetic susceptibility loci reveal underlying genomic and cellular architecture of human disease.

PubMed

Baillie, J Kenneth; Bretherick, Andrew; Haley, Christopher S; Clohisey, Sara; Gray, Alan; Neyton, Lucile P A; Barrett, Jeffrey; Stahl, Eli A; Tenesa, Albert; Andersson, Robin; Brown, J Ben; Faulkner, Geoffrey J; Lizio, Marina; Schaefer, Ulf; Daub, Carsten; Itoh, Masayoshi; Kondo, Naoto; Lassmann, Timo; Kawai, Jun; Mole, Damian; Bajic, Vladimir B; Heutink, Peter; Rehli, Michael; Kawaji, Hideya; Sandelin, Albin; Suzuki, Harukazu; Satsangi, Jack; Wells, Christine A; Hacohen, Nir; Freeman, Thomas C; Hayashizaki, Yoshihide; Carninci, Piero; Forrest, Alistair R R; Hume, David A

2018-03-01

Genetic variants underlying complex traits, including disease susceptibility, are enriched within the transcriptional regulatory elements, promoters and enhancers. There is emerging evidence that regulatory elements associated with particular traits or diseases share similar patterns of transcriptional activity. Accordingly, shared transcriptional activity (coexpression) may help prioritise loci associated with a given trait, and help to identify underlying biological processes. Using cap analysis of gene expression (CAGE) profiles of promoter- and enhancer-derived RNAs across 1824 human samples, we have analysed coexpression of RNAs originating from trait-associated regulatory regions using a novel quantitative method (network density analysis; NDA). For most traits studied, phenotype-associated variants in regulatory regions were linked to tightly-coexpressed networks that are likely to share important functional characteristics. Coexpression provides a new signal, independent of phenotype association, to enable fine mapping of causative variants. The NDA coexpression approach identifies new genetic variants associated with specific traits, including an association between the regulation of the OCT1 cation transporter and genetic variants underlying circulating cholesterol levels. NDA strongly implicates particular cell types and tissues in disease pathogenesis. For example, distinct groupings of disease-associated regulatory regions implicate two distinct biological processes in the pathogenesis of ulcerative colitis; a further two separate processes are implicated in Crohn's disease. Thus, our functional analysis of genetic predisposition to disease defines new distinct disease endotypes. We predict that patients with a preponderance of susceptibility variants in each group are likely to respond differently to pharmacological therapy. Together, these findings enable a deeper biological understanding of the causal basis of complex traits.

Shared activity patterns arising at genetic susceptibility loci reveal underlying genomic and cellular architecture of human disease

PubMed Central

Gray, Alan; Neyton, Lucile P. A.; Barrett, Jeffrey; Stahl, Eli A.; Tenesa, Albert; Andersson, Robin; Brown, J. Ben; Faulkner, Geoffrey J.; Lizio, Marina; Schaefer, Ulf; Daub, Carsten; Kondo, Naoto; Lassmann, Timo; Kawai, Jun; Kawaji, Hideya; Suzuki, Harukazu; Satsangi, Jack; Wells, Christine A.; Hacohen, Nir; Freeman, Thomas C.; Hayashizaki, Yoshihide; Forrest, Alistair R. R.; Hume, David A.

2018-01-01

Genetic variants underlying complex traits, including disease susceptibility, are enriched within the transcriptional regulatory elements, promoters and enhancers. There is emerging evidence that regulatory elements associated with particular traits or diseases share similar patterns of transcriptional activity. Accordingly, shared transcriptional activity (coexpression) may help prioritise loci associated with a given trait, and help to identify underlying biological processes. Using cap analysis of gene expression (CAGE) profiles of promoter- and enhancer-derived RNAs across 1824 human samples, we have analysed coexpression of RNAs originating from trait-associated regulatory regions using a novel quantitative method (network density analysis; NDA). For most traits studied, phenotype-associated variants in regulatory regions were linked to tightly-coexpressed networks that are likely to share important functional characteristics. Coexpression provides a new signal, independent of phenotype association, to enable fine mapping of causative variants. The NDA coexpression approach identifies new genetic variants associated with specific traits, including an association between the regulation of the OCT1 cation transporter and genetic variants underlying circulating cholesterol levels. NDA strongly implicates particular cell types and tissues in disease pathogenesis. For example, distinct groupings of disease-associated regulatory regions implicate two distinct biological processes in the pathogenesis of ulcerative colitis; a further two separate processes are implicated in Crohn’s disease. Thus, our functional analysis of genetic predisposition to disease defines new distinct disease endotypes. We predict that patients with a preponderance of susceptibility variants in each group are likely to respond differently to pharmacological therapy. Together, these findings enable a deeper biological understanding of the causal basis of complex traits. PMID:29494619

Upstream Optioneering: Optimising Higher Activity Waste Management

DOE Office of Scientific and Technical Information (OSTI.GOV)

McTeer, Jennifer; Morris, Jenny; Wickham, Stephen

2013-07-01

The Upstream Optioneering project was created by the Nuclear Decommissioning Authority (NDA) Radioactive Waste Management Directorate (RWMD) to support the development and implementation of opportunities to optimise the management of UK higher activity waste, spent fuel and other materials that may be disposed of in a geological disposal facility. The project works in an integrative manner with the NDA, RWMD and waste producers, and was split into three phases: - In Phase 1 waste management opportunities were identified and collated from across the NDA estate. - In Phase 2, opportunities collated during Phase 1, were further consolidated, analysed and prioritisedmore » to develop a three year work programme. Prioritisation ensured that resources were deployed appropriately and opportunities can be realised before the potential benefit diminishes. - Phase 3, which began in April 2012, comprises a three year work programme to address the prioritised opportunities. Work varies from direct implementation of opportunities to scoping studies that may pave the way for more detailed subsequent work by Site Licence Companies. The work programme is flexible and, subject to change control, varies depending on the needs of project sponsors (RWMD, NDA Strategy and NDA Delivery). This paper provides an overview of the Upstream Optioneering project (focusing particularly on Phases 2 and 3), summarises work carried out to date within the three year work programme, and provides some examples of the main findings concerning specific opportunities from Year One of the Phase 3 work programme. (authors)« less

Improved uncertainty quantification in nondestructive assay for nonproliferation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Burr, Tom; Croft, Stephen; Jarman, Ken

2016-12-01

This paper illustrates methods to improve uncertainty quantification (UQ) for non-destructive assay (NDA) measurements used in nuclear nonproliferation. First, it is shown that current bottom-up UQ applied to calibration data is not always adequate, for three main reasons: (1) Because there are errors in both the predictors and the response, calibration involves a ratio of random quantities, and calibration data sets in NDA usually consist of only a modest number of samples (3–10); therefore, asymptotic approximations involving quantities needed for UQ such as means and variances are often not sufficiently accurate; (2) Common practice overlooks that calibration implies a partitioningmore » of total error into random and systematic error, and (3) In many NDA applications, test items exhibit non-negligible departures in physical properties from calibration items, so model-based adjustments are used, but item-specific bias remains in some data. Therefore, improved bottom-up UQ using calibration data should predict the typical magnitude of item-specific bias, and the suggestion is to do so by including sources of item-specific bias in synthetic calibration data that is generated using a combination of modeling and real calibration data. Second, for measurements of the same nuclear material item by both the facility operator and international inspectors, current empirical (top-down) UQ is described for estimating operator and inspector systematic and random error variance components. A Bayesian alternative is introduced that easily accommodates constraints on variance components, and is more robust than current top-down methods to the underlying measurement error distributions.« less

Optimization of the Nano-Dust Analyzer (NDA) for operation under solar UV illumination

NASA Astrophysics Data System (ADS)

O`Brien, L.; Grün, E.; Sternovsky, Z.

2015-12-01

The performance of the Nano-Dust Analyzer (NDA) instrument is analyzed for close pointing to the Sun, finding the optimal field-of-view (FOV), arrangement of internal baffles and measurement requirements. The laboratory version of the NDA instrument was recently developed (O'Brien et al., 2014) for the detection and elemental composition analysis of nano-dust particles. These particles are generated near the Sun by the collisional breakup of interplanetary dust particles (IDP), and delivered to Earth's orbit through interaction with the magnetic field of the expanding solar wind plasma. NDA is operating on the basis of impact ionization of the particle and collecting the generated ions in a time-of-flight fashion. The challenge in the measurement is that nano-dust particles arrive from a direction close to that of the Sun and thus the instrument is exposed to intense ultraviolet (UV) radiation. The performed optical ray-tracing analysis shows that it is possible to suppress the number of UV photons scattering into NDA's ion detector to levels that allow both high signal-to-noise ratio measurements, and long-term instrument operation. Analysis results show that by avoiding direct illumination of the target, the photon flux reaching the detector is reduced by a factor of about 103. Furthermore, by avoiding the target and also implementing a low-reflective coating, as well as an optimized instrument geometry consisting of an internal baffle system and a conical detector housing, the photon flux can be reduced by a factor of 106, bringing it well below the operation requirement. The instrument's FOV is optimized for the detection of nano-dust particles, while excluding the Sun. With the Sun in the FOV, the instrument can operate with reduced sensitivity and for a limited duration. The NDA instrument is suitable for future space missions to provide the unambiguous detection of nano-dust particles, to understand the conditions in the inner heliosphere and its temporal variability, and to constrain the chemical differentiation and processing of IDPs.

Simultaneous observations of solar sporadic radio emission by the radio telescopes UTR-2, URAN-2 and NDA within the frequency range 8-42 MHz

NASA Astrophysics Data System (ADS)

Melnik, V.; Konovalenko, A.; Brazhenko, A.; Briand, C.; Dorovskyy, V.; Zarka, P.; Denis, L.; Bulatzen, V.; Frantzusenko, A.; Rucker, H.; Stanislavskyy, A.

2012-09-01

From 25 June till 12 August 2011 sporadic solar radio emission was observed simultaneously by three separate radio telescopes: UTR-2 (Kharkov, Ukraine), URAN-2 (Poltava, Ukraine) and NDA (Nancay, France). During these observations some interesting phenomena were observed. Some of them are discussed in this paper.

Performance of NDA techniques on a vitrified waste form

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hurd, J.R.; Veazey, G.W.; Prettyman, T.H.

1997-11-01

Rocky Flats Environmental Technology Site (RFETS) is currently considering the use of vitrified transuranic (TRU)-waste forms for the final disposition of several waste materials. To date, however, little nondestructive assay (NDA) data have been acquired in the general NDA community to assist in this endeavor. This paper describes the efforts to determine constraints and operating parameters for using NDA instrumentation on vitrified waste. The present study was conducted on a sample composed of a plutonium-contaminated ash, similar to that found in the RFETS inventory, and a borosilicate-based glass. The vitrified waste item was fabricated at Los Alamos National Laboratory (LANL)more » using methods and equipment similar to those being proposed by RFETS to treat their ash material. The focus of this study centered on the segmented gamma scanner (SGS) with 1/2-inch collimation, a technique that is presently available at RFETS. The accuracy and precision of SGS technology was evaluated, with particular attention to bias issues involving matrix geometry, homogeneity, and attenuation. Tomographic gamma scanning was utilized in the determination of the waste form homogeneity. A thermal neutron technique was also investigated and comparisons made with the gamma results.« less

Conceptual designs of NDA instruments for the NRTA system at the Rokkasho Reprocessing Plant

DOE Office of Scientific and Technical Information (OSTI.GOV)

Li, T.K.; Klosterbuer, S.F.; Menlove, H.O.

The authors are studying conceptual designs of selected nondestructive assay (NDA) instruments for the near-real-time accounting system at the rokkasho Reprocessing Plant (RRP) of Japan Nuclear Fuel Limited (JNFL). The JNFL RRP is a large-scale commercial reprocessing facility for spent fuel from boiling-water and pressurized-water reactors. The facility comprises two major components: the main process area to separate and produce purified plutonium nitrate and uranyl nitrate from irradiated reactor spent fuels, and the co-denitration process area to combine and convert the plutonium nitrate and uranyl nitrate into mixed oxide (MOX). The selected NDA instruments for conceptual design studies are themore » MOX-product canister counter, holdup measurement systems for calcination and reduction furnaces and for blenders in the co-denitration process, the isotope dilution gamma-ray spectrometer for the spent fuel dissolver solution, and unattended verification systems. For more effective and practical safeguards and material control and accounting at RRP, the authors are also studying the conceptual design for the UO{sub 3} large-barrel counter. This paper discusses the state-of-the-art NDA conceptual design and research and development activities for the above instruments.« less

DOE Office of Scientific and Technical Information (OSTI.GOV)

Maitland, R.P.; Senior, D.

The Office for Nuclear Regulation (ONR) is an independent safety, security and transport regulator of the UK nuclear industry. ONR regulates all civil nuclear reactor power stations, fuel manufacture, enrichment, spent fuel reprocessing, most defence sites and installations that store and process legacy spent fuel and radioactive waste. The responsibility for funding and strategic direction of decommissioning and radioactive waste management of state owned legacy sites has rested solely with the Nuclear Decommissioning Authority (NDA) since 2005. A key component of NDA's mandate was to encourage new strategic approaches and innovation to dealing with the UK's waste legacy and whichmore » deliver value-for-money to the UK taxpayer. ONR, as an agency of the Health and Safety Executive, is entirely independent of NDA and regulates all prescribed activities on NDA's sites. NDA's competition of site management and closure contracts has attracted significant international interest and the formation of consortia comprised of major British, US, French and Swedish organizations bidding for those contracts. The prominence of US organizations in each of those consortia reflects the scale and breadth of existing waste management and D and D projects in the US. This paper will articulate, in broad terms, the challenges faced by international organizations seeking to employ 'off-the-shelf' technology and D and D techniques, successfully employed elsewhere, into the UK regulatory context. The predominantly 'goal-setting' regulatory framework in the UK does not generally prescribe a minimum standard to which a licensee must adhere. The legal onus on licensees in the UK is to demonstrate, whatever technology is selected, that in its applications, risks are reduced 'So Far As Is Reasonably Practicable' or 'SFAIRP'. By the nature of its role, ONR adopts a conservative approach to regulation; however ONR also recognises that in the decommissioning (and ultimately the site closure) domain, it is often necessary to consider and support novel approaches to achieve the nationally desired end-state. Crucial to successful and compliant operation in this regulatory environment is early and sustained engagement of the contractor with the regulator. There must be a 'no-surprises' culture to engender regulatory confidence early in a project. The paper considers some of the challenges facing international prime and lower tier contractors when undertaking D and D contracts in the UK, and emphasizes the importance of constructive and transparent dialogue with all regulators to sustain confidence at all stages of a major decommissioning project. The paper will also articulate ONR's strategy to increase collaboration with the US Department of Energy in light of increasing UK-US synergy in the area of waste management and to benchmark respective regulatory approaches. (authors)« less

Participation of Women and Sex Analyses in Late-Phase Clinical Trials of New Molecular Entity Drugs and Biologics Approved by the FDA in 2007–2009

PubMed Central

Poon, Rita; Khanijow, Keshav; Umarjee, Sphoorti; Yu, Monica; Zhang, Lei; Parekh, Ameeta

2013-01-01

Abstract Background Biological sex differences may contribute to differential treatment outcomes for therapeutic products. This study tracks women's participation in late-phase clinical trials (LPCTs), where efficacy and safety of drugs and biologics are evaluated, of new molecular entity (NME) drugs and biologics approved by the U.S. Food and Drug Administration (FDA) in 2007–2009. Furthermore, presentations of sex-based analyses were assessed from the FDA reviews. Methods New drug applications (NDAs) and biologics license applications (BLAs) were accessed from the U.S. FDA database and evaluated for women's participation in LPCTs. Sex-based analyses for efficacy and safety contained in FDA reviews were surveyed. Ratios for women's LPCT participation (PROPORTION OF STUDY SUBJECTS) to their proportion in the disease population were calculated for each approved therapeutic product and grouped into therapeutic categories. Results Sex-specific (n=5) and pediatric (n=3) drug applications were excluded. Women's participation in LPCTs was 39%, 48%, and 42% in NDAs (n=50) and 49%, 62%, and 58% in BLAs (n=11) for 2007, 2008, and 2009, respectively. Sixty-four percent of NDAs and 91% of BLAs had participation to proportion ratios of ≥0.80. Seventy-four percent of NDA reviews and 64% of BLA reviews included safety and efficacy sex analysis. Ninety-six percent of NDA reviews and 100% of BLA reviews included efficacy sex analysis. Conclusion Women's participation in LPCTs averaged 43% for NDAs and 57% for BLAs in 2007–2009 and varied widely by indication. As a comparison, the 2001 U.S. Government Accountability Office (GAO) reported 52% of women's participation for drug clinical trials in1998–2000 and an FDA study reported 45% for BLAs approved from 1995 to 1999. This study showed that sex-analysis of both safety and efficacy in NDA has increased to 74% since the GAO report of 72%, while those for BLAs increased to 64% from 37% reported for therapeutic biologics approved in 1995–1999. Knowledge of disease prevalence and participation in clinical trials provides an understanding of recruitment and retention patterns of patients in these trials. PMID:23768021

A Strategy for Skills to meet the demands of Nuclear Decommissioning and Clean-up in the UK

DOE Office of Scientific and Technical Information (OSTI.GOV)

Brownridge, M.; Ensor, B.

The NDA remit as set out within the Energy Act includes - 'to ensure the availability of skills required to deliver the overall decommissioning and nuclear clean-up mission'. The NDA approach to meeting their statutory obligation is by: - finding the best ways of re-training, re-skilling or re-deploying people in a way that encourages a more flexible workforce; - identifying and communicating the skills and workforce requirements to deliver the mission; and - developing the infrastructure and capability initiatives in line with long term needs, for example, a National Skills Academy for Nuclear, Nuclear Institute, National Graduate Scheme, and -more » developing locally specific provision. Firstly, NDA has set the requirement for nuclear sites to write down within the Life Time Plans (LTP), at a high level, their Site Skills Strategies; furthermore, a National Skills Working Group has been established to develop tactical cross sector solutions to support the NDA's Skills Strategy. In support of the short, medium and long term needs to meet demands of the NDA sites and the nuclear decommissioning sector, as well as being aware of the broader nuclear sector, investments have been made in infrastructure and skills programmes such as: - A National Skills Academy for Nuclear - including UK wide representation of the whole nuclear sector; - A Nuclear Institute in partnership with the University of Manchester focussing on world class research and skills in Radiation Sciences and Decommissioning Engineering; - Post Graduate sponsorship for decommissioning related projects; - A National Graduate Scheme partnership with nuclear related employers; - Vocational qualifications and Apprenticeship Schemes - Engaging 14-19 year old students to encourage the take up of Science related subjects; and - A sector wide 'Skills Passport'. In conclusion: The skills challenge has many dimensions but requires addressing due to the clear link to improved business performance and the availability of key resources in a diminishing and competitive environment. The diminishing skill base is due to reasons such as demographics and competition from other industries such as the oil industry. Getting the balance between meeting regional and national requirements will prove critical to success. The lack of clarity on the long term needs will also drive the strategy. NDA recognises that the work to date is the beginning of a long term approach and programme. We have developed a skills strategy that is consistent across all 20 sites and examples of key developments in infrastructure are in progress. Looking forward NDA will seek benchmarking opportunities and ways to make tangible links between skills and performance. (authors)« less

Passive gamma analysis of the boiling-water-reactor assemblies

NASA Astrophysics Data System (ADS)

Vo, D.; Favalli, A.; Grogan, B.; Jansson, P.; Liljenfeldt, H.; Mozin, V.; Schwalbach, P.; Sjöland, A.; Tobin, S.; Trellue, H.; Vaccaro, S.

2016-09-01

This research focused on the analysis of a set of stationary passive gamma measurements taken on the spent nuclear fuel assemblies from a boiling water reactor (BWR) using pulse height analysis data acquisition. The measurements were performed on 25 different BWR assemblies in 2014 at Sweden's Central Interim Storage Facility for Spent Nuclear Fuel (Clab). This study was performed as part of the Next Generation of Safeguards Initiative-Spent Fuel project to research the application of nondestructive assay (NDA) to spent fuel assemblies. The NGSI-SF team is working to achieve the following technical goals more easily and efficiently than in the past using nondestructive assay (NDA) measurements of spent fuel assemblies: (1) verify the initial enrichment, burnup, and cooling time of facility declaration; (2) detect the diversion or replacement of pins, (3) estimate the plutonium mass, (4) estimate the decay heat, and (5) determine the reactivity of spent fuel assemblies. The final objective of this project is to quantify the capability of several integrated NDA instruments to meet the aforementioned goals using the combined signatures of neutrons, gamma rays, and heat. This report presents a selection of the measured data and summarizes an analysis of the results. Specifically, trends in the count rates measured for spectral lines from the following isotopes were analyzed as a function of the declared burnup and cooling time: 137Cs, 154Eu, 134Cs, and to a lesser extent, 106Ru and 144Ce. From these measured count rates, predictive algorithms were developed to enable the estimation of the burnup and cooling time. Furthermore, these algorithms were benchmarked on a set of assemblies not included in the standard assemblies set used by this research team.

Passive gamma analysis of the boiling-water-reactor assemblies

DOE PAGES

Vo, D.; Favalli, A.; Grogan, B.; ...

2016-09-01

This research focused on the analysis of a set of stationary passive gamma measurements taken on the spent nuclear fuel assemblies from a boiling water reactor (BWR) using pulse height analysis data acquisition. The measurements were performed on 25 different BWR assemblies in 2014 at Sweden’s Central Interim Storage Facility for Spent Nuclear Fuel (Clab). This study was performed as part of the Next Generation of Safeguards Initiative–Spent Fuel project to research the application of nondestructive assay (NDA) to spent fuel assemblies. The NGSI–SF team is working to achieve the following technical goals more easily and efficiently than in themore » past using nondestructive assay (NDA) measurements of spent fuel assemblies: (1) verify the initial enrichment, burnup, and cooling time of facility declaration; (2) detect the diversion or replacement of pins, (3) estimate the plutonium mass, (4) estimate the decay heat, and (5) determine the reactivity of spent fuel assemblies. The final objective of this project is to quantify the capability of several integrated NDA instruments to meet the aforementioned goals using the combined signatures of neutrons, gamma rays, and heat. This report presents a selection of the measured data and summarizes an analysis of the results. Specifically, trends in the count rates measured for spectral lines from the following isotopes were analyzed as a function of the declared burnup and cooling time: 137Cs, 154Eu, 134Cs, and to a lesser extent, 106Ru and 144Ce. From these measured count rates, predictive algorithms were developed to enable the estimation of the burnup and cooling time. Furthermore, these algorithms were benchmarked on a set of assemblies not included in the standard assemblies set used by this research team.« less

Implementation of Microcalorimeter Array Technology for Safeguards of Nuclear Material

NASA Astrophysics Data System (ADS)

Kossmann, Shannon; Mateju, Klara; Koehler, Katrina; Croce, Mark

2018-03-01

Safeguards of nuclear materials depend on both destructive and nondestructive assay (DA and NDA, respectively). Ultra-high-resolution microcalorimeter gamma spectroscopy has the potential to substantially reduce the performance gap between NDA and DA methods in determination of plutonium isotopic composition. This paper details the setup of a cryostat and microwave readout system for microcalorimeter gamma spectroscopy, the functionality of which has been successfully demonstrated.

Two new coordination polymers constructed by naphthalene-1,4-dicarboxylic acid and 2,4-diamino-6-methyl-triazine

DOE Office of Scientific and Technical Information (OSTI.GOV)

Li, Yamin, E-mail: liyamin@henu.edu.cn; Xiao, Changyu; Zhang, Xudong

2013-08-15

Two new transition metal coordination complexes, ([MnO(nda)](H{sub 2}dmt)(H{sub 2}O)){sub n} (1), [Ag{sub 5}(nda){sub 2.5}(dmt)]{sub n} (2), (H{sub 2}nda=naphthalene-1,4-dicarboxylic acid, dmt=2,4-diamine-6-methyl-1,3,5-triazine) have been hydrothermally synthesized by the reactions of H{sub 2}nda and dmt with the homologous MnCl{sub 2}·4H{sub 2}O and AgNO{sub 3}, respectively, and characterized by single-crystal X-ray diffraction, IR spectra, elemental analysis, thermogravimetric analysis (TGA). The compound 1 exhibits a 3D network comprising 1D metal chain (MnO(CO{sub 2}){sub 2}){sub n} connected by the ligand nda{sup 2−}, featuring a four-connected uninodal diamond -like topology. In compound 2, it is firstly observed that decanuclear silver units as secondary building units to constructmore » 3D network by the ligands dmt and nda{sup 2−}, with a rare 2-nodal (3,8)-connected tfz-d topology ((4{sup 3}){sub 2}(4{sup 6}.6{sup 18}.8{sup 4})). The interactions within each Mn(II)—Mn(II) pair of compound 1 are antiferromagnetic (g=2.07, J=−1.42(1) cm{sup −1}, zj′=−0.73(2) cm{sup −1}). In addition, compound 2 exhibits photoluminescent property at about 472 nm (λ{sub ex}=394 nm). - Graphical abstract: Two new transition metal coordination complexes 1–2 have been hydrothermally synthesized and characterized by single-crystal X-ray diffraction, IR spectra, elemental analysis thermogravimetric analysis (TGA). Highlights: • The compound 1 exhibits a 3D network with four-connected uninodal diamond-like topology. • The first 3D network of 2 with a rare tfz-d topology consists of decanuclear silver clusters as secondary building units. • The magnetic measurement indicates the compound 1 shows antiferromagnetic interactions. • The photoluminescent property of 2 has been measured.« less

Viability Study for an Unattended UF 6 Cylinder Verification Station: Phase I Final Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Smith, Leon E.; Miller, Karen A.; Garner, James R.

In recent years, the International Atomic Energy Agency (IAEA) has pursued innovative techniques and an integrated suite of safeguards measures to address the verification challenges posed by the front end of the nuclear fuel cycle. Among the unattended instruments currently being explored by the IAEA is an Unattended Cylinder Verification Station (UCVS) that could provide automated, independent verification of the declared relative enrichment, 235U mass, total uranium mass and identification for all declared UF 6 cylinders in a facility (e.g., uranium enrichment plants and fuel fabrication plants). Under the auspices of the United States and European Commission Support Programs tomore » the IAEA, a project was undertaken to assess the technical and practical viability of the UCVS concept. The US Support Program team consisted of Pacific Northwest National Laboratory (PNNL, lead), Los Alamos National Laboratory (LANL), Oak Ridge National Laboratory (ORNL) and Savanah River National Laboratory (SRNL). At the core of the viability study is a long-term field trial of a prototype UCVS system at a Westinghouse fuel fabrication facility. A key outcome of the study is a quantitative performance evaluation of two nondestructive assay (NDA) methods being considered for inclusion in a UCVS: Hybrid Enrichment Verification Array (HEVA), and Passive Neutron Enrichment Meter (PNEM). This report provides context for the UCVS concept and the field trial: potential UCVS implementation concepts at an enrichment facility; an overview of UCVS prototype design; field trial objectives and activities. Field trial results and interpretation are presented, with a focus on the performance of PNEM and HEVA for the assay of over 200 “typical” Type 30B cylinders, and the viability of an “NDA Fingerprint” concept as a high-fidelity means to periodically verify that the contents of a given cylinder are consistent with previous scans. A modeling study, combined with field-measured instrument uncertainties, provides an assessment of the partial-defect sensitivity of HEVA and PNEM for both one-time assay and (repeated) NDA Fingerprint verification scenarios. The findings presented in this report represent a significant step forward in the community’s understanding of the strengths and limitations of the PNEM and HEVA NDA methods, and the viability of the UCVS concept in front-end fuel cycle facilities. This experience will inform Phase II of the UCVS viability study, should the IAEA pursue it.« less

American Red Cross: A History And Analysis

DTIC Science & Technology

2016-12-01

strengthens the government’s provisions to the military when deployed and provides a service to the American people through disaster relief. The...suffering in the face of emergencies by mobilizing the power of volunteers and the generosity of donors” ( American National Red Cross, n.d.-a). Their... Americans and all service members and their families have support and comfort when needed ( American National Red Cross, n.d.-a). Frandsen and Lawry (2009

Naltrexone/bupropion: Contrave(R); naltrexone SR/bupropion SR.

PubMed

2010-01-01

In March 2010, Orexigen(R) Therapeutics submitted a new drug application (NDA) for approval of naltrexone sustained release (SR)/bupropion SR (Contrave(R)) for the treatment of obesity in the US. The tablet contains naltrexone SR 32 mg and bupropion SR 360 mg. The drug has been tested in four randomized, double-blind, placebo-controlled, phase III trials and the co-primary endpoints were met in each case. This review discusses the key development milestones and clinical trial program to date.

Defining the challenges of the Modern Analytical Laboratory (CPSA USA 2014): the risks and reality of personalized healthcare.

PubMed

Weng, Naidong; Needham, Shane; Lee, Mike

2015-01-01

The 17th Annual Symposium on Clinical and Pharmaceutical Solutions through Analysis (CPSA) 29 September-2 October 2014, was held at the Sheraton Bucks County Hotel, Langhorne, PA, USA. The CPSA USA 2014 brought the various analytical fields defining the challenges of the modern analytical laboratory. Ongoing discussions focused on the future application of bioanalysis and other disciplines to support investigational new drugs (INDs) and new drug application (NDA) submissions, clinical diagnostics and pathology laboratory personnel that support patient sample analysis, and the clinical researchers that provide insights into new biomarkers within the context of the modern laboratory and personalized medicine.

Neutron spectrometry for UF 6 enrichment verification in storage cylinders

DOE PAGES

Mengesha, Wondwosen; Kiff, Scott D.

2015-01-29

Verification of declared UF 6 enrichment and mass in storage cylinders is of great interest in nuclear material nonproliferation. Nondestructive assay (NDA) techniques are commonly used for safeguards inspections to ensure accountancy of declared nuclear materials. Common NDA techniques used include gamma-ray spectrometry and both passive and active neutron measurements. In the present study, neutron spectrometry was investigated for verification of UF 6 enrichment in 30B storage cylinders based on an unattended and passive measurement approach. MCNP5 and Geant4 simulated neutron spectra, for selected UF 6 enrichments and filling profiles, were used in the investigation. The simulated neutron spectra weremore » analyzed using principal component analysis (PCA). The PCA technique is a well-established technique and has a wide area of application including feature analysis, outlier detection, and gamma-ray spectral analysis. Results obtained demonstrate that neutron spectrometry supported by spectral feature analysis has potential for assaying UF 6 enrichment in storage cylinders. Thus the results from the present study also showed that difficulties associated with the UF 6 filling profile and observed in other unattended passive neutron measurements can possibly be overcome using the approach presented.« less

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cassidy, Helen; Rossiter, David

The Low Level Waste Repository (LLWR) is the primary facility for disposal of Low Level Waste (LLW) in the United Kingdom (UK), serving the UK nuclear industry and a diverse range of other sectors. Management of LLW in the UK historically was dominated by disposal to the LLWR. The value of the LLWR as a national asset was recognised by the 2007 UK Governmental Policy on management of solid LLW. At this time, analysis of the projected future demand for disposal at LLWR against facility capacity was undertaken identifying a credible risk that the capacity of LLWR would be insufficientmore » to meet future demand if existing waste management practices were perpetuated. To mitigate this risk a National Strategy for the management of LLW in the UK was developed by the Nuclear Decommissioning Authority (NDA), partnered with LLW Repository Ltd. (the organisation established in 2008 to manage the LLWR on behalf of NDA). This strategy was published in 2010 and identified three mechanisms for protection of the capacity of LLWR - application of the Waste Hierarchy by waste producers; optimised use of existing assets for LLW management; and opening of new waste treatment and disposal routes to enable diversion of waste away from the LLWR. (authors)« less

BEV Charging Behavior Observed in The EV Project for 2013

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bennett, Brion D.

2014-01-01

This fact sheet will be issued quarterly to report on the number of Nissan Leafs vehicle usage, charging locations, and charging completeness as part of the EV Project. It will be posted on the INL/AVTA and ECOtality websites and will be accessible by the general public. The raw data that is used to create the report is considered proprietary/OUO and NDA protected, but the information in this report is NOT proprietary nor NDA protected.

Criticality Safety Evaluation for Small Sample Preparation and Non-Destructive Assay (NDA) Operations in Wing 7 Basement of the CMR Facility

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kunkle, Paige Elizabeth; Zhang, Ning

Nuclear Criticality Safety (NCS) has reviewed the fissionable material small sample preparation and NDA operations in Wing 7 Basement of the CMR Facility. This is a Level-1 evaluation conducted in accordance with NCS-AP-004 [Reference 1], formerly NCS-GUIDE-01, and the guidance set forth on use of the Standard Criticality Safety Requirements (SCSRs) [Reference 2]. As stated in Reference 2, the criticality safety evaluation consists of both the SCSR CSED and the SCSR Application CSED. The SCSR CSED is a Level-3 CSED [Reference 3]. This Level-1 CSED is the SCSR Application CSED. This SCSR Application (Level-1) evaluation does not derive controls, itmore » simply applies controls derived from the SCSR CSED (Level-3) for the application of operations conducted here. The controls derived in the SCSR CSED (Level-3) were evaluated via the process described in Section 6.6.5 of SD-130 (also reproduced in Section 4.3.5 of NCS-AP-004 [Reference 1]) and were determined to not meet the requirements for consideration of elevation into the safety basis documentation for CMR. According to the guidance set forth on use of the SCSRs [Reference 2], the SCSR CSED (Level-3) is also applicable to the CMR Facility because the process and the normal and credible abnormal conditions in question are bounded by those that are described in the SCSR CSED. The controls derived in the SCSR CSED include allowances for solid materials and solution operations. Based on the operations conducted at this location, there are less-than-accountable (LTA) amounts of 233U. Based on the evaluation documented herein, the normal and credible abnormal conditions that might arise during the execution of this process will remain subcritical with the following recommended controls.« less

Next Generation Safeguards Initiative research to determine the Pu mass in spent fuel assemblies: Purpose, approach, constraints, implementation, and calibration

NASA Astrophysics Data System (ADS)

Tobin, S. J.; Menlove, H. O.; Swinhoe, M. T.; Schear, M. A.

2011-10-01

The Next Generation Safeguards Initiative (NGSI) of the U.S. Department of Energy has funded a multi-lab/multi-university collaboration to quantify the plutonium mass in spent nuclear fuel assemblies and to detect the diversion of pins from them. The goal of this research effort is to quantify the capability of various non-destructive assay (NDA) technologies as well as to train a future generation of safeguards practitioners. This research is "technology driven" in the sense that we will quantify the capabilities of a wide range of safeguards technologies of interest to regulators and policy makers; a key benefit to this approach is that the techniques are being tested in a unified manner. When the results of the Monte Carlo modeling are evaluated and integrated, practical constraints are part of defining the potential context in which a given technology might be applied. This paper organizes the commercial spent fuel safeguard needs into four facility types in order to identify any constraints on the NDA system design. These four facility types are the following: future reprocessing plants, current reprocessing plants, once-through spent fuel repositories, and any other sites that store individual spent fuel assemblies (reactor sites are the most common facility type in this category). Dry storage is not of interest since individual assemblies are not accessible. This paper will overview the purpose and approach of the NGSI spent fuel effort and describe the constraints inherent in commercial fuel facilities. It will conclude by discussing implementation and calibration of measurement systems. This report will also provide some motivation for considering a couple of other safeguards concepts (base measurement and fingerprinting) that might meet the safeguards need but not require the determination of plutonium mass.

A Comparison of Phenotypic Traits Related to Trypanotolerance in Five West African Cattle Breeds Highlights the Value of Shorthorn Taurine Breeds

PubMed Central

Berthier, David; Peylhard, Moana; Dayo, Guiguigbaza-Kossigan; Flori, Laurence; Sylla, Souleymane; Bolly, Seydou; Sakande, Hassane; Chantal, Isabelle; Thevenon, Sophie

2015-01-01

Background Animal African Trypanosomosis particularly affects cattle and dramatically impairs livestock development in sub-Saharan Africa. African Zebu (AFZ) or European taurine breeds usually die of the disease in the absence of treatment, whereas West African taurine breeds (AFT), considered trypanotolerant, are able to control the pathogenic effects of trypanosomosis. Up to now, only one AFT breed, the longhorn N’Dama (NDA), has been largely studied and is considered as the reference trypanotolerant breed. Shorthorn taurine trypanotolerance has never been properly assessed and compared to NDA and AFZ breeds. Methodology/Principal Findings This study compared the trypanotolerant/susceptible phenotype of five West African local breeds that differ in their demographic history. Thirty-six individuals belonging to the longhorn taurine NDA breed, two shorthorn taurine Lagune (LAG) and Baoulé (BAO) breeds, the Zebu Fulani (ZFU) and the Borgou (BOR), an admixed breed between AFT and AFZ, were infected by Trypanosoma congolense IL1180. All the cattle were genetically characterized using dense SNP markers, and parameters linked to parasitaemia, anaemia and leukocytes were analysed using synthetic variables and mixed models. We showed that LAG, followed by NDA and BAO, displayed the best control of anaemia. ZFU showed the greatest anaemia and the BOR breed had an intermediate value, as expected from its admixed origin. Large differences in leukocyte counts were also observed, with higher leukocytosis for AFT. Nevertheless, no differences in parasitaemia were found, except a tendency to take longer to display detectable parasites in ZFU. Conclusions We demonstrated that LAG and BAO are as trypanotolerant as NDA. This study highlights the value of shorthorn taurine breeds, which display strong local adaptation to trypanosomosis. Thanks to further analyses based on comparisons of the genome or transcriptome of the breeds, these results open up the way for better knowledge of host-pathogen interactions and, furthermore, for identifying key biological pathways. PMID:25954819

A comparison of phenotypic traits related to trypanotolerance in five west african cattle breeds highlights the value of shorthorn taurine breeds.

PubMed

Berthier, David; Peylhard, Moana; Dayo, Guiguigbaza-Kossigan; Flori, Laurence; Sylla, Souleymane; Bolly, Seydou; Sakande, Hassane; Chantal, Isabelle; Thevenon, Sophie

2015-01-01

Animal African Trypanosomosis particularly affects cattle and dramatically impairs livestock development in sub-Saharan Africa. African Zebu (AFZ) or European taurine breeds usually die of the disease in the absence of treatment, whereas West African taurine breeds (AFT), considered trypanotolerant, are able to control the pathogenic effects of trypanosomosis. Up to now, only one AFT breed, the longhorn N'Dama (NDA), has been largely studied and is considered as the reference trypanotolerant breed. Shorthorn taurine trypanotolerance has never been properly assessed and compared to NDA and AFZ breeds. This study compared the trypanotolerant/susceptible phenotype of five West African local breeds that differ in their demographic history. Thirty-six individuals belonging to the longhorn taurine NDA breed, two shorthorn taurine Lagune (LAG) and Baoulé (BAO) breeds, the Zebu Fulani (ZFU) and the Borgou (BOR), an admixed breed between AFT and AFZ, were infected by Trypanosoma congolense IL1180. All the cattle were genetically characterized using dense SNP markers, and parameters linked to parasitaemia, anaemia and leukocytes were analysed using synthetic variables and mixed models. We showed that LAG, followed by NDA and BAO, displayed the best control of anaemia. ZFU showed the greatest anaemia and the BOR breed had an intermediate value, as expected from its admixed origin. Large differences in leukocyte counts were also observed, with higher leukocytosis for AFT. Nevertheless, no differences in parasitaemia were found, except a tendency to take longer to display detectable parasites in ZFU. We demonstrated that LAG and BAO are as trypanotolerant as NDA. This study highlights the value of shorthorn taurine breeds, which display strong local adaptation to trypanosomosis. Thanks to further analyses based on comparisons of the genome or transcriptome of the breeds, these results open up the way for better knowledge of host-pathogen interactions and, furthermore, for identifying key biological pathways.

Uranium Enrichment Safeguards

DOE Office of Scientific and Technical Information (OSTI.GOV)

Demuth, Scott F.; Trahan, Alexis Chanel

2017-06-26

DIV of facility layout, material flows, and other information provided in the DIQ. Material accountancy through an annual PIV and a number of interim inventory verifications, including UF6 cylinder identification and counting, NDA of cylinders, and DA on a sample collection of UF6. Application of C/S technologies utilizing seals and tamper-indicating devices (TIDs) on cylinders, containers, storage rooms, and IAEA instrumentation to provide continuity of knowledge between inspection. Verification of the absence of undeclared material and operations, especially HEU production, through SNRIs, LFUA of cascade halls, and environmental swipe sampling

Determination of the plutonium content in a spent fuel assembly by passive and active interrogation using a differential die-away instrument

NASA Astrophysics Data System (ADS)

Henzl, V.; Croft, S.; Richard, J.; Swinhoe, M. T.; Tobin, S. J.

2013-06-01

In this paper, we present a novel approach to estimating the total plutonium content in a spent fuel assembly (SFA) that is based on combining information from a passive measurement of the total neutron count rate (PN) of the assayed SFA and a measure of its multiplication. While PN can be measured essentially with any non-destructive assay (NDA) technique capable of neutron detection, the measure of multiplication is, in our approach, determined by means of active interrogation using an instrument based on the Differential Die-Away technique (DDA). The DDA is a NDA technique developed within the U.S. Department of Energy's Next Generation Safeguards Initiative (NGSI) project focused on the utilization of NDA techniques to determine the elemental plutonium content in commercial nuclear SFA's [1]. This approach was adopted since DDA also allows determination of other SFA characteristics, such as burnup, initial enrichment, and cooling time, and also allows for detection of certain types of diversion of nuclear material. The quantification of total plutonium is obtained using an analytical correlation function in terms of the observed PN and active multiplication. Although somewhat similar approaches relating Pu content with PN have been adopted in the past, we demonstrate by extensive simulation of the fuel irradiation and NDA process that our analytical method is independent of explicit knowledge of the initial enrichment, burnup, and an absolute value of the SFA's reactivity (i.e. multiplication factor). We show that when tested with MCNPX™ simulations comprising the 64 SFA NGSI Spent Fuel Library-1 we were able to determine elemental plutonium content, using just a few calibration parameters, with an average variation in the prediction of around 1-2% across the wide dynamic range of irradiation history parameters used, namely initial enrichment (IE=2-5%), burnup (BU=15-60 GWd/tU) and cooling time (CT=1-80 y). In this paper we describe the basic approach and the success obtained against synthetic data. We recognize that our synthetic data may not fully capture the rich behavior of actual irradiated fuel and the uncertainties of the practical measurements. However, this design study is based on a rather complete nuclide inventory and the correlations for Pu seem robust to variation of input. Thus it is concluded that the proposed method is sufficiently promising that further experimentally based work is desirable.

Quantitative NDA measurements of advanced reprocessing product materials containing uranium, neptunium, plutonium, and americium

NASA Astrophysics Data System (ADS)

Goddard, Braden

The ability of inspection agencies and facility operators to measure powders containing several actinides is increasingly necessary as new reprocessing techniques and fuel forms are being developed. These powders are difficult to measure with nondestructive assay (NDA) techniques because neutrons emitted from induced and spontaneous fission of different nuclides are very similar. A neutron multiplicity technique based on first principle methods was developed to measure these powders by exploiting isotope-specific nuclear properties, such as the energy-dependent fission cross sections and the neutron induced fission neutron multiplicity. This technique was tested through extensive simulations using the Monte Carlo N-Particle eXtended (MCNPX) code and by one measurement campaign using the Active Well Coincidence Counter (AWCC) and two measurement campaigns using the Epithermal Neutron Multiplicity Counter (ENMC) with various (alpha,n) sources and actinide materials. Four potential applications of this first principle technique have been identified: (1) quantitative measurement of uranium, neptunium, plutonium, and americium materials; (2) quantitative measurement of mixed oxide (MOX) materials; (3) quantitative measurement of uranium materials; and (4) weapons verification in arms control agreements. This technique still has several challenges which need to be overcome, the largest of these being the challenge of having high-precision active and passive measurements to produce results with acceptably small uncertainties.

A Direct and Rapid Method to Determine Cyanide in Urine by Capillary Electrophoresis

PubMed Central

Zhang, Qiyang; Maddukuri, Naveen; Gong, Maojun

2015-01-01

Cyanides are poisonous chemicals that widely exist in nature and industrial processes as well as accidental fires. Rapid and accurate determination of cyanide exposure would facilitate forensic investigation, medical diagnosis, and chronic cyanide monitoring. Here, a rapid and direct method was developed for the determination of cyanide ions in urinary samples. This technique was based on an integrated capillary electrophoresis system coupled with laser-induced fluorescence (LIF) detection. Cyanide ions were derivatized with naphthalene-2,3-dicarboxaldehyde (NDA) and a primary amine (glycine) for LIF detection. Three separate reagents, NDA, glycine, and cyanide sample, were mixed online, which secured uniform conditions between samples for cyanide derivatization and reduced the risk of precipitation formation of mixtures. Conditions were optimized; the derivatization was completed in 2-4 minutes, and the separation was observed in 25 s. The limit of detection (LOD) was 4.0 nM at 3-fold signal-to-noise ratio for standard cyanide in buffer. The cyanide levels in urine samples from smokers and non-smokers were determined by using the method of standard addition, which demonstrated significant difference of cyanide levels in urinary samples from the two groups of people. The developed method was rapid and accurate, and is anticipated to be applicable to cyanide detection in waste water with appropriate modification. PMID:26342870

Effective removal of effluent organic matter (EfOM) from bio-treated coking wastewater by a recyclable aminated hyper-cross-linked polymer.

PubMed

Yang, Wenlan; Li, Xuchun; Pan, Bingcai; Lv, Lu; Zhang, Weiming

2013-09-01

Effluent organic matter (EfOM) is a complex matrix of organic substance mainly from bio-treated sewage effluent and is considered as the main constraint to further advanced treatment. Here a recyclable aminated hyper-cross-linked polymeric adsorbent (NDA-802) featured with aminated functional groups, large specific surface area, and sufficient micropore region was synthesized for effective removal of EfOM from the bio-treated coking wastewater (BTCW), and its removal characteristics was investigated. It was found that hydrophobic fraction was the main constituent (64.8% of DOC) in EfOM of BTCW, and the hydrophobic-neutral fraction had the highest SUVA level (7.06 L mg(-1) m(-1)), which were significantly different from that in the domestic wastewater. Column adsorption experiments showed that NDA-802 exhibited much higher removal efficiency of EfOM than other polymeric adsorbents D-301, XAD-4, and XAD-7, and the efficiency could be readily sustained according to continuous 28-cycle batch adsorption-regeneration experiments. Moreover, dissolved organic matter (DOM) fractionation and excitation-emission matrix (EEM) fluorescence spectroscopy study indicated that NDA-802 showed attractive adsorption preference as well as high removal efficiency of hydrophobic and aromatic compounds. Possibly ascribed to the presence of functional aminated groups, relatively large specific surface area and micropore region of the unique polymer, NDA-802 possesses high and sustained efficiency for the removal of EfOM, and provides a potential alternative for the advanced treatment. Copyright © 2013 Elsevier Ltd. All rights reserved.

Effects of urbanization on gaseous and particulate polycyclic aromatic hydrocarbons and polychlorinated biphenyls in a coastal city, China: levels, sources, and health risks.

PubMed

Hong, Youwei; Chen, Jinsheng; Zhang, Fuwang; Zhang, Han; Xu, Lingling; Yin, Liqian; Chen, Yanting

2015-10-01

Gas/particle distributions of polycyclic aromatic hydrocarbons (PAHs) and polychlorinated biphenyls (PCBs) were measured in Xiamen from May 2009 to March 2010 to evaluate the impacts of urbanization on the fate of persistent organic pollutants (POPs) in the atmospheric environment. In a newly developing area (NDA), the concentrations of 16 PAHs (gas + particle) were significantly higher than that a historically urbanized area (HUA) (p value <0.05), while the trend of 28 PCBs was reversed. Diagnostic ratios and principle component analysis (PCA) implied that atmospheric PAHs in the NDA were mainly derived from petrogenic combustion, including mixed sources of vehicle emissions, biomass burning and oil combustion, while pyrogenic combustion (e.g., traffic and coal combustion) was considered the major source of PAHs in the HUA. Atmospheric PCBs in both HUA and NDA were dominated by TriCBs and PeCBs related to the use of commercial mixtures (Aroclors 1242 and 1254). Based on the toxicological equivalent factor (TEF) approach, total benzo[a]pyrene equivalent values in the HUA and NDA were 1.12 and 2.02 ng m(-3), respectively, exceeding the standard threshold values (1.0 ng m(-3)) of China and WHO. Average daily intake of dioxin-like compounds was 0.2 pg kg(-1) day(-1) in the HUA, which are below the WHO tolerable daily intake level. The results showed that the contribution to the toxic equivalency (TEQ) was dominated by PCB169, PCB105, and PCB81.

Development of MMC Gamma Detectors for Nuclear Analysis

NASA Astrophysics Data System (ADS)

Bates, C. R.; Pies, C.; Kempf, S.; Gastaldo, L.; Fleischmann, A.; Enss, C.; Friedrich, S.

2014-09-01

Non-destructive assay (NDA) of nuclear materials would benefit from gamma detectors with improved energy resolution in cases where line overlap in current Ge detectors limits NDA accuracy. We are developing metallic magnetic calorimeter gamma-detectors for this purpose by electroplating 150 m thick Au absorbers into microfabricated molds on top of Au:Er sensors. Initial tests under non-optimized conditions show an energy resolution of 200 eV FWHM at 60 keV. Monte Carlo simulations illustrate that this resolution is starting to be sufficient for direct detection of Pu in plutonium separated from spent nuclear fuel.

Longitudinal study of mammographic density measures that predict breast cancer risk

PubMed Central

Krishnan, Kavitha; Baglietto, Laura; Stone, Jennifer; Simpson, Julie A; Severi, Gianluca; Evans, Christopher F; MacInnis, Robert J; Giles, Graham G; Apicella, Carmel; Hopper, John L

2016-01-01

Background After adjusting for age and body mass index (BMI), mammographic measures - dense area (DA), percent dense area (PDA) and non-dense area (NDA) - are associated with breast cancer risk. Our aim was to use longitudinal data to estimate the extent to which these risk-predicting measures track over time. Methods We collected 4,320 mammograms (age range, 24-83 years) from 970 women in the Melbourne Collaborative Cohort Study and the Australian Breast Cancer Family Registry. Women had on average 4.5 mammograms (range, 1-14). DA, PDA and NDA were measured using the Cumulus software and normalised using the Box-Cox method. Correlations in the normalised risk-predicting measures over time intervals of different lengths were estimated using nonlinear mixed-effects modelling of Gompertz curves. Results Mean normalised DA and PDA were constant with age to the early 40s, decreased over the next two decades, and were almost constant from the mid 60s onwards. Mean normalised NDA increased non-linearly with age. After adjusting for age and BMI, the within-woman correlation estimates for normalised DA were 0.94, 0.93, 0.91, 0.91 and 0.91 for mammograms taken 2, 4, 6, 8 and 10 years apart, respectively. Similar correlations were estimated for the age and BMI adjusted normalized PDA and NDA. Conclusion The mammographic measures that predict breast cancer risk are highly correlated over time. Impact This has implications for etiologic research and clinical management whereby women at increased risk could be identified at a young age (e.g. early 40s or even younger) and recommended appropriate screening and prevention strategies. PMID:28062399

Interactions of alcohol and postmenopausal hormone use in regards to mammographic breast density.

PubMed

Yaghjyan, Lusine; Colditz, Graham; Eliassen, Heather; Rosner, Bernard; Gasparova, Aleksandra; Tamimi, Rulla M

2018-06-25

We investigated the association of alcohol intake with mammographic breast density in postmenopausal women by their hormone therapy (HT) status. This study included 2,100 cancer-free postmenopausal women within the Nurses' Health Study and Nurses' Health Study II cohorts. Percent breast density (PD), absolute dense (DA), and non-dense areas (NDA) were measured from digitized film mammograms using a computer-assisted thresholding technique; all measures were square root transformed. Alcohol consumption was assessed with a food frequency questionnaire (0, < 5, and ≥ 5 g/day). Information regarding breast cancer risk factors was obtained from baseline or biennial questionnaires closest to the mammogram date. We used generalized linear regression to examine associations between alcohol and breast density measures in women with no HT history, current, and past HT users. In multivariable analyses, we found no associations of alcohol consumption with PD (p trend = 0.32) and DA (p trend = 0.53) and an inverse association with NDA (β = - 0.41, 95% CI - 0.73, - 0.09 for ≥ 5 g/day, p trend < 0.01). In the stratified analysis by HT status, alcohol was not associated with PD in any of the strata. We found a significant inverse association of alcohol with NDA among past HT users (β = - 0.79, 95% CI - 1.51, - 0.07 for ≥ 5 g/day, p trend = 0.02). There were no significant interactions between alcohol and HT in relation to PD, DA, and NDA (p interaction = 0.19, 0.42, and 0.43, respectively). Our findings suggest that associations of alcohol with breast density do not vary by HT status.

Asymptomatic Elite Adolescent Tennis Players' Signs of Tendinosis in Their Dominant Shoulder Compared With Their Nondominant Shoulder

PubMed Central

Johansson, Fredrik R.; Skillgate, Eva; Adolfsson, Anders; Jenner, Göran; DeBri, Edin; Swärdh, Leif; Cools, Ann M.

2015-01-01

Context Tennis is an asymmetric overhead sport with specific muscle-activation patterns, especially eccentrically in the rotator cuff. Magnetic resonance imaging (MRI) findings in asymptomatic adolescent elite tennis players have not previously been reported. Objective The first aim of the study was to describe MRI findings regarding adaptations or abnormalities, as well as muscle cross-sectional area (CSA), of the rotator cuff. The second aim of the study was to investigate the rotator cuff based on the interpretation of the MRI scans as normal versus abnormal, with the subdivision based on the grade of tendinosis, and its association with eccentric rotator cuff strength in the dominant arm (DA) of the asymptomatic elite adolescent tennis player. Setting Testing environment at the radiology department of Medicinsk Röntgen AB. Patients or Other Participants Thirty-five asymptomatic elite tennis players (age = 17.4 ± 2.7 years) were selected based on ranking and exposure time. Intervention(s) We assessed MRI scans and measured the CSA of the rotator cuff muscle. The non-DA (NDA) was used as a control. In addition, eccentric testing of the external rotators of the DA was performed with a handheld dynamometer. Results The DA and NDA displayed different frequencies of infraspinatus tendinosis (grade 1 changes) (P < .05). Rotator cuff measurements revealed larger infraspinatus and teres minor CSA (P < .05) in the DA than in the NDA. Mean eccentric external-rotation strength in the DA stratified by normal tendon and tendinosis was not different between groups (P = .723). Conclusions Asymptomatic adolescent elite tennis players demonstrated infraspinatus tendinosis more frequently in the DA than in the NDA. Clinicians must recognize these tendon changes in order to modify conditioning and performance programs appropriately. PMID:26651279

Current FDA regulatory guidance on the conduct of drug discrimination studies for NDA review: Does the scientific literature support recent recommendations?

PubMed

Gauvin, David V; Zimmermann, Zachary J; Kallman, Mary Jeanne

2016-11-01

The Controlled Substances Staff of the Center for Drug Evaluation and Research at the US Food and Drug Administration and the Pharmaceutical Research Manufacturers Association (PhRMA) conducted a series of open forum dialog sessions between 2006 and 2016. A Cross Company Abuse Liability Council (CCALC) was formed during the process of this unique collaborative effort between Industry and Federal Regulators whose goals were to establish the development of standards for the preclinical screening of new molecular entities for schedule control actions required as part of every New Drug Application process. The draft guidance document was published and disseminated in 2010, which allowed for alternative approaches to each study protocol requirement needed for NDA review, if the approach satisfied the requirements of the applicable statutes and regulations (i.e., the controlled substance act). In a series of recent pre-study protocol reviews requested by confidential Pharmaceutical Sponsors of MPI Research, the CSS staff appeared to change its policy and set forth to require all drug discrimination study data to be generated under "extinction" test sessions. MPI Research is a Contract Research Organization acting on behalf of pharmaceutical companies and bound under separate confidentiality agreements. The purpose of this review is to highlight the data appearing in peer-reviewed scientific journals that do not support the regulatory administrative constraints on one specific testing methodology (extinction) to the exclusion of another (reinforced test sessions). This mind shift represents a restrictive administrative policy by the FDA that is not supported by the published data. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

A direct and rapid method to determine cyanide in urine by capillary electrophoresis.

PubMed

Zhang, Qiyang; Maddukuri, Naveen; Gong, Maojun

2015-10-02

Cyanides are poisonous chemicals that widely exist in nature and industrial processes as well as accidental fires. Rapid and accurate determination of cyanide exposure would facilitate forensic investigation, medical diagnosis, and chronic cyanide monitoring. Here, a rapid and direct method was developed for the determination of cyanide ions in urinary samples. This technique was based on an integrated capillary electrophoresis system coupled with laser-induced fluorescence (LIF) detection. Cyanide ions were derivatized with naphthalene-2,3-dicarboxaldehyde (NDA) and a primary amine (glycine) for LIF detection. Three separate reagents, NDA, glycine, and cyanide sample, were mixed online, which secured uniform conditions between samples for cyanide derivatization and reduced the risk of precipitation formation of mixtures. Conditions were optimized; the derivatization was completed in 2-4min, and the separation was observed in 25s. The limit of detection (LOD) was 4.0nM at 3-fold signal-to-noise ratio for standard cyanide in buffer. The cyanide levels in urine samples from smokers and non-smokers were determined by using the method of standard addition, which demonstrated significant difference of cyanide levels in urinary samples from the two groups of people. The developed method was rapid and accurate, and is anticipated to be applicable to cyanide detection in waste water with appropriate modification. Published by Elsevier B.V.

The Impact of Gate Width Setting and Gate Utilization Factors on Plutonium Assay in Passive Correlated Neutron Counting

DOE PAGES

Henzlova, Daniela; Menlove, Howard Olsen; Croft, Stephen; ...

2015-06-15

In the field of nuclear safeguards, passive neutron multiplicity counting (PNMC) is a method typically employed in non-destructive assay (NDA) of special nuclear material (SNM) for nonproliferation, verification and accountability purposes. PNMC is generally performed using a well-type thermal neutron counter and relies on the detection of correlated pairs or higher order multiplets of neutrons emitted by an assayed item. To assay SNM, a set of parameters for a given well-counter is required to link the measured multiplicity rates to the assayed item properties. Detection efficiency, die-away time, gate utilization factors (tightly connected to die-away time) as well as optimummore » gate width setting are among the key parameters. These parameters along with the underlying model assumptions directly affect the accuracy of the SNM assay. In this paper we examine the role of gate utilization factors and the single exponential die-away time assumption and their impact on the measurements for a range of plutonium materials. In addition, we examine the importance of item-optimized coincidence gate width setting as opposed to using a universal gate width value. Finally, the traditional PNMC based on multiplicity shift register electronics is extended to Feynman-type analysis and application of this approach to Pu mass assay is demonstrated.« less

A Sludge Drum in the APNea System

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hensley, D.

1998-11-17

The assay of sludge drums pushes the APNea System to a definite extreme. Even though it seems clear that neutron based assay should be the method of choice for sludge drums, the difficulties posed by this matrix push any NDA technique to its limits. Special emphasis is given here to the differential die-away technique, which appears to approach the desired sensitivity. A parallel analysis of ethafoam drums will be presented, since the ethafoam matrix fits well within the operating range of the AIWea System, and, having been part of the early PDP trials, has been assayed by many in themore » NDA community.« less

Using Directional Diffusion Coefficients for Nonlinear Diffusion Acceleration of the First Order SN Equations in Near-Void Regions

DOE Office of Scientific and Technical Information (OSTI.GOV)

Schunert, Sebastian; Hammer, Hans; Lou, Jijie

2016-11-01

The common definition of the diffusion coeffcient as the inverse of three times the transport cross section is not compat- ible with voids. Morel introduced a non-local tensor diffusion coeffcient that remains finite in voids[1]. It can be obtained by solving an auxiliary transport problem without scattering or fission. Larsen and Trahan successfully applied this diffusion coeffcient for enhancing the accuracy of diffusion solutions of very high temperature reactor (VHTR) problems that feature large, optically thin channels in the z-direction [2]. It is demonstrated that a significant reduction of error can be achieved in particular in the optically thin region.more » Along the same line of thought, non-local diffusion tensors are applied modeling the TREAT reactor confirming the findings of Larsen and Trahan [3]. Previous work of the authors have introduced a flexible Nonlinear-Diffusion Acceleration (NDA) method for the first order S N equations discretized with the discontinuous finite element method (DFEM), [4], [5], [6]. This NDA method uses a scalar diffusion coeffcient in the low-order system that is obtained as the flux weighted average of the inverse transport cross section. Hence, it su?ers from very large and potentially unbounded diffusion coeffcients in the low order problem. However, it was noted that the choice of the diffusion coeffcient does not influence consistency of the method at convergence and hence the di?usion coeffcient is essentially a free parameter. The choice of the di?usion coeffcient does, however, affect the convergence behavior of the nonlinear di?usion iterations. Within this work we use Morel’s non-local di?usion coef- ficient in the aforementioned NDA formulation in lieu of the flux weighted inverse of three times the transport cross section. The goal of this paper is to demonstrate that significant en- hancement of the spectral properties of NDA can be achieved in near void regions. For testing the spectral properties of the NDA with non-local diffusion coeffcients, the periodical horizontal interface problem is used [7]. This problem consists of alternating stripes of optically thin and thick materials both of which feature scattering ratios close to unity.« less

Test results of a new detector system for gamma ray isotopic measurements

DOE Office of Scientific and Technical Information (OSTI.GOV)

Malcom, J.E.; Bonner, C.A.; Hurd, J.R.

1993-08-01

A new type of gamma-ray detector system for isotopic measurements has been developed. This new system, a ``Duo detector`` array, consists of two intrinsic germanium detectors, a planar followed by a coaxial mounted on the same axis within a single cryostat assembly. This configuration allows the isotopic analysis system to take advantage of spectral data results that are collected simultaneously from different gamma-ray energy regimes. Princeton Gamma Tech (PGT) produced several prototypes of this Duo detector array which were then tested by Rocky Flats personnel until the design was optimized. An application for this detector design is in automated, roboticizedmore » NDA systems such as those being developed at the Los Alamos TA-55 Plutonium Facility. The Duo detector design reduces the space necessary for the isotopic instrument by a factor of two (only one liquid nitrogen dewar is needed), and also reduces the complexity of the mechanical systems and controlling software. Data will be presented on measurements of nuclear material with a Duo detector for a wide variety of matrices. Results indicate that the maximum count rate can be increased up to 100,000 counts per second yet maintaining excellent resolution and energy rate product.« less

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hoover, Andrew Scott; Bennett, D. A.; Croce, Mark Philip

In 2005 the LANL/NIST team used a single high-resolution microcalorimeter detector to measure the gamma-ray spectrum of a plutonium sample. After more than a decade of research and development on this topic, both the technology and our general understanding of its capabilities have advanced greatly, such that a progress review is now timely. We examine the scenario of a large-scale reprocessing plant and conclude that current non-destructive analysis (NDA) methods are inadequate to safeguard such a facility to the desired levels, leading to undesirable dependence on massspectrometry (MS) destructive analysis (DA). The development of microcalorimeter detectors is intended to closemore » the performance gap between NDA and DA methods to address the needs of nuclear facilities.« less

An unattended verification station for UF6 cylinders: Field trial findings

NASA Astrophysics Data System (ADS)

Smith, L. E.; Miller, K. A.; McDonald, B. S.; Webster, J. B.; Zalavadia, M. A.; Garner, J. R.; Stewart, S. L.; Branney, S. J.; Todd, L. C.; Deshmukh, N. S.; Nordquist, H. A.; Kulisek, J. A.; Swinhoe, M. T.

2017-12-01

In recent years, the International Atomic Energy Agency (IAEA) has pursued innovative techniques and an integrated suite of safeguards measures to address the verification challenges posed by the front end of the nuclear fuel cycle. Among the unattended instruments currently being explored by the IAEA is an Unattended Cylinder Verification Station (UCVS), which could provide automated, independent verification of the declared relative enrichment, 235U mass, total uranium mass, and identification for all declared uranium hexafluoride cylinders in a facility (e.g., uranium enrichment plants and fuel fabrication plants). Under the auspices of the United States and European Commission Support Programs to the IAEA, a project was undertaken to assess the technical and practical viability of the UCVS concept. The first phase of the UCVS viability study was centered on a long-term field trial of a prototype UCVS system at a fuel fabrication facility. A key outcome of the study was a quantitative performance evaluation of two nondestructive assay (NDA) methods being considered for inclusion in a UCVS: Hybrid Enrichment Verification Array (HEVA), and Passive Neutron Enrichment Meter (PNEM). This paper provides a description of the UCVS prototype design and an overview of the long-term field trial. Analysis results and interpretation are presented with a focus on the performance of PNEM and HEVA for the assay of over 200 "typical" Type 30B cylinders, and the viability of an "NDA Fingerprint" concept as a high-fidelity means to periodically verify that material diversion has not occurred.

Nodularin, a cyanobacterial toxin, is synthesized in planta by symbiotic Nostoc sp.

PubMed

Gehringer, Michelle M; Adler, Lewis; Roberts, Alexandra A; Moffitt, Michelle C; Mihali, Troco K; Mills, Toby J T; Fieker, Claus; Neilan, Brett A

2012-10-01

The nitrogen-fixing bacterium, Nostoc, is a commonly occurring cyanobacterium often found in symbiotic associations. We investigated the potential of cycad cyanobacterial endosymbionts to synthesize microcystin/nodularin. Endosymbiont DNA was screened for the aminotransferase domain of the toxin biosynthesis gene clusters. Five endosymbionts carrying the gene were screened for bioactivity. Extracts of two isolates inhibited protein phosphatase 2A and were further analyzed using electrospray ionization mass spectrometry (ESI-MS)/MS. Nostoc sp. 'Macrozamia riedlei 65.1' and Nostoc sp. 'Macrozamia serpentina 73.1' both contained nodularin. High performance liquid chromatography (HPLC) HESI-MS/MS analysis confirmed the presence of nodularin at 9.55±2.4 ng μg-1 chlorophyll a in Nostoc sp. 'Macrozamia riedlei 65.1' and 12.5±8.4 ng μg-1 Chl a in Nostoc sp. 'Macrozamia serpentina 73.1' extracts. Further scans indicated the presence of the rare isoform [L-Har(2)] nodularin, which contains L-homoarginine instead of L-arginine. Nodularin was also present at 1.34±0.74 ng ml(-1) (approximately 3 pmol per g plant ww) in the methanol root extracts of M. riedlei MZ65, while the presence of [L-Har(2)] nodularin in the roots of M. serpentina MZ73 was suggested by HPLC HESI-MS/MS analysis. The ndaA-B and ndaF genomic regions were sequenced to confirm the presence of the hybrid polyketide/non-ribosomal gene cluster. A seven amino-acid insertion into the NdaA-C1 domain of N. spumigena NSOR10 protein was observed in all endosymbiont-derived sequences, suggesting the transfer of the nda cluster from N. spumigena to terrestrial Nostoc species. This study demonstrates the synthesis of nodularin and [L-Har(2)] nodularin in a non-Nodularia species and the production of cyanobacterial hepatotoxin by a symbiont in planta.

Nodularin, a cyanobacterial toxin, is synthesized in planta by symbiotic Nostoc sp.

PubMed Central

Gehringer, Michelle M; Adler, Lewis; Roberts, Alexandra A; Moffitt, Michelle C; Mihali, Troco K; Mills, Toby J T; Fieker, Claus; Neilan, Brett A

2012-01-01

The nitrogen-fixing bacterium, Nostoc, is a commonly occurring cyanobacterium often found in symbiotic associations. We investigated the potential of cycad cyanobacterial endosymbionts to synthesize microcystin/nodularin. Endosymbiont DNA was screened for the aminotransferase domain of the toxin biosynthesis gene clusters. Five endosymbionts carrying the gene were screened for bioactivity. Extracts of two isolates inhibited protein phosphatase 2A and were further analyzed using electrospray ionization mass spectrometry (ESI-MS)/MS. Nostoc sp. ‘Macrozamia riedlei 65.1' and Nostoc sp. ‘Macrozamia serpentina 73.1' both contained nodularin. High performance liquid chromatography (HPLC) HESI-MS/MS analysis confirmed the presence of nodularin at 9.55±2.4 ng μg−1 chlorophyll a in Nostoc sp. ‘Macrozamia riedlei 65.1' and 12.5±8.4 ng μg−1 Chl a in Nostoc sp. ‘Macrozamia serpentina 73.1' extracts. Further scans indicated the presence of the rare isoform [L-Har2] nodularin, which contains ℒ-homoarginine instead of ℒ-arginine. Nodularin was also present at 1.34±0.74 ng ml−1 (approximately 3 pmol per g plant ww) in the methanol root extracts of M. riedlei MZ65, while the presence of [L-Har2] nodularin in the roots of M. serpentina MZ73 was suggested by HPLC HESI-MS/MS analysis. The ndaA-B and ndaF genomic regions were sequenced to confirm the presence of the hybrid polyketide/non-ribosomal gene cluster. A seven amino-acid insertion into the NdaA-C1 domain of N. spumigena NSOR10 protein was observed in all endosymbiont-derived sequences, suggesting the transfer of the nda cluster from N. spumigena to terrestrial Nostoc species. This study demonstrates the synthesis of nodularin and [L-Har2] nodularin in a non-Nodularia species and the production of cyanobacterial hepatotoxin by a symbiont in planta. PMID:22456448

TU-F-18C-09: Mammogram Surveillance Using Texture Analysis for Breast Cancer Patients After Radiation Therapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kuo, H; Tome, W; FOX, J

2014-06-15

Purpose: To study the feasibility of applying cancer risk model established from treated patients to predict the risk of recurrence on follow-up mammography after radiation therapy for both ipsilateral and contralateral breast. Methods: An extensive set of textural feature functions was applied to a set of 196 Mammograms from 50 patients. 56 Mammograms from 28 patients were used as training set, 44 mammograms from 22 patients were used as test set and the rest were used for prediction. Feature functions include Histogram, Gradient, Co-Occurrence Matrix, Run-Length Matrix and Wavelet Energy. An optimum subset of the feature functions was selected bymore » Fisher Coefficient (FO) or Mutual Information (MI) (up to top 10 features) or a method combined FO, MI and Principal Component (FMP) (up to top 30 features). One-Nearest Neighbor (1-NN), Linear Discriminant Analysis (LDA) and Nonlinear Discriminant Analysis (NDA) were utilized to build a risk model of breast cancer from the training set of mammograms at the time of diagnosis. The risk model was then used to predict the risk of recurrence from mammogram taken one year and three years after RT. Results: FPM with NDA has the best classification power in classifying the training set of the mammogram with lesions versus those without lesions. The model of FPM with NDA achieved a true positive (TP) rate of 82% compared to 45.5% of using FO with 1-NN. The best false positive (FP) rates were 0% and 3.6% in contra-lateral breast of 1-year and 3-years after RT, and 10.9% in ipsi-lateral breast of 3-years after RT. Conclusion: Texture analysis offers high dimension to differentiate breast tissue in mammogram. Using NDA to classify mammogram with lesion from mammogram without lesion, it can achieve rather high TP and low FP in the surveillance of mammogram for patient with conservative surgery combined RT.« less

Interaction of mammographic breast density with menopausal status and postmenopausal hormone use in relation to the risk of aggressive breast cancer subtypes.

PubMed

Yaghjyan, Lusine; Tamimi, Rulla M; Bertrand, Kimberly A; Scott, Christopher G; Jensen, Matthew R; Pankratz, V Shane; Brandt, Kathy; Visscher, Daniel; Norman, Aaron; Couch, Fergus; Shepherd, John; Fan, Bo; Chen, Yunn-Yi; Ma, Lin; Beck, Andrew H; Cummings, Steven R; Kerlikowske, Karla; Vachon, Celine M

2017-09-01

We examined the associations of mammographic breast density with breast cancer risk by tumor aggressiveness and by menopausal status and current postmenopausal hormone therapy. This study included 2596 invasive breast cancer cases and 4059 controls selected from participants of four nested case-control studies within four established cohorts: the Mayo Mammography Health Study, the Nurses' Health Study, Nurses' Health Study II, and San Francisco Mammography Registry. Percent breast density (PD), absolute dense (DA), and non-dense areas (NDA) were assessed from digitized film-screen mammograms using a computer-assisted threshold technique and standardized across studies. We used polytomous logistic regression to quantify the associations of breast density with breast cancer risk by tumor aggressiveness (defined as presence of at least two of the following tumor characteristics: size ≥2 cm, grade 2/3, ER-negative status, or positive nodes), stratified by menopausal status and current hormone therapy. Overall, the positive association of PD and borderline inverse association of NDA with breast cancer risk was stronger in aggressive vs. non-aggressive tumors (≥51 vs. 11-25% OR 2.50, 95% CI 1.94-3.22 vs. OR 2.03, 95% CI 1.70-2.43, p-heterogeneity = 0.03; NDA 4th vs. 2nd quartile OR 0.54, 95% CI 0.41-0.70 vs. OR 0.71, 95% CI 0.59-0.85, p-heterogeneity = 0.07). However, there were no differences in the association of DA with breast cancer by aggressive status. In the stratified analysis, there was also evidence of a stronger association of PD and NDA with aggressive tumors among postmenopausal women and, in particular, current estrogen+progesterone users (≥51 vs. 11-25% OR 3.24, 95% CI 1.75-6.00 vs. OR 1.93, 95% CI 1.25-2.98, p-heterogeneity = 0.01; NDA 4th vs. 2nd quartile OR 0.43, 95% CI 0.21-0.85 vs. OR 0.56, 95% CI 0.35-0.89, p-heterogeneity = 0.01), even though the interaction was not significant. Our findings suggest that associations of mammographic density with breast cancer risk differ by tumor aggressiveness. While there was no strong evidence that these associations differed by menopausal status or hormone therapy, they did appear more prominent among current estrogen+progesterone users.

[Companion diagnostics "POTELIGEO TEST IHC/FCM" used with "POTELIGEO" (mogamulizumab) for adult T-cell leukemia-lymphoma (ATL) treatment].

PubMed

Goami, Takeshi

2014-05-01

Personalized medicine offers the best treatment for individual patients, it is important for an IVD manufacturer to develop companion diagnostics in parallel with the development of new drugs through close cooperation with drug companies, and supply diagnostics companies with new drugs for physicians and patients. We received approval for a premarket approval application (PMA) for two in vitro diagnostic ("IVD") reagents, POTELIGEO TEST IHC and POTELIGEO TEST FCM ("POTELIGEO TEST"), in March 2012, and subsequently launched POTELIGEO TEST in May 2012. POTELIGEO TEST is a companion diagnostic used with POTELIGEO for which Kyowa Hakko Kirin has a new drug application (NDA) that was approved in March 2012, and is designed to help physicians identify appropriate subpopulations of adult T-cell leukemia-lymphoma(ATL) patients who are most likely to respond to POTELIGEO 20 mg (mogamulizumab) Injection ("POTELIGEO").

Nano-Dust Analyzer for the detection and chemical composition measurement particles originating from near the Sun

NASA Astrophysics Data System (ADS)

OBrien, L. E.; Gemer, A.; Gruen, E.; Collette, A.; Horanyi, M.; Moebius, E.; Auer, S.; Juhasz, A.; Srama, R.; Sternovsky, Z.

2012-12-01

We report the development of the Nano-Dust Analyzer (NDA) instrument and the results from the first laboratory testing and calibration. The two STEREO spacecrafts have indicated that nano-sized dust particles, potentially with very high flux, are delivered to 1 AU from the inner solar system [Meyer-Vernet, N. et al., Solar Physics, 256, 463, 2009]. These particles are generated by collisional grinding or evaporation near the Sun and subsequently accelerated outward by the solar wind. The temporal variability and directionality are governed by conditions in the inner heliosphere and the mass analysis of the particles reveals the chemical differentiation of solid matter near the Sun. NDA is a highly sensitive dust analyzer that is developed under NASA's Heliophysics program. NDA is a linear time-of-flight mass analyzer that modeled after Cosmic Dust Analyzer (CDA) on Cassini and the more recent Lunar Dust EXperiment (LDEX) for the upcoming LADEE mission to the Moon. The ion optics of the instrument is optimized through numerical modeling. By applying technologies implemented in solar wind instruments and coronagraphs, the highly sensitive dust analyzer will be able to be pointed towards the solar direction. A laboratory prototype is built and tested and calibrated at the dust accelerator facility at the University of Colorado, Boulder, using particles with from 1 to over 50 km/s velocity.

A magnetic nanobead-based bioassay provides sensitive detection of single- and biplex bacterial DNA using a portable AC susceptometer

PubMed Central

Strömberg, Mattias; Zardán Gómez de la Torre, Teresa; Nilsson, Mats; Svedlindh, Peter; Strømme, Maria

2014-01-01

Bioassays relying on magnetic read-out using probe-tagged magnetic nanobeads are potential platforms for low-cost biodiagnostic devices for pathogen detection. For optimal assay performance it is crucial to apply an easy, efficient and robust bead-probe conjugation protocol. In this paper, sensitive (1.5 pM) singleplex detection of bacterial DNA sequences is demonstrated in a portable AC susceptometer by a magnetic nanobead-based bioassay principle; the volume-amplified magnetic nanobead detection assay (VAM-NDA). Two bead sizes, 100 and 250 nm, are investigated along with a highly efficient, rapid, robust, and stable conjugation chemistry relying on the avidin–biotin interaction for bead-probe attachment. Avidin-biotin conjugation gives easy control of the number of detection probes per bead; thus allowing for systematic investigation of the impact of varying the detection probe surface coverage upon bead immobilization in rolling circle amplified DNA-coils. The existence of an optimal surface coverage is discussed. Biplex VAM-NDA detection is for the first time demonstrated in the susceptometer: Semi-quantitative results are obtained and it is concluded that the concentration of DNA-coils in the incubation volume is of crucial importance for target quantification. The present findings bring the development of commercial biodiagnostic devices relying on the VAM–NDA further towards implementation in point-of-care and outpatient settings. PMID:24174315

Expression profiles of genes for mitochondrial respiratory energy-dissipating systems and antioxidant enzymes in wheat leaves during de-etiolation.

PubMed

Garmash, Elena V; Velegzhaninov, Ilya O; Grabelnych, Olga I; Borovik, Olga A; Silina, Ekaterina V; Voinikov, Victor K; Golovko, Tamara K

2017-08-01

Mitochondrial respiratory components participate in the maintenance of chloroplast functional activity. This study investigates the effects 48h de-etiolation of spring wheat seedlings (Triticum aestivum L., var. Irgina) on the expression of genes that encode energy-dissipating respiratory components and antioxidant enzymes under continuous light conditions. The expression of AOX1a following the prolonged darkness exhibited a pattern indicating a prominent dependence on light. The expression of other respiratory genes, including NDA2, NDB2, and UCP1b, increased during de-etiolation and dark-to-light transition; however, changes in the expression of these genes occurred later than those in AOX1a expression. A high expression of NDA1 was detected after 12h of de-etiolation. The suppression of AOX1a, NDA2, NDB2, and UCP1b was observed 24h after de-etiolation when the photosynthetic apparatus and its defence systems against excess light were completely developed. The expression patterns of the respiratory genes and several genes encoding antioxidant enzymes (MnSOD, Cu-ZnSOD, t-APX, GR, and GRX) were quite similar. Our data indicate that the induction of nuclear genes encoding respiratory and antioxidant enzymes allow the plants to control reactive oxygen species (ROS) production and avoid oxidative stress during de-etiolation. Copyright © 2017 Elsevier GmbH. All rights reserved.

An unattended verification station for UF 6 cylinders: Field trial findings

DOE PAGES

Smith, L. E.; Miller, K. A.; McDonald, B. S.; ...

2017-08-26

In recent years, the International Atomic Energy Agency (IAEA) has pursued innovative techniques and an integrated suite of safeguards measures to address the verification challenges posed by the front end of the nuclear fuel cycle. Among the unattended instruments currently being explored by the IAEA is an Unattended Cylinder Verification Station (UCVS), which could provide automated, independent verification of the declared relative enrichment, 235U mass, total uranium mass, and identification for all declared uranium hexafluoride cylinders in a facility (e.g., uranium enrichment plants and fuel fabrication plants). Under the auspices of the United States and European Commission Support Programs tomore » the IAEA, a project was undertaken to assess the technical and practical viability of the UCVS concept. The first phase of the UCVS viability study was centered on a long-term field trial of a prototype UCVS system at a fuel fabrication facility. A key outcome of the study was a quantitative performance evaluation of two nondestructive assay (NDA) methods being considered for inclusion in a UCVS: Hybrid Enrichment Verification Array (HEVA), and Passive Neutron Enrichment Meter (PNEM). This paper provides a description of the UCVS prototype design and an overview of the long-term field trial. In conclusion, analysis results and interpretation are presented with a focus on the performance of PNEM and HEVA for the assay of over 200 “typical” Type 30B cylinders, and the viability of an “NDA Fingerprint” concept as a high-fidelity means to periodically verify that material diversion has not occurred.« less

An unattended verification station for UF 6 cylinders: Field trial findings

DOE Office of Scientific and Technical Information (OSTI.GOV)

Smith, L. E.; Miller, K. A.; McDonald, B. S.

In recent years, the International Atomic Energy Agency (IAEA) has pursued innovative techniques and an integrated suite of safeguards measures to address the verification challenges posed by the front end of the nuclear fuel cycle. Among the unattended instruments currently being explored by the IAEA is an Unattended Cylinder Verification Station (UCVS), which could provide automated, independent verification of the declared relative enrichment, 235U mass, total uranium mass, and identification for all declared uranium hexafluoride cylinders in a facility (e.g., uranium enrichment plants and fuel fabrication plants). Under the auspices of the United States and European Commission Support Programs tomore » the IAEA, a project was undertaken to assess the technical and practical viability of the UCVS concept. The first phase of the UCVS viability study was centered on a long-term field trial of a prototype UCVS system at a fuel fabrication facility. A key outcome of the study was a quantitative performance evaluation of two nondestructive assay (NDA) methods being considered for inclusion in a UCVS: Hybrid Enrichment Verification Array (HEVA), and Passive Neutron Enrichment Meter (PNEM). This paper provides a description of the UCVS prototype design and an overview of the long-term field trial. In conclusion, analysis results and interpretation are presented with a focus on the performance of PNEM and HEVA for the assay of over 200 “typical” Type 30B cylinders, and the viability of an “NDA Fingerprint” concept as a high-fidelity means to periodically verify that material diversion has not occurred.« less

Wholly Aromatic Ether-imides. Potential Materials for n-Type Semiconductors

NASA Technical Reports Server (NTRS)

Dingemans, Theo J.; St.Clair, Terry L.; Samulski, Edward T.; Bushnell, Dennis M. (Technical Monitor)

2002-01-01

We report on the synthesis and characterization of a novel series low-molar-mass ether-imide rod-shaped model compounds. All ether-imides were obtained by terminating the appropriate rigid core dianhydride, i.e. pyromellitic dianhydride (PMDA), 1,4,5,8-naphthalenetetracarboxylic dianhydride (NDA), 3,3',4,4'-biphenyltetracarboxylic dianhydride (BPDA), and 3,3,4,4'-oxydiphthalic dianhydride (ODPA) with three flexible aryl-ether tails of different chain length. The mono-functional aryl-ether amines, i.e. 4-(3-phenoxy-phenoxy)-phenylamine (2) and 4-(3-phenoxy-3-phenoxy-phenoxy)-phenylamine (4), were synthesized using standard fluoro-displacement and Ullmann condensation techniques. The corresponding ether-imide model compounds were obtained in high yields using a one-step solution imidization procedure. Increasing the number of meta-substituted aryl-ether units reduces the melt transition temperatures and at the same time it increases the solubility of the model compounds. Most model compounds are crystalline solids and form isotropic melts upon heating. 2,7-Bis-(-4-phenoxy-phenyl)-benzo[Imn][3,8]phenanthroline1,3,6,8-tetraone (NDA-n0), however, displays a smectic A (SA) when cooled from the isotropic phase, followed by what appears to be either a highly ordered smectic phase or a, columnar phase. This is the first example, known to date, in which a mesophase is detected in a wholly aromatic ether-imide compound. For all compounds we present spectroscopic data and X-ray diffraction data. Cyclic voltammetry was used to determine the redox behavior and pertinent energy levels of the model compounds.

78 FR 67364 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-12

... link, or call the advisory committee information line to learn about possible modifications before... (NDA) 202293, dapagliflozin tablet, submitted by Bristol-Myers Squibb. Dapagliflozin is a sodium...

Hyaluronidase (Vitrase)--ISTA: hyaluronidase--ISTA pharmaceuticals.

PubMed

2003-01-01

ISTA Pharmaceuticals (formerly Advanced Corneal Systems) has developed an ophthalmic injectable formulation of highly purified hyaluronidase [ovine hyaluronidase, Vitrase] for the initial treatment of vitreous haemorrhage and diabetic retinopathy. Hyaluronidase is a naturally occurring enzyme that digests certain forms of carbohydrate molecules called proteoglycans. The current medical treatment for vitreous haemorrhage is vitrectomy, an invasive surgical procedure that may result in future cataract formation, retinal detachment or other complications. There are currently no approved drug therapies for vitreous haemorrhage. ISTA believes that an injection of Vitrase causes the vitreous to liquefy, thereby promoting the clearance of vision-distorting blood. The elimination of blood helps to restore vision and provides an ophthalmologist with an unobstructed view of the retina, allowing the doctor to diagnose and treat the underlying cause of the hemorrhage. In mid-1997, Advanced Corneal Systems (now ISTA Pharmaceuticals) formed a Singapore subsidiary called Visionex to develop and market the company's technologies in Southeast Asia and China. In March 2000, ISTA completed the acquisition of Visionex. Also in March 2000, subsidiaries of Allergan obtained marketing, sales and distribution agreements from ISTA for Vitrase worldwide, except Mexico (until April 2004) and Japan. ISTA will split Vitrase profits equally with Allergan and receive royalties on sales in non-US countries. ISTA is responsible for all costs of product development, preclinical studies and clinical trials, of Vitrase and may receive up to 35 million US dollars in milestone payments from Allergan upon the achievement of specified regulatory and development objectives. In December 2001, Otsuka gained exclusive rights to develop, market and commercialise Vitrase in Japan. In July 2002, ISTA announced that it has entered into an agreement with Cardinal Health for the manufacture of commercial quantities of Vitrase. The agreement covers the US, Canada, Japan and the European Union. Cardinal Health will also provide manufacturing-related information for the US New Drug Application (NDA). Sophia Laboratories distribute Vitrase in Mexico. The US FDA designated Vitrase as a fast track product in October 1998, which means the FDA will facilitate the development and expedite the review of the product. Vitrase has being investigated in two multinational, randomised, placebo-controlled, phase III trials in patients with severe vitreous haemorrhage. One was conducted in the US, Mexico and Canada (North American trial) with an enrolment of 750 patients. The second trial was conducted in Europe, Brazil, Australia and South Africa and enrolled 556 patients. In March 2002, ISTA began unmasking the data, revealing that although preliminary efficacy results did not show any statistically significant improvement in the primary endpoint, clinically relevant improvements in visual acuity and a decrease in the density of vitreous haemorrhage were observed in patients treated with a 55IU dose of Vitrase, compared with placebo-treated patients. In December 2002, the FDA accepted the NDA for Vitrase for filing. The FDA's Dermatologic and Ophthalmic Drugs Advisory Committee reviewed the Vitrase NDA on 17 March 2003 and voted 8 to 4 that there was insufficient statistical evidence to support the use of Vitrasefor the treatment of vitreous haemorrhage. However, the Committee did recognise that in certain patient subgroups, the benefits of Vitrase therapy outweighed the potential risks. The FDA has recommended that ISTA provide additional analyses from the two pivotal phase III trials conducted. In April 2003, the FDA issued an approvable letter for Vitrase for the treatment of vitreous haemorrhage. ISTA anticipates that the FDA will complete its review of the Vitrase NDA anete its review of the Vitrase NDA and issue the results during the second half of 2003. In addition, ISTA plans to submit a marketing approval application with the European Medical Evaluation Agency (EMEA) in the first half of 2003. A phase II trial in Singapore was being conducted by Visionex. However, in March 2000, ISTA completed the acquisition of Visionex. In its Securities and Exchange Commission (SEC) filing, as at 31 December 2002, ISTA stated that the continued development of Vitrase for diabetic retinopathy will be dependent upon a number of factors including the FDA's evaluation of Vitrase for the treatment of vitreous hemorrhage, the successful completion of any additional clinical trials for the diabetic retinopathy, and the continuing assessment of the market opportunity for this indication compared with other product opportunities that ISTA may be pursuing at the time. ISTA is also developing hyaluronidase products for the treatment of cataracts (Keratase) and keratoconus (Keraform).

Duchenne muscular dystrophy drugs face tough path to approval.

PubMed

Hodgkinson, L; Sorbera, L; Graul, A I

2016-03-01

Highly anticipated as new disease-modifying treatments for Duchenne muscular dystrophy (DMD), therapeutics by BioMarin Pharmaceutical (Kyndrisa™; drisapersen) and Sarepta Therapeutics (eteplirsen; AVI-4658) both recently received negative FDA reviews and are now facing battles for approval in the U.S. At present, BioMarin is committed to working with the FDA to forge a pathway to approval following the failure of its NDA, while Sarepta awaits the formal decision on its NDA, which is expected by late May 2016. Despite the critical nature of both reviews, analysts consider that there is still a narrow possibility of approval of both drugs. According to Consensus forecasts from Thomson Reuters Cortellis for Competitive Intelligence, Kyndrisa is forecast to achieve sales of USD 533.71 million in 2021. Copyright 2016 Prous Science, S.A.U. or its licensors. All rights reserved.

Low-frequency nondestructive analysis of cracks in multilayer structures using a scanning magnetic microscope

NASA Astrophysics Data System (ADS)

Adamo, M.; Nappi, C.; Sarnelli, E.

2010-09-01

The use of a scanning magnetic microscope (SMM) with a high temperature superconducting quantum interference device (SQUID) for quantitative measurements in eddy current nondestructive analysis (NDA) is presented. The SQUID has been used to detect the weak magnetic field variations around a small defect, close to a structural part generating an intensive magnetic field. The experimental data for a deep crack close to a rivet in a multilayer conducting plate have been taken in a RF-shielded environment and discussed in the light of the theoretical predictions. The results show that eddy current NDA can distinguish subsurface crack signals from wider structural signals, with defects located 10 mm below the surface. Moreover, in order to visualize the structure of the probing current when a circular induction coil is used, the simulation of eddy currents in a thick unflawed conducting plate has been carried out.

Year End Progress Report on Rattlesnake Improvements

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wang, Yaqi; DeHart, Mark David; Gleicher, Frederick Nathan

Rattlesnake is a MOOSE-based radiation transport application developed at INL to support modern multi-physics simulations. At the beginning of the last year, Rattlesnake was able to perform steady-state, transient and eigenvalue calculations for the multigroup radiation transport equations. Various discretization schemes, including continuous finite element method (FEM) with discrete ordinates method (SN) and spherical harmonics expansion method (PN) for the self-adjoint angular flux (SAAF) formulation, continuous FEM (CFEM) with SN for the least square (LS) formulation, diffusion approximation with CFEM and discontinuous FEM (DFEM), have been implemented. A separate toolkit, YAKXS, for multigroup cross section management was developed to supportmore » Rattlesnake calculations with feedback both from changes in the field variables, such as fuel temperature, coolant density, and etc., and in isotope inventory. The framework for doing nonlinear diffusion acceleration (NDA) within Rattlesnake has been set up, and both NDA calculations with SAAF-SN-CFEM scheme and Monte Carlo with OpenMC have been performed. It was also used for coupling BISON and RELAP-7 for the full-core multiphysics simulations. Within the last fiscal year, significant improvements have been made in Rattlesnake. Rattlesnake development was migrated into our internal GITLAB development environment at the end of year 2014. Since then total 369 merge requests has been accepted into Rattlesnake. It is noted that the MOOSE framework that Rattlesnake is based on is under continuous developments. Improvements made in MOOSE can improve the Rattlesnake. It is acknowledged that MOOSE developers spent efforts on patching Rattlesnake for the improvements made on the framework side. This report will not cover the code restructuring for better readability and modularity and documentation improvements, which we have spent tremendous effort on. It only details some of improvements in the following sections.« less

An appraisal of drug development timelines in the Era of precision oncology

PubMed Central

Jardim, Denis Leonardo; Schwaederle, Maria; Hong, David S.; Kurzrock, Razelle

2016-01-01

The effects of incorporating a biomarker-based (personalized or precision) selection strategy on drug development timelines for new oncology drugs merit investigation. Here we accessed documents from the Food and Drug Administration (FDA) database for anticancer agents approved between 09/1998 and 07/2014 to compare drugs developed with and without a personalized strategy. Sixty-three drugs were included (28 [44%] personalized and 35 [56%] non-personalized). No differences in access to FDA-expedited programs were observed between personalized and non-personalized drugs. A personalized approach for drug development was associated with faster clinical development (Investigational New Drug [IND] to New Drug Application [NDA] submission; median = 58.8 months [95% CI 53.8–81.8] vs. 93.5 months [95% CI 73.9–112.9], P =.001), but a similar approval time (NDA submission to approval; median=6.0 months [95% CI 5.5–8.4] vs. 6.1 months [95% CI 5.9–8.3], P = .756) compared to a non-personalized strategy. In the multivariate model, class of drug stratified by personalized status (targeted personalized vs. targeted non-personalized vs. cytotoxic) was the only independent factor associated with faster total time of clinical drug development (clinical plus approval phase, median = 64.6 vs 87.1 vs. 112.7 months [cytotoxic], P = .038). Response rates (RR) in early trials were positively correlated with RR in registration trials (r = 0.63, P = <.001), and inversely associated with total time of drug development (r = −0.29, P = .049). In conclusion, targeted agents were developed faster than cytotoxic agents. Shorter times to approval were associated, in multivariate analysis, with a biomarker-based clinical development strategy. PMID:27419632

Interlaboratory comparison program for nondestructive assay of prototype uranium reference materials

DOE Office of Scientific and Technical Information (OSTI.GOV)

Trahey, N.M.; Smith, M.M.; Voeks, A.M.

The US Department of Energy (DOE), New Brunswick Laboratory (NBS), designed and administered an interlaboratory comparison program based on the measurement of NBL-produced prototype uranium nondestructive assay (NDA) reference materials for scrap and waste. The objectives of the program were to evaluate the reliability of NDA techniques as applied to nuclear safeguards materials control and accountability needs and to investigate the feasibility of providing practical NDA scrap and waste reference materials for use throughout the nuclear safeguards community. Fourteen facilities representing seven DOE contractors, four US Nuclear Regulatory Commission (NRC) licensees, one EURATOM Laboratory, and NBL, participated in this program.more » Three stable, well-characterized uranium reference materials were developed and certified for this program. Synthetic calcined ash, cellulose fiber, and ion-exchange resin simulate selected uranium scrap and waste forms which are often encountered in fabrication and recovery operations. The synthetic calcined ash represents an intermediate density inorganic matrix while the cellulose fiber and ion-exchange resin are representative of low-density organic matrices. The materials, containing from 0 to 13% uranium enriched at 93% /sup 235/U, were sealed in specially selected containers. Nineteen prototype reference samples, plus three empty containers, one to accompany each set, was circulated to the participants between August 1979 and May 1984. Triplicate measurements for /sup 235/U on each of the 19 filled containers were required. In addition, participants could opt to perform modular configuration measurements using containers from Sets IIA and IIB to simulate non-homogeneously dispersed uranium in waste containers. All data were reported to NBL for evaluation.« less

George Kuzmycz Training Center : 5 years of American-Ukrainian efforts in the field of material control and accounting

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gavrilyuk, V. I.; Gavrylyuk, A. V.; Kirischuk, V. I.

2004-01-01

The George Kuzmycz Training Center for Physical Protection, Control and Accounting of Nuclear Material (GKTC) was established in October 1998 at the Kiev Institute for Nuclear Research. During the past six years, about 700 professionals from all Ukrainian nuclear installations, executive and regulatory bodies were trained at the GKTC. Future Material Control and Accounting (MC&A) training courses are going to be held even more frequently because Ukraine has already signed the Additional Model Protocol and its ratification by Ukrainian Parliament is expected to happen very soon. Additionally, a number of new training courses will be developed. US DOE trough Argonnemore » National Laboratory has made significant efforts to transfer Automated Inventory/Material Accounting System (AIMAS) software to Ukraine. As a result, AIMAS software can be used as a basic code for the development of the Computerized MC&A System for all Ukrainian nuclear facilities despite their differences. In 2003, a new laboratory for Nondestructive Assay (NDA) was established with assistance from the U.S. Department of Energy. As a result, GKTC training capabilities will increase substantially. Furthermore, in order to increase the efficiency of NDA laboratory, it is planned to use the NDA equipment for a program of interdiction of illicit traffic of nuclear materials in Ukraine. American-Ukrainian MC&A efforts for the last 6 years, the problems encountered and the solutions to these problems, as well as comments, suggestions and recommendations for future activity at GKTC to promote and improve the nuclear material management culture in Ukraine are discussed in detail.« less

Observational properties of decameter type IV bursts

NASA Astrophysics Data System (ADS)

Melnik, Valentin; Brazhenko, Anatoly; Rucker, Helmut; Konovalenko, Alexander; Briand, Carine; Dorovskyy, Vladimir; Zarka, Philippe; Frantzusenko, Anatoly; Panchenko, Michael; Poedts, Stefan; Zaqarashvili, Teimuraz; Shergelashvili, Bidzina

2013-04-01

Oscillations of decameter type IV bursts were registered during observations of solar radio emission by UTR-2, URAN-2 and NDA in 2011-2012. Large majority of these bursts were accompanied by coronal mass ejections (CMEs), which were observed by SOHO and STEREO in the visible light. Only in some cases decameter type IV bursts were not associated with CMEs. The largest periods of oscillations P were some tens of minutes. There were some modes of long periods of oscillations simultaneously. Periods of oscillations in flux and in polarization profiles were close. Detailed properties of oscillations at different frequencies were analyzed on the example of two type IV bursts. One of them was observed on April 7, 2011 when a CME happened. Another one (August 1, 2011) was registered without any CME. The 7 April type IV burst had two periods in the frames 75-85 and 35-85 minutes. Interesting feature of these oscillations is decreasing periods with time. The observed decreasing rates dP/dt equaled 0.03-0.07. Concerning type IV burst observed on August 1, 2011 the period of its oscillations increases from 17 min. at 30 MHz to 44 min. at 10 MHz. Connection of type IV burst oscillations with oscillations of magnetic arches and CMEs at corresponding altitudes are discussed. The work is fulfilled in the frame of FP7 project "SOLSPANET".

An integrated approach for determining plutonium mass in spent fuel assemblies with nondestructive assay

DOE Office of Scientific and Technical Information (OSTI.GOV)

Swinhoe, Martyn T; Tobin, Stephen J; Fensin, Mike L

2009-01-01

There are a variety of reasons for quantifying plutonium (Pu) in spent fuel. Below, five motivations are listed: (1) To verify the Pu content of spent fuel without depending on unverified information from the facility, as requested by the IAEA ('independent verification'). New spent fuel measurement techniques have the potential to allow the IAEA to recover continuity of knowledge and to better detect diversion. (2) To assure regulators that all of the nuclear material of interest leaving a nuclear facility actually arrives at another nuclear facility ('shipper/receiver'). Given the large stockpile of nuclear fuel at reactor sites around the world,more » it is clear that in the coming decades, spent fuel will need to be moved to either reprocessing facilities or storage sites. Safeguarding this transportation is of significant interest. (3) To quantify the Pu in spent fuel that is not considered 'self-protecting.' Fuel is considered self-protecting by some regulatory bodies when the dose that the fuel emits is above a given level. If the fuel is not self-protecting, then the Pu content of the fuel needs to be determined and the Pu mass recorded in the facility's accounting system. This subject area is of particular interest to facilities that have research-reactor spent fuel or old light-water reactor (LWR) fuel. It is also of interest to regulators considering changing the level at which fuel is considered self-protecting. (4) To determine the input accountability value at an electrochemical processing facility. It is not expected that an electrochemical reprocessing facility will have an input accountability tank, as is typical in an aqueous reprocessing facility. As such, one possible means of determining the input accountability value is to measure the Pu content in the spent fuel that arrives at the facility. (5) To fully understand the composition of the fuel in order to efficiently and safely pack spent fuel into a long-term repository. The NDA of spent fuel can be part of a system that cost-effectively meets the burnup credit needs of a repository. Behind each of these reasons is a regulatory structure with MC&A requirements. In the case of the IAEA, the accountable quantity is elemental plutonium. The material in spent fuel (fissile isotopes, fission products, etc.) emits signatures that provide information about the content and history of the fuel. A variety of nondestructive assay (NDA) techniques are available to quantify these signatures. The effort presented in this paper is investigation of the capabilities of 12 NDA techniques. For these 12, none is conceptually capable of independently determining the Pu content in a spent fuel assembly while at the same time being able to detect the diversion of a significant quantity of rods. For this reason the authors are investigating the capability of 12 NDA techniques with the end goal of integrating a few techniques together into a system that is capable of measuring Pu mass in an assembly. The work described here is the beginning of what is anticipated to be a five year effort: (1) two years of modeling to select the best technologies, (2) one year fabricating instruments and (3) two years measuring spent fuel. This paper describes the first two years of this work. In order to cost effectively and robustly model the performance of the 12 NDA techniques, an 'assembly library' was created. The library contains the following: (a) A diverse range of PWR spent fuel assemblies (burnup, enrichment, cooling time) similar to that which exists in spent pools today and in the future. (b) Diversion scenarios that capture a range of possible rod removal options. (c) The spatial and isotopic detail needed to accurately quantify the capability of all the NDA techniques so as to enable integration. It is our intention to make this library available to other researchers in the field for inter-comparison purposes. The performance of each instrument will be quantified for the full assembly library for measurements in three different media: air, water and borated water. The 12 NDA techniques being researched are the following: Delayed Gamma, Delayed Neutrons, Differential Die-Away, Lead Slowing Down Spectrometer, Neutron Multiplicity, Nuclear Resonance Fluorescence, Passive Prompt Gamma, Passive Neutron Albedo Reactivity, Self-integration Neutron Resonance Densitometry, Total Neutron (Gross Neutron), X-Ray Fluorescence, {sup 252}Cf Interrogation with Prompt Neutron Detection.« less

ACS chemical neuroscience molecule spotlight on Lorcaserin.

PubMed

Hopkins, Corey R

2010-11-17

Lorcaserin (APD-356) is the first in a new class of selective serotonin 5-hydroxytryptamine(2C) (5-HT(2C)) receptor agonists. On December 22, 2009, the compound's developer (Arena Pharmaceuticals) submitted an NDA to the FDA for approval for weight management.

Neutron Based Non-Destructive Assay (NDA) Measurement Systems for Safeguard

DOE Office of Scientific and Technical Information (OSTI.GOV)

Swinhoe, Martyn Thomas

2017-09-21

The objectives of this project are to introduce the assay methods for plutonium measurements using the HLNC; introduce the assay method for bulk uranium measurements using the AWCC; and introduce the assay method for fuel assembly measurements using the UNCL.

A magnetic nanobead-based bioassay provides sensitive detection of single- and biplex bacterial DNA using a portable AC susceptometer.

PubMed

Strömberg, Mattias; Zardán Gómez de la Torre, Teresa; Nilsson, Mats; Svedlindh, Peter; Strømme, Maria

2014-01-01

Bioassays relying on magnetic read-out using probe-tagged magnetic nanobeads are potential platforms for low-cost biodiagnostic devices for pathogen detection. For optimal assay performance it is crucial to apply an easy, efficient and robust bead-probe conjugation protocol. In this paper, sensitive (1.5 pM) singleplex detection of bacterial DNA sequences is demonstrated in a portable AC susceptometer by a magnetic nanobead-based bioassay principle; the volume-amplified magnetic nanobead detection assay (VAM-NDA). Two bead sizes, 100 and 250 nm, are investigated along with a highly efficient, rapid, robust, and stable conjugation chemistry relying on the avidin-biotin interaction for bead-probe attachment. Avidin-biotin conjugation gives easy control of the number of detection probes per bead; thus allowing for systematic investigation of the impact of varying the detection probe surface coverage upon bead immobilization in rolling circle amplified DNA-coils. The existence of an optimal surface coverage is discussed. Biplex VAM-NDA detection is for the first time demonstrated in the susceptometer: Semi-quantitative results are obtained and it is concluded that the concentration of DNA-coils in the incubation volume is of crucial importance for target quantification. The present findings bring the development of commercial biodiagnostic devices relying on the VAM-NDA further towards implementation in point-of-care and outpatient settings. © 2013 The Authors. Biotechnology Journal published by Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim. This is an open access article under the terms of the Creative Commons Attribution-License, which permits use and distribution in any medium, provided the original work is properly cited.

Factors affecting the roles of reactive species in the degradation of micropollutants by the UV/chlorine process.

PubMed

Wu, Zihao; Guo, Kaiheng; Fang, Jingyun; Yang, Xueqin; Xiao, Hong; Hou, Shaodong; Kong, Xiujuan; Shang, Chii; Yang, Xin; Meng, Fangang; Chen, Liwei

2017-12-01

The UV/chlorine process is an emerging advanced oxidation process (AOP) that produces various reactive species, such as hydroxyl radicals (HO) and reactive chlorine species (RCS). The effects of the treatment conditions, such as chlorine dosage and pH, and the water matrix components of natural organic matter (NOM), alkalinity, ammonia and halides, on the kinetics and reactive species in the degradation of four micropollutants, metronidazole (MDZ), nalidixic acid (NDA), diethyltoluamide (DEET) and caffeine (CAF), by the UV/chlorine process were investigated. The degradation of MDZ and CAF was primarily attributable to HO and ClO, respectively, while that of NDA was primarily attributable to both ClO and CO 3 - . HO, Cl and CO 3 - are important for the degradation of DEET. The second-order rate constants for ClO with CAF and CO 3 - with NDA were determined to be 5.1 (±0.2) × 10 7  M -1 s -1 and 1.4 (±0.1) × 10 7  M -1 s -1 , respectively. Increasing chlorine dosage slightly changed the contribution of HO but linearly increased that of ClO to micropollutant degradation. Increasing pH decreased the contribution of either HO or Cl but not that of ClO. Both NOM and bicarbonate decreased the contributions of HO and Cl, whereas NOM but not bicarbonate significantly decreased that of ClO. The contribution of either HO or Cl first rose and then fell as the molar ratio of ammonia to chlorine increased from 0 to 1:1, while that of ClO decreased. The co-presence of high concentrations of Cl - and Br - enhanced the contribution of ClBr - and BrCl. Copyright © 2017 Elsevier Ltd. All rights reserved.

ACS Chemical Neuroscience Molecule Spotlight on Lorcaserin

PubMed Central

2010-01-01

Lorcaserin (APD-356) is the first in a new class of selective serotonin 5-hydroxytryptamine2C (5-HT2C) receptor agonists. On December 22, 2009, the compound's developer (Arena Pharmaceuticals) submitted an NDA to the FDA for approval for weight management. PMID:22778808

Seismic performance evaluation of RC frame-shear wall structures using nonlinear analysis methods

NASA Astrophysics Data System (ADS)

Shi, Jialiang; Wang, Qiuwei

To further understand the seismic performance of reinforced concrete (RC) frame-shear wall structures, a 1/8 model structure is scaled from a main factory structure with seven stories and seven bays. The model with four-stories and two-bays was pseudo-dynamically tested under six earthquake actions whose peak ground accelerations (PGA) vary from 50gal to 400gal. The damage process and failure patterns were investigated. Furthermore, nonlinear dynamic analysis (NDA) and capacity spectrum method (CSM) were adopted to evaluate the seismic behavior of the model structure. The top displacement curve, story drift curve and distribution of hinges were obtained and discussed. It is shown that the model structure had the characteristics of beam-hinge failure mechanism. The two methods can be used to evaluate the seismic behavior of RC frame-shear wall structures well. What’s more, the NDA can be somewhat replaced by CSM for the seismic performance evaluation of RC structures.

Data Mining Techniques to Estimate Plutonium, Initial Enrichment, Burnup, and Cooling Time in Spent Fuel Assemblies

DOE Office of Scientific and Technical Information (OSTI.GOV)

Trellue, Holly Renee; Fugate, Michael Lynn; Tobin, Stephen Joesph

The Next Generation Safeguards Initiative (NGSI), Office of Nonproliferation and Arms Control (NPAC), National Nuclear Security Administration (NNSA) of the U.S. Department of Energy (DOE) has sponsored a multi-laboratory, university, international partner collaboration to (1) detect replaced or missing pins from spent fuel assemblies (SFA) to confirm item integrity and deter diversion, (2) determine plutonium mass and related plutonium and uranium fissile mass parameters in SFAs, and (3) verify initial enrichment (IE), burnup (BU), and cooling time (CT) of facility declaration for SFAs. A wide variety of nondestructive assay (NDA) techniques were researched to achieve these goals [Veal, 2010 andmore » Humphrey, 2012]. In addition, the project includes two related activities with facility-specific benefits: (1) determination of heat content and (2) determination of reactivity (multiplication). In this research, a subset of 11 integrated NDA techniques was researched using data mining solutions at Los Alamos National Laboratory (LANL) for their ability to achieve the above goals.« less

Pleconaril Sanofi Synthélabo/ViroPharma.

PubMed

Billich, A

2000-11-01

Pleconaril is an oral antiviral agent being developed by ViroPharma and Sanofi-Synthélabo (formerly Sterling Winthrop) for the potential treatment of several picornavirus-induced infections, including respiratory diseases and viral meningitis. A number of phase III clinical trials have been completed, and several others are ongoing [319499], [343187], [346302], [359231]. In early 1999, an NDA filing for viral meningitis was expected by the end of 1999 [313588], [319499]. However, an NDA had not been filed by February 2000 and, at this time, filing in the US was expected in 2000 for viral meningitis and 2001 for viral respiratory syndrome, while in Europe filing was expected in 2001 and 2002 for these indications, respectively [359231]. In July 2000, Salomon Smith Barney predicted a launch date of 2002 [387350]. In October 1999, Lehman Brothers predicted a 70% chance of the product reaching the market, with a possible launch date anticipated for 2001 and potential peak sales of US$50 million in 2009 [346267].

Delays in new drug applications in Japan and industrial R&D strategies.

PubMed

Hirai, Y; Kinoshita, H; Kusama, M; Yasuda, K; Sugiyama, Y; Ono, S

2010-02-01

The gap between Japan and both the United States (US) and the European Union (EU) with regard to access to new drugs is becoming a major issue in Japan. We analyzed the time lags involved in new drug application (NDA) and biological license application submissions in Japan, the US, and the EU in order to identify the causes of delayed access. The time lag related to submission of applications ("submission lag") was longer for in-licensed products and for non-Japanese companies. Factors related to costs of clinical studies and potential volumes of sales were not associated with the submission lag. A bridging strategy (extrapolative use of foreign clinical data in the clinical data package based on International Conference on Harmonisation guideline E5) seemed to reduce submission lag, but the association between the two diminished when the cause-and-effect relationship was specifically investigated. These results suggest that multinational companies are likely to place more emphasis on the choice of development strategies that successfully lead to their goal rather than on direct costs and expected sales when deciding to introduce their pharmaceutical products in Japan. Our findings indicate that the clinical development guidances that helps pharmaceutical companies decide on investment and strategies are also the key to narrowing the gap in access to new drugs.

A potential plant-derived antifungal acetylenic acid mediates its activity by interfering with fatty acid homeostasis

USDA-ARS?s Scientific Manuscript database

6-Nonadecynoic acid (6-NDA), a plant-derived acetylenic acid, exhibits strong inhibitory activity against the human fungal pathogens Candida albicans, Aspergillus fumigatus, and Trichophyton mentagrophytes. In the present study, transcriptional profiling coupled with mutant and biochemical analyses...

Dancing in Place: Site-Specific Work

ERIC Educational Resources Information Center

Metal-Corbin, Josie

2012-01-01

In her lecture the 2012 NDA Scholar/Artist, Josie Metal-Corbin, chronicles four decades of working with artists, educators, librarians, and scientists. The kinetic language of dance and the visual impact of specific environments provide provocative opportunities for collaboration, wherein the site becomes the framework or map for the dance design.…

[Population Council responsible for RU486 clinical trials in USA].

PubMed

Aguillaume, C J

1993-04-01

As a result of the sudden political change that came with the Clinton Administration, RU-486's manufacturer, Roussel-Uclaf, and the Population Council agreed on April 20, 1992, on the manufacture and distribution of RU-486 in the US. In the US, there are less than 1.6 million induced abortions annually. From now on, US women will be able to have a choice between medical and surgical abortion. The Population Council and Roussel-Uclaf have had a contract since 1982. The Council is solely responsible for the phase 2 clinical trial of RU-486 in the US and other countries. It must present to the US Food and Drug Administration (FDA) an amendment allowing it to begin phase 3 clinical trials. The Council will also lead the US medical facilities in this study. It will identify partners for future production of RU-486 and its distribution in the US. It will also submit to FDA a New Drug Application (NDA). FDA will review the scientific literature on RU-486 and evaluate all data submitted by the Population Council. There are still obstacles to be surmounted. The Population Council must demonstrate good judgment when selecting the criteria for choosing a pharmaceutical firm before a Technical Committee which will be part of a group of players promoting women's health, scientific experts, and other interested parties. It must find the necessary funds to conduct the clinical trials and prepare the NDA. Phase 3 clinical trials in the US must have at least 2000 women. They will test RU-486's efficacy, safety, and acceptability among women choosing medical abortion over surgical abortion. Since the Council operates in almost all countries in the world, has innovated contraceptive research and development activities, and has been endorsed by the UN, product approval of RU-486 in the US will affect policy in all countries concerned about abortion.

76 FR 24022 - Massachusetts Marine Sanitation Device Standard-Receipt of Petition

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-29

... Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not...'' N boundary of the NDA starting on the south side of Chatham is an imaginary line drawn between the... were chosen based on easy line-of-sight locations and generally represent all navigational waters...

76 FR 12916 - Benzocaine; Weight Control Drug Products for Over-the-Counter Human Use

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-09

... endpoint. Reports purporting to be two studies by Collipp (one published and one unpublished) were..., OTC weight control drug products containing benzocaine will require an approved NDA or ANDA. Studies...., a manufacturer of OTC weight control drug products, submitted two citizen petitions, one in 1990 and...

Socioeconomic Status and Band Contest Ratings

ERIC Educational Resources Information Center

Speer, Bryn

2012-01-01

The University Interscholastic League (UIL) governs Texas public school academic, athletic, and music contests and is the largest inter-school organization of its kind in the world (University Interscholastic League, n.d.a). The music division of UIL is an important part of music education in Texas, with over half a million middle school and high…

77 FR 35985 - Determination That PARAPLATIN (Carboplatin) Injection and SUSTIVA (Efavirenz) Capsules Were Not...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-15

... Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice... document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that... the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed...

76 FR 32366 - Determination That ORLAAM (Levomethadyl Acetate Hydrochloride) Oral Solution, 10 Milligrams...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-06

...) Oral Solution, 10 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or... milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This... the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed...

ROBOTIC CRAWLER PROVIDES RADIOLOGICAL PROTECTION IN HAZARDOUS ENVIRONMENT

DOE Office of Scientific and Technical Information (OSTI.GOV)

HAM, J.E.

2002-01-31

A robotic crawler was deployed into the process cells at the 224-T Building to perform cell characterization. The most significant hazard was the potential for criticality upon introduction of a moderating material. Due to the unknown fissile inventory in the cells and the potential moderation affects of a person, manned entry was considered too high of a risk, and a robotic crawler was determined to be the best option for the initial characterization. The robotic crawler provided maneuverability, allowing access to areas in the cells where debris was found. It provided visual inspection in areas with little light, using amore » low lux pan and tilt camera system. Also, it provided fissile inventory measurements using a non-destructive assay (NDA) detector. The NDA detector supplied real-time data to maintain criticality control. Other technologies used during the cell characterization were water-cooled suits and a thin water resistant synthetic anti-contamination coverall, used for heat stress reduction. Also, an aluminum framed shelter provided a weather barrier, allowing work to continue under conditions which would have stopped work without it.« less

Adsorption of trichloroethylene and benzene vapors onto hypercrosslinked polymeric resin.

PubMed

Liu, Peng; Long, Chao; Li, Qifen; Qian, Hongming; Li, Aimin; Zhang, Quanxing

2009-07-15

In this research, the adsorption equilibria of trichloroethylene (TCE) and benzene vapors onto hypercrosslinked polymeric resin (NDA201) were investigated by the column adsorption method in the temperature range from 303 to 333 K and pressures up to 8 kPa for TCE, 12 kPa for benzene. The Toth and Dubinin-Astakov (D-A) equations were tested to correlate experimental isotherms, and the experimental data were found to fit well by them. The good fits and characteristic curves of D-A equation provided evidence that a pore-filling phenomenon was involved during the adsorption of TCE and benzene onto NDA-201. Moreover, thermodynamic properties such as the Henry's constant and the isosteric enthalpy of adsorption were calculated. The isosteric enthalpy curves varied with the surface loading for each adsorbate, indicating that the hypercrosslinked polymeric resin has an energetically heterogeneous surface. In addition, a simple mathematic model developed by Yoon and Nelson was applied to investigate the breakthrough behavior on a hypercrosslinked polymeric resin column at 303 K and the calculated breakthrough curves were in high agreement with corresponding experimental data.

Nano-Dust Analyzer For the Detection and Chemical Composition Measurement of Particles Originating in the Inner Heliosphere

NASA Astrophysics Data System (ADS)

O'Brien, Leela; Gruen, E.; Sternovsky, Z.; Horanyi, M.; Juhasz, A.; Eberhard, M.; Srama, R.

2013-10-01

The development of the Nano-Dust Analyzer (NDA) instrument and the results from the first laboratory testing and calibration are reported. The two STEREO spacecrafts have indicated that nanometer-sized dust particles, potentially with very high flux, are delivered to 1 AU from the inner solar system [Meyer-Vernet, N. et al., Solar Physics, 256, 463, 2009]. These particles are generated by collisional grinding or evaporation near the Sun and accelerated outward by the solar wind. The temporal variability reveals the complex interaction with the solar wind magnetic field within 1 AU and provides the means to learn about solar wind conditions and can supply additional parameters or verification for heliospheric magnetic field models. The composition analysis will report on the processes that generated the nanometer-sized particle. NDA is a highly sensitive dust analyzer that is developed under NASA's Heliophysics program. The instrument is a linear time-of-flight mass analyzer that utilizes dust impact ionization and is modeled after the Cosmic Dust Analyzer (CDA) on Cassini. By applying technologies implemented in solar wind instruments and coronagraphs, the highly sensitive dust analyzer will be able to be pointed toward the solar direction. A laboratory prototype has been built, tested, and calibrated at the dust accelerator facility at the University of Colorado, Boulder, using particles with 1 to over 50 km/s velocity. NDA is unique in its requirement to operate with the Sun in its field-of-view. A light trap system has been designed and optimized in terms of geometry and surface optical properties to mitigate Solar UV contribution to detector noise. In addition, results from laboratory tests performed with a 1 keV ion beam at the University of New Hampshire’s Space Sciences Facility confirm the effectiveness of the instrument’s solar wind particle rejection system.

Use of a standardized JaCVAM in vivo rat comet assay protocol to assess the genotoxicity of three coded test compounds; ampicillin trihydrate, 1,2-dimethylhydrazine dihydrochloride, and N-nitrosodimethylamine.

PubMed

McNamee, J P; Bellier, P V

2015-07-01

As part of the Japanese Center for the Validation of Alternative Methods (JaCVAM)-initiative international validation study of the in vivo rat alkaline comet assay (comet assay), our laboratory examined ampicillin trihydrate (AMP), 1,2-dimethylhydrazine dihydrochloride (DMH), and N-nitrosodimethylamine (NDA) using a standard comet assay validation protocol (v14.2) developed by the JaCVAM validation management team (VMT). Coded samples were received by our laboratory along with basic MSDS information. Solubility analysis and range-finding experiments of the coded test compounds were conducted for dose selection. Animal dosing schedules, the comet assay processing and analysis, and statistical analysis were conducted in accordance with the standard protocol. Based upon our blinded evaluation, AMP was not found to exhibit evidence of genotoxicity in either the rat liver or stomach. However, both NDA and DMH were observed to cause a significant increase in % tail DNA in the rat liver at all dose levels tested. While acute hepatoxicity was observed for these compounds in the high dose group, in the investigators opinion there were a sufficient number of consistently damaged/measurable cells at the medium and low dose groups to judge these compounds as genotoxic. There was no evidence of genotoxicity from either NDA or DMH in the rat stomach. In conclusion, our laboratory observed increased DNA damage from two blinded test compounds in rat liver (later identified as genotoxic carcinogens), while no evidence of genotoxicity was observed for the third blinded test compound (later identified as a non-genotoxic, non-carcinogen). This data supports the use of a standardized protocol of the in vivo comet assay as a cost-effective alternative genotoxicity assay for regulatory testing purposes. Crown Copyright © 2015. Published by Elsevier B.V. All rights reserved.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wendelberger, James G.

These are slides from a presentation made by a researcher from Los Alamos National Laboratory. The following topics are covered: sources of error for NDA gamma measurements, precision and accuracy are two important characteristics of measurements, four items processed in a material balance area during the inventory time period, inventory difference and propagation of variance, sum in quadrature, and overview of the ID/POV process.

76 FR 53908 - Determination That OPANA ER (Oxymorphone Hydrochloride) Extended-Release Tablets, 7.5 Milligrams...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-30

... Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... milligrams (mg) and 15 mg, were not withdrawn from sale for reasons of safety or effectiveness. This... approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the...

77 FR 12309 - Determination That PHENURONE (Phenacemide) Tablet, 500 Milligrams, Was Not Withdrawn From Sale...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-29

... Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to... withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA...

75 FR 64310 - Determination That BUSPAR (Buspirone Hydrochloride) Tablets, 10 Milligrams, 15 Milligrams, and 30...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-19

..., Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug... reasons of safety or effectiveness. This determination means that FDA will not begin procedures to... withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA...

76 FR 59141 - Determination That LOXITANE (Loxapine Succinate) Capsules and Three Other Drug Products Were Not...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-23

... Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice... document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that... approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the...

78 FR 17933 - Determination That BENADRYL (diphenhydramine hydrochloride) Injection and Two Other Drug Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-25

... Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION... effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated... withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA...

75 FR 48352 - Determination That MOTRIN (Ibuprofen) Tablets and Four Other Drug Products Were Not Withdrawn...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-10

... Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA... approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the...

75 FR 81617 - Determination That TRANDATE (Labetalol Hydrochloride) Tablets, 300 Milligrams and 400 Milligrams...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-28

... Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION... effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated... withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA...

76 FR 9789 - Determination That Theophylline Oral Solution, 80 Milligrams/15 Milliliters, Was Not Withdrawn...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-22

... Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...)/15 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This... the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed...

Choices and Challenges: A Qualitative Exploration of Professional Women's Career Patterns

ERIC Educational Resources Information Center

Whitmarsh, Lona; Brown, Donalee; Cooper, Jane; Hawkins-Rodgers, Yolanda; Wentworth, Diane Keyser

2007-01-01

With the rapid changes occurring in the role of work in women's lives, this research project was designed to examine the career planning, career decision making, and work history of women in both female-dominated and gender-neutral careers (U.S. Department of Labor, n.d.-a). A qualitative analysis of structured interviews identified 6 emerging…

78 FR 67365 - Determination That Adderall (Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-12

...; Dextroamphetamine Sulfate) Tablet and 13 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or... withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin... suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines...

78 FR 34108 - Determination That SUBOXONE (Buprenorphine Hydrochloride and Naloxone Hydrochloride) Sublingual...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-06

... naloxone HCl) sublingual tablets, 2 mg/0.5 mg and 8 mg/2 mg, are the subject of NDA 20-733, held by Reckitt Benckiser Pharmaceuticals, Inc. (Reckitt), and initially approved on October 8, 2002. SUBOXONE is indicated...,'' http://www.rb.com/site/rkbr/templates/mediainvestorsgeneral2.aspx?pageid=1332&cc=GB , Reckitt Benckiser...

77 FR 9944 - Determination That REQUIP XL (Ropinerole Hydrochloride) Extended-Release Tablets, 3 Milligrams...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-21

... Parkinson's disease. REQUIP XL (ropinerole hydrochloride) extended-release tablets, 3 mg, are currently... amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j... suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines...

75 FR 21299 - Determination of Regulatory Review Period for Purposes of Patent Extension; VIMPAT-NDA 22-254

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-23

... Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term... years so long as the patented item (human drug product, animal drug product, medical device, food... and an approval phase. For human drug products, the testing phase begins when the exemption to permit...

75 FR 21298 - Determination of Regulatory Review Period for Purposes of Patent Extension; VIMPAT -NDA 22-253

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-23

... Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term... years so long as the patented item (human drug product, animal drug product, medical device, food... and an approval phase. For human drug products, the testing phase begins when the exemption to permit...

Neodymium(III) Complexes of Dialkylphosphoric and Dialkylphosphonic Acids Relevant to Liquid-Liquid Extraction Systems

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lumetta, Gregg J.; Sinkov, Sergey I.; Krause, Jeanette A.

2016-01-27

The complexes formed during the extraction of neodymium(III) into hydrophobic solvents containing acidic organophosphorus extractants were probed by single-crystal X-ray diffractometry, visible spectrophotometry, and Fourier-transform infrared spectroscopy. The crystal structure of the compound Nd(DMP)3 (1, DMP = dimethyl phosphate) revealed a polymeric arrangement in which each Nd(III) center is surrounded by six DMP oxygen atoms in a pseudo-octahedral environment. Adjacent Nd(III) ions are bridged by (MeO)2POO– anions, forming the polymeric network. The diffuse reflectance visible spectrum of 1 is nearly identical to that of the solid that is formed when an n-dodecane solution of di-(2-ethylhexyl)phosphoric acid (HA) is saturated withmore » Nd(III), indicating a similar coordination environment around the Nd center in the NdA3 solid. The visible spectrum of the HA solution fully loaded with Nd(III) is very similar to that of the NdA3 material, both displaying hypersensitive bands characteristic of an pseudo-octahedral coordination environment around Nd. These spectral characteristics persisted across a wide range of organic Nd concentrations, suggesting that the pseudo-octahedral coordination environment is maintained from dilute to saturated conditions.« less

Enrichment Assay Methods Development for the Integrated Cylinder Verification System

DOE Office of Scientific and Technical Information (OSTI.GOV)

Smith, Leon E.; Misner, Alex C.; Hatchell, Brian K.

2009-10-22

International Atomic Energy Agency (IAEA) inspectors currently perform periodic inspections at uranium enrichment plants to verify UF6 cylinder enrichment declarations. Measurements are typically performed with handheld high-resolution sensors on a sampling of cylinders taken to be representative of the facility's entire product-cylinder inventory. Pacific Northwest National Laboratory (PNNL) is developing a concept to automate the verification of enrichment plant cylinders to enable 100 percent product-cylinder verification and potentially, mass-balance calculations on the facility as a whole (by also measuring feed and tails cylinders). The Integrated Cylinder Verification System (ICVS) could be located at key measurement points to positively identify eachmore » cylinder, measure its mass and enrichment, store the collected data in a secure database, and maintain continuity of knowledge on measured cylinders until IAEA inspector arrival. The three main objectives of this FY09 project are summarized here and described in more detail in the report: (1) Develop a preliminary design for a prototype NDA system, (2) Refine PNNL's MCNP models of the NDA system, and (3) Procure and test key pulse-processing components. Progress against these tasks to date, and next steps, are discussed.« less

Optimization of the Separation of NDA-Derivatized Methylarginines by Capillary and Microchip Electrophoresis

PubMed Central

Linz, Thomas H.; Snyder, Christa M.; Lunte, Susan M.

2013-01-01

The methylated arginines (MAs) monomethylarginine (MMA), asymmetric dimethylarginine (ADMA), and symmetric dimethylarginine (SDMA) have been shown to be independent predictors of cardiovascular disease. This article describes progress regarding the development of an analytical method capable of rapidly analyzing MAs using capillary electrophoresis (CE) and microchip electrophoresis (MCE) with laser-induced fluorescence (LIF) detection. Several parameters including buffer composition and separation voltage were optimized to achieve an ideal separation. The analytes of interest were derivatized with naphthalene-2,3-dicarboxaldehyde (NDA) to produce fluorescent 1-cyanobenz[f]isoindole (CBI) derivatives and then subjected to CE analysis. Baseline resolution of SDMA, ADMA, MMA, and arginine was achieved in less than 8 min. The limits of detection for SDMA, ADMA, MMA, and arginine were determined to be 15, 20, 25, and 5 nM, respectively, which are well below the expected plasma concentrations. The CE separation method was then transferred to a glass MCE device with LIF detection. MAs were baseline resolved in 3 min on-chip using a 14 cm separation channel with detection limits of approximately 10 nM for each species. To the best of the authors’ knowledge, this is the first report of the separation of MAs by MCE. PMID:22357605

Synthesis and Exploration of Ladder-Structured Large Aromatic Dianhydrides as Organic Cathodes for Rechargeable Lithium-Ion Batteries.

PubMed

Xie, Jian; Chen, Wangqiao; Wang, Zilong; Jie, Kenneth Choo Wei; Liu, Ming; Zhang, Qichun

2017-04-18

Compared to anode materials in Li-ion batteries, the research on cathode materials is far behind, and their capacities are much smaller. Thus, in order to address these issues, we believe that organic conjugated materials could be a solution. In this study, we synthesized two non-polymeric dianhydrides with large aromatic structures: NDA-4N (naphthalenetetracarboxylic dianhydride with four nitrogen atoms) and PDA-4N (perylenetetracarboxylic dianhydride with four nitrogen atoms). Their electrochemical properties have been investigated between 2.0 and 3.9 V (vs. Li + /Li). Benefiting from multi-electron reactions, NDA-4N and PDA-4N could reversibly achieve 79.7 % and 92.3 %, respectively, of their theoretical capacity. Further cycling reveals that the organic compound with a relatively larger aromatic building block could achieve a better stability, as an obvious 36.5 % improvement of the capacity retention was obtained when the backbone was switched from naphthalene to perylene. This study proposes an opportunity to attain promising small-molecule-based cathode materials through tailoring organic structures. © 2017 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

Neodymium(III) Complexes of Dialkylphosphoric and Dialkylphosphonic Acids Relevant to Liquid-Liquid Extraction Systems.

PubMed

Lumetta, Gregg J; Sinkov, Sergey I; Krause, Jeanette A; Sweet, Lucas E

2016-02-15

The complexes formed during the extraction of neodymium(III) into hydrophobic solvents containing acidic organophosphorus extractants were probed by single-crystal X-ray diffractometry, visible spectrophotometry, and Fourier-transform infrared spectroscopy. The crystal structure of the compound Nd(DMP)3 (1, DMP = dimethyl phosphate) revealed a polymeric arrangement in which each Nd(III) center is surrounded by six DMP oxygen atoms in a pseudo-octahedral environment. Adjacent Nd(III) ions are bridged by (MeO)2POO(-) anions, forming the polymeric network. The diffuse reflectance visible spectrum of 1 is nearly identical to that of the solid that is formed when an n-dodecane solution of di(2-ethylhexyl)phosphoric acid (HA) is saturated with Nd(III), indicating a similar coordination environment around the Nd center in the NdA3 solid. The visible spectrum of the HA solution fully loaded with Nd(III) is very similar to that of the NdA3 material, both displaying hypersensitive bands characteristic of an pseudo-octahedral coordination environment around Nd. These spectral characteristics persisted across a wide range of organic Nd concentrations, suggesting that the pseudo-octahedral coordination environment is maintained from dilute to saturated conditions.

Annual Report FY2013-- A Kinematically Complete, Interdisciplinary, and Co-Institutional Measurement of the 19F(α,n) Cross-section for Nuclear Safeguards Science

DOE Office of Scientific and Technical Information (OSTI.GOV)

Peters, William A; Smith, Michael Scott; Clement, Ryan

2013-10-01

The goal of this proposal is to enable neutron detection for precision Non-Destructive Assays (NDAs) of actinide-fluoride samples. Neutrons are continuously generated from a UFx matrix in a container or sample as a result of the interaction of alpha particles from uranium-decay α particles with fluorine nuclei in the matrix. Neutrons from 19F(α,n)22Na were once considered a poorly characterized background for assays of UFx samples via 238U spontaneous fission neutron detection [SMI2010B]. However, the yield of decay-α-driven neutrons is critical for 234,235U LEU and HEU assays, as it can used to determine both the total amount of uranium and themore » enrichment [BER2010]. This approach can be extremely valuable in a variety of safeguard applications, such as cylinder monitoring in underground uranium storage facilities, nuclear criticality safety studies, nuclear materials accounting, and other nonproliferation applications. The success of neutron-based assays critically depends on an accurate knowledge of the cross section of the (α,n) reaction that generates the neutrons. The 40% uncertainty in the 19F(α,n)22Na cross section currently limits the precision of such assays, and has been identified as a key factor in preventing accurate enrichment determinations [CRO2003]. The need for higher quality cross section data for (α,n) reactions has been a recurring conclusion in reviews of the nuclear data needs to support safeguards. The overarching goal of this project is to enable neutron detection to be used for precision Non- Destructive Assays (NDAs) of actinide-fluoride samples. This will significantly advance safeguards verification at existing declared facilities, nuclear materials accounting, process control, nuclear criticality safety monitoring, and a variety of other nonproliferation applications. To reach this goal, Idaho National Laboratory (INL), in partnership with Oak Ridge National Laboratory (ORNL), Rutgers University (RU), and the University of Notre Dame (UND), will focus on three specific items: (1) making a precision (better than 10 %) determination of the absolute cross section of the 19F(α,n)22Na reaction as a function of energy; (2) determining the spectrum of neutrons and γ-rays emitted from 19F(α,n)22Na over an energy range pertinent to NDA; and (3) performing simulations with this new cross section to extract the neutron yield (neutrons/gram/second) and resulting neutron- and gamma ray-spectra when α particles interact with fluorine nuclei in actinide samples, to aid in the design and reduce uncertainty of future NDA measurements and simulations.« less

NDEC: A NEA platform for nuclear data testing, verification and benchmarking

NASA Astrophysics Data System (ADS)

Díez, C. J.; Michel-Sendis, F.; Cabellos, O.; Bossant, M.; Soppera, N.

2017-09-01

The selection, testing, verification and benchmarking of evaluated nuclear data consists, in practice, in putting an evaluated file through a number of checking steps where different computational codes verify that the file and the data it contains complies with different requirements. These requirements range from format compliance to good performance in application cases, while at the same time physical constraints and the agreement with experimental data are verified. At NEA, the NDEC (Nuclear Data Evaluation Cycle) platform aims at providing, in a user friendly interface, a thorough diagnose of the quality of a submitted evaluated nuclear data file. Such diagnose is based on the results of different computational codes and routines which carry out the mentioned verifications, tests and checks. NDEC also searches synergies with other existing NEA tools and databases, such as JANIS, DICE or NDaST, including them into its working scheme. Hence, this paper presents NDEC, its current development status and its usage in the JEFF nuclear data project.

JANIS: NEA JAva-based Nuclear Data Information System

NASA Astrophysics Data System (ADS)

Soppera, Nicolas; Bossant, Manuel; Cabellos, Oscar; Dupont, Emmeric; Díez, Carlos J.

2017-09-01

JANIS (JAva-based Nuclear Data Information System) software is developed by the OECD Nuclear Energy Agency (NEA) Data Bank to facilitate the visualization and manipulation of nuclear data, giving access to evaluated nuclear data libraries, such as ENDF, JEFF, JENDL, TENDL etc., and also to experimental nuclear data (EXFOR) and bibliographical references (CINDA). It is available as a standalone Java program, downloadable and distributed on DVD and also a web application available on the NEA website. One of the main new features in JANIS is the scripting capability via command line, which notably automatizes plots generation and permits automatically extracting data from the JANIS database. Recent NEA software developments rely on these JANIS features to access nuclear data, for example the Nuclear Data Sensitivity Tool (NDaST) makes use of covariance data in BOXER and COVERX formats, which are retrieved from the JANIS database. New features added in this version of the JANIS software are described along this paper with some examples.

NEUTRON MULTIPLICITY AND ACTIVE WELL NEUTRON COINCIDENCE VERIFICATION MEASUREMENTS PERFORMED FOR MARCH 2009 SEMI-ANNUAL DOE INVENTORY

DOE Office of Scientific and Technical Information (OSTI.GOV)

Dewberry, R.; Ayers, J.; Tietze, F.

The Analytical Development (AD) Section field nuclear measurement group performed six 'best available technique' verification measurements to satisfy a DOE requirement instituted for the March 2009 semi-annual inventory. The requirement of (1) yielded the need for SRNL Research Operations Department Material Control & Accountability (MC&A) group to measure the Pu content of five items and the highly enrich uranium (HEU) content of two. No 14Q-qualified measurement equipment was available to satisfy the requirement. The AD field nuclear group has routinely performed the required Confirmatory Measurements for the semi-annual inventories for fifteen years using sodium iodide and high purity germanium (HpGe)more » {gamma}-ray pulse height analysis nondestructive assay (NDA) instruments. With appropriate {gamma}-ray acquisition modeling, the HpGe spectrometers can be used to perform verification-type quantitative assay for Pu-isotopics and HEU content. The AD nuclear NDA group is widely experienced with this type of measurement and reports content for these species in requested process control, MC&A booking, and holdup measurements assays Site-wide. However none of the AD HpGe {gamma}-ray spectrometers have been 14Q-qualified, and the requirement of reference 1 specifically excluded a {gamma}-ray PHA measurement from those it would accept for the required verification measurements. The requirement of reference 1 was a new requirement for which the Savannah River National Laboratory (SRNL) Research Operations Department (ROD) MC&A group was unprepared. The criteria for exemption from verification were: (1) isotope content below 50 grams; (2) intrinsically tamper indicating or TID sealed items which contain a Category IV quantity of material; (3) assembled components; and (4) laboratory samples. Therefore all (SRNL) Material Balance Area (MBA) items with greater than 50 grams total Pu or greater than 50 grams HEU were subject to a verification measurement. The pass/fail criteria of reference 7 stated 'The facility will report measured values, book values, and statistical control limits for the selected items to DOE SR...', and 'The site/facility operator must develop, document, and maintain measurement methods for all nuclear material on inventory'. These new requirements exceeded SRNL's experience with prior semi-annual inventory expectations, but allowed the AD nuclear field measurement group to demonstrate its excellent adaptability and superior flexibility to respond to unpredicted expectations from the DOE customer. The requirements yielded five SRNL items subject to Pu verification and two SRNL items subject to HEU verification. These items are listed and described in Table 1.« less

Bridging the Technology Valley of Death in Joint Medical Development

DTIC Science & Technology

2015-11-01

Force lieutenant colonel, is the Air Force Medical Support Agency Advanced Development Liaison Field Engineer in Falls Church, Virginia. Prusaczyk is...Awareness, communication and coordination may be mini - mal among Service S&T and AD programs. Joint Transition Planning Process A Joint Transition...Human Proof of Phase III NDA/BLA ling Approval, Launch Concept*** Launch Review Program Initiation Materiel Technology Engineering & Production

A rational regulatory approach for positron emission tomography imaging probes: from "first in man" to NDA approval and reimbursement.

PubMed

Barrio, Jorge R; Marcus, Carol S; Hung, Joseph C; Keppler, Jennifer S

2004-01-01

We propose a new regulatory approach for positron emission tomography (PET) molecular imaging probes, essential tools in today's medicine. Even though the focus of this paper is on positron-emitting labeled probes, it is also justified to extend this proposed regulatory approach to other diagnostic nuclear medicine radiopharmaceuticals. Key aspects of this proposal include: (1) PET molecular imaging probes would be placed in a "no significant risk" category, similar to that category for devices in current Food and Drug Administration (FDA) regulations, based on overwhelming scientific evidence that demonstrates their faultless safety profile; (2) the FDA-sanctioned Radioactive Drug Research Committee (RDRC) will oversee all diagnostic research with these probes. The newly defined RDRC should approve "first in man" use; supervise a broader spectrum of diagnostic research protocols, including those looking to demonstrate initial efficacy, as well as multicenter clinical trials and the use of molecular imaging probes as a screening tool in drug discovery. The current investigational new drug (IND) mechanism is thus eliminated for these diagnostic probes; (3) when a molecular imaging probe has demonstrated diagnostic efficacy, FDA approval (i.e., NDA) will be sought. The review will be done by a newly constituted Radioactive Drug Advisory Committee (RDAC) composed of experts chosen by the professional societies, who would provide a binding assessment of the adequacy of the safety and efficacy data. When the RDAC recommends its diagnostic use on scientific and medical grounds, the molecular imaging probe becomes FDA approved. After a molecular imaging probe is approved for a diagnostic indication, the existing mechanism to seek reimbursement will be utilized; and (4) the FDA would retain its direct oversight function for traditional manufacturers engaged in commercial distribution of the approved diagnostic molecular imaging probes (i.e., under NDA) to monitor compliance with existing US Pharmacopeia (USP) requirements. With abbreviated and more appropriate regulations, new PET molecular imaging probes for diagnostic use would be then rapidly incorporated into the mainstream diagnostic medicine. Equally importantly, this approach would facilitate the use of molecular imaging in drug discovery and development, which would substantially reduce the costs and time required to bring new therapeutic drugs to market.

Minimum Detectable Activity for Tomographic Gamma Scanning System

DOE Office of Scientific and Technical Information (OSTI.GOV)

Venkataraman, Ram; Smith, Susan; Kirkpatrick, J. M.

2015-01-01

For any radiation measurement system, it is useful to explore and establish the detection limits and a minimum detectable activity (MDA) for the radionuclides of interest, even if the system is to be used at far higher values. The MDA serves as an important figure of merit, and often a system is optimized and configured so that it can meet the MDA requirements of a measurement campaign. The non-destructive assay (NDA) systems based on gamma ray analysis are no exception and well established conventions, such the Currie method, exist for estimating the detection limits and the MDA. However, the Tomographicmore » Gamma Scanning (TGS) technique poses some challenges for the estimation of detection limits and MDAs. The TGS combines high resolution gamma ray spectrometry (HRGS) with low spatial resolution image reconstruction techniques. In non-imaging gamma ray based NDA techniques measured counts in a full energy peak can be used to estimate the activity of a radionuclide, independently of other counting trials. However, in the case of the TGS each “view” is a full spectral grab (each a counting trial), and each scan consists of 150 spectral grabs in the transmission and emission scans per vertical layer of the item. The set of views in a complete scan are then used to solve for the radionuclide activities on a voxel by voxel basis, over 16 layers of a 10x10 voxel grid. Thus, the raw count data are not independent trials any more, but rather constitute input to a matrix solution for the emission image values at the various locations inside the item volume used in the reconstruction. So, the validity of the methods used to estimate MDA for an imaging technique such as TGS warrant a close scrutiny, because the pair-counting concept of Currie is not directly applicable. One can also raise questions as to whether the TGS, along with other image reconstruction techniques which heavily intertwine data, is a suitable method if one expects to measure samples whose activities are at or just above MDA levels. The paper examines methods used to estimate MDAs for a TGS system, and explores possible solutions that can be rigorously defended.« less

APNEA/WIT system nondestructive assay capability evaluation plan for select accessibly stored INEL RWMC waste forms

DOE Office of Scientific and Technical Information (OSTI.GOV)

Becker, G.K.

1997-01-01

Bio-Imaging Research Inc. (BIR) and Lockheed Martin Speciality Components (LMSC) are engaged in a Program Research and Development Agreement and a Rapid Commercialization Initiative with the Department of Energy, EM-50. The agreement required BIR and LMSC to develop a data interpretation method that merges nondestructive assay and nondestructive examination (NDA/NDE) data and information sufficient to establish compliance with applicable National TRU Program (Program) waste characterization requirements and associated quality assurance performance criteria. This effort required an objective demonstration of the BIR and LMSC waste characterization systems in their standalone and integrated configurations. The goal of the test plan is tomore » provide a mechanism from which evidence can be derived to substantiate nondestructive assay capability and utility statement for the BIT and LMSC systems. The plan must provide for the acquisition, compilation, and reporting of performance data thereby allowing external independent agencies a basis for an objective evaluation of the standalone BIR and LMSC measurement systems, WIT and APNEA respectively, as well as an expected performance resulting from appropriate integration of the two systems. The evaluation is to be structured such that a statement regarding select INEL RWMC waste forms can be made in terms of compliance with applicable Program requirements and criteria.« less

Instructional Design Briefing A Brief Overview in Relation to the China COE

DOE Office of Scientific and Technical Information (OSTI.GOV)

Osburn, Laura Ann; Glasco, Bethany Lynn

This introduction provides a roadmap and guidance for the work that will be done by SMEs to prepare NDA course material to be transitioned from LANL to the China COE. It will cover the definition of instructional design; why instructional design is important; role of instructional designer vs an instructor and how they work together; and how this relates to our work in the China COE project.

Building a Capabilities Network to Improve Disaster Preparation Efforts in the Southern Command (SOUTHCOM) Area of Responsibility (AOR)

DTIC Science & Technology

2013-11-14

Rica, Ecuador , El Salvador, Guatemala, Guyana, Haiti, Honduras, Jamaica, Nicaragua, Panama, Paraguay, Peru, Saint Lucia (American Red Cross, n.d.c) 3...contribute to society. (Children International, n.d.a) Currently or previously involved in SOUTHCOM: Honduras, Ecuador , Guatemala, Chile, Honduras...Republic, El Salvador, Guatemala, Guyana, Haiti, Honduras, Jamaica, Nicaragua, Columbia, Ecuador , Bolivia, Brazil, Peru, Paraguay, Chile, and Argentina

DOE Office of Scientific and Technical Information (OSTI.GOV)

Klumpp, John Allan; Bertelli, Luiz; Waters, Tom L.

For radionuclides such as plutonium and americium, detection of removable activity in the nose (i.e., nasal swab measurements) are frequently used to determine whether follow-up bioassay measurements are warranted following a potential intake. For this paper, the authors analyzed 429 nasal swab measurements taken following incidents or suspicious circumstances (such as an air monitor alarming) at Los Alamos National Laboratory (LANL) for which the dose was later evaluated using in vitro bioassay. Nasal swab measurements were found to be very poor predictors of dose and should not be used as such in the field. However, nasal swab measurements can bemore » indicative of whether a reliably detectable committed effective dose (CED) occurred. About 14% of nasal swab measurements between 1.25 and 16.7 Bq corresponded to CEDs greater than 1 mSv, so in general, positive nasal swabs always indicate that follow-up bioassay should be performed (positive nasal swabs less than 1.25 Bq are considered separately). This probability increased significantly for nasal swabs greater than 16.7 Bq. Only about 3% of nasal swabs with no detectable activity (NDA) corresponded to reliably detectable CEDs. As a result, a nasal swab with NDA is therefore necessary, but not sufficient, to negate the need for a follow-up bioassay if it was collected following other workplace indicators of a potential intake.« less

EURATOM safeguards efforts in the development of spent fuel verification methods by non-destructive assay

DOE Office of Scientific and Technical Information (OSTI.GOV)

Matloch, L.; Vaccaro, S.; Couland, M.

The back end of the nuclear fuel cycle continues to develop. The European Commission, particularly the Nuclear Safeguards Directorate of the Directorate General for Energy, implements Euratom safeguards and needs to adapt to this situation. The verification methods for spent nuclear fuel, which EURATOM inspectors can use, require continuous improvement. Whereas the Euratom on-site laboratories provide accurate verification results for fuel undergoing reprocessing, the situation is different for spent fuel which is destined for final storage. In particular, new needs arise from the increasing number of cask loadings for interim dry storage and the advanced plans for the construction ofmore » encapsulation plants and geological repositories. Various scenarios present verification challenges. In this context, EURATOM Safeguards, often in cooperation with other stakeholders, is committed to further improvement of NDA methods for spent fuel verification. In this effort EURATOM plays various roles, ranging from definition of inspection needs to direct participation in development of measurement systems, including support of research in the framework of international agreements and via the EC Support Program to the IAEA. This paper presents recent progress in selected NDA methods. These methods have been conceived to satisfy different spent fuel verification needs, ranging from attribute testing to pin-level partial defect verification. (authors)« less

Confirmation of the Northern Delta Aquariids (NDA, IAU #26) and the Northern June Aquilids (NZC, IAU #164)

NASA Astrophysics Data System (ADS)

Holman, David; Jenniskens, Peter

2012-10-01

This paper resolves confusion surrounding the Northern delta-Aquariids (NDA, IAU #26). Low-light level video observations with the Cameras for All-sky Meteor Surveillance project in California show distinct showers in the months of July and August. The July shower is identified as the Northern June Aquilids (NZC, IAU #164), while the August shower matches most closely prior data on the Northern delta-Aquariids. This paper validates the existence of both showers, which can now be moved to the list of established showers. The August beta-Piscids (BPI, #342) is not a separate stream, but identical to the Northern delta-Aquariids, and should be discarded from the IAU Working List. We detected the Northern June Aquilids beginning on June 14, through its peak on July 11, and to the shower's end on August 2. The meteors move in a short-period sun grazing comet orbit. Our mean orbital elements are: q = 0.124 ± 0.002 AU, 1/a = 0.512 ± 0.014 AU^{-1}, i = 37°63 ± 0°35, omega = 324°90 ± 0°27, and Omega = 107°93 ± 0°91 (N = 131). This orbit is similar to that of sungrazer comet C/2009 U10.

Simple and sensitive determination of hydrazine in drinking water by ultra-high-performance liquid chromatography-tandem mass spectrometry after derivatization with naphthalene-2,3-dialdehyde.

PubMed

Oh, Jin-Aa; Shin, Ho-Sang

2015-05-22

An ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method was developed to determine the level of hydrazine in drinking water. The method is based on the derivatization of hydrazine with naphthalene-2,3-dicarboxaldehyde (NDA) in water. The optimum conditions for UPLC-MS/MS detection were determined as follows: derivatization reagent dosage, 50mg/L of NDA; pH 2; and reaction time, 1min; room temperature. The formed derivative was injected into an LC system without extraction or purification procedures. Under the established conditions, the method was used to detect hydrazine in raw drinking water and chlorinated drinking water. The limits of detection and quantification for hydrazine in drinking water were 0.003μg/L and 0.01μg/L, respectively. The accuracy was in the range of 97-104%, and precision, expressed as relative standard deviation, was less than 9% in drinking water. Hydrazine was detected at a concentration of 0.13μg/L in one sample among 24 raw drinking water samples and in a range of 0.04-0.45μg/L in three samples among 24 chlorinated drinking water samples. Copyright © 2015 Elsevier B.V. All rights reserved.

Report: EPA Office of Inspector General’s Report on Reducing Fraud, Waste, and Abuse in the Small Business Innovative Research Program, as Required by the National Defense Authorization Act for Fiscal Year 2012, Pub. L. 112-81 (2012)

EPA Pesticide Factsheets

September 28, 2012. The EPA OIG is required by Section 5143 of the NDA Act for Fiscal Year 201 2, Pub. L. No. 112-81 (2012), to report on reducing vulnerability to fraud, waste and abuse in the Small Business Innovative Research (SBIR) program.

The Effect of Alternative Work Schedules (AWS) on Performance During Acquisition Based Testing at the U.S. Army Aberdeen Test Center

DTIC Science & Technology

2014-09-01

profile .............................................................. 11 Table 5. Eastman Kodak company profile...schedules. Company profiles for KPMG LLP, Eastman Kodak and Texas Instruments (TI) are presented in Tables 4–6. Following each profile is a summary of the...and business continuity (Giglio n.d.-a). 2. Case Two A company profile (see Table 5) and case study summary on Eastman Kodak are presented in the

Efaproxiral: GSJ 61, JP 4, KDD 86, RS 4, RSR 13.

PubMed

2005-01-01

Efaproxiral [RSR 13, GSJ 61, JP 4, KDD 86, RS 4] is a synthetic, small-molecule, radiation-sensitising agent being developed by Allos Therapeutics primarily for the treatment of cancer. It works by binding and allosterically stabilising deoxyhaemoglobin in hypoxic regions of tumour tissue. This increases oxygen uptake of the tumour tissue and restores its sensitivity to radiation therapy, making therapy potentially more successful. This first-of-its-class compound is particularly applicable for the treatment of certain tumour types that lack oxygen, such as brain metastases. In contrast to conventional chemotherapeutic agents or radiation sensitisers, there is no requirement for efaproxiral to be administered directly into tumours or to cross the blood-brain barrier for it to display efficacy. Efaproxiral is under review for approval in the US and EU as an adjunct to whole-brain radiation therapy (WBRT) for the treatment of brain metastases originating from breast cancer. It is also under clinical evaluation for a variety of other cancers, including glioblastoma, non-small cell lung cancer (NSCLC) and cervical cancer. Allos is seeking partnership opportunities for efaproxiral's development and marketing. The company has indicated that the development of efaproxiral would be in cooperation with a corporate partner, according to its 2003 Annual Report. In 1994, Allos Therapeutics acquired exclusive worldwide rights to intellectual property relating to efaproxiral from the Center for Innovative Technology (CIT). Allos has entered into arrangements with two contract manufacturers for the supply of efaproxiral, and a third manufacturer for the supply of the formulated drug product. Hovione FarmaCiencia is the primary supplier of efaproxiral, and is contracted to manufacture sufficient quantities on a commercial scale. In addition, a second manufacturer, Raylo Chemicals, is also producing quantities of efaproxiral. In December 2003, Allos entered into a long-term development and supply agreement with Baxter Healthcare who will formulate the efaproxiral into an injection. Allos is also seeking to establish an alternate supplier of efaproxiral injection. Allos submitted a rolling NDA to the US FDA consisting of three data components. Submission began in the third quarter of 2003 and was completed by the fourth quarter of 2003. The first part of the application containing non-clinical information was submitted on 5 August 2003. The second part of the NDA containing information about efaproxiral's chemistry, manufacture and controls (CMC) was submitted in October 2003. Allos submitted its final component of the rolling NDA in December 2003. In February 2004, Allos announced that the FDA had accepted the company's NDA under priority review status. The FDA granted efaproxiral orphan drug status in August 2004 as an adjunct to WBRT for the treatment of brain metastases among breast cancer patients. Efaproxiral also received fast-track status in November 2000 for the same indication in the US. In February 2004, Allos initiated a phase III trial, called ENRICH (Enhancing Whole Brain Radiation Therapy In Patients with Breast Cancer and Hypoxic Brain Metastases) to investigate efaproxiral as an adjunct to WBRT for the treatment of brain metastases. Median survival time is the primary endpoint of the study. The National Breast Cancer Coalition (NBCC) is collaborating with the company to support trial enrolment and to gain additional insight about ways to improve radiation treatment in this patient population. The ENRICH trial protocol was approved by the FDA under a Special Protocol Assessment process; as part of the protocol, two interim analyses for safety and efficacy will be performed.This multicentre, randomised, open-label study has a target enrolment of approximately 360 patients at >100 medical centres across the US, Canada, Europe and South America. Allos announced in September 2004 that recruitment of clinical sites for the trial is ongoing across the US and Canada. Completion of trial enrolment in North America is anticipated in December 2005. Subsequently, Allos announced in January 2005 that recruitment into the ENRICH trial has commenced and is ongoing in Europe; enrolment at European sites is expected to conclude by the third quarter of 2006. Allos Therapeutics announced in June 2004 that it had filed an MAA with the EMEA for marketing of exaproxiral as an adjunct to WBRT for treatment of patients with brain metastases originating from breast cancer. The application is based on positive data from a pivotal phase III (REACH, RT-009) trial in this indication. The completed REACH trial investigated efaproxiral among patients with brain metastases undergoing WBRT. The trial was conducted at multiple sites in 11 countries, including the US, Canada, Europe and Australia. In August 2002 Allos completed the enrolment of 538 patients in the study. Initially only 408 patients were to be enrolled, but the company increased the size of the trial to conduct an appropriately powered subgroup analysis in patients with brain metastases from breast and NSCLC. The study was designed to demonstrate a 35% increase in median survival in the subgroup of patients compared with standard WBRT alone. The primary endpoint was survival. Allos began screening US patients for a phase III trial in NSCLC in early 2003. However, in May 2003, the company announced that as part of its revised operating plan it had suspended the screening of patients for this trial. The trial, which was known as ELITE (Enhanced Lung cancer treatment with Induction chemotherapy and Thoracic radiation and Efaproxiral), was comparing induction chemotherapy followed by thoracic radiation therapy with supplemental oxygen, with or without efaproxiral. The trial was enrolling patients with locally advanced, unresectable NSCLC. ELITE was planned to enrol up to 600 patients across North America and Western and Eastern Europe. Phase II trials in patients with inoperable NSCLC have been conducted in the US and Canada. Patient enrolment in one of these studies was completed in August 2000, with a total of 52 patients enrolled. This was an open-label, multicentre study of induction therapy with paclitaxel plus carboplatin followed by chest irradiation and efaproxiral in patients with locally advanced NSCLC. Positive results from this study were reported at the annual meeting of the European Society for Therapeutics Radiology and Oncology in September 2002. Efaproxiral has completed phase I trials as a treatment of surgical hypoxia in elective surgery patients receiving general anaesthesia. However, no recent development has been reported for these indications. In 1994, Allos signed an agreement with CIT for the exclusive worldwide rights to 17 US patents, a European patent covering the UK, France, Italy and Germany plus two pending patents in these territories, two issued patents in Japan, and a pending patent in Canada. These patents cover methods of allosterically modifying haemoglobin with efaproxiral and other compounds, the binding site of efaproxiral and therapy in certain indications including cancer, ischaemia and hypoxia. In addition to the licensed patents from CIT, Allos exclusively owns two patent families with pending applications directed to a formulation of efaproxiral and to methods of its use in BLOD MRI (blood oxygenation level-dependent magnetic resonance imaging) applications. These patents are pending in the US, Canada and Europe, and include an international patent application. In a May 2002 interview with the Wall Street Transcript, the CEO of Allos estimated the overall market for radiation therapy to be approximately 750 000 patients/year. Of this, brain metastases, NSCLC and glioblastoma therapy accounts for about 170 000, 140 000 and 6000 patients, respectively. Allos intend to use a speciality sales force to market efaproxiral directly to radiation therapists in North America. To penetrate the non-oncology market in the US, the company will seek partnership with one or more pharmaceutical companies with direct sales forces and with established distribution systems. Allos is also hoping to secure an oncology marketing partner for non-North American territories. At the time, the company had been issued 21 patents in the US, Canada, Europe and Japan.

Comparative policies of two national dental associations: Norway and the United States.

PubMed

Helöe, L A

1991-01-01

The major issues and challenges confronting the dental professions in the United States and Norway were studied through speeches of and interviews with the presidents of the American Dental Association (ADA) and the Norwegian Dental Association (NDA) in the period 1980-86. The issues most frequently dealt with related to public authorities, particularly legislation and government involvement in dental practice. Anxiety concerning "busyness," the future dental market, and a drop in the quality of applicants to dental schools were also major subjects. The spokespersons of both associations were engaged in increasing the demand for dental services by marketing, but they were ambivalent regarding advertising, especially individual advertising. Both were concerned with protecting dentistry's autonomy. While the Norwegian presidents apparently feared the medical profession's influence upon dentistry, the Americans were concerned with the hygienists and denturists, and with the insurance companies which they suspected of intruding into the dentist-patient relationship. The presidents' statements, which frequently varied, were apparently influenced by the current domestic political climate, the basic socio-political principles of the two countries, and the different socio-demographic make-up of their memberships.

Analytical quality by design: a tool for regulatory flexibility and robust analytics.

PubMed

Peraman, Ramalingam; Bhadraya, Kalva; Padmanabha Reddy, Yiragamreddy

2015-01-01

Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design). It allows the analytical method for movement within method operable design region (MODR). Unlike current methods, analytical method developed using analytical quality by design (AQbD) approach reduces the number of out-of-trend (OOT) results and out-of-specification (OOS) results due to the robustness of the method within the region. It is a current trend among pharmaceutical industry to implement analytical quality by design (AQbD) in method development process as a part of risk management, pharmaceutical development, and pharmaceutical quality system (ICH Q10). Owing to the lack explanatory reviews, this paper has been communicated to discuss different views of analytical scientists about implementation of AQbD in pharmaceutical quality system and also to correlate with product quality by design and pharmaceutical analytical technology (PAT).

Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics

PubMed Central

Bhadraya, Kalva; Padmanabha Reddy, Yiragamreddy

2015-01-01

Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design). It allows the analytical method for movement within method operable design region (MODR). Unlike current methods, analytical method developed using analytical quality by design (AQbD) approach reduces the number of out-of-trend (OOT) results and out-of-specification (OOS) results due to the robustness of the method within the region. It is a current trend among pharmaceutical industry to implement analytical quality by design (AQbD) in method development process as a part of risk management, pharmaceutical development, and pharmaceutical quality system (ICH Q10). Owing to the lack explanatory reviews, this paper has been communicated to discuss different views of analytical scientists about implementation of AQbD in pharmaceutical quality system and also to correlate with product quality by design and pharmaceutical analytical technology (PAT). PMID:25722723

Hybridation of different chiral separation techniques with ICP-MS detection for the separation and determination of selenomethionine enantiomers: chiral speciation of selenized yeast.

PubMed

Méndez, S P; González, E B; Sanz-Medel, A

2001-05-01

Enantioseparation and determination of selenomethionine enantiomers in selenized yeast was investigated using chiral separation techniques based on different principles, coupled on-line to inductively coupled plasma mass spectrometry (ICP-MS) for selenium-specific detection. High performance liquid chromatography (HPLC) on a beta-cyclodestrin (beta-CD) column, cyclodextrin-modified micellar electrokinetic chromatography (CD-MEKC), gas chromatography (GC) on a Chirasil-L-Val column, and HPLC on a Chirobiotic T column have been investigated as the chiral separation techniques. For HPLC separation on the beta-CD column, and also for CD-MEKC, selenomethionine enantiomers were derivatized with NDA/CN(-). For chiral separation by GC, selenomethionine enantiomers were converted into their N-trifluoroacetyl (TFA)-O-alkyl esters. The developed hybridation methodologies are compared with respect to enantioselectivity, sensitivity and analysis time. The usefulness of the best-suited method [HPLC (Chirobiotic T)-ICP-MS] was demonstrated by its application to the successful chiral speciation of selenium and D-and L-selenomethionine content determination in selenized yeast. Copyright 2001 John Wiley & Sons, Ltd.

Perturbation and Nonlinear Dynamic Analysis of Different Singing Styles

PubMed Central

Butte, Caitlin J.; Zhang, Yu; Song, Huangqiang; Jiang, Jack J.

2012-01-01

Summary Previous research has used perturbation analysis methods to study the singing voice. Using perturbation and nonlinear dynamic analysis (NDA) methods in conjunction may provide more accurate information on the singing voice and may distinguish vocal usage in different styles. Acoustic samples from different styles of singing were compared using nonlinear dynamic and perturbation measures. Twenty-six songs from different musical styles were obtained from an online music database (Rhapsody, RealNetworks, Inc., Seattle, WA). One-second samples were selected from each song for analysis. Perturbation analyses of jitter, shimmer, and signal-to-noise ratio and NDA of correlation dimension (D2) were performed on samples from each singing style. Percent jitter and shimmer median values were low normal for country (0.32% and 3.82%), musical theater (MT) (0.280% and 2.80%), jazz (0.440% and 2.34%), and soul (0.430% and 6.42%). The popular style had slightly higher median jitter and shimmer values (1.13% and 6.78%) than other singing styles, although this was not statistically significant. The opera singing style had median jitter of 0.520%, and yielded significantly high shimmer (P = 0.001) of 7.72%. All six singing styles were measured reliably using NDA, indicating that operatic singing is notably more chaotic than other singing styles. Median correlation dimension values were low to normal, compared to healthy voices, in country (median D2 = 2.14), jazz (median D2 = 2.24), pop (median D2 = 2.60), MT (median D2 = 2.73), and soul (mean D2 = 3.26). Correlation dimension was significantly higher in opera (P < 0.001) with median D2 = 6.19. In this study, acoustic analysis in opera singing gave significantly high values for shimmer and D2, suggesting that it is more irregular than other singing styles; a previously unknown quality of opera singing. Perturbation analysis also suggested significant differences in vocal output in different singing styles. This preliminary study using acoustic analysis with nonlinear dynamic measures and perturbation measures may represent a valuable procedure in quantitatively describing the properties of the singing voice. Further research with human test subjects may allow us to characterize singing styles and diagnose vocal dysfunction in the singing voice. PMID:18504114

Leveraging an SNMP Agent in Terminal Equipment for Network Monitoring of U.S. Navy SATCOM

DTIC Science & Technology

2011-09-01

Network Topology TWT Traveling-wave Tube TX Transmitter UCD Uplink Channel Descriptor UDP User Datagram Protocol UFO UHF Follow-On UHF Ultra High...through DSCS III, UFO , and Milstar” (Martin, n.d.a).  “Capabilities have grown dramatically with the development of satellite and electronics...Communication Systems (DSCS) II and III and the Global Broadcast Service (GBS) payload on the UHF Follow-On ( UFO ) satellite  In 1971, the DSCS II

Interpretation of nasal swab measurements following suspected releases of actinide aerosols

DOE PAGES

Klumpp, John Allan; Bertelli, Luiz; Waters, Tom L.

2017-05-01

For radionuclides such as plutonium and americium, detection of removable activity in the nose (i.e., nasal swab measurements) are frequently used to determine whether follow-up bioassay measurements are warranted following a potential intake. For this paper, the authors analyzed 429 nasal swab measurements taken following incidents or suspicious circumstances (such as an air monitor alarming) at Los Alamos National Laboratory (LANL) for which the dose was later evaluated using in vitro bioassay. Nasal swab measurements were found to be very poor predictors of dose and should not be used as such in the field. However, nasal swab measurements can bemore » indicative of whether a reliably detectable committed effective dose (CED) occurred. About 14% of nasal swab measurements between 1.25 and 16.7 Bq corresponded to CEDs greater than 1 mSv, so in general, positive nasal swabs always indicate that follow-up bioassay should be performed (positive nasal swabs less than 1.25 Bq are considered separately). This probability increased significantly for nasal swabs greater than 16.7 Bq. Only about 3% of nasal swabs with no detectable activity (NDA) corresponded to reliably detectable CEDs. As a result, a nasal swab with NDA is therefore necessary, but not sufficient, to negate the need for a follow-up bioassay if it was collected following other workplace indicators of a potential intake.« less

Influence of meditation on anti-correlated networks in the brain.

PubMed

Josipovic, Zoran; Dinstein, Ilan; Weber, Jochen; Heeger, David J

2011-01-01

Human experiences can be broadly divided into those that are external and related to interaction with the environment, and experiences that are internal and self-related. The cerebral cortex appears to be divided into two corresponding systems: an "extrinsic" system composed of brain areas that respond more to external stimuli and tasks and an "intrinsic" system composed of brain areas that respond less to external stimuli and tasks. These two broad brain systems seem to compete with each other, such that their activity levels over time is usually anti-correlated, even when subjects are "at rest" and not performing any task. This study used meditation as an experimental manipulation to test whether this competition (anti-correlation) can be modulated by cognitive strategy. Participants either fixated without meditation (fixation), or engaged in non-dual awareness (NDA) or focused attention (FA) meditations. We computed inter-area correlations ("functional connectivity") between pairs of brain regions within each system, and between the entire extrinsic and intrinsic systems. Anti-correlation between extrinsic vs. intrinsic systems was stronger during FA meditation and weaker during NDA meditation in comparison to fixation (without mediation). However, correlation between areas within each system did not change across conditions. These results suggest that the anti-correlation found between extrinsic and intrinsic systems is not an immutable property of brain organization and that practicing different forms of meditation can modulate this gross functional organization in profoundly different ways.

Interview: Interview with Professor Malcolm Rowland.

PubMed

Rowland, Malcolm

2010-03-01

Malcolm Rowland is Professor Emeritus and former Dean of the School of Pharmacy and Pharmaceutical Sciences and a member and former director (1996-2000), of the Centre for Applied Pharmacokinetic Research, University of Manchester. He holds the positions of Adjunct Professor, School of Pharmacy, University of California, San Francisco; Member, Governing Board, EU Network of Excellence in Biosimulation; Founder member of NDA Partners; academic advisor to a Pharmaceutical initiative in prediction of human pharmacokinetics and Scientific Advisor to the EU Microdose AMS Partnership Program. He was President of the EU Federation for Pharmaceutical Sciences (1996-2000); Vice-President of the International Pharmaceutical Federation (2001-2009) and a Board Member of the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs, 2004-2008). He received his degree in Pharmacy and PhD at the University of London and was on faculty (School of Pharmacy, University of California San Francisco [1967-1975]) before taking up a professorship at Manchester. His main research interest is physiologically based pharmacokinetics and its application to drug discovery, development and use. He is author of over 300 scientific articles and co-author, with TN Tozer, of the textbooks Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications and Introduction to Pharmacokinetics and Pharmacodynamics. He was editor of the Journal of Pharmacokinetics and Pharmacodynamics (formerly Journal of Pharmacokinetics and Biopharmaceutics, 1973-2007) and, since 1977, has organized regular residential workshops in pharmacokinetics.

A DECAMETER STATIONARY TYPE IV BURST IN IMAGING OBSERVATIONS ON 2014 SEPTEMBER 6

DOE Office of Scientific and Technical Information (OSTI.GOV)

Koval, Artem; Chen, Yao; Feng, Shiwei

2016-08-01

First-of-its-kind radio imaging of a decameter solar stationary type IV radio burst has been presented in this paper. On 2014 September 6 the observations of type IV burst radio emission were carried out with the two-dimensional heliograph based on the Ukrainian T-shaped radio telescope (UTR-2), together with other telescope arrays. Starting at ∼09:55 UT and for ∼3 hr, the radio emission was kept within the observational session of UTR-2. The interesting observation covered the full evolution of this burst, “from birth to death.” During the event lifetime, two C-class solar X-ray flares with peak times 11:29 UT and 12:24 UTmore » took place. The time profile of this burst in radio has a double-humped shape that can be explained by injection of energetic electrons, accelerated by the two flares, into the burst source. According to the heliographic observations, we suggest that the burst source was confined within a high coronal loop, which was part of a relatively slow coronal mass ejection. The latter has been developed for several hours before the onset of the event. Through analysis of about 1.5 × 10{sup 6} heliograms (3700 temporal frames with 4096 images in each frame that correspond to the number of frequency channels), the radio burst source imaging shows a fascinating dynamical evolution. Both space-based ( GOES , SDO , SOHO , STEREO ) data and various ground-based instrumentation (ORFEES, NDA, RSTO, NRH) records have been used for this study.« less

Design and performance of A 3He-free coincidence counter based on parallel plate boron-lined proportional technology

DOE PAGES

Henzlova, D.; Menlove, H. O.; Marlow, J. B.

2015-07-01

Thermal neutron counters utilized and developed for deployment as non-destructive assay (NDA) instruments in the field of nuclear safeguards traditionally rely on 3He-based proportional counting systems. 3He-based proportional counters have provided core NDA detection capabilities for several decades and have proven to be extremely reliable with range of features highly desirable for nuclear facility deployment. Facing the current depletion of 3He gas supply and the continuing uncertainty of options for future resupply, a search for detection technologies that could provide feasible short-term alternative to 3He gas was initiated worldwide. As part of this effort, Los Alamos National Laboratory (LANL) designedmore » and built a 3He-free full scale thermal neutron coincidence counter based on boron-lined proportional technology. The boronlined technology was selected in a comprehensive inter-comparison exercise based on its favorable performance against safeguards specific parameters. This paper provides an overview of the design and initial performance evaluation of the prototype High Level Neutron counter – Boron (HLNB). The initial results suggest that current HLNB design is capable to provide ~80% performance of a selected reference 3He-based coincidence counter (High Level Neutron Coincidence Counter, HLNCC). Similar samples are expected to be measurable in both systems, however, slightly longer measurement times may be anticipated for large samples in HLNB. The initial evaluation helped to identify potential for further performance improvements via additional tailoring of boron-layer thickness.« less

Development of a neutron measurement system in unified non-destructive assay for the PRIDE facility

NASA Astrophysics Data System (ADS)

Seo, Hee; Park, Se-Hwan; Won, Byung-Hee; Ahn, Seong-Kyu; Shin, Hee-Sung; Na, Sang-Ho; Song, Dae-Yong; Kim, Ho-Dong; Lee, Seung Kyu

2013-12-01

The Korea Atomic Energy Research Institute (KAERI) has made an effort to develop pyroprocessing technology to resolve an on-going problem in Korea, i.e., the management of spent nuclear fuels. To this end, a test-bed facility for pyroprocessing, called PRIDE (PyRoprocessing Integrated inactive DEmonstration facility), is being constructed at KAERI. The main objective of PRIDE is to evaluate the performance of the unit processes, remote operation, maintenance, and proliferation resistance. In addition, integrating all unit processes into a one-step process is also one of the main goals. PRIDE can also provide a good opportunity to test safeguards instrumentations for a pyroprocessing facility such as nuclear material accounting devices, surveillance systems, radiation monitoring systems, and process monitoring systems. In the present study, a non-destructive assay (NDA) system for the testing of nuclear material accountancy of PRIDE was designed by integrating three different NDA techniques, i.e., neutron, gamma-ray, and mass measurements. The developed neutron detection module consists of 56 3He tubes and 16 AMPTEK A111 signal processing circuits. The amplifiers were matched in terms of the gain and showed good uniformity after a gain-matching procedure (%RSD=0.37%). The axial and the radial efficiency distributions within the cavity were then measured using a 252Cf neutron source and were compared with the MCNPX calculation results. The measured efficiency distributions showed excellent agreement with the calculations, which confirmed the accuracy of the MCNPX model of the system.

Influence of meditation on anti-correlated networks in the brain

PubMed Central

Josipovic, Zoran; Dinstein, Ilan; Weber, Jochen; Heeger, David J.

2012-01-01

Human experiences can be broadly divided into those that are external and related to interaction with the environment, and experiences that are internal and self-related. The cerebral cortex appears to be divided into two corresponding systems: an “extrinsic” system composed of brain areas that respond more to external stimuli and tasks and an “intrinsic” system composed of brain areas that respond less to external stimuli and tasks. These two broad brain systems seem to compete with each other, such that their activity levels over time is usually anti-correlated, even when subjects are “at rest” and not performing any task. This study used meditation as an experimental manipulation to test whether this competition (anti-correlation) can be modulated by cognitive strategy. Participants either fixated without meditation (fixation), or engaged in non-dual awareness (NDA) or focused attention (FA) meditations. We computed inter-area correlations (“functional connectivity”) between pairs of brain regions within each system, and between the entire extrinsic and intrinsic systems. Anti-correlation between extrinsic vs. intrinsic systems was stronger during FA meditation and weaker during NDA meditation in comparison to fixation (without mediation). However, correlation between areas within each system did not change across conditions. These results suggest that the anti-correlation found between extrinsic and intrinsic systems is not an immutable property of brain organization and that practicing different forms of meditation can modulate this gross functional organization in profoundly different ways. PMID:22287947

Risk of developing palatally displaced canines in patients with early detectable dental anomalies: a retrospective cohort study.

PubMed

Garib, Daniela Gamba; Lancia, Melissa; Kato, Renata Mayumi; Oliveira, Thais Marchini; Neves, Lucimara Teixeira das

2016-01-01

To estimate the risk of PDC occurrence in children with dental anomalies identified early during mixed dentition. The sample comprised 730 longitudinal orthodontic records from children (448 females and 282 males) with an initial mean age of 8.3 years (SD=1.36). The dental anomaly group (DA) included 263 records of patients with at least one dental anomaly identified in the initial or middle mixed dentition. The non-dental anomaly group (NDA) was composed of 467 records of patients with no dental anomalies. The occurrence of PDC in both groups was diagnosed using panoramic and periapical radiographs taken in the late mixed dentition or early permanent dentition. The prevalence of PDC in patients with and without early diagnosed dental anomalies was compared using the chi-square test (p<0.01), relative risk assessments (RR), and positive and negative predictive values (PPV and NPV). PDC frequency was 16.35% and 6.2% in DA and NDA groups, respectively. A statistically significant difference was observed between groups (p<0.01), with greater risk of PDC development in the DA group (RR=2.63). The PPV and NPV was 16% and 93%, respectively. Small maxillary lateral incisors, deciduous molar infraocclusion, and mandibular second premolar distoangulation were associated with PDC. Children with dental anomalies diagnosed during early mixed dentition have an approximately two and a half fold increased risk of developing PDC during late mixed dentition compared with children without dental anomalies.

A kinematically complete, interdisciplinary, and co-institutional measurement of the 19F(α,n) cross section for nuclear safeguards science

DOE Office of Scientific and Technical Information (OSTI.GOV)

Peters, W. A.; Smith, M. S.; Pittman, S.

2016-05-01

Alpha particles emitted from the decay of uranium in a UF 6 matrix can interact with fluorine and generate neutrons via the 19F(α,n) 22Na reaction. These neutrons can be used to determine the uranium content in a UF 6 storage cylinder. The accuracy of this self-interrogating, non-destructive assay (NDA) technique is, however, limited by the uncertainty of the 19F(α,n) 22Na cross section. We have performed complementary measurements of the 19F(α,n) 22Na reaction with both 4He and 19F beams to improve the precision of the 19F(α,n) 22Na cross section over the alpha energy range that encompasses common actinide alpha decay neededmore » for NDA studies. We have determined an absolute cross section for the 19F(α,n) 22Na reaction to an average precision of 7.6% over the alpha energy range of 3.9 – 6.7 MeV. We utilized this cross section in a simulation of a 100 g spherical UF 6 assembly and obtained a change in neutron emission rate values of approximately 10-12%, and a significant (factor of 3.6) decrease in the neutron emission rate uncertainty (from 50-51% to 13-14%), compared to simulations using the old cross section. Our new absolute cross section enables improved interpretations of NDAs of containers of arbitrary size and configuration.« less

[Prediction of School Dropout among Turkish High School Students: A Model Testing with Moderator and Mediator Variables.

PubMed

Ozer, Arif; Gençtanirim, Dilek; Ergene, Tuncay

2011-01-01

Bu araştırmada ilk olarak, dürtüsel davranma ile okulu terk etme riski arasındaki ilişkiye disiplin cezası almanın, antisosyal davranışların ve sigara-alkol kullanımının aracılık edip etmediği incelenmiştir. İkinci olarak, öğretmen desteği ve antisosyal davranış etkileşiminin okulu terk etme riski üzerindeki etkisi test edilmiştir. Araştırma grubunu 2009-2010 yılında Ankara İlinde genel liselere devam eden 478 öğrenci oluşturmuştur. Sonuçlar okulu terk etme riskini aile ve arkadaş desteğinin azalttığını, dürtüsel davranmanın ise artırdığını göstermiştir. Ayrıca disiplin cezası, alkol-sigara kullanma ve antisosyal davranışlar okulu terk etme riskini artıran aracı değişkenlerdir. Antisosyal davranışlarla okulu terk etme arasındaki ilişki öğretmen desteğine bağlı olarak değişmektedir. Öğrencilerin cinsiyet ve başarıları ile okulu terk etme riskleri arasında anlamlı bir ilişki bulunmamaktadır.

Impact of perioperative symbiotic therapy on infectious morbidity after Hpb Surgery in jaundiced patients: a randomized controlled trial.

PubMed

Russolillo, N; Ferrero, A; Vigano', L; Langella, S; Briozzo, A; Ferlini, M; Migliardi, M; Capussotti, L

2014-09-01

This study aimed at evaluating whether the administration of symbiotic therapy in jaundiced patients could reduce their postoperative infectious complications. The study was conducted between November 2008 and February 2011. Jaundiced patients scheduled for elective extrahepatic bile duct resection without liver cirrhosis, intestinal malabsorption or intolerance to symbiotic therapy were randomly assigned to receive [Group A] or not [Group B] symbiotics perioperatively. The primary endpoint was the infectious morbidity rate. Forty patients were included in the analysis (20 in each group). The patients in Group B presented a higher overall morbidity (70 vs 50%) and infectious morbidity rate (50 vs 25%), but the differences were not significant. Eleven patients in Group A (Group ndA) and 13 in Group B (Group ndB) did not receive preoperative biliary drainage. The results of the two groups were comparable. Infectious complications were higher in Group B [5 (34%) vs 0, p = 0.030], while the prevalence of natural killer (NK) cells was higher in Group ndA the day before surgery (17% ± 5.1 vs 10% ± 5.3, p < 0.01) and on post-operative day (POD) 7 (13.1% ± 4.1 vs 7.7% ± 3.4, p < 0.01). The rates of lymph node colonization were similar. The symbiotic therapy failed to reduce the rate of infectious morbidity in jaundiced patients. Further studies investigating the place of symbiotic in no-drainage patients are required.

Alpha Centauri at a Crossroads

NASA Astrophysics Data System (ADS)

Ayres, Thomas

2015-10-01

Nearby Alpha Centauri AB (G2V+K1V) contains the two best characterized solar-like dwarf stars, which also have the best studied multi-MK coronal X-ray activity cycles, extending back to the 1970's. Objective is to continue tracking the evolving multi-decadal high-energy narrative of Alpha Cen with semiannual X-ray pointings in Chandra Cycles 16-18, as the system reaches a coronal crossroads: solar twin A rising toward starspot cycle maximum, K-type companion B sinking into a minimum. HST/STIS UV spectra will support and leverage the X-ray measurements by probing chromospheric and subcoronal dynamics, with connection to the corona through the FUV Fe XII 1242 forbidden line. Only Chandra can resolve the AB X-ray pair as the Alpha Cen orbit also reaches a crossroads in 2016 (only 4 separation), and only HST/STIS can measure the bright Alpha Cen stars with sufficient UV spectral resultion and wavelength coherence. What's more, the recent validation of the STIS NDA,B,C long slits for echelle use now make feasible NUV E230H measurements (e.g., of key chromospheric tracers Mg II 2800 and Mg I 2852) which heretofore were not practical in a long-term program of this nature.

Alpha Centauri at a Crossroads

NASA Astrophysics Data System (ADS)

Ayres, Thomas

2016-10-01

Nearby Alpha Centauri AB (G2V+K1V) contains the two best characterized solar-like dwarf stars, which also have the best studied multi-MK coronal X-ray activity cycles, extending back to the 1970's. Objective is to continue tracking the evolving multi-decadal high-energy narrative of Alpha Cen with semiannual X-ray pointings in Chandra Cycles 16-18, as the system reaches a coronal crossroads: solar twin A rising toward starspot cycle maximum, K-type companion B sinking into a minimum. HST/STIS UV spectra will support and leverage the X-ray measurements by probing chromospheric and subcoronal dynamics, with connection to the corona through the FUV Fe XII 1242 forbidden line. Only Chandra can resolve the AB X-ray pair as the Alpha Cen orbit also reaches a crossroads in 2016 (only 4 separation), and only HST/STIS can measure the bright Alpha Cen stars with sufficient UV spectral resolution and wavelength coherence. What's more, the recent validation of the STIS NDA,B,C long slits for echelle use now make feasible NUV E230H measurements (e.g., of key chromospheric tracers Mg II 2800 and Mg I 2852) which heretofore were not practical in a long-term program of this nature.

The in-plant evaluation of a uranium NDA system

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sprinkle, J.K. Jr.; Baxman, H.R.; Langner, D.G.

1979-12-31

The Los Alamos Scientific Laboratory has an unirradiated enriched uranium reprocessing facility. Various types of solutions are generated in this facility, including distillates and raffinates containing ppm of uranium and concentrated solutions with up to 400 grams U/t. In addition to uranyl nitrate and HNO{sub 3}, the solutions may also contain zirconium, niobium, fluoride, and small amounts of many metals. A uranium solution assay system (USAS) has been installed to allow accurate and more timely process control, accountability, and criticality data to be obtained. The USAS assays are made by a variety of techniques that depend upon state-of-the-art high-resolution Ge(Li)more » gamma-ray spectroscopy integrated with an interactive, user-oriented computer software package. Tight control of the system`s performance is maintained by constantly monitoring the USAS status. Daily measurement control sequences are required, and the user is forced by the software to perform these sequences. Routine assays require 400 or 1000 seconds for a precision of 0.5% over the concentration range of 5--400 g/t. A comparison of the USAS precision and accuracy with that obtained by traditional destructive analytical chemistry techniques (colorimetric and volumetric) is presented.« less

The in-plant evaluation of a uranium NDA system

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sprinkle, J.K. Jr.; Baxman, H.R.; Langner, D.G.

1979-01-01

The Los Alamos Scientific Laboratory has an unirradiated enriched uranium reprocessing facility. Various types of solutions are generated in this facility, including distillates and raffinates containing ppm of uranium and concentrated solutions with up to 400 grams U/t. In addition to uranyl nitrate and HNO{sub 3}, the solutions may also contain zirconium, niobium, fluoride, and small amounts of many metals. A uranium solution assay system (USAS) has been installed to allow accurate and more timely process control, accountability, and criticality data to be obtained. The USAS assays are made by a variety of techniques that depend upon state-of-the-art high-resolution Ge(Li)more » gamma-ray spectroscopy integrated with an interactive, user-oriented computer software package. Tight control of the system's performance is maintained by constantly monitoring the USAS status. Daily measurement control sequences are required, and the user is forced by the software to perform these sequences. Routine assays require 400 or 1000 seconds for a precision of 0.5% over the concentration range of 5--400 g/t. A comparison of the USAS precision and accuracy with that obtained by traditional destructive analytical chemistry techniques (colorimetric and volumetric) is presented.« less

First regulatory inspections measuring adherence to Good Pharmacy Practices in the public sector in Uganda: a cross-sectional comparison of performance between supervised and unsupervised facilities.

PubMed

Trap, Birna; Kikule, Kate; Vialle-Valentin, Catherine; Musoke, Richard; Lajul, Grace Otto; Hoppenworth, Kim; Konradsen, Dorthe

2016-01-01

Since its inception, the Uganda National Drug Authority (NDA) has regularly inspected private sector pharmacies to monitor adherence to Good Pharmacy Practices (GPP). This study reports findings from the first public facility inspections following an intervention (SPARS: Supervision, Performance Assessment, and Recognition Strategy) to build GPP and medicines management capacity in the public sector. The study includes 455 public facilities: 417 facilities were inspected after at least four SPARS visits by trained managerial district staff (SPARS group), 38 before any exposure to SPARS. NDA inspectors measured 10 critical, 20 major, and 37 minor GPP indicators in every facility and only accredited facilities that passed all 10 critical and failed no more than 7 major indicators. Lack of compliance for a given indicator was defined as less than 75 % facilities passing that indicator. We assessed factors associated with certification using logistic regression analysis and compared number of failed indicators between the SPARS and comparative groups using two sample t-tests with equal or unequal variance. 57.4 % of inspected facilities obtained GPP certification: 57.1 % in the SPARS and 60.5 % in the comparative group (Adj. OR = 0.91, 95 % CI 0.45-1.85, p = 0.802). Overall, facilities failed an average of 10 indicators. SPARS facilities performed better than comparative facilities (9 (SD 6.1) vs. 13 (SD 7.7) failed indicators respectively; p = 0.017), and SPARS supported facilities scored better on indicators covered by SPARS. For all indicators but one minor, performance in the SPARS group was equal to or significantly better than in unsupervised facilities. Within the SPARS (intervention) group, certified facilities had < 75 % compliance on 7 indicators (all minor), and uncertified facilities on 19 (4 critical, 2 major, and 13 minor) indicators. Half of the Ugandan population obtains medicines from the public sector. Yet, we found only 3/5 of inspected public health facilities meet GPP standards. SPARS facilities tended to perform better than unsupervised facilities, substantiating the value of supporting supervision interventions in GPP areas that need strengthening. None compliant indicators can be improved through practices and behavioral changes; some require infrastructure investments. We conclude that regular NDA inspections of public sector pharmacies in conjunction with interventions to improve GPP adherence can revolutionize patient care in Uganda.

Pharmacovigilance systems in developing countries: an evaluative case study in Burkina Faso.

PubMed

Kabore, Lassane; Millet, Pascal; Fofana, Souleymane; Berdai, Driss; Adam, Caroline; Haramburu, Françoise

2013-05-01

Burkina Faso, like other Sub-Saharan African countries, has recently experienced a large-scale deployment of new medicines for the prevention and treatment of notable diseases of public health interest, including malaria, HIV/AIDS and meningitis. This new context rendered the implementation of pharmacovigilance necessary in order to monitor and establish the safety and effectiveness of these medicines. In 2008, the Ministry of Health of Burkina Faso, West Africa, launched a formal pharmacovigilance system to respond to this need. The aim of this study was to evaluate the early-stage pharmacovigilance system of Burkina Faso through a comprehensive and system-based approach with the prospect of identifying areas for improvements. We conducted a descriptive cross-sectional study in Burkina Faso. Sixteen key informants from the National Drug Authority (NDA), public health programmes (PHPs) and hospitals were interviewed. Study participants were selected based on a convenience sampling in the NDA, three teaching hospitals, two regional hospitals and six PHPs. Data were collected using the Indicator-based Pharmacovigilance Assessment Tool (IPAT), a metric instrument recently designed and validated by 'Management Sciences for Health', a US non-profit organization. The evaluation also involved the collection and review of relevant pharmacovigilance-related documentation in the institutions assessed. A scoring system was used for the quantification of assessment results. The NDA of Burkina Faso, the institution statutorily in charge of pharmacovigilance, achieved a performance score of 70 %. The basic structures for pharmacovigilance activities were in place; however, the lack of specific laws dedicated to pharmacovigilance, the lack of national guidelines and standard operating procedures on pharmacovigilance, and the insufficient coordination of pharmacovigilance stakeholders in the country were identified as the main weaknesses. Safety data collected thus far have not led to the identification of local drug-related risks; yet, relevant external safety alerts are monitored and acted upon. In 2010, 31 marketing authorizations were modified to include new safety information; seven others were suspended and the corresponding medicines were withdrawn from the national market. In PHPs, pharmacovigilance activities were not formalized, and in hospitals, pharmacovigilance structures were still under development. Relevant interventions aimed at strengthening the legal framework and structures for pharmacovigilance activities, and improving the coordination of stakeholders countrywide, should be undertaken as soon as possible. Such an investment is necessary before the national pharmacovigilance system is able to collect its own data, generate signals, evaluate and manage local medicine-related risks and then become a genuine tool for public health.

AACSD: An atomistic analyzer for crystal structure and defects

NASA Astrophysics Data System (ADS)

Liu, Z. R.; Zhang, R. F.

2018-01-01

We have developed an efficient command-line program named AACSD (Atomistic Analyzer for Crystal Structure and Defects) for the post-analysis of atomic configurations generated by various atomistic simulation codes. The program has implemented not only the traditional filter methods like the excess potential energy (EPE), the centrosymmetry parameter (CSP), the common neighbor analysis (CNA), the common neighborhood parameter (CNP), the bond angle analysis (BAA), and the neighbor distance analysis (NDA), but also the newly developed ones including the modified centrosymmetry parameter (m-CSP), the orientation imaging map (OIM) and the local crystallographic orientation (LCO). The newly proposed OIM and LCO methods have been extended for all three crystal structures including face centered cubic, body centered cubic and hexagonal close packed. More specially, AACSD can be easily used for the atomistic analysis of metallic nanocomposite with each phase to be analyzed independently, which provides a unique pathway to capture their dynamic evolution of various defects on the fly. In this paper, we provide not only a throughout overview on various theoretical methods and their implementation into AACSD program, but some critical evaluations, specific testing and applications, demonstrating the capability of the program on each functionality.

General Aviation in Nebraska: Nebraska SATS Project Background Paper No. 1

NASA Technical Reports Server (NTRS)

Smith, Russell; Wachal, Jocelyn

2000-01-01

The Nebraska SATS project is a state-level component of NASA's Small Aircraft Transportation System (SATS). During the next several years the project will examine several different factors affecting SATS implementation in Nebraska. These include economic and taxation issues, public policy issues, airport planning processes, information dissemination strategies, and systemic change factors. This background paper profiles the general aviation system in Nebraska. It is written to provide information about the "context" within which SATS will be pursued. The primary focus is thus on describing and providing background information about the current situation. A secondary focus is on drawing general conclusions about the ability of the current system to incorporate the types of changes implied by SATS. First, some brief information on the U.S. aviation system is provided. The next two sections profile the current general aviation aircraft and pilot base. Nebraska's system of general aviation airports is then described. Within this section of the paper, information is provided on the different types of general aviation airports in Nebraska, airport activity levels and current infrastructure. The fourth major section of the background paper looks at Nebraska's local airport authorities. These special purpose local governments oversee the majority of the general aviation airports in the state. Among the items examined are total expenditures, capital expenditures and planning activities. Next, the paper provides background information on the Nebraska Department of Aeronautics (NDA) and recent Federal funding for general aviation in Nebraska. The final section presents summary conclusions.

West Valley demonstration project: Implementation of the kerosene mitigation plan

DOE Office of Scientific and Technical Information (OSTI.GOV)

Blickwedehl, R.R.; Goodman, J.; Valenti, P.J.

1987-05-01

An aggressive program was implemented to mitigate the migration of radioactive kerosene believed to have originated from the West Valley NRC-Licensed Disposal Area (NDA) disposal trenches designated as SH-10 and SH-11 (Special Holes 10 and 11). This report provides a historical background of the events leading to the migration problem, the results of a detailed investigation to determine the location and source of the kerosene migration, the remediation plan to mitigate the migration, and the actions taken to successfully stabilize the kerosene. 7 refs., 19 figs., 1 tab.

CMB-8 material balance system

DOE Office of Scientific and Technical Information (OSTI.GOV)

Langner, D.; Canada, T.; Ensslin, N.

1980-08-01

We describe the automated nondestructive assay (NDA) system installed at the Los Alamos Scientific Laboratory (LASL) Group CMB-8 uranium recovery facility. A random driver (RD) is used to measure the /sup 235/U content of various solids while a uranium solution assay system (USAS) measures the /sup 235/U or total uranium content of solutions over a concentration range of a few ppM to 400 g/l. Both instruments are interfaced to and controlled by a single minicomputer. The measurement principles, mechanical specifications, system software description, and operational instructions are described.

Pharmacokinetic Studies in Healthy Subjects for the Development of an Extended-Release Tablet Formulation of Guaifenesin: A 505(b)(2) New Drug Application Approval.

PubMed

Vilson, Lineau; Owen, Joel S

2013-01-01

Guaifenesin is an expectorant used to improve mucociliary clearance (MCC) and relieve chest congestion from upper respiratory tract infections. Immediate-release (IR) guaifenesin requires dosing every 4 hours to maintain efficacy because of the drug's short half-life. Extended-release (ER) guaifenesin has been developed to prolong efficacy and reduce dosing frequency. As part of the 505(b)(2) new drug application (NDA), the pharmacokinetics (PK) of an ER bi-layer tablet formulation of guaifenesin (Mucinex®) and bioequivalence to an over-the-counter (OTC) monograph IR formulation were evaluated in healthy subjects. In one study, subjects received 1,200 mg ER guaifenesin every 12 hours or 400 mg IR guaifenesin every 4 hours for 6 days. Steady-state exposures were equivalent between the two products, as demonstrated by AUC and Cmax . In another study, subjects received a single dose of 600 mg (fasted) or 1,200 mg (fasted or fed) ER bi-layer tablet formulations. AUC and Cmax were equivalent between both states for the 1,200 mg ER dose. However, Tmax of 1,200 mg ER guaifenesin was later in the fed than the fasted state. ER guaifenesin is bioequivalent to corresponding OTC monograph doses of IR guaifenesin. ER guaifenesin offers a convenient 12-hour dosing alternative to 4-hour dosing of IR guaifenesin. © The Author(s) 2013.

Why trash don't pass? pharmaceutical licensing and safety performance of drugs.

PubMed

Banerjee, Tannista; Nayak, Arnab

2017-01-01

This paper examines how asymmetric information in pharmaceutical licensing affects the safety standards of licensed drugs. Pharmaceutical companies often license potential drug molecules at different stages of drug development from other pharmaceutical or biotechnology companies and complete the remaining of research stages before submitting the new drug application(NDA) to the food and drug administration. The asymmetric information associated with the quality of licensed molecules might result in the molecules which are less likely to succeed to be licensed out, while those with greater potential of success being held internally for development. We identify the NDAs submitted between 1993 and 2004 where new molecular entities were acquired through licensing. Controlling for other drug area specific and applicant firm specific factors, we investigate whether drugs developed with licensed molecules face higher probability of safety based recall and ultimate withdrawal from the market than drugs developed internally. Results suggest the opposite of Akerlof's (Q J Econ 84:488-500, 1970) lemons problem. Licensed molecules rather have less probability of facing safety based recalls and ultimate withdrawal from the market comparing to internally developed drug molecules. This suggests that biotechnology and small pharmaceutical firms specializing in pharmaceutical research are more efficient in developing good potential molecules because of their concentrated research. Biotechnology firms license out good potential molecules because it increases their market value and reputation. In addition, results suggest that both the number of previous approved drugs in the disease area, and also the applicant firms' total number of previous approvals in all disease areas reduce the probability that an additional approved drug in the same drug area will potentially be harmful.

Development of an NDA system for high-level waste from the Chernobyl new safe confinement construction site

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lee, Sang-yoon; Browne, Michael C; Rael, Carlos D

2010-01-01

In early 2009, preliminary excavation work has begun in preparation for the construction of the New Safe Confinement (NSC) at the Chernobyl Nuclear Power Plant (ChNPP) in Ukraine. The NSC is the structure that will replace the present containment structure and will confine the radioactive remains of the ChNPP Unit-4 reactor for the next 100 years. It is expected that special nuclear material (SNM) that was ejected from the Unit-4 reactor during the accident in 1986 could be uncovered and would therefore need to be safeguarded. ChNPP requested the assistance of the United States Department of Energy/National Nuclear Security Administrationmore » (NNSA) with developing a new non-destructive assay (NDA) system that is capable of assaying radioactive debris stored in 55-gallon drums. The design of the system has to be tailored to the unique circumstances and work processes at the NSC construction site and the ChNPP. This paper describes the Chernobyl Drum Assay System (CDAS), the solution devised by Los Alamos National Laboratory, Sonalysts Inc., and the ChNPP, under NNSA's International Safeguards and Engagement Program (INSEP). The neutron counter measures the spontaneous fission neutrons from the {sup 238}U, {sup 240}Pu, {sup 244}Cm in a waste drum and estimates the mass contents of the SNMs in the drum by using of isotopic compositions determined by fuel burnup. The preliminary evaluation on overall measurement uncertainty shows that the system meets design performance requirements imposed by the facility.« less

Türk Lise Öğrencilerinde Okul Terkinin Yordanması: Aracı ve Etkileşim Değişkenleri ile Bir Model Testi

PubMed Central

Özer, Arif; Gençtanirim, Dilek; Ergene, Tuncay

2011-01-01

Bu araştırmada ilk olarak, dürtüsel davranma ile okulu terk etme riski arasındaki ilişkiye disiplin cezası almanın, antisosyal davranışların ve sigara-alkol kullanımının aracılık edip etmediği incelenmiştir. İkinci olarak, öğretmen desteği ve antisosyal davranış etkileşiminin okulu terk etme riski üzerindeki etkisi test edilmiştir. Araştırma grubunu 2009-2010 yılında Ankara İlinde genel liselere devam eden 478 öğrenci oluşturmuştur. Sonuçlar okulu terk etme riskini aile ve arkadaş desteğinin azalttığını, dürtüsel davranmanın ise artırdığını göstermiştir. Ayrıca disiplin cezası, alkol-sigara kullanma ve antisosyal davranışlar okulu terk etme riskini artıran aracı değişkenlerdir. Antisosyal davranışlarla okulu terk etme arasındaki ilişki öğretmen desteğine bağlı olarak değişmektedir. Öğrencilerin cinsiyet ve başarıları ile okulu terk etme riskleri arasında anlamlı bir ilişki bulunmamaktadır. PMID:22003257

Fiscal Year (FY) 2017 Activities for the Spent Fuel Nondestructive Assay Project

DOE Office of Scientific and Technical Information (OSTI.GOV)

Trellue, Holly Renee; Trahan, Alexis Chanel; McMath, Garrett Earl

The main focus of research in the NA-241 spent fuel nondestructive assay (NDA) project in FY17 has been completing the fabrication and testing of two prototype instruments for upcoming spent fuel measurements at the Clab interim storage facility in Sweden. One is a passive instrument: Differential Die-away Self Interrogation-Passive Neutron Albedo Reactivity (DDSI), and one is an active instrument: Differential Die-Away-Californium Interrogation with Prompt Neutron (DDA). DDSI was fabricated and tested with fresh fuel at Los Alamos National Laboratory in FY15 and FY16, then shipped to Sweden at the beginning of FY17. Research was performed in FY17 to simplify resultsmore » from the data acquisition system, which is complex because signals from 56 different 3He detectors must be processed using list mode data. The DDA instrument was fabricated at the end of FY16. New high count rate electronics better suited for a spent fuel environment (i.e., KM-200 preamplifiers) were built specifically for this instrument in FY17, and new Tygon tubing to house electrical cables was purchased and installed. Fresh fuel tests using the DDA instrument with numerous configurations of fuel rods containing depleted uranium (DU), low enriched uranium (LEU), and LEU with burnable poisons (Gd) were successfully performed and compared to simulations.1 Additionally, members of the spent fuel NDA project team travelled to Sweden for a “spent fuel characterization and decay heat” workshop involving simulations of spent fuel and analysis of uncertainties in decay heat calculations.« less

Exploring Renner-Teller induced quenching in the reaction H(2S)+NH(a 1Delta): a combined experimental and theoretical study.

PubMed

Adam, L; Hack, W; McBane, G C; Zhu, H; Qu, Z-W; Schinke, R

2007-01-21

Experimental rate coefficients for the removal of NH(a (1)Delta) and ND(a (1)Delta) in collisions with H and D atoms are presented; all four isotope combinations are considered: NH+H, NH+D, ND+H, and ND+D. The experiments were performed in a quasistatic laser-flash photolysis/laser-induced fluorescence system at low pressures. NH(a (1)Delta) and ND(a (1)Delta) were generated by photolysis of HN(3) and DN(3), respectively. The total removal rate coefficients at room temperature are in the range of (3-5)x10(13) cm(3) mol(-1) s(-1). For two isotope combinations, NH+H and NH+D, quenching rate coefficients for the production of NH(X (3)Sigma(-)) or ND(X (3)Sigma(-)) were also determined; they are in the range of 1 x 10(13) cm(3) mol(-1) s(-1). The quenching rate coefficients directly reflect the strength of the Renner-Teller coupling between the (2)A(") and (2)A(') electronic states near linearity and so can be used to test theoretical models for describing this nonadiabatic process. The title reaction was modeled with a simple surface-hopping approach including a single parameter, which was adjusted to reproduce the quenching rate for NH+H; the same parameter value was used for all isotope combinations. The agreement with the measured total removal rate is good for all but one isotope combination. However, the quenching rates for the NH+D combination are only in fair (factor of 2) agreement with the corresponding measured data.

FT-IR Spectroscopic Evidence Of Phase Transition For NaA-ROH-Kerosine-H2O Microemulsion System Containing Nd3+ Ions

NASA Astrophysics Data System (ADS)

Liao, Hua; Xu, Zhen-Hua; Shi, Nai; Wu, Jin-Guang; Xu, Guang-Xian

1989-12-01

In the previous investigation, the saponification of naphthenic acid extractant system has been proved to be a process of the formation of a microemulsion of 14/0 type, and its full extraction of rare earths is a process of destruction of the W/O microemulsion[1]. When NdCl3 is partially extracted with NaA (sodium naphthenate) secoctylalcohol-- kerosine-- water microemulsion system (ME), both the NdA3 and the NaA co-exist in the same organic phase. However,the formation mechanism of microemulsion containing neodymium has not been much studied. In this paper, 10 aliquots of fully saponificated extractants were equilibrated with various amounts of NdC13 solutions respectively, then ten organic phases with different extraction efficiencies of neodymium from 094 to 9094 were obtained. After extraction,the volume of neodymium containing organic phase increased by 5 to 4594, because of the transfer of water molecules. The appearance of these organic phase still remained clear and transparent. The average hydrodynamic radius of the drops were found to be 100-300 Angstrom by using light scattering techniques. The results give a direct evidence of the microemulsion formation in the organic phase. Their FT-IR spectra were measured with CaFa liquid cells utilizing a Nicolet 7199B FT-IR spectrometer. The presence of various amounts of water in the organic phases was clearly detected from the relative intensity changes of 1644 cm-I, which is assigned to the bending mode of 1110 molecules. Fig.1 shows the change of water contents to the percent extraction of neodymium. Comparsion with the FT-IR spectra, it is seen that the 1560 cm-1 peak of the full saponificated extractant is attributed to the asym. stretching vibration of COO''' group, it shifted to 1536 for 100% extration of Nd ions, indicating the formation of neodymium naphthenate (NdA ) from ionic sodium naphthenate. The sym. strethching vibration of COO''' located at 1406 cm-1, it shifted to 1408 cm in 45% Nd extration. and disappeared when the percentage extration of Nd3+ was larger than 50%, at the same time, the water content dropped sharply (Fig.1).These results suggested that a series of microemulsion containing Nd ions formed in these organic phases, at the transition region ( more than 50 percentage extration of neodymium), a morphological change of the W/0 dispersion system might occur.

FY-12 INL KR CAPTURE ACTIVITIES SUPPORTING THE OFF-GAS SIGMA TEAM

DOE Office of Scientific and Technical Information (OSTI.GOV)

Troy G. Garn; Mitchell R. Greenhalgh; Jack D Law

2012-08-01

Tasks performed this year by INL Kr capture off-gas team members can be segregated into three separate task sub-sections which include: 1) The development and testing of a new engineered form sorbent, 2) An initial NDA gamma scan effort performed on the drum containing the Legacy Kr-85 sample materials, and 3) Collaborative research efforts with PNNL involving the testing of the Ni-DOBDC MOF and an initial attempt to make powdered chalcogel material into an engineered form using our binding process. This document describes the routes to success for the three task sub-sections.

Asynchronous timing and Doppler recovery in DSP based DPSK modems for fixed and mobile satellite applications

NASA Astrophysics Data System (ADS)

Koblents, B.; Belanger, M.; Woods, D.; McLane, P. J.

While conventional analog modems employ some kind of clock wave regenerator circuit for synchronous timing recovery, in sampled modem receivers the timing is recovered asynchronously to the incoming data stream, with no adjustment being made to the input sampling rate. All timing corrections are accomplished by digital operations on the sampled data stream, and timing recovery is asynchronous with the uncontrolled, input A/D system. A good timing error measurement algorithm is a zero crossing tracker proposed by Gardner. Digital, speech rate (2400 - 4800 bps) M-PSK modem receivers employing Gardner's zero crossing tracker were implemented and tested and found to achieve BER performance very close to theoretical values on the AWGN channel. Nyguist pulse shaped modem systems with excess bandwidth factors ranging from 100 to 60 percent were considered. We can show that for any symmetric M-PSK signal set Gardner's NDA algorithm is free of pattern jitter for any carrier phase offset for rectangular pulses and for Nyquist pulses having 100 percent excess bandwidth. Also, the Nyquist pulse shaped system is studied on the mobile satellite channel, where Doppler shifts and multipath fading degrade the pi/4-DQPSK signal. Two simple modifications to Gardner's zero crossing tracker enable it to remain useful in the presence of multipath fading.

Asynchronous timing and Doppler recovery in DSP based DPSK modems for fixed and mobile satellite applications

NASA Technical Reports Server (NTRS)

Koblents, B.; Belanger, M.; Woods, D.; Mclane, P. J.

1993-01-01

While conventional analog modems employ some kind of clock wave regenerator circuit for synchronous timing recovery, in sampled modem receivers the timing is recovered asynchronously to the incoming data stream, with no adjustment being made to the input sampling rate. All timing corrections are accomplished by digital operations on the sampled data stream, and timing recovery is asynchronous with the uncontrolled, input A/D system. A good timing error measurement algorithm is a zero crossing tracker proposed by Gardner. Digital, speech rate (2400 - 4800 bps) M-PSK modem receivers employing Gardner's zero crossing tracker were implemented and tested and found to achieve BER performance very close to theoretical values on the AWGN channel. Nyguist pulse shaped modem systems with excess bandwidth factors ranging from 100 to 60 percent were considered. We can show that for any symmetric M-PSK signal set Gardner's NDA algorithm is free of pattern jitter for any carrier phase offset for rectangular pulses and for Nyquist pulses having 100 percent excess bandwidth. Also, the Nyquist pulse shaped system is studied on the mobile satellite channel, where Doppler shifts and multipath fading degrade the pi/4-DQPSK signal. Two simple modifications to Gardner's zero crossing tracker enable it to remain useful in the presence of multipath fading.

Access to benznidazole for Chagas disease in the United States-Cautious optimism?

PubMed

Alpern, Jonathan D; Lopez-Velez, Rogelio; Stauffer, William M

2017-09-01

Drugs for neglected tropical diseases (NTD) are being excessively priced in the United States. Benznidazole, the first-line drug for Chagas disease, may become approved by the Food and Drug Administration (FDA) and manufactured by a private company in the US, thus placing it at risk of similar pricing. Chagas disease is an NTD caused by Trypanosoma cruzi; it is endemic to Latin America, infecting 8 million individuals. Human migration has changed the epidemiology causing nonendemic countries to face increased challenges in diagnosing and managing patients with Chagas disease. Only 2 drugs exist with proven efficacy: benznidazole and nifurtimox. Benznidazole has historically faced supply problems and drug shortages, limiting accessibility. In the US, it is currently only available under an investigational new drug (IND) protocol from the CDC and is provided free of charge to patients. However, 2 companies have stated that they intend to submit a New Drug Application (NDA) for FDA approval. Based on recent history of companies acquiring licensing rights for NTD drugs in the US with limited availability, it is likely that benznidazole will become excessively priced by the manufacturer-paradoxically making it less accessible. However, if the companies can be taken at their word, there may be reason for optimism.

Efficacy and safety of mipomersen sodium (Kynamro).

PubMed

Hovingh, Kees; Besseling, Joost; Kastelein, John

2013-07-01

Mipomersen is a first-in-class drug indicated as an adjunct to lipid-lowering medications and diet to reduce low-density lipoprotein-cholesterol (LDL-C), apolipoprotein B (apoB), total cholesterol (TC) and non-high density lipoprotein-cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH). This article summarizes the efficacy and safety profile of mipomersen based on literature, public materials available from the Endocrinologic and Metabolic Drugs Advisory Committee meeting (FDA) in review of the New Drug Application (NDA 203568) and the recent product label. Patients suffering from HoFH are characterized by elevated levels of LDL-C and are, therefore, at severely increased risk for cardiovascular disease (CVD). Currently available lipid-lowering therapies (LLT), such as statins, have been shown to lower LDL-C levels and CVD risk. However, in patients suffering from HoFH, additional therapy is urgently needed to further decrease LDL-C levels and CVD risk. Mipomersen (Kynamro) has recently been approved by the FDA as a novel LLT modality in patients with HoFH. Mipomersen has been show to result in highly relevant absolute LDL-C reductions in HoFH patients, and given the undisputed causal relationship between LDL-C levels and CVD risk, this additional LDL-C lowering is expected to result in a robust CVD risk reduction.

Risk of developing palatally displaced canines in patients with early detectable dental anomalies: a retrospective cohort study

PubMed Central

GARIB, Daniela Gamba; LANCIA, Melissa; KATO, Renata Mayumi; OLIVEIRA, Thais Marchini; NEVES, Lucimara Teixeira das

2016-01-01

ABSTRACT The early recognition of risk factors for the occurrence of palatally displaced canines (PDC) can increase the possibility of impaction prevention. Objective To estimate the risk of PDC occurrence in children with dental anomalies identified early during mixed dentition. Material and Methods The sample comprised 730 longitudinal orthodontic records from children (448 females and 282 males) with an initial mean age of 8.3 years (SD=1.36). The dental anomaly group (DA) included 263 records of patients with at least one dental anomaly identified in the initial or middle mixed dentition. The non-dental anomaly group (NDA) was composed of 467 records of patients with no dental anomalies. The occurrence of PDC in both groups was diagnosed using panoramic and periapical radiographs taken in the late mixed dentition or early permanent dentition. The prevalence of PDC in patients with and without early diagnosed dental anomalies was compared using the chi-square test (p<0.01), relative risk assessments (RR), and positive and negative predictive values (PPV and NPV). Results PDC frequency was 16.35% and 6.2% in DA and NDA groups, respectively. A statistically significant difference was observed between groups (p<0.01), with greater risk of PDC development in the DA group (RR=2.63). The PPV and NPV was 16% and 93%, respectively. Small maxillary lateral incisors, deciduous molar infraocclusion, and mandibular second premolar distoangulation were associated with PDC. Conclusion Children with dental anomalies diagnosed during early mixed dentition have an approximately two and a half fold increased risk of developing PDC during late mixed dentition compared with children without dental anomalies. PMID:28076458

Determination of blood cyanide by HPLC-MS.

PubMed

Tracqui, A; Raul, J S; Géraut, A; Berthelon, L; Ludes, B

2002-04-01

An original high-performance liquid chromatographic-mass spectrometric (HPLC-MS) procedure was developed for the determination of cyanide (CN) in whole blood. After the addition of K13C15N as internal standard, blood was placed in a microdiffusion device, the inner well of which was filled with a mixture of taurine (50mM in water)/naphthalene-2,3-dicarboxaldehyde (NDA, 10mM in methanol)/methanol/ concentrated (approximately 20%) ammonia solution (25:25:45:5, v/v). Concentrated H2SO4 was added to the blood sample, and the microdiffusion chamber was sealed. After 30 min of gentle agitation, 2 microL of the contents of the inner vial were pipetted and directly injected onto a NovaPak C18 HPLC column. Separation was performed by a gradient of acetonitrile in 2mM NH4COOH, pH 3.0 buffer (35-80% in 10 min). Detection was done with a Perkin-Elmer Sciex API-100 mass analyzer with an ionspray interface, operated in the negative ionization mode. MS data were collected as either TIC or SIM at m/z (299 + 191) and (301 + 193) for the derivatives formed with CN and 13C15N, respectively. Inspired by previous works dealing with the complexation of CN by NDA + taurine to form a 1-cyano [f] benzoisoindole derivative analyzed by HPLC-fluorimetry, this method appears simple, rapid, and extremely specific. Limits of detection and quantitation for blood CN are 5 and 15 ng/mL, respectively. The use of 13C15N as internal standard allows the quantitation of CN with elegance and accuracy in comparison with previously reported methods.

Online liquid chromatography-tandem mass spectrometry cyanide determination in blood.

PubMed

Lacroix, C; Saussereau, E; Boulanger, F; Goullé, J P

2011-04-01

An original liquid chromatography-tandem mass spectrometry (LC-MS-MS) method coupled to online extraction has been developed for cyanide determination in blood. A method involving fluorimetric detection after naphthalene-2,3-dicarboxyaldehyde (NDA) complexation by taurine in the presence of cyanide was previously described. Its performance was limited because of the absence of an internal standard (IS). Using cyanide isotope (13)C(15)N as IS allowed quantification in MS-MS. After the addition of (13)C(15)N, 25 μL of blood were diluted in water and deproteinized with methanol. Following derivatization with NDA and taurine for 10 min at 4°C, 100 μL was injected into the online LC-MS-MS system. An Oasis HLB was used as an extraction column, and a C18 Atlantis was the analytical column. The chromatographic cycle was performed with an ammonium formate (20 mM, pH 2.8) (solvent A) and acetonitrile/solvent A (90:10, v/v) gradient in 6 min. Detection was performed in negative electrospray ionization mode (ESI(-)) with a Quattro Micro. For quantification, transitions of derivatives formed with CN and (13)C(15)N were monitored, respectively, as follows: 299.3/191.3 and 301.3/193.3. The procedure was fully validated, linear from 26 to 2600 ng/mL with limit of detection of 10 ng/mL. This method, using a small blood sample, is not only simple, but also time saving. The specificity and sensitivity of LC-MS-MS coupled to online extraction and using (13)C(15)N as the IS make this method very suitable for cyanide determination in blood and could be useful in forensic toxicology.

235U Holdup Measurements in Three 321-M Exhaust HEPA Banks

DOE Office of Scientific and Technical Information (OSTI.GOV)

Dewberry, R

2005-02-24

The Analytical Development Section of Savannah River National Laboratory (SRNL) was requested by the Facilities Disposition Division to determine the holdup of enriched uranium in the 321-M facility as part of an overall deactivation project of the facility. The 321-M facility was used to fabricate enriched uranium fuel assemblies, lithium-aluminum target tubes, neptunium assemblies, and miscellaneous components for the production reactors. The results of the holdup assays are essential for determining compliance with the Waste Acceptance Criteria, Material Control & Accountability, and to meet criticality safety controls. This report covers holdup measurements of uranium residue in three HEPA filter exhaustmore » banks of the 321-M facility. Each of the exhaust banks has dimensions near 7' x 14' x 4' and represents a complex holdup problem. A portable HPGe detector and EG&G Dart system that contains the high voltage power supply and signal processing electronics were used to determine highly enriched uranium (HEU) holdup. A personal computer with Gamma-Vision software was used to control the Dart MCA and to provide space to store and manipulate multiple 4096-channel {gamma}-ray spectra. Some acquisitions were performed with the portable detector configured to a Canberra Inspector using NDA2000 acquisition and analysis software. Our results for each component uses a mixture of redundant point source and area source acquisitions that yielded HEU contents in the range of 2-10 grams. This report discusses the methodology, non-destructive assay (NDA) measurements, assumptions, and results of the uranium holdup in these items. This report includes use of transmission-corrected assay as well as correction for contributions from secondary area sources.« less

Tagatose, a new antidiabetic and obesity control drug.

PubMed

Lu, Y; Levin, G V; Donner, T W

2008-02-01

A potentially important new drug for treating type 2 diabetes, tagatose, is now in phase 3 clinical trial. The history, development, additional health benefits, mechanisms of action and the potential for the drug are presented in context with a review of the rapidly growing epidemic of type 2 diabetes and treatments for it. An epimer of fructose, the natural hexose tagatose was originally developed by Spherix Incorporated (formerly Biospherics Inc.) as a low-calorie sugar substitute. Only 20% of orally ingested tagatose is fully metabolized, principally in the liver, following a metabolic pathway identical to that of fructose. Following a decade of studies, tagatose became generally recognized as safe for use in foods and beverages under US FDA regulation. The simple sugar is commercially produced by isomerization of galactose, which is prepared from lactose. Early human studies suggested tagatose as a potential antidiabetic drug through its beneficial effects on postprandial hyperglycaemia and hyperinsulinaemia. A subsequent 14-month trial confirmed its potential for treating type 2 diabetes, and tagatose showed promise for inducing weight loss and raising high-density lipoprotein cholesterol, both important to the control of diabetes and constituting benefits independent of the disease. Furthermore, tagatose was shown to be an antioxidant and a prebiotic, both properties cited in the maintenance and promotion of health. No current therapies for type 2 diabetes provide these multiple health benefits. The predominant side effects of tagatose are gastrointestinal disturbances associated with excessive consumption, generally accommodated within 1- to 2-week period. The health and use potentials for tagatose (branded Naturlose((R)) for this use) are given with respect to current type 2 diabetes drugs and markets. Under an FDA-affirmed protocol, Spherix is currently conducting a phase 3 trial to evaluate a placebo-subtracted treatment effect based on a decrease in HbA(1c) levels. Side effects, contraindications and possibly beneficial new findings will be carefully monitored. It is hoped that early results of the trial may become available by mid-2008. If a subsequent NDA is successful, tagatose may fill a major health need.

Molecular activity prediction by means of supervised subspace projection based ensembles of classifiers.

PubMed

Cerruela García, G; García-Pedrajas, N; Luque Ruiz, I; Gómez-Nieto, M Á

2018-03-01

This paper proposes a method for molecular activity prediction in QSAR studies using ensembles of classifiers constructed by means of two supervised subspace projection methods, namely nonparametric discriminant analysis (NDA) and hybrid discriminant analysis (HDA). We studied the performance of the proposed ensembles compared to classical ensemble methods using four molecular datasets and eight different models for the representation of the molecular structure. Using several measures and statistical tests for classifier comparison, we observe that our proposal improves the classification results with respect to classical ensemble methods. Therefore, we show that ensembles constructed using supervised subspace projections offer an effective way of creating classifiers in cheminformatics.

Statistical study of EBR-II fuel elements manufactured by the cold line at Argonne-West and by Atomics International

DOE Office of Scientific and Technical Information (OSTI.GOV)

Harkness, A. L.

1977-09-01

Nine elements from each batch of fuel elements manufactured for the EBR-II reactor have been analyzed for /sup 235/U content by NDA methods. These values, together with those of the manufacturer, are used to estimate the product variance and the variances of the two measuring methods. These variances are compared with the variances computed from the stipulations of the contract. A method is derived for resolving the several variances into their within-batch and between-batch components. Some of these variance components have also been estimated by independent and more familiar conventional methods for comparison.

Counting on commitment; the quality of primary care-led diabetes management in a system with minimal incentives.

PubMed

Mc Hugh, Sheena; Marsden, Paul; Brennan, Carmel; Murphy, Katie; Croarkin, Celine; Moran, Joe; Harkins, Velma; Perry, Ivan J

2011-12-28

The aim of the present study was to assess the performance of three primary care-led initiatives providing structured care to patients with Type 2 diabetes in Ireland, a country with minimal incentives to promote the quality of care. Data, from three primary care initiatives, were available for 3010 adult patients with Type 2 diabetes. Results were benchmarked against the national guidelines for the management of Type 2 diabetes in the community and results from the National Diabetes Audit (NDA) for England (2008/2009) and the Scottish Diabetes Survey (2009). The recording of clinical processes of care was similar to results in the UK however the recording of lifestyle factors was markedly lower. Recording of HbA1c, blood pressure and lipids exceeded 85%. Recording of retinopathy screening (71%) was also comparable to England (77%) and Scotland (90%). Only 63% of patients had smoking status recorded compared to 99% in Scotland while 70% had BMI recorded compared to 89% in England. A similar proportion of patients in this initiative and the UK achieved clinical targets. Thirty-five percent of patients achieved a target HbA1c of < 6.5% (< 48 mmol/mol) compared to 25% in England. Applying the NICE target for blood pressure (≤ 140/80 mmHg), 54% of patients reached this target comparable to 60% in England. Slightly less patients were categorised as obese (> 30 kg/m²) in Ireland (50%, n = 1060) compared to Scotland (54%). This study has demonstrated what can be achieved by proactive and interested health professionals in the absence of national infrastructure to support high quality diabetes care. The quality of primary care-led diabetes management in the three initiatives studied appears broadly consistent with results from the UK with the exception of recording lifestyle factors. The challenge facing health systems is to establish quality assurance a responsibility for all health care professionals rather than the subject of special interest for a few.

Nuclear Resonance Fluorescence to Measure Plutonium Mass in Spent Nuclear Fuel

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ludewigt, Bernhard A; Quiter, Brian J.; Ambers, Scott D.

2011-01-14

The Next Generation Safeguard Initiative (NGSI) of the U.S Department of Energy is supporting a multi-lab/university collaboration to quantify the plutonium (Pu) mass in spent nuclear fuel (SNF) assemblies and to detect the diversion of pins with non-destructive assay (NDA) methods. The following 14 NDA techniques are being studied: Delayed Neutrons, Differential Die-Away, Differential Die-Away Self-Interrogation, Lead Slowing Down Spectrometer, Neutron Multiplicity, Passive Neutron Albedo Reactivity, Total Neutron (Gross Neutron), X-Ray Fluorescence, {sup 252}Cf Interrogation with Prompt Neutron Detection, Delayed Gamma, Nuclear Resonance Fluorescence, Passive Prompt Gamma, Self-integration Neutron Resonance Densitometry, and Neutron Resonance Transmission Analysis. Understanding and maturity ofmore » the techniques vary greatly, ranging from decades old, well-understood methods to new approaches. Nuclear Resonance Fluorescence (NRF) is a technique that had not previously been studied for SNF assay or similar applications. Since NRF generates isotope-specific signals, the promise and appeal of the technique lies in its potential to directly measure the amount of a specific isotope in an SNF assay target. The objectives of this study were to design and model suitable NRF measurement methods, to quantify capabilities and corresponding instrumentation requirements, and to evaluate prospects and the potential of NRF for SNF assay. The main challenge of the technique is to achieve the sensitivity and precision, i.e., to accumulate sufficient counting statistics, required for quantifying the mass of Pu isotopes in SNF assemblies. Systematic errors, considered a lesser problem for a direct measurement and only briefly discussed in this report, need to be evaluated for specific instrument designs in the future. Also, since the technical capability of using NRF to measure Pu in SNF has not been established, this report does not directly address issues such as cost, size, development time, nor concerns related to the use of Pu in measurement systems. This report discusses basic NRF measurement concepts, i.e., backscatter and transmission methods, and photon source and {gamma}-ray detector options in Section 2. An analytical model for calculating NRF signal strengths is presented in Section 3 together with enhancements to the MCNPX code and descriptions of modeling techniques that were drawn upon in the following sections. Making extensive use of the model and MCNPX simulations, the capabilities of the backscatter and transmission methods based on bremsstrahlung or quasi-monoenergetic photon sources were analyzed as described in Sections 4 and 5. A recent transmission experiment is reported on in Appendix A. While this experiment was not directly part of this project, its results provide an important reference point for our analytical estimates and MCNPX simulations. Used fuel radioactivity calculations, the enhancements to the MCNPX code, and details of the MCNPX simulations are documented in the other appendices.« less

Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications.

PubMed

Chang, Lin-Chau; Mahmood, Riaz; Qureshi, Samina; Breder, Christopher D

2017-01-01

Standardised MedDRA Queries (SMQs) have been developed since the early 2000's and used by academia, industry, public health, and government sectors for detecting safety signals in adverse event safety databases. The purpose of the present study is to characterize how SMQs are used and the impact in safety analyses for New Drug Application (NDA) and Biologics License Application (BLA) submissions to the United States Food and Drug Administration (USFDA). We used the PharmaPendium database to capture SMQ use in Summary Basis of Approvals (SBoAs) of drugs and biologics approved by the USFDA. Characteristics of the drugs and the SMQ use were employed to evaluate the role of SMQ safety analyses in regulatory decisions and the veracity of signals they revealed. A comprehensive search of the SBoAs yielded 184 regulatory submissions approved from 2006 to 2015. Search strategies more frequently utilized restrictive searches with "narrow terms" to enhance specificity over strategies using "broad terms" to increase sensitivity, while some involved modification of search terms. A majority (59%) of 1290 searches used descriptive statistics, however inferential statistics were utilized in 35% of them. Commentary from reviewers and supervisory staff suggested that a small, yet notable percentage (18%) of 1290 searches supported regulatory decisions. The searches with regulatory impact were found in 73 submissions (40% of the submissions investigated). Most searches (75% of 227 searches) with regulatory implications described how the searches were confirmed, indicating prudence in the decision-making process. SMQs have an increasing role in the presentation and review of safety analysis for NDAs/BLAs and their regulatory reviews. This study suggests that SMQs are best used for screening process, with descriptive statistics, description of SMQ modifications, and systematic verification of cases which is crucial for drawing regulatory conclusions.

Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications

PubMed Central

Chang, Lin-Chau; Mahmood, Riaz; Qureshi, Samina

2017-01-01

Purpose Standardised MedDRA Queries (SMQs) have been developed since the early 2000’s and used by academia, industry, public health, and government sectors for detecting safety signals in adverse event safety databases. The purpose of the present study is to characterize how SMQs are used and the impact in safety analyses for New Drug Application (NDA) and Biologics License Application (BLA) submissions to the United States Food and Drug Administration (USFDA). Methods We used the PharmaPendium database to capture SMQ use in Summary Basis of Approvals (SBoAs) of drugs and biologics approved by the USFDA. Characteristics of the drugs and the SMQ use were employed to evaluate the role of SMQ safety analyses in regulatory decisions and the veracity of signals they revealed. Results A comprehensive search of the SBoAs yielded 184 regulatory submissions approved from 2006 to 2015. Search strategies more frequently utilized restrictive searches with “narrow terms” to enhance specificity over strategies using “broad terms” to increase sensitivity, while some involved modification of search terms. A majority (59%) of 1290 searches used descriptive statistics, however inferential statistics were utilized in 35% of them. Commentary from reviewers and supervisory staff suggested that a small, yet notable percentage (18%) of 1290 searches supported regulatory decisions. The searches with regulatory impact were found in 73 submissions (40% of the submissions investigated). Most searches (75% of 227 searches) with regulatory implications described how the searches were confirmed, indicating prudence in the decision-making process. Conclusions SMQs have an increasing role in the presentation and review of safety analysis for NDAs/BLAs and their regulatory reviews. This study suggests that SMQs are best used for screening process, with descriptive statistics, description of SMQ modifications, and systematic verification of cases which is crucial for drawing regulatory conclusions. PMID:28570569

Alternative Respiratory Pathway Component Genes (AOX and ND) in Rice and Barley and Their Response to Stress

PubMed Central

Dametto, Lettee; Shavrukov, Yuri; Jenkins, Colin L. D.

2018-01-01

Plants have a non-energy conserving bypass of the classical mitochondrial cytochrome c pathway, known as the alternative respiratory pathway (AP). This involves type II NAD(P)H dehydrogenases (NDs) on both sides of the mitochondrial inner membrane, ubiquinone, and the alternative oxidase (AOX). The AP components have been widely characterised from Arabidopsis, but little is known for monocot species. We have identified all the genes encoding components of the AP in rice and barley and found the key genes which respond to oxidative stress conditions. In both species, AOX is encoded by four genes; in rice OsAOX1a, 1c, 1d and 1e representing four clades, and in barley, HvAOX1a, 1c, 1d1 and 1d2, but no 1e. All three subfamilies of plant ND genes, NDA, NDB and NDC are present in both rice and barley, but there are fewer NDB genes compared to Arabidopsis. Cyanide treatment of both species, along with salt treatment of rice and drought treatment of barley led to enhanced expression of various AP components; there was a high level of co-expression of AOX1a and AOX1d, along with NDB3 during the stress treatments, reminiscent of the co-expression that has been well characterised in Arabidopsis for AtAOX1a and AtNDB2. PMID:29558397

Calcitonin intranasal--unigene: Salcatonin intranasal--unigene.

PubMed

2004-01-01

An intranasal spray formulation of recombinant salmon calcitonin [salcatonin] is in development with Unigene Laboratories as therapy for postmenopausal osteoporosis. Calcitonin is an endogenous polypeptide hormone that regulates calcium and bone metabolism. It is produced by the parafollicular cells of the thyroid gland in humans and other species. Calcitonin inhibits bone loss through the suppression of osteoclast activity. Salmon calcitonin is approximately 40-50 times more potent than natural human calcitonin at inhibiting osteoclast function. It can be obtained naturally from salmon or can be synthesised with the same chemical structure. Calcitonin was originally available only as an injectable formulation, but in recent years more convenient formulations have become available. Unigene is actively seeking to license its intranasal calcitonin product in Europe and other territories outside the US. nigene licensed its intranasal calcitonin product to Upsher-Smith Laboratories in December 2002, under a $US10 million exclusive US licensing agreement. Under the terms of the agreement, Unigene received an upfront payment of $US3 million from Upsher-Smith and will be eligible to receive milestone payments and royalty payments on product sales. Unigene will be responsible for manufacturing the product at its Boonton facility in New Jersey, USA, and will sell finished calcitonin product to Upsher-Smith. Upsher-Smith will package, market and distribute the product nationwide. Unigene granted an exclusive license to Faran Laboratories in September 2003 for its intranasal calcitonin osteoporosis product in Greece. Unigene will sell the finished product to Faran, who will promote and market it throughout the country after Unigene obtains European regulatory approval and local pricing approval. Unigene will receive an upfront payment and is eligible to receive milestone payments prior to product launch. Faran will pay Unigene a fixed price for each unit of product received. Qingdao General Pharmaceutical Company was a licensee for Unigene's injectable and intranasal calcitonin products in the People's Republic of China, and Unigene had received initial payments from Qingdao General Pharmaceutical in 1996. However, in June 2000, Unigene announced that it has entered into a joint venture with Shijiazhuang Pharmaceutical Group Company for the manufacture and distribution of injectable and intranasal calcitonin for the treatment of osteoporosis in China. Unigene initially will be responsible for supplying bulk calcitonin manufactured in its production facility in New Jersey and the joint venture will be responsible for filling, packaging, promoting and marketing the products. Unigene owns 45% of the contractual joint venture. Unigene is also developing oral and injectable formulations of calcitonin. In January 2004, Unigene announced it had received an approvable letter from the US FDA to market its calcitonin intranasal spray for the treatment of osteoporosis. The letter indicates that the FDA will approve the NDA upon finalisation of the labelling and resolution of specific remaining issues, including the submission of additional information and clinical data. Unigene filed the NDA in March 2003. Using the results from a pilot study completed in the UK, Unigene filed an IND with the FDA and began clinical testing of this intranasal calcitonin in the US. Clinical studies were successfully completed by year end 2001, demonstrating significant bone marker activity and similar serum concentrations between this product and that of an existing nasal calcitonin product. The European Union's regulatory authority, the Committee for Proprietary Medicinal Products (CPMP), has confirmed the efficacy of calcitonin formulations for the treatment of postmenopausal osteoporosis and other bone disorders. The CPMP has recommended revisions to and harmonisation within the European Union of the authorised indications for calcitonin formulations. The CPMP has determined that authorised indications for intranasal calcitonin will be approved for "treatment of established post-menopausal osteoporosis in order to reduce the risk of vertebral fractures", and new prescribing information will clarify that intranasal calcitonin does not appear to reduce the number of hip fractures. These recommendations will be implemented in the near future and will eliminate discrepancies between countries and between formulations. The Chinese regulatory authorities have granted Unigene an import license for calcitonin, and Unigene and Shijiazhuang have submitted an NDA in China. If this NDA is approved, the joint venture will have up to 6 years' market exclusivity for intranasal and injectable calcitonin. Unigene was granted a US patent for the intranasal formulation of calcitonin in 2002.

Beclometasone oral--DOR BioPharma.

PubMed

2007-01-01

orBec is an oral enteric-coated tablet formulation of the corticosteroid beclometasone, which has been developed by Enteron Pharmaceuticals, a subsidiary of Corporate Technology Development (now DOR BioPharma). orBec is being developed for the treatment of gastrointestinal graft-versus-host disease (GVHD) and an NDA has been filed in the US. DOR BioPharma has also filed an MAA in Europe for the same indication.orBec is designed to reduce the need for systemic immunosuppressive drugs, thereby improving the outcome of bone marrow and stem cell transplantation.DOR BioPharma may seek a marketing partner in the US and elsewhere for orBec in GVHD and will seek a partner for other potential indications of the drug.In December 2001, Corporate Technology Development was acquired by Endorex Corporation (now DOR BioPharma). In October 1998, Enteron Pharmaceuticals (DOR BioPharma) entered into an exclusive, worldwide, royalty bearing license agreement with George B. McDonald, MD, including the right to grant sublicenses, for the rights to the intellectual property and know-how relating to orBec. In January 2007, DOR BioPharma received $US3 million under a non-binding letter of intent from Sigma-Tau Pharmaceuticals. The agreement grants Sigma-Tau an exclusive right to negotiate terms and conditions for a possible business transaction or strategic alliance regarding orBec and potentially other DOR pipeline compounds until 1 March 2007. Under the terms of the agreement, Sigma-Tau purchased $US1 million of DOR's common stock, with an additional $US2 million paid in cash. If no agreement is reached by 1 March 2007, DOR will return the $US2 million to Sigma-Tau within 60 days. DOR BioPharma received an unsolicited proposal from Cell Therapeutics, Inc. to acquire DOR BioPharma in January 2007. Because of the non-binding agreement already signed with Sigma-Tau, DOR BioPharma's board of directors cannot consider Cell Therapeutics' merger proposal at this time. orBec has been filed for approval in the US for the treatment of gastrointestinal GVHD. The US FDA accepted the NDA filing and has established a target date of 21 July 2007 for completion of review of the NDA. In November 2006, the EMEA determined that the MAA for orBec for the treatment of gastrointestinal GVHD is complete and that the review process has begun. The data provided in the MAA and NDA submissions demonstrate that orBec safely provides a lower risk of mortality compared with the current standard of care. Both filings are supported by data from two randomised, double-blinded, placebo-controlled clinical trials. The first was a 129-patient pivotal phase III clinical trial for orBec conducted at 16 bone marrow/stem cell transplant centres in the US and France. The second trial was a 60-patient phase II clinical trial conducted at the Fred Hutchinson Cancer Research Centre. In the primary endpoint of its pivotal trial, time to treatment failure through day 50, orBec failed to achieve statistical significance (p-value 0.1177). However, orBec did achieve statistical significance in the secondary endpoints of time to treatment failure through day 80, and a reduction in mortality compared with placebo. In this trial, patient survival at the prespecified endpoint of 200 days post-transplant showed a statistically significant 66% reduction in mortality among patients randomised to orBec. DOR BioPharma believes the primary endpoint was not achieved due to a higher than expected rate of treatment failures during the initial 10 days in both treatment groups. The mortality benefit in favour of orBec was confirmed in a retrospective analysis of the phase II study, in which there was a 55% reduction in mortality at 200 days post-transplant. At 1 year after randomisation, there were relatively consistent 51% and 45% reductions in the risk of mortality among patients randomised to orBec in both the phase III and phase II studies, respectively.DOR BioPharma is also conducting a phase II clinical trial to investigate orBec in the prevention of gastrointestinal GVHD. DOR BioPharma has executed an exclusive licence agreement with the University of Texas Medical Branch at Galveston for the use of oral luminally active anti-inflammatory drugs, such as orBec, for the treatment of irritable bowel syndrome.

Jupiter's Decameter Radiation as Viewed from Juno, Cassini, WIND, STEREO A, and Earth-Based Radio Observatories

NASA Astrophysics Data System (ADS)

Imai, Masafumi; Kurth, William S.; Hospodarsky, George B.; Bolton, Scott J.; Connerney, John E. P.; Levin, Steven M.; Clarke, Tracy E.; Higgins, Charles A.

2017-04-01

Jupiter is the dominant auroral radio source in our solar system, producing decameter (DAM) radiation (from a few to 40 MHz) with a flux density of up to 10-19 W/(m2Hz). Jovian DAM non-thermal radiation above 10 MHz is readily observed by Earth-based radio telescopes that are limited at lower frequencies by terrestrial ionospheric conditions and radio frequency interference. In contrast, frequencies observed by spacecraft depend upon receiver capability and the ambient solar wind plasma frequency. Observations of DAM from widely separated observers can be used to investigate the geometrical properties of the beam and learn about the generation mechanism. The first multi-observer observations of Jovian DAM emission were made using the Voyager spacecraft and ground-based radio telescopes in early 1979, but, due to geometrical constraints and limited flyby duration, a full understanding of the latitudinal beaming of Jovian DAM radiation remains elusive. This understanding is sorely needed to confirm DAM generation by the electron cyclotron maser instability, the widely assumed generation mechanism. Juno first detected Jovian DAM emissions on May 5, 2016, on approach to the Jovian system, initiating a new opportunity to perform observations of Jovian DAM radiation with Juno, Cassini, WIND, STEREO A, and Earth-based radio observatories (Long Wavelength Array Station One (LWA1) in New Mexico, USA, and Nançay Decameter Array (NDA) in France). These observers are widely distributed throughout our solar system and span a broad frequency range of 3.5 to 40.5 MHz. Juno resides in orbit at Jupiter, Cassini at Saturn, WIND around Earth, STEREO A in 1 AU orbit, and LWA1 and NDA at Earth. Juno's unique polar trajectory is expected to facilitate extraordinary stereoscopic observations of Jovian DAM, leading to a much improved understanding of the latitudinal beaming of Jovian DAM.

Cinacalcet: AMG 073, Calcimimetics--Amgen/NPS Pharmaceuticals, KRN 1493, NPS 1493.

PubMed

2003-01-01

Cinacalcet [AMG 073, KRN 1493, NPS 1493] is an orally active, second-generation calcimimetic compound licensed by NPS Pharmaceuticals to Amgen in the US for potential treatment of hyperparathyroidism (HPT). Cinacalcet modulates (increases the sensitivity of) calcium receptors on the surface of parathyroid cells thereby inhibiting the oversecretion of parathyroid hormone, which characterises HPT. It also represents a potentially significant advance for chronic kidney disease patients diagnosed with secondary HPT, a common yet serious metabolic disorder where parathyroid hormone levels are elevated. Patients with this disease can suffer from bone disease, bone pain and fractures, soft tissue calcification, vascular calcification and cardiovascular complications. Amgen has rights to develop and sell cinacalcet throughout the world except in Japan, Taiwan and China, where the compound was licensed to Kirin Brewery. Kirin is developing it as KRN 1493 in phase II clinical studies in Japan. In December 2001, commencement of a phase III clinical trial with cinacalcet for the treatment of secondary HPT, triggered a 3 million US dollars milestone payment to NPS Pharmaceuticals. In September 2003, submission of an NDA to the US FDA for cinacalcet for secondary HPT will be followed by a milestone payment of 6 million US dollars to NPS. NPS, Kirin and Amgen were also developing another compound, tecalcet, for HPT, but that project has been discontinued in favour of cinacalcet. In September 2003, Amgen submitted an NDA to the US FDA for secondary HPT in patients with chronic kidney disease. In April 2003, Amgen announced positive results from a phase III clinical trial with cinacalcet in patients with secondary HPT. In a clinical study in patients on dialysis suffering from the effects of chronically elevated levels parathyroid hormone, cinacalcet appeared to be safe and well tolerated and was significantly more effective than placebo. Two more additional efficacy studies with cinacalcet have also been completed. Phase II trials of cinacalcet in dialysis patients with secondary HPT and in patients with primary HPT were successfully completed.

Laboratory automation —some perspectives on the challenges in the implementation of the technology in pharmaceutical development

PubMed Central

North, Nigel; Smith, Simon

1998-01-01

The intensifying pressure on reducing the development time for new pharmaceutical products is resulting in an increasing need for laboratory automation. A key element for the successful implementation of robotics for drug product analysis is the establishment of a reliable process for interaction of the automation team with its various customers, for example development product team and manufacturing group. The reduction of cycle time for product development appears to be resulting in more stability studies to support NDA/MAA filings for several reasons. Key clinical information may not be available before initiation of the stability studies and simultaneous world-wide development may result in an increase in the number of product strength and pack options. PMID:18924828

Disaster Debris Recovery Database - Recovery

EPA Pesticide Factsheets

The US EPA Region 5 Disaster Debris Recovery Database includes public datasets of over 6,000 composting facilities, demolition contractors, transfer stations, landfills and recycling facilities for construction and demolition materials, electronics, household hazardous waste, metals, tires, and vehicles in the states of Illinois, Indiana, Iowa, Kentucky, Michigan, Minnesota, Missouri, North Dakota, Ohio, Pennsylvania, South Dakota, West Virginia and Wisconsin.In this update, facilities in the 7 states that border the EPA Region 5 states were added to assist interstate disaster debris management. Also, the datasets for composters, construction and demolition recyclers, demolition contractors, and metals recyclers were verified and source information added for each record using these sources: AGC, Biocycle, BMRA, CDRA, ISRI, NDA, USCC, FEMA Debris Removal Contractor Registry, EPA Facility Registry System, and State and local listings.

Disaster Debris Recovery Database - Landfills

EPA Pesticide Factsheets

The US EPA Region 5 Disaster Debris Recovery Database includes public datasets of over 6,000 composting facilities, demolition contractors, transfer stations, landfills and recycling facilities for construction and demolition materials, electronics, household hazardous waste, metals, tires, and vehicles in the states of Illinois, Indiana, Iowa, Kentucky, Michigan, Minnesota, Missouri, North Dakota, Ohio, Pennsylvania, South Dakota, West Virginia and Wisconsin.In this update, facilities in the 7 states that border the EPA Region 5 states were added to assist interstate disaster debris management. Also, the datasets for composters, construction and demolition recyclers, demolition contractors, and metals recyclers were verified and source information added for each record using these sources: AGC, Biocycle, BMRA, CDRA, ISRI, NDA, USCC, FEMA Debris Removal Contractor Registry, EPA Facility Registry System, and State and local listings.

Emergency Destruction of Information Storing Media. Appendix 2. Destruct Technology Compendium

DTIC Science & Technology

1987-12-01

L C U) 00 r. C 0 Z EC 0 00 CD CD 00 C4 C ) .0 -F 0 j o ) .0...0 cmc ,go~ S.- .) cm X.3 .1 . 1 1 1 1 1V ,a Ic 00 ON .t CM CI CmcyI CI W! W! U c t!.- CCJ .C-c v4 N OD V t 40 -z -- a- -~ LL A to) N ot SQ0 U. L CL...Y LL CL No LA ILP- LDl a .49 zII ii a A C.0 Am to- • ! t -.- t - - - - lin -sea hi ~ ~~~ CM .-. 2 2 Ll L . C C4 00 L h a so 0~ UP ,nDa gus 0. 1~2’ - - L

Counting on commitment; the quality of primary care-led diabetes management in a system with minimal incentives

PubMed Central

2011-01-01

Background The aim of the present study was to assess the performance of three primary care-led initiatives providing structured care to patients with Type 2 diabetes in Ireland, a country with minimal incentives to promote the quality of care. Methods Data, from three primary care initiatives, were available for 3010 adult patients with Type 2 diabetes. Results were benchmarked against the national guidelines for the management of Type 2 diabetes in the community and results from the National Diabetes Audit (NDA) for England (2008/2009) and the Scottish Diabetes Survey (2009). Results The recording of clinical processes of care was similar to results in the UK however the recording of lifestyle factors was markedly lower. Recording of HbA1c, blood pressure and lipids exceeded 85%. Recording of retinopathy screening (71%) was also comparable to England (77%) and Scotland (90%). Only 63% of patients had smoking status recorded compared to 99% in Scotland while 70% had BMI recorded compared to 89% in England. A similar proportion of patients in this initiative and the UK achieved clinical targets. Thirty-five percent of patients achieved a target HbA1c of < 6.5% (< 48 mmol/mol) compared to 25% in England. Applying the NICE target for blood pressure (≤ 140/80 mmHg), 54% of patients reached this target comparable to 60% in England. Slightly less patients were categorised as obese (> 30 kg/m2) in Ireland (50%, n = 1060) compared to Scotland (54%). Conclusions This study has demonstrated what can be achieved by proactive and interested health professionals in the absence of national infrastructure to support high quality diabetes care. The quality of primary care-led diabetes management in the three initiatives studied appears broadly consistent with results from the UK with the exception of recording lifestyle factors. The challenge facing health systems is to establish quality assurance a responsibility for all health care professionals rather than the subject of special interest for a few. PMID:22204759

49 CFR 365.107 - Types of applications.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 5 2010-10-01 2010-10-01 false Types of applications. 365.107 Section 365.107... APPLICATIONS FOR OPERATING AUTHORITY How To Apply for Operating Authority § 365.107 Types of applications. (a) Fitness applications. Motor property applications and certain types of motor passenger applications...

49 CFR 365.107 - Types of applications.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 5 2011-10-01 2011-10-01 false Types of applications. 365.107 Section 365.107... APPLICATIONS FOR OPERATING AUTHORITY How To Apply for Operating Authority § 365.107 Types of applications. (a) Fitness applications. Motor property applications and certain types of motor passenger applications...

HEU Holdup Measurements in 321-M B and Spare U-Al Casting Furnaces

DOE Office of Scientific and Technical Information (OSTI.GOV)

Salaymeh, S.R.

The Analytical Development Section of Savannah River Technology Center (SRTC) was requested by the Facilities Decontamination Division (FDD) to determine the holdup of enriched uranium in the 321-M facility as part of an overall deactivation project of the facility. The 321-M facility was used to fabricate enriched uranium fuel assemblies, lithium-aluminum target tubes, neptunium assemblies, and miscellaneous components for the production reactors. This report covers holdup measurements in two uranium aluminum alloy (U-Al) casting furnaces. Our results indicate an upper limit of 235U content for the B and Spare furnaces of 51 and 67 g respectively. This report discusses themore » methodology, non-destructive assay (NDA) measurements, and results of the uranium holdup on the two furnaces.« less

Vernakalant: RSD 1235, RSD-1235, RSD1235.

PubMed

2007-01-01

Vernakalant is an atrial-selective antiarrhythmic drug discovered by Cardiome Pharma (formerly Nortran Pharmaceuticals). Vernakalant may have potential in the treatment of atrial arrhythmias, including acute atrial fibrillation and atrial flutter. Vernakalant is a mixed sodium/potassium channel blocker and selectively blocks ion channels in the heart that are known to be active during episodes of atrial fibrillation. An IV formulation of vernakalant is awaiting registration in the US for the acute conversion of atrial fibrillation. Also, an oral formulation of the compound is in phase II clinical development as a chronic-use product for the maintenance of normal heart rhythm following termination of atrial fibrillation. Cardiome is seeking co-development partners for intravenous vernakalant in the treatment of atrial arrhythmia, atrial fibrillation and atrial flutter in Europe and Japan. In October 2003, Cardiome Pharma and Fujisawa Healthcare, the US subsidiary of Fujisawa Pharmaceutical Co., Ltd (now Astellas Pharma), executed a $US68 million strategic partnership agreement for the co-development of vernakalant. On 1 April 2005, Fujisawa merged with Yamanouchi to form Astellas Pharma. The partnership grants Astellas Pharma exclusive commercialisation rights for vernakalant. Under the terms of the agreement, Cardiome and Astellas Pharma will co-develop vernakalant as an intravenous formulation for the treatment of atrial fibrillation and atrial flutter for North American markets. Astellas Pharma will be financially responsible for 75% of all future clinical development costs, with Cardiome responsible for the remaining 25% of costs. Astellas Pharma will be responsible for the development plan, NDA application (and NDA re-submission costs) and registration, along with the commercial manufacturing, marketing and sale of vernakalant. Cardiome will manage the phase III trials ACT 1 and ACT 2 and will also be responsible for the continued manufacturing of clinical supplies of vernakalant. Cardiome will receive royalties on end-user sales of vernakalant reflective of Cardiome's 25% share of development costs and other financial considerations. Product rights to the IV formulation of vernakalant for markets outside of North America and world rights to the oral formulation of vernakalant for chronic atrial fibrillation are not included within the scope of this partnership. Cardiome intends to form future additional alliances for these product opportunities or maintain such opportunities for commercialisation on its own. Cardiome and Astellas amended their agreement for vernakalant in relation to the re-submission of the NDA with the US FDA. Under the terms of the new agreement, Astellas agreed to fund 100% of the costs associated with re-submission, including engagement and external consultants. Astellas also agreed to modify the timing of the $US10 million NDA milestone to the date of resubmission. In February 2005, Cardiome Pharma received a $US6 million milestone payment from its co-development partner, Fujisawa Healthcare Inc. This milestone payment was triggered by the successful completion of ACT 1.A pivotal phase II trial demonstrated in September 2002 that vernakalant rapidly and effectively terminated recent onset atrial fibrillation and the study met both primary and secondary study endpoints. Following discussions with the FDA, Cardiome initiated three separate phase III clinical trials in order to enable Cardiome to apply for marketing approval for vernakalant. In August 2003, Cardiome Pharma commenced patient dosing in its first phase III efficacy study of vernakalant for the acute treatment of atrial fibrillation. This initial study, called ACT 1 (Atrial fibrillation Conversion Trial 1), measured the safety and efficacy of vernakalant in 416 patients with atrial arrhythmias. The placebo-controlled study was carried out in 45 centers in the US, Canada and Scandinavia. The ACT 1 study included two substudies of 60 patients with atrial flutter and 119 patients with longer term atrial fibrillation. The primary efficacy endpoint was acute conversion of atrial arrhythmia to normal heart rhythm. Cardiome commenced its second phase III efficacy study in March 2004, known as ACT 2. The ACT 2 study in post-cardiac surgery (coronary artery bypass graft) patients with atrial fibrillation, evaluated the safety and efficacy of vernakalant (IV) in the termination of atrial arrhythmias in patients after cardiac surgery. Around 210 patients from 25 centres in the US, Canada and Europe were enrolled in this study. The primary efficacy endpoint was acute conversion of atrial arrhythmias to normal heart rhythm. The ACT 2 study is ongoing. The third phase III study, known as ACT 3 (Atrial arrhythmia Conversion Trial 3), was initiated by Cardiome Pharma in July 2004. In September 2005, Cardiome and Astellas reported that ACT 3 had been completed, achieving its primary endpoint, with over half of the 170 patients with recent-onset atrial fibrillation (AF) who received vernakalant intravenously converting to normal heart rhythm, compared with only 4% in the placebo group. The study was being conducted by co-development partner Astellas Pharma and measured the safety and efficacy of intravenous vernakalant in recent onset atrial arrhythmia patients. The placebo-controlled study was being carried out in 276 patients in more than 50 centres throughout the world.ACT 4, a phase III safety study evaluating safety of IV vernakalant in approximately 120 AF patients from 30 centres in the US, Canada and Europe, was initiated in October 2005. Results from this trial are expected to supplement trial results from the pivotal ACT 1 and 3 trials. This study is ongoing. Cardiome Pharma successfully completed phase I studies for its controlled-release oral formulation of vernakalant in 2005. The oral, controlled-release formulation of vernakalant is expected to help prevent or slow the recurrence of atrial fibrillation, and will be used as a follow-on therapy to intravenous vernakalant.

Development of self-interrogation neutron resonance densitometry (sinrd) to measure the fissile content in nuclear fuel

NASA Astrophysics Data System (ADS)

LaFleur, Adrienne Marie

The development of non-destructive assay (NDA) capabilities to directly measure the fissile content in spent fuel is needed to improve the timely detection of the diversion of significant quantities of fissile material. Currently, the International Atomic Energy Agency (IAEA) does not have effective NDA methods to verify spent fuel and recover continuity of knowledge in the event of a containment and surveillance systems failure. This issue has become increasingly critical with the worldwide expansion of nuclear power, adoption of enhanced safeguards criteria for spent fuel verification, and recent efforts by the IAEA to incorporate an integrated safeguards regime. In order to address these issues, the use of Self-Interrogation Neutron Resonance Densitometry (SINRD) has been developed to improve existing nuclear safeguards and material accountability measurements. The following characteristics of SINRD were analyzed: (1) ability to measure the fissile content in Light Water Reactors (LWR) fuel assemblies and (2) sensitivity and penetrability of SINRD to the removal of fuel pins from an assembly. The Monte Carlo Neutral Particle eXtended (MCNPX) transport code was used to simulate SINRD for different geometries. Experimental measurements were also performed with SINRD and were compared to MCNPX simulations of the experiment to verify the accuracy of the MCNPX model of SINRD. Based on the results from these simulations and measurements, we have concluded that SINRD provides a number of improvements over current IAEA verification methods. These improvements include: (1) SINRD provides absolute measurements of burnup independent of the operator's declaration. (2) SINRD is sensitive to pin removal over the entire burnup range and can verify the diversion of 6% of fuel pins within 3o from LWR spent LEU and MOX fuel. (3) SINRD is insensitive to the boron concentration and initial fuel enrichment and can therefore be used at multiple spent fuel storage facilities. (4) The calibration of SINRD at one reactor facility carries over to reactor sites in different countries because it uses the ratio of fission chambers (FCs) that are not facility dependent. (5) SINRD can distinguish fresh and 1-cycle spent MOX fuel from 3- and 4-cycles spent LEU fuel without using reactor burnup codes.

14 CFR 21.15 - Application for type certificate.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 1 2013-01-01 2013-01-01 false Application for type certificate. 21.15... CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS Type Certificates § 21.15 Application for type certificate. (a) An application for a type certificate is made on a form and in a manner prescribed by the FAA and is...

14 CFR 21.15 - Application for type certificate.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Application for type certificate. 21.15... CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS Type Certificates § 21.15 Application for type certificate. Link to an amendment published at 74 FR 53385, October 16, 2009. (a) An application for a type certificate...

Lubiprostone: RU 0211, SPI 0211.

PubMed

2005-01-01

Lubiprostone [RU 0211, SPI 0211] is a bicyclic fatty acid that acts as a chloride channel opener, increasing intestinal water secretion. Lubiprostone, an orally-administered formulation, is one of a series of functional fatty acid compounds discovered by Dr Ryuji Ueno, and is currently undergoing development for the treatment of constipation, constipation-predominant irritable bowel syndrome (IBS-C) and postoperative ileus with Sucampo Pharmaceutical's. Lubiprostone activates a specific chloride channel (CLC2) on cells lining the gut, thereby naturally increasing intestinal fluid secretion. The increased fluid level softens the stool, promotes spontaneous bowel movements, and reduces abdominal discomfort/pain and bloating. The chloride channel is a protein that controls cell membrane transport of chloride ion. Lubiprostone acts on the ClC-2 chloride channel, which is located in the apical intestinal membrane. In November 2004, Takeda Pharmaceuticals entered into a collaboration and licensing agreement for Lubiprostone with Sucampo Pharmaceuticals for the treatment of chronic constipation and constipation-predominant Irritable Bowel Syndrome (c-IBS). Under the terms of the agreement, Takeda received the right to market the product in the US and Canada, while Sucampo reserved the co-promotion rights for these countries. Takeda's wholly-owned US subsidiary, Takeda Pharmaceuticals North America Inc., will sell lubiprostone once the product is approved by the US FDA. Takeda will also receive an option for marketing rights in other territories, including Japan and Europe. Takeda and Sucampo agreed on the exclusive manufacturing and supply of Lubiprostone by R-Tech Ueno, Ltd, a member of the Sucampo Group. Sucampo has the potential to receive up to dollar US 210 million in initial and milestone payments, some of which are contingent upon the successful achievement of several milestones. Takeda will fund a major part of development costs not only for chronic constipation and c-IBS, but also for other indications in the gastroenterology field. Takeda will make royalty payments to Sucampo after the product is launched. In May 2005, Sucampo received dollar US 20 million from Takeda Pharmaceutical as payment for achieving a development milestone of initiating a phase III clinical trial of lubiprostone to treat patients with constipation-predominant irritable bowel syndrome. Sucampo Pharmaceuticals submitted a new drug application (NDA) for lubiprostone to the FDA on 31 March 2005 for approval in the treatment of chronic idiopathic constipation (CIC) and associated symptoms in adults. Sucampo completed three long-term, open-label safety studies, which will support the NDA for lubiprostone, in treating constipation. Results from its second open-label safety study with lubiprostone were announced in February 2004, with the first two studies demonstrating long-term safety and sustained effectiveness in constipated subjects. In the US, the final phase III study for chronic constipation was completed in the fourth quarter of 2004. In November 2004, Sucampo announced completing a phase II safety and efficacy study of lubiprostone for the treatment of IBS-C. This study, which was initiated in April 2003, randomised 195 patients with documented IBS into four treatment groups (three doses of SPI 0211 and placebo) from 19 locations throughout the US.

The Effects of Compressive Preloads on the Compression-After-Impact Strength of Carbon/Epoxy

NASA Technical Reports Server (NTRS)

Nettles, Alan T.

1994-01-01

A fixture to apply compressive loads to composite specimens during an impact event was used to assess the effect of prestresses on the compression-after-impact (CAI) strength of 16 ply quasi-isotropic carbon/epoxy test coupons. Advanced design of experiments techniques were used to evaluate a range of prestresses and impact energies on two material systems, T300/934 and IM7/8551-7. An instrumented drop tower supplied impact energies between 1 and 9 Joules for the T300/934 material and between 4 and 16 Joules for the IM7/8551-7 material. The prestress values varied between a low of 5.7 Wa and a high of 287 NDa. Results showed some change in CAI strength that could be attributed to the prestresses on the specimens.

Confirming criticality safety of TRU waste with neutron measurements and risk analyses

DOE Office of Scientific and Technical Information (OSTI.GOV)

Winn, W.G.; Hochel, R.D.

1992-04-01

The criticality safety of {sup 239}Pu in 55-gallon drums stored in TRU waste containers (culverts) is confirmed using NDA neutron measurements and risk analyses. The neutron measurements yield a {sup 239}Pu mass and k{sub eff} for a culvert, which contains up to 14 drums. Conservative probabilistic risk analyses were developed for both drums and culverts. Overall {sup 239}Pu mass estimates are less than a calculated safety limit of 2800 g per culvert. The largest measured k{sub eff} is 0.904. The largest probability for a critical drum is 6.9 {times} 10{sup {minus}8} and that for a culvert is 1.72 {times} 10{supmore » {minus}7}. All examined suspect culverts, totaling 118 in number, are appraised as safe based on these observations.« less

Alternative Radiological Characterization of Sealed Source TRU Waste for WIPP Disposal (LAUR-05-8776)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Whitworth, J.; Pearson, M.; Feldman, A.

2006-07-01

The Offsite Source Recovery (OSR) Project at Los Alamos National Laboratory is now shipping transuranic (TRU) waste containers to the Waste Isolation Pilot Plant (WIPP) in New Mexico for disposal. Sealed source waste disposal has become possible in part because OSR personnel were able to obtain Environmental Protection Agency (EPA) and DOE-CBFO approval for an alternative radiological characterization procedure relying on acceptable knowledge (AK) and modeling, rather than on non-destructive assay (NDA) of each container. This is the first successful qualification of an 'alternate methodology' under the radiological characterization requirements of the WIPP Waste Acceptance Criteria (WAC) by any TRUmore » waste generator site. This paper describes the approach OSR uses to radiologically characterize its sealed source waste and the process by which it obtained certification of this approach. (authors)« less

ROBOCAL: An automated NDA (nondestructive analysis) calorimetry and gamma isotopic system

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hurd, J.R.; Powell, W.D.; Ostenak, C.A.

1989-11-01

ROBOCAL, which is presently being developed and tested at Los Alamos National Laboratory, is a full-scale, prototype robotic system for remote calorimetric and gamma-ray analysis of special nuclear materials. It integrates a fully automated, multidrawer, vertical stacker-retriever system for staging unmeasured nuclear materials, and a fully automated gantry robot for computer-based selection and transfer of nuclear materials to calorimetric and gamma-ray measurement stations. Since ROBOCAL is designed for minimal operator intervention, a completely programmed user interface is provided to interact with the automated mechanical and assay systems. The assay system is designed to completely integrate calorimetric and gamma-ray data acquisitionmore » and to perform state-of-the-art analyses on both homogeneous and heterogeneous distributions of nuclear materials in a wide variety of matrices.« less

Magnetic Microcalorimeter (MMC) Gamma Detectors with Ultra-High Energy Resolution

DOE Office of Scientific and Technical Information (OSTI.GOV)

Friedrich, Stephen

The goal of this LCP is to develop ultra-high resolution gamma detectors based on magnetic microcalorimeters (MMCs) for accurate non-destructive analysis (NDA) of nuclear materials. For highest energy resolution, we will introduce erbium-doped silver (Ag:Er) as a novel sensor material, and implement several geometry and design changes to improve the signal-to-noise ratio. The detector sensitivity will be increased by developing arrays of 32 Ag:Er pixels read out by 16 SQUID preamplifiers, and by developing a cryogenic Compton veto to reduce the spectral background. Since best MMC performance requires detector operation at ~10 mK, we will purchase a dilution refrigerator withmore » a base temperature <10 mK and adapt it for MMC operation. The detector performance will be tested with radioactive sources of interest to the safeguards community.« less

The abuse potential of medical psilocybin according to the 8 factors of the Controlled Substances Act.

PubMed

Johnson, Matthew W; Griffiths, Roland R; Hendricks, Peter S; Henningfield, Jack E

2018-06-05

This review assesses the abuse potential of medically-administered psilocybin, following the structure of the 8 factors of the US Controlled Substances Act (CSA). Research suggests the potential safety and efficacy of psilocybin in treating cancer-related psychiatric distress and substance use disorders, setting the occasion for this review. A more extensive assessment of abuse potential according to an 8-factor analysis would eventually be required to guide appropriate schedule placement. Psilocybin, like other 5-HT2A agonist classic psychedelics, has limited reinforcing effects, supporting marginal, transient non-human self-administration. Nonetheless, mushrooms with variable psilocybin content are used illicitly, with a few lifetime use occasions being normative among users. Potential harms include dangerous behavior in unprepared, unsupervised users, and exacerbation of mental illness in those with or predisposed to psychotic disorders. However, scope of use and associated harms are low compared to prototypical abused drugs, and the medical model addresses these concerns with dose control, patient screening, preparation and follow-up, and session supervision in a medical facility. (1) psilocybin has an abuse potential appropriate for CSA scheduling if approved as medicine; (2) psilocybin can provide therapeutic benefits that may support the development of an approvable New Drug Application (NDA) but further studies are required which this review describes; (3) adverse effects of medical psilocybin are manageable when administered according to risk management approaches; and (4) although further study is required, this review suggests that placement in Schedule IV may be appropriate if a psilocybin-containing medicine is approved. Copyright © 2018. Published by Elsevier Ltd.

Gamma-ray mirror technology for NDA of spent fuel

DOE Office of Scientific and Technical Information (OSTI.GOV)

Descalle, M. A.; Ruz-Armendariz, J.; Decker, T.

Direct measurements of gamma rays emitted by fissile material have been proposed as an alternative to measurements of the gamma rays from fission products. From a safeguards applications perspective, direct detection of uranium (U) and plutonium (Pu) K-shell fluorescence emission lines and specific lines from some of their isotopes could lead to improved shipper-receiver difference or input accountability at the start of Pu reprocessing. However, these measurements are difficult to implement when the spent fuel is in the line-of-sight of the detector, as the detector is exposed to high rates dominated by fission product emissions. To overcome the combination ofmore » high rates and high background, grazing incidence multilayer mirrors have been proposed as a solution to selectively reflect U and Pu hard X-ray and soft gamma rays in the 90 to 420 keV energy into a high-purity germanium (HPGe) detector shielded from the direct line-of-sight of spent fuel. Several groups demonstrated that K-shell fluorescence lines of U and Pu in spent fuel could be detected with Ge detectors. In the field of hard X-ray optics the performance of reflective multilayer coated reflective optics was demonstrated up to 645 keV at the European Synchrotron Radiation Facility. Initial measurements conducted at Oak Ridge National Laboratory with sealed sources and scoping experiments conducted at the ORNL Irradiated Fuels Examination Laboratory (IFEL) with spent nuclear fuel further demonstrated the pass-band properties of multilayer mirrors for reflecting specific emission lines into 1D and 2D HPGe detectors, respectively.« less

Offshore Storage Resource Assessment - Final Scientific/Technical Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Savage, Bill; Ozgen, Chet

The DOE developed volumetric equation for estimating Prospective Resources (CO 2 storage) in oil and gas reservoirs was utilized on each depleted field in the Federal GOM. This required assessment of the in-situ hydrocarbon fluid volumes for the fields under evaluation in order to apply the DOE equation. This project utilized public data from the U.S. Department of the Interior, Bureau of Ocean Energy Management (BOEM) Reserves database and from a well reputed, large database (250,000+ wells) of GOM well and production data marketed by IHS, Inc. IHS interpreted structure map files were also accessed for a limited number ofmore » fields. The databases were used along with geological and petrophysical software to identify depleted oil and gas fields in the Federal GOM region. BOEM arranged for access by the project team to proprietary reservoir level maps under an NDA. Review of the BOEM’s Reserves database as of December 31, 2013 indicated that 675 fields in the region were depleted. NITEC identified and rank these 675 fields containing 3,514 individual reservoirs based on BOEM’s estimated OOIP or OGIP values available in the Reserves database. The estimated BOEM OOIP or OGIP values for five fields were validated by an independent evaluation using available petrophysical, geologic and engineering data in the databases. Once this validation was successfully completed, the BOEM ranked list was used to calculate the estimated CO 2 storage volume for each field/reservoir using the DOE CO 2 Resource Estimate Equation. This calculation assumed a range for the CO 2 efficiency factor in the equation, as it was not known at that point in time. NITEC then utilize reservoir simulation to further enhance and refine the DOE equation estimated range of CO 2 storage volumes. NITEC used a purpose built, publically available, 4-component, compositional reservoir simulator developed under funding from DOE (DE-FE0006015) to assess CO 2-EOR and CO 2 storage in 73 fields/461 reservoirs. This simulator was fast and easy to utilize and provided a valuable enhanced assessment and refinement of the estimated CO 2 storage volume for each reservoir simulated. The user interface was expanded to allow for calculation of a probability based assessment of the CO 2 storage volume based on typical uncertainties in operating conditions and reservoir properties during the CO 2 injection period. This modeling of the CO 2 storage estimates for the simulated reservoirs resulted in definition of correlations applicable to all reservoir types (a refined DOE equation) which can be used for predictive purposes using available public data. Application of the correlations to the 675 depleted fields yielded a total CO 2 storage capacity of 4,748 MM tons. The CO 2 storage assessments were supplemented with simulation modeling of eleven (11) oil reservoirs that quantified the change in the stored CO 2 storage volume with the addition of CO 2-EOR (Enhanced Oil Recovery) production. Application of CO 2-EOR to oil reservoirs resulted in higher volumes of CO 2 storage.« less

49 CFR 451.12 - Application for approval by design type.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 6 2013-10-01 2013-10-01 false Application for approval by design type. 451.12... Approval of New Containers § 451.12 Application for approval by design type. (a) For approval of new containers by design type, each application must include the following: (1) Engineering drawings and plans...

49 CFR 451.12 - Application for approval by design type.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 6 2014-10-01 2014-10-01 false Application for approval by design type. 451.12... Approval of New Containers § 451.12 Application for approval by design type. (a) For approval of new containers by design type, each application must include the following: (1) Engineering drawings and plans...

49 CFR 451.12 - Application for approval by design type.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 6 2012-10-01 2012-10-01 false Application for approval by design type. 451.12... Approval of New Containers § 451.12 Application for approval by design type. (a) For approval of new containers by design type, each application must include the following: (1) Engineering drawings and plans...

49 CFR 451.12 - Application for approval by design type.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 6 2010-10-01 2010-10-01 false Application for approval by design type. 451.12... Approval of New Containers § 451.12 Application for approval by design type. (a) For approval of new containers by design type, each application must include the following: (1) Engineering drawings and plans...

49 CFR 451.12 - Application for approval by design type.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 6 2011-10-01 2011-10-01 false Application for approval by design type. 451.12... Approval of New Containers § 451.12 Application for approval by design type. (a) For approval of new containers by design type, each application must include the following: (1) Engineering drawings and plans...

75 FR 25257 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-07

.../Treasurer/Secretary (Qualifying Individual), Application Type: New NVO License. Direct Service Inc. dba...: Chi Hao (Steve) Hung, President (Qualifying Individual), Application Type: Trade Name Change. GTS... President (Qualifying Individual), Erick S. Cicala, President, Application Type: New Off & NVO License. Lopa...

Complete mitochondrial DNA sequence of a tadpole shrimp (Triops cancriformis) and analysis of museum samples.

PubMed

Umetsu, Kazuo; Iwabuchi, Naruki; Yuasa, Isao; Saitou, Naruya; Clark, Paul F; Boxshall, Geoff; Osawa, Motoki; Igarashi, Keiji

2002-12-01

The complete mitochondrial DNA (mtNDA) of the tadpole shrimp Triops cancriformis was sequenced. The sequence consisted of 15,101 bp with an A+T content of 69%. Its gene arrangement was identical with those sequences of the water flea (Daphnia pulex) and giant tiger prawn (Penaeus monodon), whereas it differed from that of the brine shrimp (Artemia franciscana) in the arrangement of its genes for tRNAs. Phylogenetic analysis revealed T. cancriformis to be more closely related to the water flea than to the brine shrimp and giant tiger prawn. We also compared the 16S rRNA sequences of five formalin-fixed tadpole shrimps that had been collected in five different locations and stored in a museum. The sequence divergence was in the range of 0-1.51%, suggesting that those samples were closely related to each other.

REBOCOL (Robotic Calorimetry): An automated NDA (Nondestructive assay) calorimetry and gamma isotopic system

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hurd, J.R.; Bonner, C.A.; Ostenak, C.A.

1989-01-01

ROBOCAL, which is presently being developed and tested at Los Alamos National Laboratory, is a full-scale, prototypical robotic system, for remote calorimetric and gamma-ray analysis of special nuclear materials. It integrates a fully automated, multi-drawer, vertical stacker-retriever system for staging unmeasured nuclear materials, and a fully automated gantry robot for computer-based selection and transfer of nuclear materials to calorimetric and gamma-ray measurement stations. Since ROBOCAL is designed for minimal operator intervention, a completely programmed user interface and data-base system are provided to interact with the automated mechanical and assay systems. The assay system is designed to completely integrate calorimetric andmore » gamma-ray data acquisition and to perform state-of-the-art analyses on both homogeneous and heterogeneous distributions of nuclear materials in a wide variety of matrices. 10 refs., 10 figs., 4 tabs.« less

Reliability on ISS Talk Outline

NASA Technical Reports Server (NTRS)

Misiora, Mike

2015-01-01

1. Overview of ISS 2. Space Environment and it effects a. Radiation b. Microgravity 3. How we ensure reliability a. Requirements b. Component Selection i. Note: I plan to stay away from talk about Rad Hardened components and talk about why we use older processors because they are less susceptible to SEUs. c. Testing d. Redundancy / Failure Tolerance e. Sparing strategies 4. Operational Examples a. Multiple MDM Failures on 6A due to hard drive failure In general, my plan is to only talk about data that is currently available via normal internet sources to ensure that I stay away from any topics that would be Export Controlled, ITAR, or NDA-controlled. The operational example has been well-reported on in the media and those are the details that I plan to cover. Additionally I am not planning on using any slides or showing any photos during the talk.

Is Identification of Lupus Erythematosus Cells Still Useful? A Case Report.

PubMed

Xu, Min; MacNeal, Lucinda A; Wittman, Brenda J; Rutledge, Joe C

A 13-year-old girl presented with significant weight loss, depression, anemia, and neutropenia. The preliminary diagnosis was anorexia nervosa combined with depression. Due to peripheral cytopenia, a bone marrow biopsy was performed to rule out leukemia. Lupus erythematosus (LE) cells were found in the bone marrow aspirate, which prompted autoantibody testing, although clinically it was not suspected the patient had systemic lupus erythematosus (SLE). Further testing demonstrated very high levels of antinuclear antibodies (ANA) (>12 U) and anti-double strand DNA (dsNDA) (>1000 IU/mL), which confirmed the diagnosis of SLE. The patient was treated with steroids for SLE, and symptoms improved quickly. In conclusion, although the identification of LE cells as one of the diagnostic criteria for SLE has been obsolete, careful examination of bone marrow to identify LE cells is still very important in the diagnosis of unsuspected SLE.

76 FR 22104 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-20

... (Qualifying Individual), Jung Park, Shareholder, Application Type: QI Change VMA Global Logistics, Inc. (NVO... Individual), Daniel Gelpi, President, Application Type: Add NVO Service ADM Logistics, Inc. (NVO & OFF), 4666... (Qualifying Individual), Application Type: New NVO & OFF License ATC Logistics, Inc. (NVO & OFF), 14350...

78 FR 37540 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-21

... Member, Application Type: New NVO & OFF License. Shiner Electrical Trading Company, LLC. (OFF), 391... Canate, Managing Member, Application Type: New NVO & OFF License. Allyn International Services, Inc. (OFF... Trevett, CEO, Application Type: New OFF License. A-Logixtic Group, LLC (NVO), 600 Kenrick Drive, C-16...

77 FR 9657 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-17

..., President/Treasurer/Secretary, (Qualifying Individual), Application Type: Trade Name Change/QI Change...), Christopher Dale, Director/President/CEO, Application Type: Trade Name Change/QI Change. Dated: February 13...), Application Type: QI Change/Add OFF Service. Eagle Van Lines, Inc. (NVO & OFF), 5041 Beech Place, Temple Hills...

19 CFR 115.63 - Application for approval.

Code of Federal Regulations, 2012 CFR

2012-04-01

... of the design type and the serial number of the vehicle in the type series manufacturer's number; and... Procedures for Approval of Road Vehicles by Design Type § 115.63 Application for approval. Each application by a manufacturer for certification of a road vehicle by design type must include: (a) Three copies...

19 CFR 115.63 - Application for approval.

Code of Federal Regulations, 2013 CFR

2013-04-01

... of the design type and the serial number of the vehicle in the type series manufacturer's number; and... Procedures for Approval of Road Vehicles by Design Type § 115.63 Application for approval. Each application by a manufacturer for certification of a road vehicle by design type must include: (a) Three copies...

19 CFR 115.63 - Application for approval.

Code of Federal Regulations, 2014 CFR

2014-04-01

... of the design type and the serial number of the vehicle in the type series manufacturer's number; and... Procedures for Approval of Road Vehicles by Design Type § 115.63 Application for approval. Each application by a manufacturer for certification of a road vehicle by design type must include: (a) Three copies...

19 CFR 115.63 - Application for approval.

Code of Federal Regulations, 2010 CFR

2010-04-01

... of the design type and the serial number of the vehicle in the type series manufacturer's number; and... Procedures for Approval of Road Vehicles by Design Type § 115.63 Application for approval. Each application by a manufacturer for certification of a road vehicle by design type must include: (a) Three copies...

19 CFR 115.63 - Application for approval.

Code of Federal Regulations, 2011 CFR

2011-04-01

... of the design type and the serial number of the vehicle in the type series manufacturer's number; and... Procedures for Approval of Road Vehicles by Design Type § 115.63 Application for approval. Each application by a manufacturer for certification of a road vehicle by design type must include: (a) Three copies...

14 CFR 21.253 - Type certificates: application.

Code of Federal Regulations, 2010 CFR

2010-01-01

... made; (4) After placing the required technical data and type inspection report in the technical data... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Type certificates: application. 21.253....253 Type certificates: application. Link to an amendment published at 74 FR 53390, October 16, 2009...

13 CFR 108.1100 - Type of Leverage and application procedures.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Type of Leverage and application... MARKETS VENTURE CAPITAL (âNMVCâ) PROGRAM SBA Financial Assistance for NMVC Companies (Leverage) General Information About Obtaining Leverage § 108.1100 Type of Leverage and application procedures. (a) Type of...

Quantitative NDA of isotopic neutron sources.

PubMed

Lakosi, L; Nguyen, C T; Bagi, J

2005-01-01

A non-destructive method for assaying transuranic neutron sources was developed, using a combination of gamma-spectrometry and neutron correlation technique. Source strength or actinide content of a number of PuBe, AmBe, AmLi, (244)Cm, and (252)Cf sources was assessed, both as a safety issue and with respect to combating illicit trafficking. A passive neutron coincidence collar was designed with (3)He counters embedded in a polyethylene moderator (lined with Cd) surrounding the sources to be measured. The electronics consist of independent channels of pulse amplifiers and discriminators as well as a shift register for coincidence counting. The neutron output of the sources was determined by gross neutron counting, and the actinide content was found out by adopting specific spontaneous fission and (alpha,n) reaction yields of individual isotopes from the literature. Identification of an unknown source type and constituents can be made by gamma-spectrometry. The coincidences are due to spontaneous fission in the case of Cm and Cf sources, while they are mostly due to neutron-induced fission of the Pu isotopes (i.e. self-multiplication) and the (9)Be(n,2n)(8)Be reaction in Be-containing sources. Recording coincidence rate offers a potential for calibration, exploiting a correlation between the Pu amount and the coincidence-to-total ratio. The method and the equipment were tested in an in-field demonstration exercise, with participation of national public authorities and foreign observers. Seizure of the illicit transport of a PuBe source was simulated in the exercise, and the Pu content of the source was determined. It is expected that the method could be used for identification and assay of illicit, found, or not documented neutron sources.

Evaluation of international case studies within 'Live.Learn.Laugh.': a unique global public-private partnership to promote oral health.

PubMed

Dugdill, Lindsey; Pine, Cynthia M

2011-08-01

The partnership between the Féderation Dentaire International (FDI), and Unilever Oral Care, aims to raise awareness of oral health globally; to enable FDI member associations to promote oral health; and to increase the visibility of the FDI and authority of Unilever oral care brands worldwide. Country Projects between National Dental Associations (NDAs), the member associations of FDI, and Unilever Oral Care local companies have been established as a key strand of the partnership. This paper reports on the evaluation of an in-depth sample of Country Projects (n=5) to determine their potential to impact on oral health. Five country sites were selected as being indicative of different programme delivery types. Each site received a two-day visit during Spring-Summer 2009, which enabled the evaluators to audit what was delivered in practice compared with the original written project briefs and to undertake interviews of study site staff. 39 projects in 36 countries have been initiated. In those examined by site visits, clear evidence was found of capacity building to deliver oral health. In some countries, widespread population reach had been prioritised. Effectiveness of partnership working varied depending on the strength of the relationship between the NDA and local Unilever Oral Care representatives and alignment with national marketing strategy. The quality of internal evaluation varied considerably. Over a million people had been reached directly by Country Projects and this public-private partnership has made a successful start. To move towards improving oral health rather than only awareness raising; future Country Projects would benefit from being limited to certain evidence-based intervention designs, and using an agreed core indicator set in order to allow cross-country comparison of intervention outcomes. © 2011 FDI World Dental Federation.

The Sagnac-configured fiber optic calorimeter: An investigation of an improved non-destructive methodology for determining the thermal power output of heat-producing nuclear materials

NASA Astrophysics Data System (ADS)

Bayliss, Stephen Carlton

An essential component in an ever-expanding global nuclear economy is the nondestructive assay (NDA) of nuclear materials. Accurate accounting of these materials helps to insure the safe handling and disposal of them and the accurate monitoring of these materials can help prevent their diversion. A particularly useful and important NDA technique has proven to be isothermal calorimetry. With state-of-the-art calorimeters, heat rates as low as a few milliwatts can be measured, which correspond to approximately one gram of plutonium or one milligram of tritium; two materials of particular interest. In addition, calorimetry is relatively insensitive to the matrix of the sample. This work reports on the development of a calorimeter technique based on fiber optics, which can greatly increase the sensitivity of the calorimeter compared with present day devices. Specifically, this device uses an optical fiber configuration based on the Sagnac interferometer. Fundamentally, the optical fiber is replacing the resistive wire used in conventional calorimeters. The optical fiber is wrapped around two "thermels;" a reference and a sample thermel; the thermal sample to be measured is placed in the sample thermel. The light within the optical fiber of the sample arm experiences a change in phase due to the change in the index of refraction caused by the thermal load. When this light mixes with the light from the reference arm, a change in the light intensity results. An electro-optic receiver converts the time-varying light intensity to a time-varying voltage output. It is this voltage output that is stored and analyzed. A prototype fiber calorimeter has been built and proved capable of measuring heat loads in the microwatt regime. This sensitivity represents a factor of a one thousand-fold improvement over conventional calorimeters. This would allow plutonium samples as small as one milligram to be measured and microgram quantities of tritium. In addition, gram quantities of 93% enriched uranium could be measured for the first time using calorimetry. This device has not been optimized with respect to background interferences (room thermal loads and acoustics), but indications are that the sensitivity could be improved further with more development.

Can claims, misleading information, and manufacturing issues regarding dietary supplements be improved in the United States?

PubMed

Gibson, James E; Taylor, David A

2005-09-01

The safety and effectiveness of over-the-counter (OTC) drugs are assessed through the Food and Drug Administration's (FDA's) OTC drug review. Prescription drugs are approved through the rigorous new drug application (NDA) process. In contrast, dietary supplements are regulated as foods, and the FDA must determine that a dietary supplement ingredient poses a "significant or unreasonable risk of illness or injury" instead of requiring the manufacturer to provide safety data. According to the FDA, there are more than 29,000 different dietary supplements available to consumers today. This momentum has its roots in consumer interest in health and self-care and suggests that Americans are searching for alternatives to conventional foods for physical and mental well being. The Committee on the Framework for Evaluating the Safety of Dietary Supplements was formed under the auspices of the Food and Nutrition Board that produced a report entitled Dietary Supplements: A Framework for Evaluating Safety. Categories of specific information identified for use are 1) human data, 2) animal studies, 3) in vitro experiments, and 4) information on related substances. Several factors were identified to guide the FDA in applying the framework. Two of these factors are expressed as follows: 1) "the appropriate scientific standard to be used to overturn this basic assumption of safety is to demonstrate significant or unreasonable risk, not prove that an ingredient is unsafe"; and 2) "approaches taken by diverse organizations and governmental bodies, both within and outside the United States, which evaluate the safety and at times efficacy of dietary supplement ingredients, vary in their relevance to the protection of the American public from risks associated with consumption of dietary supplement ingredients".

MC and A instrumentation catalog

DOE Office of Scientific and Technical Information (OSTI.GOV)

Neymotin, L.; Sviridova, V.

1998-06-01

In 1981 and 1985, two editions of a catalog of non-destructive nuclear measurement instrumentation, and material control and surveillance equipment, were published by Brookhaven National Laboratory (BNL). The last edition of the catalog included one hundred and twenty-five entries covering a wide range of devices developed in the US and abroad. More than ten years have elapsed since the publication of the more recent Catalog. Devices described in it have undergone significant modifications, and new devices have been developed. Therefore, in order to assist specialists in the field of Material Control and Accounting (MC and A), a new catalog hasmore » been created. Work on this instrumentation catalog started in 1997 as a cooperative effort of Brookhaven National Laboratory (BNL), operated by Brookhaven Science Associates under contract to the US Department of Energy, and the All-Russian Research Institute of Automatics (VNIIA), subordinate institute of the Atomic Energy Ministry of the Russian Federation, within the collaborative US-Russia Material Protection, Control, and Accounting (MPC and A) Program. Most of the equipment included in the Catalog are non-destructive assay (NDA) measurement devices employed for purposes of accounting, confirmation, and verification of nuclear materials. Other devices also included in the Catalog are employed in the detection and deterrence of unauthorized access to or removal of nuclear materials (material control: containment and surveillance). Equipment found in the Catalog comprises either: (1) complete devices or systems that can be used for MC and A applications; or (2) parts or components of complete systems, such as multi-channel analyzers, detectors, neutron generators, and software. All devices are categorized by their status of development--from prototype to serial production.« less

Integrating ADNI Results into Alzheimer’s Disease Drug Development Programs

PubMed Central

Cummings, Jeffrey L.

2010-01-01

The Alzheimer’s Disease Neuroimaging Initiative (ADNI) is providing critical new information on biomarkers in cognitively normal elderly, persons with mild cognitive impairment (MCI), and patients with mild Alzheimer’s disease (AD). The data provide insights into the progression of the pathology of AD over time, assist in understanding which biomarkers might be most useful in clinical trials, and facilitate development of disease-modifying treatments. ADNI results are intended to support new AD Treatments development; this paper considers how ADNI information can be integrated in AD drug development programs. Cerebrospinal fluid (CSF) amyloid beta protein (Aβ) measures can be used in Phase I studies to detect any short term effects on Aβ levels in the CSF. Phase II studies may benefit most from biomarker measures that can inform decisions about Phase III. CSF Aβ levels, CSF total tau and phospotau measures, fluorodexoyglucose positron emission tomography (FDG PET), Pittsburgh Compound B (PIB) amyloid imaging, or magnetic resonance imaging (MRI) may be employed to select patient in enriched trials or as outcomes for specific disease-modifying interventions. Use of biomarkers may allow Phase II trials to be conducted more efficiently with smaller populations of patients or shorted treatment times. New drug applications (NDA) may include biomarker outcomes of phase III trials. ADNI patients are highly educated and are nearly all of Caucasian ethnicity limiting the generalizability of the results to other populations commonly included in global clinical trials. ADNI has inspired or collaborates with biomarker investigations worldwide and together these studies will provide biomarker information that can reduce development times and costs, improve drug safety, optimize drug efficacy, and bring new treatments to patients with or at risk for AD. PMID:20447734

12 CFR 1003.4 - Compilation of loan data.

Code of Federal Regulations, 2013 CFR

2013-01-01

... property type to which the loan or application relates. (6) The owner-occupancy status of the property to... type of action taken, and the date. (9) The location of the property to which the loan or application.... (2) The type of loan or application. (3) The purpose of the loan or application. (4) Whether the...

12 CFR 1003.4 - Compilation of loan data.

Code of Federal Regulations, 2014 CFR

2014-01-01

... property type to which the loan or application relates. (6) The owner-occupancy status of the property to... type of action taken, and the date. (9) The location of the property to which the loan or application.... (2) The type of loan or application. (3) The purpose of the loan or application. (4) Whether the...

77 FR 76483 - Ocean Transportation Intermediary License Applicants The Commission gives notice that the...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-28

.... Application Type: QI Change. Efrinsa Global Logistics Inc. (NVO & OFF), 8441 NW 68th Street, Miami, FL 33166... (QI), Sheila E. Lawrence, President. Application Type: New OFF License. MMC Logistics, LLC (OFF), 2853 Henderson Mill Road, Atlanta, GA 30341. Officer: John S. Chihade, Manager (QI). Application Type: New OFF...

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gruetzmacher, Kathleen M.; Bustos, Roland M.; Ferran, Scott G.

Los Alamos National Laboratory (LANL) uses the Nevada National Security Site (NNSS) as an off-site disposal facility for low-level waste (LLW), including sludge waste. NNSS has issued a position paper that indicates that systems that are not certified by the Carlsbad Field Office (CBFO) for Waste Isolation Pilot Plant (WIPP) disposal of Transuranic (TRU) waste must demonstrate equivalent practices to the CBFO certified systems in order to assign activity concentration values to assayed items without adding in the Total Measurement Uncertainty (TMU) when certifying waste for NNSS disposal. Efforts have been made to meet NNSS requirements to accept sludge wastemore » for disposal at their facility. The LANL LLW Characterization Team uses portable high purity germanium (HPGe) detector systems for the nondestructive assay (NDA) of both debris and sludge LLW. A number of performance studies have been conducted historically by LANL to support the efficacy and quality of assay results generated by the LANL HPGe systems, and, while these detector systems are supported by these performance studies and used with LANL approved procedures and processes, they are not certified by CBFO for TRU waste disposal. Beginning in 2009, the LANL LLW Characterization Team undertook additional NDA measurements of both debris and sludge simulated waste containers to supplement existing studies and procedures to demonstrate full compliance with the NNSS position paper. Where possible, Performance Demonstration Project (PDP) drums were used for the waste matrix and PDP sources were used for the radioactive sources. Sludge drums are an example of a matrix with a uniform distribution of contaminants. When attempting to perform a gamma assay of a sludge drum, it is very important to adequately simulate this uniform distribution of radionuclides in order to accurately model the assay results. This was accomplished by using a spiral radial source tube placement in a sludge drum rather than the standard three source tubes seen in debris PDP drums. Available line sources (Eu-152) were placed in the spiral tubes to further accomplish the desired uniform distribution of radionuclides. The standard PDP drum (PDP matrix drum 005) and PDP sources were used to determine the lower limits of detection (LLD) and TMU. Analysis results for the sludge drum matrix case for two HPGe detectors were tabulated and evaluated. NNSS has accepted the methodology and results of the measurements towards demonstrating equivalence to CBFO certified systems. In conclusion, the WES-WGS and CMR-OPS gamma spectroscopy teams at LANL have defined and performed measurements that serve to establish and demonstrate equivalency with the processes used by CBFO certified NDA systems. The supplemental measurements address four key areas in Appendix A of DOE/WIPP-02-3122: Annual Calibration Confirmation and Performance Check measurements; LLD determination; and TMU definition. For these measurements the containers, matrices and activity loadings are selected to represent items being assayed in real LLW cases. The LLD and the TMU bounding measurements are to be performed one time and will not be required to be repeated in future campaigns. The annual calibration and performance check measurements were performed initially and planned to repeat in annual campaigns in order to maintain NNSS certification. PDP sources and a PDP sludge drum as well as Eu-152 line sources and a spiral sludge drum were used for the measurements. In all cases, the results for accuracy and precision (%R and %RSD, respectively) were within allowable ranges as defined by the WIPP PDP program. LLD (or MDC) results were established for all the ten WIPP reportable radionuclides and U-235, and the MDC for Pu-239 was established in all cases to be well under 100 nCi/g. Useful results for reducing estimated uncertainties were established and an interesting unexpected case of high bias was observed and will be applied toward this end. (authors)« less

The influence of personality type on decision making in the physical therapy admission process.

PubMed

Bezner, J R; Boucher, B K

2001-01-01

The purpose of this study was to identify the personality types of physical therapy (PT) interviewers and applicants, using the Personality Styles (PS) assessment tool, and to determine whether an interview team's personality type influences the rating score given. The PS was validated in a study of 298 students who completed the Myers-Briggs Type Indicator (MBTI) Form G and a PS assessment. By chi-square analysis the PS model appears to be a valid representation of the MBTI (chi 2 = 86.62, p < 0.00001). Subjects for the interview portion of the study were 282 student applicants, 19 faculty, and 47 clinicians from two PT programs. A randomly assigned faculty/clinician team interviewed each applicant. Two one-way ANOVAs were performed with interview score as the dependent variable and 1) applicant personality type in relation to faculty/clinician team (same, different from both, like one) and 2) applicant personality type as the independent variables. Internal consistency of the interview rating form was alpha = 0.89. Mean interview score was 33.97/42 (SD 4.59). Interview scores were not significantly different between applicants who interviewed with clinician/faculty teams that were "like" compared with "not like" the applicants (F0.864; p = 0.423), but were significantly different between applicants with different PS personality types (F3.159; p = 0.026). Although personality type of the interview team did not impact the score given, thereby refuting the presence of interviewer bias, the rating scores did vary according to personality type of the applicant, suggesting a possible stereotyping bias in the criteria used to rate applicants.

12 CFR 203.4 - Compilation of loan data.

Code of Federal Regulations, 2013 CFR

2013-01-01

... origination. (5) The property type to which the loan or application relates. (6) The owner-occupancy status of... applied for. (8) The type of action taken, and the date. (9) The location of the property to which the... application was received. (2) The type of loan or application. (3) The purpose of the loan or application. (4...

12 CFR 203.4 - Compilation of loan data.

Code of Federal Regulations, 2014 CFR

2014-01-01

... origination. (5) The property type to which the loan or application relates. (6) The owner-occupancy status of... applied for. (8) The type of action taken, and the date. (9) The location of the property to which the... application was received. (2) The type of loan or application. (3) The purpose of the loan or application. (4...

12 CFR 203.4 - Compilation of loan data.

Code of Federal Regulations, 2012 CFR

2012-01-01

... origination. (5) The property type to which the loan or application relates. (6) The owner-occupancy status of... applied for. (8) The type of action taken, and the date. (9) The location of the property to which the... application was received. (2) The type of loan or application. (3) The purpose of the loan or application. (4...

12 CFR 203.4 - Compilation of loan data.

Code of Federal Regulations, 2011 CFR

2011-01-01

... origination. (5) The property type to which the loan or application relates. (6) The owner-occupancy status of... applied for. (8) The type of action taken, and the date. (9) The location of the property to which the... application was received. (2) The type of loan or application. (3) The purpose of the loan or application. (4...

49 CFR 1100.2 - Applicability.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 1100-1129, Rules of General Applicability, establish general rules applicable to all types of proceedings. Other rules in this subchapter establish special rules applicable to particular types of proceedings. When there is a conflict or inconsistency between a rule of general applicability and a special...

Minimally buffered data transfers between nodes in a data communications network

DOEpatents

Miller, Douglas R.

2015-06-23

Methods, apparatus, and products for minimally buffered data transfers between nodes in a data communications network are disclosed that include: receiving, by a messaging module on an origin node, a storage identifier, a origin data type, and a target data type, the storage identifier specifying application storage containing data, the origin data type describing a data subset contained in the origin application storage, the target data type describing an arrangement of the data subset in application storage on a target node; creating, by the messaging module, origin metadata describing the origin data type; selecting, by the messaging module from the origin application storage in dependence upon the origin metadata and the storage identifier, the data subset; and transmitting, by the messaging module to the target node, the selected data subset for storing in the target application storage in dependence upon the target data type without temporarily buffering the data subset.

Applications of Jungian Type Theory to Counselor Education.

ERIC Educational Resources Information Center

Dilley, Josiah S.

1987-01-01

Describes Carl Jung's theory of psychological type and the Myers-Briggs Type Indicator (MBTI), an instrument to assess Jungian type. Cites sources of information on the research and application of the theory and the MBTI. Explores how knowledge of type theory can be useful to counselor educators. (Author)

14 CFR 302.1 - Applicability and description of part.

Code of Federal Regulations, 2010 CFR

2010-01-01

... this part sets forth general rules applicable to all types of proceedings. Each of the other subparts of this part sets forth special rules applicable to the type of proceedings described in the title of... and to the rules in the subpart relating to the particular type of proceeding, if any. In addition...

76 FR 7209 - Ocean Transportation Intermediary License; Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-09

...). Application Type: New OFF License. Solomon Emeke dba Desaiah Limited (OFF), 3696 Park Avenue, 300, Ellicott City, MD 21043. Officer: Solomon Emeke, Sole Proprietor (Qualifying Individual). Application Type: New...

Measured 19F(α,n) with VANDLE for Nuclear Safeguards

NASA Astrophysics Data System (ADS)

Peters, William; Clement, R. C. C.; Smith, M. S.; Pain, S.; Febbraro, M.; Pittman, S.; Thomspon, S.; Grinder, M.; Cizewski, J. A.; Reingold, C.; Manning, B.; Burcher, S.; Bardayan, D. W.; Tan, W.-P.; Stech, E.; Smith, M. K.; Avetisyan, R.; Gyurjinyan, A.; Lowe, M.; Ilyushkin, S.; Grzywacz, R.; Madurga, M.; Paulauskas, S. V.; Taylor, S. Z.; Smith, K.

2015-10-01

One of the most promising non-destructive assay (NDA) methods to monitor UF6 canisters consists of measuring gross neutron rates induced by uranium-decay alpha particles reacting with the fluorine and emitting a neutron. This method currently lacks reliable nuclear data on the 19F(α,n) reaction cross section to determine an accurate neutron yield rate for a given sample of UF6. We have measured the cross section and coincident neutron spectrum for the alpha-decay energy range using the VANDLE system. This experiment had two parts: first at Notre Dame with a LaF3 target and and a pulsed alpha-particle beam, and second at ORNL with a windowless He-gas target and a 19F beam. The motivation for this measurement and cross section results will be presented. This work is funded in part by the DOE Office of Science, the National Nuclear Security Administration SSAA and the Office of Defense Nuclear Nonproliferation R&D, and the NSF.

Surface plasmon resonance imaging system with Mach-Zehnder phase-shift interferometry for DNA micro-array hybridization

NASA Astrophysics Data System (ADS)

Hsiu, Feng-Ming; Chen, Shean-Jen; Tsai, Chien-Hung; Tsou, Chia-Yuan; Su, Y.-D.; Lin, G.-Y.; Huang, K.-T.; Chyou, Jin-Jung; Ku, Wei-Chih; Chiu, S.-K.; Tzeng, C.-M.

2002-09-01

Surface plasmon resonance (SPR) imaging system is presented as a novel technique based on modified Mach-Zehnder phase-shifting interferometry (PSI) for biomolecular interaction analysis (BIA), which measures the spatial phase variation of a resonantly reflected light in biomolecular interaction. In this technique, the micro-array SPR biosensors with over a thousand probe NDA spots can be detected simultaneously. Owing to the feasible and swift measurements, the micro-array SPR biosensors can be extensively applied to the nonspecific adsorption of protein, the membrane/protein interactions, and DNA hybridization. The detection sensitivity of the SPR PSI imaging system is improved to about 1 pg/mm2 for each spot over the conventional SPR imaging systems. The SPR PSI imaging system and its SPR sensors have been successfully used to observe slightly index change in consequence of argon gas flow through the nitrogen in real time, with high sensitivity, and at high-throughout screening rates.

[Why multi-national clinical trials now?--Industry perspective].

PubMed

Miki, Satoshi

2007-02-01

Clinical trial environment in Japan has issues such as high clinical development cost, resource-intensive and time-consuming preparation for clinical trial conduct in each clinical site, long "White Space" and slow speed in pt.recruitment. As a result of the Guideline revision in Nov., 2005, overseas' Phase III data is now usable as pivotal data for NDA submissions. Therefore, acceleration of "hollowing out of clinical trails for registration in Japan has been the significant concern. Under such circumstances, the possible solution would be to participate in the Multi-National Clinical Trials." While other Asian countries, EU and the US have rich precedents and experiences in conducting Multi-National Clinical Trials, Japan was left alone and other Asian countries do not need any collaboration with Japan. It is proposed that Japan take initiative to set up the network such as "Asian Clinical Trial Group" and collaborate with other Asian countries from the beginning of early stage development. Eventually, Asia should become the third region to create clinical evidence, same as to EU and the US.

14 CFR 25.3 - Special provisions for ETOPS type design approvals.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 180 minutes, an applicant must comply with § 25.1535, except that it need not comply with the... ETOPS type design approval of an airplane beyond 180 minutes an applicant must comply with § 25.1535. (c) Airplanes with more than two engines. An applicant for ETOPS type design approval must comply with § 25.1535...

14 CFR 25.3 - Special provisions for ETOPS type design approvals.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 180 minutes, an applicant must comply with § 25.1535, except that it need not comply with the... ETOPS type design approval of an airplane beyond 180 minutes an applicant must comply with § 25.1535. (c) Airplanes with more than two engines. An applicant for ETOPS type design approval must comply with § 25.1535...

14 CFR 25.3 - Special provisions for ETOPS type design approvals.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 180 minutes, an applicant must comply with § 25.1535, except that it need not comply with the... ETOPS type design approval of an airplane beyond 180 minutes an applicant must comply with § 25.1535. (c) Airplanes with more than two engines. An applicant for ETOPS type design approval must comply with § 25.1535...

14 CFR 25.3 - Special provisions for ETOPS type design approvals.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 180 minutes, an applicant must comply with § 25.1535, except that it need not comply with the... ETOPS type design approval of an airplane beyond 180 minutes an applicant must comply with § 25.1535. (c) Airplanes with more than two engines. An applicant for ETOPS type design approval must comply with § 25.1535...

14 CFR 25.3 - Special provisions for ETOPS type design approvals.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 180 minutes, an applicant must comply with § 25.1535, except that it need not comply with the... ETOPS type design approval of an airplane beyond 180 minutes an applicant must comply with § 25.1535. (c) Airplanes with more than two engines. An applicant for ETOPS type design approval must comply with § 25.1535...

78 FR 59359 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-26

... (QI), Gregory M. Hinton, Operating Manager, Application Type: QI Change. Safe Movers, Inc. dba Isaac's..., Treasurer (QI), Ami Joseph, President, Application Type: Change Trade Name to Isaac's Moving & Storage. U.S...

Are race, ethnicity, and medical school affiliation associated with NIH R01 type 1 award probability for physician investigators?

PubMed

Ginther, Donna K; Haak, Laurel L; Schaffer, Walter T; Kington, Raynard

2012-11-01

To analyze the relationship among National Institutes of Health (NIH) R01 Type 1 applicant degree, institution type, and race/ethnicity, and application award probability. The authors used 2000-2006 data from the NIH IMPAC II grants database and other sources to determine which individual and institutional characteristics of applicants may affect the probability of applications being awarded funding. They used descriptive statistics and probit models to estimate correlations between race/ethnicity, degree (MD or PhD), and institution type (medical school or other institution), and application award probability, controlling for a large set of observable characteristics. Applications from medical schools were significantly more likely than those from other institutions to receive funding, as were applications from MDs versus PhDs. Overall, applications from blacks and Asians were less likely than those from whites to be awarded funding; however, among applications from MDs at medical schools, there was no difference in funding probability between whites and Asians, and the difference between blacks and whites decreased to 7.8%. The inclusion of human subjects significantly decreased the likelihood of receiving funding. Compared with applications from whites, applications from blacks have a lower probability of being awarded R01 Type 1 funding, regardless of the investigator's degree. However, funding probability is increased for applications with MD investigators and for those from medical schools. To some degree, these advantages combine so that applications from black MDs at medical schools have the smallest difference in funding probability compared with those from whites.

Are Race, Ethnicity, and Medical School Affiliation Associated With NIH R01 Type Award Probability for Physician Investigators?

PubMed Central

Ginther, Donna K.; Haak, Laurel L.; Schaffer, Walter T.; Kington, Raynard

2012-01-01

Purpose To analyze the relationship among NIH R01 Type 1 applicant degree, institution type, and race/ethnicity, and application award probability. Method The authors used 2000–2006 data from the NIH IMPAC II grants database and other sources to determine which individual and institutional characteristics of applicants may affect the probability of applications being awarded funding. They used descriptive statistics and probit models to estimate correlations between race/ethnicity, degree (MD or PhD), and institution type (medical school or other institution), and application award probability, controlling for a large set of observable characteristics. Results Applications from medical schools were significantly more likely than those from other institutions to receive funding, as were applications from MDs versus PhDs. Overall, applications from blacks and Asians were less likely than those from whites to be awarded funding; however, among applications from MDs at medical schools, there was no difference in funding probability between whites and Asians and the difference between blacks and whites decreased to 7.8 percentage points. The inclusion of human subjects significantly decreased the likelihood of receiving funding. Conclusions Compared with applications from whites, applications from blacks have a lower probability of being awarded R01 Type 1 funding, regardless of the investigator’s degree. However, funding probability is increased for applications with MD investigators and for those from medical schools. To some degree, these advantages combine so that applications from black MDs at medical schools have the smallest difference in funding probability compared with those from whites. PMID:23018334

Liquid lubrication for space applications

NASA Technical Reports Server (NTRS)

Fusaro, Robert L.; Khonsari, Michael M.

1992-01-01

Reviewed here is the state of the art of liquid lubrication for space applications. The areas discussed are types of liquid lubrication mechanisms, space environmental effects on lubrication, classification of lubricants, liquid lubricant additives, grease lubrication, mechanism materials, bearing anomalies and failures, lubricant supply techniques, and application types and lubricant needs for those applications.

Liquid lubrication for space applications

NASA Technical Reports Server (NTRS)

Fusaro, Robert L.; Khonsari, Michael M.

1993-01-01

Reviewed here is the state of the art of liquid lubrication for space applications. The areas discussed are types of liquid lubrication mechanisms, space environmental effects on lubrication, classification of lubricants, liquid lubricant additives, grease lubrication, mechanism materials, bearing anomalies and failures, lubricant supply techniques, and application types and lubricant needs for those applications.

Performance assessment of self-interrogation neutron resonance densitometry for spent nuclear fuel assay

NASA Astrophysics Data System (ADS)

Hu, Jianwei; Tobin, Stephen J.; LaFleur, Adrienne M.; Menlove, Howard O.; Swinhoe, Martyn T.

2013-11-01

Self-Interrogation Neutron Resonance Densitometry (SINRD) is one of several nondestructive assay (NDA) techniques being integrated into systems to measure spent fuel as part of the Next Generation Safeguards Initiative (NGSI) Spent Fuel Project. The NGSI Spent Fuel Project is sponsored by the US Department of Energy's National Nuclear Security Administration to measure plutonium in, and detect diversion of fuel pins from, spent nuclear fuel assemblies. SINRD shows promising capability in determining the 239Pu and 235U content in spent fuel. SINRD is a relatively low-cost and lightweight instrument, and it is easy to implement in the field. The technique makes use of the passive neutron source existing in a spent fuel assembly, and it uses ratios between the count rates collected in fission chambers that are covered with different absorbing materials. These ratios are correlated to key attributes of the spent fuel assembly, such as the total mass of 239Pu and 235U. Using count rate ratios instead of absolute count rates makes SINRD less vulnerable to systematic uncertainties. Building upon the previous research, this work focuses on the underlying physics of the SINRD technique: quantifying the individual impacts on the count rate ratios of a few important nuclides using the perturbation method; examining new correlations between count rate ratio and mass quantities based on the results of the perturbation study; quantifying the impacts on the energy windows of the filtering materials that cover the fission chambers by tallying the neutron spectra before and after the neutrons go through the filters; and identifying the most important nuclides that cause cooling-time variations in the count rate ratios. The results of these studies show that 235U content has a major impact on the SINRD signal in addition to the 239Pu content. Plutonium-241 and 241Am are the two main nuclides responsible for the variation in the count rate ratio with cooling time. In short, this work provides insights into some of the main factors that affect the performance of SINRD, and it should help improve the hardware design and the algorithm used to interpret the signal for the SINRD technique. In addition, the modeling and simulation techniques used in this work can be easily adopted for analysis of other NDA systems, especially when complex systems like spent nuclear fuel are involved. These studies were conducted at Los Alamos National Laboratory.

In Situ NDA Conformation Measurements Performed at Auxiliary Charcoal Bed and Other Main Charcoal Beds After Uranium Removal from Molten Salt Reactor Experiment ACB at Oak Ridge National Laboratory

DOE Office of Scientific and Technical Information (OSTI.GOV)

Haghighi, M. H.; Kring, C. T.; McGehee, J. T.

2002-02-26

The Molten Salt Reactor Experiment (MSRE) site is located in Tennessee, on the U.S. Department of Energy (DOE) Oak Ridge Reservation (ORR). The MSRE was run by Oak Ridge National Laboratory (ORNL) to demonstrate the desirable features of the molten-salt concept in a practical reactor that could be operated safely and reliably. It introduced the idea of a homogeneous reactor using fuel salt media and graphite moderation for power and breeder reactors. The MSRE reactor and associated components are located in cells beneath the floor in the high-bay area of Building 7503. The reactor was operated from June 1965 tomore » December 1969. When the reactor was shut down, fuel salt was drained from the reactor circuit to two drain tanks. A ''clean'' salt was then circulated through the reactor as a decontamination measure and drained to a third drain tank. When operations ceased, the fuel and flush salts were allowed to cool and solidify in the drain tanks. At shutdown, the MSRE facility complex was placed in a surveillance and maintenance program. Beginning in 1987, it was discovered that gaseous uranium (U-233/U-232) hexafluoride (UF6) had moved throughout the MSRE process systems. The UF6 had been generated when radiolysis in the fluorine salts caused the individual constituents to dissociate to their component atoms, including free fluorine. Some of the free fluorine combined with uranium fluorides (UF4) in the salt to produce UF6. UF6 is gaseous at slightly above ambient temperatures; thus, periodic heating of the fuel salts (which was intended to remedy the radiolysis problems) and simple diffusion had allowed the UF6 to move out of the salt and into the process systems of MSRE. One of the systems that UF6 migrated into due to this process was the offgas system which is vented to the MSRE main charcoal beds and MSRE auxiliary charcoal bed (ACB). Recently, the majority of the uranium laden-charcoal material residing within the ACB was safely and successfully removed using the uranium deposit removal system and equipment. After removal a series of NDA measurements was performed to determine the amount of uranium material remaining in the ACB, the amount of uranium material removed from the ACB, and the amount of uranium material remaining in the uranium removal equipment due to removal activities.« less

Delivering safety

DOE Office of Scientific and Technical Information (OSTI.GOV)

Baldwin, N.D.; Spooner, K.G.; Walkden, P.

2007-07-01

In the United Kingdom there have been significant recent changes to the management of civil nuclear liabilities. With the formation in April 2005 of the Nuclear Decommissioning Authority (NDA), ownership of the civil nuclear licensed sites in the UK, including the Magnox Reactor Stations, passed to this new organisation. The NDAs mission is to seek acceleration of the nuclear clean up programme and deliver increased value for money and, consequently, are driving their contractors to seek more innovative ways of performing work. British Nuclear Group manages the UK Magnox stations under contract to the NDA. This paper summarises the approachmore » being taken within its Reactor Sites business to work with suppliers to enhance working arrangements at sites, improve the delivery of decommissioning programmes and deliver improvements in safety and environmental performance. The UK Magnox stations are 1. generation gas-graphite reactors, constructed in the 1950's and 1960's. Two stations are currently still operating, three are shut-down undergoing defueling and the other five are being decommissioned. Despite the distractions of industry restructuring, an uncompromising policy of demanding improved performance in conjunction with improved safety and environmental standards has been adopted. Over the past 5 years, this policy has resulted in step-changes in performance at Reactor Sites, with increased electrical output and accelerated defueling and decommissioning. The improvements in performance have been mirrored by improvements in safety (DACR of 0 at 5 sites); environmental standards (reductions in energy and water consumption, increased waste recycling) and the overall health of the workforce (20% reduction in sickness absence). These achievements have, in turn, been recognised by external bodies, resulting in several awards, including: the world's first ISRS and IERS level 10 awards (Sizewell, 2006), the NUMEX plant maintenance award (Bradwell, 2006), numerous RoSPA awards at site and sector level and nomination, at Company level, for the RoSPA George Earle trophy for outstanding performance in Health and Safety (Reactor Sites, 2006). After 'setting the scene' and describing the challenges that the company has had to respond to, the paper explains how these improvements have been delivered. Specifically it explains the process that has been followed and the parts played by sites and suppliers to deliver improved performance. With the experience of already having transitioned several Magnox stations from operations to defueling and then to decommissioning, the paper describes the valuable experience that has been gained in achieving an optimum change process and maintaining momentum. (authors)« less

7 CFR 170.9 - What type of information does the application require?

Code of Federal Regulations, 2013 CFR

2013-01-01

...) MISCELLANEOUS MARKETING PRACTICES UNDER THE AGRICULTURAL MARKETING ACT OF 1946 USDA FARMERS MARKET § 170.9 What type of information does the application require? The application for participation in the USDA Farmers...

7 CFR 170.9 - What type of information does the application require?

Code of Federal Regulations, 2011 CFR

2011-01-01

...) MISCELLANEOUS MARKETING PRACTICES UNDER THE AGRICULTURAL MARKETING ACT OF 1946 USDA FARMERS MARKET § 170.9 What type of information does the application require? The application for participation in the USDA Farmers...

Effects of "Like Type" Sex Pairings between Applicants-Principals and Type of Focal Position Considered at the Screening Stage of the Selection Process

ERIC Educational Resources Information Center

Young, I. Phillip

2005-01-01

This study addresses the screening decisions for a national random sample of high school principals as viewed from the attraction-similarity theory of interpersonal perceptions. Independent variables are the sex of principals, sex of applicants, and the type of focal positions sought by hypothetical job applicants (teacher or counselor). Dependent…

42 CFR 431.305 - Types of information to be safeguarded.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 4 2011-10-01 2011-10-01 false Types of information to be safeguarded. 431.305... Information on Applicants and Recipients § 431.305 Types of information to be safeguarded. (a) The agency must have criteria that govern the types of information about applicants and recipients that are safeguarded...

14 CFR 21.253 - Type certificates: application.

Code of Federal Regulations, 2011 CFR

2011-01-01

... technical data and type inspection report in the technical data file required by § 21.293(a)(1)(i), a statement certifying that this has been done; (5) A proposed type certificate data sheet; and (6) An... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Type certificates: application. 21.253...

42 CFR 431.305 - Types of information to be safeguarded.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 4 2013-10-01 2013-10-01 false Types of information to be safeguarded. 431.305... Information on Applicants and Beneficiaries § 431.305 Types of information to be safeguarded. (a) The agency must have criteria that govern the types of information about applicants and beneficiaries that are...

76 FR 17862 - Ocean Transportation Intermediary License; Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-31

..., President/Secretary, (Qualifying Individual), Application Type: New OFF License. Wilson Transportation, Inc. (OFF), 16226 Foster Street, Overland Park, KS 66085, Officers: Jerry G. Owen, Vice President International, (Qualifying Individual), Mark A. Wilson, President/Treasurer/Secretary, Application Type: New OFF...

Assessment of limestone blended cements for transportation applications : final report.

DOT National Transportation Integrated Search

2017-09-01

This research assessed the applicability of Type IL cements satisfying AASHTO M 240 specifications for use in transportation applications in place of Type I/II cements which satisfy AASHTO M 85 specifications for construction of transportation struct...

75 FR 46938 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-04

... Logistics LLC (NVO), 120 S. Woodland Blvd., 216, DeLand, FL 32720, Officers: Dietmar Lutte, Manager Member, (Qualifying Individual), Susan Lutte, Member, Application Type: New NVO License. Bridgeline Logistics..., (Qualifying Individual), Application Type: New OFF License. [[Page 46939

Effects of Applicant Sex, Physical Attractiveness, and Type of Job on Employment Interviewers' Decisions.

ERIC Educational Resources Information Center

Gilmore, David C.; And Others

Past research on the employment interview has suggested that interviewers are influenced by many variables, including physical attractiveness. To investigate the potential interaction of applicant sex and attractiveness on hiring decisions, the type of job, applicant sex, and applicant physical attractiveness were manipulated to determine the…

Mobile Applications for Type 2 Diabetes Risk Estimation: a Systematic Review.

PubMed

Fijacko, Nino; Brzan, Petra Povalej; Stiglic, Gregor

2015-10-01

Screening for chronical diseases like type 2 diabetes can be done using different methods and various risk tests. This study present a review of type 2 diabetes risk estimation mobile applications focusing on their functionality and availability of information on the underlying risk calculators. Only 9 out of 31 reviewed mobile applications, featured in three major mobile application stores, disclosed the name of risk calculator used for assessing the risk of type 2 diabetes. Even more concerning, none of the reviewed applications mentioned that they are collecting the data from users to improve the performance of their risk estimation calculators or offer users the descriptive statistics of the results from users that already used the application. For that purpose the questionnaires used for calculation of risk should be upgraded by including the information on the most recent blood sugar level measurements from users. Although mobile applications represent a great future potential for health applications, developers still do not put enough emphasis on informing the user of the underlying methods used to estimate the risk for a specific clinical condition.

Efficacy of spray –Dried Pseudomonas fluorescens, strain CL145A (Zequanox®), for controlling Zebra Mussels (Dreissena polymorpha) within Lake Minnetonka, MN enclosures

USGS Publications Warehouse

Luoma, James A.; Severson, Todd J.

2016-01-01

The efficacy of whole water column and subsurface applications of the biopesticide Zequanox®, a commercially prepared spray-dried powder formulation of Pseudomonas fluorescens (strain CL145A), were evaluated for controlling zebra mussels (Dreissena polymorpha) within 27-m2 enclosures in Lake Minnetonka (Deephaven, Minnesota). Five treatments consisting of (1) two whole water column Zequanox applications, (2) two subsurface Zequanox applications, and (3) an untreated control were completed on each of three independent treatment days during September 2014. The two types of samplers used in the study were (1) type 1 samplers, which were custom built multi-plate samplers (wood, perforated aluminum, and tile substrates) that were placed into Robinson’s Bay in June of 2013 to allow for natural colonization by zebra mussels, and (2) type 2 samplers, which consisted of zebra mussels adhering to perforated aluminum trays that were placed into mesh containment bags. One day prior to treatment, three individual samplers of each type were distributed to test enclosures and exposed to a randomly assigned treatment. Sampling to determine the zebra mussel biomass adhering to type 1 samplers and the survival assessments for zebra mussels contained in type 2 samplers were completed ~40 days after exposure. The zebra mussel biomass adhering to type 1 samplers and the survival of zebra mussels contained in type 2 samplers were significantly less in groups treated with the highest Zequanox concentrations and in groups that received whole water column applications than comparable groups treated with lower Zequanox concentrations and subsurface applications. However, standardization of biomass and survival results to the amount of Zequanox applied showed that the lower concentrations and subsurface applications were more cost efficient, with respect to product used, at reducing zebra mussel biomass and for inducing zebra mussel mortality. Although the subsurface application methods and lower treatment concentrations were more cost efficient, biological significance and management goals should be evaluated prior to selecting the application method. Development and refinement of additional application techniques may improve the utility of the subsurface Zequanox applications.

77 FR 28880 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-16

... (NVO & OFF), 332 Hindry Avenue, Inglewood, CA 90301, Officers: Edison Chen, Manager (Qualifying Individual), Wei-Nung (Janus) Lin, Member/Manager/CEO, Application Type: QI Change/Trade Name Change. Lone... 77032, Officer: Albert E. Garcia, President/Manager/Member (Qualifying Individual), Application Type...

40 CFR 161.34 - Flagging of studies for potential adverse effects.

Code of Federal Regulations, 2011 CFR

2011-07-01

... a type listed in paragraph (b) of this section to support an application for new or amended... types and the criteria to be applied to each. Column 1 lists the study types by name. Column 2 lists the associated Pesticide Assessment Guideline number. Column 3 lists the criteria applicable to each type of...

77 FR 23719 - Ocean Transportation Intermediary License; Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-20

... Logistics, Inc. (NVO & OFF), 180 Champion Way, Northlake, IL 60164. Officers: David F. Gross, CEO (Qualifying Individual), Lance A. Lucibello, Vice President. Application Type: QI Change. CMA CGM Logistics... Fafoutis, General Manager (Qualifying Individual), Frank J. Baragona, Director. Application Type: New NVO...

77 FR 20398 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-04

...), Svi Soudai, Manager, Application Type: New OFF License. Armada USA, LLC dba Armada Logistics (NVO... Logistics (NVO & OFF), 435 Division Street, Elizabeth, NJ 07076, Officer: Carlos E. Feliu, President.../Treasurer, (Qualifying Individual), Application Type: New NVO License. HYC Logistics, Inc. (NVO & OFF), 2600...

76 FR 55909 - Ocean Transportation Intermediary License; Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-09

..., LLC dba AIM Global Logistics (NVO & OFF), 6402 Teluco Street, Houston, TX 77055, Officer: Angelica... Individual), Application Type: Name Change. BestOcean Worldwide Logistics, Inc. (NVO & OFF), 1300 Valley... Individual), Rosette Capito, Vice President, Application Type: Add OFF Service. Caterpillar Logistics Inc...

A qualitative analysis of statements on motivation of applicants for medical school.

PubMed

Wouters, Anouk; Bakker, Anneke H; van Wijk, Inge J; Croiset, Gerda; Kusurkar, Rashmi A

2014-09-23

Selection committees try to ascertain that motivated students are selected for medical school. Self-determination theory stresses that the type of motivation is more important than the quantity of motivation. Autonomous motivation, compared to controlled motivation, in students leads to better learning outcomes. Applicants can express their motivation in written statements, a selection tool which has been found to elicit heterogeneous responses, hampering the comparison of applicants. This study investigates the content of applicants' statements on motivation for medical school in particular, the possibility to distinguish the type of motivation and the differences between selected and non-selected applicants. A thematic analysis was conducted on written statements on motivation (n = 96), collected as a part of the selection procedure for the graduate entry program for medicine and research at our institution. Themes were identified as motivation-related and motivation-unrelated (additional). The motivation-related themes were further classified as autonomous and controlled types of motivation. Group percentages for each theme were compared between selected and non-selected applicants using Chi-square test and Fisher exact test. Applicants mainly described reasons belonging to autonomous type of motivation and fewer reasons belonging to controlled type of motivation. Additional themes in the statements included previous work experience and academic qualifications, ambitions, expectations and descriptions of the program and profession, personal qualities, and personal history. Applicants used strong words to support their stories. The selected and non-selected applicants did not differ in their types of motivation. Non-selected applicants provided more descriptions of personal history than selected applicants (p < 0.05). The statement on motivation does not appear to distinguish between applicants in selection for medical school. Both selected and non-selected applicants reported mainly autonomous motivation for applying, and included a lot of additional information, which was beyond the scope of what was asked from them. The findings raise a question mark on the validity and reliability of the statement on motivation as a tool for selection. It could however be of added value to enable applicants to tell their story, which they appreciate, and to create awareness of the program, resulting in an informed decision to apply.

The Challenges of Creating a Real-Time Data Management System for TRU-Mixed Waste at the Advanced Mixed Waste Treatment Plant

DOE Office of Scientific and Technical Information (OSTI.GOV)

Paff, S. W; Doody, S.

2003-02-25

This paper discusses the challenges associated with creating a data management system for waste tracking at the Advanced Mixed Waste Treatment Plant (AMWTP) at the Idaho National Engineering Lab (INEEL). The waste tracking system combines data from plant automation systems and decision points. The primary purpose of the system is to provide information to enable the plant operators and engineers to assess the risks associated with each container and determine the best method of treating it. It is also used to track the transuranic (TRU) waste containers as they move throughout the various processes at the plant. And finally, themore » goal of the system is to support paperless shipments of the waste to the Waste Isolation Pilot Plant (WIPP). This paper describes the approach, methodologies, the underlying design of the database, and the challenges of creating the Data Management System (DMS) prior to completion of design and construction of a major plant. The system was built utilizing an Oracle database platform, and Oracle Forms 6i in client-server mode. The underlying data architecture is container-centric, with separate tables and objects for each type of analysis used to characterize the waste, including real-time radiography (RTR), non-destructive assay (NDA), head-space gas sampling and analysis (HSGS), visual examination (VE) and coring. The use of separate tables facilitated the construction of automatic interfaces with the analysis instruments that enabled direct data capture. Movements are tracked using a location system describing each waste container's current location and a history table tracking the container's movement history. The movement system is designed to interface both with radio-frequency bar-code devices and the plant's integrated control system (ICS). Collections of containers or information, such as batches, were created across the various types of analyses, which enabled a single, cohesive approach to be developed for verification and validation activities. The DMS includes general system functions, including task lists, electronic signature, non-conformance reports and message systems, that cut vertically across the remaining subsystems. Oracle's security features were utilized to ensure that only authorized users were allowed to log in, and to restrict access to system functionality according to user role.« less

77 FR 75162 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-19

... Cargo & Logistics, Inc. (NVO), 15606 S. Broadway Center Street, Gardner, CA 90248. Officer: Richard Y..., President (QI). Application Type: Add Trade Name Acco Terramar. DI Global Logistics, Inc. (NVO & OFF), 1730... Arenas, President. Application Type: New NVO & OFF License. Exclusive Global Logistics, Inc. (NVO & OFF...

14 CFR 35.1 - Applicability.

Code of Federal Regulations, 2010 CFR

2010-01-01

... STANDARDS: PROPELLERS General § 35.1 Applicability. (a) This part prescribes airworthiness standards for the issue of type certificates and changes to those certificates, for propellers. (b) Each person who... requirements of this part. (c) An applicant is eligible for a propeller type certificate and changes to those...

14 CFR 35.1 - Applicability.

Code of Federal Regulations, 2011 CFR

2011-01-01

... STANDARDS: PROPELLERS General § 35.1 Applicability. (a) This part prescribes airworthiness standards for the issue of type certificates and changes to those certificates, for propellers. (b) Each person who... requirements of this part. (c) An applicant is eligible for a propeller type certificate and changes to those...

14 CFR 35.1 - Applicability.

Code of Federal Regulations, 2014 CFR

2014-01-01

... STANDARDS: PROPELLERS General § 35.1 Applicability. (a) This part prescribes airworthiness standards for the issue of type certificates and changes to those certificates, for propellers. (b) Each person who... requirements of this part. (c) An applicant is eligible for a propeller type certificate and changes to those...

14 CFR 35.1 - Applicability.

Code of Federal Regulations, 2012 CFR

2012-01-01

... STANDARDS: PROPELLERS General § 35.1 Applicability. (a) This part prescribes airworthiness standards for the issue of type certificates and changes to those certificates, for propellers. (b) Each person who... requirements of this part. (c) An applicant is eligible for a propeller type certificate and changes to those...

14 CFR 35.1 - Applicability.

Code of Federal Regulations, 2013 CFR

2013-01-01

... STANDARDS: PROPELLERS General § 35.1 Applicability. (a) This part prescribes airworthiness standards for the issue of type certificates and changes to those certificates, for propellers. (b) Each person who... requirements of this part. (c) An applicant is eligible for a propeller type certificate and changes to those...

76 FR 23598 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-27

.... Jezine Street, Saida, Lebannon, Officers: Ahmad K. Osman, Vice President/Assistant General Manager (Qualifying Individual), Hussein M. Bassal, Assistant General Manager, Application Type: New NVO License..., Application Type: New NVO License. CTC Logistics (L.A.) Inc. (NVO), 5250 W. Century Blvd., Suite 660, Los...

77 FR 13604 - Ocean Transportation Intermediary License; Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-07

... Reece, Member/ Manager, Application Type: New NVO & OFF License. Rescigno Logistics Group, LLC (NVO... LLC (NVO & OFF), 8730 NW 100th Street, Medley, FL 33178, Officers: Tibisay Tovar, Manager (Qualifying Individual), Doris Rodriguez, Manager, Application Type: New NVO & OFF License. Clover Systems, LLC dba...

75 FR 39529 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-09

...), Adam Karabashi, Secretary, Application Type: Add NVO Service and Trade Name Change Blue Ocean Shipping...: Trade Name Change Chemlogix Global LLC dba Vistalogix Global (OFF & NVO), 1777 Sentry Parkway West... Individual), John S. Hamilton, Manager/Chairman/CEO, Application Type: Trade Name Change CIL Freight Inc...

77 FR 12583 - Ocean Transportation Intermediary License; Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-01

... Wassim, President, Application Type: Add NVO Service. ATI Container Services, LLC (NVO & OFF), 11700 NW... Individual), Henry Yun, Secretary, Application Type: New NVO & OFF License. Cargo Distribution Export Inc... Moving and Services Corp. dba Fastway Cargo (NVO), 701 Penhorn Avenue, Unit 1, Secaucus, NJ 07094...

77 FR 74186 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-13

... Logistics, Inc. (NVO & OFF), 7685 NW. 80th Terrace, Medley, FL 33166, Officers: Hugo E. Martinez, Secretary.... Echevarria, President, Application Type: New NVO & OFF License, Global Wide Logistics, Inc. (NVO), 1937 Davis... Member, Application Type: QI Change. Matson Logistics Warehousing, Inc. (NVO & OFF), 1855 Gateway...

Recent development of mass spectrometry and proteomics applications in identification and typing of bacteria.

PubMed

Cheng, Keding; Chui, Huixia; Domish, Larissa; Hernandez, Drexler; Wang, Gehua

2016-04-01

Identification and typing of bacteria occupy a large fraction of time and work in clinical microbiology laboratories. With the certification of some MS platforms in recent years, more applications and tests of MS-based diagnosis methods for bacteria identification and typing have been created, not only on well-accepted MALDI-TOF-MS-based fingerprint matches, but also on solving the insufficiencies of MALDI-TOF-MS-based platforms and advancing the technology to areas such as targeted MS identification and typing of bacteria, bacterial toxin identification, antibiotics susceptibility/resistance tests, and MS-based diagnostic method development on unique bacteria such as Clostridium and Mycobacteria. This review summarizes the recent development in MS platforms and applications in bacteria identification and typing of common pathogenic bacteria. © 2016 The Authors. PROTEOMICS - Clinical Applications Published by WILEY-VCH Verlag GmbH & Co. KGaA.

78 FR 17205 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-20

... Schwartz, President, Application Type: QI Change. Covenant Global Logistics Inc (NVO & OFF), 440 Benmar..., President, Application Type: Add Trade Name CGL Shipping. EXL Logistics, Inc. (NVO), 1444 NW 82nd Avenue... Logistics, LLC (NVO & OFF), 8515 Baymeadows Way, Suite 303, Jacksonville, FL 32256, Officers: Glenn R. Patch...

77 FR 64991 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-24

... & OFF), 8579 NW 72nd Street, Miami, FL 33166. Officers: Greta E. Suarez, Manager (QI), Hector E. Escobar, Manager/Member. Application Type: New NVO & OFF License. Hospitality Logistics International LLC (NVO..., FL 33122. Officers: Luis G. Leal-Perez, Manager (QI), Doris Rodriguez, Manager. Application Type: QI...

77 FR 45610 - Ocean Transportation Intermediary License; Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-01

...), Richard A. Arkey, Vice President, Application Type: New NVO License. Aequus Worldwide Logistics Inc. (NVO..., Application Type: Name Change to Concepts in Freight, Inc. FGN Global Logistics, Inc. (NVO & OFF), 4770...), 341 Erickson Avenue, P.O. Box 124, Essington, PA 19029, Officers: Ari M. Bobrow, Export Manager...

78 FR 14792 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-07

...: Mohamed Y. Ali, Manager (QI); Abdul S. Mohamed, Member. Application Type: Add Trade Name Compass Logistics... Ugueto, Secretary. Application Type: New NVO & OFF License American Forwarding & Logistics, LLC (NVO & OFF), 1919 NW 19th Street, Unit 624, Ft. Lauderdale, FL 33311. Officers: Gabriele Awada, Manager (QI...

77 FR 24712 - Ocean Transportation Intermediary License; Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-25

... Global Logistics LLC (OFF), 9816 Whithorn Drive, Suite B, Houston, TX 77095, Officer: Herbert R. Hogg, Operating Manager (Qualifying Individual), Application Type: New OFF License. Toyo Logistics America, Inc... Individual), Application Type: New NVO License. Choiceone Logistics, Inc. (NVO & OFF), 10025 NW 116th Way, 17...

19 CFR 115.28 - Application for approval.

Code of Federal Regulations, 2013 CFR

2013-04-01

... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers by Design Type § 115.28 Application for approval. Each application by a... inspection; and (e) A statement signed by the manufacturer that: (1) A container of the design type concerned...

19 CFR 115.28 - Application for approval.

Code of Federal Regulations, 2010 CFR

2010-04-01

... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers by Design Type § 115.28 Application for approval. Each application by a... inspection; and (e) A statement signed by the manufacturer that: (1) A container of the design type concerned...

19 CFR 115.28 - Application for approval.

Code of Federal Regulations, 2012 CFR

2012-04-01

... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers by Design Type § 115.28 Application for approval. Each application by a... inspection; and (e) A statement signed by the manufacturer that: (1) A container of the design type concerned...

19 CFR 115.28 - Application for approval.

Code of Federal Regulations, 2014 CFR

2014-04-01

... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers by Design Type § 115.28 Application for approval. Each application by a... inspection; and (e) A statement signed by the manufacturer that: (1) A container of the design type concerned...

19 CFR 115.28 - Application for approval.

Code of Federal Regulations, 2011 CFR

2011-04-01

... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers by Design Type § 115.28 Application for approval. Each application by a... inspection; and (e) A statement signed by the manufacturer that: (1) A container of the design type concerned...

78 FR 8534 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-06

... (QI), Reinhard Eckhoff, Chairman, Application Type: QI Change M E Dey Cargo Corporation dba Orient Grace Container Line (NVO & OFF), 510 Plaza Drive, Suite 1210, Atlanta, GA 30349, Officers: John Davis, Secretary (QI), Debra A. Watmore, President, Application Type: Name Change to Dey Cargo Corporation, dba...

78 FR 75345 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-11

... License. TOP Since Logistics, Inc. (NVO & OFF), 1255 Corporate Center Drive, Suite 210, Monterey Park, CA..., President (QI). Application Type: New NVO License. American Forwarding & Logistics, LLC (NVO & OFF), 3330 NW... Stachow, Managing Member. Application Type: QI Change. Cromarti Logistics LLC (NVO), 2810 Grants Lake Blvd...

78 FR 30921 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-23

.... Reyes, Vice President, Application Type: New NVO & OFF License Dove Global Logistics, Inc. (NVO), 2160..., Application Type: New NVO License ICargo Global Logistics Inc dba ICargo Express (NVO), 2085 New York Avenue... Movers, Inc., dba Isaac's Moving & Storage Sealaska Global Logistics, LLC (NVO & OFF), 5324 Georgia...

77 FR 21559 - Ocean Transportation Intermediary License; Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-10

.... Global Distribution & Logistics LLC (NVO & OFF), 7977 NW 21st Street, Miami, FL 33122. Officers: Jose L.../ Treasurer. Application Type: New NVO & OFF License. Icon Logistics Services LLC (NVO), 14440 Cherry Lane Ct... Vinusa, President. Application Type: New NVO License. Javelin Logistics Corporation (NVO & OFF), 7447...

78 FR 21365 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-10

...), Application Type: QI Change. Morgan USA Logistics Inc (NVO), 16 Birchwood Park Drive, Syosset, NY 11791... Hull Logistics, LLC (NVO & OFF), 17890 Cedarwood Drive, Riverside, CA 92803, Officers: Stanley J... Baines, Chairman of the Board, Application Type: New NVO & OFF License. Point Global Logistics, LLC (OFF...

76 FR 62407 - Ocean Transportation Intermediary License; Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-07

... at (202) 523-5843 or by e-mail at [email protected] . Alltransport International Logistics, Inc. (NVO), 63... Individual), Application Type: New NVO License. American Global Logistics LLC dba AGL (NVO & OFF), 3399... Individual), Dariusz Brodecki, Chairman, Application Type: QI Change. Crowley Logistics, Inc. (NVO & OFF...

Investing in International Information Exchange Activities to Improve the Safety, Cost Effectiveness and Schedule of Cleanup - 13281

DOE Office of Scientific and Technical Information (OSTI.GOV)

Seed, Ian; James, Paula; Mathieson, John

2013-07-01

With decreasing budgets and increasing pressure on completing cleanup missions as quickly, safely and cost-effectively as possible, there is significant benefit to be gained from collaboration and joint efforts between organizations facing similar issues. With this in mind, the US Department of Energy (DOE) and the UK Nuclear Decommissioning Authority (NDA) have formally agreed to share information on lessons learned on the development and application of new technologies and approaches to improve the safety, cost effectiveness and schedule of the cleanup legacy wastes. To facilitate information exchange a range of tools and methodologies were established. These included tacit knowledge exchangemore » through facilitated meetings, conference calls and Site visits as well as explicit knowledge exchange through document sharing and newsletters. A DOE web-based portal has been established to capture these exchanges and add to them via discussion boards. The information exchange is operating at the Government-to-Government strategic level as well as at the Site Contractor level to address both technical and managerial topic areas. This effort has resulted in opening a dialogue and building working relationships. In some areas joint programs of work have been initiated thus saving resource and enabling the parties to leverage off one another activities. The potential benefits of high quality information exchange are significant, ranging from cost avoidance through identification of an approach to a problem that has been proven elsewhere to cost sharing and joint development of a new technology to address a common problem. The benefits in outcomes significantly outweigh the costs of the process. The applicability of the tools and methods along with the lessons learned regarding some key issues is of use to any organization that wants to improve value for money. In the waste management marketplace, there are a multitude of challenges being addressed by multiple organizations and the effective pooling and exchange of knowledge and experience can only be of benefit to all participants to help complete the cleanup mission more quickly and more cost effectively. This paper examines in detail the tools and processes used to promote information exchange and the progress made to date. It also discusses the challenges and issues involved and proposes recommendations to others who are involved in similar activities. (authors)« less

Natural product and natural product derived drugs in clinical trials.

PubMed

Butler, Mark S; Robertson, Avril A B; Cooper, Matthew A

2014-11-01

There are a significant number of natural product (NP) drugs in development. We review the 100 NP and NP-derived compounds and 33 Antibody Drug Conjugates (ADCs) with a NP-derived cytotoxic component being evaluated in clinical trials or in registration at the end of 2013. 38 of these compounds and 33 ADCs are being investigated as potential oncology treatments, 26 as anti-infectives, 19 for the treatment of cardiovascular and metabolic diseases, 11 for inflammatory and related diseases and 6 for neurology. There was a spread of the NP and NP-derived compounds through the different development phases (17 in phase I, 52 in phase II, 23 in phase III and 8 NDA and/or MAA filed), while there were 23 ADCs in phase I and 10 in phase II. 50 of these 100 compounds were either NPs or semi-synthetic (SS) NPs, which indicated the original NP still plays an important role. NP and NP-derived compounds for which clinical trials have been halted or discontinued since 2008 are listed in the Supplementary Information. The 25 NP and NP-derived drugs launched since 2008 are also reviewed, and late stage development candidates and new NP drug pharmacophores analysed. The short term prospect for new NP and NP-derived drug approvals is bright, with 31 compounds in phase III or in registration, which should ensure a steady stream of approvals for at least the next five years. However, there could be future issues for new drug types as only five new drug pharmacophores discovered in the last 15 years are currently being evaluated in clinical trials. The next few years will be critical for NP-driven lead discovery, and a concerted effort is required to identify new biologically active pharmacophores and to progress these and existing compounds through pre-clinical drug development into clinical trials.

32 CFR 865.114 - Decisional document.

Code of Federal Regulations, 2010 CFR

2010-07-01

... punishment). (xii) Conviction by court-martial. (xiii) Prior military service and type of discharge received. (3) A list of the type of documents submitted by or on behalf of the applicant (including a written... documentary evidence), if any. (4) A statement whether the applicant testified, and a list of the type of...

14 CFR 21.251 - Limits of applicability.

Code of Federal Regulations, 2011 CFR

2011-01-01

... certification; (2) Changes in the type design of products for which the manufacturer holds, or obtains, a type... type certificate under § 21.253, to permit the operation of those aircraft for the purpose of research and development, crew training, market surveys, or the showing of compliance with the applicable...

Some new retarded nonlinear Volterra-Fredholm type integral inequalities with maxima in two variables and their applications.

PubMed

Xu, Run; Ma, Xiangting

2017-01-01

In this paper, we establish some new retarded nonlinear Volterra-Fredholm type integral inequalities with maxima in two independent variables, and we present the applications to research the boundedness of solutions to retarded nonlinear Volterra-Fredholm type integral equations.

77 FR 30530 - Ocean Transportation Intermediary License; Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-23

... Individual), Application Type: New NVO License. Global Wine Logistics, Inc. (NVO & OFF), 197 Route 19 South... Hextall, President/CEO, Application Type: Add NVO Service/Trade Name Change. M & D Global Logistics, Inc... Service. Metro Freight Services, Inc. dba Maritime Express Lines (M.E.L.) (NVO & OFF), 1225 W. St. George...

Revised catalog of types of CODES applications implemented using linked state data : crash outcome data evaluation system (CODES)

DOT National Transportation Integrated Search

2000-06-01

The purpose of the Revised Catalog of Types of CODES Applications Implemented Using Linked : State Data (CODES) is to inspire the development of new applications for linked data that support : efforts to reduce death, disability, severity, and health...

78 FR 48870 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-12

...: Tufan Duygun, Manager (QI), Ozisik Serhat, Member, Application Type: Add Trade Name Daimon Logistics USA... & OFF), 3950 S 700 E, Suite 101, Salt Lake City, UT 84107, Officers: Rachel A. Kingston, Manager (QI), Elijah E. Kingston, Manager, Application Type: New NVO & OFF License. DMS America, L.L.C. (NVO & OFF...

78 FR 55698 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-11

...), Karla Costilla, Member/Manager, Application Type: New NVO & OFF License. ICAT Logistics, Inc. (OFF..., Washington, DC 20573, by telephone at (202) 523-5843 or by email at [email protected] . Abaco Logistics Corporation..., CFO, Application Type: QI Change & Add OFF Service. American General Logistics, Inc. (NVO), 626 N...

76 FR 79682 - Ocean Transportation Intermediary License; Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-22

... at (202) 523-5843 or by email at [email protected] . A.C.T. Logistics, LLC (NVO), 154-09 146th Avenue, 3rd...-President/Secretary. Application Type: License Transfer. Canyon Global Logistics, LLC (NVO & OFF), 2928-B..., General Manager, (Qualifying Individual), Oleg Ardachev, President. Application Type: New OFF License...

75 FR 44261 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-28

... Logistics Global, LLC (NVO & OFF), 10990 Roe Avenue, MS E101, Overland Park, KS 66211. Officers: Tina M...). Application Type: New NVO & OFF License. CJC Logistics LLC (NVO & OFF), 186 Alps Road, Wayne, NJ 07470... (Qualifying Individual). Application Type: New NVO & OFF License. Joker Logistics USA, Inc. (NVO & OFF), 11301...

77 FR 61752 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-11

..., Application Type: New OFF License. Korchina Logistics USA, Inc. (NVO & OFF), 18120 S. Broadway Street, Unit A, Gardena, CA 90248, Officers: Jong (A.K.A. Jake) K. Park, CFO (QI), Eric Sun, President, Application Type... License. Ocean Line Logistics Inc. (NVO & OFF), 630 W. Duarte Road, 205, Arcadia, CA 91007, Officer...

76 FR 554 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-05

... at (202) 523-5843 or by e-mail at [email protected] . Antillean Logistics Center, Inc. (NVO & OFF), 3038 NW...), Annette Morgan, Secretary. Application Type: QI Change. Charter Logistics USA Inc. (NVO), 15929 Gard...), Stina Storr, Member/Managing Member. Application Type: New NVO License. DW Logistics Solutions, Inc...

75 FR 54884 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-09

... License. Advanced Logistics, Inc. (NVO), 3301 NW 97th Avenue, Miami, FL 33172. Officers: Arturo R. Alvarez... President. Application Type: New OFF License. Altus Oil & Gas Services, Inc. dba Altus Project Logistics.... Application Type: New NVO & OFF License. Barracuda Global Logistics LLC dba BGLSHIP (NVO & OFF), 417 Stamets...

78 FR 5441 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-25

... Trade Name Blu Logistics. Brutos International Corp. (NVO & OFF), 428 S. Atlantic Blvd., Suite 203, Monterey Park, CA 91754, Officers: Janet Li, Secretary (QI), Jesse Wu, CEO/CFO, Application Type: New NVO..., President (QI), Olen D. Woods, Director, Application Type: New NVO License. Global Logistics New Jersey, LLC...

The evaluation of dentinal tubule occlusion by desensitizing agents: a real-time measurement of dentinal fluid flow rate and scanning electron microscopy.

PubMed

Kim, S Y; Kim, E J; Kim, D S; Lee, I B

2013-01-01

The aims of this study were to examine changes in dentinal fluid flow (DFF) during the application of a desensitizing agent and to compare the permeability reduction levels among different types of desensitizing agents. A cervical cavity was prepared for the exposure of cervical dentin on an extracted human premolar connected to a subnanoliter fluid flow measuring device under 20 cm of water pressure. The cavity was acid-etched with 32% phosphoric acid to make dentin highly permeable. The different types of desensitizing agents that were applied on the cavity were Seal&Protect as the light-curing adhesive type, SuperSeal and BisBlock as oxalate types, Gluma Desensitizer as the protein-precipitation type, and Bi-Fluoride 12 as the fluoride type. DFF was measured from the time before the application of the desensitizing agent throughout the application procedure to five minutes after the application. The characteristics of dentinal tubule occlusion of each desensitizing agent were examined by scanning electron microscopy. The DFF rate after each desensitizing agent application was significantly reduced when compared to the initial DFF rate before application for all of the desensitizing agents (p<0.05). Seal&Protect showed a greater reduction in the DFF rate when compared to Gluma Desensitizer and Bi-Fluoride 12 (p<0.05). SuperSeal and BisBlock exhibited a greater reduction in DFF rate when compared to Bi-Fluoride 12 (p<0.05). The dentin hypersensitivity treatment effects of the employed desensitizing agents in this study were confirmed through real-time measurements of DFF changes. The light-curing adhesive and oxalate types showed greater reduction in the DFF rate than did the protein-precipitation and fluoride types.

Patent life of antiretroviral drugs approved in the US from 1987 to 2007.

PubMed

Rodriguez-Monguio, Rosa; Seoane-Vazquez, Enrique

2009-06-01

This study analyzes the effective patent life of antiretroviral (ARV) new molecular entities (NMEs) approved for marketing in the United States (US) between 1987 and 2007. The study includes all NMEs approved during the study period with at least one patent listed in the Orange Book (OB). Drugs discontinued from the market were excluded from the analysis. Data sources are the US Food and Drug Administration (FDA) and the US Patent and Trademark Office. A comparison between the effective patent life of ARV NMEs and NMEs from other therapeutic classes was performed. The first and last patents were used to estimate the minimum and maximum effective patent life of NMEs. Group differences were assessed using group comparison t-tests, Chi-Square and Fishers' exact tests. The FDA approved 547 NMEs during the study period; 153 NMEs did not have a patent listed in the OB or were discontinued from the US market. The patent analysis included 22 ARV NMEs and 372 other NMEs. ARV MNEs had a range from 1 to 15 patents listed in the OB. The FDA new drug application (NDA) review time was shorter for ARVs (5.8+/-2.3 months) than for other NMEs (23.6+/-18.7 months). ARV NMEs had an average of 13.2+/-3.8 years of effective patent life for the first patent versus 11.0+/-4.2 years for other NMEs. ARV NMEs had an average of 17.5+/-3.6 years of effective patent life for the last patent versus the 14.8+/-4.8 years for other NMEs. The effective patent life listed for the last patent of seven ARV NMEs (31.8%) exceeded 20 years. Shortening the drug approval process increased the effective patent life of ARVs and facilitated faster entry of new drugs into the market. ARVs had an average of 2-3 more years of effective patent life than other therapeutic classes and, therefore, a longer period without generic competition.

Change in formulation and its potential clinical and pharmacoeconomic value: example of extended release venlafaxine.

PubMed

Haeusler, Jean-Marc C

2009-05-01

The 505(b)(2) route of a New Drug Application (NDA) allows published literature or previous FDA findings of safety and effectiveness to be used for approval. Such drugs are not therapeutic equivalents (i.e., generics); instead, the FDA calls them pharmaceutical alternatives. A recent example is the approval of venlafaxine extended-release (ER) tablets, developed as an alternative to the widely used ER venlafaxine capsules. The smaller size of the tablets makes them available in a 225-mg strength, which is the approved maximum dose in major depressive disorder after up-titration but currently unavailable in the capsule formulation, requiring patients on this dose to take two or three capsules; in addition, the tablets are priced at a discount compared to the capsules. The objective of this review was to investigate how the change in formulation of ER venlafaxine from capsules to tablets, as an example of such a change in formulation, can potentially offer value to patients and society, with a specific focus on pill burden, drug cost, and adherence. Based on a MEDLINE literature search, the pertinent literature was reviewed in a qualitative manner. Simplifying treatment regimens, reducing pill burden, and reducing drug costs are recognized strategies for improving adherence. This can be of particular benefit in psychiatric illness because of high rates of nonadherence to treatment. Lack of adherence may negatively impact treatment outcomes and increase disease cost. As such, the ER venlafaxine tablets have the potential to reduce pill burden, improve adherence and outcomes, and reduce cost to patients and society. These preliminary findings need to be corroborated with more primary research and a systematic review of formulation changes. A change in formulation of established therapies such as ER venlafaxine has the potential to offer clinical and pharmacoeconomic benefits to patients and society.

32 CFR 724.803 - The decisional document.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) Convictions by court-martial; (xvii) Prior military service and type of discharge received. (2) Any other... picture of the overall quality of the applicant's service. (b) A list of the type of documents submitted... whether the applicant testified, and a list of the type of witnesses, if any , who testified on behalf of...

Primary battery design and safety guidelines handbook

NASA Technical Reports Server (NTRS)

Bragg, Bobby J.; Casey, John E.; Trout, J. Barry

1994-01-01

This handbook provides engineers and safety personnel with guidelines for the safe design or selection and use of primary batteries in spaceflight programs. Types of primary batteries described are silver oxide zinc alkaline, carbon-zinc, zinc-air alkaline, manganese dioxide-zionc alkaline, mercuric oxide-zinc alkaline, and lithium anode cells. Along with typical applications, the discussions of the individual battery types include electrochemistry, construction, capacities and configurations, and appropriate safety measures. A chapter on general battery safety covers hazard sources and controls applicable to all battery types. Guidelines are given for qualification and acceptance testing that should precede space applications. Permissible failure levels for NASA applications are discussed.

Application of remote sensor data to geologic analysis of the Bonanza test site Colorado

NASA Technical Reports Server (NTRS)

Lee, K. (Compiler)

1975-01-01

Selected samples of anomalous surface features commonly associated with the various types of uranium deposits are presented and recommendations for sensor applications are given. The features studied include: epigenetic uranium ore roll type; precambrian basal conglomerate type; vein-type uranium deposits; pipe-structure or diatreme deposits; evaporitic uranium deposits. The hydrogeology of the Mosquito Range and the San Luis Valley is also examined.

Metformin extended release: metformin gastric retention, metformin GR, metformin XR.

PubMed

2005-01-01

Metformin extended release [Glumetza, metformin hydrochloride, metformin gastric retention, metformin GR] is a proprietary once-a-day formulation of metformin hydrochloride under development with Depomed for the treatment of diabetes mellitus. In May 2002, Depomed licensed manufacturing and marketing rights for its proprietary formulation of metformin extended release (500mg dose) to Biovail Corporation for the US (including Puerto Rico) and Canada. Under the terms of the agreement, Biovail will pay DepoMed a 25 million dollars milestone fee upon approval of the 500mg dosage and also customary royalties on the net sales in the US and Canada. Biovail also agreed to acquire approximately 2.4 million of additionally issued Depomed shares for 12.3 million dollars. Biovail has subsequently developed a 1000mg dose of metformin extended release [metformin XR] using its proprietary Smartcoat delivery technology allowing a graduated release of the active drug from the tablet. In April 2004, Depomed and Biovail amended their original license agreement of May 2002. Under the terms of the amended agreement, Depomed will receive royalties on sales of Biovail's 1000mg tablet in the US and Canada. In turn, Biovail acquired access to Depomed's clinical data for the metformin 500mg tablet that will be used to accelerate regulatory filings for Biovail's 1000mg tablet and establish equivalence between the two dosages. Biovail is seeking marketing partners for metformin extended release (Glumetza) in the US. The company anticipates signing an agreement for the US during the second half of 2005. In Canada, Biovail Corporation will market Glumetzatrade mark through its Canadian division, Bioval Pharmaceuticals Canada. Depomed has an agreement with LG Life Sciences for the commercialisation and distribution of metformin extended release in Korea. Metformin GR is available for partnership in Europe and Asia. Biovail Corporation and Depomed announced in June 2005 that the US FDA has approved metformin extended release (Glumetza) 500mg and 1000mg tablets for the treatment of type 2 diabetes mellitus. Biovail plans launching the product in the fourth quarter of 2005. In July 2005, Biovail paid Depomed a 25 million dollars milestone payment following approval of metformin extended release in the US for type 2 diabetes. In March 2005, Biovail Corporation and Depomed announced that they have received an approvable letter from the FDA for the once-daily, extended-release formulation of metformin extended release (Glumetza) 500mg and 1000mg tablets. The letter specified an issue related to finalising one manufacturing specification. There were no clinical labeling issues identified in the letter. Both companies filed a response to a specified issue at the FDA on 8 April 2005. The companies believed that the response will be classified as a Class I response with a 60-day review period. The 500mg dosage was developed by Depomed using its patented drug delivery GR technology, while Biovail developed metformin 1000mg dose using its proprietary Smartcoat delivery technology. Biovail's NDA for a once-daily, extended-release formulation of metformin HCl for the treatment of type II diabetes was filed in April 2004 and accepted for review in June 2004 by the FDA. Depomed completed two double-blind, pivotal, phase III clinical trials with metformin extended release 500mg at 60 sites in the US in more than 1000 patients with type 2 diabetes. In three different dosing regimens, metformin extended release significantly decreased the glycosylated haemoglobin level similarly to that of metformin immediate-release. Biovail successfully compared metformin extended release 1000mg dose with Depomed's 500mg dose in multiple equivalence studies. In these studies, metformin extended release was well tolerated and demonstrated an excellent safety profile in terms of gastrointestinal adverse events. On 1 June 2005, Depomed and Biovail Comporation, the licensee, announced that the Therapeutic Products Directorate in Canada issued a Notice of Compliance for metformin extended release (Glumetza) 500mg and 1000mg for the treatment of type 2 diabetes. Biovail Pharmaceuticals Canada plans to launch the product in the fourth quarter of 2005. Biovail has submitted an application for metformin extended release with the Therapeutic Products Directorate in Canada. and received notification of acceptance for review in August 2004. Bristol-Myers Squibb is marketing a proprietary, once-daily extended-release formulation of metformin (Glucophage XR). Several companies are developing controlled-release and extended-release formulations of metformin.

Sex Discrimination in Simulated Employment Contexts: A Meta-analytic Investigation.

ERIC Educational Resources Information Center

Davison, Heather K.; Burke, Michael J.

2000-01-01

The hypothesis that applicant and rater sex, job sex-type, and job-relevant information would affect discrimination against applicants was tested in simulations. Both sexes received lower ratings when applying for opposite-sex-typed jobs. Both male and female raters rated male applicants higher. Differences between male and female ratings…

7 CFR 52.47 - Changing types of service.

Code of Federal Regulations, 2012 CFR

2012-01-01

... Changing types of service. If an applicant cancels a new year-round contract before a full year has elapsed, the applicant shall be charged the difference between the year-round rate and less than year-round rate for the full period the year-round contract was in effect. If an applicant cancels a year-round...

7 CFR 52.47 - Changing types of service.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Changing types of service. If an applicant cancels a new year-round contract before a full year has elapsed, the applicant shall be charged the difference between the year-round rate and less than year-round rate for the full period the year-round contract was in effect. If an applicant cancels a year-round...

78 FR 66713 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-06

..., Washington, DC 20573, by telephone at (202) 523-5843 or by email at [email protected] . Action One Logistics, Inc... President, Application Type: New NVO & OFF License. Andes Logistics USA LLC (NVO & OFF) 7500 NW 25 Street, 7..., Application Type: QI Change. Cargo Freight Services, Ltd. (NVO), 510 Plaza Drive, Suite 2720, College Park, GA...

Decommissioning of the Dragon High Temperature Reactor (HTR) Located at the Former United Kingdom Atomic Energy Authority (UKAEA) Research Site at Winfrith - 13180

DOE Office of Scientific and Technical Information (OSTI.GOV)

Smith, Anthony A.

2013-07-01

The Dragon Reactor was constructed at the United Kingdom Atomic Energy Research Establishment at Winfrith in Dorset through the late 1950's and into the early 1960's. It was a High Temperature Gas Cooled Reactor (HTR) with helium gas coolant and graphite moderation. It operated as a fuel testing and demonstration reactor at up to 20 MW (Thermal) from 1964 until 1975, when international funding for this project was terminated. The fuel was removed from the core in 1976 and the reactor was put into Safestore. To meet the UK's Nuclear Decommissioning Authority (NDA) objective to 'drive hazard reduction' [1] itmore » is necessary to decommission and remediate all the Research Sites Restoration Ltd (RSRL) facilities. This includes the Dragon Reactor where the activated core, pressure vessel and control rods and the contaminated primary circuit (including a {sup 90}Sr source) still remain. It is essential to remove these hazards at the appropriate time and return the area occupied by the reactor to a safe condition. (author)« less

Low-complexity DOA estimation from short data snapshots for ULA systems using the annihilating filter technique

NASA Astrophysics Data System (ADS)

Bellili, Faouzi; Amor, Souheib Ben; Affes, Sofiène; Ghrayeb, Ali

2017-12-01

This paper addresses the problem of DOA estimation using uniform linear array (ULA) antenna configurations. We propose a new low-cost method of multiple DOA estimation from very short data snapshots. The new estimator is based on the annihilating filter (AF) technique. It is non-data-aided (NDA) and does not impinge therefore on the whole throughput of the system. The noise components are assumed temporally and spatially white across the receiving antenna elements. The transmitted signals are also temporally and spatially white across the transmitting sources. The new method is compared in performance to the Cramér-Rao lower bound (CRLB), the root-MUSIC algorithm, the deterministic maximum likelihood estimator and another Bayesian method developed precisely for the single snapshot case. Simulations show that the new estimator performs well over a wide SNR range. Prominently, the main advantage of the new AF-based method is that it succeeds in accurately estimating the DOAs from short data snapshots and even from a single snapshot outperforming by far the state-of-the-art techniques both in DOA estimation accuracy and computational cost.

Multi-Detector Analysis System for Spent Nuclear Fuel Characterization

DOE Office of Scientific and Technical Information (OSTI.GOV)

Reber, Edward Lawrence; Aryaeinejad, Rahmat; Cole, Jerald Donald

1999-09-01

The Spent Nuclear Fuel (SNF) Non-Destructive Analysis (NDA) program at INEEL is developing a system to characterize SNF for fissile mass, radiation source term, and fissile isotopic content. The system is based on the integration of the Fission Assay Tomography System (FATS) and the Gamma-Neutron Analysis Technique (GNAT) developed under programs supported by the DOE Office of Non-proliferation and National Security. Both FATS and GNAT were developed as separate systems to provide information on the location of special nuclear material in weapons configuration (FATS role), and to measure isotopic ratios of fissile material to determine if the material was frommore » a weapon (GNAT role). FATS is capable of not only determining the presence and location of fissile material but also the quantity of fissile material present to within 50%. GNAT determines the ratios of the fissile and fissionable material by coincidence methods that allow the two prompt (immediately) produced fission fragments to be identified. Therefore, from the combination of FATS and GNAT, MDAS is able to measure the fissile material, radiation source term, and fissile isotopics content.« less

A secreted antibacterial neuropeptide shapes the microbiome of Hydra.

PubMed

Augustin, René; Schröder, Katja; Murillo Rincón, Andrea P; Fraune, Sebastian; Anton-Erxleben, Friederike; Herbst, Eva-Maria; Wittlieb, Jörg; Schwentner, Martin; Grötzinger, Joachim; Wassenaar, Trudy M; Bosch, Thomas C G

2017-09-26

Colonization of body epithelial surfaces with a highly specific microbial community is a fundamental feature of all animals, yet the underlying mechanisms by which these communities are selected and maintained are not well understood. Here, we show that sensory and ganglion neurons in the ectodermal epithelium of the model organism hydra (a member of the animal phylum Cnidaria) secrete neuropeptides with antibacterial activity that may shape the microbiome on the body surface. In particular, a specific neuropeptide, which we call NDA-1, contributes to the reduction of Gram-positive bacteria during early development and thus to a spatial distribution of the main colonizer, the Gram-negative Curvibacter sp., along the body axis. Our findings warrant further research to test whether neuropeptides secreted by nerve cells contribute to the spatial structure of microbial communities in other organisms.Certain neuropeptides, in addition to their neuromodulatory functions, display antibacterial activities of unclear significance. Here, the authors show that a secreted neuropeptide modulates the distribution of bacterial communities on the body surface during development of the model organism Hydra.

The Beaming Structures of Jupiter’s Decametric Common S-bursts Observed from the LWA1, NDA, and URAN2 Radio Telescopes

NASA Astrophysics Data System (ADS)

Imai, Masafumi; Lecacheux, Alain; Clarke, Tracy E.; Higgins, Charles A.; Panchenko, Mykhaylo; Dowell, Jayce; Imai, Kazumasa; Brazhenko, Anatolii I.; Frantsuzenko, Anatolii V.; Konovalenko, Alexandr A.

2016-08-01

On 2015 February 21, simultaneous observations of Jupiter's decametric radio emission between 10 and 33 MHz were carried out using three powerful low-frequency radio telescopes: the Long Wavelength Array Station One in the USA, the Nançay Decameter Array in France, and the URAN2 telescope in Ukraine. We measured the lag times of short-bursts (S-bursts) for 105 minutes of data over effective baselines of up to 8460 km by using cross-correlation analysis of the spectrograms from each instrument. Of particular interest is the measurement of the beaming thickness of S-bursts, testing if either flashlight- or beacon-like beaming is emanating from Jupiter. We find that the lag times for all pairs drift slightly as time elapses, in agreement with expectations from the flashlight-like beaming model. This leads to a new constraint of the minimum beaming thickness of 2.″66. Also, we find that most of the analyzed data abound with S-bursts, whose occurrence probability peaks at 17-18 MHz.

The Cassini project: Lessons learned through operations

NASA Astrophysics Data System (ADS)

McCormick, Egan D.

1998-01-01

The Cassini space probe requires 180 238Pu Light-weight Radioisotopic Heater Units (LWRHU) and 216 238Pu General Purpose Heat Source (GPHS) pellets. Additional LWRHU and GPHS pellets required for non-destructive (NDA) and destructive assay purposes were fabricated bringing the original pellet requirement to 224 LWRHU and 252 GPHS. Due to rejection of pellets resulting from chemical impurities in the fuel and/or failure to meet dimensional specifications a total of 320 GPHS pellets were fabricated for the mission. Initial plans called for LANL to process a total of 30 kg of oxide powder for pressing into monolithic ceramic pellets. The original 30 kg commitment was processed within the time frame allotted; an additional 8 kg were required to replace fuel lost due to failure to meet Quality Assurance specifications for impurities and dimensions. During the time frame allotted for pellet production, operations were impacted by equipment failure, unacceptable fuel impurities levels, and periods of extended down time, >30 working days during which little or no processing occurred. Throughout the production process, the reality of operations requirements varied from the theory upon which production schedules were based.

Sosyal İletişim Ölçeğinin Okul Öncesi Çocuklardaki Geçerlik ve Güvenirliği

PubMed Central

Öner, Pınar; Öner, Özgür; Çöp, Esra; Munir, Kerim M.

2014-01-01

ÖZET Sosyal iletişim ölçeğinin okul öncesi çocuklardaki geçerlik ve güvenirliği Amaç Bu çalışmada Otizm Spektrum Bozukluklarının değerlendirilmesinde kullanılan Sosyal İletişim Ölçeğinin (SİÖ) Türkçe’ye uyarlanarak geçerlik ve güvenirliğinin belirlenmesi amaçlanmıştır. SİÖ, Otizm Tanı Görüşmesi (Autism Diagnostic Interview-ADI) temel alınarak hazırlanmış ve bu görüşmenin kısaltılarak ölçek haline getirilmiş şeklidir. Yöntem 2010–2011 yıllarında polikliniğimize başvuran olgular arasından DSM-IV ölçütlerine göre otizm (n=49) ve Başka Türlü Adlandırılamayan Yaygın Gelişimsel Bozukluk (n=18) tanısı alan 18–60 ay arası çocuklar, Otizm Spektrum Bozukluğu (OSB) grubu olarak çalışmaya alınmıştır. Kontrol grubu olarak aynı yaş grubundaki gelişimsel geriliği olan (25 Mental Retardasyon, 26 konuşma gecikmesi) 51 çocuk ve tipik gelişim gösteren 71 çocuk çalışmaya alınmıştır. Grupların ölçek puanlarının karşılaştırılmasında tek yönlü varyans analizi ve post-hoc Tukey HSD testi kullanılmıştır. Güvenilirlik analizi için iç tutarlılık göstergesi olarak Cronbach alfa değerleri, madde-toplam puan korelasyonları ve test-tekrar test güvenirliği hesaplanmıştır. Faktörlerin belirlenmesi için ana bileşenler yöntemi ve varimax rotasyonu kullanılmıştır. Kesim noktaları, duyarlılık, özgüllük, negatif ve pozitif yordayıcı değerlerin hesaplanması için Receiver Operator Characteristic (ROC) eğrileri kullanılmıştır. Bulgular Ana bileşenler yöntemi ve bunu izleyen varimax rotasyonu sonucunda 3 faktör elde edilmiştir. Bu faktörler sırasıyla İletişim, Karşılıklı Sosyal Etkileşim ve Basmakalıp Davranışlar/Kısıtlı İlgi Alanları olarak adlandırılmıştır. Ölçeğin toplam puanının Cronbach alfa değeri 0.88 olarak bulunmuştur. Ölçeğin toplam puanı için test-tekrar test güvenilirliği (r=0.90, p<0.01) olarak saptanmıştır. Gruplar arasında SİÖ Toplam, İletişim, Karşılıklı Sosyal Etkileşim ve Basmakalıp Davranışlar/Kısıtlı İlgi Alanları puanları anlamlı farklılıklar göstermektedir. OSB grubunda SİÖ Toplam, Karşılıklı Sosyal Etkileşim ve Basmakalıp Davranışlar/Kısıtlı İlgi Alanları puanları en yüksekken İletişim puanı en düşüktür. Gelişim Gerilik (GG) grubu ile sağlıklı kontrol grubunun SİÖ İletişim ve Basmakalıp Davranışlar/Kısıtlı İlgi Alanları puanları arasında anlamlı fark bulunmamıştır. ROC analizlerine göre hem Toplam hem de Karşılıklı Sosyal Etkileşim puanları, OSB grubu ile sağlıklı kontrol grubunu çok iyi (eğri altındaki alan sırasıyla 0.89 ve 0.91) şekilde ayırırken Basmakalıp Davranışlar/Kısıtlı İlgi Alanları puanı da daha az ayırıcıdır (eğri altındaki alan 0.72). SİÖ Toplam puanı için kesim noktası 14.5 puan olarak belirlendiğinde duyarlılık 0.84, özgüllük 0.81, pozitif yordama değeri 0.82 ve negatif yordama değeri 0.83 olarak bulunmaktadır. Karşılıklı Sosyal Etkileşim puanı için kesim noktası 7.5 puan olarak belirlendiğinde duyarlılık 0.91, özgüllük 0.82 pozitif yordama değeri 0.83 ve negatif yordama değeri 0.90 olarak saptanmıştır. Sonuç Sonuçlar, 60 ay öncesi çocuklarda SİÖ’de Toplam puanın, OSB olgularını GG olgularından ve sağlıklı kontrollerden ayırabildiğini, ancak Karşılıklı Sosyal Etkileşim puanının daha da duyarlı ve özgül olduğunu ortaya koymaktadır. Bunun yanında, pozitif ve negatif yordayıcılık incelendiğinde yine de yanlış pozitifliğin ve negatifliğin oldukça yüksek olabileceği görülmüştür. Özellikle küçük çocuklarda Karşılıklı Sosyal Etkileşim maddeleri klinikte ayırıcı tanı için faydalı görünmektedir. Hem tanı hem de takibe yardım amacıyla değerli bir araç olarak kabul edilen ADI uygulanmasının mümkün olmayacağı durumlarda onun yerine daha kısa ve daha pratik bir ölçüm yöntemi olarak kullanılabilecek bu ölçeğin Türkçe’ye kazandırılmış olması önemlidir. PMID:25580078

Parseval-Type Relations for Laplace Transform and their Applications

ERIC Educational Resources Information Center

Herman, S.; Maceli, J.; Rogala, M.; Yurekli, O.

2008-01-01

In the present note, two Parseval-type relations involving the Laplace transform are given. The application of the relations is demonstrated in evaluating improper integrals and Laplace transforms of trigonometric functions.

Recent development of mass spectrometry and proteomics applications in identification and typing of bacteria

PubMed Central

Chui, Huixia; Domish, Larissa; Hernandez, Drexler; Wang, Gehua

2016-01-01

Identification and typing of bacteria occupy a large fraction of time and work in clinical microbiology laboratories. With the certification of some MS platforms in recent years, more applications and tests of MS‐based diagnosis methods for bacteria identification and typing have been created, not only on well‐accepted MALDI‐TOF‐MS‐based fingerprint matches, but also on solving the insufficiencies of MALDI‐TOF‐MS‐based platforms and advancing the technology to areas such as targeted MS identification and typing of bacteria, bacterial toxin identification, antibiotics susceptibility/resistance tests, and MS‐based diagnostic method development on unique bacteria such as Clostridium and Mycobacteria. This review summarizes the recent development in MS platforms and applications in bacteria identification and typing of common pathogenic bacteria. PMID:26751976

The use of impression management tactics in structured interviews: a function of question type?

PubMed

Ellis, Aleksander P J; West, Bradley J; Ryan, Ann Marie; DeShon, Richard P

2002-12-01

This study investigated impression management tactic use during structured interviews containing both experience-based and situational questions. Specifically, the authors examined whether applicants' use of impression management tactics depended on question type. Results from 119 structured interviews indicated that almost all of the applicants used some form of impression management. Significantly more assertive than defensive impression management tactics were used, and among assertive tactics, applicants tended to use self-promotion rather than ingratiation. However, different question types prompted the use of different impression management tactics. Ingratiation tactics were used significantly more when applicants answered situational questions, whereas self-promotion tactics were used significantly more when applicants answered experience-based questions. Furthermore, the use of self-promotion and ingratiation tactics was positively related to interviewer evaluations.

14 CFR 61.64 - Use of a flight simulator and flight training device.

Code of Federal Regulations, 2011 CFR

2011-01-01

... test. (e) Use of a flight simulator for the powered-lift rating. If an applicant uses a flight simulator for training or the practical test for the powered-lift category or type rating— (1) The flight simulator— (i) Must represent the category and type of powered-lift rating (if a type rating is applicable...

14 CFR 61.64 - Use of a flight simulator and flight training device.

Code of Federal Regulations, 2010 CFR

2010-01-01

... test. (e) Use of a flight simulator for the powered-lift rating. If an applicant uses a flight simulator for training or the practical test for the powered-lift category or type rating— (1) The flight simulator— (i) Must represent the category and type of powered-lift rating (if a type rating is applicable...

Application Use, Online Relationship Types, Self-Disclosure, and Internet Abuse among Children and Youth: Implications for Education and Internet Safety Programs

ERIC Educational Resources Information Center

Blau, Ina

2011-01-01

This study explores the relationships between Internet abuse (IA)--self-disclosure, online application usage, and relationship types--traditional long-distance, purely virtual, and migratory mixed-mode. An online questionnaire was administered to 2884 children and youth. According to the hypotheses, applications differed in their relationships…

Levitation or suspension: Which one is better for the heavy-load HTS maglev transportation

NASA Astrophysics Data System (ADS)

Liu, Wei; Kang, Dong; Yang, X. F.; Wang, Fei; Peng, G. H.; Zheng, Jun; Ma, G. T.; Wang, J. S.

2015-09-01

Because of the limitation of permanent magnet (PM), the efficient of bulk high-Tc superconductor (HTSC) in a high-Tc superconducting (HTS) maglev system is not very high. It is better to magnetize the bulk HTSC with a high trapped field to increase the force density. The different application type of magnetized bulk HTSC in a maglev system, namely, levitation or suspension type, will bring quite different operation performance. This paper discusses the influence of application type on operation performance of magnetized bulk HTSC by experiments and simulations. From the discussion, it can be found which application type is better for the heavy-load HTS maglev system.

78 FR 2347 - National Standards for Traffic Control Devices; the Manual on Uniform Traffic Control Devices for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-11

... rulemaking. This document asks for responses to a series of questions regarding formats, types of material to... the types of material that could potentially be moved from the MUTCD to the Applications Supplement... seeks input on the type of material to be included in the MUTCD and the Applications Supplement, as well...

13 CFR 123.401 - What types of mitigation measures can your business include in an application for a pre-disaster...

Code of Federal Regulations, 2011 CFR

2011-01-01

... can your business include in an application for a pre-disaster mitigation loan? 123.401 Section 123.401 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION DISASTER LOAN PROGRAM Pre-Disaster Mitigation Loans § 123.401 What types of mitigation measures can your business include in an application for...

13 CFR 123.401 - What types of mitigation measures can your business include in an application for a pre-disaster...

Code of Federal Regulations, 2014 CFR

2014-01-01

... can your business include in an application for a pre-disaster mitigation loan? 123.401 Section 123.401 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION DISASTER LOAN PROGRAM Pre-Disaster Mitigation Loans § 123.401 What types of mitigation measures can your business include in an application for...

13 CFR 123.401 - What types of mitigation measures can your business include in an application for a pre-disaster...

Code of Federal Regulations, 2012 CFR

2012-01-01

... can your business include in an application for a pre-disaster mitigation loan? 123.401 Section 123.401 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION DISASTER LOAN PROGRAM Pre-Disaster Mitigation Loans § 123.401 What types of mitigation measures can your business include in an application for...

13 CFR 123.401 - What types of mitigation measures can your business include in an application for a pre-disaster...

Code of Federal Regulations, 2013 CFR

2013-01-01

... can your business include in an application for a pre-disaster mitigation loan? 123.401 Section 123.401 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION DISASTER LOAN PROGRAM Pre-Disaster Mitigation Loans § 123.401 What types of mitigation measures can your business include in an application for...

Advances in the manufacturing, types, and applications of biosensors

NASA Astrophysics Data System (ADS)

Ravindra, Nuggehalli M.; Prodan, Camelia; Fnu, Shanmugamurthy; Padronl, Ivan; Sikha, Sushil K.

2007-12-01

In recent years, there have been significant technological advancements in the manufacturing, types, and applications of biosensors. Applications include clinical and non-clinical diagnostics for home, bio-defense, bio-remediation, environment, agriculture, and the food industry. Biosensors have progressed beyond the detection of biological threats such as anthrax and are finding use in a number of non-biological applications. Emerging biosensor technologies such as lab-on-a-chip have revolutionized the integration approaches for a very flexible, innovative, and user-friendly platform. An overview of the fundamentals, types, applications, and manufacturers, as well as the market trends of biosensors is presented here. Two case studies are discussed: one focused on a characterization technique—patch clamping and dielectric spectroscopy as a biological sensor—and the other about lithium phthalocyanine, a material that is being developed for in-vivo oxymetry.

Segmented Gamma Scanner for Small Containers of Uranium Processing Waste- 12295

DOE Office of Scientific and Technical Information (OSTI.GOV)

Morris, K.E.; Smith, S.K.; Gailey, S.

2012-07-01

The Segmented Gamma Scanner (SGS) is commonly utilized in the assay of 55-gallon drums containing radioactive waste. Successfully deployed calibration methods include measurement of vertical line source standards in representative matrices and mathematical efficiency calibrations. The SGS technique can also be utilized to assay smaller containers, such as those used for criticality safety in uranium processing facilities. For such an application, a Can SGS System is aptly suited for the identification and quantification of radionuclides present in fuel processing wastes. Additionally, since the significant presence of uranium lumping can confound even a simple 'pass/fail' measurement regimen, the high-resolution gamma spectroscopymore » allows for the use of lump-detection techniques. In this application a lump correction is not required, but the application of a differential peak approach is used to simply identify the presence of U-235 lumps. The Can SGS is similar to current drum SGSs, but differs in the methodology for vertical segmentation. In the current drum SGS, the drum is placed on a rotator at a fixed vertical position while the detector, collimator, and transmission source are moved vertically to effect vertical segmentation. For the Can SGS, segmentation is more efficiently done by raising and lowering the rotator platform upon which the small container is positioned. This also reduces the complexity of the system mechanism. The application of the Can SGS introduces new challenges to traditional calibration and verification approaches. In this paper, we revisit SGS calibration methodology in the context of smaller waste containers, and as applied to fuel processing wastes. Specifically, we discuss solutions to the challenges introduced by requiring source standards to fit within the confines of the small containers and the unavailability of high-enriched uranium source standards. We also discuss the implementation of a previously used technique for identifying the presence of uranium lumping. The SGS technique is a well-accepted NDA technique applicable to containers of almost any size. It assumes a homogenous matrix and activity distribution throughout the entire container; an assumption that is at odds with the detection of lumps within the assay item typical of uranium-processing waste. This fact, in addition to the difficultly in constructing small reference standards of uranium-bearing materials, required the methodology used for performing an efficiency curve calibration to be altered. The solution discussed in this paper is demonstrated to provide good results for both the segment activity and full container activity when measuring heterogeneous source distributions. The application of this approach will need to be based on process knowledge of the assay items, as biases can be introduced if used with homogenous, or nearly homogenous, activity distributions. The bias will need to be quantified for each combination of container geometry and SGS scanning settings. One recommended approach for using the heterogeneous calibration discussed here is to assay each item using a homogenous calibration initially. Review of the segment activities compared to the full container activity will signal the presence of a non-uniform activity distribution as the segment activity will be grossly disproportionate to the full container activity. Upon seeing this result, the assay should either be reanalyzed or repeated using the heterogeneous calibration. (authors)« less

Solid state switch panel. [determination of optimum transducer type for required switches

NASA Technical Reports Server (NTRS)

Beenfeldt, E.

1973-01-01

An intensive study of various forms of transducers was conducted with application towards hermetically sealing the transducer and all electronics. The results of the study indicated that the Hall effect devices and a LED/phototransistor combination were the most practical for this type of application. Therefore, hardware was developed utilizing a magnet/Hall effect transducer for single action switches and LED/phototransistor transducers for rotary multiposition or potentiometer applications. All electronics could be housed in a hermetically sealed compartment. A number of switches were built and models were hermetically sealed to prove the feasibility of this type of fabrication. One of each type of switch was subjected to temperature cycling, vibration, and EMI tests. The results of these tests are presented.

10 CFR 2.2 - Subparts.

Code of Federal Regulations, 2014 CFR

2014-01-01

... part sets forth special rules applicable to the type of proceeding described in the first section of that subpart. Subpart C sets forth general rules applicable to all types of proceedings except... prevent disclosure of Restricted Data. [69 FR 2233, Jan. 14, 2004] ...

10 CFR 2.2 - Subparts.

Code of Federal Regulations, 2013 CFR

2013-01-01

... part sets forth special rules applicable to the type of proceeding described in the first section of that subpart. Subpart C sets forth general rules applicable to all types of proceedings except... prevent disclosure of Restricted Data. [69 FR 2233, Jan. 14, 2004] ...

Introduction to Remote Sensing Image Registration

NASA Technical Reports Server (NTRS)

Le Moigne, Jacqueline

2017-01-01

For many applications, accurate and fast image registration of large amounts of multi-source data is the first necessary step before subsequent processing and integration. Image registration is defined by several steps and each step can be approached by various methods which all present diverse advantages and drawbacks depending on the type of data, the type of applications, the a prior information known about the data and the type of accuracy that is required. This paper will first present a general overview of remote sensing image registration and then will go over a few specific methods and their applications

N- and P-type Ca2+ channels are involved in acetylcholine release at a neuroneuronal synapse: only the N-type channel is the target of neuromodulators.

PubMed Central

Fossier, P; Baux, G; Tauc, L

1994-01-01

Cholinergic transmission in an identified neuro-neuronal synapse of the Aplysia buccal ganglion was depressed by application of a partially purified extract of the funnel-web-spider venom (FTx) or of its synthetic analog (sFTx). This specific blocker of voltage-dependent P-type Ca2+ channels did not interfere with the effect of the N-type Ca2+ channel blocker omega-conotoxin, which could further decrease synaptic transmission after a previous application of FTx. Similar results were obtained when the reversal order of application of these two Ca2+ channel blockers was used. Both P- and N-type Ca2+ currents trigger acetylcholine release in the presynaptic neuron. The neuromodulatory effects of FMRF-amide, histamine, and buccalin on transmitter release disappeared after the blockade of the N-type Ca2+ channels but remained still effective in the presence of FTx. These results indicate that only N-type Ca2+ channels appear to be sensitive to the neuromodulators we have identified. PMID:7910963

N- and P-type Ca2+ channels are involved in acetylcholine release at a neuroneuronal synapse: only the N-type channel is the target of neuromodulators.

PubMed

Fossier, P; Baux, G; Tauc, L

1994-05-24

Cholinergic transmission in an identified neuro-neuronal synapse of the Aplysia buccal ganglion was depressed by application of a partially purified extract of the funnel-web-spider venom (FTx) or of its synthetic analog (sFTx). This specific blocker of voltage-dependent P-type Ca2+ channels did not interfere with the effect of the N-type Ca2+ channel blocker omega-conotoxin, which could further decrease synaptic transmission after a previous application of FTx. Similar results were obtained when the reversal order of application of these two Ca2+ channel blockers was used. Both P- and N-type Ca2+ currents trigger acetylcholine release in the presynaptic neuron. The neuromodulatory effects of FMRF-amide, histamine, and buccalin on transmitter release disappeared after the blockade of the N-type Ca2+ channels but remained still effective in the presence of FTx. These results indicate that only N-type Ca2+ channels appear to be sensitive to the neuromodulators we have identified.

Properties and Clinical Application of Three Types of Dental Glass-Ceramics and Ceramics for CAD-CAM Technologies

PubMed Central

Ritzberger, Christian; Apel, Elke; Höland, Wolfram; Peschke, Arnd; Rheinberger, Volker M.

2010-01-01

The main properties (mechanical, thermal and chemical) and clinical application for dental restoration are demonstrated for three types of glass-ceramics and sintered polycrystalline ceramic produced by Ivoclar Vivadent AG. Two types of glass-ceramics are derived from the leucite-type and the lithium disilicate-type. The third type of dental materials represents a ZrO2 ceramic. CAD/CAM technology is a procedure to manufacture dental ceramic restoration. Leucite-type glass-ceramics demonstrate high translucency, preferable optical/mechanical properties and an application as dental inlays, onlays and crowns. Based on an improvement of the mechanical parameters, specially the strength and toughness, the lithium disilicate glass-ceramics are used as crowns; applying a procedure to machine an intermediate product and producing the final glass-ceramic by an additional heat treatment. Small dental bridges of lithium disilicate glass-ceramic were fabricated using a molding technology. ZrO2 ceramics show high toughness and strength and were veneered with fluoroapatite glass-ceramic. Machining is possible with a porous intermediate product.

Library-Specific Microcomputer Software.

ERIC Educational Resources Information Center

Levert, Virginia M.

1985-01-01

Discusses number and type of microcomputer software programs useful to libraries and types of hardware on which they run, as identified by Nolan Information Management Services. Highlights include general application programs, applications designed to support library technical processes, producers of library software, and choosing among options.…

76 FR 55083 - Notice of Submission of Proposed Information Collection to OMB; McKinney-Vento Technical...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-06

... necessary interventions. The new format for this type of collection also makes it easier for applicants to... necessary interventions. The new format for this type of collection also makes it easier for applicants to...

Redundancy for electric motors in spacecraft applications

NASA Technical Reports Server (NTRS)

Smith, Robert J.; Flew, Alastair R.

1986-01-01

The parts of electric motors which should be duplicated in order to provide maximum reliability in spacecraft application are identified. Various common types of redundancy are described. The advantages and disadvantages of each are noted. The principal types are illustrated by reference to specific examples. For each example, constructional details, basic performance data and failure modes are described, together with a discussion of the suitability of particular redundancy techniques to motor types.

Advantages of using an abbreviated dossier for drug master file applications in Taiwan.

PubMed

Sun, I-Chen

2016-10-01

In Taiwan, the quality of active pharmaceutical ingredients is recorded in a drug master file (DMF), the applications for which can be submitted in two dossier types, either full (complete technical information) or abbreviated (partially complete technical information with an approved document issued by developed countries). However, the advantages of the abbreviated approach remain unknown. This study compared full and abbreviated dossier profiles and reviewed their outcomes in acceptance rates and deficiencies leading to rejection. Data were collected from new submissions of both dossier types that were completed in 2014 by the Center for Drug Evaluation, Taiwan. The results revealed that the abbreviated applications took shorter review time and had a higher acceptance rate. Among the eligible types of document for abbreviated applications, Certification of Suitability to the Monographs of the European Pharmacopeia (CEP) was the most frequently used. For categorical deficiencies, both dossier types presented the deficiencies in similar sections leading to rejection, namely Manufacture (3.2.S.2), Control of drug substance (3.2.S.4), and Stability (3.2.S.7). In summary, CEP serves a favorable document for the abbreviated DMF application in which it shortens the review time, increases the acceptance rate, and its deficiencies are similar to those of the full DMF application. Copyright © 2016 Elsevier Inc. All rights reserved.

[THE COMPARATIVE ANALYSIS OF RESULTS OF DETECTION OF CARCINOGENIC TYPES OF HUMAN PAPILLOMA VIRUS BY QUALITATIVE AND QUANTITATIVE TESTS].

PubMed

Kuzmenko, E T; Labigina, A V; Leshenko, O Ya; Rusanov, D N; Kuzmenko, V V; Fedko, L P; Pak, I P

2015-05-01

The analysis of results of screening (n = 3208; sexually active citizen aged from 18 to 59 years) was carried out to detect oncogene types of human papilloma virus in using qualitative (1150 females and 720 males) and quantitative (polymerase chain reaction in real-time (843 females and 115 males) techniques. The human papilloma virus of high oncogene type was detected in 65% and 68.4% of females and in 48.6% and 53% of males correspondingly. Among 12 types of human papilloma virus the most frequently diagnosed was human papilloma virus 16 independently of gender of examined and technique of analysis. In females, under application of qualitative tests rate of human papilloma virus 16 made up to 18.3% (n = 280) and under application of quantitative tests Rte of human papilloma virus made up to 14.9% (n = 126; p ≤ 0.05). Under examination of males using qualitative tests rate of human papilloma virus 16 made up to 8.3% (n = 60) and under application of qualitative tests made up to 12.2% (n = 14; p ≥ 0.05). Under application of qualitative tests rate of detection on the rest ofoncogene types of human papilloma virus varied in females from 3.4% to 8.4% and in males from 1.8% to 5.9%. Under application of qualitative tests to females rate of human papilloma virus with high viral load made up to 68.4%, with medium viral load - 2.85% (n = 24) and with low viral load -0.24% (n = 2). Under application of quantitative tests in males rate of detection of types of human papilloma virus made up to 53% and at that in all high viral load was established. In females, the most of oncogene types of human papilloma virus (except for 31, 39, 59) are detected significantly more often than in males.

Incorporation of varying types of temporal data in a neural network

NASA Technical Reports Server (NTRS)

Cohen, M. E.; Hudson, D. L.

1992-01-01

Most neural network models do not specifically deal with temporal data. Handling of these variables is complicated by the different uses to which temporal data are put, depending on the application. Even within the same application, temporal variables are often used in a number of different ways. In this paper, types of temporal data are discussed, along with their implications for approximate reasoning. Methods for integrating approximate temporal reasoning into existing neural network structures are presented. These methods are illustrated in a medical application for diagnosis of graft-versus-host disease which requires the use of several types of temporal data.

78 FR 18592 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-27

.... Salvat, Vice President, Application Type: Add NVO Service Bayshore Logistics & Services, LLC (NVO & OFF... Chester Transport, Inc. (NVO & OFF), 46090 Lake Center Plaza, Suite 208, Sterling, VA 20165, Officer... Type: Business Structure Change to L.A.S. Shipping L.L.C. & Add NVO Service Logistics International...

13 CFR 107.1100 - Types of Leverage and application procedures.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Types of Leverage and application procedures. 107.1100 Section 107.1100 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION SMALL BUSINESS INVESTMENT COMPANIES SBA Financial Assistance for Licensees (Leverage) General Information About...

77 FR 59193 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-26

... Type: New OFF License. Bring Logistics US, Inc. (NVO & OFF), 4500 N. Sam Houston Parkway W., 130...: New NVO & OFF License. Contract Logistics, LLC (NVO & OFF), 4911 N. Portland Avenue, Suite 200.... Roush, Manager, Application Type: New NVO & OFF License. Crescent Line Inc. dba Globe Express Services...

41 CFR 109-40.000-50 - Applicability to contractors.

Code of Federal Regulations, 2010 CFR

2010-07-01

... contractors. 109-40.000-50 Section 109-40.000-50 Public Contracts and Property Management Federal Property...-50 Applicability to contractors. DOE-PMR 109-40, Transportation and Traffic Management, should be applied to cost-type contractors' transportation and traffic management activities. Departure by cost-type...

The Influence of Sexual Orientation on the Perceived Fit of Male Applicants for Both Male- and Female-Typed Jobs.

PubMed

Clarke, Heather M; Arnold, Kara A

2018-01-01

Research demonstrates the bias faced by individuals engaged in occupations that are perceived as inconsistent with their gender. The lack of fit model and role congruity theory explain how gender stereotypes give rise to the perception that an individual lacks the attributes necessary to be successful in a gender-incongruent job. Men employed in jobs traditionally held by women are perceived as wimpy and undeserving of respect. The majority of studies in this area have, however, failed to account for the sexual orientation of the individual being rated. Therefore, we carried out an experiment where 128 adults with experience in recruitment and selection, recruited through Qualtrics, rated heterosexual and gay male applicants applying for a gender-typed job. The heterosexual male was rated less effectual, less respect-worthy, and less hirable in the female-typed job condition than in the male-typed job condition. The gay male applicant, however, was rated similarly on all criteria across job gender-types, suggesting the gay male applicant was viewed as androgynous rather than high in femininity and low in masculinity as inferred by implicit inversion theory. The implications of these findings are discussed.

The Influence of Sexual Orientation on the Perceived Fit of Male Applicants for Both Male- and Female-Typed Jobs

PubMed Central

Clarke, Heather M.; Arnold, Kara A.

2018-01-01

Research demonstrates the bias faced by individuals engaged in occupations that are perceived as inconsistent with their gender. The lack of fit model and role congruity theory explain how gender stereotypes give rise to the perception that an individual lacks the attributes necessary to be successful in a gender-incongruent job. Men employed in jobs traditionally held by women are perceived as wimpy and undeserving of respect. The majority of studies in this area have, however, failed to account for the sexual orientation of the individual being rated. Therefore, we carried out an experiment where 128 adults with experience in recruitment and selection, recruited through Qualtrics, rated heterosexual and gay male applicants applying for a gender-typed job. The heterosexual male was rated less effectual, less respect-worthy, and less hirable in the female-typed job condition than in the male-typed job condition. The gay male applicant, however, was rated similarly on all criteria across job gender-types, suggesting the gay male applicant was viewed as androgynous rather than high in femininity and low in masculinity as inferred by implicit inversion theory. The implications of these findings are discussed. PMID:29774007

Soil types influence the fate of antibiotic-resistant bacteria and antibiotic resistance genes following the land application of sludge composts.

PubMed

Zhang, Junya; Sui, Qianwen; Tong, Juan; Zhong, Hui; Wang, Yawei; Chen, Meixue; Wei, Yuansong

2018-05-21

Sewage sludge was generally considered a significant reservoir of antibiotic resistance genes (ARGs) and could enter agricultural systems as fertilizer after composting. Soil types and the discrepancy of sludge composts could have influenced the fate of antibiotic-resistant bacteria (ARB) following the land application of sludge composts, which deserved to be clarified. Thus, the fate of ARB and ARGs following the land application of three types of sludge composts (A, B, and C) to three different soils (red soil, loess, and black soil) was investigated. The results showed that tetX, which was enriched the most during composting, did not affect the soil resistome, whereas tetG did. Soil types influenced the dynamics of ARB and ARGs significantly, whereas no significant difference was observed among compost types. The advantage of reducing ARGs during the composting process in compost B did not extend to land application. Land application of composts influenced the microbial community significantly at the early stage, but the microbial community returned to the control pattern gradually. Changes in the microbial community contributed more to the dynamics of ARGs in red and black soil compared with other factors, including co-selection from heavy metals, horizontal gene transfer, biomass and environmental factors, whereas horizontal gene transfer, reflected by intI1 levels, contributed the most in loess. Copyright © 2018 Elsevier Ltd. All rights reserved.

77 FR 54911 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-06

...: Jorge L. Garcia, President (QI), Nora Garcia, Vice President, Application Type: New OFF Ocean World... FEDERAL MARITIME COMMISSION Ocean Transportation Intermediary License Applicants The Commission gives notice that the following applicants have filed an application for an Ocean Transportation...

34 CFR 21.20 - Types of eligible applicants.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 34 Education 1 2010-07-01 2010-07-01 false Types of eligible applicants. 21.20 Section 21.20 Education Office of the Secretary, Department of Education EQUAL ACCESS TO JUSTICE How Is Eligibility... employees. (d) A cooperative association— (1) As defined in section 15(a) of the Agricultural Marketing Act...

76 FR 67730 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-02

... Type: New OFF License LF Freight USA LLC dba LF Logistics dba LF Freight dba IDS Logistics USA, dba IDS Freight Services, dba AGI Logistics USA, dba AGI Logistics, 230-59 International Airport Center Blvd., 270... Individual), Caetano R. Lopes, Vice President, Application Type: Add NVO Service Eztrans Logistics Ltd. (NVO...

78 FR 76612 - Notice of Receipt of Pesticide Products; Registration Applications To Register New Uses

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-18

... Herbicide). Docket ID number: EPA-HQ-OPP-2013-0768. Applicant: BASF Corporation, 26 Davis Dr., P.O. Box 13528, Research Triangle Park, NC 27709. Active ingredient: Pendimethalin. Product type: Herbicide... ingredient: Sulfentrazone. Product type: Herbicide. Proposed use: Formulation into end-use sulfentrazone...

Atomization from agricultural spray nozzles: Effects of air shear and tank mix adjuvants

USDA-ARS?s Scientific Manuscript database

Spray adjuvants can have a substantial impact on spray atomization from agricultural nozzles; however, this process is also affected by the nozzle type, operating pressure and, for aerial application, the airspeed of application. Different types of ground spray nozzle can dramatically affect the im...

78 FR 10173 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-13

..., Washington, DC 20573, by telephone at (202) 523-5843 or by email at [email protected] . Agility Project Logistics... Weischwill, Senior Vice President, Application Type: QI Change. Ally Logistics LLC (NVO & OFF), 387 Hatherly... Type: New OFF License. Brisk Logistics Inc. (NVO & OFF), 1677 Elmhurst Road, Elk Grove Village, IL...

76 FR 47182 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-04

..., President, Application Type: New OFF & NVO License. Rado Logistics, Inc. (OFF & NVO), 2251 Sylvan Road... Type: New NVO License. KT Logistics, Inc. (OFF & NVO), 1915 McKinley Avenue, Suite E, La Verne, CA... & NVO License. Cargo Alliance Inc. (OFF & NVO), 583 Monterey Pass Road, Suite C, Monterey Park, CA 91754...

Modulation format identification enabled by the digital frequency-offset loading technique for hitless coherent transceiver.

PubMed

Fu, Songnian; Xu, Zuying; Lu, Jianing; Jiang, Hexun; Wu, Qiong; Hu, Zhouyi; Tang, Ming; Liu, Deming; Chan, Calvin Chun-Kit

2018-03-19

We propose a blind and fast modulation format identification (MFI) enabled by the digital frequency-offset (FO) loading technique for hitless coherent transceiver. Since modulation format information is encoded to the FO distribution during digital signal processing (DSP) at the transmitter side (Tx), we can use the fast Fourier transformation based FO estimation (FFT-FOE) method to obtain the FO distribution of individual data block after constant modulus algorithm (CMA) pre-equalization at the receiver side, in order to realize non-data-aided (NDA) and fast MFI. The obtained FO can be also used for subsequent FO compensation (FOC), without additional complexity. We numerically investigate and experimentally verify the proposed MFI with high accuracy and fast format switching among 28 Gbaud dual-polarization (DP)-4/8/16/64QAM, time domain hybrid-4/16QAM, and set partitioning (SP)-128QAM. In particular, the proposed MFI brings no performance degradation, in term of tolerance of amplified spontaneous emission (ASE) noise, laser linewidth, and fiber nonlinearity. Finally, a hitless coherent transceiver enabled by the proposed MFI with switching-block of only 2048 symbols is demonstrated over 1500 km standard single mode fiber (SSMF) transmission.

NDA Batch 2002-13

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hollister, R

QC sample results (daily background check drum and 100-gram SGS check drum) were within acceptance criteria established by WIPP's Quality Assurance Objectives for TRU Waste Characterization. Replicate runs were performed on drum LL85501243TRU. Replicate measurement results are identical at the 95% confidence level as established by WIPP criteria. HWM NCAR No. 02-1000168 issued on 17-Oct-2002 regarding a partially dislodged Cd sheet filter on the HPGe coaxial detector. This physical geometry occurred on 01-Oct-2002 and was not corrected until 10-Oct-2002, during which period is inclusive of the present batch run of drums. Per discussions among the Independent Technical Reviewer, Expert Reviewermore » and the Technical QA Supervisor, as well as in consultation with John Fleissner, Technical Point of Contact from Canberra, the analytical results are technically reliable. All QC standard runs during this period were in control. Data packet for SGS Batch 2002-13 generated using passive gamma-ray spectroscopy with the Pu Facility SGS unit is technically reasonable. All QC samples are in compliance with establiShed control limits. The batch data packet has been reviewed for correctness, completeness, consistency and compliance with WIPP's Quality Assurance Objectives and determined to be acceptable.« less

Optimisation of the Management of Higher Activity Waste in the UK - 13537

DOE Office of Scientific and Technical Information (OSTI.GOV)

Walsh, Ciara; Buckley, Matthew

2013-07-01

The Upstream Optioneering project was created in the Nuclear Decommissioning Authority (UK) to support the development and implementation of significant opportunities to optimise activities across all the phases of the Higher Activity Waste management life cycle (i.e. retrieval, characterisation, conditioning, packaging, storage, transport and disposal). The objective of the Upstream Optioneering project is to work in conjunction with other functions within NDA and the waste producers to identify and deliver solutions to optimise the management of higher activity waste. Historically, optimisation may have occurred on aspects of the waste life cycle (considered here to include retrieval, conditioning, treatment, packaging, interimmore » storage, transport to final end state, which may be geological disposal). By considering the waste life cycle as a whole, critical analysis of assumed constraints may lead to cost savings for the UK Tax Payer. For example, it may be possible to challenge the requirements for packaging wastes for disposal to deliver an optimised waste life cycle. It is likely that the challenges faced in the UK are shared in other countries. It is therefore likely that the opportunities identified may also apply elsewhere, with the potential for sharing information to enable value to be shared. (authors)« less

Associations of mitochondrial haplogroups and mitochondrial DNA copy numbers with end-stage renal disease in a Han population.

PubMed

Zhang, Yuheng; Zhao, Ying; Wen, Shuzhen; Yan, Rengna; Yang, Qinglan; Chen, Huimei

2017-09-01

Mitochondrial DNA (mtDNA) is closely related to mitochondrion function, and variations have been suggested to be involved in pathogenesis of complex diseases. The present study sought to elucidate mitochondrial haplogroups and mtDNA copy number in end-stage renal disease (ESRD) in a Han population. First, the mitochondrial haplogroups of 37 ESRD patients were clustered into several haplogroups, and haplogroup A & D were taken as the candidate risk haplogroups for ESRD. Second, the frequencies of A and D were assessed in 344 ESRD patients and 438 healthy controls, respectively. Haplogroup D was found to be risk maker for ESRD in young subjects (<30 years) with an OR of 2.274. Finally, intracellular and cell-free mtDNA copy numbers were evaluated with quantitative-PCR. The ESRD patients exhibited greater cell-free mtDNA contents than the healthy controls but less intracellular mtDNA. Haplogroup D exhibited a further increase in cell-free mtDNA content and a decrease in intracellular mtDNA content among the ESRDs patients. Our findings suggest that mtNDA haplogroup D may contributes to pathogenesis of early-onset ESRD through alterations of mtDNA copy numbers.

HEU Holdup Measurements on 321-M A-Lathe

DOE Office of Scientific and Technical Information (OSTI.GOV)

Dewberry, R.A.

The Analytical Development Section of SRTC was requested by the Facilities Disposition Division (FDD) of the Savannah River Site to determine the holdup of enriched uranium in the 321-M facility as part of an overall deactivation project of the facility. The 321-M facility was used to fabricate enriched uranium fuel assemblies, lithium-aluminum target tubes, neptunium assemblies, and miscellaneous components for the production reactors. The results of the holdup assays are essential for determining compliance with the solid waste Waste Acceptance Criteria, Material Control and Accountability, and to meet criticality safety controls. Three measurement systems were used to determine highly enrichedmore » uranium (HEU) holdup. This report covers holdup measurements on the A-Lathe that was used to machine uranium-aluminum-alloy (U-Al). Our results indicated that the lathe contained more than the limits stated in the Waste Acceptance Criteria (WAC) for the solid waste E-Area Vaults. Thus the lathe was decontaminated three times and assayed four times in order to bring the amounts of uranium to an acceptable content. This report will discuss the methodology, Non-Destructive Assay (NDA) measurements, and results of the U-235 holdup on the lathe.« less

Stimulating collaboration between human and veterinary health care professionals.

PubMed

Eussen, Björn G M; Schaveling, Jaap; Dragt, Maria J; Blomme, Robert Jan

2017-06-13

Despite the need to control outbreaks of (emerging) zoonotic diseases and the need for added value in comparative/translational medicine, jointly addressed in the One Health approach [One health Initiative (n.d.a). About the One Health Initiative. http://www.onehealthinitiative.com/about.php . Accessed 13 September 2016], collaboration between human and veterinary health care professionals is limited. This study focuses on the social dilemma experienced by health care professionals and ways in which an interdisciplinary approach could be developed. Based on Gaertner and Dovidio's Common Ingroup Identity Model, a number of questionnaires were designed and tested; with PROGRESS, the relation between collaboration and common goal was assessed, mediated by decategorization, recategorization, mutual differentiation and knowledge sharing. This study confirms the Common Ingroup Identity Model stating that common goals stimulate collaboration. Decategorization and mutual differentiation proved to be significant in this relationship; recategorization and knowledge sharing mediate this relation. It can be concluded that the Common Ingroup Identity Model theory helps us to understand how health care professionals perceive the One Health initiative and how they can intervene in this process. In the One Health approach, professional associations could adopt a facilitating role.

Emergency Medical Service (EMS) Utilization by Syrian Refugees Residing in Ankara, Turkey.

PubMed

Altıner, Ali Osman; Yeşil, Sıdıka Tekeli

2018-04-01

Introduction Many Syrians have left their country and migrated to other countries since March 2011, due to the civil war. As of March 2016, a total of 2,747,946 Syrian refugees had immigrated to Turkey. Some Syrian refugees have been living in camps, while 2,475,134 have been living in metropolitan areas, such as Ankara. Study Objective This study investigated Emergency Medical Service (EMS) utilization among Syrian refugees residing in Ankara. This study was a descriptive, cross-sectional database analysis using data obtained from the Department of EMS of the Ankara Provincial Health Directorate. Five stations in the Altındağ region of Ankara responded to 42% of all calls from Syrian refugees. Prehospital EMS in Ankara have been used mostly by Syrian refugees younger than 18-years-old. Study findings also suggest that medical staff in regions where Syrian refugees are likely to be treated should be supported and provided with the ability to overcome language barriers and cultural differences. Altıner AO , Tekeli Yeşil S . Emergency Medical Service (EMS) utilization by Syrian refugees residing in Ankara, Turkey. Prehosp Disaster Med. 2018;33(2):160-164.

Comparison of web-based and face-to-face interviews for application to an anesthesiology training program: a pilot study

PubMed Central

Malkin, Mathew R.; Lenart, John; Stier, Gary R.; Gatling, Jason W.; Applegate II, Richard L.

2016-01-01

Objectives This study compared admission rates to a United States anesthesiology residency program for applicants completing face-to-face versus web-based interviews during the admissions process. We also explored factors driving applicants to select each interview type. Methods The 211 applicants invited to interview for admission to our anesthesiology residency program during the 2014-2015 application cycle were participants in this pilot observational study. Of these, 141 applicants selected face-to-face interviews, 53 applicants selected web-based interviews, and 17 applicants declined to interview. Data regarding applicants' reasons for selecting a particular interview type were gathered using an anonymous online survey after interview completion. Residency program admission rates and survey answers were compared between applicants completing face-to-face versus web-based interviews. Results One hundred twenty-seven (75.1%) applicants completed face-to-face and 42 (24.9%) completed web-based interviews. The admission rate to our residency program was not significantly different between applicants completing face-to-face versus web-based interviews. One hundred eleven applicants completed post-interview surveys. The most common reasons for selecting web-based interviews were conflict of interview dates between programs, travel concerns, or financial limitations. Applicants selected face-to-face interviews due to a desire to interact with current residents, or geographic proximity to the residency program. Conclusions These results suggest that completion of web-based interviews is a viable alternative to completion of face-to-face interviews, and that choice of interview type does not affect the rate of applicant admission to the residency program. Web-based interviews may be of particular interest to applicants applying to a large number of programs, or with financial limitations. PMID:27039029

14 CFR 21.41 - Type certificate.

Code of Federal Regulations, 2013 CFR

2013-01-01

... PROCEDURES FOR PRODUCTS AND PARTS Type Certificates § 21.41 Type certificate. Each type certificate is considered to include the type design, the operating limitations, the certificate data sheet, the applicable... 14 Aeronautics and Space 1 2013-01-01 2013-01-01 false Type certificate. 21.41 Section 21.41...

14 CFR 21.41 - Type certificate.

Code of Federal Regulations, 2014 CFR

2014-01-01

... PROCEDURES FOR PRODUCTS AND PARTS Type Certificates § 21.41 Type certificate. Each type certificate is considered to include the type design, the operating limitations, the certificate data sheet, the applicable... 14 Aeronautics and Space 1 2014-01-01 2014-01-01 false Type certificate. 21.41 Section 21.41...

14 CFR 21.41 - Type certificate.

Code of Federal Regulations, 2011 CFR

2011-01-01

... PROCEDURES FOR PRODUCTS AND PARTS Type Certificates § 21.41 Type certificate. Each type certificate is considered to include the type design, the operating limitations, the certificate data sheet, the applicable... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Type certificate. 21.41 Section 21.41...

14 CFR 21.41 - Type certificate.

Code of Federal Regulations, 2010 CFR

2010-01-01

... PROCEDURES FOR PRODUCTS AND PARTS Type Certificates § 21.41 Type certificate. Each type certificate is considered to include the type design, the operating limitations, the certificate data sheet, the applicable... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Type certificate. 21.41 Section 21.41...

14 CFR 21.41 - Type certificate.

Code of Federal Regulations, 2012 CFR

2012-01-01

... PROCEDURES FOR PRODUCTS AND PARTS Type Certificates § 21.41 Type certificate. Each type certificate is considered to include the type design, the operating limitations, the certificate data sheet, the applicable... 14 Aeronautics and Space 1 2012-01-01 2012-01-01 false Type certificate. 21.41 Section 21.41...

Development of p-type oxide semiconductors based on tin oxide and its alloys: application to thin film transistors

NASA Astrophysics Data System (ADS)

Barros, Ana Raquel Xarouco de

In spite of the recent p-type oxide TFTs developments based on SnOx and CuxO, the results achieved so far refer to devices processed at high temperatures and are limited by a low hole mobility and a low On-Off ratio and still there is no report on p-type oxide TFTs with performance similar to n-type, especially when comparing their field-effect mobility values, which are at least one order of magnitude higher on n-type oxide TFTs. Achieving high performance p-type oxide TFTs will definitely promote a new era for electronics in rigid and flexible substrates, away from silicon. None of the few reported p-channel oxide TFTs is suitable for practical applications, which demand significant improvements in the device engineering to meet the real-world electronic requirements, where low processing temperatures together with high mobility and high On-Off ratio are required for TFT and CMOS applications. The present thesis focuses on the study and optimization of p-type thin film transistors based on oxide semiconductors deposited by r.f. magnetron sputtering without intentional substrate heating. In this work several p-type oxide semiconductors were studied and optimized based on undoped tin oxide, Cu-doped SnOx and In-doped SnO2.

Fiber Bragg grating sensors in harsh environments: considerations and industrial monitoring applications

NASA Astrophysics Data System (ADS)

Méndez, Alexis

2017-06-01

Over the last few years, fiber optic sensors (FOS) have seen an increased acceptance and widespread use in industrial sensing and in structural monitoring in civil, aerospace, marine, oil & gas, composites and other applications. One of the most prevalent types in use today are fiber Bragg grating (FBG) sensors. Historically, FOS have been an attractive solution because of their EM immunity and suitability for use in harsh environments and rugged applications with extreme temperatures, radiation exposure, EM fields, high voltages, water contact, flammable atmospheres, or other hazards. FBG sensors have demonstrated that can operate reliably in many different harsh environment applications but proper type and fabrication process are needed, along with suitable packaging and installation procedure. In this paper, we review the impact that external factors and environmental conditions play on FBG's performance and reliability, and describe the appropriate sensor types and protection requirements suitable for a variety of harsh environment applications in industrial furnaces, cryogenic coolers, nuclear plants, maritime vessels, oil & gas wells, aerospace crafts, automobiles, and others.

Application procedures for hydropower licenses, exemptions, and preliminary permits

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1982-04-01

This document provides essential information regarding the FERC's regulations and procedures for filing an application with the Commission for hydropower licenses, exemptions and preliminary permits. Each section is page numbered with a roman numeral followed by consecutive arabic numbering. The appendices are page numbered with an alphabetical prefix and consecutve page numbering within each section. The first section of this book contains background descriptions of the Commission's authority and regulations and serves as an introduction to the Commission's hydropower licensing program. Two general tables follow this introductory text and provide a quick reference to the types of applications and themore » relationship between the Commission's orders and regulations. Following the introduction are sections which include the Commission's regulations by application type: preliminary permits; licenses; and exemptions. Each section contains an introduction describing application procedures by type of action requested. There are two appendices provided contain information on the consultation process and lists of agencies to be consulted and a section by section analyses of the Commission's orders.« less

The Application of a Nonlinear Fracture Mechanics Parameter to Ductile Fatigue Crack Growth

DTIC Science & Technology

1982-12-01

ADAl I4~ � AFWAL-TR-83-4023 0 THE APPLICATION OF A NONLINEAR FRACTURE MECHANICS PARAMETER TO DUCTILE FATIGUE CRACK GROW4TH University of Dayton...SubtSle) S. TYPE OF REPORT & PERIOD COVERED The Application of a Nonlinear Fracture Final Report Mechanics Parameter to Ductile Fatigue Sept. 1978...5, and 6. To date, no single elastic-plastic fracture mechanics ( EPFM ) "type parameter has achieved universal acceptance for its corre- lation

Space applicable DOE photovoltaic technology: An update

NASA Technical Reports Server (NTRS)

Scott-Monck, J.; Stella, P.; Berman, P.

1981-01-01

Photovoltaic development projects applicable to space power are identified. When appropriate, the type of NASA support that would be necessary to implement these technologies for space use is indicated. It is conducted that the relatively small market and divergent operational requirements for space power are mainly responsible for the limited transfer of terrestrial technology to space applications. Information on the factors which control the cost and type of technology is provided. Terrestrial modules using semiconductor materials are investigated.

Influence of Application Time and Etching Mode of Universal Adhesives on Enamel Adhesion.

PubMed

Sai, Keiichi; Takamizawa, Toshiki; Imai, Arisa; Tsujimoto, Akimasa; Ishii, Ryo; Barkmeier, Wayne W; Latta, Mark A; Miyazaki, Masashi

2018-01-01

To investigate the influence of application time and etching mode of universal adhesives on enamel adhesion. Five universal adhesives, Adhese Universal, Bondmer Lightless, Clearfil Universal Bond Quick, G-Premio Bond, and Scotchbond Universal, were used. Bovine incisors were prepared and divided into four groups of ten teeth each. SBS, Ra, and SFE were determined after the following procedures: 1. self-etch mode with immediate air blowing after application (IA); 2. self-etch mode with prolonged application time (PA); 3. etch-and-rinse mode with IA; 4. etch-and-rinse mode with PA. After 24-h water storage, the bonded assemblies were subjected to shear bond strength (SBS) tests. For surface roughness (Ra) and surface free energy (SFE) measurements, the adhesives were simply applied to the enamel and rinsed with acetone and water before the measurements were carried out. Significantly higher SBS and Ra values were obtained with etch-and-rinse mode than with self-etch mode regardless of the application time or type of adhesive. Although most adhesives showed decreased SFE values with increased application time in self-etch mode, SFE values in etch-and-rinse mode were dependent on the adhesive type and application time. Etching mode, application time, and type of adhesive significantly influenced the SBS, Ra, and SFE values.

Designing patient-centric applications for chronic disease management.

PubMed

Tsalatsanis, Athanasios; Gil-Herrera, Eleazar; Yalcin, Ali; Djulbegovic, Benjamin; Barnes, Laura

2011-01-01

Chronic diseases such as diabetes and heart disease are the leading causes of disability and death in the developed world. Technological interventions such as mobile applications have the ability to facilitate and motivate patients in chronic disease management, but these types of interventions present considerable design challenges. The primary objective of this paper is to present the challenges arising from the design and implementation of software applications aiming to assist patients in chronic disease management. We also outline preliminary results regarding a self-management application currently under development targeting young adults suffering from type 1 diabetes.

50 CFR 259.30 - Application for Interim Capital Construction Fund Agreement (“Interim CCF Agreement”).

Code of Federal Regulations, 2010 CFR

2010-10-01

... of the applicant's actual intentions. Vague or contingent objectives will not be acceptable. (b...-carrying capacity, age, length, type of fishing gear, number of passengers carried or in the case of...) General characteristics (i.e., net tonnage, fish-carrying capacity, age, length, type of fishing gear...

The power of neural nets

NASA Technical Reports Server (NTRS)

Ryan, J. P.; Shah, B. H.

1987-01-01

Implementation of the Hopfield net which is used in the image processing type of applications where only partial information about the image may be available is discussed. The image classification type of algorithm of Hopfield and other learning algorithms, such as the Boltzmann machine and the back-propagation training algorithm, have many vital applications in space.

76 FR 14395 - Ocean Transportation Intermediary License Applicants

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-16

..., Manager/President. Application Type: QI Change. Geoffrey Au dba ABC Logistics Company (NVO), 2250 Gellert... at (202) 523-5843 or by e-mail at [email protected] . Arkman Logistics Inc. (NVO), 1001 Fargo Avenue, Elk... Type: New NVO & OFF License. BCargo Logistics, S.A. de C.V. (NVO), Av. Revolucion 725-A, Col. Jardin...

The Effects of Purpose Orientations on Recent High School Graduates' College Application Decisions

ERIC Educational Resources Information Center

Sharma, Gitima; Kim, Jungnam; Bryan, Julia

2017-01-01

Using the 2002 Educational Longitudinal Study database, the authors examined the different types of purpose orientations amongst a nationally representative sample of adolescents and the effect of these purpose orientations on high school graduates' college application decisions. Results indicated four types of purpose orientations: career,…

7 CFR 1951.10 - Application of payments on production type loan accounts.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 14 2011-01-01 2011-01-01 false Application of payments on production type loan accounts. 1951.10 Section 1951.10 Agriculture Regulations of the Department of Agriculture (Continued) RURAL HOUSING SERVICE, RURAL BUSINESS-COOPERATIVE SERVICE, RURAL UTILITIES SERVICE, AND FARM SERVICE AGENCY, DEPARTMENT OF AGRICULTURE (CONTINUED)...

7 CFR 1951.10 - Application of payments on production type loan accounts.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 14 2010-01-01 2009-01-01 true Application of payments on production type loan accounts. 1951.10 Section 1951.10 Agriculture Regulations of the Department of Agriculture (Continued) RURAL HOUSING SERVICE, RURAL BUSINESS-COOPERATIVE SERVICE, RURAL UTILITIES SERVICE, AND FARM SERVICE AGENCY, DEPARTMENT OF AGRICULTURE (CONTINUED)...

7 CFR 1951.10 - Application of payments on production type loan accounts.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 14 2012-01-01 2012-01-01 false Application of payments on production type loan accounts. 1951.10 Section 1951.10 Agriculture Regulations of the Department of Agriculture (Continued) RURAL HOUSING SERVICE, RURAL BUSINESS-COOPERATIVE SERVICE, RURAL UTILITIES SERVICE, AND FARM SERVICE AGENCY, DEPARTMENT OF AGRICULTURE (CONTINUED)...

7 CFR 1951.10 - Application of payments on production type loan accounts.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 14 2014-01-01 2014-01-01 false Application of payments on production type loan accounts. 1951.10 Section 1951.10 Agriculture Regulations of the Department of Agriculture (Continued) RURAL HOUSING SERVICE, RURAL BUSINESS-COOPERATIVE SERVICE, RURAL UTILITIES SERVICE, AND FARM SERVICE AGENCY, DEPARTMENT OF AGRICULTURE (CONTINUED)...