Sample records for planned interim analysis

  1. 75 FR 12217 - Notice of Availability for Comments Regarding the Planned Environmental Assessment Interim Report...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-15

    ... public comments for a planned Environmental Assessment. The Corps is directed to conduct a study of.... The study is structured as a series of interim reports. Interim Report IIIa, limited to the impacts of.... Comments are requested to assist in determining the level of analysis and impacts to be considered for...

  2. Interim Assessment Data: A Case Study on Modifying Instruction Based on Benchmark Feedback

    ERIC Educational Resources Information Center

    Lange, Tracey M.

    2014-01-01

    The role of data analysis in the jobs of instructional leaders has become as commonplace as teachers creating lesson plans and taking roll in the classroom. Teachers and building leaders routinely use interim assessment data to develop thoughtful and robust instructional plans that address identified areas of student need. The link between the…

  3. 78 FR 48503 - Proposed Revision to Missiles Generated by Extreme Winds

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-08

    ...-0800, ``Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR..., ``Design-Basis Hurricane and Hurricane Missiles for Nuclear Power Plants,'' and Interim Staff Guidance DC... and Hurricane Missiles for Nuclear Power Plants'' (ADAMS, Accession No. ML110940300), and Interim...

  4. Detailed Skylab ECS consumables analysis for the interim revision flight plan (November, 1972, SL-1 launch)

    NASA Technical Reports Server (NTRS)

    Wells, C.; Kolkhorst, H. E.

    1971-01-01

    The consumables analysis was performed for the Skylab 2, 3, and 4 Preliminary Reference Interim Revision Flight Plan. The analysis and the results are based on the mission requirements as specified in the flight plan and on other available data. The results indicate that the consumables requirements for the Skylab missions allow for remaining margins (percent) of oxygen, nitrogen, and water nominal as follows: 83.5, 90.8, and 88.7 for mission SL-2; 57.1, 64.1, and 67.3 for SL-3; and 30.8, 44.3, and 46.5 for SL-4. Performance of experiment M509 as scheduled in the flight plan results in venting overboard the cluster atmosphere. This is due to the addition of nitrogen for propulsion and to the additional oxygen introduced into the cabin when the experiment is performed with the crewman suited.

  5. 40 CFR 52.243 - Interim approval of the Carbon Monoxide plan for the South Coast.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 3 2010-07-01 2010-07-01 false Interim approval of the Carbon Monoxide plan for the South Coast. 52.243 Section 52.243 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS California § 52.243 Interim approval of the Carbon...

  6. 40 CFR 52.243 - Interim approval of the Carbon Monoxide plan for the South Coast.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 3 2014-07-01 2014-07-01 false Interim approval of the Carbon Monoxide plan for the South Coast. 52.243 Section 52.243 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS California § 52.243 Interim approval of the Carbon...

  7. 40 CFR 52.243 - Interim approval of the Carbon Monoxide plan for the South Coast.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 3 2013-07-01 2013-07-01 false Interim approval of the Carbon Monoxide plan for the South Coast. 52.243 Section 52.243 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS California § 52.243 Interim approval of the Carbon...

  8. 40 CFR 52.243 - Interim approval of the Carbon Monoxide plan for the South Coast.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 3 2012-07-01 2012-07-01 false Interim approval of the Carbon Monoxide plan for the South Coast. 52.243 Section 52.243 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS California § 52.243 Interim approval of the Carbon...

  9. Planning applications in image analysis

    NASA Technical Reports Server (NTRS)

    Boddy, Mark; White, Jim; Goldman, Robert; Short, Nick, Jr.

    1994-01-01

    We describe two interim results from an ongoing effort to automate the acquisition, analysis, archiving, and distribution of satellite earth science data. Both results are applications of Artificial Intelligence planning research to the automatic generation of processing steps for image analysis tasks. First, we have constructed a linear conditional planner (CPed), used to generate conditional processing plans. Second, we have extended an existing hierarchical planning system to make use of durations, resources, and deadlines, thus supporting the automatic generation of processing steps in time and resource-constrained environments.

  10. Interim Action Proposed Plan for the Chemicals, Metals, and Pesticides (CMP) Pits Operable Unit

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

    Bradley, J.

    2002-06-18

    The purpose of this Interim Action Proposed Plan (IAPP) is to describe the preferred interim remedial action for addressing the Chemicals, Metals, and Pesticides (CMP) Pits Operable Unit and to provide an opportunity for public input into the remedial action selection process.

  11. FY 1987 current fiscal year work plan

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

    Not Available

    This Current Year Work Plan presents a detailed description of the activities to be performed by the Joint Integration Office during FY87. It breaks down the activities into two major work areas: Program Management and Program Analysis. Program Management is performed by the JIO by providing technical planning and guidance for the development of advanced TRU waste management capabilities. This includes equipment/facility design, engineering, construction, and operations. These functions are integrated to allow transition from interim storage to final disposition. JIO tasks include program requirements identification, long-range technical planning, budget development, program planning document preparation, task guidance, task monitoring, informationmore » gathering and task reporting to DOE, interfacing with other agencies and DOE lead programs, integrating public involvement with program efforts, and preparation of program status reports for DOE. Program Analysis is performed by the JIO to support identification and assessment of alternatives, and development of long-term TRU waste program capabilities. This work plan includes: system analyses, requirements analyses, interim and procedure development, legislative and regulatory analyses, dispatch and traffic analyses, and data bases.« less

  12. 76 FR 59066 - Notice of Regulatory Review Plan

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-23

    ... [No. 2011-N-10] Notice of Regulatory Review Plan AGENCY: Federal Housing Finance Agency. ACTION... of and requesting comments on the FHFA interim regulatory review plan for review of existing... comments on all aspects of the interim regulatory review plan, including legal and policy considerations...

  13. 42 CFR 417.572 - Budget and enrollment forecast and interim reports.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Budget and enrollment forecast and interim reports... PLANS, AND HEALTH CARE PREPAYMENT PLANS Medicare Payment: Cost Basis § 417.572 Budget and enrollment forecast and interim reports. (a) Annual submittal. The HMO or CMP must submit an annual operating budget...

  14. Quantifying the bias in the estimated treatment effect in randomized trials having interim analyses and a rule for early stopping for futility.

    PubMed

    Walter, S D; Han, H; Briel, M; Guyatt, G H

    2017-04-30

    In this paper, we consider the potential bias in the estimated treatment effect obtained from clinical trials, the protocols of which include the possibility of interim analyses and an early termination of the study for reasons of futility. In particular, by considering the conditional power at an interim analysis, we derive analytic expressions for various parameters of interest: (i) the underestimation or overestimation of the treatment effect in studies that stop for futility; (ii) the impact of the interim analyses on the estimation of treatment effect in studies that are completed, i.e. that do not stop for futility; (iii) the overall estimation bias in the estimated treatment effect in a single study with such a stopping rule; and (iv) the probability of stopping at an interim analysis. We evaluate these general expressions numerically for typical trial scenarios. Results show that the parameters of interest depend on a number of factors, including the true underlying treatment effect, the difference that the trial is designed to detect, the study power, the number of planned interim analyses and what assumption is made about future data to be observed after an interim analysis. Because the probability of stopping early is small for many practical situations, the overall bias is often small, but a more serious issue is the potential for substantial underestimation of the treatment effect in studies that actually stop for futility. We also consider these ideas using data from an illustrative trial that did stop for futility at an interim analysis. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  15. Amendment to the interim final rules for group health plans and health insurance coverage relating to status as a grandfathered health plan under the Patient Protection and Affordable Care Act. Amendment to interim final rules with request for comments.

    PubMed

    2010-11-17

    This document contains an amendment to interim final regulations implementing the rules for group health plans and health insurance coverage in the group and individual markets under provisions of the Patient Protection and Affordable Care Act regarding status as a grandfathered health plan; the amendment permits certain changes in policies, certificates, or contracts of insurance without loss of grandfathered status.

  16. Linear Programming for Vocational Education Planning. Interim Report.

    ERIC Educational Resources Information Center

    Young, Robert C.; And Others

    The purpose of the paper is to define for potential users of vocational education management information systems a quantitative analysis technique and its utilization to facilitate more effective planning of vocational education programs. Defining linear programming (LP) as a management technique used to solve complex resource allocation problems…

  17. Terrestrial gravity data analysis for interim gravity model improvement

    NASA Technical Reports Server (NTRS)

    1987-01-01

    This is the first status report for the Interim Gravity Model research effort that was started on June 30, 1986. The basic theme of this study is to develop appropriate models and adjustment procedures for estimating potential coefficients from terrestrial gravity data. The plan is to use the latest gravity data sets to produce coefficient estimates as well as to provide normal equations to NASA for use in the TOPEX/POSEIDON gravity field modeling program.

  18. Maximum inflation of the type 1 error rate when sample size and allocation rate are adapted in a pre-planned interim look.

    PubMed

    Graf, Alexandra C; Bauer, Peter

    2011-06-30

    We calculate the maximum type 1 error rate of the pre-planned conventional fixed sample size test for comparing the means of independent normal distributions (with common known variance) which can be yielded when sample size and allocation rate to the treatment arms can be modified in an interim analysis. Thereby it is assumed that the experimenter fully exploits knowledge of the unblinded interim estimates of the treatment effects in order to maximize the conditional type 1 error rate. The 'worst-case' strategies require knowledge of the unknown common treatment effect under the null hypothesis. Although this is a rather hypothetical scenario it may be approached in practice when using a standard control treatment for which precise estimates are available from historical data. The maximum inflation of the type 1 error rate is substantially larger than derived by Proschan and Hunsberger (Biometrics 1995; 51:1315-1324) for design modifications applying balanced samples before and after the interim analysis. Corresponding upper limits for the maximum type 1 error rate are calculated for a number of situations arising from practical considerations (e.g. restricting the maximum sample size, not allowing sample size to decrease, allowing only increase in the sample size in the experimental treatment). The application is discussed for a motivating example. Copyright © 2011 John Wiley & Sons, Ltd.

  19. 76 FR 17159 - Office of New Reactors; Final Interim Staff Guidance on Standard Review Plan, Section 17.4...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-28

    ... Interim Staff Guidance on Standard Review Plan, Section 17.4, ``Reliability Assurance Program'' AGENCY... design reliability assurance program (RAP). This ISG updates the guidance provided to the staff in Standard Review Plan (SRP), Section 17.4, ``Reliability Assurance Program,'' of NUREG-0800, ``Standard...

  20. 46 CFR 8.570 - Interim approval of prototype SIP company or vessel plans.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 1 2010-10-01 2010-10-01 false Interim approval of prototype SIP company or vessel... of prototype SIP company or vessel plans. (a) A company operating under an approved prototype SIP... continue operating under the plans while revisions are developed to bring the prototype SIP company or...

  1. Interim Draft: Biological Sampling and Analysis Plan Outline ...

    EPA Pesticide Factsheets

    Standard Operation Procedures This interim sampling and analysis plan (SAP) outline was developed specifically as an outline of the output that will be generated by a developing on-line tool called the MicroSAP. The goal of the MicroSAP tool is to assist users with development of SAPs needed for site characterization, verification sampling, and post decontamination sampling stages of biological sampling and analysis activities in which the EPA would be responsible for conducting sampling. These activities could include sampling and analysis for a biological contamination incident, a research study, or an exercise. The development of this SAP outline did not consider the initial response of an incident, as it is assumed that the initial response would have been previously completed by another agency during the response, or the clearance phase, as it is assumed that separate committee would be established to make decisions regarding clearing a site. This outline also includes considerations for capturing the associated data quality objectives in the SAP.

  2. RESPONSE PROTOCOL TOOLBOX: PLANNING FOR AND RESPONDING TO DRINKING WATER CONTAMINATION THREATS AND INCIDENTS. MODULE 1: WATER UTILITIES PLANNING GUIDE - INTERIM FINAL - DECEMBER 2003

    EPA Science Inventory

    The interim final Response Protocol Toolbox: Planning for and Responding to Contamination Threats to Drinking Water Systems is designed to help the water sector effectively and appropriately respond to intentional contamination threats and incidents. It was produced by EPA, buil...

  3. NAVSTAR GPS Simulation and Analysis Program (Interim Report)

    DOT National Transportation Integrated Search

    1983-10-01

    This study assesses the capability of the planned NAVSTAR Global Positioning System (GPS) to meet civil navigation requirements. When it becomes operational in about 1983, NAVSTAR GPS will provide accurate two-dimensional and three-dimensional servic...

  4. Interim Budget Plan.

    ERIC Educational Resources Information Center

    Office of Student Financial Assistance (ED), Washington, DC.

    This report provides the interim budget plan of the U.S. Department of Education's Office of Student Financial Assistance (OSFA) for fiscal year 2000. It reviews factors influencing OSFA's budget request, including legislative requirements, recent accomplishments, the need to maintain both the Direct Loan and Federal Family Education Loan…

  5. 33 CFR 385.9 - Implementation principles.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... of the Plan at specific time intervals during implementation. Interim targets to evaluate progress on... accordance with § 385.39. Interim goals and interim targets shall be consistent with each other. (c... ensure that new information resulting from changed or unforeseen circumstances, new scientific and...

  6. 33 CFR 385.9 - Implementation principles.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... of the Plan at specific time intervals during implementation. Interim targets to evaluate progress on... accordance with § 385.39. Interim goals and interim targets shall be consistent with each other. (c... ensure that new information resulting from changed or unforeseen circumstances, new scientific and...

  7. 33 CFR 385.9 - Implementation principles.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... of the Plan at specific time intervals during implementation. Interim targets to evaluate progress on... accordance with § 385.39. Interim goals and interim targets shall be consistent with each other. (c... ensure that new information resulting from changed or unforeseen circumstances, new scientific and...

  8. 33 CFR 385.9 - Implementation principles.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... of the Plan at specific time intervals during implementation. Interim targets to evaluate progress on... accordance with § 385.39. Interim goals and interim targets shall be consistent with each other. (c... ensure that new information resulting from changed or unforeseen circumstances, new scientific and...

  9. Data Validation Package August 2015 Groundwater Sampling at the Grand Junction, Colorado, Disposal Site October 2015

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

    Frazier, William; Baur, Gary

    2015-11-03

    The 1998 Interim Long-Term Surveillance Plan for the Cheney Disposal Site Near Grand Junction, Colorado, requires annual monitoring to assess the performance of the disposal cell. Monitoring wells 0731, 0732 and 0733 were sampled as specified in the plan. Sampling and analyses were conducted in accordance with Sampling and Analysis Plan for the U.S. Department of Energy Office of Legacy Management Sites.

  10. 42 CFR 417.574 - Interim settlement.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Interim settlement. 417.574 Section 417.574 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... PLANS Medicare Payment: Cost Basis § 417.574 Interim settlement. (a) Determination. Within 30 days...

  11. Adaptive graph-based multiple testing procedures

    PubMed Central

    Klinglmueller, Florian; Posch, Martin; Koenig, Franz

    2016-01-01

    Multiple testing procedures defined by directed, weighted graphs have recently been proposed as an intuitive visual tool for constructing multiple testing strategies that reflect the often complex contextual relations between hypotheses in clinical trials. Many well-known sequentially rejective tests, such as (parallel) gatekeeping tests or hierarchical testing procedures are special cases of the graph based tests. We generalize these graph-based multiple testing procedures to adaptive trial designs with an interim analysis. These designs permit mid-trial design modifications based on unblinded interim data as well as external information, while providing strong family wise error rate control. To maintain the familywise error rate, it is not required to prespecify the adaption rule in detail. Because the adaptive test does not require knowledge of the multivariate distribution of test statistics, it is applicable in a wide range of scenarios including trials with multiple treatment comparisons, endpoints or subgroups, or combinations thereof. Examples of adaptations are dropping of treatment arms, selection of subpopulations, and sample size reassessment. If, in the interim analysis, it is decided to continue the trial as planned, the adaptive test reduces to the originally planned multiple testing procedure. Only if adaptations are actually implemented, an adjusted test needs to be applied. The procedure is illustrated with a case study and its operating characteristics are investigated by simulations. PMID:25319733

  12. Interim Land Use Control Implementation Plan

    NASA Technical Reports Server (NTRS)

    Applegate, Joseph L.

    2014-01-01

    This Interim Land Use Control Implementation Plan (LUCIP) has been prepared to inform current and potential future users of the Kennedy Space Center (KSC) Contractors Road Heavy Equipment (CRHE) Area (SWMU 055; "the Site") of institutional controls that have been implemented at the Site1. Although there are no current unacceptable risks to human health or the environment associated with the CRHE Area, an interim institutional land use control (LUC) is necessary to prevent human health exposure to volatile organic compound (VOC)-affected groundwater at the Site. Controls will include periodic inspection, condition certification, and agency notification.

  13. 75 FR 70114 - Amendment to the Interim Final Rules for Group Health Plans and Health Insurance Coverage...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-17

    ...This document contains an amendment to interim final regulations implementing the rules for group health plans and health insurance coverage in the group and individual markets under provisions of the Patient Protection and Affordable Care Act regarding status as a grandfathered health plan; the amendment permits certain changes in policies, certificates, or contracts of insurance without loss of grandfathered status.

  14. Medical loss ratio rebate requirements for non-federal governmental plans. Interim final rule with request for comments.

    PubMed

    2011-12-07

    This interim final rule with comment period revises the regulations implementing medical loss ratio (MLR) requirements for health insurance issuers under the Public Health Service Act in order to establish rules governing the distribution of rebates by issuers in group markets for non-Federal governmental plans.

  15. RESPONSE PROTOCOL TOOLBOX: PLANNING FOR AND RESPONDING TO DRINKING WATER CONTAMINATION THREATS AND INCIDENTS. OVERVIEW AND APPLICATION. INTERIM FINAL - DECEMBER 2003

    EPA Science Inventory

    The interim final Response Protocol Toolbox: Planning for and Responding to Contamination Threats to Drinking Water Systems is designed to help the water sector effectively and appropriately respond to intentional contamination threats and incidents. It was produced by EPA, buil...

  16. RESPONSE PROTOCOL TOOLBOX: PLANNING FOR AND RESPONDING TO DRINKING WATER CONTAMINATION THREATS AND INCIDENTS. MODULE 4: ANALYTICAL GUIDE. INTERIM FINAL - DECEMBER 2003

    EPA Science Inventory

    The interim final Response Protocol Toolbox: Planning for and Responding to Contamination Threats to Drinking Water Systems is designed to help the water sector effectively and appropriately respond to intentional contamination threats and incidents. It was produced by EPA, buil...

  17. 40 CFR 93.119 - Criteria and procedures: Interim emissions in areas without motor vehicle emissions budgets.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... applies to the net effect of the action (transportation plan, TIP, or project not from a conforming plan..., SO2 and/or ammonia in PM2.5 areas if the EPA Regional Administrator or the director of the State air... be operational or in effect in the analysis year, except that regulatory TCMs may not be assumed to...

  18. 40 CFR 93.119 - Criteria and procedures: Interim emissions in areas without motor vehicle emissions budgets.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... applies to the net effect of the action (transportation plan, TIP, or project not from a conforming plan..., SO2 and/or ammonia in PM2.5 areas if the EPA Regional Administrator or the director of the State air... be operational or in effect in the analysis year, except that regulatory TCMs may not be assumed to...

  19. 40 CFR 93.119 - Criteria and procedures: Interim emissions in areas without motor vehicle emissions budgets.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... applies to the net effect of the action (transportation plan, TIP, or project not from a conforming plan..., SO2 and/or ammonia in PM2.5 areas if the EPA Regional Administrator or the director of the State air... be operational or in effect in the analysis year, except that regulatory TCMs may not be assumed to...

  20. 40 CFR 265.113 - Closure; time allowed for closure.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... includes an amended waste analysis plan, ground-water monitoring and response program, human exposure....113 Section 265.113 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND...

  1. Land Use Management for Solid Waste Programs

    ERIC Educational Resources Information Center

    Brown, Sanford M., Jr.

    1974-01-01

    The author discusses the problems of solid waste disposal and examines various land use management techniques. These include the land use plan, zoning, regionalization, land utilities, and interim use. Information concerning solid waste processing site zoning and analysis is given. Bibliography included. (MA)

  2. Patient Protection and Affordable Care Act; third party payment of qualified health plan premiums. Interim final rule with comment period.

    PubMed

    2014-03-19

    This interim final rule requires issuers of qualified health plans (QHPs), including stand-alone dental plans (SADPs), to accept premium and cost-sharing payments made on behalf of enrollees by the Ryan White HIV/AIDS Program, other Federal and State government programs that provide premium and cost sharing support for specific individuals, and Indian tribes, tribal organizations, and urban Indian organizations.

  3. 78 FR 5830 - Draft Environmental Assessment and Proposed Habitat Conservation Plan for the Interim Operations...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-28

    ... Operations of PacifiCorp's Klamath Hydroelectric Project on the Klamath River, Klamath County, OR, and... Environmental Policy Act (NEPA) for the interim operations of the Klamath Hydroelectric Project in [[Page 5831... habitats upon which they depend, resulting from the interim operations of the Klamath Hydroelectric Project...

  4. RESPONSE PROTOCOL TOOLBOX: PLANNING FOR AND RESPONDING TO DRINKING WATER CONTAMINATION THREATS AND INCIDENTS, MODULE 3: SITE CHARACTERIZATION AND SAMPLING GUIDE. INTERIM FINAL - DECEMBER 2003

    EPA Science Inventory

    The interim final Response Protocol Toolbox: Planning for and Responding to Contamination Threats to Drinking Water Systems is designed to help the water sector effectively and appropriately respond to intentional contamination threats and incidents. It was produced by EPA, buil...

  5. 77 FR 26987 - Connect America Fund; A National Broadband Plan for Our Future; Establishing Just and Reasonable...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-08

    ... ETCs and incumbent LECs serving competitive areas, disaggregation plans (which permit incumbent LECs to...'' exception to the interim cap for competitive ETCs. The interim cap limited the total annual amount of high-cost support competitive ETCs in any state could receive to the amount competitive ETCs in that state...

  6. An Interim Report on a Fifteen Point Plan to Reduce Racial Isolation and Provide Quality Integrated Education.

    ERIC Educational Resources Information Center

    Rochester City School District, NY.

    This is an interim report of the second full year of the "Fifteen Point Plan." Although majority of comparisons between groups shows no significant statistical differences, differentials in achievement may become more noticeable as the program effects are reinforced with time, and through cumulative experience. From data analyzed after…

  7. 33 CFR 385.39 - Evaluating progress towards other water-related needs of the region provided for in the Plan.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE PROGRAMMATIC REGULATIONS... other. (3) The Department of the Army shall include these interim targets in appropriate Corps of... provided for in the Plan. These interim targets shall reflect the incremental accomplishment of the...

  8. 33 CFR 385.39 - Evaluating progress towards other water-related needs of the region provided for in the Plan.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE PROGRAMMATIC REGULATIONS... other. (3) The Department of the Army shall include these interim targets in appropriate Corps of... provided for in the Plan. These interim targets shall reflect the incremental accomplishment of the...

  9. 33 CFR 385.39 - Evaluating progress towards other water-related needs of the region provided for in the Plan.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE PROGRAMMATIC REGULATIONS... other. (3) The Department of the Army shall include these interim targets in appropriate Corps of... provided for in the Plan. These interim targets shall reflect the incremental accomplishment of the...

  10. 33 CFR 385.39 - Evaluating progress towards other water-related needs of the region provided for in the Plan.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE PROGRAMMATIC REGULATIONS... other. (3) The Department of the Army shall include these interim targets in appropriate Corps of... provided for in the Plan. These interim targets shall reflect the incremental accomplishment of the...

  11. 33 CFR 385.39 - Evaluating progress towards other water-related needs of the region provided for in the Plan.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE PROGRAMMATIC REGULATIONS... other. (3) The Department of the Army shall include these interim targets in appropriate Corps of... provided for in the Plan. These interim targets shall reflect the incremental accomplishment of the...

  12. Photomorphic analysis techniques: An interim spatial analysis using satellite remote sensor imagery and historical data

    NASA Technical Reports Server (NTRS)

    Keuper, H. R.; Peplies, R. W.; Gillooly, R. P.

    1977-01-01

    The use of machine scanning and/or computer-based techniques to provide greater objectivity in the photomorphic approach was investigated. Photomorphic analysis and its application in regional planning are discussed. Topics included: delineation of photomorphic regions; inadequacies of existing classification systems; tonal and textural characteristics and signature analysis techniques; pattern recognition and Fourier transform analysis; and optical experiments. A bibliography is included.

  13. IUS/TUG orbital operations and mission support study. Volume 2: Interim upper stage operations

    NASA Technical Reports Server (NTRS)

    1975-01-01

    Background data and study results are presented for the interim upper stage (IUS) operations phase of the IUS/tug orbital operations study. The study was conducted to develop IUS operational concepts and an IUS baseline operations plan, and to provide cost estimates for IUS operations. The approach used was to compile and evaluate baseline concepts, definitions, and system, and to use that data as a basis for the IUS operations phase definition, analysis, and costing analysis. Both expendable and reusable IUS configurations were analyzed and two autonomy levels were specified for each configuration. Topics discussed include on-orbit operations and interfaces with the orbiter, the tracking and data relay satellites and ground station support capability analysis, and flight control center sizing to support the IUS operations.

  14. 40 CFR 93.119 - Criteria and procedures: Interim emissions in areas without motor vehicle emissions budgets.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... applies to the net effect of the action (transportation plan, TIP, or project not from a conforming plan... notified the MPO and DOT; and (10) VOC, SO2 and/or ammonia in PM2.5 areas if the EPA Regional Administrator... effect in the analysis year, except that regulatory TCMs may not be assumed to begin at a future time...

  15. INTERIM -- Starlink Software Environment

    NASA Astrophysics Data System (ADS)

    Pearce, Dave; Pavelin, Cliff; Lawden, M. D.

    Early versions of this paper were based on a number of other papers produced at a very early stage of the Starlink project. They contained a description of a specific implementation of a subroutine library, speculations on the desirable attributes of a software environment, and future development plans. They reflected the experimental nature of the Starlink software environment at that time. Since then, the situation has changed. The implemented subroutine library, INTERIM_DIR:INTERIM.OLB, is now a well established and widely used piece of software. A completely new Starlink software environment (ADAM) has been developed and distributed. Thus the library released in 1980 as `STARLINK' and now called `INTERIM' has reached the end of its development cycle and is now frozen in its current state, apart from bug corrections. This paper has, therefore, been completely rewritten and restructured to reflect the new situation. Its aim is to describe the facilities of the INTERIM subroutine library as clearly and concisely as possible. It avoids speculation, discussion of design decisions, and announcements of future plans.

  16. Registration Review Schedules

    EPA Pesticide Factsheets

    This schedule indicates plans for completion of risk assessments, proposed interim decisions and interim decisions for pesticides in the Registration Review program, EPA reviews all registered pesticides at least every 15 years as required by FIFRA.

  17. The use of group sequential, information-based sample size re-estimation in the design of the PRIMO study of chronic kidney disease.

    PubMed

    Pritchett, Yili; Jemiai, Yannis; Chang, Yuchiao; Bhan, Ishir; Agarwal, Rajiv; Zoccali, Carmine; Wanner, Christoph; Lloyd-Jones, Donald; Cannata-Andía, Jorge B; Thompson, Taylor; Appelbaum, Evan; Audhya, Paul; Andress, Dennis; Zhang, Wuyan; Solomon, Scott; Manning, Warren J; Thadhani, Ravi

    2011-04-01

    Chronic kidney disease is associated with a marked increase in risk for left ventricular hypertrophy and cardiovascular mortality compared with the general population. Therapy with vitamin D receptor activators has been linked with reduced mortality in chronic kidney disease and an improvement in left ventricular hypertrophy in animal studies. PRIMO (Paricalcitol capsules benefits in Renal failure Induced cardia MOrbidity) is a multinational, multicenter randomized controlled trial to assess the effects of paricalcitol (a selective vitamin D receptor activator) on mild to moderate left ventricular hypertrophy in patients with chronic kidney disease. Subjects with mild-moderate chronic kidney disease are randomized to paricalcitol or placebo after confirming left ventricular hypertrophy using a cardiac echocardiogram. Cardiac magnetic resonance imaging is then used to assess left ventricular mass index at baseline, 24 and 48 weeks, which is the primary efficacy endpoint of the study. Because of limited prior data to estimate sample size, a maximum information group sequential design with sample size re-estimation is implemented to allow sample size adjustment based on the nuisance parameter estimated using the interim data. An interim efficacy analysis is planned at a pre-specified time point conditioned on the status of enrollment. The decision to increase sample size depends on the observed treatment effect. A repeated measures analysis model, using available data at Week 24 and 48 with a backup model of an ANCOVA analyzing change from baseline to the final nonmissing observation, are pre-specified to evaluate the treatment effect. Gamma-family of spending function is employed to control family-wise Type I error rate as stopping for success is planned in the interim efficacy analysis. If enrollment is slower than anticipated, the smaller sample size used in the interim efficacy analysis and the greater percent of missing week 48 data might decrease the parameter estimation accuracy, either for the nuisance parameter or for the treatment effect, which might in turn affect the interim decision-making. The application of combining a group sequential design with a sample-size re-estimation in clinical trial design has the potential to improve efficiency and to increase the probability of trial success while ensuring integrity of the study.

  18. Annotating MYC Status in Treatment-Resistant Metastatic Castration-Resistant Prostate Cancer With Gallium-68 Citrate PET

    DTIC Science & Technology

    2017-09-01

    ongoing and interim analysis is planned within the next 6 months. Planned analyses include: 1) correlation of gallium citrate uptake on PET with MYC...utility of Gallium citrate PET as a pharmacodynamic and predictive biomarker of MYC pathway inhibition in mCRPC. Correlative pre- and post-treatment...completed Milestone Achieved: Last patient completes study follow up scan 36 Not yet completed Assess correlation between SUVmax on gallium

  19. Experiences with an adaptive design for a dose-finding study in patients with osteoarthritis.

    PubMed

    Miller, Frank; Björnsson, Marcus; Svensson, Ola; Karlsten, Rolf

    2014-03-01

    Dose-finding studies in non-oncology areas are usually conducted in Phase II of the development process of a new potential medicine and it is key to choose a good design for such a study, as the results will decide if and how to proceed to Phase III. The present article has focus on the design of a dose-finding study for pain in osteoarthritis patients treated with the TRPV1 antagonist AZD1386. We describe different design alternatives in the planning of this study, the reasoning for choosing the adaptive design and experiences with conduct and interim analysis. Three alternatives were proposed: one single dose-finding study with parallel design, a programme with a smaller Phase IIa study followed by a Phase IIb dose-finding study, and an adaptive dose-finding study. We describe these alternatives in detail and explain why the adaptive design was chosen for the study. We give insights in design aspects of the adaptive study, which need to be pre-planned, like interim decision criteria, statistical analysis method and setup of a Data Monitoring Committee. Based on the interim analysis it was recommended to stop the study for futility since AZD1386 showed no significant pain decrease based on the primary variable. We discuss results and experiences from the conduct of the study with the novel design approach. Huge cost savings have been done compared to if the option with one dose-finding design for Phase II had been chosen. However, we point out several challenges with this approach. Copyright © 2014 Elsevier Inc. All rights reserved.

  20. 76 FR 37207 - Group Health Plans and Health Insurance Issuers: Rules Relating to Internal Claims and Appeals...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-24

    ...This document contains amendments to interim final regulations implementing the requirements regarding internal claims and appeals and external review processes for group health plans and health insurance coverage in the group and individual markets under provisions of the Affordable Care Act. These rules are intended to respond to feedback from a wide range of stakeholders on the interim final regulations and to assist plans and issuers in coming into full compliance with the law through an orderly and expeditious implementation process.

  1. Commentary: Interim leadership of academic departments at U.S. medical schools.

    PubMed

    Grigsby, R Kevin; Aber, Robert C; Quillen, David A

    2009-10-01

    Medical schools and teaching hospitals are experiencing more frequent turnover of department chairs. Loss of a department chair creates instability in the department and may have a negative effect on the organization at large. Interim leadership of academic departments is common, and interim chairs are expected to immediately demonstrate skills and leadership abilities. However, little is known about how persons are prepared to assume the interim chair role. Newer competencies for effective leadership include an understanding of the business of medicine, interpersonal and communication skills, the ability to deal with conflict and solve adaptive challenges, and the ability to build and work on teams. Medical schools and teaching hospitals need assistance to meet the unique training and support needs of persons serving as interim leaders. For example, the Association of American Medical Colleges and individual chair societies can develop programs to allow current chairs to reflect on their present positions and plan for the future. Formal leadership training, mentorship opportunities, and conscientious succession planning are good first steps in preparing to meet the needs of academic departments during transitions in leadership. Also, interim leadership experience may be useful as a means for "opening the door" to underrepresented persons, including women, and increasing the diversity of the leadership team.

  2. Our Greatest Natural Resource: Investing in the Future of Alaska's Children. A Report of the Governor's Interim Commission on Children and Youth.

    ERIC Educational Resources Information Center

    Alaska Office of the Governor, Juneau.

    In 1987, the Governor of Alaska's Interim Commission on Children and Youth was given two tasks: (1) to develop a plan for a first-class child care system for working parents statewide that is workable, fair and sensibly integrates with the public schools; and (2) to produce a comprehensive plan to combat the problems facing Alaskans so they are…

  3. Interim rules for amending ERISA disclosure requirements for group health plans; approval of information collection requirements--DoL. Interim rules; approval of information collection requirements.

    PubMed

    1997-07-07

    On April 8, 1997, the Department of Labor published interim final rules governing disclosure requirements for private sector group health plans (62 FR 16979). The rules implemented changes to made to certain provisions of the Employee Retirement Income Security Act of 1974 (ERISA), enacted as part of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Newborns' and Mothers' Health Protection Act of 1996 (NMHPA). In the April 8 publication, the Department submitted its revision of the currently approved collection regarding Summary Plan Description requirements under ERISA to the Office of Management and Budget (OMB) for emergency review under the Paperwork Reduction Act of 1965 (PRA 95). This document amends the April 8 Federal Register document to properly display the OMB control number, 1210-0039.

  4. Rulemaking to Affirm Interim Amendments to Dates in Federal Implementation Plans Addressing Interstate Transport of Ozone and Fine Particulate Matter (81 FR 13275)

    EPA Pesticide Factsheets

    This rulemaking affirms and makes permanent certain amendments previously made on an interim basis to the Code of Federal Regulations (CFR) provisions implementing the Cross-State Air Pollution Rule (CSAPR).

  5. Pilot-scale treatability test plan for the 200-BP-5 operable unit

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

    Not Available

    This document presents the treatability test plan for pilot-scale pump and treat testing at the 200-BP-5 Operable Unit. This treatability test plan has been prepared in response to an agreement between the U.S. Department of Energy (DOE), the U.S. Environmental Protection Agency (EPA), and the State of Washington Department of Ecology (Ecology), as documented in Hanford Federal Facility Agreement and Consent Order (Tri-Party Agreement, Ecology et al. 1989a) Change Control Form M-13-93-03 (Ecology et al. 1994) and a recent 200 NPL Agreement Change Control Form (Appendix A). The agreement also requires that, following completion of the activities described in thismore » test plan, a 200-BP-5 Operable Unit Interim Remedial Measure (IRM) Proposed Plan be developed for use in preparing an Interim Action Record of Decision (ROD). The IRM Proposed Plan will be supported by the results of this treatability test plan, as well as by other 200-BP-5 Operable Unit activities (e.g., development of a qualitative risk assessment). Once issued, the Interim Action ROD will specify the interim action(s) for groundwater contamination at the 200-BP-5 Operable Unit. The treatability test approach is to conduct a pilot-scale pump and treat test for each of the two contaminant plumes associated with the 200-BP-5 Operable Unit. Primary contaminants of concern are {sup 99}Tc and {sup 60}Co for underwater affected by past discharges to the 216-BY Cribs, and {sup 90}Sr, {sup 239/240}Pu, and Cs for groundwater affected by past discharges to the 216-B-5 Reverse Well. The purpose of the pilot-scale treatability testing presented in this testplan is to provide the data basis for preparing an IRM Proposed Plan. To achieve this objective, treatability testing must: Assess the performance of groundwater pumping with respect to the ability to extract a significant amount of the primary contaminant mass present in the two contaminant plumes.« less

  6. Planning and Designing School Computer Facilities. Interim Report.

    ERIC Educational Resources Information Center

    Alberta Dept. of Education, Edmonton. Finance and Administration Div.

    This publication provides suggestions and considerations that may be useful for school jurisdictions developing facilities for computers in schools. An interim report for both use and review, it is intended to assist school system planners in clarifying the specifications needed by the architects, other design consultants, and purchasers involved.…

  7. 14 CFR 136.41 - Interim operating authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... AND NATIONAL PARKS AIR TOUR MANAGEMENT National Parks Air Tour Management § 136.41 Interim operating... terminate 180 days after the date on which an air tour management plan is established for the park and tribal lands; (6) Shall promote protection of national park resources, visitor experiences, and tribal...

  8. School Health Program. Interim Guide. Grade 9.

    ERIC Educational Resources Information Center

    Northwest Territories Dept. of Education, Yellowknife.

    This interim guide, a component of the Northwest Territories (Canada) School Health Program, includes instructional strategies, lesson plans, reproducibles, and teacher background materials for ninth grade classes. The material is organized around the three curriculum units: (1) the mental and emotional well-being unit which has three lessons on…

  9. Internal pilots for a class of linear mixed models with Gaussian and compound symmetric data

    PubMed Central

    Gurka, Matthew J.; Coffey, Christopher S.; Muller, Keith E.

    2015-01-01

    SUMMARY An internal pilot design uses interim sample size analysis, without interim data analysis, to adjust the final number of observations. The approach helps to choose a sample size sufficiently large (to achieve the statistical power desired), but not too large (which would waste money and time). We report on recent research in cerebral vascular tortuosity (curvature in three dimensions) which would benefit greatly from internal pilots due to uncertainty in the parameters of the covariance matrix used for study planning. Unfortunately, observations correlated across the four regions of the brain and small sample sizes preclude using existing methods. However, as in a wide range of medical imaging studies, tortuosity data have no missing or mistimed data, a factorial within-subject design, the same between-subject design for all responses, and a Gaussian distribution with compound symmetry. For such restricted models, we extend exact, small sample univariate methods for internal pilots to linear mixed models with any between-subject design (not just two groups). Planning a new tortuosity study illustrates how the new methods help to avoid sample sizes that are too small or too large while still controlling the type I error rate. PMID:17318914

  10. 75 FR 26981 - Notice of Establishment of Interim Final Supplementary Rules for Public Lands Managed by the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-13

    ... DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLCACO8000 L16100000 DX0000] Notice of..., California AGENCY: Bureau of Land Management, Interior. ACTION: Notice of Establishment of Interim Final Supplementary Rules. SUMMARY: In accordance with the Record of Decision for the Sierra Resource Management Plan...

  11. 77 FR 50069 - National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-20

    .... Grace & Co., Inc./Wayne Interim Storage (USDOE) Superfund Site AGENCY: Environmental Protection Agency... issuing a Notice of Intent to Delete the W.R. Grace & Co., Inc./Wayne Interim Storage (USDOE) Superfund..., NY 10007-1866. Hand Delivery: U.S. EPA Superfund Records Center, Region II, 290 Broadway, 18th Floor...

  12. System architecture for the Canadian interim mobile satellite system

    NASA Technical Reports Server (NTRS)

    Shariatmadar, M.; Gordon, K.; Skerry, B.; Eldamhougy, H.; Bossler, D.

    1988-01-01

    The system architecture for the Canadian Interim Mobile Satellite Service (IMSS) which is planned for commencement of commercial service in late 1989 is reviewed. The results of an associated field trial program which was carried out to determine the limits of coverage and the preliminary performance characteristics of the system are discussed.

  13. KSC Press Site Transformer Bldg. (K7-1205c) SWMU 074 Interim Measure Work Plan

    NASA Technical Reports Server (NTRS)

    Starr, A. Scott; Applegate, Joe

    2014-01-01

    This document presents and discusses the Interim Measure (IM) Work Plan for the Press Site Transformer Building (K7-1205C). The purpose of the proposed IM activities is to remove soil affected with polychlorinated biphenyls (PCBs) greater than the Florida Department of Environmental Protection (FDEP) residential direct-exposure Soil Cleanup Target Level (R-SCTL) of 0.5 milligrams per kilogram and encapsulate concrete exhibiting PCB concentration greater than the Toxic Substance Control Act (TSCA) threshold of 50 milligrams per kilogram.

  14. 12 CFR 195.27 - Strategic plan.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Assessing Performance § 195.27 Strategic plan. (a) Alternative election. The appropriate Federal banking... under an approved plan for at least one year. (b) Data reporting. The appropriate Federal banking agency... any multi-year plan must include annual interim measurable goals under which the appropriate Federal...

  15. 12 CFR 195.27 - Strategic plan.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Assessing Performance § 195.27 Strategic plan. (a) Alternative election. The appropriate Federal banking... under an approved plan for at least one year. (b) Data reporting. The appropriate Federal banking agency... any multi-year plan must include annual interim measurable goals under which the appropriate Federal...

  16. 12 CFR 195.27 - Strategic plan.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Assessing Performance § 195.27 Strategic plan. (a) Alternative election. The appropriate Federal banking... under an approved plan for at least one year. (b) Data reporting. The appropriate Federal banking agency... any multi-year plan must include annual interim measurable goals under which the appropriate Federal...

  17. A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials

    PubMed Central

    2009-01-01

    Background Decisions about interim analysis and early stopping of clinical trials, as based on recommendations of Data Monitoring Committees (DMCs), have far reaching consequences for the scientific validity and clinical impact of a trial. Our aim was to evaluate the frequency and quality of the reporting on DMC composition and roles, interim analysis and early termination in pediatric trials. Methods We conducted a systematic review of randomized controlled clinical trials published from 2005 to 2007 in a sample of four general and four pediatric journals. We used full-text databases to identify trials which reported on DMCs, interim analysis or early termination, and included children or adolescents. Information was extracted on general trial characteristics, risk of bias, and a set of parameters regarding DMC composition and roles, interim analysis and early termination. Results 110 of the 648 pediatric trials in this sample (17%) reported on DMC or interim analysis or early stopping, and were included; 68 from general and 42 from pediatric journals. The presence of DMCs was reported in 89 of the 110 included trials (81%); 62 papers, including 46 of the 89 that reported on DMCs (52%), also presented information about interim analysis. No paper adequately reported all DMC parameters, and nine (15%) reported all interim analysis details. Of 32 trials which terminated early, 22 (69%) did not report predefined stopping guidelines and 15 (47%) did not provide information on statistical monitoring methods. Conclusions Reporting on DMC composition and roles, on interim analysis results and on early termination of pediatric trials is incomplete and heterogeneous. We propose a minimal set of reporting parameters that will allow the reader to assess the validity of trial results. PMID:20003383

  18. Federal Early Childhood Programs: A Description and Analysis of Research, Child Care, State Grant and Teacher Training Programs Pertaining to Young Children. Interim Report.

    ERIC Educational Resources Information Center

    Searcy, Ellen Ouhl

    The main objectives of this report about the Federal effort in early learning research are to assist the National Program on Early Childhood Education (NPECE) in planning its research and development program, to identify predicted "popular" areas of research for the future, and to identify possible NPECE funding sources. The report…

  19. Integrating intelligent transportation systems within the transportation planning process : an interim handbook.

    DOT National Transportation Integrated Search

    1998-01-01

    The Final Rule on Statewide Planning and Metropolitan Planning issued by the Federal Highway Administration (FHWA) and Federal Transit Administration (FTA) in October, 1993 established revised and more comprehensive processes for metropolitan and sta...

  20. Interim Status Closure Plan Open Burning Treatment Unit Technical Area 16-399 Burn Tray

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

    Vigil-Holterman, Luciana R.

    2012-05-07

    This closure plan describes the activities necessary to close one of the interim status hazardous waste open burning treatment units at Technical Area (TA) 16 at the Los Alamos National Laboratory (LANL or the Facility), hereinafter referred to as the 'TA-16-399 Burn Tray' or 'the unit'. The information provided in this closure plan addresses the closure requirements specified in the Code of Federal Regulations (CFR), Title 40, Part 265, Subparts G and P for the thermal treatment units operated at the Facility under the Resource Conservation and Recovery Act (RCRA) and the New Mexico Hazardous Waste Act. Closure of themore » open burning treatment unit will be completed in accordance with Section 4.1 of this closure plan.« less

  1. Recruitment failure and futility were the most common reasons for discontinuation of clinical drug trials. Results of a nationwide inception cohort study in the Netherlands.

    PubMed

    van den Bogert, Cornelis A; Souverein, Patrick C; Brekelmans, Cecile T M; Janssen, Susan W J; Koëter, Gerard H; Leufkens, Hubert G M; Bouter, Lex M

    2017-08-01

    The objective of the study was to identify the reasons for discontinuation of clinical drug trials and to evaluate whether efficacy-related discontinuations were adequately planned in the trial protocol. All clinical drug trials in the Netherlands, reviewed by institutional review boards in 2007, were followed until December 2015. Data were obtained through the database of the Dutch competent authority (Central Committee on Research Involving Human Subjects [CCMO]) and a questionnaire to the principal investigators. Reasons for trial discontinuation were the primary outcome of the study. Three reasons for discontinuation were analyzed separately: all cause, recruitment failure, and efficacy related (when an interim analysis had demonstrated futility or superiority). Among the efficacy-related discontinuations, we examined whether the data monitoring committee, the stopping rule, and the moment of the interim analysis in the trial progress were specified in the trial protocol. Of the 574 trials, 102 (17.8%) were discontinued. The most common reasons were recruitment failure (33 of 574; 5.7%) and solely efficacy related (30 of 574; 5.2%). Of the efficacy-related discontinuations, 10 of 30 (33.3%) of the trial protocols reported all three aspects in the trial protocol, and 20 of 30 (66.7%) reported at least one aspect in the trial protocol. One out of five clinical drug trials is discontinued before the planned trial end, with recruitment failure and futility as the most common reasons. The target sample size of trials should be feasible, and interim analyses should be adequately described in trial protocols. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. A Proposal: The Circular School Year.

    ERIC Educational Resources Information Center

    Reeves, Robert L.

    A proposed plan outlined in this speech divides the school year into three instructional units of 12 weeks each during which time student attendance is required. Three interim units of 15 work days and five vacation days are scheduled in April, August, and December. These interim units are designed to be used by students for remedial work,…

  3. Interim definitions for old growth Douglas-fir and mixed-conifer forests in the Pacific Northwest and California.

    Treesearch

    J.F. Franklin; F. Hall; W. Laudenslayer; C. Maser; J. Nunan; J. Poppino; C.J. Ralph; T. Spies

    1986-01-01

    Interim definitions of old-growth forests are provided to guide efforts in land-management planning until comprehensive definitions based on research that is currently underway can be formulated. The basic criteria for identifying old-growth Douglas-fir (Pseudotsuga menziesii (Mirb.) Franco) and mixed-conifer forests in western Washington and...

  4. Interim guidance for implementing SAFETEA-LU provisions on planning, environment, and air quality for FHWA authorities

    DOT National Transportation Integrated Search

    2007-02-14

    This final rule revises the regulations governing the development of metropolitan transportation plans and programs for urbanized areas, State transportation plans and programs and the regulations for Congestion Management Systems. The revision resul...

  5. Southern California ITS Priority Corridor strategic deployment plan : interim report

    DOT National Transportation Integrated Search

    1998-08-01

    This deployment plan will be the "blueprint" for agencies to follow to ensure that projects are designed and built to conform to the National ITS Architecture and Standards, a requirement for funding under TEA 21. The federal ITS planning and deploym...

  6. Artificial Intelligence: An Analysis of Potential Applications to Training, Performance Measurement, and Job Performance Aiding. Interim Report for Period September 1982-July 1983.

    ERIC Educational Resources Information Center

    Richardson, J. Jeffrey

    This paper is part of an Air Force planning effort to develop a research, development, and applications program for the use of artificial intelligence (AI) technology in three target areas: training, performance measurement, and job performance aiding. The paper is organized in five sections that (1) introduce the reader to AI and those subfields…

  7. Environmental Survey preliminary report, Kansas City Plant, Kansas City, Missouri

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

    Not Available

    1988-01-01

    This report presents the preliminary findings from the first phase of the Environmental Survey of the United States Department of Energy (DOE), Kansas City Plant (KCP), conducted March 23 through April 3, 1987. The Survey is being conducted by a multidisciplinary team of environmental specialists, led and managed by the Office of Environment, Safety and Health's Office of Environmental Audit. Individual team members are outside experts being supplied by a private contractor. The objective of the Survey is to identify environmental problems and areas of environmental risk associated with the KCP. The Survey covers all environmental media and all areasmore » of environmental regulations. It is being performed in accordance with the DOE Environmental Survey Manual. This phase of the Survey involves the review of existing site environmental data observations of the operations performed at the KCP, and interviews with site personnel. The Survey team developed a Sampling and Analysis Plan to assist in further assessing certain environmental problems identified during its on-site activities. The Sampling and Analysis Plan is being executed by DOE's Argonne National Laboratory. When completed, the results will be incorporated into the KCP Environmental Survey Interim Report. The Interim Report will reflect the final determinations of the KCP Survey. 94 refs., 39 figs., 55 tabs.« less

  8. Environmental Survey preliminary report, Brookhaven National Laboratory, Upton, New York

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

    Not Available

    1988-06-01

    This report presents the preliminary findings from the first phase of the Environmental Survey of the United States Department of Energy (DOE) Brookhaven National Laboratory (BNL) conducted April 6 through 17, 1987. The Survey is being conducted by an interdisciplinary team of environmental specialists, led and managed by the Office of Environment, Safety and Health's Office of Environmental Audit. Individual team components are being supplied by a private contractor. The objective of the Survey is to identify environmental problems and areas of environmental risk associated with BNL. The Survey covers all environmental media and all areas of environmental regulation. Itmore » is being performed in accordance with the DOE Environmental Survey Manual. This phase of the Survey involves the review of existing site environmental data, observations of the operations carried on at BNL, and interviews with site personnel. The Survey team developed a Sampling and Analysis Plan to assist in further assessing specific environmental problems identified during its on-site activities. The Sampling and Analysis Plan will be executed by Oak Ridge National Laboratory. When completed, the results will be incorporated into the BNL Environmental Survey Interim Report. The Interim Report will reflect the final determinations of the BNL Survey. 80 refs., 24 figs., 48 tabs.« less

  9. 75 FR 34537 - Interim Final Rules for Group Health Plans and Health Insurance Coverage Relating to Status as a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-17

    ... 45 CFR Part 147 Group Health Plans and Health Insurance Coverage Relating to Status as a... for Group Health Plans and Health Insurance Coverage Relating to Status as a Grandfathered Health Plan... group health plans and health insurance coverage in the group and individual markets under provisions of...

  10. 78 FR 17835 - Approval and Promulgation of Federal Implementation Plan for Oil and Natural Gas Well Production...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-22

    ...The EPA is taking final action to promulgate a Reservation- specific Federal Implementation Plan in order to regulate emissions from oil and natural gas production facilities located on the Fort Berthold Indian Reservation in North Dakota. The Federal Implementation Plan includes basic air quality regulations for the protection of communities in and adjacent to the Fort Berthold Indian Reservation. The Federal Implementation Plan requires owners and operators of oil and natural gas production facilities to reduce emissions of volatile organic compounds emanating from well completions, recompletions, and production and storage operations. This Federal Implementation Plan will be implemented by the EPA, or a delegated tribal authority, until replaced by a Tribal Implementation Plan. The EPA proposed a Reservation-specific Federal Implementation Plan concurrently with an interim final rule on August 15, 2012. This final Federal Implementation Plan replaces the interim final rule in all intents and purposes on the effective date of the final rule. The EPA is taking this action pursuant to the Clean Air Act (CAA).

  11. Interim Stabilization Equipment Essential and Support Drawing Plan

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

    KOCH, M.R.

    The purpose of this document is to list the Interim Stabilization equipment drawings that are classified as Essential or Support drawings. Essential Drawings: Those drawings identified by the facility staff as necessary to directly support the safe operation of the facility or equipment. Support Drawings: Those drawings identified by the facility staff that further describe the design details of structures, systems or components shown on essential drawings.

  12. Interim OECA Guidance on Enhancing Regional-State Planning and Communication on Compliance Assurance Work in Authorized States

    EPA Pesticide Factsheets

    Guidance outlining principles and best practices for State and EPA collaboration in inspections and enforcement. work planning and implementation. National Enforcement Initiatives, and outcome and performance measurement.

  13. Digital approach to planning computer-guided surgery and immediate provisionalization in a partially edentulous patient.

    PubMed

    Arunyanak, Sirikarn P; Harris, Bryan T; Grant, Gerald T; Morton, Dean; Lin, Wei-Shao

    2016-07-01

    This report describes a digital approach for computer-guided surgery and immediate provisionalization in a partially edentulous patient. With diagnostic data obtained from cone-beam computed tomography and intraoral digital diagnostic scans, a digital pathway of virtual diagnostic waxing, a virtual prosthetically driven surgical plan, a computer-aided design and computer-aided manufacturing (CAD/CAM) surgical template, and implant-supported screw-retained interim restorations were realized with various open-architecture CAD/CAM systems. The optional CAD/CAM diagnostic casts with planned implant placement were also additively manufactured to facilitate preoperative inspection of the surgical template and customization of the CAD/CAM-fabricated interim restorations. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  14. 76 FR 37037 - Requirements for Group Health Plans and Health Insurance Issuers Relating to Internal Claims and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-24

    ... Requirements for Group Health Plans and Health Insurance Issuers Relating to Internal Claims and Appeals and... interim final regulations published July 23, 2010 with respect to group health plans and health insurance..., group health plans, and health insurance issuers providing group health insurance coverage. The text of...

  15. Tribal child welfare. Interim final rule.

    PubMed

    2012-01-06

    The Administration for Children and Families (ACF) is issuing this interim final rule to implement statutory provisions related to the Tribal title IV-E program. Effective October 1, 2009, section 479B(b) of the Social Security Act (the Act) authorizes direct Federal funding of Indian Tribes, Tribal organizations, and Tribal consortia that choose to operate a foster care, adoption assistance and, at Tribal option, a kinship guardianship assistance program under title IV-E of the Act. The Fostering Connections to Success and Increasing Adoptions Act of 2008 requires that ACF issue interim final regulations which address procedures to ensure that a transfer of responsibility for the placement and care of a child under a State title IV-E plan to a Tribal title IV-E plan occurs in a manner that does not affect the child's eligibility for title IV-E benefits or medical assistance under title XIX of the Act (Medicaid) and such services or payments; in-kind expenditures from third-party sources for the Tribal share of administration and training expenditures under title IV-E; and other provisions to carry out the Tribal-related amendments to title IV-E. This interim final rule includes these provisions and technical amendments necessary to implement a Tribal title IV-E program.

  16. Groundwater Interim Measures Work Plan for the Former Chemical Plant

    EPA Pesticide Factsheets

    May 2012 Groundwater IMWP, revised per EPA's approval, focuses on the installation of a groundwater containment system to mitigate groundwater migration from the former plant. A prior 2002 work plan is included in its entirety in Appendix B.

  17. 40 CFR 265.118 - Post-closure plan; amendment of plan.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... the wastes, application of advanced technology, or alternative disposal, treatment, or re-use.... 265.118 Section 265.118 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT...

  18. Implementation of high performance concrete in Louisiana bridges : interim report.

    DOT National Transportation Integrated Search

    1998-02-01

    The report contains a research plan to assist in the implementation of high performance concrete in the Charenton Canal Bridge in Louisiana. The research involves a literature review, plan review, development of a quality control program for the conc...

  19. 75 FR 41787 - Requirement for Group Health Plans and Health Insurance Issuers To Provide Coverage of Preventive...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-19

    ... Requirement for Group Health Plans and Health Insurance Issuers To Provide Coverage of Preventive Services... Insurance Oversight of the U.S. Department of Health and Human Services are issuing substantially similar interim final regulations with respect to group health plans and health insurance coverage offered in...

  20. Environmental Survey preliminary report, Los Alamos National Laboratory, Los Alamos, New Mexico

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

    Not Available

    1988-01-01

    This report presents the preliminary findings from the first phase of the Environmental Survey of the United States Department of Energy's (DOE) Los Alamos National Laboratory (LANL), conducted March 29, 1987 through April 17, 1987. The Survey is being conducted by an interdisciplinary team of environmental specialists, led and managed by the Office of Environment, Safety and Health's Office of Environmental Audit. Individual team components are outside experts being supplied by a private contractor. The objective of the Survey is to identify environmental problems and areas of environmental risk associated with the LANL. The Survey covers all environmental media andmore » all areas of environmental regulation. It is being performed in accordance with the DOE Environmental Survey Manual. The on-site phase of the Survey involves the review of existing site environmental data, observations of the operations carried on at the LANL, and interviews with site personnel. The Survey team developed Sampling and Analysis Plan to assist in further assessing certain of the environmental problems identified during its on-site activities. The Sampling and Analysis Plan will be executed by the Idaho National Engineering Laboratory. When completed, the results will be incorporated into the LANL Environmental Survey Interim Report. The Interim Report will reflect the final determinations of the Survey for the LANL. 65 refs., 68 figs., 73 tabs.« less

  1. Environmental Survey preliminary report, Pantex Facility, Amarillo, Texas

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

    Not Available

    This report presents the preliminary findings from the first phase of the Environmental Survey of the United States Department of Energy (DOE) Pantex Facility, conducted November 3 through 14, 1986.The Survey is being conducted by an interdisciplinary team of environmental specialist, led and managed by the Office of Environment, Safety and Health's Office of Environmental Audit. Individual team components are outside experts being supplied by a private contractor. The objective of the Survey is to identify environmental problems and areas of environmental risk associated with the Pantex Facility. The Survey covers all environmental media and all areas of environmental regulation.more » It is being performed in accordance with the DOE Environmental Survey Manual. The on-site phase of the Survey involves the review of existing site environmental data, observations of the operations carried on at the Pantex Facility, and interviews with site personnel. The Survey team developed a Sampling and Analysis Plan to assist in further assessing certain of the environmental problems identified during its on-site activities. The Sampling and Analysis Plan will be executed by the Oak Ridge National Laboratory. When completed, the results will be incorporated into the Pantex Facility Environmental Survey Interim Report. The Interim Report will reflect the final determinations of the Survey for the Pantex Facility. 65 refs., 44 figs., 27 tabs.« less

  2. Interim-status groundwater monitoring plan for the 216-B-63 trench. Revision 1

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

    Sweeney, M.D.

    1995-06-13

    This document outlines the groundwater monitoring plan for interim-status detection-level monitoring of the 216-B-63 Trench. This is a revision of the initial groundwater monitoring plan prepared for Westinghouse Hanford Company (WHC) by Bjornstad and Dudziak (1989). The 216-B-63 Trench, located at the Hanford Site in south-central Washington State, is an open, unlined, earthern trench approximately 1.2 m (4 ft) wide at the bottom, 427 m (1400 ft) long, and 3 m (10 ft) deep that received wastewater containing hazardous waste and radioactive materials from B Plant, located in the 200 East Area. Liquid effluent discharge to the 216-B-63 Trench beganmore » in March 1970 and ceased in February 1992. The trench is now managed by Waste Tank Operations.« less

  3. 2006 Annual Operations Report for INTEC Operable Unit 3-13, Group 1, Tank Farm Interim Action

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

    D. E. Shanklin

    2007-02-14

    This annual operations report describes the requirements followed and activities conducted to inspect, monitor, and maintain the items installed during performance of the Waste Area Group 3, Operable Unit 3-13, Group 1, Tank Farm Interim Action, at the Idaho Nuclear Technology and Engineering Center. This report covers the time period from January 1 through December 31, 2006, and describes inspection and monitoring activities for the surface-sealed areas within the tank farm, concrete-lined ditches and culverts in and around the tank farm, the lift station, and the lined evaporation pond. These activities are intended to assure that the interim action ismore » functioning adequately to meet the objectives stated in the Operable Unit 3-13, Record of Decision for the Group 1, Tank Farm Interim Action (DOE/ID-10660) as described in the Group 1 Remedial Design/Remedial Action Work Plan (DOE/ID-10772).« less

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

    Frenkel, G.; Paterson, T.S.; Smith, M.E.

    The Institute for Defense Analyses (IDA) has collected and analyzed information on battle management algorithm technology that is relevant to Battle Management/Command, Control and Communications (BM/C3). This Memorandum Report represents a program plan that will provide the BM/C3 Directorate of the Strategic Defense Initiative Organization (SDIO) with administrative and technical insight into algorithm technology. This program plan focuses on current activity in algorithm development and provides information and analysis to the SDIO to be used in formulating budget requirements for FY 1988 and beyond. Based upon analysis of algorithm requirements and ongoing programs, recommendations have been made for research areasmore » that should be pursued, including both the continuation of current work and the initiation of new tasks. This final report includes all relevant material from interim reports as well as new results.« less

  5. 75 FR 74045 - Guidance on Planning, Implementing, Maintaining, and Enforcing Institutional Controls at...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-30

    ..., Implementing, Maintaining, and Enforcing Institutional Controls at Contaminated Sites AGENCY: Environmental... stakeholder input regarding the issues addressed in the EPA interim final guidance, titled Institutional Controls: A Guide to Planning, Implementing, Maintaining, and Enforcing Institutional Controls at...

  6. How much do hazard mitigation plans cost? An analysis of federal grant data.

    PubMed

    Jackman, Andrea M; Beruvides, Mario G

    2013-01-01

    Under the Disaster Mitigation Act of 2000 and Federal Emergency Management Agency's subsequent Interim Final Rule, the requirement was placed on local governments to author and gain approval for a Hazard Mitigation Plan (HMP) for the areas under their jurisdiction. Low completion percentages for HMPs--less than one-third of eligible governments--were found by an analysis conducted 3 years after the final deadline for the aforementioned legislation took place. Follow-up studies showed little improvement at 5 and 8 years after the deadline. It was hypothesized that the cost of a HMP is a significant factor in determining whether or not a plan is completed. A study was conducted using Boolean Matrix Analysis methods to determine what, if any, characteristics of a certain community will most influence the cost of a HMP. The frequency of natural hazards experienced by the planning area, the number of jurisdictions participating in the HMEP, the population, and population density were found to significantly affect cost. These variables were used in a regression analysis to determine their predictive power for cost. It was found that along with two interaction terms, the variables explain approximately half the variation in HMP cost.

  7. 43 CFR 3809.401 - Where do I file my plan of operations and what information must I include with it?

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... would not result in unnecessary or undue degradation of public lands. (b) Your plan of operations must... BLM to determine that the plan of operations prevents unnecessary or undue degradation: (1) Operator... closure (including periods of seasonal closure) to prevent unnecessary or undue degradation. The interim...

  8. 76 FR 40457 - Administrative Simplification: Adoption of Operating Rules for Eligibility for a Health Plan and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-08

    ... Plan and Health Care Claim Status Transactions; Interim Final Rule #0;#0;Federal Register / Vol. 76, No... Simplification: Adoption of Operating Rules for Eligibility for a Health Plan and Health Care Claim Status... rules for the health care industry and directed the Secretary of Health and Human Services to ``adopt a...

  9. 75 FR 27141 - Group Health Plans and Health Insurance Issuers Providing Dependent Coverage of Children to Age...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-13

    ... Group Health Plans and Health Insurance Issuers Providing Dependent Coverage of Children to Age 26 Under... Information and Insurance Oversight of the U.S. Department of Health and Human Services are issuing substantially similar interim final regulations with respect to group health plans and health insurance coverage...

  10. 76 FR 75771 - Emergency Planning Guidance for Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-05

    ... Guidance for Nuclear Power Plants AGENCY: Nuclear Regulatory Commission. ACTION: Issuance of NUREG... Support of Nuclear Power Plants;'' NSIR/DPR-ISG-01, ``Interim Staff Guidance Emergency Planning for Nuclear Power Plants;'' and NUREG/CR-7002, ``Criteria for Development of Evacuation Time Estimate Studies...

  11. Northeast Artificial Intelligence Consortium Annual Report 1987. Volume 2, Part B. Discussing, Using, and Recognizing Plans

    DTIC Science & Technology

    1989-03-01

    1978. Williams. B.C. Qualitative Analysis of MOS Circuits. Artificial Inteligence . 1984. 24.. Wilson. K. From Association to Structure. Amsterdam:North...D-A208 378 RADC-TR-88-324, Vol II (of nine), Part B Interim Report March 1969 4. NORTHEAST ARTIFICIAL INTELLIGENCE CONSORTIUM ANNUAL REPORT 1987...II (of nine), Part B 6a. NAME OF PERFORMING ORGANIZATION 6b. OFFICE SYMBOL 7a. NAME OF MONITORING ORGANIZATION Northeast Artificial (ff ’aolicbl

  12. Additional EIPC Study Analysis: Interim Report on High Priority Topics

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

    Hadley, Stanton W

    Between 2010 and 2012 the Eastern Interconnection Planning Collaborative (EIPC) conducted a major long-term resource and transmission study of the Eastern Interconnection (EI). With guidance from a Stakeholder Steering Committee (SSC) that included representatives from the Eastern Interconnection States Planning Council (EISPC) among others, the project was conducted in two phases. Phase 1 involved a long-term capacity expansion analysis that involved creation of eight major futures plus 72 sensitivities. Three scenarios were selected for more extensive transmission- focused evaluation in Phase 2. Five power flow analyses, nine production cost model runs (including six sensitivities), and three capital cost estimations weremore » developed during this second phase. The results from Phase 1 and 2 provided a wealth of data that could be examined further to address energy-related questions. A list of 13 topics was developed for further analysis; this paper discusses the first five.« less

  13. INTERIM EPA GUIDANCE FOR GEOSPATIAL-RELATED QUALITY ASSURANCE PROJECT PLANS

    EPA Science Inventory

    This guidance supplements EPA Guidance for Quality,Assurance Project Plans (EPA QA/G-5), in that the focus here is on collection and use of geospatial rather than other environmental data (e.g., strictly chemical or biological data), including unique aspects of data storage, retr...

  14. 7 CFR 3560.71 - Construction financing.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 15 2014-01-01 2014-01-01 false Construction financing. 3560.71 Section 3560.71... Construction financing. (a) Construction financing plan. Prior to loan approval, applicants must submit to the Agency for its concurrence a plan for the construction financing and securing of the loan. (b) Interim...

  15. 7 CFR 3560.71 - Construction financing.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 15 2011-01-01 2011-01-01 false Construction financing. 3560.71 Section 3560.71... Construction financing. (a) Construction financing plan. Prior to loan approval, applicants must submit to the Agency for its concurrence a plan for the construction financing and securing of the loan. (b) Interim...

  16. Interim Courses: The World as a Classroom.

    ERIC Educational Resources Information Center

    Shiflet, George W. Jr.; Shealy, Malcolm H., Jr.

    1989-01-01

    Described are some of the considerations necessary in planning a field studies course in the tropics. Discussed are site selection; planning and preparation; course structure; the advantages of travel courses; and recommendations concerning liability, multiple instructors, hotels, sailboats, and tours. A list of 26 references is included. (CW)

  17. 7 CFR 3560.71 - Construction financing.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 15 2010-01-01 2010-01-01 false Construction financing. 3560.71 Section 3560.71... Construction financing. (a) Construction financing plan. Prior to loan approval, applicants must submit to the Agency for its concurrence a plan for the construction financing and securing of the loan. (b) Interim...

  18. Effects of an Advocacy Trial on Food Industry Salt Reduction Efforts—An Interim Process Evaluation

    PubMed Central

    Trevena, Helen; Petersen, Kristina; Thow, Anne Marie; Neal, Bruce

    2017-01-01

    The decisions made by food companies are a potent factor shaping the nutritional quality of the food supply. A number of non-governmental organizations (NGOs) advocate for corporate action to reduce salt levels in foods, but few data define the effectiveness of advocacy. This present report describes the process evaluation of an advocacy intervention delivered by one Australian NGO directly to food companies to reduce the salt content of processed foods. Food companies were randomly assigned to intervention (n = 22) or control (n = 23) groups. Intervention group companies were exposed to pre-planned and opportunistic communications, and control companies to background activities. Seven pre-defined interim outcome measures provided an indication of the effect of the intervention and were assessed using intention-to-treat analysis. These were supplemented by qualitative data from nine semi-structured interviews. The mean number of public communications supporting healthy food made by intervention companies was 1.5 versus 1.8 for control companies (p = 0.63). Other outcomes, including the mean number of news articles, comments and reports (1.2 vs. 1.4; p = 0.72), a published nutrition policy (23% vs. 44%; p = 0.21), public commitment to the Australian government’s Food and Health Dialogue (FHD) (41% vs. 61%; p = 0.24), evidence of a salt reduction plan (23% vs. 30%; p = 0.56), and mean number of communications with the NGO (15 vs. 11; p = 0.28) were also not significantly different. Qualitative data indicated the advocacy trial had little effect. The absence of detectable effects of the advocacy intervention on the interim markers indicates there may be no impact of the NGO advocacy trial on the primary outcome of salt reduction in processed foods. PMID:29039802

  19. 76 FR 17160 - Office of New Reactors; Final Interim Staff Guidance on the Review of Nuclear Power Plant Designs...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-28

    ...The NRC staff is issuing its Final Interim Staff Guidance (ISG) DC/COL-ISG-021 titled ``Interim Staff Guidance on the Review of Nuclear Power Plant Designs Using a Gas Turbine Driven Standby Emergency Alternating Current Power System,'' Agencywide Documents Access and Management System (ADAMS) Accession No. ML102510119 for DC/ COL-ISG-021 and ADAMS Accession No. ML102510164 for Attachment 1 to DC/ COL-ISG-021. This ISG provides new guidance for applicants submitting a combined license (COL) or design certification (DC) application for new nuclear power reactors under Title 10 of the Code of Federal Regulations, part 52. In addition, it supplements the guidance provided to the NRC staff in NUREG-0800, ``Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants,'' March 2007, Standard Review Plan (SRP), Section 8.3.1 and Sections 9.5.4 through 9.5.8. The NRC staff issues DC/COL-ISGs to facilitate activities associated with NRC review of applications for DCs and COLs. The NRC staff intends to incorporate DC/COL-ISG-021 into the next revision of SRP Section 8.3.1 and Sections 9.5.4 through 9.5.8 and Regulatory Guide 1.206, ``Combined License Applications for Nuclear Power Plants (LWR Edition),'' June 2007. Disposition: On February 3, 2010, the NRC staff issued proposed DC/ COL-ISG-021 on ``Review of Nuclear Power Plant Designs Using a Gas Turbine Driven Standby Emergency Alternating Current Power System,'' ADAMS Accession No. ML092640035. The NRC staff received comments on the proposed guidance. This final issuance resolves the majority of the comments. The NRC staff responses to these comments can be found in ADAMS Accession No. ML102510176.

  20. Effects of an Advocacy Trial on Food Industry Salt Reduction Efforts-An Interim Process Evaluation.

    PubMed

    Trevena, Helen; Petersen, Kristina; Thow, Anne Marie; Dunford, Elizabeth K; Wu, Jason H Y; Neal, Bruce

    2017-10-17

    The decisions made by food companies are a potent factor shaping the nutritional quality of the food supply. A number of non-governmental organizations (NGOs) advocate for corporate action to reduce salt levels in foods, but few data define the effectiveness of advocacy. This present report describes the process evaluation of an advocacy intervention delivered by one Australian NGO directly to food companies to reduce the salt content of processed foods. Food companies were randomly assigned to intervention ( n = 22) or control ( n = 23) groups. Intervention group companies were exposed to pre-planned and opportunistic communications, and control companies to background activities. Seven pre-defined interim outcome measures provided an indication of the effect of the intervention and were assessed using intention-to-treat analysis. These were supplemented by qualitative data from nine semi-structured interviews. The mean number of public communications supporting healthy food made by intervention companies was 1.5 versus 1.8 for control companies ( p = 0.63). Other outcomes, including the mean number of news articles, comments and reports (1.2 vs. 1.4; p = 0.72), a published nutrition policy (23% vs. 44%; p = 0.21), public commitment to the Australian government's Food and Health Dialogue (FHD) (41% vs. 61%; p = 0.24), evidence of a salt reduction plan (23% vs. 30%; p = 0.56), and mean number of communications with the NGO (15 vs. 11; p = 0.28) were also not significantly different. Qualitative data indicated the advocacy trial had little effect. The absence of detectable effects of the advocacy intervention on the interim markers indicates there may be no impact of the NGO advocacy trial on the primary outcome of salt reduction in processed foods.

  1. Evaluation of Hose in Hose Transfer Line Service Life for Hanfords Interim Stabilization Program

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

    TORRES, T.D.

    RPP-6153, Engineering Task Plan for Hose-in-Hose Transfer System for the Interim Stabilization Program (Torres, 2000a), defines the programmatic goals, functional requirements, and technical criteria for the development and subsequent installation of waste transfer line equipment to support Hanford's Interim Stabilization Program. RPP-6028, Specification for Hose in Hose Transfer Lines for Hanford's Interim Stabilization Program (Torres, 2000b), has been issued to define the specific requirements for the design, manufacture, and verification of transfer line assemblies for specific waste transfer applications associated with Interim Stabilization. Included in RPP-6028 are tables defining the chemical constituents of concern to which transfer lines will bemore » exposed. Current Interim Stabilization Program planning forecasts that the at-grade transfer lines will be required to convey pumpable waste for as much as three years after commissioning, RPP-6028 Section 3.2.7. Performance Incentive Number ORP-05 requires that all the Single Shell Tanks be Interim Stabilized by September 30, 2003. The Tri-Party Agreement (TPA) milestone M-41-00, enforced by a federal consent decree, requires all the Single Shell Tanks to be Interim stabilized by September 30, 2004. By meeting the Performance Incentive the TPA milestone is met. Prudent engineering dictates that the equipment used to transfer waste have a life in excess of the forecasted operational time period, with some margin to allow for future adjustments to the planned schedule. This document evaluates the effective service life of the Hose-in-Hose Transfer Lines, based on information submitted by the manufacturer, published literature and calculations. The effective service life of transfer line assemblies is a function of several factors. Foremost among these are the hose material's resistance to the harmful effects of process fluid characteristics, ambient environmental conditions, exposure to ionizing radiation and the manufacturer's stated shelf life. In order to determine the transfer line service life this evaluation examines the certification of shelf life, the certification of chemical compatibility with waste, catalog information of ambient ratings and published literature on the effects of exposure to ionizing radiation on the mechanical properties of elastomeric materials. During initial hose procurements, the hose-in-hose transfer line vendor River Bend Hose Specialty (RBHS) submitted a letter, dated 6/8/00, which recommended the service and shelf life of the hose to be seven years. In submittals for later hose procurements, RBHS submitted a letter, dated 11/6/00, which recommended the service life of the hose to be three years. This submittal was followed by documentation, on 2/14/01, which submitted new storage requirements and restated the seven year shelf life. RBHS revised their original hose service life estimate to a more conservative three years due to concerns over the effects of chemicals in transferred waste. The above mentioned submittals from RBHS are the primary drivers of the three year service life limit established by this document.« less

  2. National Program Plan for Research and Development in Solar Heating and Cooling. Interim Report.

    ERIC Educational Resources Information Center

    Energy Research and Development Administration, Washington, DC. Div. of Solar Energy.

    This report presents the Energy Research and Development Administration (ERDA) program plan for solar heating and cooling of buildings and for agricultural and industrial process applications. An overview of the program plan is followed by a description of the ten paths to the solar heating and cooling of buildings and a brief discussion of the…

  3. 40 CFR 265.112 - Closure plan; amendment of plan.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... (CONTINUED) INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND.... By May 19, 1981, or by six months after the effective date of the rule that first subjects a facility... description of other activities necessary during the partial and final closure periods to ensure that all...

  4. 40 CFR 265.51 - Purpose and implementation of contingency plan.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) SOLID WASTES (CONTINUED) INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT... contingency plan must be designed to minimize hazards to human health or the environment from fires, explosions, or any unplanned sudden or non-sudden release of hazardous waste or hazardous waste constituents...

  5. 40 CFR 265.51 - Purpose and implementation of contingency plan.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) SOLID WASTES (CONTINUED) INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT... contingency plan must be designed to minimize hazards to human health or the environment from fires, explosions, or any unplanned sudden or non-sudden release of hazardous waste or hazardous waste constituents...

  6. 40 CFR 265.51 - Purpose and implementation of contingency plan.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) SOLID WASTES (CONTINUED) INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT... contingency plan must be designed to minimize hazards to human health or the environment from fires, explosions, or any unplanned sudden or non-sudden release of hazardous waste or hazardous waste constituents...

  7. 76 FR 46621 - Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services Under...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-03

    ...This document contains amendments to the interim final regulations implementing the rules for group health plans and health insurance coverage in the group and individual markets under provisions of the Patient Protection and Affordable Care Act regarding preventive health services.

  8. 75 FR 62610 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Plant...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-12

    ...: Draft Regulatory Guide DG-1237, ``Guidance on Making Changes to Emergency Plans for Nuclear Power Reactors,'' Interim Staff Guidance (ISG) NSIR/DPR-ISG-01, ``Emergency Planning for Nuclear Power Plants... NUCLEAR REGULATORY COMMISSION Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS...

  9. 75 FR 21695 - Interim Notice of Funding Availability for the Department of Transportation's National...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... district plans, and other strategies, including land acquisition, designed to create walkable, mixed-use... million of the available TIGER II funds for the planning, preparation, or design of Eligible Projects... manner that will be sustainable for generations to come. Therefore, for projects designed to enhance...

  10. 40 CFR 265.51 - Purpose and implementation of contingency plan.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) SOLID WASTES (CONTINUED) INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT..., explosions, or any unplanned sudden or non-sudden release of hazardous waste or hazardous waste constituents to air, soil, or surface water. (b) The provisions of the plan must be carried out immediately...

  11. 78 FR 22257 - Updates to Protective Action Guides Manual: Protective Action Guides (PAGs) and Planning Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-15

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OAR-2007-0268; FRL-9707-2] Updates to Protective Action Guides Manual: Protective Action Guides (PAGs) and Planning Guidance for Radiological Incidents AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of document availability for interim use and public...

  12. 75 FR 43528 - Seeking Public Comment on Draft National Health Security Strategy Biennial Implementation Plan

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Seeking Public Comment on Draft National Health Security Strategy Biennial Implementation Plan AGENCY: Department of Health and Human... Interim Implementation Guide for the National Health Security Strategy of the United States of America...

  13. Proceedings of the Joint Logistics Commanders Joint Policy Coordinating Group on Computer Resource Management; Computer Software Management Software Workshop, 2-5 April 1979.

    DTIC Science & Technology

    1979-08-21

    Appendix s - Outline and Draft Material for Proposed Triservice Interim Guideline on Application of Software Acceptance Criteria....... 269 Appendix 9...AND DRAFT MATERIAL FOR PROPOSED TRISERVICE INTERIM GUIDELINE ON APPLICATION OF SOFTWARE ACCEPTANCE CRITERIA I I INTRODUCTION The purpose of this guide...contract item (CPCI) (code) 5. CPCI test plan 6. CPCI test procedures 7. CPCI test report 8. Handbooks and manuals. Al though additional material does

  14. LEO and GEO missions

    NASA Technical Reports Server (NTRS)

    Mercanti, Enrico

    1987-01-01

    The occurrence of the Challenger disaster in early 1986 caused a severe reevaluation of the space program. Plans already established had to be drastically revised and new plans had to be made. NASA created the Space Leadership Planning Group (SLPG) to formulate space mission plans covering a 50 year period based on Agency goals and objectives responsive to the National Commission on Space recommendations. An interim view of the status of SLPG plans for low altitude and geosynchronous missions is presented.

  15. 78 FR 20503 - Energy Conservation Program: Availability of the Interim Technical Support Document for High...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-05

    ... Conservation Program: Availability of the Interim Technical Support Document for High-Intensity Discharge Lamps... high-intensity discharge (HID) lamps energy conservation standards in the Federal Register. This... interim analysis for high- intensity discharge lamps energy conservation standards. The notice provided...

  16. Making Big High Schools Smaller. A Review of the Implementation of the House Plan in New York City's Most Troubled High Schools.

    ERIC Educational Resources Information Center

    Public Education Association, New York, NY.

    This interim report evaluates the implementation of the "House Plan," a plan to create small personalized schools within the 110 large comprehensive high schools in New York (New York) by subdividing all ninth grades into separate units. This evaluation covers only the 37 "dropout prevention" high schools which had been…

  17. Mobile Launch Platform Vehicle Assembly Area (SWMU 056) Biosparge Expansion Interim Measures Work Plan

    NASA Technical Reports Server (NTRS)

    Burcham, Michael S.; Daprato, Rebecca C.

    2016-01-01

    This document presents the design details for an Interim Measure (IM) Work Plan (IMWP) for the Mobile Launch Platform/Vehicle Assembly Building (MLPV) Area, located at the John F. Kennedy Space Center (KSC), Florida. The MLPV Area has been designated Solid Waste Management Unit Number 056 (SWMU 056) under KSC's Resource Conservation and Recovery Act (RCRA) Corrective Action Program. This report was prepared by Geosyntec Consultants (Geosyntec) for the National Aeronautics and Space Administration (NASA) under contract number NNK09CA02B and NNK12CA13B, project control number ENV1642. The Advanced Data Package (ADP) presentation covering the elements of this IMWP report received KSC Remediation Team (KSCRT) approval at the December 2015 Team Meeting; the meeting minutes are included in Appendix A.

  18. 15 CFR 990.56 - Restoration selection-use of a Regional Restoration Plan or existing restoration project.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., DEPARTMENT OF COMMERCE OIL POLLUTION ACT REGULATIONS NATURAL RESOURCE DAMAGE ASSESSMENTS Restoration Planning... acquire the equivalent of the injured natural resources and services and compensate for interim losses. (b... incident; (iii) Addresses, and is currently relevant to, the same or comparable natural resources and...

  19. 15 CFR 990.56 - Restoration selection-use of a Regional Restoration Plan or existing restoration project.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ..., DEPARTMENT OF COMMERCE OIL POLLUTION ACT REGULATIONS NATURAL RESOURCE DAMAGE ASSESSMENTS Restoration Planning... acquire the equivalent of the injured natural resources and services and compensate for interim losses. (b... incident; (iii) Addresses, and is currently relevant to, the same or comparable natural resources and...

  20. 40 CFR 96.284 - Opt-in process.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS FOR STATE IMPLEMENTATION PLANS CAIR SO2 Opt-in Units... of interim review, if the plan appears to contain information demonstrating that the SO2 emissions... section, the owner or operator shall monitor and report the SO2 emissions rate and the heat input of the...

  1. Improved survival with vemurafenib in melanoma with BRAF V600E mutation.

    PubMed

    Chapman, Paul B; Hauschild, Axel; Robert, Caroline; Haanen, John B; Ascierto, Paolo; Larkin, James; Dummer, Reinhard; Garbe, Claus; Testori, Alessandro; Maio, Michele; Hogg, David; Lorigan, Paul; Lebbe, Celeste; Jouary, Thomas; Schadendorf, Dirk; Ribas, Antoni; O'Day, Steven J; Sosman, Jeffrey A; Kirkwood, John M; Eggermont, Alexander M M; Dreno, Brigitte; Nolop, Keith; Li, Jiang; Nelson, Betty; Hou, Jeannie; Lee, Richard J; Flaherty, Keith T; McArthur, Grant A

    2011-06-30

    Phase 1 and 2 clinical trials of the BRAF kinase inhibitor vemurafenib (PLX4032) have shown response rates of more than 50% in patients with metastatic melanoma with the BRAF V600E mutation. We conducted a phase 3 randomized clinical trial comparing vemurafenib with dacarbazine in 675 patients with previously untreated, metastatic melanoma with the BRAF V600E mutation. Patients were randomly assigned to receive either vemurafenib (960 mg orally twice daily) or dacarbazine (1000 mg per square meter of body-surface area intravenously every 3 weeks). Coprimary end points were rates of overall and progression-free survival. Secondary end points included the response rate, response duration, and safety. A final analysis was planned after 196 deaths and an interim analysis after 98 deaths. At 6 months, overall survival was 84% (95% confidence interval [CI], 78 to 89) in the vemurafenib group and 64% (95% CI, 56 to 73) in the dacarbazine group. In the interim analysis for overall survival and final analysis for progression-free survival, vemurafenib was associated with a relative reduction of 63% in the risk of death and of 74% in the risk of either death or disease progression, as compared with dacarbazine (P<0.001 for both comparisons). After review of the interim analysis by an independent data and safety monitoring board, crossover from dacarbazine to vemurafenib was recommended. Response rates were 48% for vemurafenib and 5% for dacarbazine. Common adverse events associated with vemurafenib were arthralgia, rash, fatigue, alopecia, keratoacanthoma or squamous-cell carcinoma, photosensitivity, nausea, and diarrhea; 38% of patients required dose modification because of toxic effects. Vemurafenib produced improved rates of overall and progression-free survival in patients with previously untreated melanoma with the BRAF V600E mutation. (Funded by Hoffmann-La Roche; BRIM-3 ClinicalTrials.gov number, NCT01006980.).

  2. Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors.

    PubMed

    Strosberg, Jonathan; El-Haddad, Ghassan; Wolin, Edward; Hendifar, Andrew; Yao, James; Chasen, Beth; Mittra, Erik; Kunz, Pamela L; Kulke, Matthew H; Jacene, Heather; Bushnell, David; O'Dorisio, Thomas M; Baum, Richard P; Kulkarni, Harshad R; Caplin, Martyn; Lebtahi, Rachida; Hobday, Timothy; Delpassand, Ebrahim; Van Cutsem, Eric; Benson, Al; Srirajaskanthan, Rajaventhan; Pavel, Marianne; Mora, Jaime; Berlin, Jordan; Grande, Enrique; Reed, Nicholas; Seregni, Ettore; Öberg, Kjell; Lopera Sierra, Maribel; Santoro, Paola; Thevenet, Thomas; Erion, Jack L; Ruszniewski, Philippe; Kwekkeboom, Dik; Krenning, Eric

    2017-01-12

    Patients with advanced midgut neuroendocrine tumors who have had disease progression during first-line somatostatin analogue therapy have limited therapeutic options. This randomized, controlled trial evaluated the efficacy and safety of lutetium-177 ( 177 Lu)-Dotatate in patients with advanced, progressive, somatostatin-receptor-positive midgut neuroendocrine tumors. We randomly assigned 229 patients who had well-differentiated, metastatic midgut neuroendocrine tumors to receive either 177 Lu-Dotatate (116 patients) at a dose of 7.4 GBq every 8 weeks (four intravenous infusions, plus best supportive care including octreotide long-acting repeatable [LAR] administered intramuscularly at a dose of 30 mg) ( 177 Lu-Dotatate group) or octreotide LAR alone (113 patients) administered intramuscularly at a dose of 60 mg every 4 weeks (control group). The primary end point was progression-free survival. Secondary end points included the objective response rate, overall survival, safety, and the side-effect profile. The final analysis of overall survival will be conducted in the future as specified in the protocol; a prespecified interim analysis of overall survival was conducted and is reported here. At the data-cutoff date for the primary analysis, the estimated rate of progression-free survival at month 20 was 65.2% (95% confidence interval [CI], 50.0 to 76.8) in the 177 Lu-Dotatate group and 10.8% (95% CI, 3.5 to 23.0) in the control group. The response rate was 18% in the 177 Lu-Dotatate group versus 3% in the control group (P<0.001). In the planned interim analysis of overall survival, 14 deaths occurred in the 177 Lu-Dotatate group and 26 in the control group (P=0.004). Grade 3 or 4 neutropenia, thrombocytopenia, and lymphopenia occurred in 1%, 2%, and 9%, respectively, of patients in the 177 Lu-Dotatate group as compared with no patients in the control group, with no evidence of renal toxic effects during the observed time frame. Treatment with 177 Lu-Dotatate resulted in markedly longer progression-free survival and a significantly higher response rate than high-dose octreotide LAR among patients with advanced midgut neuroendocrine tumors. Preliminary evidence of an overall survival benefit was seen in an interim analysis; confirmation will be required in the planned final analysis. Clinically significant myelosuppression occurred in less than 10% of patients in the 177 Lu-Dotatate group. (Funded by Advanced Accelerator Applications; NETTER-1 ClinicalTrials.gov number, NCT01578239 ; EudraCT number 2011-005049-11 .).

  3. Evaluation and analysis of Seasat-A scanning multichannel Microwave Radiometer (SMMR) Antenna Pattern Correction (APC) algorithm

    NASA Technical Reports Server (NTRS)

    Kitzis, J. L.; Kitzis, S. N.

    1979-01-01

    The brightness temperature data produced by the SMMR final Antenna Pattern Correction (APC) algorithm is discussed. The algorithm consisted of: (1) a direct comparison of the outputs of the final and interim APC algorithms; and (2) an analysis of a possible relationship between observed cross track gradients in the interim brightness temperatures and the asymmetry in the antenna temperature data. Results indicate a bias between the brightness temperature produced by the final and interim APC algorithm.

  4. Deep Vadose Zone Treatability Test for the Hanford Central Plateau. Interim Post-Desiccation Monitoring Results, Fiscal Year 2015

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

    Truex, Michael J.; Strickland, Christopher E.; Oostrom, Martinus

    A field test of desiccation is being conducted as an element of the Deep Vadose Zone Treatability Test Program. The active desiccation portion of the test has been completed. Monitoring data have been collected at the field test site during the post-desiccation period and are reported herein. This is an interim data summary report that includes about 4 years of post-desiccation monitoring data. The DOE field test plan proscribes a total of 5 years of post-desiccation monitoring.

  5. 78 FR 12243 - Interim Final Determination To Stay and Defer Sanctions, Placer County Air Pollution Control...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-22

    ...EPA is making an interim final determination to stay the imposition of offset sanctions and to defer the imposition of highway sanctions based on a proposed approval of a revision to the Placer County Air Pollution Control District (PCAPCD) and Feather River Air Quality Management District (FRAQMD) portion of the California State Implementation Plan (SIP) published elsewhere in this Federal Register. The SIP revision concerns two permitting rules submitted by the PCAPCD and FRAQMD, respectively: Rule 502, New Source Review, and Rule 10.1, New Source Review.

  6. Individual Pesticides in Registration Review

    EPA Pesticide Factsheets

    You can used the Chemical Search database to search pesticides by chemical name and find their registration review dockets, along with Work Plans, risk assessments, interim and final decisions, tolerance rules, and cancellation actions.

  7. Patient-related and financial outcomes analysis of conventional full-arch rehabilitation versus the All-on-4 concept: a cohort study.

    PubMed

    Babbush, Charles A; Kanawati, Ali; Kotsakis, Georgios A; Hinrichs, James E

    2014-04-01

    Patient-related variables such as cost of treatment, length of the treatment period, and comfort provided by the interim prosthesis when treatment planning for full-arch rehabilitation are often neglected in dental publications. Two patient cohorts were followed up longitudinally in this study: the "All-on-4 treatment concept group" and the "historical group." The number of implants, total treatment time, number of surgical procedures, number of sinus grafts, necessity for immediate provisional implants, adjusted cost associated for treatment in each group, and the quality of interim prosthesis were compared. The total adjusted cost for patients receiving All-on-4 treatment concept averaged at $42,422 ± 3860 (&OV0556;31,392 ± 2856), whereas the mean total adjusted cost for the historical group was $57,944 ± 20,198 (&OV0556;42,879 ± 2113) (P = 0.01). The difference in cost had a mean value of $7307 (&OV0556;5407) per jaw. Factors associated with complexity of treatment and patient comfort, such as the quality of interim prosthesis, number of surgeries, and duration of treatment time, all significantly favored the All-on-4 treatment concept group in comparison with conventional treatment modalities. When implant rehabilitation of the total jaw is sought, the All-on-4 treatment concept should be considered the least costly and least time consuming treatment option.

  8. 75 FR 41726 - Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-19

    ... cessation, obesity, and other topics. Immunizations for routine use in children, adolescents, and adults... aspirin use, tobacco cessation, and obesity. 3. Estimated Number of Affected Entities For purposes of the... already chosen to cover these services. For example, most health plans cover most childhood and some adult...

  9. Group health plans and health insurance issuers relating to coverage of preventive services under the Patient Protection and Affordable Care Act. Final rules.

    PubMed

    2012-02-15

    These regulations finalize, without change, interim final regulations authorizing the exemption of group health plans and group health insurance coverage sponsored by certain religious employers from having to cover certain preventive health services under provisions of the Patient Protection and Affordable Care Act.

  10. 77 FR 37920 - Proposed Extension of Information Collection Requests Submitted for Public Comment: National...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-25

    ... Bulletin (FAB) 2009-1 to provide interim guidance under section 101(f) of ERISA in order to assist plan... notices plan administrators may use to satisfy the annual funding notice content requirements. The FAB... the guidance contained in the FAB and has acted in accordance with a good faith, reasonable...

  11. 40 CFR 52.1120 - Identification of plan.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... a new regulation 310 CMR 7.19 “Interim Sulfur-in-Fuel Limitations for Fossil Fuel Utilization... May 22, 1985, including Method 27, record form, potential leak points, major tank truck leak sources...

  12. 40 CFR 52.1120 - Identification of plan.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... a new regulation 310 CMR 7.19 “Interim Sulfur-in-Fuel Limitations for Fossil Fuel Utilization... May 22, 1985, including Method 27, record form, potential leak points, major tank truck leak sources...

  13. 40 CFR 52.1120 - Identification of plan.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... a new regulation 310 CMR 7.19 “Interim Sulfur-in-Fuel Limitations for Fossil Fuel Utilization... May 22, 1985, including Method 27, record form, potential leak points, major tank truck leak sources...

  14. 40 CFR 52.1120 - Identification of plan.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... a new regulation 310 CMR 7.19 “Interim Sulfur-in-Fuel Limitations for Fossil Fuel Utilization... May 22, 1985, including Method 27, record form, potential leak points, major tank truck leak sources...

  15. 40 CFR 52.1120 - Identification of plan.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... a new regulation 310 CMR 7.19 “Interim Sulfur-in-Fuel Limitations for Fossil Fuel Utilization... May 22, 1985, including Method 27, record form, potential leak points, major tank truck leak sources...

  16. Approval of information collection requirements for the joint interim rules for health insurance portability for group health plans, and the individual market health insurance reform: portability from group to individual coverage; federal rules for access in the individual market; state alternative mechanisms to federal rules--IRS, DOL, HCFA. Interim rules with request for comments; approval of information collection requirements.

    PubMed

    1997-07-02

    On April 8, 1997, the Department of the Treasury, the Department of Labor, and the Department of Health and Human Services (Departments) published joint interim rules governing the access, portability and renewability requirements for group health plans and issuers offering group health insurance coverage in connection with a group health plan. The rules implemented changes made to certain provisions of the Internal Revenue Code of 1986 (Code), the Employee Retirement Income Security Act of 1974 (ERISA), and the Public Health Service Act (PHS Act) enacted as part of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). In the April 8 publication, the Departments submitted the group market information collection requirements, for, among other things, establishing creditable coverage, notice of special enrollment rights, and notice of pre-existing condition exclusion periods, to be Office of Management and Budget (OMB) for emergency review under the Paperwork Reduction Act of 1995 (PRA 95). In addition, on April 8, 1997 the Department of Health and Human Services submitted the HIPAA individual market information collection requirements to OMB for emergency review under the PRA 1995. This document amends the April 8 Federal Register documents to properly display the OMB control numbers.

  17. Additional EIPC Study Analysis. Final Report

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

    Hadley, Stanton W; Gotham, Douglas J.; Luciani, Ralph L.

    Between 2010 and 2012 the Eastern Interconnection Planning Collaborative (EIPC) conducted a major long-term resource and transmission study of the Eastern Interconnection (EI). With guidance from a Stakeholder Steering Committee (SSC) that included representatives from the Eastern Interconnection States Planning Council (EISPC) among others, the project was conducted in two phases. Phase 1 involved a long-term capacity expansion analysis that involved creation of eight major futures plus 72 sensitivities. Three scenarios were selected for more extensive transmission- focused evaluation in Phase 2. Five power flow analyses, nine production cost model runs (including six sensitivities), and three capital cost estimations weremore » developed during this second phase. The results from Phase 1 and 2 provided a wealth of data that could be examined further to address energy-related questions. A list of 14 topics was developed for further analysis. This paper brings together the earlier interim reports of the first 13 topics plus one additional topic into a single final report.« less

  18. Statistical analysis plan for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART). A randomized controlled trial

    PubMed Central

    Damiani, Lucas Petri; Berwanger, Otavio; Paisani, Denise; Laranjeira, Ligia Nasi; Suzumura, Erica Aranha; Amato, Marcelo Britto Passos; Carvalho, Carlos Roberto Ribeiro; Cavalcanti, Alexandre Biasi

    2017-01-01

    Background The Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) is an international multicenter randomized pragmatic controlled trial with allocation concealment involving 120 intensive care units in Brazil, Argentina, Colombia, Italy, Poland, Portugal, Malaysia, Spain, and Uruguay. The primary objective of ART is to determine whether maximum stepwise alveolar recruitment associated with PEEP titration, adjusted according to the static compliance of the respiratory system (ART strategy), is able to increase 28-day survival in patients with acute respiratory distress syndrome compared to conventional treatment (ARDSNet strategy). Objective To describe the data management process and statistical analysis plan. Methods The statistical analysis plan was designed by the trial executive committee and reviewed and approved by the trial steering committee. We provide an overview of the trial design with a special focus on describing the primary (28-day survival) and secondary outcomes. We describe our data management process, data monitoring committee, interim analyses, and sample size calculation. We describe our planned statistical analyses for primary and secondary outcomes as well as pre-specified subgroup analyses. We also provide details for presenting results, including mock tables for baseline characteristics, adherence to the protocol and effect on clinical outcomes. Conclusion According to best trial practice, we report our statistical analysis plan and data management plan prior to locking the database and beginning analyses. We anticipate that this document will prevent analysis bias and enhance the utility of the reported results. Trial registration ClinicalTrials.gov number, NCT01374022. PMID:28977255

  19. 76 FR 14568 - Federal Acquisition Regulation; Use of Commercial Services Item Authority

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-16

    ...-AL44 Federal Acquisition Regulation; Use of Commercial Services Item Authority AGENCIES: Department of... interim rule amending the Federal Acquisition Regulation (FAR) to implement section 868 of the Duncan... interim rule. II. Discussion/Analysis The analysis of public comments by the Defense Acquisition...

  20. Safety and efficacy of lithium in combination with riluzole for treatment of amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial.

    PubMed

    Aggarwal, Swati P; Zinman, Lorne; Simpson, Elizabeth; McKinley, Jane; Jackson, Katherine E; Pinto, Hanika; Kaufman, Petra; Conwit, Robin A; Schoenfeld, David; Shefner, Jeremy; Cudkowicz, Merit

    2010-05-01

    In a pilot study, lithium treatment slowed progression of amyotrophic lateral sclerosis (ALS). We aimed to confirm or disprove these findings by assessing the safety and efficacy of lithium in combination with riluzole in patients with ALS. We did a double-blind, placebo-controlled trial with a time-to-event design. Between January and June, 2009, patients with ALS who were taking a stable dose of riluzole for at least 30 days were randomly assigned (1:1) by a centralised computer to receive either lithium or placebo. Patients, caregivers, investigators, and all site study staff with the exception of site pharmacists were masked to treatment assignment. The primary endpoint was the time to an event, defined as a decrease of at least six points on the revised ALS functional rating scale score or death. Interim analyses were planned for when 84 patients had been allocated treatment, 6 months later or after 55 events, and after 100 events. Analysis was by intention to treat. The stopping boundary for futility at the first interim analysis was a p value of at least 0.68. We used a log-rank test to compare the distributions of the time to an event between the lithium and placebo groups. This trial is registered with ClinicalTrials.gov, NCT00818389. At the first interim analysis, 22 of 40 patients in the lithium group had an event compared with 20 of 44 patients in the placebo group (log rank p=0.51). The hazard ratio of reaching the primary endpoint was 1.13 (95% CI 0.61-2.07). The study was stopped at the first interim analysis because criterion for futility was met (p=0.78). The difference in mean decline in the ALS functional rating scale score between the lithium group and the placebo group was 0.15 (95% CI -0.43 to 0.73, p=0.61). There were no major safety concerns. Falls (p=0.04) and back pain (p=0.05) were more common in the lithium group than in the placebo group. We found no evidence that lithium in combination with riluzole slows progression of ALS more than riluzole alone. The time-to-event endpoint and use of prespecified interim analyses enabled a clear result to be obtained rapidly. This design should be considered for future trials testing the therapeutic efficacy of drugs that are easily accessible to people with ALS. National Institute of Neurological Disorders and Stroke, ALS Association, and ALS Society of Canada. Copyright 2010 Elsevier Ltd. All rights reserved.

  1. Interim Terrain Data (ITD) and Vector Product Interim Terrain Data (VITD) user's guide

    DOT National Transportation Integrated Search

    1996-09-01

    This guide is intended to be a convenient reference for users of these types of terrain analysis data. ITD is a digitized version of the standard 1:50,000-scale tactical terrain analysis data base (TTADB) product produced by the Defense Mapping Agenc...

  2. IUS/TUG orbital operations and mission support study. Volume 3: Space tug operations

    NASA Technical Reports Server (NTRS)

    1975-01-01

    A study was conducted to develop space tug operational concepts and baseline operations plan, and to provide cost estimates for space tug operations. Background data and study results are presented along with a transition phase analysis (the transition from interim upper state to tug operations). A summary is given of the tug operational and interface requirements with emphasis on the on-orbit checkout requirements, external interface operational requirements, safety requirements, and system operational interface requirements. Other topics discussed include reference missions baselined for the tug and details for the mission functional flows and timelines derived for the tug mission, tug subsystems, tug on-orbit operations prior to the tug first burn, spacecraft deployment and retrieval by the tug, operations centers, mission planning, potential problem areas, and cost data.

  3. The Australasian Resuscitation in Sepsis Evaluation (ARISE) trial statistical analysis plan.

    PubMed

    Delaney, Anthony P; Peake, Sandra L; Bellomo, Rinaldo; Cameron, Peter; Holdgate, Anna; Howe, Belinda; Higgins, Alisa; Presneill, Jeffrey; Webb, Steve

    2013-09-01

    The Australasian Resuscitation in Sepsis Evaluation (ARISE) study is an international, multicentre, randomised, controlled trial designed to evaluate the effectiveness of early goal-directed therapy compared with standard care for patients presenting to the emergency department with severe sepsis. In keeping with current practice, and considering aspects of trial design and reporting specific to non-pharmacological interventions, our plan outlines the principles and methods for analysing and reporting the trial results. The document is prepared before completion of recruitment into the ARISE study, without knowledge of the results of the interim analysis conducted by the data safety and monitoring committee and before completion of the two related international studies. Our statistical analysis plan was designed by the ARISE chief investigators, and reviewed and approved by the ARISE steering committee. We reviewed the data collected by the research team as specified in the study protocol and detailed in the study case report form. We describe information related to baseline characteristics, characteristics of delivery of the trial interventions, details of resuscitation, other related therapies and other relevant data with appropriate comparisons between groups. We define the primary, secondary and tertiary outcomes for the study, with description of the planned statistical analyses. We have developed a statistical analysis plan with a trial profile, mock-up tables and figures. We describe a plan for presenting baseline characteristics, microbiological and antibiotic therapy, details of the interventions, processes of care and concomitant therapies and adverse events. We describe the primary, secondary and tertiary outcomes with identification of subgroups to be analysed. We have developed a statistical analysis plan for the ARISE study, available in the public domain, before the completion of recruitment into the study. This will minimise analytical bias and conforms to current best practice in conducting clinical trials.

  4. Beyond the Facade of Language Planning for Nepalese Primary Education: Monolingual Hangover, Elitism and Displacement of Local Languages?

    ERIC Educational Resources Information Center

    Phyak, Prem Bahadur

    2011-01-01

    The recent political transformation of Nepal from a constitutional monarchy to a federal democratic republic and from a Hindu polity to a secular country has brought about some crucial changes in language planning. The Interim Constitution of Nepal has not only recognized the multilingual and multicultural reality of the country but has also…

  5. A Guide for Planning Facilities for Occupational Preparation Programs in the Machine Trades. Interim Report. Research 24.

    ERIC Educational Resources Information Center

    Larson, Milton E.

    This guide is designed for use by any person or groups of persons responsible for planning occupational programs in the machine trades. Its major purpose is to elicit the necessary information for the writing of educational specifications for facilities to house needed vocational programs in machine tool operation, machine shop, and tool and die…

  6. Allotments from federal employees. Interim rule with request for comments.

    PubMed

    2006-11-17

    The Office of Personnel Management (OPM) is issuing interim regulations dealing with the use of OPM's allotment authority to allow for pretax salary reductions as part of OPM's flexible benefits plan. Using an allotment from an employee's pay to the employing agency allows certain payments (e.g., employee health insurance premiums, contributions to a flexible spending arrangement, and contributions to a health savings account) to be paid with pretax dollars, as provided under section 125 of the Internal Revenue Code. In addition, these regulations include certain policy clarifications and changes to make the regulations more readable.

  7. Adaptive design clinical trials: a review of the literature and ClinicalTrials.gov

    PubMed Central

    Bothwell, Laura E; Avorn, Jerry; Khan, Nazleen F; Kesselheim, Aaron S

    2018-01-01

    Objectives This review investigates characteristics of implemented adaptive design clinical trials and provides examples of regulatory experience with such trials. Design Review of adaptive design clinical trials in EMBASE, PubMed, Cochrane Registry of Controlled Clinical Trials, Web of Science and ClinicalTrials.gov. Phase I and seamless Phase I/II trials were excluded. Variables extracted from trials included basic study characteristics, adaptive design features, size and use of independent data monitoring committees (DMCs) and blinded interim analyses. We also examined use of the adaptive trials in new drug submissions to the Food and Drug Administration (FDA) and European Medicines Agency (EMA) and recorded regulators’ experiences with adaptive designs. Results 142 studies met inclusion criteria. There has been a recent growth in publicly reported use of adaptive designs among researchers around the world. The most frequently appearing types of adaptations were seamless Phase II/III (57%), group sequential (21%), biomarker adaptive (20%), and adaptive dose-finding designs (16%). About one-third (32%) of trials reported an independent DMC, while 6% reported blinded interim analysis. We found that 9% of adaptive trials were used for FDA product approval consideration, and 12% were used for EMA product approval consideration. International regulators had mixed experiences with adaptive trials. Many product applications with adaptive trials had extensive correspondence between drug sponsors and regulators regarding the adaptive designs, in some cases with regulators requiring revisions or alterations to research designs. Conclusions Wider use of adaptive designs will necessitate new drug application sponsors to engage with regulatory scientists during planning and conduct of the trials. Investigators need to more consistently report protections intended to preserve confidentiality and minimise potential operational bias during interim analysis. PMID:29440155

  8. NASA Project Planning and Control Handbook

    NASA Technical Reports Server (NTRS)

    Moreland, Robert; Claunch, Cathy L.

    2016-01-01

    This handbook provides an overview of the fundamental principles and explains the functions and products that go into project planning and control. The 2010 Interim Results of the NASA Program Planning and Control (PPC) Study identified seven categories of activities for PPC, and those provide the basis for the seven functions described in this handbook. This handbook maps out the interfaces and interactions between PPC functions, as well as their external interfaces. This integration of information and products within and between functions is necessary to form the whole picture of how a project is progressing. The handbook descriptions are meant to facilitate consistent, common, and comprehensive approaches for providing valued analysis, assessment, and evaluation focused on the project level at NASA. The handbook also describes activities in terms of function rather than the job title or the specific person or organization responsible for the activity, which could differ by Center or size of a project. This handbook is primarily guidance for project planning and control: however, the same principles apply to programs and generally apply to institutional planning and control.

  9. Federal enforcement in group and individual health insurance markets. Final rule.

    PubMed

    2005-11-25

    This rule makes final an interim final rule that details procedures we use for enforcing title XXVII of the Public Health Service Act as added by the Health Insurance Portability and Accountability Act of 1996, and as amended by the Mental Health Parity Act of 1996, the Newborns' and Mothers' Health Protection Act of 1996, and the Women's Health and Cancer Rights Act of 1998. Specifically, we are responsible for enforcing title XXVII requirements in States that do not enact the legislation necessary to enforce those requirements, or otherwise fail to substantially enforce the requirements. We are also responsible for taking enforcement actions against non-Federal governmental plans. The regulation describes the process we use in both enforcement contexts. This final rule deletes an appendix to the interim rule that listed examples of violations of title XXVII and corrects the description of a cross-reference, but makes no substantive changes to the interim final rule.

  10. 40 CFR 93.109 - Criteria and procedures for determining conformity of transportation plans, programs, and...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) through (k) of this section explain when the budget, interim emissions, and hot-spot tests are required... § 93.115 Project from a conforming plan and TIP § 93.116 CO, PM10, and PM2.5 hot-spots. § 93.117 PM10... Currently conforming plan and TIP § 93.116 CO, PM10, and PM2.5 hot-spots. § 93.117 PM10 and PM2.5 control...

  11. 40 CFR 93.109 - Criteria and procedures for determining conformity of transportation plans, programs, and...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) through (k) of this section explain when the budget, interim emissions, and hot-spot tests are required... § 93.115 Project from a conforming plan and TIP § 93.116 CO, PM10, and PM2.5 hot-spots. § 93.117 PM10... Currently conforming plan and TIP § 93.116 CO, PM10, and PM2.5 hot-spots. § 93.117 PM10 and PM2.5 control...

  12. Durability of geosynthetics for highway applications : interim report

    DOT National Transportation Integrated Search

    2003-06-01

    BRT will utilize Intelligent Transportation System (ITS) technology, modern land use planning and transportation policies to support new concepts for rapid transit systems based on bus-like vehicles. The success of some of these pioneering systems, s...

  13. Planning for progress, productivity, and performance.

    PubMed

    Benedict, J M

    1983-10-01

    A project is described for the interim renovation of a labor intensive existing foodservice facility. The renovated area will provide effective food management during the hospital's redevelopment period, including a new foodservice. Objectives of the interim project were to conserve labor while emphasizing control and centralization, provide economic foodservices with improved quality, and incorporate one tray distribution system throughout the hospital complex. Immediate measures were necessary in order to generate funds to proceed. Renovations had to occur without disrupting food-service to patients. The project was planned over a three year period and included an ingredient control area, two patient tray service centres, a renewed production kitchen and test kitchen facility. Each phase has been financed on the understanding that the costs of construction and equipment will be repaid within one fiscal year of operating the renovated facility. Positive results are being achieved, attributable to the support and encouragement received from staff during the change process.

  14. Pupil Inquiry Behavior Analysis and Change Activity. Interim Project Report.

    ERIC Educational Resources Information Center

    Manion, Raymond C.

    This interim report discusses progress toward three major goals of the Pupil Inquiry Behavior Analysis and Change Activity: increased pupil inquiry, changed teacher behavior to facilitate pupil inquiry, and the development of a 32-week course of instruction to provide for these behavioral changes. Data currently available deals with the emotional…

  15. Publishing interim results of randomised clinical trials in peer-reviewed journals.

    PubMed

    Counsell, Nicholas; Biri, Despina; Fraczek, Joanna; Hackshaw, Allan

    2017-02-01

    Interim analyses of randomised controlled trials are sometimes published before the final results are available. In several cases, the treatment effects were noticeably different after patient recruitment and follow-up completed. We therefore conducted a literature review of peer-reviewed journals to compare the reported treatment effects between interim and final publications and to examine the magnitude of the difference. We performed an electronic search of MEDLINE from 1990 to 2014 (keywords: 'clinical trial' OR 'clinical study' AND 'random*' AND 'interim' OR 'preliminary'), and we manually identified the corresponding final publication. Where the electronic search produced a final report in which the abstract cited interim results, we found the interim publication. We also manually searched every randomised controlled trial in eight journals, covering a range of impact factors and general medical and specialist publications (1996-2014). All paired articles were checked to ensure that the same comparison between interventions was available in both. In all, 63 studies are included in our review, and the same quantitative comparison was available in 58 of these. The final treatment effects were smaller than the interim ones in 39 (67%) trials and the same size or larger in 19 (33%). There was a marked reduction, defined as a ≥20% decrease in the size of the treatment effect from interim to final analysis, in 11 (19%) trials compared to a marked increase in 3 (5%), p = 0.057. The magnitude of percentage change was larger in trials where commercial support was reported, and increased as the proportion of final events at the interim report decreased in trials where commercial support was reported (interaction p = 0.023). There was no evidence of a difference between trials that stopped recruitment at the interim analysis where this was reported as being pre-specified versus those that were not pre-specified (interaction p = 0.87). Published interim trial results were more likely to be associated with larger treatment effects than those based on the final report. Publishing interim results should be discouraged, in order to have reliable estimates of treatment effects for clinical decision-making, regulatory authority reviews and health economic analyses. Our work should be expanded to include conference publications and manual searches of additional journal publications.

  16. Geographic information system development in the CARETS project

    USGS Publications Warehouse

    Mitchell, William B.; Fegeas, Robin G.; Fitzpatrick, Katherine A.; Hallam, Cheryl A.

    1977-01-01

    Experience in the development of a geographic information system to support the CARETS project has confirmed the considerable advantages that may accrue by paralleling the system development with a rational and balanced system production effort which permits the integration of the education and training of users with interim deliverable products to them. Those advantages include support for a long-term staff plan that recognizes substantial staff changes through system development and implementation, a fiscal plan that provides continuity in resources necessary for total system development, and a feedback system which allows the user to communicate his experiences in using the system. Thus far balance between system development and system production has not been achieved because of continuing large-scale spatial data processing requirements coupled with strong and insistent demands from users for immediately deliverable products from the system. That imbalance has refocussed staffing and fiscal plans from long-term system development to short- and near-term production requirements, continuously extends total system development time, and increases the possibility that later system development may reduce the usefulness of current interim products.

  17. TOSCA - first international registry to address knowledge gaps in the natural history and management of tuberous sclerosis complex.

    PubMed

    Kingswood, John C; Bruzzi, Paolo; Curatolo, Paolo; de Vries, Petrus J; Fladrowski, Carla; Hertzberg, Christoph; Jansen, Anna C; Jozwiak, Sergiusz; Nabbout, Rima; Sauter, Matthias; Touraine, Renaud; O'Callaghan, Finbar; Zonnenberg, Bernard; Crippa, Stefania; Comis, Silvia; d'Augères, Guillaume Beaure; Belousova, Elena; Carter, Tom; Cottin, Vincent; Dahlin, Maria; Ferreira, José Carlos; Macaya, Alfons; Benedik, Mirjana Perkovic; Sander, Valentin; Youroukos, Sotirios; Castellana, Ramon; Ulker, Bulent; Feucht, Martha

    2014-11-26

    Tuberous sclerosis complex (TSC) is a rare, multisystem, genetic disorder with an estimated prevalence between 1/6800 and 1/15000. Although recent years have seen huge progress in understanding the pathophysiology and in the management of TSC, several questions remain unanswered. A disease registry could be an effective tool to gain more insights into TSC and thus help in the development of improved management strategies. TuberOus SClerosis registry to increase disease Awareness (TOSCA) is a multicentre, international disease registry to assess manifestations, interventions, and outcomes in patients with TSC. Patients of any age diagnosed with TSC, having a documented visit for TSC within the preceding 12 months, or newly diagnosed individuals are eligible. Objectives include mapping the course of TSC manifestations and their effects on prognosis, identifying patients with rare symptoms and co-morbidities, recording interventions and their outcomes, contributing to creation of an evidence-base for disease assessment and therapy, informing further research on TSC, and evaluating the quality of life of patients with TSC. The registry includes a 'core' section and subsections or 'petals'. The 'core' section is designed to record general information on patients' background collected at baseline and updated annually. Subsections will be developed over time to record additional data related to specific disease manifestations and will be updated annually. The registry aimed to enrol approximately 2000 patients from about 250 sites in 31 countries. The initial enrolment period was of 24 months. A follow-up observation period of up to 5 years is planned. A pre-planned administrative analysis of 'core' data from the first 100 patients was performed to evaluate the feasibility of the registry. Results showed a high degree of accuracy of the data collection procedure. Annual interim analyses are scheduled. Results of first interim analysis will be presented subsequent to data availability in 2014. The results of TOSCA will assist in filling the gaps in understanding the natural history of TSC and help in planning better management and surveillance strategies. This large-scale international registry to study TSC could serve as a model to encourage planning of similar registries for other rare diseases.

  18. Contractors Road Heavy Equipment Area SWMU 055 Corrective Measures Implementation Progress Report Kennedy Space Center, Florida

    NASA Technical Reports Server (NTRS)

    Johnson, Jill W. (Compiler)

    2015-01-01

    This Corrective Measures Implementation (CMI) Progress Report documents: (i) activities conducted as part of supplemental assessment activities completed from June 2009 through November 2014; (ii) Engineering Evaluation (EE) Advanced Data Packages (ADPs); and (iii) recommendations for future activities related to corrective measures at the Site. Applicable meeting minutes are provided as Appendix A. The following EE ADPs for CRHE are included with this CMI Progress Report: center dot Supplemental Site Characterization ADP (Step 1 EE) (Appendix B) center dot Site Characterization ADP (Step 1 EE) for Hot Spot 1 (HS1) (Appendix C) center dot Remedial Alternatives Evaluation (Step 2 EE) ADP for HS1 (Appendix D) center dot Interim Measures Work Plan (Step 3 EE) ADP for HS1 (Appendix E) center dot Site Characterization ADP (Step 1 EE) ADP for Hot Spot 2 (HS2), High Concentration Plume (HCP), and Low Concentration Plume (LCP) (Appendix F) A summary of direct-push technology (DPT) and groundwater monitoring well sampling results are provided in Appendices G and H, respectively. The Interim Land Use Control Implementation Plan (LUCIP) is provided as Appendix I. Monitoring well completion reports, other applicable field forms, survey data, and analytical laboratory reports are provided as Appendices J through M, respectively, in the electronic copy of this document. Selected Site photographs are provided in Appendix N. The interim groundwater monitoring plan and document revision log are included as Appendices O and P, respectively. KSC Electronic Data Deliverable (KEDD) files are provided on the attached compact disk.

  19. Predicting analysis time in events-driven clinical trials using accumulating time-to-event surrogate information.

    PubMed

    Wang, Jianming; Ke, Chunlei; Yu, Zhinuan; Fu, Lei; Dornseif, Bruce

    2016-05-01

    For clinical trials with time-to-event endpoints, predicting the accrual of the events of interest with precision is critical in determining the timing of interim and final analyses. For example, overall survival (OS) is often chosen as the primary efficacy endpoint in oncology studies, with planned interim and final analyses at a pre-specified number of deaths. Often, correlated surrogate information, such as time-to-progression (TTP) and progression-free survival, are also collected as secondary efficacy endpoints. It would be appealing to borrow strength from the surrogate information to improve the precision of the analysis time prediction. Currently available methods in the literature for predicting analysis timings do not consider utilizing the surrogate information. In this article, using OS and TTP as an example, a general parametric model for OS and TTP is proposed, with the assumption that disease progression could change the course of the overall survival. Progression-free survival, related both to OS and TTP, will be handled separately, as it can be derived from OS and TTP. The authors seek to develop a prediction procedure using a Bayesian method and provide detailed implementation strategies under certain assumptions. Simulations are performed to evaluate the performance of the proposed method. An application to a real study is also provided. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

  20. Shale embankment construction criteria : experimental feature interim report.

    DOT National Transportation Integrated Search

    1985-06-01

    The research was conducted in the summer of 1983 during the realignment construction of the Mystic Creek - Camas Valley section on the Coos Bay - Roseburg Highway. Construction is still in progress. As outlined in the experimental features work plan ...

  1. Calibration of the MEPDG transfer functions in Georgia : task order 2 report.

    DOT National Transportation Integrated Search

    2015-03-28

    The Georgia Department of Transportation (GDOT) currently uses the empirical 1972 AASHTO Interim Guide for : Design of Pavement Structures as their standard pavement design procedure. However, GDOT plans to transition to the : Mechanistic Empirical P...

  2. 48 CFR 1509.170-8 - Contractor Performance Report.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Contractor Performance... AGENCY ACQUISITION PLANNING CONTRACTOR QUALIFICATIONS Contractor Performance Evaluations 1509.170-8 Contractor Performance Report. (a) Contractor Performance Reports (interim and final) must be prepared...

  3. Rural applications of advanced traveler information systems : recommended actions

    DOT National Transportation Integrated Search

    1997-07-01

    The Recommended Action Plan is one in a series of interim documents for the Rural Applications of Advanced Traveler Information Systems (ATIS) project. Based on the investigation of user needs, a technology review, and concept development and assessm...

  4. An initial evaluation of potential options for managing riparian reserves of the Aquatic Conservation Strategy of the Northwest Forest Plan

    Treesearch

    Gordon H. Reeves; Brian R. Pickard; K. Norman Johnson

    2016-01-01

    The Aquatic Conservation Strategy (ACS) of the Northwest Forest Plan guides management of riparian and aquatic ecosystems on federal lands in western Oregon, western Washington, and northern California. We applied new scientific findings and tools to evaluate two potential options, A and B, for refining interim riparian reserves to meet ACS goals and likely challenges...

  5. 77 FR 52614 - Pre-Existing Condition Insurance Plan Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-30

    ...This document contains an amendment regarding program eligibility to the interim final regulation implementing the Pre- Existing Condition Plan program under provisions of the Patient Protection and Affordable Care Act. In light of a new process recently announced by the Department of Homeland Security, eligibility for the program is being amended so that the program does not inadvertently expand the scope of that process.

  6. Return levels of temperature extremes in southern Pakistan

    NASA Astrophysics Data System (ADS)

    Zahid, Maida; Blender, Richard; Lucarini, Valerio; Caterina Bramati, Maria

    2017-12-01

    Southern Pakistan (Sindh) is one of the hottest regions in the world and is highly vulnerable to temperature extremes. In order to improve rural and urban planning, it is useful to gather information about the recurrence of temperature extremes. In this work, return levels of the daily maximum temperature Tmax are estimated, as well as the daily maximum wet-bulb temperature TWmax extremes. We adopt the peaks over threshold (POT) method, which has not yet been used for similar studies in this region. Two main datasets are analyzed: temperatures observed at nine meteorological stations in southern Pakistan from 1980 to 2013, and the ERA-Interim (ECMWF reanalysis) data for the nearest corresponding locations. The analysis provides the 2-, 5-, 10-, 25-, 50-, and 100-year return levels (RLs) of temperature extremes. The 90 % quantile is found to be a suitable threshold for all stations. We find that the RLs of the observed Tmax are above 50 °C at northern stations and above 45 °C at the southern stations. The RLs of the observed TWmax exceed 35 °C in the region, which is considered as a limit of survivability. The RLs estimated from the ERA-Interim data are lower by 3 to 5 °C than the RLs assessed for the nine meteorological stations. A simple bias correction applied to ERA-Interim data improves the RLs remarkably, yet discrepancies are still present. The results have potential implications for the risk assessment of extreme temperatures in Sindh.

  7. Prognostic value of interim FDG-PET in R-CHOP-treated diffuse large B-cell lymphoma: Systematic review and meta-analysis.

    PubMed

    Adams, Hugo J A; Kwee, Thomas C

    2016-10-01

    This study aimed to systematically review and meta-analyze the prognostic value of interim (18)F-fluoro-2-deoxy-d-glucose positron emission tomography (FDG-PET) in diffuse large B-cell lymphoma (DLBCL) patients treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP). MEDLINE and EMBASE were systematically searched for suitable studies. Included studies were methodologically appraised, and results were summarized both descriptively and meta-analytically. Nine studies, comprising a total of 996 R-CHOP-treated DLBCL patients, were included. Overall, studies were of moderate methodological quality. The area under the summary receiver operating curve (AUC) of interim FDG-PET in predicting treatment failure and death were 0.651 and 0.817, respectively. There was no heterogeneity in diagnostic odds ratios across available studies (I(2)=0.0%). At multivariable analysis, 2 studies reported interim FDG-PET to have independent prognostic value in addition to the International Prognostic Index (IPI) in predicting treatment failure, whereas 3 studies reported that this was not the case. One study reported interim FDG-PET to have independent prognostic value in addition to the IPI in predicting death, whereas 2 studies reported that this was not the case. In conclusion, interim FDG-PET in R-CHOP-treated DLBCL has some correlation with outcome, but its prognostic value is homogeneously suboptimal across studies and it has not consistently proven to surpass the prognostic potential of the IPI. Moreover, there is a lack of studies that compared interim FDG-PET to the recently developed and superior National Comprehensive Cancer Network-IPI. Therefore, at present there is no scientific base to support the clinical use of interim FDG-PET in R-CHOP-treated DLBCL. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  8. IUS/TUG orbital operations and mission support study. Volume 4: Project planning data

    NASA Technical Reports Server (NTRS)

    1975-01-01

    Planning data are presented for the development phases of interim upper stage (IUS) and tug systems. Major project planning requirements, major event schedules, milestones, system development and operations process networks, and relevant support research and technology requirements are included. Topics discussed include: IUS flight software; tug flight software; IUS/tug ground control center facilities, personnel, data systems, software, and equipment; IUS mission events; tug mission events; tug/spacecraft rendezvous and docking; tug/orbiter operations interface, and IUS/orbiter operations interface.

  9. Efficacy of a Carrageenan gel Against Transmission of Cervical HPV (CATCH): Interim analysis of a randomized, double-blind, placebo-controlled, phase 2B trial.

    PubMed

    Magnan, Sindy; Tota, Joseph E; El-Zein, Mariam; Burchell, Ann N; Schiller, John T; Ferenczy, Alex; Tellier, Pierre-Paul; Coutlée, François; Franco, Eduardo L

    2018-04-20

    We evaluated the efficacy of a carrageenan-based lubricant gel in reducing the risk of genital human papillomavirus (HPV) infections in women. We conducted a planned interim analysis of a randomized, double-blind, placebo-controlled, phase 2B trial. Women aged 18 years and older were randomly assigned (1:1) to a carrageenan-based or a placebo gel to be self-applied every other day for the first month and prior to and following each intercourse during follow-up. Assessments were done at 0·5, 1, 3, 6, 9, and 12 months. The primary outcome was incidence of a new infection by an HPV type that was not present at baseline. Analyses were performed by intention-to-treat. Between January 2013 and June 2017, 280 participants were randomly assigned to the carrageenan (n=141) or the placebo (n=139) arm. All participants were included in safety analyses, but 3 (1%) were excluded from efficacy analyses (HPV results unavailable: carrageenan=2, placebo=1). The median follow-up time was 9·2 months (inter-quartile range: 1·9-13·2). 59 (42%) of 139 participants in the carrageenan arm and 78 (57%) of 138 participants in the placebo arm got infected by at least one new HPV type (hazard ratio=0·64, 95% confidence interval=0·45-0·89, p=0·009). 62 (44%) of 141 participants in the carrageenan arm versus 43 (31%) of 139 participants in the placebo arm reported an adverse event (p=0.02); none of which were deemed related to the gels. Our trial's interim analysis suggests that using a carrageenan-based lubricant gel can reduce the risk of genital HPV infections in women. Copyright © 2018 European Society of Clinical Microbiology and Infectious Diseases. All rights reserved.

  10. Interim analysis: A rational approach of decision making in clinical trial.

    PubMed

    Kumar, Amal; Chakraborty, Bhaswat S

    2016-01-01

    Interim analysis of especially sizeable trials keeps the decision process free of conflict of interest while considering cost, resources, and meaningfulness of the project. Whenever necessary, such interim analysis can also call for potential termination or appropriate modification in sample size, study design, and even an early declaration of success. Given the extraordinary size and complexity today, this rational approach helps to analyze and predict the outcomes of a clinical trial that incorporate what is learned during the course of a study or a clinical development program. Such approach can also fill the gap by directing the resources toward relevant and optimized clinical trials between unmet medical needs and interventions being tested currently rather than fulfilling only business and profit goals.

  11. CT-based texture analysis potentially provides prognostic information complementary to interim fdg-pet for patients with hodgkin's and aggressive non-hodgkin's lymphomas.

    PubMed

    Ganeshan, B; Miles, K A; Babikir, S; Shortman, R; Afaq, A; Ardeshna, K M; Groves, A M; Kayani, I

    2017-03-01

    The purpose of this study was to investigate the ability of computed tomography texture analysis (CTTA) to provide additional prognostic information in patients with Hodgkin's lymphoma (HL) and high-grade non-Hodgkin's lymphoma (NHL). This retrospective, pilot-study approved by the IRB comprised 45 lymphoma patients undergoing routine 18F-FDG-PET-CT. Progression-free survival (PFS) was determined from clinical follow-up (mean-duration: 40 months; range: 10-62 months). Non-contrast-enhanced low-dose CT images were submitted to CTTA comprising image filtration to highlight features of different sizes followed by histogram-analysis using kurtosis. Prognostic value of CTTA was compared to PET FDG-uptake value, tumour-stage, tumour-bulk, lymphoma-type, treatment-regime, and interim FDG-PET (iPET) status using Kaplan-Meier analysis. Cox regression analysis determined the independence of significantly prognostic imaging and clinical features. A total of 27 patients had aggressive NHL and 18 had HL. Mean PFS was 48.5 months. There was no significant difference in pre-treatment CTTA between the lymphoma sub-types. Kaplan-Meier analysis found pre-treatment CTTA (medium feature scale, p=0.010) and iPET status (p<0.001) to be significant predictors of PFS. Cox analysis revealed that an interaction between pre-treatment CTTA and iPET status was the only independent predictor of PFS (HR: 25.5, 95% CI: 5.4-120, p<0.001). Specifically, pre-treatment CTTA risk stratified patients with negative iPET. CTTA can potentially provide prognostic information complementary to iPET for patients with HL and aggressive NHL. • CT texture-analysis (CTTA) provides prognostic information complementary to interim FDG-PET in Lymphoma. • Pre-treatment CTTA and interim PET status were significant predictors of progression-free survival. • Patients with negative interim PET could be further stratified by pre-treatment CTTA. • Provide precision surveillance where additional imaging reserved for patients at greatest recurrence-risk. • Assists in risk-adapted treatment strategy based on interim PET and CTTA.

  12. Randomized Clinical Trial Comparing Proton Beam Radiation Therapy with Transarterial Chemoembolization for Hepatocellular Carcinoma: Results of an Interim Analysis

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

    Bush, David A., E-mail: dbush@llu.edu; Smith, Jason C.; Slater, Jerry D.

    2016-05-01

    Purpose: To describe results of a planned interim analysis of a prospective, randomized clinical trial developed to compare treatment outcomes among patients with newly diagnosed hepatocellular carcinoma (HCC). Methods and Materials: Eligible subjects had either clinical or pathologic diagnosis of HCC and met either Milan or San Francisco transplant criteria. Patients were randomly assigned to transarterial chemoembolization (TACE) or to proton beam radiation therapy. Patients randomized to TACE received at least 1 TACE with additional TACE for persistent disease. Proton beam radiation therapy was delivered to all areas of gross disease to a total dose of 70.2 Gy in 15 daily fractionsmore » over 3 weeks. The primary endpoint was progression-free survival, with secondary endpoints of overall survival, local tumor control, and treatment-related toxicities as represented by posttreatment days of hospitalization. Results: At the time of this analysis 69 subjects were available for analysis. Of these, 36 were randomized to TACE and 33 to proton. Total days of hospitalization within 30 days of TACE/proton was 166 and 24 days, respectively (P<.001). Ten TACE and 12 proton patients underwent liver transplantation after treatment. Viable tumor identified in the explanted livers after TACE/proton averaged 2.4 and 0.9 cm, respectively. Pathologic complete response after TACE/proton was 10%/25% (P=.38). The 2-year overall survival for all patients was 59%, with no difference between treatment groups. Median survival time was 30 months (95% confidence interval 20.7-39.3 months). There was a trend toward improved 2-year local tumor control (88% vs 45%, P=.06) and progression-free survival (48% vs 31%, P=.06) favoring the proton beam treatment group. Conclusions: This interim analysis indicates similar overall survival rates for proton beam radiation therapy and TACE. There is a trend toward improved local tumor control and progression-free survival with proton beam. There are significantly fewer hospitalization days after proton treatment, which may indicate reduced toxicity with proton beam therapy.« less

  13. Texturing of concrete pavements : interim report No. 2.

    DOT National Transportation Integrated Search

    1976-09-01

    The purpose of this research study is to document and evaluate the findings of the Category II experimental concrete texturing project. Under this plan of experimental study, several texting techniques were tried and will be compared in order to dete...

  14. Proof of concept deployment plan.

    DOT National Transportation Integrated Search

    2008-02-01

    The U.S. Department of Transportation (USDOT) Next Generation 9-1-1 (NG9-1-1) : Proof-of-Concept (POC) demonstration is envisioned to test key features and : functionalities of the NG9-1-1 system. The Interim POC System Design Document : defines the ...

  15. 40 CFR 265.54 - Amendment of contingency plan.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Section 265.54 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND..., explosions, or releases of hazardous waste or hazardous waste constituents, or changes the response necessary...

  16. 40 CFR 265.54 - Amendment of contingency plan.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Section 265.54 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND..., explosions, or releases of hazardous waste or hazardous waste constituents, or changes the response necessary...

  17. 48 CFR 1509.170-6 - Filing of forms.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Section 1509.170-6 Federal Acquisition Regulations System ENVIRONMENTAL PROTECTION AGENCY ACQUISITION PLANNING CONTRACTOR QUALIFICATIONS Contractor Performance Evaluations 1509.170-6 Filing of forms. The original copy of completed Contractor Performance Reports (interim and final) shall be filed in each...

  18. TRU Waste Management Program. Cost/schedule optimization analysis

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

    Detamore, J.A.; Raudenbush, M.H.; Wolaver, R.W.

    This Current Year Work Plan presents in detail a description of the activities to be performed by the Joint Integration Office Rockwell International (JIO/RI) during FY86. It breaks down the activities into two major work areas: Program Management and Program Analysis. Program Management is performed by the JIO/RI by providing technical planning and guidance for the development of advanced TRU waste management capabilities. This includes equipment/facility design, engineering, construction, and operations. These functions are integrated to allow transition from interim storage to final disposition. JIO/RI tasks include program requirements identification, long-range technical planning, budget development, program planning document preparation, taskmore » guidance development, task monitoring, task progress information gathering and reporting to DOE, interfacing with other agencies and DOE lead programs, integrating public involvement with program efforts, and preparation of reports for DOE detailing program status. Program Analysis is performed by the JIO/RI to support identification and assessment of alternatives, and development of long-term TRU waste program capabilities. These analyses include short-term analyses in response to DOE information requests, along with performing an RH Cost/Schedule Optimization report. Systems models will be developed, updated, and upgraded as needed to enhance JIO/RI's capability to evaluate the adequacy of program efforts in various fields. A TRU program data base will be maintained and updated to provide DOE with timely responses to inventory related questions.« less

  19. RH-TRU Waste Shipments from Battelle Columbus Laboratories to the Hanford Nuclear Facility for Interim Storage

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

    Eide, J.; Baillieul, T. A.; Biedscheid, J.

    2003-02-26

    Battelle Columbus Laboratories (BCL), located in Columbus, Ohio, must complete decontamination and decommissioning (D&D) activities for nuclear research buildings and grounds by 2006, as directed by Congress. Most of the resulting waste (approximately 27 cubic meters [m3]) is remote-handled (RH) transuranic (TRU) waste destined for disposal at the Waste Isolation Pilot Plant (WIPP). The BCL, under a contract to the U.S. Department of Energy (DOE) Ohio Field Office, has initiated a plan to ship the TRU waste to the DOE Hanford Nuclear Facility (Hanford) for interim storage pending the authorization of WIPP for the permanent disposal of RH-TRU waste. Themore » first of the BCL RH-TRU waste shipments was successfully completed on December 18, 2002. This BCL shipment of one fully loaded 10-160B Cask was the first shipment of RH-TRU waste in several years. Its successful completion required a complex effort entailing coordination between different contractors and federal agencies to establish necessary supporting agreements. This paper discusses the agreements and funding mechanisms used in support of the BCL shipments of TRU waste to Hanford for interim storage. In addition, this paper presents a summary of the efforts completed to demonstrate the effectiveness of the 10-160B Cask system. Lessons learned during this process are discussed and may be applicable to other TRU waste site shipment plans.« less

  20. Mitigation Between Regional Transportation Needs and Preservation of Eelgrass Beds: Interim Report of Phase I Results

    DOT National Transportation Integrated Search

    1995-12-01

    Demand for increased ferry service and expanding regional transportation plans mandate that the Washington State Department of Transportation (WSDOT) consider widening existing dock structures over the waters of Puget Sound. However, concerns about t...

  1. Accounting for interim safety monitoring of an adverse event upon termination of a clinical trial.

    PubMed

    Dallas, Michael J

    2008-01-01

    Upon termination of a clinical trial that uses interim evaluations to determine whether the trial can be stopped, a proper statistical analysis must account for the interim evaluations. For example, in a group-sequential design where the efficacy of a treatment regimen is evaluated at interim stages, and the opportunity to stop the trial based on positive efficacy findings exists, the terminal p-value, point estimate, and confidence limits of the outcome of interest must be adjusted to eliminate bias. While it is standard practice to adjust terminal statistical analyses due to opportunities to stop for "positive" findings, adjusting due to opportunities to stop for "negative" findings is also important. Stopping rules for negative findings are particularly useful when monitoring a specific rare serious adverse event in trials designed to show safety with respect to the event. In these settings, establishing conservative stopping rules are appropriate, and therefore accounting for the interim monitoring can have a substantial effect on the final results. Here I present a method to account for interim safety monitoring and illustrate its usefulness. The method is demonstrated to have advantages over methodology that does not account for interim monitoring.

  2. Manned Systems Utilization Analysis. Study 2.1: Space Servicing Pilot Program Study. [for automated payloads

    NASA Technical Reports Server (NTRS)

    Wolfe, R. R.

    1975-01-01

    Space servicing automated payloads was studied for potential cost benefits for future payload operations. Background information is provided on space servicing in general, and on a pilot flight test program in particular. An fight test is recommended to demonstrate space servicing. An overall program plan is provided which builds upon the pilot program through an interim servicing capability. A multipayload servicing concept for the time when the full capability tug becomes operational is presented. The space test program is specifically designed to provide low-cost booster vehicles and a flight test platform for several experiments on a single flight.

  3. FY 1986 current fiscal year work plan

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

    Not Available

    This Current Year Work Plan presents in detail a description of the activities to be performed by the Joint Integration Office/RI during FY86. It breaks down the activities into two major work areas: Program Management and Program Analysis. Program Management is performed by the JIO/RI by providing technical planning and guidance for the development of advanced TRU waste management capabilities. This includes equipment/facility design, engineering, construction, and operations. These functions are integrated to allow transition from interim storage to final disposition. JIO/RI tasks include program requirements identification, long-range technical planning, budget development, program planning document preparation, task guidance development, taskmore » monitoring, task progress information gathering and reporting to DOE, interfacing with other agencies and DOE lead programs, integrating public involvement with program efforts, and preparation of reports for DOE detailing program status. Program Analysis is performed by the JIO/RI to support identification and assessment of alternatives, and development of long-term TRU waste program capabilities. These analyses include short term analyses in response to DOE information requests, along with performing an RH Cost/Schedule Optimization report. System models will be developed, updated, and upgraded as needed to enhance JIO/RI's capability to evaluate the adequacy of program efforts in various fields. A TRU program data base will be maintained and updated to provide DOE with timely responses to inventory related questions.« less

  4. Continuous Covariate Imbalance and Conditional Power for Clinical Trial Interim Analyses

    PubMed Central

    Ciolino, Jody D.; Martin, Renee' H.; Zhao, Wenle; Jauch, Edward C.; Hill, Michael D.; Palesch, Yuko Y.

    2014-01-01

    Oftentimes valid statistical analyses for clinical trials involve adjustment for known influential covariates, regardless of imbalance observed in these covariates at baseline across treatment groups. Thus, it must be the case that valid interim analyses also properly adjust for these covariates. There are situations, however, in which covariate adjustment is not possible, not planned, or simply carries less merit as it makes inferences less generalizable and less intuitive. In this case, covariate imbalance between treatment groups can have a substantial effect on both interim and final primary outcome analyses. This paper illustrates the effect of influential continuous baseline covariate imbalance on unadjusted conditional power (CP), and thus, on trial decisions based on futility stopping bounds. The robustness of the relationship is illustrated for normal, skewed, and bimodal continuous baseline covariates that are related to a normally distributed primary outcome. Results suggest that unadjusted CP calculations in the presence of influential covariate imbalance require careful interpretation and evaluation. PMID:24607294

  5. Review and evaluation of models that produce trip tables from ground counts : interim report.

    DOT National Transportation Integrated Search

    1996-01-01

    This research effort was motivated by the desires of planning agencies to seek alternative methods of deriving current or base year Origin-Destination (O-D) trip tables without adopting conventional O-D surveys that are expensive, time consuming and ...

  6. Integrating intelligent transportation systems within the transportation planning process : an interim handbook

    DOT National Transportation Integrated Search

    1999-06-01

    The main purpose of Phase I of this project was to develop a methodology for predicting consequences of hazardous material (HM) crashes, such as injuries and property damage. An initial step in developing a risk assessment is to reliably estimate the...

  7. 40 CFR 52.134 - Compliance schedules.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... beyond July 31, 1975, shall apply any reasonable interim measures of control designed to reduce the... progress shall include, but not be limited to: Submittal of the final control plan to the Administrator... of component parts to accomplish emission control equipment or process modification; completion of...

  8. 40 CFR 52.134 - Compliance schedules.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... beyond July 31, 1975, shall apply any reasonable interim measures of control designed to reduce the... progress shall include, but not be limited to: Submittal of the final control plan to the Administrator... of component parts to accomplish emission control equipment or process modification; completion of...

  9. 40 CFR 52.134 - Compliance schedules.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... beyond July 31, 1975, shall apply any reasonable interim measures of control designed to reduce the... progress shall include, but not be limited to: Submittal of the final control plan to the Administrator... of component parts to accomplish emission control equipment or process modification; completion of...

  10. 40 CFR 52.134 - Compliance schedules.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... beyond July 31, 1975, shall apply any reasonable interim measures of control designed to reduce the... progress shall include, but not be limited to: Submittal of the final control plan to the Administrator... of component parts to accomplish emission control equipment or process modification; completion of...

  11. 40 CFR 52.134 - Compliance schedules.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... beyond July 31, 1975, shall apply any reasonable interim measures of control designed to reduce the... progress shall include, but not be limited to: Submittal of the final control plan to the Administrator... of component parts to accomplish emission control equipment or process modification; completion of...

  12. An Interim Update to the 2035 Socioeconomic and Travel Demand Forecasts for Virginia

    DOT National Transportation Integrated Search

    2012-10-01

    In support of the update to Virginias 2035 Statewide Multimodal Plan, this report provides an update to select : socioeconomic forecasts initially made in 2009 based on a review of data from national sources and the literature. Mobility : needs ex...

  13. An interim update to the 2035 socioeconomic and travel demand forecasts for Virginia.

    DOT National Transportation Integrated Search

    2012-09-01

    "In support of the update to Virginias 2035 Statewide Multimodal Plan, this report provides an update to select : socioeconomic forecasts initially made in 2009 based on a review of data from national sources and the literature. Mobility : needs e...

  14. An interim update to the 2035 socioeconomic and travel demand forecasts for Virginia.

    DOT National Transportation Integrated Search

    2012-10-01

    In support of the update to Virginias 2035 Statewide Multimodal Plan, this report provides an update to select : socioeconomic forecasts initially made in 2009 based on a review of data from national sources and the literature. Mobility : needs ex...

  15. High performance concrete in Washington state SR 18/SR 516 overcrossing : interim report on girder monitoring

    DOT National Transportation Integrated Search

    1999-04-30

    This report documents a sample of heavy-duty truck activity. This research effort was originated by the Planning and Technical Support Division of the California Air Resources Board (CARB) and jointly supported by the Federal Highway Administration (...

  16. Mobile Launch Platform Vehicle Assembly Building Area (SWMU 056) Hot Spot 3 Bioremediation Interim Measures Work Plan, Kennedy Space Center, Florida

    NASA Technical Reports Server (NTRS)

    Whitney L. Morrison; Daprato, Rebecca C.

    2016-01-01

    This Interim Measures Work Plan (IMWP) presents an approach and design for the remediation of chlorinated volatile organic compound (CVOC) groundwater impacts using bioremediation (biostimulation and bioaugmentation) in Hot Spot 3, which is defined by the area where CVOC (trichloroethene [TCE], cis-1,2-dichloroethene [cDCE], and vinyl chloride [VC]) concentrations are greater than 10 times their respective Florida Department of Environmental Protection (FDEP) Natural Attenuation Default Concentration (NADC) [10xNADC] near the western Mobile Launch Platform (MLP) structure. The IM treatment area is the Hot Spot 3 area, which is approximately 0.07 acres and extends from approximately 6 to 22 and 41 to 55 feet below land surface (ft BLS). Within Hot Spot 3, a source zone (SZ; area with TCE concentrations greater than 1% solubility [11,000 micrograms per liter (micrograms/L)]) was delineated and is approximately 0.02 acres and extends from approximately 6 to 16 and 41 to 50 ft BLS.

  17. Final Decision Document for the Basin a Neck Groundwater Intercept and Treatment System Interim Response Action at the Rocky Mountain Arsenal.

    DTIC Science & Technology

    1989-02-01

    PLAN A Health and Safety Plan has been developed for the prevention of occupational injuries and illnesses during field activities at RMA. This plan...Bicycloheptadiene BCHPD 0(2) Bromoform CHBR3 100(4) note: total trihalomethanes Cadmium CD 10(1) 5(3)* 10(4) I Carbon tetrachloride CCL4 0(3) 5(4) Chlordane CLDAN...comments, numerous carcinogenicity tests in a variety of animals indicate that aldrin and dieldrin promote only liver tumors and the tumors develop only

  18. Analysis of Transportation Options for Commercial Spent Fuel in the U.S.

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

    Kalinina, Elena; Busch, Ingrid Karin

    The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S.more » Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage and associated transportation of spent nuclear fuel (SNF) highand associated transportation of spent nuclear fuel (SNF) and high and associated transportation of spent nuclear fuel (SNF) highand associated transportation of spent nuclear fuel (SNF) and high and associated transportation of spent nuclear fuel (SNF) highand associated transportation of spent nuclear fuel (SNF) and highand associated transportation of spent nuclear fuel (SNF) and high and associated transportation of spent nuclear fuel (SNF) high and associated transportation of spent nuclear fuel (SNF) high and associated transportation of spent nuclear fuel (SNF) high and associated transportation of spent nuclear fuel (SNF) high and associated transportation of spent nuclear fuel (SNF) high and associated transportation of spent nuclear fuel (SNF) high and associated transportation of spent nuclear fuel (SNF) highand associated transportation of spent nuclear fuel (SNF) and high and associated transportation of spent nuclear fuel (SNF) high and associated transportation of spent nuclear fuel (SNF) highand associated transportation of spent nuclear fuel (SNF)...« less

  19. Adjustable Autonomy and Human-Agent Teamwork in Practice: An Interim Report on Space Applications

    NASA Technical Reports Server (NTRS)

    Bradshaw, Jeffrey M.; Feltovich, Paul; Hoffman, Robert; Jeffers, Renia; Suri, Niranhan; Uszok, Andrzej; VanHoof, Ron; Acquisti, Alessandro; Prescott, Debbie

    2003-01-01

    We give a preliminary perspective on the basic principles and pitfalls of adjustable autonomy and human-centered teamwork. We then summarize the interim results of our study on the problem of work practice modeling and human-agent collaboration in space applications, the development of a broad model of human-agent teamwork grounded in practice, and the integration of the Brahms, KAoS, and NOMADS agent frameworks. We hope our work will benefit those who plan and participate in work activities in a wide variety of space applications, as well as those who are interested in design and execution tools for teams of robots that can function as effective assistants to humans.

  20. 78 FR 37719 - Interim Final Determination To Defer Sanctions; California; South Coast Air Quality Management...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-24

    ... Determination To Defer Sanctions; California; South Coast Air Quality Management District AGENCY: Environmental... Quality Management District's (SCAQMD) portion of the California State Implementation Plan (SIP) published... California submitted the ``South Coast Air Quality Management District Proposed Contingency Measures for the...

  1. 76 FR 10089 - Value-Added Producer Grant Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-23

    ..., business plans, and marketing strategies. The program will also provide working capital for expenses such as implementing an existing viable marketing strategy. The Agency will implement the program to meet... projects that develop mid-tier value marketing chains. DATES: This interim rule is effective March 25, 2011...

  2. Interim report deliverable 1.1 : RADAR sensors for transportation applications of the restricted use technology study

    DOT National Transportation Integrated Search

    2005-09-30

    Under Deliverable 1.1 of the Work Plan governing the Altarum Restricted Use Technology Study, the Altarum project team is required to produce an unclassified summary and comprehensive written report of RADAR systems that can potentially address trans...

  3. Interim report deliverable 2.1 : electro-optical sensors for transportation applications of the restricted use technology study

    DOT National Transportation Integrated Search

    2005-09-30

    Under Deliverable 2.1 of the Work Plan governing the Altarum Restricted Use Technology Study, the Altarum project team is required to produce an unclassified summary and comprehensive written report of Electro-Optical (EO) systems that can potentiall...

  4. Spent Nuclear Fuel (SNF) Project Execution Plan

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

    LEROY, P.G.

    2000-11-03

    The Spent Nuclear Fuel (SNF) Project supports the Hanford Site Mission to cleanup the Site by providing safe, economic, environmentally sound management of Site spent nuclear fuel in a manner that reduces hazards by staging it to interim onsite storage and deactivates the 100 K Area facilities.

  5. Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); TRICARE Retired Reserve for members of the Retired Reserve. Interim final rule with comment period.

    PubMed

    2010-08-06

    This interim final rule establishes requirements and procedures for implementation of TRICARE Retired Reserve. This interim final rule addresses provisions of the National Defense Authorization Act for Fiscal Year 2010 (NDAA-10). The purpose of this interim final rule is to establish the TRICARE Retired Reserve program that implements section 705 of the NDAA-10. Section 705 allows members of the Retired Reserve who are qualified for non-regular retirement, but are not yet 60 years of age, to qualify to purchase medical coverage equivalent to the TRICARE Standard (and Extra) benefit unless that member is either enrolled in, or is eligible to enroll in, a health benefit plan under Chapter 89 of Title 5, United States Code, as well as certain survivors. The amount of the premium that qualified members pay to purchase these benefits will represent the full cost as determined on an appropriate actuarial basis for coverage under the TRICARE Standard (and Extra) benefit including the cost of the program administration. There will be one premium for member-only coverage and a separate premium for member and family coverage. The rules and procedures otherwise outlined in Part 199 of 32 CFR relating to the operation and administration of the TRICARE Standard and Extra programs including the required cost-shares, deductibles and catastrophic caps for retired members and their dependents will apply to this program. The rule is being published as an interim final rule with comment period in order to comply with statutory effective dates.

  6. Hyperinsulinemic Normoglycemia during Cardiac Surgery Reduces a Composite of 30-day Mortality and Serious In-hospital Complications: A Randomized Clinical Trial.

    PubMed

    Duncan, Andra E; Sessler, Daniel I; Sato, Hiroaki; Sato, Tamaki; Nakazawa, Keisuke; Carvalho, George; Hatzakorzian, Roupen; Codere-Maruyama, Takumi; Abd-Elsayed, Alaa; Bose, Somnath; Said, Tamer; Mendoza-Cuartas, Maria; Chowdary, Hyndhavi; Mascha, Edward J; Yang, Dongsheng; Gillinov, A Marc; Schricker, Thomas

    2018-06-01

    Hyperinsulinemic normoglycemia augments myocardial glucose uptake and utilization. We tested the hypothesis that hyperinsulinemic normoglycemia reduces 30-day mortality and morbidity after cardiac surgery. This dual-center, parallel-group, superiority trial randomized cardiac surgical patients between August 2007 and March 2015 at the Cleveland Clinic, Cleveland, Ohio, and Royal Victoria Hospital, Montreal, Canada, to intraoperative glycemic management with (1) hyperinsulinemic normoglycemia, a fixed high-dose insulin and concomitant variable glucose infusion titrated to glucose concentrations of 80 to 110 mg · dl; or (2) standard glycemic management, low-dose insulin infusion targeting glucose greater than 150 mg · dl. The primary outcome was a composite of 30-day mortality, mechanical circulatory support, infection, renal or neurologic morbidity. Interim analyses were planned at each 12.5% enrollment of a maximum 2,790 patients. At the third interim analysis (n = 1,439; hyperinsulinemic normoglycemia, 709, standard glycemic management, 730; 52% of planned maximum), the efficacy boundary was crossed and study stopped per protocol. Time-weighted average glucose concentration (means ± SDs) with hyperinsulinemic normoglycemia was 108 ± 20 versus 150 ± 33 mg · dl with standard glycemic management, P < 0.001. At least one component of the composite outcome occurred in 49 (6.9%) patients receiving hyperinsulinemic normoglycemia versus 82 (11.2%) receiving standard glucose management (P < efficacy boundary 0.0085); estimated relative risk (95% interim-adjusted CI) 0.62 (0.39 to 0.97), P = 0.0043. There was a treatment-by-site interaction (P = 0.063); relative risk for the composite outcome was 0.49 (0.26 to 0.91, P = 0.0007, n = 921) at Royal Victoria Hospital, but 0.96 (0.41 to 2.24, P = 0.89, n = 518) at the Cleveland Clinic. Severe hypoglycemia (less than 40 mg · dl) occurred in 6 (0.9%) patients. Intraoperative hyperinsulinemic normoglycemia reduced mortality and morbidity after cardiac surgery. Providing exogenous glucose while targeting normoglycemia may be preferable to simply normalizing glucose concentrations.

  7. Preliminary Concept of Operations for the Spent Fuel Management System--WM2017

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

    Cumberland, Riley M; Adeniyi, Abiodun Idowu; Howard, Rob L

    The Nuclear Fuels Storage and Transportation Planning Project (NFST) within the U.S. Department of Energy s Office of Nuclear Energy is tasked with identifying, planning, and conducting activities to lay the groundwork for developing interim storage and transportation capabilities in support of an integrated waste management system. The system will provide interim storage for commercial spent nuclear fuel (SNF) from reactor sites and deliver it to a repository. The system will also include multiple subsystems, potentially including; one or more interim storage facilities (ISF); one or more repositories; facilities to package and/or repackage SNF; and transportation systems. The project teammore » is analyzing options for an integrated waste management system. To support analysis, the project team has developed a Concept of Operations document that describes both the potential integrated system and inter-dependencies between system components. The goal of this work is to aid systems analysts in the development of consistent models across the project, which involves multiple investigators. The Concept of Operations document will be updated periodically as new developments emerge. At a high level, SNF is expected to travel from reactors to a repository. SNF is first unloaded from reactors and placed in spent fuel pools for wet storage at utility sites. After the SNF has cooled enough to satisfy loading limits, it is placed in a container at reactor sites for storage and/or transportation. After transportation requirements are met, the SNF is transported to an ISF to store the SNF until a repository is developed or directly to a repository if available. While the high level operation of the system is straightforward, analysts must evaluate numerous alternative options. Alternative options include the number of ISFs (if any), ISF design, the stage at which SNF repackaging occurs (if any), repackaging technology, the types of containers used, repository design, component sizing, and timing of events. These alternative options arise due to technological, economic, or policy considerations. As new developments regularly emerge, the operational concepts will be periodically updated. This paper gives an overview of the different potential alternatives identified in the Concept of Operations document at a conceptual level.« less

  8. Cost Sensitivity Analysis for Consolidated Interim Storage of Spent Fuel: Evaluating the Effect of Economic Environment Parameters

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

    Cumberland, Riley M.; Williams, Kent Alan; Jarrell, Joshua J.

    This report evaluates how the economic environment (i.e., discount rate, inflation rate, escalation rate) can impact previously estimated differences in lifecycle costs between an integrated waste management system with an interim storage facility (ISF) and a similar system without an ISF.

  9. A randomised trial of adaptive pacing therapy, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome (PACE): statistical analysis plan

    PubMed Central

    2013-01-01

    Background The publication of protocols by medical journals is increasingly becoming an accepted means for promoting good quality research and maximising transparency. Recently, Finfer and Bellomo have suggested the publication of statistical analysis plans (SAPs).The aim of this paper is to make public and to report in detail the planned analyses that were approved by the Trial Steering Committee in May 2010 for the principal papers of the PACE (Pacing, graded Activity, and Cognitive behaviour therapy: a randomised Evaluation) trial, a treatment trial for chronic fatigue syndrome. It illustrates planned analyses of a complex intervention trial that allows for the impact of clustering by care providers, where multiple care-providers are present for each patient in some but not all arms of the trial. Results The trial design, objectives and data collection are reported. Considerations relating to blinding, samples, adherence to the protocol, stratification, centre and other clustering effects, missing data, multiplicity and compliance are described. Descriptive, interim and final analyses of the primary and secondary outcomes are then outlined. Conclusions This SAP maximises transparency, providing a record of all planned analyses, and it may be a resource for those who are developing SAPs, acting as an illustrative example for teaching and methodological research. It is not the sum of the statistical analysis sections of the principal papers, being completed well before individual papers were drafted. Trial registration ISRCTN54285094 assigned 22 May 2003; First participant was randomised on 18 March 2005. PMID:24225069

  10. Pioneer 11's encounter with Jupiter and mission to Saturn

    NASA Technical Reports Server (NTRS)

    Dyer, J. W.

    1975-01-01

    Plans for Pioneer 11's approach to Saturn are described. A flyby somewhat parallel to the ring plane is being proposed as an interim target, with a future option held for a possible high risk (or suicide) plunge through the nearly transparent space between Saturn and its rings.

  11. Interim Regional Supplement to the Corps of Engineers Wetland Delineation Manual: Great Plans Region

    DTIC Science & Technology

    2008-03-01

    artemisiifolia Iva annua Cardiospermum halicacabum Xanthium strumarium FACW FACU− FAC FAC FAC− 40 15 15 8 6 Yes Yes Yes No No Total...virgatum 50 40 90 2 180 FAC species Iva annua Celtis laevigata Cardiospermum halicacabum Xanthium strumarium Toxicodendron radicans3 15 12

  12. School, Work and Family Planning. Interim Impacts in Project Redirection.

    ERIC Educational Resources Information Center

    Polit, Denise F.; And Others

    Project Redirection was designed to help pregnant and parenting adolescents progress toward eventual self-sufficiency by linking them with community agencies and volunteers at four geographically and ethnically diverse sites in the United States. Distinctive features of the program include: (1) a broad scope of services including employability…

  13. 40 CFR 52.241 - Interim approval of enhanced inspection and maintenance program.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS California... Act (Pub. L. 104-59), the California SIP is approved as meeting the provisions of section 182(c)(3.... (a) [Reserved] (b) Approval. On June 5, 2009, the California Air Resources Board submitted a revision...

  14. INTERIM GUIDANCE FOR DEVELOPING GLOBAL POSITIONING SYSTEM DATA COLLECTION STANDARD OPERATING PROCEDURES AND QUALITY ASSURANCE PROJECT PLANS

    EPA Science Inventory

    The United States Environmental Protection Agency Geospatial Quality Council developed this document to harmonize the process of collecting, editing, and exporting spatial data of known quality using the Global Positioning System (GPS). Each organizational entity may adopt this d...

  15. 77 FR 62596 - Interim Guidance on State Freight Plans and State Freight Advisory Committees

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-15

    ...), Maritime Administration (MARAD), Pipeline and Hazardous Materials Safety Administration (PHSMA), Research... Research Program (23 U.S.C. 505). They may also use carryover balances from National Highway System funds... system's users and to the general public (for example, reductions in crashes, fatalities, and injuries...

  16. 77 FR 30002 - Primary Power, LLC v. PJM Interconnection, LLC; Notice of Complaint

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-21

    ... Respondent) for the Respondent's failure to designate the Complainant to construct, own, and finance two static VAR compensator (``SVC'') projects sponsored by the Complainant that have been included in the PJM Regional Transmission Expansion Plan. The Complainant requests that the Commission grant emergency, interim...

  17. Information Sharing Environment Interim Implementation Plan

    DTIC Science & Technology

    2006-01-01

    10 3.2.3 Integrating Results into the Broader ISE Implementation ........................ 11 3.3 ISE Governance ...and State, Local, and Tribal Governments , Law Enforcement Agencies, and the Private Sector...parallel with these efforts, Congress enacted three laws providing the U.S. Government with greater authority for collecting, analyzing, and disseminating

  18. Altarum restricted use technology study : interim report, deliverable 3.1 : list of invitees for the focus group

    DOT National Transportation Integrated Search

    2005-09-01

    This study, an 18-month effort, seeks to apply restricted use technology to the mandates of MDOT. For Deliverable 3.1 described in the Work Plan governing the Altarum Restricted Use Technology Study, the Altarum project team is required to provide a ...

  19. Training forensic staff.

    PubMed

    Hall-McGee, P

    1997-01-01

    The author provides a training package for forensic staff on how to handle prisoner patients who are being treated at a healthcare facility. She covers such topics as fire and evacuation plans, interim life safety measures, blood and bloodborne pathogens exposure, universal precautions, respiratory protection and TB, and voluntary medical immobilization and protection devices.

  20. Field monitoring of the I-295 bridge over the James River : instrumentation installation and construction period studies : interim report.

    DOT National Transportation Integrated Search

    1988-01-01

    This report reviews the various techniques considered for instrumenting the Rte. 1-295 cable-stayed bridge over the James River near Richmond, Virginia. From this review an instrumentation plan is developed to meet the following objectives: 1. to det...

  1. A phase II flexible screening design allowing for interim analysis and comparison with historical control.

    PubMed

    Wu, Wenting; Bot, Brian; Hu, Yan; Geyer, Susan M; Sargent, Daniel J

    2013-07-01

    Sargent and Goldberg [1] proposed a randomized phase II flexible screening design (SG design) which took multiple characteristics of candidate regimens into consideration in selecting a regimen for further phase III testing. In this paper, we extend the SG design by including provisions for an interim analysis and/or a comparison to a historical control. By including a comparison with a historical control, a modified SG design not only identifies a more promising treatment but also assures that the regimen has a clinically meaningful level of efficacy as compared to a historical control. By including an interim analysis, a modified SG design could reduce the number of patients exposed to inferior treatment regimens. When compared to the original SG design, the modified designs increase the sample size moderately, but expand the utility of the flexible screening design substantially. Copyright © 2013 Elsevier Inc. All rights reserved.

  2. Re-use of pilot data and interim analysis of pivotal data in MRMC studies: a simulation study

    NASA Astrophysics Data System (ADS)

    Chen, Weijie; Samuelson, Frank; Sahiner, Berkman; Petrick, Nicholas

    2017-03-01

    Novel medical imaging devices are often evaluated with multi-reader multi-case (MRMC) studies in which radiologists read images of patient cases for a specified clinical task (e.g., cancer detection). A pilot study is often used to measure the effect size and variance parameters that are necessary for sizing a pivotal study (including sizing readers, non-diseased and diseased cases). Due to the practical difficulty of collecting patient cases or recruiting clinical readers, some investigators attempt to include the pilot data as part of their pivotal study. In other situations, some investigators attempt to perform an interim analysis of their pivotal study data based upon which the sample sizes may be re-estimated. Re-use of the pilot data or interim analyses of the pivotal data may inflate the type I error of the pivotal study. In this work, we use the Roe and Metz model to simulate MRMC data under the null hypothesis (i.e., two devices have equal diagnostic performance) and investigate the type I error rate for several practical designs involving re-use of pilot data or interim analysis of pivotal data. Our preliminary simulation results indicate that, under the simulation conditions we investigated, the inflation of type I error is none or only marginal for some design strategies (e.g., re-use of patient data without re-using readers, and size re-estimation without using the effect-size estimated in the interim analysis). Upon further verifications, these are potentially useful design methods in that they may help make a study less burdensome and have a better chance to succeed without substantial loss of the statistical rigor.

  3. Conditional power and predictive power based on right censored data with supplementary auxiliary information.

    PubMed

    Sun, Libo; Wan, Ying

    2018-04-22

    Conditional power and predictive power provide estimates of the probability of success at the end of the trial based on the information from the interim analysis. The observed value of the time to event endpoint at the interim analysis could be biased for the true treatment effect due to early censoring, leading to a biased estimate of conditional power and predictive power. In such cases, the estimates and inference for this right censored primary endpoint are enhanced by incorporating a fully observed auxiliary variable. We assume a bivariate normal distribution of the transformed primary variable and a correlated auxiliary variable. Simulation studies are conducted that not only shows enhanced conditional power and predictive power but also can provide the framework for a more efficient futility interim analysis in terms of an improved accuracy in estimator, a smaller inflation in type II error and an optimal timing for such analysis. We also illustrated the new approach by a real clinical trial example. Copyright © 2018 John Wiley & Sons, Ltd.

  4. Additional EIPC Study Analysis: Interim Report on Medium Priority Topics

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

    Hadley, Stanton W.; Gotham, Douglas J.

    Between 2010 and 2012 the Eastern Interconnection Planning Collaborative (EIPC) conducted a major long-term resource and transmission study of the Eastern Interconnection (EI). With guidance from a stakeholder steering committee (SSC) that included representatives from the Eastern Interconnection States’ Planning Council (EISPC) among others, the project was conducted in two phases. The first was a 2015–2040 analysis that looked at a broad array of possible future scenarios, while the second focused on a more detailed examination of the grid in 2030. The studies provided a wealth of information on possible future generation, demand, and transmission alternatives. However, at the conclusionmore » there were still unresolved questions and issues. The US Department of Energy, which had sponsored the study, asked Oak Ridge National Laboratory researchers and others who worked on the project to conduct an additional study of the data to provide further insights for stakeholders and the industry. This report documents the second part of that follow-on study [an earlier report (Hadley 2013) covered the first part, and a subsequent report will address the last part].« less

  5. Australasian Resuscitation In Sepsis Evaluation trial statistical analysis plan.

    PubMed

    Delaney, Anthony; Peake, Sandra L; Bellomo, Rinaldo; Cameron, Peter; Holdgate, Anna; Howe, Belinda; Higgins, Alisa; Presneill, Jeffrey; Webb, Steve

    2013-10-01

    The Australasian Resuscitation In Sepsis Evaluation (ARISE) study is an international, multicentre, randomised, controlled trial designed to evaluate the effectiveness of early goal-directed therapy compared with standard care for patients presenting to the ED with severe sepsis. In keeping with current practice, and taking into considerations aspects of trial design and reporting specific to non-pharmacologic interventions, this document outlines the principles and methods for analysing and reporting the trial results. The document is prepared prior to completion of recruitment into the ARISE study, without knowledge of the results of the interim analysis conducted by the data safety and monitoring committee and prior to completion of the two related international studies. The statistical analysis plan was designed by the ARISE chief investigators, and reviewed and approved by the ARISE steering committee. The data collected by the research team as specified in the study protocol, and detailed in the study case report form were reviewed. Information related to baseline characteristics, characteristics of delivery of the trial interventions, details of resuscitation and other related therapies, and other relevant data are described with appropriate comparisons between groups. The primary, secondary and tertiary outcomes for the study are defined, with description of the planned statistical analyses. A statistical analysis plan was developed, along with a trial profile, mock-up tables and figures. A plan for presenting baseline characteristics, microbiological and antibiotic therapy, details of the interventions, processes of care and concomitant therapies, along with adverse events are described. The primary, secondary and tertiary outcomes are described along with identification of subgroups to be analysed. A statistical analysis plan for the ARISE study has been developed, and is available in the public domain, prior to the completion of recruitment into the study. This will minimise analytic bias and conforms to current best practice in conducting clinical trials. © 2013 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

  6. Progression-free survival of early interim PET-positive patients with advanced stage Hodgkin's lymphoma treated with BEACOPPescalated alone or in combination with rituximab (HD18): an open-label, international, randomised phase 3 study by the German Hodgkin Study Group.

    PubMed

    Borchmann, Peter; Haverkamp, Heinz; Lohri, Andreas; Mey, Ulrich; Kreissl, Stefanie; Greil, Richard; Markova, Jana; Feuring-Buske, Michaela; Meissner, Julia; Dührsen, Ulrich; Ostermann, Helmut; Keller, Ulrich; Maschmeyer, Georg; Kuhnert, Georg; Dietlein, Markus; Kobe, Carsten; Eich, Hans; Baues, Christian; Stein, Harald; Fuchs, Michael; Diehl, Volker; Engert, Andreas

    2017-04-01

    Advanced stage Hodgkin's lymphoma represents a heterogeneous group of patients with different risk profiles. Data suggests that interim PET assessment during chemotherapy is superior to baseline international prognostic scoring in terms of predicting long-term treatment outcome in patients with Hodgkin's lymphoma. We therefore hypothesised that early interim PET-imaging after two courses of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP) might be suitable for guiding treatment in patients with advanced stage Hodgkin's lymphoma. We aimed to assess whether intensifying standard chemotherapy (BEACOPP escalated ) by adding rituximab would improve progression-free survival in patients with positive PET after two courses of chemotherapy. In this open-label, international, randomised, phase 3 study, we recruited patients aged 18-60 years with newly diagnosed, advanced stage Hodgkin's lymphoma from 160 hospitals and 77 private practices in Germany, Switzerland, Austria, the Netherlands, and the Czech Republic. Interim PET-imaging was done after two cycles of BEACOPP escalated and centrally assessed by an expert panel. Patients with a positive PET after 2 cycles of BEACOPP escalated chemotherapy (PET-2) were randomly assigned (1:1) to receive six additional courses of either BEACOPP escalated (BEACOPP escalated group) or BEACOPP escalated plus rituximab (R-BEACOPP escalated group). PET-2 was assessed using a 5-point scale with 18 FDG uptake higher than the mediastinal blood pool (corresponding to Deauville scale 3) defined as positive. BEACOPP escalated was given as previously described; rituximab was given intravenously at a dose of 375 mg/m 2 (maximum total dose 700 mg), the first administration starting 24 h before starting the fourth cycle of BEACOPP escalated (day 0 and day 3 in cycle 4, day 1 in cycles 5-8). Randomisation was done centrally and used the minimisation method including a random component, stratified according to centre, age, stage, international prognostic score, and sex. The primary efficacy endpoint was 5 year progression-free survival, analysed in the intention-to-treat population. We are reporting this second planned interim analysis as the final report of the trial. The trial is registered with ClinicalTrials.gov, number NCT00515554. Between May 14, 2008, and May 31, 2011, we enrolled 1100 patients. 440 patients had a positive PET-2 and were randomly assigned to either the BEACOPP escalated group (n=220) or the R-BEACOPP escalated group (n=220). With a median follow-up of 33 months (IQR 25-42) for progression-free survival, estimated 3 year progression-free survival was 91·4% (95% CI 87·0-95·7) for patients in the BEACOPP escalated group and 93·0% (89·4-96·6) for those in the R-BEACOPP escalated group (difference 1·6%, 95% CI -4·0 to 7·3; log rank p=0·99). Common grade 3-4 adverse events were leucopenia (207 [95%] of 218 patients in the BEACOPP escalated group vs 211 [96%] of 220 patients in the R-BEACOPP escalated group), and severe infections (51 [23%] vs 43 [20%] patients). Based on a futility analysis, the independent data monitoring committee recommended publication of this second planned interim analysis as the final result. Six (3%) of 219 patients in the BEACOPP escalated group and ten (5%) of 220 in the R-BEACOPP escalated group died; fatal treatment-related toxic effects occurred in one (<1%) patient in the BEACOPP escalated group and three (1%) in the R-BEACOPP escalated group, all of them due to infection. The addition of rituximab to BEACOPP escalated did not improve the progression-free survival of PET-2 positive patients with advanced stage Hodgkin's lymphoma. However, progression-free survival for PET-2 positive patients was much better than expected, exceeding even the outcome of PET-2-unselected patients in the previous HD15 trial. Thus, PET-2 cannot identify patients at high-risk for treatment failure in the context of the very effective German Hodgkin Study Group standard treatment for advanced stage Hodgkin's lymphoma. Deutsche Krebshilfe; Swiss State Secretariat for Education, Research and Innovation (SERI); and Roche Pharma. Copyright © 2017 Elsevier Ltd. All rights reserved.

  7. Interim Closure Activities at Corrective Action Unit 114: Area 25 EMAD Facility, Nevada National Security Site, Nevada

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

    Boehlecke, R. F.

    This letter report documents interim activities that have been completed at CAU 114 to support ongoing access and generate information necessary to plan future closure activities. General housekeeping and cleanup of debris was conducted in the EMAD yard, cold bays, support areas of Building 3900, and postmortem cell tunnel area of the hot bay. All non-asbestos ceiling tiles and loose and broken non-friable asbestos floor tiles were removed from support galleries and office areas. Non-radiologically contaminated piping and equipment in the cold areas of the building and in the two 120-ton locomotives in the yard were tapped, characterized, drained, andmore » verified free of contents.« less

  8. PROJECT W-551 DETERMINATION DATA FOR EARLY LAW INTERIM PRETREATMENT SYSTEM SELECTION

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

    TEDESCHI AR

    This report provides the detailed assessment forms and data for selection of the solids separation and cesium separation technology for project W-551, Interim Pretreatment System. This project will provide early pretreated low activity waste feed to the Waste Treatment Plant to allow Waste Treatment Plan Low Activity Waste facility operation prior to construction completion of the Pretreatment and High Level Waste facilities. The candidate solids separations technologies are rotary microfiltration and crossflow filtration, and the candidate cesium separation technologies are fractional crystallization, caustic-side solvent extraction, and ion-exchange using spherical resorcinol-formaldehyde resin. This data was used to prepare a cross-cutting technologymore » summary, reported in RPP-RPT-37740.« less

  9. Failsafe automation of Phase II clinical trial interim monitoring for stopping rules.

    PubMed

    Day, Roger S

    2010-02-01

    In Phase II clinical trials in cancer, preventing the treatment of patients on a study when current data demonstrate that the treatment is insufficiently active or too toxic has obvious benefits, both in protecting patients and in reducing sponsor costs. Considerable efforts have gone into experimental designs for Phase II clinical trials with flexible sample size, usually implemented by early stopping rules. The intended benefits will not ensue, however, if the design is not followed. Despite the best intentions, failures can occur for many reasons. The main goal is to develop an automated system for interim monitoring, as a backup system supplementing the protocol team, to ensure that patients are protected. A secondary goal is to stimulate timely recording of patient assessments. We developed key concepts and performance needs, then designed, implemented, and deployed a software solution embedded in the clinical trials database system. The system has been in place since October 2007. One clinical trial tripped the automated monitor, resulting in e-mails that initiated statistician/investigator review in timely fashion. Several essential contributing activities still require human intervention, institutional policy decisions, and institutional commitment of resources. We believe that implementing the concepts presented here will provide greater assurance that interim monitoring plans are followed and that patients are protected from inadequate response or excessive toxicity. This approach may also facilitate wider acceptance and quicker implementation of new interim monitoring algorithms.

  10. TRICARE; changes included in the National Defense Authorization Act for fiscal year 2005; TRICARE Dental Program. Interim final rule.

    PubMed

    2005-09-21

    The Department is publishing this interim final rule to implement sections 711 and 715 of the Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005 (NDAA-05), Public Law 108-375. Specifically, that legislation makes young dependents of deceased Service members eligible for enrollment in the TRICARE Dental Program when the child was not previously enrolled because of age, and authorizes post-graduate dental residents in a dental treatment facility of the uniformed services under a graduate dental education program accredited by the American Dental Association to provide dental treatment to dependents who are 12 years of age or younger and who are covered by a dental plan established under 10 U.S.C. 1076a. This rule also corrects certain references in 32 CFR 199.13. The rule is being published as an interim final rule with comment period in order to comply with statutory effective dates. Public comments are invited and will be considered for possible revisions to the final rule.

  11. 78 FR 63388 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Dayton-Springfield...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-24

    ...-2018) Point 2.06 2.28 2.70 Area 2.92 2.81 2.90 Onroad 4.88 4.15 1.93 Nonroad 1.17 0.96 0.77 Total 11.03...* Interim Maintenance reduction (2004-2018) Point 1.15 1.25 1.26 Area 3.06 2.91 2.91 Onroad 5.62 4.83 2.14...-Springfield area's ozone maintenance plan established 2005 and 2018 budgets. The Toledo area and the Ohio...

  12. Conditional estimation using prior information in 2-stage group sequential designs assuming asymptotic normality when the trial terminated early.

    PubMed

    Shimura, Masashi; Maruo, Kazushi; Gosho, Masahiko

    2018-04-23

    Two-stage designs are widely used to determine whether a clinical trial should be terminated early. In such trials, a maximum likelihood estimate is often adopted to describe the difference in efficacy between the experimental and reference treatments; however, this method is known to display conditional bias. To reduce such bias, a conditional mean-adjusted estimator (CMAE) has been proposed, although the remaining bias may be nonnegligible when a trial is stopped for efficacy at the interim analysis. We propose a new estimator for adjusting the conditional bias of the treatment effect by extending the idea of the CMAE. This estimator is calculated by weighting the maximum likelihood estimate obtained at the interim analysis and the effect size prespecified when calculating the sample size. We evaluate the performance of the proposed estimator through analytical and simulation studies in various settings in which a trial is stopped for efficacy or futility at the interim analysis. We find that the conditional bias of the proposed estimator is smaller than that of the CMAE when the information time at the interim analysis is small. In addition, the mean-squared error of the proposed estimator is also smaller than that of the CMAE. In conclusion, we recommend the use of the proposed estimator for trials that are terminated early for efficacy or futility. Copyright © 2018 John Wiley & Sons, Ltd.

  13. Evaluation of ERA-interim and MERRA Cloudiness in the Southern Oceans

    NASA Technical Reports Server (NTRS)

    Naud, Catherine M.; Booth, James F.; Del Genio, Anthony D.

    2014-01-01

    The Southern Ocean cloud cover modeled by the Interim ECMWF Re-Analysis (ERA-Interim) and Modern- Era Retrospective Analysis for Research and Applications (MERRA) reanalyses are compared against Moderate Resolution Imaging Spectroradiometer (MODIS) and Multiangle Imaging Spectroradiometer (MISR) observations. ERA-Interim monthly mean cloud amounts match the observations within 5%, while MERRA significantly underestimates the cloud amount. For a compositing analysis of clouds in warm season extratropical cyclones, both reanalyses show a low bias in cloud cover. They display a larger bias to the west of the cyclones in the region of subsidence behind the cold fronts. This low bias is larger for MERRA than for ERA-Interim. Both MODIS and MISR retrievals indicate that the clouds in this sector are at a low altitude, often composed of liquid, and of a broken nature. The combined CloudSat-Cloud-Aerosol Lidar and Infrared Pathfinder Satellite Observations (CALIPSO) cloud profiles confirm these passive observations, but they also reveal that low-level clouds in other parts of the cyclones are also not properly represented in the reanalyses. The two reanalyses are in fairly good agreement for the dynamic and thermodynamic characteristics of the cyclones, suggesting that the cloud, convection, or boundary layer schemes are the problem instead. An examination of the lower-tropospheric stability distribution in the cyclones from both reanalyses suggests that the parameterization of shallow cumulus clouds may contribute in a large part to the problem. However, the differences in the cloud schemes and in particular in the precipitation processes, which may also contribute, cannot be excluded.

  14. Different predictive values of interim 18F-FDG PET/CT in germinal center like and non-germinal center like diffuse large B-cell lymphoma.

    PubMed

    Kim, Jihyun; Lee, Jeong-Ok; Paik, Jin Ho; Lee, Won Woo; Kim, Sang Eun; Song, Yoo Sung

    2017-01-01

    Diffuse large B-cell lymphoma (DLBCL) is a pathologically heterogeneous disease with different prognoses according to its molecular profiles. Despite the broad usage of 18 F-fluoro-2-dexoxy-D-glucose (FDG) positron emission tomography/computed tomography (PET/CT), previous studies that have investigated the value of interim 18 F-FDG PET/CT in DLBCL have given the controversial results. The purpose of this study was to evaluate the prognostic value of interim 18 F-FDG PET/CT in DLBCL according to germinal center B cell-like (GCB) and non-GCB molecular profiling. We enrolled 118 newly diagnosed DLBCL patients treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP). Interim 18 F-FDG PET/CT scans performed after 2 or 3 cycles of R-CHOP treatment were evaluated based on the Lugano response criteria. Patients were grouped as GCB or non-GCB molecular subtypes according to immunohistochemistry results of CD10, BCL6, and MUM1, based on Hans' algorithm. In total 118 DLBCL patients, 35 % were classified as GCB, and 65 % were classified as non-GCB. Interim PET/CT was negative in 70 %, and positive in 30 %. During the median follow-up period of 23 months, the positive interim 18 F-FDG PET/CT group showed significantly inferior progression free survival (PFS) compared to the negative interim 18 F-FDG PET/CT group (P = 0.0004) in entire patients. A subgroup analysis according to molecular profiling demonstrated significant difference of PFS between the positive and negative interim 18 F-FDG PET groups in GCB subtype of DLBCL (P = 0.0001), but there was no significant difference of PFS between the positive and negative interim 18 F-FDG PET groups in non-GCB subtype of DLBCL. Interim 18 F-FDG PET/CT scanning had a significant predictive value for disease progression in patients with the GCB subtype of DLBCL treated with R-CHOP, but not in those with the non-GCB subtype. Therefore, molecular profiles of DLBCL should be considered for interim 18 F-FDG PET/CT practice.

  15. Validation of the maximum allowable amounts of recycled binder, RAP, and RAS using accelerated pavement testing - interim report.

    DOT National Transportation Integrated Search

    2014-05-01

    This report summarizes the work conducted on Project 0-6682 up to August 31, 2013. The report is : organized in five chapters corresponding to separate tasks in the project work plan, as follows: : Chapter 1 presents the summary of the findings f...

  16. 40 CFR 799.9346 - TSCA 90-day inhalation toxicity.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) should be used for each test group. (B) If interim sacrifices are planned, the number of animals shall be... substantially alter the chemical or toxicological properties of the test substance. (ii) One lot of the test... control group. Except for treatment with the test substance, animals in the control group shall be handled...

  17. 40 CFR 799.9346 - TSCA 90-day inhalation toxicity.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) should be used for each test group. (B) If interim sacrifices are planned, the number of animals shall be... substantially alter the chemical or toxicological properties of the test substance. (ii) One lot of the test... control group. Except for treatment with the test substance, animals in the control group shall be handled...

  18. 40 CFR 799.9346 - TSCA 90-day inhalation toxicity.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) should be used for each test group. (B) If interim sacrifices are planned, the number of animals shall be... substantially alter the chemical or toxicological properties of the test substance. (ii) One lot of the test... control group. Except for treatment with the test substance, animals in the control group shall be handled...

  19. 40 CFR 799.9346 - TSCA 90-day inhalation toxicity.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) should be used for each test group. (B) If interim sacrifices are planned, the number of animals shall be... substantially alter the chemical or toxicological properties of the test substance. (ii) One lot of the test... control group. Except for treatment with the test substance, animals in the control group shall be handled...

  20. 40 CFR 799.9346 - TSCA 90-day inhalation toxicity.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) should be used for each test group. (B) If interim sacrifices are planned, the number of animals shall be... substantially alter the chemical or toxicological properties of the test substance. (ii) One lot of the test... control group. Except for treatment with the test substance, animals in the control group shall be handled...

  1. 77 FR 29884 - Assessment of Fees on Large Bank Holding Companies and Nonbank Financial Companies Supervised by...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-21

    ... the development of policies, procedures, rules, and regulations and other planning activities of the... holding companies and foreign banking organizations; the interim final rule applies to nonbank financial... determination date. Foreign banking organizations that have eligible assets of $50 billion or more will be...

  2. 29 CFR 1952.242 - Completed developmental steps.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false Completed developmental steps. 1952.242 Section 1952.242... Completed developmental steps. (a) In accordance with § 1952.243(d) Alaska completed its interim training... completed on or before October 1, 1976, all developmental steps specified in the plan as approved on July 31...

  3. 76 FR 56507 - Availability of Information, Public Observation of Meetings, Procedure, Practice for Hearings...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-13

    ... to issue orders) with respect to the supervision of SLHCs and their non-depository subsidiaries... notice of intent also advised that the Board would issue an interim final rule to effectuate the... elimination of requirements in OTS rules for prefiling meetings and submission of draft business plans, and...

  4. 75 FR 69917 - New NOAA Cooperative Institutes (CIs): (1) A Cooperative Institute To Improve Mesoscale and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-16

    ... described in the proposal? Is there a well-developed business plan that includes fiscal and human resource... the Area of Marine Resources AGENCY: Oceanic and Atmospheric Research (OAR), National Oceanic and... resources. Applicants should review the CI Interim Handbook prior to preparing a proposal for this...

  5. Kennedy Space Center Press Site (SWMU 074) Interim Measure Report

    NASA Technical Reports Server (NTRS)

    Applegate, Joseph L.

    2015-01-01

    This report summarizes the Interim Measure (IM) activities conducted at the Kennedy Space Center (KSC) Press Site ("the Press Site"). This facility has been designated as Solid Waste Management Unit 074 under KSC's Resource Conservation and Recovery Act Corrective Action program. The activities were completed as part of the Vehicle Assembly Building (VAB) Area Land Use Controls Implementation Plan (LUCIP) Elimination Project. The purpose of the VAB Area LUCIP Elimination Project was to delineate and remove soil affected with constituents of concern (COCs) that historically resulted in Land Use Controls (LUCs). The goal of the project was to eliminate the LUCs on soil. LUCs for groundwater were not addressed as part of the project and are not discussed in this report. This report is intended to meet the Florida Department of Environmental Protection (FDEP) Corrective Action Management Plan requirement as part of the KSC Hazardous and Solid Waste Amendments permit and the U.S. Environmental Protection Agency's (USEPA's) Toxic Substance Control Act (TSCA) self-implementing polychlorinated biphenyl (PCB) cleanup requirements of 40 Code of Federal Regulations (CFR) 761.61(a).

  6. Trends in study design and the statistical methods employed in a leading general medicine journal.

    PubMed

    Gosho, M; Sato, Y; Nagashima, K; Takahashi, S

    2018-02-01

    Study design and statistical methods have become core components of medical research, and the methodology has become more multifaceted and complicated over time. The study of the comprehensive details and current trends of study design and statistical methods is required to support the future implementation of well-planned clinical studies providing information about evidence-based medicine. Our purpose was to illustrate study design and statistical methods employed in recent medical literature. This was an extension study of Sato et al. (N Engl J Med 2017; 376: 1086-1087), which reviewed 238 articles published in 2015 in the New England Journal of Medicine (NEJM) and briefly summarized the statistical methods employed in NEJM. Using the same database, we performed a new investigation of the detailed trends in study design and individual statistical methods that were not reported in the Sato study. Due to the CONSORT statement, prespecification and justification of sample size are obligatory in planning intervention studies. Although standard survival methods (eg Kaplan-Meier estimator and Cox regression model) were most frequently applied, the Gray test and Fine-Gray proportional hazard model for considering competing risks were sometimes used for a more valid statistical inference. With respect to handling missing data, model-based methods, which are valid for missing-at-random data, were more frequently used than single imputation methods. These methods are not recommended as a primary analysis, but they have been applied in many clinical trials. Group sequential design with interim analyses was one of the standard designs, and novel design, such as adaptive dose selection and sample size re-estimation, was sometimes employed in NEJM. Model-based approaches for handling missing data should replace single imputation methods for primary analysis in the light of the information found in some publications. Use of adaptive design with interim analyses is increasing after the presentation of the FDA guidance for adaptive design. © 2017 John Wiley & Sons Ltd.

  7. Comparison of a real-time PCR method with a culture method for the detection of Salmonella enterica serotype enteritidis in naturally contaminated environmental samples from integrated poultry houses.

    PubMed

    Lungu, Bwalya; Waltman, W Douglas; Berghaus, Roy D; Hofacre, Charles L

    2012-04-01

    Conventional culture methods have traditionally been considered the "gold standard" for the isolation and identification of foodborne bacterial pathogens. However, culture methods are labor-intensive and time-consuming. A Salmonella enterica serotype Enteritidis-specific real-time PCR assay that recently received interim approval by the National Poultry Improvement Plan for the detection of Salmonella Enteritidis was evaluated against a culture method that had also received interim National Poultry Improvement Plan approval for the analysis of environmental samples from integrated poultry houses. The method was validated with 422 field samples collected by either the boot sock or drag swab method. The samples were cultured by selective enrichment in tetrathionate broth followed by transfer onto a modified semisolid Rappaport-Vassiliadis medium and then plating onto brilliant green with novobiocin and xylose lysine brilliant Tergitol 4 plates. One-milliliter aliquots of the selective enrichment broths from each sample were collected for DNA extraction by the commercial PrepSEQ nucleic acid extraction assay and analysis by the Salmonella Enteritidis-specific real-time PCR assay. The real-time PCR assay detected no significant differences between the boot sock and drag swab samples. In contrast, the culture method detected a significantly higher number of positive samples from boot socks. The diagnostic sensitivity of the real-time PCR assay for the field samples was significantly higher than that of the culture method. The kappa value obtained was 0.46, indicating moderate agreement between the real-time PCR assay and the culture method. In addition, the real-time PCR method had a turnaround time of 2 days compared with 4 to 8 days for the culture method. The higher sensitivity as well as the reduction in time and labor makes this real-time PCR assay an excellent alternative to conventional culture methods for diagnostic purposes, surveillance, and research studies to improve food safety.

  8. A Process Evaluation of Project Developmental Continuity. Interim Report VI: Executive Summary. Recommendations for Continuing the Impact Study.

    ERIC Educational Resources Information Center

    Granville, Arthur C.; Love, John M.

    This brief report summarizes the analysis and conclusions presented in detail in Interim Report VI regarding the feasibility of conducting a longitudinal study of Project Developmental Continuity (PDC). This project is a Head Start demonstration program aimed at providing educational and developmental continuity between children's Head Start and…

  9. Effect of Naproxen Prophylaxis on Heterotopic Ossification Following Hip Arthroscopy: A Double-Blind Randomized Placebo-Controlled Trial.

    PubMed

    Beckmann, James T; Wylie, James D; Potter, Michael Q; Maak, Travis G; Greene, Thomas H; Aoki, Stephen K

    2015-12-16

    Heterotopic ossification (HO) is a known complication of hip arthroscopy. Our objective was to determine the effect of postoperative naproxen therapy on the development of HO following arthroscopic surgery for femoroacetabular impingement. Between August 2011 and April 2013, 108 eligible patients were enrolled and randomized to take naproxen or a placebo for three weeks postoperatively. Radiographs were made at routine follow-up visits for one year following surgery. The primary outcome measure was the development of HO, as classified with the Brooker criteria and two-dimensional measurements on radiographs made at least seventy-five days postoperatively (average, 322 days). The primary analysis, performed with a Fisher exact test, compared the proportion of subjects with HO between the treatment and control groups. A single a priori interim analysis was planned at the midpoint of the study. Our data safety and monitoring board stopped this study when the interim analysis showed that the stopping criterion had been met for demonstration of efficacy of the naproxen intervention. The prevalence of HO was 46% (twenty-two of the forty-eight in the final analysis) in the placebo group versus 4% (two of forty-eight) in the naproxen group (p < 0.001). Medication compliance was 69% overall, but it did not differ between the naproxen and placebo groups. Minor adverse reactions to the study medications were reported in 42% of the patients taking naproxen versus 35% of those taking the placebo (p = 0.45). In this trial, prophylaxis with naproxen was effective in reducing the prevalence of HO without medication-related morbidity. Copyright © 2015 by The Journal of Bone and Joint Surgery, Incorporated.

  10. National NIF Diagnostic Program Fiscal Year 2002 Second Quarter Report

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

    MacGowan, B

    Since October 2001 the development of the facility diagnostics for NIF has been funded by the NIF Director through the National NIF Diagnostic Program (NNDP). The current emphasis of the NNDP is on diagnostics for the early NIF quad scheduled to be available for experiment commissioning in FY03. During the past six months the NNDP has set in place processes for funding diagnostics, developing requirements for diagnostics, design reviews and monthly status reporting. Those processes are described in an interim management plan for diagnostics (''National NIF Diagnostic Program Interim Plan'', NIF-0081315, April 2002) and a draft Program Execution Plan (''Programmore » Execution Plan for the National NlF Diagnostic Program'', NIF-0072083, October 2001) and documents cited therein. Work has been funded at Lawrence Livermore National Laboratory (LLNL), Los Alamos National Laboratory (LANL), Naval Research Laboratory (NRL), Sandia National Laboratories (SNL), Bechtel Nevada at Los Alamos and Santa Barbara. There are no major technical risks with the early diagnostics. The main concerns relate to integration of the diagnostics into the facility, all such issues are being worked. This report is organized to show the schedule and budget status and a summary of Change Control Board actions for the past six months. The following sections then provide short descriptions of the status of each diagnostic. Where design reviews or requirements documents are cited, the documents are available on the Diagnostics file server or on request.« less

  11. A global validation of ERA-Interim integrated water vapor estimates using ground-based GNSS observations

    NASA Astrophysics Data System (ADS)

    Ahmed, F.; Dousa, J.; Hunegnaw, A.; Teferle, F. N.; Bingley, R.

    2017-12-01

    Integrated water vapor (IWV) derived from climate reanalysis models, such as the European Centre for Medium-range Weather Forecasts (ECMWF) ReAnalysis-Interim (ERA-Interim), is widely used in many atmospheric applications. Therefore, it is of interest to assess the quality of this reanalysis product using available observations. Observations from Global Navigation Satellite Systems (GNSS) are, as of now, available for a period of over 2 decades and their global availability makes it possible to validate the IWV obtained from climate reanalysis models in different geographical and climatic regions. In this study, primarily, three 5-year long homogeneously reprocessed GNSS-derived IWV datasets containing over 400 globally distributed ground-based GNSS stations have been used to validate the IWV estimates obtained from the ERA-Interim climate reanalysis model in 25 different climate zones. The IWV from ERA-Interim has been obtained by vertically integrating the specific humidity at all model levels above the locations of GNSS stations. It has been studied how the difference between the ERA-Interim IWV and the GNSS-derived IWV varies with respect to the different climate zones as well as with respect to the difference in the model orography and latitude. The results show a dependence of the ability of ERA-Interim to model the IWV on difference in climate types and latitude. This dependence, however, is dictated by the concentration of water vapor in different climate zones and at different latitudes. Furthermore, as a secondary focus of this study, the weighted mean atmospheric temperature (Tm) obtained from ERA-Interim has been compared to its equivalent obtained using two widely used approximations globally.

  12. Interim reliability-evaluation program: analysis of the Browns Ferry, Unit 1, nuclear plant. Appendix C - sequence quantification

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

    Mays, S.E.; Poloski, J.P.; Sullivan, W.H.

    1982-07-01

    This report describes a risk study of the Browns Ferry, Unit 1, nuclear plant. The study is one of four such studies sponsored by the NRC Office of Research, Division of Risk Assessment, as part of its Interim Reliability Evaluation Program (IREP), Phase II. This report is contained in four volumes: a main report and three appendixes. Appendix C generally describes the methods used to estimate accident sequence frequency values. Information is presented concerning the approach, example collection, failure data, candidate dominant sequences, uncertainty analysis, and sensitivity analysis.

  13. Global Spent Fuel Logistics Systems Study (GSFLS). Volume 2. GSFLS visit findings and evaluations. Interim report

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

    None

    1978-01-31

    This report is a part of the interim report documentation for the Global Spent Fuel Logistics System (GSFLS) study. This report describes a global framework that evaluates spent fuel disposition requirements, influencing factors and strategies. A broad sampling of foreign governmental officials, electric utility spokesmen and nuclear power industry officials responsible for GSFLS policies, plans and programs were surveyed as to their views with respect to national and international GSFLS related considerations. The results of these GSFLS visit findings are presented herein. These findings were then evaluated in terms of technical, institutional and legal/regulatory implications. The GSFLS evaluations, in conjunctionmore » with perceived US spent fuel objectives, formed the basis for selecting a set of GSFLS strategies which are reported herein.« less

  14. Have first-time medical school deans been serving longer than we thought? A 50-year analysis.

    PubMed

    Keyes, Joseph A; Alexander, Hershel; Jarawan, Hani; Mallon, William T; Kirch, Darrell G

    2010-12-01

    To describe the lengths of service of deans at accredited U.S. MD-granting medical schools from academic years 1959 to 2008 and to determine whether the median length of service of deans changed over time. The authors used the database of the Council of Deans of the Association of American Medical Colleges to seek data, from July 1, 1959 to June 30, 2009, on lengths of service of 842 deans and interim deans at all 125 accredited U.S. MD-granting medical schools existing in 2007. All but 8 schools verified their data, which included the date of the beginning of service, the date of the end of service, and whether the individual served in a permanent or interim capacity. Across five-year cohorts of the first-time deans and interim deans studied, the median length of service was 4.4 years. When the authors excluded individuals who were interim deans exclusively and focused the analysis on the 639 persons who were "permanent" deans, the median length of service was 6.0 years across five-year cohorts. Analysis of one-year cohorts of deans showed similar results (median = 6.1 years), although the medians for six of the seven most recent one-year cohorts ranged from 5.0 to 5.7 years. Through cohort analysis, the median length of service of permanent medical school deans was longer than that found in previous studies, and it has remained relatively stable.

  15. A Process Evaluation of Project Developmental Continuity, Interim Report VII, Volume 1: Findings from the PDC Implementation Study.

    ERIC Educational Resources Information Center

    Smith, Allen G.; And Others

    This third year interim report, one of a series of documents on the evaluation of Project Developmental Continuity (PDC), presents findings from three major analyses of program implementation; measurement of the extent each program has implemented the basic PDC Guidelines; a description of patterns of that implementation; and analysis of some…

  16. Comparisons of Cooperative and Non-Cooperative Students: An Analysis of Student Accounting System Data. Interim Report, June, 1981.

    ERIC Educational Resources Information Center

    Frazier, Don

    The major purpose of this study was to identify unique effects of cooperative vocational education. This interim report is of results of the analyses of existing data bases. Comparisons of cooperative and non-cooperative vocational programs are made on the following variables: enrollments by age, sex and race, school status, work status,…

  17. National Home Start Evaluation Interim Report VII. Twenty-Month Program Analysis and Findings.

    ERIC Educational Resources Information Center

    Love, John M.; And Others

    This interim evaluation report focuses on process (formative) and outcome (summative) data collected in spring 1975 on the National Home Start Program. Home Start, a federally-funded 3-year (1972-1975) home-based demonstration program for low-income families with 3- to 5-year-old children was designed to enhance a mother's skills in dealing with…

  18. Job Training for the Homeless: Report on Demonstration's First Year. Research and Evaluation Report Series 91-F.

    ERIC Educational Resources Information Center

    Bailis, Lawrence N.; And Others

    An interim evaluation analyzed the first year of operation of the Job Training for the Homeless Demonstration Program (JTHDP). Data were collected from quarterly progress reports and evaluation reports submitted by 32 local JTHDP projects. The projects exceeded planned levels of clients served and achieved other positive outcomes, including…

  19. Occupational Component. 26-Level Courses. Teacher Resource Manual. Integrated Occupational Program. Interim-1991: Curriculum.

    ERIC Educational Resources Information Center

    Alberta Dept. of Education, Edmonton. Curriculum Branch.

    This planning and instructional manual is designed to assist teachers in implementing the 20 10-credit-hour courses that make up the 26-level occupational component of the Integrated Occupational Program (IOP) in Alberta, Canada. (The IOP was developed to assist students who experience difficulties in secondary education and to help students make…

  20. 40 CFR 266.103 - Interim status standards for burners.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... complying with the CO controls of § 266.104(c), the CO limit is established based on the compliance test... testing planned, including a complete copy of the test protocol and Quality Assurance/Quality Control (QA...; (vi) In subpart G (Closure and post-closure), §§ 265.111-265.115; (vii) In subpart H (Financial...

  1. 40 CFR 266.103 - Interim status standards for burners.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... complying with the CO controls of § 266.104(c), the CO limit is established based on the compliance test... testing planned, including a complete copy of the test protocol and Quality Assurance/Quality Control (QA...; (vi) In subpart G (Closure and post-closure), §§ 265.111-265.115; (vii) In subpart H (Financial...

  2. 40 CFR 266.103 - Interim status standards for burners.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... complying with the CO controls of § 266.104(c), the CO limit is established based on the compliance test... testing planned, including a complete copy of the test protocol and Quality Assurance/Quality Control (QA...; (vi) In subpart G (Closure and post-closure), §§ 265.111-265.115; (vii) In subpart H (Financial...

  3. 40 CFR 266.103 - Interim status standards for burners.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... complying with the CO controls of § 266.104(c), the CO limit is established based on the compliance test... testing planned, including a complete copy of the test protocol and Quality Assurance/Quality Control (QA...; (vi) In subpart G (Closure and post-closure), §§ 265.111-265.115; (vii) In subpart H (Financial...

  4. 40 CFR 266.103 - Interim status standards for burners.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... complying with the CO controls of § 266.104(c), the CO limit is established based on the compliance test... testing planned, including a complete copy of the test protocol and Quality Assurance/Quality Control (QA...; (vi) In subpart G (Closure and post-closure), §§ 265.111-265.115; (vii) In subpart H (Financial...

  5. 78 FR 14533 - Official Release of EMFAC2011 Motor Vehicle Emission Factor Model for Use in the State of California

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-06

    ... testing of interim versions of the model with air districts and Metropolitan Planning Organizations (MPOs... Motor Vehicle Emission Factor Model for Use in the State of California AGENCY: Environmental Protection... of the latest version of the California EMFAC model (short for EMission FACtor) for use in state...

  6. A Guide for Planning Facilities for Occupational Preparation Programs in Metallurgy Technology. Interim Report. Research 28.

    ERIC Educational Resources Information Center

    German, Carl, Jr.

    The major purpose of this guide is to elicit the information necessary for writing educational specifications for facilities to house technical education programs in metallurgy. It is organized in these parts: (1) Part I discusses the major purpose, underlying assumptions, recent instructional trends, and guiding principles utilized in the…

  7. Using Scientific Information to Develop Management Strategies for Commercial Redwood Timberlands

    Treesearch

    Jeffrey C. Barrett

    2007-01-01

    In 1999, PALCO (Pacific Lumber Company), a private landowner, and the state and federal governments agreed to implement a unique Habitat Conservation Plan (HCP) on 89,000 hectares of commercial redwood and Douglas-fir timberlands in Humboldt County, California. The aquatics portion of the PALCO HCP contains a set of "interim" conservation strategies developed...

  8. 75 FR 43329 - Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Internal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-23

    ... circumstances and, in such cases, the State process must provide notice of the decision as expeditiously as... by the Secretary of Labor. Similarly, with respect to internal claims and appeals processes for... incorporate additional consumer protections so that the State process will continue to apply after the end of...

  9. Multiple Alternatives for Educational Evaluation and Decision-Making. Interim Draft. Paper and Report Series No. 72.

    ERIC Educational Resources Information Center

    Wholeben, Brent E.

    This volume is an exposition of a mathematical modeling technique for use in the evaluation and solution of complex educational problems at all levels. It explores in detail the application of simple algebraic techniques to such issues as program reduction, fiscal rollbacks, and computer curriculum planning. Part I ("Introduction to the…

  10. Extended-Day Kindergarten versus Half-Day Kindergarten: What One School District Decided.

    ERIC Educational Resources Information Center

    Firlik, Russell

    The New Canaan Public Schools reduced its extended-day (21 hours per week) kindergarten program to half-day sessions (15 hours per week) in an interim program during a 2-year school construction-expansion phase. During a 9-month planning process, an ad hoc committee representing equal membership of teachers and parents from three elementary…

  11. Draft Final Decision Document for the North Boundary System Improvements Interim Response Action at the Rocky Mountain Arsenal

    DTIC Science & Technology

    1989-04-01

    and Safety Plan has been developed for the prevention of occupational injuries and illnesses during field activities at RMA. This plan addresses...totaltriThelomethanes radmiutm CD 10(1) 5 .13)* 10(4 Larbon tetrachloride CCL4 0(3)5.4 ’tordane CDN0.004(l) 0.00046(5) CLI3oride CL 250,000(l...numerous carcinogenicity tests in a variety of animals indicate that dieldrin promotes only liver tumors and the tumors develop only in mice. On the basis of

  12. Traffic data collection for transportation planning in the Dallas-Fort Worth area. Interim research report, January 1994-July 1995

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

    Perkinson, D.G.; Dresser, G.B.

    1995-07-01

    The Texas Transportation Institute (TTI), under a contract with the Dallas District of the Texas Department of Transportation (TxDOT), provided traffic data for the North Central Texas Council of Governments (NCTOG) for their transportation planning in the Dallas-Fort Worth area. This effort included volume counts, vehicle classification counts, and speed data for 23 urban corridors in the area. In addition, external station volume counts were collected for 32 external stations, and journey travel time data were collected for nine activity centers.

  13. Optimal Futility Interim Design: A Predictive Probability of Success Approach with Time-to-Event Endpoint.

    PubMed

    Tang, Zhongwen

    2015-01-01

    An analytical way to compute predictive probability of success (PPOS) together with credible interval at interim analysis (IA) is developed for big clinical trials with time-to-event endpoints. The method takes account of the fixed data up to IA, the amount of uncertainty in future data, and uncertainty about parameters. Predictive power is a special type of PPOS. The result is confirmed by simulation. An optimal design is proposed by finding optimal combination of analysis time and futility cutoff based on some PPOS criteria.

  14. Predictive probability methods for interim monitoring in clinical trials with longitudinal outcomes.

    PubMed

    Zhou, Ming; Tang, Qi; Lang, Lixin; Xing, Jun; Tatsuoka, Kay

    2018-04-17

    In clinical research and development, interim monitoring is critical for better decision-making and minimizing the risk of exposing patients to possible ineffective therapies. For interim futility or efficacy monitoring, predictive probability methods are widely adopted in practice. Those methods have been well studied for univariate variables. However, for longitudinal studies, predictive probability methods using univariate information from only completers may not be most efficient, and data from on-going subjects can be utilized to improve efficiency. On the other hand, leveraging information from on-going subjects could allow an interim analysis to be potentially conducted once a sufficient number of subjects reach an earlier time point. For longitudinal outcomes, we derive closed-form formulas for predictive probabilities, including Bayesian predictive probability, predictive power, and conditional power and also give closed-form solutions for predictive probability of success in a future trial and the predictive probability of success of the best dose. When predictive probabilities are used for interim monitoring, we study their distributions and discuss their analytical cutoff values or stopping boundaries that have desired operating characteristics. We show that predictive probabilities utilizing all longitudinal information are more efficient for interim monitoring than that using information from completers only. To illustrate their practical application for longitudinal data, we analyze 2 real data examples from clinical trials. Copyright © 2018 John Wiley & Sons, Ltd.

  15. A Process Evaluation of Project Developmental Continuity, Interim Report VII, Volume 3: Assessment of Program Impact Through the Head Start Year.

    ERIC Educational Resources Information Center

    Granville, Arthur C.; And Others

    This interim report, part of a series of documents examining the feasibility of the longitudinal evaluation of Project Developmental Continuity (PDC), presents the results of an analysis of PDC impact at the Head Start level, using Spring 1977 data. PDC is a Head Start Demonstration Program aimed at providing educational and developmental…

  16. Effectiveness Monitoring Report, MWMF Tritium Phytoremediation Interim Measures.

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

    Hitchcock, Dan; Blake, John, I.

    2003-02-10

    This report describes and presents the results of monitoring activities during irrigation operations for the calendar year 2001 of the MWMF Interim Measures Tritium Phytoremediation Project. The purpose of this effectiveness monitoring report is to provide the information on instrument performance, analysis of CY2001 measurements, and critical relationships needed to manage irrigation operations, estimate efficiency and validate the water and tritium balance model.

  17. Planning and supervision of reactor defueling using discrete event techniques

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

    Garcia, H.E.; Imel, G.R.; Houshyar, A.

    1995-12-31

    New fuel handling and conditioning activities for the defueling of the Experimental Breeder Reactor II are being performed at Argonne National Laboratory. Research is being conducted to investigate the use of discrete event simulation, analysis, and optimization techniques to plan, supervise, and perform these activities in such a way that productivity can be improved. The central idea is to characterize this defueling operation as a collection of interconnected serving cells, and then apply operational research techniques to identify appropriate planning schedules for given scenarios. In addition, a supervisory system is being developed to provide personnel with on-line information on themore » progress of fueling tasks and to suggest courses of action to accommodate changing operational conditions. This paper provides an introduction to the research in progress at ANL. In particular, it briefly describes the fuel handling configuration for reactor defueling at ANL, presenting the flow of material from the reactor grid to the interim storage location, and the expected contributions of this work. As an example of the studies being conducted for planning and supervision of fuel handling activities at ANL, an application of discrete event simulation techniques to evaluate different fuel cask transfer strategies is given at the end of the paper.« less

  18. Transcranial laser therapy in acute stroke treatment: results of neurothera effectiveness and safety trial 3, a phase III clinical end point device trial.

    PubMed

    Hacke, Werner; Schellinger, Peter D; Albers, Gregory W; Bornstein, Natan M; Dahlof, Bjorn L; Fulton, Rachael; Kasner, Scott E; Shuaib, Ashfaq; Richieri, Steven P; Dilly, Stephen G; Zivin, Justin; Lees, Kennedy R

    2014-11-01

    On the basis of phase II trials, we considered that transcranial laser therapy could have neuroprotective effects in patients with acute ischemic stroke. We studied transcranial laser therapy in a double-blind, sham-controlled randomized clinical trial intended to enroll 1000 patients with acute ischemic stroke treated ≤24 hours after stroke onset and who did not undergo thrombolytic therapy. The primary efficacy measure was the 90-day functional outcome as assessed by the modified Rankin Scale, with hierarchical Bayesian analysis incorporating relevant previous data. Interim analyses were planned after 300 and 600 patients included. The study was terminated on recommendation by the Data Monitoring Committee after a futility analysis of 566 completed patients found no difference in the primary end point (transcranial laser therapy 140/282 [49.6%] versus sham 140/284 [49.3%] for good functional outcome; modified Rankin Scale, 0-2). The results remained stable after inclusion of all 630 randomized patients (adjusted odds ratio, 1.024; 95% confidence interval, 0.705-1.488). Once the results of the interim futility analysis became available, all study support was immediately withdrawn by the capital firms behind PhotoThera, and the company was dissolved. Proper termination of the trial was difficult but was finally achieved through special efforts by former employees of PhotoThera, the CRO Parexel and members of the steering and the safety committees. We conclude that transcranial laser therapy does not have a measurable neuroprotective effect in patients with acute ischemic stroke when applied within 24 hours after stroke onset. http://www.clinicaltrials.gov. Unique identifier: NCT01120301. © 2014 American Heart Association, Inc.

  19. A Process Evaluation of Project Developmental Continuity. Interim Report II, Part A: Program Case Studies. Volume 2.

    ERIC Educational Resources Information Center

    Spencer, Lynn, Ed.

    These 7 case studies are part of a series of documents on the evaluation of Project Developmental Continuity (PDC), a Head Start demonstration program aimed at providing educational and developmental continuity between children's Head Start and primary school experiences. Each case study reviews the planning year at a PDC demonstration site in one…

  20. A Process Evaluation of Project Developmental Continuity. Interim Report II, Part A: Program Case Studies. Volume I.

    ERIC Educational Resources Information Center

    Spencer, Lynn, Ed.

    These 8 case studies are part of a series of documents on the evaluation of Project Developmental Continuity (PDC), a Head Start demonstration program aimed at providing educational and developmental continuity between children's Head Start and primary school experiences. Each case study reviews the planning year at a PDC demonstration site in one…

  1. Consortium for Planning, Developing, and Implementing Exploratory Industrial Career Development Models (Phase I of Three Phases). Interim Report.

    ERIC Educational Resources Information Center

    Oregon State Univ., Corvallis.

    The report describes the organizational phase of a project designed to create program models and supporting literature for exploratory industrial career development programs for grades seven to ten. The project was undertaken by Oregon State University in cooperation with the Oregon State Department of Education and involved the formation of a…

  2. 78 FR 48323 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Update of the Motor...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-08

    ... and VOCs for the years 2009 (interim year) and 2018 (maintenance year) that were produced using the... approved MOBILE6.2-based MVEBs for the years 2009 and 2018 is provided in Table 2. Even though there is an...) and maintenance (2018) years are significantly less than the attainment year emissions, which is the...

  3. 40 CFR 52.875 - Original identification of plan section.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... applicable to stationary sources subject to prevention of significant deterioration (PSD) permit requirements... interim stack height policy for each PSD permit issued until such time as EPA revises its general stack... submitted rule revisions to K.A.R. 28-19-17, the PSD rule; to K.A.R. 28-19-19, the CEM rule; and to K.A.R...

  4. A Guide for Planning Facilities for Occupational Preparation Programs in Data Processing. Interim Report. Research 25.

    ERIC Educational Resources Information Center

    McIntosh, William A.

    This guide lists a series of pivotal questions about the educational program to be offered, and the answers to these questions bear directly on the numbers and kinds of instructional areas needed in the contemplated facilities. Much of the material is presented in a checklist format which allows for consideration of alternatives in facility…

  5. 40 CFR 52.875 - Original identification of plan section.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... applicable to stationary sources subject to prevention of significant deterioration (PSD) permit requirements... interim stack height policy for each PSD permit issued until such time as EPA revises its general stack... submitted rule revisions to K.A.R. 28-19-17, the PSD rule; to K.A.R. 28-19-19, the CEM rule; and to K.A.R...

  6. 40 CFR 52.875 - Original identification of plan section.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... applicable to stationary sources subject to prevention of significant deterioration (PSD) permit requirements... interim stack height policy for each PSD permit issued until such time as EPA revises its general stack... submitted rule revisions to K.A.R. 28-19-17, the PSD rule; to K.A.R. 28-19-19, the CEM rule; and to K.A.R...

  7. 40 CFR 52.875 - Original identification of plan section.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... applicable to stationary sources subject to prevention of significant deterioration (PSD) permit requirements... interim stack height policy for each PSD permit issued until such time as EPA revises its general stack... submitted rule revisions to K.A.R. 28-19-17, the PSD rule; to K.A.R. 28-19-19, the CEM rule; and to K.A.R...

  8. 75 FR 37187 - Patient Protection and Affordable Care Act: Preexisting Condition Exclusions, Lifetime and Annual...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-28

    ... 147.108) generally apply for plan years beginning on or after January 1, 2014, except that in the case... the case of enrollees who are under 19 years of age, these interim final regulations under PHS Act... to the Department of Labor, identified by RIN 1210-AB43, by one of the following methods: Federal e...

  9. 77 FR 31513 - Patient Protection and Affordable Care Act; Establishment of Exchanges and Qualified Health Plans...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-29

    ... the final rule, interim final rule, published in the Federal Register on March 27, 2012, entitled...)(2) of the final rule that at least two types of entities must serve as Navigators.'' On page 18336... of personally identifiable information in Sec. 155.260(a) of the proposed rule published on July 15...

  10. 10 CFR 8.5 - Interpretation by the General Counsel of § 73.55 of this chapter; illumination and physical...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Interpretation by the General Counsel of § 73.55 of this chapter; illumination and physical search requirements. 8.5 Section 8.5 Energy NUCLEAR REGULATORY... 0220, Draft Interim Acceptance Criteria for a Physical Security Plan for Nuclear Power Plants (March...

  11. Interim Report on Interagency National Personnel Recovery Architecture

    DTIC Science & Technology

    2003-07-01

    adversaries are smart , however, and rather than face our forces on open battlefields, they will seek to use any asymmetric advantage open to them. If...Liaison Officer SARNEG Search and Rescue Numeric Encryption Grid SARPO Search and Rescue Planning Officer SARREQ Search and Rescue Request SARSAT...Unconventional Assisted Recovery UARCC Unconventional Assisted Recovery Coordination Center UARM Unconventional Assisted Recovery Mechanism UART

  12. Development of a Curriculum to Meet Changing Manpower Needs of the Computer and Business Machine Industries; Interim Developments. Final Report.

    ERIC Educational Resources Information Center

    Lescarbeau, Roland F.; And Others

    This suggested curriculum guide represents the consensus of opinion by the representatives of seven schools comprising the Technical Education Consortium, with advice of industrial experts concerning the essential educational needs of the technicians they would employ. It will serve as a guide to schools planning to institute a program applicable…

  13. 10 CFR 8.5 - Interpretation by the General Counsel of § 73.55 of this chapter; illumination and physical...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Interpretation by the General Counsel of § 73.55 of this chapter; illumination and physical search requirements. 8.5 Section 8.5 Energy NUCLEAR REGULATORY... 0220, Draft Interim Acceptance Criteria for a Physical Security Plan for Nuclear Power Plants (March...

  14. 10 CFR 8.5 - Interpretation by the General Counsel of § 73.55 of this chapter; illumination and physical...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Interpretation by the General Counsel of § 73.55 of this chapter; illumination and physical search requirements. 8.5 Section 8.5 Energy NUCLEAR REGULATORY... 0220, Draft Interim Acceptance Criteria for a Physical Security Plan for Nuclear Power Plants (March...

  15. School Capital Manual. An Interim Guide for School Boards, Administrators, Facility Planners and Consultants Who Engage in School Building Projects.

    ERIC Educational Resources Information Center

    Alberta Dept. of Education, Edmonton.

    This manual is intended for use by the Alberta, Canada, school boards, administrators, consultants, education staff, and other individuals involved in school building projects. The purpose of the School Capital Plan, funding, and Alberta Education's funding framework are detailed. The school building project components of the School Capital Plan…

  16. Drug Abuse Among Indian Children: Inhalant Abuse Among Young Native Americans. Interim Report.

    ERIC Educational Resources Information Center

    Oetting, E. R.; Goldstein, George S.

    Because of the relatively high rate of drug use among American Indian adolescents, this project was planned to survey the use of drugs, especially inhalants, by American Indian children aged 9-12. As a means of gathering data, interviews were rejected in favor of a simply-worded survey administered to over 1000 children in 9 Southwestern tribes.…

  17. Interim Measures Report for the Headquarters Building Area Location of Concern (LOC) 2E East SWMU 104 John F. Kennedy Space Center, Florida

    NASA Technical Reports Server (NTRS)

    Sager, Eric D.

    2016-01-01

    The Hazardous and Solid Waste Amendment portion of the National Aeronautics and Space Administration (NASA) Resource Conservation and Recovery Act (RCRA) Permit issued by the Florida Department of Environmental Protection (FDEP), requires identification and evaluation of all known Solid Waste Management Units (SWMUs) and Locations of Concern (LOCs) located on Kennedy Space Center (KSC) property. The KSC Headquarters Building Area (KHQA) has been identified as SWMU 104 under KSC's RCRA Program. This report summarizes the Interim Measure (IM) conducted by Geosyntec Consultants (Geosyntec) for NASA under Indefinite Delivery Indefinite Quantity Contract NNK12CA13B at the KHQA to mitigate potential exposure to polychlorinated biphenyl (PCB)-affected media at the eastern side of LOC 2E. The IM activities were conducted in June and July 2015 to remediate PCBs above the FDEP Residential Direct-Exposure (R-) Soil Cleanup Target Level (SCTL) of 0.5 milligram per kilogram (mg/kg) established by Chapter 62-777, Florida Administrative Code. The IM was performed in accordance with the IM Work Plan (IMWP) approved by the FDEP, dated August 2012. IM activities were conducted in accordance with the KSC Generic PCB Work Plan (NASA 2007).

  18. Revised ground-water monitoring compliance plan for the 300 area process trenches

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

    Schalla, R.; Aaberg, R.L.; Bates, D.J.

    1988-09-01

    This document contains ground-water monitoring plans for process-water disposal trenches located on the Hanford Site. These trenches, designated the 300 Area Process Trenches, have been used since 1973 for disposal of water that contains small quantities of both chemicals and radionuclides. The ground-water monitoring plans contained herein represent revision and expansion of an effort initiated in June 1985. At that time, a facility-specific monitoring program was implemented at the 300 Area Process Trenches as part of a regulatory compliance effort for hazardous chemicals being conducted on the Hanford Site. This monitoring program was based on the ground-water monitoring requirements formore » interim-status facilities, which are those facilities that do not yet have final permits, but are authorized to continue interim operations while engaged in the permitting process. The applicable monitoring requirements are described in the Resource Conservation and Recovery Act (RCRA), 40 CFR 265.90 of the federal regulations, and in WAC 173-303-400 of Washington State's regulations (Washington State Department of Ecology 1986). The program implemented for the process trenches was designed to be an alternate program, which is required instead of the standard detection program when a facility is known or suspected to have contaminated the ground water in the uppermost aquifer. The plans for the program, contained in a document prepared by the US Department of Energy (USDOE) in 1985, called for monthly sampling of 14 of the 37 existing monitoring wells at the 300 Area plus the installation and sampling of 2 new wells. 27 refs., 25 figs., 15 tabs.« less

  19. Results of the first interim analysis of the RAPPER II trial in patients with spinal cord injury: ambulation and functional exercise programs in the REX powered walking aid.

    PubMed

    Birch, Nick; Graham, Jon; Priestley, Tom; Heywood, Chris; Sakel, Mohamed; Gall, Angela; Nunn, Andrew; Signal, Nada

    2017-06-19

    The RAPPER II study investigates the feasibility, safety and acceptability of using the REX self-stabilising robotic exoskeleton in people with spinal cord injury (SCI) who are obligatory wheelchair users. Feasibility is assessed by the completion of transfer into the REX device, competency in achieving autonomous control and completion of upper body exercise in an upright position in the REX device. Safety is measured by the occurrence of serious adverse events. Device acceptability is assessed with a user questionnaire. RAPPER II is a prospective, multi-centre, open label, non-randomised, non-comparative cohort study in people with SCI recruited from neurological rehabilitation centres in the United Kingdom, Australia and New Zealand. This is the planned interim report of the first 20 participants. Each completed a transfer into the REX, were trained to achieve machine control and completed Timed Up and Go (TUG) tests as well as upper body exercises in standing in a single first time session. The time to achieve each task as well as the amount of assistance required was recorded. After finishing the trial tasks a User Experience questionnaire, exploring device acceptability, was completed. All participants could transfer into the REX. The mean transfer time was 439 s. Nineteen completed the exercise regime. Eighteen could achieve autonomous control of the REX, 17 of whom needed either no assistance or the help of just one therapist. Eighteen participants completed at least one TUG test in a mean time of 313 s, 15 with the assistance of just one therapist. The questionnaire demonstrated high levels of acceptability amongst users. There were no Serious Adverse Events. This first interim analysis of RAPPER II shows that it is feasible and safe for people with SCI to use the REX powered assisted walking device to ambulate and exercise in. Participants with tetraplegia and paraplegia could walk and perform a functional exercise program when standing needing only modest levels of assistance in most cases. User acceptability was high. ClinicalTrials.gov , NCT02417532 . Registered 11 April 2015.

  20. Environmental analysis for development planning in Chambers County, Texas, land use policy component, interim summary of federal influence over land use

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

    Mixon, J.

    1973-11-21

    This summary covers major Federal programs that affect land use and indicates some of the influence which these programs may have on Chambers County, Texas. The first part is divided into specific areas of study and includes the history of Federal assistance programs to date. These areas are housing and urban development, the Rural Development Act of 1972, transportation, mass transit, energy, air pollution controls, the National Environmental Policy Act of 1969; power plant siting, the Environmental Protection Agency (EPA), Coastal Zone Management (CZM), the National Land Use Policy (NLUP) and Planning Assistance Act, and the interrelation of EPA, CZM,more » and NLUP. The second part deals with constitutional power in relation to transportation, housing and slum clearance, urban renewal, Federal assistance for new communities and open space acquisition, the Rural Development Act of 1972, the EPA, CZM, NLUP and Planning Assistance Act, and power plant siting bills. Included are the legislative history of these land use acts and their actual terminology, control and enforcement procedures and research and developing funding. Specific references to Texas, and especially Chambers County, in relation to these programs are made throughout the report.« less

  1. Interim heterogeneity changes measured using entropy texture features on T2-weighted MRI at 3.0 T are associated with pathological response to neoadjuvant chemotherapy in primary breast cancer.

    PubMed

    Henderson, Shelley; Purdie, Colin; Michie, Caroline; Evans, Andrew; Lerski, Richard; Johnston, Marilyn; Vinnicombe, Sarah; Thompson, Alastair M

    2017-11-01

    To investigate whether interim changes in hetereogeneity (measured using entropy features) on MRI were associated with pathological residual cancer burden (RCB) at final surgery in patients receiving neoadjuvant chemotherapy (NAC) for primary breast cancer. This was a retrospective study of 88 consenting women (age: 30-79 years). Scanning was performed on a 3.0 T MRI scanner prior to NAC (baseline) and after 2-3 cycles of treatment (interim). Entropy was derived from the grey-level co-occurrence matrix, on slice-matched baseline/interim T2-weighted images. Response, assessed using RCB score on surgically resected specimens, was compared statistically with entropy/heterogeneity changes and ROC analysis performed. Association of pCR within each tumour immunophenotype was evaluated. Mean entropy percent differences between examinations, by response category, were: pCR: 32.8%, RCB-I: 10.5%, RCB-II: 9.7% and RCB-III: 3.0%. Association of ultimate pCR with coarse entropy changes between baseline/interim MRI across all lesions yielded 85.2% accuracy (area under ROC curve: 0.845). Excellent sensitivity/specificity was obtained for pCR prediction within each immunophenotype: ER+: 100%/100%; HER2+: 83.3%/95.7%, TNBC: 87.5%/80.0%. Lesion T2 heterogeneity changes are associated with response to NAC using RCB scores, particularly for pCR, and can be useful across all immunophenotypes with good diagnostic accuracy. • Texture analysis provides a means of measuring lesion heterogeneity on MRI images. • Heterogeneity changes between baseline/interim MRI can be linked with ultimate pathological response. • Heterogeneity changes give good diagnostic accuracy of pCR response across all immunophenotypes. • Percentage reduction in heterogeneity is associated with pCR with good accuracy and NPV.

  2. Carfilzomib or bortezomib in relapsed or refractory multiple myeloma (ENDEAVOR): an interim overall survival analysis of an open-label, randomised, phase 3 trial.

    PubMed

    Dimopoulos, Meletios A; Goldschmidt, Hartmut; Niesvizky, Ruben; Joshua, Douglas; Chng, Wee-Joo; Oriol, Albert; Orlowski, Robert Z; Ludwig, Heinz; Facon, Thierry; Hajek, Roman; Weisel, Katja; Hungria, Vania; Minuk, Leonard; Feng, Shibao; Zahlten-Kumeli, Anita; Kimball, Amy S; Moreau, Philippe

    2017-10-01

    The phase 3 ENDEAVOR trial was a head-to-head comparison of two proteasome inhibitors in patients with relapsed or refractory multiple myeloma. Progression-free survival was previously reported to be significantly longer with carfilzomib administered in combination with dexamethasone than with bortezomib and dexamethasone in an interim analysis. The aim of this second interim analysis was to compare overall survival between the two treatment groups. ENDEAVOR was a phase 3, open-label, randomised controlled trial in patients with relapsed or refractory multiple myeloma. Patients were recruited from 198 hospitals and outpatient clinics in 27 countries in Europe, North America, South America, and the Asia-Pacific region. Patients were aged 18 years or older, had relapsed or refractory multiple myeloma, and had received between one and three previous lines of therapy. Patients were randomly assigned (1:1) to receive carfilzomib and dexamethasone (carfilzomib group) or bortezomib and dexamethasone (bortezomib group) through a blocked randomisation scheme (block size of four), stratified by International Staging System stage, previous lines of treatment, previous proteasome inhibitor therapy, and planned route of bortezomib delivery if assigned to the bortezomib group. Carfilzomib (20 mg/m 2 on days 1 and 2 of cycle 1; 56 mg/m 2 thereafter) was given as a 30-min intravenous infusion on days 1, 2, 8, 9, 15, and 16 of 28-day cycles; bortezomib (1·3 mg/m 2 ) was given as an intravenous bolus or subcutaneous injection on days 1, 4, 8, and 11 of 21-day cycles. Dexamethasone (20 mg oral or intravenous infusion) was given on days 1, 2, 8, 9, 15, 16, 22, and 23 in the carfilzomib group and on days 1, 2, 4, 5, 8, 9, 11, and 12 in the bortezomib group. The primary endpoint of ENDEAVOR, progression-free survival, has been previously reported. A stratified log-rank test was used to compare overall survival between treatment groups for this prospectively planned second interim analysis. Efficacy assessments were done in all randomly assigned patients (the intention-to-treat population) and the safety analysis included patients who received at least one dose of study treatment. This trial is registered with ClinicalTrials.gov, number NCT01568866, and is no longer enrolling patients. Between June 20, 2012, and June 30, 2014, 1096 patients were assessed for eligibility, of whom 929 were randomly assigned (464 to the carfilzomib group and 465 to the bortezomib group). The cutoff date for this prespecified interim analysis was Jan 3, 2017. Median overall survival was 47·6 months (95% CI 42·5-not evaluable) in the carfilzomib group versus 40·0 months (32·6-42·3) in the bortezomib group (hazard ratio 0·791 [95% CI 0·648-0·964], one-sided p=0·010). Grade 3 or worse adverse events were reported in 377 (81%) of 463 patients in the carfilzomib group and 324 (71%) of 456 patients in the bortezomib group, and serious adverse events in 273 (59%) patients in the carfilzomib group and 182 (40%) in the bortezomib group. The most frequent grade 3 or worse adverse events were anaemia (76 [16%] of 463 patients in the carfilzomib group vs 46 [10%] of 456 patients in the bortezomib group), hypertension (67 [15%] vs 15 [3%]), pneumonia (42 [9%] vs 39 [9%]), thrombocytopenia (41 [9%] vs 43 [9%]), fatigue (31 [7%] vs 35 [8%]), dyspnoea (29 [6%] vs ten [2%]), decreased lymphocyte count (29 [6%] vs nine [2%]), diarrhoea (18 [4%] vs 39 [9%]), and peripheral neuropathy (six [1%] vs 28 [6%]). Treatment-related deaths occurred in five (1%) of 463 patients in the carfilzomib group (pneumonia [n=2], interstitial lung disease [n=1], septic shock [n=1], and unknown [n=1]) and two (<1%) of 456 patients in the bortezomib group (cardiac arrest [n=1] and pneumonia [n=1]). Carfilzomib provided a significant and clinically meaningful reduction in the risk of death compared with bortezomib. To our knowledge, carfilzomib is the first and only multiple myeloma treatment that extends overall survival in the relapsed setting over the current standard of care. This study is informative for deciding which proteasome inhibitor to use for treating this disease. Onyx Pharmaceuticals Inc, an Amgen Inc subsidiary. Copyright © 2017 Elsevier Ltd. All rights reserved.

  3. Capitation funding of primary health organisations in New Zealand: are enrolled populations being funded according to need?

    PubMed

    Langton, Jennifer; Crampton, Peter

    2008-04-18

    To determine whether the three main funding formulas for Primary Health Organisations achieved a stated aim of the Primary Health Care Strategy to fund enrolled populations according to need. National data were obtained from the Ministry of Health for a 12-month period beginning in April 2004: these included demographic characteristics of the enrolled Primary Health Organisation population, plus rates tables for: First-Contact Services, Services to Improve Access, and Health Promotion. Funding for Access and Interim practices for four-quarters was calculated for each of these three funding streams. Analysis of the demographic characteristics of Access and Interim practices was undertaken. Maori and Pacific peoples made up a greater proportion of the Access population than the Interim, had higher rates of deprivation than the non-Maori/non-Pacific population, and demonstrated a younger age distribution. The first quarter (April 2004-June 2004) showed there was preferential funding for Access PHOs and in particular high-needs groups. In quarter two, this level of preferential funding had diminished, coinciding with the introduction of increased government funding for all Interim enrolees aged 65 and over. The greater funding for Access enrolees was notably eroded with the introduction of Access-level funding for those aged 65+ in Interim PHOs. Since these data were analysed all remaining Interim age groups have shifted to Access-level funding, benefiting non-Maori /non-Pacific in Interim PHOs. The rapid shift to Access-level funding for First Contact Services has seen a continued erosion of the redistributive effect of the original needs-based formulas. A system cannot be considered equitable if some members of society are not realising their health potential, and financing of primary care should remain redistributive until such a time as this objective is attained.

  4. Postconstruction report for the mercury tanks interim action at the Oak Ridge Y-12 Plant, Oak Ridge, Tennessee

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

    Voskuil, T.L.

    1993-09-01

    Three underground concrete settling tanks (tanks 2101-U, 2104-U, and 2100-U) at the Y-12 Plant on the Oak Ridge Reservation in Oak Ridge, Tennessee, contained contaminated sludges contributing mercury to the Upper East Fork Poplar Creek (UEFPC). These tanks were cleaned out as an interim action under the Comprehensive Environmental Response, Compensation, and Liability Act as part of the Reduction of Mercury in Plant Effluent subproject. Cleaning out these tanks prevented the sludge that had settled in the bottom from resuspending and carrying mercury into UEFPC. Tanks 2104-U and 2100-U were returned to service and will continue to receive effluent frommore » buildings 9201-4 and 9201-5. Tank 2101-U had been abandoned and its effluent redirected to Tank 2100-U during previous activities. This interim action permanently sealed Tank 2101-U from the storm sewer system. Upon removal of materials and completion of cleanup, inspections determined that the project`s cleanup criteria had been met. The structural integrity of the tanks was also inspected, and minor cracks identified in tanks 2101-U and 2104-U were repaired. This project is considered to have been completed successfully because it met its performance objectives as addressed in the Interim Record of Decision and the work plan: to remove the waste from the three storage tanks; to ensure that the tanks were cleaned to the levels specified; to return tanks 2100-U and 2104-U to service; to isolate Tank 2101-U permanently; and to manage the wastes in an appropriate fashion.« less

  5. Functions and requirements document for interim store solidified high-level and transuranic waste

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

    Smith-Fewell, M.A., Westinghouse Hanford

    1996-05-17

    The functions, requirements, interfaces, and architectures contained within the Functions and Requirements (F{ampersand}R) Document are based on the information currently contained within the TWRS Functions and Requirements database. The database also documents the set of technically defensible functions and requirements associated with the solidified waste interim storage mission.The F{ampersand}R Document provides a snapshot in time of the technical baseline for the project. The F{ampersand}R document is the product of functional analysis, requirements allocation and architectural structure definition. The technical baseline described in this document is traceable to the TWRS function 4.2.4.1, Interim Store Solidified Waste, and its related requirements, architecture,more » and interfaces.« less

  6. A Procedure for Structural Weight Estimation of Single Stage to Orbit Launch Vehicles (Interim User's Manual)

    NASA Technical Reports Server (NTRS)

    Martinovic, Zoran N.; Cerro, Jeffrey A.

    2002-01-01

    This is an interim user's manual for current procedures used in the Vehicle Analysis Branch at NASA Langley Research Center, Hampton, Virginia, for launch vehicle structural subsystem weight estimation based on finite element modeling and structural analysis. The process is intended to complement traditional methods of conceptual and early preliminary structural design such as the application of empirical weight estimation or application of classical engineering design equations and criteria on one dimensional "line" models. Functions of two commercially available software codes are coupled together. Vehicle modeling and analysis are done using SDRC/I-DEAS, and structural sizing is performed with the Collier Research Corp. HyperSizer program.

  7. Requirements for advance reproduction in Allegheny hardwoods - an interim guide

    Treesearch

    Ted J. Grisez; Maurice R. Peace

    1973-01-01

    Reproduction tallies on 65 areas planned for clearcutting were compared with reproduction 2 to 4 years after cutting. As a result, we recommend that 70 percent of the area be stocked with at least 5,000 black cherry seedlings or 30,000 seedlings per acre of desirable species before cutting. If this requirement had been used on these 65 areas, the proportion of...

  8. 75 FR 27121 - Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Dependent...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-13

    ... whom 3.1 million are uninsured) do not have a parent who has either ESI or non-group insurance, and... young adults whose parents are covered either by ESI or by non- group insurance: 3.44 million are currently uninsured, 2.42 million are covered by their own non-group insurance, 5.55 million are covered by...

  9. AN EXPLORATORY INVESTIGATION OF SELECTED STUDENT TYPES AT THREE UNIVERSITY OF CALIFORNIA CAMPUSES, A PRELIMINARY REPORT.

    ERIC Educational Resources Information Center

    MOCK, KATHLEEN; AND OTHERS

    A CONCERN OVER THE LOSS OF POTENTIALLY CAPABLE STUDENTS LED RESEARCH PERSONNEL ON THE DAVIS, LOS ANGELES, AND SANTA BARBARA CAMPUSES OF THE UNIVERSITY OF CALIFORNIA TO JOIN FORCES IN A STUDY TO IDENTIFY WAYS FOR ACCOMMODATING THE VARIOUS TYPES OF STUDENTS ADMITTED TO THE THREE SCHOOLS. A 2-YEAR PROJECT WAS PLANNED. THIS INTERIM REPORT COVERED A…

  10. Data Use "Multi-State" Spotlight: Using Data Fidelity Tools to Improve Data Quality. Transforming State Systems to Improve Outcomes for Children with Disabilities

    ERIC Educational Resources Information Center

    Ruedel, Kristin; Nelson, Gena; Bailey, Tessie

    2018-01-01

    To evaluate interim progress toward the State-identified Measurable Result (SIMR), states require access to high-quality data from local education agencies (LEAs) and early intervention service providers. In a review of 2017 Phase III State Systemic Improvement Plans (SSIP), 43 Part C states noted limitations or concerns related to data and…

  11. The variable polarity plasma arc welding process: Its application to the Space Shuttle external tank

    NASA Technical Reports Server (NTRS)

    Nunes, A. C., Jr.; Bayless, O. E., Jr.; Jones, C. S., III; Munafo, A. P.; Wilson, W. A.

    1983-01-01

    The technical history of the variable polarity plasma arc (VPPA) welding process being introduced as a partial replacement for the gas shielded tungsten arc process in assembly welding of the space shuttle external tank is described. Interim results of the weld strength qualification studies, and plans for further work on the implementation of the VPPA process are included.

  12. Fostering community understanding of sufficient benefit and early stopping for a phase 2B HIV prevention clinical trial in Africa.

    PubMed

    White, Rhonda; Chileshe, Modesta; Dawson, Liza; Donnell, Deborah; Hillier, Sharon; Morar, Neetha; Noguchi, Lisa; Dixon, Dennis

    2011-02-01

    Most trials of interventions are designed to address the traditional null hypothesis of no benefit. VOICE, a phase 2B HIV prevention trial funded by NIH and conducted in Africa, is designed to assess if the intervention will prevent a substantial fraction of infections. Planned interim analysis may provide conclusive evidence against the traditional null hypothesis without establishing substantial benefit. At this interim point, the Data and Safety Monitoring Board would then face the dilemma of knowing the product has some positive effect, but perhaps not as great an effect as the protocol has declared necessary. In March 2008, NIH program staff recommended that the VOICE protocol team discuss the stopping rules with stakeholders prior to initiating the protocol. The goals of the workshop were to inform community representatives about the potential ethical dilemma associated with stopping rules and engage in dialogue about these issues. We describe the resulting community consultation and summarize the outcomes. A 2-day workshop was convened with the goal of having a clear and transparent consultation with the stakeholders around the question, 'Given emerging evidence that a product could prevent some infections, would the community support a decision to continue accruing to the trial?' Participants included research staff and community stakeholders. Lectures with visual aids, discussions, and exercises using interactive learning tasks were used, with a focus on statistics and interpreting data from trials, particularly interim data. Results of oral and written evaluations by participants were reviewed. The feedback was mostly positive, with some residual confusion regarding statistical concepts. However, discussions with attendees later revealed that not all felt prepared to engage fully in the workshop. This was the presenters' first experience facilitating a formal discussion with an audience that had no advanced science, research, or mathematics training. Community representatives' concern regarding speaking for their communities without consulting them also created a challenge for the workshop. Open discussion around trial stopping rules requires that all discussants have an understanding of trial design concepts and feel a sense of empowerment to ask and answer questions. The VOICE CWG workshop was a first step toward the goal of open discussion regarding trial stopping rules and interim results for the study; however, ongoing education and dialogue must occur to ensure that all stakeholders fully participate in the process.

  13. Should Sponsors and DSMBs Share Interim Results Across Trials?

    PubMed Central

    Shah, Seema K.; Dawson, Liza; Dixon, Dennis O.; Lie, Reidar K.

    2011-01-01

    Increasing numbers of multinational clinical trials have generated new ethical obligations of research sponsors and their DSMBs. Although sponsors and DSMBs clearly have ethical obligations to protect subjects in their trials, future patients, and the integrity of their trial, the obligations they have to protect subjects in other trials have been overlooked. When interim results from clinical trials can significantly affect the conduct of other trials and the welfare of the subjects in those trials, sponsors and DSMBs may have obligations to disclose results to the relevant parties. We propose that sponsors and DSMBs routinely work together in advance to develop a plan for disclosing relevant information in cases where it is necessary to protect the welfare of subjects in other trials. Channels of communication between sponsors, DSMBs, IRBs, and others involved in similar and concurrent trials will better protect both research participants and the integrity of the research enterprise. PMID:21937922

  14. The Family and Medical Leave Act of 1993--Wage and Hour Division, Department of Labor. Interim final rule; request for comments.

    PubMed

    1993-06-04

    This document contains interim regulations implementing the Family and Medical Leave Act of 1993 called ("FMLA" or "the Act"). The Act is effective on August 5, 1993, six months from the date of its enactment. Where a collective bargaining agreement is in effect on August 5, 1993, the Act is effective when the collective bargaining agreement terminates or February 5, 1994, whichever is earlier. The purpose of these regulations is to set forth the requirements of Title I and Title IV of the Act. Title I applies to covered private employers and public agencies (except for most of the Federal Government, which is governed by Title II). Title IV of the Act primarily concerns the relationship between FMLA and other laws, as well as collective bargaining agreements and other employer plans and programs.

  15. On the comparisons of tropical relative humidity in the lower and middle troposphere among COSMIC radio occultations, MERRA and ECMWF data sets

    NASA Astrophysics Data System (ADS)

    Vergados, P.; Mannucci, A. J.; Ao, C. O.; Jiang, J. H.; Su, H.

    2015-01-01

    The spatial variability of the tropical tropospheric relative humidity (RH) throughout the vertical extent of the troposphere is examined using Global Positioning System Radio Occultation (GPSRO) observations from the Constellation Observing System for Meteorology, Ionosphere and Climate (COSMIC) mission. These high vertical resolution observations capture the detailed structure and moisture budget of the Hadley Cell circulation. We compare the COSMIC observations with the European Center for Medium-range Weather Forecast (ECMWF) Re-Analysis Interim (ERA-Interim) and the Modern-Era Retrospective analysis for Research and Applications (MERRA) climatologies. Qualitatively, the spatial pattern of RH in all data sets matches up remarkably well, capturing distinct features of the general circulation. However, RH discrepancies exist between ERA-Interim and COSMIC data sets, which are noticeable across the tropical boundary layer. Specifically, ERA-Interim shows a drier Inter Tropical Convergence Zone (ITCZ) by 15-20% compared both to COSMIC and MERRA data sets, but this difference decreases with altitude. Unlike ECMWF, MERRA shows an excellent agreement with the COSMIC observations except above 400 hPa, where GPSRO observations capture drier air by 5-10%. RH climatologies were also used to evaluate intraseasonal variability. The results indicate that the tropical middle troposphere at ±5-25° is most sensitive to seasonal variations. COSMIC and MERRA data sets capture the same magnitude of the seasonal variability, but ERA-Interim shows a weaker seasonal fluctuation up to 10% in the middle troposphere inside the dry air subsidence regions of the Hadley Cell. Over the ITCZ, RH varies by maximum 9% between winter and summer.

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

    Benioff, R.; Ness, E.; Hirst, J.

    Under its Support for National Action Plans (SNAP) initiative, the U.S. Country Studies Program is providing financial and technical assistance to 18 countries for the development of climate change action plans. Although most of the countries have not yet completed their plans, the important lessons learned thus far are valuable and should be shared with other countries and international institutions that have an interest in the process of action plan development. This interim report describes the experience of 11 countries that are the furthest along in their planning activity and who have offered to share their results to date withmore » the larger community of interested nations. These action plans delineate specific mitigation and adaptation measures that the countries will implement and integrate into their ongoing development programs. This report focuses on the measures the countries have selected and the methods they used to prepare their action plans. This executive summary presents key lessons and common themes using a structure similar to that used in the individual country chapters.« less

  17. Progress report on CCIR studies for guaranteeing access to the geostationary satellite orbit

    NASA Astrophysics Data System (ADS)

    Reinhart, E. E.

    Overall responsibility for preparing a report on the technical information necessary for the World Administrative Radio Conference to be held in the spring of 1984 is vested in the Interim Working Party (IWP) 4/1. The various approaches being considered by the IWP 4/1 to guarantee orbital access are described, along with the criteria that the party has proposed for evaluating and comparing the approaches. These approaches include the following: a regional detailed long-term (10-20 years) a priori allotment plan, a periodically revised (3-5 years) regional detailed allotment plan, a regional or subregional allotment plan with guaranteed access, guaranteed access by means of multilateral coordination, and coordination procedures and technical factors that are revised periodically.

  18. Interim Air Purity Guidelines for Dry Deck Shelter (DDS) Operations

    DTIC Science & Technology

    1990-10-01

    The acceptable limits for gaseous contaminants in submarine compressed air for use as diver’s breathing air are derived from the 8-hour Time Weighted...accompanying documentation. Cylinders must be declared as hazardous cargo (" Air , Compressed Non-Flammable Gas") prior to air transport. Analysis of cylinder...capi NAVAL MEDICAL RESEARCH INSTITUTE Bethesda, MD 20889-5055 NMRI 90-109 October 1990 AD-A231 432 INTERIM AIR PURITY GUIDELINES FOR DRY DECK

  19. Strategic planning for national security: Lessons from business experience. Interim report

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

    Bracken, P.

    1990-02-01

    United States defense planning is at a crossroads and it is therefore useful to review not only discrete issues, but even basic concepts of strategic planning. This Note reviews concepts used in the business world to build insights about how to view current and prospective problems, opportunities, and choices. The author draws upon the business literature for both ideas and metaphors. He observes that U.S. national security planning could profit greatly from an approach that distinguishes among core, environmental, and hedging strategies, and that considers security analogs to such business concepts as defining the business, dealing with new competitors, controllingmore » the intensity of competition, entry and exit barriers, and the need to redeploy assets and restructure the organization. He then relates these concepts to specific problems of national security interest.« less

  20. Space station thermal control surfaces. Volume 1: Interim report

    NASA Technical Reports Server (NTRS)

    Maag, C. R.; Millard, J. M.

    1978-01-01

    The U.S. space program goals for long-duration manned missions place particular demands on thermal-control systems. The objective of this program is to develop plans which are based on the present thermal-control technology, and which will keep pace with the other space program elements. The program tasks are as follows: (1) requirements analysis, with the objectives to define the thermal-control-surface requirements for both space station and 25 kW power module, to analyze the missions, and to determine the thermal-control-surface technology needed to satisfy both sets of requirements; (2) technology assessment, with the objectives to perform a literature/industry survey on thermal-control surfaces, to compare current technology with the requirements developed in the first task, and to determine what technology advancements are required for both the space station and the 25 kW power module; and (3) program planning that defines new initiative and/or program augmentation for development and testing areas required to provide the proper environment control for the space station and the 25 kW power module.

  1. Interim analysis of postoperative chemoradiotherapy with capecitabine and oxaliplatin versus capecitabine alone for pathological stage II and III rectal cancer: a randomized multicenter phase III trial.

    PubMed

    Feng, Yan-Ru; Zhu, Yuan; Liu, Lu-Ying; Wang, Wei-Hu; Wang, Shu-Lian; Song, Yong-Wen; Wang, Xin; Tang, Yuan; Liu, Yue-Ping; Ren, Hua; Fang, Hui; Zhang, Shi-Ping; Liu, Xin-Fan; Yu, Zi-Hao; Li, Ye-Xiong; Jin, Jing

    2016-05-03

    The aim of this study is to present an interim analysis of a phase III trial (NCT00714077) of postoperative concurrent capecitabine and radiotherapy with or without oxaliplatin for pathological stage II and III rectal cancer. Patients with pathologically confirmed stage II and III rectal cancer were randomized to either radiotherapy with concurrent capecitabine (Cap-RT group) or with capecitabine and oxaliplatin (Capox-RT group). The primary endpoint was 3-year disease-free survival rate (DFS). The 3-year DFS rate was 73.9% in the Capox-RT group and 71.6% in the Cap-RT group (HR 0.92, p = 0.647), respectively. No significant difference was observed in overall survival, cumulative incidence of local recurrence and distant metastasis between the two groups (p > 0.05). More grade 3-4 acute toxicity was observed in the Capox-RT group than in the Cap-RT group (38.1% vs. 29.2%, p = 0.041). Inclusion of oxaliplatin in the capecitabine-based postoperative regimen did not improve DFS but increased toxicities for pathological stage II and III rectal cancer in this interim analysis.

  2. Comparative risk assessments for the production and interim storage of glass and ceramic waste forms: Defense waste processing facility

    NASA Astrophysics Data System (ADS)

    Huang, J. C.; Wright, W. V.

    1982-04-01

    The Defense Waste Processing Facility (DWPF) for immobilizing nuclear high level waste (HLW) is scheduled to be built. High level waste is produced when reactor components are subjected to chemical separation operations. Two candidates for immobilizing this HLW are borosilicate glass and crystalline ceramic, either being contained in weld sealed stainless steel canisters. A number of technical analyses are being conducted to support a selection between these two waste forms. The risks associated with the manufacture and interim storage of these two forms in the DWPF are compared. Process information used in the risk analysis was taken primarily from a DWPF processibility analysis. The DWPF environmental analysis provided much of the necessary environmental information.

  3. Interim reliability-evaluation program: analysis of the Browns Ferry, Unit 1, nuclear plant. Appendix B - system descriptions and fault trees

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

    Mays, S.E.; Poloski, J.P.; Sullivan, W.H.

    1982-07-01

    This report describes a risk study of the Browns Ferry, Unit 1, nuclear plant. The study is one of four such studies sponsored by the NRC Office of Research, Division of Risk Assessment, as part of its Interim Reliability Evaluation Program (IREP), Phase II. This report is contained in four volumes: a main report and three appendixes. Appendix B provides a description of Browns Ferry, Unit 1, plant systems and the failure evaluation of those systems as they apply to accidents at Browns Ferry. Information is presented concerning front-line system fault analysis; support system fault analysis; human error models andmore » probabilities; and generic control circuit analyses.« less

  4. Geographic patterns of at-risk species: A technical document supporting the USDA Forest Service Interim Update of the 2000 RPA Assessment

    Treesearch

    Curtis H. Flather; Michael S. Knowles; Jason McNees

    2008-01-01

    This technical document supports the Forest Service's requirement to assess the status of renewable natural resources as mandated by the Forest and Rangeland Renewable Resources Planning Act of 1974. It updates past reports on the trends and geographic patterns of species formally listed as threatened or endangered under the Endangered Species Act of 1973. We...

  5. Arms Control and Nonproliferation: A Catalog of Treaties and Agreements

    DTIC Science & Technology

    2011-03-23

    produced two agreements— the Interim Agreement ... on Certain Measures with Respect to the Limitation of...Iranian missile threat. The system was to include 10 interceptors based in Poland and a radar in the Czech Republic . Russia’s former President Putin and...that Moscow would not do so if the United States reversed its plan to emplace GMD facilities in Poland and the Czech Republic . Congress resisted the

  6. Northeast Artificial Intelligence Consortium Annual Report. Volume 2. 1988 Discussing, Using, and Recognizing Plans (NLP)

    DTIC Science & Technology

    1989-10-01

    Encontro Portugues de Inteligencia Artificial (EPIA), Oporto, Portugal, September 1985. [15] N. J. Nilsson. Principles Of Artificial Intelligence. Tioga...FI1 F COPY () RADC-TR-89-259, Vol II (of twelve) Interim Report October 1969 AD-A218 154 NORTHEAST ARTIFICIAL INTELLIGENCE CONSORTIUM ANNUAL...7a. NAME OF MONITORING ORGANIZATION Northeast Artificial Of p0ilcabe) Intelligence Consortium (NAIC) Rome_____ Air___ Development____Center

  7. Risk management. National Aeronautics and Space Administration (NASA). Interim rule adopted as final with changes.

    PubMed

    2000-11-22

    This is a final rule amending the NASA FAR Supplement (NFS) to emphasize considerations of risk management, including safety, security (including information technology security), health, export control, and damage to the environment, within the acquisition process. This final rule addresses risk management within the context of acquisition planning, selecting sources, choosing contract type, structuring award fee incentives, administering contracts, and conducting contractor surveillance.

  8. Hydrazine Blending and Storage Facility, Interim Response Action Implementation. Final Safety Plan

    DTIC Science & Technology

    1989-08-30

    operators and visitors, will be required to wear a personal hydrazine dosimeter at all times. These will be available from commercial sources and/or the Naval...suspectea or carcinogenic pocen:tal for =an. -- t, :t ha a,,-cn OSL ?:L. Is I pPm or 1.3 mg/m 3 . zo pp=n4p"NIOSI. (1978) hs a oe -nded a ceiling level

  9. The density management and riparian buffer study: a large-scale silviculture experiment informing riparian management in the Pacific Northwest, USA

    Treesearch

    Paul D. Anderson; Nathan J. Poage

    2014-01-01

    The advent of the Northwest Forest Plan (NWFP) in the early 1990s signaled a new paradigm for management of 9.9 million ha of federal forest lands in western Washington and Oregon, USA. The emphasis shifted from commodity timber production to ensuring sustained ecological functioning to meet a broad array of ecosystem services including economic benefits. Under interim...

  10. Software Estimation: Developing an Accurate, Reliable Method

    DTIC Science & Technology

    2011-08-01

    Lake, CA ,93555- 6110 8. PERFORMING ORGANIZATION REPORT NUMBER 9. SPONSORING/MONITORING AGENCY NAME(S) AND ADDRESS(ES) 10. SPONSOR/MONITOR’S ACRONYM(S...Activity, the systems engineering team is responsible for system and software requirements. 2 . Process Dashboard is a software planning and tracking tool... CA 93555- 6110 760-939-6989 Brad Hodgins is an interim TSP Mentor Coach, SEI-Authorized TSP Coach, SEI-Certified PSP/TSP Instructor, and SEI

  11. How well do Reanalysis represent polar lows?

    NASA Astrophysics Data System (ADS)

    Zappa, G.; Shaffrey, L.; Hodges, K.

    2013-12-01

    Polar lows are intense maritime mesocyclones forming at high latitudes during polar air outbreaks. The associated high surface winds can be an important cause of coastal damage.They also seem to play a relevant role in the climate system by modulating the oceanic surface heat fluxes. This creates strong interest in understanding whether modern reanalysis datasets are able to represent polar lows, as well as how their representation may be sensitive to the model resolution. In this talk we investigate how ERA-Interim reanalysis represents the polar lows identified by the Norwegian meteorological services and listed in the STARS (Combination of Sea Surface Temperature and AltimeteR Synergy) dataset for the period 2002-2011. The sensitivity to resolution is explored by comparing ERA-Interim to the ECMWF operational analyses (2008-2011), which have three times higher horizontal resolution compared to ERA-Interim. We show that ERAI-Interim has excellent ability to capture the observed polar lows events with up to 90% of the observed events being found in the reanalysis. However, ERA-Interim tends to have polar lows of weaker dynamical intensity, in terms of both winds and vorticity, and with less spatial structure than in the ECMWF operational analyses (See Fig 1). Furthermore, we apply an objective feature tracking algorithm to the 3 hourly vorticity at 850 hPa with constraints on vorticity intensity and atmospheric static stability to objectively identify polar lows in the ERA-Interim reanalysis. We show that for the stronger polar lows the objective climatology shows good agreement with the STARS dataset over the 2002-2011 period. This allows us to extend the polar lows climatology over the whole ERA Interim period. Differences with another reanalysis product (NCEP-CFSR) will be also discussed. Fig 1: Composite of the tangential wind speed at 925 hPa for 34 polar lows observed in the Norwegian sea between 2008-2010 as represented by the ERA-Interim reanalysis (left) and by the ECMWF Operational analysis (right). Positive values indicate cyclonic circulation. The composite is centered on the polar low vorticity maxima and it is presented for a radial cap of 5 degrees of radius on the sphere (~550Km).

  12. Symptomatic treatment in multiple sclerosis-interim analysis of a nationwide registry.

    PubMed

    Skierlo, S; Rommer, P S; Zettl, U K

    2017-04-01

    To analyze symptomatic treatment in patients with multiple sclerosis (MS). Multiple sclerosis is a chronic inflammatory disease of the central nervous system, with accumulating disability symptoms like spasticity, voiding disorders, depression, and pain might occur. The nationwide German MS registry was initiated 2001 under guidance of the German MS society (Deutsche MS Gesellschaft). This study was performed as an interim analysis to lay foundation for future work on this topic. A subcohort of 5113 patients was assessed for this interim analysis. The mean age of the patients was 45.3 years; mean EDSS was 4.2. More than two-third of the enrolled patients were females (70.9%). Most frequent symptoms were fatigue (60%), followed by spasticity (52.5%) and voiding disorders (51.7%). The likelihood of treatment was highest for epileptic disorders (68.8%), spasticity (68.5%), pain (60.7%), and depression (58.9%). Multivariate regression analysis showed that retirement was the strongest factor predictive for antispastic treatment (β=.061, P=.005). Almost all patients in this analysis suffer from symptoms due to advanced MS. Treatment for the various symptoms differed tremendously. The likelihood of treatment correlated with the availability of effective therapeutic agents. Clinicians should put more awareness on MS symptoms. Symptomatic treatment may improve quality of life. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  13. 76 FR 4369 - Interim Deputation Agreements; Interim BIA Adult Detention Facility Guidelines

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-25

    ... Adult Detention Facility Guidelines AGENCY: Bureau of Indian Affairs, Interior. ACTION: Notice. SUMMARY: This notice announces the online publication of the Interim BIA Adult Detention Facility Guidelines and... Indian Affairs Web site. DATES: These Interim BIA Adult Detention Facility Guidelines and Interim Model...

  14. U.S. Policy Toward the Israeli-Egyptian Conflict September 1970-February 1972: The Analysis of a Failure of American Diplomacy.

    DTIC Science & Technology

    1983-12-01

    opportunity existed in the Middle East for the conclusion of an interim settlement in the dispute between Egypt and Israel. Egyptian President Anwar el -Sadat...Richard M. Nixon; Henry A. Kissinger; William P. Rogers; Joseph Sisco; Donald Bergus; Michael Sterner; Golda Meir; Abba Eban; Moshe Dayan; Anwar el ...for the conclusion of an interim settlement in the dispute between Egypt and Israel. Egyptian President Anwar el -Sadat declared his willingness to

  15. Evaluation and Analysis of SEASAT-A Scanning Multichannel Microwave Radiometer (SSMR) Antenna Pattern Correction (APC) Algorithm. Sub-task 4: Interim Mode T Sub B Versus Cross and Nominal Mode T Sub B

    NASA Technical Reports Server (NTRS)

    Kitzis, J. L.; Kitzis, S. N.

    1979-01-01

    The brightness temperature data produced by the SMMR Antenna Pattern Correction algorithm are evaluated. The evaluation consists of: (1) a direct comparison of the outputs of the interim, cross, and nominal APC modes; (2) a refinement of the previously determined cos beta estimates; and (3) a comparison of the world brightness temperature (T sub B) map with actual SMMR measurements.

  16. KDHE Project Code: C6-074-00002: Progress and Monitoring Report for the LDB/SVE/AS System at the Former CCC/USDA Grain Storage Facility, Agra, Kansas, in January-June 2015

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

    LaFreniere, Lorraine M.

    In 2008-2009, to address the carbon tetrachloride contamination detected on its former property, the CCC/USDA implemented a source area cleanup in accord with the document Interim Measure Work Plan/Design for Agra, Kansas (IMWP/D; Argonne 2008). The cleanup involves five large-diameter boreholes (LDBs) coupled with soil vapor extraction (SVE) and air sparge (AS) systems. The work plan was approved by the Kansas Department of Health and Environment (KDHE) in November 2008 (KDHE 2008b), and operation began in May 2009.

  17. KDHE Project Code: C6-074-00002: Progress and Monitoring Report for the LDB/SVE/AS System at the Former CCC/USDA Grain Storage Facility, Agra, Kansas, in January-June 2013

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

    LaFreniere, Lorraine

    In 2008-2009, to address the carbon tetrachloride contamination detected on its former property, the CCC/USDA implemented a source area cleanup in accord with the document Interim Measure Work Plan/Design for Agra, Kansas (IMWP/D; Argonne 2008). The cleanup involves five large-diameter boreholes (LDBs) coupled with soil vapor extraction (SVE) and air sparging (AS). The work plan was approved by the Kansas Department of Health and Environment (KDHE) in November 2008 (KDHE 2008b), and operation began in May 2009.

  18. KDHE POroject Code: C6-074-00002: Progress and Monitoring Report for the LBD/SVE/AS System at the Former CCC/USDA Grain Storage Facility, Agra, Kansas, in January-June 2016

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

    LaFreniere, Lorraine M.

    In 2008-2009, to address the carbon tetrachloride contamination detected on its former property, the CCC/USDA implemented a source area cleanup in accord with the document Interim Measure Work Plan/Design for Agra, Kansas (IMWP/D; Argonne 2008). The cleanup involves five large-diameter boreholes (LDBs) coupled with soil vapor extraction (SVE) and air sparge (AS) systems. The work plan was approved by the Kansas Department of Health and Environment (KDHE) in November 2008 (KDHE 2008b), and operation began in May 2009.

  19. Modeling Parenting Programs as an Interim Service for Families Waiting for Children's Mental Health Treatment.

    PubMed

    Cunningham, Charles E; Rimas, Heather; Chen, Yvonne; Deal, Ken; McGrath, Patrick; Lingley-Pottie, Patricia; Reid, Graham J; Lipman, Ellen; Corkum, Penny

    2015-01-01

    Using a discrete choice conjoint experiment, we explored the design of parenting programs as an interim strategy for families waiting for children's mental health treatment. Latent class analysis yielded 4 segments with different design preferences. Simulations predicted the Fast-Paced Personal Contact segment, 22.1% of the sample, would prefer weekly therapist-led parenting groups. The Moderate-Paced Personal Contact segment (24.7%) preferred twice-monthly therapist-led parenting groups with twice-monthly lessons. The Moderate-Paced E-Contact segment (36.3%), preferred weekly to twice-monthly contacts, e-mail networking, and a program combining therapist-led sessions with the support of a computerized telephone e-coach. The Slow-Paced E-Contact segment (16.9%) preferred an approach combining monthly therapist-led sessions, e-coaching, and e-mail networking with other parents. Simulations predicted 45.3% of parents would utilize an option combining 5 therapist coaching calls with 5 e-coaching calls, a model that could reduce costs and extend the availability of interim services. Although 41.0% preferred weekly pacing, 58% were predicted to choose an interim parenting service conducted at a twice-monthly to monthly pace. The results of this study suggest that developing interim services reflecting parental preferences requires a choice of formats that includes parenting groups, telephone-coached distance programs, and e-coaching options conducted at a flexible pace.

  20. 24 CFR 35.820 - Interim controls.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Interim controls. 35.820 Section 35...-Possession Multifamily Property § 35.820 Interim controls. HUD shall conduct interim controls in accordance... accordance with § 35.815. Interim controls are considered completed when clearance is achieved in accordance...

  1. 24 CFR 35.820 - Interim controls.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 24 Housing and Urban Development 1 2012-04-01 2012-04-01 false Interim controls. 35.820 Section 35...-Possession Multifamily Property § 35.820 Interim controls. HUD shall conduct interim controls in accordance... accordance with § 35.815. Interim controls are considered completed when clearance is achieved in accordance...

  2. Whole-brain radiotherapy and high-dose methylprednisolone for elderly patients with primary central nervous system lymphoma: Results of North Central Cancer Treatment Group (NCCTG) 96-73-51

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

    Laack, Nadia N.; Ballman, Karla V.; Mayo Clinic Cancer Center, Rochester, MN

    Purpose: The aim of this study was to evaluate the efficacy, toxicity, and survival of whole-brain radiotherapy-treated (WBRT) and high-dose methylprednisolone (HDMP)-treated in elderly patients with primary central nervous system lymphoma (PCNSL). Methods and Materials: Patients with PCNSL who were 70 years and older received 1 g of methylprednisolone daily for 5 days, 30 days after WBRT. Patients then received 1 g of methylprednisolone every 28 days until progression. The primary endpoint was overall survival (OS) at 6 months. Results were compared with those in patients on the previous North Central Cancer Treatment Group (NCCTG) trial who received pre-WBRT cytoxan,more » adriamycin, vincristine, prednisone (CHOP) and high-dose cytarabine (CHOP-WBRT). A planned interim analysis was performed. The current regimen would be considered inactive if survival was not improved from patients treated with CHOP-WBRT. Results: Nineteen patients were accrued between 1998 and 2003. Median age was 76 years. Interim analysis revealed a 6-month survival of 33%, resulting in closure of the trial. Toxicity, OS, and event-free survival (EFS) were similar to those in patients more than 70 years of age who received CHOP-WBRT. The subgroup of patients who received HDMP had longer OS (12.1 vs. 7.0 months, p = 0.76) and EFS (11.7 vs. 4.0 months, p = 0.04) compared with the CHOP-WBRT patients alive 60 days after the start of treatment. Conclusions: Patients on-study long enough to receive HDMP had prolongation of OS and EFS compared to patients receiving CHOP-WBRT. Although the numbers of patients are too small for statistical conclusions, the HDMP regimen deserves further study.« less

  3. Health-related quality of life, cognitive screening, and functional status in a randomized phase III trial (EF-14) of tumor treating fields with temozolomide compared to temozolomide alone in newly diagnosed glioblastoma.

    PubMed

    Zhu, Jay-Jiguang; Demireva, Petya; Kanner, Andrew A; Pannullo, Susan; Mehdorn, Maximilian; Avgeropoulos, Nicholas; Salmaggi, Andrea; Silvani, Antonio; Goldlust, Samuel; David, Carlos; Benouaich-Amiel, Alexandra

    2017-12-01

    We characterized health-related quality of life (HRQoL), cognitive, and functional status in newly diagnosed glioblastoma (GBM) patients receiving Tumor treating fields (TTFields) with temozolomide (TMZ) versus TMZ alone in a planned interim analysis of a randomized phase III trial [NCT00916409], which showed significant improvement in progression-free and overall survival with TTFields/TMZ. After radiotherapy with concomitant TMZ, newly diagnosed GBM patients were randomized (2:1) to TTFields/TMZ (n = 210) or TMZ (n = 105). Interim analysis was performed in 315 patients with ≥18 months of follow-up. HRQoL, a secondary endpoint, was evaluated in per-protocol patient population and expressed as change from baseline (CFB) at 3, 6, and 9 months for each subscale in the EORTC QLQ-C30/BN20. Karnofsky performance scores (KPS) and Mini-Mental State Examination scores (MMSE) were assessed. CFB in HRQoL was balanced in treatment groups at the 12-month time point. Initially, HRQoL improved in patients treated with TTFields/TMZ (CFB3: 24% and CFB6: 13%) versus TMZ (CFB3: -7% and CFB6: -17%), though this difference was no longer evident at the 9-month point. General scales, including physical and social functioning, showed no difference at 9 and 12 months. TTFields/TMZ group reported higher concerns of "itchy skin". KPS over 12 months was just below 90 in both groups. Cognitive status (MMSE) was stable over time. HRQoL, KPS, and MMSE were balanced in both groups over time. There was no preliminary evidence that HRQoL, cognitive, and functional status is adversely affected by the continuous use of TTFields.

  4. Rolling out of kangaroo mother care in secondary level facilities in Bihar-Some experiences.

    PubMed

    Neogi, Sutapa B; Chauhan, Monika; Sharma, Jyoti; Negandhi, Preeti; Sethy, Ghanshyam

    2016-01-01

    Preterm birth is one of the leading causes of under-five child deaths worldwide and in India. Kangaroo mother care (KMC) is a powerful and easy-to-use method to promote health and well-being and reduce morbidity and mortality in preterm/low birth weight (LBW) babies. As the part of the roll-out of India Newborn Action Plan interventions, we implemented KMC in select facilities with an objective to assess the responsiveness of public health system to roll out KMC. KMC intervention was implemented in two select high priority districts, Gaya and Purnea in Bihar over the duration of 8 months from August 2015 to March 2016. The implementation of intervention was phased out into; situation analysis, implementation of intervention, and interim assessment. KMC model, as envisaged keeping in mind the building blocks of health system, was established in 6 identified health-care facilities. A pretested simple checklist was used to assess the awareness, knowledge, skills, and practice of KMC during baseline situational analysis and interim assessment phases for comparison. The intervention clearly seemed to improve the awareness among auxiliary nurse midwives/nurses about KMC. Improvements were also observed in the availability of infrastructure required for KMC and support logistics like facility for manual expression of breast milk, cups/suitable devices such as paladi cups for feeding small babies and digital weighing scale. Although the recording of information regarding LBW babies and KMC practice improved, still there is scope for much improvement. There is a commitment at the national level to promote KMC in every facility. The present experience shows the possibility of rolling out KMC in secondary level facilities with support from government functionaries.

  5. Energy policy act transportation study: Interim report on natural gas flows and rates

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

    NONE

    1995-11-17

    This report, Energy Policy Act Transportation Study: Interim Report on Natural Gas Flows and Rates, is the second in a series mandated by Title XIII, Section 1340, ``Establishment of Data Base and Study of Transportation Rates,`` of the Energy Policy Act of 1992 (P.L. 102--486). The first report Energy Policy Act Transportation Study: Availability of Data and Studies, was submitted to Congress in October 1993; it summarized data and studies that could be used to address the impact of legislative and regulatory actions on natural gas transportation rates and flow patterns. The current report presents an interim analysis of naturalmore » gas transportation rates and distribution patterns for the period from 1988 through 1994. A third and final report addressing the transportation rates and flows through 1997 is due to Congress in October 2000. This analysis relies on currently available data; no new data collection effort was undertaken. The need for the collection of additional data on transportation rates will be further addressed after this report, in consultation with the Congress, industry representatives, and in other public forums.« less

  6. Flight set 360L007 (STS-33) insulation component. Volume 3: Final release

    NASA Technical Reports Server (NTRS)

    Hicken, Steve

    1990-01-01

    Volume 3 of this postfire report deals with the insulation component of the RSRM. The report is released twice for each flight set. The interim release contract date is on or before 60 days after the last field joint or nozzle to case joint is disassembled at KSC and contain the results of the KSC visual evaluation. The data contained in Volume 3 interim release supersedes the insulation data presented in the KSC 10 day report. The final release contract data is on or before 60 days after the last factory joint is disassembled at the Clearfield H-7 facility and contains the results of all visual evaluations and a thermal safety factor analysis. The data contained in the Volume 3 final release supersedes the interim release and the insulation data presented in the Clearfield 10 day report.

  7. 75 FR 984 - Draft Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at CERCLA and RCRA Sites

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-07

    ... Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at CERCLA and RCRA Sites AGENCY... Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at Comprehensive Environmental Response... interim PRGs for dioxin in soil. These draft recommended interim PRGs were calculated using existing, peer...

  8. Predicting clinical trial results based on announcements of interim analyses

    PubMed Central

    2014-01-01

    Background Announcements of interim analyses of a clinical trial convey information about the results beyond the trial’s Data Safety Monitoring Board (DSMB). The amount of information conveyed may be minimal, but the fact that none of the trial’s stopping boundaries has been crossed implies that the experimental therapy is neither extremely effective nor hopeless. Predicting success of the ongoing trial is of interest to the trial’s sponsor, the medical community, pharmaceutical companies, and investors. We determine the probability of trial success by quantifying only the publicly available information from interim analyses of an ongoing trial. We illustrate our method in the context of the National Surgical Adjuvant Breast and Bowel (NSABP) trial, C-08. Methods We simulated trials based on the specifics of the NSABP C-08 protocol that were publicly available. We quantified the uncertainty around the treatment effect using prior weights for the various possibilities in light of other colon cancer studies and other studies of the investigational agent, bevacizumab. We considered alternative prior distributions. Results Subsequent to the trial’s third interim analysis, our predictive probabilities were: that the trial would eventually be successful, 48.0%; would stop for futility, 7.4%; and would continue to completion without statistical significance, 44.5%. The actual trial continued to completion without statistical significance. Conclusions Announcements of interim analyses provide information outside the DSMB’s sphere of confidentiality. This information is potentially helpful to clinical trial prognosticators. ‘Information leakage’ from standard interim analyses such as in NSABP C-08 is conventionally viewed as acceptable even though it may be quite revealing. Whether leakage from more aggressive types of adaptations is acceptable should be assessed at the design stage. PMID:24607270

  9. Comparisons of the tropospheric specific humidity from GPS radio occultations with ERA-Interim, NASA MERRA, and AIRS data

    NASA Astrophysics Data System (ADS)

    Vergados, Panagiotis; Mannucci, Anthony J.; Ao, Chi O.; Verkhoglyadova, Olga; Iijima, Byron

    2018-03-01

    We construct a 9-year data record (2007-2015) of the tropospheric specific humidity using Global Positioning System radio occultation (GPS RO) observations from the Constellation Observing System for Meteorology, Ionosphere, and Climate (COSMIC) mission. This record covers the ±40° latitude belt and includes estimates of the zonally averaged monthly mean specific humidity from 700 up to 400 hPa. It includes three major climate zones: (a) the deep tropics (±15°), (b) the trade winds belts (±15-30°), and (c) the subtropics (±30-40°). We find that the RO observations agree very well with the European Centre for Medium-Range Weather Forecasts Re-Analysis Interim (ERA-Interim), the Modern-Era Retrospective Analysis for Research and Applications (MERRA), and the Atmospheric Infrared Sounder (AIRS) by capturing similar magnitudes and patterns of variability in the monthly zonal mean specific humidity and interannual anomaly over annual and interannual timescales. The JPL and UCAR specific humidity climatologies differ by less than 15 % (depending on location and pressure level), primarily due to differences in the retrieved refractivity. In the middle-to-upper troposphere, in all climate zones, JPL is the wettest of all data sets, AIRS is the driest of all data sets, and UCAR, ERA-Interim, and MERRA are in very good agreement, lying between the JPL and AIRS climatologies. In the lower-to-middle troposphere, we present a complex behavior of discrepancies, and we speculate that this might be due to convection and entrainment. Conclusively, the RO observations could potentially be used as a climate variable, but more thorough analysis is required to assess the structural uncertainty between centers and its origin.

  10. Population and harvest trends of big game and small game species: a technical document supporting the USDA Forest Service Interim Update of the 2000 RPA Assessment

    Treesearch

    Curtis H. Flather; Michael S. Knowles; Stephen J. Brady

    2009-01-01

    This technical document supports the Forest Service's requirement to assess the status of renewable natural resources as mandated by the Forest and Rangeland Renewable Resources Planning Act of 1974 (RPA). It updates past reports on national and regional trends in population and harvest estimates for species classified as big game and small game. The trends...

  11. Interim Feasibility Report and Draft Environmental Impact Statement, Grays Harbor, Chehalis and Hoquiam Rivers, Washington, Channel Improvements for Navigation.

    DTIC Science & Technology

    1982-06-01

    these conditions . Therefore, the no-action plan is not being recommended. With the present channel conditions and anticipated slow growth for... conditions very similar to those of today. No ocean disposal is anticipated. Because no significant growth in socioeconomic activity is expected without...accuracy; however, project construction provides conditions favorable for growth . The service industry would be expected to closely follow any increase

  12. The Road to a College Diploma: The Complex Reality of Raising Educational Achievement for Hispanics in the United States. An Interim Report of the President's Advisory Commission on Educational Excellence for Hispanic Americans.

    ERIC Educational Resources Information Center

    White House Initiative on Educational Excellence for Hispanic Americans, Washington, DC.

    In 2001, the President's Advisory Commission on Educational Excellence for Hispanic Americans was created to develop a multi-year plan for closing the achievement gap facing Hispanic Americans and attaining the goals established by the 2001 No Child Left Behind Act. The Commission defined five strategic imperatives: coordinating a national…

  13. Overall Quality Assurance Project Plan, Remedial Investigation/Feasibility Study Fort Sheridan, Illinois, Volume 1.

    DTIC Science & Technology

    1995-03-15

    billion volume ppm parts per million PT pole-mounted PTFE polytetrafluoro-ethylene PUF polyurethane foam PVC polyvinyl chloride QA quality assurance...and Illinois Environmental Protection Agency (IEPA) quality assurance (QA) objectives. The format of the OQAPP is based on "Interim Guidelines and...County. The till material deposited in the Fort Sheridan region has been classified as the Wadsworth Till Member of the Wedron Formation . This till

  14. Application of fuzzy logic-neural network based reinforcement learning to proximity and docking operations

    NASA Technical Reports Server (NTRS)

    Jani, Yashvant

    1992-01-01

    As part of the Research Institute for Computing and Information Systems (RICIS) activity, the reinforcement learning techniques developed at Ames Research Center are being applied to proximity and docking operations using the Shuttle and Solar Max satellite simulation. This activity is carried out in the software technology laboratory utilizing the Orbital Operations Simulator (OOS). This interim report provides the status of the project and outlines the future plans.

  15. 40 CFR 57.803 - Issuance of tentative determination; notice.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... determination. (1) The EPA staff shall formulate and prepare: (i) A “Staff Computational Analysis,” using the... Computational Analysis, discussing the estimated cost of interim controls, and assessing the effect upon the...

  16. 40 CFR 57.803 - Issuance of tentative determination; notice.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... determination. (1) The EPA staff shall formulate and prepare: (i) A “Staff Computational Analysis,” using the... Computational Analysis, discussing the estimated cost of interim controls, and assessing the effect upon the...

  17. 40 CFR 57.803 - Issuance of tentative determination; notice.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... determination. (1) The EPA staff shall formulate and prepare: (i) A “Staff Computational Analysis,” using the... Computational Analysis, discussing the estimated cost of interim controls, and assessing the effect upon the...

  18. 40 CFR 57.803 - Issuance of tentative determination; notice.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... determination. (1) The EPA staff shall formulate and prepare: (i) A “Staff Computational Analysis,” using the... Computational Analysis, discussing the estimated cost of interim controls, and assessing the effect upon the...

  19. Modified Interim Mandibular Advancement (MIMA) Appliance for Symptomatic Correction of Obstructive Sleep Apnea

    PubMed Central

    Singh, Harpreet; Mishra, Harsh Ashok; Gupta, Ankur

    2016-01-01

    Obstructive Sleep Apnea (OSA) is a chronic, progressive, multifactorial, life-threatening disorder that causes significant impact on patient’s life. Patients with OSA [Apnea/Hypopnea Index (AHI)>30] who cannot tolerate Continuous Positive Airway Pressure (CPAP) therapy or are not surgical candidates may benefit from oral appliances. This paper describes interim appliance devised from existing Hawley’s retainer in patients with OSA. A 38-year-old man of athletic built with history of orthodontic treatment six months back due to esthetic concerns and wearing upper Hawley’s retainer, reported with chief complaint of frequent nocturnal awakening along with excessive daytime somnolence. Based on diagnostic aids, he was diagnosed with Class II Division 1 malocclusion with severe mandibular retrusion. Sleep test revealed AHI score of 34, suggestive of severe OSA. With ENT and Oral surgeon concurrence, mandibular advancement of 7mm with Bilateral Sagital Split Osteotomy (BSSO) with distraction was contemplated as a viable functional and curative stable treatment plan. Because of non-adherence and non-compliance with CPAP therapy and on request of patient, an interim anterior positioning appliance was devised to facilitate comfortable sound sleep till the time surgery is impending. After three months of wearing this customized appliance, improved quality of sleep was discernible; both subjectively as reported by patient and objectively using sleep test (AHI=9.8). PMID:27656589

  20. The atmospheric effects of stratospheric aircraft: A fourth program report

    NASA Technical Reports Server (NTRS)

    Stolarski, Richard S. (Editor); Wesoky, Howard L. (Editor); Wofsy, Steven C.; Ravishankara, A. R.; Rodriguez, Jose M.; Grose, William L.

    1995-01-01

    This document presents the fourth report from the Atmospheric Effects of Stratospheric Aircraft (AESA) component of NASA's High-Speed Research Program (HSRP). Market and technology considerations continue to provide an impetus for high-speed civil transport research. A recent AESA interim assessment report and a review of that report have shown that considerable uncertainty still exists about the possible impact of aircraft on the atmosphere. The AESA has been designed to develop the body of scientific knowledge necessary for the evaluation of the impact of stratospheric aircraft on the atmosphere. The first Program report presented the basic objectives and plans for AESA. This fourth report comes after the interim assessment and sets forth directions for the 1995 assessment at the end of AESA Phase 1. It also sets forth the goals and directions for AESA Phase 2, as reported at the 1994 Atmospheric Effects of Aviation Project (AEAP) annual meeting held in June. The focus of the Phase 2 effort is to obtain the best possible closure on the outstanding problems identified in the interim assessment and NASA/NRC review. Topics discussed in this report include how high-speed civil transports (HSCT) might affect stratospheric ozone, emissions scenarios and databases to assess potential atmospheric effects from HSCT's, calculated results from 2-D zonal mean models using emissions data, engine trace constituent measurements.

  1. Sampling and Analysis Plan for U.S. Department of Energy Office of Legacy Management Sites

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

    None

    2012-10-24

    This plan incorporates U.S. Department of Energy (DOE) Office of Legacy Management (LM) standard operating procedures (SOPs) into environmental monitoring activities and will be implemented at all sites managed by LM. This document provides detailed procedures for the field sampling teams so that samples are collected in a consistent and technically defensible manner. Site-specific plans (e.g., long-term surveillance and maintenance plans, environmental monitoring plans) document background information and establish the basis for sampling and monitoring activities. Information will be included in site-specific tabbed sections to this plan, which identify sample locations, sample frequencies, types of samples, field measurements, and associatedmore » analytes for each site. Additionally, within each tabbed section, program directives will be included, when developed, to establish additional site-specific requirements to modify or clarify requirements in this plan as they apply to the corresponding site. A flowchart detailing project tasks required to accomplish routine sampling is displayed in Figure 1. LM environmental procedures are contained in the Environmental Procedures Catalog (LMS/PRO/S04325), which incorporates American Society for Testing and Materials (ASTM), DOE, and U.S. Environmental Protection Agency (EPA) guidance. Specific procedures used for groundwater and surface water monitoring are included in Appendix A. If other environmental media are monitored, SOPs used for air, soil/sediment, and biota monitoring can be found in the site-specific tabbed sections in Appendix D or in site-specific documents. The procedures in the Environmental Procedures Catalog are intended as general guidance and require additional detail from planning documents in order to be complete; the following sections fulfill that function and specify additional procedural requirements to form SOPs. Routine revision of this Sampling and Analysis Plan will be conducted annually at the beginning of each fiscal year when attachments in Appendix D, including program directives and sampling location/analytical tables, will be reviewed by project personnel and updated. The sampling location/analytical tables in Appendix D, however, may have interim updates according to project direction that are not reflected in this plan. Deviations from location/analytical tables in Appendix D prior to sampling will be documented in project correspondence (e.g., startup letters). If significant changes to other aspects of this plan are required before the annual update, then the plan will be revised as needed.« less

  2. Interim analysis of survival in a prospective, multi-center registry cohort of cutaneous melanoma tested with a prognostic 31-gene expression profile test.

    PubMed

    Hsueh, Eddy C; DeBloom, James R; Lee, Jonathan; Sussman, Jeffrey J; Covington, Kyle R; Middlebrook, Brooke; Johnson, Clare; Cook, Robert W; Slingluff, Craig L; McMasters, Kelly M

    2017-08-29

    A 31-gene expression profile (GEP) test that provides risk classification of cutaneous melanoma (CM) patients has been validated in several retrospective studies. The objective of the reported study was a prospective evaluation of the GEP performance in patients enrolled in two clinical registries. Three-hundred twenty two CM patients enrolled in the EXPAND (NCT02355587) and INTEGRATE (NCT02355574) registries met the criteria of age ≥ 16 years, successful GEP result and ≥1 follow-up visit for inclusion in this interim analysis. Primary endpoints were recurrence-free (RFS), distant metastasis-free (DMFS), and overall survival (OS). Median follow-up was 1.5 years for event-free patients. Median age for subjects was 58 years (range 18-87) and median Breslow thickness was 1.2 mm (range 0.2-12.0). Eighty-eight percent (282/322) of cases had stage I/II disease and 74% (237/322) had a SLN biopsy. Seventy-seven percent (248/322) had class 1 molecular profiles. 1.5-year RFS, DMFS, and OS rates were 97 vs. 77%, 99 vs. 89%, and 99 vs. 92% for class 1 vs. class 2, respectively (p < 0.0001 for each). Multivariate Cox regression showed Breslow thickness, mitotic rate, and GEP class to significantly predict recurrence (p < 0.01), while tumor thickness was the only significant predictor of distant metastasis and overall survival in this interim analysis. Interim analysis of patient outcomes from a combined prospective cohort supports the 31-gene GEP's ability to stratify early-stage CM patients into two groups with significantly different metastatic risk. RFS outcomes in this real-world cohort are consistent with previously published analyses with retrospective specimens. GEP testing complements current clinicopathologic features and increases identification of high-risk patients. ClinicalTrials.gov, NCT02355574  and NCT02355587.

  3. Using phase II data for the analysis of phase III studies: An application in rare diseases.

    PubMed

    Wandel, Simon; Neuenschwander, Beat; Röver, Christian; Friede, Tim

    2017-06-01

    Clinical research and drug development in orphan diseases are challenging, since large-scale randomized studies are difficult to conduct. Formally synthesizing the evidence is therefore of great value, yet this is rarely done in the drug-approval process. Phase III designs that make better use of phase II data can facilitate drug development in orphan diseases. A Bayesian meta-analytic approach is used to inform the phase III study with phase II data. It is particularly attractive, since uncertainty of between-trial heterogeneity can be dealt with probabilistically, which is critical if the number of studies is small. Furthermore, it allows quantifying and discounting the phase II data through the predictive distribution relevant for phase III. A phase III design is proposed which uses the phase II data and considers approval based on a phase III interim analysis. The design is illustrated with a non-inferiority case study from a Food and Drug Administration approval in herpetic keratitis (an orphan disease). Design operating characteristics are compared to those of a traditional design, which ignores the phase II data. An analysis of the phase II data reveals good but insufficient evidence for non-inferiority, highlighting the need for a phase III study. For the phase III study supported by phase II data, the interim analysis is based on half of the patients. For this design, the meta-analytic interim results are conclusive and would justify approval. In contrast, based on the phase III data only, interim results are inconclusive and require further evidence. To accelerate drug development for orphan diseases, innovative study designs and appropriate methodology are needed. Taking advantage of randomized phase II data when analyzing phase III studies looks promising because the evidence from phase II supports informed decision-making. The implementation of the Bayesian design is straightforward with public software such as R.

  4. Flight Set 360T004 (STS-30) Insulation Component, Interim Release, Volume 3

    NASA Technical Reports Server (NTRS)

    Passman, James A.

    1989-01-01

    The insulation component of the Redesigned Solid Rocket Motor (RSRM) is discussed. The results of all visual evaluations and a thermal safety factor analysis are given. The data contained here supersedes the interim release and the insulation data presented in the Clearfield 10 day report. The objective is to document the postflight condition of the internal and external insulation of nozzle to case joints, the case field joints, the igniter to case joints, and the acreage insulation which made up RSRM-4A and RSRM-4B.

  5. Interim Calibration Report for the SMMR Simulator

    NASA Technical Reports Server (NTRS)

    Gloersen, P.; Cavalieri, D.

    1979-01-01

    The calibration data obtained during the fall 1978 Nimbus-G underflight mission with the scanning multichannel microwave radiometer (SMMR) simulator on board the NASA CV-990 aircraft were analyzed and an interim calibration algorithm was developed. Data selected for the analysis consisted of in flight sky, first-year sea ice, and open water observations, as well as ground based observations of fixed targets with varied temperatures of selected instrument components. For most of the SMMR channels, a good fit to the selected data set was obtained with the algorithm.

  6. Remedial investigation work plan for Bear Creek Valley Operable Unit 1 (S-3 Ponds, Boneyard/Burnyard, Oil Landfarm, Sanitary Landfill 1, and the Burial Grounds, including Oil Retention Ponds 1 and 2) at the Oak Ridge Y-12 Plant, Oak Ridge, Tennessee. Volume 1, Main text

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

    Not Available

    1993-09-01

    The intent and scope of the work plan are to assemble all data necessary to facilitate selection of remediation alternatives for the sites in Bear Creek Valley Operable Unit 1 (BCV OU 1) such that the risk to human health and the environment is reduced to acceptable levels based on agreements with regulators. The ultimate goal is to develop a final Record Of Decision (ROD) for all of the OUs in BCV, including the integrator OU. However, the initial aim of the source OUs is to develop a ROD for interim measures. For source OUs such as BCV OU 1,more » data acquisition will not be carried out in a single event, but will be carried out in three stages that accommodate the schedule for developing a ROD for interim measures and the final site-wide ROD. The three stages are as follows: Stage 1, Assemble sufficient data to support decisions such as the need for removal actions, whether to continue with the remedial investigation (RI) process, or whether no further action is required. If the decision is made to continue the RI/FS process, then: Stage 2, Assemble sufficient data to allow for a ROD for interim measures that reduce risks to the human health and the environment. Stage 3, Provide input from the source OU that allows a final ROD to be issued for all OUs in the BCV hydrologic regime. One goal of the RI work plan will be to ensure that sampling operations required for the initial stage are not repeated at later stages. The overall goals of this RI are to define the nature and extent of contamination so that the impact of leachate, surface water runoff, and sediment from the OU I sites on the integrator OU can be evaluated, the risk to human health and the environment can be defined, and the general physical characteristics of the subsurface can be determined such that remedial alternatives can be screened.« less

  7. Creation of a 3-dimensional virtual dental patient for computer-guided surgery and CAD-CAM interim complete removable and fixed dental prostheses: A clinical report.

    PubMed

    Harris, Bryan T; Montero, Daniel; Grant, Gerald T; Morton, Dean; Llop, Daniel R; Lin, Wei-Shao

    2017-02-01

    This clinical report proposes a digital workflow using 2-dimensional (2D) digital photographs, a 3D extraoral facial scan, and cone beam computed tomography (CBCT) volumetric data to create a 3D virtual patient with craniofacial hard tissue, remaining dentition (including surrounding intraoral soft tissue), and the realistic appearance of facial soft tissue at an exaggerated smile under static conditions. The 3D virtual patient was used to assist the virtual diagnostic tooth arrangement process, providing patient with a pleasing preoperative virtual smile design that harmonized with facial features. The 3D virtual patient was also used to gain patient's pretreatment approval (as a communication tool), design a prosthetically driven surgical plan for computer-guided implant surgery, and fabricate the computer-aided design and computer-aided manufacturing (CAD-CAM) interim prostheses. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  8. Interim Safe Storage of Plutonium Production Reactors at the US DOE Hanford Site - 13438

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

    Schilperoort, Daryl L.; Faulk, Darrin

    2013-07-01

    Nine plutonium production reactors located on DOE's Hanford Site are being placed into an Interim Safe Storage (ISS) period that extends to 2068. The Environmental Impact Statement (EIS) for ISS [1] was completed in 1993 and proposed a 75-year storage period that began when the EIS was finalized. Remote electronic monitoring of the temperature and water level alarms inside the safe storage enclosure (SSE) with visual inspection inside the SSE every 5 years are the only planned operational activities during this ISS period. At the end of the ISS period, the reactor cores will be removed intact and buried inmore » a landfill on the Hanford Site. The ISS period allows for radioactive decay of isotopes, primarily Co-60 and Cs-137, to reduce the dose exposure during disposal of the reactor cores. Six of the nine reactors have been placed into ISS by having an SSE constructed around the reactor core. (authors)« less

  9. Coverage of Certain Preventive Services Under the Affordable Care Act. Final rules.

    PubMed

    2015-07-14

    This document contains final regulations regarding coverage of certain preventive services under section 2713 of the Public Health Service Act (PHS Act), added by the Patient Protection and Affordable Care Act, as amended, and incorporated into the Employee Retirement Income Security Act of 1974 and the Internal Revenue Code. Section 2713 of the PHS Act requires coverage without cost sharing of certain preventive health services by non-grandfathered group health plans and health insurance coverage. These regulations finalize provisions from three rulemaking actions: Interim final regulations issued in July 2010 related to coverage of preventive services, interim final regulations issued in August 2014 related to the process an eligible organization uses to provide notice of its religious objection to the coverage of contraceptive services, and proposed regulations issued in August 2014 related to the definition of "eligible organization,'' which would expand the set of entities that may avail themselves of an accommodation with respect to the coverage of contraceptive services.

  10. Interim report on pandemic H1N1 influenza virus infections in South Africa, April to October 2009: epidemiology and factors associated with fatal cases.

    PubMed

    Archer, Bn; Cohen, C; Naidoo, D; Thomas, J; Makunga, C; Blumberg, L; Venter, M; Timothy, Ga; Puren, A; McAnerney, Jm; Cengimbo, A; Schoub, Bd

    2009-10-22

    We provide an interim report on pandemic H1N1 influenza activity in South Africa, with a focus on the epidemiology and factors associated with deaths. Following the importation of the virus on 14 July 2009, and the epidemic peak during the week starting 3 August, the incidence in South Africa has declined. A total of 12,331 cases and 91 deaths have been laboratory-confirmed as of 12 October 2009. Age distribution and risk groups were similar to those observed elsewhere. The median age of patients who died (33.5 years) was significantly higher than that of the non-fatal cases (15.0 years, p<0.01). The most common underlying conditions among fatal cases were infection with human immunodeficiency virus (17/32 tested) and pregnancy (25/45 women of reproductive age). Active tuberculosis coinfection was present in seven of 72 fatal cases. These findings should be taken into consideration when planning vaccination strategies for 2010.

  11. Oral features and computerized rehabilitation of a young patient with CHARGE syndrome using minimally invasive long-term interim CAD-CAM restorations.

    PubMed

    Liebermann, Anja; Rafael, Caroline Freitas; Edelhoff, Daniel; Ramberger, Marc; Schweiger, Josef; Maziero Volpato, Claudia Angela; Saeidi Pour, Reza

    2017-04-01

    Patients with CHARGE syndrome (where CHARGE stands for coloboma of the iris or retina, heart defects or cardiac malformations, atresia/stenosis of the choanae, retardation of growth and development, genital anomalies, and ear abnormalities) present several orofacial anomalies. Their treatment depends on the specific type of manifestation. To perform the complex oral rehabilitation and achieve a conservative, esthetic, and functional exploration of the definitive treatment goal, computer-aided design and computer-aided manufacturing (CAD-CAM) polymers can be used as long-term interim restorations. This article reports the treatment of a young patient with CHARGE syndrome combined with oral alterations. CAD-CAM polymers offer an intermediate treatment with satisfying esthetics and function at low biological cost until bone growth is completed. This period facilitates additional planning for the definitive restoration. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  12. IVHS Countermeasures for Rear-End Collision, Task 1 Vol. V: 1985 NASS Case Analysis

    DOT National Transportation Integrated Search

    1994-02-15

    The Task 1 Interim Report consists of six volumes. This Volume, Volume V, 1985 NASS Analysis, presents the results of the analysis of the 1985 NASS crash data. Data from 1985 was selected for analysis because it provided more insight into roadway var...

  13. Exploring approaches to the administration of a long-term care facility: The application of a community planning and development process.

    PubMed

    Caldwell, W J

    1996-01-01

    This article outlines the approaches taken to the management of two long-term care facilities by the County of Huron in southwestern Ontario in 1994. Lay-offs, a move to new facilities, loss of local political confidence, changes in key administrative personnel and low staff morale prompted the county to ask an interim administrative team to develop and implement an appropriate response. The article explains how community development and planning principles and techniques were applied to the management of the homes to achieve an overall improvement in communication, staff morale and attitude. These approaches may prove helpful to other administrations facing major change.

  14. Remedial Investigation/Feasibility Study/Interim Response Actions

    DTIC Science & Technology

    1988-03-25

    organosulfur compounds (CC/FP), organophosphorus compounds (CC/FPD), hydrocarbons (CC/FID), volatile aromatic compounds (GC/ PID ), volatile halogenated...ICP metals, mercury and arsenic (AA). Water samples are being analyzed for volatile halogenated organics (GC/CON), volatile aromatic organics (GC/ PID ...Feb Mar Apr May Jun Jul Aug SepSI - I I I I I • .. I I I ----+----- 685 27-90 so ONSITE DISPOSAL FACILITY .i * 686 27-01 Prep FLUE Plan Fz=m8u> 6e7

  15. Progress on plutonium stabilization

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

    Hurt, D.

    1996-05-01

    The Defense Nuclear Facilities Safety Board has safety oversight responsibility for most of the facilities where unstable forms of plutonium are being processed and packaged for interim storage. The Board has issued recommendations on plutonium stabilization and has has a considerable influence on DOE`s stabilization schedules and priorities. The Board has not made any recommendations on long-term plutonium disposition, although it may get more involved in the future if DOE develops plans to use defense nuclear facilities for disposition activities.

  16. Summary of Federal Aviation Administration Responses to National Transportation Safety Board Safety Recommendations.

    DTIC Science & Technology

    1981-01-01

    NASA was already being incorporated by several equipment manufacturers in their own development plans. A-78-29. In the interim, amend 14 CFR to...not necessary. Research and development previously accomplished by the U.S. Army and by NASA was already being incorporated by several equipment...by industry., On July 12, our Bureau of Technology hosted a U.S. Army/FAA/ NASA meeting to brief FAA and NASA representatives, at the technical level

  17. Study of water supply & sanitation practices in India using geographic information systems: some design & other considerations in a village setting.

    PubMed

    Gopal, Srila; Sarkar, Rajiv; Banda, Kalyan; Govindarajan, Jeyanthi; Harijan, B B; Jeyakumar, M B; Mitta, Philip; Sadanala, M E; Selwyn, Tryphena; Suresh, C R; Thomas, V A; Devadason, Pethuru; Kumar, Ranjit; Selvapandian, David; Kang, Gagandeep; Balraj, Vinohar

    2009-03-01

    Availability of clean water and adequate sanitation facilities are of prime importance for limiting diarrhoeal diseases. We examined the water and sanitation facilities of a village in southern India using geographic information system (GIS) tools. Places of residence, water storage and distribution, sewage and places where people in the village defaecated were mapped and drinking water sources were tested for microbial contamination in Nelvoy village, Vellore district, Tamil Nadu. Water in the village was found to be microbiologically unfit for consumption. Analysis using direct observations supplemented by GIS maps revealed poor planning, poor engineering design and lack of policing of the water distribution system causing possible contamination of drinking water from sewage at multiple sites. Until appropriate engineering designs for water supply and sewage disposal to suit individual village needs are made available, point-of-use water disinfection methods could serve as an interim solution.

  18. 5 CFR 772.102 - Interim personnel actions.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 2 2011-01-01 2011-01-01 false Interim personnel actions. 772.102 Section 772.102 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS (CONTINUED) INTERIM RELIEF General § 772.102 Interim personnel actions. When an employee or...

  19. 5 CFR 772.102 - Interim personnel actions.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Interim personnel actions. 772.102 Section 772.102 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS (CONTINUED) INTERIM RELIEF General § 772.102 Interim personnel actions. When an employee or...

  20. Certification and verification for Northrup model NSC-01-0732 fresnel lens concentrating solar collector

    NASA Technical Reports Server (NTRS)

    1979-01-01

    Structural analysis and certification of the collector system is presented. System verification against the interim performance criteria is presented and indicated by matrices. The verification discussion, analysis, and test results are also given.

  1. Empowering members of a rural southern community in Nigeria to plan to take action to prevent maternal mortality: A participatory action research project.

    PubMed

    Esienumoh, Ekpoanwan E; Allotey, Janette; Waterman, Heather

    2018-04-01

    To facilitate the empowerment of members of a rural community to plan to take action to prevent maternal mortality. Globally, about 300,000 maternal deaths occur yearly. Sub-Saharan Africa and Southern Asia regions account for almost all the deaths. Within those regions, India and Nigeria account for over a third of the global maternal deaths. Problem of maternal mortality in Nigeria is multifaceted. About 80% of maternal deaths are avoidable, given strategies which include skilled attendants, emergency obstetric care and community mobilisation. In this article, a strategy of community empowerment to plan to take action to prevent maternal mortality is discussed. Participatory action research was used. Twelve volunteers were recruited as coresearchers into the study through purposive and snowball sampling who, following an orientation workshop, undertook participatory qualitative data collection with an additional 29 community members. Participatory thematic analysis of the data was undertaken which formed the basis of the plan of action. Community members attributed maternal morbidities and deaths to superstitious causes, delayed referrals by traditional birth attendants, poor transportation and poor resourcing of health facilities. Following critical reflection, actions were planned to empower the people to prevent maternal deaths through community education and advocacy meetings with stakeholders to improve health and transportation infrastructures; training of existing traditional birth attendants in the interim and initiating their collaboration with skilled birth attendants. The community is a resource which if mobilised through the process of participatory action research can be empowered to plan to take action in collaboration with skilled birth attendants to prevent maternal mortality. Interventions to prevent maternal deaths should include community empowerment to have better understanding of their circumstances as well as their collaboration with health professionals. © 2018 John Wiley & Sons Ltd.

  2. Cassini Camera Contamination Anomaly: Experiences and Lessons Learned

    NASA Technical Reports Server (NTRS)

    Haemmerle, Vance R.; Gerhard, James H.

    2006-01-01

    We discuss the contamination 'Haze' anomaly for the Cassini Narrow Angle Camera (NAC), one of two optical telescopes that comprise the Imaging Science Subsystem (ISS). Cassini is a Saturn Orbiter with a 4-year nominal mission. The incident occurred in 2001, five months after Jupiter encounter during the Cruise phase and ironically at the resumption of planned maintenance decontamination cycles. The degraded optical performance was first identified by the Instrument Operations Team with the first ISS Saturn imaging six weeks later. A distinct haze of varying size from image to image marred the images of Saturn. A photometric star calibration of the Pleiades, 4 days after the incident, showed stars with halos. Analysis showed that while the halo's intensity was only 1 - 2% of the intensity of the central peak of a star, the halo contained 30 - 70% of its integrated flux. This condition would impact science return. In a review of our experiences, we examine the contamination control plan, discuss the analysis of the limited data available and describe the one-year campaign to remove the haze from the camera. After several long conservative heating activities and interim analysis of their results, the contamination problem as measured by the camera's point spread function was essentially back to preanomaly size and at a point where there would be more risk to continue. We stress the importance of the flexibility of operations and instrument design, the need to do early infight instrument calibration and continual monitoring of instrument performance.

  3. Interim Expertise

    ERIC Educational Resources Information Center

    Anyaso, Hilary Hurd

    2009-01-01

    The Registry for College and University Presidents places former executives in interim presidential and other senior-level posts and is familiar with the challenges interim executives and institutions encounter in times of leadership transitions. However, the one big advantage interims bring to institutions, says Registry Vice President Kevin J.…

  4. 40 CFR 155.56 - Interim registration review decision.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Interim registration review decision... PROGRAMS REGISTRATION STANDARDS AND REGISTRATION REVIEW Registration Review Procedures § 155.56 Interim registration review decision. The Agency may issue, when it determines it to be appropriate, an interim...

  5. 17 CFR 210.8-03 - Interim financial statements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (§ 249.308(a) of this chapter) must be reviewed by an independent public accountant using professional... interim financial statements have been reviewed by an independent public accountant, a report of the accountant on the review must be filed with the interim financial statements. Interim financial statements...

  6. 24 CFR 35.1330 - Interim controls.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 24 Housing and Urban Development 1 2012-04-01 2012-04-01 false Interim controls. 35.1330 Section... Lead-Paint Hazard Evaluation and Hazard Reduction Activities § 35.1330 Interim controls. Interim controls of lead-based paint hazards identified in a risk assessment shall be conducted in accordance with...

  7. 7 CFR 1738.21 - Interim financing.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Interim financing. 1738.21 Section 1738.21... Interim financing. (a) Upon notification by RUS that an applicant's application is considered complete, the applicant may enter into an interim financing agreement with a lender other than RUS or use its...

  8. An Approach for Evaluating the Technical Quality of Interim Assessments

    ERIC Educational Resources Information Center

    Li, Ying; Marion, Scott; Perie, Marianne; Gong, Brian

    2010-01-01

    Increasing numbers of schools and districts have expressed interest in interim assessment systems to prepare for summative assessments and to improve teaching and learning. However, with so many commercial interim assessments available, schools and districts are struggling to determine which interim assessment is most appropriate to their needs.…

  9. 47 CFR 51.611 - Interim wholesale rates.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... selecting a particular discount rate. The same discount percentage rate shall be used to establish interim... 47 Telecommunication 3 2010-10-01 2010-10-01 false Interim wholesale rates. 51.611 Section 51.611... Resale § 51.611 Interim wholesale rates. (a) If a state commission cannot, based on the information...

  10. 7 CFR 15a.71 - Interim procedures.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 1 2010-01-01 2010-01-01 false Interim procedures. 15a.71 Section 15a.71 Agriculture Office of the Secretary of Agriculture EDUCATION PROGRAMS OR ACTIVITIES RECEIVING OR BENEFITTING FROM FEDERAL FINANCIAL ASSISTANCE Procedures (Interim) § 15a.71 Interim procedures. For the purposes of...

  11. 77 FR 55230 - Japan Lessons-Learned Project Directorate Interim Staff Guidance JLD-ISG-2012-01; Compliance With...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-07

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0068] Japan Lessons-Learned Project Directorate Interim... Commission (NRC). ACTION: Japan Lessons-Learned Project Directorate interim staff guidance; issuance. SUMMARY...-Learned Project Directorate Interim Staff Guidance (JLD-ISG), JLD-ISG-2012-01, ``Compliance with Order EA...

  12. 77 FR 55231 - Japan Lessons-Learned Project Directorate Interim Staff Guidance JLD-ISG-2012-02; Compliance With...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-07

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0069] Japan Lessons-Learned Project Directorate Interim...-Learned Project Directorate interim staff guidance; issuance. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or the Commission) is issuing the Final Japan Lessons-Learned Project Directorate Interim...

  13. 7 CFR 1735.75 - Interim financing.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Interim financing. 1735.75 Section 1735.75... Involving Loan Funds § 1735.75 Interim financing. (a) A borrower may submit a written request for RUS approval of interim financing if it is necessary to close an acquisition before the loan to finance the...

  14. 13 CFR 120.890 - Source of interim financing.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ....890 Section 120.890 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION BUSINESS LOANS Development Company Loan Program (504) Interim Financing § 120.890 Source of interim financing. A Project may... experience or qualifications, SBA may require the interim loan to be managed by a third party such as a bank...

  15. 13 CFR 120.890 - Source of interim financing.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ....890 Section 120.890 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION BUSINESS LOANS Development Company Loan Program (504) Interim Financing § 120.890 Source of interim financing. A Project may... experience or qualifications, SBA may require the interim loan to be managed by a third party such as a bank...

  16. 13 CFR 120.890 - Source of interim financing.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ....890 Section 120.890 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION BUSINESS LOANS Development Company Loan Program (504) Interim Financing § 120.890 Source of interim financing. A Project may... experience or qualifications, SBA may require the interim loan to be managed by a third party such as a bank...

  17. 13 CFR 120.890 - Source of interim financing.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ....890 Section 120.890 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION BUSINESS LOANS Development Company Loan Program (504) Interim Financing § 120.890 Source of interim financing. A Project may... experience or qualifications, SBA may require the interim loan to be managed by a third party such as a bank...

  18. 13 CFR 120.890 - Source of interim financing.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ....890 Section 120.890 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION BUSINESS LOANS Development Company Loan Program (504) Interim Financing § 120.890 Source of interim financing. A Project may... experience or qualifications, SBA may require the interim loan to be managed by a third party such as a bank...

  19. Compliance with prospective trial registration guidance remained low in high-impact journals and has implications for primary end point reporting.

    PubMed

    Dal-Ré, Rafael; Ross, Joseph S; Marušić, Ana

    2016-07-01

    To examine compliance with International Committee of Medical Journal Editors' (ICMJE) policy on prospective trial registration along with predictors of compliance. Cross-sectional analysis of all articles reporting trial results published in the six highest-impact general medicine journals in January-June 2014 that were registered in a public trial registry. The main outcome measure was compliance with ICMJE policy. The time frame for trial primary end point ascertainment was used to assess whether retrospective registration could have allowed changing of primary end points following an interim analysis. Forty of 144 (28%) articles did not comply with the ICMJE policy. Trials of non-FDA-regulated interventions were less compliant than trials of FDA-regulated interventions (i.e., medicines, medical devices) (42% vs. 21%; P = 0.016). Twenty-nine of these 40 (72%; 20% overall) were registered before any interim analysis of primary end points could have been conducted; 11 (28%; 8% overall) were registered after primary end point ascertainment, such that investigators could have had the opportunity to conduct an interim analysis before trial registration. Twenty-eight percent of trials published in high-impact journals were retrospectively registered including nearly 10% that were registered after primary end point ascertainment could have had taken place. Prospective registration should be prompted and enforced to ensure transparency and accountability in clinical research. Copyright © 2016 Elsevier Inc. All rights reserved.

  20. Deep Vadose Zone Treatability Test for the Hanford Central Plateau: Interim Post-Desiccation Monitoring Results, Fiscal Year 2014

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

    Truex, Michael J.; Strickland, Christopher E.; Johnson, Christian D.

    Over decades of operation, the U.S. Department of Energy (DOE) and its predecessors have released nearly 2 trillion L (450 billion gal.) of liquid into the vadose zone at the Hanford Site. Much of this discharge of liquid waste into the vadose zone occurred in the Central Plateau, a 200 km 2 (75 mi 2) area that includes approximately 800 waste sites. Some of the inorganic and radionuclide contaminants in the deep vadose zone at the Hanford Site are at depths below the limit of direct exposure pathways, but may need to be remediated to protect groundwater. The Tri-Party Agenciesmore » (DOE, U.S. Environmental Protection Agency, and Washington State Department of Ecology) established Milestone M 015 50, which directed DOE to submit a treatability test plan for remediation of technetium-99 (Tc-99) and uranium in the deep vadose zone. These contaminants are mobile in the subsurface environment and have been detected at high concentrations deep in the vadose zone, and at some locations have reached groundwater. Testing technologies for remediating Tc-99 and uranium will also provide information relevant for remediating other contaminants in the vadose zone. A field test of desiccation is being conducted as an element of the DOE test plan published in March 2008 to meet Milestone M 015 50. The active desiccation portion of the test has been completed. Monitoring data have been collected at the field test site during the post-desiccation period and are reported herein. This is an interim data summary report that includes about 3 years of post-desiccation monitoring data. The DOE field test plan proscribes a total of 5 years of post-desiccation monitoring.« less

  1. 75 FR 13610 - Office of New Reactors; Interim Staff Guidance on Implementation of a Seismic Margin Analysis for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-22

    ... Staff Guidance on Implementation of a Seismic Margin Analysis for New Reactors Based on Probabilistic... Seismic Margin Analysis for New Reactors Based on Probabilistic Risk Assessment,'' (Agencywide Documents.../COL-ISG-020 ``Implementation of a Seismic Margin Analysis for New Reactors Based on Probabilistic Risk...

  2. Data Validation Package August 2015 Groundwater Sampling at the Grand Junction, Colorado, Disposal Site October 2015

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

    Frazier, William; Baur, Gary

    Sampling Period: August 4, 2015. The 1998 Interim Long-Term Surveillance Plan for the Cheney Disposal Site Near Grand Junction, Colorado, requires annual monitoring to assess the performance of the disposal cell. Monitoring wells 0731, 0732, and 0733 were sampled as specified in the plan. Sampling and analyses were conducted in accordance with Sampling and Analysis Plan for the U.S. Department of Energy Office of Legacy Management Sites (LMS/PRO/S04351, continually updated). The water level was measured at each sampled well. The water level in well 0733, located in the disposal cell, is lower than water levels in adjacent wells 0731 andmore » 0732, indicating a hydraulic gradient toward the disposal cell. Results from this sampling event were generally consistent with results from the past as shown in the attached concentration-versus-time graphs. There have been no large changes in contaminant concentration observed over the last several years with the following exception. The uranium concentration in well 0733 has been trending upward since 2003. High uranium concentrations are expected in this well because it is located in the disposal cell. The selenium concentrations observed in wells 0731 and 0732 are elevated when compared to the disposal cell 0733. Wells 0731 and 0732 are completed at the alluvium/Mancos contact; here, elevated selenium concentrations are expected due to contributions from the Mancos shale.« less

  3. Comparative Analysis of Languages for Machine Processing. Interim Report.

    ERIC Educational Resources Information Center

    Zierer, Ernesto; And Others

    This report gives the results obtained in the semantic and syntactic analysis of the Japanese particles "de,""ni,""e," and "wo" in comparison to their equivalents in English, German, and Spanish. The study is based on the so-called "Correlational Analysis" as proposed by Ernst von Glaserfeld. The…

  4. Strategic Environmental Research & Development Program (SERDP): Phase I and Phase II Strategic Investment Plans FY 1992 and Interim Status Report of the Council.

    DTIC Science & Technology

    1993-10-01

    VLF/ELF) communication systems, used for early warning and strategic communications, are dependent on the electron densities in the "C" and "D...information into optical or electronic signals that can be remotely monitored. During FY92, an in-depth and definitive assessment of the feasibility...particularly metal finishing and electronics operations. BENEFITS: The broad program described above will provide the opportunity for EPA, the

  5. Potential System Integration Issues in the Joint Multi-Role (JMR) Joint Common Architecture (JCA) Demonstration System

    DTIC Science & Technology

    2015-12-01

    the MIS System/Subsystem Specification ( SSS ), and supplementary BAA document. On June 26, 2014, the SEI provided a draft interim report of the...findings and issues. The SEI team also received July 3, 2014, versions of the MIS Stakeholder Requirements, MIS SSS , and build plan and July 17, 2014...versions of the MIS SSS together with the MIS system model. On July 14–15, 2014, the SEI presented a summary of the issues at the two contractors

  6. National Task Force on a Uniform Measurement Unit for the Recognition of Continuing Education: Working Papers; and The Continuing Education Unit: A Uniform Unit of Measure for Non-Credit Continuing Education Programs (An Interim Statement of the National Task Force).

    ERIC Educational Resources Information Center

    National Univ. Extension Association, Washington, DC.

    In 1968, a national planning conference, under the joint sponsorship of 34 organizations responsing to continuing education needs, created the National Task Force to determine the feasibility of a uniform unit of measurement and develop a proposal for field testing the concept. Stressing that continuing education units should supplement, not…

  7. Systems special investigation group

    NASA Technical Reports Server (NTRS)

    1991-01-01

    An interim report concerning the Long Duration Exposure Facility (LDEF) is presented by a Boeing Systems special investigation group (SIG). The SIG activities were divided into five engineering disciplines: electrical, mechanical, optics, thermal, and batteries/solar cells. The responsibilities of the SIG included the following areas: support de-integration at Kennedy Space Center (KSC); testing of hardware at Boeing; review of principal investigator (PI) test plans and test results; support of test activities at PI labs; and collation of all test results into the SIG database.

  8. The role of the Data and Safety Monitoring Board in a clinical trial: The CRISIS Study

    PubMed Central

    Holubkov, Richard; Casper, T. Charles; Dean, J. Michael; Anand, K. J. S.; Zimmerman, Jerry; Meert, Kathleen L.; Newth, Christopher J. L.; Berger, John; Harrison, Rick; Willson, Douglas F.; Nicholson, Carol

    2012-01-01

    Objective Randomized clinical trials are commonly overseen by a data and safety monitoring board (DSMB) comprised of experts in medicine, ethics, and biostatistics. DSMB responsibilities include protocol approval, interim review of study enrollment, protocol compliance, safety, and efficacy data. DSMB decisions can affect study design and conduct, as well as reported findings. Researchers must incorporate DSMB oversight into the design, monitoring, and reporting of randomized trials. Design Case study, narrative review. Methods The DSMB’s role during the comparative pediatric Critical Illness Stress-Induced Immune Suppression (CRISIS) Prevention Trial is described. Findings The NIH-appointed CRISIS DSMB was charged with monitoring sample size adequacy and feasibility, safety with respect to adverse events and 28-day mortality, and efficacy with respect to the primary nosocomial infection/sepsis outcome. The Federal Drug Administration also requested DSMB interim review before opening CRISIS to children below one year of age. The first interim analysis found higher 28-day mortality in one treatment arm. The DSMB maintained trial closure to younger children, and requested a second interim data review six months later. At this second meeting, mortality was no longer of concern, while a weak efficacy trend of lower infection/sepsis rates in one study arm emerged. As over 40% of total patients had been enrolled, the DSMB elected to examine conditional power, and unmask treatment arm identities. Upon finding somewhat greater efficacy in the placebo arm, the DSMB recommended stopping CRISIS due to futility. Conclusions The design and operating procedures of a multicenter randomized trial must consider a pivotal DSMB role. Maximum study design flexibility must be allowed, and investigators must be prepared for protocol modifications due to interim findings. The DSMB must have sufficient clinical and statistical expertise to assess potential importance of interim treatment differences in the setting of multiple looks at accumulating data with numerous outcomes and subgroups. PMID:23392377

  9. Data Analysis of GPM Constellation Satellites-IMERG and ERA-Interim precipitation products over West of Iran

    NASA Astrophysics Data System (ADS)

    Sharifi, Ehsan; Steinacker, Reinhold; Saghafian, Bahram

    2016-04-01

    Precipitation is a critical component of the Earth's hydrological cycle. The primary requirement in precipitation measurement is to know where and how much precipitation is falling at any given time. Especially in data sparse regions with insufficient radar coverage, satellite information can provide a spatial and temporal context. Nonetheless, evaluation of satellite precipitation is essential prior to operational use. This is why many previous studies are devoted to the validation of satellite estimation. Accurate quantitative precipitation estimation over mountainous basins is of great importance because of their susceptibility to hazards. In situ observations over mountainous areas are mostly limited, but currently available satellite precipitation products can potentially provide the precipitation estimation needed for meteorological and hydrological applications. One of the newest and blended methods that use multi-satellites and multi-sensors has been developed for estimating global precipitation. The considered data set known as Integrated Multi-satellitE Retrievals (IMERG) for GPM (Global Precipitation Measurement) is routinely produced by the GPM constellation satellites. Moreover, recent efforts have been put into the improvement of the precipitation products derived from reanalysis systems, which has led to significant progress. One of the best and a worldwide used model is developed by the European Centre for Medium Range Weather Forecasts (ECMWF). They have produced global reanalysis daily precipitation, known as ERA-Interim. This study has evaluated one year of precipitation data from the GPM-IMERG and ERA-Interim reanalysis daily time series over West of Iran. IMERG and ERA-Interim yield underestimate the observed values while IMERG underestimated slightly and performed better when precipitation is greater than 10mm. Furthermore, with respect to evaluation of probability of detection (POD), threat score (TS), false alarm ratio (FAR) and probability of false detection (POFD) IMERG yields a better value of POD, TS, FAR and POFD in comparison to era-Interim. Overall, ERA-Interim product produced fewer robust results when compared to IMERG.

  10. The Homestake Interim Laboratory and Homestake DUSEL

    NASA Astrophysics Data System (ADS)

    Lesko, Kevin T.

    2011-12-01

    The former Homestake gold mine in Lead South Dakota is proposed for the National Science Foundation's Deep Underground Science and Engineering Laboratory (DUSEL). The gold mine provides expedient access to depths in excess of 8000 feet below the surface (>7000 mwe). Homestake's long history of promoting scientific endeavours includes the Davis Solar Neutrino Experiment, a chlorine-based experiment that was hosted at the 4850 Level for more than 30 years. As DUSEL, Homestake would be uncompromised by competition with mining interests or other shared uses. The facility's 600-km of drifts would be available for conversion for scientific and educational uses. The State of South Dakota, under Governor Rounds' leadership, has demonstrated exceptionally strong support for Homestake and the creation of DUSEL. The State has provided funding totalling $46M for the preservation of the site for DUSEL and for the conversion and operation of the Homestake Interim Laboratory. Motivated by the strong educational and outreach potential of Homestake, the State contracted a Conversion Plan by world-recognized mine-engineering contractor to define the process of rehabilitating the facility, establishing the appropriate safety program, and regaining access to the facility. The State of South Dakota has established the South Dakota Science and Technology Authority to oversee the transfer of the Homestake property to the State and the rehabilitation and preservation of the facility. The Homestake Scientific Collaboration and the State of South Dakota's Science and Technology Authority has called for Letters of Interest from scientific, educational and engineering collaborations and institutions that are interested in hosting experiments and uses in the Homestake Interim Facility in advance of the NSF's DUSEL, to define experiments starting as early as 2007. The Homestake Program Advisory Committee has reviewed these Letters and their initial report has been released. Options for developing the Homestake Interim Laboratory and evolving this facility into DUSEL are presented.

  11. MUC-4 Test Results and Analysis

    DTIC Science & Technology

    1992-01-01

    PAGE unclassified Standard Form 298 (Rev. 8-98) Prescribed by ANSI Std Z39-18 MUC3 MUC4 STEMS 15,285 INFLECTED FORMS 14,56 1 TOTALS est at 10,000...34 . As an indication of system development during MUC4 , we can compare our TST3 results with our results on th e MUC-4 interim test (TST2) . The relevant... MUC4 Interim Test) Summary Scores SLOT POS ACT COR PAR INC ICR IPA SPU MIS NON REC PRE OVG inc-total 529 1189 160 63 24 0 23 942 282 718 36 16 79 perp

  12. 12 CFR 552.2-2 - Procedures for organization of interim Federal stock association.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Procedures for organization of interim Federal stock association. (a) Applications for permission to organize... chapter or § 552.2-1(b)(3) of this part. (b) Approval of an application for permission to organize an... the interim was chartered to facilitate. Applications for permission to organize an interim Federal...

  13. Impact evaluation of Morgantown PRT 1975-1976 ridership: Interim Analysis

    DOT National Transportation Integrated Search

    1977-06-01

    An analysis of the ridership levels of the Morgantown PRT system during its : initial period of operation, the 1975-1976 academic year, is presented. PRT ridership : by day, weekly ridership trends in terms of exogeneous events, the influence of : fe...

  14. 40 CFR 265.13 - General waste analysis.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 27 2013-07-01 2013-07-01 false General waste analysis. 265.13 Section 265.13 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND DISPOSAL...

  15. 40 CFR 265.13 - General waste analysis.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 26 2011-07-01 2011-07-01 false General waste analysis. 265.13 Section 265.13 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND DISPOSAL...

  16. 40 CFR 265.13 - General waste analysis.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 26 2014-07-01 2014-07-01 false General waste analysis. 265.13 Section 265.13 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND DISPOSAL...

  17. 40 CFR 265.13 - General waste analysis.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 27 2012-07-01 2012-07-01 false General waste analysis. 265.13 Section 265.13 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND DISPOSAL...

  18. Interim analysis report : model deployment of a regional, multi-modal 511 traveler information system

    DOT National Transportation Integrated Search

    2004-02-17

    This document presents the results of the analysis of baseline, or "pre-enhancement," data describing the operation of the existing 511 telephone traveler information system operated by the Arizona Department of Transportation (ADOT). The model deplo...

  19. Safety and pharmacokinetic profile of rufinamide in pediatric patients aged less than 4 years with Lennox-Gastaut syndrome: An interim analysis from a multicenter, randomized, active-controlled, open-label study.

    PubMed

    Arzimanoglou, Alexis; Ferreira, Jose A; Satlin, Andrew; Mendes, Shannon; Williams, Betsy; Critchley, David; Schuck, Edgar; Hussein, Ziad; Kumar, Dinesh; Dhadda, Shobha; Bibbiani, Francesco

    2016-05-01

    A good knowledge of safety and age group-specific pharmacokinetics (PK) of antiepileptic drugs (AEDs) in young pediatric patients is of great importance in clinical practice. This paper presents 6-month interim safety and PK from an ongoing 2-year open-label study (Study 303) of adjunctive rufinamide treatment in pediatric subjects ≥ 1 to < 4 years with inadequately controlled epilepsies of the Lennox-Gastaut syndrome (LGS) spectrum. Subjects (N = 37) were randomized to either rufinamide or any other approved AED chosen by the investigator as adjunctive therapy to the subject's existing regimen of 1-3 AEDs. Interim safety results showed that treatment-emergent adverse events (TEAEs) were similar between the rufinamide (22 [88.0%]) and any-other-AED group (9 [81.8%]), with most events considered mild or moderate. A population PK analysis was conducted including plasma rufinamide concentrations from Study 303 and two other study populations of LGS subjects ≥ 4 years. The rufinamide PK profile was dose independent. The apparent clearance (CL/F) estimated from the PK model was 2.19 L/h; it was found to increase significantly as a function of body weight. Coadministration of valproic acid significantly decreased rufinamide CL/F. CL/F was not significantly affected by other concomitant AEDs, age, gender, race, hepatic function, or renal function. No adjustments to body weight-based rufinamide dosing in subjects ≥ 1 to < 4 years are necessary. Rufinamide was safe and well tolerated in these pediatric subjects. Results from the interim analysis demonstrate that rufinamide's safety and PK profile is comparable in subjects ≥ 1 to < 4 and ≥ 4 years with LGS. Study 303 (clinicaltrials.gov: NCT01405053). Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  20. 76 FR 14559 - Federal Acquisition Regulation; Justification and Approval of Sole-Source 8(a) Contracts

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-16

    ... Space Administration (NASA). ACTION: Interim rule. SUMMARY: DoD, GSA, and NASA are issuing an interim..., and NASA are issuing an interim rule amending the FAR, to implement section 811 of the National... meetings, DoD, GSA, and NASA weighed the costs and benefits of publishing this rule as proposed or interim...

  1. Interim Administrators in Higher Education: A National Study

    ERIC Educational Resources Information Center

    Huff, Marie Thielke; Neubrander, Judy

    2015-01-01

    The focus of this paper is on the roles and experiences of interim administrators in higher education. A survey was given to current and recent interim administrators in four-year public universities and colleges across the United States. The goals were to identify the advantages and disadvantages of using and serving as interims, and to solicit…

  2. eHealth and IMIA's Strategic Planning Process - IMIA conference introductory address.

    PubMed

    Murray, Peter; Haux, Reinhold; Lorenzi, Nancy

    2008-01-01

    The International Medical Informatics Association (IMIA) is the only organization in health and biomedical informatics which is fully international in scope, bridging the academic, health practice, education, and health industry worlds through conferences, working groups, special interest groups and publications. Authored by the IMIA Interim Vice President for Strategic Planning Implementation and co-authored by the current IMIA President and the IMIA Past-President, the intention of this paper is to introduce IMIA's current strategic planning process and to set this process in relation to 'eHealth: Combining Health Telematics, Telemedicine, Biomedical Engineering and Bioinformatics to the Edge', the theme of this conference. From the viewpoint of an international organization such as IMIA, an eHealth strategy needs to be considered in a comprehensive way, including broadly stimulating high-quality health and biomedical informatics research and education, as well as providing support to bridging outcomes towards a new practice of health care in a changing world.

  3. Northeast Artificial Intelligence Consortium annual report. Volume 2. 1988. Discussing, using, and recognizing plans (NLP). Interim report, January-December 1988

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

    Shapiro, S.C.; Woolf, B.

    The Northeast Artificial Intelligence Consortium (NAIC) was created by the Air Force Systems Command, Rome Air Development Center, and the Office of Scientific Research. Its purpose is to conduct pertinent research in artificial intelligence and to perform activities ancillary to this research. This report describes progress that has been made in the fourth year of the existence of the NAIC on the technical research tasks undertaken at the member universities. The topics covered in general are: versatile expert system for equipment maintenance, distributed AI for communications system control, automatic photointerpretation, time-oriented problem solving, speech understanding systems, knowledge base maintenance, hardwaremore » architectures for very large systems, knowledge-based reasoning and planning, and a knowledge acquisition, assistance, and explanation system. The specific topic for this volume is the recognition of plans expressed in natural language, followed by their discussion and use.« less

  4. RESEARCH METHOD FOR SAMPLING AND ANALYSIS OF FIBROUS AMPHIBOLE IN VERMICULITE ATTIC INSULATION

    EPA Science Inventory

    NRMRL hosted a meeting on July 17-18, 2003 entitled, "Analytical Method for Bulk Analysis of Vermiculite." The purpose of this effort was to produce an interim research method for use by U.S. EPA's Office of Research and Development (ORD) for the analysis of bulk vermiculite for...

  5. 78 FR 8295 - Guarantees for Bonds Issued for Community or Economic Development Purposes

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-05

    .... V. Rulemaking Analysis A. Executive Order (E.O.) 12866; Regulatory Impact Analysis It has been... Budget. The Regulatory Impact Analysis prepared by the CDFI Fund for the interim rule is provided below... Community Investment Impact System (CIIS), which collects data from CDFIs that have received awards from the...

  6. Amendments to Summary Plan Description regulations. Pension and Welfare Benefits Administration, Labor. Final rule.

    PubMed

    2000-11-21

    This document contains a final rule amending the regulations governing the content of the Summary Plan Description (SPD) required to be furnished to employee benefit plan participants and beneficiaries under the Employee Retirement Income Security Act of 1974, as amended (ERISA). These amendments implement information disclosure recommendations of the President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry, as set forth in their November 20, 1997, report, "Consumer Bill of Rights and Responsibilities." Specifically, the amendments clarify benefit, medical provider, and other information required to be disclosed in, or as part of, the SPD of a group health plan and repeal the limited exemption with respect to SPDs of welfare plans providing benefits through qualified health maintenance organizations (HMOs). In addition, this document contains several amendments updating and clarifying provisions relating to the content of SPDs that affect both pension and welfare benefit plans. This document also adopts in final form certain regulations that were effective on an interim basis implementing amendments to ERISA enacted as part of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). This final rule will affect employee pension and welfare benefit plans, including group health plans, as well as administrators, fiduciaries, participants and beneficiaries of such plans.

  7. Highway planning and operations for the Dallas district: Implementation and evaluation of concurrent flow HOV lanes in Texas. Project summary report 1994-14S, September 1996--August 1997

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

    Skowronek, D.A.; Stoddard, A.M.; Ranft, S.E.

    1997-11-01

    Limited capital investment for major transportation improvements and growth in metropolitan areas require the most efficient use of the existing transportation system. One means to achieve this is high-occupancy vehicle (HOV) lanes. While an extensive system of permanent HOV lanes is planned for the Dallas-Fort Worth urbanized area, the Texas Department of Transportation (TxDOT) and Dallas Area Rapid Transit (DART) have pursued and continue to pursue short-term or interim HOV lane projects that would enhance public transportation and overall mobility. There are currently 57 km (35.4 mi) of interim HOV lanes operational in the Dallas area, including a barrier-separated contraflowmore » lane on I-30 (East R.L. Thornton Freeway) and buffer-separated concurrent flow HOV lanes on I-35E North (Stemmons Freeway) and I-635 (Lyndon B. Johnson Freeway). The objective of this research is to investigate the operational effectiveness of concurrent flow (buffer-separated) versus contraflow (barrier-separated) HOV lanes. Issues such as person movement, carpool formation, travel time savings, violation rates, and project cost effectiveness are addressed. By understanding the operational performance and issues of both concurrent flow (buffer-separated) HOV lanes and contraflow (barrier-separated) HOV lanes, recommendations can be made on suggested HOV lane policies, including the type of permanent HOV lanes to be implemented in the Dallas area.« less

  8. Interim analyses in 2 x 2 crossover trials.

    PubMed

    Cook, R J

    1995-09-01

    A method is presented for performing interim analyses in long term 2 x 2 crossover trials with serial patient entry. The analyses are based on a linear statistic that combines data from individuals observed for one treatment period with data from individuals observed for both periods. The coefficients in this linear combination can be chosen quite arbitrarily, but we focus on variance-based weights to maximize power for tests regarding direct treatment effects. The type I error rate of this procedure is controlled by utilizing the joint distribution of the linear statistics over analysis stages. Methods for performing power and sample size calculations are indicated. A two-stage sequential design involving simultaneous patient entry and a single between-period interim analysis is considered in detail. The power and average number of measurements required for this design are compared to those of the usual crossover trial. The results indicate that, while there is minimal loss in power relative to the usual crossover design in the absence of differential carry-over effects, the proposed design can have substantially greater power when differential carry-over effects are present. The two-stage crossover design can also lead to more economical studies in terms of the expected number of measurements required, due to the potential for early stopping. Attention is directed toward normally distributed responses.

  9. On the comparisons of tropical relative humidity in the lower and middle troposphere among COSMIC radio occultations and MERRA and ECMWF data sets

    NASA Astrophysics Data System (ADS)

    Vergados, P.; Mannucci, A. J.; Ao, C. O.; Jiang, J. H.; Su, H.

    2015-04-01

    The spatial variability of the tropical tropospheric relative humidity (RH) throughout the vertical extent of the troposphere is examined using Global Positioning System Radio Occultation (GPSRO) observations from the Constellation Observing System for Meteorology, Ionosphere, and Climate (COSMIC) mission. These high vertical resolution observations capture the detailed structure and moisture budget of the Hadley Cell circulation. We compare the COSMIC observations with the European Center for Medium-range Weather Forecast (ECMWF) Reanalysis Interim (ERA-Interim) and the Modern-Era Retrospective analysis for Research and Applications (MERRA) climatologies. Qualitatively, the spatial pattern of RH in all data sets matches up remarkably well, capturing distinct features of the general circulation. However, RH discrepancies exist between ERA-Interim and COSMIC data sets that are noticeable across the tropical boundary layer. Specifically, ERA-Interim shows a drier Intertropical Convergence Zone (ITCZ) by 15-20% compared to both COSMIC and MERRA data sets, but this difference decreases with altitude. Unlike ECMWF, MERRA shows an excellent agreement with the COSMIC observations except above 400 hPa, where GPSRO observations capture drier air by 5-10%. RH climatologies were also used to evaluate intraseasonal variability. The results indicate that the tropical middle troposphere at ±5-25° is most sensitive to seasonal variations. COSMIC and MERRA data sets capture the same magnitude of the seasonal variability, but ERA-Interim shows a weaker seasonal fluctuation up to 10% in the middle troposphere inside the dry air subsidence regions of the Hadley Cell. Over the ITCZ, RH varies by maximum 9% between winter and summer.

  10. IVHS Countermeasures for Rear-End Collisions, Task 1 Vol. III: 1991 NASS CDS Case Analysis

    DOT National Transportation Integrated Search

    1994-02-15

    This report is from the NHTSA sponsored program, "IVHS Countermeasures for Rear-End Collisions". The Task 1 Interim Report consists of six volumes. This Volume, Volume III, 1991 NASS CDS Clinical Case Analysis presents the results of a clinical case ...

  11. 42 CFR 418.307 - Periodic interim payments.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... (CONTINUED) MEDICARE PROGRAM HOSPICE CARE Payment for Hospice Care § 418.307 Periodic interim payments... payments. The biweekly interim payment amount is based on the total estimated Medicare payments for the...

  12. 75 FR 10645 - Low Pathogenic Avian Influenza; Voluntary Control Program and Payment of Indemnity

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-09

    ...We are adopting as a final rule, with changes, an interim rule that amended the regulations by establishing, under the auspices of the National Poultry Improvement Plan, a voluntary program for the control of the H5/H7 subtypes of low pathogenic avian influenza in commercial poultry. As amended by this document, the rule provides that the amount of indemnity for which contract growers are eligible will be reduced by any payment they have already received on their contracts when poultry in their care are destroyed, clarifies the roles of cooperating State agencies with respect to H5/H7 low pathogenic avian influenza outbreaks, provides that consistency with humane euthanasia guidelines will be considered when selecting a method for the destruction of poultry, and provides additional guidance for cleaning and disinfecting an affected premises. The control program and indemnity provisions established by the interim rule are necessary to help ensure that the H5/H7 subtypes of low pathogenic avian influenza are detected and eradicated when they occur within the United States.

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

    Kupar, J.; Hasek, M.

    The Sanitary Landfill Corrective Action Plan proposes a two pronged approach to remediation. The first part of the total remediation strategy is the placement of a RCRA style closure cap to provide source control of contaminants into the groundwater. The second part of the proposed remediation package is a phased approach primarily using an in situ bioremediation system for groundwater clean up of the Constituents of Concern (COCs) that exceed their proposed Alternate Concentration Limits (ACL). The phased in approach of groundwater clean up will involve operation of the in situ bioremediation system, followed by evaluation of the Phase 1more » system and, if necessary, additional phased remediation strategies. This document presents pertinent information on operations, well locations, anticipated capture zones, monitoring strategies, observation wells and other information which will allow a decision on the acceptability of the remedial strategy as an interim corrective action prior to permit application approval. The proposed interim phase of the remediation program will position two horizontal bioremediation wells such that the respective zones of influence will intersect the migration path for the highest concentrations of each plume.« less

  14. 75 FR 56601 - Privacy Act of 1974: New System of Records

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-16

    ...The Patient Protection and Affordable Care Act (the Affordable Care Act), Public Law 111-148, was enacted on March 23, 2010; the Health Care and Education Reconciliation Act (the Reconciliation Act), Public Law 111-152, was enacted on March 30, 2010. The Affordable Care Act and implementing regulations (codified in HHS interim final rules (IFR) at 45 CFR Part 147) require that non-grandfathered health insurance plans and issuers offering group and individual coverage have effective internal claims and appeals and external review processes. The effective date for these requirements is plan or policy years beginning on or after September 23, 2010. Regarding external review, the statute requires that health plans and issuers must comply with either a state external review process or a process meeting standards issued by the Secretary of Health and Human Services (HHS) that is ``similar to'' a state process meeting requirements in section 2719 (a ``federal external review process''). The IFR includes a transition period prior to July 1, 2011, during which time HHS will work with states to assist in making any necessary changes so that the state process will meet the minimum consumer protections identified in 45 CFR 147.136 that must be met in order for the state process to apply. During this interim period, health insurance issuers in states with external review laws in effect prior to September 23, 2010 will follow that state's external review law to the extent applicable. In states that have not passed an external review law that is in effect on September 23, 2010, a health insurance issuer must follow an interim federal external review process that will be administered by the Office of Personnel Management (OPM). The system of records will be created as OPM assists HHS by providing external reviews of adverse benefit determinations and final internal adverse benefit determinations as requested by eligible claimants and their authorized representatives (``claimants''). The system of records will include any data relevant to these external reviews, and OPM proposes to add this new system of records to its inventory of records systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended. This action is necessary to meet the requirements of the Privacy Act to publish in the Federal Register notice of the existence and character of records maintained by the agency (5 U.S.C. 552a(e)(4)).

  15. [Response to US review rules on patent subject matter of traditional Chinese medicine compositions].

    PubMed

    Liu, Pan; Cao, Ya-di; Gong, Rui-Juan; Liu, Wei

    2018-02-01

    The United States Patent and Trademark Office(USPTO) issued Interim Guidance on Patent Subject Matter Eligibility on December 16， 2014， bringing certain effects to the review rules on patent application of Chinese medicine compositions. Based on the Interim Guidance， cases analysis was used in this paper to analyze the patent subject matter issues of traditional Chinese medicine compositions in the United States. The researches have shown that the application documents should be properly written in the United States when the patent for Chinese medicine compositions is applied， which can improve the probability of authorization. Copyright© by the Chinese Pharmaceutical Association.

  16. Mobile source air toxics mitigation measures.

    DOT National Transportation Integrated Search

    2013-10-01

    In accordance with the Federal Highway Administration (FHWA) Interim Guidance Update on Mobile Source Air Toxic Analysis in NEPA Documents (September 30, 2009), transportation projects subject to the National Environmental Policy Act (NEPA) mus...

  17. Safe Passage Data Analysis: Interim Report

    DOT National Transportation Integrated Search

    1993-04-01

    The purpose of this report is to describe quantitatively the costs and benefits of screener : proficiency evaluation and reporting systems (SPEARS) equipment, particularly computer-based : instruction (CBI) systems, compared to current methods of tra...

  18. Analysis of the factors that impact the reliability of high level waste canister materials

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

    Boyd, W.K.; Hall, A.M.

    1977-09-19

    The analysis encompassed identification and analysis of potential threats to canister integrity arising in the course of waste solidification, interim storage at the fuels reprocessing plant, wet and dry shipment, and geologic storage. Fabrication techniques and quality assurance requirements necessary to insure optimum canister reliability were considered taking into account such factors as welding procedure, surface preparation, stress relief, remote weld closure, and inspection methods. Alternative canister materials and canister systems were also considered in terms of optimum reliability in the face of threats to the canister's integrity, ease of fabrication, inspection, handling and cost. If interim storage in airmore » is admissible, the sequence suggested comprises producing a glass-type waste product in a continuous ceramic melter, pouring into a carbon steel or low-alloy steel canister of moderately heavy wall thickness, storing in air upright on a pad and surrounded by a concrete radiation shield, and thereafter placing in geologic storage without overpacking. Should the decision be to store in water during the interim period, then use of either a 304 L stainless steel canister overpacked with a solution-annealed and fast-cooled 304 L container, or a single high-alloy canister, is suggested. The high alloy may be Inconel 600, Incoloy Alloy 800, or Incoloy Alloy 825. In either case, it is suggested that the container be overpacked with a moderately heavy wall carbon steel or low-alloy steel cask for geologic storage to ensure ready retrievability. 19 figs., 5 tables.« less

  19. Safety and efficacy of long-term treatment with teneligliptin: Interim analysis of a post-marketing surveillance of more than 10,000 Japanese patients with type 2 diabetes mellitus.

    PubMed

    Kadowaki, Takashi; Haneda, Masakazu; Ito, Hiroshi; Ueno, Makoto; Matsukawa, Miyuki; Yamakura, Tomoko; Sasaki, Kazuyo; Kimura, Mayumi; Iijima, Hiroaki

    2018-02-01

    This post-marketing surveillance examined the safety and efficacy of long-term teneligliptin therapy in Japanese patients. We report interim results (cut-off date: 28 June 2017) of a 3-year PMS undertaken in subjects with type 2 diabetes mellitus (T2DM). Survey items included demographics, treatments, adverse drug reactions (ADRs), and laboratory variables. A subgroup analysis was also performed across three age groups (<65 years; 65 to <75 years; ≥75 years). Main outcome measures were incidence of ADRs, laboratory variables, and change in glycated hemoglobin (HbA1c) from baseline over time. Of 11,677 patients registered, data from 10,532 patients (6,338 males/4,194 females) were analyzed for the safety analysis set; the median administration period was 731 days. Overall, ADRs and serious ADRs were reported in 364 (3.46%) and 91 patients (0.86%), respectively. The most common ADRs were all hypoglycemia (0.32%), constipation (0.27%), and hepatic function abnormal (0.24%). No change in mean body weight occurred, and a reduction in mean HbA1c was observed until 2 years. The safety and efficacy profiles did not differ markedly among the three age groups. These interim results show that teneligliptin was well tolerated and improved hyperglycemia in Japanese patients with T2DM in clinical practice.

  20. Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma.

    PubMed

    Choueiri, Toni K; Escudier, Bernard; Powles, Thomas; Mainwaring, Paul N; Rini, Brian I; Donskov, Frede; Hammers, Hans; Hutson, Thomas E; Lee, Jae-Lyun; Peltola, Katriina; Roth, Bruce J; Bjarnason, Georg A; Géczi, Lajos; Keam, Bhumsuk; Maroto, Pablo; Heng, Daniel Y C; Schmidinger, Manuela; Kantoff, Philip W; Borgman-Hagey, Anne; Hessel, Colin; Scheffold, Christian; Schwab, Gisela M; Tannir, Nizar M; Motzer, Robert J

    2015-11-05

    Cabozantinib is an oral, small-molecule tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR) as well as MET and AXL, each of which has been implicated in the pathobiology of metastatic renal-cell carcinoma or in the development of resistance to antiangiogenic drugs. This randomized, open-label, phase 3 trial evaluated the efficacy of cabozantinib, as compared with everolimus, in patients with renal-cell carcinoma that had progressed after VEGFR-targeted therapy. We randomly assigned 658 patients to receive cabozantinib at a dose of 60 mg daily or everolimus at a dose of 10 mg daily. The primary end point was progression-free survival. Secondary efficacy end points were overall survival and objective response rate. Median progression-free survival was 7.4 months with cabozantinib and 3.8 months with everolimus. The rate of progression or death was 42% lower with cabozantinib than with everolimus (hazard ratio, 0.58; 95% confidence interval [CI] 0.45 to 0.75; P<0.001). The objective response rate was 21% with cabozantinib and 5% with everolimus (P<0.001). A planned interim analysis showed that overall survival was longer with cabozantinib than with everolimus (hazard ratio for death, 0.67; 95% CI, 0.51 to 0.89; P=0.005) but did not cross the significance boundary for the interim analysis. Adverse events were managed with dose reductions; doses were reduced in 60% of the patients who received cabozantinib and in 25% of those who received everolimus. Discontinuation of study treatment owing to adverse events occurred in 9% of the patients who received cabozantinib and in 10% of those who received everolimus. Progression-free survival was longer with cabozantinib than with everolimus among patients with renal-cell carcinoma that had progressed after VEGFR-targeted therapy. (Funded by Exelixis; METEOR ClinicalTrials.gov number, NCT01865747.).

  1. Moisture balance over the Iberian Peninsula computed using a high resolution regional climate model. The impact of 3DVAR data assimilation.

    NASA Astrophysics Data System (ADS)

    González-Rojí, Santos J.; Sáenz, Jon; Ibarra-Berastegi, Gabriel

    2016-04-01

    A numerical downscaling exercise over the Iberian Peninsula has been run nesting the WRF model inside ERA Interim. The Iberian Peninsula has been covered by a 15km x 15 km grid with 51 vertical levels. Two model configurations have been tested in two experiments spanning the period 2010-2014 after a one year spin-up (2009). In both cases, the model uses high resolution daily-varying SST fields and the Noah land surface model. In the first experiment (N), after the model is initialised, boundary conditions drive the model, as usual in numerical downscaling experiments. The second experiment (D) is configured the same way as the N case, but 3DVAR data assimilation is run every six hours (00Z, 06Z, 12Z and 18Z) using observations obtained from the PREPBUFR dataset (NCEP ADP Global Upper Air and Surface Weather Observations) using a 120' window around analysis times. For the data assimilation experiment (D), seasonally (monthly) varying background error covariance matrices have been prepared according to the parameterisations used and the mesoscale model domain. For both N and D runs, the moisture balance of the model runs has been evaluated over the Iberian Peninsula, both internally according to the model results (moisture balance in the model) and also in terms of the observed moisture fields from observational datasets (particularly precipitable water and precipitation from observations). Verification has been performed both at the daily and monthly time scales. The verification has also been performed for ERA Interim, the driving coarse-scale dataset used to drive the regional model too. Results show that the leading terms that must be considered over the area are the tendency in the precipitable water column, the divergence of moisture flux, evaporation (computed from latent heat flux at the surface) and precipitation. In the case of ERA Interim, the divergence of Qc is also relevant, although still a minor player in the moisture balance. Both mesoscale model runs are more effective at closing the moisture balance over the whole Iberian Peninsula than ERA Interim. The N experiment (no data assimilation) shows a better closure than the D case, as could be expected from the lack of analysis increments in it. This result is robust both at the daily and monthly time scales. Both ERA Interim and the D experiment produce a negative residual in the balance equation (compatible with excess evaporation or increased convergence of moisture over the Iberian Peninsula). This is a result of the data assimilation process in the D dataset, since in the N experiment the residual is mainly positive. The seasonal cycle of evaporation is much closer in the D experiment to the one in ERA Interim than in the N case, with a higher evaporation during summer months. However, both regional climate model runs show a lower evaporation rate than ERA Interim, particularly during summer months.

  2. An interim reference model for the variability of the middle atmosphere H2O vapor distribution

    NASA Technical Reports Server (NTRS)

    Remsberg, E. E.; Russell, J. M., III; Wu, C. Y.

    1989-01-01

    Water vapor is an important minor constituent in the studies of the middle atmosphere for a variety of reasons, including its role as a source for active HO(y) chemicals and its use in analysis of transport processes. A number of in situ and remote techniques were employed in the determination of water vapor distributions. Two of the more complete data sets were used to develop an interim reference profile. First, there are the seven months of Nimbus 7 limb infrared monitor of the stratosphere (LIMS) data obtained during Nov. 1978 to May 1979 over the range 64S to 84N latitude and from about 100 to 1 mb in the mid-mesosphere at several fixed Northern Hemisphere mid-latitude sites. These two data sets were combined to give a mid-lattitude, interim reference water vapor profile for the entire vertical range of the middle atmosphere and with accuracies of better than 25 percent. The daily variability of stratospheric water vapor profiles about the monthly mean was also established from these data sets for selected months. Information is also provided on the longitudinal variability of LIMS water vapor profiles about the daily, weekly, and monthly zonal means. Generally, the interim reference water vapor profile and its variability are consistent with prevailing ideas about chemistry and transport.

  3. Final closure plan for the high-explosives open burn treatment facility at Lawrence Livermore National Laboratory Experimental Test Site 300

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

    Mathews, S.

    This document addresses the interim status closure of the HE Open Bum Treatment Facility, as detailed by Title 22, Division 4.5, Chapter 15, Article 7 of the Califonia Code of Regulations (CCR) and by Title 40, Code of Federal Regulations (CFR) Part 265, Subpart G, ``Closure and Post Closure.`` The Closure Plan (Chapter 1) and the Post- Closure Plan (Chapter 2) address the concept of long-term hazard elimination. The Closure Plan provides for capping and grading the HE Open Bum Treatment Facility and revegetating the immediate area in accordance with applicable requirements. The Closure Plan also reflects careful consideration ofmore » site location and topography, geologic and hydrologic factors, climate, cover characteristics, type and amount of wastes, and the potential for contaminant migration. The Post-Closure Plan is designed to allow LLNL to monitor the movement, if any, of pollutants from the treatment area. In addition, quarterly inspections will ensure that all surfaces of the closed facility, including the cover and diversion ditches, remain in good repair, thus precluding the potential for contaminant migration.« less

  4. Dallas Freeway/HOV system planning study: Year 2015. A summary of recommended hov improvements. Interim research report, September 1992-August 1993

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

    Walters, C.H.; Lomax, T.J.; Poe, C.M.

    1995-07-01

    The Dallas Freeway/High-Occupany Vehicle Lane System Planning Study is a joint project in cooperation with the Texas Department of Transportation (TxDOT), Dallas Area Rapid Transit (DART), the North Central Texas Council of Governments (NCTCOG), and the Texas Transportation Institute (TTI). The intent of this effort is to assist in the development of an area-wide freeway/HOV system that recognizes implementation constraints (right-of-way and construction costs) and provides reasonable peak-hour operating conditions on all freeway facilities, while incorporating the long-range plans developed by TxDOT, DART, and NCTCOG. The proposed system is a set of recommendations to be considered and evaluated as partmore » of the development of the NCTCOG Mobility 2010 Plan Update, the long-range transportation plan for the Dallas area. HOV facilities are a significant part of the recommended system in the Dallas System Planning Study, and their implementation is important to the successful operation of the Dallas area transportation system in the future. The report, therefore, focuses on the recommended HOV improvements from the methodology.« less

  5. Storage for greater-than-Class C low-level radioactive waste

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

    Beitel, G.A.

    1991-12-31

    EG and G Idaho, Inc., at the Idaho National Engineering Laboratory (INEL) is actively pursuing technical storage alternatives for greater-than-Class C low-level radioactive waste (GTCC LLW) until a suitable licensed disposal facility is operating. A recently completed study projects that between 2200 and 6000 m{sup 3} of GTCC LLW will be generated by the year 2035; the base case estimate is 3250 m{sup 3}. The current plan envisions a disposal facility available as early as the year 2010. A long-term dedicated storage facility could be available in 1997. In the meantime, it is anticipated that a limited number of sealedmore » sources that are no longer useful and have GTCC concentrations of radionuclides will require storage. Arrangements are being made to provide this interim storage at an existing DOE waste management facility. All interim stored waste will subsequently be moved to the dedicated storage facility once it is operating. Negotiations are under way to establish a host site for interim storage, which may be operational, at the earliest, by the second quarter of 1993. Two major activities toward developing a long-term dedicated storage facility are ongoing. (a) An engineering study, which explores costs for alternatives to provide environmentally safe storage and satisfy all regulations, is being prepared. Details of some of the findings of that study will be presented. (b) There is also an effort under way to seek the assistance of one or more private companies in providing dedicated storage. Alternatives and options will be discussed.« less

  6. Replacement of a hopeless maxillary central incisor: a technique for the fabrication of an immediate implant-supported interim restoration.

    PubMed

    Graiff, Lorenzo; Vigolo, Paolo

    2012-04-01

    Placement of a dental implant and an interim restoration in the esthetic zone immediately following tooth extraction is now a common procedure. However, in such clinical situations, the fabrication of an appropriate interim restoration may be challenging. The aim of this article is to present a technique for modifying the extracted tooth so it can be used as an implant-supported interim restoration.

  7. The Role of Robots and Automation in Space

    NASA Technical Reports Server (NTRS)

    Heer, E.

    1978-01-01

    Advanced space transportation systems based on the shuttle and interim upper stage will open the way to the use of large-scale industrial and commercial systems in space. The role of robot and automation technology in the cost-effective implementation and operation of such systems in the next two decades is discussed. Planning studies initiated by NASA are described as applied to space exploration, global services, and space industrialization, and a forecast of potential missions in each category is presented. The appendix lists highlights of space robot technology from 1967 to the present.

  8. High resolution infrared datasets useful for validating stratospheric models

    NASA Technical Reports Server (NTRS)

    Rinsland, Curtis P.

    1992-01-01

    An important objective of the High Speed Research Program (HSRP) is to support research in the atmospheric sciences that will improve the basic understanding of the circulation and chemistry of the stratosphere and lead to an interim assessment of the impact of a projected fleet of High Speed Civil Transports (HSCT's) on the stratosphere. As part of this work, critical comparisons between models and existing high quality measurements are planned. These comparisons will be used to test the reliability of current atmospheric chemistry models. Two suitable sets of high resolution infrared measurements are discussed.

  9. Response Action Plan for the Basin F Interim Response Action Waste Pile.

    DTIC Science & Technology

    1992-10-01

    the Waste Pile via an 8-Inch diameter HDPE stand pipe. A stainless - steel submersible pump provides the lift to deliver the collected liquid 5 to the...2.1.4 Settlement Measuring System 3 Nine settlement plates were installed at the base of the Waste Pile during its construction. A 1-Inch steel pipe...PLATE STEEL CONDUIT. PIPE GS: 5219.61 GS: 5219.98 GS: 5219.56 GS: 5219.50 SPSP: 5217.87 SPSP: 5217.94 SPSP: 5218.59 THP: 5221.25 THP: 5221.41 THP

  10. FOD Prevention at NASA-Marshall Space Flight Center

    NASA Technical Reports Server (NTRS)

    Lowrey, Nikki M.

    2011-01-01

    NASA now requires all flight hardware projects to develop and implement a Foreign Object Damage (FOD) Prevention Program. With the increasing use of composite and bonded structures, NASA now also requires an Impact Damage Protection Plan for these items. In 2009, Marshall Space Flight Center released an interim directive that required all Center organizations to comply with FOD protocols established by on-site Projects, to include prevention of impact damage. The MSFC Technical Standards Control Board authorized the development of a new MSFC technical standard for FOD Prevention.

  11. Preliminary design package for residential heating/cooling system: Rankine air conditioner redesign

    NASA Technical Reports Server (NTRS)

    1978-01-01

    A summary of the preliminary redesign and development of a marketable single family heating and cooling system is presented. The interim design and schedule status of the residential (3-ton) redesign, problem areas and solutions, and the definition of plans for future design and development activities were discussed. The proposed system for a single-family residential heating and cooling system is a single-loop, solar-assisted, hydronic-to-warm-air heating subsystem with solar-assisted domestic water heating and a Rankine-driven expansion air-conditioning subsystem.

  12. Interim analysis of STR effectiveness

    DOT National Transportation Integrated Search

    1978-01-01

    The present report describes the status of the NHTSA Short Term Rehabilitation Study (STR) as of December, 1977, and summarizes the progress of data collection efforts by the eleven participating ASAP projects. Outcome measures considered as indicati...

  13. Palbociclib for Advanced Breast Cancer

    Cancer.gov

    An interim analysis of the PALOMA3 trial shows that women with hormone receptor-positive metastatic breast cancer who received palbociclib plus fulvestrant had longer progression-free survival rates than women who received a placebo plus fulvestrant.

  14. The role of the Data and Safety Monitoring Board in a clinical trial: the CRISIS study.

    PubMed

    Holubkov, Richard; Casper, T Charles; Dean, J Michael; Anand, K J S; Zimmerman, Jerry; Meert, Kathleen L; Newth, Christopher J L; Berger, John; Harrison, Rick; Willson, Douglas F; Nicholson, Carol

    2013-05-01

    Randomized clinical trials are commonly overseen by a Data and Safety Monitoring Board comprised of experts in medicine, ethics, and biostatistics. Data and Safety Monitoring Board responsibilities include protocol approval, interim review of study enrollment, protocol compliance, safety, and efficacy data. Data and Safety Monitoring Board decisions can affect study design and conduct, as well as reported findings. Researchers must incorporate Data and Safety Monitoring Board oversight into the design, monitoring, and reporting of randomized trials. Case study, narrative review. The Data and Safety Monitoring Board's role during the comparative pediatric Critical Illness Stress-Induced Immune Suppression (CRISIS) Prevention Trial is described. The National Institutes of Health-appointed CRISIS Data and Safety Monitoring Board was charged with monitoring sample size adequacy and feasibility, safety with respect to adverse events and 28-day mortality, and efficacy with respect to the primary nosocomial infection/sepsis outcome. The Federal Drug Administration also requested Data and Safety Monitoring Board interim review before opening CRISIS to children below 1 yr of age. The first interim analysis found higher 28-day mortality in one treatment arm. The Data and Safety Monitoring Board maintained trial closure to younger children and requested a second interim data review 6 months later. At this second meeting, mortality was no longer of concern, whereas a weak efficacy trend of lower infection/sepsis rates in one study arm emerged. As over 40% of total patients had been enrolled, the Data and Safety Monitoring Board elected to examine conditional power and unmask treatment arm identities. On finding somewhat greater efficacy in the placebo arm, the Data and Safety Monitoring Board recommended stopping CRISIS due to futility. The design and operating procedures of a multicenter randomized trial must consider a pivotal Data and Safety Monitoring Board role. Maximum study design flexibility must be allowed, and investigators must be prepared for protocol modifications due to interim findings. The Data and Safety Monitoring Board must have sufficient clinical and statistical expertise to assess potential importance of interim treatment differences in the setting of multiple looks at accumulating data with numerous outcomes and subgroups.

  15. Comparison of trends and abrupt changes of the South Asia high from 1979 to 2014 in reanalysis and radiosonde datasets

    NASA Astrophysics Data System (ADS)

    Shi, Chunhua; Huang, Ying; Guo, Dong; Zhou, Shunwu; Hu, Kaixi; Liu, Yu

    2018-05-01

    The South Asian High (SAH) has an important influence on atmospheric circulation and the Asian climate in summer. However, current comparative analyses of the SAH are mostly between reanalysis datasets and there is a lack of sounding data. We therefore compared the climatology, trends and abrupt changes in the SAH in the Japanese 55-year Reanalysis (JRA-55) dataset, the National Centers for Environmental Prediction Climate Forecast System Reanalysis (NCEP-CFSR) dataset, the European Center for Medium-Range Weather Forecasts Reanalysis Interim (ERA-interim) dataset and radiosonde data from China using linear analysis and a sliding t-test. The trends in geopotential height in the control area of the SAH were positive in the JRA-55, NCEP-CFSR and ERA-interim datasets, but negative in the radiosonde data in the time period 1979-2014. The negative trends for the SAH were significant at the 90% confidence level in the radiosonde data from May to September. The positive trends in the NCEP-CFSR dataset were significant at the 90% confidence level in May, July, August and September, but the positive trends in the JRA-55 and ERA-Interim were only significant at the 90% confidence level in September. The reasons for the differences in the trends of the SAH between the radiosonde data and the three reanalysis datasets in the time period 1979-2014 were updates to the sounding systems, changes in instrumentation and improvements in the radiation correction method for calculations around the year 2000. We therefore analyzed the trends in the two time periods of 1979-2000 and 2001-2014 separately. From 1979 to 2000, the negative SAH trends in the radiosonde data mainly agreed with the negative trends in the NCEP-CFSR dataset, but were in contrast with the positive trends in the JRA-55 and ERA-Interim datasets. In 2001-2014, however, the trends in the SAH were positive in all four datasets and most of the trends in the radiosonde and NCEP-CFSR datasets were significant. It is therefore better to use the NCEP-CFSR dataset than the JRA-55 and ERA-Interim datasets when discussing trends in the SAH.

  16. TECNOB Study: Ad Interim Results of a Randomized Controlled Trial of a Multidisciplinary Telecare Intervention for Obese Patients with Type-2 Diabetes.

    PubMed

    Castelnuovo, Gianluca; Manzoni, Gian Mauro; Cuzziol, Paola; Cesa, Gian Luca; Corti, Stefania; Tuzzi, Cristina; Villa, Valentina; Liuzzi, Antonio; Petroni, Maria Letizia; Molinari, Enrico

    2011-03-04

    Obesity increases the risk of many health complications such as hypertension, coronary heart disease and type 2 diabetes, needs long-lasting treatment for effective results and involves high public and private care-costs. Therefore, it is imperative that enduring and low-cost clinical programs for obesity and related co-morbidities are developed and evaluated. Information and communication technologies (ICT) can help clinicians to deliver treatment in a cost-effective and time-saving manner to a large number of obese individuals with co-morbidities. To examine ad interim effectiveness of a 12-month multidisciplinary telecare intervention for weight loss provided to obese patients with type 2 diabetes. A single-center randomized controlled trial (TECNOB study) started in December 2008. At present, 72 obese patients with type 2 diabetes have been recruited and randomly allocated to the TECNOB program (n=37) or to a control condition (n=39). However, only 34 participants have completed at least the 3-month follow-up and have been included in this ad interim analysis. 21 out of them have reached also the 6-month follow-up and 13 have achieved the end of the program. Study is still on-going. All participants attended 1-month inpatient intensive program that involved individualized medical care, diet therapy, physical training and brief psychological counseling. At discharge, participants allocated to the TECNOB program were instructed to use a weight-loss web-site, a web-based videoconference tool, a dietary software installed into their cellular phones and an electronic armband measuring daily steps and energy expenditure. Weight and disordered eating-related behaviors and cognitions (EDI-2) at entry to hospital, at discharge from hospital, at 3,6 and 12 months. Ad interim analysis of data from 34 participants showed no statistically significant difference between groups in weight change at any time-point. However, within-group analysis revealed significant reductions of initial weight at discharge from hospital, at 3 months, at 6 months but not at 12 months. Control group had higher scores in Interpersonal distrust at 12 months. This ad interim findings revealed that the effect of the inpatient treatment was high and probably overwhelmed the effect of the TECNOB intervention. Much statistical power and long-term follow-up may enhance the probability to detect the TECNOB effect over and above the great one exerted by the inpatient program.

  17. International validation study for interim PET in ABVD-treated, advanced-stage hodgkin lymphoma: interpretation criteria and concordance rate among reviewers.

    PubMed

    Biggi, Alberto; Gallamini, Andrea; Chauvie, Stephane; Hutchings, Martin; Kostakoglu, Lale; Gregianin, Michele; Meignan, Michel; Malkowski, Bogdan; Hofman, Michael S; Barrington, Sally F

    2013-05-01

    At present, there are no standard criteria that have been validated for interim PET reporting in lymphoma. In 2009, an international workshop attended by hematologists and nuclear medicine experts in Deauville, France, proposed to develop simple and reproducible rules for interim PET reporting in lymphoma. Accordingly, an international validation study was undertaken with the primary aim of validating the prognostic role of interim PET using the Deauville 5-point score to evaluate images and with the secondary aim of measuring concordance rates among reviewers using the same 5-point score. This paper focuses on the criteria for interpretation of interim PET and on concordance rates. A cohort of advanced-stage Hodgkin lymphoma patients treated with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) were enrolled retrospectively from centers worldwide. Baseline and interim scans were reviewed by an international panel of 6 nuclear medicine experts using the 5-point score. Complete scan datasets of acceptable diagnostic quality were available for 260 of 440 (59%) enrolled patients. Independent agreement among reviewers was reached on 252 of 260 patients (97%), for whom at least 4 reviewers agreed the findings were negative (score of 1-3) or positive (score of 4-5). After discussion, consensus was reached in all cases. There were 45 of 260 patients (17%) with positive interim PET findings and 215 of 260 patients (83%) with negative interim PET findings. Thirty-three interim PET-positive scans were true-positive, and 12 were false-positive. Two hundred three interim PET-negative scans were true-negative, and 12 were false-negative. Sensitivity, specificity, and accuracy were 0.73, 0.94, and 0.91, respectively. Negative predictive value and positive predictive value were 0.94 and 0.73, respectively. The 3-y failure-free survival was 83%, 28%, and 95% for the entire population and for interim PET-positive and -negative patients, respectively (P < 0.0001). The agreement between pairs of reviewers was good or very good, ranging from 0.69 to 0.84 as measured with the Cohen kappa. Overall agreement was good at 0.76 as measured with the Krippendorf α. The 5-point score proposed at Deauville for reviewing interim PET scans in advanced Hodgkin lymphoma is accurate and reproducible enough to be accepted as a standard reporting criterion in clinical practice and for clinical trials.

  18. Guidance: Interim Municipal Settlement Policy

    EPA Pesticide Factsheets

    Interim guidance and fact sheets regarding settlements involving municipalities or municipal waste under Section 122 CERCLA as amended by SARA. Interim policy sets forth the criteria by which EPA generally determines whether to exercise enforcement discretion to pursue MSW generators and transporters as PRPs.

  19. Efficacy and safety of sublingual ramelteon as an adjunctive therapy in the maintenance treatment of bipolar I disorder in adults: A phase 3, randomized controlled trial.

    PubMed

    Mahableshwarkar, Atul R; Calabrese, Joseph R; Macek, Thomas A; Budur, Kumar; Adefuye, Adedeji; Dong, Xinxin; Hanson, Elizabeth; Sachs, Gary S

    2017-10-15

    The optimal long-term management strategy for bipolar I disorder patients is not yet established. Evidence supports the rationale for circadian rhythm regulation to prevent mood episode relapse in bipolar patients. This study evaluated the efficacy and safety of a new sublingual formulation of the melatonin receptor agonist ramelteon (ramelteon SL) as adjunctive therapy in the maintenance treatment of bipolar I patients. In a double-blinded trial in the United States and Latin America, adult bipolar I disorder patients stable for ≥ 8 weeks before baseline and with a mood episode 8 weeks to 9 months before screening, were randomized to once-daily ramelteon SL 0.1mg (n = 164), 0.4mg (n = 160), or 0.8mg (n = 154), or placebo (n = 164), in addition to their existing treatment. The primary endpoint was time from randomization to relapse of symptoms. The prespecified futility criterion in a planned, unblinded, independent interim analysis was the failure of all ramelteon SL doses to achieve a conditional power ≥ 30% compared with placebo. No significant differences between any dose of ramelteon SL and placebo were observed. The study was terminated after meeting the futility criteria. Ramelteon SL was well tolerated, with a safety profile consistent with that for oral ramelteon. A low rate of relapse events precluded detection of any statistically significant difference between groups. The study failed to demonstrate the efficacy of ramelteon SL as adjunctive maintenance therapy for bipolar disorder. Interim analyses for futility in clinical studies are valuable in preventing unnecessary exposure of subjects to interventions. Copyright © 2017. Published by Elsevier B.V.

  20. Randomized, placebo-controlled, phase III trial of sunitinib plus prednisone versus prednisone alone in progressive, metastatic, castration-resistant prostate cancer.

    PubMed

    Michaelson, M Dror; Oudard, Stephane; Ou, Yen-Chuan; Sengeløv, Lisa; Saad, Fred; Houede, Nadine; Ostler, Peter; Stenzl, Arnulf; Daugaard, Gedske; Jones, Robert; Laestadius, Fredrik; Ullèn, Anders; Bahl, Amit; Castellano, Daniel; Gschwend, Juergen; Maurina, Tristan; Chow Maneval, Edna; Wang, Shaw-Ling; Lechuga, Maria Jose; Paolini, Jolanda; Chen, Isan

    2014-01-10

    We evaluated angiogenesis-targeted sunitinib therapy in a randomized, double-blind trial of metastatic castration-resistant prostate cancer (mCRPC). Men with progressive mCRPC after docetaxel-based chemotherapy were randomly assigned 2:1 to receive sunitinib 37.5 mg/d continuously or placebo. Patients also received oral prednisone 5 mg twice daily. The primary end point was overall survival (OS); secondary end points included progression-free survival (PFS). Two interim analyses were planned. Overall, 873 patients were randomly assigned to receive sunitinib (n = 584) or placebo (n = 289). The independent data monitoring committee stopped the study for futility after the second interim analysis. After a median overall follow-up of 8.7 months, median OS was 13.1 months and 11.8 months for sunitinib and placebo, respectively (hazard ratio [HR], 0.914; 95% CI, 0.762 to 1.097; stratified log-rank test, P = .168). PFS was significantly improved in the sunitinib arm (median 5.6 v 4.1 months; HR, 0.725; 95% CI, 0.591 to 0.890; stratified log-rank test, P < .001). Toxicity and rates of discontinuations because of adverse events (AEs; 27% v 7%) were greater with sunitinib than placebo. The most common treatment-related grade 3/4 AEs were fatigue (9% v 1%), asthenia (8% v 2%), and hand-foot syndrome (7% v 0%). Frequent treatment-emergent grade 3/4 hematologic abnormalities were lymphopenia (20% v 11%), anemia (9% v 8%), and neutropenia (6% v < 1%). The addition of sunitinib to prednisone did not improve OS compared with placebo in docetaxel-refractory mCRPC. The role of antiangiogenic therapy in mCRPC remains investigational.

  1. Long-term efficacy and safety of mipomersen in patients with familial hypercholesterolaemia: 2-year interim results of an open-label extension.

    PubMed

    Santos, Raul D; Duell, P Barton; East, Cara; Guyton, John R; Moriarty, Patrick M; Chin, Wai; Mittleman, Robert S

    2015-03-01

    To evaluate the efficacy and safety of extended dosing with mipomersen in patients with familial hypercholesterolaemia (HC) taking maximally tolerated lipid-lowering therapy. A planned interim analysis of an ongoing, open-label extension trial in patients (n = 141) with familial HC receiving a subcutaneous injection of 200 mg mipomersen weekly plus maximally tolerated lipid-lowering therapy for up to 104 weeks. The mean changes in low-density lipoprotein cholesterol (LDL-C) from baseline to weeks 26 (n = 130), 52 (n = 111), 76 (n = 66), and 104 (n = 53) were -28, -27, -27, and -28%; and in apolipoprotein B -29, -28, -30, and -31%, respectively. Reductions in total cholesterol, non-high-density lipoprotein-cholesterol, and lipoprotein(a) were comparable with decreases in LDL-C and apolipoprotein B levels. Mean high-density lipoprotein cholesterol increased from baseline by 7 and 6% at weeks 26 and 52, respectively. The long-term safety profile of mipomersen was similar to that reported in the associated randomized placebo-controlled Phase 3 trials. Adverse events included injection site reactions and flu-like symptoms. There was an incremental increase in the median liver fat during the initial 6-12 months that appeared to diminish with continued mipomersen exposure beyond 1 year and returned towards baseline 24 weeks after last drug dose suggestive of adaptation. The median alanine aminotransferase level showed a similar trend over time. Long-term treatment with mipomersen for up to 104 weeks provided sustained reductions in all atherosclerotic lipoproteins measured and a safety profile consistent with prior controlled trials in these high-risk patient populations. CLINICALTRIALS.GOV: NCT00694109. © The Author 2013. Published by Oxford University Press on behalf of the European Society of Cardiology.

  2. Long-term efficacy and safety of mipomersen in patients with familial hypercholesterolaemia: 2-year interim results of an open-label extension

    PubMed Central

    Santos, Raul D.; Duell, P. Barton; East, Cara; Guyton, John R.; Moriarty, Patrick M.; Chin, Wai; Mittleman, Robert S.

    2015-01-01

    Aims To evaluate the efficacy and safety of extended dosing with mipomersen in patients with familial hypercholesterolaemia (HC) taking maximally tolerated lipid-lowering therapy. Methods and results A planned interim analysis of an ongoing, open-label extension trial in patients (n = 141) with familial HC receiving a subcutaneous injection of 200 mg mipomersen weekly plus maximally tolerated lipid-lowering therapy for up to 104 weeks. The mean changes in low-density lipoprotein cholesterol (LDL-C) from baseline to weeks 26 (n = 130), 52 (n = 111), 76 (n = 66), and 104 (n = 53) were −28, −27, −27, and −28%; and in apolipoprotein B −29, −28, −30, and −31%, respectively. Reductions in total cholesterol, non-high-density lipoprotein-cholesterol, and lipoprotein(a) were comparable with decreases in LDL-C and apolipoprotein B levels. Mean high-density lipoprotein cholesterol increased from baseline by 7 and 6% at weeks 26 and 52, respectively. The long-term safety profile of mipomersen was similar to that reported in the associated randomized placebo-controlled Phase 3 trials. Adverse events included injection site reactions and flu-like symptoms. There was an incremental increase in the median liver fat during the initial 6–12 months that appeared to diminish with continued mipomersen exposure beyond 1 year and returned towards baseline 24 weeks after last drug dose suggestive of adaptation. The median alanine aminotransferase level showed a similar trend over time. Conclusion Long-term treatment with mipomersen for up to 104 weeks provided sustained reductions in all atherosclerotic lipoproteins measured and a safety profile consistent with prior controlled trials in these high-risk patient populations. Clinicaltrials.gov NCT00694109. PMID:24366918

  3. Science Opportunities Enabled by NASA's Constellation System: Interim Report

    NASA Astrophysics Data System (ADS)

    Committee On Science Opportunities Enabled By Nasa'S Constellation System, National Research Council

    To begin implementation of the Vision for Space Exploration (recently renamed "United States Space Exploration Policy"), NASA has begun development of new launch vehicles and a human-carrying spacecraft that are collectively called the Constellation System. In November 2007, NASA asked the NRC to evaluate the potential for the Constellation System to enable new space science opportunities. For this interim report, 11 existing "Vision Mission" studies of advanced space science mission concepts inspired by earlier NASA forward-looking studies were evaluated. The focus was to assess the concepts and group them into two categories: more-deserving or less deserving of future study. This report presents a description of the Constellation System and its opportunities for enabling new space science opportunities, and a systematic analysis of the 11 Vision Mission studies. For the final report, the NRC issued a request for information to the relevant communities to obtain ideas for other mission concepts that will be assessed by the study committee, and several issues addressed only briefly in the interim report will be explored more fully.

  4. 75 FR 65349 - Decision To Evaluate a Petition To Designate a Class of Employees From BWX Technologies Inc...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-22

    ...: Lynchburg, Virginia. Job Titles and/or Job Duties: All Atomic Weapons Employer employees. Period of..., Interim Director, Division of Compensation Analysis and Support, National Institute for Occupational...

  5. 75 FR 4822 - Decision To Evaluate a Petition To Designate a Class of Employees for the Lawrence Livermore...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-29

    ...: Lawrence Livermore National Laboratory. Location: Livermore, California. Job Titles and/or Job Duties: All... L. Hinnefeld, Interim Director, Office of Compensation Analysis and Support, National Institute for...

  6. Road weather connected vehicle applications : benefit-cost analysis interim report.

    DOT National Transportation Integrated Search

    2013-01-01

    RWMP is currently engaged in a project to evaluate the potential benefits of road weather connected vehicle applications. Of particular interest are the potential improvements in safety, reductions in travel time, improved travel reliability, reducti...

  7. INTERIM ANALYSIS OF THE CONTRIBUTION OF HIGH-LEVEL EVIDENCE FOR DENGUE VECTOR CONTROL.

    PubMed

    Horstick, Olaf; Ranzinger, Silvia Runge

    2015-01-01

    This interim analysis reviews the available systematic literature for dengue vector control on three levels: 1) single and combined vector control methods, with existing work on peridomestic space spraying and on Bacillus thuringiensis israelensis; further work is available soon on the use of Temephos, Copepods and larvivorous fish; 2) or for a specific purpose, like outbreak control, and 3) on a strategic level, as for example decentralization vs centralization, with a systematic review on vector control organization. Clear best practice guidelines for methodology of entomological studies are needed. There is a need to include measuring dengue transmission data. The following recommendations emerge: Although vector control can be effective, implementation remains an issue; Single interventions are probably not useful; Combinations of interventions have mixed results; Careful implementation of vector control measures may be most important; Outbreak interventions are often applied with questionable effectiveness.

  8. 28 CFR 94.41 - Interim emergency payment.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Interim emergency payment. 94.41 Section 94.41 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CRIME VICTIM SERVICES International Terrorism Victim Expense Reimbursement Program Payment of Claims § 94.41 Interim emergency payment...

  9. 28 CFR 94.41 - Interim emergency payment.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Interim emergency payment. 94.41 Section 94.41 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CRIME VICTIM SERVICES International Terrorism Victim Expense Reimbursement Program Payment of Claims § 94.41 Interim emergency payment...

  10. 28 CFR 94.41 - Interim emergency payment.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Interim emergency payment. 94.41 Section 94.41 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CRIME VICTIM SERVICES International Terrorism Victim Expense Reimbursement Program Payment of Claims § 94.41 Interim emergency payment...

  11. 28 CFR 94.41 - Interim emergency payment.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Interim emergency payment. 94.41 Section 94.41 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CRIME VICTIM SERVICES International Terrorism Victim Expense Reimbursement Program Payment of Claims § 94.41 Interim emergency payment...

  12. 28 CFR 94.41 - Interim emergency payment.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Interim emergency payment. 94.41 Section 94.41 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CRIME VICTIM SERVICES International Terrorism Victim Expense Reimbursement Program Payment of Claims § 94.41 Interim emergency payment...

  13. 76 FR 4369 - Special Law Enforcement Commissions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-25

    ... DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs Special Law Enforcement Commissions AGENCY... of the Interim Special Law Enforcement Commission Policy, Rules and Procedures, the Interim Special Law Enforcement Commission Protocols and the Interim Domestic Violence Waiver that will be used by the...

  14. 47 CFR 51.715 - Interim transport and termination pricing.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 3 2010-10-01 2010-10-01 false Interim transport and termination pricing. 51... SERVICES (CONTINUED) INTERCONNECTION Reciprocal Compensation for Transport and Termination of Telecommunications Traffic § 51.715 Interim transport and termination pricing. (a) Upon request from a...

  15. 47 CFR 51.715 - Interim transport and termination pricing.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 3 2011-10-01 2011-10-01 false Interim transport and termination pricing. 51... SERVICES (CONTINUED) INTERCONNECTION Reciprocal Compensation for Transport and Termination of Telecommunications Traffic § 51.715 Interim transport and termination pricing. (a) Upon request from a...

  16. Investigation of Kelvin wave periods during Hai-Tang typhoon using Empirical Mode Decomposition

    NASA Astrophysics Data System (ADS)

    Kishore, P.; Jayalakshmi, J.; Lin, Pay-Liam; Velicogna, Isabella; Sutterley, Tyler C.; Ciracì, Enrico; Mohajerani, Yara; Kumar, S. Balaji

    2017-11-01

    Equatorial Kelvin waves (KWs) are fundamental components of the tropical climate system. In this study, we investigate Kelvin waves (KWs) during the Hai-Tang typhoon of 2005 using Empirical Mode Decomposition (EMD) of regional precipitation, zonal and meridional winds. For the analysis, we use daily precipitation datasets from the Global Precipitation Climatology Project (GPCP) and wind datasets from the European Centre for Medium-Range Weather Forecasts (ECMWF) Interim Re-analysis (ERA-Interim). As an additional measurement, we use in-situ precipitation datasets from rain-gauges over the Taiwan region. The maximum accumulated precipitation was approximately 2400 mm during the period July 17-21, 2005 over the southwestern region of Taiwan. The spectral analysis using the wind speed at 950 hPa found in the 2nd, 3rd, and 4th intrinsic mode functions (IMFs) reveals prevailing Kelvin wave periods of ∼3 days, ∼4-6 days, and ∼6-10 days, respectively. From our analysis of precipitation datasets, we found the Kelvin waves oscillated with periods between ∼8 and 20 days.

  17. 78 FR 55339 - Regulatory Capital Rules: Regulatory Capital, Implementation of Basel III, Capital Adequacy...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-10

    ...The Federal Deposit Insurance Corporation (FDIC) is adopting an interim final rule that revises its risk-based and leverage capital requirements for FDIC-supervised institutions. This interim final rule is substantially identical to a joint final rule issued by the Office of the Comptroller of the Currency (OCC) and the Board of Governors of the Federal Reserve System (Federal Reserve) (together, with the FDIC, the agencies). The interim final rule consolidates three separate notices of proposed rulemaking that the agencies jointly published in the Federal Register on August 30, 2012, with selected changes. The interim final rule implements a revised definition of regulatory capital, a new common equity tier 1 minimum capital requirement, a higher minimum tier 1 capital requirement, and, for FDIC-supervised institutions subject to the advanced approaches risk-based capital rules, a supplementary leverage ratio that incorporates a broader set of exposures in the denominator. The interim final rule incorporates these new requirements into the FDIC's prompt corrective action (PCA) framework. In addition, the interim final rule establishes limits on FDIC-supervised institutions' capital distributions and certain discretionary bonus payments if the FDIC-supervised institution does not hold a specified amount of common equity tier 1 capital in addition to the amount necessary to meet its minimum risk-based capital requirements. The interim final rule amends the methodologies for determining risk-weighted assets for all FDIC-supervised institutions. The interim final rule also adopts changes to the FDIC's regulatory capital requirements that meet the requirements of section 171 and section 939A of the Dodd-Frank Wall Street Reform and Consumer Protection Act. The interim final rule also codifies the FDIC's regulatory capital rules, which have previously resided in various appendices to their respective regulations, into a harmonized integrated regulatory framework. In addition, the FDIC is amending the market risk capital rule (market risk rule) to apply to state savings associations. The FDIC is issuing these revisions to its capital regulations as an interim final rule. The FDIC invites comments on the interaction of this rule with other proposed leverage ratio requirements applicable to large, systemically important banking organizations. This interim final rule otherwise contains regulatory text that is identical to the common rule text adopted as a final rule by the Federal Reserve and the OCC. This interim final rule enables the FDIC to proceed on a unified, expedited basis with the other federal banking agencies pending consideration of other issues. Specifically, the FDIC intends to evaluate this interim final rule in the context of the proposed well- capitalized and buffer levels of the supplementary leverage ratio applicable to large, systemically important banking organizations, as described in a separate Notice of Proposed Rulemaking (NPR) published in the Federal Register August 20, 2013. The FDIC is seeking commenters' views on the interaction of this interim final rule with the proposed rule regarding the supplementary leverage ratio for large, systemically important banking organizations.

  18. Statistical aspects of the TNK-S2B trial of tenecteplase versus alteplase in acute ischemic stroke: an efficient, dose-adaptive, seamless phase II/III design.

    PubMed

    Levin, Bruce; Thompson, John L P; Chakraborty, Bibhas; Levy, Gilberto; MacArthur, Robert; Haley, E Clarke

    2011-08-01

    TNK-S2B, an innovative, randomized, seamless phase II/III trial of tenecteplase versus rt-PA for acute ischemic stroke, terminated for slow enrollment before regulatory approval of use of phase II patients in phase III. (1) To review the trial design and comprehensive type I error rate simulations and (2) to discuss issues raised during regulatory review, to facilitate future approval of similar designs. In phase II, an early (24-h) outcome and adaptive sequential procedure selected one of three tenecteplase doses for phase III comparison with rt-PA. Decision rules comparing this dose to rt-PA would cause stopping for futility at phase II end, or continuation to phase III. Phase III incorporated two co-primary hypotheses, allowing for a treatment effect at either end of the trichotomized Rankin scale. Assuming no early termination, four interim analyses and one final analysis of 1908 patients provided an experiment-wise type I error rate of <0.05. Over 1,000 distribution scenarios, each involving 40,000 replications, the maximum type I error in phase III was 0.038. Inflation from the dose selection was more than offset by the one-half continuity correction in the test statistics. Inflation from repeated interim analyses was more than offset by the reduction from the clinical stopping rules for futility at the first interim analysis. Design complexity and evolving regulatory requirements lengthened the review process. (1) The design was innovative and efficient. Per protocol, type I error was well controlled for the co-primary phase III hypothesis tests, and experiment-wise. (2a) Time must be allowed for communications with regulatory reviewers from first design stages. (2b) Adequate type I error control must be demonstrated. (2c) Greater clarity is needed on (i) whether this includes demonstration of type I error control if the protocol is violated and (ii) whether simulations of type I error control are acceptable. (2d) Regulatory agency concerns that protocols for futility stopping may not be followed may be allayed by submitting interim analysis results to them as these analyses occur.

  19. 14 CFR 136.41 - Interim operating authority.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 3 2012-01-01 2012-01-01 false Interim operating authority. 136.41 Section 136.41 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED... technology, as appropriate, and (9) Shall allow for modifications of the interim operating authority based on...

  20. 14 CFR 136.41 - Interim operating authority.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 3 2014-01-01 2014-01-01 false Interim operating authority. 136.41 Section 136.41 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED... technology, as appropriate, and (9) Shall allow for modifications of the interim operating authority based on...

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