WorldWideScience

Sample records for alternative procedures approved

  1. 78 FR 37463 - Expedited Approval of Alternative Test Procedures for the Analysis of Contaminants Under the Safe...

    Science.gov (United States)

    2013-06-21

    ... Approval of Alternative Test Procedures for the Analysis of Contaminants Under the Safe Drinking Water Act... page 32570, with the table entitled ``ALTERNATIVE TESTING METHODS FOR CONTAMINANTS LISTED AT 40 CFR 141... Contaminants Listed at 40 CFR 141.25(a) SM 21st Edition SM 22nd Edition Contaminant Methodology \\1\\ \\28\\ ASTM...

  2. 75 FR 32295 - Expedited Approval of Alternative Test Procedures for the Analysis of Contaminants Under the Safe...

    Science.gov (United States)

    2010-06-08

    ... Approval of Alternative Test Procedures for the Analysis of Contaminants Under the Safe Drinking Water Act... methods for use in measuring the levels of contaminants in drinking water and determining compliance with... required to measure contaminants in drinking water samples. In addition, EPA Regions as well as States and...

  3. 40 CFR 1065.12 - Approval of alternate procedures.

    Science.gov (United States)

    2010-07-01

    ... Compliance Officer an initial written request describing the alternate procedure and why you believe it is... described in this section, we may ask you to submit to us in writing supplemental information showing that... allowed procedure, considering the following factors: (1) The cost, difficulty, and availability to switch...

  4. 46 CFR 163.002-9 - Approval procedure.

    Science.gov (United States)

    2010-10-01

    ... COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS... designs. A pilot hoist that does not meet the materials, construction, or performance requirements of this... or in addition to the approval tests required by this subpart, show that the alternative materials...

  5. 6 CFR 25.9 - Procedures for certification of approved products for Homeland Security.

    Science.gov (United States)

    2010-01-01

    ... Procedures for certification of approved products for Homeland Security. (a) Application Procedure. An applicant seeking a Certification of anti-terrorism Technology as an Approved Product for Homeland Security... application for renewal must be made using the “Application for Certification of an Approved Product for...

  6. 46 CFR 160.077-6 - Approval procedures.

    Science.gov (United States)

    2010-10-01

    ... Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS... to the particular design or that by design or construction the PFD cannot fail the test. (c) Alternative Requirements. A PFD that does not meet requirements in this subpart may still be approved if the...

  7. Revised guideline for the approval procedure of package designs in Germany

    International Nuclear Information System (INIS)

    Nitsche, F.; Roedel, R.

    2004-01-01

    The IAEA Regulations for the Safe Transport of Radioactive Material, TS-R-1 are applied in Germany through the implementation of the Dangerous Goods Transport Regulations for class 7 of the International Modal Organisations (ADR, RID, IMDG-Code, ICAO-TI). Based on this the approval procedures for packages designs applied in Germany are in compliance with the provisions of TS-R-1. The Guideline R 003 issued by the Ministry of Transport, Building and Housing (BMVBW) in 1991 is the basis for the package design approval procedures in Germany. This Guideline has been reviewed and revised to reflect latest developments in the regulations as well as in the regulatory practice. In particular it has been extended to the approval procedures of Type C packages, packages subject to transitional arrangements, special form and low dispersible radioactive material and provides more detailed information to the applicant about the requested documentation. Publication of this revised guideline has been delayed but it is expected to take place in October 2004. The paper gives an overview about the main parts and provisions of this revised Guideline R 003 with the focus on package design approval procedures

  8. 7 CFR 1948.82 - Plan and State Investment Strategy approval procedure.

    Science.gov (United States)

    2010-01-01

    ... the State Investment Strategy for Energy Impacted Areas. (c) Appropriate growth management and/or... 7 Agriculture 13 2010-01-01 2009-01-01 true Plan and State Investment Strategy approval procedure... Impacted Area Development Assistance Program § 1948.82 Plan and State Investment Strategy approval...

  9. 48 CFR 2052.215-78 - Travel approvals and reimbursement-Alternate 1.

    Science.gov (United States)

    2010-10-01

    ... reimbursement-Alternate 1. 2052.215-78 Section 2052.215-78 Federal Acquisition Regulations System NUCLEAR... Clauses 2052.215-78 Travel approvals and reimbursement—Alternate 1. As prescribed in 2015.209-70(d), the contracting officer shall insert the following clause in cost reimbursement solicitations and contracts which...

  10. First approval procedure of the TL dosimetric service of the NPP in Slovenia

    International Nuclear Information System (INIS)

    Janzekovic, H.; Krizman, M.; Pucelj, B.; Stuhec, M.; Zdesar, U.

    2001-01-01

    The individual dosimetry of exposed workers in a NPP is one of the essential parts which demonstrates the radiation protection standards achieved in a facility. According to the current legislation the Ministry of Health of the Republic of Slovenia has the authority to grant approvals to personal dosimetric services which perform the dosimetric monitoring of workers in Slovenia. Due to the fact that the detailed approval procedure is not given in national regulations, the Ministry of Health in 2000 established a group of experts with the task to prepare technical and organising requirements for such approval. Based on international documents [1,2,3] the Approval procedure for the thermoluminescence dosimetric (TL) services was created. Following this procedure the assessment of the TL dosimetric service in the NPP was performed. The problems related to the technical and organising requirements with the emphasise on the QA/QC criteria of the TL dosimetric service will be discussed.(author)

  11. 7 CFR 1735.94 - Final approval and closing procedure.

    Science.gov (United States)

    2010-01-01

    ..., DEPARTMENT OF AGRICULTURE GENERAL POLICIES, TYPES OF LOANS, LOAN REQUIREMENTS-TELECOMMUNICATIONS PROGRAM Requirements for All Acquisitions and Mergers § 1735.94 Final approval and closing procedure. (a) Legal documents relating to the acquisition or merger, including copies of required franchises, commission orders...

  12. 14 CFR 39.21 - Where can I get information about FAA-approved alternative methods of compliance?

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Where can I get information about FAA-approved alternative methods of compliance? 39.21 Section 39.21 Aeronautics and Space FEDERAL AVIATION... information about FAA-approved alternative methods of compliance? Each airworthiness directive identifies the...

  13. On the question of a site plan approval procedure for large-scale power stations

    International Nuclear Information System (INIS)

    Roemermann, K.

    1982-01-01

    The author discusses the question whether a plan approval procedure for large-sclae power plants might contribute to shortening the period of time currently used for the licensing of such plants. On the basis of current practice which includes a planning and building permission by virtue of section 35 of the building law (BBauG) together with an approval of plans within the framework of regional planning, the author explains and discusses various models of site plan approval procedures, (a.o. section 38 of the Federal building law). (HP) [de

  14. 29 CFR 1956.24 - Procedures for withdrawal of approval.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false Procedures for withdrawal of approval. 1956.24 Section 1956.24 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... do so, at least developmentally), no industrial or occupational issues may be considered a separable...

  15. 42 CFR 423.171 - Procedures for approval of accreditation as a basis for deeming compliance.

    Science.gov (United States)

    2010-10-01

    ... BENEFIT Cost Control and Quality Improvement Requirements § 423.171 Procedures for approval of... 42 Public Health 3 2010-10-01 2010-10-01 false Procedures for approval of accreditation as a basis for deeming compliance. 423.171 Section 423.171 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES...

  16. 22 CFR 3a.4 - Procedure for requesting approval.

    Science.gov (United States)

    2010-04-01

    ... is also required by law for the applicant's acceptance of civil employment from a foreign government... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Procedure for requesting approval. 3a.4 Section 3a.4 Foreign Relations DEPARTMENT OF STATE GENERAL ACCEPTANCE OF EMPLOYMENT FROM FOREIGN GOVERNMENTS...

  17. Regional planning and plan approval procedures for development and modification of HV grids; Raumordnungs- und Planfeststellungsverfahren fuer den Aus- und Umbau der Hochspannungsnetze

    Energy Technology Data Exchange (ETDEWEB)

    Hennig, Jan; Luehmann, Tobias [Sozietaet Gleiss Lutz, Berlin (Germany)

    2012-07-01

    If renewable energy sources are to be integrated, HV grids in Germany must be expanded and upgraded massively. Plans for new ultrahigh voltage lines find a legal basis in the grid expansion acceleration act (NABEG) of 2011 while most of the plans for 110 kV HV lines are still based on the conventional regional planning procedures with public participation followed by a plan approval procedure. With the decentralisation of power supply, these distribution grids are rapidly developing into power collecting grids, which makes high demands in terms of adaptation and upgrading. The contribution presents the legal boundary conditions and practical challenges accompanying the planning of HV lines outside the scope of the NABEG. It outlines the limited options for priorisation of test points in the regional planning and subsequent plan approval procedures and shows how friction between these may be reduced. Buried cables as an alternative to overhead cables are given particular attention as these have come into focus with the energy turnaround legislation of 2011.

  18. 75 FR 50930 - Final Determination To Approve Alternative Final Cover Request for the Lake County, Montana Landfill

    Science.gov (United States)

    2010-08-18

    ... Determination To Approve Alternative Final Cover Request for the Lake County, Montana Landfill AGENCY... VIII is making a final determination to approve an alternative final cover for the Lake County landfill, a municipal solid waste landfill (MSWLF) owned and operated by Lake County, Montana on the...

  19. 46 CFR 160.076-13 - Approval procedures for inflatable PFDs.

    Science.gov (United States)

    2010-10-01

    ..., CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Inflatable Recreational Personal..., construction specifications, and bill of materials. (2) The information specified in § 159.005-5(a)(2) (i... or construction, it is not possible for the PFD to fail that test. (g) Alternative requirements. A...

  20. 25 CFR 170.934 - Are alternative dispute resolution procedures available?

    Science.gov (United States)

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false Are alternative dispute resolution procedures available... alternative dispute resolution (ADR) procedures is to provide an inexpensive and expeditious forum to resolve... (including for non-construction the mediation and alternative dispute resolution options listed in 25 U.S.C...

  1. 13 CFR 134.216 - Alternative dispute resolution procedures.

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Alternative dispute resolution....216 Alternative dispute resolution procedures. At any time during the pendency of a case, the parties may submit a joint motion requesting that the Judge permit the use of alternative dispute resolution...

  2. 76 FR 48101 - Petition for Approval of Alternate; Odometer Disclosure Requirements

    Science.gov (United States)

    2011-08-08

    ... implement an electronic vehicle title transfer system, the State of Florida has petitioned for approval of... certificate of title for transfers of motor vehicles. With electronic titling there would not be a paper... proposed alternate disclosure requirements for vehicle transfers involving casual or private sales. NHTSA...

  3. A Review of Clinical Data for Currently Approved Hysteroscopic Sterilization Procedures

    Science.gov (United States)

    Basinski, Cindy M

    2010-01-01

    Two hysteroscopic permanent sterilization procedures are approved for use in the United States: Essure® Permanent Birth Control System (Conceptus Incorporated, Mountain View, CA) and Adiana® Permanent Contraception (Hologic, Inc., Bedford, MA). This review compares the clinical trial data for these procedures. A notable difference is the resultant clinical pregnancy risk. The clinical trials for the Essure procedure have reported no pregnancies in 643 relying women in the 9 years since initiation of the studies. The clinical trial for the Adiana procedure has reported 12 pregnancies in 570 relying women in nearly 5 years of collected data. Other clinical outcome parameters concerning Essure and Adiana are examined in this review. PMID:21364861

  4. 46 CFR 71.50-25 - Alternative Hull Examination (AHE) procedure.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 3 2010-10-01 2010-10-01 false Alternative Hull Examination (AHE) procedure. 71.50-25... INSPECTION AND CERTIFICATION Drydocking § 71.50-25 Alternative Hull Examination (AHE) procedure. (a) To complete the underwater survey you must— (1) Perform a general examination of the underwater hull plating...

  5. 15 CFR 400.32 - Procedure for review of request for approval of manufacturing or processing.

    Science.gov (United States)

    2010-01-01

    ... approval of manufacturing or processing. 400.32 Section 400.32 Commerce and Foreign Trade Regulations... REGULATIONS OF THE FOREIGN-TRADE ZONES BOARD Manufacturing and Processing Activity-Reviews § 400.32 Procedure for review of request for approval of manufacturing or processing. (a) Request as part of application...

  6. 4 CFR 21.10 - Express options, flexible alternative procedures, accelerated schedules, summary decisions, and...

    Science.gov (United States)

    2010-01-01

    ... alternative procedures to promptly and fairly resolve a protest, including alternative dispute resolution... 4 Accounts 1 2010-01-01 2010-01-01 false Express options, flexible alternative procedures... alternative procedures, accelerated schedules, summary decisions, and status and other conferences. (a) At the...

  7. The alternative site selection procedure as covered in the report by the Repository Site Selection Procedures Working Group

    International Nuclear Information System (INIS)

    Brenner, M.

    2005-01-01

    The 2002 Act on the Regulated Termination of the Use of Nuclear Power for Industrial Electricity Generation declared Germany's opting out of the peaceful uses of nuclear power. The problem of the permanent management of radioactive residues is becoming more and more important also in the light of that political decision. At the present time, there are no repositories offering the waste management capacities required. Such facilities need to be created. At the present stage, eligible repository sites are the Konrad mine, a former iron ore mine near Salzgitter, and the Gorleben salt dome. While the fate of the Konrad mine as a repository for waste generating negligible amounts of heat continues to be uncertain, despite a plan approval decision of June 2002, the Gorleben repository is still in the planning phase, at present in a dormant state, so to speak. The federal government expressed doubt about the suitability of the Gorleben site. Against this backdrop, the Federal Ministry for the Environment, Nature Conservation, and Nuclear Safety in February 1999 established AkEnd, the Working Group on Repository Site Selection Procedures. The Group was charged with developing, based on sound scientific criteria, a transparent site selection procedure in order to facilitate the search for repository sites. The Working Group presented its final report in December 2002 after approximately four years of work. The Group's proposals about alternative site selection procedures are explained in detail and, above all, reviewed critically. (orig.)

  8. 15 CFR 20.18 - Alternative funds disbursal procedure.

    Science.gov (United States)

    2010-01-01

    ... 15 Commerce and Foreign Trade 1 2010-01-01 2010-01-01 false Alternative funds disbursal procedure. 20.18 Section 20.18 Commerce and Foreign Trade Office of the Secretary of Commerce NONDISCRIMINATION... undisbursed funds from the terminated award, make a new award to an alternate recipient, i.e. any public or...

  9. 19 CFR 101.9 - Test programs or procedures; alternate requirements.

    Science.gov (United States)

    2010-04-01

    ... basis for selecting participants. (b) NCAP testing. For purposes of conducting an approved test program or procedure designed to evaluate planned components of the National Customs Automation Program (NCAP... publication requirement. For tests affecting the NCAP, notice shall be published in the Federal Register not...

  10. Blood banking and regulation: procedures, problems, and alternatives

    National Research Council Canada - National Science Library

    Dauer, Edward A

    This volume examines regulatory and policymaking procedures in blood banking, regulatory enforcement and compliance, innovations and alternatives in regulation, congressional oversight and regulatory...

  11. 46 CFR 115.645 - Alternative Hull Examination (AHE) Procedure.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 4 2010-10-01 2010-10-01 false Alternative Hull Examination (AHE) Procedure. 115.645... AND CERTIFICATION Hull and Tailshaft Examinations § 115.645 Alternative Hull Examination (AHE... underwater hull plating and a detailed examination of all hull welds, propellers, tailshafts, rudders, and...

  12. 46 CFR 50.20-30 - Alternative materials or methods of construction.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 2 2010-10-01 2010-10-01 false Alternative materials or methods of construction. 50.20... ENGINEERING GENERAL PROVISIONS Plan Submittal and Approval § 50.20-30 Alternative materials or methods of construction. (a) When new or alternative procedures, designs, or methods of construction are submitted for...

  13. 75 FR 53371 - Liquefied Natural Gas Facilities: Obtaining Approval of Alternative Vapor-Gas Dispersion Models

    Science.gov (United States)

    2010-08-31

    .... PHMSA-2010-0226] Liquefied Natural Gas Facilities: Obtaining Approval of Alternative Vapor-Gas... safety standards for siting liquefied natural gas (LNG) facilities. Those standards require that an..., and Handling of Liquefied Natural Gas. That consensus [[Page 53372

  14. 77 FR 21451 - Approval and Promulgation of Air Quality Implementation Plans; Colorado; Procedural Rules...

    Science.gov (United States)

    2012-04-10

    ... Promulgation of Air Quality Implementation Plans; Colorado; Procedural Rules; Conflicts of Interest AGENCY... potential conflicts of interest. We are also approving the remaining portion of Colorado's January 7, 2008... or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on...

  15. 46 CFR 160.055-9 - Procedure for approval-standard and nonstandard life preservers.

    Science.gov (United States)

    2010-10-01

    ... design shall follow the procedures of subpart 159.005 of this chapter, as explained in § 160.001-3 of... manufacturer by the Coast Guard for a nonstandard life preserver approved after tests. (d) Private brand labels. Private brand labels are those bearing the name and address of a distributor in lieu of the manufacturer...

  16. Academic Program Approval and Review Practices

    Directory of Open Access Journals (Sweden)

    Don G. Creamer

    1999-08-01

    Full Text Available This report outlines general and specific processes for both program approval and program review practices found in 50 states and eight foreign countries and regions.  Models that depict these procedures are defined and the strengths and weakness of each are discussed.  Alternatives to current practice by state agencies in the U.S. are described that might provide for greater decentralization of these practices while maintaining institutional accountability.

  17. European type-approval test procedure for evaporative emissions from passenger cars against real-world mobility data from two Italian provinces.

    Science.gov (United States)

    Martini, Giorgio; Paffumi, Elena; De Gennaro, Michele; Mellios, Giorgos

    2014-07-15

    This paper presents an evaluation of the European type-approval test procedure for evaporative emissions from passenger cars based on real-world mobility data. The study relies on two large databases of driving patterns from conventional fuel vehicles collected by means of on-board GPS systems in the Italian provinces of Modena and Firenze. Approximately 28,000 vehicles were monitored, corresponding to approximately 36 million kilometres over a period of one month. The driving pattern of each vehicle was processed to derive the relation between trip length and parking duration, and the rate of occurrence of parking events against multiple evaporative cycles, defined on the basis of the type-approval test procedure as 12-hour diurnal time windows. These results are used as input for an emission simulation model, which calculates the total evaporative emissions given the characteristics of the evaporative emission control system of the vehicle and the ambient temperature conditions. The results suggest that the evaporative emission control system, fitted to the vehicles from Euro 3 step and optimised for the current type-approval test procedure, could not efficiently work under real-world conditions, resulting in evaporative emissions well above the type-approval limit, especially for small size vehicles and warm climate conditions. This calls for a revision of the type-approval test procedure in order to address real-world evaporative emissions. Copyright © 2014. Published by Elsevier B.V.

  18. 22 CFR 218.39 - Alternate funds disbursal procedure.

    Science.gov (United States)

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Alternate funds disbursal procedure. 218.39 Section 218.39 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT NONDISCRIMINATION ON THE BASIS OF... recipient, any public or non-profit private organization or agency, or State or political subdivision of the...

  19. 75 FR 6597 - Determination to Approve Alternative Final Cover Request for the Lake County, MT Landfill...

    Science.gov (United States)

    2010-02-10

    ... to Approve Alternative Final Cover Request for the Lake County, MT Landfill; Opportunity for Public... for the Lake County landfill, a municipal solid waste landfill (MSWLF) owned and operated by Lake... operating criteria for MSWLFs, including landfill location restrictions, operating standards, design...

  20. Lattice QCD and the Schwarz alternating procedure

    CERN Document Server

    Lüscher, Martin

    2003-01-01

    A numerical simulation algorithm for lattice QCD is described, in which the short- and long-distance effects of the sea quarks are treated separately. The algorithm can be regarded, to some extent, as an implementation at the quantum level of the classical Schwarz alternating procedure for the solution of elliptic partial differential equations. No numerical tests are reported here, but theoretical arguments suggest that the algorithm should work well also at small quark masses.

  1. 29 CFR 37.64 - What procedures must the Director follow when CRC has completed a post-approval compliance review?

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 1 2010-07-01 2010-07-01 true What procedures must the Director follow when CRC has completed a post-approval compliance review? 37.64 Section 37.64 Labor Office of the Secretary of Labor... (WIA) Compliance Procedures § 37.64 What procedures must the Director follow when CRC has completed a...

  2. Electronic Approval of Invoices (AEF)

    CERN Document Server

    2004-01-01

    With a view to the simplification of administrative procedures, AS and FI Departments have completed the second phase of the new procedure for the electronic approval of invoices via the EDH application. The aim of this new procedure is to rationalise the invoice approval process, notably by eliminating paper copies from the approval circuit. This will simplify the processing of invoices and facilitate their timely settlement, while at the same time maintaining a high level of security. Phase II includes handling the electronic approval process of invoices whose amounts do not correspond exactly to those of the associated orders. In such cases, budgetary approval is required for the entire invoiced amount. Further information can be obtained at : http://ais.cern.ch/projs/AEF/help/F_help.htm Phase II of the procedure will be introduced gradually with effect from April 2004. Finance Department, Accounts Payable Section Tel: 72295 Organisation and Procedures Tel: 75885 Information Technologies Department,...

  3. Is suvorexant a better choice than alternative hypnotics? [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Daniel F. Kripke

    2015-08-01

    Full Text Available Suvorexant is a novel dual orexin receptor antagonist (DORA newly introduced in the U.S. as a hypnotic, but no claim of superiority over other hypnotics has been offered.  The manufacturer argued that the 5 and 10 mg starting doses recommended by the FDA might be ineffective.  The manufacturer's main Phase III trials had not even included the 10 mg dosage, and the 5 mg dosage had not been tested at all in registered clinical trials at the time of approval.  Popular alternative hypnotics may be similarly ineffective, since the FDA has also reduced the recommended doses for zolpidem and eszopiclone.  The "not to exceed" suvorexant dosage of 20 mg does slightly increase sleep.  Because of slow absorption, suvorexant has little effect on latency to sleep onset but some small effect in suppressing wakening after sleep onset and in improving sleep efficiency. The FDA would not approve the manufacturer's preferred 40 mg suvorexant dosage, because of concern with daytime somnolence, driving impairment, and possible narcolepsy-like symptoms.  In its immediate benefits-to-risks ratio, suvorexant is unlikely to prove superior to currently available hypnotics—possibly worse—so there is little reason to prefer over the alternatives this likely more expensive hypnotic less-tested in practice.  Associations are being increasingly documented relating hypnotic usage with incident cancer, with dementia risks, and with premature death.  There is some basis to speculate that suvorexant might be safer than alternative hypnotics in terms of cancer, dementia, infections, and mortality.  These safety considerations will remain unproven speculations unless adequate long-term trials can be done that demonstrate suvorexant advantages.

  4. 12 CFR 24.5 - Public welfare investment after-the-fact notice and prior approval procedures.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 1 2010-01-01 2010-01-01 false Public welfare investment after-the-fact notice and prior approval procedures. 24.5 Section 24.5 Banks and Banking COMPTROLLER OF THE CURRENCY... capital and surplus represented by the proposed investment and by the bank's aggregate outstanding public...

  5. 19 CFR 115.41 - Certificate of approval for containers approved after manufacture.

    Science.gov (United States)

    2010-04-01

    ... after manufacture. 115.41 Section 115.41 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT... PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115.41 Certificate of approval for containers approved after manufacture. The Certifying Authority shall...

  6. 7 CFR 1710.406 - Loan approval.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Loan approval. 1710.406 Section 1710.406 Agriculture... GENERAL AND PRE-LOAN POLICIES AND PROCEDURES COMMON TO ELECTRIC LOANS AND GUARANTEES Application Requirements and Procedures for Loans § 1710.406 Loan approval. (a) A loan is approved when the Administrator...

  7. Electronic Approval of Invoices (AEF)

    CERN Multimedia

    2003-01-01

    With a view to the simplification of administrative procedures, AS and FI Divisions have drawn up a new procedure for the electronic approval of invoices via the EDH application. The aim of this new procedure is to rationalise the invoice approval process, notably by eliminating paper copies from the approval circuit. This will simplify the processing of invoices and facilitate their timely settlement, while at the same time maintaining a high level of security. This new procedure, in its current phase, will be gradually implemented from 1 November 2003 onwards. For clarification and further information, please see: http://ais.cern.ch/projs/AEF/help/help.htm . Finance Division, Accounts Payable Tel.: 7.22.95

  8. Alternative practices of achieving anaesthesia for dental procedures: a review.

    Science.gov (United States)

    Angelo, Zavattini; Polyvios, Charalambous

    2018-04-01

    Managing pain and anxiety in patients has always been an essential part of dentistry. To prevent pain, dentists administer local anaesthesia (LA) via a needle injection. Unfortunately, anxiety and fear that arise prior to and/or during injection remains a barrier for many children and adults from receiving dental treatment. There is a constant search for techniques to alleviate the invasive and painful nature of the needle injection. In recent years, researchers have developed alternative methods which enable dental anaesthesia to be less invasive and more patient-friendly. The aim of this review is to highlight the procedures and devices available which may replace the conventional needle-administered local anaesthesia. The most known alternative methods in providing anaesthesia in dentistry are: topical anaesthesia, electronic dental anaesthesia, jet-injectors, iontophoresis, and computerized control local anaesthesia delivery systems. Even though these procedures are well accepted by patients to date, it is the authors' opinion that the effectiveness practicality of such techniques in general dentistry is not without limitations.

  9. Medicaid program; Medicaid Management Information Systems; conditions of approval and reapproval and procedures for reduction of federal financial participation--Health Care Financing Administration. Proposed rule.

    Science.gov (United States)

    1983-03-03

    This proposal adds to regulations new conditions and procedures for initial approval and for reapproval of Medicaid Management Information Systems (MMIS) to update the regulations to reflect additional requirements added by section 901 of the Mental Health Systems Act of 1980 (Pub. L. 96-398). The proposal specifies procedures for reducing the level of Federal financial participation in a State's administrative expenditures when a State fails to meet the conditions for initial operation, initial approval or reapproval of an MMIS. It also proposes procedures with respect to waivers of the conditions of approval and reapproval and to appeals of adverse decisions. These provisions are intended to improve States' MMIS, and to ensure efficient system operations, and to detect cases of fraud, waste, and abuse effectively.

  10. Medicaid program; Medicaid Management Information Systems; conditions of approval and reapproval and procedures for reduction of Federal financial participation--HCFA. Final rule.

    Science.gov (United States)

    1985-07-30

    This final rule provides the additional requirements to the conditions and procedures for initial approval and reapproval of Medicaid Management Information Systems (MMIS) that were added by section 1903(r) of the Social Security Act (as amended by section 901 of the Mental Health Systems Act of 1980, Pub. L. 96-398). These provisions are intended to improve States' MMIS, ensure efficient system operations, and make the procedures for detection of fraud, waste, and abuse more effective. In addition, this final rule specifies the procedures we follow in reducing the level of Federal financial participation in State administrative expenditures if a State fails to meet the conditions for initial operation, initial approval, or reapproval of an MMIS.

  11. Increasing spelling achievement: an analysis of treatment procedures utilizing an alternating treatments design.

    OpenAIRE

    Ollendick, T H; Matson, J L; Esveldt-Dawson, K; Shapiro, E S

    1980-01-01

    Two studies which examine the effectiveness of spelling remediation procedures are reported. In both studies, an alternating treatment design was employed. In the first study, positive practice overcorrection plus positive reinforcement was compared to positive practice alone and a no-remediation control condition. In the second study, positive practice plus positive reinforcement was compared to a traditional corrective procedure plus positive reinforcement and a traditional procedure when u...

  12. Proximal Tibia Bone Graft: An alternative Donor Source especially for Foot and Ankle Procedures

    Directory of Open Access Journals (Sweden)

    Jia TY

    2015-03-01

    Full Text Available Among the many donor sites for harvesting autologous bone graft, the iliac crest has been the most commonly used. However, for foot and ankle procedures the proximal tibia has gained popularity as an alternative donor site due to its anatomic proximity to the primary surgical site. In this article we evaluated the possible complications associated with harvesting proximal tibia bone graft. Our study showed the low incidence of morbidity in harvesting proximal tibia bone graft, thereby providing a good alternative donor for foot and ankle procedures.

  13. Decisions in licensing and plan approval procedures, investigated from the viewpoint of legal reservation

    International Nuclear Information System (INIS)

    Boerger, M.

    1987-01-01

    Starting from the basic idea that also in the field of environmental law, (constitutional) system immanent problem solution is possible only after basic constitutional questions have been clarified, this study in hand is an attempt towards defining the constitutional approach for an adequate use of the various types of action of the executive in the procedures for approval and licensing of privately owned plant or equipment. The study goes into the problems encountered with the legal reservation with regard to licensing and plan approval decisions. The basic types of action of the executive are subdivided according to intent, i.e. assigned to the supervisory or the planning intents, and are examined for a possible scope of discretion opened up for the administration. The decisive question in this context is the scope of action that may be given to the administration by the legislation, and to what extent such 'freedom' will stand the acceptance test by the courts. (orig./HSCH) [de

  14. Evaluation of alternative surface runoff accounting procedures using the SWAT model

    Science.gov (United States)

    For surface runoff estimation in the Soil and Water Assessment Tool (SWAT) model, the curve number (CN) procedure is commonly adopted to calculate surface runoff by utilizing antecedent soil moisture condition (SCSI) in field. In the recent version of SWAT (SWAT2005), an alternative approach is ava...

  15. On the scope of the Federal Government to issue orders in plan approval procedures under para. 9b of the Atomic Energy Act as provided by article 85 section 3 of the Basic Law

    International Nuclear Information System (INIS)

    Ossenbuehl, F.

    1991-01-01

    Under Paragraph 9b of the Atomic Energy Act the Lower Saxonian Minister of the Environment has the competence for the plan approval procedure concerning the final disposal site Konrad. The plan approval procedure under atomic energy law is a unitary administrative procedure which makes further administrative procedures and administrative decisions superfluous on the strength of its unitary character and without impingement on constitutional law. In conducting the plan approval procedure the Lower Saxonican Minister of the Environment is acting within the framework of Laender administration on behalf of the Federation. To this extent he is subject to the orders of the Federal Minister of the Enviroment under Article 85 Section 3 of The Basic Law with respect to the formation of the procedure and procedural decisions as well as decisions on the merits pending. The concentrating effect of the plan approval procedure under atomic energy law also extends to permits under water law. (orig./HSCH) [de

  16. Judicial problems in connection with preliminary decision and construction design approval in nuclear licensing procedures

    International Nuclear Information System (INIS)

    Schmieder, K.

    1977-01-01

    Standardization in nuclear engineering makes two demands on a legal instrument which is to make this standardization possible and which is to promote standardization in the nuclear licensing practice: On the basis of just one licence for a constructional part or a component, its applicability in any number of subsequent facility licensing procedures has to be warranted, and by virtue of its binding effect, standardization has to create a sufficiently big confidence protection with manufacturers, constructioneers and operators to offer sufficiently effective incentives for standardization. The nuclear preliminary decision pursuant to section 7 a of the Atomic Energy Act in the form of the component preliminary decision appears to be unsuitable as a legal instrument for standardization, as the preliminary decision refers exclusively to the construction of a concrete facility. For standardization in reactor engineering, the construction design approval appears to be basically the proper legal instrument on account of its legal structure as well as its economic effect. Its binding effect encouters a limitation with regard to third parties in so far that this limitation could question again the binding effect in a subsequent site-dependent nuclear licence procedure. The legal structure of the extent of the binding effect, which is decisive for the suitability of the construction design approval, lies with the legislator. The following questions have to be regulated: Ought the applicant to have a legal claim on the granting of a construction design approval, or ought it to be at the discretion of the authorities, and secondly, the extent of the binding effect in terms of time on the basis of the fixation of a time limit, or on the basis of the possibility of subsequent conditions to be imposed, or the revocation. (orig./HP) [de

  17. The alternative site selection procedure as covered in the report by the Repository Site Selection Procedures Working Group; Das Verfahren der alternativen Standortsuche im Bericht des Arbeitskreises Auswahlverfahren Endlagerstandorte

    Energy Technology Data Exchange (ETDEWEB)

    Brenner, M. [Jena Univ. (Germany). Juristische Fakultaet

    2005-01-01

    The 2002 Act on the Regulated Termination of the Use of Nuclear Power for Industrial Electricity Generation declared Germany's opting out of the peaceful uses of nuclear power. The problem of the permanent management of radioactive residues is becoming more and more important also in the light of that political decision. At the present time, there are no repositories offering the waste management capacities required. Such facilities need to be created. At the present stage, eligible repository sites are the Konrad mine, a former iron ore mine near Salzgitter, and the Gorleben salt dome. While the fate of the Konrad mine as a repository for waste generating negligible amounts of heat continues to be uncertain, despite a plan approval decision of June 2002, the Gorleben repository is still in the planning phase, at present in a dormant state, so to speak. The federal government expressed doubt about the suitability of the Gorleben site. Against this backdrop, the Federal Ministry for the Environment, Nature Conservation, and Nuclear Safety in February 1999 established AkEnd, the Working Group on Repository Site Selection Procedures. The Group was charged with developing, based on sound scientific criteria, a transparent site selection procedure in order to facilitate the search for repository sites. The Working Group presented its final report in December 2002 after approximately four years of work. The Group's proposals about alternative site selection procedures are explained in detail and, above all, reviewed critically. (orig.)

  18. Optimal decision procedures for satisfiability in fragments of alternating-time temporal logics

    DEFF Research Database (Denmark)

    Goranko, Valentin; Vester, Steen

    2014-01-01

    We consider several natural fragments of the alternating-time temporal logics ATL*and ATL with restrictions on the nesting between temporal operators and strate-gicquantifiers. We develop optimal decision procedures for satisfiability in these fragments, showing that they have much lower complexi...

  19. Evaluation of alternatives in EIA

    Energy Technology Data Exchange (ETDEWEB)

    Ikonen, A. [Posiva Oy, Helsinki (Finland)

    2000-07-01

    According to the Finnish law, a 'Decision in Principle' is required for the final disposal facility for spent nuclear fuel. The decision is made by the government and it needs to be approved by the Parliament. Before the decision can be made an EIA report must be produced for the facility. Alternatives in the management of spent fuel were already described in EIA programme which was drafted in the scoping stage. In the programme arguments for the so-called 'base alternative' were presented. However, a more extensive evaluation of the alternatives was required by the contact authority based on the first hearing. This presentation shows how alternatives were evaluated in assessment phase and how people reacted to them during the second hearing. The presentation is based on the general summary of EIA report and the statements given on the report. In Finland the environmental impact assessment procedure has been finished and the Decision in Principle is expected to be taken in the near future. (author)

  20. Mediation and Other Alternative Dispute Resolution Procedures in Special Education. Final Report.

    Science.gov (United States)

    Schrag, Judy A.

    This report discusses the use of mediation and alternative dispute resolution approaches in special education disagreements between the school and the parents of a child with a disability. The procedural safeguards and due process provisions of the Individuals with Disabilities Education Act (IDEA) are explained. The report notes alternative…

  1. A Schwarz alternating procedure for singular perturbation problems

    Energy Technology Data Exchange (ETDEWEB)

    Garbey, M. [Universit Claude Bernard Lyon, Villeurbanne (France); Kaper, H.G. [Argonne National Lab., IL (United States)

    1994-12-31

    The authors show that the Schwarz alternating procedure offers a good algorithm for the numerical solution of singular perturbation problems, provided the domain decomposition is properly designed to resolve the boundary and transition layers. They give sharp estimates for the optimal position of the domain boundaries and present convergence rates of the algorithm for various second-order singular perturbation problems. The splitting of the operator is domain-dependent, and the iterative solution of each subproblem is based on a modified asymptotic expansion of the operator. They show that this asymptotic-induced method leads to a family of efficient massively parallel algorithms and report on implementation results for a turning-point problem and a combustion problem.

  2. 9 CFR 147.52 - Approved tests.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Approved tests. 147.52 Section 147.52 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... Approved Tests § 147.52 Approved tests. (a) The procedures for the bacteriological examination of poultry...

  3. 27 CFR 5.55 - Certificates of label approval.

    Science.gov (United States)

    2010-04-01

    ..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF DISTILLED SPIRITS Requirements for Approval of... certificates of label approval and certificates of exemption from label approval, as well as appeal procedures...

  4. Cognitive Properties of Approval Voting : an Experimental Approach

    Directory of Open Access Journals (Sweden)

    Krzysztof Przybyszewski

    2011-01-01

    Full Text Available The paper summarizes two series of experiments demonstrating the cognitive properties of approval voting. The former series is devoted to mental processes induced in decision makers who use the method of approval voting. Based on cognitive effort, the use of choice strategies is presented in this paper. The observations of respondents show that most of them use relatively effortless strategy of eliminating alternatives and attributes. Few respondents use more sophisticated methods. The other series of experiments analyses the number of alternatives chosen in approval voting. It appears that the average number is not constant, even for similar votes but it depends on the subject of voting. The number of chosen alternatives and the subjective significance of the scope of voting are negatively or positively correlated in the case of special votes. The analyzed experiments show that the cognitive properties of approval voting have a diverse structure. (original abstract

  5. [Complementary and alternative procedures for fibromyalgia syndrome : Updated guidelines 2017 and overview of systematic review articles].

    Science.gov (United States)

    Langhorst, J; Heldmann, P; Henningsen, P; Kopke, K; Krumbein, L; Lucius, H; Winkelmann, A; Wolf, B; Häuser, W

    2017-06-01

    The regular update of the guidelines on fibromyalgia syndrome, AWMF number 145/004, was scheduled for April 2017. The guidelines were developed by 13 scientific societies and 2 patient self-help organizations coordinated by the German Pain Society. Working groups (n =8) with a total of 42 members were formed balanced with respect to gender, medical expertise, position in the medical or scientific hierarchy and potential conflicts of interest. A search of the literature for systematic reviews of randomized controlled trials of complementary and alternative therapies from December 2010 to May 2016 was performed in the Cochrane library, MEDLINE, PsycINFO and Scopus databases. Levels of evidence were assigned according to the classification system of the Oxford Centre for Evidence-Based Medicine version 2009. The strength of recommendations was formed by multiple step formalized procedures to reach a consensus. Efficacy, risks, patient preferences and applicability of available therapies were weighed up against each other. The guidelines were reviewed and approved by the board of directors of the societies engaged in the development of the guidelines. Meditative movement therapies (e.g. qi gong, tai chi and yoga) are strongly recommended. Acupuncture and weight reduction in cases of obesity can be considered.

  6. 19 CFR 115.55 - Termination of approval.

    Science.gov (United States)

    2010-04-01

    ... vehicle by a major repair or alteration of any of the essential features required in § 115.51. Repairs by... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Individual Road Vehicles § 115.55 Termination of approval. Approval of a road...

  7. Comparative cost analysis -- computed tomography vs. alternative diagnostic procedures, 1977-1980

    International Nuclear Information System (INIS)

    Gempel, P.A.; Harris, G.H.; Evans, R.G.

    1977-12-01

    In comparing the total national cost of utilizing computed tomography (CT) for medically indicated diagnoses with that of conventional x-ray, ultrasonography, nuclear medicine, and exploratory surgery, this investigation concludes that there was little, if any, added net cost from CT use in 1977 or will there be in 1980. Computed tomography, generally recognized as a reliable and useful diagnostic modality, has the potential to reduce net costs provided that an optimal number of units can be made available to physicians and patients to achieve projected reductions in alternative procedures. This study examines the actual cost impact of CT on both cranial and body diagnostic procedures. For abdominal and mediastinal disorders, CT scanning is just beginning to emerge as a diagnostic modality. As such, clinical experience is somewhat limited and the authors assume that no significant reduction in conventional procedures took place in 1977. It is estimated that the approximately 375,000 CT body procedures performed in 1977 represent only a 5 percent cost increase over use of other diagnostic modalities. It is projected that 2,400,000 CT body procedures will be performed in 1980 and, depending on assumptions used, total body diagnostic costs will increase only slightly or be reduced. Thirty-one tables appear throughout the text presenting cost data broken down by types of diagnostic procedures used and projections by years. Appendixes present technical cost components for diagnostic procedures, the comparative efficacy of CT as revealed in abstracts of published literature, selected medical diagnoses, and references

  8. 7 CFR 1726.253 - Prior approved contract modification related to alternative bid provision for payment to...

    Science.gov (United States)

    2010-01-01

    ... alternative bid provision for payment to contractor for bulk purchase of materials. 1726.253 Section 1726.253... contractor for bulk purchase of materials. When construction is to be performed over an extended period of... AGRICULTURE ELECTRIC SYSTEM CONSTRUCTION POLICIES AND PROCEDURES Modifications to RUS Standard Contract Forms...

  9. 24 CFR 248.223 - Alternative State strategy.

    Science.gov (United States)

    2010-04-01

    ... 24 Housing and Urban Development 2 2010-04-01 2010-04-01 false Alternative State strategy. 248.223... Preservation Act of 1987 § 248.223 Alternative State strategy. (a) The Commissioner may approve a State strategy providing for State approval of plans of action that involve termination of low income...

  10. 33 CFR 115.70 - Advance approval of bridges.

    Science.gov (United States)

    2010-07-01

    ... 33 Navigation and Navigable Waters 1 2010-07-01 2010-07-01 false Advance approval of bridges. 115... BRIDGES BRIDGE LOCATIONS AND CLEARANCES; ADMINISTRATIVE PROCEDURES § 115.70 Advance approval of bridges. (a) The General Bridge Act of 1946 requires the approval of the location and plans of bridges prior...

  11. 77 FR 8865 - Recent Postings of Broadly Applicable Alternative Test Methods

    Science.gov (United States)

    2012-02-15

    ... Applicable Alternative Test Methods AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of availability. SUMMARY: This notice announces the broadly applicable alternative test method approval decisions... INFORMATION CONTACT: An electronic copy of each alternative test method approval document is available on the...

  12. Patient-Centered Drug Approval: The Role of Patient Advocacy in the Drug Approval Process.

    Science.gov (United States)

    Mattingly, T Joseph; Simoni-Wastila, Linda

    2017-10-01

    Recent approval of eteplirsen for Duchenne muscular dystrophy (DMD), a rare disease with few treatment alternatives, has reignited the debate over the U.S. drug approval process. The evolution of legal and regulatory restrictions to the marketing and sale of pharmaceuticals has spanned more than a century, and throughout this history, patient advocacy has played a significant role. Scientific evidence from clinical trials serves as the foundation for drug approval, but the patient voice has become increasingly influential. Although the gold standard for establishing safety and efficacy through randomized controlled trials has been in place for more than 50 years, it poses several limitations for rare disorders where patient recruitment for traditional clinical trials is a major barrier. Organized efforts by patient advocacy groups to help patients with rare diseases access investigational therapy have had a legislative and regulatory effect. After approval by the FDA, patient access to therapy may still be limited by cost. A managed care organization (MCO) with the fiduciary responsibility of managing the health of a population must weigh coverage decisions for costly therapies with questionable effectiveness against alternatives within the constraint of a finite budget. Even when the FDA deems a drug safe and effective, an MCO may determine that the drug should only be made available at a tier level where out-of-pocket costs are still too high for many patients. This limitation of availability may be due to cost, other treatment alternatives, or outcomes from existing clinical evidence. However, if the MCO makes a costly new treatment for a rare disease readily available, it may temporarily satisfy a small contingency at the cost of all of its members. This article examines the risks and benefits of patient-centered drug approval and the potential economic effect of patient-centered drug approval on population health. There is no funding to disclose. Mattingly

  13. 27 CFR 4.50 - Certificates of label approval.

    Science.gov (United States)

    2010-04-01

    ..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE Requirements for Approval of Labels of... of exemption from label approval, as well as appeal procedures, see part 13 of this chapter. [T.D...

  14. Research ethics board approval for an international thromboprophylaxis trial.

    Science.gov (United States)

    Lutz, Kristina; Wilton, Kelly; Zytaruk, Nicole; Julien, Lisa; Hall, Richard; Harvey, Johanne; Skrobik, Yoanna; Vlahakis, Nicholas; Meade, Laurie; Matte, Andrea; Meade, Maureen; Burns, Karen; Albert, Martin; Cash, Bronwyn Barlow; Vallance, Shirley; Klinger, James; Heels-Ansdell, Diane; Cook, Deborah

    2012-06-01

    Research ethics board (REB) review of scientific protocols is essential, ensuring participants' dignity, safety, and rights. The objectives of this study were to examine the time from submission to approval, to analyze predictors of approval time, and to describe the scope of conditions from REBs evaluating an international thromboprophylaxis trial. We generated survey items through literature review and investigators' discussions, creating 4 domains: respondent and institutional demographics, the REB application process, and alternate consent models. We conducted a document analysis that involved duplicate assessment of themes from REB critique of the protocol and informed consent forms (ICF). Approval was granted from 65 REB institutions, requiring 58 unique applications. We analyzed 44 (75.9%) of 58 documents and surveys. Survey respondents completing the applications had 8 (5-12) years of experience; 77% completed 4 or more REB applications in previous 5 years. Critical care personnel were represented on 54% of REBs. The time to approval was a median (interquartile range) of 75 (42, 150) days, taking longer for sites with national research consortium membership (89.1 vs 31.0 days, P = .03). Document analysis of the application process and ICF yielded 5 themes: methodology, data management, consent procedures, cataloguing, and miscellaneous. Protocol-specific themes focused on trial implementation, external critiques, and budget. The only theme specific to the ICF was risks and benefits. The most frequent comments on the protocol and ICF were about methodology and miscellaneous issues; ICF comments also addressed study risks and benefits. More studies on methods to enhance efficiency and consistency of the REB approval processes for clinical trials are needed while still maintaining high ethical standards. Copyright © 2012 Elsevier Inc. All rights reserved.

  15. Approval plans issues and innovations

    CERN Document Server

    Katz, Linda S

    2013-01-01

    How can you, as an acquisition librarians, keep current on the output of hundreds of publishers? The answer, of course, is that you cannot. For over 30 years, approval plans have been used by librarians to acquire current titles, save staff time, and build core collections. Even today, these reasons seem appropriate, as libraries try to maintain up-to-date collections and control personnel and operating budgets. However, as shown in Approval Plans: Issues and Innovations, the use of approval plans is not so simple and straightforward; their use is subject to complex procedures and policies--an

  16. Approval procedures for clinical trials in the field of radiation oncology; Genehmigungsverfahren klinischer Studien im Bereich der Radioonkologie

    Energy Technology Data Exchange (ETDEWEB)

    Simon, Monique; Buettner, Daniel [Deutsches Konsortium fuer Translationale Krebsforschung (DKTK), Dresden (Germany); Deutsches Krebsforschungszentrum (DKFZ), Heidelberg (Germany); Medizinische Fakultaet und Universitaetsklinikum Carl Gustav Carus, Technische Universitaet Dresden, Klinik fuer Strahlentherapie und Radioonkologie und OncoRay - Nationales Zentrum fuer Strahlenforschung in der Onkologie, Dresden (Germany); Habeck, Matthias; Habeck, Uta; Brix, Gunnar [Bundesamt fuer Strahlenschutz (BfS), Fachbereich Strahlenschutz und Gesundheit, Neuherberg (Germany); Krause, Mechthild; Baumann, Michael [Deutsches Konsortium fuer Translationale Krebsforschung (DKTK), Dresden (Germany); Deutsches Krebsforschungszentrum (DKFZ), Heidelberg (Germany); Medizinische Fakultaet und Universitaetsklinikum Carl Gustav Carus, Technische Universitaet Dresden, Klinik fuer Strahlentherapie und Radioonkologie und OncoRay - Nationales Zentrum fuer Strahlenforschung in der Onkologie, Dresden (Germany); Helmholtz-Zentrum Dresden - Rossendorf, Institut fuer Radioonkologie und OncoRay - Nationales Zentrum fuer Strahlenforschung in der Onkologie, Dresden (Germany); Willich, Normann [Universitaetsklinikum Muenster, Klinik fuer Strahlentherapie - Radioonkologie, Muenster (Germany); Wenz, Frederik [Universitaetsmedizin Mannheim, Medizinische Fakultaet Mannheim, Universitaet Heidelberg, Klinik fuer Strahlentherapie und Radioonkologie, Mannheim (Germany); Schmidberger, Heinz [Universitaetsmedizin Mainz, Klinik fuer Radioonkologie und Strahlentherapie, Mainz (Germany); Debus, Juergen [Universitaetsklinikum Heidelberg, Klinik fuer Radioonkologie und Strahlentherapie, Heidelberg (Germany); Noelling, Torsten

    2015-12-15

    Application of ionizing radiation for the purpose of medical research in Germany needs to be approved by the national authority for radiation protection (Bundesamt fuer Strahlenschutz, BfS). For studies in the field of radiation oncology, differentiation between use of radiation for ''medical care (Heilkunde)'' versus ''medical research'' frequently leads to contradictions. The aim of this article is to provide principle investigators, individuals, and institutions involved in the process, as well as institutional review or ethics committees, with the necessary information for this assessment. Information on the legal frame and the approval procedures are also provided. A workshop was co-organized by the German Society for Radiation Oncology (DEGRO), the Working Party for Radiation Oncology (ARO) of the German Cancer Society (DKG), the German Society for Medical Physics (DGMP), and the German Cancer Consortium (DKTK) in October 2013. This paper summarizes the results of the workshop and the follow-up discussions between the organizers and the BfS. Differentiating between ''Heilkunde'' which does not need to be approved by the BfS and ''medical research'' is whether the specific application of radiation (beam quality, dose, schedule, target volume, etc.) is a clinically established and recognized procedure. This must be answered by the qualified physician(s) (''fachkundiger Arzt'' according to German radiation protection law) in charge of the study and the treatments of the patients within the study, taking into consideration of the best available evidence from clinical studies, guidelines and consensus papers. Among the important parameters for assessment are indication, total dose, and fractionation. Radiation treatments applied outside clinical trials do not require approval by the BfS, even if they are applied within a randomized or nonrandomized clinical trial

  17. 14 CFR 21.8 - Approval of articles.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Approval of articles. 21.8 Section 21.8 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS General § 21.8 Approval of articles. If an article is required to be...

  18. Waste Feed Delivery Environmental Permits and Approvals Plan

    International Nuclear Information System (INIS)

    TOLLEFSON, K.S.

    2000-01-01

    This plan describes the environmental permits approvals, and other requirements that may affect establishment of a waste feed delivery system for the Hanford Site's River Protection Project. This plan identifies and screens environmental standards for potential applicability, outlines alternatives for satisfying applicable standards, and describes preferred permitting and approval approaches

  19. Waste Feed Delivery Environmental Permits and Approvals Plan

    Energy Technology Data Exchange (ETDEWEB)

    TOLLEFSON, K.S.

    2000-01-18

    This plan describes the environmental permits approvals, and other requirements that may affect establishment of a waste feed delivery system for the Hanford Site's River Protection Project. This plan identifies and screens environmental standards for potential applicability, outlines alternatives for satisfying applicable standards, and describes preferred permitting and approval approaches.

  20. 75 FR 36301 - Review and Approval of Projects

    Science.gov (United States)

    2010-06-25

    ... SUSQUEHANNA RIVER BASIN COMMISSION 18 CFR Parts 806 and 808 Review and Approval of Projects AGENCY... document contains proposed rules that would amend the project review regulations of the Susquehanna River... the scope of withdrawals requiring review and approval; improve notice procedures for all project...

  1. Editorial: Ethics approval: responsibilities of journal editors, authors ...

    African Journals Online (AJOL)

    Meaningful progress of medicine depends on research that must ultimately involve human subjects. Obtaining ethical approval therefore, especially in medical sciences, should be a moral reflex for researchers. This unfortunately is not the case, with numerous researchers bypassing the ethics approval procedure, or simply ...

  2. Bivalirudin for Pediatric Procedural Anticoagulation: A Narrative Review.

    Science.gov (United States)

    Zaleski, Katherine L; DiNardo, James A; Nasr, Viviane G

    2018-02-14

    Bivalirudin (Angiomax; The Medicines Company, Parsippany, NJ), a direct thrombin inhibitor, has found increasing utilization as a heparin alternative in the pediatric population, most commonly for the treatment of thrombosis secondary to heparin-induced thrombocytopenia. Due to the relative rarity of heparin-induced thrombocytopenia as well as the lack of Food and Drug Administration-approved indications in this age group, much of what is known regarding the pharmacokinetics and pharmacodynamics of bivalirudin in this population has been extrapolated from adult data. This narrative review will present recommendations regarding the use of bivalirudin for procedural anticoagulation in the pediatric population based on the published literature.

  3. Environmental procedures

    International Nuclear Information System (INIS)

    1992-01-01

    The European Bank has pledged in its Agreement to place environmental management at the forefront of its operations to promote sustainable economic development in central and eastern Europe. The Bank's environmental policy is set out in the document titled, Environmental Management: The Bank's Policy Approach. This document, Environmental Procedures, presents the procedures which the European Bank has adopted to implement this policy approach with respect to its operations. The environmental procedures aim to: ensure that throughout the project approval process, those in positions of responsibility for approving projects are aware of the environmental implications of the project, and can take these into account when making decisions; avoid potential liabilities that could undermine the success of a project for its sponsors and the Bank; ensure that environmental costs are estimated along with other costs and liabilities; and identify opportunities for environmental enhancement associated with projects. The review of environmental aspects of projects is conducted by many Bank staff members throughout the project's life. This document defines the responsibilities of the people and groups involved in implementing the environmental procedures. Annexes contain Environmental Management: The Bank's Policy Approach, examples of environmental documentation for the project file and other ancillary information

  4. De minimis applications for alternative disposal of very low level radioactive waste at Duke Power Company

    International Nuclear Information System (INIS)

    Lan, C.

    1986-01-01

    Existing NRC regulations provide no minimum level of radioactivity in waste from a licensee's facility that may be disposed of in a manner other than as radioactive waste. With one exception, in 10CFRsection20.306, licensees may dispose of certain levels of tritium and carbon-14 in liquid-scintillation and animal-carcass waste without regard to its radioactivity. In the interim, before specific or generic provisions for disposing of very low level radioactive wastes are adopted through rule making, licensees have another alternative for obtaining approval to dispose of large volumes of materials contaminated with very low levels of radioactivity under provision 10CFRsection20.302(a) ''Method for obtaining approval of proposed disposal procedures.'' This paper provides the experiences of obtaining both NRC and states (North Carolina and South Carolina) approval for disposing of very low-level radioactive wastes from Duke Power Company's nuclear stations. The approved disposal procedures include landfarming of water treatment residues, on-site disposal (burial) of sand and feedwater heaters, and include offsite release for treatment and disposal of sanitary sewage sludge. In summary, users of radioactive materials should not exclude this approach in their quest to reduce the volume of radioactive waste. It is expected that such submittals could provide a data base for further development of generic limits for radioactive wastes

  5. The procedure of alternative site selection within the report of the study group on the radioactive waste final repository selection process (AKEnd)

    International Nuclear Information System (INIS)

    Brenner, M.

    2005-01-01

    The paper discusses the results of the report of the study group on the radioactive waste final repository selection process with respect to the alternative site selection procedure. Key points of the report are the long-term safety, the alternativity of sites and the concept of one repository. The critique on this report is focussed on the topics site selection and licensing procedures, civil participation, the factor time and the question of cost

  6. 30 CFR 90.206 - Approved sampling devices; equivalent concentrations.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved sampling devices; equivalent... LABOR COAL MINE SAFETY AND HEALTH MANDATORY HEALTH STANDARDS-COAL MINERS WHO HAVE EVIDENCE OF THE DEVELOPMENT OF PNEUMOCONIOSIS Sampling Procedures § 90.206 Approved sampling devices; equivalent...

  7. AMPT-induced monoamine depletion in humans: evaluation of two alternative [123I]IBZM SPECT procedures

    International Nuclear Information System (INIS)

    Boot, Erik; Booij, Jan; Hasler, Gregor; Zinkstok, Janneke R.; Haan, Lieuwe de; Linszen, Don H.; Amelsvoort, Therese A. van

    2008-01-01

    Acute monoamine depletion paradigms using alpha-methyl-para-tyrosine (AMPT) combined with single photon emission computed tomography (SPECT) have been used successfully to evaluate disturbances in central dopaminergic neurotransmission. However, severe side effects due to relatively high doses (4,500 to 8,000 mg) of AMPT have been reasons for study withdrawal. Thus, we assessed the effectiveness and tolerability of two alternative procedures, using lower doses of AMPT. Six healthy subjects underwent three measurements of striatal dopamine D 2 receptor (D 2 R)-binding potential (BP ND ) with SPECT and the selective radiolabeled D 2 R antagonist [ 123 I]IBZM. All subjects were scanned in the absence of pharmacological intervention (baseline) and after two different depletion procedures. In the first depletion session, over 6 h, subjects were administered 1,500 mg of AMPT before scanning. In the second depletion session, over 25 h, subjects were administered 40 mg AMPT/kg body weight. We also administered the Subjective Well-being Under Neuroleptic Treatment Scale, a self-report instrument designed to measure the subjective experience of patients on neuroleptic medication. We found no change of mean D 2 R BP ND after the first and short AMPT challenge compared to the baseline. However, we found a significant increase in striatal D 2 R BP ND binding after the AMPT challenge adjusted for bodyweight compared to both other regimen. Although subjective well-being worsened after the prolonged AMPT challenge, no severe side effects were reported. Our results imply a low-dosage, suitable alternative to the common AMPT procedure. The probability of side effects and study withdrawal can be reduced by this procedure. (orig.)

  8. 12 CFR 211.24 - Approval of offices of foreign banks; procedures for applications; standards for approval...

    Science.gov (United States)

    2010-01-01

    ... combat money laundering. The Board also may take into account whether the home country supervisor is developing a legal regime to address money laundering or is participating in multilateral efforts to combat money laundering. In approving an application under this paragraph (c)(1)(iii), the Board, after...

  9. 7 CFR 1737.41 - Procedure for obtaining approval.

    Science.gov (United States)

    2010-01-01

    ... RUS financing. (3) The proposed interim financing presents unacceptable loan security risks to RUS, or..., DEPARTMENT OF AGRICULTURE PRE-LOAN POLICIES AND PROCEDURES COMMON TO INSURED AND GUARANTEED TELECOMMUNICATIONS LOANS Interim Financing of Construction of Telephone Facilities § 1737.41 Procedure for obtaining...

  10. Extended device profiles and testing procedures for the approval process of integrated medical devices using the IEEE 11073 communication standard.

    Science.gov (United States)

    Janß, Armin; Thorn, Johannes; Schmitz, Malte; Mildner, Alexander; Dell'Anna-Pudlik, Jasmin; Leucker, Martin; Radermacher, Klaus

    2018-02-23

    Nowadays, only closed and proprietary integrated operating room systems (IORS) from big manufacturers are available on the market. Hence, the interconnection of components from third-party vendors is only possible with increased time and costs. In the context of the German Federal Ministry of Education and Research (BMBF)-funded project OR.NET (2012-2016), the open integration of medical devices from different manufacturers was addressed. An integrated operating theater based on the open communication standard IEEE 11073 shall give clinical operators the opportunity to choose medical devices independently of the manufacturer. This approach would be advantageous especially for hospital operators and small- and medium-sized enterprises (SME) of medical devices. Actual standards and concepts regarding technical feasibility and the approval process do not cope with the requirements for a modular integration of medical devices in the operating room (OR), based on an open communication standard. Therefore, innovative approval strategies and corresponding certification and test procedures, which cover actual legal and normative standards, have to be developed in order to support the future risk management and the usability engineering process of open integrated medical devices in the OR. The use of standardized device and service profiles and a three-step testing procedure, including conformity, interoperability and integration tests are described in this paper and shall support the manufacturers to integrate their medical devices without disclosing the medical devices' risk analysis and related confidential expertise or proprietary information.

  11. Update on Nonsurgical Lung Volume Reduction Procedures

    Directory of Open Access Journals (Sweden)

    J. Alberto Neder

    2016-01-01

    Full Text Available There has been a surge of interest in endoscopic lung volume reduction (ELVR strategies for advanced COPD. Valve implants, coil implants, biological LVR (BioLVR, bronchial thermal vapour ablation, and airway stents are used to induce lung deflation with the ultimate goal of improving respiratory mechanics and chronic dyspnea. Patients presenting with severe air trapping (e.g., inspiratory capacity/total lung capacity (TLC 225% predicted and thoracic hyperinflation (TLC > 150% predicted have the greatest potential to derive benefit from ELVR procedures. Pre-LVRS or ELVR assessment should ideally include cardiological evaluation, high resolution CT scan, ventilation and perfusion scintigraphy, full pulmonary function tests, and cardiopulmonary exercise testing. ELVR procedures are currently available in selected Canadian research centers as part of ethically approved clinical trials. If a decision is made to offer an ELVR procedure, one-way valves are the first option in the presence of complete lobar exclusion and no significant collateral ventilation. When the fissure is not complete, when collateral ventilation is evident in heterogeneous emphysema or when emphysema is homogeneous, coil implants or BioLVR (in that order are the next logical alternatives.

  12. 40 CFR Appendix A to Subpart Mmmm... - Alternative Capture Efficiency and Destruction Efficiency Measurement and Monitoring Procedures...

    Science.gov (United States)

    2010-07-01

    ... alternative procedure for destruction efficiency determines the organic carbon content of the volatiles... portion of the coating and the efficiency of the capture system. The organic carbon content of the control... to the surrounding atmosphere. 3.0Control Device Efficiency. 3.1Determine the weight fraction carbon...

  13. Multi-criteria approval for evaluating landscape management strategies (Case study: Fruška Gora National Park)

    OpenAIRE

    Lakićević Milena D.; Srđević Bojan M.; Srđević Zorica B.

    2015-01-01

    This paper deals with the problem of multi-criteria evaluation of four management strategies for Fruška Gora National Park. The criteria set was defined in ac­cordance with the IUCN guidelines for management of national parks. Four strategies were evaluated by testing preference intensities for each alternative with the respect to each cri­terion. Alternatives with preference above the approval threshold were approved, and a multi-criteria approval matrix w...

  14. FFTF operations procedures preparation guide. Revision 2

    International Nuclear Information System (INIS)

    1976-12-01

    The Guide is intended to provide guidelines for the initial preparation of FFTF Operating Procedures. The Procedures Preparation Guide was developed from the plan presented and approved in the FFTF Reactor Plant Procedures Plan, PC-1, Revision 3

  15. 30 CFR 90.204 - Approved sampling devices; maintenance and calibration.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved sampling devices; maintenance and... LABOR COAL MINE SAFETY AND HEALTH MANDATORY HEALTH STANDARDS-COAL MINERS WHO HAVE EVIDENCE OF THE DEVELOPMENT OF PNEUMOCONIOSIS Sampling Procedures § 90.204 Approved sampling devices; maintenance and...

  16. AMPT-induced monoamine depletion in humans: evaluation of two alternative [{sup 123}I]IBZM SPECT procedures

    Energy Technology Data Exchange (ETDEWEB)

    Boot, Erik [Academic Medical Centre (AMC), University of Amsterdam, Department of Psychiatry, Amsterdam (Netherlands); De Bruggen, Centre for People with Intellectual Disability, Zwammerdam (Netherlands); Booij, Jan [AMC, Department of Nuclear Medicine, Amsterdam (Netherlands); Hasler, Gregor [University Hospital, Department of Psychiatry, Zuerich (Switzerland); Zinkstok, Janneke R.; Haan, Lieuwe de; Linszen, Don H.; Amelsvoort, Therese A. van [Academic Medical Centre (AMC), University of Amsterdam, Department of Psychiatry, Amsterdam (Netherlands)

    2008-07-15

    Acute monoamine depletion paradigms using alpha-methyl-para-tyrosine (AMPT) combined with single photon emission computed tomography (SPECT) have been used successfully to evaluate disturbances in central dopaminergic neurotransmission. However, severe side effects due to relatively high doses (4,500 to 8,000 mg) of AMPT have been reasons for study withdrawal. Thus, we assessed the effectiveness and tolerability of two alternative procedures, using lower doses of AMPT. Six healthy subjects underwent three measurements of striatal dopamine D{sub 2} receptor (D{sub 2}R)-binding potential (BP{sub ND}) with SPECT and the selective radiolabeled D{sub 2}R antagonist [{sup 123}I]IBZM. All subjects were scanned in the absence of pharmacological intervention (baseline) and after two different depletion procedures. In the first depletion session, over 6 h, subjects were administered 1,500 mg of AMPT before scanning. In the second depletion session, over 25 h, subjects were administered 40 mg AMPT/kg body weight. We also administered the Subjective Well-being Under Neuroleptic Treatment Scale, a self-report instrument designed to measure the subjective experience of patients on neuroleptic medication. We found no change of mean D{sub 2}R BP{sub ND} after the first and short AMPT challenge compared to the baseline. However, we found a significant increase in striatal D{sub 2}R BP{sub ND} binding after the AMPT challenge adjusted for bodyweight compared to both other regimen. Although subjective well-being worsened after the prolonged AMPT challenge, no severe side effects were reported. Our results imply a low-dosage, suitable alternative to the common AMPT procedure. The probability of side effects and study withdrawal can be reduced by this procedure. (orig.)

  17. BWR Steam Dryer Alternating Stress Assessment Procedures

    Energy Technology Data Exchange (ETDEWEB)

    Morante, R. J. [Brookhaven National Lab. (BNL), Upton, NY (United States); Hambric, S. A. [Brookhaven National Lab. (BNL), Upton, NY (United States); Ziada, S. [Brookhaven National Lab. (BNL), Upton, NY (United States)

    2016-12-01

    This report presents an overview of Boiling Water Reactor (BWR) steam dryer design; the fatigue cracking failures that occurred at the Quad Cities (QC) plants and their root causes; a history of BWR Extended Power Uprates (EPUs) in the USA; and a discussion of steam dryer modifications/replacements, alternating stress mechanisms on steam dryers, and structural integrity evaluations (static and alternating stress).

  18. Bariatric Surgery Procedures

    Science.gov (United States)

    ... Meetings of Interest Online Education Job Board CME Policies CBN Fellowship Certificate Research Grant Program Resources All Resources Approved Procedures Patient Safety Vignettes Dr. Mason Historical Library Governing Documents Guidelines Access and Insurance Position and ...

  19. 30 CFR 90.205 - Approved sampling devices; operation; air flowrate.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved sampling devices; operation; air... LABOR COAL MINE SAFETY AND HEALTH MANDATORY HEALTH STANDARDS-COAL MINERS WHO HAVE EVIDENCE OF THE DEVELOPMENT OF PNEUMOCONIOSIS Sampling Procedures § 90.205 Approved sampling devices; operation; air flowrate...

  20. Program Baseline Change Control Procedure

    International Nuclear Information System (INIS)

    1993-02-01

    This procedure establishes the responsibilities and process for approving initial issues of and changes to the technical, cost, and schedule baselines, and selected management documents developed by the Office of Civilian Radioactive Waste Management (OCRWM) for the Civilian Radioactive Waste Management System. This procedure implements the OCRWM Baseline Management Plan and DOE Order 4700.1, Chg 1. It streamlines the change control process to enhance integration, accountability, and traceability of Level 0 and Level I decisions through standardized Baseline Change Proposal (BCP) forms to be used by the Level 0, 1, 2, and 3 Baseline Change Control Boards (BCCBs) and to be tracked in the OCRWM-wide Configuration Information System (CIS) Database.This procedure applies to all technical, cost, and schedule baselines controlled by the Energy System Acquisition Advisory Board (ESAAB) BCCB (Level 0) and, OCRWM Program Baseline Control Board (PBCCB) (Level 1). All baseline BCPs initiated by Level 2 or lower BCCBs, which require approval from ESAAB or PBCCB, shall be processed in accordance with this procedure. This procedure also applies to all Program-level management documents controlled by the OCRWM PBCCB

  1. 33 CFR 101.125 - Approved Alternative Security Programs.

    Science.gov (United States)

    2010-07-01

    ... 106 of this subchapter, as applicable: (a) American Gaming Association Alternative Security Program..., and Towboats and Barges, dated September 24, 2003. (c) Passenger Vessel Association Industry Standards...

  2. Traditional couching is not an effective alternative procedure for cataract surgery in Mali.

    Science.gov (United States)

    Schémann, J F; Bakayoko, S; Coulibaly, S

    2000-12-01

    In Mali, more cataract patients receive sight-restoring surgery using a traditional "couching" procedure (the lens inside the vitreous body) than by modern cataract surgery. In order to evaluate the relative effectiveness and other outcomes of the traditional procedure compared to the modern surgical intervention, we conducted a population-based survey in a rural district of Mali in 1996. A total of 99,800 persons from 160 villages were eligible to be included in the sample. All individuals operated for cataract by a modern procedure were checked for visual acuity and questioned regarding their clinical history, the cost of the surgery and their satisfaction with the surgery immediately following the operation and presently. Each patient was paired with one person operated by a traditional cataract surgical procedure. From a total population of 99,800 we found 85 individuals (0.085%) who had been operated by intracapsular extraction (ICCE) without lens implantation and we paired these with 82 individuals operated by the traditional method and by a local healer. In both groups, males were predominant (74.4% in the modern group and 61.3% in the traditional) and the median age was 65 and 68 years, respectively. Men with a higher social status (defined as administrative or religious authority) were slightly more common among those operated by ICCE (18.9%) than among those operated by the traditional healer (4.4%). Nearly half (47.6%) of the patients operated by couching did not know that a modern alternative existed. The mean cost to the patient of the two procedures was similar; with traditional couching costing on average US$ 42.10 and modern surgery (including transport and drugs) costing US$ 52.40. The traditional healer was often paid partially in kind and the price paid varied according to the patient's ability to pay. The clinical results differed greatly between the two methods. After aphakic correction of eyes operated by ICCE, 5.3% had good vision (33/18), 76

  3. 46 CFR 159.007-3 - Production inspections and tests: Independent laboratory's procedures.

    Science.gov (United States)

    2010-10-01

    ...'s procedures. 159.007-3 Section 159.007-3 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL APPROVAL OF EQUIPMENT AND... meets the inspection and test procedures of the laboratory; and (3) Are accepted by the Commandant under...

  4. Project W-314 phase I environmental permits and approvals plan

    International Nuclear Information System (INIS)

    TOLLEFSON, K.S.

    1999-01-01

    This document describes the range of environmental actions, including required permits and other agency approvals, for Project W-314 activities in the Hanford Site's Tank Waste Remediation System. This document outlines alternative approaches to satisfying applicable environmental standards, and describes selected strategies for acquiring permits and other approvals needed for waste feed delivery to proceed. This document also includes estimated costs and schedule to obtain the required permits and approvals based on the selected strategy. It also provides estimated costs for environmental support during design and construction based on the preliminary project schedule provided

  5. 75 FR 15645 - Approval and Promulgation of Air Quality Implementation Plans; Texas; Revisions to the Emission...

    Science.gov (United States)

    2010-03-30

    ... clarify EPA's role in the approval of emission quantification protocols. While the previous SIP- approved... approve severable portions of two revisions to the Texas State Implementation Plan (SIP) submitted by the... to further clarify procedures for using emission protocols and to update the approved list of...

  6. Innovations in Arizona's Accountability Policies and Frameworks for Alternative Schools

    Science.gov (United States)

    Schlessman, Amy

    2014-01-01

    This study presents Arizona's innovations in academic accountability policy and academic accountability frameworks for alternative schools. A timeline of statutes and regulations including the State Board of Education approved alternative school definition provides Arizona's context for alternative school accountability policy and frameworks.…

  7. 27 CFR 5.51 - Label approval and release.

    Science.gov (United States)

    2010-04-01

    ..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF DISTILLED SPIRITS Requirements for Withdrawal..., and revocation of certificates of label approval, as well as appeal procedures, see part 13 of this...

  8. Percutaneous transesophageal gastro-tubing (PTEG) as an alternative long-term tube feeding procedure when gastrostomy is not feasible.

    Science.gov (United States)

    Toh Yoon, Ezekiel Wong; Nishihara, Kazuki

    2017-12-01

    Percutaneous transesophageal gastro-tubing (PTEG) is a minimally invasive technique to access the gut via an esophagostomy. However, this procedure is not well known and the literature available is still fairly limited. This observational study was conducted to evaluate our experience using this method as an alternative long-term tube feeding procedure when gastrostomy is not suitable. A total of 15 patients (10 males and 5 females) who underwent PTEG at our institution from 2012 to 2016 were observed and analyzed in this study. The average age was 80.1 (71-93) years. Underlying conditions that required PTEG were previous gastric resection in 11 patients, left diaphragm disorder in 2 patients, interposing transverse colon between the abdominal wall and anterior gastric wall in 1 patient, and severe gastrostomy site leakage in 1 patient. Tube placement was successful in all patients by approaching the left side of the neck, using a 15 Fr size tube. The mean postoperative length of stay was 22 (8-48) days. Postoperative adverse events included accidental tube dislodgement in three patients, tracheoesophageal fistula in one patient, inferior thyroid artery injury in one patient and thyroid gland mispuncture in one patient. There was no procedure-related mortality nor mortality at 30 days. Eight patients were discharged with some oral intake. PTEG is feasible in patients requiring long-term tube feeding for whom gastrostomy is unsuitable. It is an effective long-term tube feeding procedure and should be offered as a more comfortable alternative to nasogastric tubing.

  9. 27 CFR 24.136 - Procedure for alternating proprietors.

    Science.gov (United States)

    2010-04-01

    ... initiated, the wine premises, or parts thereof, may be alternated. Any transfer of wine, spirits, or other..., floor, or room to be alternated will be completely finished and all wine, spirits, and other accountable.... However, wine, spirits, and other accountable materials may be retained in locked tanks at wine premises...

  10. TMACS Test Procedure TP011: Panalarm Interface

    International Nuclear Information System (INIS)

    Seghers, R.; Washburn, S.J.

    1994-01-01

    The TMACS Software Test Procedures translate the project's acceptance criteria into test steps. The TMACS Test Plan (WHC-SD-WM-TP-148) is fulfilled when all Test Cases are approved. This Test Procedure tests the TMACS Panalarm Interface functions

  11. Alternative Middle School Models: An Exploratory Study

    Science.gov (United States)

    Duffield, Stacy Kay

    2018-01-01

    A Midwestern state allocated grant funding to encourage more accessible alternative programming at the middle level. Seventeen schools were approved for this grant and used the funds to supplement the operation of a new or existing program. This study provides policymakers and educators with an overview of the various types of alternative middle…

  12. 27 CFR 4.40 - Label approval and release.

    Science.gov (United States)

    2010-04-01

    ..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE Requirements for Withdrawal of Wine From..., denial, and revocation of certificates of label approval, as well as appeal procedures, see part 13 of...

  13. 77 FR 67026 - Proposed Extension of the Approval of Information Collection Requirements

    Science.gov (United States)

    2012-11-08

    ... Information Collection: Requests to Approve Conformed Wage Classifications and Unconventional Fringe Benefit... alternative formats (Large Print, Braille, Audio Tape, or Disc), upon request, by calling (202) 693-0023 (not... request materials in alternative formats. SUPPLEMENTARY INFORMATION: I. Background The Wage and Hour...

  14. 7 CFR 983.52 - Failed lots/rework procedure.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Failed lots/rework procedure. 983.52 Section 983.52..., ARIZONA, AND NEW MEXICO Regulations § 983.52 Failed lots/rework procedure. (a) Substandard pistachios... committee may establish, with the Secretary's approval, appropriate rework procedures. (b) Failed lot...

  15. 40 CFR 131.21 - EPA review and approval of water quality standards.

    Science.gov (United States)

    2010-07-01

    ... (CONTINUED) WATER PROGRAMS WATER QUALITY STANDARDS Procedures for Review and Revision of Water Quality Standards § 131.21 EPA review and approval of water quality standards. (a) After the State submits its... analysis. (b) The Regional Administrator's approval or disapproval of a State water quality standard shall...

  16. FFTF reactor plant procedures plan

    International Nuclear Information System (INIS)

    1972-01-01

    The document presented defines the plan to be used to coordinate the preparation, review, approval, and issuance of the operating procedure documents required to ensure safe and efficient operation of FFTF

  17. Multi-criteria approval for evaluating landscape management strategies (Case study: Fruška Gora National Park

    Directory of Open Access Journals (Sweden)

    Lakićević Milena D.

    2015-01-01

    Full Text Available This paper deals with the problem of multi-criteria evaluation of four management strategies for Fruška Gora National Park. The criteria set was defined in ac­cordance with the IUCN guidelines for management of national parks. Four strategies were evaluated by testing preference intensities for each alternative with the respect to each cri­terion. Alternatives with preference above the approval threshold were approved, and a multi-criteria approval matrix was generated. According to the matrix, the most suitable management strategy was identified. It implies an intense protection of natural resources and landscape diversity in the national park by applying bio-engineering measures. This illustrative example proved that multi-criteria approval can be considered as a good deci­sion support tool when there is no need for a deeper insight into cardinal values of criteria weights and alternatives, or if the decision maker has to select few from many of alterna­tives to reduce the decision problem. For a more precise analysis, it is recommended to combine multi-criteria approval with other decision support tools, and future studies might deal with this problem in order to define an alternative framework for decision making in landscape management. [Projekat Ministarstva nauke Republike Srbije, br. 174003: Theory and application of analytic hierarchy process (AHP in multi-criteria decision making under conditions of risk and uncer­tainty (individual and group context

  18. 27 CFR 7.31 - Label approval and release.

    Science.gov (United States)

    2010-04-01

    ..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF MALT BEVERAGES Requirements for Withdrawal of... approval, as well as appeal procedures, see part 13 of this chapter. [T.D. ATF-66, 45 FR 40552, June 13...

  19. 27 CFR 7.41 - Certificates of label approval.

    Science.gov (United States)

    2010-04-01

    ..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF MALT BEVERAGES Requirements for Approval of..., as well as appeal procedures, see part 13 of this chapter. [T.D. ATF-406, 64 FR 2129, Jan. 13, 1999...

  20. 7 CFR 58.141 - Alternate quality control program.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Alternate quality control program. 58.141 Section 58... Service 1 Quality Specifications for Raw Milk § 58.141 Alternate quality control program. When a plant has in operation an acceptable quality program, at the producer level, which is approved by the...

  1. Approval Procedure for Technical Specifications for Procurement by Quotation and Tender

    International Nuclear Information System (INIS)

    Shaharum Ramli; Izhar Abu Hussin; Ying, K.K.

    2015-01-01

    Technical specifications for procurement requires the approval of the Jawatankuasa Penyemak Spesifikasi Teknikal Tender/ Sebutharga Agensi Nuklear Malaysia. This paper provides guidance for those who have to prepare a technical specification. In addition, the technical specification online library is introduced to facilitate them to re-use old technical specifications for new procurements or to make those the bases for drafting new specifications. (author)

  2. Procedure for getting safety classed concrete structures approved by Finnish Radiation and Nuclear Safety Authority

    International Nuclear Information System (INIS)

    Halme, Ville-Juhani

    2015-01-01

    Posiva is preparing geological final disposal in the Finnish bedrock in Olkiluoto, Eurajoki. The final disposal facility includes encapsulation plant and underground repository. Most of the main civil structures are concrete structures. STUK is the supervising authority in civil structures. The National Building Code of Finland and STUK's Regulatory Guide on nuclear safety (YVL) are the most important instructions when constructing concrete structures into nuclear installation. Posiva has classified concrete structures in two classes according STUK's YVL-guidance: EYT (non-nuclear) and Safety Class 3 (SC 3, nuclear safety significance). When building SC 3 concrete structures, specific protocol must be followed. Protocol includes planned routines for design, construction, supervision, quality control (QC) and quality assurance (QA) activities. Documents relating concrete structures must be approved by Posiva and STUK before construction work. After structures have been designed and actual building is ongoing, there are two main steps. Before concreting, readiness inspection for concreting must be arranged. Readiness inspection will be arranged according to a specific plan and the date must be informed to STUK. After establishing readiness for concreting, casting work can begin. Once concrete structures are done, inspected and approved, final documentation according to a quality control plan will be reviewed by Posiva. After Posiva's approval, final documentation will be sent for STUK's approval. In the end STUK will give the permission for commissioning of the concrete structures after approved commissioning inspection. The document is made up of an abstract and a poster

  3. 48 CFR 432.003 - Simplified acquisition procedures financing.

    Science.gov (United States)

    2010-10-01

    ... procedures financing. 432.003 Section 432.003 Federal Acquisition Regulations System DEPARTMENT OF AGRICULTURE GENERAL CONTRACTING REQUIREMENTS CONTRACT FINANCING 432.003 Simplified acquisition procedures financing. (a) The chief of the contracting office may approve contract financing on a contract to be...

  4. Alternative procedure for the cold test for soybean seeds Procedimento alternativo para o teste de frio em semente de soja

    Directory of Open Access Journals (Sweden)

    Bruno Guilherme Torres Licursi Vieira

    2010-10-01

    Full Text Available The growing demand for high quality soybean [Glycine max (L. Merrill] seeds requires a precise seed quality control system from the seed industry. One way to accomplish this is by improving vigor testing. Cold test has been traditionally employed for corn seeds. However, it has also been used for other seed crops such as cotton (Gossypium spp., soybean (Glycine Max, dry bean (Phaseolus vulgaris and pea (Pisum sativum. This study was carried out with the objective of adjusting an alternative procedure for the cold test to determine soybean seed vigor. Six commercial soybean seed lots of the cultivar BRS 133 were used. The physiological potential of the seed lots was evaluated by germination on paper towel and sand box, seedling field emergence, tetrazolium, accelerated aging and electrical conductivity tests. Seed moisture content was also determined. The temperature used for the cold test procedures was 10ºC during five days. Four cold test procedures were evaluated: i plastic boxes with soil; ii rolled paper towel with soil; iii rolled paper towel without soil, and iv an alternative procedure, using rolled paper towel without soil under cold water. A completely randomized experimental design with eight replications was used and the means were compared by the Tukey test (p = 0.05. To verify the dependence between the alternative test and others single linear correlation was used. All cold test procedures had similar coefficients of variation (CV, highlighting that rolled paper towel with soil and the alternative procedure had the best performance, with an average of 94% and 93% normal seedlings and CV of 3.2% and 3.6%, respectively. The alternative procedure has satisfactory results for estimating soybean seed vigor, yielding consistent results compared to the traditional procedure.A crescente demanda por semente de soja [Glycine max (L. Merrill] de alta qualidade tem requerido da indústria de sementes um controle de qualidade mais preciso

  5. 28 CFR 58.26 - Procedures for inclusion on the approved provider list.

    Science.gov (United States)

    2010-07-01

    ... provider list. (a) As used in this section the term “provider” means a provider of a personal financial... of a Personal Financial Management Course” (application), including all appendices, and submit it at... directors; and a merger or consolidation with another entity; (2) The provider shall request approval by...

  6. 30 CFR 285.913 - What happens if I fail to comply with my approved decommissioning application?

    Science.gov (United States)

    2010-07-01

    ... approved decommissioning application? 285.913 Section 285.913 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT OF THE INTERIOR OFFSHORE RENEWABLE ENERGY ALTERNATE USES OF EXISTING FACILITIES ON THE OUTER CONTINENTAL SHELF Decommissioning Compliance with An Approved Decommissioning Application § 285.913 What...

  7. 21 CFR 314.530 - Withdrawal procedures.

    Science.gov (United States)

    2010-04-01

    ... Serious or Life-Threatening Illnesses § 314.530 Withdrawal procedures. (a) For new drugs approved under... benefit; (2) The applicant fails to perform the required postmarketing study with due diligence; (3) Use...

  8. 42 CFR 447.256 - Procedures for CMS action on assurances and State plan amendments.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false Procedures for CMS action on assurances and State... for Inpatient Hospital and Long-Term Care Facility Services Payment Rates § 447.256 Procedures for CMS action on assurances and State plan amendments. (a) Criteria for approval. (1) CMS approval action on...

  9. Analysis of generalized Schwarz alternating procedure for domain decomposition

    Energy Technology Data Exchange (ETDEWEB)

    Engquist, B.; Zhao, Hongkai [Univ. of California, Los Angeles, CA (United States)

    1996-12-31

    The Schwartz alternating method(SAM) is the theoretical basis for domain decomposition which itself is a powerful tool both for parallel computation and for computing in complicated domains. The convergence rate of the classical SAM is very sensitive to the overlapping size between each subdomain, which is not desirable for most applications. We propose a generalized SAM procedure which is an extension of the modified SAM proposed by P.-L. Lions. Instead of using only Dirichlet data at the artificial boundary between subdomains, we take a convex combination of u and {partial_derivative}u/{partial_derivative}n, i.e. {partial_derivative}u/{partial_derivative}n + {Lambda}u, where {Lambda} is some {open_quotes}positive{close_quotes} operator. Convergence of the modified SAM without overlapping in a quite general setting has been proven by P.-L.Lions using delicate energy estimates. The important questions remain for the generalized SAM. (1) What is the most essential mechanism for convergence without overlapping? (2) Given the partial differential equation, what is the best choice for the positive operator {Lambda}? (3) In the overlapping case, is the generalized SAM superior to the classical SAM? (4) What is the convergence rate and what does it depend on? (5) Numerically can we obtain an easy to implement operator {Lambda} such that the convergence is independent of the mesh size. To analyze the convergence of the generalized SAM we focus, for simplicity, on the Poisson equation for two typical geometry in two subdomain case.

  10. 77 FR 51551 - Proposed Renewal of Information Collection: Alternatives Process in Hydropower Licensing

    Science.gov (United States)

    2012-08-24

    ...: Alternatives Process in Hydropower Licensing AGENCY: Office of the Secretary, Office of Environmental Policy... approval for the collection of information for Alternatives Process in Hydropower Licensing. This... comments should reference Alternatives Process in Hydropower Licensing. FOR FURTHER INFORMATION CONTACT: To...

  11. Low molecular-weight phenols in Tannat wines made by alternative winemaking procedures.

    Science.gov (United States)

    Favre, Guzmán; Peña-Neira, Álvaro; Baldi, Cecilia; Hernández, Natalia; Traverso, Sofía; Gil, Graciela; González-Neves, Gustavo

    2014-09-01

    Low molecular weight phenols of Tannat red wines produced by Traditional Maceration (TM), Prefermentative Cold Maceration (PCM), Maceration Enzyme (ENZ) and grape-Seed Tannins additions (ST), were performed and discussed. Alternatives to TM increased wine phenolic contents but unequally, ST increased mainly smaller flavans-3-ol, PCM anthocyanins and ENZ proanthocyanidins (up to 2250 mg/L). However low molecular weight flavan-3-ols remained below 9 mg/L in all wines, showing that there is not necessarily a correspondence between wine richness in total tannins and flavan-3-ols contents at low molecular weight. PCM wines had particularly high concentrations of tyrosol and tryptophol, yeast metabolism derived compounds. The use of grape-seed enological tannins did not increase grape seed derived phenolic compounds such as gallic acid. Caftaric acid was found in concentrations much higher than those reported in other grape varieties. Wine phenolic content and composition was considerably affected by the winemaking procedures tested. Copyright © 2014 Elsevier Ltd. All rights reserved.

  12. 40 CFR 63.1573 - What are my monitoring alternatives?

    Science.gov (United States)

    2010-07-01

    .... (2) You shall measure and record the alkalinity of the water (or scrubbing liquid) exiting the wet... is the approved alternative for monitoring pH or alkalinity levels? You may use the alternative in... pH of the water (or scrubbing liquid) exiting the wet scrubber or internal scrubbing system at least...

  13. Problems of the current law concerning official plan approval

    International Nuclear Information System (INIS)

    Bluemel, W.

    1986-01-01

    The booklet presents lectures held in October 1985 at the Speyer University for Administration Science, on the subject of the law concerning official plan approval. The lectures have been selected for their common interest in the requirements of nature conservation and landscape protection. These requirements and the current practice of plan approval procedure are the main issue of the lectures which discuss aspects of environmental impact statements, consideration of ecological requirements, and the role of the landscape conservation plan accompanying official project planning documents. (HSCH) [de

  14. Credit Risk Management - Loan Approval Process

    Directory of Open Access Journals (Sweden)

    Lulzim Rashiti

    2016-03-01

    Full Text Available The aim of this study is on understanding the international regulations issued by Basel I, Basel II and Basel III to best supervise and manage credit risk management policies. Part of paper will focus on the description and impacts of the regulations and the pivotal importance they play in providing a sound banking system. Credit risk represents another important element that will be analysed considering that it lays the foundation during the loan consideration and approval process. The paper will also explain in detail procedures and responsibilities shared along the process of loan acceptance by a banker. To sum up, the overall process from application to loan approval or denial will be explained pointing out the implications that are faced along the way

  15. 40 CFR 85.1414 - Alternative test procedures.

    Science.gov (United States)

    2010-07-01

    ... (CONTINUED) CONTROL OF AIR POLLUTION FROM MOBILE SOURCES Urban Bus Rebuild Requirements § 85.1414 Alternative... shall be representative of in-use urban bus operation. The requestor shall supply relevant technical... test is representative of in-use urban bus operation, the Agency shall determine whether to set such...

  16. An Alternative and Rapid Method for the Extraction of Nucleic Acids from Ixodid Ticks by Potassium Acetate Procedure

    Directory of Open Access Journals (Sweden)

    Islay Rodríguez

    2014-08-01

    Full Text Available Four variants of the potassium acetate procedure for DNA extraction from ixodid ticks at different stage of their life cycles were evaluated and compared with phenol-chloroform and ammonium hydroxide methods. The most rapid and most efficient variant was validated in the DNA extraction procedure from the engorged ticks collected from bovine, canine as well as from house ticks for the screening of Borrelia burgdorferi sensu lato, Anaplasma spp. and Babesia spp. The ammonium hydroxide procedure was used for non-engorged ticks. All the variants were efficient and allowed obtaining PCR-quality material according to the specific amplification of 16S rRNA gene fragment of the original tick. DNA extracted from the ticks under the study was tested by multiplex PCR for the screening of tick-borne pathogens. Anaplasma spp. and Babesia spp. amplification products were obtained from 29/48 extracts. Ammonium hydroxide protocol was not efficient for two extracts. Detection of amplification products from the PCR indicated that DNA had been successfully extracted. The potassium acetate procedure could be an alternative, rapid, and reliable method for DNA extraction from the ixodid ticks, mainly for poorly-resourced laboratories.

  17. 40 CFR 1043.50 - Approval of methods to meet Tier 1 retrofit NOX standards.

    Science.gov (United States)

    2010-07-01

    ... retrofit NOX standards. 1043.50 Section 1043.50 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... SUBJECT TO THE MARPOL PROTOCOL § 1043.50 Approval of methods to meet Tier 1 retrofit NOX standards. Regulation 13 of Annex VI provides for certification of Approved Methods, which are retrofit procedures that...

  18. In-Trail Procedure Air Traffic Control Procedures Validation Simulation Study

    Science.gov (United States)

    Chartrand, Ryan C.; Hewitt, Katrin P.; Sweeney, Peter B.; Graff, Thomas J.; Jones, Kenneth M.

    2012-01-01

    In August 2007, Airservices Australia (Airservices) and the United States National Aeronautics and Space Administration (NASA) conducted a validation experiment of the air traffic control (ATC) procedures associated with the Automatic Dependant Surveillance-Broadcast (ADS-B) In-Trail Procedure (ITP). ITP is an Airborne Traffic Situation Awareness (ATSA) application designed for near-term use in procedural airspace in which ADS-B data are used to facilitate climb and descent maneuvers. NASA and Airservices conducted the experiment in Airservices simulator in Melbourne, Australia. Twelve current operational air traffic controllers participated in the experiment, which identified aspects of the ITP that could be improved (mainly in the communication and controller approval process). Results showed that controllers viewed the ITP as valid and acceptable. This paper describes the experiment design and results.

  19. 75 FR 59717 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated...

    Science.gov (United States)

    2010-09-28

    ..., New Executive Office Building, Room 10235, Washington, DC 20503. Final approval under OMB delegated... a bank shall establish and maintain written policies and procedures to prevent excessive exposure to... selecting correspondents and terminating those relationships. The policies and procedures should be reviewed...

  20. Yttrium-90 Resin Microsphere Radioembolization Using an Antireflux Catheter: An Alternative to Traditional Coil Embolization for Nontarget Protection

    International Nuclear Information System (INIS)

    Morshedi, Maud M.; Bauman, Michael; Rose, Steven C.; Kikolski, Steven G.

    2015-01-01

    PurposeSerious complications can result from nontarget embolization during yttrium-90 (Y-90) transarterial radioembolization. Hepatoenteric artery coil embolization has been traditionally performed to prevent nontarget radioembolization. The U.S. Food and Drug Administration–approved Surefire Infusion System (SIS) catheter, designed to prevent reflux, is an alternative to coils. The hypothesis that quantifiable SIS procedural parameters are comparable to coil embolization was tested.MethodsFourteen patients aged 36–79 years with colorectal, neuroendocrine, hepatocellular, and other predominantly bilobar hepatic tumors who underwent resin microsphere Y-90 radioembolization using only the SIS catheter (n = 7) versus only detachable coils (n = 7) for nontarget protection were reviewed retrospectively. Procedure time, fluoroscopy time, contrast dose, radiation dose, and cost were evaluated.ResultsMultivariate analysis identified significant cohort differences in the procedural parameters evaluated (F(10, 3) = 10.39, p = 0.04). Between-group comparisons of the pretreatment planning procedure in the SIS catheter group compared to the coil embolization group demonstrated a significant reduction in procedure time (102.6 vs. 192.1 min, respectively, p = 0.0004), fluoroscopy time (14.3 vs. 49.7 min, respectively, p = 0.0016), and contrast material dose (mean dose of 174.3 vs. 265.0 mL, respectively, p = 0.0098). Procedural parameters were not significantly different between the two groups during subsequent dose delivery procedures. Overall cost of combined first-time radioembolization procedures was significantly less in the SIS group ($4252) compared to retrievable coil embolization ($11,123; p = 0.001).ConclusionThe SIS catheter results in a reduction in procedure time, fluoroscopy time, and contrast material dose and may be an attractive cost-effective alternative to detachable coil embolization for prevention of nontarget radioembolization

  1. Yttrium-90 Resin Microsphere Radioembolization Using an Antireflux Catheter: An Alternative to Traditional Coil Embolization for Nontarget Protection

    Energy Technology Data Exchange (ETDEWEB)

    Morshedi, Maud M., E-mail: maud.morshedi@my.rfums.org; Bauman, Michael, E-mail: mbauman@ucsd.edu; Rose, Steven C., E-mail: scrose@ucsd.edu; Kikolski, Steven G., E-mail: skikolski@gmail.com [University of California San Diego Health Sciences, Radiology Department, University of California San Diego Medical Center (United States)

    2015-04-15

    PurposeSerious complications can result from nontarget embolization during yttrium-90 (Y-90) transarterial radioembolization. Hepatoenteric artery coil embolization has been traditionally performed to prevent nontarget radioembolization. The U.S. Food and Drug Administration–approved Surefire Infusion System (SIS) catheter, designed to prevent reflux, is an alternative to coils. The hypothesis that quantifiable SIS procedural parameters are comparable to coil embolization was tested.MethodsFourteen patients aged 36–79 years with colorectal, neuroendocrine, hepatocellular, and other predominantly bilobar hepatic tumors who underwent resin microsphere Y-90 radioembolization using only the SIS catheter (n = 7) versus only detachable coils (n = 7) for nontarget protection were reviewed retrospectively. Procedure time, fluoroscopy time, contrast dose, radiation dose, and cost were evaluated.ResultsMultivariate analysis identified significant cohort differences in the procedural parameters evaluated (F(10, 3) = 10.39, p = 0.04). Between-group comparisons of the pretreatment planning procedure in the SIS catheter group compared to the coil embolization group demonstrated a significant reduction in procedure time (102.6 vs. 192.1 min, respectively, p = 0.0004), fluoroscopy time (14.3 vs. 49.7 min, respectively, p = 0.0016), and contrast material dose (mean dose of 174.3 vs. 265.0 mL, respectively, p = 0.0098). Procedural parameters were not significantly different between the two groups during subsequent dose delivery procedures. Overall cost of combined first-time radioembolization procedures was significantly less in the SIS group ($4252) compared to retrievable coil embolization ($11,123; p = 0.001).ConclusionThe SIS catheter results in a reduction in procedure time, fluoroscopy time, and contrast material dose and may be an attractive cost-effective alternative to detachable coil embolization for prevention of nontarget radioembolization.

  2. 76 FR 24372 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Update to Materials...

    Science.gov (United States)

    2011-05-02

    ... revised the procedures for incorporating by reference Federally- approved SIPs, as a result of... document, IBR procedures and ``Identification of plan'' format are discussed in further detail in the May...) of the Administrative Procedures Act (APA) which, upon finding ``good cause,'' authorizes agencies to...

  3. Alternate superior Julia sets

    International Nuclear Information System (INIS)

    Yadav, Anju; Rani, Mamta

    2015-01-01

    Alternate Julia sets have been studied in Picard iterative procedures. The purpose of this paper is to study the quadratic and cubic maps using superior iterates to obtain Julia sets with different alternate structures. Analytically, graphically and computationally it has been shown that alternate superior Julia sets can be connected, disconnected and totally disconnected, and also fattier than the corresponding alternate Julia sets. A few examples have been studied by applying different type of alternate structures

  4. COLLABORATIVE PROCEDURE TO ACHIEVE AN EFFECTIVE JURISDICTIONAL TUTELAGE

    Directory of Open Access Journals (Sweden)

    Darilê Marques da Matta

    2015-12-01

    Full Text Available Set in a constitutional context, the procedure should be an effective instrument for the guarantee and realization of rights. Attentive to the needs imposed by the state of Law, the new Civil Procedure Code, approved this year, 2 015, seeks to settle several constitutional guarantees, for the purpose of making the procedure more effective. From the inclusion of collaborative institutes, the new Civil Procedure C ode introduces the concept of self-composition and cooperation of procedural agents to achieve, timely, effective jurisdictional tutelage.

  5. Space Geodesy Project Information and Configuration Management Procedure

    Science.gov (United States)

    Merkowitz, Stephen M.

    2016-01-01

    This plan defines the Space Geodesy Project (SGP) policies, procedures, and requirements for Information and Configuration Management (CM). This procedure describes a process that is intended to ensure that all proposed and approved technical and programmatic baselines and changes to the SGP hardware, software, support systems, and equipment are documented.

  6. Delineating an alternate convergent synthesis of brexpiprazole: a ...

    Indian Academy of Sciences (India)

    A Sravanth Kumar

    2018-06-14

    Jun 14, 2018 ... that had reached the market with the approved indi- cation of schizophrenia ... nist induced adverse effects such as akathisia, insomnia,. *For correspondence .... Despite providing an alternate amination strategy,. Xiangrui's ...

  7. 42 CFR 488.60 - Special procedures for approving end stage renal disease facilities.

    Science.gov (United States)

    2010-10-01

    ... of the Public Health Service concerning the facility's contribution to the ESRD services of the network. (3) Data concerning the facility's compliance with professional norms and standards. (4) Data pertaining to the facility's qualifications for approval or for any expansion of services. (b) Determining...

  8. Aviation Maintenance Technology. Course Content Guides. FAA Approved Curriculum.

    Science.gov (United States)

    Shrawder, Jack; And Others

    Course content guides are provided for the 30 courses in this aviation maintenance technology curriculum approved by the Federal Aviation Administration. Course titles are physics for technicians; aircraft information, regulations, and procedures; aircraft assembly; fundamentals of aircraft electronics; aircraft electrical components; aircraft…

  9. Technology Overview Using Case Studies of Alternative Landfill Technologies and Associated Regulatory Topics

    National Research Council Canada - National Science Library

    2003-01-01

    ... alternative landfill cover projects. The purpose of the case studies is to present examples of the flexibility used in the regulatory framework for approving alternative landfill cover designs, current research information about the use...

  10. 78 FR 11984 - Approval and Promulgation of Implementation Plans; State of Hawaii; Update to Materials...

    Science.gov (United States)

    2013-02-21

    ... procedures for incorporating by reference federally-approved SIPs, as a result of consultations between EPA... procedures and ``Identification of plan'' format are discussed in further detail in the May 22, 1997 Federal... cause'' exemption in section 553(b)(3)(B) of the Administrative Procedures Act (APA) which, upon finding...

  11. 14 CFR 17.31 - Use of alternative dispute resolution.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Use of alternative dispute resolution. 17... PROCEDURAL RULES PROCEDURES FOR PROTESTS AND CONTRACTS DISPUTES Alternative Dispute Resolution § 17.31 Use of alternative dispute resolution. (a) The Office of Dispute Resolution for Acquisition shall encourage the...

  12. Alternative Antimicrobial Commercial Egg Washing Procedures.

    Science.gov (United States)

    Hudson, Lauren K; Harrison, Mark A; Berrang, Mark E; Jones, Deana R

    2016-07-01

    Commercial table eggs are washed prior to packaging. Standard wash procedures use an alkaline pH and warm water. If a cool water method could be developed that would still provide a microbiologically safe egg, the industry may save energy costs associated with water heating. Four wash procedures were evaluated for Salmonella reduction: pH 11 at 48.9°C (industry standard), pH 11 at ambient temperature (∼20°C), pH 6 at 48.9°C, and pH 6 at ambient temperature. Alkaline washes contained potassium hydroxide-based detergent, while pH 6 washes contained approximately 200 ppm of chlorine and a proprietary chlorine stabilizer (T-128). When eggs were inoculated by immersion in a cell suspension of Salmonella Enteritidis and Salmonella Typhimurium, all treatments resulted in a slight and similar reduction of Salmonella numbers (approximately 0.77 log CFU/ml of shell emulsion reduction). When eggs were inoculated by droplet on the shell surface, Salmonella counts were reduced by approximately 5 log CFU when washed with chlorine plus the chlorine stabilizer at both temperatures and with the alkaline wash at the high temperature. The reductions in Salmonella by these treatments were not significantly (P > 0.05) different from each other but were significantly (P pH 11 warm water wash and may be a viable option to reduce cost, increase shelf life, and slow pathogen growth in and on shell eggs.

  13. Inventory information approval system certification and flexible spending account purchases.

    Science.gov (United States)

    Shuey, Brandon; Williams, La Vonn A

    2010-01-01

    There is no question that 2009 was a year of change within the pharmacy industry. Several new requirements were implemented, including the need for an Inventory Information Approval System for accepting flexible spending or health reimbursement account cords. Some pharmacies relied on the 90% exemption rule, which is discussed within this article, or an alternative method to avoid the expense of a point of sale. However, with flexible spending or health reimbursement account card participation expected to reach 85% in 2010, now bay be the time for compounding pharmacists to weigh the pros and cons of Inventory Information Approval System certification.

  14. 32 CFR 93.5 - Procedures.

    Science.gov (United States)

    2010-07-01

    ... SERVICE OF PROCESS; RELEASE OF OFFICIAL INFORMATION IN LITIGATION; AND TESTIMONY BY NSA PERSONNEL AS WITNESSES § 93.5 Procedures. (a) Release of official information in litigation. NSA personnel shall not..., but a record of such approval will be made and retained in the OGC. NSA personnel shall not provide...

  15. 14 CFR 151.29 - Procedures: Offer, amendment, and acceptance.

    Science.gov (United States)

    2010-01-01

    ... resolution or ordinance must, as appropriate under the local law— (1) Set forth the terms of the offer at... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Procedures: Offer, amendment, and... § 151.29 Procedures: Offer, amendment, and acceptance. (a) Upon approving a project, the Administrator...

  16. 7 CFR 1726.252 - Prior approved contract modification related to liability for special and consequential damages.

    Science.gov (United States)

    2010-01-01

    ... consequential damages on account of breach of this contract shall not exceed in total an amount equal to... 7 Agriculture 11 2010-01-01 2010-01-01 false Prior approved contract modification related to... CONSTRUCTION POLICIES AND PROCEDURES Modifications to RUS Standard Contract Forms § 1726.252 Prior approved...

  17. 29 CFR 5.16 - Training plans approved or recognized by the Department of Labor prior to August 20, 1975.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 1 2010-07-01 2010-07-01 true Training plans approved or recognized by the Department of... STANDARDS ACT) Davis-Bacon and Related Acts Provisions and Procedures § 5.16 Training plans approved or... contractor shall be required to obtain approval of a training program which, prior to August 20, 1975, was...

  18. 14 CFR 17.33 - Election of alternative dispute resolution process.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Election of alternative dispute resolution... TRANSPORTATION PROCEDURAL RULES PROCEDURES FOR PROTESTS AND CONTRACTS DISPUTES Alternative Dispute Resolution § 17.33 Election of alternative dispute resolution process. (a) The Office of Dispute Resolution for...

  19. 48 CFR 6302.30 - Alternative dispute resolution methods (Rule 30).

    Science.gov (United States)

    2010-10-01

    ... TRANSPORTATION BOARD OF CONTRACT APPEALS RULES OF PROCEDURE 6302.30 Alternative dispute resolution methods (Rule... Alternative Dispute Resolution (ADR): Settlement Judges and Mini-Trials. These procedures are designed to... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Alternative dispute...

  20. Aesthetic procedures in office practice.

    Science.gov (United States)

    Small, Rebecca

    2009-12-01

    Since the approval of botulinum toxin, dermal fillers, and lasers for cosmetic use, minimally invasive aesthetic procedures have rapidly become the treatments of choice for age-related facial changes. In the past 10 years, aesthetic procedures have increased nearly five-fold. Of the 10.2 million aesthetic treatments performed in 2008, 83 percent were minimally invasive procedures. Botulinum toxin and dermal filler injections, laser hair reduction, chemical peels, laser skin resurfacing, microdermabrasion, and intense pulsed light photorejuvenation were the most commonly performed procedures in 2008. These procedures are effective and associated with minimal discomfort, and they have a low incidence of adverse effects and short recovery times. High patient and physician satisfaction have contributed to their growing popularity and availability in the primary care setting. As patient demand for aesthetic treatments increases, family physicians should be familiar with common minimally invasive aesthetic procedures when advising patients or incorporating aesthetic care into office practice.

  1. Approval of raxibacumab for the treatment of inhalation anthrax under the US Food and Drug Administration Animal rule

    Directory of Open Access Journals (Sweden)

    Chia-Wei eTsai

    2015-12-01

    Full Text Available On December 14, 2012, the FDA approved raxibacumab, the first product developed under Project BioShield to achieve this milestone, and the first biologic product to be approved through the FDA animal efficacy rule (or Animal Rule. Raxibacumab is approved for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibiotic drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. The approval of Raxibacumab illustrates many of the challenges that product developers may encounter when pursuing approval under the Animal Rule and highlights a number of important regulatory and policy issues.

  2. New alternative Mitrofanoff channel based on spiral intestinal lengthening and tailoring.

    Science.gov (United States)

    Cervellione, Raimondo M; Hajnal, Daniel; Varga, Gabriella; Rakoczy, George; Kubiak, Rainer; Kaszaki, Jozsef; Boros, Mihaly; Harwood, Rachel; Dickson, Alan P; Cserni, Tamas

    2015-06-01

    The occasional lack of appendix and the increasing use of the Malone anterograde continence enema (MACE) procedure have expanded the need for alternative Mitrofanoff channels. The Monti procedure does not always provide adequate length, the anastomosis of the double Monti, and the potential kink of the Casale channel is not ideal for smooth catheterisation. We tested the concept of spiral intestinal lengthening and tailoring (SILT), we developed originally for short bowel syndrome, to create a long and straight alternative Mitrofanoff channel (Figure). After ethical approval five mini-pigs underwent spiral intestinal lengthening and tailoring (SILT) without any previous bowel dilatation procedure. (Mean bowel width was 20.5 ± 0.57 mm). The spiral line was marked on a 6-8-cm-long ileum approximately 15 mm apart with a 60° angle to the longitudinal axis of the bowel. When the incision was completed, the mesentery was incised perpendicularly where the spiral incision line met the mesentery. The maximum length segment hanging on a single 1.5-cm-wide well-vascularised mesentery was detached. The capillary red blood cell velocity (RBCV) and perfusion rate (PR) was measured at the edges of the opened bowel strip by in vivo microscopy using orthogonal polarising spectral imaging (Cytoscan A/R, Cytometrics, Philadelphia, PA, USA). The bowel strips have been reconstructed in spiral fashion over a 12F catheter and were implanted into the bladder. Viability, patency, and microcirculation were assessed 4 weeks later. Conventional microscopy with HE staining was performed. The mean length of the spiral channel (100 ± 26.4 mm) was longer than could have been achieved with the double Monti or Casale procedure (4 times the bowel width). A 17% and 8.3% reduction was measured in the median values of the RBCV and the PR at the edges of the bowel strip at the primary surgery. All implanted channels remained viable, straight, patent, and easily catheterisable after 4 weeks, with full

  3. Standard Operating Procedure for Accelerated Corrosion Testing at ARL

    Science.gov (United States)

    2017-11-01

    ARL-TN-0855 ● NOV 2017 US Army Research Laboratory Standard Operating Procedure for Accelerated Corrosion Testing at ARL by... Corrosion Testing at ARL by Thomas A Considine Weapons and Materials Research Directorate, ARL Approved for public...November 2017 2. REPORT TYPE Technical Note 3. DATES COVERED (From - To) 4. TITLE AND SUBTITLE Standard Operating Procedure for Accelerated

  4. Amendment to the agreement between CERN and Ukraine concerning the granting of the status of Associate Member at CERN Extension of the deadline for the notification of the completion of the internal approval procedures of the agreement by Ukraine

    CERN Document Server

    2015-01-01

    Amendment to the agreement between CERN and Ukraine concerning the granting of the status of Associate Member at CERN Extension of the deadline for the notification of the completion of the internal approval procedures of the agreement by Ukraine

  5. Waste feed delivery environmental permits and approvals plan

    International Nuclear Information System (INIS)

    Papp, I.G.

    1998-01-01

    This document describes the range of environmental actions, including required permits and other agency approvals, that may affect waste feed delivery (WFD) activities in the Hanford Site's Tank Waste Remediation System (TWRS). This plan expands on the summary level information in the Tank Waste Remediation System Environmental Program Plan (HNF 1773) to address requirements that are most pertinent to WFD. This plan outlines alternative approaches to satisfying applicable environmental standards, and describes selected strategies for acquiring permits and other approvals needed for WFD to proceed. Appendices at the end of this plan provide preliminary cost and schedule estimates for implementing the selected strategies. The rest of this section summarizes the scope of WFD activities, including important TWRS operating information, and describes in more detail the objectives, structure, and content of this plan

  6. Requirements for the approval of dosimetry services under the Ionising Radiations Regulations 1985: Pt. 1: External radiations

    International Nuclear Information System (INIS)

    1991-01-01

    Guidance for dosimetry services on the requirements for approval by the Health and Safety Executive (HSE) is provided in three parts. This part sets out the procedures and criteria that will be used by HSE in the assessment of dosimetry services seeking approval in relation to external radiations (including accidents). (author)

  7. Bone Graft Alternatives

    Science.gov (United States)

    ... Spine Treatment Spondylolisthesis BLOG FIND A SPECIALIST Treatments Bone Graft Alternatives Patient Education Committee Patient Education Committee ... procedure such as spinal fusion. What Types of Bone Grafts are There? Bone grafts that are transplanted ...

  8. 40 CFR 610.64 - Track test procedures.

    Science.gov (United States)

    2010-07-01

    ... truck or trailer. (4) Fuel economy will be determined by either a gravimetric or volumetric method. (c... dynamometer except that fuel economy will be measured by gravimetric or volumetric methods. ... either a volumetric or gravimetric procedure approved by the Administrator. (5) Vehicle speed and...

  9. Requirements for the approval of dosimetry services under the Ionising Radiations Regulations 1985: Pt. 2: Internal radiations

    International Nuclear Information System (INIS)

    1991-01-01

    Guidance for dosimetry services on the requirements for approval by the Health and Safety Executive (HSE) is provided in three parts. This part sets out the procedures and criteria that will be used by HSE in the assessment of dosimetry services seeking approval in relation to internal radiations (including radon decay products). (author)

  10. 34 CFR 299.11 - What items are included in the complaint procedures?

    Science.gov (United States)

    2010-07-01

    ... violations of section 14503 (participation of private school children), the Secretary will follow the procedures in section 14505(b). (Approved by the Office of Management and Budget under OMB control number... complaint procedures to parents of students, and appropriate private school officials or representatives...

  11. Test procedure forms for sludge retrieval and packaging

    International Nuclear Information System (INIS)

    Feigenbutz, L.V.

    1994-01-01

    This document provides test procedure forms for sludge retrieval and packaging tests in the 305 Cold Test Facility. The completed and approved forms provide all descriptions, criteria and analysis to safely perform sludge equipment tests in the 305 Cold Test Facility

  12. Environmental protection and procedural law

    International Nuclear Information System (INIS)

    Mutschler, U.

    1978-01-01

    For the power industry which is 'independent of licensing', the Ule/Laubinger statement as well as its discussion on the 52th German legal experts' day are of considerable importance. It is therefore absolutely necessary to critically investigate the statements of this expert's opinion and the considerations on which they are based. This investigation is limited to those licensing procedures which in the terminology of experts, are 'similar to the plan approval procedure'. This applies mainly to the procedures according to paragraph 4 ff of the Federal Act on the Protection Against Nuisances and paragraph 7 of the Atomic Energy Law: Preliminaries publication of documents, inspection of files, public hearing, taking of evidence, persons with special responsibilities, administrative proceedings, actions by associations. The deficiencies in the execution of environmental procedural law is briefly mentioned. The notes in the article refer only to air pollution. (orig./HP) [de

  13. The procedure of alternative site selection within the report of the study group on the radioactive waste final repository selection process (AKEnd); Das Verfahren der alternativen Standortsuche im Bericht des Arbeitskreises Auswahlverfahren Endlagerstandorte (AKEnd)

    Energy Technology Data Exchange (ETDEWEB)

    Brenner, M. [Jena Univ. (Germany)

    2005-07-01

    The paper discusses the results of the report of the study group on the radioactive waste final repository selection process with respect to the alternative site selection procedure. Key points of the report are the long-term safety, the alternativity of sites and the concept of one repository. The critique on this report is focussed on the topics site selection and licensing procedures, civil participation, the factor time and the question of cost.

  14. Competent authority approval of package designs in the United Kingdom

    International Nuclear Information System (INIS)

    Morgan-Warren, E.J.

    1999-01-01

    Type B packages and all packages containing fissile material, as well as special form radioactive materials, special arrangements and certain shipments, are required to be approved by the competent authority. In the United Kingdom competent authority approval is carried out on behalf of the Secretary of State by the Radioactive Materials Transport Division (RMTD) of the Department of the Environment, Transport and the Regions (DETR). Competent authority approval of a package design is given only after a detailed assessment of the design by the specialist staff of RMTD. There are three facets to the assessment procedure, namely engineering, criticality and radiation protection, and quality assurance. The engineering assessor ensures that the designer has demonstrated the integrity of the containment and shielding systems under the regulatory conditions. The criticality assessor examines criticality safety and radiation protection measures, and together with the engineering assessor, decides whether this is maintained under regulatory conditions. The quality assurance assessor verifies that the applicant has established the necessary controls to ensure that the design requirements are met. The applicant is responsible for making the case for approval, but the assessment is facilitated if the competent authority is involved with the designer at an early stage in development and during the construction of any test prototype. When a regulatory test programme is required, it is designed and carried out by the applicant, but agreed and witnessed by representatives of RMTD. Following the test programme, the applicant submits a formal application, supported by a design safety report (DSR). The DSR provides a full analysis of the design and the test results, including the behaviour of the package under normal and accident conditions of transport, the manufacturing and maintenance procedures, quality assurance and the emergency provisions for the operation of the package

  15. Utilization of the Rutherford backscattering technique for precise measurements of thickness by an alternative procedure

    International Nuclear Information System (INIS)

    Chagas, E.F.

    1985-01-01

    This technique was used to determine the thickness of targets on very thick substrates as this type of target is used a lot in nuclear physics, and especially in γ spectroscpy. The difficulties introduced in this case, occur because of the appearance of a small peak on a very high continuous background, due to the fact that the atomic number of the substrate is bigger than that of the targets. These difficulties are overcome using an alternative procedure to determine precisely the loss of energy of the beam whilst crossing the refered target. Targets of 59 Co, 46-48-50 Ti and 10 B on substrate of Pd and Ta, with thicknesses betwnn 30μg/cm 2 and 500μg/cm 2 were measured with a precision of 5%. The biggest sources of imprecision are the amounts of dE/dX. (Author) [pt

  16. 28 CFR 42.734 - Alternative funding.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Alternative funding. 42.734 Section 42.734 Judicial Administration DEPARTMENT OF JUSTICE NONDISCRIMINATION; EQUAL EMPLOYMENT OPPORTUNITY...; Implementation of the Age Discrimination Act of 1975 Compliance Procedures § 42.734 Alternative funding. When...

  17. Still special? Harvesting procedures for industrial hemp

    Directory of Open Access Journals (Sweden)

    Hans-Jörg Gusovius

    2016-01-01

    Full Text Available A multitude of different harvesting procedures is available after the re-approval of hemp growing in Germany about 20 years ago. Established, but as well recent machine developments enable the supply of raw materials for further processing or as food and feed materials. The necessary specialization level results in high but, compared to other established crops, not exceeding procedural costs. In this study, harvesting procedures and technologies are analyzed that are currently used under Northern European cultivation conditions. However, technological enhancements are still needed in order to improve the competitiveness of fibre hemp in the crop rotation as well as of hemp-based semi-finished and finished products.

  18. Requirements for the approval of dosimetry services under the Ionising Radiations Regulations 1985: Pt. 3: Coordination and record-keeping

    International Nuclear Information System (INIS)

    1991-01-01

    Guidance for dosimetry services on the requirements for approval by the Health and Safety Executive (HSE) is provided in three parts. This part sets out the procedures and criteria that will be used by HSE in the assessment of dosimetry services seeking approval for coordination and record keeping. (author)

  19. Assessing environmental vulnerability in EIA-The content and context of the vulnerability concept in an alternative approach to standard EIA procedure

    International Nuclear Information System (INIS)

    Kvaerner, Jens; Swensen, Grete; Erikstad, Lars

    2006-01-01

    In the traditional EIA procedure environmental vulnerability is only considered to a minor extent in the early stages when project alternatives are worked out. In Norway, an alternative approach to EIA, an integrated vulnerability model (IVM), emphasising environmental vulnerability and alternatives development in the early stages of EIA, has been tried out in a few pilot cases. This paper examines the content and use of the vulnerability concept in the IVM approach, and discusses the concept in an EIA context. The vulnerability concept is best suited to overview analyses and large scale spatial considerations. The concept is particularly useful in the early stages of EIA when alternatives are designed and screened. By introducing analyses of environmental vulnerability at the start of the EIA process, the environment can be a more decisive issue for the creation of project alternatives as well as improving the basis for scoping. Vulnerability and value aspects should be considered as separate dimensions. There is a need to operate with a specification between general and specific vulnerability. The concept of environmental vulnerability has proven useful in a wide range of disciplines. Different disciplines have different lengths of experience regarding vulnerability. In disciplines such as landscape planning and hydrogeology we find elements suitable as cornerstones in the further development of an interdisciplinary methodology. Further development of vulnerability criteria in different disciplines and increased public involvement in the early stages of EIA are recommended

  20. 42 CFR 8.28 - Expedited procedures for review of immediate suspension.

    Science.gov (United States)

    2010-10-01

    ... GENERAL PROVISIONS CERTIFICATION OF OPIOID TREATMENT PROGRAMS Procedures for Review of Suspension or Proposed Revocation of OTP Certification, and of Adverse Action Regarding Withdrawal of Approval of an...

  1. 17 CFR 202.11 - Public Company Accounting Oversight Board budget approval process.

    Science.gov (United States)

    2010-04-01

    ... 17 Commodity and Securities Exchanges 2 2010-04-01 2010-04-01 false Public Company Accounting Oversight Board budget approval process. 202.11 Section 202.11 Commodity and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION INFORMAL AND OTHER PROCEDURES § 202.11 Public Company Accounting Oversight...

  2. 78 FR 68005 - Approval and Promulgation of Implementation Plans; Mississippi; Transportation Conformity SIP...

    Science.gov (United States)

    2013-11-13

    ...] Approval and Promulgation of Implementation Plans; Mississippi; Transportation Conformity SIP--Memorandum... transportation conformity criteria and procedures related to interagency consultation and enforceability of... conformity process to allow direct consultation among agencies at the Federal, state and local levels. This...

  3. 48 CFR 833.214 - Alternative dispute resolution (ADR).

    Science.gov (United States)

    2010-10-01

    ... Alternative dispute resolution (ADR). Contracting officers and contractors are encouraged to use alternative dispute resolution (ADR) procedures. CBCA guidance on ADR may be obtained at http://www.cbca.gsa.gov. ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Alternative dispute...

  4. Anatomy of Alternating Quantifier Satisfiability (Work in progress)

    DEFF Research Database (Denmark)

    Dung, Phan Anh; Bjørner, Nikolaj; Monniaux, David

    We report on work in progress to generalize an algorithm recently introduced in [10] for checking satisfiability of formulas with quantifier alternation. The algorithm uses two auxiliary procedures: a procedure for producing a candidate formula for quantifier elimination and a procedure for elimi...

  5. 46 CFR 272.42 - Audit requirements and procedures.

    Science.gov (United States)

    2010-10-01

    ... procedures. (a) Required audit. In connection with the audit of the Operator's subsidizable expenses, the... of audit results. Upon completion of the audit by the Office of Inspector General, the MARAD Office of Financial Approvals shall notify the Operator of the audit results, including any items disallowed...

  6. 13 CFR 127.303 - How will SBA select and identify approved certifiers?

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false How will SBA select and identify approved certifiers? 127.303 Section 127.303 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION WOMEN-OWNED SMALL BUSINESS FEDERAL CONTRACT ASSISTANCE PROCEDURES Certification of EDWOSB or WOSB Status...

  7. 78 FR 16159 - Application Procedures and Criteria for Approval of Providers of a Personal Financial Management...

    Science.gov (United States)

    2013-03-14

    ... and Criteria for Approval of Providers of a Personal Financial Management Instructional Course by... personal financial management instructional course (``providers'') satisfy all prerequisites of the United... in an instructional course concerning personal financial management (``instructional course'' or...

  8. 25 CFR 291.13 - When do Class III gaming procedures for an Indian tribe become effective?

    Science.gov (United States)

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false When do Class III gaming procedures for an Indian tribe... ECONOMIC ENTERPRISES CLASS III GAMING PROCEDURES § 291.13 When do Class III gaming procedures for an Indian tribe become effective? Upon approval of Class III gaming procedures for the Indian tribe under either...

  9. Review of technologies and alternatives for dispositioning DOE/INEL spent nuclear fuels

    International Nuclear Information System (INIS)

    Bendixsen, C.L.; Olson, A.L.; Christian, J.D.; Thomas, T.R.

    1994-01-01

    Following the decision to cease processing of spent nuclear fuels (SNF) for purposes of uranium recovery, the Idaho National Engineering Laboratory is evaluating alternatives for management of the 90+ types of SNF now stored thereon. Two major classes of alternatives include direct disposal of SNF with little or minimal repackaging and chemical processing to reduce high-activity waste volumes and to reduce the number and type of waste forms requiring regulatory approval. The disposal alternatives are described and the primary advantages and disadvantages identified

  10. Procedural law problems with the construction of installations (plants) for the final storage of radioactive materials

    International Nuclear Information System (INIS)

    Hoppe, W.; Bunse, B.

    1984-01-01

    The underground exploration of the salt-mine Gorleben has to be permitted according to sec. 126 para. 3, 51 et seq. Federal Mining Act. There is, however, no need for carrying out a nuclear law procedure for the official approval of the plan because the construction of the exploration mine does not represent the construction of a final storage facility. The operation of exploration measures does not create legally relevant prejudices for procedures of the official approval of the plan according to Atomic Energy Law. (HP) [de

  11. 12 CFR 611.1010 - Bank charter amendment procedures.

    Science.gov (United States)

    2010-01-01

    ... change that is properly the subject of a bank charter; (b) Upon approval of an appropriate resolution by the bank board, the certified resolution, together with supporting documentation, shall be submitted... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Bank charter amendment procedures. 611.1010...

  12. Final Rule: NESHAP for the Portland Cement Manufacturing Industry: Alternative Monitoring Method

    Science.gov (United States)

    EPA is extending its approval for the use of an alternative method to show compliance with hydrogen chloride (HCl) emissions limits in the National Emission Standards for Hazardous Air Pollutants for the Portland Cement Manufacturing Industry

  13. A cost and operational effectiveness analysis of alternative anti-surface warfare platforms

    OpenAIRE

    Skinner, Walter Mark.

    1993-01-01

    Approved for public release; distribution is unlimited. A Cost and Operational Effectiveness Analysis (COEA) is performed for three alternative anti-surface warfare (ASUW) platforms that will conduct operations in multi-service regional scenarios. Estimated program costs, historical cost variances, and measures of operational effectiveness are determined for each COEA alternative, and service life extension effects are examined. The data is merged in a mixed-integer optimization model, MPA...

  14. 40 CFR 86.163-00 - Spot check correlation procedures for vehicles tested using a simulation of the environmental...

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 18 2010-07-01 2010-07-01 false Spot check correlation procedures for... Complete Heavy-Duty Vehicles; Test Procedures § 86.163-00 Spot check correlation procedures for vehicles... running change approval, each model year for any manufacturer undergoing the spot checking procedures of...

  15. 76 FR 58265 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2011-09-20

    ... for review and approval according to the procedures prescribed in 5 CFR 1320.12. On May 9, 2011 (76 FR... of processes used to adjust and improve the physical and aesthetic characteristics of the leather...

  16. 48 CFR 6101.54 - Alternative dispute resolution [Rule 54].

    Science.gov (United States)

    2010-10-01

    ... CONTRACT APPEALS, GENERAL SERVICES ADMINISTRATION CONTRACT DISPUTE CASES 6101.54 Alternative dispute resolution [Rule 54]. (a) Availability of alternative dispute resolution (ADR) procedures at the Board. The... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Alternative dispute...

  17. 49 CFR 107.709 - Processing of an application for approval, including an application for renewal or modification.

    Science.gov (United States)

    2010-10-01

    ... TRANSPORTATION HAZARDOUS MATERIALS AND OIL TRANSPORTATION HAZARDOUS MATERIALS PROGRAM PROCEDURES Approvals... before the disposition of an application. (b) At any time during the processing of an application, the...

  18. Alternatives to criminal procedure against juvenile and young adult offenders and alternative to criminal procedure in the cases of domestic violence

    Directory of Open Access Journals (Sweden)

    Cvjetko Božica

    2006-01-01

    Full Text Available In the paper, the author is analyzing the Act on juvenile courts of the Republic of Croatia, which foresees a broad possibility of implementing the principle of opportunity in the pre-trial, i.e. reinvestigation phase of the procedure in terms of the decision of the public prosecutor about the criminal charge against these persons, including the implementation of particular obligations as informal sanctions. Particular attention is paid to the special obligation called off-court agreement. The aim of the off-court agreement is “reconciliation between the juvenile or young adult offender and the victim of the crime, and establishment of the social peace”. Similar project and the implementation of the principle of opportunity is used in the cases of the criminal offence of domestic violence. The main aim of these obligations is to offer professional assistance to the families which are in crisis and have difficulties related to the violent behavior of one family member - mostly the father. Such an approach is more efficient than the long lasting criminal procedure, testifying and strengthening the crisis in the family. This paper gives also an insight into the legal provisions concerning this measure and its implementation in practice.

  19. Report on noninvasive prenatal testing: classical and alternative approaches [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Kateryna S. Pantiukh

    2016-04-01

    Full Text Available Concerns of traditional prenatal aneuploidy testing methods, such as low accuracy of noninvasive and health risks associated with invasive procedures, were overcome with the introduction of novel noninvasive methods based on genetics (NIPT. These were rapidly adopted into clinical practice in many countries after a series of successful trials of various independent submethods. Here we present results of own NIPT trial carried out in Moscow, Russia. 1012 samples were subjected to the method aimed at measuring chromosome coverage by massive parallel sequencing. Two alternative approaches are ascertained: one based on maternal/fetal differential methylation and another based on allelic difference. While the former failed to provide stable results, the latter was found to be promising and worthy of conducting a large-scale trial. One critical point in any NIPT approach is the determination of fetal cell-free DNA fraction, which dictates the reliability of obtained results for a given sample. We show that two different chromosome Y representation measures—by real-time PCR and by whole-genome massive parallel sequencing—are practically interchangeable (r=0.94. We also propose a novel method based on maternal/fetal allelic difference which is applicable in pregnancies with fetuses of either sex. Even in its pilot form it correlates well with chromosome Y coverage estimates (r=0.74 and can be further improved by increasing the number of polymorphisms.

  20. U.S. Food and Drug Administration drug approval: slow advances in obstetric care in the United States.

    Science.gov (United States)

    Wing, Deborah A; Powers, Barbara; Hickok, Durlin

    2010-04-01

    The process for drug approval in the United States is complex and time-consuming. There are comparatively few drugs with U.S. Food and Drug Administration (FDA)-approved indications for obstetric use in this country at this time; however, several are under development. We review the process for drug approval and recount the approval histories of obstetric drugs reviewed in the recent past. We also outline the current status of two progestational agents that are under development. For a variety of reasons, including a small market compared with others such as cardiology or oncology, and the potential of being drawn into medical-legal litigation, sponsors are disinclined to pursue drug development for obstetric purposes in this country. We compare the procedures for review and approval of drugs in the United States with those in Europe, and note that recent changes within the FDA may result in not only more drugs being approved but also changes in labeling of already approved drugs. Special programs to facilitate drug development and reforms to modernize the process and improve safety are discussed. These may result in changes in labeling of already approved drugs. Obstacles such as funding and liability are also discussed.

  1. PENILE ENHANCEMENT PROCEDURES: UROLOGICAL AND ETHICOLEGAL ISSUES

    Directory of Open Access Journals (Sweden)

    Marco Vella

    2012-04-01

    Full Text Available Phalloplasty procedures for most men requiring penile augmentation surgery are cosmetic procedures; generally the patients have a normal-sized and fully functional penis but they think that their penis is too small. There are not well defined indications for penile enhancement surgery and, except for the treatment of “micropenis”, there are not established guidelines and the outcome measures for success are still unclear. All penile enhancement techniques often do not reach the expected result and the grade of patient’s satisfaction is frequently poor. Phalloplasty procedures for psychological dysmorfism are not approved by any scientific society and the majority of these procedures are performed in private settings. The ethical and medicolegal problems resulting from a penis enhancement can be various and numerous, but few of them are reported in literature. After phalloplasty an attribution of professional responsibility and request of reimbursement is not rare. In this contribution the authors summarize a panorama of several urological and medico-legal aspects related to phalloplasty procedures.

  2. Surface Environmental Surveillance Procedures Manual

    Energy Technology Data Exchange (ETDEWEB)

    RW Hanf; TM Poston

    2000-09-20

    Environmental surveillance data are used in assessing the impact of current and past site operations on human health and the environment, demonstrating compliance with applicable local, state, and federal environmental regulations, and verifying the adequacy of containment and effluent controls. SESP sampling schedules are reviewed, revised, and published each calendar year in the Hanford Site Environmental Surveillance Master Sampling Schedule. Environmental samples are collected by SESP staff in accordance with the approved sample collection procedures documented in this manual.

  3. 38 CFR 17.65 - Approvals and provisional approvals of community residential care facilities.

    Science.gov (United States)

    2010-07-01

    ... approvals of community residential care facilities. 17.65 Section 17.65 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS MEDICAL Community Residential Care § 17.65 Approvals and provisional approvals of community residential care facilities. (a) An approval of a facility meeting all of...

  4. 78 FR 59701 - Medicare Program; Approval of Accrediting Organization for Suppliers of Advanced Diagnostic...

    Science.gov (United States)

    2013-09-27

    ...] Medicare Program; Approval of Accrediting Organization for Suppliers of Advanced Diagnostic Imaging... accredit suppliers seeking to furnish the technical component (TC) of advanced diagnostic imaging services... advanced diagnostic imaging (ADI) service and establish procedures to ensure that the criteria used by an...

  5. A study on the alternative option for nuclear policy

    International Nuclear Information System (INIS)

    Choi, J. W.; Choi, H. J.; Lee, J. Y.; Cho, D. K.; Jeon, K. S.; Park, S. W.; Hahn, D. H.; Yoon, J. S.; Lee, K. S.

    2008-02-01

    Since a decision-making by intuitive judgement under uncertain future conditions can not select an optimum alternative, reaching an agreement for alternatives between experts requires a development of several scientific opinion collection methodologies and performing these methodologies. Therefore, opinion collection for all points related to the nuclear energy, public hearing induction related researches and the acts, procedure, etc. performed in developed countries such as U.S, U.K, France, etc. are reviewed and analyzed in this research. And after the analysis of domestic spent nuclear fuel management plan, Task Force Team composed of experts in several related areas is organized to suggest strategies and directions which are necessary for making a national policy. Beside, Task Force Team selects an optimum technical alternative by the analysis and comparison in depth between these technical alternatives to establish the policy direction. They also established the procedures such as opinion collecting, etc. through policy conference and forum and suggested the technical data related nuclear policy which supports the nuclear policy conference. Results from this research are expected to decrease the trial and error that has been occurred in the present policy-making procedure such as radioactive waste repository related procedure and contribute for socio-cultural stability. Moreover, opinion collection plan for developing a nuclear policy alternative is expected to contribute for making a nuclear policy in the nuclear policy conference so that the nuclear technology will be enhanced more

  6. A study on the alternative option for nuclear policy

    Energy Technology Data Exchange (ETDEWEB)

    Choi, J. W.; Choi, H. J.; Lee, J. Y.; Cho, D. K.; Jeon, K. S.; Park, S. W.; Hahn, D. H.; Yoon, J. S.; Lee, K. S. [KAERI, Daejeon (Korea, Republic of)

    2008-02-15

    Since a decision-making by intuitive judgement under uncertain future conditions can not select an optimum alternative, reaching an agreement for alternatives between experts requires a development of several scientific opinion collection methodologies and performing these methodologies. Therefore, opinion collection for all points related to the nuclear energy, public hearing induction related researches and the acts, procedure, etc. performed in developed countries such as U.S, U.K, France, etc. are reviewed and analyzed in this research. And after the analysis of domestic spent nuclear fuel management plan, Task Force Team composed of experts in several related areas is organized to suggest strategies and directions which are necessary for making a national policy. Beside, Task Force Team selects an optimum technical alternative by the analysis and comparison in depth between these technical alternatives to establish the policy direction. They also established the procedures such as opinion collecting, etc. through policy conference and forum and suggested the technical data related nuclear policy which supports the nuclear policy conference. Results from this research are expected to decrease the trial and error that has been occurred in the present policy-making procedure such as radioactive waste repository related procedure and contribute for socio-cultural stability. Moreover, opinion collection plan for developing a nuclear policy alternative is expected to contribute for making a nuclear policy in the nuclear policy conference so that the nuclear technology will be enhanced more.

  7. Alaska Regional Energy Resources Planning Project. Phase 2: coal, hydroelectric and energy alternatives. Volume I. Beluga Coal District Analysis

    Energy Technology Data Exchange (ETDEWEB)

    Rutledge, G.; Lane, D.; Edblom, G.

    1980-01-01

    This volume deals with the problems and procedures inherent in the development of the Beluga Coal District. Socio-economic implications of the development and management alternatives are discussed. A review of permits and approvals necessary for the initial development of Beluga Coal Field is presented. Major land tenure issues in the Beluga Coal District as well as existing transportation routes and proposed routes and sites are discussed. The various coal technologies which might be employed at Beluga are described. Transportation options and associated costs of transporting coal from the mine site area to a connecting point with a major, longer distance transportation made and of transporting coal both within and outside (exportation) the state are discussed. Some environmental issues involved in the development of the Beluga Coal Field are presented. (DMC)

  8. MITS Feed and Withdrawal Subsystem: operating procedures

    International Nuclear Information System (INIS)

    Brown, W.S.

    1980-01-01

    This document details procedures for the operation of the MITS (Machine Interface Test System) Feed and Withdrawal Subsystem (F and W). Included are fill with UF 6 , establishment of recycle and thruput flows, shutdown, UF 6 makeup, dump to supply container, Cascade dump to F and W, and lights cold trap dump, all normal procedures, plus an alternate procedure for trapping light gases

  9. 28 CFR 35.176 - Alternative means of dispute resolution.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Alternative means of dispute resolution... DISABILITY IN STATE AND LOCAL GOVERNMENT SERVICES Compliance Procedures § 35.176 Alternative means of dispute resolution. Where appropriate and to the extent authorized by law, the use of alternative means of dispute...

  10. Practices and Procedures in the Administration of ITV Distance Learning Programs at Selected Institutions in Higher Education.

    Science.gov (United States)

    Koontz, F. R.

    The purpose of this study was to obtain current data on practices and procedures in the administration of distance learning programs in the areas of: (1) needs assessment; (2) student demographics; (3) telecourse acquisition procedures and sources; (4) criteria used to evaluate credit telecourses; (5) institutional approval procedures; (6)…

  11. Dynamic alarm response procedures

    International Nuclear Information System (INIS)

    Martin, J.; Gordon, P.; Fitch, K.

    2006-01-01

    The Dynamic Alarm Response Procedure (DARP) system provides a robust, Web-based alternative to existing hard-copy alarm response procedures. This paperless system improves performance by eliminating time wasted looking up paper procedures by number, looking up plant process values and equipment and component status at graphical display or panels, and maintenance of the procedures. Because it is a Web-based system, it is platform independent. DARP's can be served from any Web server that supports CGI scripting, such as Apache R , IIS R , TclHTTPD, and others. DARP pages can be viewed in any Web browser that supports Javascript and Scalable Vector Graphics (SVG), such as Netscape R , Microsoft Internet Explorer R , Mozilla Firefox R , Opera R , and others. (authors)

  12. A Study on Becoming an Alternatively Certified Career and Technical Educator

    Science.gov (United States)

    Cotton-Flanagan, Kymberli A.

    2011-01-01

    This mixed method study examined the perspectives of twelve practicing high school CTE teachers engaged in a newly approved university model for alternative certification. Using Creswell's (2008) Sequential Exploratory Design and the lens of adult learning theory as established in Knowles' (1970) Theory of Andragogy, this study examines how…

  13. Innovative and Alternative Technology Assessment Manual

    Energy Technology Data Exchange (ETDEWEB)

    None

    1980-02-01

    This four chapter, six appendix manual presents the procedures and methodology as well as the baseline costs and energy information necessary for the analysis and evaluation of innovative and alternative technology applications submitted for federal grant assistance under the innovative and alternative technology provisions of the Clean Water Act of 1977. The manual clarifies and interprets the intent of Congress and the Environmental Protection Agency in carrying out the mandates of the innovative and alternative provisions of the Clean Water Act of 1977. [DJE 2005

  14. The European Medicines Agency's approval of new medicines for type 2 diabetes.

    Science.gov (United States)

    Blind, Eberhard; Janssen, Heidi; Dunder, Kristina; de Graeff, Pieter A

    2018-05-08

    Since 2005, more than 40 new medicines for the treatment of type 2 diabetes have been introduced on the market. These consist of 15 new active substances establishing three new classes of non-insulin products, and several new or modified insulin products and combinations. The approval of these products in Europe is regulated via the centralized procedure at the European Medicines Agency. Demonstration of benefit with regard to improved glucose control remains the principal outcome required from confirmatory studies to demonstrate efficacy. For the majority of these new medicines approved since 2005, cardiovascular outcome trials have now been completed, and have invariably supported the cardiovascular safety of these products. In some of these trials additional important benefits have been observed, for instance, a reduction in major adverse cardiovascular events and improvement of renal outcome. The existing regulatory framework and the continuous adaption of regulatory requirements to emerging developments will continue to guide the approval of new products in the future. © 2018 John Wiley & Sons Ltd.

  15. Alternative Dispute Resolution ( ADR / ODR and Mitigation of Litigation in the Context of the New Code of Civil Procedure: A Shorter Path to Fair Legal System?

    Directory of Open Access Journals (Sweden)

    Leandro André Francisco Lima

    2016-06-01

    Full Text Available This study addresses the use of Alternative Dispute Resolution (ADR’s methods, owing to the new Civil Law Procedure Code, having as it’s theoretical framework the concept of access to justice as a Right to a fair Law system. It’s asked about the possibilities of using the alternative Online Dispute Resolution (ODR's tools by jurisdiction, provided by the information technology, in order to maximize the effects relating to that Right. The pertinence of this question is glimpsed in view of the broad society accession to the virtual life. It is used the hypothetical-deductive method. The research is theoretical, bibliographical and documentary.

  16. Analysis of lomustine drug content in FDA-approved and compounded lomustine capsules.

    Science.gov (United States)

    KuKanich, Butch; Warner, Matt; Hahn, Kevin

    2017-02-01

    OBJECTIVE To determine the lomustine content (potency) in compounded and FDA-approved lomustine capsules. DESIGN Evaluation study. SAMPLE 2 formulations of lomustine capsules (low dose [7 to 11 mg] and high dose [40 to 48 mg]; 5 capsules/dose/source) from 3 compounders and from 1 manufacturer of FDA-approved capsules. PROCEDURES Lomustine content was measured by use of a validated high-pressure liquid chromatography method. An a priori acceptable range of 90% to 110% of the stated lomustine content was selected on the basis of US Pharmacopeia guidelines. RESULTS The measured amount of lomustine in all compounded capsules was less than the stated content (range, 59% to 95%) and was frequently outside the acceptable range (failure rate, 2/5 to 5/5). Coefficients of variation for lomustine content ranged from 4.1% to 16.7% for compounded low-dose capsules and from 1.1% to 10.8% for compounded high-dose capsules. The measured amount of lomustine in all FDA-approved capsules was slightly above the stated content (range, 104% to 110%) and consistently within the acceptable range. Coefficients of variation for lomustine content were 0.5% for low-dose and 2.3% for high-dose FDA-approved capsules. CONCLUSIONS AND CLINICAL RELEVANCE Compounded lomustine frequently did not contain the stated content of active drug and had a wider range of lomustine content variability than did the FDA-approved product. The sample size was small, and larger studies are needed to confirm these findings; however, we recommend that compounded veterinary formulations of lomustine not be used when appropriate doses can be achieved with FDA-approved capsules or combinations of FDA-approved capsules.

  17. 75 FR 70936 - Accreditation and Approval of Inspectorate America Corporation, as a Commercial Gauger and...

    Science.gov (United States)

    2010-11-19

    ... to 19 CFR 151.12 and 19 CFR 151.13, Inspectorate America Corporation, 2 Williams Street, Chelsea, MA 02150, has been approved to gauge and accredited to test petroleum and petroleum products for customs... conduct the specific test or gauger service requested. Alternatively, inquires regarding the specific test...

  18. Are behaviors at one alternative in concurrent schedules independent of contingencies at the other alternative?

    Science.gov (United States)

    MacDonall, James S

    2017-09-01

    Some have reported changing the schedule at one alternative of a concurrent schedule changed responding at the other alternative (Catania, 1969), which seems odd because no contingencies were changed there. When concurrent schedules are programmed using two schedules, one associated with each alternative that operate continuously, changing the schedule at one alternative also changes the switch schedule at the other alternative. Thus, changes in responding at the constant alternative could be due to the change in the switch schedule. To assess this possibility, six rats were exposed to a series of conditions that alternated between pairs of interval schedules at both alternatives and a pair of interval schedules at one, constant, alternative and a pair of extinction schedules at the other alternative. Comparing run lengths, visit durations and response rates at the constant alternative in the alternating conditions did not show consistent increases and decreases when a strict criterion for changes was used. Using a less stringent definition (any change in mean values) showed changes. The stay/switch analysis suggests it may be inaccurate to apply behavioral contrast to procedures that change from concurrent variable-interval variable-interval schedules to concurrent variable-interval extinction schedules because the contingencies in neither alternative are constant. © 2017 Society for the Experimental Analysis of Behavior.

  19. 14 CFR 17.35 - Selection of neutrals for the alternative dispute resolution process.

    Science.gov (United States)

    2010-01-01

    ... dispute resolution process. 17.35 Section 17.35 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURAL RULES PROCEDURES FOR PROTESTS AND CONTRACTS DISPUTES Alternative Dispute Resolution § 17.35 Selection of neutrals for the alternative dispute resolution process. (a) In...

  20. Quality assurance procedure for an industrial radiography linear accelerator

    International Nuclear Information System (INIS)

    Vishwakarma, R.R.; Kannan, R.; Yadav, R.K.

    2001-01-01

    Any radiation generating equipment can be marketed and used in India, only after obtaining specific type approval from the Competent Authority i.e. Chairman, Atomic Energy Regulatory Board (AERB). Generally linear accelerators are allowed to be used in the country based on the type approval issued by the regulatory authority of the country of its origin. So type approval of imported linear accelerators do not involve many parameters to be tested in our country. However for an indigenous accelerator, test procedures are to be defined and the same are to be followed during type approval process. No such protocol is available for linear accelerators used in industrial radiography. Recently some Indian manufacturers have started manufacturing and supplying such accelerators. A need for developing an indigenous protocol for type approval/NOC of such accelerators has arisen and the same has been developed. Various requirements for such protocol are discussed in this paper. Measurements have been performed on one of the 4 MV indigenous unit. Results of such measurements are also presented. Need for a regular periodic quality assurance program is necessary for imported as well as indigenous accelerators. A program for such quality assurance is also listed in the paper. (author)

  1. 48 CFR 33.214 - Alternative dispute resolution (ADR).

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Alternative dispute... GENERAL CONTRACTING REQUIREMENTS PROTESTS, DISPUTES, AND APPEALS Disputes and Appeals 33.214 Alternative dispute resolution (ADR). (a) The objective of using ADR procedures is to increase the opportunity for...

  2. Ethics approval: responsibilities of journal editors, authors and research ethics committees.

    Science.gov (United States)

    Bain, Luchuo Engelbert

    2017-01-01

    Meaningful progress of medicine depends on research that must ultimately involve human subjects. Obtaining ethical approval therefore, especially in medical sciences, should be a moral reflex for researchers. This unfortunately is not the case, with numerous researchers bypassing the ethics approval procedure, or simply unaware of its importance. Good research involves risks taken by research participants and uses tax payers' money in the process. These mandates the research endeavor to aim at attaining the highest degree of respect for the sacrifices made by others for science. Most researchers mistake scientific clearance or approval, for ethics approval. For a study to be ethical sound, it must be scientifically sound. This is only one of the activities carried out during protocol review. It is not uncommon for sensitive ethical concerns, especially in the social sciences to be overlooked and considered not to be accompanied by any serious risks for the research participants.The researcher has the responsibility of systematically consulting the competent ethics committee for advice and consequent approvals or ethical waivers. Journal editors and reviewers have the duty to systematically evaluate the ethical soundness of manuscripts submitted for review. Capacity building in research ethics and institutional support for Research Ethics Committees to speed up protocol review could reduce the incentive of carrying out research in human subjects without ethics approvals. It is hypocritical and idle to continue to expect optimal reviews on time and of good quality, from ethics committees functioning purely on altruistic grounds. Capacity building for researchers in research ethics, and institutional reforms and support for Research Ethics Committees appear not to have received the attention they truly deserve.

  3. Alternative procedures for reducing allogeneic blood transfusion in elective orthopedic surgery.

    Science.gov (United States)

    Kleinert, Kathrin; Theusinger, Oliver M; Nuernberg, Johannes; Werner, Clément M L

    2010-09-01

    Perioperative blood loss is a major problem in elective orthopedic surgery. Allogeneic transfusion is the standard treatment for perioperative blood loss resulting in low postoperative hemoglobin, but it has a number of well-recognized risks, complications, and costs. Alternatives to allogeneic blood transfusion include preoperative autologous donation and intraoperative salvage with postoperative autotransfusion. Orthopedic surgeons are often unaware of the different pre- and intraoperative possibilities of reducing blood loss and leave the management of coagulation and use of blood products completely to the anesthesiologists. The goal of this review is to compare alternatives to allogeneic blood transfusion from an orthopedic and anesthesia point of view focusing on estimated costs and acceptance by both parties.

  4. Meta-analysis of the technical performance of an imaging procedure: guidelines and statistical methodology.

    Science.gov (United States)

    Huang, Erich P; Wang, Xiao-Feng; Choudhury, Kingshuk Roy; McShane, Lisa M; Gönen, Mithat; Ye, Jingjing; Buckler, Andrew J; Kinahan, Paul E; Reeves, Anthony P; Jackson, Edward F; Guimaraes, Alexander R; Zahlmann, Gudrun

    2015-02-01

    Medical imaging serves many roles in patient care and the drug approval process, including assessing treatment response and guiding treatment decisions. These roles often involve a quantitative imaging biomarker, an objectively measured characteristic of the underlying anatomic structure or biochemical process derived from medical images. Before a quantitative imaging biomarker is accepted for use in such roles, the imaging procedure to acquire it must undergo evaluation of its technical performance, which entails assessment of performance metrics such as repeatability and reproducibility of the quantitative imaging biomarker. Ideally, this evaluation will involve quantitative summaries of results from multiple studies to overcome limitations due to the typically small sample sizes of technical performance studies and/or to include a broader range of clinical settings and patient populations. This paper is a review of meta-analysis procedures for such an evaluation, including identification of suitable studies, statistical methodology to evaluate and summarize the performance metrics, and complete and transparent reporting of the results. This review addresses challenges typical of meta-analyses of technical performance, particularly small study sizes, which often causes violations of assumptions underlying standard meta-analysis techniques. Alternative approaches to address these difficulties are also presented; simulation studies indicate that they outperform standard techniques when some studies are small. The meta-analysis procedures presented are also applied to actual [18F]-fluorodeoxyglucose positron emission tomography (FDG-PET) test-retest repeatability data for illustrative purposes. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  5. 13 CFR 127.304 - How does a concern obtain certification from an approved certifier?

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false How does a concern obtain certification from an approved certifier? 127.304 Section 127.304 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION WOMEN-OWNED SMALL BUSINESS FEDERAL CONTRACT ASSISTANCE PROCEDURES Certification of EDWOSB or WOSB...

  6. 77 FR 75243 - Self-Regulatory Organizations; Options Clearing Corporation; Order Approving Proposed Rule Change...

    Science.gov (United States)

    2012-12-19

    ... modeling and risk management procedures (``Risk Management Proposal'') \\9\\ is approved by the Commission... risk modeling enhancements with respect to longer-tenor options, including OTC S&P 500 Index Options... http://www.sec.gov/rules/petitions/2012/petn4-644.pdf . This Order does not address the relief...

  7. An approved personal dosimetry service based on an electronic dosimeter

    International Nuclear Information System (INIS)

    Marshall, T.O.; Bartlett, D.T.; Burgess, P.H.; Campbell, J.I.; Hill, C.E.; Pook, E.A.; Sandford, D.J.

    1991-01-01

    At the Second Conference on Radiation Protection and Dosimetry a paper was presented which, in part, announced the development of an electronic dosimeter to be undertaken in the UK by the National Radiological Protection Board (NRPB) and Siemens Plessey Controls Ltd. This dosimeter was to be of a standard suitable for use as the basis of an approved personal dosimetry service for photon and beta radiations. The project has progressed extremely well and dosimeters and readers are about to become commercially available. The system and the specification of the dosimeter are presented. The NRPB is in the process of applying for approval by the Health and Safety Executive (HSE) to operate as personal monitoring service based on this dosimeter. As part of the approval procedure the dosimeter is being type tested and is also undergoing an HSE performance test and wearer trials. The tests and the wearer trials are described and a summary of the results to date presented. The way in which the service will be organized and operated is described and a comparison is made between the running of the service and others based on passive dosimeters at NRPB

  8. Legal questions concerning the licensing procedure of nuclear power plants

    International Nuclear Information System (INIS)

    Boerner, B.

    1978-01-01

    The publication contains 4 articles which deal with legal practice and problems of the licensing procedure in the Federal Republic of Germany: 1) Actions brought by joint boards from the constitutional point of view (Burmeister, J.); 2) court review of the assessment of technical and economic questions concerning the licensing of power plant construction (Ossenbuehl, F.); 3) the site plan approval procedure as a legal problem (Friauf, K.H.); 4) legal questions concerning the immediate enforceability (Papier, H.J.). (HP) [de

  9. Unproven diagnostic procedures in IgE-mediated allergic diseases.

    Science.gov (United States)

    Niggemann, B; Grüber, C

    2004-08-01

    A considerable body of literature on therapeutic aspects of complementary and alternative medicine has been published in recent years, but little is known on diagnostic procedures. This short review lists complementary and alternative diagnostic procedures for the diagnosis of allergic diseases and presents an assessment of their usefulness for the daily practice. The review of the literature revealed that neither the determination of specific immunoglobulin G-antibodies in serum, the hair-analysis, the cytotoxic test, kinesiology, iridology, or electrodermal testing represent useful tests for the daily practice. To date, no complementary or alternative diagnostic procedure can be recommended as a meaningful element in the diagnostic work-up of allergic diseases. This is especially true for food allergy: properly performed oral food challenges still represent the gold standard for implementing specific diets in food allergic individuals. Ineffective diagnostic approaches may be costly for the consumer and delay appropriate therapy.

  10. IRS/TUEV activities during the licensing procedure. Safety assessment and preexamination

    International Nuclear Information System (INIS)

    Fendler, H.

    1976-01-01

    Short summary about the IRS/TUEV activities in the licensing procedure for a nuclear power plant: work for assessments, for pre-examination and approval specifications and drawings and for the quality control, time and the manpower necessary for this work. (orig./HP) [de

  11. Weighted overlap dominance – a procedure for interactive selection on multidimensional interval data

    DEFF Research Database (Denmark)

    Hougaard, Jens Leth; Nielsen, Kurt

    2011-01-01

    We present an outranking procedure that supports selection of alternatives represented by multiple attributes with interval valued data. The procedure is interactive in the sense that the decision maker directs the search for preferred alternatives by providing weights of the different attributes...

  12. 76 FR 38992 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Update to Materials...

    Science.gov (United States)

    2011-07-05

    ... for Pennsylvania. Since the publication of the last IBR update, EPA has approved the following... revision'' and ``Applicable geographic area'' columns for the entry ``Continuous Source Testing Manual.'' 2... section 553(b)(3)(B) of the Administrative Procedures Act (APA) which, upon finding ``good cause...

  13. Approved requirements for the packaging, labelling and carriage of radioactive material by rail

    International Nuclear Information System (INIS)

    1996-01-01

    This document specifies the detailed provisions in the United Kingdom with respect to rail transport for packages and packaging, test procedures for radioactive materials, information concerning the preparation of radioactive materials and the operation of tanks and container wagons. The Approved Requirements came into force on 1 September 1996 and are legally binding. (UK)

  14. Pharmacotherapy of alcoholism - an update on approved and off-label medications.

    Science.gov (United States)

    Soyka, Michael; Müller, Christian A

    2017-08-01

    Only a few medications are available for the treatment of alcohol use disorders (AUDs). Areas covered: This paper discusses approved AUD medications, including the opioid antagonists naltrexone and nalmefene (the latter is licensed for reduction of alcohol consumption only), the putative glutamate receptor antagonist acamprosate and the aldehyde dehydrogenase inhibitor disulfiram. It also covers off-label medications of interest, including topiramate, gabapentin, ondansetron, varenicline, baclofen, sodium oxybate and antidepressants. Clinical implications, benefits and risks of treatment are discussed. Expert opinion: Acamprosate, naltrexone, nalmefene and disulfiram are the only approved 'alcohol-specific' drugs. Acamprosate and naltrexone have been evaluated in numerous clinical trials and represent evidence-based treatments in AUDs. Nalmefene use, however, is controversial. Supervised disulfiram is a second-line treatment approach. Compounds developed and licensed for different neuropsychiatric disorders are potential alternatives. Encouraging results have been reported for topiramate, gabapentin and also varenicline, which might be useful in patients with comorbid nicotine dependence. The GABA (γ-aminobutyric acid)-B receptor agonist baclofen has shown mixed results; it is currently licensed for the treatment of AUDs in France only. Gabapentin may be close to approval in the USA. Further studies of these novel treatment approaches in AUDs are needed.

  15. Cruas site: inception of 'large jobsite' procedure

    International Nuclear Information System (INIS)

    Bottini, R.

    1980-01-01

    In France, the construction sites of nuclear plants are governed by a series of government decisions approved in July 1975 relating to so-called 'large jobsites of territorial improvements'. Using as an example the 'large jobsite' of the Cruas plant, now under construction, the author illustrates the practical application of the considered procedure, amongst others from the standpoints of organization measures and the quality of the living conditions of workers [fr

  16. An alternative method for noise analysis using pixel variance as part of quality control procedures on digital mammography systems

    International Nuclear Information System (INIS)

    Bouwman, R; Broeders, M; Van Engen, R; Young, K; Lazzari, B; Ravaglia, V

    2009-01-01

    According to the European Guidelines for quality assured breast cancer screening and diagnosis, noise analysis is one of the measurements that needs to be performed as part of quality control procedures on digital mammography systems. However, the method recommended in the European Guidelines does not discriminate sufficiently between systems with and without additional noise besides quantum noise. This paper attempts to give an alternative and relatively simple method for noise analysis which can divide noise into electronic noise, structured noise and quantum noise. Quantum noise needs to be the dominant noise source in clinical images for optimal performance of a digital mammography system, and therefore the amount of electronic and structured noise should be minimal. For several digital mammography systems, the noise was separated into components based on the measured pixel value, standard deviation (SD) of the image and the detector entrance dose. The results showed that differences between systems exist. Our findings confirm that the proposed method is able to discriminate systems based on their noise performance and is able to detect possible quality problems. Therefore, we suggest to replace the current method for noise analysis as described in the European Guidelines by the alternative method described in this paper.

  17. Development of Irradiation Procedure for Gamma Irradiation Chamber Bio beam GM 8000

    International Nuclear Information System (INIS)

    Shuhaimi Shamsudin; Affrida Abu Hassan; Zaiton Ahmad; Abdul Rahim Harun; Ahmad Zainuri Mohd Dzomir

    2015-01-01

    Bio Beam GM 8000 gamma irradiation chamber obtained a conditional approval to operate on March 27, 2012, and later acquired a full approval on December 13, 2012. The objective for the procurement of this gamma chamber is to develop an acute irradiation facility for biological samples, including plants tissues, insects, pupae, microorganisms, as well as animal and human cells. To ensure a smooth and efficient operation, irradiation procedures were developed and improved over time. This paper discusses the operation and management of the Bio Beam GM 8000 facility, including irradiation procedures and sample preparation, application for services through online e-client system, consultancy, quality assurance and information dissemination to internal as well as external clients. In addition, this paper also discusses the potential, constraints and improvement measures taken to optimize the use of this facility in order to meet its objectives. (author)

  18. A comparative assessment of alternative waste management procedures for selected reprocessing wastes

    International Nuclear Information System (INIS)

    Hickford, G.E.; Plews, M.J.

    1983-07-01

    This report, which has been prepared by Associated Nuclear Services for the Department of the Environment, presents the results of a study and comparative assessment of management procedures for low and intermediate level solid waste streams arising from current and future fuel reprocessing operations on the Sellafield site. The characteristics and origins of the wastes under study are discussed and a reference waste inventory is presented, based on published information. Waste management strategy in the UK and its implications for waste conditioning, packaging and disposal are discussed. Wastes currently arising which are not suitable for Drigg burial or sea dumping are stored in an untreated form. Work is in hand to provide additional and improved disposal facilities which will accommodate all the waste streams under study. For each waste stream viable procedures are identified for further assessment. The procedures comprise a series of on-site operations-recovery from storage, pre-treatment, treatment, encapsulation, and packaging, prior to storage or disposal of the conditioned waste form. Assessments and comparisons of each procedure for each waste are presented. These address various process, operational, economic, radiological and general safety factors. The results are presented in a series of tables with supporting text. For the majority of wastes direct encapsulation with minimal treatment appears to be a viable procedure. Occupational exposure and general safety are not identified as significant factors governing the choice of procedures. The conditioned wastes meet the general requirements for safe handling during storage and transportation. The less active wastes suitable for disposal by currently available routes meet the appropriate disposal criteria. It is not possible to consider in detail the suitability for disposal of the more active wastes for which disposal facilities are not yet available. (Author)

  19. 78 FR 16783 - Approval and Promulgation of Implementation Plans; Georgia; Control Techniques Guidelines and...

    Science.gov (United States)

    2013-03-19

    ... Administrative Procedure Act (APA) which, upon finding ``good cause,'' authorizes agencies to dispense with... action addressing approval of the Georgia RACT rules. EPA also finds that there is good cause under APA.... Section 553(d)(3) of the APA allows an effective date less than 30 days after publication ``as otherwise...

  20. 77 FR 52096 - Self-Regulatory Organizations; EDGX Exchange, Inc.; Order Approving a Proposed Rule Change, as...

    Science.gov (United States)

    2012-08-28

    ...'s rules, the financial and regulatory risk management controls and supervisory procedures required...-Regulatory Organizations; EDGX Exchange, Inc.; Order Approving a Proposed Rule Change, as Modified by... that broker-dealers appropriately control the risks associated with market access, so as not to...

  1. Alternatives to the sequential lineup: the importance of controlling the pictures.

    Science.gov (United States)

    Lindsay, R C; Bellinger, K

    1999-06-01

    Because sequential lineups reduce false-positive choices, their use has been recommended (R. C. L. Lindsay, 1999; R. C. L. Lindsay & G. L. Wells, 1985). Blind testing is included in the recommended procedures. Police, concerned about blind testing, devised alternative procedures, including self-administered sequential lineups, to reduce use of relative judgments (G. L. Wells, 1984) while permitting the investigating officer to conduct the procedure. Identification data from undergraduates exposed to a staged crime (N = 165) demonstrated that 4 alternative identification procedures tested were less effective than the original sequential lineup. Allowing witnesses to control the photographs resulted in higher rates of false-positive identification. Self-reports of using relative judgments were shown to be postdictive of decision accuracy.

  2. Energy efficiency procedures for agricultural machinery used in onion cultivation (Allium fistulosum) as an alternative to reduce carbon emissions under the clean development mechanism at Aquitania (Colombia)

    Science.gov (United States)

    Ochoa, K.; Carrillo, S.; Gutierrez, L.

    2014-06-01

    Climate change has both causes and consequences over agriculture. This paper focuses on the first element and presents scenarios for ASOLAGO -an onion cropper's association in Colombia with 250 members- to reduce their carbon footprint. It evaluates a case study at "La Primavera" farm using a methodology approved by the United Nations Framework Convention on Climate Change. Land preparation and crop irrigation were analyzed as stages in order to propose energy efficiency alternatives for both the farm and the association. They include field efficiency, fuel economy and energy efficiency from biofuels for the first stage as well as solar and wind energy supply for the second. A cost-benefit analysis to generate additional income selling additional power produced by the system to the National Grid was done.

  3. Redfield Energy Approval

    Science.gov (United States)

    This September 19, 2016 letter from EPA approves the petition from Poet Biorefining-Lake Crystal, regarding non-This October 27, 2016 letter from EPA approves the petition from Redfield Energy, LLC, regarding non-grandfathered ethanol produced

  4. Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications.

    Science.gov (United States)

    DiMasi, Joseph A

    2013-06-01

    Much of the literature on trends and factors affecting biopharmaceutical innovation has focused overwhelmingly on the development and approval of never-before approved drugs and biologics. Little attention has been paid to new uses for already-approved compounds, which can be an important form of innovation. This paper aimed to determine and analyze recent trends in the number and type of new or modified US indication approvals for drugs and biologics. We also examine regulatory approval-phase times for new-use efficacy supplements and compare them to approval-phase times for original-use approvals over the same period. We developed a data set of efficacy supplements approved by the US Food and Drug Administration (FDA) from 1998 to 2011 that includes information on the type, approval-phase time (time from submission to the FDA of an application for marketing approval to approval of the application), and FDA therapeutic-significance rating for the approved application, which we obtained from an FDA Web site. This data set was merged with a Tufts Center for the Study of Drug Development (CSDD) data set of US new drug and biologics approvals. We developed descriptive statistics on trends in the number and type of new-use efficacy supplements, on US regulatory approval-phase times for the supplements, and on original new drug and biologics approvals over the study period and for the time from original- to new-use approval. The total number of new-use efficacy-supplement approvals did not exhibit a marked trend, but the number of new pediatric-indication approvals increased substantially. Approval-phase times for new-use supplements varied by therapeutic class and FDA therapeutic-significance rating. Mean approval-phase times were highest for central nervous system compounds (13.8 months) and lowest for antineoplastics (8.9 months). The mean time from original to supplement approval was substantially longer for new pediatric indications than for other new uses. Mean

  5. 75 FR 47817 - Notice of Availability: Test Tools and Test Procedures Approved for the Office of the National...

    Science.gov (United States)

    2010-08-09

    ..., Implementation Specifications, and Certification Criteria for Electronic Health Record Technology'' (HIT... Approved for the Office of the National Coordinator for Health Information Technology (ONC) Temporary Certification Program AGENCY: Office of the National Coordinator for Health Information Technology, Office of...

  6. Port exteriorization appendectomy in children: An alternative to the ...

    African Journals Online (AJOL)

    Introduction Laparoscopic appendectomy is usually performed using an intracorporeal approach. The conventional procedure uses three ports. The port exteriorization appendectomy uses two trocars to perform the entire procedure and can be considered an efficient alternative to the conventional approach, especially in ...

  7. 78 FR 46516 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Update to Materials...

    Science.gov (United States)

    2013-08-01

    ... for incorporating by reference Federally- approved SIPs, as a result of consultations between EPA and... and ``Identification of plan'' format are discussed in further detail in the May 22, 1997 Federal... ``good cause'' exemption in section 553(b)(3)(B) of the Administrative Procedures Act (APA) which, upon...

  8. 78 FR 58465 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Update to Materials...

    Science.gov (United States)

    2013-09-24

    ... for incorporating by reference Federally- approved SIPs, as a result of consultations between EPA and... and ``Identification of plan'' format are discussed in further detail in the May 22, 1997 Federal... the ``good cause'' exemption in section 553(b)(3)(B) of the Administrative Procedures Act (APA) which...

  9. Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015.

    Science.gov (United States)

    Ghobadi, Comeron W; Hayman, Emily L; Finkle, Joshua H; Walter, Jessica R; Xu, Shuai

    2017-01-01

    The aim of this study was to critically assess the clinical evidence leading to radiologic medical device approvals via the premarket approval pathway from 2000 to 2015. This study used the publically available FDA premarket database for radiologic device approvals over the past 15 years (September 1, 2000, to August 31, 2015). Approval characteristics were collected for each device, and statistical analysis was performed on the data for each pivotal trial. Additionally, methodological quality of the pivotal trial was determined using the Quality Assessment of Diagnostic Accuracy Studies tool. Twenty-three class III radiologic device approvals were identified, with breast imaging accounting for 16 (70%) and computer-aided detection software accounting for 9 (39%) approvals. The median premarket approval time was 475 days (range, 180-1,116). Twenty-one devices were approved on the basis of multireader, multicenter studies, one on the basis of a randomized controlled trial, and one on the basis of a preclinical technical equivalence trial. The median number of patients per pivotal trial was 201 (range, 25-3,946). Twenty-six of the 34 pivotal trials (76%) had at least one methodologic bias. Breast imaging devices had a greater number of patients per pivotal trial (P = .009) and more prospective studies. With regard to all modalities, increased time to device approval correlated with weaker trial quality (r = 0.600, P assessing diagnostic technologies. Given that radiologic devices play a key role in modern medicine, further efforts should be made to increase transparency of clinical data leading to approval. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  10. Alternatives to animal experimentation in basic research.

    Science.gov (United States)

    Gruber, Franz P; Hartung, Thomas

    2004-01-01

    In contrast to animal testing required by law to guarantee minimum safety standards for the licensing of drugs and chemicals, there are no regulations in basic research forcing scientists to perform animal tests. By (usually) free choice, questions are posed and hypotheses are examined which, in many cases, can only be answered by means of animal tests. Just as easily, different questions could be asked or different hypotheses could be examined which do not require animal tests. The only criterion for the choice of a topic is its relevance which cannot necessarily be judged in the short-term. Thus, it is up to the individual scientist to judge what is worth studying and therefore worth animal consumption. The educated mind will consider ethical aspects of this choice. However, on the other hand, this decision is largely influenced by questions of efficacy or (in a negative sense) by the obstacles posed to an animal consuming approach. Here, peer review and general attitude will strongly influence the methodology chosen. Availability and awareness of adequate in vitro techniques represent the prerequisites for the use of alternative methods. The least one can do in basic research is to avoid tests which cause severe suffering to animals, as is required in Switzerland and other European countries by binding ethical principles and guidelines. The increasing standard of approval and control procedures has improved the situation over the years. There are many examples of successful alternative methods in basic research. But, the application of such methods is in most cases limited to the laboratories in which they were developed, calling for technology transfer. Exceptions are procedures that are used worldwide, like the production of monoclonal antibodies, which instead of using the ascites mouse can also be performed in vitro with some good will. In these cases, commercialisation of the techniques has aided their spread within the scientific community. Sadly, many

  11. "Les Grangettes" no longer approved hospital as of 1.1.2012

    CERN Multimedia

    HR Department

    2012-01-01

    The negotiations for a new tariff agreement with "Les Grangettes", conducted jointly by CERN and partner international organizations, did not reach a positive conclusion. As a result, "Les Grangettes" ceased being an approved hospital on 31 December 2011.   This means that for hospitalizations in "Les Grangettes" as of 1 January 2012 the conditions applicable to unapproved hospitals will apply. In particular: no third-party payment (i.e. you will be charged directly); reimbursement at a fixed 80% rate, whatever the expenses incurred; and expenses incurred will not contribute towards increasing FCA. CHIS members looking for an alternative are invited to consider “Clinique Générale Beaulieu” (located in the same area of Geneva and with which the existing agreement has been extended for 2012 and 2013) or another approved hospital (see the list on the CHIS web site). Note that, as a transitory measur...

  12. 30 CFR 18.95 - Approval of machines constructed of components approved, accepted or certified under Bureau of...

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approval of machines constructed of components... APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.95 Approval of machines constructed of components approved...

  13. Hybrid NOTES transvaginal intraperitoneal onlay mesh in abdominal wall hernias: an alternative to traditional laparoscopic procedures.

    Science.gov (United States)

    Descloux, Alexandre; Pohle, Sebastian; Nocito, Antonio; Keerl, Andreas

    2015-12-01

    Abdominal wall hernias are increasingly treated by laparoscopic placement of an intraperitoneal onlay mesh (IPOM). We present an alternative technique for women: the laparoscopic-assisted transvaginal IPOM. Before surgery, all patients underwent a gynecological examination. The patients agreed to IPOM repair via a transvaginal approach, and written informed consent for surgery was obtained. Pneumoperitoneum was established with a Veress needle at the umbilicus. This access was subsequently dilated to 5 mm (VersaStep), and a 5-mm laparoscope was inserted. Under laparoscopic view, the transvaginal trocars (12-mm VersaStep and 5-mm flexible accesses) were safely inserted after lifting the uterus with a uterus manipulator. After preparation of the falciform ligament, the ligamentum teres and the preperitoneal fat, a lightweight composite mesh was introduced through the transvaginal access and fixed with absorbable tacks using the double-crown technique. From September 2011 to December 2012, we performed six laparoscopic-assisted transvaginal IPOM procedures (one epigastric, three umbilical, two combined epigastric and umbilical hernias; all were primary hernias). In the initial phase, only patients with small or medium primary abdominal wall hernia were selected (max. 3 cm diameter). Median hospital stay was 3 days (range 2-6 days). One minor complication occurred perioperatively (second-degree skin burn to the labia majora). At 1-year follow-up, we identified one recurrence in a high-risk patient with a body mass index higher than 35 kg/m(2). No infection and no mortality were observed. Although no final conclusion can be made regarding the presumed non-inferiority of this technique in terms of recurrence and mesh infection compared with traditional laparoscopic IPOM, laparoscopic-assisted transvaginal IPOM is a feasible alternative to treat abdominal wall hernias.

  14. 14 CFR 121.633 - Considering time-limited systems in planning ETOPS alternates.

    Science.gov (United States)

    2010-01-01

    ... dispatch or flight release if the time needed to fly to that airport (at the approved one-engine... airplane's most limiting ETOPS Significant System (including the airplane's most limiting fire suppression... Alternate Airport in a dispatch or flight release if the time needed to fly to that airport: (1) at the all...

  15. 77 FR 64343 - Notice of Availability: Test Tools and Test Procedures Approved for the Office of the National...

    Science.gov (United States)

    2012-10-19

    ... Approved for the Office of the National Coordinator for Health Information Technology (ONC) HIT Certification Program AGENCY: Office of the National Coordinator for Health Information Technology, Office of... performing the testing of EHR technology under the ONC HIT Certification Program, particularly when the...

  16. Perioperative antibiotics for surgical site infection in pancreaticoduodenectomy: does the SCIP-approved regimen provide adequate coverage?

    Science.gov (United States)

    Donald, Graham W; Sunjaya, Dharma; Lu, Xuyang; Chen, Formosa; Clerkin, Barbara; Eibl, Guido; Li, Gang; Tomlinson, James S; Donahue, Timothy R; Reber, Howard A; Hines, Oscar J

    2013-08-01

    The Joint Commission Surgical Care Improvement Project (SCIP) includes performance measures aimed at reducing surgical site infections (SSI). One measure defines approved perioperative antibiotics for general operative procedures. However, there may be a subset of procedures not adequately covered with the use of approved antibiotics. We hypothesized that piperacillin-tazobactam is a more appropriate perioperative antibiotic for pancreaticoduodenectomy (PD). In collaboration with hospital epidemiology and the Division of Infectious Diseases, we retrospectively reviewed records of 34 patients undergoing PD between March and May 2008 who received SCIP-approved perioperative antibiotics and calculated the SSI rate. After changing our perioperative antibiotic to piperacillin-tazobactam, we prospectively reviewed PDs performed between June 2008 and March 2009 and compared the SSI rates before and after the change. For 34 patients from March through May 2008, the SSI rate for PD was 32.4 per 100 cases. Common organisms from wound cultures were Enterobacter and Enterococcus (50.0% and 41.7%, respectively), and these were cefoxitin resistant. From June 2008 through March 2009, 106 PDs were performed. During this period, the SSI rate was 6.6 per 100 surgeries, 80% lower than during March through May 2008 (relative risk, 0.204; 95% confidence interval [CI], 0.086-0.485; P = .0004). Use of piperacillin-tazobactam as a perioperative antibiotic in PD may reduce SSI compared with the use of SCIP-approved antibiotics. Continued evaluation of SCIP performance measures in relationship to patient outcomes is integral to sustained quality improvement. Copyright © 2013 Mosby, Inc. All rights reserved.

  17. Cost effectiveness methodology for evaluating Korean international communication system alternatives.

    OpenAIRE

    Hwang, Tae Kyun.

    1987-01-01

    Approved for public release; distribution in unlimited. Cost and Effectiveness models are developed by using of cost-effectiveness technique for fiber optic cable and satellite communication media. The models are applied to the Korean international communication problem. Alternative selection is required since the two medias different in cost and effectiveness. The major difficulties encountered were data gathering and measuring the effectiveness of the Korean international ...

  18. 77 FR 52097 - Self-Regulatory Organizations; EDGA Exchange, Inc.; Order Approving a Proposed Rule Change, as...

    Science.gov (United States)

    2012-08-28

    ... financial and regulatory risk management controls and supervisory procedures required by Rule 15c3-5 under...-Regulatory Organizations; EDGA Exchange, Inc.; Order Approving a Proposed Rule Change, as Modified by... that broker-dealers appropriately control the risks associated with market access, so as not to...

  19. 76 FR 4968 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change...

    Science.gov (United States)

    2011-01-27

    ...-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change Relating to Listing and Trading Shares of the AdvisorShares Active Bear ETF January 19, 2011. I. Introduction On... of the security or investment in the portfolio. \\14\\ Under accounting procedures followed by the Fund...

  20. Splash Safety During Dermatologic Procedures Among US Dermatology Residents.

    Science.gov (United States)

    Korta, Dorota Z; Chapman, Lance W; Lee, Patrick K; Linden, Kenneth G

    2017-07-01

    Dermatologists are at potential risk of acquiring infections from contamination of the mucous membranes by blood and body fluids. However, there are little data on splash safety during procedural dermatology. To determine dermatology resident perceptions about splash risk during dermatologic procedures and to quantify the rate of protective equipment use. An anonymous on-line survey was sent to 108 United States ACGME-approved dermatology residency programs assessing frequency of facial protection during dermatologic procedures, personal history of splash injury, and, if applicable, reasons for not always wearing facial protection. A total of 153 dermatology residents responded. Rates of facial protection varied by procedure, with the highest rates during surgery and the lowest during local anesthetic injection. Over 54% of respondents reported suffering facial splash while not wearing facial protection during a procedure. In contrast, 88.9% of respondents correctly answered that there is a small risk of acquiring infection from mucosal splash. Residency program recommendations for facial protection seem to vary by procedure. The authors' results demonstrate that although facial splash is a common injury, facial protection rates and protective recommendations vary significantly by procedure. These data support the recommendation for enhanced facial protection guidelines during procedural dermatology.

  1. Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka

    Directory of Open Access Journals (Sweden)

    Siriwardhana Chesmal

    2008-02-01

    Full Text Available Abstract Background International guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri Lanka. Methods We obtained ERC approval in Sri Lanka and the United Kingdom. Theses from 1985 to 2005 available at the Postgraduate Institute of Medicine (PGIM library affiliated to the University of Colombo were scrutinised using checklists agreed in consultation with senior research collaborators. A Medline search was carried out with MeSH major and minor heading 'Sri Lanka' as the search term for international publications originating in Sri Lanka during 1999 to 2004. All research publications from CMJ during 1999 to 2005 were also scrutinized. Results Of 291 theses, 34% documented ERC approvals and 61% documented obtaining consent. From the international journal survey, 250 publications originated from Sri Lanka of which only 79 full text original research publications could be accessed electronically. Of these 38% documented ERC approval and 39% documented obtaining consent. In the Ceylon Medical Journal 36% documented ERC approval and 37% documented obtaining consent. Conclusion Only one third of the publications scrutinized recorded ERC approval and procurement of informed consent. However, there is a positive trend in documenting these ethical requirements in local postgraduate research and in the local medical journal.

  2. Drugs Approved for Breast Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Breast Cancer This page lists cancer drugs approved by the ... are not listed here. Drugs Approved to Prevent Breast Cancer Evista (Raloxifene Hydrochloride) Raloxifene Hydrochloride Tamoxifen Citrate Drugs ...

  3. Procedural Skills Education – Colonoscopy as a Model

    Directory of Open Access Journals (Sweden)

    Maitreyi Raman

    2008-01-01

    Full Text Available Traditionally, surgical and procedural apprenticeship has been an assumed activity of students, without a formal educational context. With increasing barriers to patient and operating room access such as shorter work week hours for residents, and operating room and endoscopy time at a premium, alternate strategies to maximizing procedural skill development are being considered. Recently, the traditional surgical apprenticeship model has been challenged, with greater emphasis on the need for surgical and procedural skills training to be more transparent and for alternatives to patient-based training to be considered. Colonoscopy performance is a complex psychomotor skill requiring practioners to integrate multiple sensory inputs, and involves higher cortical centres for optimal performance. Colonoscopy skills involve mastery in the cognitive, technical and process domains. In the present review, we propose a model for teaching colonoscopy to the novice trainee based on educational theory.

  4. The procedure of statutory approval including EIA for the Warndt/Luisenthal colliery; Das bergrechtliche Zulassungsverfahren mit UVP fuer das Bergwerk Warndt/Luisenthal

    Energy Technology Data Exchange (ETDEWEB)

    Matthes, U.; Wenk, N. [Prognos AG, Basel (Switzerland)

    2002-07-01

    The amendment of the Federal Mining Act (BBergG 1990) provides, concerning special mining projects, a procedure of the official approval of a plan including public participation and Environmental Impact Assessment (EIA). To fit the claim of checking all possible environmental impacts of the projects, the BBergG demands on level of the framework operating plan, that the EIA has to be more extensive and detailed, compared to former (framework operating) plans of mining projects. This commentary sets out these new professional requirements by example of a mining project with high impact on housing estate (in that on humans, cultural goods and real assets). The way, how the planning procedure was handled and the EIA, focussed on social indicators, has been carried out, contributed to a de-emotionalized dialog with the affected people. By this means solutions were found to reduce negative mining impacts. (orig.) [German] Seit der Novelle des Bundesberggesetzes (BBergG) im Jahre 1990 ist fuer bestimmte bergbauliche Vorhaben ein Planfeststellungsverfahren mit Oeffentlichkeitsbeteiligung und Umweltvetraeglichkeitspruefung (UVP) vorgeschrieben. Die Regelungen des BBergG verlangen bei der UVP wegen des Anspruchs, alle moeglichen Umwelteinwirkungen des Vorhabens bereits auf der Ebene des Rahmenbetriebsplanes einer umfassenden und abschliessenden Betrachtung zu unterziehen, eine gegenueber Rahmenbetriebsplaenen herkoemmlicher Art betraechtliche Untersuchungs- und Prueftiefe. Am Beispiel eines beantragten Abbauvorhabens, das grossflaechig besiedeltes Gebiet beruehrt, wird die Vorgehensweise dargestellt. Besonderes Schwergewicht lag, dem Vorhaben entsprechend, auf den bergbaulichen Auswirkungen auf die UVP-Schutzgueter 'Mensch' sowie 'Kultur- und sonstige Sachgueter'. Die Verfahrensberatung sowie die strukturierte und sachgerechte Analyse und Aufbereitung der Umweltwirkungen haben dazu beigetragen, den Dialog mit den Betroffenen zu versachlichen und gemeinsam

  5. Securing classification and regulatory approval for deepwater projects: management challenges in a global environment

    Energy Technology Data Exchange (ETDEWEB)

    Feijo, Luiz P.; Burton, Gareth C. [American Bureau of Shipping (ABS), Rio de Janeiro, RJ (Brazil)

    2008-07-01

    As the offshore industry continues to develop and move into increasingly deeper waters, technological boundaries are being pushed to new limits. Along with these advances, the design, fabrication and installation of deepwater oil and gas projects has become an increasingly global endeavor. After providing an overview of the history and role of Classification Societies, this paper reviews the challenges of securing classification and regulatory approval in a global environment. Operational, procedural and technological changes which one Classification Society; the American Bureau of Shipping, known as ABS, has implemented to address these challenges are presented. The result of the changes has been a more customized service aiming at faster and more streamlined classification approval process. (author)

  6. 30 CFR 204.215 - Are the information collection requirements in this subpart approved by the Office of Management...

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 2 2010-07-01 2010-07-01 false Are the information collection requirements in this subpart approved by the Office of Management and Budget (OMB)? 204.215 Section 204.215 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT OF THE INTERIOR MINERALS REVENUE MANAGEMENT ALTERNATIVES...

  7. 75 FR 11988 - Notice of Request for Approval To Collect New Information: Collection of Safety Culture Data

    Science.gov (United States)

    2010-03-12

    ..., information about changes to the safety culture of the affected workplaces will be used as one of several data...: RITA-2008-0002] Notice of Request for Approval To Collect New Information: Collection of Safety Culture.... mail to Federal offices in Washington, DC, we recommend that persons consider an alternative method...

  8. Drugs Approved for Thyroid Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Thyroid Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Thyroid Cancer Cabozantinib-S-Malate Caprelsa (Vandetanib) Cometriq (Cabozantinib-S-Malate) Doxorubicin ...

  9. Energy efficiency procedures for agricultural machinery used in onion cultivation (Allium fistulosum) as an alternative to reduce carbon emissions under the clean development mechanism at Aquitania (Colombia)

    International Nuclear Information System (INIS)

    Ochoa, K; Carrillo, S; Gutierrez, L

    2014-01-01

    Climate change has both causes and consequences over agriculture. This paper focuses on the first element and presents scenarios for ASOLAGO -an onion cropper's association in Colombia with 250 members- to reduce their carbon footprint. It evaluates a case study at ''La Primavera'' farm using a methodology approved by the United Nations Framework Convention on Climate Change. Land preparation and crop irrigation were analyzed as stages in order to propose energy efficiency alternatives for both the farm and the association. They include field efficiency, fuel economy and energy efficiency from biofuels for the first stage as well as solar and wind energy supply for the second. A cost-benefit analysis to generate additional income selling additional power produced by the system to the National Grid was done

  10. Alternate Energy Report, Koleda Childress Inc., dated November 15, 1991

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1991-11-15

    Policies, programs, and current status of alternate energy and global warming concerns in the United States are reported. The House and Senate have both approved legislation to fund the Department of Energy's fossil energy program for fiscal 1992. For Department of Energy's fossil energy research and development activities, the final version provides approximately $450 million instead of the $227 million requested by President Bush in February. Of this amount, approximately $57 million is designated to fund coal gasification, coal liquefaction, and oil shale research and development. Last year Congress appropriated $459 million for fossil fuels research and development and $76 million for synthetic fuels. The Environment Ministers of the 12 European Community (EC) member states have given informal approval to a carbon tax proposal drafted last month by the European Commission, the EC's executive body. EC Energy Ministers, however, are less supportive of the approval, and express reluctance to commit EC member states to a carbon tax unless other large energy consumers also agree to limits on CO2 emissions. (NEDO)

  11. 75 FR 27647 - Approval and Promulgation of Air Quality Implementation Plans; Texas; Revisions to the Emission...

    Science.gov (United States)

    2010-05-18

    ... severable portions of two revisions to the Texas State Implementation Plan (SIP) submitted by the State of... further clarify procedures for using emission protocols and to update the approved list of emission credit... to recently recodified 30 TAC Chapter 117 provisions. EPA has determined that these SIP revisions...

  12. Report to the Congress on alternative methods for the Strategic Petroleum Reserve

    Energy Technology Data Exchange (ETDEWEB)

    1990-02-01

    The purpose of this study is to fulfill the requirements of Public Law No. 101-46, approved June 30, 1989. The study describes and evaluates alternative methods for financing the future expansion of the Strategic petroleum Reserve (SPR), both to the current target level of 750 million barrels and to potential future levels of up to one billion barrels.

  13. Applications for approval to market a new drug; complete response letter; amendments to unapproved applications. Final rule.

    Science.gov (United States)

    2008-07-10

    The Food and Drug Administration (FDA) is amending its regulations on new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for approval to market new drugs and generic drugs (drugs for which approval is sought in an ANDA). The final rule discontinues FDA's use of approvable letters and not approvable letters when taking action on marketing applications. Instead, we will send applicants a complete response letter to indicate that the review cycle for an application is complete and that the application is not ready for approval. We are also revising the regulations on extending the review cycle due to the submission of an amendment to an unapproved application and starting a new review cycle after the resubmission of an application following receipt of a complete response letter. In addition, we are adding to the regulations on biologics license applications (BLAs) provisions on the issuance of complete response letters to BLA applicants. We are taking these actions to implement the user fee performance goals referenced in the Prescription Drug User Fee Amendments of 2002 (PDUFA III) that address procedures and establish target timeframes for reviewing human drug applications.

  14. Urban Transportation Planning Short Course: Evaluation of Alternative Transportation Systems.

    Science.gov (United States)

    Federal Highway Administration (DOT), Washington, DC.

    This urban transportation pamphlet delves into the roles of policy groups and technical staffs in evaluating alternative transportation plans, evaluation criteria, systems to evaluate, and evaluation procedures. The introduction admits the importance of subjective, but informed, judgment as an effective tool in weighing alternative transportation…

  15. SOME CONSIDERATIONS REGARDING THE AD-HOC INTERNAL ARBITRATION PROCEDURE IN THE NEW CODE OF CIVIL PROCEDURE

    Directory of Open Access Journals (Sweden)

    Daniela Cristina Creţ

    2013-12-01

    Full Text Available One of the institutions to have undergone essential changes as a result of the 2013 entry into force of the New Code of civil procedure is arbitration. Arbitration is an alternative way of settling conflicts by means of a specialized person or institution, based on the will of the parties or on an international convention. This article will present a few introductory aspects that are essential for a foray into the field, as well as analyze the main aspects of arbitral procedure from the perspective of novelties and changes brought to the provisions of the New Code of civil procedure (hereinafter referred to as N.C.C.P..

  16. A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making.

    Science.gov (United States)

    Coppens, D G M; de Wilde, S; Guchelaar, H J; De Bruin, M L; Leufkens, H G M; Meij, P; Hoekman, J

    2018-05-02

    There is a widely held expectation of clinical advance with the development of gene and cell-based therapies (GCTs). Yet, establishing benefits and risks is highly uncertain. We examine differences in decision-making for GCT approval between jurisdictions by comparing regulatory assessment procedures in the United States (US), European Union (EU) and Japan. A cohort of 18 assessment procedures was analyzed by comparing product characteristics, evidentiary and non-evidentiary factors considered for approval and post-marketing risk management. Product characteristics are very heterogeneous and only three products are marketed in multiple jurisdictions. Almost half of all approved GCTs received an orphan designation. Overall, confirmatory evidence or indications of clinical benefit were evident in US and EU applications, whereas in Japan approval was solely granted based on non-confirmatory evidence. Due to scientific uncertainties and safety risks, substantial post-marketing risk management activities were requested in the EU and Japan. EU and Japanese authorities often took unmet medical needs into consideration in decision-making for approval. These observations underline the effects of implemented legislation in these two jurisdictions that facilitate an adaptive approach to licensing. In the US, the recent assessments of two chimeric antigen receptor-T cell (CAR-T) products are suggestive of a trend toward a more permissive approach for GCT approval under recent reforms, in contrast to a more binary decision-making approach for previous approvals. It indicates that all three regulatory agencies are currently willing to take risks by approving GCTs with scientific uncertainties and safety risks, urging them to pay accurate attention to post-marketing risk management. Copyright © 2018 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  17. Criteria for approving equipment for continued operation

    International Nuclear Information System (INIS)

    Narayanan, T.V.

    1993-01-01

    In May 1988, the Pressure Vessel Research Committee (PVRC) of the Welding Research Council (WRC) initiated four projects in support of ASME's efforts to develop Codes and Standards for life prediction and life extension of nuclear and fossil power plant components. These projects are: (1) Criteria for Approving Equipment for Continued Operation (2) Guidelines and Procedures for Evaluating Piping for Continued Operation (3) Nondestructive Evaluation of Material Degradation (4) Operation and Maintenance History and Life Cycle Management. The PVRC awarded a contract to Foster Wheeler Development Corporation to undertake the first of these projects. The specific objective was to develop a program plan that will lead to development of ''Criteria for Approving Equipment for Continued Operation.'' The program is divided into the following four tasks: Task 1: Literature Search; Task 2: Telephone Interview and Consultation; Task 3: Program Plan Development; Task 4: Preparation of a Summary Report. This report is in fulfillment of the above project. As part of this study, the author reviewed about 145 reports, papers and books relating to various aspects of life extension. Various experts were also consulted who are involved in EPRI, NRC, ASME, PVRC, MPC, and utility studies as well as other research projects. The conclusions and recommendations for Code-related activities are summarized

  18. 78 FR 44884 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Update to Materials...

    Science.gov (United States)

    2013-07-25

    ... reference Federally- approved SIPs, as a result of consultations between EPA and the Office of the Federal...'' format are discussed in further detail in the May 22, 1997 Federal Register document. On February 10... under the ``good cause'' exemption in section 553(b)(3)(B) of the Administrative Procedures Act (APA...

  19. Innovations in Bariatric Surgery.

    Science.gov (United States)

    Zhu, Catherine; Pryor, Aurora D

    2015-11-01

    Surgery has consistently been demonstrated to be the most effective long-term therapy for the treatment of obesity. However, despite excellent outcomes with current procedures, most patients with obesity- and weight-related comorbidities who meet criteria for surgical treatment choose not to pursue surgery out of fear of operative risks and complications or concerns about high costs. Novel minimally invasive procedures and devices may offer alternative solutions for patients who are hesitant to pursue standard surgical approaches. These procedures may be used for primary treatment of obesity, early intervention for patients approaching morbid obesity, temporary management prior to bariatric surgery, or revision of bypass surgery associated with weight regain. Novel bariatric procedures can in general be divided into four categories: endoluminal space-occupying devices, gastric suturing and restrictive devices, absorption-limiting devices, and neural-hormonal modulating devices. Many of these are only approved as short-term interventions, but these devices may be effective for patients desiring low-risk procedures or a transient effect. We will see the expansion of indications and alternatives for metabolic surgery as these techniques gain approval.

  20. 46 CFR 502.411 - Mediation and other alternative means of dispute resolution.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 9 2010-10-01 2010-10-01 false Mediation and other alternative means of dispute... PROVISIONS RULES OF PRACTICE AND PROCEDURE Alternative Dispute Resolution § 502.411 Mediation and other alternative means of dispute resolution. (a) Parties are encouraged to utilize mediation or other forms of...

  1. The lifetime of the nuclear alternators

    International Nuclear Information System (INIS)

    Guillard, J.M.; Guigues, B.

    1989-01-01

    The lifetime of an alternator, used in the nuclear domain, is investigated. The preventive actions, concerning the stresses (electrical mechanical or thermal), adopted during the fabrication processes and the severity and frequency of unordinary operating conditions, are analyzed. The aging modes of the alternator main units are studied. The procedures that can be applied to detect the beginning of the degradation, and to avoid an accident during operation are discussed. The turboalternators aging mechanisms are reviewed. It is shown that the mechanical or thermal fatigue, due to regime changements during operation and successive starts, are the main sources of problems. The alternator aging depends on the periodic inspections, on the preventive maintenance, and on the operating conditions [fr

  2. Soil washing physical separations test procedure - 300-FF-1 operable unit

    Energy Technology Data Exchange (ETDEWEB)

    Belden, R.D.

    1993-10-08

    This procedure provides the operations approach, a field sampling plan, and laboratory procedures for a soil washing test to be conducted by Alternative Remedial Technologies, Inc. (ART) in the 300-FF-1 area at the Hanford site. The {open_quotes}Quality Assurance Project Plan for the Soil Washing Physical Separations Test, 300-FF-1 Operable Unit,{close_quotes} Hanford, Washington, Alternative Remedial Technologies, Inc., February 1994 (QAPP) is provided in a separate document that presents the procedural and organizational guidelines for this test. This document describes specifications, responsibilities, and general procedures to be followed to conduct physical separation soil treatability tests in the North Process Pond of the 300-FF-1 Operable Unit (OU) at the Hanford Site. These procedures are based on the {open_quotes}300-FF-1 Physical Separations CERCLA Treatability Test Plan, DOE/RL 92-2l,{close_quotes} (DOE-RL 1993).

  3. Soil washing physical separations test procedure - 300-FF-1 operable unit

    International Nuclear Information System (INIS)

    Belden, R.D.

    1993-01-01

    This procedure provides the operations approach, a field sampling plan, and laboratory procedures for a soil washing test to be conducted by Alternative Remedial Technologies, Inc. (ART) in the 300-FF-1 area at the Hanford site. The open-quotes Quality Assurance Project Plan for the Soil Washing Physical Separations Test, 300-FF-1 Operable Unit,close quotes Hanford, Washington, Alternative Remedial Technologies, Inc., February 1994 (QAPP) is provided in a separate document that presents the procedural and organizational guidelines for this test. This document describes specifications, responsibilities, and general procedures to be followed to conduct physical separation soil treatability tests in the North Process Pond of the 300-FF-1 Operable Unit (OU) at the Hanford Site. These procedures are based on the open-quotes 300-FF-1 Physical Separations CERCLA Treatability Test Plan, DOE/RL 92-2l,close quotes (DOE-RL 1993)

  4. Utilization of reconstructed cultured human skin models as an alternative skin for permeation studies of chemical compounds

    OpenAIRE

    Kano, Satoshi; 藤堂, 浩明; 杉江, 謙一; 藤本, 英哲; 中田, 圭一; 徳留, 嘉寛; 橋本, フミ惠; 杉林, 堅次

    2010-01-01

    Two reconstructed human skin models, EpiskinSM and EpiDermTM, have been approved as alternative membranes for skin corrosive/irritation experiments due to their close correlation with animal skin. Such reconstructed human skin models were evaluated as alternative membranes for skin permeation experiments. Seven drugs with different lipophilicities and almost the same molecular weight were used as test penetrants. Relationships were investigated between permeability coefficients (P values) of ...

  5. Alternative Refrigerant Evaluation for High-Ambient-Temperature Environments: R-22 and R-410A Alternatives for Rooftop Air Conditioners

    Energy Technology Data Exchange (ETDEWEB)

    Abdelaziz, Omar [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Shrestha, Som S. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Shen, Bo [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Linkous, Randall Lee [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Goetzler, William [Navigant Consulting Inc., Burlington, MA (United States); Guernsey, Matt [Navigant Consulting Inc., Burlington, MA (United States); Bargach, Youssef [Navigant Consulting Inc., Burlington, MA (United States)

    2016-09-01

    The Oak Ridge National Laboratory (ORNL) High-Ambient-Temperature Evaluation Program for Low-Global Warming Potential (Low-GWP) Refrigerants aims to develop an understanding of the performance of low-GWP alternative refrigerants relative to hydrochlorofluorocarbon (HCFC) and hydrofluorocarbon (HFC) refrigerants in packaged or Rooftop Unit (RTU) air conditioners under high-ambient-temperature conditions. This final report describes the parties involved, the alternative refrigerants selection process, the test procedures, and the final results.

  6. Proposal of a new analytical procedure for the measurement of water absorption by stone. Preliminary study for an alternative to the Italian technical normative NORMAL 07-81

    Directory of Open Access Journals (Sweden)

    Plattner Susanne

    2012-06-01

    Full Text Available Abstract Background Italian technical normative in the field of cultural heritage is often considered insufficient or not suitable in practise, therefore efforts are necessary to design new and/or improve already existing ones. Results In this paper an alternative analytical procedure for the determination of water absorption (by full immersion by stone material, described in the NORMAL 07-81 document, is proposed. Improvements concern methods accuracy and reduction of sample size; further also density data is obtained. Conclusions The new procedure was applied on three different marble samples and outcomes are encouraging, but further testing is running to better understand to what extent sample size can be reduced without worsening accuracy of results, taking into account that stone is a very heterogeneous material.

  7. Radiosurgical fistulotomy; an alternative to conventional procedure in fistula in ano.

    Science.gov (United States)

    Gupta, Pravin J

    2003-01-01

    Most surgeons continue to prefer the classic lay open technique [fistulotomy] as the gold standard of treatment in anal fistula. In this randomized study, a comparison is made between conventional fistulotomy and fistulotomy performed by a radio frequency device. One hundred patients of low anal fistula posted for fistulotomy were randomized prospectively to either a conventional or radio frequency technique. Parameters measured included time taken for the procedure, amount of blood loss, postoperative pain, return to work, and recurrence rate. The patient demographic was comparable in 2 groups. The radio frequency fistulotomy was quicker as compared to a conventional one [22 versus 37 minutes, p = 0.001], amount of bleeding was significantly less [47 ml versus 134 ml, p = 0.002], and hospital stay was less when patient was operated by radio frequency method [37 hours versus 56 hours in conventional method, p = 0.001]. The postoperative pain in the first 24 hours was more in conventional group [2 to 5 versus 0 to 3 on visual analogue scale]. The patients from radio frequency group resumed their duties early with a reduced healing period of the wounds [47 versus 64 days, p = 0.01]. The recurrence or failure rates were comparable in the radio frequency and conventional groups [2% versus 6%]. Fistulotomy procedure using a radio frequency technique has significant advantages over a conventional procedure with regard to operation time, blood loss, return to normal activity, and healing time of the wound.

  8. 78 FR 17108 - Approval and Promulgation of Implementation Plans; State of Washington; Revised Format for...

    Science.gov (United States)

    2013-03-20

    ...), EPA revised the procedures for IBR'ing Federally-approved SIPs, as a result of consultations between... Violations--Notices 9/8/93 2/22/95, 60 FR 9778 132 Criminal Penalty 11/13/94 10/24/95, 60 FR 54439 133 Civil............ Regulatory Actions & Civil 9/21/95 2/26/97, 62 FR 8624......... Penalties. 400-240......... Criminal...

  9. Alternative Refrigerant Evaluation for High-Ambient Temperature Environments: R-22 and R-410A Alternatives for Mini-Split Air Conditioners

    Energy Technology Data Exchange (ETDEWEB)

    Abdelaziz, Omar [ORNL; Munk, Jeffrey D [ORNL; Shrestha, Som S [ORNL; Linkous, Randall Lee [ORNL; Goetzler, William [Navigant Consulting Inc.; Guernsey, Matt [Navigant Consulting Inc.; Kassuga, Theo [Navigant Consulting Inc.

    2015-08-01

    The Oak Ridge National Laboratory (ORNL) High-Ambient Temperature Testing Program for Low-GWP Refrigerants aims to develop an understanding of the performance of low-Global Warming Potential (low-GWP) alternatives to Hydrochlorofluorocarbon (HCFC) and Hydrofluorocarbon (HFC) refrigerants in mini-split air conditioners under high ambient temperature conditions. This interim working paper describes the parties involved, the alternative refrigerants selection process, the test procedures, and the preliminary results.

  10. Alternative Refrigerant Evaluation for High-Ambient-Temperature Environments: R-22 and R-410A Alternatives for Mini-Split Air Conditioners

    Energy Technology Data Exchange (ETDEWEB)

    Abdelaziz, Omar [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Shrestha, Som S. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Munk, Jeffrey D. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Linkous, Randall Lee [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Goetzler, William [Navigant Consulting Inc., Burlington, MA (United States); Guernsey, Matt [Navigant Consulting Inc., Burlington, MA (United States); Kassuga, Theo [Navigant Consulting Inc., Burlington, MA (United States)

    2015-10-01

    The Oak Ridge National Laboratory (ORNL) High-Ambient-Temperature Evaluation Program for low– global warming potential (Low-GWP) Refrigerants aims to develop an understanding of the performance of low-GWP alternative refrigerants to hydrochlorofluorocarbon (HCFC) and hydrofluorocarbon (HFC) refrigerants in mini-split air conditioners under high-ambient-temperature conditions. This final report describes the parties involved, the alternative refrigerant selection process, the test procedures, and the final results.

  11. Comparing solar energy alternatives

    Energy Technology Data Exchange (ETDEWEB)

    White, J R

    1984-01-01

    The paper outlines a computational procedure for comparing the merits of alternative processes to convert solar radiation to heat, electrical power, or chemical energy. The procedure uses the ratio of equipment investment to useful work as an index. Comparisons with conversion counterparts based on conventional fuels are also facilitated by examining this index. The procedure is illustrated by comparisons of (1) photovoltaic converters of differing efficiencies; (2) photovoltaic converters with and without focusing concentrators; (3) photovoltaic conversion plus electrolysis vs photocatalysis for the production of hydrogen; (4) photovoltaic conversion plus plasma arcs vs photocatalysis for nitrogen fixation. Estimates for conventionally-fuelled processes are included for comparison. The reasons why solar-based concepts fare poorly in such comparisons are traced to the low energy density of solar radiation and its low stream time factor resulting from the limited number of daylight hours available and clouds obscuring the sun.

  12. Comparing solar energy alternatives

    Energy Technology Data Exchange (ETDEWEB)

    White, J R

    1984-01-01

    This paper outlines a computational procedure for comparing the merits of alternative processes to convert solar radiation to heat, electrical power, or chemical energy. The procedure uses the ratio of equipment investment to useful work as an index. Comparisons with conversion counterparts based on conventional fuels are also facilitated by examining this index. The procedure is illustrated by comparisons of (1) photovoltaic converters of differing efficiencies; (2) photovoltaic converters with and without focusing concentrators; (3) photovoltaic conversion plus electrolysis vs photocatalysis for the production of hydrogen; (4) photovoltaic conversion plus plasma arcs vs photocatalysis for nitrogen fixation. Estimates for conventionally-fuelled processes are included for comparison. The reasons why solar-based concepts fare poorly in such comparisons are traced to the low energy density of solar radiation and its low stream time factor resulting from the limited number of daylight hours available and clouds obscuring the sun. 11 references.

  13. Operational circular No. 9 – Principles and procedures governing complaints of harassment

    CERN Multimedia

    HR Department

    2011-01-01

    Operational Circular No. 9 entitled "Principles and Procedures Governing Complaints of Harassment", approved by the Director-General following discussion in the Standing Concertation Committee meeting on 21 March 2011, is available on the intranet site of the Human Resources Department: https://cern.ch/hr-docs/opcirc/opcirc.asp Operational Circular No. 9 is applicable to any person working at or on behalf of CERN. It cancels and replaces Administrative Circular No. 32 entitled "Principles and Procedures Governing Complaints of Harassment” of February 2000. Department Head Office

  14. 42 CFR 137.365 - What is the procedure for the Secretary's review and approval of project planning and design...

    Science.gov (United States)

    2010-10-01

    ... SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES TRIBAL SELF-GOVERNANCE Construction Roles of the...-Governance Tribe? (a) The Secretary shall review and approve planning documents to ensure compliance with... design documents for general compliance with requirements of the construction project agreement. (b) The...

  15. 78 FR 2333 - Approval of the Clean Air Act, Section 112(l), Authority for Hazardous Air Pollutants: Asbestos...

    Science.gov (United States)

    2013-01-11

    ...] Approval of the Clean Air Act, Section 112(l), Authority for Hazardous Air Pollutants: Asbestos Management... protection, Administrative practice and procedure, Air pollution control, Hazardous substances, Incorporation...-Sw 2100: Management and Control of Asbestos Disposal Sites Not Operated after July 9, 1981,'' and the...

  16. Alternate Energy Report, Koleda Childress and Company

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1988-11-01

    This is a NEDO (New Energy and Industrial Technology Development Organization) report on alternate energy dated November 1, 1988, based on a Koleda Childress and Company of EPA report. As for moves in the US Government, Congress approved an additional budget of $575 million for the Clean Coal Technology Program. President Reagan has signed it and the appropriation will be available in fiscal 1990. The Department of Energy selected sixteen projects for negotiations. It earmarked $382 million for fiscal 1989 for research on fossil fuels with emphasis laid on coal liquefaction, coal combustion systems, heat engines, EOR (enhanced oil recovery), etc. The U.S. Congress has extended for one year the production tax credit for synthetic fuel projects using coal and oil shale as raw materials. The development status is described for the Dow Syngas project and IGCC (integrated gasification combined cycle) technology. The President signed into law the Alternative Motor Fuels Act of 1988, which covers ethanol, methanol, and natural gas. Enactment of an acid rain control act will be put off until 1989. Alternative fuels for the transportation sector are also taken up. Direct methane-to-liquids conversion is an interesting technology. (NEDO)

  17. New veterinary medicinal products authorised by centralised procedure

    Directory of Open Access Journals (Sweden)

    Simona Sturzu

    2012-06-01

    Full Text Available Veterinary medicinal products that are subject to authorization via the centralized procedure according to Regulation (EC no. 726/2004 are included in the Community register of veterinary medicines, that is published on the European Commission website and product information of them are published on the website of the European Medicines Agency. Each competent authority involved in the linguistic review process of product information annexed to the Marketing Authorization for medicinal products authorized centrally (SPC, leaflet, information about the marketing authorization holder, product labeling conditions, approve the version in the language mother of each Member State. In the second half of 2011 have received marketing authorization via the centralized procedure a total of four veterinary medicinal products, presented above.

  18. Methodology for development of health physics procedures at research reactors in agreement states

    International Nuclear Information System (INIS)

    Woodard, R.C.; Bauer, T.L.; Wehring, B.W.

    1991-01-01

    The University of Texas at Austin is awaiting final license approval to operate a new 1 MW TRIGA reactor for teaching and research. All reactor and laboratory operations, experiments, and monitoring are carried out under health physics procedures that address to ensure consideration of all applicable documents as references in order to comply with the regulations and accepted good practices. This paper examines the development of one procedure Radioactive Material Control by use of the method. The process is examined as a tool to apply to any health physics procedure development. Further discussion focuses on the regulatory anomalies observed during development of the procedure and presents the arguments for the authors resolution of these issues. The design of the reactor facility is also detailed to allow for understanding of the problems encountered during procedural development

  19. [Alternative approaches in thyroid surgery].

    Science.gov (United States)

    Maurer, E; Wächter, S; Bartsch, D K

    2017-08-01

    In thyroid surgery multiple different cervical minimally invasive (partly endoscopically assisted) and extracervical endoscopic (partly robot-assisted) approaches have been developed in the last 20 years. The aim of all these alternative approaches to the thyroid gland is optimization of the cosmetic result. The indications for the use of alternative and conventional approaches are principally the same. Important requirements for the use of alternative methods are nevertheless a broad experience in conventional thyroid operations of the thyroid and adequate patient selection under consideration of the size of the thyroid and the underlying pathology. Contraindications for the use of alternative approaches are a large size of the thyroid gland including local symptoms, advanced carcinomas, reoperations and previous radiations of the anterior neck. The current article gives an overview of the clinically implemented alternative approaches for thyroid surgery. Of those the majority must still be considered as experimental. The alternative approaches to the thyroid gland can be divided in cervical minimally invasive, extracervical endosopic (robot-assisted) and transoral operations (natural orifice transluminal endoscopic surgery, NOTES). Since conventional thyroid operations are standardized procedures with low complication rates, alternative approaches to the thyroid gland are considered critically in Germany. The request for a perfect cosmetic result should not overweigh patients' safety. Only a few alternative approaches (e. g. MIVAT, RAT) can yet be considered as a safe addition in experienced hands in highly selected patients.

  20. A symptom based decision tree approach to boiling water reactor emergency operating procedures

    International Nuclear Information System (INIS)

    Knobel, R.C.

    1984-01-01

    This paper describes a Decision Tree approach to development of BWR Emergency Operating Procedures for use by operators during emergencies. This approach utilizes the symptom based Emergency Procedure Guidelines approved for implementation by the USNRC. Included in the paper is a discussion of the relative merits of the event based Emergency Operating Procedures currently in use at USBWR plants. The body of the paper is devoted to a discussion of the Decision Tree Approach to Emergency Operating Procedures soon to be implemented at two United States Boiling Water Reactor plants, why this approach solves many of the problems with procedures indentified in the post accident reviews of Three Mile Island procedures, and why only now is this approach both desirable and feasible. The paper discusses how nuclear plant simulators were involved in the development of the Emergency Operating Procedure decision trees, and in the verification and validation of these procedures. (orig./HP)

  1. Basic And Alternative Rules In Evaluation Of Tangible And Intangible Assets

    OpenAIRE

    Luminiţa Rus

    2010-01-01

    The purpose of this report is to bring to the forefront the basic and alternative national rules in evaluation of tangible and intangible assets approved by the Order of the Ministry of Public Finance no. 3055/2009, compared with the International Standards of Accounting matters and positioning of this accounting treatment in the context of the International Regulations. It also is reviewing fiscal influence of these valuation rules.

  2. BASIC AND ALTERNATIVE RULES IN EVALUATION OF TANGIBLE AND INTANGIBLE ASSETS

    Directory of Open Access Journals (Sweden)

    LUMINIŢA RUS

    2010-01-01

    Full Text Available The purpose of this report is to bring to the forefront the basic and alternative national rules in evaluation of tangible and intangible assets approved by the Order of the Ministry of Public Finance no. 3055/2009, compared with the International Standards of Accounting matters and positioning of this accounting treatment in the context of the International Regulations. It also is reviewing fiscal influence of these valuation rules.

  3. An alternative technique for simulating volumetric cylindrical sources in the Morse code utilization

    International Nuclear Information System (INIS)

    Vieira, W.J.; Mendonca, A.G.

    1985-01-01

    In the solution of deep-penetration problems using the Monte Carlo method, calculation techniques and strategies are used in order to increase the particle population in the regions of interest. A common procedure is the coupling of bidimensional calculations, with (r,z) discrete ordinates transformed into source data, and tridimensional Monte Carlo calculations. An alternative technique for this procedure is presented. This alternative proved effective when applied to a sample problem. (F.E.) [pt

  4. MNR Approvals for waterpower projects

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2011-07-01

    On May 5, 2011, the Ontario Waterpower Association hosted the emergent hydro workshop in Peterborough. In the course of the workshop, the Ministry of Natural Resources (MNR) presented the different requirements for approval of waterpower projects. Various legislation administered by MNR applies to waterpower projects: the Public Lands Act, the Lakes and Rivers Improvement Act, the Endangered Species Act, 2007, and other legislation. The Public Lands Act provides policy and procedure for water power site release; the Lakes and Rivers Improvement Act was designed to manage, protect and preserve waters, land, fish, wildlife and other natural resources; the Endangered Species Act, 2007, is intended to protect species from extinction by protecting their habitats and promoting their recovery. MNR also administer other legislation, including the Aggregate Resources Act and the Forest Fires Prevention Act. This presentation provided an overview of the various pieces of legislation regulating waterpower projects which are administered by MNR.

  5. Irradiation as an alternative to methyl bromide: the Australian situation

    Energy Technology Data Exchange (ETDEWEB)

    Heather, N W [Gatton College, University of Queensland, Queensland (Australia)

    1999-05-01

    International agreement to phase out the fumigant Methyl bromide (MeBr) will have serious implications for pest and disease control in Australia, particularly grain pest control, quarantine usage on fresh horticultural produce and control of soil pathogens or nematodes. Irradiation is a practical alternative but is not currently approved for use in Australia. Other options are available but none of the viable methods except irradiation have the short application time needed for treatment of grams found to be infested during loading at export. This usage is vital, as Australian grain is exported at very high standards of freedom from insects, assured by Government regulatory requirements. Irradiation is contrasted against other alternatives including heat and cold, especially for fresh horticultural produce. (author) 4 refs, 5 tabs

  6. Irradiation as an alternative to methyl bromide: the Australian situation

    International Nuclear Information System (INIS)

    Heather, N.W.

    1999-01-01

    International agreement to phase out the fumigant Methyl bromide (MeBr) will have serious implications for pest and disease control in Australia, particularly grain pest control, quarantine usage on fresh horticultural produce and control of soil pathogens or nematodes. Irradiation is a practical alternative but is not currently approved for use in Australia. Other options are available but none of the viable methods except irradiation have the short application time needed for treatment of grams found to be infested during loading at export. This usage is vital, as Australian grain is exported at very high standards of freedom from insects, assured by Government regulatory requirements. Irradiation is contrasted against other alternatives including heat and cold, especially for fresh horticultural produce. (author)

  7. Assessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: a cohort study.

    Science.gov (United States)

    Larochelle, Matthieu; Downing, Nicholas S; Ross, Joseph S; David, Frank S

    2017-02-08

    To quantify the potential effect of reciprocal approval legislation on access to clinically impactful therapeutics in the USA. A cohort study. New therapeutics approved by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and/or Health Canada between 2000 and 2010. Characteristics of new therapeutics approved by the EMA and/or Health Canada before the FDA, including mechanistic novelty, likely clinical impact, size of the affected population and FDA review outcome. From 2001 to 2010, 282 drugs were approved in the USA, Europe or Canada, including 172 (61%) first approved in the USA, 24 (9%) never approved in the USA, and 86 (30%) approved in the USA after Europe and/or Canada. Of the 110 new drugs approved in Europe and/or Canada before the USA, 37 (34%) had a novel mechanisms of action compared with drugs already approved by the FDA, but only 10 (9%) were for conditions lacking alternate available therapies in the USA at the time of ex-US approval-of which the majority (9/10; 90%) were indicated for rare diseases. 12 of the 37 agents with novel mechanisms of action approved first in Europe and/or Canada (32%) had their initial FDA submissions rejected for safety reasons-including 2 drugs that were ultimately withdrawn from the market in Europe due to safety concerns. If enacted, reciprocal approval legislation would most likely benefit only a small number of US patients receiving treatment for rare diseases, and the benefit may be somewhat mitigated by an increased exposure to harms. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  8. Utilizing today's technology to improve the procedure development process

    International Nuclear Information System (INIS)

    Morgan, R.A.; White, P.A.

    1995-01-01

    The purpose of this paper is to describe the systematic approach being utilized by the Civilian Radioactive Waste Management System, Managing and Operating (M ampersand O) Contractor to electronically connect geographically-separated organizational work units for the common goal of developing, reviewing, and approving Quality Administrative Procedures. The Board members were equipped with a common electronic network access. The results of establishing a GRB and an electronic network have proven to be very cost effective

  9. 78 FR 55057 - Authority To Manufacture Carbon Fiber for the U.S. Market Not Approved; Foreign-Trade Subzone...

    Science.gov (United States)

    2013-09-09

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1914] Authority To Manufacture Carbon... behalf of Toho Tenax America, Inc. (TTA), to manufacture carbon fiber under zone procedures for the U.S... approve the application requesting authority to manufacture carbon fiber for the U.S. market under zone...

  10. ProSeal laryngeal mask airway: An alternative to endotracheal intubation in paediatric patients for short duration surgical procedures

    Directory of Open Access Journals (Sweden)

    Jaya Lalwani

    2010-01-01

    Full Text Available The laryngeal mask airway (LMA is a supraglottic airway management device. The LMA is preferred for airway management in paediatric patients for short duration surgical procedures. The recently introduced ProSeal (PLMA, a modification of Classic LMA, has a gastric drainage tube placed lateral to main airway tube which allows the regurgitated gastric contents to bypass the glottis and prevents the pulmonary aspiration. This study was done to compare the efficacy of ProSeal LMA with an endotracheal tube in paediatric patients with respect to number of attempts for placement of devices, haemodynamic responses and perioperative respiratory complications. Sixty children, ASA I and II, weighing 10-20 kg between 2 and 8 years of age group of either sex undergoing elective ophthalmological and lower abdominal surgeries of 30-60 min duration, randomly divided into two groups of 30 patients each were studied. The number of attempts for endotracheal intubation was less than the placement of PLMA. Haemodynamic responses were significantly higher (P<0.05 after endotracheal intubation as compared to the placement of PLMA. There were no significant differences in mean SpO 2 (% and EtCO 2 levels recorded at different time intervals between the two groups. The incidence of post-operative respiratory complications cough and bronchospasm was higher after extubation than after removal of PLMA. The incidence of soft tissue trauma was noted to be higher for PLMA after its removal. There were no incidences of aspiration and hoarseness/sore throat in either group. It is concluded that ProSeal LMA can be safely considered as a suitable and effective alternative to endotracheal intubation in paediatric patients for short duration surgical procedures.

  11. Proposed Changes to EPA's Transuranic Waste Characterization Approval Process

    International Nuclear Information System (INIS)

    Joglekar, R.D.; Feltcorn, E.M.; Ortiz, A.M.

    2003-01-01

    This paper describes the changes to the waste characterization (WC) approval process proposed in August 2002 by the U.S. Environmental Protection Agency (EPA or the Agency or we). EPA regulates the disposal of transuranic (TRU) waste at the Waste Isolation Pilot Plant (WIPP) repository in Carlsbad, New Mexico. EPA regulations require that waste generator/storage sites seek EPA approval of WC processes used to characterize TRU waste destined for disposal at WIPP. The regulations also require that EPA verify, through site inspections, characterization of each waste stream or group of waste streams proposed for disposal at the WIPP. As part of verification, the Agency inspects equipment, procedures, and interviews personnel to determine if the processes used by a site can adequately characterize the waste in order to meet the waste acceptance criteria for WIPP. The paper discusses EPA's mandate, current regulations, inspection experience, and proposed changes. We expect that th e proposed changes will provide equivalent or improved oversight. Also, they would give EPA greater flexibility in scheduling and conducting inspections, and should clarify the regulatory process of inspections for both Department of Energy (DOE) and the public

  12. 78 FR 22490 - Administrative Practice and Procedure; Postal Service; Review of Price Cap Rules

    Science.gov (United States)

    2013-04-16

    ...] Administrative Practice and Procedure; Postal Service; Review of Price Cap Rules AGENCY: Postal Regulatory Commission. ACTION: Proposed rule. SUMMARY: The Commission is initiating a review of its Price Cap Rules. The... implemented without a price cap calculation. Docket No. R2011-5, Order Approving Market Dominant Price...

  13. Marketing Approval of Ethical Kampo Medicines.

    Science.gov (United States)

    Hakamatsuka, Takashi

    2017-01-01

    Kampo medicine is an original traditional medicine in Japan. Currently, 148 ethical Kampo formulations (Kampo prescription drugs) are registered in the National Health Insurance Price List. Kampo medicines can be prescribed under the national insurance system, which shows that they are part of conventional medicine in Japan. Japan has a unified drug approval system that does not distinguish between Western and Kampo medicines, and both are subject to the same regulations. The application for the market approval of ethical Kampo medicines is based on the general notification for drugs, i.e., "Handling of Ethical Combination Drugs" in "Precautions Necessary When Applying for Drug Marketing Approval" (Yakushokushinsa Notification No. 1121-12 of November 21, 2014). Furthermore, applications for the market approval of ethical Kampo medicines should follow the Kampo-specific notification of "Handling of Ethical Kampo Medicines" (Yakushin Notification No. 804 of June 25, 1980). Data from comparative studies with standard decoctions must be submitted with approval applications according to Yakushin 2 Notification No. 120 of May 31, 1985. The safety, efficacy, and quality of Kampo medicines are comprehensively assured by the Japanese Pharmacopoeia, Good Manufacturing Practice, Good Agricultural and Collection Practices, marketing approval certificate, approval standard, and pharmacovigilance. I believe that the basic framework for the market approval of ethical Kampo medicines has been established as described above. The key factors for the practical application of superior manufacturing technology and research achievements and the promotion of drug development are the specific guidelines for the approval of drugs of herbal origin.

  14. 40 CFR 145.31 - Approval process.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 22 2010-07-01 2010-07-01 false Approval process. 145.31 Section 145.31 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS (CONTINUED) STATE UIC PROGRAM REQUIREMENTS Program Approval, Revision and Withdrawal § 145.31 Approval process. (a...

  15. 40 CFR 52.2122 - Approval status.

    Science.gov (United States)

    2010-07-01

    ... sources covered by CTGs issued by the previous January. (b) EPA disapproved South Carolina's generic...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) South Carolina § 52.2122 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves South Carolina's plans for...

  16. Ciprofloxacin Use in Hospitalized Children: Approved or Off-label?

    Science.gov (United States)

    Faghihi, Toktam; Tekmehdash, Leila Yavari; Radfar, Mania; Gholami, Kheirollah

    2017-01-01

    Fluoroquinolones are not routinely used as the first-line antimicrobial therapy in pediatrics. The American Academy of Pediatrics (AAP) and the United States Food and Drug Administration (FDA) approved fluoroquinolones on certain indications in children. The aim of this study was to evaluate to what extent and how ciprofloxacin is used on approved indication or as off-label. Besides, dose adequacy and treatment duration were assessed. In a 10-month observational study, all children receiving systemic ciprofloxacin were assessed. We classified ciprofloxacin prescription to an AAP/FDA or off-label indication. The off-label prescriptions were further categorized to justified and unjustified therapy subgroups. The AAP/FDA category and the justified subgroup constituted the appropriate prescriptions. During the study period, 32 patients were prescribed ciprofloxacin. In general, 37% (12) of prescriptions determined to be appropriate. Of the appropriate prescriptions, 7 were AAP/FDA-approved indications. Children with Crohn's disease with abdominal abscess and children with infectious bloody diarrhea constituted the off-label; justified therapy subgroup. Unjustified prescriptions mainly occurred in the presence of a suitable alternative antibiotic for ciprofloxacin. Mean ± SD of ciprofloxacin dose (mg/kg/day) and duration (days) were 21.25 ± 6.35 and 13.56 ± 8.48, respectively. Of the appropriate prescriptions, 41% were underdosed. Underdosing was more encountered in patients with cystic fibrosis. Duration of treatment of the appropriate prescriptions was determined to be appropriate. The majority of children were receiving ciprofloxacin off-label and in an inappropriate manner. This issue emphasizes that antimicrobial stewardship program on ciprofloxacin use in pediatric hospitals should be implemented. Further studies evaluating clinical and microbiological outcomes of these programs in children are needed.

  17. 75 FR 48302 - Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval...

    Science.gov (United States)

    2010-08-10

    ....gov ). FOR FURTHER INFORMATION CONTACT: For information on credit account approval for reimbursable..., at (301) 851-2908. SUPPLEMENTARY INFORMATION: Title: Credit Account Approval for Reimbursable... Inspection Service [Docket No. APHIS-2010-0071] Notice of Request for Extension of Approval of an Information...

  18. 78 FR 54617 - Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval...

    Science.gov (United States)

    2013-09-05

    ...] Notice of Request for Extension of Approval of an Information Collection; Credit Account Approval for... (202) 799-7039 before coming. FOR FURTHER INFORMATION CONTACT: For information on credit account... Coordinator, at (301) 851-2908. SUPPLEMENTARY INFORMATION: Title: Credit Account Approval for Reimbursable...

  19. The Ross II procedure: pulmonary autograft in the mitral position.

    Science.gov (United States)

    Athanasiou, Thanos; Cherian, Ashok; Ross, Donald

    2004-10-01

    The surgical management of mitral valve disease in women of childbearing age, young patients, and children with congenital mitral valve defects is made difficult by the prospect of lifelong anticoagulation. We suggest the use of a pulmonary autograft in the mitral position (Ross II procedure) as an alternative surgical technique. We present a review of the literature, historical perspectives, indications, selection criteria, and surgical technique for the Ross II procedure. Our literature search identified 14 studies that reported results from the Ross II operation. Performed in 103 patients, the overall in-hospital mortality was 7 (6.7%), with a late mortality of 10 (9%). Although further research is needed, current evidence suggests the Ross II operation is a valuable alternative in low-risk young patients where valve durability and the complication rate from other procedures is unsatisfactory and anticoagulation not ideal.

  20. 40 CFR 52.1772 - Approval status.

    Science.gov (United States)

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) North Carolina § 52.1772 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves North Carolina's plans for... CTGs issued by the previous January. (b) New Source review permits issued pursuant to section 173 of...

  1. Thoracic epidural analgesia for breast oncological procedures: A better alternative to general anesthesia

    Directory of Open Access Journals (Sweden)

    Parli Raghavan Ravi

    2017-01-01

    Full Text Available Objective: The objective of the study was to compare the outcomes of the incidence of nausea/vomiting and other complications along with the time taken for discharged in patients undergoing Thoracic Epidural Analgesia (TEA and General Anaesthesia (GA for breast oncological surgeries. Background: GA with or without TEA or other postoperative pain-relieving strategies remains the traditional anesthetic technique used for breast oncological procedures. We initiated the use of high segmental TEA for patients undergoing these procedures in our hospital. Methods: Eighty patients undergoing breast oncological procedures performed by one surgical team were randomly allocated into two groups receiving TEA and GA. The Chi-square test and Fisher's exact test were used for categorical parameters, paired t-test and Student's t-test was used for continuous measurements. Results: In comparison with GA, TEA was associated with lesser incidence of complications of nausea/vomiting. In lumpectomy with axillary node dissection, 1 out of 18 patients (5.55% in the TEA group had nausea/vomiting, while 11 out of 19 (57.8% of the GA group had similar symptoms (P < 0.001. The discharge rate for the thoracic epidural group was 12 out of 18 by day 3 (66.6% while all patients in the GA group required more than 3 days of hospitalization (P < 0.001. Conclusion: Thoracic epidural anesthesia is a safe technique and its use in breast oncological procedures could improve patients' recovery and facilitate their early discharge to home.

  2. Evaluation of alternative macroinvertebrate sampling techniques for use in a new tropical freshwater bioassessment scheme

    OpenAIRE

    Isabel Eleanor Moore; Kevin Joseph Murphy

    2015-01-01

    Aim: The study aimed to determine the effectiveness of benthic macroinvertebrate dredge net sampling procedures as an alternative method to kick net sampling in tropical freshwater systems, specifically as an evaluation of sampling methods used in the Zambian Invertebrate Scoring System (ZISS) river bioassessment scheme. Tropical freshwater ecosystems are sometimes dangerous or inaccessible to sampling teams using traditional kick-sampling methods, so identifying an alternative procedure that...

  3. 30 CFR 14.10 - Post-approval product audit.

    Science.gov (United States)

    2010-07-01

    ..., AND APPROVAL OF MINING PRODUCTS REQUIREMENTS FOR THE APPROVAL OF FLAME-RESISTANT CONVEYOR BELTS General Provisions § 14.10 Post-approval product audit. (a) Approved conveyor belts will be subject to... based. MSHA will select an approved conveyor belt to be audited; the selected belt will be...

  4. 75 FR 71724 - Real Estate Settlement Procedures Act (RESPA): Solicitation of Information on Changes in...

    Science.gov (United States)

    2010-11-24

    ... credit approval decision with respect to each mortgage loan application? What level of scrutiny do... Procedures Act (RESPA): Solicitation of Information on Changes in Warehouse Lending and Other Loan Funding... guidance under RESPA to address possible changes in warehouse lending and other financing mechanisms used...

  5. Efficient Reanalysis Procedures in Structural Topology Optimization

    DEFF Research Database (Denmark)

    Amir, Oded

    This thesis examines efficient solution procedures for the structural analysis problem within topology optimization. The research is motivated by the observation that when the nested approach to structural optimization is applied, most of the computational effort is invested in repeated solutions...... on approximate reanalysis. For cases where memory limitations require the utilization of iterative equation solvers, we suggest efficient procedures based on alternative termination criteria for such solvers. These approaches are tested on two- and three-dimensional topology optimization problems including...

  6. 40 CFR 123.61 - Approval process.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 21 2010-07-01 2010-07-01 false Approval process. 123.61 Section 123... REQUIREMENTS Program Approval, Revision, and Withdrawal § 123.61 Approval process. (a) After determining that a...; and (6) Briefly outline the fundamental aspects of the State's proposed program, and the process for...

  7. Matching bunched beams to alternating gradient focusing systems

    International Nuclear Information System (INIS)

    Lysenko, W.P.

    1980-07-01

    A numerical procedure for generating phase-space distributions matched to alternating gradient focusing systems has been tested. For a smooth-focusing system a matched distribution can be calculated. With a particle tracing simulation code such a distribution can be followed while adiabatically deforming the focusing forces until an alternating gradient configuration is reached. The distribution remains matched; that is, the final distribution is periodic with the structure period. This method is useful because it can produce distributions matched to nonlinear forces. This is a feature that elliptical distributions, with ellipse parameters obtained from the Courant-Snyder theory, do not have. External nonlinearities, including nonlinear couplings, were included in our examples but space charge was not. This procedure is expected to work with space charge but will require a three-dimensional space charge calculation in the simulation code

  8. 77 FR 6536 - Approval for Manufacturing Authority; Foreign-Trade Zone 177; Best Chair, Inc., d/b/a Best Home...

    Science.gov (United States)

    2012-02-08

    ... manufacturing authority on behalf of Best Chair, Inc., d/ b/a Best Home Furnishings, Inc., within FTZ 177 in... application for manufacturing authority under zone procedures within FTZ 177 on behalf of Best Chair, Inc., d... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1807] Approval for Manufacturing...

  9. 14 CFR Appendix A to Part 17 - Alternative Dispute Resolution (ADR)

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Alternative Dispute Resolution (ADR) A...—Alternative Dispute Resolution (ADR) A. The FAA dispute resolution procedures encourage the parties to..., pursuant to the Administrative Dispute Resolution Act of 1996, Pub. L. 104-320, 5 U.S.C. 570-579, and...

  10. Doctor-patient communication and cancer patients' choice of alternative therapies as supplement or alternative to conventional care.

    Science.gov (United States)

    Salamonsen, Anita

    2013-03-01

    Cancer patients' use of complementary and alternative medicine (CAM) is widespread, despite the fact that clinical studies validating the efficacy of CAM remain sparse in the Nordic countries. The purpose of this study was to explore possible connections between cancer patients' communication experiences with doctors and the decision to use CAM as either supplement or alternative to conventional treatment (CT). The Regional Committee for Medical and Health Research Ethics and the Norwegian Data Inspectorate approved the study. From a group of 52 cancer patients with self-reported positive experiences from use of CAM, 13 were selected for qualitative interviews. Six used CAM as supplement, and seven as alternative to CT, periodically or permanently. Communication experiences with 46 doctors were described. The analysis revealed three connections between doctor-patient communication and patients' treatment decisions: (i) negative communication experiences because of the use of CAM; (ii) negative communication experiences resulted in the decision to use CAM, and in some cases to decline CT; and (iii) positive communication experiences led to the decision to use CAM as supplement, not alternative to CT. The patients, including the decliners of CT, wanted to discuss treatment decisions in well-functioning interpersonal processes with supportive doctors. In doctors' practices and education of doctors, a greater awareness of potential positive and negative outcomes of doctor-patient communication that concern CAM issues could be of importance. More research is needed to safeguard CAM users' treatment decisions and their relationship to conventional health care. © 2012 The Author. Scandinavian Journal of Caring Sciences © 2012 Nordic College of Caring Science.

  11. Readability and Content Assessment of Informed Consent Forms for Medical Procedures in Croatia.

    Science.gov (United States)

    Vučemilo, Luka; Borovečki, Ana

    2015-01-01

    High quality of informed consent form is essential for adequate information transfer between physicians and patients. Current status of medical procedure consent forms in clinical practice in Croatia specifically in terms of the readability and the content is unknown. The aim of this study was to assess the readability and the content of informed consent forms for diagnostic and therapeutic procedures used with patients in Croatia. 52 informed consent forms from six Croatian hospitals on the secondary and tertiary health-care level were tested for reading difficulty using Simple Measure of Gobbledygook (SMOG) formula adjusted for Croatian language and for qualitative analysis of the content. The averaged SMOG grade of analyzed informed consent forms was 13.25 (SD 1.59, range 10-19). Content analysis revealed that informed consent forms included description of risks in 96% of the cases, benefits in 81%, description of procedures in 78%, alternatives in 52%, risks and benefits of alternatives in 17% and risks and benefits of not receiving treatment or undergoing procedures in 13%. Readability of evaluated informed consent forms is not appropriate for the general population in Croatia. The content of the forms failed to include in high proportion of the cases description of alternatives, risks and benefits of alternatives, as well as risks and benefits of not receiving treatments or undergoing procedures. Data obtained from this research could help in development and improvement of informed consent forms in Croatia especially now when Croatian hospitals are undergoing the process of accreditation.

  12. Readability and Content Assessment of Informed Consent Forms for Medical Procedures in Croatia

    Science.gov (United States)

    Vučemilo, Luka; Borovečki, Ana

    2015-01-01

    Background High quality of informed consent form is essential for adequate information transfer between physicians and patients. Current status of medical procedure consent forms in clinical practice in Croatia specifically in terms of the readability and the content is unknown. The aim of this study was to assess the readability and the content of informed consent forms for diagnostic and therapeutic procedures used with patients in Croatia. Methods 52 informed consent forms from six Croatian hospitals on the secondary and tertiary health-care level were tested for reading difficulty using Simple Measure of Gobbledygook (SMOG) formula adjusted for Croatian language and for qualitative analysis of the content. Results The averaged SMOG grade of analyzed informed consent forms was 13.25 (SD 1.59, range 10–19). Content analysis revealed that informed consent forms included description of risks in 96% of the cases, benefits in 81%, description of procedures in 78%, alternatives in 52%, risks and benefits of alternatives in 17% and risks and benefits of not receiving treatment or undergoing procedures in 13%. Conclusions Readability of evaluated informed consent forms is not appropriate for the general population in Croatia. The content of the forms failed to include in high proportion of the cases description of alternatives, risks and benefits of alternatives, as well as risks and benefits of not receiving treatments or undergoing procedures. Data obtained from this research could help in development and improvement of informed consent forms in Croatia especially now when Croatian hospitals are undergoing the process of accreditation. PMID:26376183

  13. MR imaging of right ventricular function after the Ross procedure for aortic valve replacement: initial experience

    NARCIS (Netherlands)

    Grotenhuis, Heynric B.; de Roos, Albert; Ottenkamp, Jaap; Schoof, Paul H.; Vliegen, Hubert W.; Kroft, Lucia J. M.

    2008-01-01

    PURPOSE: To prospectively assess right ventricular (RV) function after the Ross procedure by using magnetic resonance (MR) imaging. MATERIALS AND METHODS: The local ethics committee approved the study and informed consent was obtained from all participants prior to enrollment in the study. Seventeen

  14. 40 CFR 72.22 - Alternate designated representative.

    Science.gov (United States)

    2010-07-01

    ... designated representative is selected shall include a procedure for the owners and operators of the source and affected units at the source to authorize the alternate designated representative to act in lieu...) In the event of a conflict, any action taken by the designated representative shall take precedence...

  15. Alternatives to School Disciplinary and Suspension Problems.

    Science.gov (United States)

    South Carolina State Dept. of Education, Columbia. Div. of Instruction.

    Policies and procedures for disciplining students should be designed to teach them responsibility, rather than simply punish them. Providing educational opportunities to behavioral deviants is a problem that does not have a simple solution. However, alternatives to suspension or expulsion must be attempted before these disciplinary actions are…

  16. 40 CFR 52.1323 - Approval status.

    Science.gov (United States)

    2010-07-01

    ... on January 16, 1979 (44 FR 3274) are met. (b) The Administrator approves Rule 10 CSR 10-2.290 as.... (c) The Administrator approves Rule 10 CSR 10-2.230 as identified under § 52.1320, paragraph (c)(70... SIP would be the emission limits stated in the rule. (d) The Administrator approves Rule 10 CSR 10-5...

  17. Normative questions connected with the procedure for approval and operation of nuclear installations

    International Nuclear Information System (INIS)

    Nocera, F.

    1980-03-01

    Recent regulatory developments in the licensing procedure for nuclear installations in Italy are discussed in the light of technical and scientific developments and international rules. The author then discusses the questions likely to be further defined and regulated, i.e. requirements for possession of fuels and fuel storage facilities, nuclear plant decommissioning, protection of the population with reference to the directives of the European Communities. (NEA) [fr

  18. 30 CFR 14.7 - Approval marking and distribution records.

    Science.gov (United States)

    2010-07-01

    ..., EVALUATION, AND APPROVAL OF MINING PRODUCTS REQUIREMENTS FOR THE APPROVAL OF FLAME-RESISTANT CONVEYOR BELTS General Provisions § 14.7 Approval marking and distribution records. (a) An approved conveyor belt must be marketed only under the name specified in the approval. (b) Approved conveyor belt must be legibly and...

  19. Requirements, guidance and logic in planning environmental investigations: Approval versus implementation

    International Nuclear Information System (INIS)

    Brice, D.A.; Meredith, D.V.; Harris, M.Q.

    1993-01-01

    In today's litigious society, it is important for both private parties and government to plan and conduct environmental investigations in a scientifically sound manner, documenting the purpose, methods, and results in a consistent fashion throughout the exercise. Planning documents are prepared during the initial phases of environmental investigations. Project objectives, including data quality requirements, specific work to be conducted to fulfill data needs, and operating procedures are specified. Regulatory agency approval of these documents is often required prior to plan implementation. These approvals are necessary and appropriate to fulfilling the agency's mandated role. Many guidance documents prepared by regulatory agencies suggest the content and format of various scoping documents. These guidances help standardize thought processes and considerations in planning, and provide a template to ensure that both the plan and the proposed work will fulfill regulatory requirements. This work describes the preparation and use of guidance documents for planning environmental studies. The goals and some of the pitfalls of such documents are discussed. Guidance should include the following elements: the purpose of the guidance and a description of where it applies; the type of items to be addressed in planning; identification of requirements are applicable to all projects for which the guidance is intended; identification of requirements only applicable in certain situations; a description of items to facilitate planning; a suggested format for fulfilling requirements; example applications of the guidance. Disagreements arise between planners and reviewers/approvers when elements of guidance are used as leverage to require work not directly related to project objectives. Guidance may be inappropriately used as a milestone by which site-specific plans are judged. Regulatory agency review and approval may be regarded as a primary objective of the plan

  20. Sedation for procedures outside the operating room in children

    International Nuclear Information System (INIS)

    Molina Rodriguez, Ericka

    2014-01-01

    Sedation is defined in the pediatric population. An adequate preoperative assessment is established in patients subjected to a sedation. Fundamental characteristics of drugs used during a sedation are determined. Recommendations about surveillance and monitoring are established in a patient sedated. Principal characteristics of sedation are defined in patients exposed to radiological diagnostic and therapeutic procedures. Considerations in sedation are identified for procedures in the laboratory of digestive endoscopy. Alternatives of sedation are mentioned for oncological patients subjected to invasive procedures. Working conditions and specifications of anesthesia are determined in the cardiac catheterization room [es

  1. An Alternative View of Some FIA Sample Design and Analysis Issues

    Science.gov (United States)

    Paul C. Van Deusen

    2005-01-01

    Sample design and analysis decisions are the result of compromises and inputs from many sources. The end result would likely change if different individuals or groups were involved in the planning process. Discussed here are some alternatives to the procedures that are currently being used for the annual inventory. The purpose is to indicate that alternatives exist and...

  2. Drugs Approved for Kidney (Renal Cell) Cancer

    Science.gov (United States)

    ... Your Treatment Research Drugs Approved for Kidney (Renal Cell) Cancer This page lists cancer drugs approved by the ... not listed here. Drugs Approved for Kidney (Renal Cell) Cancer Afinitor (Everolimus) Aldesleukin Avastin (Bevacizumab) Axitinib Bevacizumab Cabometyx ( ...

  3. Alternatives to animal testing: A review.

    Science.gov (United States)

    Doke, Sonali K; Dhawale, Shashikant C

    2015-07-01

    The number of animals used in research has increased with the advancement of research and development in medical technology. Every year, millions of experimental animals are used all over the world. The pain, distress and death experienced by the animals during scientific experiments have been a debating issue for a long time. Besides the major concern of ethics, there are few more disadvantages of animal experimentation like requirement of skilled manpower, time consuming protocols and high cost. Various alternatives to animal testing were proposed to overcome the drawbacks associated with animal experiments and avoid the unethical procedures. A strategy of 3 Rs (i.e. reduction, refinement and replacement) is being applied for laboratory use of animals. Different methods and alternative organisms are applied to implement this strategy. These methods provide an alternative means for the drug and chemical testing, up to some levels. A brief account of these alternatives and advantages associated is discussed in this review with examples. An integrated application of these approaches would give an insight into minimum use of animals in scientific experiments.

  4. 76 FR 56362 - Removal of Approved Non-U.S.-Licensed Space Stations From the Section 214 Exclusion List

    Science.gov (United States)

    2011-09-13

    ...'s web page, the Bureau plans to insert a link entitled Space Stations Approved for U.S. Market Access. Once users click on that link, they will be taken to a page with that same title that provides... pursuant to the DISCO II procedures. The web page will include links to other lists already maintained for...

  5. An Overview of the Effective Use of Alternative Dispute Resolution in Education

    Science.gov (United States)

    Fowler, Gerard A.

    2006-01-01

    This article presents a brief overview of the current forms of alternative dispute resolution available in educational settings, along with insight into their development and success. In this article, I assess the influence of early alternative dispute resolution procedures in terms of their relevance to the settlement of conflicts within schools…

  6. Proposing an alternative linear a successful example

    International Nuclear Information System (INIS)

    Ortman, D.

    1994-01-01

    The mandated Sub-Title D landfill liner design which meets the basic Sub-Title D performance requirement (no exceedance of groundwater quality standards at the landfill boundary in 30 years) specifies construction of a two foot thick clay layer with a hydraulic conductivity no greater than 10 -7 cm/sec and a 60 mil HDPE membrane. This mandated design is easily accepted by the regulatory community but very difficult and expensive to properly construct. Fundamental problems arise constructing a clay linear that meets the 10 -7 cm/sec hydraulic conductivity requirement and, in cold climates, protecting the clay but their use requires obtaining special approval for an open-quotes alternative linearclose quotes from the appropriate regulatory agency. This paper presents a simple example of an open-quotes alternative linerclose quotes proposal that has been accepted by the Montana Department of Health and Environmental Sciences for a new landfill. The arguments presented for the use of a GCL combine site-specific parameters with easily understood calculations to demonstrate compliance with the basic Sub-Title D performance requirement. 8 refs., 6 tabs

  7. Trial endpoints for drug approval in oncology: Chemoprevention.

    Science.gov (United States)

    Beitz, J

    2001-04-01

    As with other drugs, new drug applications for marketing approval of chemopreventive drugs must include data from adequate and well-controlled clinical trials that demonstrate effectiveness and safety for the intended use. This article summarizes the regulatory requirements for traditional marketing approval, as well as for approval under the accelerated approval regulations. Unlike traditional approval, accelerated approval is based on a surrogate endpoint that is reasonably likely to predict clinical benefit. Discussions with the Food and Drug Administration (FDA) regarding the validity of trial endpoints that may serve as surrogates for clinical benefit for accelerated approval should take place as early as possible in drug development. Meetings with the FDA to discuss these issues may be requested throughout the clinical development of a new drug.

  8. Alternative normalization methods demonstrate widespread cortical hypometabolism in untreated de novo Parkinson's disease

    DEFF Research Database (Denmark)

    Berti, Valentina; Polito, C; Borghammer, Per

    2012-01-01

    , recent studies suggested that conventional data normalization procedures may not always be valid, and demonstrated that alternative normalization strategies better allow detection of low magnitude changes. We hypothesized that these alternative normalization procedures would disclose more widespread...... metabolic alterations in de novo PD. METHODS: [18F]FDG PET scans of 26 untreated de novo PD patients (Hoehn & Yahr stage I-II) and 21 age-matched controls were compared using voxel-based analysis. Normalization was performed using gray matter (GM), white matter (WM) reference regions and Yakushev...... normalization. RESULTS: Compared to GM normalization, WM and Yakushev normalization procedures disclosed much larger cortical regions of relative hypometabolism in the PD group with extensive involvement of frontal and parieto-temporal-occipital cortices, and several subcortical structures. Furthermore...

  9. Alternate Energy Report, Koleda Childress Inc., dated August 15, 1991

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1991-08-15

    Policies and current states of alternate energy and global warming concerns in the United States are reported. The House Subcommittee on Energy and Power marking up draft national energy legislation has completed draft titles on the Strategic Petroleum Reserve, energy efficiency, and natural gas, and begun work on an alternate fuel titles. The alternate fuel title includes liquefied petroleum gas, hydrogen, and electricity. A bill on electric vehicles has been approved by the House Science Committee. Under the bill the Department of Energy will establish a cooperative research program of automakers and the electric utility industry to develop advanced batteries for electric vehicles. The bill authorizes a total of $570.5 million for this program for fiscal years 1992 through 1998. At the meeting of the leaders of the seven leading industrialized countries held in London in July, a joint declaration was issued calling for the completion of an effective framework convention on climate change for reducing emissions of carbon dioxide and other greenhouse gases by the time of United Nations Conference on Environment and Development to be called next June. (NEDO)

  10. Blinding in trials of interventional procedures is possible and worthwhile [version 2; referees: 3 approved

    Directory of Open Access Journals (Sweden)

    Karolina Wartolowska

    2018-01-01

    Full Text Available In this paper, we use evidence from our earlier review of surgical randomised controlled trials with a placebo arm to show that blinding in trials of interventional procedures is feasible. We give examples of ingenious strategies that have been used to simulate the active procedure and to make the placebo control indistinguishable from the active treatment. We discuss why it is important to blind of patients, assessors, and caregivers and what types of bias that may occur in interventional trials. Finally, we describe the benefits of blinding, from the obvious ones such as avoiding bias, as well as less evident benefits such as avoiding patient drop out in the control arm.

  11. Trends in global approvals of biotech crops (1992-2014).

    Science.gov (United States)

    Aldemita, Rhodora R; Reaño, Ian Mari E; Solis, Renando O; Hautea, Randy A

    2015-01-01

    With the increasing number of genetically modified (GM) events, traits, and crops that are developed to benefit the global population, approval of these technologies for food, feed, cultivation and import in each country may vary depending on needs, demand and trade interest. ISAAA established a GMO Approval Database to document global approvals of biotech crops. GM event name, crops, traits, developer, year of approval for cultivation, food/feed, import, and relevant dossiers were sourced from credible government regulatory websites and biosafety clearinghouses. This paper investigates the trends in GM approvals for food, feed and cultivation based on the number of approving countries, GM crops, events, and traits in the last 23 y (1992-2014), rationale for approval, factors influencing approvals, and their implications in GM crop adoption. Results show that in 2014, there was an accumulative increase in the number of countries granting approvals at 29 (79% developing countries) for commercial cultivation and 31 (70% developing countries) for food and 19 (80% developing developing) for feed; 2012 had the highest number of approving countries and cultivation approvals; 2011 had the highest number of country approvals for feed, and 2014 for food approvals. Herbicide tolerance trait had the highest events approved, followed by insect tolerance traits. Approvals for food product quality increased in the second decade. Maize had the highest number of events approved (single and stacked traits), and stacked traits product gradually increased which is already 30% of the total trait approvals. These results may indicate understanding and acceptance of countries to enhance regulatory capability to be able to benefit from GM crop commercialization. Hence, the paper provided information on the trends on the growth of the GM crop industry in the last 23 y which may be vital in predicting future GM crops and traits.

  12. 40 CFR 52.2352 - Change to approved plan.

    Science.gov (United States)

    2010-07-01

    ... Utah's approved State Implementation Plan (SIP). This rule language pertains to State Sales Tax... 40 Protection of Environment 4 2010-07-01 2010-07-01 false Change to approved plan. 52.2352... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Utah § 52.2352 Change to approved...

  13. Alternative dispute resolution of medical-legal issues.

    Science.gov (United States)

    Barton, H M

    1991-02-01

    Even the most casual observer of medical-legal litigation knows that such disputes take a long time to resolve, cost too much, and often leave parties no better off than before. Litigation also has deleterious effects where the parties have an ongoing relationship outside the courtroom. Such problems plague all litigation, however, and have prompted courts and legislatures to explore alternatives to the traditional means of solving private disputes through the filing and trial of lawsuits. In Texas, this effort resulted in the 1989 passage of the Texas Alternative Dispute Resolution Act (Texas ADR Act), which declares a state policy encouraging "the peaceable resolution of disputes....and the early settlement of pending litigation through voluntary settlement procedures" (1). This article examines alternative dispute resolution methods and explores their application to medical-legal issues.

  14. Forenkling af procedurer for klinisk lægemiddelforskning i EU på vej

    DEFF Research Database (Denmark)

    Bach, Karin Friis; Jørgensen, Annette

    2013-01-01

    to a greater harmonisation within the EU, a more smooth approval procedure, and a lowering of the administrative burden. Details are still to be discussed, and waiting until 2016 when the new rules are adopted is definitely a problem, but all together the new proposal is to be regarded as good news......Simplification of procedures for clinical drug trials in the EU is coming up A proposal for a new regulation on clinical trials that will replace the Clinical Trials Directive has been launched by the EU Commission the 17 July 2012. The proposal contains ideas that undoubtedly will lead...

  15. The Evolution of Approval Services.

    Science.gov (United States)

    Warzala, Martin

    1994-01-01

    Describes major developments in book approval plans used by academic libraries for acquisition and for information dissemination and document distribution services based on approval-like concepts. Topics addressed include publishers; marketing; the impact of library automation; value-added services; the economic climate; the influence of…

  16. Could conscious sedation with midazolam for dental procedures be ...

    African Journals Online (AJOL)

    CS) with intravenous midazolam could become an alternative modality to general anesthesia (GA) for dental procedures. Materials and Methods: In our study, 58 and 47 American Society of Anesthesiologists (ASA).1 pediatric patients, aged ...

  17. 48 CFR 750.7105 - Approving authorities.

    Science.gov (United States)

    2010-10-01

    ... CONTRACT MANAGEMENT EXTRAORDINARY CONTRACTUAL ACTIONS Extraordinary Contractual Actions To Protect Foreign Policy Interests of the United States 750.7105 Approving authorities. All authority to approve actions...

  18. Long-term strategies for flood risk management: scenario definition and strategic alternative design

    NARCIS (Netherlands)

    Bruijn, de K.; Klijn, F.; McGahey, C.; Mens, M.; Wolfert, H.P.

    2008-01-01

    This report reviews some mainstream existing methods of scenario development and use, as well as experiences with the design and assessment of strategic alternatives for flood risk management. Next, a procedure and methods are proposed and discussed. Thirdly, the procedure and methods are tried on

  19. Belief in the efficacy of alternative medicine among general practitioners in The Netherlands

    NARCIS (Netherlands)

    Knipschild, P.; Kleijnen, J.; ter Riet, G.

    1990-01-01

    A survey among 293 GPs in the Netherlands showed that many believe in the efficacy of common alternative procedures. High scores were especially found for manual therapy, yoga, acupuncture, hot bath therapy and homoeopathy. Other procedures, such as iridology, faith healing and many food

  20. A Survey of Procedural Methods for Terrain Modelling

    NARCIS (Netherlands)

    Smelik, R.M.; Kraker, J.K. de; Groenewegen, S.A.; Tutenel, T.; Bidarra, R.

    2009-01-01

    Procedural methods are a promising but underused alternative to manual content creation. Commonly heard drawbacks are the randomness of and the lack of control over the output and the absence of integrated solutions, although more recent publications increasingly address these issues. This paper

  1. 9975 Shipping Package Performance Of Alternate Materials For Long-Term Storage Application

    International Nuclear Information System (INIS)

    Skidmore, E.; Hoffman, E.; Daugherty, W.

    2010-01-01

    The Model 9975 shipping package specifies the materials of construction for its various components. With the loss of availability of material for two components (cane fiberboard overpack and Viton(reg s ign) GLT O-rings), alternate materials of construction were identified and approved for use for transport (softwood fiberboard and Viton(reg s ign) GLT-S O-rings). As these shipping packages are part of a long-term storage configuration at the Savannah River Site, additional testing is in progress to verify satisfactory long-term performance of the alternate materials under storage conditions. The test results to date can be compared to comparable results on the original materials of construction to draw preliminary conclusions on the performance of the replacement materials.

  2. 41 CFR 102-38.315 - Are we required to use Alternative Disputes Resolution for sales contracts?

    Science.gov (United States)

    2010-07-01

    ... Alternative Disputes Resolution for sales contracts? 102-38.315 Section 102-38.315 Public Contracts and... required to use Alternative Disputes Resolution for sales contracts? No, you are not required to use Alternative Disputes Resolution (ADR) for sales contracts. However, you are encouraged to use ADR procedures...

  3. Selection and Evaluation of Alternative Solvents for Caprolactam Extraction

    NARCIS (Netherlands)

    van Delden, M.L.; Kuipers, N.J.M.; de Haan, A.B.

    2006-01-01

    Because of the strict legislation for currently applied solvents in the industrial extraction of caprolactam, being benzene, toluene and chlorinated hydrocarbons, a need exists for alternative, environmentally benign solvents. An experimental screening procedure consisting of several steps was used

  4. Selection and evaluation of alternative solvents for caprolactam extraction

    NARCIS (Netherlands)

    Delden, van M.L.; Kuipers, N.J.M.; Haan, de A.B.

    2006-01-01

    Because of the strict legislation for currently applied solvents in the industrial extraction of caprolactam, being benzene, toluene and chlorinated hydrocarbons, a need exists for alternative, environmentally benign solvents. An experimental screening procedure consisting of several steps was used

  5. Vedolizumab: first global approval.

    Science.gov (United States)

    Poole, Raewyn M

    2014-07-01

    Vedolizumab [Entyvio(®) (US, Europe)], a humanized monoclonal antibody α4β7 integrin receptor antagonist, has been developed by Millennium Pharmaceuticals (d/b/a Takeda Pharmaceuticals International) for the treatment of ulcerative colitis and Crohn's disease. Vedolizumab has received its first global approval for the treatment of ulcerative colitis and Crohn's disease in the US, for use in adult patients with moderate-to-severe disease who have had an inadequate response, loss of response or intolerance to one or more standard therapies (corticosteroids, immunomodulators or tumour necrosis factor-α inhibitor) or demonstrated dependence on corticosteroids. Vedolizumab has since been approved for ulcerative colitis and Crohn's disease in the EU, Norway, Iceland and Liechtenstein. This article summarizes the milestones in the development of vedolizumab leading to its first approval for the treatment of ulcerative colitis and Crohn's disease.

  6. Effect of methylphenidate on enhancement of spatial learning by novel alternated dual task.

    Science.gov (United States)

    Veetil, Praveen Kottath; Mukkadan, Joseph Kurian

    2011-01-01

    The novel alternated dual task (ADT) arranged rats to learn T-maze spontaneous alternation task and radial arm maze (RAM) task alternatively, and by doing ADT, rats could acquire the tasks more easily than non alternated dual task (NADT) group. Also retention capacity of ADT group was significantly more and ADT help to learn a complex task faster than learning it in isolation from other tasks. In the present study effect of methylphenidate (MPD), a mood elevator, known to enhance learning and memory, on ADT procedure is assessed. Also effect of ADT procedure and MPD on spatial learning and memory are compared. Different groups were assigned by administering MPD (intraperitoneal injection at a dose of 3 mg/kg body weight) during different phases of behavioural experiments, and control groups received saline injection. MPD administration increased both acquisition and retention capacities. The amelioration attained for retention of complex task by ADT procedure, could be achieved by NADT rats only by administration of MPD. The influence of ADT procedure on acquisition and retention of TM and RAM tasks were similar to the effects of MPD, especially for the RAM task. MPD at low dose is found to enhance the learning and memory capacity in rats, than deteriorating it, supporting the use of MPD as a drug to treat attention deficit hyperactive disorder. The recent reports suggesting the effect of MPD only on retention and not on acquisition could not be confirmed, as enhancement for both acquisition and retention was found in this study.

  7. Design and drafting document control procedures for CPRF/ZTH experiment

    International Nuclear Information System (INIS)

    Pollat, L.L.; Kewish, R.W.

    1989-01-01

    This paper will present, in general, the control procedures for design approval, review, changes, and release of engineering documents. It will also discuss interface control for tasks so that possible design interference does not occur. A document control procedure to insure that design criteria are met and technical specifications translate into workable drawings was instituted to support the Confinement Physics Research Facility (CPRF/ZTH) construction program. Our goal, to eliminate any conflicts that might arise between various tasks as the final designs are developed, required tight control and up-to-date design information. Detailed procedure for reviews were instituted, since circumventing the process of design and drafting anywhere might have proven disastrous to the CPRF/ZTH program. Design is a process of translating technical requirements, according to established standards, into drawings that are usable for fabrication and assembly. Both the designer and engineer are responsible for adhering to standards that have been established by the Mechanical Engineering Section for the CPRF/ZTH program. 6 refs., 5 figs

  8. 20 CFR 617.22 - Approval of training.

    Science.gov (United States)

    2010-04-01

    .... Perkins Vocational and Applied Technology Education Act, and employers). (i) This means that training is...) Conditions for approval. Training shall be approved for an adversely affected worker if the State agency...) available for an adversely affected worker. (i) This means that for the worker for whom approval of training...

  9. Participation and Performance Reporting for the Alternate Assessment Based on Modified Achievement Standards (AA-MAS). Technical Report 58

    Science.gov (United States)

    Albus, Deb; Thurlow, Martha L.; Lazarus, Sheryl S.

    2011-01-01

    This report examines publicly reported participation and performance data for the alternate assessment based on modified achievement standards (AA-MAS). The authors' analysis of these data included all states publicly reporting AA-MAS data, regardless of whether they had received approval to use the results for Title I accountability calculations.…

  10. Procedures for Selecting Items for Computerized Adaptive Tests.

    Science.gov (United States)

    Kingsbury, G. Gage; Zara, Anthony R.

    1989-01-01

    Several classical approaches and alternative approaches to item selection for computerized adaptive testing (CAT) are reviewed and compared. The study also describes procedures for constrained CAT that may be added to classical item selection approaches to allow them to be used for applied testing. (TJH)

  11. 30 CFR 75.1108 - Approved conveyor belts.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved conveyor belts. 75.1108 Section 75... Fire-Resistant Hydraulic Fluids on Underground Equipment § 75.1108 Approved conveyor belts. (a) Until December 31, 2009 conveyor belts placed in service in underground coal mines shall be: (1) Approved under...

  12. 45 CFR 1340.13 - Approval of applications.

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 4 2010-10-01 2010-10-01 false Approval of applications. 1340.13 Section 1340.13... NEGLECT PREVENTION AND TREATMENT PROGRAM CHILD ABUSE AND NEGLECT PREVENTION AND TREATMENT Grants to States § 1340.13 Approval of applications. (a) The Commissioner shall approve an application for an award for...

  13. Improvement of national legislation in alternative resolution of legal disputes area

    Directory of Open Access Journals (Sweden)

    Ярослав Павлович Любченко

    2016-01-01

    Full Text Available Problem setting. Current legislation does not adequately regulate using of alternative dispute resolution. The article emphasizes the need for amending existing legislation to ensure its compliance with international standards, its obligations in connection with the signing of the Association Agreement and ensure efficient use of alternative dispute resolution (hereinafter - ADR party relations. Recent research and publications analysis. Problems of alternative dispute resolution were viewed in their works viewed N. Bondarenko-Zelinska, Y. Pritika, O. Spectr, A. Shypilova, V. Yakovleva and others. Paper objective The article goal is to analyze the proposals of the Constitutional Commission in the field of justice, as well as analysis of bills related to ADR, research of problems of legal regulation, which will help optimize procedures and improve the law in general. The paper main body. Realization of economic, political, governmental, legal and other reforms in society lead to a significant strengthening of social and legal tensions, the emergence of a large number of conflicts in the legal field. Traditionally, parties use courts that are organized and funded by the state in order to protect rights and legal interests. However, justice for many obvious advantages has several disadvantages: a large workload of courts, length and complexity of the proceedings, considerable legal costs not properly worked out mechanism of the principle of competition and equality. Conclusions of the research. Problems of alternative dispute resolution in domestic legal literature are mostly synthesis and theoretical. Various alternative forms, procedures, and methods are used by foreign countries, along with the traditional proceedings. They do not replace justice and do not deprive the persons right for judicial protection. Instead, give them a choice between public or non-governmental (private forms of resolving legal disputes, allowing parties to decide which

  14. Analysis of quantile regression as alternative to ordinary least squares

    OpenAIRE

    Ibrahim Abdullahi; Abubakar Yahaya

    2015-01-01

    In this article, an alternative to ordinary least squares (OLS) regression based on analytical solution in the Statgraphics software is considered, and this alternative is no other than quantile regression (QR) model. We also present goodness of fit statistic as well as approximate distributions of the associated test statistics for the parameters. Furthermore, we suggest a goodness of fit statistic called the least absolute deviation (LAD) coefficient of determination. The procedure is well ...

  15. Belief in the efficacy of alternative medicine among general practitioners in The Netherlands.

    Science.gov (United States)

    Knipschild, P; Kleijnen, J; ter Riet, G

    1990-01-01

    A survey among 293 GPs in the Netherlands showed that many believe in the efficacy of common alternative procedures. High scores were especially found for manual therapy, yoga, acupuncture, hot bath therapy and homoeopathy. Other procedures, such as iridology, faith healing and many food supplements, were considered less useful.

  16. Workflow optimisation for multimodal imaging procedures: a case of combined X-ray and MRI-guided TACE.

    Science.gov (United States)

    Fernández-Gutiérrez, Fabiola; Wolska-Krawczyk, Malgorzata; Buecker, Arno; Houston, J Graeme; Melzer, Andreas

    2017-02-01

    This study presents a framework for workflow optimisation of multimodal image-guided procedures (MIGP) based on discrete event simulation (DES). A case of a combined X-Ray and magnetic resonance image-guided transarterial chemoembolisation (TACE) is presented to illustrate the application of this method. We used a ranking and selection optimisation algorithm to measure the performance of a number of proposed alternatives to improve a current scenario. A DES model was implemented with detail data collected from 59 TACE procedures and durations of magnetic resonance imaging (MRI) diagnostic procedures usually performed in a common MRI suite. Fourteen alternatives were proposed and assessed to minimise the waiting times and improve workflow. Data analysis observed an average of 20.68 (7.68) min of waiting between angiography and MRI for TACE patients in 71.19% of the cases. Following the optimisation analysis, an alternative was identified to reduce waiting times in angiography suite up to 48.74%. The model helped to understand and detect 'bottlenecks' during multimodal TACE procedures, identifying a better alternative to the current workflow and reducing waiting times. Simulation-based workflow analysis provides a cost-effective way to face some of the challenges of introducing MIGP in clinical radiology, highligthed in this study.

  17. 46 CFR 188.10-3 - Approved container.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 7 2010-10-01 2010-10-01 false Approved container. 188.10-3 Section 188.10-3 Shipping... PROVISIONS Definition of Terms Used in This Subchapter § 188.10-3 Approved container. This term means a container which is properly labeled, marked and approved by DOT for the commodity which it contains. [CGFR...

  18. Testing a potential alternative to traditional identification procedures: Reaction time-based concealed information test does not work for lineups with cooperative witnesses.

    Science.gov (United States)

    Sauerland, Melanie; Wolfs, Andrea C F; Crans, Samantha; Verschuere, Bruno

    2017-11-27

    Direct eyewitness identification is widely used, but prone to error. We tested the validity of indirect eyewitness identification decisions using the reaction time-based concealed information test (CIT) for assessing cooperative eyewitnesses' face memory as an alternative to traditional lineup procedures. In a series of five experiments, a total of 401 mock eyewitnesses watched one of 11 different stimulus events that depicted a breach of law. Eyewitness identifications in the CIT were derived from longer reaction times as compared to well-matched foil faces not encountered before. Across the five experiments, the weighted mean effect size d was 0.14 (95% CI 0.08-0.19). The reaction time-based CIT seems unsuited for testing cooperative eyewitnesses' memory for faces. The careful matching of the faces required for a fair lineup or the lack of intent to deceive may have hampered the diagnosticity of the reaction time-based CIT.

  19. Office-based deep sedation for pediatric ophthalmologic procedures using a sedation service model.

    Science.gov (United States)

    Lalwani, Kirk; Tomlinson, Matthew; Koh, Jeffrey; Wheeler, David

    2012-01-01

    Aims. (1) To assess the efficacy and safety of pediatric office-based sedation for ophthalmologic procedures using a pediatric sedation service model. (2) To assess the reduction in hospital charges of this model of care delivery compared to the operating room (OR) setting for similar procedures. Background. Sedation is used to facilitate pediatric procedures and to immobilize patients for imaging and examination. We believe that the pediatric sedation service model can be used to facilitate office-based deep sedation for brief ophthalmologic procedures and examinations. Methods. After IRB approval, all children who underwent office-based ophthalmologic procedures at our institution between January 1, 2000 and July 31, 2008 were identified using the sedation service database and the electronic health record. A comparison of hospital charges between similar procedures in the operating room was performed. Results. A total of 855 procedures were reviewed. Procedure completion rate was 100% (C.I. 99.62-100). There were no serious complications or unanticipated admissions. Our analysis showed a significant reduction in hospital charges (average of $1287 per patient) as a result of absent OR and recovery unit charges. Conclusions. Pediatric ophthalmologic minor procedures can be performed using a sedation service model with significant reductions in hospital charges.

  20. Office-Based Deep Sedation for Pediatric Ophthalmologic Procedures Using a Sedation Service Model

    Directory of Open Access Journals (Sweden)

    Kirk Lalwani

    2012-01-01

    Full Text Available Aims. (1 To assess the efficacy and safety of pediatric office-based sedation for ophthalmologic procedures using a pediatric sedation service model. (2 To assess the reduction in hospital charges of this model of care delivery compared to the operating room (OR setting for similar procedures. Background. Sedation is used to facilitate pediatric procedures and to immobilize patients for imaging and examination. We believe that the pediatric sedation service model can be used to facilitate office-based deep sedation for brief ophthalmologic procedures and examinations. Methods. After IRB approval, all children who underwent office-based ophthalmologic procedures at our institution between January 1, 2000 and July 31, 2008 were identified using the sedation service database and the electronic health record. A comparison of hospital charges between similar procedures in the operating room was performed. Results. A total of 855 procedures were reviewed. Procedure completion rate was 100% (C.I. 99.62–100. There were no serious complications or unanticipated admissions. Our analysis showed a significant reduction in hospital charges (average of $1287 per patient as a result of absent OR and recovery unit charges. Conclusions. Pediatric ophthalmologic minor procedures can be performed using a sedation service model with significant reductions in hospital charges.

  1. A simplified LBB evaluation procedure for austenitic and ferritic steel piping

    International Nuclear Information System (INIS)

    Gamble, R.M.; Wichman, K.R.

    1997-01-01

    The NRC previously has approved application of LBB analysis as a means to demonstrate that the probability of pipe rupture was extremely low so that dynamic loads associated with postulated pipe break could be excluded from the design basis (1). The purpose of this work was to: (1) define simplified procedures that can be used by the NRC to compute allowable lengths for circumferential throughwall cracks and assess margin against pipe fracture, and (2) verify the accuracy of the simplified procedures by comparison with available experimental data for piping having circumferential throughwall flaws. The development of the procedures was performed using techniques similar to those employed to develop ASME Code flaw evaluation procedures. The procedures described in this report are applicable to pipe and pipe fittings with: (1) wrought austenitic steel (Ni-Cr-Fe alloy) having a specified minimum yield strength less than 45 ksi, and gas metal-arc, submerged arc and shielded metal-arc austentic welds, and (2) seamless or welded wrought carbon steel having a minimum yield strength not greater than 40 ksi, and associated weld materials. The procedures can be used for cast austenitic steel when adequate information is available to place the cast material toughness into one of the categories identified later in this report for austenitic wrought and weld materials

  2. A simplified LBB evaluation procedure for austenitic and ferritic steel piping

    Energy Technology Data Exchange (ETDEWEB)

    Gamble, R.M.; Wichman, K.R.

    1997-04-01

    The NRC previously has approved application of LBB analysis as a means to demonstrate that the probability of pipe rupture was extremely low so that dynamic loads associated with postulated pipe break could be excluded from the design basis (1). The purpose of this work was to: (1) define simplified procedures that can be used by the NRC to compute allowable lengths for circumferential throughwall cracks and assess margin against pipe fracture, and (2) verify the accuracy of the simplified procedures by comparison with available experimental data for piping having circumferential throughwall flaws. The development of the procedures was performed using techniques similar to those employed to develop ASME Code flaw evaluation procedures. The procedures described in this report are applicable to pipe and pipe fittings with: (1) wrought austenitic steel (Ni-Cr-Fe alloy) having a specified minimum yield strength less than 45 ksi, and gas metal-arc, submerged arc and shielded metal-arc austentic welds, and (2) seamless or welded wrought carbon steel having a minimum yield strength not greater than 40 ksi, and associated weld materials. The procedures can be used for cast austenitic steel when adequate information is available to place the cast material toughness into one of the categories identified later in this report for austenitic wrought and weld materials.

  3. Integration of new technology into clinical practice after FDA approval.

    Science.gov (United States)

    Govil, Ashul; Hao, Steven C

    2016-10-01

    Development of new medical technology is a crucial part of the advancement of medicine and our ability to better treat patients and their diseases. This process of development is long and arduous and requires a significant investment of human, financial and material capital. However, technology development can be rewarded richly by its impact on patient outcomes and successful sale of the product. One of the major regulatory hurdles to technology development is the Food and Drug Administration (FDA) approval process, which is necessary before a technology can be marketed and sold in the USA. Many businesses, medical providers and consumers believe that the FDA approval process is the only hurdle prior to use of the technology in day-to-day care. In order for the technology to be adopted into clinical use, reimbursement for both the device as well as the associated work performed by physicians and medical staff must be in place. Work and coverage decisions require Current Procedural Terminology (CPT) code development and Relative Value Scale Update Committee (RUC) valuation determination. Understanding these processes is crucial to the timely availability of new technology to patients and providers. Continued and better partnerships between physicians, industry, regulatory bodies and payers will facilitate bringing technology to market sooner and ensure appropriate utilization.

  4. Elimination of Whole Effluent Toxicity NPDES Permit Limits through the Use of an Alternative Testing Species and Reasonable Potential Analysis

    International Nuclear Information System (INIS)

    PAYNE, W.L.

    2004-01-01

    The cladoceran, Ceriodaphnia dubia (C. dubia), is required by the State of South Carolina to be used in whole effluent toxicity (WET) compliance tests in order to meet limits contained within National Pollutant Discharge Elimination System (NPDES) permits. Westinghouse Savannah River Company (WSRC) experienced WET test failures for no clear reason over a long period of time. Toxicity identification examinations on effluents did not indicate the presence of toxicants; therefore, the WET test itself was brought under suspicion. Research was undertaken with an alternate cladoceran, Daphnia ambigua (D. ambigua). It was determined that this species survives better in soft water, so approval was obtained from regulating authorities to use this ''alternate'' species in WET tests. The result was better test results and elimination of non-compliances. The successful use of D. ambigua allowed WSRC to gain approval from the South Carolina Department of Health and Environmental Control (SCDHEC) to remove WET limits from the NPDES permit

  5. SQUG cable tray and conduit evaluation procedure

    International Nuclear Information System (INIS)

    Smith, P.D.; Eder, S.J.; Conoscente, J.P.

    1990-01-01

    Cable tray and conduit systems for electrical cables are a common feature and industrial facilities. They have an excellent performance history in past strong earthquake, even though they are rarely designed for earthquakes. Considerable data have been gathered on their performance in earthquakes and in shake table testing. The data have been used to develop a procedure for the verification of the seismic adequacy of cable tray and conduit systems in operating nuclear plants. The procedure is discussed in this paper. It will result in substantial savings, such as reduced engineering effort, fewer modifications of existing hardware, and simpler documentation, relative to alternate procedures like dynamic analysis of shake table testing. The procedure ensures safety-function in a unique manner since the methodology used to develop it (1) is based on a large body of historical data and (2) uses a relative approach of ensuring that nuclear plant systems will perform at least as well as systems that performed well in past earthquakes. (orig.)

  6. A Comparison of Error-Correction Procedures on Skill Acquisition during Discrete-Trial Instruction

    Science.gov (United States)

    Carroll, Regina A.; Joachim, Brad T.; St. Peter, Claire C.; Robinson, Nicole

    2015-01-01

    Previous research supports the use of a variety of error-correction procedures to facilitate skill acquisition during discrete-trial instruction. We used an adapted alternating treatments design to compare the effects of 4 commonly used error-correction procedures on skill acquisition for 2 children with attention deficit hyperactivity disorder…

  7. Radioimmunoassay and related procedures in medicine 1982

    International Nuclear Information System (INIS)

    1982-01-01

    Of the 77 papers submitted, 69 were included in INIS. The papers included in the proceedings cover the following sessions: reagents and separation procedures; assay for free hormones; assay for biological substances; assay for drugs; data processing; intralaboratory quality control; external surveillance of assay performance; assay service in developing countries; public health applications; clinical applications; alternatives to radioassay

  8. Trends in global approvals of biotech crops (1992–2014)

    Science.gov (United States)

    Aldemita, Rhodora R; Reaño, Ian Mari E; Solis, Renando O; Hautea, Randy A

    2015-01-01

    ABSTRACT With the increasing number of genetically modified (GM) events, traits, and crops that are developed to benefit the global population, approval of these technologies for food, feed, cultivation and import in each country may vary depending on needs, demand and trade interest. ISAAA established a GMO Approval Database to document global approvals of biotech crops. GM event name, crops, traits, developer, year of approval for cultivation, food/feed, import, and relevant dossiers were sourced from credible government regulatory websites and biosafety clearinghouses. This paper investigates the trends in GM approvals for food, feed and cultivation based on the number of approving countries, GM crops, events, and traits in the last 23 y (1992–2014), rationale for approval, factors influencing approvals, and their implications in GM crop adoption. Results show that in 2014, there was an accumulative increase in the number of countries granting approvals at 29 (79% developing countries) for commercial cultivation and 31 (70% developing countries) for food and 19 (80% developing developing) for feed; 2012 had the highest number of approving countries and cultivation approvals; 2011 had the highest number of country approvals for feed, and 2014 for food approvals. Herbicide tolerance trait had the highest events approved, followed by insect tolerance traits. Approvals for food product quality increased in the second decade. Maize had the highest number of events approved (single and stacked traits), and stacked traits product gradually increased which is already 30% of the total trait approvals. These results may indicate understanding and acceptance of countries to enhance regulatory capability to be able to benefit from GM crop commercialization. Hence, the paper provided information on the trends on the growth of the GM crop industry in the last 23 y which may be vital in predicting future GM crops and traits. PMID:26039675

  9. 34 CFR 668.149 - Special provisions for the approval of assessment procedures for special populations for whom no...

    Science.gov (United States)

    2010-07-01

    ... procedure or instrument measures both basic verbal and quantitative skills at the secondary school level. (2... recommended by the test developer, provided that the test administrator— (i) Uses those procedures or... verbal and quantitative skills at the secondary school level; and (4) The passing scores and the methods...

  10. Cocaine choice procedures in animals, humans, and treatment-seekers: Can we bridge the divide?

    Science.gov (United States)

    Moeller, Scott J.; Stoops, William W.

    2015-01-01

    Individuals with cocaine use disorder chronically self-administer cocaine to the detriment of other rewarding activities, a phenomenon best modeled in laboratory drug-choice procedures. These procedures can evaluate the reinforcing effects of drugs versus comparably valuable alternatives under multiple behavioral arrangements and schedules of reinforcement. However, assessing drug-choice in treatment-seeking or abstaining humans poses unique challenges: for ethical reasons, these populations typically cannot receive active drugs during research studies. Researchers have thus needed to rely on alternative approaches that approximate drug-choice behavior or assess more general forms of decision-making, but whether these alternatives have relevance to real-world drug-taking that can inform clinical trials is not well-understood. In this mini-review, we (A) summarize several important modulatory variables that influence cocaine choice in nonhuman animals and non-treatment seeking humans; (B) discuss some of the ethical considerations that could arise if treatment-seekers are enrolled in drug-choice studies; (C) consider the efficacy of alternative procedures, including non-drug-related decision-making and ‘simulated’ drug-choice (a choice is made, but no drug is administered) to approximate drug choice; and (D) suggest opportunities for new translational work to bridge the current divide between preclinical and clinical research. PMID:26432174

  11. Introducing Alternative-Based Thresholding for Defining Functional Regions of Interest in fMRI

    Directory of Open Access Journals (Sweden)

    Jasper Degryse

    2017-04-01

    Full Text Available In fMRI research, one often aims to examine activation in specific functional regions of interest (fROIs. Current statistical methods tend to localize fROIs inconsistently, focusing on avoiding detection of false activation. Not missing true activation is however equally important in this context. In this study, we explored the potential of an alternative-based thresholding (ABT procedure, where evidence against the null hypothesis of no effect and evidence against a prespecified alternative hypothesis is measured to control both false positives and false negatives directly. The procedure was validated in the context of localizer tasks on simulated brain images and using a real data set of 100 runs per subject. Voxels categorized as active with ABT can be confidently included in the definition of the fROI, while inactive voxels can be confidently excluded. Additionally, the ABT method complements classic null hypothesis significance testing with valuable information by making a distinction between voxels that show evidence against both the null and alternative and voxels for which the alternative hypothesis cannot be rejected despite lack of evidence against the null.

  12. HyApproval - Handbook for the approval of hydrogen refuelling stations - First preliminary achievements

    Energy Technology Data Exchange (ETDEWEB)

    Wurster, R.; Vandendungen, G.; Guichard, J.; Molag, M.; Barron, J.; Reijalt, M.; Hill, H.J.; Landinger, H.

    2007-05-15

    The EU-funded project HyApproval [www.hyapproval.org] aims at developing a universal Handbook to facilitate the approval process of Hydrogen Refuelling Stations (HRS) in Europe. The main goal of the HyApproval partnership with 22 partners from Europe and one each from China, Japan and the USA is to provide a Handbook of technical and regulatory requirements to assist authorisation officials, companies and organisations in the safe implementation and operation of HRS. Achievements during the first 15 months: analyses of HRS technology concepts and of equipment and safety distances/ Intermediate Design Paper/ Regulations, Codes and Standards (RCS) review and comparison/ first Handbook draft and first review sessions with HySafe experts/ safety matrix/ identification of accident scenarios/ agreement on safety documentation/ critical review of reliability data from collections and risk studies/ risk assessment (RA) criteria definition and RA/ matrix of acceptability and awareness levels/ database of Fire Associations and First Responders/ calendar of hydrogen events/ general description of CGH{sub 2} interfaces. (au)

  13. Optimized procedure for calibration and verification multileaf collimator from Elekta Synergy accelerator

    International Nuclear Information System (INIS)

    Castel Millan, A.; Perellezo Mazon, A.; Fernandez Ibiza, J.; Arnalte Olloquequi, M.; Armengol Martinez, S.; Rodriguez Rey, A.; Guedea Edo, F.

    2011-01-01

    The objective of this work is to design an optimized procedure for calibration and verification of a multileaf collimator used so as to allow the EPID and the image plate in a complementary way, using different processing systems. With this procedure we have two equivalent alternative as the same parameters obtained for the calibration of multileaf Elekta Synergy accelerator.

  14. Emotion Monitoring – Verification of Physiological Characteristics Measurement Procedures

    Directory of Open Access Journals (Sweden)

    Landowska Agnieszka

    2014-12-01

    Full Text Available This paper concerns measurement procedures on an emotion monitoring stand designed for tracking human emotions in the Human-Computer Interaction with physiological characteristics. The paper addresses the key problem of physiological measurements being disturbed by a motion typical for human-computer interaction such as keyboard typing or mouse movements. An original experiment is described, that aimed at practical evaluation of measurement procedures performed at the emotion monitoring stand constructed at GUT. Different locations of sensors were considered and evaluated for suitability and measurement precision in the Human- Computer Interaction monitoring. Alternative locations (ear lobes and forearms for skin conductance, blood volume pulse and temperature sensors were proposed and verified. Alternative locations proved correlation with traditional locations as well as lower sensitiveness to movements like typing or mouse moving, therefore they can make a better solution for monitoring the Human-Computer Interaction.

  15. Legislation hampers medical research in acute situations

    DEFF Research Database (Denmark)

    Thomsen, Jakob Hartvig; Hassager, Christian; Bro-Jeppesen, John

    2015-01-01

    situations. The Ethics Committees' approval of the trial justified by their competence and authority, combined with the NOK´s insight into the patient's wishes may be a relevant and feasible alternative to the current consent procedure. FUNDING: This work was supported by the European Regional Development...

  16. Analysis of the Education Program Approval Process: A Program Evaluation.

    Science.gov (United States)

    Fountaine, Charles A.; And Others

    A study of the education program approval process involving the Veterans Administration (VA) and the State Approving Agencies (SAAs) had the following objectives: to describe the present education program approval process; to determine time and costs associated with the education program approval process; to describe the approval process at…

  17. ALTERNATIVE DISPUTE RESOLUTION

    Directory of Open Access Journals (Sweden)

    Mihaela Irina IONESCU

    2016-05-01

    Full Text Available Alternative dispute resolution (ADR includes dispute resolution processes and techniques that act as a means for disagreeing parties to come to an agreement short of litigation. It is a collective term for the ways that parties can settle disputes, with (or without the help of a third party. Despite historic resistance to ADR by many popular parties and their advocates, ADR has gained widespread acceptance among both the general public and the legal profession in recent years. In fact, some courts now require some parties to resort to ADR of some type, before permitting the parties' cases to be tried. The rising popularity of ADR can be explained by the increasing caseload of traditional courts, the perception that ADR imposes fewer costs than litigation, a preference for confidentiality, and the desire of some parties to have greater control over the selection of the individual or individuals who will decide their dispute. Directive 2013/11/EU of the European Parliament and of the Council on alternative dispute resolution for consumer disputes and amending Regulation (EC No 2006/2004 and Directive 2009/22/EC (hereinafter „Directive 2013/11/EU” aims to ensure a high level of consumer protection and the proper functioning of the internal market by ensuring that complaints against traders can be submitted by consumers on a voluntary basis, to entities of alternative disputes which are independent, impartial, transparent, effective, simple,quick and fair. Directive 2013/11/EU establishes harmonized quality requirements for entities applying alternative dispute resolution procedure (hereinafter "ADR entity" to provide the same protection and the same rights of consumers in all Member States. Besides this, the present study is trying to present broadly how are all this trasposed in the romanian legislation.

  18. Treatment of intervertebral disc degenerative disease using percutaneous nucleotomy–an overview of less invasive procedures

    Directory of Open Access Journals (Sweden)

    Miran Jeromel

    2014-04-01

    Full Text Available Background: Less invasive treatment methods for intervertebral disc disease and decompression of neural structures as a consequence of contained disc herniation represent an alternative to surgical procedure. Percutaneus nucleotomy uses a percutaneous approach to the intervertebral disc. The article presents the evolution of numerous procedureds in clinical practice.Methods: Percutaneous nucleoplasty is a fluoroscopy-guided procedure which enables controlled and safe entrance into the intervertebral disc. The procedure is performed under strict aseptic conditions, using a local anaesthesia with the patient under analgosedation. Based on the principle of therapeutic intradiscal action, the procedures can be divided into three groups: chemical (chemonucleolysis with chimopapain, alcohol, ozone, mechanical (automated percutaneous lumbar discectomy – APLD, arthroscopic discectomy and thermical methods (laser, radiofrequency ablation, intradiscal electrothermal annuloplasty – IDET, Coblation®.Results: Percutaneous nucleotomy by the majority of the mentioned procedures results in a therapeutic effect (reduction of pain and decompression of neural structures. Fast recovery represents a major advantage of less invasive treatment.Conclusions: Less invasive method (nucleotomy using different procedures represents a successful alternative approach to surgical discectomy. Proper patient selection and safe technique are mandatory in order to achieve a good clinical outcome.

  19. Inferior alveolar nerve block: Alternative technique

    OpenAIRE

    Thangavelu, K.; Kannan, R.; Kumar, N. Senthil

    2012-01-01

    Background: Inferior alveolar nerve block (IANB) is a technique of dental anesthesia, used to produce anesthesia of the mandibular teeth, gingivae of the mandible and lower lip. The conventional IANB is the most commonly used the nerve block technique for achieving local anesthesia for mandibular surgical procedures. In certain cases, however, this nerve block fails, even when performed by the most experienced clinician. Therefore, it would be advantageous to find an alternative simple techni...

  20. Simulating the Use of Alternative Fuels in a Turbofan Engine

    Science.gov (United States)

    Litt, Jonathan S.; Chin, Jeffrey Chevoor; Liu, Yuan

    2013-01-01

    The interest in alternative fuels for aviation has created a need to evaluate their effect on engine performance. The use of dynamic turbofan engine simulations enables the comparative modeling of the performance of these fuels on a realistic test bed in terms of dynamic response and control compared to traditional fuels. The analysis of overall engine performance and response characteristics can lead to a determination of the practicality of using specific alternative fuels in commercial aircraft. This paper describes a procedure to model the use of alternative fuels in a large commercial turbofan engine, and quantifies their effects on engine and vehicle performance. In addition, the modeling effort notionally demonstrates that engine performance may be maintained by modifying engine control system software parameters to account for the alternative fuel.

  1. Verification of examination procedures in clinical laboratory for imprecision, trueness and diagnostic accuracy according to ISO 15189:2012: a pragmatic approach.

    Science.gov (United States)

    Antonelli, Giorgia; Padoan, Andrea; Aita, Ada; Sciacovelli, Laura; Plebani, Mario

    2017-08-28

    Background The International Standard ISO 15189 is recognized as a valuable guide in ensuring high quality clinical laboratory services and promoting the harmonization of accreditation programmes in laboratory medicine. Examination procedures must be verified in order to guarantee that their performance characteristics are congruent with the intended scope of the test. The aim of the present study was to propose a practice model for implementing procedures employed for the verification of validated examination procedures already used for at least 2 years in our laboratory, in agreement with the ISO 15189 requirement at the Section 5.5.1.2. Methods In order to identify the operative procedure to be used, approved documents were identified, together with the definition of performance characteristics to be evaluated for the different methods; the examination procedures used in laboratory were analyzed and checked for performance specifications reported by manufacturers. Then, operative flow charts were identified to compare the laboratory performance characteristics with those declared by manufacturers. Results The choice of performance characteristics for verification was based on approved documents used as guidance, and the specific purpose tests undertaken, a consideration being made of: imprecision and trueness for quantitative methods; diagnostic accuracy for qualitative methods; imprecision together with diagnostic accuracy for semi-quantitative methods. Conclusions The described approach, balancing technological possibilities, risks and costs and assuring the compliance of the fundamental component of result accuracy, appears promising as an easily applicable and flexible procedure helping laboratories to comply with the ISO 15189 requirements.

  2. Antegrade Ureteral Stenting is a Good Alternative for the Retrograde Approach.

    Science.gov (United States)

    van der Meer, Rutger W; Weltings, Saskia; van Erkel, Arian R; Roshani, Hossain; Elzevier, Henk W; van Dijk, Lukas C; van Overhagen, Hans

    2017-07-01

    Double J (JJ) stents for treating obstructive ureteral pathology are generally inserted through a retrograde route with cystoscopic guidance. Antegrade percutaneous insertion using fluoroscopy can be performed alternatively but is less known. Indications, success rate and complications of antegrade ureteral stenting were evaluated. Data of consecutive patients in which antegrade ureteral stenting was performed were retrospectively analysed using the radiology information system and patient records. Patient characteristics, details of the antegrade JJ stent insertion procedure and registered complications were collected. Furthermore, it was investigated if prior to the antegrade procedure a retrograde attempt for JJ stent insertion was performed. Total 130 attempts for antegrade JJ stent insertion were performed in 100 patients. A percutaneous nephrostomy catheter had already been placed in the majority of kidneys (n = 109) for initial treatment of hydronephrosis. Most prevelant indication for a JJ stent was obstructive ureteral pathology due to malignancy (n = 63). A JJ stent was successfully inserted in 125 of 130 procedures. In 21 cases, previous retrograde ureteral stenting had failed but, subsequent antegrade ureteral stenting was successful. There were 8 procedure related complications; 6 infections, 1 false tract and 1 malposition. Antegrade percutaneous insertion of a JJ stent is a good alternative for retrograde insertion.

  3. 77 FR 61610 - Interagency Coordinating Committee on the Validation of Alternative Methods Evaluation Report and...

    Science.gov (United States)

    2012-10-10

    ... safety testing procedures that use a maximum of three animals per test substance. This recommendation... international collaborations, scientists from the European Union Reference Laboratory for Alternatives to Animal... testing procedures that use a maximum of three animals per test substance. Consistent with ICCVAM's duty...

  4. 49 CFR 1522.109 - TSA review and approval.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 9 2010-10-01 2010-10-01 false TSA review and approval. 1522.109 Section 1522.109..., DEPARTMENT OF HOMELAND SECURITY SECURITY RULES FOR ALL MODES OF TRANSPORTATION TSA-APPROVED VALIDATION FIRMS AND VALIDATORS TSA-Approved Validation Firms and Validators for the Certified Cargo Screening Program...

  5. 49 CFR 1522.115 - Renewal of TSA approval.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 9 2010-10-01 2010-10-01 false Renewal of TSA approval. 1522.115 Section 1522.115..., DEPARTMENT OF HOMELAND SECURITY SECURITY RULES FOR ALL MODES OF TRANSPORTATION TSA-APPROVED VALIDATION FIRMS AND VALIDATORS TSA-Approved Validation Firms and Validators for the Certified Cargo Screening Program...

  6. 29 CFR 1952.157 - Changes to approved plan.

    Science.gov (United States)

    2010-07-01

    ... (CONTINUED) APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS North Carolina § 1952.157 Changes to approved plan. (a) Legislation. (1) On March 29, 1994, the Assistant Secretary approved North Carolina's... section 17 of the Act as amended on November 5, 1990. (2) [Reserved] (b) The Voluntary Protection Program...

  7. 48 CFR 2922.103-4 - Approvals.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Approvals. 2922.103-4 Section 2922.103-4 Federal Acquisition Regulations System DEPARTMENT OF LABOR SOCIOECONOMIC PROGRAMS APPLICATION OF LABOR LAWS TO GOVERNMENT ACQUISITIONS Basic Labor Policies 2922.103-4 Approvals. The “agency...

  8. 38 CFR 21.7220 - Course approval.

    Science.gov (United States)

    2010-07-01

    ...) VOCATIONAL REHABILITATION AND EDUCATION All Volunteer Force Educational Assistance Program (Montgomery GI...; Pub. L. 98-525) (b) Course approval criteria. In administering benefits payable under 38 U.S.C...) Section 21.4265—Practical training approved as institutional training or on-job training; (10) Section 21...

  9. Alternative comparison, analysis, and evaluation of solid waste and materials system alternatives

    International Nuclear Information System (INIS)

    Brothers, A.J.

    1995-09-01

    This paper presents a comprehensive analysis of the impact of solid waste technical options on values and objectives that are important to the public. It is written in support of the Solid Waste and Materials Systems Alternatives Study (WHC, 1995). Described are the values that were identified, the major programmatic risks, how the impacts were measured, the performance of alternatives, the methodology used for the analysis, and the implications of the results. Decision analysis was used to guide the collection and analysis of data and the logic of the evaluation. Decision analysis is a structured process for the analysis and evaluation of alternatives. It is theoretically grounded in a set of axioms that capture the basic principles of decision making (von Neuman and Morgenstern 1947). Decision analysis objectively specifies what factors are to be considered, how they are to be measured and evaluated, and heir relative importance. The result is an analysis in which the underlying rationale or logic upon which the decision is based is made explicit. This makes possible open discussion of the decision basis in which facts and values are clearly distinguished, resulting in a well- documented decision that can be clearly explained and justified. The strategy of decision analysis is to analyze the various components relevant to the decision separately and then integrate the individual judgments to arrive at an overall decision. This assures that all the relevant factors are identified and their relative importance is considered. The procedure for obtaining the individual judgments, and the decision rules, for combining them and evaluating alternatives, have both theoretical and empirical foundation in mathematics, economics, and psychology

  10. NRC perspective on alternative disposal methods

    International Nuclear Information System (INIS)

    Pittiglio, C.L.; Tokar, M.

    1987-01-01

    In this paper is discussed an NRC staff strategy for the development of technical criteria and procedures for the licensing of various alternatives for disposal of low-level radioactive waste. Steps taken by the staff to identify viable alternative disposal methods and to comply with the requirements of the Low-Level Radioactive Waste Policy Amendments Act (LLRWPAA) of 1985 are also discussed. The strategy proposed by the NRC staff is to focus efforts in FY 87 on alternative concepts that incorporate concrete materials with soil or rock cover (e.g., below ground vaults and earth-mounded concrete bunkers), which several State and State Compacts have identified as preferred disposal options. While the NRC staff believes that other options, such as above ground vaults and mined cavities, are workable and licensable, the staff also believes, for reasons addressed in the paper, that it is in the best interest of the industry and the public to encourage standardization and to focus limited resources on a manageable number of alternative options. Therefore, guidance on above ground vaults, which are susceptible to long-term materials degradation due to climatological effects, and mined cavities, which represent a significant departure from the current experience base for low-level radioactive waste disposal, will receive minimal attention. 6 references

  11. Application of data processing in technological procedures for Dolni Rozinka uranium mines

    International Nuclear Information System (INIS)

    Sterzel, J.; Havelka, J.; Chrast, M.

    1987-01-01

    A program was written for technological procedures for mining operations, driving of horizontal workings, driving of raises, boring of long survey boreholes, driving of wide workings, and for working support withdrawal. Each of the said types of technological procedures is specific as concerns data and different information contents but the basic configuration is the same. The procedure is divided into three parts. Part one shows basic data on the working and technological operations from which wages are calculated and material is inventoried. Part two offers necessary information on retreat paths, special duties during blasting operations, during material handling, and all other information required by safety specifications. Part three consists of a signature list containing the names of the team of the given section and of the area foremen, and approval columns. The programs are written in COBOL-DOS/4 allowing the operation of up to 30 remote terminals of the EC 7920 type. The advantage of the computer-assisted production of technological procedures is the possibility of using the technological procedures already defined for the production of new technological procedures, this by a mere change in parameters. The data base is also a source for analytical activities of practically all production units. (J.B.)

  12. Preparation of biological samples for transmission X-ray microanalysis: a review of alternative procedures to the use of sectioned material

    International Nuclear Information System (INIS)

    Sigee, D.C.

    1988-01-01

    Although transmission X-ray microanalysis of biological material has traditionally been carried out mainly on sectioned preparations, a number of alternative procedures exist. These are considered under three major headings - whole cell preparations, analysis of cell homogenates and biological fluids, and applications of the technique to microsamples of purified biochemicals. These three aspects provide a continuous range of investigative level - from the cellular to the molecular. The use of X-ray microanalysis with whole cell preparations is considered in reference to eukaryote (animal) cells and prokaryotes - where it has particular potential in environmental studies on bacteria. In the case of cell homogenates and biological fluids, the technique has been used mainly with microdroplets of animal material. The use of X-ray microanalysis with purified biochemicals is considered in relation to both particulate and non-particulate samples. In the latter category, the application of this technique for analysis of thin films of metalloprotein is particularly emphasised. It is concluded that wider use could be made of the range of preparative techniques available - both within a particular investigation, and in diverse fields of study. Transmission X-ray microanalysis has implications for environmental, physiological and molecular biology as well as cell biology

  13. 78 FR 73457 - Airworthiness Directives; the Boeing Company Airplanes

    Science.gov (United States)

    2013-12-06

    ... would enable us to provide cost estimates for the on-condition actions specified in this proposed AD..., Revision 4, dated January 11, 2013. For information on the procedures and compliance times, see this....'' This proposed AD would require that requests for approval of alternative methods of compliance (AMOCs...

  14. Value measurement of nuclear medicine procedures

    International Nuclear Information System (INIS)

    Potchen, E.J.; Harris, G.I.; Schonbein, W.R.; Rashford, N.J.

    1977-01-01

    The difficulty in measuring the benefit component for cost/benefit analysis of diagnostic procedures in medicine is portrayed as a complex issue relating the objective of intent to a classification of types of decisions a physician must make in evaluating a patient's problem. Ultimately, it seems desirable to develop measuring instruments such as attitude measurement tools by which the relative value of alternative diagnostic procedures could be measured in terms of what they contribute to diminishing the patient's personal perception of disease. Even without this idealized objective, it is reasonable to assume that diagnostic tests which do not contain information, defined as a change in the randomness of a state of knowledge, could not be expected to ultimately benefit the patient. Thus diagnostic information should provide a rational direction for the physician to modify the course of the patient's illness. Since information can be measured as a change in randomness of a knowledge state, we can determine the information content of a specific nuclear medicine procedure when faced with an array of diagnostic problems. These measurements remain to be made for clinical nuclear medicine procedures and are currently under study

  15. E-Approval Plans in Research Libraries

    Science.gov (United States)

    Pickett, Carmelita; Tabacaru, Simona; Harrell, Jeanne

    2014-01-01

    Research libraries have long invested in approval plan services, which offer an economical way to acquire scholarly and scientific publications. Traditional approval plans have evolved and now enable libraries to expand their e-book offerings to better serve researchers. Publishers offer a myriad of e-book purchasing options. These range from…

  16. Premarket Approvals (PMA)

    Data.gov (United States)

    U.S. Department of Health & Human Services — Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An...

  17. 75 FR 28814 - FHA Lender Approval, Annual Renewal, Periodic Updates and Required Reports From FHA Approved Lenders

    Science.gov (United States)

    2010-05-24

    ... proposal. This information is required for: (1) FHA lender approval, (2) Annual renewal of each FHA lender... following information: Title of Proposal: FHA Lender Approval, Annual Renewal, Periodic Updates and Required... and HUD-92001-C. Description of the Need for the Information and Its Proposed Use: This information is...

  18. 7 CFR 1710.105 - State regulatory approvals.

    Science.gov (United States)

    2010-01-01

    ... and Basic Policies § 1710.105 State regulatory approvals. (a) In States where a borrower is required... loans are approved by RUS: (1) Loans requiring an Environmental Impact Statement; (2) Loans to finance...

  19. Perspectives used for gaining approval of budgets.

    Science.gov (United States)

    Franks-Joiner, G L

    1990-01-01

    Nurse executives think about problems using a certain perspective which may influence decisions on budgetary matters. The nurse executives' perspective used in decision-making may influence which budget proposals are developed and approved. A study was performed to determine the perspective used by nurse executives in decision-making on supplementary budget item proposals and whether perspective use influenced approval. Findings showed that use of the system view or dual-domain perspective in a proposal may enhance nurse executives' changes of gaining approval.

  20. 78 FR 2315 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-01-10

    ... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

  1. 78 FR 15402 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-03-11

    ... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

  2. 78 FR 11947 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-02-20

    ... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

  3. 78 FR 17281 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-03-20

    ... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

  4. 77 FR 16317 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-03-20

    ... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

  5. 77 FR 66909 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-11-07

    ... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule... below, receiving approval for the consumptive use of water pursuant to the Commission's approval by rule...

  6. 77 FR 21143 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-04-09

    ... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

  7. 77 FR 25010 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-04-26

    ... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule... below, receiving approval for the consumptive use of water pursuant to the Commission's approval by rule...

  8. 77 FR 34455 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-06-11

    ... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

  9. 77 FR 55891 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-09-11

    ... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

  10. 77 FR 55892 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-09-11

    ... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

  11. 77 FR 59239 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-09-26

    ... SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process...

  12. Evaluation of efficient XML interchange (EXI) for large datasets and as an alternative to binary JSON encodings

    OpenAIRE

    Hill, Bruce W.

    2015-01-01

    Approved for public release; distribution is unlimited Current and emerging Navy information concepts, including network-centric warfare and Navy Tactical Cloud, presume high network throughput and interoperability. The Extensible Markup Language (XML) addresses the latter requirement, but its verbosity is problematic for afloat networks. JavaScript Object Notation (JSON) is an alternative to XML common in web applications and some non-relational databases. Compact, binary encodings exist ...

  13. 77 FR 38523 - Expedited Approval of Alternative Test Procedures for the Analysis of Contaminants Under the Safe...

    Science.gov (United States)

    2012-06-28

    ... technique offers high alpha counting efficiency since the electronic pulse shape discrimination reduces... Coupled Plasma-Mass Spectrometry. ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428... Inductively Coupled Plasma-Mass Spectrometry. ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA...

  14. 78 FR 32558 - Expedited Approval of Alternative Test Procedures for the Analysis of Contaminants Under the Safe...

    Science.gov (United States)

    2013-05-31

    ... (APHA 1998). CFR 141.74(a)(1) 9221 F 9221 F, 20th Edition E. coli 40 CFR 141.402(c)(2) (APHA 1998). 9221 F.1 9221 F, 20th Edition E. coli 40 CFR 141.852(a)(5) (APHA 1998). 9222 D 9222 D, 20th Edition Fecal... Organism Methodology \\6\\ \\1\\ \\28\\ SM Online \\3\\ Other E.coli ONPG-MUG Test.... 9223 B 9223 B 9223 B 9223 B...

  15. 76 FR 37014 - Expedited Approval of Alternative Test Procedures for the Analysis of Contaminants Under the Safe...

    Science.gov (United States)

    2011-06-24

    ... conditions, and detection. The method performance data (e.g., detection levels, accuracy and precision... and Alkaline Earth Cations and Ammonium in Water and Wastewater by Ion Chromatography. ASTM.... Standard Test Method for Determination of Dissolved Alkali and Alkaline Earth Cations and Ammonium in Water...

  16. Interdisciplinary environmental impact statement examinations with parallel licensing procedures

    International Nuclear Information System (INIS)

    Gassner, E.

    1990-01-01

    The article investigates the question how the interdisciplinary, collective, integrative environmental impact statement can predominate the decisions in individual licensing procedures. It illustrates the requirements of the Act on Environmental Impact Statements. According to this Act, measures are to be found which deal with the overall complex, i.e. the entire system. In the article, the monitoring project organization's primary responsibility is emphasized: Analysis and prognosis of a project's environmental impacts are transferred to this organization for decision-preparation. Subsequent corrections or supplementations during the official approval procedure, or incorporation of the public through the authorities, do not change the matter. An all-comprehensive assessment must be based on all-comprehensive standards. From the point of view of immissions this is minimization of adverse effects on the nature cycle and landscape matters; from the point of view of emissions it is the duty of environment-compatible waste management within the sense of waste management legislation having to serve public welfare. (orig.) [de

  17. Assessment of 25 kW free-piston Stirling technology alternatives for solar applications

    Science.gov (United States)

    Erbeznik, Raymond M.; White, Maurice A.; Penswick, L. B.; Neely, Ronald E.; Ritter, Darren C.; Wallace, David A.

    1992-01-01

    The final design, construction, and testing of a 25-kW free-piston advanced Stirling conversion system (ASCS) are examined. The final design of the free-piston hydraulic ASCS consists of five subsystems: heat transport subsystem (solar receiver and pool boiler), free-piston hydraulic Stirling engine, hydraulic subsystem, cooling subsystem, and electrical and control subsystem. Advantages and disadvantages are identified for each technology alternative. Technology alternatives considered are gas bearings vs flexure bearings, stationary magnet linear alternator vs moving magnetic linear alternator, and seven different control options. Component designs are generated using available in-house procedures to meet the requirements of the free-piston Stirling convertor configurations.

  18. Applying for ethical approval for research: the main issues.

    Science.gov (United States)

    Gelling, Leslie

    2016-01-13

    The need to obtain research ethical approval is common to all research involving human participants. This approval must be obtained before research participants can be approached and before data collection can begin. The process of ethical review is one way that research participants can be confident that possible risks have been considered, minimised and deemed acceptable. This article outlines some of the main issues researchers should consider when planning an application for research ethical approval by answering the following six questions: 'Do I need research ethical approval?', 'How many applications will I need to make?', 'Where should I apply for research ethical approval?', 'What do I need to include in my application?', 'What do research ethics committees look for?' and 'What other approvals might I need?' Answering these questions will enable researchers to navigate the ethical review process.

  19. Poet Marion Approval

    Science.gov (United States)

    This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-North Manchester, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable

  20. Poet Portland Approval

    Science.gov (United States)

    This update August 9, 2016 letter from EPA approves the petition, with modifications, from Poet Biorefining-Portland, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel

  1. Poet Alexandria Approval

    Science.gov (United States)

    This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-Alexandria, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel

  2. Poet Laddonia Approval

    Science.gov (United States)

    This update Auugust 9, 2016 letter from EPA approves with modifications, the petition from Poet Biorefining Laddonia, Poet Laddonia Facility, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act f

  3. Intentional replantation: A viable alternative for management of palatogingival groove

    Directory of Open Access Journals (Sweden)

    Vijay Kumar

    2013-01-01

    Full Text Available Radicular groove is an anatomical malformation that often leads to combined endodontic-periodontic lesions. Treatment of complex groove presents a clinical challenge to the operator. A case of type III palatogingival groove is successfully treated with intentional replantation. With the understanding of the procedure and strict adherence to guidelines improves, practitioners can use intentional replantation as an easy and cost-effective alternative for the management of radicular groove. The paper presents a brief review of palatogingival groove and highlights an easy and predictable alternative for its management.

  4. 21 CFR 56.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. 56.110 Section 56.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL...

  5. The use of cyanoacrylate in surgical anastomosis: An alternative to ...

    African Journals Online (AJOL)

    To present anastomosis with cyanoacrylate as a cheap, simple, fast, and available technique for anastomosis in urological, vascular, gynecological, and general surgical procedures. This method may in the future be a good alternative to microsurgery, particularly in centers where facilities are unavailable and the financial ...

  6. Approval of multiple unit trains by means of the simulation of contact wire/pantograph; Triebfahrzeugzulassung mithilfe der Simulation Fahrdraht/Stromabnehmer

    Energy Technology Data Exchange (ETDEWEB)

    Reichmann, Thomas; Raubold, Johannes [Siemens AG, Erlangen (Germany). Industry Sector, Mobility Div.

    2011-04-15

    The simulation program employed at Siemens adopting the finite element method delivers reliable findings about the dynamic interaction between pantographs and overhead contact lines and was verified by a validation according to EN 50318. In particular, a considerable reduction of measurement expenses for approval procedures of multiple unit trains with a lot of combination options for pantograph arrangements can be achieved by means of these simulations. (orig.)

  7. Automation of procedure writing for the RLWTF

    International Nuclear Information System (INIS)

    Farnham, M.; MacDonald, A.

    1998-01-01

    In August of 1997, the Radioactive Liquid Waste Treatment Facility (RLWTF) at Los Alamos National Laboratory (LANL) recognized the need to re-engineer document management business process. All nuclear facilities at LANL are required to ensure that both the latest approved revision of controlled documents and any changes to those documents are available to operating personnel at all times. The Nuclear Materials Technology (NMT) Division was also re-engineering its document management business processes and searching for a solution. Both groups contacted several internal and external organizations in search of potential software solutions in use that would meet requirements. This report describes the objectives and features required by the software package, the choice of Procedure Design as the software package, and its implementation

  8. The California Multimedia Risk Assessment Protocol for Alternative Fuels

    Science.gov (United States)

    Hatch, T.; Ginn, T. R.; McKone, T. E.; Rice, D. W.

    2013-12-01

    Any new fuel in California requires approval by the state agencies overseeing human and environmental health. In order to provide a systematic evaluation of new fuel impacts, California now requires a multimedia risk assessment (MMRA) for fuel approval. The fuel MMRA involves all relevant state agencies including: the California Air Resources Board (CARB), the State Water Resources Control Board (SWRCB), the Office of Environmental Health Hazards Assessment (OEHHA), and the Department of Toxic Substances Control (DTSC) overseen by the California Environmental Protection Agency (CalEPA). The lead agency for MMRAs is the CARB. The original law requiring a multimedia assessment is California Health and Safety Code 43830.8. In addition, the low carbon fuel standard (LCFS), the Global Warming Solutions Act (AB32), and the Verified Diesel Emission Control Strategy (VDECS) have provisions that can require a multimedia assessment. In this presentation, I give an overview of the California multimedia risk assessment (MMRA) for new fuels that has been recently developed and applied to several alternative fuels. The objective of the California MMRA is to assess risk of potential impacts of new fuels to multiple environmental media including: air, water, and soil. Attainment of this objective involves many challenges, including varying levels of uncertainty, relative comparison of incommensurate risk factors, and differing levels of priority assigned to risk factors. The MMRA is based on a strategy of relative risk assessment and flexible accommodation of distinct and diverse fuel formulations. The approach is tiered by design, in order to allow for sequentially more sophisticated investigations as knowledge gaps are identified and re-prioritized by the ongoing research. The assessment also involves peer review in order to provide coupling between risk assessment and stakeholder investment, as well as constructive or confrontational feedback. The multimedia assessment

  9. Searching for evidence or approval? A commentary on database search in systematic reviews and alternative information retrieval methodologies.

    Science.gov (United States)

    Delaney, Aogán; Tamás, Peter A

    2018-03-01

    Despite recognition that database search alone is inadequate even within the health sciences, it appears that reviewers in fields that have adopted systematic review are choosing to rely primarily, or only, on database search for information retrieval. This commentary reminds readers of factors that call into question the appropriateness of default reliance on database searches particularly as systematic review is adapted for use in new and lower consensus fields. It then discusses alternative methods for information retrieval that require development, formalisation, and evaluation. Our goals are to encourage reviewers to reflect critically and transparently on their choice of information retrieval methods and to encourage investment in research on alternatives. Copyright © 2017 John Wiley & Sons, Ltd.

  10. Anatomical study of forearm arteries with ultrasound for percutaneous coronary procedures.

    Science.gov (United States)

    Yan, Zhen-xian; Zhou, Yu-jie; Zhao, Ying-xin; Zhou, Zhi-ming; Yang, Shi-wei; Wang, Zhi-jian

    2010-04-01

    In recent years, the radial artery (RA) has become an alternative vascular access site for percutaneous coronary procedures, and the ulnar artery (UA) is another possibility. The objective of this study was to investigate the anatomy of the forearm arteries with ultrasound (US) and to evaluate the effect of the anatomy of the right RA (RRA) on the outcomes of transradial coronary procedures. The 638 patients undergoing transradial coronary procedures were examined with US for measurement of the diameters of the forearm arteries and determination of their anatomical abnormalities before the procedures. The next day the incidence of RA occlusion was recorded. The diameters of the radial and ulnar arteries were similar (P>0.05). The procedure time was longer in patients with anatomical abnormalities (Pforearm arteries of Chinese people are similar. The small diameter and anatomical abnormalities of the RRA could result in longer procedure time, more incidence of procedure failure and RA occlusion.

  11. Poet Fostoria Approval

    Science.gov (United States)

    This August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-Fostoria, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6)

  12. Technical procedures for utilities and solid waste: Environmental Field Program, Deaf Smith County site, Texas: Final draft

    International Nuclear Information System (INIS)

    1987-08-01

    The evaluation of environmental issues and concerns and the addressing of statutory requirements are fundamental parts in the characterization of the site in Deaf Smith County, Texas for the US Department of Energy's Salt Repository Project (SRP). To ensure that the environmental field program comprehensively addresses the issues and requirements of the project, a site study plan (SSP) has been prepared for Utilities and Solid Waste considerations. This technical procedure (TP) has been developed to implement the field program described in the Utilities and Solid Waste Site Study Plan. The purpose and scope of the Utilities and Solid Waste Technical Procedure is to develop and implement a data collection procedure to fulfill the data base needs of the Utilities and Solid Waste SSP. The procedure describes a method of obtaining, assessing and verifying the capabilities of the regional service utilities and disposal contractors. This data base can be used to identify a preferred service source for the engineering contractor. The technical procedure was produced under the guidelines established in Technical Administrative Procedure No. 1.0, Preparation, Review and Approval of Technical Procedures

  13. Immunotherapy Combination Approved for Advanced Kidney Cancer

    Science.gov (United States)

    FDA has approved the combination of the immunotherapy drugs nivolumab (Opdivo) and ipilimumab (Yervoy) as an initial treatment for some patients with advanced kidney cancer. The approval is expected to immediately affect patient care, as this Cancer Currents post explains.

  14. New drugs: evidence relating to their therapeutic value after introduction to the market.

    Science.gov (United States)

    Ujeyl, Mariam; Schlegel, Claudia; Walter, Siegbert; Gundert-Remy, Ursula

    2012-02-01

    Drug approval is based on three criteria: quality, efficacy, and safety. We investigated the types of study design and statistical methods employed to demonstrate safety and efficacy of proprietary medicinal products (PMPs) that were approved for use in the European Union through the centralized procedure. We retrospectively analyzed the European Public Assessment Reports of PMPs that the European Medicinal Agency approved, either initially or for extended indications, in 2009 and 2010. Data were analyzed for 39 PMPs: 64% of these were new active substances, and 36% were approved for extended indications. 46% of the PMPs had been studied in an active-control trial. In only 28%, superiority of the new PMPs compared to active control had been tested. 46% of the approvals included testing of a patient-relevant primary endpoint. The median size of population used to demonstrate safety was 1700 persons. The centralized procedure does not require comparative information from active-control trials. Accordingly, as our descriptive analysis revealed, this information is often not available at the time of market introduction. Pivotal studies only rarely clearly demonstrate an added therapeutic value of a new PMP compared to existing alternatives.

  15. Poet Leipsic Approval

    Science.gov (United States)

    This August 9, 2016 letter from EPA approves,wtih modifications, the petition from Poet Biorefining-Leipsic, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs

  16. Explanation of procedure on site medical emergency response for nuclear accident

    International Nuclear Information System (INIS)

    Liu Yulong; Jiang Zhong

    2012-01-01

    National occupational health standard-Procedure on Site Medical Emergency Response for Nuclear Accident has been approved and issued by the Ministry of Health. This standard is formulated according to the Emergency Response Law of the People's Republic of China, Law of the People 's Republic of China on Prevention and Control of Occupational Diseases, Regulations on Emergency Measures for Nuclear Accidents at Nuclear Power Plants, and Health Emergency Plans for Nuclear and Radiological Accidents of Ministry of Health, supporting the use of On-site Medical Emergency Planning and Preparedness for Nuclear Accidents and Off-site Medical Emergency Planning and Preparedness for Nuclear Accidents. Nuclear accident on-site medical response procedure is a part of the on-site emergency plan. The standard specifies the basic content and requirements of the nuclear accident on-site medical emergency response procedures of nuclear facilities operating units to guide and regulate the work of nuclear accident on-site medical emergency response of nuclear facilities operating units. The criteria-related contents were interpreted in this article. (authors)

  17. Guidance for package approvals in the United Kingdom

    International Nuclear Information System (INIS)

    Morgan-Warren, E.J.

    2004-01-01

    Approval is required under the transport regulations for a wide range of package designs and operations, and applications for competent authority approval and validation are received from many sources, both in the UK and overseas. To assist package designers and applicants for approval, and to promote consistency in applications and their assessment, the UK Department for Transport issues guidance on the interpretation of the transport regulations and the requirements of an application for approval and its supporting safety case. The general guidance document, known as the Guide to an Application for UK Competent Authority Approval of Radioactive Material in Transport, has been issued for many years and updated to encompass the provisions of each successive edition of the IAEA transport regulations. The guide has been referred to in a number of international fora, including PATRAM, and was cited as a 'good practice' in the report of the IAEA TRANSAS appraisal of the UK in 2002. Specialist guides include the Guide to the Suitability of Elastomeric Seal Materials, which is the subject of a separate paper in this conference, and the Guide to the Approval of Freight Containers as Types IP-2 and IP-3 Packages. This paper discusses the guidance material and summarises the administrative and technical information required in support of applications for approval of package designs, special form and low-dispersible radioactive materials, shipments, special arrangements, modifications and validations. (author)

  18. 40 CFR 86.347-79 - Alternative calculations for diesel engines.

    Science.gov (United States)

    2010-07-01

    ... Emission Regulations for New Gasoline-Fueled and Diesel-Fueled Heavy-Duty Engines; Gaseous Exhaust Test Procedures § 86.347-79 Alternative calculations for diesel engines. (a) This section applies to Diesel engines only. Gasoline-fueled engines must use the calculations in § 86.345. (b) For Diesel engines, the...

  19. Radionuclide air emissions at Department of Energy facilities

    Energy Technology Data Exchange (ETDEWEB)

    Duvall, K. [Department of Energy, Washington, DC (United States)

    1995-02-01

    Facilities operated by the U.S. Department of Energy (DOE) handle and process radioactive materials in conjunction with their research, nuclear materials production, remediation and waste disposal activities. Radionuclide emissions to the atmosphere from DOE facilities are regulated by the Environmental Protection Agency (EPA) under 40 CFR Part 61, Subpart H for emissions other than radon. Subpart H requires DOE to monitor emissions from stacks and calculate a potential offsite dose to an individual using EPA approved methods and procedures. DOE has applied to EPA for approval to use alternative methods for some of the EPA requirements for continuous monitoring. The use of alternative methods such as single-point sampling with a shrouded probe will have an impact at several major DOE facilities. These facilities are identified.

  20. 45 CFR 95.611 - Prior approval conditions.

    Science.gov (United States)

    2010-10-01

    ... Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION GENERAL ADMINISTRATION... for Department approval, signed by the appropriate State official, to the Director, Administration for... of procurement activities beyond that approved in the APD; (D) A change in system concept, or a...

  1. An alternative approach to KP hierarchy in matrix models

    International Nuclear Information System (INIS)

    Bonora, L.; Xiong, C.S.

    1992-01-01

    We show that there exists an alternative procedure in order to extract differential hierarchies, such as the KdV hierarchy, from one-matrix models, without taking a continuum limit. To prove this we introduce the Toda lattice and reformulate it in operator form. We then consider the reduction to the systems appropriate for a one-matrix model. (orig.)

  2. Procedural Modeling for Digital Cultural Heritage

    Directory of Open Access Journals (Sweden)

    Simon Haegler

    2009-01-01

    Full Text Available The rapid development of computer graphics and imaging provides the modern archeologist with several tools to realistically model and visualize archeological sites in 3D. This, however, creates a tension between veridical and realistic modeling. Visually compelling models may lead people to falsely believe that there exists very precise knowledge about the past appearance of a site. In order to make the underlying uncertainty visible, it has been proposed to encode this uncertainty with different levels of transparency in the rendering, or of decoloration of the textures. We argue that procedural modeling technology based on shape grammars provides an interesting alternative to such measures, as they tend to spoil the experience for the observer. Both its efficiency and compactness make procedural modeling a tool to produce multiple models, which together sample the space of possibilities. Variations between the different models express levels of uncertainty implicitly, while letting each individual model keeping its realistic appearance. The underlying, structural description makes the uncertainty explicit. Additionally, procedural modeling also yields the flexibility to incorporate changes as knowledge of an archeological site gets refined. Annotations explaining modeling decisions can be included. We demonstrate our procedural modeling implementation with several recent examples.

  3. Development of a multi-criteria evaluation framework for alternative light-duty vehicles technologies

    Energy Technology Data Exchange (ETDEWEB)

    Fazeli, R.; Leal, V.; Sousa, J.P.

    2011-07-15

    Multi-Attribute Utility Theory (MAUT) is very popular in the context of multi-criteria decision making because it easily incorporates the decision maker's preferences. The basic goal of MAUT is to replace available information by ''utility values'' allowing the comparison of alternatives. For the basic MCDA problem of choosing the best alternative, it is useful for a DM to start by eliminating those alternatives that do not seem to be interesting. This procedure is often called ''screening''. Screening helps by allowing the DM to concentrate on a smaller set that (very likely) contains the best alternative. In this work we have applied a sequential screening process, starting with a Pareto Optimal (PO) approach, followed by a Data Envelopment Analysis (DEA) based screening and Trade-off Weights (TW) procedure. To illustrate the approach, Portugal was chosen as a case study. Besides, at this preliminary stage of the research, we just considered alternatives with 100% of one specific fuel/technology combination (alternatives with fleets combining different shares of fuels/technologies will be analyzed in the next phase of the research). MAUT was applied to identify the utility values of each alternative for each group of attributes. Then the sequential screening approach was applied. The final screening set includes DICI-DME, Fuel Cell using Hydrogen, the Fuel Cell with reformer using Methanol, and Hybrid Gasoline. As a conclusion, preliminary results clearly show the potential of the developed approach in setting a framework for supporting better and sounder decision-making on which AFV technologies should be supported. (Author)

  4. 8 CFR 207.6 - Control over approved refugee numbers.

    Science.gov (United States)

    2010-01-01

    ... 8 Aliens and Nationality 1 2010-01-01 2010-01-01 false Control over approved refugee numbers. 207... ADMISSION OF REFUGEES § 207.6 Control over approved refugee numbers. Current numerical accounting of approved refugees is maintained for each special group designated by the President. As refugee status is...

  5. 47 CFR 400.5 - Approval and award.

    Science.gov (United States)

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Approval and award. 400.5 Section 400.5 Telecommunication NATIONAL TELECOMMUNICATIONS AND INFORMATION ADMINISTRATION, DEPARTMENT OF COMMERCE, AND NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION E-911 GRANT PROGRAM § 400.5 Approval...

  6. 13 CFR 302.18 - Post-approval requirements.

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Post-approval requirements. 302.18 Section 302.18 Business Credit and Assistance ECONOMIC DEVELOPMENT ADMINISTRATION, DEPARTMENT OF COMMERCE... Federal cost principles (collectively, “Post-Approval Requirements”). A Recipient's failure to comply with...

  7. Refuge alternatives relief valve testing and design with updated test stand.

    Science.gov (United States)

    Lutz, T J; Bissert, P T; Homce, G T; Yonkey, J A

    2018-03-01

    Underground refuge alternatives require an air source to supply breathable air to the occupants. This requires pressure relief valves to prevent unsafe pressures from building up within the refuge alternative. The U.S. Mine Safety and Health Administration (MSHA) mandates that pressure relief valves prevent pressure from exceeding 1.25 kPa (0.18 psi), or as specified by the manufacturer, above mine atmospheric pressure when a fan or compressor is used for the air supply. The U.S. National Institute for Occupational Safety and Health (NIOSH) tested a variety of pressure relief valves using an instrumented test fixture consisting of data acquisition equipment, a centrifugal blower, ductwork and various sensors to determine if the subject pressure relief valves meet the MSHA requirement. Relief pressures and flow characteristics, including opening pressure and flow rate, were measured for five different pressure relief valves under a variety of conditions. The subject pressure relief valves included two off-the-shelf modified check valves, two check valves used in MSHA-approved built-in-place refuge alternatives, and a commercially available valve that was designed for a steel refuge alternative and is currently being used in some built-in-place refuge alternatives. The test results showed relief pressures ranging from 0.20 to 1.53 kPa (0.03 to 0.22 psi) and flow rates up to 19.3 m 3 /min (683 scfm). As tested, some of the pressure relief valves did not meet the 1.25 kPa (0.18 psi) relief specification.

  8. Postmining land use: economic comparison of forestry and pastureland alternatives

    Science.gov (United States)

    Charles H. Wolf

    1980-01-01

    The influence of soil properties, legal requirements, and economics on postmining land use is described, and enterprise budgets are prepared to demonstrate procedures for evaluating forest and pastureland alternatives. A comparison of cow-calf operations with hybrid poplar and black walnut plantations suggests that a combination of pastureland and black walnut...

  9. Monti’s procedure as an alternative technique in complex urethral distraction defect

    Directory of Open Access Journals (Sweden)

    Jalil Hosseini

    2010-06-01

    Full Text Available PURPOSE: Pelvic fracture urethral distraction defect is usually managed by the end to end anastomotic urethroplasty. Surgical repair of those patients with post-traumatic complex posterior urethral defects, who have undergone failed previous surgical treatments, remains one of the most challenging problems in urology. Appendix urinary diversion could be used in such cases. However, the appendix tissue is not always usable. We report our experience on management of patients with long urethral defect with history of one or more failed urethroplasties by Monti channel urinary diversion. MATERIALS AND METHODS: From 2001 to 2007, we evaluated data from 8 male patients aged 28 to 76 years (mean age 42.5 in whom the Monti technique was performed. All cases had history of posterior urethral defect with one or more failed procedures for urethral reconstruction including urethroplasty. A 2 to 2.5 cm segment of ileum, which had a suitable blood supply, was cut. After the re-anastomosis of the ileum, we closed the opened ileum transversely surrounding a 14-16 Fr urethral catheter using running Vicryl sutures. The newly built tube was used as an appendix during diversion. RESULTS: All patients performed catheterization through the conduit without difficulty and stomal stenosis. Mild stomal incontinence occurred in one patient in the supine position who became continent after adjustment of the catheterization intervals. There was no dehiscence, necrosis or perforation of the tube. CONCLUSION: Based on our data, Monti’s procedure seems to be a valuable technique in patients with very long complicated urethral defect who cannot be managed with routine urethroplastic techniques.

  10. Welding procedure specification for arc welding of St 52-3N steel plates with covered electrodes

    International Nuclear Information System (INIS)

    Cvetkovski, S.; Slavkov, D.; Magdeski, J.

    2003-01-01

    In this paper the results of approval welding technology for arc welding of plates made of St 52-3N steel are presented. Metal arc welding with covered electrode is used welding process. Test specimens are butt welded in different welding positions P A , P F , P C and P D . Before start welding preliminary welding procedure was prepared. After welding of test specimens non destructive and destructive testing was performed. Obtained results were compared with standard DIN 17100 which concerns to chemical composition and mechanical properties of base material. It was confirmed that in all cases mechanical properties of welded joint are higher than those of base material, so preliminary welding procedure (pWTS) can be accepted as welding procedure specification WPS for metal arc welding of St52-3N steel. (Original)

  11. 12 CFR 614.4470 - Loans subject to bank approval.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Loans subject to bank approval. 614.4470 Section 614.4470 Banks and Banking FARM CREDIT ADMINISTRATION FARM CREDIT SYSTEM LOAN POLICIES AND OPERATIONS Loan Approval Requirements § 614.4470 Loans subject to bank approval. (a) The following loans...

  12. Ulnar artery: The Ulysses ultimate resort for coronary procedures

    Directory of Open Access Journals (Sweden)

    George Hahalis, MD, PhD

    2016-07-01

    Full Text Available Despite the increasing worldwide adoption of the transradial access site, the ulnar artery (UA only very infrequently serves as a primary option for coronary procedures. In contrast to the uncertainty surrounding previous reports regarding the feasibility and safety, recent data from larger registries and randomized trials provide more conclusive evidence that the transulnar route may be safely selected as an alternative arterial access approach. However, a default transulnar strategy appears time-consuming and is associated with higher crossover rates compared with the radial artery (RA. Once arterial access is obtained, the likelihood of a successful coronary procedure is high and similar between the two forearm arteries. The UA has similar flow-mediating vasodilating properties with and seems at least as vulnerable as the RA with regard to incident occlusion, with UA occlusion (UAO rates being probably higher than previously anticipated. A learning curve effect may not be apparent for crossover rates among experienced radialists, but increasing experience is associated with reduction in the fluoroscopy time, contrast volume and frequency of large hematoma formation. The UA may represents an important alternative access site for coronary procedures, and experienced radial operators should obtain additional skills to perform the transulnar approach. Nevertheless, in view of this method's lower feasibility compared to the RA, an initial ulnar access strategy should be reserved for carefully selected patients to ensure satisfactory cannulation rates.

  13. A Stepwise Fitting Procedure for automated fitting of Ecopath with Ecosim models

    Directory of Open Access Journals (Sweden)

    Erin Scott

    2016-01-01

    Full Text Available The Stepwise Fitting Procedure automates testing of alternative hypotheses used for fitting Ecopath with Ecosim (EwE models to observation reference data (Mackinson et al. 2009. The calibration of EwE model predictions to observed data is important to evaluate any model that will be used for ecosystem based management. Thus far, the model fitting procedure in EwE has been carried out manually: a repetitive task involving setting >1000 specific individual searches to find the statistically ‘best fit’ model. The novel fitting procedure automates the manual procedure therefore producing accurate results and lets the modeller concentrate on investigating the ‘best fit’ model for ecological accuracy.

  14. Alternate Energy Report, Koleda Childress Inc., dated March 16, 1992

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1992-03-16

    Policies, programs, and current status of alternate energy and global warming concerns in the United States are reported. The House Energy and Commerce Committee has approved a 12-title comprehensive energy policy bill. The bill includes provisions on energy efficiency, natural gas, octane mislabelling, Strategic Petroleum Reserve, coal policy, alternative fuels, renewable energy, global warming, uranium enrichment, and power policy. The omnibus energy policy bill passed by the Senate last month contains a provision on a program to transfer U.S. clean coal technologies to developing countries. One of the objectives of the program, which will focus on technologies including pressurized fluidized bed and integrated gasification combined cycle, is to reduce the U.S. trade imbalance. As the climate treaty negotiations of the Intergovernmental Negotiating Committee on a Framework Climate Convention have evolved for a long time, several groups of nations have formed loose and informal coalitions to advocate common positions, for example, coalition of countries of western Europe, of the U.S. and Saudi Arabia, and of less developed countries. (NEDO)

  15. 48 CFR 52.222-16 - Approval of Wage Rates.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 2 2010-10-01 2010-10-01 false Approval of Wage Rates. 52....222-16 Approval of Wage Rates. As prescribed in 22.407(b), insert the following clause: Approval of Wage Rates (FEB 1988) All straight time wage rates, and overtime rates based thereon, for laborers and...

  16. 7 CFR 1717.609 - RUS approval of general manager.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false RUS approval of general manager. 1717.609 Section... Operational Controls § 1717.609 RUS approval of general manager. (a) If a borrower's mortgage or loan contract... general manager of the borrower's system, such approval is hereby granted provided that the borrower is in...

  17. 28 CFR 551.11 - Authority to approve a marriage.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Authority to approve a marriage. 551.11... MISCELLANEOUS Marriages of Inmates § 551.11 Authority to approve a marriage. (a) The Warden may approve the marriage of a federal inmate confined in a federal institution. This authority may not be delegated below...

  18. 2016 in review: FDA approvals of new molecular entities.

    Science.gov (United States)

    Griesenauer, Rebekah H; Kinch, Michael S

    2017-11-01

    An overview of drugs approved by FDA in 2016 reveals dramatic disruptions in long-term trends. The number of new molecular entities (NMEs) dropped, reflecting the lowest rate of small-molecule approvals observed in almost five decades. In addition, the pace of industry consolidation slowed substantially. The impact of mergers and acquisitions decreased the total number of organizations with past approval experience and continued research and development (R&D) activities to 102, divided evenly between more established pharmaceutical and newer biotechnology companies. Despite these substantial differences, the industry continued to pursue regulatory incentives, as evidenced by a continued increase in the fraction of NMEs approved using an orphan or priority designation, and almost all oncology drugs approved in 2016 utilized these mechanisms. Copyright © 2017 Elsevier Ltd. All rights reserved.

  19. Towards Verification of Operational Procedures Using Auto-Generated Diagnostic Trees

    Science.gov (United States)

    Kurtoglu, Tolga; Lutz, Robyn; Patterson-Hine, Ann

    2009-01-01

    The design, development, and operation of complex space, lunar and planetary exploration systems require the development of general procedures that describe a detailed set of instructions capturing how mission tasks are performed. For both crewed and uncrewed NASA systems, mission safety and the accomplishment of the scientific mission objectives are highly dependent on the correctness of procedures. In this paper, we describe how to use the auto-generated diagnostic trees from existing diagnostic models to improve the verification of standard operating procedures. Specifically, we introduce a systematic method, namely the Diagnostic Tree for Verification (DTV), developed with the goal of leveraging the information contained within auto-generated diagnostic trees in order to check the correctness of procedures, to streamline the procedures in terms of reducing the number of steps or use of resources in them, and to propose alternative procedural steps adaptive to changing operational conditions. The application of the DTV method to a spacecraft electrical power system shows the feasibility of the approach and its range of capabilities

  20. 24 CFR 886.107 - Approval of applications.

    Science.gov (United States)

    2010-04-01

    ...) The Owner's Affirmative Fair Housing Marketing Plan is approvable. (b) The HUD-approved unit rents are... climatic or geological conditions or local codes are examples which may justify such variations. (d) A... neighborhood in a substantially adverse manner. Examples of such adverse effects are (1) substantial move-outs...

  1. Alternative method for determining the constant offset in lidar signal

    Science.gov (United States)

    Vladimir A. Kovalev; Cyle Wold; Alexander Petkov; Wei Min Hao

    2009-01-01

    We present an alternative method for determining the total offset in lidar signal created by a daytime background-illumination component and electrical or digital offset. Unlike existing techniques, here the signal square-range-correction procedure is initially performed using the total signal recorded by lidar, without subtraction of the offset component. While...

  2. Authorization procedure for the construction and operation of nuclear installations within the EC Member States, including supervision and control

    International Nuclear Information System (INIS)

    Amaducci, Sandro; Didier, J.M.

    1978-01-01

    This report is an updating of the report EUR 5284, Authorization procedure for the construction and operation of nuclear installations within the EEC Member States, prepared in 1974 by J.M. Didier and Associates. Recent developments regarding the authorization procedure for the construction and operation of nuclear installations have taken place in Italy (introduction of a site approval procedure) and in Denmark (adoption of an overall legislation on the subject, however not yet in force). With respect to supervision and control of nuclear installations during construction and operation, competences of, as well as their exercise by, supervisory authorities in all EC Member States, with the exception of Ireland, are also analysed in the current study

  3. Alternative test method to assess the energy performance of frost-free refrigerating appliances

    International Nuclear Information System (INIS)

    Hermes, Christian J.L.; Melo, Cláudio; Knabben, Fernando T.

    2013-01-01

    This paper outlines an alternative test method to evaluate the energy consumption of frost-free refrigerators and freezers for residential applications. While the standardized methods require the refrigerating appliance to be kept running according to its onboard control system, which usually drives the refrigerator through an on–off cycling pattern, the proposed approach assesses the refrigerator energy performance in the steady-state regime, being therefore much faster and more reliable. In this procedure, the cooling capacity is matched to the cooling loads by PID-controlled electrical heaters installed within the refrigerated compartments, so that the compartment temperatures are kept at the desired standardized levels. Comparisons between the experimental results obtained using the steady-state energy test and the standardized procedures showed that the former follows closely the trends observed for the latter. - Highlights: ► An alternative test method to assess the energy consumption of refrigerators is proposed. ► PID-controlled electrical heaters were installed within the compartments. ► Steady-state and ISO energy tests were performed and compared. ► Both proposed and standardized test procedures showed similar trends.

  4. EFSA Panel on Biological Hazards (BIOHAZ); Scientific Opinion on the „Biomation‟ application for an alternative method for the treatment of animal-by-products

    DEFF Research Database (Denmark)

    Hald, Tine

    A method alternative to the ones already approved in the current legislation, called ‘Biomation’ process, for the treatment of Category (Cat.) 2 and 3 Animal By-Products (ABP) was assessed. The process consists of an alkaline treatment. The target parameters are: particle size ≤ 5mm, temperature 70...

  5. New Breast Cancer Treatment Approved | NIH MedlinePlus the Magazine

    Science.gov (United States)

    ... Breast Cancer Treatment Approved Follow us New Breast Cancer Treatment Approved Photo: Wikimedia Commons IN THE NEWS - Breast ... Food and Drug Administration approved a new breast cancer treatment that aims to reduce the risk of the ...

  6. Alternative Dispute Resolution as a form of protection of civil rights, freedoms and interests

    Directory of Open Access Journals (Sweden)

    Олег Степанович Ткачук

    2016-06-01

    Full Text Available The article is devoted to the problems of alternative civil dispute resolution and understanding of this phenomenon in western legal tradition and through the national paradigm of forms of protection of civil rights, freedoms and interests. The conception of “alternative dispute resolution” was analyzed by foreign and national scholars, such as M. Cappelletti, B. Garth, F. Sander, E. I. Nosyreva, O. M. Spektor, V. V. Komarov and others. The main objective of the paper is to analyse the essence of alternative dispute resolution as an order of protection and as a form of protection of civil rights. The author delimits such categories as order of protection and form of protection. From this point of view alternative dispute resolution is considered to be an independent form of protection of civil rights, freedoms and interests as well as judicial, administrative, notarial forms of protection and the protection in European court of human rights. As a result alternative dispute resolution can be understood as a form of protection of civil rights, freedoms and interests which consists of quasi-judicial and consensual methods of resolving civil disputes, based on voluntariness of treatment of persons, who was a participators of dispute, and voluntariness of enforcement of final decision of such procedure, which thought can be enforced coercively in a simplified procedure

  7. Judicial civil procedure dragging out in Kosovo

    Directory of Open Access Journals (Sweden)

    Rrustem Qehaja

    2016-03-01

    Full Text Available This article tends to deal with one of the most worrying issues in the judicial system of Kosovo the problem of judicial civil procedure dragging out. The article analyses the reasons of these dragging outs of the judicial civil procedure focusing on the context of one of the basic procedural principles in civil procedure-the principle of economy or efficiency in the courts. Dragging out of civil procedure in Kosovo has put in question not only the basic principles of civil procedure, but it also challenges the general principles related to human rights and freedoms sanctioned not only by the highest legal act of the country, but also with international treaties. The article tends to give a reflection to the most important reasons that effect and influence in these dragging outs of civil procedure, as well as, at the same time aims to give the necessary alternatives to pass through them by identifying dilemmas within the judicial practice. As a result, the motives of this scientific paper are exactly focused at the same time on identifying the dilemmas, as well as presenting ideas, to overstep them, including the judicial practice of the European Court of Human Rights on Article 6 of the European Convention on Human Rights, by which it is given the possibility to offering people efficient and within a reasonable time legal protection of their rights before national courts. For these reasons, the paper elaborates this issue based on both, the legal theory and judicial practice.

  8. FDA approves efavirenz. Food and Drug Administration.

    Science.gov (United States)

    Highleyman, L

    1998-10-01

    The Food and Drug Administration (FDA) approved DuPont Pharma's new non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (Sustiva, DMP-266). Efavirenz has shown promise in trials with over 2000 participants for up to 24 weeks, and early data suggests it may be as effective as protease inhibitors when used in a combination regimen. It is the first anti-HIV drug approved for once-daily dosing. Efavirenz is well tolerated, and the main side effects reported are dizziness, insomnia, abnormal dreams, and skin rash. Efavirenz has been approved for adults and children, but should not be used by pregnant women. Contact information is provided.

  9. Accelerated approval of oncology products: the food and drug administration experience.

    Science.gov (United States)

    Johnson, John R; Ning, Yang-Min; Farrell, Ann; Justice, Robert; Keegan, Patricia; Pazdur, Richard

    2011-04-20

    We reviewed the regulatory history of the accelerated approval process and the US Food and Drug Administration (FDA) experience with accelerated approval of oncology products from its initiation in December 11, 1992, to July 1, 2010. The accelerated approval regulations allowed accelerated approval of products to treat serious or life-threatening diseases based on surrogate endpoints that are reasonably likely to predict clinical benefit. Failure to complete postapproval trials to confirm clinical benefit with due diligence could result in removal of the accelerated approval indication from the market. From December 11, 1992, to July 1, 2010, the FDA granted accelerated approval to 35 oncology products for 47 new indications. Clinical benefit was confirmed in postapproval trials for 26 of the 47 new indications, resulting in conversion to regular approval. The median time between accelerated approval and regular approval of oncology products was 3.9 years (range = 0.8-12.6 years) and the mean time was 4.7 years, representing a substantial time savings in terms of earlier availability of drugs to cancer patients. Three new indications did not show clinical benefit when confirmatory postapproval trials were completed and were subsequently removed from the market or had restricted distribution plans implemented. Confirmatory trials were not completed for 14 new indications. The five longest intervals from receipt of accelerated approval to July 1, 2010, without completion of trials to confirm clinical benefit were 10.5, 6.4, 5.5, 5.5, and 4.7 years. The five longest intervals between accelerated approval and successful conversion to regular approval were 12.6, 9.7, 8.1, 7.5, and 7.4 years. Trials to confirm clinical benefit should be part of the drug development plan and should be in progress at the time of an application seeking accelerated approval to prevent an ineffective drug from remaining on the market for an unacceptable time.

  10. The Dyslexia Handbook: Procedures Concerning Dyslexia and Related Disorders = Manual sobre la dislexia: Procedimientos relacionados con la dislexia y otros desordenes.

    Science.gov (United States)

    Texas Education Agency, Austin.

    This handbook, available in English and Spanish, contains the Texas State Board of Education's approved procedures concerning dyslexia and related disorders and information regarding the state's dyslexia statutes and their relation to the federal Rehabilitation Act of 1973, Section 504, and the Individuals with Disabilities Education Act. Chapters…

  11. 48 CFR 1819.7203 - Mentor approval process.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Mentor approval process... ADMINISTRATION SOCIOECONOMIC PROGRAMS SMALL BUSINESS PROGRAMS NASA Mentor-Protégé Program 1819.7203 Mentor approval process. (a) An entity seeking to participate as a mentor must apply to the NASA Headquarters...

  12. Using the Multiple Choice Procedure to Measure College Student Gambling

    Science.gov (United States)

    Butler, Leon Harvey

    2010-01-01

    Research suggests that gambling is similar to addictive behaviors such as substance use. In the current study, gambling was investigated from a behavioral economics perspective. The Multiple Choice Procedure (MCP) with gambling as the target behavior was used to assess for relative reinforcing value, the effect of alternative reinforcers, and…

  13. [Reporting ethics board approval in German medical theses and journals].

    Science.gov (United States)

    Zenz, Michael; Zenz, Julia; Grieger, Maximilian

    2018-06-05

    Since 1975, the Declaration of Helsinki of the World Medical Association (WMA) has clearly required ethics committee approval for research into humans. Nevertheless, this Declaration is violated quite often. As many English-language publications have addressed the theme of ethics board approval in theses and other published works, it is now to be investigated in Germany for the first time.From 2013 to 2014, a total of 1,482 medical theses at four selected universities in addition to three German-language scientific journals were reviewed. In 543 theses, reference to ethics approval would have been required according to the criteria of the Declaration of Helsinki.However, ethics approval was stated in only 58.7% of cases, and even less frequently if the prevailing doctoral regulations or instructions did not refer to the necessity of obtaining ethics approval. Theses on pediatrics mentioned ethics approval most frequently (78.6%), whereas the proportion of surgical papers was the lowest (34.9%). Among the journals, Der Nervenarzt mentioned ethics approval most frequently (59.4%) and Der Chirurg least frequently (30%).Our results point to significant deficits in mentioning ethics approval in medical theses and publications. These deficits could easily be compensated for by a thorough approach of the referees of doctoral regulations and by journal reviewers and editors.

  14. An alternative procedure for direct generation of seismic floor spectra

    International Nuclear Information System (INIS)

    Singh, M.P.; Sharma, A.M.

    1983-01-01

    Several approaches have been developed for generation of floor spectra which do not require seismic inputs in the form of acceleration time histories but can use a prescribed set of ground response spectra directly. These approaches are often referred to as direct approaches. Most of these approaches are based on the method of mode displacement of structural dynamics. Some problems can, however, occur with these approaches if the response of a system is affected by the high frequency modes and if these modes are omitted from the analyses. Herein an alternative approach based on the method of mode acceleration is proposed wherein the effect of high frequency modes is correctly included without their explicit evaluation. The seismic inputs in this approach are required to be prescribed in terms of relative acceleration and velocity spectra. The approach is very effective for the calculation of floor spectra for structural systems which have significant contribution from high frequency modes, and also for floors close to the base which are usually affected by the higher modes. In other cases too, this approach has been shown to provide better results than the mode displacement approach for a given number of modes used in the analysis. Thus, a general use of this approach in lieu of the mode displacement approach is advocated. (orig.)

  15. The reform of the law on administrative procedure. Papers and discussions

    International Nuclear Information System (INIS)

    Bluemel, W.; Pitschas, R.

    1994-01-01

    Three particularly complex problem areas have been in top place of the seminar's agenda: First, there is the urgent need for standardisation of administrative procedure in view of the current splintering into subject area-specific variety, as proposed e.g. in the draft of the Code of Environmental Law, or probably to be laid down in a revision of plan approval legislation. The second problem cluster relates to the time factor which is of significance in procedures for certification of large-scale industrial projects with a bearing on the environment. The third topical problem addresses the evolution of modalities of administrative acts. The current situation is characterised by the need for further differentiation of administrative acts on the one hand, and the prerogative influence of EC Directives in the field of environmental protection and technology governing the modalities of enforcement available to the national administrative authorities [de

  16. 40 CFR 86.1823-01 - Durability demonstration procedures for exhaust emissions.

    Science.gov (United States)

    2010-07-01

    ...) Discussion of the manufacturer's in-use verification procedures including testing performed, vehicle... performed should also be documented in the manufacturer's submission. The in-use verification program shall...), the Alternate Service Accumulation Durability Program described in § 86.094-13(e) or the Standard Self...

  17. Conditioning procedure and color discrimination in the honeybee Apis mellifera

    Science.gov (United States)

    Giurfa, Martin

    We studied the influence of the conditioning procedure on color discrimination by free-flying honeybees. We asked whether absolute and differential conditioning result in different discrimination capabilities for the same pairs of colored targets. In absolute conditioning, bees were rewarded on a single color; in differential conditioning, bees were rewarded on the same color but an alternative, non-rewarding, similar color was also visible. In both conditioning procedures, bees learned their respective task and could also discriminate the training stimulus from a novel stimulus that was perceptually different from the trained one. Discrimination between perceptually closer stimuli was possible after differential conditioning but not after absolute conditioning. Differences in attention inculcated by these training procedures may underlie the different discrimination performances of the bees.

  18. 14 CFR 21.609 - Approval for deviation.

    Science.gov (United States)

    2010-01-01

    ... deviation. (a) Each manufacturer who requests approval to deviate from any performance standard of a TSO shall show that the standards from which a deviation is requested are compensated for by factors or... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Approval for deviation. 21.609 Section 21...

  19. Ordinal Position, Approval Motivation, and Interpersonal Attraction

    Science.gov (United States)

    Nowicki, Stephen, Jr.

    1971-01-01

    Results of the study suggest that birth-order effects might be included within the wider framework of approval-dependency theory. Females tend to account for a significant share of birth-order effects. More particularly, firstborn females accounted for much of the differences in expressed attraction as well as need for social approval. (Author)

  20. General Technical Approvals for Decentralised Sustainable Urban Drainage Systems (SUDS—The Current Situation in Germany

    Directory of Open Access Journals (Sweden)

    Carsten Dierkes

    2015-03-01

    Full Text Available The use of decentralised, sustainable urban drainage systems (SUDS for the treatment of stormwater runoff is becoming increasingly prevalent in Germany. Decentralised SUDS can offer a viable and attractive alternative to end of pipe treatment systems for stormwater runoff from urban areas. However, there is still some uncertainty regarding the long-term performance of SUDS, and the general legislative requirements for SUDS approval and testing. Whilst the allowable pollution levels in stormwater runoff that infiltrate into ground and/or water table are regulated across Germany by the Federal Soil Protection Law, there is presently no federal law addressing the discharge requirements for surface water runoff. The lack of clear guidance can make it difficult for planners and designers to implement these innovative and sustainable stormwater treatment systems. This study clarifies the current understanding of urban stormwater treatment requirements and new technical approval guidelines for decentralised SUDS devices in Germany. The study findings should assist researchers, designers and asset managers to better anticipate and understand the performance, effective life-spans, and the planning and maintenance requirements for decentralised SUDS systems. This should help promote even greater use of these systems in the future.